Immunogenicity and safety of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with DTPa vaccine in Japanese children: A randomized, controlled study.

PubMed

Iwata, Satoshi; Kawamura, Naohisa; Kuroki, Haruo; Tokoeda, Yasunobu; Miyazu, Mitsunobu; Iwai, Asayuki; Oishi, Tomohiro; Sato, Tomohide; Suyama, Akari; François, Nancy; Shafi, Fakrudeen; Ruiz-Guiñazú, Javier; Borys, Dorota

2015-01-01

This phase III, randomized, open-label, multicenter study (NCT01027845) conducted in Japan assessed the immunogenicity, safety, and reactogenicity of 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV, given intramuscularly) co-administered with diphtheria-tetanus-acellular pertussis vaccine (DTPa, given subcutaneously). Infants (N=360 ) were randomized (2:1) to receive either PHiD-CV and DTPa (PHiD-CV group) or DTPa alone (control group) as 3-dose primary vaccination (3-4-5 months of age) and booster vaccination (17-19 months of age). Immune responses were measured before and one month after primary/booster vaccination and adverse events (AEs) were recorded. Post-primary immune responses were non-inferior to those in pivotal/efficacy European or Latin American pneumococcal protein D-conjugate vaccine studies. For each PHiD-CV serotype, at least 92.6% of infants post-primary vaccination and at least 97.7% of children post-booster had pneumococcal antibody concentrations ≥0.2 μg/ml, and at least 95.4% post-primary and at least 98.1% post-booster had opsonophagocytic activity (OPA) titers ≥8 . Geometric mean antibody concentrations and OPA titers (except OPA titer for 6B) were higher post-booster than post-priming for each serotype. All PHiD-CV-vaccinated children had anti-protein D antibody concentrations ≥100 EL.U/ml one month post-primary/booster vaccination and all were seroprotected/seropositive against each DTPa antigen. Redness and irritability were the most common solicited AEs in both groups. Incidences of unsolicited AEs were comparable between groups. Serious AEs were reported for 47 children (28 in PHiD-CV group); none were assessed as vaccine-related. In conclusion, PHiD-CV induced robust immune responses and was well tolerated when co-administered with DTPa in a 3-dose priming plus booster regimen to Japanese children.

Immunogenicity and safety of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with DTPa vaccine in Japanese children: A randomized, controlled study

PubMed Central

Iwata, Satoshi; Kawamura, Naohisa; Kuroki, Haruo; Tokoeda, Yasunobu; Miyazu, Mitsunobu; Iwai, Asayuki; Oishi, Tomohiro; Sato, Tomohide; Suyama, Akari; François, Nancy; Shafi, Fakrudeen; Ruiz-Guiñazú, Javier; Borys, Dorota

2015-01-01

This phase III, randomized, open-label, multicenter study (NCT01027845) conducted in Japan assessed the immunogenicity, safety, and reactogenicity of 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV, given intramuscularly) co-administered with diphtheria-tetanus-acellular pertussis vaccine (DTPa, given subcutaneously). Infants (N=360 ) were randomized (2:1) to receive either PHiD-CV and DTPa (PHiD-CV group) or DTPa alone (control group) as 3-dose primary vaccination (3–4–5 months of age) and booster vaccination (17–19 months of age). Immune responses were measured before and one month after primary/booster vaccination and adverse events (AEs) were recorded. Post-primary immune responses were non-inferior to those in pivotal/efficacy European or Latin American pneumococcal protein D-conjugate vaccine studies. For each PHiD-CV serotype, at least 92.6% of infants post-primary vaccination and at least 97.7% of children post-booster had pneumococcal antibody concentrations ≥0.2 μg/ml, and at least 95.4% post-primary and at least 98.1% post-booster had opsonophagocytic activity (OPA) titers ≥8 . Geometric mean antibody concentrations and OPA titers (except OPA titer for 6B) were higher post-booster than post-priming for each serotype. All PHiD-CV-vaccinated children had anti-protein D antibody concentrations ≥100 EL.U/ml one month post-primary/booster vaccination and all were seroprotected/seropositive against each DTPa antigen. Redness and irritability were the most common solicited AEs in both groups. Incidences of unsolicited AEs were comparable between groups. Serious AEs were reported for 47 children (28 in PHiD-CV group); none were assessed as vaccine-related. In conclusion, PHiD-CV induced robust immune responses and was well tolerated when co-administered with DTPa in a 3-dose priming plus booster regimen to Japanese children. PMID:25830489

Effect of a multidisciplinary supportive program for family caregivers of patients with heart failure on caregiver burden, quality of life, and depression: A randomized controlled study.

PubMed

Hu, Xiaolin; Dolansky, Mary A; Su, Yonglin; Hu, Xiuying; Qu, Moying; Zhou, Lingjuan

2016-10-01

Caregivers of patients with heart failure experience burden and negative health outcomes. Adequate support for family caregivers improves their well-being and the quality of care provided to the patients. However, little is known about the benefits of interventions for caregivers of patients with heart failure in China. To test the effects of a multidisciplinary supportive program for family caregivers on caregiver burden, quality of life, and depression. A randomized controlled design with repeated measures was used in this study. A total of 118 participants were randomized into experimental (n=59) and control groups (n=59) from May to December 2014 in one hospital in Chengdu, People's Republic of China. Participants in the experimental group received a 3-month multidisciplinary supportive program, consisting of three 60-min sessions of group classes, three 30-min peer support groups, and regular telephone follow-ups and consultations, while participants in the control group received usual care only. Outcomes were caregiver burden, quality of life, and depression. Data were collected at baseline, post-test (3 months after discharge), and 3 months after post-test (6 months after discharge). The repeated measures analysis of variance was used to examine the effects of groups, changes over time, and time-group interaction on outcome variables. There were significant improvements in caregiver burden, mental health, and depression after post-test and 3 months after post-test in the experimental group. However, there was no significant improvement in caregivers' physical health at either 3 or 6 months following discharge. A multidisciplinary supportive program for caregivers of heart failure patients had positive effects and provides a unique perspective of an intervention considering Chinese culture and customs. Copyright © 2016 Elsevier Ltd. All rights reserved.

A Pilot Study on Telephone Cognitive Behavioral Therapy for Patients Six-Months Post-Bariatric Surgery

PubMed Central

Cassin, Stephanie E.; Wnuk, Susan; Du, Chau; Jackson, Timothy; Hawa, Raed; Parikh, Sagar V.

2017-01-01

Objective This study aimed to determine the feasibility and preliminary efficacy of a post-operative telephone-based cognitive behavioral therapy intervention (Tele-CBT) in improving eating pathology and psychosocial functioning. Methods Six-month post-operative bariatric surgery patients (n = 19) received six sessions of Tele-CBT. Study outcome variables included binge eating (BES), emotional eating (EES), depressive symptoms (PHQ-9), and anxiety symptoms (GAD-7). Results Retention was 73.7 % post-intervention. Tele-CBT resulted in significant reductions in mean difference scores on BES, EES-Total, EES-Anxiety, EES-Anger, PHQ9, and GAD7. Tele-CBT patients experienced a mean weight loss of 8.62 ± 15.02 kg between 6-months post-surgery (pre-Tele-CBT) and 12-months post-surgery. Conclusions These preliminary results suggest that post-surgery Tele-CBT is feasible and can improve post-surgery symptoms of psychopathology in this uncontrolled study, supporting the need for a randomized controlled trial. PMID:27491293

A prospective randomized clinical trial to investigate the effect of silicone gel sheeting (Cica-Care) on post-traumatic hypertrophic scar among the Chinese population.

PubMed

Li-Tsang, Cecilia W P; Lau, Joy C M; Choi, Jenny; Chan, Chetwyn C C; Jianan, Li

2006-09-01

This study aimed to determine the efficacy of silicone gel (Cica-Care) on severe post-traumatic hypertophic scars among the Chinese population. A randomized clinical trial (RCT) was conducted on 45 Chinese patients with post-traumatic hypertrophic scars. Twenty-two subjects were placed in the experimental group with silicone gel sheeting (SGS) applied 24h per day for 6 months while all subjects were taught to massage the scar daily for 15 min serving as the control intervention. Scar assessments were conducted regularly to measure the changes in thickness, pigmentation, vascularity, pliability, itchiness and pain. Two-way repeated ANOVA showed a significant difference between MT group and SGS group on scar thickness. The post hoc comparison analysis showed that the difference was significant at the post-2-month (p=0.008) and post-6-month (p<0.001) intervention. The SGS group also showed changes in pigmentation which resembled normal skin but no statistical significance was found. Pain, itchiness and pliability were also improved after intervention. This study indicated that silicone gel sheeting (Cica-Care) was effective to reduce thickness, pain, itchiness and pliability of the severe hypertrophic scar among the Chinese population. The moisturization effect of the tough and hard scar might contribute to the reduction of the skin thickness after 6 month's intervention.

Did you get any help? A post-hoc secondary analysis of a randomized controlled trial of psychoeducation for patients with antisocial personality disorder in outpatient substance abuse treatment programs.

PubMed

Thylstrup, Birgitte; Schrøder, Sidsel; Fridell, Mats; Hesse, Morten

2017-01-09

People in treatment for substance use disorder commonly have comorbid personality disorders, including antisocial personality disorder. Little is known about treatments that specifically address comorbid antisocial personality disorder. Self-rated help received for antisocial personality disorder was assessed during follow-ups at 3, 9 and 15 months post-randomization of a randomized trial of psychoeducation for people with comorbid substance use and antisocial personality disorder (n = 175). Randomization to psychoeducation was associated with increased perceived help for antisocial personality disorder. Perceived help for antisocial personality disorder was in turn associated with more days abstinent and higher treatment satisfaction at the 3-month follow-up, and reduced risk of dropping out of treatment after the 3-month follow-up, and perceived help mediated the effects of random assignment on days abstinent at 3-month. Brief psychoeducation for antisocial personality disorder increased patients' self-rated help for antisocial personality disorder in substance abuse treatment, and reporting having received help for antisocial personality disorder was in turn associated with better short-term outcomes, e.g., days abstinent, dropout from treatment and treatment satisfaction. ISRCTN registry, ISRCTN67266318 , retrospectively registered 17/7/2012.

The MANDELA study: A multicenter, randomized, open-label, parallel group trial to refine the use of everolimus after heart transplantation.

PubMed

Deuse, Tobias; Bara, Christoph; Barten, Markus J; Hirt, Stephan W; Doesch, Andreas O; Knosalla, Christoph; Grinninger, Carola; Stypmann, Jörg; Garbade, Jens; Wimmer, Peter; May, Christoph; Porstner, Martina; Schulz, Uwe

2015-11-01

In recent years a series of trials has sought to define the optimal protocol for everolimus-based immunosuppression in heart transplantation, with the goal of minimizing exposure to calcineurin inhibitors (CNIs) and harnessing the non-immunosuppressive benefits of everolimus. Randomized studies have demonstrated that immunosuppressive potency can be maintained in heart transplant patients receiving everolimus despite marked CNI reduction, although very early CNI withdrawal may be inadvisable. A potential renal advantage has been shown for everolimus, but the optimal time for conversion and the adequate reduction in CNI exposure remain to be defined. Other reasons for use of everolimus include a substantial reduction in the risk of cytomegalovirus infection, and evidence for inhibition of cardiac allograft vasculopathy, a major cause of graft loss. The ongoing MANDELA study is a 12-month multicenter, randomized, open-label, parallel-group study in which efficacy, renal function and safety are compared in approximately 200 heart transplant patients. Patients receive CNI therapy, steroids and everolimus or mycophenolic acid during months 3 to 6 post-transplant, and are then randomized at month 6 post-transplant (i) to convert to CNI-free immunosuppression with everolimus and mycophenolic acid or (ii) to continue reduced-exposure CNI, with concomitant everolimus. Patients are then followed to month 18 post-transplant The rationale and expectations for the trial and its methodology are described herein. Copyright © 2015 Elsevier Inc. All rights reserved.

Hyperbaric oxygen for post-concussive symptoms in United States military service members: a randomized clinical trial.

PubMed

Weaver, Lindell K; Wilson, Steffanie H; Lindblad, Anne S; Churchill, Susan; Deru, Kayla; Price, Robert C; Williams, Chris S; Orrison, William W; Walker, James M; Meehan, Anna; Mirow, Susan

2018-01-01

In prior military randomized trials, participants with persistent symptoms after mild traumatic brain injury (TBI) reported improvement regardless of receiving hyperbaric oxygen (HBO₂) or sham intervention. This study's objectives were to identify outcomes for future efficacy trials and describe changes by intervention. This Phase II, randomized, double-blind, sham-controlled trial enrolled military personnel with mild TBI and persistent post-concussive symptoms. Participants were randomized to receive 40 HBO₂ (1.5 atmospheres absolute (ATA), ⟩99% oxygen, 60 minutes) or sham chamber sessions (1.2 ATA, room air, 60 minutes) over 12 weeks. Participants and evaluators were blinded to allocation. Outcomes assessed at baseline, 13 weeks and six months included symptoms, quality of life, neuropsychological, neurological, electroencephalography, sleep, auditory, vestibular, autonomic, visual, neuroimaging, and laboratory testing. Participants completed 12-month questionnaires. Intention-to-treat results are reported. From 9/11/2012 to 5/19/2014, 71 randomized participants received HBO₂ (n=36) or sham (n=35). At baseline, 35 participants (49%) met post-traumatic stress disorder (PTSD) criteria. By the Neurobehavioral Symptom Inventory, the HBO₂ group had improved 13-week scores (mean change -3.6 points, P=0.03) compared to sham (+3.9 points). In participants with PTSD, change with HBO₂ was more pronounced (-8.6 vs. +4.8 points with sham, P=0.02). PTSD symptoms also improved in the HBO₂ group, and more so in the subgroup with PTSD. Improvements regressed at six and 12 months. Hyperbaric oxygen improved some cognitive processing speed and sleep measures. Participants with PTSD receiving HBO₂ had improved functional balance and reduced vestibular complaints at 13 weeks. By 13 weeks, HBO₂ improved post-concussive and PTSD symptoms, cognitive processing speed, sleep quality, and balance function, most dramatically in those with PTSD. Changes did not persist beyond six months. Several outcomes appeared sensitive to change; additional studies are warranted. Copyright© Undersea and Hyperbaric Medical Society.

Influence of Hip Abductor Strength on Functional Outcomes Before and After Total Knee Arthroplasty: Post Hoc Analysis of a Randomized Controlled Trial.

PubMed

Loyd, Brian J; Jennings, Jason M; Judd, Dana L; Kim, Raymond H; Wolfe, Pamela; Dennis, Douglas A; Stevens-Lapsley, Jennifer E

2017-09-01

Total knee arthroplasty (TKA) is associated with declines in hip abductor (HA) muscle strength; however, a longitudinal analysis demonstrating the influence of TKA on trajectories of HA strength change has not been conducted. The purpose of this study was to quantify changes in HA strength from pre-TKA through 3 months post-TKA and to characterize the relationship between HA strength changes and physical performance. This study is a post hoc analysis of a randomized controlled trial. Data from 162 participants (89 women, mean age = 63 y) were used for analysis. Data were collected by masked assessors preoperatively and at 1 and 3 months following surgery. Outcomes included: Timed "Up and Go" test (TUG), Stair Climbing Test (SCT), Six-Minute Walk Test (6MWT), and walking speed. Paired t tests were used for between- and within-limb comparisons of HA strength. Multivariable regression was used to determine contributions of independent variables, HA and knee extensor strength, to the dependent variables of TUG, SCT, 6MWT, and walking speed at each time point. Hip abductor strength was significantly lower in the surgical limb pre-TKA (mean = 0.015; 95% CI = 0.010-0.020), 1 month post-TKA (0.028; 0.023-0.034), and 3 months post-TKA (0.02; 0.014-0.025) compared with the nonsurgical limb. Hip abductor strength declined from pre-TKA to 1 month post-TKA (18%), but not at the 3-month time point (0%). Hip abductor strength independently contributed to performance-based outcomes pre-TKA; however, this contribution was not observed post-TKA. The post hoc analysis prevents examining all outcomes likely to be influenced by HA strength. Surgical limb HA strength is impaired prior to TKA, and worsens following surgery. Furthermore, HA strength contributes to performance-based outcomes, supporting the hypothesis that HA strength influences functional recovery. © 2017 American Physical Therapy Association

Promoting healthful family meals to prevent obesity: HOME Plus, a randomized controlled trial.

PubMed

Fulkerson, Jayne A; Friend, Sarah; Flattum, Colleen; Horning, Melissa; Draxten, Michelle; Neumark-Sztainer, Dianne; Gurvich, Olga; Story, Mary; Garwick, Ann; Kubik, Martha Y

2015-12-15

Family meal frequency has been shown to be strongly associated with better dietary intake; however, associations with weight status have been mixed. Family meals-focused randomized controlled trials with weight outcomes have not been previously conducted. Therefore, this study purpose was to describe weight-related outcomes of the HOME Plus study, the first family meals-focused randomized controlled trial to prevent excess weight gain among youth. Families (n = 160 8-12-year-old children and their parents/guardians) were randomized to intervention (n = 81) or control (n = 79) groups. Data were collected at baseline (2011-2012), post-intervention (12-months post-baseline) and follow-up (21-months post-baseline). The intervention included ten monthly group sessions (nutrition education; hands-on meal and snack planning, preparation, and skill development; screen time reductions) and five motivational, goal-setting phone calls. The main outcome was child body mass index (BMI) z-score. General linear models, adjusted for baseline values and demographics, showed no significant treatment group differences in BMI z-scores at post-intervention or follow-up; however, a promising reduction in excess weight gain was observed. Post-hoc stratification by pubertal onset indicated prepubescent children in the intervention group had significantly lower BMI z-scores than their control group counterparts. The study used a strong theoretical framework, rigorous design, quality measurement and a program with high fidelity to test a family meals-focused obesity prevention intervention. It showed a modest decrease in excess weight gain. The significant intervention effect among prepubescent children suggests the intervention may be more efficacious among relatively young children, although more research with appropriately powered samples are needed to replicate this finding. This study is registered at www.clinicaltrials.gov NCT01538615. Registered 01/17/2012.

Safety and immunogenicity of a booster dose of a 3-antigen Staphylococcus aureus vaccine (SA3Ag) in healthy adults: A randomized phase 1 study.

PubMed

Marshall, Helen; Nissen, Michael; Richmond, Peter; Shakib, Sepehr; Jiang, Qin; Cooper, David; Rill, Denise; Baber, James; Eiden, Joseph; Gruber, William C; Jansen, Kathrin U; Anderson, Annaliesa S; Zito, Edward T; Girgenti, Douglas

2016-11-01

A 2-stage, phase 1, randomized, placebo-controlled study in healthy adults to assess immunogenicity and safety of a booster dose at three dose levels of a 3-antigen Staphylococcus aureus vaccine (SA3Ag) containing recombinant clumping factor A (ClfA) and capsular polysaccharides 5 and 8 (CP5 and CP8) conjugated to a diphtheria toxoid. Six months after initial single vaccination, in Stage 2, SA3Ag recipients were randomized (1:1) to booster vaccination or placebo, while Stage 1 placebo recipients received placebo again. Pre- and post-vaccination blood samples were analyzed. In Stage 2 (n = 345), pre-booster CP5 and CP8 titers remained high with no increase post-booster. ClfA titers remained high after initial vaccination and increased post-booster, approaching the peak response to the initial dose. Post-booster local reactions were more frequent and of greater severity than reported after the initial vaccination, particularly for the high-dose level recipients. Post hoc analysis showed no dose-response pattern and no obvious association between diphtheria toxoid titers and local reactions after initial or booster vaccination. Immune responses after the initial vaccination persisted for the 12 months studied, with little additional response after the booster dose at 6 months. Post-booster injection site reactions were more frequent and more severe but self-limiting. CLINICALTRIALS. NCT01018641. Copyright © 2016 The British Infection Association. Published by Elsevier Ltd. All rights reserved.

A Randomized Trial of Peer-Delivered Self-Management Support for Hypertension

PubMed Central

Schapira, Marilyn M.; Fletcher, Kathlyn E.; Hayes, Avery; Morzinski, Jeffrey; Laud, Purushottam; Eastwood, Dan; Ertl, Kristyn; Patterson, Leslie; Mosack, Katie E.

2014-01-01

BACKGROUND Peer-led interventions to improve chronic disease self-management can improve health outcomes but are not widely used. Therefore, we tested a peer-led hypertension self-management intervention delivered at regular meetings of community veterans’ organizations. METHODS We randomized 58 organizational units (“posts”) of veterans’ organizations in southeast Wisconsin to peer-led vs. professionally delivered self-management education. Volunteer peer leaders at peer-led posts delivered monthly presentations regarding hypertension self-management during regular post meetings. Volunteer post representatives at seminar posts encouraged post members to attend 3 didactic seminars delivered by health professionals at a time separate from the post meeting. Volunteers in both groups encouraged members to self-monitor using blood pressure cuffs, weight scales, and pedometers. Our primary outcome was change in systolic blood pressure (SBP) at 12 months. RESULTS We measured SBP in 404 participants at baseline and in 379 participants at 12 months. SBP decreased significantly (4.4mm Hg; P < 0.0001) overall; the decrease was similar in peer-led and seminar posts (3.5mm Hg vs. 5.4mm Hg; P = 0.24). Among participants with uncontrolled BP at baseline, SBP decreased by 10.1mm Hg from baseline to 12 months but was again similar in the 2 groups. This pattern was also seen at 6 months and with diastolic blood pressure. CONCLUSIONS Our peer-led educational intervention was not more effective than didactic seminars for SBP control. Although peer-led educational programs have had important impacts in a number of studies, we did not find our intervention superior to a similar intervention delivered by healthcare professionals. Clinical trial registration ClinicalTrials.gov NCT00571038. PMID:24755206

Protocol for the Locomotor Experience Applied Post-stroke (LEAPS) trial: a randomized controlled trial

PubMed Central

Duncan, Pamela W; Sullivan, Katherine J; Behrman, Andrea L; Azen, Stanley P; Wu, Samuel S; Nadeau, Stephen E; Dobkin, Bruce H; Rose, Dorian K; Tilson, Julie K

2007-01-01

Background Locomotor training using body weight support and a treadmill as a therapeutic modality for rehabilitation of walking post-stroke is being rapidly adopted into clinical practice. There is an urgent need for a well-designed trial to determine the effectiveness of this intervention. The objective of the Locomotor Experience Applied Post-Stroke (LEAPS) trial is to determine if there is a difference in the proportion of participants who recover walking ability at one year post-stroke when randomized to a specialized locomotor training program (LTP), conducted at 2- or 6-months post-stroke, or those randomized to a home based non-specific, low intensity exercise intervention (HEP) provided 2 months post-stroke. We will determine if the timing of LTP delivery affects gait speed at 1 year and whether initial impairment severity interacts with the timing of LTP. The effect of number of treatment sessions will be determined by changes in gait speed taken pre-treatment and post-12, -24, and -36 sessions. Methods/Design We will recruit 400 adults with moderate or severe walking limitations within 30 days of stroke onset. At two months post stroke, participants are stratified by locomotor impairment severity as determined by overground walking speed and randomly assigned to one of three groups: (a) LTP-Early; (b) LTP-Late or (c) Home Exercise Program -Early. The LTP program includes body weight support on a treadmill and overground training. The LTP and HEP interventions are delivered for 36 sessions over 12 weeks. Primary outcome measure include successful walking recovery defined as the achievement of a 0.4 m/s gait speed or greater by persons with initial severe gait impairment or the achievement of a 0.8 m/s gait speed or greater by persons with initial moderate gait impairment. LEAPS is powered to detect a 20% difference in the proportion of participants achieving successful locomotor recovery between the LTP groups and the HEP group, and a 0.1 m/s mean difference in gait speed change between the two LTP groups. Discussion The goal of this single-blinded, phase III randomized clinical trial is to provide evidence to guide post-stroke walking recovery programs. Trial registration NCT00243919. PMID:17996052

Does self-efficacy mediate functional change in older adults participating in an exercise program after hip fracture? A randomized controlled trial.

PubMed

Chang, Feng-Hang; Latham, Nancy K; Ni, Pengsheng; Jette, Alan M

2015-06-01

To examine whether self-efficacy mediated the effect of the Home-based Post-Hip Fracture Rehabilitation program on activity limitations in older adults after hip fracture and whether the mediating effect was different between sex and age groups. Randomized controlled trial. Community. Participants with hip fracture (N=232; mean age ± SD, 79±9.4y) were randomly assigned to intervention (n=120, 51.7%) and attention control (n=112, 48.3%) groups. The 6-month intervention, the Home-based Post-Hip Fracture Rehabilitation, is a functionally oriented, home-based exercise program. Data were collected at baseline, postintervention (6mo), and follow-up (9mo). Activity Measure for Post-Acute Care. The mediating effect of the Home-based Post-Hip Fracture Rehabilitation program on Basic Mobility function through self-efficacy for exercise was significant at 9 months (βindirect=.21). Similarly, the mediating effect of the intervention on Daily Activity function through self-efficacy for exercise was significant at 9 months (βindirect=.49). In subgroup analyses, the mediating effect was significant at 9 months in the younger group (age, ≤79y) in comparison to the older group and was significant in women in comparison to men. Self-efficacy may play a partial mediating role in the effect on some longer-term functional outcomes in the Home-based Post-Hip Fracture Rehabilitation intervention. The results suggest that program components that target self-efficacy should be incorporated in future hip fracture rehabilitation interventions. Age and sex of the targeted participants may also need to be considered when developing interventions. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Transobturator TVT-O versus retropubic TVT: results of a multicenter randomized controlled trial at 24 months follow-up.

PubMed

Deffieux, Xavier; Daher, Nagib; Mansoor, Aslam; Debodinance, Philippe; Muhlstein, Joël; Fernandez, Hervé

2010-11-01

The purpose of this study is to compare the retropubic tension-free vaginal tape (TVT) procedure with the inside-out transobturator approach (TVT-O). Multicenter randomized controlled trial. One hundred forty-nine patients were randomly allocated to either TVT (n = 75) or TVT-O (n = 74). Interview, medical examination, pain scores, success rates, and quality of life assessment were recorded pre-operatively, and 2, 6, 12, and 24 months post-operatively. One hundred forty-nine patients underwent surgery, and 132 completed a 24-month follow-up. Bladder injury rate was 5% (4/75) in the TVT group and 2% (2/74) in the TVT-O group (p = 0.68). There was no significant difference between the two groups, concerning overall cure rate and the patients' satisfaction rate at 24 months follow-up. The range of mean pain scores was significantly higher after the TVT-O procedure post-operatively but not at 24 months follow-up. TVT and TVT-O procedures both have an outcome associated with an increase in quality of life with no significant differences in satisfaction rates at 2 years follow-up.

A Four-Session Sleep Intervention Program Improves Sleep for Older Adult Day Health Care Participants: Results of a Randomized Controlled Trial

PubMed Central

Song, Yeonsu; Hughes, Jaime; Jouldjian, Stella; Dzierzewski, Joseph M.; Fung, Constance H; Rodriguez Tapia, Juan Carlos; Mitchell, Michael N.; Alessi, Cathy A

2017-01-01

Abstract Study Objective To test the effectiveness of a 4-week behavioral Sleep Intervention Program (SIP: sleep compression, modified stimulus control, and sleep hygiene) compared to a 4-week information-only control (IC) among older adults attending a VA Adult Day Health Care (ADHC) program in a double-blind, randomized, clinical trial. Methods Forty-two individuals (mean age: 77 years, 93% male) enrolled in a VA ADHC program were randomized to receive SIP or IC. All completed in-person sleep and health assessments at baseline, post-treatment and 4-months follow-up that included 3 days/nights of wrist actigraphy, the Pittsburgh Sleep Quality Index (PSQI), and the Insomnia Severity Index (ISI). Mixed repeated measures analysis was used to compare sleep outcomes at post-treatment and 4-months follow-up, with baseline values as covariates. Results SIP participants (n = 21) showed significant improvement on actigraphy sleep efficiency (p = .007), number of nighttime awakenings (p = .016), and minutes awake at night (p = .001) at post-treatment, compared to IC participants (n = 21). Benefits were slightly attenuated but remained significant at 4-month follow-up (all p’s < .05). There were no differences in total sleep time between groups. There was significant improvement on PSQI factor 3 (daily disturbances) at 4-month follow-up (p = .016), but no differences were observed between SIP and IC on other PSQI components or ISI scores at post-treatment or 4-month follow-up. Conclusions A short behavioral sleep intervention may have important benefits in improving objectively measured sleep in older adults participating in ADHC. Future studies are needed to study implementation of this intervention into routine clinical care within ADHC. PMID:28482053

Randomized trial comparing caregiver-only family-focused treatment to standard health education on the 6-month outcome of bipolar disorder.

PubMed

Perlick, Deborah A; Jackson, Carlos; Grier, Savannah; Huntington, Brittney; Aronson, Andrew; Luo, Xiaodong; Miklowitz, David J

2018-03-12

Caregivers of people with bipolar disorder often have depression and health problems. This study aimed to evaluate the sustained effects of a 12-15 week psychoeducational intervention on the health and mental health of caregivers of persons with bipolar disorder. We also evaluated the effects of the intervention on patients' mood symptoms over 6 months post-treatment. Caregivers of 46 persons with bipolar disorder were randomized to 12-15 weeks of a caregiver-only adaptation of family-focused treatment (FFT), in which caregivers were instructed on self-care strategies and ways to assist the patient in managing the illness, or to 8-12 sessions of standard health education. Independent evaluators assessed caregivers' depression and physical health and patients' mood symptoms before treatment, immediately after the treatment, and at 6 months post-treatment. Randomization to FFT was associated with greater decreases in depression for both caregivers and patients over a 6-month follow-up period post-treatment. Reductions in patients' depression scores over 6 months post-treatment were mediated by reductions in caregivers' depression scores (z = -2.74, P < .01). Interventions that are effective in reducing mood symptoms and improving health behavior in caregivers may have important health and mental health benefits for patients with bipolar disorder. Specifically, a treatment focused on caregiver education about bipolar disorder and the need for the caregiver to attend to his/her own health and mental health can benefit patients, even without their direct participation. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Habit-based interventions for weight loss maintenance in adults with overweight and obesity: a randomized controlled trial.

PubMed

Cleo, Gina; Glasziou, Paul; Beller, Elaine; Isenring, Elisabeth; Thomas, Rae

2018-04-23

The objective of this study was to determine whether habit-based interventions are clinically beneficial in achieving long-term (12-month) weight loss maintenance and explore whether making new habits or breaking old habits is more effective. Volunteer community members aged 18-75 years who had overweight or obesity (BMI ≥ 25 kg/m 2 ) were randomized in a single-blind, three-arm, randomized controlled trial. Ten Top Tips (TTT), Do Something Different (DSD), and the attention-only waitlist (WL) control groups were conducted for 12 weeks from July to October 2015. Participants were followed up post-intervention (all groups) and at 6 and 12-month post-intervention (Ten Top Tips and Do Something Different only). The primary outcome was weight-loss maintenance at 12-month follow-up. Secondary outcomes included weight loss at all time points, fruit and vegetable consumption, exercise, wellbeing, depression, anxiety, habit strength, and openness to change. Of the 130 participants assessed for eligibility, 75 adults (mean BMI 34.5 kg/m 2 [SD 6.2]), with a mean age of 51 years were recruited. Assessments were completed post-intervention by 66/75 (88%) of participants and by 43/50 (86%) at 12 months. At post-intervention, participants in the Ten Top Tips (-3.3 kg; 95% CI -5.2, -1.4) and Do Something Different (-2.9 kg; 95% CI -4.3, -1.4) interventions lost significantly more weight (P = < .001) than those on the waitlist control (-0.4 kg; 95% CI -1.2, 0.3). Both intervention groups continued to lose further weight to the 12-month follow-up; TTT lost an additional -2.4 kg (95% CI -5.1, 0.4) and DSD lost -1.7 kg (95% CI -3.4, -0.1). At 12-month post-intervention, 28/43 (65%) of participants in both intervention groups had reduced their total body weight by ≥5%, a clinically important change. Habit-based weight-loss interventions-forming new habits (TTT) and breaking old habits (DSD), resulted in clinically important weight-loss maintenance at 12-month follow-up.

Randomized clinical trial of 270° posterior versus 180° anterior partial laparoscopic fundoplication for gastro-oesophageal reflux disease.

PubMed

Roks, D J; Koetje, J H; Oor, J E; Broeders, J A; Nieuwenhuijs, V B; Hazebroek, E J

2017-06-01

Partial fundoplications provide similar reflux control with fewer post-fundoplication symptoms compared with Nissen fundoplication for gastro-oesophageal reflux disease (GORD). The best choice of procedure for partial fundoplication remains unclear. The aim of this study was to compare the outcome of two different types of partial fundoplication for GORD. A double-blind RCT was conducted between 2012 and 2015 in two hospitals specializing in antireflux surgery. Patients were randomized to undergo either a laparoscopic 270° posterior fundoplication (Toupet) or a laparoscopic 180° anterior fundoplication. The primary outcome was postoperative dysphagia at 12 months, measured by the Dakkak score. Subjective outcome was analysed at 1, 3, 6 and 12 months after surgery. Objective reflux control was assessed before and 6 months after surgery. Ninety-four patients were randomized to laparoscopic Toupet or laparoscopic 180° anterior fundoplication (47 in each group). At 12 months, 85 patients (90 per cent) were available for follow-up. Objective scores were available for 76 (81 per cent). Postoperative Dakkak dysphagia score at 12 months was similar in the two groups (mean 5·9 for Toupet versus 6·4 for anterior fundoplication; P = 0·773). Subjective outcome at 12 months demonstrated no significant differences in control of reflux or post-fundoplication symptoms. Overall satisfaction and willingness to undergo surgery did not differ between the groups. Postoperative endoscopy and 24-h pH monitoring showed no significant differences in mean oesophageal acid exposure time or recurrent pathological oesophageal acid exposure. Both types of partial fundoplication provided similar control of GORD at 12 months, with no difference in post-fundoplication symptoms. Registration number: NTR5702 (www.trialregister.nl). © 2017 BJS Society Ltd Published by John Wiley & Sons Ltd.

A randomized clinical trial of methadone maintenance for prisoners: findings at 6 months post-release.

PubMed

Gordon, Michael S; Kinlock, Timothy W; Schwartz, Robert P; O'Grady, Kevin E

2008-08-01

This study examined the effectiveness of methadone maintenance initiated prior to or just after release from prison at 6 months post-release. A three-group randomized controlled trial was conducted between September 2003 and June 2005. A Baltimore pre-release prison. Two hundred and eleven adult pre-release inmates who were heroin-dependent during the year prior to incarceration. Participants were assigned randomly to the following: counseling only: counseling in prison, with passive referral to treatment upon release (n = 70); counseling + transfer: counseling in prison with transfer to methadone maintenance treatment upon release (n = 70); and counseling + methadone: methadone maintenance and counseling in prison, continued in a community-based methadone maintenance program upon release (n = 71). Addiction Severity Index at study entry and follow-up. Additional assessments at 6 months post-release were treatment record review; urine drug testing for opioids, cocaine and other illicit drugs. Counseling + methadone participants were significantly more likely than both counseling only and counseling + transfer participants to be retained in drug abuse treatment (P = 0.0001) and significantly less likely to have an opioid-positive urine specimen compared to counseling only (P = 0.002). Furthermore, counseling + methadone participants reported significantly fewer days of involvement in self-reported heroin use and criminal activity than counseling only participants. Methadone maintenance, initiated prior to or immediately after release from prison, increases treatment entry and reduces heroin use at 6 months post-release compared to counseling only. This intervention may be able to fill an urgent treatment need for prisoners with heroin addiction histories.

Randomized Trial of Vitamin C/E Complex for Prevention of Radiation-Induced Xerostomia in Patients with Head and Neck Cancer.

PubMed

Chung, Man Ki; Kim, Do Hun; Ahn, Yong Chan; Choi, Joon Young; Kim, Eun Hye; Son, Young-Ik

2016-09-01

The present study was conducted to determine the preventive efficacy of vitamin C/E complex supplementation for radiotherapy (RT)-induced xerostomia in patients with head and neck cancer. Prospective, double-blinded, randomized, placebo-controlled study. A single tertiary referral institution. The trial group (n = 25) received antioxidant supplements (100 IU of vitamin E + 500 mg of vitamin C) twice per day during RT, while the control group (n = 20) received an identical placebo. Pre-RT and 1 and 6 months post-RT, patient-reported xerostomia questionnaires, observer-rated xerostomia score, and salivary scintigraphy were serially obtained to compare xerostomia severity between the 2 groups. The trial group showed greater improvements in xerostomia questionnaire and score at 6 months post-RT when compared with those at 1 month post-RT (P = .007 and .008, respectively). In contrast, the control group showed no changes between 1 and 6 months post-RT. By salivary scintigraphy, there was no difference in maximal accumulation or ejection fraction between the 2 groups. However, the trial group maintained significantly better oral indices at the prestimulatory (P = .01) and poststimulatory (P = .009) stages at 1 month post-RT, compared with the control group. At the final follow-up, there was no difference in overall survival and disease-free survival between the 2 groups. Our data suggest that short-term supplementation with an antioxidant vitamin E/C complex exerts a protective effect against RT-induced xerostomia. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2016.

A randomized trial of peer-delivered self-management support for hypertension.

PubMed

Whittle, Jeff; Schapira, Marilyn M; Fletcher, Kathlyn E; Hayes, Avery; Morzinski, Jeffrey; Laud, Purushottam; Eastwood, Dan; Ertl, Kristyn; Patterson, Leslie; Mosack, Katie E

2014-11-01

Peer-led interventions to improve chronic disease self-management can improve health outcomes but are not widely used. Therefore, we tested a peer-led hypertension self-management intervention delivered at regular meetings of community veterans' organizations. We randomized 58 organizational units ("posts") of veterans' organizations in southeast Wisconsin to peer-led vs. professionally delivered self-management education. Volunteer peer leaders at peer-led posts delivered monthly presentations regarding hypertension self-management during regular post meetings. Volunteer post representatives at seminar posts encouraged post members to attend 3 didactic seminars delivered by health professionals at a time separate from the post meeting. Volunteers in both groups encouraged members to self-monitor using blood pressure cuffs, weight scales, and pedometers. Our primary outcome was change in systolic blood pressure (SBP) at 12 months. We measured SBP in 404 participants at baseline and in 379 participants at 12 months. SBP decreased significantly (4.4mm Hg; P < 0.0001) overall; the decrease was similar in peer-led and seminar posts (3.5mm Hg vs. 5.4mm Hg; P = 0.24). Among participants with uncontrolled BP at baseline, SBP decreased by 10.1mm Hg from baseline to 12 months but was again similar in the 2 groups. This pattern was also seen at 6 months and with diastolic blood pressure. Our peer-led educational intervention was not more effective than didactic seminars for SBP control. Although peer-led educational programs have had important impacts in a number of studies, we did not find our intervention superior to a similar intervention delivered by healthcare professionals. ClinicalTrials.gov NCT00571038. © Published by Oxford University Press on behalf of American Journal of Hypertension Ltd 2014. This work is written by (a) US Government employees(s) and is in the public domain in the US.

Randomized Controlled Trial of BASICS for Heavy Drinking Mandated and Volunteer Undergraduates: 12-Month Outcomes

PubMed Central

Terlecki, Meredith A.; Buckner, Julia D.; Larimer, Mary E.; Copeland, Amy L.

2014-01-01

This is the first randomized trial testing whether heavy drinking undergraduates mandated to the Brief Alcohol Screening and Intervention for College Students (BASICS) program following a campus alcohol violation would benefit as much as heavy drinking volunteers up to one year post-intervention using control groups with high-risk drinkers to model disciplinary-related and naturalistic changes in drinking. Participants (61% male; 51% mandated; 84% Caucasian; Mage = 20.14 years) were screened for heavy drinking and randomized to BASICS (n = 115) or assessment-only control (n = 110). Outcome measures (drinking, alcohol problems) were collected at baseline, 4 weeks, 3, 6, and 12 months post-intervention. At 4 weeks post-intervention, intent-to-treat multilevel longitudinal models showed that regardless of referral group (mandated or volunteer) BASICS significantly decreased weekly drinking, typical drinks, and peak drinks relative to controls (ds = .41-.92). BASICS had a large effect on decreases in alcohol problems (d = .87). At 12 months post-intervention, BASICS participants (regardless of referral group) reported significantly fewer alcohol problems (d = .56) compared to controls. Significant long-term intervention gains for peak and typical drinks were sustained in both referral groups relative to controls (ds = .42; .11). Referral group had no significant main effect and did not interact with intervention condition to predict outcomes. Given that BASICS was associated with less drinking and fewer alcohol problems (even among heavier drinking mandated students up to one year post-intervention), provision of BASICS-style programs within disciplinary settings may help reduce heavy and problematic drinking among at-risk students. PMID:25844834

The effects of gait retraining in runners with patellofemoral pain: A randomized trial.

PubMed

Roper, Jenevieve L; Harding, Elizabeth M; Doerfler, Deborah; Dexter, James G; Kravitz, Len; Dufek, Janet S; Mermier, Christine M

2016-06-01

Running popularity has increased resulting in a concomitant increase in running-related injuries with patellofemoral pain most commonly reported. The purpose of this study was to determine whether gait retraining by modifying footstrike patterns from rearfoot strike to forefoot strike reduces patellofemoral pain and improves associated biomechanical measures, and whether the modification influences risk of ankle injuries. Sixteen subjects (n=16) were randomly placed in the control (n=8) or experimental (n=8) group. The experimental group performed eight gait retraining running sessions over two weeks where footstrike pattern was switched from rearfoot strike to forefoot strike, while the control group performed running sessions with no intervention. Variables were recorded pre-, post-, and one-month post-running trials. Knee pain was significantly reduced post-retraining (P<0.05; effect size=0.294) and one-month follow-up (P<0.05; effect size=0.294). Knee abduction was significantly improved post-retraining (P<0.05; effect size=0.291) and one-month follow-up (P<0.05; effect size=0.291). Ankle flexion was significantly different post-retraining (P<0.05; effect size=0.547), as well as ankle range of motion post-retraining (P<0.05; effect size=0.425) and one-month follow-up (P<0.05; effect size=0.425). Findings suggest running with a forefoot strike pattern leads to reduced knee pain, and should be considered a possible strategy for management of patellofemoral pain in recreational runners. This trial is registered at the US National Institutes of Health (clinicaltrials.gov) #NCT02567123. Published by Elsevier Ltd.

Basic life support knowledge of secondary school students in cardiopulmonary resuscitation training using a song.

PubMed

Fonseca Del Pozo, Francisco Javier; Valle Alonso, Joaquin; Canales Velis, Nancy Beatriz; Andrade Barahona, Mario Miguel; Siggers, Aidan; Lopera, Elisa

2016-07-20

To examine the effectiveness of a "cardiopulmonary resuscitation song" in improving the basic life support skills of secondary school students. This pre-test/post-test control design study enrolled secondary school students from two middle schools randomly chosen in Córdoba, Andalucia, Spain. The study included 608 teenagers. A random sample of 87 students in the intervention group and 35 in the control group, aged 12-14 years were selected. The intervention included a cardiopulmonary resuscitation song and video. A questionnaire was conducted at three-time points: pre-intervention, one month and eight months post-intervention. On global knowledge of cardiopulmonary resuscitation, there were no significant differences between the intervention group and the control group in the trial pre-intervention and at the month post-intervention. However, at 8 months there were significant differences with a p-value = 0.000 (intervention group, 95% CI: 6.39 to 7.13 vs. control group, 95% CI: 4.75 to 5.92), F(1,120)=16.644, p=0.000). In addition, significant differences about students' basic life support knowledge about chest compressions at eight months post-intervention (F(1,120)=15.561, p=0.000) were found. Our study showed that incorporating the song component in the cardiopulmonary resuscitation teaching increased its effectiveness and the ability to remember the cardiopulmonary resuscitation algorithm. Our study highlights the need for different methods in the cardiopulmonary resuscitation teaching to facilitate knowledge retention and increase the number of positive outcomes after sudden cardiac arrest.

Selective prevention of combat-related post-traumatic stress disorder using attention bias modification training: a randomized controlled trial.

PubMed

Wald, I; Fruchter, E; Ginat, K; Stolin, E; Dagan, D; Bliese, P D; Quartana, P J; Sipos, M L; Pine, D S; Bar-Haim, Y

2016-09-01

Efficacy of pre-trauma prevention for post-traumatic stress disorder (PTSD) has not yet been established in a randomized controlled trial. Attention bias modification training (ABMT), a computerized intervention, is thought to mitigate stress-related symptoms by targeting disruptions in threat monitoring. We examined the efficacy of ABMT delivered before combat in mitigating risk for PTSD following combat. We conducted a double-blind, four-arm randomized controlled trial of 719 infantry soldiers to compare the efficacy of eight sessions of ABMT (n = 179), four sessions of ABMT (n = 184), four sessions of attention control training (ACT; n = 180), or no-training control (n = 176). Outcome symptoms were measured at baseline, 6-month follow-up, 10 days following combat exposure, and 4 months following combat. Primary outcome was PTSD prevalence 4 months post-combat determined in a clinical interview using the Clinician-Administered PTSD Scale. Secondary outcomes were self-reported PTSD and depression symptoms, collected at all four assessments. PTSD prevalence 4 months post-combat was 7.8% in the no-training control group, 6.7% with eight-session ABMT, 2.6% with four-session ABMT, and 5% with ACT. Four sessions of ABMT reduced risk for PTSD relative to the no-training condition (odds ratio 3.13, 95% confidence interval 1.01-9.22, p < 0.05, number needed to treat = 19.2). No other between-group differences were found. The results were consistent across a variety of analytic techniques and data imputation approaches. Four sessions of ABMT, delivered prior to combat deployment, mitigated PTSD risk following combat exposure. Given its low cost and high scalability potential, and observed number needed to treat, research into larger-scale applications is warranted. The ClinicalTrials.gov identifier is NCT01723215.

Thought Field Therapy Compared to Cognitive Behavioral Therapy and Wait-List for Agoraphobia: A Randomized, Controlled Study with a 12-Month Follow-up.

PubMed

Irgens, Audun C; Hoffart, Asle; Nysæter, Tor E; Haaland, Vegard Ø; Borge, Finn-Magnus; Pripp, Are H; Martinsen, Egil W; Dammen, Toril

2017-01-01

Background: Thought field therapy (TFT) is used for many psychiatric conditions, but its efficacy has not been sufficiently documented. Hence, there is a need for studies comparing TFT to well-established treatments. This study compares the efficacy of TFT and cognitive behavioral therapy (CBT) for patients with agoraphobia. Methods: Seventy-two patients were randomized to CBT ( N = 24), TFT ( N = 24) or a wait-list condition (WLC) ( N = 24) after a diagnostic procedure including the MINI PLUS that was performed before treatment or WLC. Following a 3 months waiting period, the WL patients were randomized to CBT ( n = 12) or TFT ( n = 12), and all patients were reassessed after treatment or waiting period and at 12 months follow-up. At first we compared the three groups CBT, TFT, and WL. After the post WL randomization, we compared CBT ( N = 12 + 24 = 36) to TFT ( N = 12 + 24 = 36), applying the pre-treatment scores as baseline for all patients. The primary outcome measure was a symptom score from the Anxiety Disorders Interview Scale that was performed by an interviewer blinded to the treatment condition. For statistical comparisons, we used the independent sample's t -test, the Fisher's exact test and the ANOVA and ANCOVA tests. Results: Both CBT and TFT showed better results than the WLC ( p < 0.001) at post-treatment. Post-treatment and at the 12-month follow-up, there were not significant differences between CBT and TFT ( p = 0.33 and p = 0.90, respectively). Conclusion: This paper reports the first study comparing TFT to CBT for any disorder. The study indicated that TFT may be an efficient treatment for patients with agoraphobia. Trial Registration: https://clinicaltrials.gov/, identifier NCT00932919.

Thought Field Therapy Compared to Cognitive Behavioral Therapy and Wait-List for Agoraphobia: A Randomized, Controlled Study with a 12-Month Follow-up

PubMed Central

Irgens, Audun C.; Hoffart, Asle; Nysæter, Tor E.; Haaland, Vegard Ø.; Borge, Finn-Magnus; Pripp, Are H.; Martinsen, Egil W.; Dammen, Toril

2017-01-01

Background: Thought field therapy (TFT) is used for many psychiatric conditions, but its efficacy has not been sufficiently documented. Hence, there is a need for studies comparing TFT to well-established treatments. This study compares the efficacy of TFT and cognitive behavioral therapy (CBT) for patients with agoraphobia. Methods: Seventy-two patients were randomized to CBT (N = 24), TFT (N = 24) or a wait-list condition (WLC) (N = 24) after a diagnostic procedure including the MINI PLUS that was performed before treatment or WLC. Following a 3 months waiting period, the WL patients were randomized to CBT (n = 12) or TFT (n = 12), and all patients were reassessed after treatment or waiting period and at 12 months follow-up. At first we compared the three groups CBT, TFT, and WL. After the post WL randomization, we compared CBT (N = 12 + 24 = 36) to TFT (N = 12 + 24 = 36), applying the pre-treatment scores as baseline for all patients. The primary outcome measure was a symptom score from the Anxiety Disorders Interview Scale that was performed by an interviewer blinded to the treatment condition. For statistical comparisons, we used the independent sample’s t-test, the Fisher’s exact test and the ANOVA and ANCOVA tests. Results: Both CBT and TFT showed better results than the WLC (p < 0.001) at post-treatment. Post-treatment and at the 12-month follow-up, there were not significant differences between CBT and TFT (p = 0.33 and p = 0.90, respectively). Conclusion: This paper reports the first study comparing TFT to CBT for any disorder. The study indicated that TFT may be an efficient treatment for patients with agoraphobia. Trial Registration: https://clinicaltrials.gov/, identifier NCT00932919. PMID:28676782

Rapid Re-Infection with Soil-Transmitted Helminths after Triple-Dose Albendazole Treatment of School-Aged Children in Yunnan, People's Republic of China

PubMed Central

Yap, Peiling; Du, Zun-Wei; Wu, Fang-Wei; Jiang, Jin-Yong; Chen, Ran; Zhou, Xiao-Nong; Hattendorf, Jan; Utzinger, Jürg; Steinmann, Peter

2013-01-01

Post-treatment soil-transmitted helminth re-infection patterns were studied as part of a randomized controlled trial among school-aged children from an ethnic minority group in Yunnan province, People's Republic of China. Children with a soil-transmitted helminth infection (N = 194) were randomly assigned to triple-dose albendazole or placebo and their infection status monitored over a 6-month period using the Kato-Katz and Baermann techniques. Baseline prevalence of Trichuris trichiura, Ascaris lumbricoides, hookworm, and Strongyloides stercoralis were 94.5%, 93.3%, 61.3%, and 3.1%, respectively, with more than half of the participants harboring triple-species infections. For the intervention group (N = 99), the 1-month post-treatment cure rates were 96.7%, 91.5%, and 19.6% for hookworm, A. lumbricoides, and T. trichiura, respectively. Egg reduction rates were above 88% for all three species. Rapid re-infection with A. lumbricoides was observed: the prevalence 4 and 6 months post-treatment was 75.8% and 83.8%, respectively. Re-infection with hookworm and T. trichiura was considerably slower. PMID:23690551

Prospective randomized clinical trial of a change in gastric emptying and nutritional status after a pylorus-preserving pancreaticoduodenectomy: comparison between an antecolic and a vertical retrocolic duodenojejunostomy.

PubMed

Imamura, Naoya; Chijiiwa, Kazuo; Ohuchida, Jiro; Hiyoshi, Masahide; Nagano, Motoaki; Otani, Kazuhiro; Kondo, Kazuhiro

2014-04-01

Although an antecolic duodenojejunostomy was reported to reduce post-operative delayed gastric emptying (DGE) compared with a retrocolic duodenojejunostomy after a pylorus-preserving pancreaticoduodenectomy (PPPD), the long-term effects of these procedures have rarely been studied. The aim of this prospective, randomized, clinical trial was to investigate the influence of the reconstruction route on post-operative gastric emptying and nutrition. Reconstruction was performed in 116 patients with an antecolic duodenojejunostomy (A group, n = 58) or a vertical retrocolic duodenojejunostomy (VR group, n = 58). Post-operative complications, including DGE, gastric emptying variables assessed by (13) C-acetate breath test and nutrition, were compared between the two groups for 1 year post-operatively. The incidence of DGE was not significantly different between the procedures (A group: 12.1%; VR group: 20.7%, P = 0.316). At post-operative month 1, gastric emptying was prolonged in the VR versus the A group but not significantly so. At post-operative month 6, gastric emptying was accelerated significantly in the A versus the VR group. Post-operative weight recovery was significantly better in the VR versus the A group at post-operative month 12 (percentage of pre-operative weight, A group: 93.8 ± 1.2%; VR group: 98.5 ± 1.3%, P = 0.015). A vertical retrocolic duodenojejunostomy was an acceptable procedure for the lower incidence of DGE and may contribute to better weight gain affected by moderate gastric emptying. © 2013 International Hepato-Pancreato-Biliary Association.

Prospective randomized clinical trial of a change in gastric emptying and nutritional status after a pylorus-preserving pancreaticoduodenectomy: comparison between an antecolic and a vertical retrocolic duodenojejunostomy

PubMed Central

Imamura, Naoya; Chijiiwa, Kazuo; Ohuchida, Jiro; Hiyoshi, Masahide; Nagano, Motoaki; Otani, Kazuhiro; Kondo, Kazuhiro

2014-01-01

Background Although an antecolic duodenojejunostomy was reported to reduce post-operative delayed gastric emptying (DGE) compared with a retrocolic duodenojejunostomy after a pylorus-preserving pancreaticoduodenectomy (PPPD), the long-term effects of these procedures have rarely been studied. The aim of this prospective, randomized, clinical trial was to investigate the influence of the reconstruction route on post-operative gastric emptying and nutrition. Methods Reconstruction was performed in 116 patients with an antecolic duodenojejunostomy (A group, n = 58) or a vertical retrocolic duodenojejunostomy (VR group, n = 58). Post-operative complications, including DGE, gastric emptying variables assessed by 13C-acetate breath test and nutrition, were compared between the two groups for 1 year post-operatively. Results The incidence of DGE was not significantly different between the procedures (A group: 12.1%; VR group: 20.7%, P = 0.316). At post-operative month 1, gastric emptying was prolonged in the VR versus the A group but not significantly so. At post-operative month 6, gastric emptying was accelerated significantly in the A versus the VR group. Post-operative weight recovery was significantly better in the VR versus the A group at post-operative month 12 (percentage of pre-operative weight, A group: 93.8 ± 1.2%; VR group: 98.5 ± 1.3%, P = 0.015). Conclusions A vertical retrocolic duodenojejunostomy was an acceptable procedure for the lower incidence of DGE and may contribute to better weight gain affected by moderate gastric emptying. PMID:23991719

Adolescent Abstinence and Unprotected Sex in CyberSenga, an Internet-Based HIV Prevention Program: Randomized Clinical Trial of Efficacy

PubMed Central

Ybarra, Michele L.; Bull, Sheana S.; Prescott, Tonya L.; Korchmaros, Josephine D.; Bangsberg, David R.; Kiwanuka, Julius P.

2013-01-01

Context Cost-effective, scalable programs are urgently needed in countries deeply affected by HIV. Methods This parallel-group RCT was conducted in four secondary schools in Mbarara, Uganda. Participants were 12 years and older, reported past-year computer or Internet use, and provided informed caregiver permission and youth assent. The intervention, CyberSenga, was a five-hour online healthy sexuality program. Half of the intervention group was further randomized to receive a booster at four-months post-intervention. The control arm received ‘treatment as usual’ (i.e., school-delivered sexuality programming). The main outcome measures were: 1) condom use and 2) abstinence in the past three months at six-months' post-intervention. Secondary outcomes were: 1) condom use and 2) abstinence at three-month's post-intervention; and 6-month outcomes by booster exposure. Analyses were intention to treat. Results All 416 eligible youth were invited to participate, 88% (n = 366) of whom enrolled. Participants were randomized to the intervention (n = 183) or control (n = 183) arm; 91 intervention participants were further randomized to the booster. No statistically significant results were noted among the main outcomes. Among the secondary outcomes: At three-month follow-up, trends suggested that intervention participants (81%) were more likely to be abstinent than control participants (74%; p = 0.08), and this was particularly true among youth who were abstinent at baseline (88% vs. 77%; p = 0.02). At six-month follow-up, those in the booster group (80%) reported higher rates of abstinence than youth in the intervention, no booster (57%) and control (55%) groups (p = 0.15); they also reported lower rates of unprotected sex (5%) compared to youth in the intervention, no booster (24%) and control (21%) groups (p = 0.21) among youth sexually active at baseline. Conclusions The CyberSenga program may affect HIV preventive behavior among abstinent youth in the short term and, with the booster, may also promote HIV preventive behavior among sexually active youth in the longer term. Trial Registration NCT00906178. PMID:23967069

Home-based neurologic music therapy for arm hemiparesis following stroke: results from a pilot, feasibility randomized controlled trial.

PubMed

Street, Alexander J; Magee, Wendy L; Bateman, Andrew; Parker, Michael; Odell-Miller, Helen; Fachner, Jorg

2018-01-01

To assess the feasibility of a randomized controlled trial to evaluate music therapy as a home-based intervention for arm hemiparesis in stroke. A pilot feasibility randomized controlled trial, with cross-over design. Randomization by statistician using computer-generated, random numbers concealed in opaque envelopes. Participants' homes across Cambridgeshire, UK. Eleven people with stroke and arm hemiparesis, 3-60 months post stroke, following discharge from community rehabilitation. Each participant engaged in therapeutic instrumental music performance in 12 individual clinical contacts, twice weekly for six weeks. Feasibility was estimated by recruitment from three community stroke teams over a 12-month period, attrition rates, completion of treatment and successful data collection. Structured interviews were conducted pre and post intervention to establish participant tolerance and preference. Action Research Arm Test and Nine-hole Peg Test data were collected at weeks 1, 6, 9, 15 and 18, pre and post intervention by a blinded assessor. A total of 11 of 14 invited participants were recruited (intervention n = 6, waitlist n = 5). In total, 10 completed treatment and data collection. It cannot be concluded whether a larger trial would be feasible due to unavailable data regarding a number of eligible patients screened. Adherence to treatment, retention and interview responses might suggest that the intervention was motivating for participants. ClinicalTrials.gov identifier NCT 02310438.

A Four-Session Sleep Intervention Program Improves Sleep for Older Adult Day Health Care Participants: Results of a Randomized Controlled Trial.

PubMed

Martin, Jennifer L; Song, Yeonsu; Hughes, Jaime; Jouldjian, Stella; Dzierzewski, Joseph M; Fung, Constance H; Rodriguez Tapia, Juan Carlos; Mitchell, Michael N; Alessi, Cathy A

2017-08-01

To test the effectiveness of a 4-week behavioral Sleep Intervention Program (SIP: sleep compression, modified stimulus control, and sleep hygiene) compared to a 4-week information-only control (IC) among older adults attending a VA Adult Day Health Care (ADHC) program in a double-blind, randomized, clinical trial. Forty-two individuals (mean age: 77 years, 93% male) enrolled in a VA ADHC program were randomized to receive SIP or IC. All completed in-person sleep and health assessments at baseline, post-treatment and 4-months follow-up that included 3 days/nights of wrist actigraphy, the Pittsburgh Sleep Quality Index (PSQI), and the Insomnia Severity Index (ISI). Mixed repeated measures analysis was used to compare sleep outcomes at post-treatment and 4-months follow-up, with baseline values as covariates. SIP participants (n = 21) showed significant improvement on actigraphy sleep efficiency (p = .007), number of nighttime awakenings (p = .016), and minutes awake at night (p = .001) at post-treatment, compared to IC participants (n = 21). Benefits were slightly attenuated but remained significant at 4-month follow-up (all p's < .05). There were no differences in total sleep time between groups. There was significant improvement on PSQI factor 3 (daily disturbances) at 4-month follow-up (p = .016), but no differences were observed between SIP and IC on other PSQI components or ISI scores at post-treatment or 4-month follow-up. A short behavioral sleep intervention may have important benefits in improving objectively measured sleep in older adults participating in ADHC. Future studies are needed to study implementation of this intervention into routine clinical care within ADHC. Published by Oxford University Press on behalf of Sleep Research Society (SRS) 2017. This work is written by (a) US Government employee(s) and is in the public domain in the US.

Attention bias modification augments cognitive-behavioral group therapy for social anxiety disorder: a randomized controlled trial.

PubMed

Lazarov, Amit; Marom, Sofi; Yahalom, Naomi; Pine, Daniel S; Hermesh, Haggai; Bar-Haim, Yair

2017-12-20

Cognitive-behavioral group therapy (CBGT) is a first-line treatment for social anxiety disorder (SAD). However, since many patients remain symptomatic post-treatment, there is a need for augmenting procedures. This randomized controlled trial (RCT) examined the potential augmentation effect of attention bias modification (ABM) for CBGT. Fifty patients with SAD from three therapy groups were randomized to receive an 18-week standard CBGT with either ABM designed to shift attention away from threat (CBGT + ABM), or a placebo protocol not designed to modify threat-related attention (CBGT + placebo). Therapy groups took place in a large mental health center. Clinician and self-report measures of social anxiety and depression were acquired pre-treatment, post-treatment, and at 3-month follow-up. Attention bias was assessed at pre- and post-treatment. Patients randomized to the CBGT + ABM group, relative to those randomized to the CBGT + placebo group, showed greater reductions in clinician-rated SAD symptoms post-treatment, with effects maintained at 3-month follow-up. Group differences were not evident for self-report or attention-bias measures, with similar reductions in both groups. Finally, reduction in attention bias did not mediate the association between group and reduction in Liebowitz Social Anxiety Scale Structured Interview (LSAS) scores. This is the first RCT to examine the possible augmenting effect of ABM added to group-based cognitive-behavioral therapy for adult SAD. Training patients' attention away from threat might augment the treatment response to standard CBGT in SAD, a possibility that could be further evaluated in large-scale RCTs.

A pragmatic randomized controlled trial to evaluate the effectiveness of a facilitated exercise intervention as a treatment for postnatal depression: the PAM-PeRS trial.

PubMed

Daley, A J; Blamey, R V; Jolly, K; Roalfe, A K; Turner, K M; Coleman, S; McGuinness, M; Jones, I; Sharp, D J; MacArthur, C

2015-08-01

Postnatal depression affects about 10-15% of women in the year after giving birth. Many women and healthcare professionals would like an effective and accessible non-pharmacological treatment for postnatal depression. Women who fulfilled the International Classification of Diseases (ICD)-10 criteria for major depression in the first 6 months postnatally were randomized to receive usual care plus a facilitated exercise intervention or usual care only. The intervention involved two face-to-face consultations and two telephone support calls with a physical activity facilitator over 6 months to support participants to engage in regular exercise. The primary outcome was symptoms of depression using the Edinburgh Postnatal Depression Scale (EPDS) at 6 months post-randomization. Secondary outcomes included EPDS score as a binary variable (recovered and improved) at 6 and 12 months post-randomization. A total of 146 women were potentially eligible and 94 were randomized. Of these, 34% reported thoughts of self-harming at baseline. After adjusting for baseline EPDS, analyses revealed a -2.04 mean difference in EPDS score, favouring the exercise group [95% confidence interval (CI) -4.11 to 0.03, p = 0.05]. When also adjusting for pre-specified demographic variables the effect was larger and statistically significant (mean difference = -2.26, 95% CI -4.36 to -0.16, p = 0.03). Based on EPDS score a larger proportion of the intervention group was recovered (46.5% v. 23.8%, p = 0.03) compared with usual care at 6 months follow-up. This trial shows that an exercise intervention that involved encouragement to exercise and to seek out social support to exercise may be an effective treatment for women with postnatal depression, including those with thoughts of self-harming.

Cognitive therapy as an early treatment for post-traumatic stress disorder in children and adolescents: a randomized controlled trial addressing preliminary efficacy and mechanisms of action.

PubMed

Meiser-Stedman, Richard; Smith, Patrick; McKinnon, Anna; Dixon, Clare; Trickey, David; Ehlers, Anke; Clark, David M; Boyle, Adrian; Watson, Peter; Goodyer, Ian; Dalgleish, Tim

2017-05-01

Few efficacious early treatments for post-traumatic stress disorder (PTSD) in children and adolescents exist. Previous trials have intervened within the first month post-trauma and focused on secondary prevention of later post-traumatic stress; however, considerable natural recovery may still occur up to 6-months post-trauma. No trials have addressed the early treatment of established PTSD (i.e. 2- to 6-months post-trauma). Twenty-nine youth (8-17 years) with PTSD (according to age-appropriate DSM-IV or ICD-10 diagnostic criteria) after a single-event trauma in the previous 2-6 months were randomly allocated to Cognitive Therapy for PTSD (CT-PTSD; n = 14) or waiting list (WL; n = 15) for 10 weeks. Significantly more participants were free of PTSD after CT-PTSD (71%) than WL (27%) at posttreatment (intent-to-treat, 95% CI for difference .04-.71). CT-PTSD yielded greater improvement on child-report questionnaire measures of PTSD, depression and anxiety; clinician-rated functioning; and parent-reported outcomes. Recovery after CT-PTSD was maintained at 6- and 12-month posttreatment. Beneficial effects of CT-PTSD were mediated through changes in appraisals and safety-seeking behaviours, as predicted by cognitive models of PTSD. CT-PTSD was considered acceptable on the basis of low dropout and high treatment credibility and therapist alliance ratings. This trial provides preliminary support for the efficacy and acceptability of CT-PTSD as an early treatment for PTSD in youth. Moreover, the trial did not support the extension of 'watchful waiting' into the 2- to 6-month post-trauma window, as significant improvements in the WL arm (particularly in terms of functioning and depression) were not observed. Replication in larger samples is needed, but attention to recruitment issues will be required. © 2016 The Authors. Journal of Child Psychology and Psychiatry published by John Wiley & Sons Ltd on behalf of Association for Child and Adolescent Mental Health.

Balance and Gait Training With Augmented Feedback Improves Balance Confidence in People With Parkinson's Disease: A Randomized Controlled Trial.

PubMed

Shen, Xia; Mak, Margaret K Y

2014-07-01

Background Fear of falling has been identified as an important and independent fall-risk predictor in patients with Parkinson's disease (PD). However, there are inconsistent findings on the effects of balance and gait training on balance confidence. Objective To explore whether balance and gait training with augmented feedback can enhance balance confidence in PD patients immediately after treatment and at 3- and 12-month follow-ups. Methods A total of 51 PD patients were randomly assigned to a balance and gait training (BAL) group or to an active control (CON) group. The BAL group received balance and gait training with augmented feedback, whereas CON participants received lower-limb strength training for 12 weeks. Outcome measures included Activities-Specific Balance Confidence (ABC) Scale, limits-of-stability test, single-leg-stance test, and spatiotemporal gait characteristics. All tests were administered before intervention (Pre), immediately after training (Post), and at 3 months (Post3m) and 12 months (Post12m) after treatment completion. Results The ABC score improved marginally at Post and significantly at Post3m and Post12m only in the BAL group (P < .017). Both participant groups increased their end point excursion at Post, but only the BAL group maintained the improvement at Post3m. The BAL group maintained significantly longer time-to-loss-of-balance during the single-leg stance test than the CON group at Post3m and Post12m (P < .05). For gait characteristics, both participant groups increased gait velocity, but only the BAL group increased stride length at Post, Post3m, and Post12m (P < .017). Conclusions Positive findings from this study provide evidence that BAL with augmented feedback could enhance balance confidence and balance and gait performance in patients with PD. © The Author(s) 2014.

Hyperbaric oxygen for mild traumatic brain injury: Design and baseline summary.

PubMed

Weaver, Lindell K; Chhoeu, Austin; Lindblad, Anne S; Churchill, Susan; Wilson, Steffanie H

2016-01-01

The Brain Injury and Mechanisms of Action of Hyperbaric Oxygen for Persistent Post-Concussive Symptoms after Mild Traumatic Brain Injury (mTBI) (BIMA) study, sponsored by the Department of Defense, is a randomized double-blind, sham-controlled clinical trial that has a longer duration of follow-up and more comprehensive assessment battery compared to recent HBO₂ studies. BIMA randomized 71 participants from September 2012 to May 2014. Primary results are expected in 2017. Randomized military personnel received hyperbaric oxygen (HBO₂) at 1.5 atmospheres absolute (ATA) or sham chamber sessions at 1.2 ATA, air, for 60 minutes daily for 40 sessions. Outcomes include neuropsychological, neuroimaging, neurological, vestibular, autonomic function, electroencephalography, and visual systems evaluated at baseline, immediately following intervention at 13 weeks and six months with self-report symptom and quality of life questionnaires at 12 months, 24 months and 36 months. Characteristics include: median age 33 years (range 21-53); 99% male; 82% Caucasian; 49% diagnosed post-traumatic stress disorder; 28% with most recent injury three months to one year prior to enrollment; 32% blast injuries; and 73% multiple injuries. This manuscript describes the study design, outcome assessment battery, and baseline characteristics. Independent of a therapeutic role of HBO₂, results of BIMA will aid understanding of mTBI. ClinicalTrials.gov Identifier: NCT01611194; https://clinicaltrials.gov/show/NCT01611194. Copyright© Undersea and Hyperbaric Medical Society.

Effect of 1% sodium alendronate in the non-surgical treatment of periodontal intraosseous defects: a 6-month clinical trial

PubMed Central

DUTRA, Bernardo Carvalho; OLIVEIRA, Alcione Maria Soares Dutra; OLIVEIRA, Peterson Antônio Dutra; MANZI, Flavio Ricardo; CORTELLI, Sheila Cavalca; COTA, Luís Otávio de Miranda; COSTA, Fernando Oliveira

2017-01-01

Abstract Background and objectives Few studies have evaluated the effect of the topical application of sodium alendronate (ALN) on the treatment of intrabuccal bone defects, especially those caused by periodontitis. This 6-month randomized placebo controlled clinical trial aimed at evaluating the effect of non-surgical periodontal treatment associated with the use of 1% ALN, through clinical evaluations and cone-beam computed tomography (CBCT). Material and Methods Twenty individuals with chronic periodontitis underwent periodontal examination at the baseline as well as 3 and 6 months after periodontal treatment, registering clinical attachment level (CAL), periodontal probing depth (PPD), and bleeding on probing (BOP) as the clinical outcomes. After manual scaling and root planing, 40 bilateral sites with interproximal vertical bone defects were randomly treated with either 1% ALN gel or a placebo. Bone defects were evaluated through CBCT at the baseline and 6 months post-treatment. The clinical and CBCT parameters were compared using the Wilcoxon and Friedman tests (p<0.05). Results Although ALN produced a greater CAL gain when compared to the placebo at 6 months post-treatment (p=0.021), both treatments produced similar effects on the PPD, BOP, and bone height. Significant differences in bone fill were observed only in patients of the ALN group (4.5 to 3.8 mm; p=0.003) at 6 months post-treatment. Conclusions Topical application of 1% ALN might be a beneficial adjuvant to non-surgical periodontal therapy. PMID:28678950

Boy Scout 5-a-day badge: Outcome results of a troop and internet intervention

USDA-ARS?s Scientific Manuscript database

The effects of a Boy Scout Five-A-Day Badge program on fruit-juice (FJ) and low fat vegetable (LV) consumption were evaluated using a two-condition (treatment, active-attention placebo-control) group randomized trial, with 3 data collection periods (baseline, immediate post, 6-month post). Forty-two...

Effects of Brief Psychoeducational Program on Stigma in Malaysian Pre-clinical Medical Students: A Randomized Controlled Trial.

PubMed

Fernandez, Aaron; Tan, Kit-Aun; Knaak, Stephanie; Chew, Boon How; Ghazali, Sazlina Shariff

2016-12-01

If presented with serious mental illness (SMI), individuals' low help-seeking behaviors and poor adherence to treatment are associated with negative stereotypes and attitudes of healthcare providers. In this study, we examined the effects of a brief psychoeducational program on reducing stigma in pre-clinical medical students. One hundred and two pre-clinical medical students (20-23 years old) were randomly assigned to face-to-face contact + educational lecture (n = 51) condition or video-based contact + educational lecture (n = 51) condition. Measures of pre-clinical medical students' mental illness-related stigma using the Opening Minds Stigma Scale for Health Care Providers (OMS-HC) were administered at pre-, post-treatment, and 1-month follow-up. A 2 (condition: face-to-face contact + educational lecture, video-based contact + educational lecture) by 3 (time: pre-treatment, post-treatment, and 1-month follow-up) mixed model MANOVA was conducted on the Attitudes, Disclosure and Help-Seeking, and Social Distance OMS-HC subscales. Participants' scores on all subscales changed significantly across time, regardless of conditions. To determine how participants' scores changed significantly over time on each subscale, Bonferroni follow-up comparisons were performed to access pairwise differences for the main effect of time. Specifically, pairwise comparisons produced a significant reduction in Social Distance subscale between pre-treatment and post-treatment and between pre-treatment and 1-month follow-up, and a significant increase between post-treatment and 1-month follow-up, regardless of conditions. With respect to the Attitudes and Disclosure and Help-Seeking subscales, pairwise comparisons produced a significant reduction in scores between pre-treatment and post-treatment and a significant increase between post-treatment and 1-month follow-up. Our findings provide additional evidence that educational lecture on mental illness, coupled with either face-to-face contact or video-based contact, is predictive of positive outcomes in anti-stigma programs targeting future healthcare providers.

Telephone Problem Solving for Service Members with Mild Traumatic Brain Injury: A Randomized, Clinical Trial.

PubMed

Bell, Kathleen R; Fann, Jesse R; Brockway, Jo Ann; Cole, Wesley R; Bush, Nigel E; Dikmen, Sureyya; Hart, Tessa; Lang, Ariel J; Grant, Gerald; Gahm, Gregory; Reger, Mark A; St De Lore, Jef; Machamer, Joan; Ernstrom, Karin; Raman, Rema; Jain, Sonia; Stein, Murray B; Temkin, Nancy

2017-01-15

Mild traumatic brain injury (mTBI) is a common injury for service members in recent military conflicts. There is insufficient evidence of how best to treat the consequences of mTBI. In a randomized, clinical trial, we evaluated the efficacy of telephone-delivered problem-solving treatment (PST) on psychological and physical symptoms in 356 post-deployment active duty service members from Joint Base Lewis McChord, Washington, and Fort Bragg, North Carolina. Members with medically confirmed mTBI sustained during deployment to Iraq and Afghanistan within the previous 24 months received PST or education-only (EO) interventions. The PST group received up to 12 biweekly telephone calls from a counselor for subject-selected problems. Both groups received 12 educational brochures describing common mTBI and post-deployment problems, with follow-up for all at 6 months (end of PST), and at 12 months. At 6 months, the PST group significantly improved on a measure of psychological distress (Brief Symptom Inventory; BSI-18) compared to the EO group (p = 0.005), but not on post-concussion symptoms (Rivermead Post-Concussion Symptoms Questionnaire [RPQ]; p = 0.19), the two primary endpoints. However, these effects did not persist at 12-month follow-up (BSI, p = 0.54; RPQ, p = 0.45). The PST group also had significant short-term improvement on secondary endpoints, including sleep (p = 0.01), depression (p = 0.03), post-traumatic stress disorder (p = 0.04), and physical functioning (p = 0.03). Participants preferred PST over EO (p < 0.001). Telephone-delivered PST appears to be a well-accepted treatment that offers promise for reducing psychological distress after combat-related mTBI and could be a useful adjunct treatment post-mTBI. Further studies are required to determine how to sustain its effects. (Trial registration: ClinicalTrials.gov Identifier: NCT01387490 https://clinicaltrials.gov ).

Incidence of chronic groin pain following open mesh inguinal hernia repair, and effect of elective division of the ilioinguinal nerve: meta-analysis of randomized controlled trials.

PubMed

Charalambous, M P; Charalambous, C P

2018-06-01

Chronic post-operative groin pain is a substantial complication following open mesh inguinal hernia repair. The exact cause of this pain is still unclear, but entrapment or trauma of the ilioinguinal nerve may have a role to play. Elective division of this nerve during hernia repair has been proposed in an attempt to reduce the incidence of chronic groin pain. We performed a meta-analysis of nine randomized controlled trials comparing preservation versus elective division of the ilioinguinal nerve during this operation. A substantial proportion of patients having open mesh inguinal hernia repair experience chronic groin pain when the ilioinguinal nerve is preserved (estimated rate of 9.4% at 6 months and 4.8% at 1 year). Elective division of the nerve resulted in a significant reduction of groin pain at 6-months post-surgery (RR 0.47, p = 0.02), including moderate/severe pain (RR 0.57, p = 0.01). However, division of the nerve also resulted in an increase of subjective groin numbness at this time point (RR 1.55, p = 0.06). At 12-month post-surgery, the beneficial effect of nerve division on chronic pain was reduced, with no significant difference in the rates of overall groin pain (RR 0.69, p = 0.38), or of moderate-to-severe groin pain (RR 0.99, p = 0.98) between the two groups. The prevalence of groin numbness was also similar between the two groups at 12-month post-surgery (RR 0.79, p = 0.48). Routine elective division of the ilioinguinal nerve during open mesh inguinal hernia repair does not significantly reduce chronic groin pain beyond 6 months, and may result in increased rates of groin numbness, especially in the first 6-months post-surgery.

Randomized Clinical Trial of Motivational Enhancement of Substance Use Treatment among Incarcerated Adolescents: Post-Release Condom Non-Use

ERIC Educational Resources Information Center

Rosengard, Cynthia; Stein, L. A. R.; Barnett, Nancy P.; Monti, Peter M.; Golembeske, Charles; Lebeau-Craven, Rebecca; Miranda, Robert

2007-01-01

Evaluated impact of motivational enhancement (ME) of substance abuse treatment compared to relaxation training (RT) on sex without condoms (overall and involving substance use) 3 months following release among incarcerated adolescents. This randomized clinical trial involved 114 incarcerated adolescents from the Northeast. Regression analyses…

Reduced Reward-driven Eating Accounts for the Impact of a Mindfulness-Based Diet and Exercise Intervention on Weight Loss: Data from the SHINE Randomized Controlled Trial

PubMed Central

Mason, Ashley E.; Epel, Elissa S.; Aschbacher, Kirstin; Lustig, Robert H.; Acree, Michael; Kristeller, Jean; Cohn, Michael; Dallman, Mary; Moran, Patricia J.; Bacchetti, Peter; Laraia, Barbara; Hecht, Frederick M.; Daubenmier, Jennifer

2016-01-01

Many individuals with obesity report overeating despite intentions to maintain or lose weight. Two barriers to long-term weight loss are reward-driven eating, which is characterized by a lack of control over eating, a preoccupation with food, and a lack of satiety; and psychological stress. Mindfulness training may address these barriers by promoting awareness of hunger and satiety cues, self-regulatory control, and stress reduction. We examined these two barriers as potential mediators of weight loss in the Supporting Health by Integrating Nutrition and Exercise (SHINE) randomized controlled trial, which compared the effects of a 5.5-month diet and exercise intervention with or without mindfulness training on weight loss among adults with obesity. Intention-to-treat multiple mediation models tested whether post-intervention reward-driven eating and psychological stress mediated the impact of intervention arm on weight loss at 12-and 18-months post-baseline among 194 adults with obesity (BMI: 30–45). Mindfulness (relative to control) participants had significant reductions in reward-driven eating at 6 months (post-intervention), which, in turn, predicted weight loss at 12 months. Post-intervention reward-driven eating mediated 47.1% of the total intervention arm effect on weight loss at 12 months [β=-0.06, SE(β)=0.03, p=.030, 95% CI (−0.12, −0.01)]. This mediated effect was reduced when predicting weight loss at 18 months (p=.396), accounting for 23.0% of the total intervention effect, despite similar weight loss at 12 months. Psychological stress did not mediate the effect of intervention arm on weight loss at 12 or 18 months. In conclusion, reducing reward-driven eating, which can be achieved using a diet and exercise intervention that includes mindfulness training, may promote weight loss (clinicaltrials.gov registration: NCT00960414). PMID:26867697

Reduced reward-driven eating accounts for the impact of a mindfulness-based diet and exercise intervention on weight loss: Data from the SHINE randomized controlled trial.

PubMed

Mason, Ashley E; Epel, Elissa S; Aschbacher, Kirstin; Lustig, Robert H; Acree, Michael; Kristeller, Jean; Cohn, Michael; Dallman, Mary; Moran, Patricia J; Bacchetti, Peter; Laraia, Barbara; Hecht, Frederick M; Daubenmier, Jennifer

2016-05-01

Many individuals with obesity report over eating despite intentions to maintain or lose weight. Two barriers to long-term weight loss are reward-driven eating, which is characterized by a lack of control over eating, a preoccupation with food, and a lack of satiety; and psychological stress. Mindfulness training may address these barriers by promoting awareness of hunger and satiety cues, self-regulatory control, and stress reduction. We examined these two barriers as potential mediators of weight loss in the Supporting Health by Integrating Nutrition and Exercise (SHINE) randomized controlled trial, which compared the effects of a 5.5-month diet and exercise intervention with or without mindfulness training on weight loss among adults with obesity. Intention-to-treat multiple mediation models tested whether post-intervention reward-driven eating and psychological stress mediated the impact of intervention arm on weight loss at 12- and 18-months post-baseline among 194 adults with obesity (BMI: 30-45). Mindfulness (relative to control) participants had significant reductions in reward-driven eating at 6 months (post-intervention), which, in turn, predicted weight loss at 12 months. Post-intervention reward-driven eating mediated 47.1% of the total intervention arm effect on weight loss at 12 months [β = -0.06, SE(β) = 0.03, p = .030, 95% CI (-0.12, -0.01)]. This mediated effect was reduced when predicting weight loss at 18 months (p = .396), accounting for 23.0% of the total intervention effect, despite similar weight loss at 12 months. Psychological stress did not mediate the effect of intervention arm on weight loss at 12 or 18 months. In conclusion, reducing reward-driven eating, which can be achieved using a diet and exercise intervention that includes mindfulness training, may promote weight loss (clinicaltrials.gov registration: NCT00960414). Published by Elsevier Ltd.

Post-Discharge Care of Pediatric Traumatic Brain Injury in Argentina: A Multi-Center Randomized Controlled Trial

PubMed Central

Carney, Nancy A.; Petroni, Gustavo J.; Luján, Silvia B.; Ballarini, Nicolás M.; Faguaga, Gabriela A.; du Coudray, Hugo E. M.; Huddleston, Amy E.; Baggio, Gloria M.; Becerra, Juan M.; Busso, Leonardo O.; Dikmen, Sureyya S.; Falcone, Roberto; García, Mirta E.; Carrillo, Osvaldo R. González; Medici, Paula L.; Quaglino, Marta B.; Randisi, Carina A.; Sáenz, Silvia S.; Temkin, Nancy R.; Vanella, Elida E.

2016-01-01

Objective To develop, in partnership with families of children with traumatic brain injury (TBI), a post-discharge intervention that is effective, simple and sustainable. Design Randomized Controlled Trial Setting Seven Level 1 Pediatric Trauma Centers in Argentina. Patients Persons less than 19 years of age admitted to one of the study hospitals with a diagnosis of severe, moderate, or complicated mild TBI, and were discharged alive. Interventions Patients were randomly assigned to either the Intervention or Standard Care group. A specially trained Community Resource Coordinator (CRC) was assigned to each family in the Intervention group. We hypothesized that children with severe, moderate, and complicated mild TBI who received the intervention would have significantly better functional outcomes at 6-months post-discharge than those who received standard care. We further hypothesized there would be a direct correlation between patient outcome and measures of family function. Measurements and Main Results The primary outcome measure was a composite measured at 6-months post-injury. There were 308 patients included in the study; 61% male. Forty-four percent sustained a complicated mild TBI, 18% moderate, and 38% severe. Sixty-five percent of the patients were 8 years old or younger, and over 70% were transported to the hospital without ambulance assistance. There was no significant difference between groups on the primary outcome measure. There was a statistically significant correlation between the primary outcome measure and scores on the Family Impact Module of the PedsQL (ρ= 0.57; p < 0.0001). Children with better outcomes lived with families reporting better function at 6-months post-injury. Conclusions While no significant effect of the intervention was demonstrated, this study represents the first conducted in Latin America that documents the complete course of treatment for pediatric patients with TBI spanning hospital transport through hospital care and into the post-discharge setting. PMID:27243414

Mindfulness-based resilience training to reduce health risk, stress reactivity, and aggression among law enforcement officers: A feasibility and preliminary efficacy trial.

PubMed

Christopher, Michael S; Hunsinger, Matthew; Goerling, Lt Richard J; Bowen, Sarah; Rogers, Brant S; Gross, Cynthia R; Dapolonia, Eli; Pruessner, Jens C

2018-06-01

The primary objective of this study was to assess feasibility and gather preliminary outcome data on Mindfulness-Based Resilience Training (MBRT) for law enforcement officers. Participants (n = 61) were randomized to either an 8-week MBRT course or a no intervention control group. Self-report and physiological data were collected at baseline, post-training, and three months following intervention completion. Attendance, adherence, post-training participant feedback, and interventionist fidelity to protocol all demonstrated feasibility of MBRT for law enforcement officers. Compared to no intervention controls, MBRT participants experienced greater reductions in salivary cortisol, self-reported aggression, organizational stress, burnout, sleep disturbance, and reported increases in psychological flexibility and non-reactivity at post-training; however, group differences were not maintained at three-month follow-up. This initial randomized trial suggests MBRT is a feasible intervention. Outcome data suggest MBRT targets key physiological, psychological, and health risk factors in law enforcement officers, consistent with the potential to improve officer health and public safety. However, follow-up training or "booster" sessions may be needed to maintain training gains. A fully powered longitudinal randomized trial is warranted. Copyright © 2018 Elsevier B.V. All rights reserved.

IMPACT OF SCHOOL-BASED HIV PREVENTION PROGRAM IN POST-CONFLICT LIBERIA

PubMed Central

Atwood, Katharine A.; Kennedy, Stephen B.; Shamblen, Steve; Tegli, Jemee; Garber, Salome; Fahnbulleh, Pearl W.; Korvah, Prince M.; Kolubah, Moses; Mulbah-Kamara, Comfort; Fulton, Shannon

2013-01-01

This paper presents findings of a feasibility study to adapt and evaluate the impact of an evidence-based HIV prevention intervention on sexual risk behaviors of in-school 6th grade youth in post-conflict Liberia (n = 812). The study used an attention-matched, group randomized controlled trial. Four matched pairs of elementary/middle schools in Monrovia, Liberia, were randomly assigned to either an adapted eight-module HIV prevention or a general health curriculum. Three- and nine-month impacts of the intervention on sexual risk behaviors and on mediating variables are presented. The intervention significantly impacted protective peer norms and positive condom attitudes and increased frequency of condom use at the nine-month follow-up. The intervention did not impact sexual initiation or multiple sex partnerships. Future intervention research should address the salient pressures that are unique to post-conflict settings and include longer follow-up time periods and smaller class sizes to meaningfully impact sexual initiation and multiple sex partnerships. PMID:22339146

Immunogenicity, reactogenicity and safety of 2 doses of an adjuvanted herpes zoster subunit vaccine administered 2, 6 or 12 months apart in older adults: Results of a phase III, randomized, open-label, multicenter study.

PubMed

Lal, Himal; Poder, Airi; Campora, Laura; Geeraerts, Brecht; Oostvogels, Lidia; Vanden Abeele, Carline; Heineman, Thomas C

2018-01-02

In phase III trials, 2 doses of a herpes zoster (HZ) subunit vaccine (HZ/su; 50 µg varicella-zoster virus glycoprotein E [gE] and AS01 B Adjuvant System) administered 2-months apart in older adults (≥50 and ≥70 years) demonstrated >90% efficacy in preventing HZ and had a clinically acceptable safety profile. Here we report immunogenicity, reactogenicity and safety following administration of 2 HZ/su doses at intervals longer than 2 months. In this Phase III, open-label trial conducted in the US and Estonia, 354 adults ≥50 years were randomized 1:1:1 to receive 2 HZ/su doses 2, 6, or 12 months apart. gE-specific humoral immune responses were evaluated at pre-vaccination, 1 and 12 months post-dose 2. Co-primary objectives were to compare immune responses to HZ/su 1 month post-dose 2 when given 6-months or 12-months apart to those administered 2-months apart. For each participant, safety information was collected from dose 1 to 12 months post-dose 2. 346 participants completed the study and 343 were included in the according-to-protocol cohort for immunogenicity. One month post-dose 2, vaccine response rates were 96.5% (97.5% confidence interval [CI]: 90.4; 99.2) and 94.5% (97.5% CI: 87.6; 98.3) for the 0, 6- and 0, 12-month schedules, respectively, both schedules meeting the pre-defined criterion. Non-inferiority of anti-gE geometric mean concentrations was demonstrated for HZ/su administered on 0, 6-month compared to a 0, 2-month schedule; however, HZ/su administered on a 0, 12-month schedule did not meet the non-inferiority criterion. Injection site pain was the most commonly reported solicited adverse event (AE). 26 participants each reported at least 1 serious AE; none were assessed as related to vaccination. Immune responses to HZ/su administered at 0, 6-month were non-inferior to those elicited by a 0, 2-month schedule. HZ/su exhibited a clinically acceptable safety profile for all dosing intervals. Clinicaltrials.gov (NCT01751165). Copyright © 2017. Published by Elsevier Ltd.

Home-based neurologic music therapy for arm hemiparesis following stroke: results from a pilot, feasibility randomized controlled trial

PubMed Central

Street, Alexander J; Magee, Wendy L; Bateman, Andrew; Parker, Michael; Odell-Miller, Helen; Fachner, Jorg

2017-01-01

Objective: To assess the feasibility of a randomized controlled trial to evaluate music therapy as a home-based intervention for arm hemiparesis in stroke. Design: A pilot feasibility randomized controlled trial, with cross-over design. Randomization by statistician using computer-generated, random numbers concealed in opaque envelopes. Setting: Participants’ homes across Cambridgeshire, UK. Subjects: Eleven people with stroke and arm hemiparesis, 3–60 months post stroke, following discharge from community rehabilitation. Interventions: Each participant engaged in therapeutic instrumental music performance in 12 individual clinical contacts, twice weekly for six weeks. Main measures: Feasibility was estimated by recruitment from three community stroke teams over a 12-month period, attrition rates, completion of treatment and successful data collection. Structured interviews were conducted pre and post intervention to establish participant tolerance and preference. Action Research Arm Test and Nine-hole Peg Test data were collected at weeks 1, 6, 9, 15 and 18, pre and post intervention by a blinded assessor. Results: A total of 11 of 14 invited participants were recruited (intervention n = 6, waitlist n = 5). In total, 10 completed treatment and data collection. Conclusion: It cannot be concluded whether a larger trial would be feasible due to unavailable data regarding a number of eligible patients screened. Adherence to treatment, retention and interview responses might suggest that the intervention was motivating for participants. Trial registration: ClinicalTrials.gov identifier NCT 02310438. PMID:28643570

Peer-facilitated cognitive dissonance versus healthy weight eating disorders prevention: A randomized comparison.

PubMed

Becker, Carolyn Black; Wilson, Chantale; Williams, Allison; Kelly, Mackenzie; McDaniel, Leda; Elmquist, Joanna

2010-09-01

Research supports the efficacy of both cognitive dissonance (CD) and healthy weight (HW) eating disorders prevention, and indicates that CD can be delivered by peer-facilitators, which facilitates dissemination. This study investigated if peer-facilitators can deliver HW when it is modified for their use and extended follow-up of peer-facilitated CD as compared to previous trials. Based on pilot data, we modified HW (MHW) to facilitate peer delivery, elaborate benefits of the healthy-ideal, and place greater emphasis on consuming nutrient dense foods. Female sorority members (N=106) were randomized to either two 2-h sessions of CD or MHW. Participants completed assessment pre- and post-intervention, and at 8-week, 8-month, and 14-month follow-up. Consistent with hypotheses, CD decreased negative affect, thin-ideal internalization, and bulimic pathology to a greater degree post-intervention. Both CD and MHW reduced negative affect, internalization, body dissatisfaction, dietary restraint, and bulimic pathology at 14 months. Copyright © 2010 Elsevier Ltd. All rights reserved.

HR Positions on the Internet.

ERIC Educational Resources Information Center

Coghill, Carey Cox; Kirk, James J.

The question of whether the online job market reflects the trends predicted for the job market was examined in a study of a random sample of 690 Internet job postings over a 6-month period. Each listing was categorized by type of position, desired qualifications, salary, and job specifications. Of the human resources (HR) jobs posted, 7.2% were…

The impact of group counseling on depression, post-traumatic stress and function outcomes: a prospective comparison study in the Peter C. Alderman trauma clinics in northern Uganda.

PubMed

Nakimuli-Mpungu, Etheldreda; Okello, James; Kinyanda, Eugene; Alderman, Stephen; Nakku, Juliet; Alderman, Jeffrey S; Pavia, Alison; Adaku, Alex; Allden, Kathleen; Musisi, Seggane

2013-10-01

The effectiveness of group interventions for adults with mental distress in post-conflict settings is less clear in sub-Saharan Africa. To assess the impact of group counseling intervention on depression, post-traumatic stress and function outcomes among adults attending the Peter C. Alderman Foundation (PCAF) trauma clinics in northern Uganda. 631 War affected adults were enrolled into PCAF trauma clinics. Using a quasi-experimental design, assessments were conducted at baseline, at 3 and 6 months following initiation of care. Multivariate longitudinal regression models were used to determine change in depression, post-traumatic stress and function scores over time among group counseling participants and non-participants. In comparison to non-participants, participants had faster reduction in depression scores during the 6-month follow-up period [β=-1.84, 95%CI (-3.38 to -0.30), p=0.019] and faster reduction in post-traumatic stress scores during the 3-month follow-up period [β=-2.14, 95%CI (-4.21 to -0.10), p=0.042]. At 3-month follow up, participants who attended two or more sessions had faster increase in function scores [β=3.51, 95%CI (0.61-6.40), p=0.018] than participants who attended only one session. Selection bias due to the use of non-random samples. Substantial attrition rates and small sample sizes may have resulted in insufficient statistical power to determine meaningful differences. The group counseling intervention offered in the PCAF clinics may have considerable mental health benefits over time. There is need for more research to structure, standardize and test the efficacy of this intervention using a randomized controlled trial. © 2013 Elsevier B.V. All rights reserved.

High- and low-intensity exercise do not improve cognitive function after stroke: A randomized controlled trial.

PubMed

Tang, Ada; Eng, Janice J; Krassioukov, Andrei V; Tsang, Teresa S M; Liu-Ambrose, Teresa

2016-11-11

To determine the effects of high versus low-intensity exercise on cognitive function following stroke. Secondary analysis from a randomized controlled trial with blinded assessors. 50-80 years old, living in the community, > 1 year post-stroke. Participants were randomized into a high-intensity Aerobic Exercise or low-intensity non-aerobic Balance/Flexibility program. Both programs were 6 months long, with 3 60-min sessions/week. Verbal item and working memory, selective attention and conflict resolution, set shifting were assessed before and after the program. Forty-seven participants completed the study (22/25 in Aerobic Exercise group, 25/25 in Balance/Flexibility group). There was an improvement in verbal item memory in both groups (time effect p = 0.04), and no between-group differences in improvement in the other outcomes (p > 0.27). There was no association between pre-exercise cognitive function and post-exercise improvement. In contrast to a small body of previous research suggesting positive benefits of exercise on cognition post-stroke, the current study found that 6 months of high or low intensity exercise was not effective in improving cognitive function, specifically executive functions. Further research in this area is warranted to establish the effectiveness of post-stroke exercise programs on cognition, and examine the mechanisms that underlie these changes.

A Randomized, Prospective, Parallel Group Study of Laparoscopic vs. Laparoendoscopic Single Site Donor Nephrectomy for Kidney Donation

PubMed Central

Aull, Meredith J.; Afaneh, Cheguevara; Charlton, Marian; Serur, David; Douglas, Melissa; Christos, Paul J.; Kapur, Sandip; Del Pizzo, Joseph J.

2014-01-01

Few prospective, randomized studies have assessed benefits of laparoendoscopic single site donor nephrectomy (LESS-DN) over laparoscopic donor nephrectomy (LDN). Our center initiated such a trial in January 2011, following subjects randomized to LESS-DN vs. LDN from surgery through 5 years post-donation. Subjects complete recovery/satisfaction questionnaires at 2, 6, and 12 months post-donation; transplant recipient outcomes are also recorded. 100 subjects (49 LESS-DN, 51 LDN) underwent surgery; donor demographics were similar between groups, and included a predominance of female, living unrelated donors, mean age of 47 years who underwent left donor nephrectomy. Operative parameters (overall time, time to extraction, warm ischemia time, blood loss) were similar between groups. Conversion to hand-assist laparoscopy was required in 3 LESS-DN (6.1%) vs. 2 LDN (3.9%; P=0.67). Questionnaires revealed 97.2% of LESS-DN vs. 79.5% of LDN (P=0.03) were 100% recovered by two months after donation. No significant difference was seen in satisfaction scores between the groups. Recipient outcomes were similar between groups. Our randomized trial comparing LESS donor nephrectomy to LDN confirms that LESS-DN offers a safe alternative to conventional LDN in terms of intra- and post-operative complications. LDN and LESS-DN offer similar recovery and satisfaction after donation. PMID:24934732

A Randomized Controlled Trial of Mindfulness Meditation for Chronic Insomnia

PubMed Central

Ong, Jason C.; Manber, Rachel; Segal, Zindel; Xia, Yinglin; Shapiro, Shauna; Wyatt, James K.

2014-01-01

Study Objectives: To evaluate the efficacy of mindfulness meditation for the treatment of chronic insomnia. Design: Three-arm, single-site, randomized controlled trial. Setting: Academic medical center. Participants: Fifty-four adults with chronic insomnia. Interventions: Participants were randomized to either mindfulness-based stress reduction (MBSR), mindfulness-based therapy for insomnia (MBTI), or an eight-week self-monitoring (SM) condition. Measurements and Results: Patient-reported outcome measures were total wake time (TWT) from sleep diaries, the pre-sleep arousal scale (PSAS), measuring a prominent waking correlate of insomnia, and the Insomnia Severity Index (ISI) to determine remission and response as clinical endpoints. Objective sleep measures were derived from laboratory polysomnography and wrist actigraphy. Linear mixed models showed that those receiving a meditation-based intervention (MBSR or MBTI) had significantly greater reductions on TWT minutes (43.75 vs 1.09), PSAS (7.13 vs 0.16), and ISI (4.56 vs 0.06) from baseline-to-post compared to SM. Post hoc analyses revealed that each intervention was superior to SM on each of the patient-reported measures, but no significant differences were found when comparing MBSR to MBTI from baseline-to-post. From baseline to 6-month follow-up, MBTI had greater reductions in ISI scores than MBSR (P < 0.05), with the largest difference occurring at the 3-month follow-up. Remission and response rates in MBTI and MBSR were sustained from post-treatment through follow-up, with MBTI showing the highest rates of treatment remission (50%) and response (78.6%) at the 6-month follow-up. Conclusions: Mindfulness meditation appears to be a viable treatment option for adults with chronic insomnia and could provide an alternative to traditional treatments for insomnia. Trial Registration: Mindfulness-Based Approaches to Insomnia: clinicaltrials.gov, identifier: NCT00768781 Citation: Ong JC, Manber R, Segal Z, Xia Y, Shapiro S, Wyatt JK. A randomized controlled trial of mindfulness meditation for chronic insomnia. SLEEP 2014;37(9):1553-1563. PMID:25142566

Greater occipital nerve block in the treatment of triptan-overuse headache: A randomized comparative study.

PubMed

Karadaş, Ö; Özön, A Ö; Özçelik, F; Özge, A

2017-04-01

This study aims to investigate the efficiency of a single and repeated greater occipital nerve (GON) block using lidocaine in the treatment of triptan-overuse headache (TOH), whose importance has increased lately. In the study, 105 consecutive subjects diagnosed with TOH were evaluated. The subjects were randomized into three groups. In Group 1 (n=35), only triptan was abruptly withdrawn. In Group 2 (n=35), triptan was abruptly withdrawn and single GON block was performed. In Group 3 (n=35), triptan was abruptly withdrawn and three-stage GON block was performed. All patients were injected bilaterally with a total amount of 5 cc 1% lidocaine in each stage. During follow-up, the number of headache days per month, the severity of pain (VAS), the number of triptans used, and hsCRP and IL-6 levels were recorded three times; in the pretreatment period, in the second month post-treatment, and in the fourth month post-treatment. They were then compared. There was a statistically significant difference in the post-treatment fourth month in comparison with the pretreatment period in Group 3 (P<.05). Compared to Group 1, the number of headache days, VAS, and decrease in triptan need in Group 3 was statistically significant compared to Group 2 (P<.05). Compared to pretreatment, in the fourth month post-treatment, both hsCRP and IL-6 levels were lower only in Group 3 (P<.05). We are of the opinion that repeated GON block in addition to the discontinuation of medication has significant efficacy for TOH cases. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Promoting a positive transition to parenthood: a randomized clinical trial of couple relationship education.

PubMed

Halford, W Kim; Petch, Jemima; Creedy, Debra K

2010-03-01

The transition to parenthood is often associated with a decline in couple relationship adjustment. Couples (n = 71) expecting their first child were randomly assigned to either: (a) Becoming a Parent (BAP), a maternal parenting education program; or (b) Couple CARE for Parents (CCP), a couple relationship and parenting education program. Couples were assessed pre-intervention (last trimester of pregnancy), post-intervention (5 months postpartum), and follow-up (12 months postpartum). Relative to BAP, CCP reduced negative couple communication from pre- to post-intervention, and prevented erosion of relationship adjustment and self-regulation in women but not men from pre-intervention to follow-up. Mean parenting stress reflected positive adjustment to parenthood with no differences between BAP and CCP. CCP shows promise as a brief program that can enhance couple communication and women's adjustment to parenthood.

Effects of creatine supplementation on renal function: a randomized, double-blind, placebo-controlled clinical trial.

PubMed

Gualano, Bruno; Ugrinowitsch, Carlos; Novaes, Rafael Batista; Artioli, Guilherme Gianini; Shimizu, Maria Heloisa; Seguro, Antonio Carlos; Harris, Roger Charles; Lancha, Antonio Herbert

2008-05-01

Creatine (CR) supplementation is commonly used by athletes. However, its effects on renal function remain controversial. The aim of this study was to evaluate the effects of creatine supplementation on renal function in healthy sedentary males (18-35 years old) submitted to exercise training. A randomized, double-blind, placebo-controlled trial was performed. Subjects (n = 18) were randomly allocated to receive treatment with either creatine (CR) ( approximately 10 g day(-1) over 3 months) or placebo (PL) (dextrose). All subjects undertook moderate intensity aerobic training, in three 40-min sessions per week, during 3 months. Serum creatinine, serum and urinary sodium and potassium were determined at baseline and at the end of the study. Cystatin C was assessed prior to training (PRE), after 4 (POST 4) and 12 weeks (POST 12). Cystatin C levels (mg L(-1)) (PRE CR: 0.82 +/- 0.09; PL: 0.88 +/- 0.07 vs. POST 12 CR: 0.71 +/- 0.06; PL: 0.75 +/- 0.09, P = 0.0001) were decreased over time, suggesting an increase in glomerular filtration rate. Serum creatinine decreased with training in PL but was unchanged with training in CR. No significant differences were observed within or between groups in other parameters investigated. The decrease in cystatin C indicates that high-dose creatine supplementation over 3 months does not provoke any renal dysfunction in healthy males undergoing aerobic training. In addition, the results suggest that moderate aerobic training per se may improve renal function.

A randomized controlled trial of mindfulness meditation for chronic insomnia.

PubMed

Ong, Jason C; Manber, Rachel; Segal, Zindel; Xia, Yinglin; Shapiro, Shauna; Wyatt, James K

2014-09-01

To evaluate the efficacy of mindfulness meditation for the treatment of chronic insomnia. Three-arm, single-site, randomized controlled trial. Academic medical center. Fifty-four adults with chronic insomnia. Participants were randomized to either mindfulness-based stress reduction (MBSR), mindfulness-based therapy for insomnia (MBTI), or an eight-week self-monitoring (SM) condition. Patient-reported outcome measures were total wake time (TWT) from sleep diaries, the pre-sleep arousal scale (PSAS), measuring a prominent waking correlate of insomnia, and the Insomnia Severity Index (ISI) to determine remission and response as clinical endpoints. Objective sleep measures were derived from laboratory polysomnography and wrist actigraphy. Linear mixed models showed that those receiving a meditation-based intervention (MBSR or MBTI) had significantly greater reductions on TWT minutes (43.75 vs 1.09), PSAS (7.13 vs 0.16), and ISI (4.56 vs 0.06) from baseline-to-post compared to SM. Post hoc analyses revealed that each intervention was superior to SM on each of the patient-reported measures, but no significant differences were found when comparing MBSR to MBTI from baseline-to-post. From baseline to 6-month follow-up, MBTI had greater reductions in ISI scores than MBSR (P < 0.05), with the largest difference occurring at the 3-month follow-up. Remission and response rates in MBTI and MBSR were sustained from post-treatment through follow-up, with MBTI showing the highest rates of treatment remission (50%) and response (78.6%) at the 6-month follow-up. Mindfulness meditation appears to be a viable treatment option for adults with chronic insomnia and could provide an alternative to traditional treatments for insomnia. Mindfulness-Based Approaches to Insomnia: clinicaltrials.gov, identifier: NCT00768781. © 2014 Associated Professional Sleep Societies, LLC.

Mothering from the Inside Out: Results of a second randomized clinical trial testing a mentalization-based intervention for mothers in addiction treatment

PubMed Central

Suchman, Nancy E.; DeCoste, Cindy L.; McMahon, Thomas J.; Dalton, Rachel; Mayes, Linda C.; Borelli, Jessica

2016-01-01

Mothers with histories of alcohol and drug addiction have shown greater difficulty parenting young children than mothers with no history of substance misuse. This study was the second randomized clinical trial testing the efficacy of Mothering from the Inside Out (MIO), a 12-week mentalization-based individual therapy designed to address psychological deficits commonly associated with chronic substance use that also interfere with the capacity to parent young children. Eighty-seven mothers caring for a child between 11 and 60 months of age were randomly assigned to receive 12 sessions of MIO versus 12 sessions of Parent Education (PE)—a psychoeducation active control comparison. Maternal reflective functioning, representations of caregiving, mother-child interaction quality, and child attachment were evaluated at baseline and post-treatment and 3-month follow up. Mother-child interaction quality was assessed again at 12-month follow up. In comparison with PE mothers, MIO mothers demonstrated a higher capacity for reflective functioning and representational coherence at post-treatment and 3-month follow up. At 12-month follow up, compared to PE cohorts, MIO mothers demonstrated greater sensitivity, their children showed greater involvement, and MIO dyads showed greater reciprocity. As addiction severity increased, MIO also appeared to serve as a protective factor for maternal reflective functioning, quality of mother-child interactions, and child attachment status. Results demonstrate the promise of mentalization-based interventions provided concomitant with addiction treatment for mothers and their young children. PMID:28401850

Testing a workplace physical activity intervention: a cluster randomized controlled trial

PubMed Central

2011-01-01

Background Increased physical activity levels benefit both an individuals' health and productivity at work. The purpose of the current study was to explore the impact and cost-effectiveness of a workplace physical activity intervention designed to increase physical activity levels. Methods A total of 1260 participants from 44 UK worksites (based within 5 organizations) were recruited to a cluster randomized controlled trial with worksites randomly allocated to an intervention or control condition. Measurement of physical activity and other variables occurred at baseline, and at 0 months, 3 months and 9 months post-intervention. Health outcomes were measured during a 30 minute health check conducted in worksites at baseline and 9 months post intervention. The intervention consisted of a 3 month tool-kit of activities targeting components of the Theory of Planned Behavior, delivered in-house by nominated facilitators. Self-reported physical activity (measured using the IPAQ short-form) and health outcomes were assessed. Results and discussion Multilevel modelling found no significant effect of the intervention on MET minutes of activity (from the IPAQ) at any of the follow-up time points controlling for baseline activity. However, the intervention did significantly reduce systolic blood pressure (B = -1.79 mm/Hg) and resting heart rate (B = -2.08 beats) and significantly increased body mass index (B = .18 units) compared to control. The intervention was found not to be cost-effective, however the substantial variability round this estimate suggested that further research is warranted. Conclusions The current study found mixed support for this worksite physical activity intervention. The paper discusses some of the tensions involved in conducting rigorous evaluations of large-scale randomized controlled trials in real-world settings. Trial registration Current controlled trials ISRCTN08807396 PMID:21481265

Efficacy of bupropion alone and in combination with nicotine gum

PubMed Central

Piper, Megan E.; Federman, E. Belle; McCarthy, Danielle E.; Bolt, Daniel M.; Smith, Stevens S.; Fiore, Michael C.; Baker, Timothy B.

2010-01-01

In this double-blind placebo-controlled smoking cessation treatment study, 608 participants were randomly assigned to receive active bupropion and active 4-mg gum (AA, n = 228), active bupropion and placebo gum (AP, n = 224), or placebo bupropion and placebo gum (PP, n = 156). Relative to the PP group, the AA and AP groups were each significantly more likely to be abstinent at one week, end of treatment and six months, but not twelve months post-quit. After the first week post-quit there were no differences in abstinence rates between the AA and AP groups. There were no significant individual difference variables that moderated outcome beyond one week post-quit. PMID:17763111

Comprehensive behavioral-motivational nutrition education improves depressive symptoms following bariatric surgery: a randomized, controlled trial of obese Hispanic Americans.

PubMed

Petasne Nijamkin, Monica; Campa, Adriana; Samiri Nijamkin, Shani; Sosa, Jorge

2013-01-01

To evaluate the effect of 2 post-bariatric support interventions on depressive symptoms of Hispanic Americans treated with gastric bypass for morbid or severe obesity. Prospective randomized, controlled trial conducted in a laparoscopic institution. During the Phase 1 clinical trial (from preoperative evaluation to 6 months after surgery), all participants received standard care. During Phase 2 (6-12 months after surgery), participants were randomly assigned to receive either standard care (n = 72) or comprehensive support (n = 72). Comprehensive group participants received 6 educational sessions focused on behavior change strategies and motivation with nutrition counseling. Depression scores and weight change over time. Independent samples t tests and regression analysis assessed relationships among depression scores and excess weight loss. Participants receiving behavioral-motivational intervention scored significantly lower on Beck's Depression Inventory questionnaire scores than those receiving standard care. For those with depressive symptoms at randomization, 24% of participants who received the comprehensive intervention reported no depressive symptoms at 12 months after surgery, compared with 6% of those who received standard care (P < .001). Patients' depressive mood improvement was significantly and positively associated with excess weight loss and attendance at educational sessions (P < .001). Findings support the importance of post-bariatric comprehensive behavioral-motivational nutrition education for decreasing risk for depression and improving weight loss. Copyright © 2013 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

Optimal Duration for Voice Rest After Vocal Fold Surgery: Randomized Controlled Clinical Study.

PubMed

Kaneko, Mami; Shiromoto, Osamu; Fujiu-Kurachi, Masako; Kishimoto, Yo; Tateya, Ichiro; Hirano, Shigeru

2017-01-01

Voice rest is commonly recommended after phonomicrosurgery to prevent worsening of vocal fold injuries. However, the most effective duration of voice rest is unknown. Recently, early vocal stimulation was recommended as a means to improve wound healing. The purpose of this study is to examine the optimal duration of voice rest after phonomicrosurgery. Randomized controlled clinical study. Patients undergoing phonomicrosurgery for leukoplakia, carcinoma in situ, vocal fold polyp, Reinke's edema, and cyst were chosen. Participants were randomly assigned to voice rest for 3 or 7 postoperative days. Voice therapy was administered to both groups after voice rest. Grade, roughness, breathiness, asthenia, and strain (GRBAS) scale, stroboscopic examination, aerodynamic assessment, acoustic analysis, and Voice Handicap Index-10 (VHI-10) were performed pre- and postoperatively at 1, 3, and 6 months. Stroboscopic examination evaluated normalized mucosal wave amplitude (NMWA). Parameters were compared between both groups. Thirty-one patients were analyzed (3-day group, n = 16; 7-day group, n = 15). Jitter, shimmer, and VHI-10 were significantly better in the 3-day group at 1 month post operation. GRBAS was significantly better in the 3-day group at 1 and 3 months post operation, and NMWA was significantly better in the 3-day group at 1, 3, and 6 months post operation compared to the 7-day group. The data suggest that 3 days of voice rest followed by voice therapy may lead to better wound healing of the vocal fold compared to 7 days of voice rest. Appropriate mechanical stimulation during early stages of vocal fold wound healing may lead to favorable functional recovery. Copyright © 2017 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

Housing First improves subjective quality of life among homeless adults with mental illness: 12-month findings from a randomized controlled trial in Vancouver, British Columbia.

PubMed

Patterson, Michelle; Moniruzzaman, Akm; Palepu, Anita; Zabkiewicz, Denise; Frankish, Charles J; Krausz, Michael; Somers, Julian M

2013-08-01

This study used an experimental design to examine longitudinal changes in subjective quality of life (QoL) among homeless adults with mental illness after assignment to different types of supported housing or to treatment as usual (TAU, no housing or supports through the study). We hypothesized that subjective QoL would improve over time among participants assigned to supported housing as compared to TAU, regardless of the type of supported housing received or participants' level of need. Participants (n = 497) were stratified by level of need ("high" or "moderate") and randomly assigned to Housing First (HF) in scattered-site apartments, HF in a congregate setting (high needs only), or TAU. Linear mixed-effects regression was used to model the association between study arm and self-reported QoL at baseline and at 6 and 12 months post-baseline by need level. Based on the adjusted overall score on the QoL measure, participants randomized to HF reported significantly greater overall QoL as compared to TAU, regardless of need level or type of supported housing at both 6 and 12 months post-baseline. Scores on the safety and living situation subscales were significantly greater for both high and moderate need participants assigned to supported housing regardless of type at both 6 and 12 months post-baseline as compared to TAU. Despite multiple health and social challenges faced by homeless individuals with mental illness, HF in both scattered-site and congregate models results in significantly greater perceived QoL as compared to individuals who do not receive HF even after a relatively short period of time.

"Healthy Habits, Healthy Girls—Brazil": an obesity prevention program with added focus on eating disorders

USDA-ARS?s Scientific Manuscript database

The purpose of the study was to evaluate the immediate post-intervention and 6-month post-intervention effects of a Brazilian school-based randomized controlled trial for girls targeting shared risk factors for obesity and disordered eating. A total of 253 girls, mean of 15.6 (0.05) years from 1st t...

Survival of two post systems--five-year results of a randomized clinical trial.

PubMed

Schmitter, Marc; Hamadi, Khaled; Rammelsberg, Peter

2011-01-01

To assess the survival rate of two different post systems after 5 years of service with a prospective randomized controlled trial. One hundred patients in need of a post were studied. Half of the patients received long glass fiber-reinforced posts, while the other half received long metal screw posts. The posts were assigned randomly. After at least 5 years (mean, 61.37 months), follow-ups were established. When a complication occurred prior to this recall, the type and time of the complication was documented. Statistical analysis was performed using the log-rank test and Kaplan-Meier analysis. Additionally, a Cox regression was performed to analyze risk factors. The survival rate of fiber-reinforced posts was 71.8%. In the metal screw post group, the survival rate was significantly lower, 50.0% (log-rank test, P = .026). Metal posts resulted more often in more unfavorable complications (eg, root fractures); consequently, more teeth (n = 17) had to be extracted. The Cox regression identified the following risk factors: position of the tooth (anterior vs posterior teeth), degree of coronal tooth destruction, and the post system (fiber-reinforced post vs metal screw post). Fiber-reinforced restorations loosened in several patients; in some of these cases (n = 6), patients did not notice this, leading to the extraction of teeth. Long metal screw posts should be used with great care in endodontically treated teeth. Besides the selection of the post system, other factors influence the survival of the restoration.

The Mothers and Toddlers Program, an attachment-based parenting intervention for substance using women: Post-treatment results from a randomized clinical pilot

PubMed Central

Suchman, Nancy E.; DeCoste, Cindy; Castiglioni, Nicole; McMahon, Thomas J.; Rounsaville, Bruce; Mayes, Linda

2010-01-01

This is a report of post-treatment findings from a completed randomized pilot study testing the preliminary efficacy of The Mothers and Toddlers Program (MTP), a 12 week attachment-based individual parenting therapy for mothers enrolled in substance abuse treatment and caring for children ages birth to 36 months. Forty-seven mothers were randomized to MTP versus the Parent Education Program (PE) – a comparison intervention providing individual case management and child guidance brochures. At post-treatment, MTP mothers demonstrated better reflective functioning in the Parent Development Interview, representational coherence and sensitivity, and caregiving behavior than PE mothers. Partial support was also found for proposed mechanisms of change in the MTP model. Together, preliminary findings suggest that attachment-based interventions may be more effective than traditional parent training for enhancing relationships between substance using women and their young children. PMID:20730641

A clustered randomized trial of the effects of feedback using academic detailing compared to postal bulletin on prescribing of preventative cardiovascular therapy.

PubMed

Naughton, Corina; Feely, John; Bennett, Kathleen

2007-10-01

Interventions to promote prescribing of preventive therapies in patients with cardiovascular disease (CVD) or diabetes have reported variable success. (i) To evaluate the effect of prescribing feedback on GP practice using academic detailing compared to postal bulletin on prescribing of CVD preventive therapies in patients with CVD or diabetes at 3 and 6 months post intervention and (ii) to evaluate the intervention from a GP's perspective. Volunteer GP practices (n = 98) were randomized to receive individualized prescribing feedback via academic detailing (postal bulletin plus outreach visit) (n = 48) or postal bulletin (n = 50). The proportion of CVD or diabetic patients on statins and antiplatelet agents/warfarin pre- and post-intervention was calculated for each GP practice. Multivariate regression with a random effects model was used to compare differences between the groups adjusting for GP clustering and confounding factors. beta-Coefficients and 95% confidence intervals (CIs) are presented. There was a 3% increase in statin prescribing in CVD patients at 6 months post-intervention for both randomized groups, but there was no statistical difference between the groups (beta = 0.004; 95% CI = -0.01 to 0.02). Statin and antiplatelet/warfarin prescribing also increased in the diabetic population; there was no significant differences between the groups. GPs participating in the project expressed a high level of satisfaction with both interventions. Prescribing of preventive therapies increased in both randomized groups over the study period. But academic detailing did not have an additional effect on changing prescribing over the postal bulletin alone.

Post-fracture care: do we need to educate patients rather than doctors? The PREVOST randomized controlled trial.

PubMed

Merle, B; Chapurlat, R; Vignot, E; Thomas, T; Haesebaert, J; Schott, A-M

2017-05-01

We conducted a multicenter, randomized controlled trial to evaluate the impact of a population-based patient-centered post-fracture care program with a dedicated case manager, PREVention of OSTeoporosis (PREVOST), on appropriate post-fracture osteoporosis management. We showed that, compared to usual care, BMD investigation post-fracture was significantly improved (+20%) by our intervention program. Our study aims to evaluate the impact of a population-based patient-centered post-fracture care program, PREVOST, on appropriate post-fracture care. Multicenter, randomized controlled trial enrolling 436 women aged 50 to 85 years and attending a French hospital, for a low-energy fracture of the wrist or humerus. Randomization was stratified by age, hospital department, and site of fracture. The intervention was performed by a trained case manager who interacted only with the patients, with repeated oral and written information about fragility fractures and osteoporosis management, and prompting them to visit their primary care physicians. Control group received usual care. The primary outcome was the initiation of an appropriate post-fracture care defined by Bone Mineral Density (BMD) and/or anti-osteoporotic treatment prescription at 6 months. At 6 months, 53% of women in intervention group initiated a post-fracture care versus 33% for usual care (adjOR 2.35, 95%CI [1.58-3.50], p < 0.001). Post-fracture care was more frequent after wrist than humerus fracture (adjOR 1.93, 95%CI [1.14-3.30], p = 0.015) and decreased with age (adjOR for 10 years increase 0.76, 95%CI [0.61-0.96], p = 0.02). The intervention resulted in BMD prescription in 50% of patients (adjOR 2.10, 95%CI [1.41-3.11], p < 0.001) and in BMD performance in 41% of patients (adjOR 2.12, 95%CI [1.40-3.20], p < 0.001) versus 33 and 25% for usual care, respectively. Having performed a BMD increased treatment prescription; however, only 46% of women with a low BMD requiring a treatment according to the French guidelines received a prescription. A patient-centered care program with a dedicated case manager can significantly improve post-fracture BMD investigation.

Comparing the efficacy of mature mud pack and hot pack treatments for knee osteoarthritis.

PubMed

Sarsan, Ayşe; Akkaya, Nuray; Ozgen, Merih; Yildiz, Necmettin; Atalay, Nilgun Simsir; Ardic, Fusun

2012-01-01

The objective of this study is to compare the efficacy of mature mud pack and hot pack therapies on patients with knee osteoarthritis. This study was designed as a prospective, randomized-controlled, and single-blinded clinical trial. Twenty-seven patients with clinical and radiologic evidence of knee osteoarthritis were randomly assigned into two groups and were treated with mature mud packs (n 15) or hot packs (n=12). Patients were evaluated for pain [based on the visual analog scale (VAS)], function (WOMAC, 6 min walking distance), quality of life [Short Form-36 (SF-36)], and serum levels of tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), and insulin-like growth factor-1 (IGF-1) at baseline, post-treatment, and 3 and 6~months after treatment. The mud pack group shows a significant improvement in VAS, pain, stifness, and physical function domains of WOMAC. The difference between groups of pain and physical activity domains is significant at post-treatment in favor of mud pack. For a 6 min walking distance, mud pack shows significant improvement, and the difference is significant between groups in favor of mud pack at post-treatment and 3 and 6 months after treatment. Mud pack shows significant improvement in the pain subscale of SF-36 at the third month continuing until the sixth month after the treatment. Significant improvements are found for the social function, vitality/energy, physical role disability, and general health subscales of SF-36 in favor of the mud pack compared with the hot pack group at post-treatment. A significant increase is detected for IGF-1 in the mud pack group 3 months after treatment compared with the baseline, and the difference is significant between groups 3 months after the treatment. Mud pack is a favorable option compared with hotpack for pain relief and for the improvement of functional conditions in treating patients with knee osteoarthritis.

Reactogenicity, safety and immunogenicity of a protein-based pneumococcal vaccine in Gambian children aged 2-4 years: A phase II randomized study.

PubMed

Odutola, A; Ota, M O; Ogundare, E O; Antonio, M; Owiafe, P; Worwui, A; Greenwood, B; Alderson, M; Traskine, M; Verlant, V; Dobbelaere, K; Borys, D

2016-01-01

Pneumococcal conjugate vaccines (PCVs) have been successful in preventing invasive pneumococcal disease but effectiveness has been challenged by replacement of vaccine serotypes with non-vaccine serotypes. Vaccines targeting common pneumococcal protein(s) found in most/all pneumococci may overcome this limitation. This phase II study assessed safety and immunogenicity of a new protein-based pneumococcal vaccine containing polysaccharide conjugates of 10 pneumococcal serotypes combined with pneumolysin toxoid(dPly) and pneumococcal histidine triad protein D(PhtD) (PHiD-CV/dPly/PhtD-30) in African children. 120 Gambian children (2-4 years, not previously vaccinated against Streptococcus pneumoniae) randomized (1:1) received a single dose of PHiD-CV/dPly/PhtD-30 or PCV13. Adverse events occurring over 4 d post-vaccination were reported, and blood samples obtained pre- and 1-month post-vaccination. Serious adverse events were reported for 6 months post-vaccination. Solicited local and systemic adverse events were reported at similar frequency in each group. One child (PHiD-CV/dPly/PhtD-30 group) reported a grade 3 local reaction to vaccination. Haematological and biochemical parameters seemed similar pre- and 1-month post-vaccination in each group. High pre-vaccination Ply and PhtD antibody concentrations were observed in each group, but only increased in PHiD-CV/dPly/PhtD-30 vaccinees one month post-vaccination. One month post-vaccination, for each vaccine serotype ≥96.2% of PHiD-CV/dPly/PhtD-30 vaccinees had serotype-specific polysaccharide antibody concentrations ≥0.20µg/mL except serotypes 6B (80.8%) and 23F (65.4%), and ≥94.1% had OPA titres of ≥8 except serotypes 1 (51.9%), 5 (38.5%) and 6B (78.0%), within ranges seen in PCV13-vaccinated children. A single dose of PHiD-CV/dPly/PhtD-30 vaccine, administered to Gambian children aged 2-4 y not previously vaccinated with a pneumococcal vaccine, was well-tolerated and immunogenic.

Impact of Attention Training on Academic Achievement, Executive Functioning, and Behavior: A Randomized Controlled Trial.

PubMed

Kirk, Hannah; Gray, Kylie; Ellis, Kirsten; Taffe, John; Cornish, Kim

2017-03-01

Children with intellectual and developmental disabilities (IDD) experience significant difficulties in attention, learning, executive functions, and behavioral regulation. Emerging evidence suggests that computerized cognitive training may remediate these impairments. In a double blind controlled trial, 76 children with IDD (4-11 years) were randomized to either an attention training (n = 38) or control program (n = 38). Both programs were completed at home over a 5-week period. Outcome measures assessed literacy, numeracy, executive functioning, and behavioral/emotional problems, and were conducted at baseline, post-training, and 3-month follow-up. No training effects were observed at post-training; however, children in the training group showed greater improvements in numeracy skills at the 3-month follow-up. These results suggest that attention training may be beneficial for children with IDD; however, the modest nature of the intervention effects indicate that caution should be taken when interpreting clinical significance.

Persistent effect at 30-month post intervention of a community-based randomized trial of KM2H2 in reducing stroke and heart attack among senior hypertensive patients.

PubMed

Gong, Jie; Xu, Yunan; Chen, Xinguang; Yang, Niannian; Li, Fang; Yan, Yaqiong

2018-01-02

The effect of the Keep Moving toward Healthy Heart and Healthy Brain (KM2H2) program at 6-month post intervention has been assessed.  The purpose of this study is to evaluate the KM2H 2 program at 30-month post intervention. A total of 450 senior hypertensive patients from 12 community health centers were randomized by center to either receive KM2H 2 plus standard care (6 centers, n = 232) or standard care only (6 centers, n = 218). Data for outcome measures at 30-month post intervention were analyzed. New cases of stroke and heart attack were verified with medical records; levels of physical activity were assessed using self-reported questionnaire. In addition to comparative analysis, adjusted incidence rate and program effects were determined using mixed effects modeling method. At the 30-month follow-up, the adjusted incidence rate [95% CI] of stroke was 11.81% [5.90, 17.72] for patients in the intervention group and 19.78% [14.07, 25.50] (p = 0.03) for the control group. The adjusted incidence rate of heart attack was 3.34% [1.91, 8.58] and 6.68% [1.64, 11.73] for the intervention and control groups (p = 0.16), respectively; the proportion and the duration of engaging in regular physical activity were significantly greater for the intervention group than the control group. The reductions in blood pressure between the intervention and the control was not statistically significant. The KM2H 2 program showed a persistent effect up to 30 months post intervention in enhancing physical activity and reducing the risk of cardio-cerebrovascular events, particularly stroke. These findings demonstrate the persistent effect of the KM2H 2 and suggest the need for a full-scale evaluation of the intervention program for practical use. ISRCTN Register ISRCTN12608966 . Registered 03 March 2015. Retrospectively registered.

Systematic Review and Meta-Analysis: Infliximab or Cyclosporine as Rescue Therapy in Patients With Severe Ulcerative Colitis Refractory to Steroids.

PubMed

Narula, Neeraj; Marshall, John K; Colombel, Jean-Frederic; Leontiadis, Grigorios I; Williams, John G; Muqtadir, Zack; Reinisch, Walter

2016-04-01

Acute severe steroid-refractory ulcerative colitis (UC) carries a poor prognosis and requires optimal management. A systematic review and meta-analysis were conducted to assess cyclosporine and infliximab (IFX) as rescue agents in patients with steroid-refractory UC. A literature search identified studies that investigated IFX and cyclosporine in steroid-refractory UC patients. The primary outcome was short-term response to treatment. Secondary outcomes included the rates of colectomy at 3 months and 12 months, adverse drug reactions, post-operative complications in those who received rescue therapy but underwent colectomy subsequently, and mortality. Odds ratios (ORs) with 95% confidence intervals (CIs) are reported. Overall, 16 studies with 1,473 participants were eligible for inclusion. Among three randomized controlled trials, no significant difference was seen with IFX compared with cyclosporine with regard to treatment response and 3- or 12-month colectomy. Among 13 non-randomized studies, IFX was associated with significantly higher rates of treatment response (OR 2.96 (95% CI 2.12-4.14, χ(2)=6.50, I(2)=0%)) and a lower 12-month colectomy rate (OR 0.42 (95% CI 0.22-0.83, χ(2)=30.94, I(2)=71%)), with no significant difference seen in the 3-month colectomy rate (OR 0.53 (95% CI 0.22-1.28, χ(2)=22.73, I(2)=69%)) compared with cyclosporine. There were no significant differences between IFX and cyclosporine in adverse drug-related events, post-operative complications, or mortality. In the management of steroid-refractory severe UC, no definitive difference between IFX and cyclosporine is demonstrated by randomized trials, but non-randomized studies suggest that IFX is associated with better treatment response and lower risk of colectomy at 12 months. Prospective studies comparing dose-optimized IFX with cyclosporine are needed.

The effect of peer support on breast-feeding duration among primiparous women: a randomized controlled trial.

PubMed

Dennis, Cindy-Lee; Hodnett, Ellen; Gallop, Ruth; Chalmers, Beverley

2002-01-08

Most mothers stop breast-feeding before the recommended 6 months post partum. A systematic review showed that breast-feeding support programs by health care professionals did not substantially improve breast-feeding outcomes beyond 2 months post partum. We conducted a randomized controlled trial to evaluate the effect of peer (mother-to-mother) support on breast-feeding duration among first-time breast-feeding mothers. We recruited 256 breast-feeding mothers from 2 semi-urban community hospitals near Toronto and randomly assigned them to a control group (conventional care) or a peer support group (conventional care plus telephone-based support, initiated within 48 hours after hospital discharge, from a woman experienced with breast-feeding who attended a 2.5-hour orientation session). Follow-up of breast-feeding duration, maternal satisfaction with infant feeding method and perceptions of peer support received was conducted at 4, 8 and 12 weeks post partum. Significantly more mothers in the peer support group than in the control group continued to breast-feed at 3 months post partum (81.1% v. 66.9%, p = 0.01) and did so exclusively (56.8% v. 40.3%, p = 0.01). Breast-feeding rates at 4, 8 and 12 weeks post partum were 92.4%, 84.8% and 81.1% respectively among the mothers in the peer support group, as compared with 83.9%, 75.0% and 66.9% among those in the control group (p < or = 0.05 for all time periods). The corresponding relative risks were 1.10 (95% confidence interval [CI] 1.01-2.72) at 4 weeks, 1.13 (95% CI 1.00-1.28) at 8 weeks and 1.21 (95% CI 1.04-1.41) at 12 weeks post partum. In addition, when asked for an overall rating of their feeding experience, significantly fewer mothers in the peer support group than in the control group were dissatisfied (1.5% v. 10.5%) (p = 0.02). Of the 130 mothers who evaluated the peer support intervention, 81.6% were satisfied with their peer volunteer experience and 100% felt that all new breast-feeding mothers should be offered this peer support intervention. The telephone-based peer support intervention was effective in maintaining breast-feeding to 3 months post partum and improving satisfaction with the infant feeding experience. The high satisfaction with and acceptance of the intervention indicates that breast-feeding peer support programs, in conjunction with professional health services, are effective.

The effect of peer support on breast-feeding duration among primiparous women: a randomized controlled trial

PubMed Central

Dennis, Cindy-Lee; Hodnett, Ellen; Gallop, Ruth; Chalmers, Beverley

2002-01-01

Background Most mothers stop breast-feeding before the recommended 6 months post partum. A systematic review showed that breast-feeding support programs by health care professionals did not substantially improve breast-feeding outcomes beyond 2 months post partum. We conducted a randomized controlled trial to evaluate the effect of peer (mother-to-mother) support on breast-feeding duration among first-time breast-feeding mothers. Methods We recruited 256 breast-feeding mothers from 2 semi-urban community hospitals near Toronto and randomly assigned them to a control group (conventional care) or a peer support group (conventional care plus telephone-based support, initiated within 48 hours after hospital discharge, from a woman experienced with breast-feeding who attended a 2.5-hour orientation session). Follow-up of breast-feeding duration, maternal satisfaction with infant feeding method and perceptions of peer support received was conducted at 4, 8 and 12 weeks post partum. Results Significantly more mothers in the peer support group than in the control group continued to breast-feed at 3 months post partum (81.1% v. 66.9%, p = 0.01) and did so exclusively (56.8% v. 40.3%, p = 0.01). Breast-feeding rates at 4, 8 and 12 weeks post partum were 92.4%, 84.8% and 81.1% respectively among the mothers in the peer support group, as compared with 83.9%, 75.0% and 66.9% among those in the control group (p ≤ 0.05 for all time periods). The corresponding relative risks were 1.10 (95% confidence interval [CI] 1.01–2.72) at 4 weeks, 1.13 (95% CI 1.00–1.28) at 8 weeks and 1.21 (95% CI 1.04–1.41) at 12 weeks post partum. In addition, when asked for an overall rating of their feeding experience, significantly fewer mothers in the peer support group than in the control group were dissatisfied (1.5% v. 10.5%) (p = 0.02). Of the 130 mothers who evaluated the peer support intervention, 81.6% were satisfied with their peer volunteer experience and 100% felt that all new breast-feeding mothers should be offered this peer support intervention. Interpretation The telephone-based peer support intervention was effective in maintaining breast-feeding to 3 months post partum and improving satisfaction with the infant feeding experience. The high satisfaction with and acceptance of the intervention indicates that breast-feeding peer support programs, in conjunction with professional health services, are effective. PMID:11800243

Computerized cognitive behavioural therapy at work: a randomized controlled trial in employees with recent stress-related absenteeism.

PubMed

Grime, Paul R

2004-08-01

Emotional distress has major implications for employees and employers. Cognitive behavioural therapy (CBT) is a recommended treatment, but demand outstrips supply. CBT is well suited to computerization. Most employee assistance programmes have not been systematically evaluated and computerized CBT has not previously been studied in the workplace. To evaluate the effect of an 8 week computerized cognitive behavioural therapy programme, 'Beating The Blues', on emotional distress in employees with recent stress-related absenteeism, and to explore the reasons for non-participation. An open, randomized trial in a London NHS occupational health department. Forty-eight public sector employees, with 10 or more cumulative days stress-related absenteeism in the last 6 months, randomized equally to 'Beating The Blues' plus conventional care, or conventional care alone. Main outcome measures were Hospital Anxiety and Depression Scale and Attributional Style Questionnaire scores at end of treatment and 1, 3 and 6 months later; and reasons for non-participation. At end of treatment and 1 month later, adjusted mean depression scores and adjusted mean negative attributional style scores were significantly lower in the intervention group. One month post-treatment, adjusted mean anxiety scores were also significantly lower in the intervention group. The differences were not statistically significant at 3 and 6 months post-treatment. Non-participation was common and related to access problems, preference for other treatments, time commitment, scepticism about the intervention and the employer connection. 'Beating The Blues' may accelerate psychological recovery in employees with recent stress-related absenteeism. Greater flexibility and accessibility might improve uptake.

Does self-efficacy mediate functional change in older adults participating in an exercise program after hip fracture? A randomized control trial

PubMed Central

Latham, Nancy K.; Ni, Pengsheng; Jette, Alan M.

2015-01-01

Objectives This study examined whether self-efficacy mediated the effect of the HIP Rehab exercise program on activity limitations in older adults after hip fracture, and whether the mediation effect was different between different gender and age groups. Design Randomized controlled trial (RCT) Setting Community Participants Two hundred and thirty two participants aged 79±9.4 years with hip fracture were randomly assigned to intervention (n=120) or attention control (n=112) groups. Interventions The 6-month intervention, the HIP Rehab, is a functionally-oriented, home-based exercise program. Data was collected at baseline, post-intervention (6 months), and follow-up (9 months). Main outcome measure Activity Measure for Post-Acute Care (AM-PAC) Results The mediation effect of the HIP Rehab exercise program on Basic Mobility function through self-efficacy for exercise was significant at 9 months (βindirect=0.21). Similarly, the mediation effect of the intervention on Daily Activity function through self-efficacy for exercise was significant at 9 months (βindirect=0.49). In subgroup analyses, the mediation effect was significant at 9 months in the younger group (≤79 years old) in comparison to the older group, and was significant in females in comparison to males. Conclusion Self-efficacy may play a partial mediating role for the effect on some longer-term functional outcomes in the HIP Rehab intervention. The results suggest that program components that target self-efficacy should be incorporated in the future hip fracture rehabilitation interventions. Age and gender of the targeted participants may also need to be considered when developing interventions. PMID:25701101

The Efficacy of Web-Based and Print-Delivered Computer-Tailored Interventions to Reduce Fat Intake: Results of a Randomized, Controlled Trial

ERIC Educational Resources Information Center

Kroeze, Willemieke; Oenema, Anke; Campbell, Marci; Brug, Johannes

2008-01-01

Objective: To test and compare the efficacy of interactive- and print-delivered computer-tailored nutrition education targeting saturated fat intake reduction. Design: A 3-group randomized, controlled trial (2003-2005) with posttests at 1 and 6 months post-intervention. Setting: Worksites and 2 neighborhoods in the urban area of Rotterdam.…

Promoting parental management of teen driving

PubMed Central

Simons-Morton, B; Hartos, J; Leaf, W; Beck, K

2002-01-01

Methods: Parent-teen dyads (n = 452) were recruited when teens received learner's permits and interviewed over the telephone at baseline, licensure, and three months post-licensure. After baseline, families were randomized to either the intervention group that received persuasive communications or to the comparison group that received general information about driving safety. Results: Both parents and teens in the intervention group reported significantly greater limits on teen driving at licensure and three months post-licensure. In multivariate analyses, intervention and baseline driving expectations had significant effects on driving limits at licensure. Intervention and driving limits established at licensure were associated with three month driving limits. Conclusion: The findings indicate that exposure to the Checkpoints Program increased parental limits on teen driving. PMID:12221027

Intervention-related increases in preoperative physical activity are maintained 6-months after Bariatric surgery: results from the bari-active trial.

PubMed

Bond, D S; Thomas, J G; Vithiananthan, S; Unick, J; Webster, J; Roye, G D; Ryder, B A; Sax, H C

2017-03-01

Higher preoperative physical activity (PA) strongly predicts higher post-operative PA in bariatric surgery (BS) patients, providing rationale for preoperative PA interventions (PAIs). However, whether PAI-related increases can be maintained post-operatively has not been examined. This study compared PA changes across pre- (baseline, post-intervention) and post-operative (6-month follow up) periods in participants randomized to 6 weeks of preoperative PAI or standard care control (SC). Of 75 participants initially randomized, 36 (PAI n=22; SC n=14) underwent BS. Changes in daily bout-related (⩾10-min bouts) moderate-to-vigorous PA (MVPA) and steps were assessed via the SenseWear Armband monitor. PAI received weekly counseling to increase walking exercise. Retention (86%) at post-operative follow up was similar between groups. Intent-to-treat analyses showed that PAI vs SC had greater increases across time (baseline, post-intervention, follow up) in bout-related MVPA minutes/day (4.3±5.1, 26.3±21.3, 28.7±26.3 vs 10.4±22.9, 11.4±16.0, 18.5±28.2; P=0.013) and steps/day (5163±2901, 7950±3286, 7870±3936 vs 5163±2901, 5601±3368, 5087±2603; P<0.001). PAI differed from SC on bout-related MVPA at post-intervention (P=0.016; d=0.91), but not follow up (P=0.15; d=0.41), and steps at post-intervention (P=0.031; d=0.78) and follow up (P=0.024; d=0.84). PAI participants maintained preoperative PA increases post-operatively. Findings support preoperative PAIs and research to test whether PA changes can be sustained and influence surgical outcomes beyond the initial post-operative period.

Results from a randomized trial of a web-based, tailored decision aid for women at high risk for breast cancer

PubMed Central

Banegas, Matthew P.; McClure, Jennifer B.; Barlow, William E.; Ubel, Peter A.; Smith, Dylan M.; Zikmund-Fisher, Brian J.; Greene, Sarah M.; Fagerlin, Angela

2013-01-01

Objective To assess the impact of Guide to Decide (GtD), a web-based, personally-tailored decision aid designed to inform women’s decisions about prophylactic tamoxifen and raloxifene use. Methods Postmenopausal women, age 46–74, with BCRAT 5-year risk ≥1.66% and no prior history of breast cancer were randomized to one of three study arms: intervention (n = 690), Time 1 control (n = 160), or 3-month control (n = 162). Intervention participants viewed GtD prior to completing a post-test and 3 month follow-up assessment. Controls did not. We assessed the impact of GtD on women’s decisional conflict levels and treatment decision behavior at post-test and at 3 months, respectively. Results Intervention participants had significantly lower decisional conflict levels at post-test (p < 0.001) and significantly higher odds of making a decision about whether or not to take prophylactic tamoxifen or raloxifene at 3-month follow-up (p < 0.001) compared to control participants. Conclusion GtD lowered decisional conflict and helped women at high risk of breast cancer decide whether to take prophylactic tamoxifen or raloxifene to reduce their cancer risk. Practice implications Web-based, tailored decision aids should be used more routinely to facilitate informed medical decisions, reduce patients’ decisional conflict, and empower patients to choose the treatment strategy that best reflects their own values. PMID:23395006

Better Respiratory Education and Treatment Help Empower (BREATHE) study: Methodology and baseline characteristics of a randomized controlled trial testing a transitional care program to improve patient-centered care delivery among chronic obstructive pulmonary disease patients.

PubMed

Aboumatar, H; Naqibuddin, M; Chung, S; Adebowale, H; Bone, L; Brown, T; Cooper, L A; Gurses, A P; Knowlton, A; Kurtz, D; Piet, L; Putcha, N; Rand, C; Roter, D; Shattuck, E; Sylvester, C; Urteaga-Fuentes, A; Wise, R; Wolff, J L; Yang, T; Hibbard, J; Howell, E; Myers, M; Shea, K; Sullivan, J; Syron, L; Wang, Nae-Yuh; Pronovost, P

2017-11-01

Chronic Obstructive Pulmonary Disease (COPD) is a leading cause of hospitalizations. Interventional studies focusing on the hospital-to-home transition for COPD patients are few. In the BREATHE (Better Respiratory Education and Treatment Help Empower) study, we developed and tested a patient and family-centered transitional care program that helps prepare hospitalized COPD patients and their family caregivers to manage COPD at home. In the study's initial phase, we co-developed the BREATHE transitional care program with COPD patients, family-caregivers, and stakeholders. The program offers tailored services to address individual patients' needs and priorities at the hospital and for 3months post discharge. We tested the program in a single-blinded RCT with 240 COPD patients who were randomized to receive the program or 'usual care'. Program participants were offered the opportunity to invite a family caregiver, if available, to enroll with them into the study. The primary outcomes were the combined number of COPD-related hospitalizations and Emergency Department (ED) visits per participant at 6months post discharge, and the change in health-related quality of life over the 6months study period. Other measures include 'all cause' hospitalizations and ED visits; patient activation; self-efficacy; and, self-care behaviors. Unlike 1month transitional care programs that focus on patients' post-acute care needs, the BREATHE program helps hospitalized COPD patients manage the post discharge period as well as prepare them for long term self-management of COPD. If proven effective, this program may offer a timely solution for hospitals in their attempts to reduce COPD rehospitalizations. Copyright © 2017 Elsevier Inc. All rights reserved.

The Efficacy of Massage in Reducing Nodule Formation After Poly-L-Lactic Acid Administration for Facial Volume Loss: A Randomized, Evaluator-Blinded Clinical Trial.

PubMed

Wu, Douglas C; Goldman, Mitchel P

2016-11-01

The risk of nodule formation following poly-L-lactic acid (PLLA) injections for facial volume loss is well known. Traditionally, post-treatment massage according to the 5-5-5 rule (5 times per day for 5 minutes for 5 days) has been applied to mitigate this risk. However, such a regimen may be onerous for patient compliance. Using currently accepted injection technique and product dilution, the efficacy of massage for nodule prevention has never been formally evaluated. To evaluate the efficacy of massage in reducing the incidence of nodule formation post-PLLA injection. After obtaining informed consent, 20 subjects with facial lipoatrophy were enrolled in this randomized, evaluator-blinded clinical trial. Each subject was treated with 1 vial of PLLA each month for 3 months. Vials were diluted with 1 mL of 1% lidocaine and 7 ml of bacteriostatic water, shaken with a vortex and refrigerated for 24 to 48 hours before injection. Ten subjects were instructed to massage the treated areas according to the 5-5-5 rule and 10 subjects did not perform any massage post-treatment. Six-month follow-up data were collected for treatment efficacy and adverse events. No nodules were reported by subjects or detected by the blinded evaluator regardless of massage status. Significant improvements in facial lipoatrophy were detected 1, 3, and 6 months after the final treatment session and were not statistically different between the 2 groups. Using currently recommended guidelines for product preparation and injection, the application of massage post-PLLA facial treatment does not have a significant impact on nodule formation or treatment efficacy.

Helping Aged Victims of Crime (the HAVoC Study): Common Crime, Older People and Mental Illness.

PubMed

Serfaty, Marc; Ridgewell, Anna; Drennan, Vari; Kessel, Anthony; Brewin, Chris R; Leavey, Gerard; Wright, Anwen; Laycock, Gloria; Blanchard, Martin

2016-03-01

Limited data suggest that crime may have a devastating impact on older people. Although identification and treatment may be beneficial, no well-designed studies have investigated the prevalence of mental disorder and the potential benefits of individual manualized CBT in older victims of crime. To identify mental health problems in older victims of common crime, provide preliminary data on its prevalence, and conduct a feasibility randomized controlled trial (RCT) using mixed methods. Older victims, identified through police teams, were screened for symptoms of anxiety, depression or post-traumatic stress disorder (PTSD) one (n = 581) and 3 months (n = 486) after experiencing a crime. Screen positive participants were offered diagnostic interviews. Of these, 26 participants with DSM-IV diagnoses agreed to be randomized to Treatment As Usual (TAU) or TAU plus our manualized CBT informed Victim Improvement Package (VIP). The latter provided feedback on the VIP. Recruitment, assessment and intervention are feasible and acceptable. At 3 months 120/486 screened as cases, 33 had DSM-IV criteria for a psychiatric disorder; 26 agreed to be randomized to a pilot trial. There were trends in favour of the VIP in all measures except PTSD at 6 months post crime. This feasibility RCT is the first step towards improving the lives of older victims of common crime. Without intervention, distress at 3 and 6 months after a crime remains high. However, the well-received VIP appeared promising for depressive and anxiety symptoms, but possibly not posttraumatic stress disorder.

Influence of clinical baseline findings on the survival of 2 post systems: a randomized clinical trial.

PubMed

Schmitter, Marc; Rammelsberg, Peter; Gabbert, Olaf; Ohlmann, Brigitte

2007-01-01

The aim of this prospective randomized controlled trial was to evaluate the influence of clinical baseline characteristics on the survival of 2 post systems. One hundred patients needing a post were included. Half the patients received a glass fiber-reinforced post (FRP), and the other half received metal screw posts (MSP). The posts were assigned randomly. In addition to demographic data, the following parameters were recorded: type of tooth (incisor/canine versus molar/premolar), length of the post in relation to root length (percentage), extent of coronal tooth destruction (percentage), ferrule height (in millimeters), type of restoration (fixed or removable partial denture), and presence of antagonistic contacts (yes/no). After at least 1 year (mean: 13.84 months), the patients were recalled. Statistical analysis was performed using the log-rank test and Cox regression analysis. The survival rate of FRPs was 93.5%. In the MSP group, the survival rate was significantly lower (75.6%; log-rank test, P = .049). Additionally, the metal posts were associated with more unfavorable complications, for example, root fracture. The type of the tooth and the degree of coronal tooth destruction influenced the survival of MSPs, whereas no influence of these variables could be seen for FRPs. FRPs are superior to MSPs with respect to short-term clinical performance. Especially for MSPs, clinical survival depends on several variables.

Group interventions for co-morbid insomnia and osteoarthritis pain in primary care: the lifestyles cluster randomized trial design.

PubMed

Von Korff, Michael; Vitiello, Michael V; McCurry, Susan M; Balderson, Benjamin H; Moore, Amy L; Baker, Laura D; Yarbro, Patricia; Saunders, Kathleen; Keefe, Francis J; Rybarczyk, Bruce D

2012-07-01

Six weekly sessions of group cognitive-behavioral therapy for insomnia and osteoarthritis pain (CBT-PI), and for osteoarthritis pain alone (CBT-P) were compared to an education only control (EOC). Basic education about pain and sleep was comparable, so EOC controlled for information and group participation. Active interventions differed from EOC in training pain coping skills (CBT-P and CBT-PI) and sleep enhancement techniques (CBT-PI). Persons with osteoarthritis age 60 or older were screened for osteoarthritis pain and insomnia severity via mailed survey. Primary outcomes were pain severity (pain intensity and interference ratings from the Graded Chronic Pain Scale) and insomnia severity (Insomnia Severity Index). Secondary outcomes were arthritis pain (AIMS-2 symptom scale) and sleep efficiency assessed by wrist actigraphy. Ancillary outcomes included: cognitive function, depression, and health care use. A clustered randomized design provided adequate power to identify moderate effects on primary outcomes (effect size>0.35). Modified intent to treat analyses, including all participants who attended the first session, assessed effects across CBT-PI, CBT-P, and EOC groups. Treatment effects were assessed post-intervention (2 months) and at 9 months, with durability of intervention effects evaluated at 18 months. The trial was executed in 6 primary clinics, randomizing 367 participants, with 93.2% of randomized patients attending at least 4 group sessions. Response rates for post-intervention and 9 month assessments were 96.7% and 92.9% respectively. This hybrid efficacy-effectiveness trial design evaluates whether interventions yield specific benefits for clinical and behavioral outcomes relative to an education only control when implemented in a primary care setting. Copyright © 2012 Elsevier Inc. All rights reserved.

The impact of performance incentives on child health outcomes: results from a cluster randomized controlled trial in the Philippines

PubMed Central

Peabody, John W; Shimkhada, Riti; Quimbo, Stella; Solon, Orville; Javier, Xylee; McCulloch, Charles

2014-01-01

Improving clinical performance using measurement and payment incentives, including pay for performance (or P4P), has, so far, shown modest to no benefit on patient outcomes. Our objective was to assess the impact of a P4P programme on paediatric health outcomes in the Philippines. We used data from the Quality Improvement Demonstration Study. In this study, the P4P intervention, introduced in 2004, was randomly assigned to 10 community district hospitals, which were matched to 10 control sites. At all sites, physician quality was measured using Clinical Performance Vignettes (CPVs) among randomly selected physicians every 6 months over a 36-month period. In the hospitals randomized to the P4P intervention, physicians received bonus payments if they met qualifying scores on the CPV. We measured health outcomes 4–10 weeks after hospital discharge among children 5 years of age and under who had been hospitalized for diarrhoea and pneumonia (the two most common illnesses affecting this age cohort) and had been under the care of physicians participating in the study. Health outcomes data collection was done at baseline/pre-intervention and 2 years post-intervention on the following post-discharge outcomes: (1) age-adjusted wasting, (2) C-reactive protein in blood, (3) haemoglobin level and (4) parental assessment of child’s health using general self-reported health (GSRH) measure. To evaluate changes in health outcomes in the control vs intervention sites over time (baseline vs post-intervention), we used a difference-in-difference logistic regression analysis, controlling for potential confounders. We found an improvement of 7 and 9 percentage points in GSRH and wasting over time (post-intervention vs baseline) in the intervention sites relative to the control sites (P ≤ 0.001). The results from this randomized social experiment indicate that the introduction of a performance-based incentive programme, which included measurement and feedback, led to improvements in two important child health outcomes. PMID:24134922

Survival in Malnourished Older Patients Receiving Post-Discharge Nutritional Support; Long-Term Results of a Randomized Controlled Trial.

PubMed

Neelemaat, F; van Keeken, S; Langius, J A E; de van der Schueren, M A E; Thijs, A; Bosmans, J E

2017-01-01

Previous analyses have shown that a post-discharge individualized nutritional intervention had positive effects on body weight, lean body mass, functional limitations and fall incidents in malnourished older patients. However, the impact of this intervention on survival has not yet been studied. The objective of this randomized controlled study was to examine the effect of a post-discharge individualized nutritional intervention on survival in malnourished older patients. Malnourished older patients, aged ≥ 60 years, were randomized during hospitalization to a three-months post-discharge nutritional intervention group (protein and energy enriched diet, oral nutritional supplements, vitamin D3/calcium supplement and telephone counseling by a dietitian) or to a usual care regimen (control group). Survival data were collected 4 years after enrollment. Survival analyses were performed using intention-to-treat analysis by Log-rank tests and Cox regression adjusted for confounders. The study population consisted of 94 men (45%) and 116 women with a mean age of 74.5 (SD 9.5) years. There were no statistically significant differences in baseline characteristics. Survival data was available in 208 out of 210 patients. After 1 and 4 years of follow-up, survival rates were respectively 66% and 29% in the intervention group (n=104) and 73% and 30% in the control group (n=104). There were no statistically significant differences in survival between the two groups 1 year (HR= 0.933, 95% CI=0.675-1.289) and 4 years after enrollment (HR=0.928, 95% CI=0.671-1.283). The current study failed to show an effect of a three-months post-discharge multi-component nutritional intervention in malnourished older patients on long-term survival, despite the positive effects on short-term outcome such as functional limitations and falls.

Comparison of the incidence of patient-reported post-operative dysphagia between ACDF with a traditional anterior plate and artificial cervical disc replacement.

PubMed

Yang, Yi; Ma, Litai; Liu, Hao; Liu, Yilian; Hong, Ying; Wang, Beiyu; Ding, Chen; Deng, Yuxiao; Song, Yueming; Liu, Limin

2016-09-01

Compared with anterior cervical discectomy and fusion (ACDF), cervical disc replacement (CDR) has provided satisfactory clinical results. The incidence of post-operative dysphagia between ACDF with a traditional anterior plate and CDR remains controversial. Considering the limited studies and knowledge in this area, a retrospective study focusing on post-operative dysphagia was conducted. The Bazaz grading system was used to assess the severity of dysphagia at post-operative intervals including 1 week, 1 month, 3 months, 6 months, 12 months and 24 months respectively. The Chi-square test, Student t-test, Mann-Whitney U tests and Ordinal Logistic regression were used for data analysis when appropriate. Statistical significance was accepted at a probability value of <0.05. Two hundred and thirty-one patients in the CDR group and one hundred and fifty-eight patients in Plate group were included in this study. The total incidences of dysphagia in the CDR and plate group were 36.58% and 60.43% at one week, 29.27% and 38.85% at one month, 21.95% and 31.65% at three months, 6.83% and 17.99% at six months, 5.85% and 14.39% at 12 months, and 4.39% and 10.07% at the final follow-up respectively (All P<0.05, Mann-Whitney U test). Ordinal Logistic regression analysis showed that female patients, two-level surgery, C4/5 surgery, and anterior cervical plating were significant risk factors for post-operative dysphagia (all P<0.05). Comparing ACDF with a plate, CDR with a Prestige LP can significantly reduce both transient and persistent post-operative dysphagia. Female patients, two-level surgery, C4/5 surgery and anterior cervical plating were associated with a higher incidence of dysphagia. Future prospective, randomized, controlled studies are needed to further validate these findings. Copyright © 2016 Elsevier B.V. All rights reserved.

Contralaterally Controlled Functional Electrical Stimulation Improves Hand Dexterity in Chronic Hemiparesis: A Randomized Trial

PubMed Central

Knutson, Jayme S.; Gunzler, Douglas D.; Wilson, Richard D.; Chae, John

2016-01-01

Background and Purpose It is unknown whether one method of neuromuscular stimulation for post-stroke upper limb rehabilitation is more effective than another. Our aim was to compare the effects of contralaterally controlled functional electrical stimulation (CCFES) to cyclic neuromuscular electrical stimulation (cNMES). Methods Stroke patients with chronic (> 6 months) moderate to severe upper extremity hemiparesis (n=80) were randomized to receive 10 sessions/week of CCFES- or cNMES-assisted hand opening exercise at home plus 20 sessions of functional task practice in the lab over 12 weeks. The task practice for the CCFES group was stimulation-assisted. The primary outcome was change in Box and Blocks Test (BBT) score at 6-months post-treatment. Upper extremity Fugl-Meyer (UEFM) and Arm Motor Abilities Test (AMAT) were also measured. Results At 6-months post-treatment, the CCFES group had greater improvement on the BBT, 4.6 (95% CI: 2.2, 7.0), than the cNMES group, 1.8 (95% CI: 0.6, 3.0); between-group difference, 2.8 (95% CI: 0.1, 5.5), p=0.045. No significant between-group difference was found for the UEFM (p=.888) or AMAT (p=.096). Participants who had the largest improvements on BBT were less than two years post-stroke with moderate (i.e., not severe) hand impairment at baseline. Among these, the 6-month post-treatment BBT gains of the CCFES group, 9.6 (95% CI: 5.6, 13.6), were greater than those of the cNMES group, 4.1 (95% CI: 1.7, 6.5); between-group difference, 5.5 (95% CI: 0.8, 10.2), p=0.023. Conclusions CCFES improved hand dexterity more than cNMES in chronic stroke survivors. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT00891319. PMID:27608819

Pharmacological Strategies in the Prevention of Relapse Following Electroconvulsive Therapy

PubMed Central

Prudic, Joan; Haskett, Roger; McCall, W. Vaughn; Isenberg, Keith; Cooper, Thomas; Rosenquist, Peter B.; Mulsant, Benoit H.; Sackeim, Harold A.

2012-01-01

Objective To determine whether starting antidepressant medication at the start of ECT reduces postECT relapse and to determine whether continuation pharmacotherapy with nortriptyline and lithium (NT-Li) differs in efficacy or side effects from continuation pharmacotherapy with venlafaxine and lithium (VEN-Li). Method During an acute ECT phase, 319 patients were randomized to treatment with moderate dosage bilateral ECT or high dosage right unilateral ECT. They were also randomized to concurrent treatment with placebo, NT, or VEN. Of 181 patients to meet postECT remission criteria, 122 (67.4%) participated in a second continuation pharmacotherapy phase. Patients earlier randomized to NT or VEN continued on the antidepressant, while patients earlier randomized to placebo were now randomized to NT or VEN. Li was added for all patients who were followed until relapse or 6 months. Results Starting an antidepressant medication at the beginning of the ECT course did not impact on the rate or timing of relapse relative to starting pharmacotherapy after ECT completion. The combination of NT-Li did not differ from VEN-Li in any relapse or side effect measure. Older age was strongly associated with lower relapse risk, whereas the type of ECT administered in the acute phase and medication resistance were not predictive. Across sites, 50% of patients relapsed, 33.6% continued in remission 6 months postECT, and 16.4% dropped out. Conclusions Starting an antidepressant medication during ECT does not impact relapse and there are concerns about administering Li during an acute ECT course. Nortriptyline and venlafaxine were equally effective in prolonging remission, although relapse rates following ECT are substantial despite intensive pharmacology. As opposed to the usual abrupt cessation of ECT, the impact of an ECT taper should be evaluated. PMID:23303417

Does Effectiveness of Adolescent Smoking-Cessation Intervention Endure Into Young Adulthood? 7-Year Follow-Up Results from a Group-Randomized Trial.

PubMed

Peterson, Arthur V; Marek, Patrick M; Kealey, Kathleen A; Bricker, Jonathan B; Ludman, Evette J; Heffner, Jaimee L

2016-01-01

The Hutchinson Study of High School Smoking was the first randomized trial to show effectiveness of a smoking cessation intervention on 6-months prolonged smoking abstinence at one year post-intervention in a large population-based sample of adolescent smokers. An important question remains: Do the positive effects from teen smoking cessation interventions seen at up to 12 months post-intervention endure into young adulthood? This study examines for the first time whether such positive early effects from teen smoking cessation intervention can endure into young adulthood in the absence of additional intervention. High school smokers (n = 2,151) were proactively recruited into the trial from fifty randomly selected Washington State high schools randomized to the experimental (Motivational Interviewing + Cognitive Behavioral Skills Training telephone counseling intervention) or control (no intervention) condition. These smokers were followed to 7 years post high school to ascertain rates of six-year prolonged smoking abstinence in young adulthood. All statistical tests are two-sided. No evidence of intervention impact at seven years post high school was observed for the main endpoint of six-year prolonged abstinence, neither among all smokers (14.2% in the experimental condition vs. 13.1% in the control condition, difference = +1.1%, 95% confidence interval (CI) = -3.4 to 5.8, p = .61), nor among the subgroups of daily smokers and less-than-daily smokers, nor among other a priori subgroups. But, observed among males was some evidence of an intervention impact on two endpoints related to progress towards quitting: reduction in number of days smoked in the past month, and increase in the length of the longest quit attempt in the past year. There was no evidence from this trial among adolescent smokers that positive effectiveness of the proactive telephone intervention for smoking abstinence, observed previously at one year post-intervention, was sustained for the long-term into young adulthood. In light of the positive short-term effectiveness consistently observed from this and other trials for teen smokers, together with the lack of evidence from this study that such short-term impact can endure into young adulthood, sustained interventions that continue into young adulthood should be developed and tested for long-term impact. ClinicalTrials.gov NCT00115882.

A Single-Blind randomized controlled trial to evaluate the effect of extended counseling on uptake of pre-antiretroviral care in eastern uganda

PubMed Central

2011-01-01

Background Many newly screened people living with HIV (PLHIV) in Sub-Saharan Africa do not understand the importance of regular pre-antiretroviral (ARV) care because most of them have been counseled by staff who lack basic counseling skills. This results in low uptake of pre-ARV care and late treatment initiation in resource-poor settings. The effect of providing post-test counseling by staff equipped with basic counseling skills, combined with home visits by community support agents on uptake of pre-ARV care for newly diagnosed PLHIV was evaluated through a randomized intervention trial in Uganda. Methods An intervention trial was performed consisting of post-test counseling by trained counselors, combined with monthly home visits by community support agents for continued counseling to newly screened PLHIV in Iganga district, Uganda between July 2009 and June 2010, Participants (N = 400) from three public recruitment centres were randomized to receive either the intervention, or the standard care (the existing post-test counseling by ARV clinic staff who lack basic training in counseling skills), the control arm. The outcome measure was the proportion of newly screened and counseled PLHIV in either arm who had been to their nearest health center for clinical check-up in the subsequent three months +2 months. Treatment was randomly assigned using computer-generated random numbers. The statistical significance of differences between the two study arms was assessed using chi-square and t-tests for categorical and quantitative data respectively. Risk ratios and 95% confidence intervals were used to assess the effect of the intervention. Results Participants in the intervention arm were 80% more likely to accept (take up) pre-ARV care compared to those in the control arm (RR 1.8, 95% CI 1.4-2.1). No adverse events were reported. Conclusions Provision of post-test counseling by staff trained in basic counseling skills, combined with home visits by community support agents had a significant effect on uptake of pre-ARV care and appears to be a cost-effective way to increase the prerequisites for timely ARV initiation. Trial registration The trial was registered by Current Controlled Trials Ltd C/OBioMed Central Ltd as ISRCTN94133652 and received financial support from Sida and logistical support from the European Commission. PMID:21794162

Mediation of Short and Longer Term Effects of an Intervention Program to Enhance Resilience in Immigrants from Mainland China to Hong Kong

PubMed Central

Yu, Nancy X.; Lam, T. H.; Liu, Iris K. F.; Stewart, Sunita M.

2015-01-01

Few clinical trials report on the active intervention components that result in outcome changes, although this is relevant to further improving efficacy and adapting effective programs to other populations. This paper presents follow-up analyses of a randomized controlled trial to enhance adaptation by increasing knowledge and personal resilience in two separate brief interventions with immigrants from Mainland China to Hong Kong (Yu et al., 2014b). The present paper extends our previous one by reporting on the longer term effect of the interventions on personal resilience, and examining whether the Resilience intervention worked as designed to enhance personal resilience. The four-session intervention targeted at self-efficacy, positive thinking, altruism, and goal setting. In this randomized controlled trial, 220 immigrants were randomly allocated to three arms: Resilience, Information (an active control arm), and Control arms. Participants completed measures of the four active components (self-efficacy, positive thinking, altruism, and goal setting) at baseline and immediately after the intervention. Personal resilience was assessed at baseline, post-intervention, and 3- and 6-month follow-ups. The results showed that the Resilience arm had greater increases in the four active components post-intervention. Changes in each of the four active components at the post-intervention assessment mediated enhanced personal resilience at the 3-month follow-up in the Resilience arm. Changes in self-efficacy and goal setting showed the largest effect size, and altruism showed the smallest. The arm effects of the Resilience intervention on enhanced personal resilience at the 6-month follow-up were mediated by increases of personal resilience post-intervention (Resilience vs. Control) and at the 3-month follow-up (Resilience vs. Information). These findings showed that these four active components were all mediators in this Resilience intervention. Our results of the effects of short term increases in personal resilience on longer term increase in personal resilience in some models suggest how changes in intervention outcomes might persist over time. PMID:26640446

Effects of mental health interventions for students in higher education are sustainable over time: a systematic review and meta-analysis of randomized controlled trials.

PubMed

Winzer, Regina; Lindberg, Lene; Guldbrandsson, Karin; Sidorchuk, Anna

2018-01-01

Symptoms of depression, anxiety, and distress are more common in undergraduates compared to age-matched peers. Mental ill health among students is associated with impaired academic achievement, worse occupational preparedness, and lower future occupational performance. Research on mental health promoting and mental ill health preventing interventions has shown promising short-term effects, though the sustainability of intervention benefits deserve closer attention. We aimed to identify, appraise and summarize existing data from randomized control trials (RCTs) reporting on whether the effects of mental health promoting and mental ill health preventing interventions were sustained at least three months post-intervention, and to analyze how the effects vary for different outcomes in relation to follow-up length. Further, we aimed to assess whether the effect sustainability varied by intervention type, study-level determinants and of participant characteristics. A systematic search in MEDLINE, PsycInfo, ERIC, and Scopus was performed for RCTs published in 1995-2015 reporting an assessment of mental ill health and positive mental health outcomes for, at least, three months of post-intervention follow-up. Random-effect modeling was utilized for quantitative synthesis of the existing evidence with standardized mean difference (Hedges' g ) used to estimate an aggregated effect size. Sustainability of the effects of interventions was analyzed separately for 3-6 months, 7-12 months, and 13-18 months of post-intervention follow-up. About 26 studies were eligible after reviewing 6,571 citations. The pooled effects were mainly small, but significant for several categories of outcomes. Thus, for the combined mental ill health outcomes, symptom-reduction sustained up to 7-12 months post-intervention (standardized mean difference (Hedges' g ) effect size (ES) = -0.28 (95% CI [-0.49, -0.08])). Further, sustainability of symptom-reductions were evident for depression with intervention effect lasting up to 13-18 months (ES = -0.30 (95% CI [-0.51, -0.08])), for anxiety up to 7-12 months (ES = -0.27 (95% CI [-0.54, -0.01])), and for stress up to 3-6 months (ES = -0.30 (95% CI [-0.58, -0.03])). The effects of interventions to enhance positive mental health were sustained up to 3-6 months for the combined positive mental health outcomes (ES = 0.32 (95% CI [0.05, 0.59])). For enhanced active coping, sustainability up to 3-6 months was observed with a medium and significant effect (ES = 0.75 (95% CI [0.19, 1.30])). The evidence suggests long-term effect sustainability for mental ill health preventive interventions, especially for interventions to reduce the symptoms of depression and symptoms of anxiety. Interventions to promote positive mental health offer promising, but shorter-lasting effects. Future research should focus on mental health organizational interventions to examine their potential for students in tertiary education.

Effects of prophylactic ibuprofen and paracetamol administration on the immunogenicity and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugated vaccine (PHiD-CV) co-administered with DTPa-combined vaccines in children: An open-label, randomized, controlled, non-inferiority trial.

PubMed

Falup-Pecurariu, Oana; Man, Sorin C; Neamtu, Mihai L; Chicin, Gratiana; Baciu, Ginel; Pitic, Carmen; Cara, Alexandra C; Neculau, Andrea E; Burlea, Marin; Brinza, Ileana L; Schnell, Cristina N; Sas, Valentina; Lupu, Valeriu V; François, Nancy; Swinnen, Kristien; Borys, Dorota

2017-03-04

Prophylactic paracetamol administration impacts vaccine immune response; this study ( www.clinicaltrials.gov : NCT01235949) is the first to assess PHiD-CV immunogenicity following prophylactic ibuprofen administration. In this phase IV, multicenter, open-label, randomized, controlled, non-inferiority study in Romania (November 2010-December 2012), healthy infants were randomized 3:3:3:1:1:1 to prophylactically receive immediate, delayed or no ibuprofen (IIBU, DIBU, NIBU) or paracetamol (IPARA, DPARA, NPARA) after each of 3 primary doses (PHiD-CV at age 3/4/5 months co-administered with DTPa-HBV-IPV/Hib at 3/5 and DTPa-IPV/Hib at 4 months) or booster dose (PHiD-CV and DTPa-HBV-IPV/Hib; 12-15 months). Non-inferiority of immune response one month post-primary vaccination in terms of percentage of infants with anti-pneumococcal antibody concentrations ≥0.2 µg/mL (primary objective) was demonstrated if the upper limit (UL) of the 98.25% confidence interval of difference between groups (NIBU vs IIBU, NIBU vs DIBU) was <10% for ≥7/10 serotypes. Immunogenicity and reactogenicity/safety were evaluated, including confirmatory analysis of difference in fever incidences post-primary vaccination in IBU or DIBU group compared to NIBU. Of 850 infants randomized, 812 were included in the total vaccinated cohort. Non-inferiority was demonstrated for both comparisons (UL was <10% for 9/10 vaccine serotypes; exceptions: 6B [NIBU], 23F [IIBU]). However, fever incidence post-primary vaccination in the IIBU and DIBU groups did not indicate a statistically significant reduction. Prophylactic administration (immediate or delayed) of paracetamol decreased fever incidence but seemed to reduce immune response to PHiD-CV, except when given only at booster. Twenty-seven serious adverse events were reported for 15 children; all resolved and were not vaccination-related.

Randomized Trial of ConquerFear: A Novel, Theoretically Based Psychosocial Intervention for Fear of Cancer Recurrence.

PubMed

Butow, Phyllis N; Turner, Jane; Gilchrist, Jemma; Sharpe, Louise; Smith, Allan Ben; Fardell, Joanna E; Tesson, Stephanie; O'Connell, Rachel; Girgis, Afaf; Gebski, Val J; Asher, Rebecca; Mihalopoulos, Cathrine; Bell, Melanie L; Zola, Karina Grunewald; Beith, Jane; Thewes, Belinda

2017-12-20

Purpose Fear of cancer recurrence (FCR) is prevalent, distressing, and long lasting. This study evaluated the impact of a theoretically/empirically based intervention (ConquerFear) on FCR. Methods Eligible survivors had curable breast or colorectal cancer or melanoma, had completed treatment (not including endocrine therapy) 2 months to 5 years previously, were age > 18 years, and had scores above the clinical cutoff on the FCR Inventory (FCRI) severity subscale at screening. Participants were randomly assigned at a one-to-one ratio to either five face-to-face sessions of ConquerFear (attention training, metacognitions, acceptance/mindfulness, screening behavior, and values-based goal setting) or an attention control (Taking-it-Easy relaxation therapy). Participants completed questionnaires at baseline (T0), immediately post-therapy (T1), and 3 (T2) and 6 months (T3) later. The primary outcome was FCRI total score. Results Of 704 potentially eligible survivors from 17 sites and two online databases, 533 were contactable, of whom 222 (42%) consented; 121 were randomly assigned to intervention and 101 to control. Study arms were equivalent at baseline on all measured characteristics. ConquerFear participants had clinically and statistically greater improvements than control participants from T0 to T1 on FCRI total ( P < .001) and severity subscale scores ( P = .001), which were maintained at T2 ( P = .017 and P = .023, respectively) and, for FCRI total only, at T3 ( P = .018), and from T0 to T1 on three FCRI subscales (coping, psychological distress, and triggers) as well as in general anxiety, cancer-specific distress (total), and mental quality of life and metacognitions (total). Differences in FCRI psychological distress and cancer-specific distress (total) remained significantly different at T3. Conclusion This randomized trial demonstrated efficacy of ConquerFear compared with attention control (Taking-it-Easy) in reduction of FCRI total scores immediately post-therapy and 3 and 6 months later and in many secondary outcomes immediately post-therapy. Cancer-specific distress (total) remained more improved at 3- and 6-month follow-up.

Effectiveness of the first French psychoeducational program on unipolar depression: study protocol for a randomized controlled trial.

PubMed

Ducasse, Déborah; Courtet, Philippe; Sénèque, Maude; Genty, Catherine; Picot, Marie-Christine; Schwan, Raymund; Olié, Emilie

2015-11-17

Major Depressive Disorder (MDD) is highly prevalent and was associated with greater morbidity, mortality (including suicide), and healthcare costs. By 2030, MDD will become the leading cause of disability in high-income countries. Notably, among patients with a previous experience of a major depressive episode, it was indeed estimated that up to 85 % of those patients will suffer from relapse. Two main factors were associated with a significantly higher risk of relapse: poor medication adherence and low self-efficacy in disease management. Interestingly, these issues could become the targets of psychoeducational programs for chronic diseases. Indded psychoeducational program for depression are recommended in international guidelines, but have not yet been proposed in France. We propose to evaluate the first French psychoeducational program for depression "ENVIE" in a multicenter randomized controlled trial. The group intervention will include 9 weekly sessions. Its aim is to educate patients on the latest knowledge on depression and effective treatments through didactic and interactive sessions. Patients will experiment the latest innovating psychological skills (from acceptance and commitment therapy) to cope with depressive symptoms and maintain motivation in behavioral activation. In total, 332 unipolar non-chronic (<2 years) outpatients with moderate to severe depression, without psychotic features, will be randomly allocated to the add-on ENVIE program (N = 166) or to a waiting list (N = 166). The follow-up will last 15 months and include 5 assessment visits. The primary endpoint will be the remission rate of the index episode at 15 months post-inclusion, defined by a Montgomery and Asberg Depression Rating Scale (MADRS) score ≤ 12 over an 8-week period, and without relapse during follow-up. We will also assess the response rate and relapse at 15 months post-inclusion, hospitalization rate and adherence to treatment during the follow-up period, quality of life and global functioning upon inclusion and at 9 and 15 months post inclusion. If the proposed trial shows the effectiveness of the intervention, but also an increased remission rate in depressed outpatients at 15-months post-inclusion, in addition to improved treatment adherence in patients, it will further promotes arguments in favor of a wide dissemination of psychoeducational programs for depression. This trial is registered under number 2015-A00249-40 (PURE clinical trial: NCT02501226 ) (June 30th, 2015).

A randomized trial of internet-based versus traditional sexual counseling for couples after localized prostate cancer treatment.

PubMed

Schover, Leslie R; Canada, Andrea L; Yuan, Ying; Sui, Dawen; Neese, Leah; Jenkins, Rosell; Rhodes, Michelle M

2012-01-15

After treatment for prostate cancer, multidisciplinary sexual rehabilitation involving couples appears more promising than traditional urologic treatment for erectile dysfunction (ED). The authors of this report conducted a randomized trial comparing traditional or internet-based sexual counseling with waitlist (WL) control. Couples were randomized adaptively to a 3-month WL, a 3-session face-to-face format (FF), or an internet-based format (WEB1). A second internet-based group (WEB2) was added to examine the relation between web site use and outcomes. At baseline, post-WL, post-treatment, and 6-month, and 12-month follow-up assessments, participants completed the International Index of Erectile Function (IIEF), the Female Sexual Function Index (FSFI), the Brief Symptom Inventory-18 to measure emotional distress, and the abbreviated Dyadic Adjustment Scale. Outcomes did not change during the WL period. Of 115 couples that were randomized to FF or WEB1 and 71 couples in the WEB2 group, 34% dropped out. Neither drop-outs nor improvements in outcomes differed significantly between the 3 treatment groups. In a linear mixed-model analysis that included all participants, mean ± standard deviation IIEF scores improved significantly across time (baseline, 29.7 ± 17.9; 12 months, 36.2 ± 22.4; P < .001). FSFI scores also improved significantly (baseline, 15.4 ± 8.5; 12 months, 18.2 ± 10.7; P = .034). Better IIEF scores were associated with finding an effective medical treatment for ED and normal female sexual function at baseline. In the WEB2 group, IIEF scores improved significantly more in men who completed >75% of the intervention. An internet-based sexual counseling program for couples was as effective as a brief, traditional sex therapy format in producing enduring improvements in sexual outcomes after prostate cancer. Copyright © 2011 American Cancer Society.

Effects of cryoanalgesia on post-thoracotomy pain and on the structure of intercostal nerves: a human prospective randomized trial and a histological study.

PubMed

Moorjani, N; Zhao, F; Tian, Y; Liang, C; Kaluba, J; Maiwand, M O

2001-09-01

The choice of analgesia in the management of post-thoracotomy pain remains controversial. Although several alternative forms of post-thoracotomy analgesia exist, all have their disadvantages. Cryoanalgesia, localized freezing of intercostal nerves, has been reported to have variable effectiveness and an incidence of long-term cutaneous sensory changes. We carried out an animal study to assess the reversibility of histological changes induced by cryoanalgesia and a prospective randomized trial to compare the effectiveness of cryoanalgesia with conventional analgesia (parenteral opiates). In six anaesthetized dogs, intercostal nerves were exposed to a varying duration of cryo-application (30, 60, 90 and 120 s). The nerves were biopsied and examined histologically at regular intervals over the following 6 months. In the clinical study, 200 consecutive patients undergoing thoracotomy were randomized to cryoanalgesia and conventional (parenteral opiates) analgesia groups. Postoperative pain scores, respiratory function tests and use of opiate analgesia were measured for the two groups. Following application of the cryoprobe, degeneration and fragmentation of the axons was evident with associated inflammatory changes. As the endoneurium remained intact, axonal regeneration took place after the resolution of axonal swelling. Over the course of weeks, recovery of the intercostal nerve occurred and was complete after 1 month for the 30 and 60 s groups. For nerves exposed to longer durations of cryoanalgesia, the time taken for complete recovery was proportionally increased. Clinically, there was a statistically significant (P<0.05) improvement in postoperative pain scores and use of opiate analgesia and an improvement (P>0.05) in respiratory function tests for patients in the cryoanalgesia group. The previously suggested cutaneous sensory changes resolved within 6 months with complete restoration of function. We suggest that cryoanalgesia be considered as a simple, inexpensive, long-term form of post-thoracotomy pain relief, which does not cause any long-term histological damage to intercostal nerves.

A randomized placebo-controlled clinical trial of five smoking cessation pharmacotherapies

PubMed Central

Piper, Megan E.; Smith, Stevens S.; Schlam, Tanya R.; Fiore, Michael C.; Jorenby, Douglas E.; Fraser, David; Baker, Timothy B.

2010-01-01

Context Little direct evidence exists on the relative efficacies of different smoking cessation pharmacotherapies, yet such evidence is needed to make informed decisions about their clinical use. Objective The primary objective of this research was to assess the relative efficacies of five smoking cessation pharmacotherapy interventions using placebo-controlled, head-to-head comparisons. Design This was a randomized double-blind, placebo-controlled clinical trial. Setting Smokers were recruited from the community at two urban research sites. Patients Participants were 1504 adult smokers who smoked at least 10 cigarettes per day during the past 6 months and reported being motivated to quit smoking. Participants were excluded if they reported: using any form of tobacco other than cigarettes; current use of bupropion; having a current psychosis or schizophrenia diagnosis; or having medical contraindications for any of the study medications. Interventions Participants were randomized to one of six treatment conditions: nicotine lozenge, nicotine patch, bupropion SR, nicotine patch + nicotine lozenge, bupropion + nicotine lozenge or placebo. In addition, all participants received six individual counseling sessions. Main Outcome Measures The main outcome measures were biochemically-confirmed 7-day point-prevalence abstinence assessed at 1 week post-quit, end of treatment (8 weeks post-quit) and 6 months post-quit. Other outcomes were initial cessation, number of days to lapse, number of days to relapse, and latency to relapse after the first lapse. Results All pharmacotherapies differed from placebo when examined without protection for multiple comparisons (OR’s = 1.63–2.34). With such protection, only the nicotine patch + nicotine lozenge (OR = 2.34, p < .001) produced significantly higher abstinence rates at 6-months post-quit than did placebo. Conclusions While the nicotine lozenge, bupropion, and bupropion + lozenge produced effects that were comparable to those reported in previous research, the nicotine patch + lozenge produced the greatest benefit relative to placebo for smoking cessation. PMID:19884613

Post-wildfire management effects on short-term evolution of soil properties (Catalonia, Spain, SW-Europe).

PubMed

Francos, Marcos; Pereira, Paulo; Alcañiz, Meritxell; Úbeda, Xavier

2018-08-15

Post-fire management practices after wildfires have an important impact on soil properties. Nevertheless, little research has been carried out. The aim of this study is to examine the impact of different post-wildfire forest management practices in a 10-month period immediately after a severe wildfire on soil properties. Two months after a wildfire, three experimental areas were designed, each one with different post-fire management: Cut and Remove (CR) where burned trunks were cut after fire and removed manually from the area; No Treatment (NT) where no intervention was carried out; and, Cut and Leave (CL) where burned trunks were cut and left randomly on topsoil. In each treatment, we collected nine samples (0-5cm deep). In total, we sampled 27 samples in each sampling date, two and ten months after the wildfire. The properties analyzed were aggregate stability (AS), total nitrogen (TN), soil organic matter (SOM), inorganic carbon (IC), C/N ratio, pH, electrical conductivity (EC), extractable calcium (Ca), magnesium (Mg), sodium (Na) and potassium (K). Soil C/N ratio was significantly higher in CR and CL treatments 10months after fire comparing to 2months after. On the other hand, pH, extractable Ca, Mg and K were significantly higher in all the treatments 2months after fire than 10months after. Aggregate stability, TN and SOM were significantly higher in CR comparing to CL, 10months after the fire. IC was significantly higher in CL than in NT treatment, also, 10months after the fire. Electrical conductivity was significantly higher in CR and CL treatments 2months after fire comparing to 10months after. According to the results, CR and CL post-fire management did not differ importantly from the NT scenario, showing that manual wood management does not have detrimental impacts on soil properties compared to mechanical operations. Copyright © 2018 Elsevier B.V. All rights reserved.

Healing the heart: a randomized pilot study of a spiritual retreat for depression in acute coronary syndrome patients.

PubMed

Warber, Sara L; Ingerman, Sandra; Moura, Vera L; Wunder, Jenna; Northrop, Alyssa; Gillespie, Brenda W; Durda, Kate; Smith, Katherine; Rhodes, Katherine S; Rubenfire, Melvyn

2011-01-01

Depression is associated with increased risk of cardiovascular morbidity and mortality in coronary heart disease. Numerous conventional and complementary therapies may address depression. Few involving spirituality have been tested. The aim of this study was to compare the effects of a nondenominational spiritual retreat, Medicine for the Earth (MFTE), on depression and other measures of well-being six- to 18-months post acute coronary syndrome (ACS). A randomized controlled pilot study of MFTE, Lifestyle Change Program (LCP), or usual cardiac care (control) was conducted in Southeastern Michigan. ACS patients were recruited via local and national advertising (n = 58 enrolled, 41 completed). The four-day MFTE intervention included guided imagery, meditation, drumming, journal writing, and nature-based activities. The four-day LCP included nutrition education, exercise, and stress management. Both retreat groups received follow-up phone coaching biweekly for three months. Validated self-report scales of depression, spiritual well-being, perceived stress, and hope were collected at baseline, immediately post-retreat, and at three and six months. Depression was not significantly different among groups (P = .21). However, the MFTE group had the highest depression scores at baseline and had significantly lower scores at all postintervention time points (P ≤ .002). Hope significantly improved among MFTE participants, an effect that persisted at three- and six-month follow-up (P = .014). Although several measures showed improvement in all groups by six months, the MFTE group had immediate improvement post-retreat, which was maintained. This pilot study shows that a nondenominational spiritual retreat, MFTE, can be used to increase hope while reducing depression in patients with ACS. Copyright © 2011 Elsevier Inc. All rights reserved.

Impact of a Behavioral Weight Loss Intervention on Comorbidities in Overweight and Obese Breast Cancer Survivors

PubMed Central

Sedjo, Rebecca L.; Flatt, Shirley W.; Byers, Tim; Colditz, Graham A.; Demark-Wahnefried, Wendy; Ganz, Patricia A.; Wolin, Kathleen Y.; Elias, Anthony; Krontiras, Helen; Liu, Jingxia; Naughton, Michael; Pakiz, Bilgé; Parker, Barbara A.; Wyatt, Holly; Rock, Cheryl L.

2017-01-01

Purpose Comorbid medical conditions are common among breast cancer survivors, contribute to poorer long-term survival and increased overall mortality, and may be ameliorated by weight loss. This secondary analysis evaluated the impact of a weight loss intervention on comorbid medical conditions immediately following an intervention (12-months) and one-year post-intervention (24-month) using data from the Exercise and Nutrition to Enhance Recovery and Good health for You (ENERGY) trial – a phase III trial which was aimed at and successfully promoted weight loss. Methods ENERGY randomized 692 overweight/obese women who had completed treatment for early stage breast cancer to either a one-year group-based behavioral intervention designed to achieve and maintain weight loss or to a less intensive control intervention. Minimal support was provided post-intervention. New medical conditions, medical conditions in which non-cancer medications were prescribed, hospitalizations, and emergency room visits were compared at baseline, year 1 and 2. Changes over time were analyzed using chi-squared tests, Kaplan-Meier and logistic regression analyses. Results At 12 months, women randomized to the intervention had fewer new medical conditions compared to the control group (19.6% vs. 32.2%, p<0.001); however, by 24 months, there was no longer a significant difference. No difference was observed in each of four conditions for which non-cancer medications were prescribed, hospital visits, or emergency visits at either 12 or 24 months. Conclusions These results support a short-term benefit of modest weight loss on the likelihood of comorbid conditions; however, recidivism and weight regain likely explain no benefit at one-year post-intervention follow-up. PMID:26945570

Improving Adherence to Secondary Stroke Prevention Strategies Through Motivational Interviewing: Randomized Controlled Trial.

PubMed

Barker-Collo, Suzanne; Krishnamurthi, Rita; Witt, Emma; Feigin, Valery; Jones, Amy; McPherson, Kathryn; Starkey, Nicola; Parag, Varsha; Jiang, Yannan; Barber, P Alan; Rush, Elaine; Bennett, Derrick; Aroll, Bruce

2015-12-01

Stroke recurrence rates are high (20%-25%) and have not declined over past 3 decades. This study tested effectiveness of motivational interviewing (MI) for reducing stroke recurrence, measured by improving adherence to recommended medication and lifestyle changes compared with usual care. Single-blind, prospective phase III randomized controlled trial of 386 people with stroke assigned to either MI treatment (4 sessions at 28 days, 3, 6, and 9 months post stroke) or usual care; with outcomes assessed at 28 days, 3, 6, 9, and 12 months post stroke. Primary outcomes were change in systolic blood pressure and low-density lipoprotein cholesterol levels as indicators of adherence at 12 months. Secondary outcomes included self-reported adherence, new stroke, or coronary heart disease events (both fatal and nonfatal); quality of life (Short Form-36); and mood (Hospital Anxiety and Depression Scale). MI did not significantly change measures of blood pressure (mean difference in change, -0.2.35 [95% confidence interval, -6.16 to 1.47]) or cholesterol (mean difference in change, -0.0.12 [95% confidence interval, -0.30 to 0.06]). However, it had positive effects on self-reported medication adherence at 6 months (1.979; 95% confidence interval, 0.98-3.98; P=0.0557) and 9 months (4.295; 95% confidence interval, 1.56-11.84; P=0.0049) post stroke. Improvement across other measures was also observed, but the differences between MI and usual care groups were not statistically significant. MI improved self-reported medication adherence. All other effects were nonsignificant, though in the direction of a treatment effect. Further study is required to determine whether MI leads to improvement in other important areas of functioning (eg, caregiver burden). URL: http://www.anzctr.org.au. Unique identifier: ACTRN-12610000715077. © 2015 American Heart Association, Inc.

Topical Mitomycin C in functional endoscopic sinus surgery.

PubMed

Venkatraman, Vaidyanathan; Balasubramanian, Deepak; Gopalakrishnan, Suria; Saxena, Sunil Kumar; Shanmugasundaram, Nirmal

2012-07-01

In recent literature, there has been an interest in the use of Mitomycin C to reduce post-operative complications following endoscopic sinus surgery. We report our results on a prospective, randomized controlled trial involving 50 patients with chronic bilateral rhino sinusitis. We eliminated various confounding factors by studying a single group of patients, with symmetrical disease, without pre-existing gross anatomical abnormalities. Patients requiring revision sinus surgery were excluded. On completion of the surgery, a cotton pledget soaked in Mitomycin C was placed in one nostril (test) and saline-soaked pledget (control) was placed in the other side of the nose, both in the middle meatus. The side of the nasal cavity receiving the topical Mitomycin C was randomized. The patients were assessed periodically (first week, first month, third month and sixth month) for synechiae formation and presence or absence of their symptoms. At the first week follow up, there was a statistically significant difference in the incidence of synechiae between the saline and Mitomycin C side. Furthermore, there was a statistically significant improvement with regards to patient symptoms (nasal block and discharge) in the Mitomycin C side when compared to the saline side. At the third and sixth month, there was no difference between the two groups. The incidence of adverse tissue reaction (granulation, discharge, polypoidal mucosa and crusting) was less in the Mitomycin C side when compared to the saline side at the first month follow up. Topically applied Mitomycin C reduces the incidence of synechiae in the immediate post-operative period in patients undergoing endoscopic sinus surgery. There is also an improvement in nasal obstruction and discharge with a reduction in the incidence of adverse tissue reaction in the early post-operative period.

Efficacy of an HIV/STI Sexual Risk-Reduction Intervention for African American Adolescent Girls in Juvenile Detention Centers: A Randomized Controlled Trial

PubMed Central

DiClemente, Ralph J.; Davis, Teaniese L.; Swartzendruber, Andrea; Fasula, Amy M.; Boyce, Lorin; Gelaude, Deborah; Gray, Simone C.; Hardin, James; Rose, Eve; Carry, Monique; Sales, Jessica M.; Brown, Jennifer L.; Staples-Horne, Michelle

2014-01-01

Background Few HIV/STI interventions exist for African American adolescent girls in juvenile detention. Objective The objective was to evaluate the efficacy of an intervention to reduce incident STIs, improve HIV-preventive behaviors, and enhance psychosocial outcomes. Methods We conducted a randomized controlled trial among African American adolescent girls (13-17 years, N=188) in juvenile detention from March 2011 to May 2012. Assessments occurred at baseline and 3- and 6-months post-randomization and included: audio computer-assisted self-interview, condom skills assessment, and self-collected vaginal swab to detect Chlamydia and gonorrhea. Intervention The Imara intervention included three individual-level sessions and four phone sessions; expedited partner therapy was offered to STI-positive adolescents. The comparison group received the usual care provided by the detention center: STI testing, treatment and counseling. Results At the 6-month assessment (3-months post-intervention) Imara participants reported higher condom use self-efficacy (p<0.001), HIV/STI knowledge (p<0.001), and condom use skills (p<0.001) compared to control participants. No significant differences were observed between trial conditions in incident Chlamydia or gonorrhea infections, condom use, or number of vaginal sex partners. Conclusions Imara for detained African American adolescent girls can improve condom use skills and psychosocial outcomes; however, a critical need for interventions to reduce sexual risk remains. PMID:25190056

Efficacy of an HIV/STI sexual risk-reduction intervention for African American adolescent girls in juvenile detention centers: a randomized controlled trial.

PubMed

DiClemente, Ralph J; Davis, Teaniese L; Swartzendruber, Andrea; Fasula, Amy M; Boyce, Lorin; Gelaude, Deborah; Gray, Simone C; Hardin, James; Rose, Eve; Carry, Monique; Sales, Jessica M; Brown, Jennifer L; Staples-Horne, Michelle

2014-01-01

Few HIV/STI interventions exist for African American adolescent girls in juvenile detention. The objective was to evaluate the efficacy of an intervention to reduce incident STIs, improve HIV-preventive behaviors, and enhance psychosocial outcomes. We conducted a randomized controlled trial among African American adolescent girls (13-17 years, N = 188) in juvenile detention from March 2011 to May 2012. Assessments occurred at baseline and 3- and 6-months post-randomization and included: audio computer-assisted self-interview, condom skills assessment, and self-collected vaginal swab to detect Chlamydia and gonorrhea. The Imara intervention included three individual-level sessions and four phone sessions; expedited partner therapy was offered to STI-positive adolescents. The comparison group received the usual care provided by the detention center: STI testing, treatment, and counseling. At the 6-month assessment (3-months post-intervention), Imara participants reported higher condom use self-efficacy (p < 0.001), HIV/STI knowledge (p < 0.001), and condom use skills (p < 0.001) compared to control participants. No significant differences were observed between trial conditions in incident Chlamydia or gonorrhea infections, condom use, or number of vaginal sex partners. Imara for detained African American adolescent girls can improve condom use skills and psychosocial outcomes; however, a critical need for interventions to reduce sexual risk remains.

Randomized, Double-Blind, Placebo-Controlled Study on Decolonization Procedures for Methicillin-Resistant Staphylococcus aureus (MRSA) among HIV-Infected Adults

PubMed Central

Weintrob, Amy; Bebu, Ionut; Agan, Brian; Diem, Alona; Johnson, Erica; Lalani, Tahaniyat; Wang, Xun; Bavaro, Mary; Ellis, Michael; Mende, Katrin; Crum-Cianflone, Nancy

2015-01-01

Background HIV-infected persons have increased risk of MRSA colonization and skin and soft-tissue infections (SSTI). However, no large clinical trial has examined the utility of decolonization procedures in reducing MRSA colonization or infection among community-dwelling HIV-infected persons. Methods 550 HIV-infected adults at four geographically diverse US military HIV clinics were prospectively screened for MRSA colonization at five body locations every 6 months during a 2-year period. Those colonized were randomized in a double-blind fashion to nasal mupirocin (Bactroban) twice daily and hexachlorophene (pHisoHex) soaps daily for 7 days compared to placeboes similar in appearance but without specific antibacterial activity. The primary endpoint was MRSA colonization at 6-months post-randomization; secondary endpoints were time to MRSA clearance, subsequent MRSA infections/SSTI, and predictors for MRSA clearance at the 6-month time point. Results Forty-nine (9%) HIV-infected persons were MRSA colonized and randomized. Among those with 6-month colonization data (80% of those randomized), 67% were negative for MRSA colonization in both groups (p = 1.0). Analyses accounting for missing 6-month data showed no significant differences could have been achieved. In the multivariate adjusted models, randomization group was not associated with 6-month MRSA clearance. The median time to MRSA clearance was similar in the treatment vs. placebo groups (1.4 vs. 1.8 months, p = 0.35). There was no difference on subsequent development of MRSA infections/SSTI (p = 0.89). In a multivariable model, treatment group, demographics, and HIV-specific factors were not predictive of MRSA clearance at the 6-month time point. Conclusion A one-week decolonization procedure had no effect on MRSA colonization at the 6-month time point or subsequent infection rates among community-dwelling HIV-infected persons. More aggressive or novel interventions may be needed to reduce the burden of MRSA in this population. Trial Registration ClinicalTrials.gov NCT00631566 PMID:26018036

A store-based intervention to increase fruit and vegetable consumption: The El Valor de Nuestra Salud cluster randomized controlled trial

PubMed Central

Ayala, Guadalupe X.; Baquero, Barbara; Pickrel, Julie L.; Mayer, Joni; Belch, George; Rock, Cheryl L.; Linnan, Laura; Gittelsohn, Joel; Sanchez-Flack, Jennifer; Elder, John P.

2015-01-01

Introduction Most evidence-based interventions to improve fruit and vegetable (FV) consumption target individual behaviors and family systems; however, these changes are difficult to sustain without environmental support. This paper describes an innovative social and structural food store-based intervention to increase availability and accessibility of FVs in tiendas (small-to medium-sized Latino food stores) and purchasing and consumption of FVs among tienda customers. Methods Using a cluster randomized controlled trial with 16 tiendas pair-matched and randomized to an intervention or wait-list control condition, this study will evaluate a 2-month intervention directed at tiendas, managers, and employees followed by a 4-month customer-directed food marketing campaign. The intervention involves social (e.g., employee trainings) and structural (e.g., infrastructure) environmental changes. Three hundred sixty-nine customers (approximately 23 per tienda) serve on an evaluation cohort and complete assessments (interviews and measurements of weight) at 3 time points: baseline, 6-months post-baseline, and 12-months post-baseline. The primary study outcome is customer-reported daily consumption of FVs. Manager interviews and monthly tienda audits and collection of sales data will provide evidence of tienda-level intervention effects, our secondary outcomes. Process evaluation methods assess dose delivered, dose received, and fidelity. Results Recruitment of tiendas, managers, employees, and customers is complete. Demographic data shows that 30% of the customers are males, thus providing a unique opportunity to examine the effects of a tienda-based intervention on Latino men. Conclusions Determining whether a tienda-based intervention can improve customers’ FV purchasing and consumption will provide key evidence for how to create healthier consumer food environments. PMID:25924592

A store-based intervention to increase fruit and vegetable consumption: The El Valor de Nuestra Salud cluster randomized controlled trial.

PubMed

Ayala, Guadalupe X; Baquero, Barbara; Pickrel, Julie L; Mayer, Joni; Belch, George; Rock, Cheryl L; Linnan, Laura; Gittelsohn, Joel; Sanchez-Flack, Jennifer; Elder, John P

2015-05-01

Most evidence-based interventions to improve fruit and vegetable (FV) consumption target individual behaviors and family systems; however, these changes are difficult to sustain without environmental support. This paper describes an innovative social and structural food store-based intervention to increase availability and accessibility of FVs in tiendas (small- to medium-sized Latino food stores) and purchasing and consumption of FVs among tienda customers. Using a cluster randomized controlled trial with 16 tiendas pair-matched and randomized to an intervention or wait-list control condition, this study will evaluate a 2-month intervention directed at tiendas, managers, and employees followed by a 4-month customer-directed food marketing campaign. The intervention involves social (e.g., employee trainings) and structural (e.g., infrastructure) environmental changes. Three hundred sixty-nine customers (approximately 23 per tienda) serve on an evaluation cohort and complete assessments (interviews and measurements of weight) at 3 time points: baseline, 6-months post-baseline, and 12-months post-baseline. The primary study outcome is customer-reported daily consumption of FVs. Manager interviews and monthly tienda audits and collection of sales data will provide evidence of tienda-level intervention effects, our secondary outcomes. Process evaluation methods assess dose delivered, dose received, and fidelity. Recruitment of tiendas, managers, employees, and customers is complete. Demographic data shows that 30% of the customers are males, thus providing a unique opportunity to examine the effects of a tienda-based intervention on Latino men. Determining whether a tienda-based intervention can improve customers' FV purchasing and consumption will provide key evidence for how to create healthier consumer food environments. Copyright © 2015 Elsevier Inc. All rights reserved.

Randomized clinical trial of cognitive behavioral therapy (CBT) versus acceptance and commitment therapy (ACT) for mixed anxiety disorders

PubMed Central

Arch, Joanna; Eifert, Georg H.; Davies, Carolyn; Plumb Vilardaga, Jennifer C.; Rose, Raphael D.; Craske, Michelle G.

2016-01-01

Objective Randomized comparisons of acceptance-based treatments with traditional cognitive behavioral therapy (CBT) for anxiety disorders are lacking. To address this research gap, we compared acceptance and commitment therapy (ACT) to CBT for heterogeneous anxiety disorders. Method One hundred twenty eight individuals (52% female, mean age = 38, 33% minority) with one or more DSM-IV anxiety disorders began treatment following randomization to 12 sessions of CBT or ACT; both treatments included behavioral exposure. Assessments at pre-treatment, post-treatment, 6-month, and 12-month follow-up measured anxiety specific (principal disorder Clinical Severity Ratings [CSR], Anxiety Sensitivity Index, Penn State Worry Questionnaire, Fear Questionnaire avoidance) and non-anxiety specific (Quality of Life Index [QOLI], Acceptance and Action Questionnaire-16 [AAQ]) outcomes. Treatment adherence and therapist competency ratings, treatment credibility, and co-occurring mood and anxiety disorders were investigated. Results CBT and ACT improved similarly across all outcomes from pre- to post-treatment. During follow-up, ACT showed steeper CSR improvements than CBT (p < .05, d = 1.33) and at 12-month follow-up, ACT showed lower CSRs than CBT among completers (p < .05, d = 1.05). At 12-month follow-up, ACT reported higher AAQ than CBT (p = .08, d = .42; Completers: p < .05, d = .59) whereas CBT reported higher QOLI than ACT (p < .05, d = .43). Attrition and comorbidity improvements were similar, although ACT utilized more non-study psychotherapy at 6-month follow-up. Therapist adherence and competency were good; treatment credibility was higher in CBT. Conclusions Overall improvement was similar between ACT and CBT, indicating that ACT is a highly viable treatment for anxiety disorders. PMID:22563639

Effects of an HIV peer prevention intervention on sexual and injecting risk behaviors among injecting drug users and their risk partners in Thai Nguyen, Vietnam: A randomized controlled trial

PubMed Central

Go, Vivian F.; Frangakis, Constantine; Le Minh, Nguyen; Latkin, Carl A.; Ha, Tran Viet; Mo, Tran Thi; Sripaipan, Teerada; Davis, Wendy; Zelaya, Carla; Vu, Pham The; Chen, Yong; Celentano, David D.; Quan, Vu Minh

2014-01-01

Globally, 30% of new HIV infections outside sub-Saharan Africa involve injecting drug users (IDU) and in many countries, including Vietnam, HIV epidemics are concentrated among IDU. We conducted a randomized controlled trial in Thai Nguyen, Vietnam, to evaluate whether a peer oriented behavioral intervention could reduce injecting and sexual HIV risk behaviors among IDU and their network members. 419 HIV-negative index IDU aged 18 years or older and 516 injecting and sexual network members were enrolled. Each index participant was randomly assigned to receive a series of six small group peer educator-training sessions and three booster sessions in addition to HIV testing and counseling (HTC) (intervention; n = 210) or HTC only (control; n = 209). Follow-up, including HTC, was conducted at 3, 6, 9 and 12 months post-intervention. The proportion of unprotected sex dropped significantly from 49% to 27% (SE (difference) = 3%, p < 0.01) between baseline and the 3-month visit among all index-network member pairs. However, at 12 months, post-intervention, intervention participants had a 14% greater decline in unprotected sex relative to control participants (Wald test = 10.8, df = 4, p = 0.03). This intervention effect is explained by trial participants assigned to the control arm who missed at least one standardized HTC session during follow-up and subsequently reported increased unprotected sex. The proportion of observed needle/syringe sharing dropped significantly between baseline and the 3-month visit (14% vs. 3%, SE (difference) = 2%, p < 0.01) and persisted until 12 months, but there was no difference across trial arms (Wald test = 3.74, df = 3, p = 0.44). PMID:24034963

A Pilot Randomized Controlled Trial of the Effects of Chair Yoga on Pain and Physical Function Among Community-Dwelling Older Adults With Lower Extremity Osteoarthritis

PubMed Central

Park, Juyoung; McCaffrey, Ruth; Newman, David; Liehr, Patricia; Ouslander, Joseph G.

2016-01-01

Objectives To determine effects of Sit ‘N’ Fit Chair Yoga, compared to a Health Education program (HEP), on pain and physical function in older adults with lower extremity osteoarthritis (OA) who could not participate in standing exercise Design Two-arm randomized controlled trial Setting One HUD senior housing facility and one day senior center in south Florida Participants Community-dwelling older adults (N = 131) were randomly assigned to chair yoga (n = 66) or HEP (n = 65). Thirteen dropped after assignment but prior to the intervention; 6 dropped during the intervention; 106 of 112 completed at least 12 of 16 sessions (95% retention rate). Interventions Participants attended either chair yoga or HEP. Both interventions consisted of twice-weekly 45-minute sessions for 8 weeks. Measurements Primary: pain, pain interference; secondary: balance, gait speed, fatigue, functional ability measured at baseline, after 4 weeks of intervention, at the end of the 8-week intervention, and post-intervention (1 and 3 months). Results The chair yoga group showed greater reduction in pain interference during the intervention (p = .01), sustained through 3 months (p = .022). WOMAC pain (p = .048), gait speed (p = .024), and fatigue (p = .037) were improved in the yoga group during the intervention (p = .048) but improvements were not sustained post intervention. Chair yoga had no effect on balance. Conclusion An 8-week chair yoga program was associated with reduction in pain, pain interference, and fatigue, and improvement in gait speed, but only the effects on pain interference were sustained 3 months post intervention. Chair yoga should be further explored as a nonpharmacologic intervention for older people with OA in the lower extremities. Trial Registration ClinicalTrials.gov: NCT02113410 PMID:28008603

Attention Bias Modification training in individuals with depressive symptoms: A randomized controlled trial.

PubMed

Yang, Wenhui; Ding, Zhirui; Dai, Ting; Peng, Fang; Zhang, John X

2015-12-01

Negative attentional biases are often considered to have a causal role in the onset and maintenance of depressive symptoms. This suggests that reduction of such biases may be a plausible strategy in the treatment of depressive symptoms. The present clinical randomized controlled trial examined long-term effects of a computerized attention bias modification (ABM) procedure on individuals with elevated depressive symptoms. In a double-blind study design, 77 individuals with ongoing mild to severe symptoms of depression were randomly assigned to one of three conditions: 1) ABM training (n = 27); 2) placebo (n = 27); 3) assessment-only (n = 23). In both the ABM and placebo conditions, participants completed 8 sessions of 216-trials (1728 in total) during a 2-week period. Assessments were conducted at pre-training and post-training (0, 2, 4, 8-week, 3, 7-month follow-ups). Change in depressive symptoms and restoration of asymptomatic level were the primary outcome measures. In the ABM, but not the other two conditions, significant reductions in depressive symptoms were found at post-training and maintained during the 3-month follow-up. Importantly, more participants remained asymptomatic in the ABM condition, as compared to the other two conditions, from post-training to 7-month follow-up. ABM also significantly reduced secondary outcome measures including rumination and trait anxiety, and notably, the ABM effect on reducing depressive symptoms was mediated by rumination. Generalization of the findings may be limited because the present sample included only college students. The ABM effect on reducing depressive symptoms was maintained for at least 3-month duration in individuals with elevated depressive symptoms, and these results suggest that ABM may be a useful tool for the prevention of depressive symptoms. CLINICALTRIALS.GOV: NCT01628016. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

Mindfulness-based yoga intervention for women with depression.

PubMed

Schuver, Katie J; Lewis, Beth A

2016-06-01

The purpose of this study was to examine the efficacy of a 12-week mindfulness-based yoga intervention on depressive symptoms and rumination among depressed women. Prospective, randomized, controlled 12 week intervention pilot study. Depressive symptoms were assessed at baseline, post-intervention (12 weeks), and one-month follow-up. Women with a history of diagnosed depression and currently depressed were randomized to a mindfulness-based yoga condition or a walking control. The mindfulness-based yoga intervention consisted of a home-based yoga asana, pranayama and meditation practice with mindfulness education sessions delivered over the telephone. The walking control condition consisted of home-based walking sessions and health education sessions delivered over the phone. The Beck Depression Inventory (BDI) and Ruminative Responses Scale (RRS). Both groups reported decreases in depressive symptoms from baseline to post-intervention, f(1,33)=34.83, p<0.001, and from baseline to one-month follow-up, f(1,33)=37.01, p<0.001. After controlling for baseline, there were no significant between group differences on depression scores at post-intervention and the one-month follow-up assessment. The mindfulness-based yoga condition reported significantly lower levels of rumination than the control condition at post-intervention, after controlling for baseline levels of rumination, f(1,31)=6.23, p<0.01. These findings suggest that mindfulness-based yoga may provide tools to manage ruminative thoughts among women with elevated depressive symptoms. Future studies, with larger samples are needed to address the effect of yoga on depression and further explore the impact on rumination. Copyright © 2016 Elsevier Ltd. All rights reserved.

Memantine before Mastectomy Prevents Post-Surgery Pain: A Randomized, Blinded Clinical Trial in Surgical Patients.

PubMed

Morel, Véronique; Joly, Dominique; Villatte, Christine; Dubray, Claude; Durando, Xavier; Daulhac, Laurence; Coudert, Catherine; Roux, Delphine; Pereira, Bruno; Pickering, Gisèle

2016-01-01

Neuropathic pain following surgical treatment for breast cancer with or without chemotherapy is a clinical burden and patients frequently report cognitive, emotional and quality of life impairment. A preclinical study recently showed that memantine administered before surgery may prevent neuropathic pain development and cognitive dysfunction. With a translational approach, a clinical trial has been carried out to evaluate whether memantine administered before and after mastectomy could prevent the development of neuropathic pain, the impairment of cognition and quality of life. A randomized, pilot clinical trial included 40 women undergoing mastectomy in the Oncology Department, University Hospital, Clermont-Ferrand, France. Memantine (5 to 20 mg/day; n = 20) or placebo (n = 20) was administered for four weeks starting two weeks before surgery. The primary endpoint was pain intensity measured on a (0-10) numerical rating scale at three months post-mastectomy. Data analyses were performed using mixed models and the tests were two-sided, with a type I error set at α = 0.05. Compared with placebo, patients receiving memantine showed at three months a significant difference in post-mastectomy pain intensity, less rescue analgesia and a better emotional state. An improvement of pain symptoms induced by cancer chemotherapy was also reported. This study shows for the first time the beneficial effect of memantine to prevent post-mastectomy pain development and to diminish chemotherapy-induced pain symptoms. The lesser analgesic consumption and better well-being of patients for at least six months after treatment suggests that memantine could be an interesting therapeutic option to diminish the burden of breast cancer therapy. Clinicaltrials.gov NCT01536314.

A randomized trial of MBSR versus aerobic exercise for social anxiety disorder.

PubMed

Jazaieri, Hooria; Goldin, Philippe R; Werner, Kelly; Ziv, Michal; Gross, James J

2012-07-01

Effective treatments for social anxiety disorder (SAD) exist, but additional treatment options are needed for nonresponders as well as those who are either unable or unwilling to engage in traditional treatments. Mindfulness-based stress reduction (MBSR) is one nontraditional treatment that has demonstrated efficacy in treating other mood and anxiety disorders, and preliminary data suggest its efficacy in SAD as well. Fifty-six adults (52% female; 41% Caucasian; age mean [M] ± standard deviation [SD]: 32.8 ± 8.4) with SAD were randomized to MBSR or an active comparison condition, aerobic exercise (AE). At baseline and post-intervention, participants completed measures of clinical symptoms (Liebowitz Social Anxiety Scale, Social Interaction Anxiety Scale, Beck Depression Inventory-II, and Perceived Stress Scale) and subjective well-being (Rosenberg Self-Esteem Scale, Satisfaction with Life Scale, Self-Compassion Scale, and UCLA-8 Loneliness Scale). At 3 months post-intervention, a subset of these measures was readministered. For clinical significance analyses, 48 healthy adults (52.1% female; 56.3% Caucasian; age [M ± SD]: 33.9 ± 9.8) were recruited. MBSR and AE participants were also compared with a separate untreated group of 29 adults (44.8% female; 48.3% Caucasian; age [M ± SD]: 32.3 ± 9.4) with generalized SAD who completed assessments over a comparable time period with no intervening treatment. A 2 (Group) x 2 (Time) repeated measures analyses of variance (ANOVAs) on measures of clinical symptoms and well-being were conducted to examine pre-intervention to post-intervention and pre-intervention to 3-month follow-up. Both MBSR and AE were associated with reductions in social anxiety and depression and increases in subjective well-being, both immediately post-intervention and at 3 months post-intervention. When participants in the randomized controlled trial were compared with the untreated SAD group, participants in both interventions exhibited improvements on measures of clinical symptoms and well-being. Nontraditional interventions such as MBSR and AE merit further exploration as alternative or complementary treatments for SAD. © 2012 Wiley Periodicals, Inc.

Prophylaxis of Venous Thromboembolism in Geriatric Settings: A Cluster-Randomized Multicomponent Interventional Trial.

PubMed

Rwabihama, Jean Paul; Audureau, Etienne; Laurent, Marie; Rakotoarisoa, Lalaina; Jegou, Marc; Saddedine, Sofiane; Krypciak, Sébastien; Herbaud, Stéphane; Benzengli, Hind; Segaux, Lauriane; Guery, Esther; Ambime, Gabin; Rabus, Marie-Thérèse; Perilliat, Jean-Guy; David, Jean-Philippe; Paillaud, Elena

2018-06-01

To evaluate the efficacy of an intervention on the practice of venous thromboembolism prevention. A multicenter, prospective, controlled, cluster-randomized, multifaceted intervention trial consisting of educational lectures, posters, and pocket cards reminding physicians of the guidelines for thromboprophylaxis use. Twelve geriatric departments with 1861 beds total, of which 202, 803, and 856 in acute care, post-acute care, and long-term care wards, respectively. Patients hospitalized between January 1 and May 31, 2015, in participating departments. The primary endpoint was the overall adequacy of thromboprophylaxis prescription at the patient level, defined as a composite endpoint consisting of indication, regimen, and duration of treatment. Geriatric departments were divided into an intervention group (6 departments) and control group (6 departments). The preintervention period was 1 month to provide baseline practice levels, the intervention period 2 months, and the postintervention period 1 month in acute care and post-acute care wards or 2 months in long-term care wards. Multivariable regression was used to analyze factors associated with the composite outcome. We included 2962 patients (1426 preintervention and 1536 postintervention), with median age 85 [79;90] years. For the overall 18.9% rate of inadequate thromboprophylaxis, 11.1% was attributable to underuse and 7.9% overuse. Intervention effects were more apparent in post-acute and long-term care wards although not significantly [odds ratio 1.44 (95% confidence interval 0.78;2.66), P = .241; and 1.44 (0.68, 3.06), P = .345]. Adequacy rates significantly improved in the postintervention period for the intervention group overall (from 78.9% to 83.4%; P = .027) and in post-acute care (from 75.4% to 86.3%; P = .004) and long-term care (from 87.0% to 91.7%; P = .050) wards, with no significant trend observed in the control group. This study failed to demonstrate improvement in prophylaxis adequacy with our intervention. However, the intervention seemed to improve practices in post-acute and long-term care but not acute care wards. Copyright © 2018 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

The Effect of Three-Monthly Albendazole Treatment on Malarial Parasitemia and Allergy: A Household-Based Cluster-Randomized, Double-Blind, Placebo-Controlled Trial

PubMed Central

Kaisar, Maria M. M.; May, Linda; Prasetyani, Margaretta A.; Wahyuni, Sitti; Djuardi, Yenny; Ariawan, Iwan; Wibowo, Heri; Lell, Bertrand; Sauerwein, Robert; Brice, Gary T.; Sutanto, Inge; van Lieshout, Lisette; de Craen, Anton J. M.; van Ree, Ronald; Verweij, Jaco J.; Tsonaka, Roula; Houwing-Duistermaat, Jeanine J.; Luty, Adrian J. F.; Sartono, Erliyani; Supali, Taniawati; Yazdanbakhsh, Maria

2013-01-01

Background Helminth infections are proposed to have immunomodulatory activities affecting health outcomes either detrimentally or beneficially. We evaluated the effects of albendazole treatment, every three months for 21 months, on STH, malarial parasitemia and allergy. Methods and Findings A household-based cluster-randomized, double-blind, placebo-controlled trial was conducted in an area in Indonesia endemic for STH. Using computer-aided block randomization, 481 households (2022 subjects) and 473 households (1982 subjects) were assigned to receive placebo and albendazole, respectively, every three months. The treatment code was concealed from trial investigators and participants. Malarial parasitemia and malaria-like symptoms were assessed in participants older than four years of age while skin prick test (SPT) to allergens as well as reported symptoms of allergy in children aged 5–15 years. The general impact of treatment on STH prevalence and body mass index (BMI) was evaluated. Primary outcomes were prevalence of malarial parasitemia and SPT to any allergen. Analysis was by intention to treat. At 9 and 21 months post-treatment 80.8% and 80.1% of the study subjects were retained, respectively. The intensive treatment regiment resulted in a reduction in the prevalence of STH by 48% in albendazole and 9% in placebo group. Albendazole treatment led to a transient increase in malarial parasitemia at 6 months post treatment (OR 4.16(1.35–12.80)) and no statistically significant increase in SPT reactivity (OR 1.18(0.74–1.86) at 9 months or 1.37 (0.93–2.01) 21 months). No effect of anthelminthic treatment was found on BMI, reported malaria-like- and allergy symptoms. No adverse effects were reported. Conclusions The study indicates that intensive community treatment of 3 monthly albendazole administration for 21 months over two years leads to a reduction in STH. This degree of reduction appears safe without any increased risk of malaria or allergies. Trial Registration Controlled-Trials.com ISRCTN83830814 PMID:23526959

Evaluation of a new syringe presentation of reduced-antigen content diphtheria, tetanus, and acellular pertussis vaccine in healthy adolescents - A single blind randomized trial

PubMed Central

Pavia-Ruz, Noris; Abarca, Katia; Lepetic, Alejandro; Cervantes-Apolinar, Maria Yolanda; Hardt, Karin; Jayadeva, Girish; Kuriyakose, Sherine; Han, Htay Htay; de la O, Manuel

2015-01-01

Reduced-antigen-content diphtheria-tetanus-acellular pertussis (dTpa) vaccine, Boostrix™, is indicated for booster vaccination of children, adolescents and adults. The original prefilled disposable dTpa syringe presentation was recently replaced by another prefilled-syringe presentation with latex-free tip-caps and plunger-stoppers. 671 healthy adolescents aged 10–15 years who had previously received 5 or 6 previous DT(P)/dT(pa) vaccine doses, were randomized (1:1) to receive dTpa booster, injected using the new (dTpa-new) or previous syringe (dTpa-previous) presentations. Immunogenicity was assessed before and 1-month post-booster vaccination; safety/reactogenicity were assessed during 31-days post-vaccination. Non-inferiority of dTpa-new versus dTpa-previous was demonstrated for all antigens (ULs 95% CIs for GMC ratios ranged between 1.03-1.13). 1-month post-booster, immune responses were in similar ranges for all antigens with both syringe presentations. dTpa delivered using either syringe presentation was well-tolerated. These clinical results complement the technical data and support the use of the new syringe presentation to deliver the dTpa vaccine. PMID:26075317

Efficacy and Mediation of a Theory-Based Physical Activity Intervention for African American Men Who Have Sex with Men: A Randomized Controlled Trial.

PubMed

Zhang, Jingwen; Jemmott, John B; O'Leary, Ann; Stevens, Robin; Jemmott, Loretta Sweet; Icard, Larry D; Hsu, Janet; Rutledge, Scott E

2017-02-01

Few trials have tested physical-activity interventions among sexual minorities, including African American men who have sex with men (MSM). We examined the efficacy and mediation of the Being Responsible for Ourselves (BRO) physical-activity intervention among African American MSM. African American MSM were randomized to the physical-activity intervention consisting of three 90-min one-on-one sessions or an attention-matched control intervention and completed pre-intervention, immediately post-intervention, and 6- and 12-month post-intervention audio computer-based surveys. Of the 595 participants, 503 completed the 12-month follow-up. Generalized estimating equation models revealed that the intervention increased self-reported physical activity compared with the control intervention, adjusted for pre-intervention physical activity. Mediation analyses suggested that the intervention increased reasoned action approach variables, subjective norm and self-efficacy, increasing intention immediately post-intervention, which increased physical activity during the follow-up period. Interventions targeting reasoned action approach variables may contribute to efforts to increase African American MSM's physical activity. The trial was registered with the ClinicalTrials.gov Identifier NCT02561286 .

Sexual risk reduction among non-injection drug users: report of a randomized controlled trial.

PubMed

Castor, Delivette; Pilowsky, Daniel J; Hadden, Bernadette; Fuller, Crystal; Ompad, Danielle C; de Leon, Cora L; Neils, Greg; Hoepner, Lori; Andrews, Howard F; Latkin, Carl; Hoover, Donald R

2010-01-01

We conducted a randomized controlled trial of a sexual risk-reduction intervention targeting non-injection drug users (NIDUs) and members of their drug-use/sexual networks (N=270). The intervention was based primarily on the social-influencing approach, and was delivered in four sessions. Sexual risk behaviors were examined at baseline, and 3, 6, 9, and 12 months after the completion of the intervention using the vaginal equivalent episodes (VEE), a weighted sexual risk behavior index. VEE scores decreased in both the active and control conditions in the first six months post-intervention and continued to decline in the control group. However, in the active condition, VEE scores increased after the nine-month assessment and approached baseline levels by the 12-month assessment. There was no evidence of significant differences in high-risk sexual behaviors between the intervention and control conditions. Future studies are needed to improve behavioral interventions in this population.

Improving psychosocial outcomes for caregivers of people with poor prognosis gastrointestinal cancers: a randomized controlled trial (Family Connect).

PubMed

Shaw, Joanne M; Young, Jane M; Butow, Phyllis N; Badgery-Parker, Tim; Durcinoska, Ivana; Harrison, James D; Davidson, Patricia M; Martin, David; Sandroussi, Charbel; Hollands, Michael; Joseph, David; Das, Amitabha; Lam, Vincent; Johnston, Emma; Solomon, Michael J

2016-02-01

This study investigated the effectiveness of a structured telephone intervention for caregivers of people diagnosed with poor prognosis gastrointestinal cancer to improve psychosocial outcomes for both caregivers and patients. Caregivers of patients starting treatment for upper gastrointestinal or Dukes D colorectal cancer were randomly assigned (1:1) to the Family Connect telephone intervention or usual care. Caregivers in the intervention group received four standardized telephone calls in the 10 weeks following patient hospital discharge. Caregivers' quality of life (QOL), caregiver burden, unmet supportive care needs and distress were assessed at 3 and 6 months. Patients' QOL, unmet supportive care needs, distress and health service utilization were also assessed at these time points. Caregivers (128) were randomized to intervention or usual care groups. At 3 months, caregiver QOL scores and other caregiver-reported outcomes were similar in both groups. Intervention group participants experienced a greater sense of social support (p = .049) and reduced worry about finances (p = .014). Patients whose caregiver was randomized to the intervention also had fewer emergency department presentations and unplanned hospital readmissions at 3 months post-discharge (total 17 vs. 5, p = .01). This standardized intervention did not demonstrate any significant improvements in caregiver well-being but did result in a decrease in patient emergency department presentations and unplanned hospital readmissions in the immediate post-discharge period. The trend towards improvements in a number of caregiver outcomes and the improvement in health service utilization support further development of telephone-based caregiver-focused supportive care interventions.

Small incision lenticule extraction (SMILE) versus laser in-situ keratomileusis (LASIK): study protocol for a randomized, non-inferiority trial.

PubMed

Ang, Marcus; Tan, Donald; Mehta, Jodhbir S

2012-05-31

Small incision lenticule extraction or SMILE is a novel form of 'flapless' corneal refractive surgery that was adapted from refractive lenticule extraction (ReLEx). SMILE uses only one femtosecond laser to complete the refractive surgery, potentially reducing surgical time, side effects, and cost. If successful, SMILE could potentially replace the current, widely practiced laser in-situ keratomileusis or LASIK. The aim of this study is to evaluate whether SMILE is non-inferior to LASIK in terms of refractive outcomes at 3 months post-operatively. Single tertiary center, parallel group, single-masked, paired-eye design, non-inferiority, randomized controlled trial. Participants who are eligible for LASIK will be enrolled for study after informed consent. Each participant will be randomized to receive SMILE and LASIK in each eye. Our primary hypothesis (stated as null) in this non-inferiority trial would be that SMILE differs from LASIK in adults (>21 years old) with myopia (> -3.00 diopter (D)) at a tertiary eye center in terms of refractive predictability at 3 months post-operatively. Our secondary hypothesis (stated as null) in this non-inferiority trial would be that SMILE differs from LASIK in adults (>21 years old) with myopia (> -3.00 D) at a tertiary eye center in terms of other refractive outcomes (efficacy, safety, higher-order aberrations) at 3 months post-operatively. Our primary outcome is refractive predictability, which is one of several standard refractive outcomes, defined as the proportion of eyes achieving a postoperative spherical equivalent (SE) within ±0.50 D of the intended target. Randomization will be performed using random allocation sequence generated by a computer with no blocks or restrictions, and implemented by concealing the number-coded surgery within sealed envelopes until just before the procedure. In this single-masked trial, subjects and their caregivers will be masked to the assigned treatment in each eye. This novel trial will provide information on whether SMILE has comparable, if not superior, refractive outcomes compared to the established LASIK for myopia, thus providing evidence for translation into clinical practice. Clinicaltrials.gov NCT01216475.

Randomized Controlled Trial of Group Cognitive Behavioural Therapy for Post-Traumatic Stress Disorder in Children and Adolescents Exposed to Tsunami in Thailand.

PubMed

Pityaratstian, Nuttorn; Piyasil, Vinadda; Ketumarn, Panom; Sitdhiraksa, Nanthawat; Ularntinon, Sirirat; Pariwatcharakul, Pornjira

2015-09-01

Post-traumatic stress disorder (PTSD) is a common and debilitating consequence of natural disaster in children and adolescents. Accumulating data show that cognitive behavioural therapy (CBT) is an effective treatment for PTSD. However, application of CBT in a large-scale disaster in a setting with limited resources, such as when the tsunami hit several Asian countries in 2004, poses a major problem. This randomized controlled trial aimed to test for the efficacy of the modified version of CBT for children and adolescents with PSTD. Thirty-six children (aged 10-15 years) who had been diagnosed with PSTD 4 years after the tsunami were randomly allocated to either CBT or wait list. CBT was delivered in 3-day, 2-hour-daily, group format followed by 1-month posttreatment self-monitoring and daily homework. Compared to the wait list, participants who received CBT demonstrated significantly greater improvement in symptoms of PTSD at 1-month follow-up, although no significant improvement was observed when the measures were done immediately posttreatment. Brief, group CBT is an effective treatment for PTSD in children and adolescents when delivered in conjunction with posttreatment self-monitoring and daily homework.

Prolonged breast-feeding and mortality up to two years post-partum among HIV-positive women in Zambia

PubMed Central

Kuhn, Louise; Kasonde, Prisca; Sinkala, Moses; Kankasa, Chipepo; Semrau, Katherine; Vwalika, Cheswa; Tsai, Wei-Yann; Aldrovandi, Grace M.; Thea, Donald M.

2005-01-01

Background A previously reported association between prolonged lactation and maternal mortality has generated concern that breast-feeding may be detrimental for HIV-positive women. Methods As part of a trial conducted in Lusaka, Zambia, 653 HIV-positive women were randomly assigned either to a counseling program that encouraged abrupt cessation of breast-feeding at 4 months (group A) or to a program that encouraged prolonged breast-feeding for the duration of the woman’s own informed choice (group B). We examined whether mortality up to 2 years post-partum increased with breast-feeding for a longer duration. Results There was no difference in mortality 12 months after delivery between 326 HIV-positive women randomly assigned to short breast-feeding [group A: 4.93%; 95% confidence interval (CI), 2.42–7.46] versus 327 women assigned to long breast-feeding (group B: 4.89%; 95% CI, 2.38–7.40). Analysis based on actual practice, rather than random assignment, also demonstrated no increased mortality due to breast-feeding. Conclusions Although HIV-related mortality was high in this cohort of untreated HIV-positive women, prolonged lactation was not associated with increased mortality. PMID:16184038

Prevention of generalized anxiety disorder using a web intervention, iChill: randomized controlled trial.

PubMed

Christensen, Helen; Batterham, Philip; Mackinnon, Andrew; Griffiths, Kathleen M; Kalia Hehir, Kanupriya; Kenardy, Justin; Gosling, John; Bennett, Kylie

2014-09-02

Generalized Anxiety Disorder (GAD) is a high prevalence, chronic disorder. Web-based interventions are acceptable, engaging, and can be delivered at scale. Few randomized controlled trials evaluate the effectiveness of prevention programs for anxiety, or the factors that improve effectiveness and engagement. The intent of the study was to evaluate the effectiveness of a Web-based program in preventing GAD symptoms in young adults, and to determine the role of telephone and email reminders. A 5-arm randomized controlled trial with 558 Internet users in the community, recruited via the Australian Electoral Roll, was conducted with 6- and 12-month follow-up. Five interventions were offered over a 10-week period. Group 1 (Active website) received a combined intervention of psycho-education, Internet-delivered Cognitive Behavioral Therapy (ICBT) for anxiety, physical activity promotion, and relaxation. Group 2 (Active website with telephone) received the identical Web program plus weekly telephone reminder calls. Group 3 (Active website with email) received the identical Web program plus weekly email reminders. Group 4 (Control) received a placebo website. Group 5 (Control with telephone) received the placebo website plus telephone calls. Main outcome measures were severity of anxiety symptoms as measured by the GAD 7-item scale (GAD-7) (at post-test, 6, and 12 months). Secondary measures were GAD caseness, measured by the Mini International Neuropsychiatric Interview (MINI) at 6 months, Centre for Epidemiologic Studies-Depression scale (CES-D), Anxiety Sensitivity Index (ASI), Penn State Worry Questionnaire (PSWQ), and Days out of Role. GAD-7 symptoms reduced over post-test, 6-month, and 12-month follow-up. There were no significant differences between Group 4 (Control) and Groups 1 (Active website), 2 (Active website with telephone), 3 (Active website with email), or 5 (Control with telephone) at any follow-up. A total of 16 cases of GAD were identified at 6 months, comprising 6.7% (11/165) from the Active groups (1, 2, 3) and 4.5% (5/110) from the Control groups (4, 5), a difference that was not significant. CES-D, ASI, and PSWQ scores were significantly lower for the active website with email reminders at post-test, relative to the control website condition. Indicated prevention of GAD was not effective in reducing anxiety levels, measured by GAD-7. There were significant secondary effects for anxiety sensitivity, worry, and depression. Challenges for indicated prevention trials are discussed. International Standard Randomized Controlled Trial Number (ISRCTN): 76298775; http://www.controlled-trials.com/ISRCTN76298775 (Archived by WebCite at http://www.webcitation.org/6S9aB5MAq).

A Randomized Clinical Trial of Methadone Maintenance for Prisoners: Results at Twelve-Months Post-Release

PubMed Central

Kinlock, Timothy W.; Gordon, Michael S.; Schwartz, Robert P.; Fitzgerald, Terrence T.; O’Grady, Kevin E.

2009-01-01

This study examined the impact of prison-initiated methadone maintenance at 12-months post-release. Males with pre-incarceration heroin dependence (n=204) were randomly assigned to: 1) Counseling Only: counseling in prison, with passive referral to treatment upon release; 2) Counseling+Transfer: counseling in prison with transfer to methadone maintenance treatment upon release; and 3) Counseling+Methadone: counseling and methadone maintenance in prison, continued in the community upon release. The mean number of days in community-based drug abuse treatment were, respectively, Counseling Only 23.1, Counseling+Transfer 91.3, and Counseling+Methadone 166.0, p <.01; all pairwise comparisons were statistically significant (all ps < .01). Counseling+Methadone participants were also significantly less likely than participants in each of the other two groups to be opioid-positive or cocaine-positive according to urine drug testing. These results support the effectiveness of prison-initiated methadone for males in the United States. Further study is required to confirm the findings for women. PMID:19339140

Effectiveness and specificity of a classroom-based group intervention in children and adolescents exposed to war in Lebanon.

PubMed

Karam, Elie G; Fayyad, John; Nasser Karam, Aimee; Cordahi Tabet, Caroline; Melhem, Nadine; Mneimneh, Zeina; Dimassi, Hani

2008-01-01

The purpose of this study was to examine the effectiveness and specificity of a classroom-based psychosocial intervention after war. All students (n=2500) of six villages in Southern Lebanon designated as most heavily exposed to war received a classroom-based intervention delivered by teachers, consisting of cognitive-behavioural and stress inoculation training strategies. A random sample of treated students (n=101) and a matched control group (n=93) were assessed one month post-war and one year later. Mental disorders and psychosocial stressors were assessed using the Diagnostic Interview for Children and Adolescents - Revised with children and parents. War exposure was measured using the War Events Questionnaire. The prevalence of major depressive disorder (MDD), separation anxiety disorder (SAD) and post-traumatic stress disorder (PTSD) was examined pre-war, one month post-war (pre-intervention), and one year post-war. Specificity of treatment was determined by rating teachers' therapy diaries. The rates of disorders peaked one month post-war and decreased over one year. There was no significant effect of the intervention on the rates of MDD, SAD or PTSD. Post-war MDD, SAD and PTSD were associated with pre-war SAD and PTSD, family violence parameters, financial problems and witnessing war events. These findings have significant policy and public health implications, given current practices of delivering universal interventions immediately post-war.

Effects of an employer-based intervention on employment outcomes for youth with significant support needs due to autism.

PubMed

Wehman, Paul; Schall, Carol M; McDonough, Jennifer; Graham, Carolyn; Brooke, Valerie; Riehle, J Erin; Brooke, Alissa; Ham, Whitney; Lau, Stephanie; Allen, Jaclyn; Avellone, Lauren

2017-04-01

The purpose of this study was to develop and investigate an employer-based 9-month intervention for high school youth with autism spectrum disorder to learn job skills and acquire employment. The intervention modified a program titled Project SEARCH and incorporated the use of applied behavior analysis to develop Project SEARCH plus Autism Spectrum Disorder Supports. A randomized clinical trial compared the implementation of Project SEARCH plus Autism Spectrum Disorder Supports with high school special education services as usual. Participants were 49 high-school-aged individuals between the ages of 18 and 21 years diagnosed with an autism spectrum disorder and eligible for supported employment. Students also had to demonstrate independent self-care. At 3 months post-graduation, 90% of the treatment group acquired competitive, part-time employment earning US$9.53-US$10.66 per hour. Furthermore, 87% of those individuals maintained employment at 12 months post-graduation. The control group's employment outcomes were 6% acquiring employment by 3 months post-graduation and 12% acquiring employment by 12 months post-graduation. The positive employment outcomes generated by the treatment group provide evidence that youth with autism spectrum disorder can gain and maintain competitive employment. Additionally, there is evidence that they are able to advance within that time toward more weekly hours worked, while they also displayed increasing independence in the work setting.

Comparative effectiveness of post-discharge interventions for hospitalized smokers: study protocol for a randomized controlled trial

PubMed Central

2012-01-01

Background A hospital admission offers smokers an opportunity to quit. Smoking cessation counseling provided in the hospital is effective, but only if it continues for more than one month after discharge. Providing smoking cessation medication at discharge may add benefit to counseling. A major barrier to translating this research into clinical practice is sustaining treatment during the transition to outpatient care. An evidence-based, practical, cost-effective model that facilitates the continuation of tobacco treatment after discharge is needed. This paper describes the design of a comparative effectiveness trial testing a hospital-initiated intervention against standard care. Methods/design A two-arm randomized controlled trial compares the effectiveness of standard post-discharge care with a multi-component smoking cessation intervention provided for three months after discharge. Current smokers admitted to Massachusetts General Hospital who receive bedside smoking cessation counseling, intend to quit after discharge and are willing to consider smoking cessation medication are eligible. Study participants are recruited following the hospital counseling visit and randomly assigned to receive Standard Care or Extended Care after hospital discharge. Standard Care includes a recommendation for a smoking cessation medication and information about community resources. Extended Care includes up to three months of free FDA-approved smoking cessation medication and five proactive computerized telephone calls that use interactive voice response technology to provide tailored motivational messages, offer additional live telephone counseling calls from a smoking cessation counselor, and facilitate medication refills. Outcomes are assessed at one, three, and six months after hospital discharge. The primary outcomes are self-reported and validated seven-day point prevalence tobacco abstinence at six months. Other outcomes include short-term and sustained smoking cessation, post-discharge utilization of smoking cessation treatment, hospital readmissions and emergency room visits, and program cost per quit. Discussion This study tests a disseminable smoking intervention model for hospitalized smokers. If effective and widely adopted, it could help to reduce population smoking rates and thereby reduce tobacco-related mortality, morbidity, and health care costs. Trial registration United States Clinical Trials Registry NCT01177176. PMID:22852832

Outcomes of a group-randomized trial to prevent excess weight gain, reduce screen behaviours and promote physical activity in 10-year-old children: switch-play.

PubMed

Salmon, J; Ball, K; Hume, C; Booth, M; Crawford, D

2008-04-01

To evaluate the effectiveness of an intervention to prevent excess weight gain, reduce time spent in screen behaviours, promote participation in and enjoyment of physical activity (PA), and improve fundamental movement skills among children. In 2002, 311 children (78% response; 49% boys), average age 10 years 8 months, were recruited from three government schools in low socioeconomic areas of Melbourne, Australia. Group-randomized controlled trial. Children were randomized by class to one of the four conditions: a behavioural modification group (BM; n=66); a fundamental movement skills group (FMS; n=74); a combined BM/FMS group (BM/FMS; n=93); and a control (usual curriculum) group (n=62). Data were collected at baseline, post intervention, 6- and 12-month follow-up periods. BMI data were available for 295 children at baseline and 268 at 12-month follow-up. After adjusting for food intake and PA, there was a significant intervention effect from baseline to post intervention on age- and sex-adjusted BMI in the BM/FMS group compared with controls (-1.88 kg m(-2), P<0.01), which was maintained at 6- and 12-month follow-up periods (-1.53 kg m(-2), P<0.05). Children in the BM/FMS group were less likely than controls to be overweight/obese between baseline and post intervention (adjusted odds ratio (AOR)=0.36, P<0.05); also maintained at 12-month follow-up (AOR=0.38, P<0.05). Compared with controls, FMS group children recorded higher levels and greater enjoyment of PA; and BM children recorded higher levels of PA and TV viewing across all four time points. Gender moderated the intervention effects for participation in and enjoyment of PA, and fundamental movement skills. This programme represents a promising approach to preventing excess weight gain and promoting participation in and enjoyment of PA. Examination of the mediators of this intervention and further tailoring of the programme to suit both genders is required.

Efficacy of Oral Metronidazole with Vaginal Clindamycin or Vaginal Probiotic for Bacterial Vaginosis: Randomised Placebo-Controlled Double-Blind Trial

PubMed Central

Bradshaw, Catriona S.; Pirotta, Marie; De Guingand, Deborah; Hocking, Jane S.; Morton, Anna N.; Garland, Suzanne M.; Fehler, Glenda; Morrow, Andrea; Walker, Sandra; Vodstrcil, Lenka A.; Fairley, Christopher K.

2012-01-01

Background To determine if oral metronidazole (MTZ-400mg bid) with 2% vaginal clindamycin-cream (Clind) or a Lactobacillus acidophilus vaginal-probiotic containing oestriol (Prob) reduces 6-month bacterial vaginosis (BV) recurrence. Methods Double-blind placebo-controlled parallel-group single-site study with balanced randomization (1∶1∶1) conducted at Melbourne Sexual Health Centre, Australia. Participants with symptomatic BV [Nugent Score (NS) = 7–10 or ≥3 Amsel's criteria and NS = 4–10], were randomly allocated to MTZ-Clind, MTZ-Prob or MTZ-Placebo and assessed at 1,2,3 and 6 months. MTZ and Clind were administered for 7 days and Prob and Placebo for 12 days. Primary outcome was BV recurrence (NS of 7–10) on self-collected vaginal-swabs over 6-months. Cumulative BV recurrence rates were compared between groups by Chi-squared statistics. Kaplan-Meier, log rank and Cox regression analyses were used to compare time until and risk of BV recurrence between groups. Results 450 18–50 year old females were randomized and 408 (91%), equally distributed between groups, provided ≥1 NS post-randomization and were included in analyses; 42 (9%) participants with no post-randomization data were excluded. Six-month retention rates were 78% (n = 351). One-month BV recurrence (NS 7–10) rates were 3.6% (5/140), 6.8% (9/133) and 9.6% (13/135) in the MTZ-Clind, MTZ-Prob and MTZ-Placebo groups respectively, p = 0.13. Hazard ratios (HR) for BV recurrence at one-month, adjusted for adherence to vaginal therapy, were 0.43 (95%CI 0.15–1.22) and 0.75 (95% CI 0.32–1.76) in the MTZ-Clind and MTZ-Prob groups compared to MTZ-Plac respectively. Cumulative 6-month BV recurrence was 28.2%; (95%CI 24.0–32.7%) with no difference between groups, p = 0.82; HRs for 6-month BV recurrence for MTZ-Clind and MTZ-Prob compared to MTZ-Plac, adjusted for adherence to vaginal therapy were 1.09(95% CI = 0.70–1.70) and 1.03(95% CI = 0.65–1.63), respectively. No serious adverse events occurred. Conclusion Combining the recommended first line therapies of oral metronidazole and vaginal clindamycin, or oral metronidazole with an extended-course of a commercially available vaginal-L.acidophilus probiotic, does not reduce BV recurrence. Trial Registration ANZCTR.org.au ACTRN12607000350426 PMID:22509319

A randomized trial using motivational interviewing for maintenance of blood pressure improvements in a community-engaged lifestyle intervention: HUB city steps

PubMed Central

Landry, Alicia; Madson, Michael; Thomson, Jessica; Zoellner, Jamie; Connell, Carol; Yadrick, Kathleen

2015-01-01

Little is known about the effective dose of motivational interviewing for maintaining intervention-induced health outcome improvements. The purpose of this study was to compare effects of two doses of motivational interviewing for maintaining blood pressure improvements in a community-engaged lifestyle intervention conducted with African-Americans. Participants were tracked through a 12-month maintenance phase following a 6-month intervention targeting physical activity and diet. For the maintenance phase, participants were randomized to receive a low (4) or high (10) dose of motivational interviewing delivered via telephone by trained research staff. Generalized linear models were used to test for group differences in blood pressure. Blood pressure significantly increased during the maintenance phase. No differences were apparent between randomized groups. Results suggest that 10 or fewer motivational interviewing calls over a 12-month period may be insufficient to maintain post-intervention improvements in blood pressure. Further research is needed to determine optimal strategies for maintaining changes. PMID:26590242

Longitudinal Changes in Menopausal Symptoms Comparing Women Randomized to Low-Dose Oral Conjugated Estrogens or Transdermal Estradiol Plus Micronized Progesterone Versus Placebo: the Kronos Early Estrogen Prevention Study (KEEPS)

PubMed Central

Santoro, Nanette; Allshouse, Amanda; Neal-Perry, Genevieve; Pal, Lubna; Lobo, Rogerio A.; Naftolin, Frederick; Black, Dennis M.; Brinton, Eliot A.; Budoff, Matthew J.; Cedars, Marcelle I.; Dowling, N. Maritza; Dunn, Mary; Gleason, Carey E.; Hodis, Howard N.; Isaac, Barbara; Magnani, Maureen; Manson, JoAnn E.; Miller, Virginia M.; Taylor, Hugh S.; Wharton, Whitney; Wolff, Erin; Zepeda, Viola; Harman, S. Mitchell

2016-01-01

Objective To compare the efficacy of two forms of menopausal hormone therapy in alleviating vasomotor symptoms, insomnia, and irritability in early menopausal women over four years. Methods 727 women, aged 42–58, within three years of their final menstrual period were randomized to receive oral conjugated estrogens (o-CEE) 0.45 mg (n=230) or transdermal estradiol (t-E2) 50mcg (n=225; both with micronized progesterone 200mg for 12 days each month), or placebos (PBO; n=275). Menopausal symptoms were recorded at screening and at 6, 12, 24, 36 and 48 months post-randomization. Differences in proportions of women with symptoms at baseline and at each followup timepoint were compared by treatment arm using exact chi-square tests in an intent-to-treat (ITT) analysis. Differences in treatment effect by race/ethnicity and body mass index (BMI) were tested using generalized linear mixed effects modeling. Results Moderate-to-severe hot flashes (from 44% at baseline to 28.3% for PBO, 7.4% for t-E2 and 4.2% for o-CEE) and night sweats (from 35% at baseline to 19% for PBO, 5.3% for t-E2 and 4.7% for o-CEE) were reduced significantly by 6 months in women randomized to either active hormone compared to PBO (P<0.001 for both symptoms), with no significant differences between the active treatment arms. Insomnia and irritability decreased from baseline to 6 months post randomization in all groups. There was an intermittent reduction in insomnia in both active treatment arms vs PBO, with o-CEE more effective than PBO at 36 and 48 months (p=0.002mad 0.05) and t-E2 more effective than PBO at 48 months (p=0.004). Neither hormone treatment significantly affected irritability compared to PBO. Symptom relief for active treatment vs PBO was not significantly modified by BMI or race/ethnicity. Conclusions Recently-menopausal women had similar and substantial reductions in hot flashes and night sweats with lower than conventional doses of oral or transdermal estrogen. These reductions were sustained over 4 years. Insomnia was intermittently reduced compared to placebo for both hormone regimens. PMID:27779568

Rigid versus flexible dentine-like endodontic posts--clinical testing of a biomechanical concept: seven-year results of a randomized controlled clinical pilot trial on endodontically treated abutment teeth with severe hard tissue loss.

PubMed

Sterzenbach, Guido; Franke, Alexandra; Naumann, Michael

2012-12-01

This is the first clinical long-term pilot study that tested the biomimetic concept of using more flexible, dentine-like (low Young modulus) glass fiber-reinforced epoxy resin posts (GFREPs) compared with rather rigid, stiff (higher Young modulus) titanium posts (TPs) in order to improve the survival rate of severely damaged endodontically treated teeth. Ninety-one subjects in need of postendodontic restorations in teeth with 2 or less remaining cavity walls were randomly assigned to receive either a tapered TP (n = 46) or a tapered GFREP (n = 45). The posts were adhesively luted using self-adhesive resin cement. The composite core build-ups were prepared ensuring a circumferential 2-mm ferrule. The primary endpoint was a loss of restoration for any reason. To study group differences, the log-rank test was calculated (P < .05). Hazard plots were constructed. After 84 months of observation (mean = 71.2 months), 7 restorations failed (ie, 4 GFREPs and 3 TPs). The failure modes were as follows: GFREP:root fracture (n = 3), core fracture (n = 1) and TP:endodontic failure (n = 3). No statistical difference was found between the survival rates (GFREPs = 90.2%, TPs = 93.5%, P = .642). The probability of no failure was comparable for both post materials (risk ratio; 95% confidence interval, 0.965-0.851/1.095). When using self-adhesive luted prefabricated posts in severely destroyed abutment teeth with 2 or less cavity walls and a 2-mm ferrule, postendodontic restorations achieved high long-term survival rates irrespective of the post material used (ie, glass fiber vs titanium). Copyright © 2012 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

A toddler PCV booster dose following 3 infancy priming doses increases circulating serotype-specific IGG levels but does not increase protection against carriage.

PubMed

Dagan, Ron; Ben-Shimol, Shalom; Simell, Birgit; Greenberg, David; Porat, Nurith; Käyhty, Helena; Givon-Lavi, Noga

2018-05-11

We compared PCV7 serological response and protection against carriage in infants receiving 3 doses (2, 4, 6 months; 3+0 schedule) to those receiving a booster (12 months; 3+1). A prospective, randomized controlled study, conducted between 2005 and 2008, before PCVs were implemented in Israel. Healthy infants were randomized 1:1:1 to receive 3+1, 3+0 and 0+2 (control group; 12, 18 months doses). Nasopharyngeal/oropharyngeal swabs were obtained at all visits. Serum serotype-specific IgG concentrations and opsonic activities (OPA) were measured at 2, 7, 13 and 19 months. This study was registered with Current Controlled Trials, Ltd. ISRCTN28445844. Overall, 544 infants were enrolled: 3+1 (n = 178), 3+0 (n = 178) and 0+2 (n = 188). Post-priming (7 months), antibody concentrations were similar in both groups, except for serotype 18C (higher in 3+0). Post-booster (13, 19 months), ELISA and OPA levels were significantly higher in 3+1 than in 3+0 group. Nasopharyngeal/oropharyngeal cultures were positive for Streptococcus pneumoniae in 2673 (54.3%) visits. Acquisition rates (vaccine and non-vaccine serotypes) were similar for 3+1 and 3+0 groups at 7-30 months and for 0+2 group at 19-30 months. PCV7 booster after 3 priming doses increased substantially IgG concentrations but did not further reduced vaccine-serotype nasopharyngeal acquisition, suggesting that protection from pneumococcal carriage does not depend primarily on serum IgG. Copyright © 2018 Elsevier Ltd. All rights reserved.

Depressive symptom deterioration among predominantly Hispanic diabetes patients in safety net care.

PubMed

Ell, Kathleen; Katon, Wayne; Lee, Pey-Jiuan; Kapetanovic, Suad; Guterman, Jeffrey; Xie, Bin; Chou, Chih-Ping

2012-01-01

This study examines clinical predictors of symptom deterioration (relapse/recurrence) at the completion of a clinical intervention trial of depressed, low-income, predominantly Hispanic diabetes patients who were randomized to socio-culturally adapted collaborative depression treatment or usual care and who no longer met clinically significant depression criteria at 12 months post-trial baseline. A sub-cohort of 193 diabetes patients with major depression symptoms at baseline, who were randomized to a 12-month collaborative care intervention (INT) (problem-solving therapy and/or pharmacotherapy, telephone symptom monitoring/relapse prevention, behavioral activation and patient navigation support) or enhanced usual care (EUC), and who did not meet major depression criteria at 12 months were subsequently observed over 18 to 24 months. Post-trial depression symptom deterioration was similar between INT (35.2%) and EUC (35.3%) groups. Among the combined groups, significant predictors of symptom deterioration were baseline history of previous depression and/or dysthymia (odds ratio [OR] = 2.66), 12-month PHQ-9 score (OR = 1.22), antidepressant treatment receipt during the initial 12-months (OR = 2.38), 12-month diabetes symptoms (OR = 2.27), and new ICD-9 medical diagnoses in the initial 12 months (OR = 1.11) (R2 = 27%; max-rescaled R2 = 37%; likelihood ratio test, χ2 = 59.79, df = 5, P < 0.0001). Among predominantly Hispanic diabetes patients in community safety net primary care clinics whose depression had improved over 1 year, more than one-third experienced symptom deterioration over the following year. A primary care management depression care protocol that includes ongoing depression symptom monitoring, antidepressant adherence, and diabetes and co-morbid illness monitoring plus depression medication adjustment and behavioral activation may reduce and/or effectively treat depression symptom deterioration. Copyright © 2012 The Academy of Psychosomatic Medicine. All rights reserved.

Evaluation of a Low Energy, Low Density, Non-Ablative Fractional 1927 nm Wavelength Laser for Facial Skin Resurfacing.

PubMed

Brauer, Jeremy A; Alabdulrazzaq, Hamad; Bae, Yoon-Soo Cindy; Geronemus, Roy G

2015-11-01

We investigated the safety, tolerability and efficacy of a low energy low density, non-ablative fractional 1,927-nm laser in the treatment of facial photodamage, melasma, and post inflammatory hyperpigmentation. Prospective non-randomized trial. Single center, private practice with a dedicated research department. Subjects with clinically diagnosed facial photodamage, melasma, or post inflammatory hyperpigmentation. Subjects received four to six treatments at 14-day intervals (+/- 3 days) with a low energy low density non-ablative fractional 1,927-nm laser (Solta Hayward, CA) with an energy level of 5 mJ, and density coverage of either 5%, 7.5%, or 10%, with a total of up to 8 passes. Blinded assessment of clinical photos for overall improvement at one and three months post final treatment. Investigator improvement scores, and subject pain and satisfaction scores for overall improvement were recorded as well. We enrolled 23 subjects, average age 45.0 years (range, 25-64 years), 22 with Fitzpatrick Skin Types I-IV and 1 with Type VI, with facial photodamage, melasma, or post inflammatory hyperpigmentation. Approximately 55% of subjects reported marked to very significant improvement at one and three months post final treatment. Blinded assessment of photography of 20 subjects revealed an average of moderate improvement at one-month follow up and mild to moderate improvement at three months. Average subject pain score was 3.4/10 during treatment. Favorable outcomes were demonstrated using the low energy low density, non-ablative fractional 1,927-nm laser in facial resurfacing for photodamage, melasma, and post inflammatory hyperpigmentation. Results were maintained at the 3-month follow up, as demonstrated by investigator and subject assessments, as well as blinded evaluations by three independent dermatologists utilizing photographs obtained from a standardized facial imaging device.

Effects of mental health interventions for students in higher education are sustainable over time: a systematic review and meta-analysis of randomized controlled trials

PubMed Central

Guldbrandsson, Karin; Sidorchuk, Anna

2018-01-01

Background Symptoms of depression, anxiety, and distress are more common in undergraduates compared to age-matched peers. Mental ill health among students is associated with impaired academic achievement, worse occupational preparedness, and lower future occupational performance. Research on mental health promoting and mental ill health preventing interventions has shown promising short-term effects, though the sustainability of intervention benefits deserve closer attention. We aimed to identify, appraise and summarize existing data from randomized control trials (RCTs) reporting on whether the effects of mental health promoting and mental ill health preventing interventions were sustained at least three months post-intervention, and to analyze how the effects vary for different outcomes in relation to follow-up length. Further, we aimed to assess whether the effect sustainability varied by intervention type, study-level determinants and of participant characteristics. Material and Methods A systematic search in MEDLINE, PsycInfo, ERIC, and Scopus was performed for RCTs published in 1995–2015 reporting an assessment of mental ill health and positive mental health outcomes for, at least, three months of post-intervention follow-up. Random-effect modeling was utilized for quantitative synthesis of the existing evidence with standardized mean difference (Hedges’ g) used to estimate an aggregated effect size. Sustainability of the effects of interventions was analyzed separately for 3–6 months, 7–12 months, and 13–18 months of post-intervention follow-up. Results About 26 studies were eligible after reviewing 6,571 citations. The pooled effects were mainly small, but significant for several categories of outcomes. Thus, for the combined mental ill health outcomes, symptom-reduction sustained up to 7–12 months post-intervention (standardized mean difference (Hedges’ g) effect size (ES) = −0.28 (95% CI [−0.49, −0.08])). Further, sustainability of symptom-reductions were evident for depression with intervention effect lasting up to 13–18 months (ES = −0.30 (95% CI [−0.51, −0.08])), for anxiety up to 7–12 months (ES = −0.27 (95% CI [−0.54, −0.01])), and for stress up to 3–6 months (ES = −0.30 (95% CI [−0.58, −0.03])). The effects of interventions to enhance positive mental health were sustained up to 3–6 months for the combined positive mental health outcomes (ES = 0.32 (95% CI [0.05, 0.59])). For enhanced active coping, sustainability up to 3–6 months was observed with a medium and significant effect (ES = 0.75 (95% CI [0.19, 1.30])). Discussion The evidence suggests long-term effect sustainability for mental ill health preventive interventions, especially for interventions to reduce the symptoms of depression and symptoms of anxiety. Interventions to promote positive mental health offer promising, but shorter-lasting effects. Future research should focus on mental health organizational interventions to examine their potential for students in tertiary education. PMID:29629247

Treatment of Binge Eating Disorder in Racially and Ethnically Diverse Obese Patients in Primary Care: Randomized Placebo-Controlled Clinical Trial of Self-Help and Medication

PubMed Central

Grilo, Carlos M.; Masheb, Robin M.; White, Marney A.; Gueorguieva, Ralitza; Barnes, Rachel D.; Walsh, B. Timothy; McKenzie, Katherine C.; Genao, Inginia; Garcia, Rina

2014-01-01

Objective The objective was to determine whether treatments with demonstrated efficacy for binge eating disorder (BED) in specialist treatment centers can be delivered effectively in primary care settings to racially/ethnically diverse obese patients with BED. This study compared the effectiveness of self-help cognitive-behavioral therapy (shCBT) and an anti-obesity medication (sibutramine), alone and in combination, and it is only the second placebo-controlled trial of any medication for BED to evaluate longer-term effects after treatment discontinuation. Method 104 obese patients with BED (73% female, 55% non-white) were randomly assigned to one of four 16-week treatments (balanced 2-by-2 factorial design): sibutramine (N=26), placebo (N=27), shCBT+sibutramine (N=26), or shCBT+placebo (N=25). Medications were administered in double-blind fashion. Independent assessments were performed monthly throughout treatment, post-treatment, and at 6- and 12-month follow-ups (16 months after randomization). Results Mixed-models analyses revealed significant time and medication-by-time interaction effects for percent weight loss, with sibutramine but not placebo associated with significant change over time. Percent weight loss differed significantly between sibutramine and placebo by the third month of treatment and at post-treatment. After the medication was discontinued at post-treatment, weight re-gain occurred in sibutramine groups and percent weight loss no longer differed among the four treatments at 6- and 12-month follow-ups. For binge-eating, mixed-models revealed significant time and shCBT-by-time interaction effects: shCBT had significantly lower binge-eating frequency at 6-month follow-up but the treatments did not differ significantly at any other time point. Demographic factors did not significantly predict or moderate clinical outcomes. Discussion Our findings suggest that pure self-help CBT and sibutramine did not show long-term effectiveness relative to placebo for treating BED in racially/ethnically diverse obese patients in primary care. Overall, the treatments differed little with respect to binge-eating and associated outcomes. Sibutramine was associated with significantly greater acute weight loss than placebo and the observed weight-regain following discontinuation of medication suggests that anti-obesity medications need to be continued for weight loss maintenance. Demographic factors did not predict/moderate clinical outcomes in this diverse patient group. PMID:24857821

Experiences with insecticide-treated curtains: a qualitative study in Iquitos, Peru.

PubMed

Paz-Soldan, Valerie A; Bauer, Karin M; Lenhart, Audrey; Cordova Lopez, Jhonny J; Elder, John P; Scott, Thomas W; McCall, Philip J; Kochel, Tadeusz J; Morrison, Amy C

2016-07-16

Dengue is an arthropod-borne viral disease responsible for approximately 400 million infections annually; the only available method of prevention is vector control. It has been previously demonstrated that insecticide treated curtains (ITCs) can lower dengue vector infestations in and around houses. As part of a larger trial examining whether ITCs could reduce dengue transmission in Iquitos, Peru, the objective of this study was to characterize the participants' experience with the ITCs using qualitative methods. Knowledge, attitudes, and practices (KAP) surveys (at baseline, and 9 and 27 months post-ITC distribution, with n = 593, 595 and 511, respectively), focus group discussions (at 6 and 12 months post-ITC distribution, with n = 18 and 33, respectively), and 11 one-on-one interviews (at 12 months post-distribution) were conducted with 605 participants who received ITCs as part of a cluster-randomized trial. Focus groups at 6 months post-ITC distribution revealed that individuals had observed their ITCs to function for approximately 3 months, after which they reported the ITCs were no longer working. Follow up revealed that the ITCs required re-treatment with insecticide at approximately 1 year post-distribution. Over half (55.3 %, n = 329) of participants at 9 months post-ITC distribution and over a third (34.8 %, n = 177) at 27 months post-ITC distribution reported perceiving a decrease in the number of mosquitoes in their home. The percentage of participants who would recommend ITCs to their family or friends in the future remained high throughout the study (94.3 %, n = 561 at 9 months and 94.6 %, n = 488 at 27 months post-distribution). When asked why, participants reported that ITCs were effective at reducing mosquitoes (81.6 and 37.8 %, at 9 and 27 months respectively), that they prevent dengue (5.7 and 51.2 %, at 9 and 27 months), that they are "beautiful" (5.9 and 3.1 %), as well as other reasons (6.9 and 2.5 %). ITCs have substantial potential for long term dengue vector control because they are liked by users, both for their perceived effectiveness and for aesthetic reasons, and because they require little proactive behavioral effort on the part of the users. Our results highlight the importance of gathering process (as opposed to outcome) data during vector control studies, without which researchers would not have become aware that the ITCs had lost effectiveness early in the trial.

Analysis of time series for postal shipments in Regional VII East Java Indonesia

NASA Astrophysics Data System (ADS)

Kusrini, DE; Ulama, B. S. S.; Aridinanti, L.

2018-03-01

The change of number delivery goods through PT. Pos Regional VII East Java Indonesia indicates that the trend of increasing and decreasing the delivery of documents and non-documents in PT. Pos Regional VII East Java Indonesia is strongly influenced by conditions outside of PT. Pos Regional VII East Java Indonesia so that the prediction the number of document and non-documents requires a model that can accommodate it. Based on the time series plot monthly data fluctuations occur from 2013-2016 then the model is done using ARIMA or seasonal ARIMA and selected the best model based on the smallest AIC value. The results of data analysis about the number of shipments on each product sent through the Sub-Regional Postal Office VII East Java indicates that there are 5 post offices of 26 post offices entering the territory. The largest number of shipments is available on the PPB (Paket Pos Biasa is regular package shipment/non-document ) and SKH (Surat Kilat Khusus is Special Express Mail/document) products. The time series model generated is largely a Random walk model meaning that the number of shipment in the future is influenced by random effects that are difficult to predict. Some are AR and MA models, except for Express shipment products with Malang post office destination which has seasonal ARIMA model on lag 6 and 12. This means that the number of items in the following month is affected by the number of items in the previous 6 months.

Clinical Trial of Abstinence-Based Vouchers and Cognitive-Behavioral Therapy for Cannabis Dependence

ERIC Educational Resources Information Center

Budney, Alan J.; Moore, Brent A.; Rocha, Heath L.; Higgins, Stephen T.

2006-01-01

Ninety cannabis-dependent adults seeking treatment were randomly assigned to receive cognitive-behavioral therapy, abstinence-based voucher incentives, or their combination. Treatment duration was 14 weeks, and outcomes were assessed for 12 months post treatment. Findings suggest that (a) abstinence-based vouchers were effective for engendering…

Short-Term-Effectiveness of a Relationship Education Program for Distressed Military Couples, in the Context of Foreign Assignments for the German Armed Forces. Preliminary Findings From a Randomized Controlled Study.

PubMed

Kröger, Christoph; Kliem, Sören; Zimmermann, Peter; Kowalski, Jens

2018-04-01

This study examines the short-term effectiveness of a relationship education program designed for military couples. Distressed couples were randomly placed in either a wait-list control group or an intervention group. We conducted training sessions before a 3-month foreign assignment, and refresher courses approximately 6-week post-assignment. We analyzed the dyadic data of 32 couples, using hierarchical linear modeling in a two-level model. Reduction in unresolved conflicts was found in the intervention group, with large pre-post effects for both partners. Relationship satisfaction scores were improved, with moderate-to-large effects only for soldiers, rather than their partners. Post-follow-up effect sizes suggested further improvement in the intervention group. Future research should examine the long-term effectiveness of this treatment. © 2017 American Association for Marriage and Family Therapy.

Contralaterally Controlled Functional Electrical Stimulation Improves Hand Dexterity in Chronic Hemiparesis: A Randomized Trial.

PubMed

Knutson, Jayme S; Gunzler, Douglas D; Wilson, Richard D; Chae, John

2016-10-01

It is unknown whether one method of neuromuscular electrical stimulation for poststroke upper limb rehabilitation is more effective than another. Our aim was to compare the effects of contralaterally controlled functional electrical stimulation (CCFES) with cyclic neuromuscular electrical stimulation (cNMES). Stroke patients with chronic (>6 months) moderate to severe upper extremity hemiparesis (n=80) were randomized to receive 10 sessions/wk of CCFES- or cNMES-assisted hand opening exercise at home plus 20 sessions of functional task practice in the laboratory for 12 weeks. The task practice for the CCFES group was stimulation assisted. The primary outcome was change in Box and Block Test (BBT) score at 6 months post treatment. Upper extremity Fugl-Meyer and Arm Motor Abilities Test were also measured. At 6 months post treatment, the CCFES group had greater improvement on the BBT, 4.6 (95% confidence interval [CI], 2.2-7.0), than the cNMES group, 1.8 (95% CI, 0.6-3.0), between-group difference of 2.8 (95% CI, 0.1-5.5), P=0.045. No significant between-group difference was found for the upper extremity Fugl-Meyer (P=0.888) or Arm Motor Abilities Test (P=0.096). Participants who had the largest improvements on BBT were <2 years post stroke with moderate (ie, not severe) hand impairment at baseline. Among these, the 6-month post-treatment BBT gains of the CCFES group, 9.6 (95% CI, 5.6-13.6), were greater than those of the cNMES group, 4.1 (95% CI, 1.7-6.5), between-group difference of 5.5 (95% CI, 0.8-10.2), P=0.023. CCFES improved hand dexterity more than cNMES in chronic stroke survivors. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00891319. © 2016 American Heart Association, Inc.

The impact of performance incentives on child health outcomes: results from a cluster randomized controlled trial in the Philippines.

PubMed

Peabody, John W; Shimkhada, Riti; Quimbo, Stella; Solon, Orville; Javier, Xylee; McCulloch, Charles

2014-08-01

Improving clinical performance using measurement and payment incentives, including pay for performance (or P4P), has, so far, shown modest to no benefit on patient outcomes. Our objective was to assess the impact of a P4P programme on paediatric health outcomes in the Philippines. We used data from the Quality Improvement Demonstration Study. In this study, the P4P intervention, introduced in 2004, was randomly assigned to 10 community district hospitals, which were matched to 10 control sites. At all sites, physician quality was measured using Clinical Performance Vignettes (CPVs) among randomly selected physicians every 6 months over a 36-month period. In the hospitals randomized to the P4P intervention, physicians received bonus payments if they met qualifying scores on the CPV. We measured health outcomes 4-10 weeks after hospital discharge among children 5 years of age and under who had been hospitalized for diarrhoea and pneumonia (the two most common illnesses affecting this age cohort) and had been under the care of physicians participating in the study. Health outcomes data collection was done at baseline/pre-intervention and 2 years post-intervention on the following post-discharge outcomes: (1) age-adjusted wasting, (2) C-reactive protein in blood, (3) haemoglobin level and (4) parental assessment of child's health using general self-reported health (GSRH) measure. To evaluate changes in health outcomes in the control vs intervention sites over time (baseline vs post-intervention), we used a difference-in-difference logistic regression analysis, controlling for potential confounders. We found an improvement of 7 and 9 percentage points in GSRH and wasting over time (post-intervention vs baseline) in the intervention sites relative to the control sites (P ≤ 0.001). The results from this randomized social experiment indicate that the introduction of a performance-based incentive programme, which included measurement and feedback, led to improvements in two important child health outcomes. Published by Oxford University Press in association with The London School of Hygiene and Tropical Medicine © The Author 2013; all rights reserved.

An intervention that reduces stress in people who combine work with informal care: randomized controlled trial results.

PubMed

Boezeman, Edwin J; Nieuwenhuijsen, Karen; Sluiter, Judith K

2018-06-01

The aim of the research was to examine whether a role-focused self-help course intervention would decrease caregiver stress and distress, and functioning problems, among people who suffer stress because they combine paid work with informal care. A pre-registered (NTR 5528) randomized controlled design was applied (intervention vs. wait list control). Participants (n = 128) were people who had paid work and were suffering stress due to their involvement in informal care activities. Participants allocated to the intervention group (n = 65) received the role-focused self-help course. Control group members (n = 63) received this intervention after all measurements. Prior to the random allocation (pre-test), and 1 month (post-test 1) and 2 months (post-test 2) after allocation, all participants completed a questionnaire that measured their caregiver stress (primary outcome), distress, work functioning, negative care-to-work interference and negative care-to-social and personal life interference. Mixed model ANOVAs were used to test the effectiveness of the intervention. Two months after allocation, the intervention group participants had lower levels of caregiver stress and distress compared with the control group participants. The intervention did not directly resolve impaired work functioning or interference of care with work and social/personal life. The intervention decreases caregiver stress and distress in people who suffer stress because they combine paid work with informal caring. The intervention (Dutch version) can be downloaded at no cost from www.amc.nl/mantelzorgstress.

Extended-release naltrexone for pre-release prisoners: A randomized trial of medical mobile treatment

PubMed Central

Gordon, Michael S.; Vocci, Frank J.; Fitzgerald, Terrence T.; O'Grady, Kevin E.; O'Brien, Charles P.

2017-01-01

Background Extended-release naltrexone (XR-NTX), is an effective treatment for opioid use disorder but is rarely initiated in US prisons or with criminal justice populations. Mobile treatment for chronic diseases have been implemented in a variety of settings. Mobile treatment may provide an opportunity to expand outreach to parolees to surmount barriers to traditional clinic treatment. Methods Male and female prisoners (240) with pre-incarceration histories of opioid use disorder who are within one month of release from prison will be enrolled in this randomized clinical trial. Participants are randomized to one of two study arms: 1) [XR-NTX-OTx] One injection of long-acting naltrexone in prison, followed by 6 monthly injections post-release at a community opioid treatment program; or 2) [XR-NTX+ MMTx] One injection of long-acting naltrexone in prison followed by 6 monthly injections post-release at the patient's place of residence utilizing mobile medical treatment. The primary outcomes are: treatment adherence; opioid use; criminal activity; re-arrest; reincarceration; and HIV risk-behaviors. Results We describe the background and rationale for the study, its aims, hypotheses, and study design. Conclusions The use of long-acting injectable naltrexone may be a promising form of treatment for pre-release prisoners. Finally, as many individuals in the criminal justice system drop out of treatment, this study will assess whether treatment at their place of residence will improve adherence and positively affect treatment outcomes. PMID:28011389

Extended-release naltrexone for pre-release prisoners: A randomized trial of medical mobile treatment.

PubMed

Gordon, Michael S; Vocci, Frank J; Fitzgerald, Terrence T; O'Grady, Kevin E; O'Brien, Charles P

2017-02-01

Extended-release naltrexone (XR-NTX), is an effective treatment for opioid use disorder but is rarely initiated in US prisons or with criminal justice populations. Mobile treatment for chronic diseases has been implemented in a variety of settings. Mobile treatment may provide an opportunity to expand outreach to parolees to surmount barriers to traditional clinic treatment. Male and female prisoners (240) with pre-incarceration histories of opioid use disorder who are within one month of release from prison will be enrolled in this randomized clinical trial. Participants are randomized to one of two study arms: 1) [XR-NTX-OTx] One injection of long-acting naltrexone in prison, followed by 6 monthly injections post-release at a community opioid treatment program; or 2) [XR-NTX+ MMTx] One injection of long-acting naltrexone in prison followed by 6 monthly injections post-release at the patient's place of residence utilizing mobile medical treatment. The primary outcomes are: treatment adherence; opioid use; criminal activity; re-arrest; reincarceration; and HIV risk-behaviors. We describe the background and rationale for the study, its aims, hypotheses, and study design. The use of long-acting injectable naltrexone may be a promising form of treatment for pre-release prisoners. Finally, as many individuals in the criminal justice system drop out of treatment, this study will assess whether treatment at their place of residence will improve adherence and positively affect treatment outcomes. ClinicalTrials.gov: NCT02867124. Copyright © 2016 Elsevier Inc. All rights reserved.

Rehabilitation of Executive Functions in Patients with Chronic Acquired Brain Injury with Goal Management Training, External Cuing, and Emotional Regulation: A Randomized Controlled Trial.

PubMed

Tornås, Sveinung; Løvstad, Marianne; Solbakk, Anne-Kristin; Evans, Jonathan; Endestad, Tor; Hol, Per Kristian; Schanke, Anne-Kristine; Stubberud, Jan

2016-04-01

Executive dysfunction is a common consequence of acquired brain injury (ABI), causing significant disability in daily life. This randomized controlled trial investigated the efficacy of Goal Management Training (GMT) in improving executive functioning in patients with chronic ABI. Seventy patients with a verified ABI and executive dysfunction were randomly allocated to GMT (n=33) or a psycho-educative active control condition, Brain Health Workshop (BHW) (n=37). In addition, all participants received external cueing by text messages. Neuropsychological tests and self-reported questionnaires of executive functioning were administered pre-intervention, immediately after intervention, and at 6 months follow-up. Assessors were blinded to group allocation. Questionnaire measures indicated significant improvement of everyday executive functioning in the GMT group, with effects lasting at least 6 months post-treatment. Both groups improved on the majority of the applied neuropsychological tests. However, improved performance on tests demanding executive attention was most prominent in the GMT group. The results indicate that GMT combined with external cueing is an effective metacognitive strategy training method, ameliorating executive dysfunction in daily life for patients with chronic ABI. The strongest effects were seen on self-report measures of executive functions 6 months post-treatment, suggesting that strategies learned in GMT were applied and consolidated in everyday life after the end of training. Furthermore, these findings show that executive dysfunction can be improved years after the ABI.

Effects of water fluoridation on caries experience in the primary dentition in a high caries risk community in Queensland, Australia.

PubMed

Koh, Rongzhen; Pukallus, Margaret L; Newman, Bruce; Foley, Michael; Walsh, Laurence J; Seow, W Kim

2015-01-01

In December 2008, artificial water fluoridation was introduced for the first time to the Logan-Beaudesert district in the state of Queensland, Australia. The aim of this study was to evaluate the effects of water fluoridation in the primary dentition in this community after a period of 36 months. Children aged 4-9 years with clinical examinations and bitewing radiographs (BWs) taken before water fluoridation (pre-F) were randomly selected as comparison controls for age matched children who had been exposed to a mean period of 36 months of water fluoridation (post-F). A total of 201 sets of pre-F BWs from children (mean age 6.95 ± 1.05 years) and 256 sets of post-F BWs from children (mean age 7.19 ± 1.23 years) attending schools in the district were randomly selected. Caries experience in the primary dentition was determined as decayed, missing or filled teeth/surfaces (dmft/dmfs). The caries prevalence for the pre-F group was 87% compared to 75% in the post-F group (Odds ratio (OR): 0.44, 95% CI: 0.27-0.72). Overall, there was a 19 percent reduction of mean dmft from 4.54 in the pre-F group to 3.66 in the post-F group (p = 0.005). After fluoridation, the dmfs was reduced from 6.68 to 5.17 (p = 0.0056). The distal surfaces of maxillary first primary molars experienced the greatest reduction (26%) in caries experience after water fluoridation (p < 0.001). After only 36 months of water fluoridation there was a significant drop in caries prevalence from 87 to 75% and a 19% reduction in caries experience in a community with one of the highest caries rates in Australia.

Memantine before Mastectomy Prevents Post-Surgery Pain: A Randomized, Blinded Clinical Trial in Surgical Patients

PubMed Central

Morel, Véronique; Joly, Dominique; Villatte, Christine; Dubray, Claude; Durando, Xavier; Daulhac, Laurence; Coudert, Catherine; Roux, Delphine; Pereira, Bruno; Pickering, Gisèle

2016-01-01

Background Neuropathic pain following surgical treatment for breast cancer with or without chemotherapy is a clinical burden and patients frequently report cognitive, emotional and quality of life impairment. A preclinical study recently showed that memantine administered before surgery may prevent neuropathic pain development and cognitive dysfunction. With a translational approach, a clinical trial has been carried out to evaluate whether memantine administered before and after mastectomy could prevent the development of neuropathic pain, the impairment of cognition and quality of life. Method A randomized, pilot clinical trial included 40 women undergoing mastectomy in the Oncology Department, University Hospital, Clermont-Ferrand, France. Memantine (5 to 20 mg/day; n = 20) or placebo (n = 20) was administered for four weeks starting two weeks before surgery. The primary endpoint was pain intensity measured on a (0–10) numerical rating scale at three months post-mastectomy. Results Data analyses were performed using mixed models and the tests were two-sided, with a type I error set at α = 0.05. Compared with placebo, patients receiving memantine showed at three months a significant difference in post-mastectomy pain intensity, less rescue analgesia and a better emotional state. An improvement of pain symptoms induced by cancer chemotherapy was also reported. Conclusions This study shows for the first time the beneficial effect of memantine to prevent post-mastectomy pain development and to diminish chemotherapy-induced pain symptoms. The lesser analgesic consumption and better well-being of patients for at least six months after treatment suggests that memantine could be an interesting therapeutic option to diminish the burden of breast cancer therapy. Trial Registration Clinicaltrials.gov NCT01536314 PMID:27050431

Who Benefits from Gender Responsive Treatment? Accounting for Abuse History on Longitudinal Outcomes for Women in Prison.

PubMed

Saxena, Preeta; Messina, Nena; Grella, Christine E

2014-04-01

This study explores outcome variation among women offenders who participated in gender-responsive substance abuse treatment (GRT). In order to identify subgroups of participants that may differentially benefit from this treatment, secondary analyses examined the interaction between randomization into GRT and a history of abuse (physical/sexual) on depression and number of substances used post- treatment. The sample consisted of 115 incarcerated women assessed at baseline and 6- and 12-months post parole. Longitudinal regression showed that women reporting abuse randomized into GRT had significantly reduced odds of depression ( OR = .29, p < .05, 95% CI = .10 - .86) and lowered rates of number of substances used ( IRR = .52, p < .05, 95% CI = 0.28-0.98), in comparison to those who reported abuse and were randomized to the non-GRT group. GRT for women offenders who have experienced prior abuse would maximize the benefits of the trauma-informed, gender-sensitive intervention.

A Comparative Study of Whole Body Vibration Training and Pelvic Floor Muscle Training on Women's Stress Urinary Incontinence: Three- Month Follow- Up.

PubMed

Farzinmehr, Azizeh; Moezy, Azar; Koohpayehzadeh, Jalil; Kashanian, Maryam

2015-11-01

To determine whether Whole Body Vibration Training (WBVT) is effective at improving pelvic floor muscles strength in women with Stress Urinary Incontinence (SUI). The study was designed as a randomized clinical trial. 43 women with SUI were randomly assigned in two groups; WBVT and Pelvic Floor Muscle Training (PFMT) and received interventions for four weeks. Pelvic floor muscle (PFM) strength, quality of life and incontinence intensity were evaluated. All measurements were conducted pre and post intervention and also after 3 months in all participants. The ANOVA and the independent sample t test were applied respectively to determine the differences in each group and between the groups. This study showed the WBVT protocol in this study was effective in pelvic floor muscles strength similar to PFMT, and also in reducing the severity of incontinence and increasing I-QOL questionnaire score. We found significant differences in each group pre and post intervention (p = 0.0001); but no significant difference in comparison of two groups' outcomes. Also after three-month follow up, there was no significant difference between groups. The findings of this study showed the beneficial effects of WBVT in improving pelvic floor muscles strength and quality of life in patients with urinary incontinence in four-week treatment period and after three months follow up.

A study of parent/grandparent education for managing a febrile illness using the CALM approach.

PubMed

Broome, Marion E; Dokken, Deborah L; Broome, Carroll D; Woodring, Barbara; Stegelman, Mark F

2003-01-01

The purpose of this study was to examine the effectiveness of fever management education in increasing knowledge, confidence, comfort, and satisfaction of the parent/grandparent. A randomized repeated measures design was used to evaluate the effectiveness of an educational brochure and video. After baseline data were collected on parent/grandparents of children receiving standard care, each site was randomized into two groups: Group 1 parents were given a video and brochure about fever management as they left the clinic/office; Group 2 were shown the video and given the brochure before seeing their health care provider. The parent/grandparents of 216 children, mean age 21.8 months, completed the Fever Management Questionnaire (FMQ) at 48-72 hours, 1, 3, and 6 months post-education. Knowledge scores of parents/grandparents in both CALM groups were significantly higher than those in the control group at 48 hours and 1-month post-visit. By 6 months, the knowledge level of the parent/grandparents in CALM2, those who viewed the video in the office, was significantly different from the other two groups. Satisfaction, comfort, and confidence of all three groups were high at all three points. Parents/grandparents in both CALM groups were highly satisfied with the education they received. Educating parent/grandparents about fever management using written and video materials is effective in increasing knowledge about fever management.

Efficacy of stem cell in improvement of left ventricular function in acute myocardial infarction - MI3 Trial

PubMed Central

Nair, Velu; Madan, Hemant; Sofat, Sunil; Ganguli, Prosenjit; Jacob, M.J.; Datta, Rajat; Bharadwaj, Prashant; Sarkar, R.S.; Pandit, A.J.; Nityanand, Soniya; Goel, Pravin K.; Garg, Naveen; Gambhir, Sanjay; George, Paul V.; Chandy, Sunil; Mathews, Vikram; George, Oomen K.; Talwar, K.K.; Bahl, Ajay; Marwah, Neelam; Bhatacharya, Anish; Bhargava, Balram; Airan, Balram; Mohanty, Sujata; Patel, Chetan D.; Sharma, Alka; Bhatnagar, Shinjini; Mondal, A.; Jose, Jacob; Srivastava, A.

2015-01-01

Background & objectives: Acute myocardial infarction (AMI) is characterized by irreparable and irreversible loss of cardiac myocytes. Despite major advances in the management of AMI, a large number of patients are left with reduced left ventricular ejection fraction (LVEF), which is a major determinant of short and long term morbidity and mortality. A review of 33 randomized control trials has shown varying improvement in left ventricular (LV) function in patients receiving stem cells compared to standard medical therapy. Most trials had small sample size and were underpowered. This phase III prospective, open labelled, randomized multicenteric trial was undertaken to evaluate the efficacy in improving the LVEF over a period of six months, after injecting a predefined dose of 5-10 × 108 autologous mononuclear cells (MNC) by intra-coronary route, in patients, one to three weeks post ST elevation AMI, in addition to the standard medical therapy. Methods: In this phase III prospective, multicentric trial 250 patients with AMI were included and randomized into stem cell therapy (SCT) and non SCT groups. All patients were followed up for six months. Patients with AMI having left ventricular ejection fraction (LVEF) of 20-50 per cent were included and were randomized to receive intracoronary stem cell infusion after successfully completing percutaneous coronary intervention (PCI). Results: On intention-to-treat analysis the infusion of MNCs had no positive impact on LVEF improvement of ≥ 5 per cent. The improvement in LVEF after six months was 5.17 ± 8.90 per cent in non SCT group and 4.82 ± 10.32 per cent in SCT group. The adverse effects were comparable in both the groups. On post hoc analysis it was noted that the cell dose had a positive impact when infused in the dose of ≥ 5 × 108(n=71). This benefit was noted upto three weeks post AMI. There were 38 trial deviates in the SCT group which was a limitation of the study. Interpretation & conclusions: Infusion of stem cells was found to have no benefit in ST elevation AMI. However, the procedure was safe. A possible benefit was seen when the predefined cell dose was administered which was noted upto three weeks post AMI, but this was not significant and needs confirmation by larger trials. PMID:26354213

Impact of the condolence letter on the experience of bereaved families after a death in intensive care: study protocol for a randomized controlled trial.

PubMed

Kentish-Barnes, Nancy; Chevret, Sylvie; Azoulay, Elie

2016-02-20

As intensive care mortality is high, end of life is a subject of major concern for intensivists. In this context, relatives are particularly vulnerable and prone to post-ICU syndrome, in the form of high levels of anxiety, depression, post-traumatic stress, and complicated grief. Grieving families suffer from a feeling of abandonment and evoke the need to get back in touch with the team to ask questions and remove doubts, but very few actually do. Aiding families during the grieving process is an important aspect of palliative care. A condolence letter represents an opportunity to recognize the pain of the family member and the strong tie that linked the family member to the ICU team, and to offer additional information if necessary. The goal of the study is to measure the impact of the condolence letter on the experience of bereaved families after a death in the ICU. Our hypothesis is that a post-death follow-up in the form of a condolence letter sent by the ICU physician who was in charge of the patient may help to reduce the risks of presenting symptoms of anxiety/depression, post-traumatic stress, and complicated grief. This is a randomized, controlled, multicenter study. Research will compare two groups of bereaved family members: one group that does not receive a condolence letter (control) and one group that receives a condolence letter 15 days after the death (intervention). Each of the 22 participating centers will include 12 relatives. Participating relatives will be followed up by phone with a call at 1 month and one at 6 months to complete questionnaires, permitting evaluation of post-ICU burden. The main outcome is anxiety and depression measured at 1 month. Other outcomes include evaluation of quality of dying and death, post-traumatic stress, and complicated grief. This study will allow us to assess if sending a condolence letter can reduce the risks of presenting symptoms of anxiety and depression, complicated grief, and symptoms of post-traumatic stress disorder after the death of a loved one in the ICU. Clinicaltrials.gov NCT02325297 (23 December 2014).

A cluster randomized trial of strategies to increase uptake amongst young women invited for their first cervical screen: The STRATEGIC trial.

PubMed

Kitchener, H; Gittins, M; Cruickshank, M; Moseley, C; Fletcher, S; Albrow, R; Gray, A; Brabin, L; Torgerson, D; Crosbie, E J; Sargent, A; Roberts, C

2018-06-01

Objectives To measure the feasibility and effectiveness of interventions to increase cervical screening uptake amongst young women. Methods A two-phase cluster randomized trial conducted in general practices in the NHS Cervical Screening Programme. In Phase 1, women in practices randomized to intervention due for their first invitation to cervical screening received a pre-invitation leaflet and, separately, access to online booking. In Phase 2, non-attenders at six months were randomized to one of: vaginal self-sample kits sent unrequested or offered; timed appointments; nurse navigator; or the choice between nurse navigator or self-sample kits. Primary outcome was uplift in intervention vs. control practices, at 3 and 12 months post invitation. Results Phase 1 randomized 20,879 women. Neither pre-invitation leaflet nor online booking increased screening uptake by three months (18.8% pre-invitation leaflet vs. 19.2% control and 17.8% online booking vs. 17.2% control). Uptake was higher amongst human papillomavirus vaccinees at three months (OR 2.07, 95% CI 1.69-2.53, p < 0.001). Phase 2 randomized 10,126 non-attenders, with 32-34 clusters for each intervention and 100 clusters as controls. Sending self-sample kits increased uptake at 12 months (OR 1.51, 95% CI 1.20-1.91, p = 0.001), as did timed appointments (OR 1.41, 95% CI 1.14-1.74, p = 0.001). The offer of a nurse navigator, a self-sample kits on request, and choice between timed appointments and nurse navigator were ineffective. Conclusions Amongst non-attenders, self-sample kits sent and timed appointments achieved an uplift in screening over the short term; longer term impact is less certain. Prior human papillomavirus vaccination was associated with increased screening uptake.

Efficacy of a Community-Based Physical Activity Program KM2H2 for Stroke and Heart Attack Prevention among Senior Hypertensive Patients: A Cluster Randomized Controlled Phase-II Trial.

PubMed

Gong, Jie; Chen, Xinguang; Li, Sijian

2015-01-01

To evaluate the efficacy of the program Keep Moving toward Healthy Heart and Healthy Brain (KM2H2) in encouraging physical activities for the prevention of heart attack and stroke among hypertensive patients enrolled in the Community-Based Hypertension Control Program (CBHCP). Cluster randomized controlled trial with three waves of longitudinal assessments at baseline, 3 and 6 months post intervention. Community-based and patient-centered self-care for behavioral intervention in urban settings of China. A total of 450 participants diagnosed with hypertension from 12 community health centers in Wuhan, China were recruited, and were randomly assigned by center to receive either KM2H2 plus standard CBHCP care (6 centers and 232 patients) or the standard care only (6 centers and 218 patients). KM2H2 is a behavioral intervention guided by the Transtheoretical Model, the Model of Personalized Medicine and Social Capital Theory. It consists of six intervention sessions and two booster sessions engineered in a progressive manner. The purpose is to motivate and maintain physical activities for the prevention of heart attack and stroke. Heart attack and stroke (clinically diagnosed, primary outcome), blood pressure (measured, secondary outcome), and physical activity (self-report, tertiary outcome) were assessed at the individual level during the baseline, 3- and 6-month post-intervention. Relative to the standard care, receiving KM2H2 was associated with significant reductions in the incidence of heart attack (3.60% vs. 7.03%, p < .05) and stroke (5.11% vs. 9.90%, p<0.05), and moderate reduction in blood pressure (-3.72 mmHg in DBP and -2.92 mmHg in DBP) at 6-month post-intervention; and significant increases in physical activity at 3- (d = 0.53, 95% CI: 0.21, 0.85) and 6-month (d = 0.45, 95% CI: 0.04, 0.85) post-intervention, respectively. The program KM2H2 is efficacious to reduce the risk of heart attack and stroke among senior patients who are on anti-hypertensive medication. Findings of this study provide solid data supporting a formal phase-III trial to establish the effectiveness of KM2H2 for use in community settings for prevention. ISRCTN Register ISRCTN12608966.

Reducing depressive or anxiety symptoms in post-stroke patients: Pilot trial of a constructive integrative psychosocial intervention

PubMed Central

Fang, Yihong; Mpofu, Elias; Athanasou, James

2017-01-01

Background: About 30% of stroke survivors clinically have depressive symptoms at some point following stroke and anxiety prevalence is around 20-25%. Objective: The purpose of this brief report is to evaluate a pilot trial of a constructive integrative psychosocial intervention (CIPI) over standard care in post-stroke depression or anxiety. Methods: Patients were randomly assigned to either CIPI (n = 23) or standard care (n = 19). Patients were assessed using the Hospital Anxiety and Depression Scale at the 1st, 3rd, and 6th months to monitor changes of mood. Results: A Wilcoxon signed-rank test indicated that compared to admission baseline, patients with the intervention had significantly normal post-stroke depression symptom levels at the 1st, 3rd, and 6th months (P < 0.005). Conclusion: CIPI appears to be of incremental value in treating depression as well as anxiety in subacute care. PMID:29085269

The effects of mindfulness-based stress reduction on psychosocial outcomes and quality of life in early-stage breast cancer patients: a randomized trial.

PubMed

Henderson, Virginia P; Clemow, Lynn; Massion, Ann O; Hurley, Thomas G; Druker, Susan; Hébert, James R

2012-01-01

The aim of this study was determine the effectiveness of a mindfulness-based stress-reduction (MBSR) program on quality of life (QOL) and psychosocial outcomes in women with early-stage breast cancer, using a three-arm randomized controlled clinical trial (RCT). This RCT consisting of 172 women, aged 20-65 with stage I or II breast cancer consisted of the 8-week MBSR, which was compared to a nutrition education program (NEP) and usual supportive care (UC). Follow-up was performed at three post-intervention points: 4 months, 1, and 2 years. Standardized, validated self-administered questionnaires were adopted to assess psychosocial variables. Statistical analysis included descriptive and regression analyses incorporating both intention-to-treat and post hoc multivariable approaches of the 163 women with complete data at baseline, those who were randomized to MBSR experienced a significant improvement in the primary measures of QOL and coping outcomes compared to the NEP, UC, or both, including the spirituality subscale of the FACT-B as well as dealing with illness scale increases in active behavioral coping and active cognitive coping. Secondary outcome improvements resulting in significant between-group contrasts favoring the MBSR group at 4 months included meaningfulness, depression, paranoid ideation, hostility, anxiety, unhappiness, and emotional control. Results tended to decline at 12 months and even more at 24 months, though at all times, they were as robust in women with lower expectation of effect as in those with higher expectation. The MBSR intervention appears to benefit psychosocial adjustment in cancer patients, over and above the effects of usual care or a credible control condition. The universality of effects across levels of expectation indicates a potential to utilize this stress reduction approach as complementary therapy in oncologic practice.

Effects of atorvastatin on brain contusion volume and functional outcome of patients with moderate and severe traumatic brain injury; a randomized double-blind placebo-controlled clinical trial.

PubMed

Farzanegan, Gholam Reza; Derakhshan, Nima; Khalili, Hosseinali; Ghaffarpasand, Fariborz; Paydar, Shahram

2017-10-01

The aim of the current study was to investigate the effects of atorvastatin on brain contusion volume and functional outcome of patients with moderate and severe traumatic brain injury (TBI). The study was conducted as a randomized clinical trial during a 16-month period from May 2015 and August 2016 in a level I trauma center in Shiraz, Southern Iran. We included 65 patients with moderate (GCS: 9-13) to severe (GCS: 5-8) TBI who had brain contusions of less than 30cc volume. We excluded those who required surgical intervention. Patients were randomly assigned to receive daily 20mg atorvastatin for 10days (n=21) or placebo in the same dosage (n=23). The brain contusion volumetry was performed on days 0, 3 and 7 utilizing spiral thin-cut brain CT-Scan (1-mm thickness). The outcome measured included modified Rankin scale (MRS), Glasgow Outcome Scale (GOS) and Disability rating Scale (DRS) which were all evaluated 3months post-injury. There was no significant difference between two study group regarding the baseline, 3rd day and 7th day of the contusion volume and the rate of contusion expansion. However, functional outcome scales of GOS, MRS and DRS at 3-months post-injury were significantly better in atorvastatin arm of the study compared to placebo (p values of 0.043, 0.039 and 0.030 respectively). Even though atorvastatin was not found to be more effective than placebo in reducing contusion expansion rate, it was associated with improved functional outcomes at 3-months following moderate to severe TBI. Copyright © 2017 Elsevier Ltd. All rights reserved.

Robotically assisted treadmill exercise training for improving peak fitness in chronic motor incomplete spinal cord injury: A randomized controlled trial

PubMed Central

Scott, William; York, Henry; Theyagaraj, Melita; Price-Miller, Naomi; McQuaid, Jean; Eyvazzadeh, Megan; Ivey, Frederick M.; Macko, Richard F.

2016-01-01

Objective To assess the effectiveness of robotically assisted body weight supported treadmill training (RABWSTT) for improving cardiovascular fitness in chronic motor incomplete spinal cord injury (CMISCI). Design Pilot prospective randomized, controlled clinical trial. Setting Outpatient rehabilitation specialty hospital. Participants Eighteen individuals with CMISCI with American Spinal Injury Association (ASIA) level between C4 and L2 and at least one-year post injury. Interventions CMISCI participants were randomized to RABWSTT or a home stretching program (HSP) three times per week for three months. Those in the home stretching group were crossed over to three months of RABWSTT following completion of the initial three month phase. Outcome measures Peak oxygen consumption (peak VO2) was measured during both robotic treadmill walking and arm cycle ergometry: twice at baseline, once at six weeks (mid-training) and twice at three months (post-training). Peak VO2 values were normalized for body mass. Results The RABWSTT group improved peak VO2 by 12.3% during robotic treadmill walking (20.2 ± 7.4 to 22.7 ± 7.5 ml/kg/min, P = 0.018), compared to a non-significant 3.9% within group change observed in HSP controls (P = 0.37). Neither group displayed a significant change in peak VO2 during arm cycle ergometry (RABWSTT, 8.5% (P = 0.25); HSP, 1.76% (P = 0.72)). A repeated measures analysis showed statistically significant differences between treatments for peak VO2 during both robotic treadmill walking (P = 0.002) and arm cycle ergometry (P = 0.001). Conclusion RABWSTT is an effective intervention model for improving peak fitness levels assessed during robotic treadmill walking in persons with CMISCI. PMID:25520035

A pilot randomized controlled trial of a self-management group intervention for people with early-stage dementia (The SMART study).

PubMed

Quinn, Catherine; Toms, Gill; Jones, Carys; Brand, Andrew; Edwards, Rhiannon Tudor; Sanders, Fiona; Clare, Linda

2016-05-01

Self-management equips people to manage the symptoms and lifestyle changes that occur in long-term health conditions; however, there is limited evidence about its effectiveness for people with early-stage dementia. This pilot randomized controlled trial (RCT) explored the feasibility of a self-management intervention for people with early-stage dementia. The participants were people with early-stage dementia (n = 24) and for each participant a caregiver also took part. Participants were randomly allocated to either an eight-week self-management group intervention or treatment as usual (TAU). Assessments were conducted at baseline, three months and six months post-randomization by a researcher blind to group allocation. The primary outcome measure was self-efficacy score at three months. Thirteen people with dementia were randomized to the intervention and 11 to TAU. Two groups were run, the first consisting of six people with dementia and the second of seven people with dementia. There was a small positive effect on self-efficacy with the intervention group showing gains in self-efficacy compared to the TAU group at three months (d = 0.35), and this was maintained at six months (d = 0.23). In terms of intervention acceptability, attrition was minimal, adherence was good, and satisfaction ratings were high. Feedback from participants was analyzed with content analysis. The findings suggest the positive aspects of the intervention were that it fostered independence and reciprocity, promoted social support, offered information, and provided clinician support. This study has provided preliminary evidence that self-management may be beneficial for people with early-stage dementia.

Effect of oral contraceptive containing ethinyl estradiol combined with drospirenone vs. desogestrel on clinical and biochemical parameters in patients with polycystic ovary syndrome.

PubMed

Kriplani, Alka; Periyasamy, Anurekha Janaki; Agarwal, Nutan; Kulshrestha, Vidushi; Kumar, Anand; Ammini, Ariachery Chinnama

2010-08-01

A prospective randomized trial was conducted to compare efficacy of a drospirenone-containing combined oral contraceptives (COC) with desogestrel-containing COC in women with polycystic ovary-syndrome (PCOS) not desirous of child-bearing. Sixty women were randomized into study group [ethinylestradiol (EE) 30 mcg+drospirenone 3 mg] and control group (EE 30 mcg+desogestrel 150 mcg), treated for 6 months and followed up at 1 month, 3 months, 6 months, during treatment and 3 and 6 months post-treatment. Acne and hirsutism scoring, bodyweight, body mass index (BMI), blood pressure (BP), ultrasound parameters, lipid profile, glycemic profile and hormonal profile were compared. Cycles were regular in both groups during treatment. Effect of regular cycles persisted in 44.83% (13/30) vs. 17.24% (5/30) in study vs. control group at 6 months post-treatment with 33.3% decreased hirsutism score in the study group (versus no change in control group) even at 6 months after stopping treatment. With treatment, BMI fell by 0.52 kg/m(2) in the study group; systolic and diastolic BP fell in the study group while it rose in the control group. Low-density lipoprotein significantly decreased and high-density lipoprotein was elevated in the study group (p<.05). The study group showed a significant fall in fasting/postprandial blood sugar and insulin and total testosterone against a rise in the control group. In women with PCOS, a drospirenone containing COC has better outcome in terms of persistent regular cycles, antiandrogenic effect, fall in BMI and BP, better lipid profile, favorable glycemic and hormonal profile than desogestrel-containing COC. Copyright 2010 Elsevier Inc. All rights reserved.

An Experimental Trial of Adaptive Programming in Drug Court: Outcomes at 6, 12 and 18 Months.

PubMed

Marlowe, Douglas B; Festinger, David S; Dugosh, Karen L; Benasutti, Kathleen M; Fox, Gloria; Harron, Ashley

2014-06-01

Test whether an adaptive program improves outcomes in drug court by adjusting the schedule of court hearings and clinical case-management sessions pursuant to a priori performance criteria. Consenting participants in a misdemeanor drug court were randomly assigned to the adaptive program (n = 62) or to a baseline-matching condition (n = 63) in which they attended court hearings based on the results of a criminal risk assessment. Outcome measures were re-arrest rates at 18 months post-entry to the drug court and urine drug test results and structured interview results at 6 and 12 months post-entry. Although previously published analyses revealed significantly fewer positive drug tests for participants in the adaptive condition during the first 18 weeks of drug court, current analyses indicate the effects converged during the ensuing year. Between-group differences in new arrest rates, urine drug test results and self-reported psychosocial problems were small and non-statistically significant at 6, 12 and 18 months post-entry. A non-significant trend (p = .10) suggests there may have been a small residual impact (Cramer's ν = .15) on new misdemeanor arrests after 18 months. Adaptive programming shows promise for enhancing short-term outcomes in drug courts; however, additional efforts are needed to extend the effects beyond the first 4 to 6 months of enrollment.

Goal management training of executive functions in patients with spina bifida: a randomized controlled trial.

PubMed

Stubberud, Jan; Langenbahn, Donna; Levine, Brian; Stanghelle, Johan; Schanke, Anne-Kristine

2013-07-01

Executive dysfunction causes significant real-life disability for patients with spina bifida (SB). However, no previous research has been directed toward the amelioration of executive functioning deficits amongst persons with SB. Goal Management Training (GMT) is a compensatory cognitive rehabilitation approach, addressing underlying deficits in sustained attention to improve executive function. GMT has received empirical support in studies of other patient groups. The purpose of the present study was to determine the efficacy of GMT in treating subjects with SB, using inpatient intervention periods. We hypothesized post-intervention changes in scores on neuropsychological measures to reflect improved attentional control, including sustained attention and inhibitory control. Thirty-eight adult subjects with SB were included in this randomized controlled trial. Inclusion was based upon the presence of executive functioning complaints. Experimental subjects (n = 24) received 21 hr of GMT, with efficacy of GMT being compared to results of subjects in a wait-list condition (n = 14). All subjects were assessed at baseline, post-intervention, and at 6-month follow-up. Findings indicated superior effects of GMT on domain-specific neuropsychological measures and on a functional "real-life" measure, all lasting at least 6 months post-treatment. These results show that deficits in executive functioning can be ameliorated in patients with congenital brain dysfunction.

Randomized controlled trial of an online mother-daughter body image and well-being intervention.

PubMed

Diedrichs, Phillippa C; Atkinson, Melissa J; Garbett, Kirsty M; Williamson, Heidi; Halliwell, Emma; Rumsey, Nichola; Leckie, George; Sibley, Chris G; Barlow, Fiona Kate

2016-09-01

Poor body image is a public health issue. Mothers are a key influence on adolescent girls' body image. This study evaluated an accessible, scalable, low-intensity internet-based intervention delivered to mothers (Dove Self Esteem Project Website for Parents) on mothers' and their adolescent daughters' body image and psychosocial well-being. British mother-daughter dyads (N = 235) participated in a cluster randomized controlled trial (assessment-only control; mothers viewed the website without structured guidance [website-unstructured]; mothers viewed the website via a tailored pathway [website-tailored]). Dyads completed standardized self-report measures of body image, related risk factors, and psychosocial outcomes at baseline, 2 weeks post-exposure, 6-week, and 12-month follow-up. Dyadic models showed that relative to the control, mothers who viewed the website reported significantly higher self-esteem at post-exposure (website-tailored), higher weight esteem at 6-week follow-up (website-tailored), lower negative affect at 12-month follow-up (website-tailored), engaged in more self-reported conversations with their daughters about body image at post-exposure and 6-week follow-up, and were 3-4.66 times more likely to report seeking additional support for body image issues at post-exposure (website-tailored), 6-week, and 12-month (website-tailored) follow-up. Daughters whose mothers viewed the website had higher self-esteem and reduced negative affect at 6-week follow-up. There were no differences on daughters' body image, and risk factors among mothers or daughters, at post-exposure or follow-up. Tailoring website content appeared beneficial. This intervention offers a promising 'first-step' toward improving psychosocial well-being among mothers and daughters. In order to further optimize the intervention, future research to improve body image-related outcomes and to understand mechanisms for change would be beneficial. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Robot-assisted gait training in multiple sclerosis patients: a randomized trial.

PubMed

Schwartz, Isabella; Sajin, Anna; Moreh, Elior; Fisher, Iris; Neeb, Martin; Forest, Adina; Vaknin-Dembinsky, Adi; Karusis, Dimitrios; Meiner, Zeev

2012-06-01

Preservation of locomotor activity in multiple sclerosis (MS) patients is of utmost importance. Robotic-assisted body weight-supported treadmill training is a promising method to improve gait functions in neurologically impaired patients, although its effectiveness in MS patients is still unknown. To compare the effectiveness of robot-assisted gait training (RAGT) with that of conventional walking treatment (CWT) on gait and generalized functions in a group of stable MS patients. A prospective randomized controlled trial of 12 sessions of RAGT or CWT in MS patients of EDSS score 5-7. Primary outcome measures were gait parameters and the secondary outcomes were functional and quality of life parameters. All tests were performed at baseline, 3 and 6 months post-treatment by a blinded rater. Fifteen and 17 patients were randomly allocated to RAGT and CWT, respectively. Both groups were comparable at baseline in all parameters. As compared with baseline, although some gait parameters improved significantly following the treatment at each time point there was no difference between the groups. Both FIM and EDSS scores improved significantly post-treatment with no difference between the groups. At 6 months, most gait and functional parameters had returned to baseline. Robot-assisted gait training is feasible and safe and may be an effective additional therapeutic option in MS patients with severe walking disabilities.

Risk factors for urinary tract infection following incontinence surgery.

PubMed

Nygaard, Ingrid; Brubaker, Linda; Chai, Toby C; Markland, Alayne D; Menefee, Shawn A; Sirls, Larry; Sutkin, Gary; Zimmern, Phillipe; Arisco, Amy; Huang, Liyuan; Tennstedt, Sharon; Stoddard, Anne

2011-10-01

The purpose of this study is to describe risk factors for post-operative urinary tract infection (UTI) the first year after stress urinary incontinence surgery. Multivariable logistic regression analyses were performed on data from 1,252 women randomized in two surgical trials, Stress Incontinence Surgical Treatment Efficacy trial (SISTEr) and Trial Of Mid-Urethral Slings (TOMUS). Baseline recurrent UTI (rUTI; ≥3 in 12 months) increased the risk of UTI in the first 6 weeks in both study populations, as did sling procedure and self-catheterization in SISTEr, and bladder perforation in TOMUS. Baseline rUTI, UTI in the first 6 weeks, and PVR > 100 cc at 12 months were independent risk factors for UTI between 6 weeks and 12 months in the SISTEr population. Few (2.3-2.4%) had post-operative rUTI, precluding multivariable analysis. In women with pre-operative rUTI, successful surgery (negative cough stress test) at 1 year did not appear to decrease the risk of persistent rUTI. Pre-operative rUTI is the strongest risk factor for post-operative UTI.

Impact of oral ibandronate 150 mg once monthly on bone structure and density in post-menopausal osteoporosis or osteopenia derived from in vivo μCT.

PubMed

Bock, Oliver; Börst, Hendrikje; Beller, Gisela; Armbrecht, Gabriele; Degner, Corina; Martus, Peter; Roth, Heinz-Jürgen; Felsenberg, Dieter

2012-01-01

The effect of ibandronate 150 mg/once monthly in the treatment of post-menopausal osteopenia and osteoporosis on bone micro-structure at the distal tibia and radius has not been considered to date. Seventy post-menopausal women with osteoporosis or osteopenia were recruited. All subjects received calcium and vitamin D supplementation and were randomized to either a group which took 150 mg ibandronate oral monthly or a placebo group over a 12-month period. μCT measures of the distal tibia and radius were conducted every three months, with DXA lumbar spine and hip measurements conducted only pre and post and serum markers of bone formation and resorption measured every 6 months. After 12-months no significant impact of ibandronate on the primary outcome measures bone-volume to tissue-volume and trabecular separation at the distal tibia (p≥0.15) was found. Further multiple regression analyses of the primary end-points indicated a significant effect favoring the ibandronate intervention (p=0.045). Analysis of secondary end-points showed greater increases in distal tibia cortical thickness, cortical density and total density (p≤0.043) with ibandronate and no significant effects at the distal radius, but greater increases of hip DXA-BMD and lumbar spine DXA-BMD (p≤0.017). Ibandronate use resulted in a marked reduction in bone turnover (p<0.001). While ibandronate resulted in greater mineralization of bone, this effect differed from one body region to another. There was some impact of ibandronate on bone structure (cortical thickness) at the distal tibia, but not on bone-volume to tissue-volume or trabecular separation. Copyright © 2011 Elsevier Inc. All rights reserved.

A Randomized Experimental Study of Gender-Responsive Substance Abuse Treatment for Women in Prison

PubMed Central

Messina, Nena; Grella, Christine E.; Cartier, Jerry; Torres, Stephanie

2009-01-01

This experimental pilot study compared post-release outcomes for 115 women who participated in prison-based substance abuse treatment. Women were randomized to a gender-responsive treatment (GRT) program using manualized curricula (Helping Women Recover and Beyond Trauma) or a standard prison-based therapeutic community (TC). Data were collected from the participants at prison program entry and 6 and 12 months after release. Bivariate and multivariate analyses were conducted. Results indicate that both groups improved in psychological well-being; however, GRT participants had greater reductions in drug use, were more likely to remain in residential aftercare longer (2.6 months vs. 1.8 months, p < .05), and were less likely to have been reincarcerated within 12 months after parole (31% vs. 45%, respectively; a 67% reduction in odds for the experimental group, p < .05). Findings show the beneficial effects of treatment components oriented toward women's needs and support the integration of GRT in prison programs for women. PMID:20015605

A randomized controlled trial of an audio-based treatment program for child anxiety disorders.

PubMed

Infantino, Alyssa; Donovan, Caroline L; March, Sonja

2016-04-01

The aim of this study was to investigate the efficacy of an audio-based cognitive-behavioural therapy (CBT) program for child anxiety disorders. Twenty-four children aged 5-11 years were randomly allocated into either the audio-based CBT program condition (Audio, n = 12) or a waitlist control (WL; n = 12) group. Outcome measures included a clinical diagnostic interview, clinician-rated global assessment of functioning, and parent and child self-report ratings of anxiety and internalisation. Assessments were conducted prior to treatment, 12 weeks following treatment, and at 3-month follow-up. Results indicated that at post-assessment, 58.3% of children receiving treatment compared to 16.7% of waitlist children were free of their primary diagnosis, with this figure rising to 66.67% at the 3-month follow-up time point. Additionally, at post-assessment, 25.0% of children in the treatment condition compared to .0% of the waitlist condition were free of all anxiety diagnoses, with this figure rising to 41.67% for the treatment group at 3-month follow-up. Overall, the findings suggest that the audio program tested in this study has the potential to be an efficacious treatment alternative for anxious children. Copyright © 2016 Elsevier Ltd. All rights reserved.

Effect of Two Frequencies of Whole-Body Vibration Training on Balance and Flexibility of the Elderly: A Randomized Controlled Trial.

PubMed

Tseng, Shiuan-Yu; Hsu, Pi-Shan; Lai, Chung-Liang; Liao, Wan-Chun; Lee, Meng-Chih; Wang, Chun-Hou

2016-10-01

The aim of this study was to investigate the effects of whole-body vibration training with different frequencies on the balance and flexibility of the healthy elderly. The participants were recruited from hospital volunteers and the community; all of them were healthy subjects, all over 65 years of age. The study involved three randomized groups in a parallel and single-blind design. The main outcome variables included the limits of stability test and the sit and reach test, which were measured at pre-training, Month 1 (Mid-training), Month 3 (Post-training), and Month 6 (Follow-up). A total of 45 subjects, with a mean age of 69.6 ± 3.9 years, were randomly divided into three groups. There was significant interaction in the performance of the limits of stability and sit and reach tests in the different groups at the four different time points (F = 25.218, P < 0.001, F = 12.235, P < 0.001, respectively). There was a significant difference in balance performance between the vibration groups at the frequencies of 20 Hz and 40 Hz and the control group at Month 1, Month 3, and Month 6 (P < 0.001). Whole-body vibration training at 20 Hz has significant benefit to the balance and flexibility of the elderly who do not engage in habitual exercise.

Efficacy and safety of vi-tetanus toxoid conjugated typhoid vaccine (PedaTyph™) in Indian children: School based cluster randomized study.

PubMed

Mitra, Monjori; Shah, Nitin; Ghosh, Apurba; Chatterjee, Suparna; Kaur, Iqbal; Bhattacharya, Nisha; Basu, Suparna

2016-04-02

Vi polysaccharide typhoid vaccines cannot be used in children <2 years owing to poor immunogenic and T cell independent properties. Conjugate vaccine prepared by binding Vi to tetanus toxoids (Vi-TT) induces protective levels even in children <2 years. We evaluated efficacy and safety following vaccination with a Vi-TT vaccine in children 6 months to 12 years of age. Overall, 1765 subjects were recruited from two registered municipal urban slums of southern Kolkata. Most of the children of the slum dwellers attended the schools in the locality which was selected with permission from the school authority. Schools were randomly divided into vaccinated (Test group) and unvaccinated group (Control group). Children and their siblings of test group received 2-doses of PedaTyph™ vaccine at 6 weeks interval. Control group received vaccines as per national guidelines. Adverse events (AEs) were examined after 30 minutes, 1 month and clinical events were observed till 12 months post-vaccination. Incidence of culture positive typhoid fever in the control group was 1.27% vis-a-vis none in vaccine group during 12 months. In subgroup evaluated for immunogenicity, an antibody titer value of 1.8 EU/ml (95% CI: 1.5 EU/ml, 2.2 EU/ml), 32 EU/ml (95% CI: 27.0 EU/ml, 39.0 EU/ml) and 14 EU/ml (95% CI: 12.0 EU/ml, 17.0 EU/ml) at baseline, 6 weeks and 12 months, respectively was observed. Sero-conversion among the sub-group was 100% after 6 weeks of post-vaccination and 83% after 12 months considering 4-fold rise from baseline. The efficacy of vaccine was 100 % (95% CI: 97.6%, 100%) in the first year of follow-up with minimal AEs post vaccination. Vi conjugate typhoid vaccine conferred 100% protection against typhoid fever in 1765 children 6 months to 12 years of age with high immunogenicity in a subgroup from the vaccine arm.

Postcards in Persia: A Twelve to Twenty-four Month Follow-up of a Randomized Controlled Trial for Hospital-Treated Deliberate Self-Poisoning.

PubMed

Hassanian-Moghaddam, Hossein; Sarjami, Saeedeh; Kolahi, Ali-Asghar; Lewin, Terry; Carter, Gregory

2017-01-02

This study reports the outcomes, during follow-up, of a low-cost postcard intervention in a Randomized Control Trial of hospital-treated self-poisoning (n = 2300). The intervention was 9 postcards over 12 months (plus usual treatment) versus usual treatment. Three binary endpoints at 12-24 months (n = 2001) were: any suicidal ideation, suicide attempt, or self-cutting. There was a significant reduction in any suicidal ideation (RRR 0.20 CI 95% 0.13-0.27), (NNT 8, 6-13), and any suicide attempt (RRR 0.31, 0.06-0.50), (NNT 35, 19-195), in this non-western population. However, there was no effect on self-cutting (RRR -0.01, -1.05-0.51). Sustained, brief contact by mail may reduce some forms of suicidal behavior in self-poisoning patients during the post intervention phase.

Effectiveness of proactive telephone counselling for smoking cessation in parents: Study protocol of a randomized controlled trial

PubMed Central

2011-01-01

Background Smoking is the world's fourth most common risk factor for disease, the leading preventable cause of death, and it is associated with tremendous social costs. In the Netherlands, the smoking prevalence rate is high. A total of 27.7% of the population over age 15 years smokes. In addition to the direct advantages of smoking cessation for the smoker, parents who quit smoking may also decrease their children's risk of smoking initiation. Methods/Design A randomized controlled trial will be conducted to evaluate the effectiveness of proactive telephone counselling to increase smoking cessation rates among smoking parents. A total of 512 smoking parents will be proactively recruited through their children's primary schools and randomly assigned to either proactive telephone counselling or a control condition. Proactive telephone counselling will consist of up to seven counsellor-initiated telephone calls (based on cognitive-behavioural skill building and Motivational Interviewing), distributed over a period of three months. Three supplementary brochures will also be provided. In the control condition, parents will receive a standard brochure to aid smoking cessation. Assessments will take place at baseline, three months after start of the intervention (post-measurement), and twelve months after start of the intervention (follow-up measurement). Primary outcome measures will include sustained abstinence between post-measurement and follow-up measurement and 7-day point prevalence abstinence and 24-hours point prevalence abstinence at both post- and follow-up measurement. Several secondary outcome measures will also be included (e.g., smoking intensity, smoking policies at home). In addition, we will evaluate smoking-related cognitions (e.g., attitudes towards smoking, social norms, self-efficacy, intention to smoke) in 9-12 year old children of smoking parents. Discussion This study protocol describes the design of a randomized controlled trial to evaluate the effectiveness of proactive telephone counselling in smoking cessation. It is expected that, in the telephone counseling condition, parental smoking cessation rates will be higher and children's cognitions will be less favorable about smoking compared to the control condition. Trial registration The protocol for this study is registered with the Netherlands Trial Register NTR2707. PMID:21943207

Translating knowledge for action against stroke--using 5-minute videos for stroke survivors and caregivers to improve post-stroke outcomes: study protocol for a randomized controlled trial (Movies4Stroke).

PubMed

Kamal, Ayeesha Kamran; Khoja, Adeel; Usmani, Bushra; Muqeet, Abdul; Zaidi, Fabiha; Ahmed, Masood; Shakeel, Saadia; Soomro, Nabila; Gowani, Ambreen; Asad, Nargis; Ahmed, Asma; Sayani, Saleem; Azam, Iqbal; Saleem, Sarah

2016-01-27

Two thirds of the global mortality of stroke is borne by low and middle income countries (LMICs). Pakistan is the world's sixth most populous country with a stroke-vulnerable population and is without a single dedicated chronic care center. In order to provide evidence for a viable solution responsive to this health care gap, and leveraging the existing >70% mobile phone density, we thought it rational to test the effectiveness of a mobile phone-based video intervention of short 5-minute movies to educate and support stroke survivors and their primary caregivers. Movies4Stroke will be a randomized control, outcome assessor blinded, parallel group, single center superiority trial. Participants with an acute stroke, medically stable, with mild to moderate disability and having a stable primary caregiver will be included. After obtaining informed consent the stroke survivor-caregiver dyad will be randomized. Intervention participants will have the movie program software installed in their phone, desktop, or Android device which will allow them to receive, view and repeat 5-minute videos on stroke-related topics at admission, discharge and first and third months after enrollment. The control arm will receive standard of care at an internationally accredited center with defined protocols. The primary outcome measure is medication adherence as ascertained by a locally validated Morisky Medication Adherence Scale and control of major risk factors such as blood pressure, blood sugar and blood cholesterol at 12 months post discharge. Secondary outcome measures are post-stroke complications and mortality, caregiver knowledge and change in functional outcomes after acute stroke at 1, 3, 6, 9 and 12 months. Movies4Stroke is designed to enroll 300 participant dyads after inflating 10% to incorporate attrition and non-compliance and has been powered at 95% to detect a 15% difference between intervention and usual care arm. Analysis will be done by the intention-to-treat principle. Movies4Stroke is a randomized trial testing an application aimed at supporting caregivers and stroke survivors in a LMIC with no rehabilitation or chronic support systems. NCT02202330 (28 January 2015).

Modified Therapeutic Community Treatment for Offenders with Co-Occurring Disorders: Mental Health Outcomes

ERIC Educational Resources Information Center

Sullivan, Christopher J.; Sacks, Stanley; McKendrick, Karen; Banks, Steven; Sacks, Joann Y.; Stommel, Joseph

2007-01-01

This paper examines outcomes 12 months post-prison release for offenders with co-occurring disorders (n = 185) randomly assigned to either a mental health control treatment (C) or a modified therapeutic community (E). Significant between-group differences were not found for mental health measures, although improvements were observed for each…

Design and Outcomes of a "Mothers In Motion" Behavioral Intervention Pilot Study

ERIC Educational Resources Information Center

Chang, Mei-Wei; Nitzke, Susan; Brown, Roger

2010-01-01

Objective: This paper describes the design and findings of a pilot "Mothers In Motion" (P-"MIM") program. Design: A randomized controlled trial that collected data via telephone interviews and finger stick at 3 time points: baseline and 2 and 8 months post-intervention. Setting: Three Special Supplemental Nutrition Program for…

Biomarker Evaluation Does Not Confirm Efficacy of Computer-Tailored Nutrition Education

ERIC Educational Resources Information Center

Kroeze, Willemieke; Dagnelie, Pieter C.; Heymans, Martijn W.; Oenema, Anke; Brug, Johannes

2011-01-01

Objective: To evaluate the efficacy of computer-tailored nutrition education with objective outcome measures. Design: A 3-group randomized, controlled trial with posttests at 1 and 6 months post-intervention. Setting: Worksites and 2 neighborhoods in the urban area of Rotterdam. Participants: A convenience sample of healthy Dutch adults (n = 442).…

Psychological Effects of Automated External Defibrillator Training A randomized trial

PubMed Central

Meischke, Hendrika; Diehr, Paula; Phelps, Randi; Damon, Susan; Rea, Tom

2011-01-01

Objectives The objective of this study was to test if an Automated External Defibrillator (AED) training program would positively affect the mental health of family members of high risk patients. Methods 305 ischemic heart disease patients and their family members were randomized to one of four AED training programs: two video-based training programs and two face-to-face training programs that emphasized self-efficacy and perceived control. Patients and family members were surveyed at baseline, 3 and 9 months post ischemic event on demographic characteristics, measures of quality of life (SF=36) , self-efficacy and perceived control. For this study, family members were the focus rather than the patients. Results Regression analyses showed that family members in the face-to-face training programs did not score better on any of the mental health status variables than family members who participated in the other training programs but for an increase in self-efficacy beliefs at 3 months post training. Conclusion The findings suggest that a specifically designed AED training program emphasizing self-efficacy and perceived control beliefs is not likely to enhance family member mental health. PMID:21411144

Reducing Internalizing Symptoms among High-Risk, Hispanic Adolescents: Mediators of a Preventive Family Intervention

PubMed Central

Perrino, Tatiana; Brincks, Ahnalee; Howe, George; Brown, C. Hendricks; Prado, Guillermo; Pantin, Hilda

2016-01-01

Familias Unidas is a family-focused preventive intervention that has been found to reduce drug use and sexual risk behaviors among Hispanic adolescents. In some trials, Familias Unidas has also been found to be efficacious in reducing adolescent internalizing symptoms (i.e., depressive and anxiety symptoms), even though the intervention did not specifically target internalizing symptoms. This study examines potential mediators or mechanisms by which Familias Unidas influences internalizing symptoms, specifically the role of intervention-targeted improvements in parent-adolescent communication and reductions in youth externalizing behaviors. A total of 213 Hispanic eighth grade students with a history of externalizing behavior problems and their primary caregivers were recruited from the public school system. Participants, with a mean age of 13.8 years, were randomized into the Familias Unidas intervention or community practice control condition, and assessed at baseline, 6-months, 18-months, and 30-months post-baseline. A cascading mediation model was tested in which the Familias Unidas intervention was hypothesized to decrease adolescent internalizing symptoms through two mediators: improvements in parent-adolescent communication leading to decreases in externalizing behaviors. Findings show that the intervention had significant direct effects on youth internalizing symptoms at 30-months post-baseline. In addition, the cascading mediation model was supported in which the Familias Unidas intervention predicted significant improvements in parent-adolescent communication at 6-months, subsequently decreasing externalizing behaviors at 18-months, and ultimately reducing youth internalizing symptoms at 30-months post-baseline. Implications for prevention interventions are discussed. PMID:27154768

Does stage tailoring matter in brief alcohol interventions for job-seekers? A randomized controlled trial.

PubMed

Freyer-Adam, Jennis; Baumann, Sophie; Schnuerer, Inga; Haberecht, Katja; Bischof, Gallus; John, Ulrich; Gaertner, Beate

2014-11-01

To investigate whether or not a stage tailored intervention is more effective than a non-stage tailored intervention of the same intensity in reducing alcohol use among job-seekers with unhealthy alcohol use, and whether initial motivation to change is a moderator of efficacy. A three-group randomized controlled trial with 3-, 6- and 15-month follow-ups. Three job agencies in Germany. A total of 1243 job-seekers with unhealthy alcohol use were randomized to (i) stage tailored intervention based on the transtheoretical model of change (ST), (ii) non-stage tailored intervention based on the theory of planned behaviour (NST) and (iii) assessment only (controls). Participants received feedback letters and manuals at baseline and 3 months later. Piecewise latent growth models were calculated measuring change in 'alcohol use' from baseline to month 3 (active intervention phase) and from months 3 to 15 (post-intervention phase, primary outcome). Motivation to change was included as a 4-point continuous measure. All groups reduced alcohol use from months 0 to 3 (controls: mean = -0.866, NST: mean = -0.883, ST: mean = -0.718, Ps ≤ 0.001). Post-intervention (months 3-15), low-motivated individuals in the ST group showed a greater reduction than those in the control group (β = 0.135, P = 0.039, Cohen's d = 0.42) and in the NST group (β = 0.180, P = 0.009, Cohen's d = 0.55). In contrast, compared to the ST group (β = 0.030, P = 0.361), alcohol use decreased more strongly with higher initial motivation in the NST group (β = -0.118, P = 0.010). Among job-seekers with high levels of alcohol consumption, an intervention tailored to motivational 'stage of change' was more effective than a non-stage tailored intervention for reducing alcohol use 15 months after baseline assessment in participants with low initial motivation to change. © 2014 Society for the Study of Addiction.

A multi-site single blind clinical study to compare the effects of prolonged exposure, eye movement desensitization and reprocessing and waiting list on patients with a current diagnosis of psychosis and co morbid post traumatic stress disorder: study protocol for the randomized controlled trial Treating Trauma in Psychosis.

PubMed

de Bont, Paul A J M; van den Berg, David P G; van der Vleugel, Berber M; de Roos, Carlijn; Mulder, Cornelis L; Becker, Eni S; de Jongh, Ad; van der Gaag, Mark; van Minnen, Agnes

2013-05-23

Trauma contributes to psychosis and in psychotic disorders post-traumatic stress disorder (PTSD) is often a comorbid disorder. A problem is that PTSD is underdiagnosed and undertreated in people with psychotic disorders. This study's primary goal is to examine the efficacy and safety of prolonged exposure and eye movement desensitization and reprocessing (EMDR) for PTSD in patients with both psychotic disorders and PTSD, as compared to a waiting list. Secondly, the effects of both treatments are determined on (a) symptoms of psychosis, in particular verbal hallucinations, (b) depression and social performance, and (c) economic costs. Thirdly, goals concern links between trauma exposure and psychotic symptomatology and the prevalence of exposure to traumatic events, and of PTSD. Fourthly predictors, moderators, and mediators for treatment success will be explored. These include cognitions and experiences concerning treatment harm, credibility and burden in both participants and therapists. A short PTSD-screener assesses the possible presence of PTSD in adult patients (21- to 65- years old) with psychotic disorders, while the Clinician Administered PTSD Scale interview will be used for the diagnosis of current PTSD. The M.I.N.I. Plus interview will be used for diagnosing lifetime psychotic disorders and mood disorders with psychotic features. The purpose is to include consenting participants (N = 240) in a multi-site single blind randomized clinical trial. Patients will be allocated to one of three treatment conditions (N = 80 each): prolonged exposure or EMDR (both consisting of eight weekly sessions of 90 minutes each) or a six-month waiting list. All participants are subjected to blind assessments at pre-treatment, two months post treatment, and six months post treatment. In addition, participants in the experimental conditions will have assessments at mid treatment and at 12 months follow-up. The results from the post treatment measurement can be considered strong empirical indicators of the safety and effectiveness of prolonged exposure and EMDR. The six-month and twelve-month follow-up data have the potential of reliably providing documentation of the long-term effects of both treatments on the various outcome variables. Data from pre-treatment and midtreatment can be used to reveal possible pathways of change. Trial registration: ISRCTN79584912.

Warm Handoff Versus Fax Referral for Linking Hospitalized Smokers to Quitlines.

PubMed

Richter, Kimber P; Faseru, Babalola; Shireman, Theresa I; Mussulman, Laura M; Nazir, Niaman; Bush, Terry; Scheuermann, Taneisha S; Preacher, Kristopher J; Carlini, Beatriz H; Magnusson, Brooke; Ellerbeck, Edward F; Cramer, Carol; Cook, David J; Martell, Mary J

2016-10-01

Few hospitals treat patients' tobacco dependence. To be effective, hospital-initiated cessation interventions must provide at least 1 month of supportive contact post-discharge. Individually randomized clinical trial. Recruitment commenced July 2011; analyses were conducted October 2014-June 2015. The study was conducted in two large Midwestern hospitals. Participants included smokers who were aged ≥18 years, planned to stay quit after discharge, and spoke English or Spanish. Hospital-based cessation counselors delivered the intervention. For patients randomized to warm handoff, staff immediately called the quitline from the bedside and handed the phone to participants for enrollment and counseling. Participants randomized to fax were referred on the day of hospital discharge. Outcomes at 6 months included quitline enrollment/adherence, medication use, biochemically verified cessation, and cost effectiveness. Significantly more warm handoff than fax participants enrolled in quitline (99.6% vs 59.6%; relative risk, 1.67; 95% CI=1.65, 1.68). One in four (25.4% warm handoff, 25.3% fax) were verified to be abstinent at 6-month follow-up; this did not differ significantly between groups (relative risk, 1.02; 95% CI=0.82, 1.24). Cessation medication use in the hospital and receipt of a prescription for medication at discharge did not differ between groups; however, significantly more fax participants reported using cessation medication post-discharge (32% vs 25%, p=0.01). The average incremental cost-effectiveness ratio of enrolling participants into warm handoff was $0.14. Hospital-borne costs were significantly lower in warm handoff than in fax ($5.77 vs $9.41, p<0.001). One in four inpatient smokers referred to quitline by either method were abstinent at 6 months post-discharge. Among motivated smokers, fax referral and warm handoff are efficient and comparatively effective ways to link smokers with evidence-based care. For hospitals, warm handoff is a less expensive and more effective method for enrolling smokers in quitline services. Copyright © 2016 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Small incision lenticule extraction (SMILE) versus laser in-situ keratomileusis (LASIK): study protocol for a randomized, non-inferiority trial

PubMed Central

2012-01-01

Background Small incision lenticule extraction or SMILE is a novel form of ‘flapless’ corneal refractive surgery that was adapted from refractive lenticule extraction (ReLEx). SMILE uses only one femtosecond laser to complete the refractive surgery, potentially reducing surgical time, side effects, and cost. If successful, SMILE could potentially replace the current, widely practiced laser in-situ keratomileusis or LASIK. The aim of this study is to evaluate whether SMILE is non-inferior to LASIK in terms of refractive outcomes at 3 months post-operatively. Methods/Design Single tertiary center, parallel group, single-masked, paired-eye design, non-inferiority, randomized controlled trial. Participants who are eligible for LASIK will be enrolled for study after informed consent. Each participant will be randomized to receive SMILE and LASIK in each eye. Our primary hypothesis (stated as null) in this non-inferiority trial would be that SMILE differs from LASIK in adults (>21 years old) with myopia (> −3.00 diopter (D)) at a tertiary eye center in terms of refractive predictability at 3 months post-operatively. Our secondary hypothesis (stated as null) in this non-inferiority trial would be that SMILE differs from LASIK in adults (>21 years old) with myopia (> −3.00 D) at a tertiary eye center in terms of other refractive outcomes (efficacy, safety, higher-order aberrations) at 3 months post-operatively. Our primary outcome is refractive predictability, which is one of several standard refractive outcomes, defined as the proportion of eyes achieving a postoperative spherical equivalent (SE) within ±0.50 D of the intended target. Randomization will be performed using random allocation sequence generated by a computer with no blocks or restrictions, and implemented by concealing the number-coded surgery within sealed envelopes until just before the procedure. In this single-masked trial, subjects and their caregivers will be masked to the assigned treatment in each eye. Discussion This novel trial will provide information on whether SMILE has comparable, if not superior, refractive outcomes compared to the established LASIK for myopia, thus providing evidence for translation into clinical practice. Trial registration Clinicaltrials.gov NCT01216475. PMID:22647480

Mediation of effects of a theory-based behavioral intervention on self-reported physical activity in South African men.

PubMed

Jemmott, John B; Stephens-Shields, Alisa; O'Leary, Ann; Jemmott, Loretta Sweet; Teitelman, Anne; Ngwane, Zolani; Mtose, Xoliswa

2015-03-01

Increasing physical activity is an important public-health goal worldwide, but there are few published mediation analyses of physical-activity interventions in low-to-middle-income countries like South Africa undergoing a health transition involving markedly increased mortality from non-communicable diseases. This article reports secondary analyses on the mediation of a theory-of-planned-behavior-based behavioral intervention that increased self-reported physical activity in a trial with 1181 men in Eastern Cape Province, South Africa. Twenty-two matched-pairs of neighborhoods were randomly selected. Within pairs, neighborhoods were randomized to a health-promotion intervention or an attention-matched control intervention with baseline, immediate-post, and 6- and 12-month post-intervention assessments. Theory-of-planned-behavior constructs measured immediately post-intervention were tested as potential mediators of the primary outcome, self-reported physical activity averaged over the 6- and 12-month post-intervention assessments, using a product-of-coefficients approach in a generalized-estimating-equations framework. Data were collected in 2007-2010. Attitude, subjective norm, self-efficacy, and intention were significant mediators of intervention-induced increases in self-reported physical activity. The descriptive norm, not affected by the intervention, was not a mediator, but predicted increased self-reported physical activity. The results suggest that interventions targeting theory-of-planned-behavior constructs may contribute to efforts to increase physical activity to reduce the burden of non-communicable diseases among South African men. Copyright © 2015 Elsevier Inc. All rights reserved.

Effects of a Brief Psychoeducational Intervention for Family Conflict: Constructive Conflict, Emotional Insecurity and Child Adjustment.

PubMed

Miller-Graff, Laura E; Cummings, E Mark; Bergman, Kathleen N

2016-10-01

The role of emotional security in promoting positive adjustment following exposure to marital conflict has been identified in a large number of empirical investigations, yet to date, no interventions have explicitly addressed the processes that predict child adjustment after marital conflict. The current study evaluated a randomized controlled trial of a family intervention program aimed at promoting constructive marital conflict behaviors thereby increasing adolescent emotional security and adjustment. Families (n = 225) were randomized into 1 of 4 conditions: Parent-Adolescent (n = 75), Parent-Only (n = 75), Self-Study (n = 38) and No Treatment (n = 37). Multi-informant and multi-method assessments were conducted at baseline, post-treatment and 6-month follow-up. Effects of treatment on destructive and constructive conflict behaviors were evaluated using multilevel models where observations were nested within individuals over time. Process models assessing the impact of constructive and destructive conflict behaviors on emotional insecurity and adolescent adjustment were evaluated using path modeling. Results indicated that the treatment was effective in increasing constructive conflict behaviors (d = 0.89) and decreasing destructive conflict behaviors (d = -0.30). For the Parent-Only Group, post-test constructive conflict behaviors directly predicted lower levels of adolescent externalizing behaviors at 6-month follow-up. Post-test constructive conflict skills also indirectly affected adolescent internalizing behaviors through adolescent emotional security. These findings support the use of a brief psychoeducational intervention in improving post-treatment conflict and emotional security about interparental relationships.

Mediation of Effects of a Theory-Based Behavioral Intervention on Self-Reported Physical Activity in South African Men

PubMed Central

Jemmott, John B.; Stephens, Alisa; O’Leary, Ann; Jemmott, Loretta Sweet; Teitelman, Anne; Ngwane, Zolani; Mtose, Xoliswa

2015-01-01

Objective Increasing physical activity is an important public-health goal worldwide, but there are few published mediation analyses of physical-activity interventions in low-to-middle-income countries like South Africa undergoing a health transition involving markedly increased mortality from non-communicable diseases. This article reports secondary analyses on the mediation of a theory-of-planned-behavior-based behavioral intervention that increased self-reported physical activity in a trial with 1,181 men in Eastern Cape Province, South Africa. Method Twenty-two matched-pairs of neighborhoods were randomly selected. Within pairs, neighborhoods were randomized to a health-promotion intervention or an attention-matched control intervention with baseline, immediate-post, and 6- and 12-month post-intervention assessments. Theory-of-planned-behavior constructs measured immediately post-intervention were tested as potential mediators of the primary outcome, self-reported physical activity averaged over the 6- and 12-month post-intervention assessments, using a product-of-coefficients approach in a generalized-estimating-equations framework. Data were collected in 2007–2010. Results Attitude, subjective norm, self-efficacy, and intention were significant mediators of intervention-induced increases in self-reported physical activity. The descriptive norm, not affected by the intervention, was not a mediator, but predicted increased self-reported physical activity. Conclusion The results suggest that interventions targeting theory-of-planned-behavior constructs may contribute to efforts to increase physical activity to reduce the burden of non-communicable diseases among South African men. PMID:25565482

Racial Differences in Outcomes of an Advance Care Planning Intervention for Dialysis Patients and Their Surrogates.

PubMed

Song, Mi-Kyung; Ward, Sandra E; Lin, Feng-Chang; Hamilton, Jill B; Hanson, Laura C; Hladik, Gerald A; Fine, Jason P

2016-02-01

African Americans' beliefs about end-of-life care may differ from those of whites, but racial differences in advance care planning (ACP) outcomes are unknown. The aim of this study was to compare the efficacy of an ACP intervention on preparation for end-of-life decision making and post-bereavement outcomes for African Americans and whites on dialysis. A secondary analysis of data from a randomized trial comparing an ACP intervention (Sharing Patient's Illness Representations to Increase Trust [SPIRIT]) with usual care was conducted. There were 420 participants, 210 patient-surrogate dyads (67.4% African Americans), recruited from 20 dialysis centers in North Carolina. The outcomes of preparation for end-of-life decision making included dyad congruence on goals of care, surrogate decision-making confidence, a composite of the two, and patient decisional conflict assessed at 2, 6, and 12 months post-intervention. Surrogate bereavement outcomes included anxiety, depression, and post-traumatic distress symptoms assessed at 2 weeks, and at 3 and 6 months after the patient's death. SPIRIT was superior to usual care in improving dyad congruence (odds ration [OR] = 2.31, p = 0.018), surrogate decision-making confidence (β = 0.18, p = 0.021), and the composite (OR = 2.19, p = 0.028) 2 months post-intervention, but only for African Americans. SPIRIT reduced patient decisional conflict at 6 months for whites and at 12 months for African Americans. Finally, SPIRIT was superior to usual care in reducing surrogates' bereavement depressive symptoms for African Americans but not for whites (β = -3.49, p = 0.003). SPIRIT was effective in improving preparation for end-of-life decision-making and post-bereavement outcomes in African Americans.

Effect of chlorhexidine and ethanol on the durability of the adhesion of the fiber post relined with resin composite to the root canal.

PubMed

Cecchin, Doglas; de Almeida, José Flávio Affonso; Gomes, Brenda P F A; Zaia, Alexandre Augusto; Ferraz, Caio Cesar Randi

2011-05-01

The aim of this study was to investigate the effects of pretreatment of gel chlorhexidine and ethanol on the bond strength and durability of the adhesion of the fiber post relined with resin composite to the root dentin. Sixty bovine incisor roots were divided into four groups: irrigation with physiologic solution (control), 5 minutes with chlorhexidine, 1 minute with ethanol, and 5 minutes with chlorhexidine followed by 1 minute with ethanol. Fiber posts relined with resin composite were cemented with RelyX ARC (3M ESPE, St Paul, MN) and a self-etching adhesive system Clearfil SE Bond (Kuraray, Kurashiki, Japan). Each group was randomly divided into three subgroups: 24 hours of water storage, 12 months of water storage, and 12 months of oil storage. All roots were sectioned transversely in the coronal, middle, and apical regions, producing 1-mm thick slices, and the push-out test was performed. Statistical analysis was performed using analysis of variance and the Tukey test for post hoc comparisons (α = 0.05). Immediate groups showed similar bond strength values with or without chlorhexidine and/or ethanol pretreatment (P > .05). A significant decrease in the bond strength in the control group was observed after 12 months of storage in water and oil (P < .05). The use of chlorhexidine- and/or ethanol-preserved bond strength in the groups stored in water and oil for 12 months (P < .05). Chlorhexidine and/or ethanol pretreatment were capable of preserving the bond strength of the fiber post relined with resin composite to root dentin for 12 months. Copyright © 2011 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

12-month blood pressure results of catheter-based renal artery denervation for resistant hypertension: the SYMPLICITY HTN-3 trial.

PubMed

Bakris, George L; Townsend, Raymond R; Flack, John M; Brar, Sandeep; Cohen, Sidney A; D'Agostino, Ralph; Kandzari, David E; Katzen, Barry T; Leon, Martin B; Mauri, Laura; Negoita, Manuela; O'Neill, William W; Oparil, Suzanne; Rocha-Singh, Krishna; Bhatt, Deepak L

2015-04-07

Results of the SYMPLICITY HTN-3 (Renal Denervation in Patients With Uncontrolled Hypertension) trial confirmed the safety but not the efficacy of renal denervation for treatment-resistant hypertension at 6 months post procedure. This study sought to analyze the 12-month SYMPLICITY HTN-3 results for the original denervation group, the sham subjects who underwent denervation after the 6-month endpoint (crossover group), and the sham subjects who did not undergo denervation after 6 months (non-crossover group). Eligible subjects were randomized 2:1 to denervation or sham procedure. Subjects were unblinded to their treatment group after the 6-month primary endpoint was ascertained; subjects in the sham group meeting eligibility requirements could undergo denervation. Change in blood pressure (BP) at 12 months post randomization (6 months for crossover subjects) was analyzed. The 12-month follow-up was available for 319 of 361 denervation subjects and 48 of 101 non-crossover subjects; 6-month denervation follow-up was available for 93 of 101 crossover subjects. In denervation subjects, the 12-month office systolic BP (SBP) change was greater than that observed at 6 months (-15.5 ± 24.1 mm Hg vs. -18.9 ± 25.4 mm Hg, respectively; p = 0.025), but the 24-h SBP change was not significantly different at 12 months (p = 0.229). The non-crossover group office SBP decreased by -32.9 ± 28.1 mm Hg at 6 months, but this response regressed to -21.4 ± 19.9 mm Hg (p = 0.01) at 12 months, increasing to 11.5 ± 29.8 mm Hg. These data support no further reduction in office or ambulatory BP after 1-year follow-up. Loss of BP reduction in the non-crossover group may reflect decreased medication adherence or other related factors. (Renal Denervation in Patients With Uncontrolled Hypertension [SYMPLICITY HTN-3]; NCT01418261). Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Effects of an HIV peer prevention intervention on sexual and injecting risk behaviors among injecting drug users and their risk partners in Thai Nguyen, Vietnam: a randomized controlled trial.

PubMed

Go, Vivian F; Frangakis, Constantine; Le Minh, Nguyen; Latkin, Carl A; Ha, Tran Viet; Mo, Tran Thi; Sripaipan, Teerada; Davis, Wendy; Zelaya, Carla; Vu, Pham The; Chen, Yong; Celentano, David D; Quan, Vu Minh

2013-11-01

Globally, 30% of new HIV infections outside sub-Saharan Africa involve injecting drug users (IDU) and in many countries, including Vietnam, HIV epidemics are concentrated among IDU. We conducted a randomized controlled trial in Thai Nguyen, Vietnam, to evaluate whether a peer oriented behavioral intervention could reduce injecting and sexual HIV risk behaviors among IDU and their network members. 419 HIV-negative index IDU aged 18 years or older and 516 injecting and sexual network members were enrolled. Each index participant was randomly assigned to receive a series of six small group peer educator-training sessions and three booster sessions in addition to HIV testing and counseling (HTC) (intervention; n = 210) or HTC only (control; n = 209). Follow-up, including HTC, was conducted at 3, 6, 9 and 12 months post-intervention. The proportion of unprotected sex dropped significantly from 49% to 27% (SE (difference) = 3%, p < 0.01) between baseline and the 3-month visit among all index-network member pairs. However, at 12 months, post-intervention, intervention participants had a 14% greater decline in unprotected sex relative to control participants (Wald test = 10.8, df = 4, p = 0.03). This intervention effect is explained by trial participants assigned to the control arm who missed at least one standardized HTC session during follow-up and subsequently reported increased unprotected sex. The proportion of observed needle/syringe sharing dropped significantly between baseline and the 3-month visit (14% vs. 3%, SE (difference) = 2%, p < 0.01) and persisted until 12 months, but there was no difference across trial arms (Wald test = 3.74, df = 3, p = 0.44). Copyright © 2013 Elsevier Ltd. All rights reserved.

Study and treatment of post Lyme disease (STOP-LD): a randomized double masked clinical trial.

PubMed

Krupp, L B; Hyman, L G; Grimson, R; Coyle, P K; Melville, P; Ahnn, S; Dattwyler, R; Chandler, B

2003-06-24

To determine whether post Lyme syndrome (PLS) is antibiotic responsive. The authors conducted a single-center randomized double-masked placebo-controlled trial on 55 patients with Lyme disease with persistent severe fatigue at least 6 or more months after antibiotic therapy. Patients were randomly assigned to receive 28 days of IV ceftriaxone or placebo. The primary clinical outcomes were improvement in fatigue, defined by a change of 0.7 points or more on an 11-item fatigue questionnaire, and improvement in cognitive function (mental speed), defined by a change of 25% or more on a test of reaction time. The primary laboratory outcome was an experimental measure of CSF infection, outer surface protein A (OspA). Outcome data were collected at the 6-month visit. Patients assigned to ceftriaxone showed improvement in disabling fatigue compared to the placebo group (rate ratio, 3.5; 95% CI, 1.50 to 8.03; p = 0.001). No beneficial treatment effect was observed for cognitive function or the laboratory measure of persistent infection. Four patients, three of whom were on placebo, had adverse events associated with treatment, which required hospitalization. Ceftriaxone therapy in patients with PLS with severe fatigue was associated with an improvement in fatigue but not with cognitive function or an experimental laboratory measure of infection in this study. Because fatigue (a nonspecific symptom) was the only outcome that improved and because treatment was associated with adverse events, this study does not support the use of additional antibiotic therapy with parenteral ceftriaxone in post-treatment, persistently fatigued patients with PLS.

A parent-based intervention to promote healthy eating and active behaviours in pre-school children: evaluation of the MEND 2-4 randomized controlled trial.

PubMed

Skouteris, H; Hill, B; McCabe, M; Swinburn, B; Busija, L

2016-02-01

There is a paucity of studies evaluating targeted obesity prevention interventions in pre-school children. We conducted a randomized controlled trial to evaluate the efficacy of a parent-based obesity prevention intervention for pre-schoolers - MEND (Mind, Exercise, Nutrition … Do It!) 2-4 on child diet, eating habits, physical activity/sedentary behaviours, and body mass index (BMI). Parent-child dyads attended 10 weekly 90-min workshops relating to nutrition, physical activity and behaviours, including guided active play and healthy snack time. Assessments were conducted at baseline, immediately post-intervention, and 6 and 12 months post-intervention; child intake of vegetables, fruit, beverages, processed snack foods, fussiness, satiety responsiveness, physical activity, sedentary behaviour and neophobia were assessed via parent proxy report. Parent and child height and weight were measured. Two hundred one parent-child dyads were randomized to intervention (n = 104) and control (n = 97). Baseline mean child age was 2.7 (standard deviation [SD] 0.6) years, and child BMI-for-age z-score (World Health Organization) was 0.66 (SD 0.88). We found significant positive group effects for vegetable (P = 0.01) and snack food (P = 0.03) intake, and satiety responsiveness (P = 0.047) immediately post-intervention. At 12 months follow-up, intervention children exhibited less neophobia (P = 0.03) than controls. Future research should focus on additional strategies to support parents to continue positive behaviour change. ACTRN12610000200088. © 2015 World Obesity.

Randomized Clinical Trial of Family-Based Treatment and Cognitive-Behavioral Therapy for Adolescent Bulimia Nervosa

PubMed Central

Le Grange, Daniel; Lock, James; Agras, W. Stewart; Bryson, Susan W.; Jo, Booil

2015-01-01

Objective There is a paucity of randomized clinical trials (RCTs) for adolescents with bulimia nervosa (BN). Prior studies suggest cognitive-behavioral therapy adapted for adolescents (CBT-A) and family-based treatment (FBT-BN) could be effective for this patient population. The objective of this study was to compare the relative efficacy of these two specific therapies, FBT-BN and CBT-A. In addition, a smaller group was randomized to a non-specific treatment (supportive psychotherapy [SPT]), whose data were to be used if there were no differences between FBT-BN and CBT-A at end of treatment (EOT). Method This two-site RCT (Chicago and Stanford) randomized 130 participants (aged 12–18 years) meeting DSM, 4th Edition criteria for BN or partial BN (binge eating and purging ≥once per week for six months). Outcomes were assessed at baseline, EOT, 6 and 12 months post treatment. Treatments involved 18 outpatient sessions over 6 months. Primary outcome was defined as abstinence from binge eating and purging for 4 weeks prior to assessment, using the Eating Disorder Examination. Results Participants in FBT-BN achieved higher abstinence rates than in CBT-A at EOT (39% vs. 20%; p=.040, number needed to treat [NNT]=5) and at 6-month follow-up (44% vs. 25%; p=.030, NNT=5). Abstinence rates between these two groups did not differ statistically at 12- month follow-up (49% vs. 32%; p=.130, NNT=6). Conclusion FBT-BN is more effective in promoting abstinence from binge eating and purging than CBT-A in adolescent BN at EOT and 6-month follow-up. By 12-month follow-up there were no statistically significant differences between the two treatments. PMID:26506579

A weight-neutral versus weight-loss approach for health promotion in women with high BMI: A randomized-controlled trial.

PubMed

Mensinger, Janell L; Calogero, Rachel M; Stranges, Saverio; Tylka, Tracy L

2016-10-01

Weight loss is the primary recommendation for health improvement in individuals with high body mass index (BMI) despite limited evidence of long-term success. Alternatives to weight-loss approaches (such as Health At Every Size - a weight-neutral approach) have been met with their own concerns and require further empirical testing. This study compared the effectiveness of a weight-neutral versus a weight-loss program for health promotion. Eighty women, aged 30-45 years, with high body mass index (BMI ≥ 30 kg/m(2)) were randomized to 6 months of facilitator-guided weekly group meetings using structured manuals that emphasized either a weight-loss or weight-neutral approach to health. Health measurements occurred at baseline, post-intervention, and 24-months post-randomization. Measurements included blood pressure, lipid panels, blood glucose, BMI, weight, waist circumference, hip circumference, distress, self-esteem, quality of life, dietary risk, fruit and vegetable intake, intuitive eating, and physical activity. Intention-to-treat analyses were performed using linear mixed-effects models to examine group-by-time interaction effects and between and within-group differences. Group-by-time interactions were found for LDL cholesterol, intuitive eating, BMI, weight, and dietary risk. At post-intervention, the weight-neutral program had larger reductions in LDL cholesterol and greater improvements in intuitive eating; the weight-loss program had larger reductions in BMI, weight, and larger (albeit temporary) decreases in dietary risk. Significant positive changes were observed overall between baseline and 24-month follow-up for waist-to-hip ratio, total cholesterol, physical activity, fruit and vegetable intake, self-esteem, and quality of life. These findings highlight that numerous health benefits, even in the absence of weight loss, are achievable and sustainable in the long term using a weight-neutral approach. The trial positions weight-neutral programs as a viable health promotion alternative to weight-loss programs for women of high weight. Copyright © 2016 Elsevier Ltd. All rights reserved.

A Pilot Randomized Controlled Trial of the Effects of Chair Yoga on Pain and Physical Function Among Community-Dwelling Older Adults With Lower Extremity Osteoarthritis.

PubMed

Park, Juyoung; McCaffrey, Ruth; Newman, David; Liehr, Patricia; Ouslander, Joseph G

2017-03-01

To determine effects of Sit 'N' Fit Chair Yoga, compared to a Health Education program (HEP), on pain and physical function in older adults with lower extremity osteoarthritis (OA) who could not participate in standing exercise. Two-arm randomized controlled trial. One HUD senior housing facility and one day senior center in south Florida. Community-dwelling older adults (N = 131) were randomly assigned to chair yoga (n = 66) or HEP (n = 65). Thirteen dropped after assignment but prior to the intervention; six dropped during the intervention; 106 of 112 completed at least 12 of 16 sessions (95% retention rate). Participants attended either chair yoga or HEP. Both interventions consisted of twice-weekly 45-minute sessions for 8 weeks. Primary: pain, pain interference; secondary: balance, gait speed, fatigue, functional ability measured at baseline, after 4 weeks of intervention, at the end of the 8-week intervention, and post-intervention (1 and 3 months). The chair yoga group showed greater reduction in pain interference during the intervention (P = .01), sustained through 3 months (P = .022). WOMAC pain (P = .048), gait speed (P = .024), and fatigue (P = .037) were improved in the yoga group during the intervention (P = .048) but improvements were not sustained post intervention. Chair yoga had no effect on balance. An 8-week chair yoga program was associated with reduction in pain, pain interference, and fatigue, and improvement in gait speed, but only the effects on pain interference were sustained 3 months post intervention. Chair yoga should be further explored as a nonpharmacologic intervention for older people with OA in the lower extremities. ClinicalTrials.gov: NCT02113410. © 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.

A pilot randomized controlled trial of cognitive behavioral therapy for perinatal depression adapted for women with low incomes.

PubMed

O'Mahen, Heather; Himle, Joseph A; Fedock, Gina; Henshaw, Erin; Flynn, Heather

2013-07-01

Perinatal women with identified depression in prenatal care settings have low rates of engagement and adherence with depression-specific psychotherapy. We report the feasibility and symptom outcomes of Cognitive Behavioral Therapy (CBT) modified (mCBT) to address the needs of perinatal, low-income women with Major Depressive Disorder (MDD). Pregnant women (n = 1421) were screened for depressive symptoms in obstetrics clinics in conjunction with prenatal care visits. A total of 59 women met diagnostic criteria for MDD; 55 women were randomly assigned to mCBT or Treatment as Usual (TAU). The mCBT intervention included an initial engagement session, outreach, specific perinatal content and interpersonal components. Measures were gathered at pre-treatment, 16 week post-randomization, and 3-month follow-up. Most participants attended at least one CBT session and met study criteria for treatment adherence. Active research staff outreach promoted engagement and retention in the trial. Treatment satisfaction was rated as very good. In both observed and multiple imputation results, women who received mCBT demonstrated greater improvement in depressed mood than those in TAU at 16-week post-randomization and 3-month follow-up, Cohen's d = -0.71 (95% CI -4.93, -5.70). Modified CBT offers promise as a feasible and acceptable treatment for perinatal women with low-incomes in prenatal care settings. Targeted delivery and content modifications are needed to engage populations tailored to setting and psychosocial challenges specific to the perinatal period. © 2013 Wiley Periodicals, Inc.

The effects of a 3-month controlled hiking programme on the functional abilities of patients following total knee arthroplasty: a prospective, randomized trial.

PubMed

Hepperger, Caroline; Gföller, Peter; Hoser, Christian; Ulmer, Hanno; Fischer, Felix; Schobersberger, Wolfgang; Fink, Christian

2017-11-01

Improvements in pain, function and sports activity are the main goals of patients following total knee arthroplasty (TKA). Participation in sports has become an increasingly important contributor to patients' quality of life (QoL). Hiking is one of the most popular summer activities among elderly people in alpine regions. Consequently, this randomized controlled trial investigates the impact of a 3-month guided hiking programme on patients' functional abilities and QoL following TKA. It was hypothesized that patients who participate in this programme would demonstrate improvements in functional and QoL parameters compared with a control group. Forty-eight TKA patients were included and randomized into either the intervention group (IG; n = 25) or the control group (CG; n = 23). The IG participated in a 3-month hiking programme (2-3 times a week), whereas the CG performed activities of daily living. The stair climb test (SCT), QoL questionnaires and isokinetic force measurements were completed at three time points (i.e. pre-test, post-test, retention-test). ANOVAs for repeated measurements were conducted for the SCT results. The Friedman test and the Mann-Whitney U test were performed for the QoL parameters. After the 3-month hiking programme, the IG achieved faster overall walking times on the SCT. The time decreased from 4.3 ± 0.6 s (pre-test) to 3.6 ± 0.4 s (post-test) for the stair ascent (p = 0.060) and from 3.6 ± 0.6 s (pre-test) to 3.2 ± 0.5 s (post-test) for the stair descent (p = 0.036). The IG showed significant improvement on some of the subscales of the Knee Injury and Osteoarthritis Outcome Score from pre-test to retention-test (p < 0.01). In the CG, no significant changes were observed (n.s.). The results indicate moderate improvement in the functional abilities and QoL of TKA patients who participated in a 3-month guided hiking programme compared with the patients in the CG. Hiking did not have any acute detrimental effects on the TKA patients during this study period. II.

Randomized clinical study comparing metallic and glass fiber post in restoration of endodontically treated teeth.

PubMed

Gbadebo, Olaide S; Ajayi, Deborah M; Oyekunle, Oyekunle O Dosumu; Shaba, Peter O

2014-01-01

Post-retained crowns are indicated for endodontically treated teeth (ETT) with severely damaged coronal tissue. Metallic custom and prefabricated posts have been used over the years, however, due to unacceptable color, extreme rigidity and corrosion, fiber posts, which are flexible, aesthetically pleasing and have modulus of elasticity comparable with dentin were introduced. To compare clinical performance of metallic and glass fiber posts in restoration of ETT. 40 ETT requiring post retained restorations were included. These teeth were randomly allocated into 2 groups. Twenty teeth were restored using a glass fiber-reinforced post (FRP) and 20 others received stainless steel parapost (PP), each in combination with composite core buildups. Patients were observed at 1 and 6 months after post placement and cementation of porcelain fused to metal (PFM) crown. Marginal gap consideration, post retention, post fracture, root fracture, crown fracture, crown decementation and loss of restoration were part of the data recorded. All teeth were assessed clinically and radiographically. Fisher's exact test was used for categorical values while log-rank test was used for descriptive statistical analysis. One tooth in the PP group failed, secondary to decementation of the PFM crown giving a 2.5% overall failure while none in the FRP group failed. The survival rate of FRP was thus 100% while it was 97.5% in the PP group. This however was not statistically significant (log-rank test, P = 0.32). Glass FRPs performed better than the metallic post based on short-term clinical performance.

Estimated medical expenditure and risk of job loss among rheumatoid arthritis patients undergoing tofacitinib treatment: post hoc analyses of two randomized clinical trials

PubMed Central

Rendas-Baum, Regina; Kosinski, Mark; Singh, Amitabh; Mebus, Charles A.; Wilkinson, Bethany E.; Wallenstein, Gene V.

2017-01-01

Abstract Objectives. RA causes high disability levels and reduces health-related quality of life, triggering increased costs and risk of unemployment. Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. These post hoc analyses of phase 3 data aimed to assess monthly medical expenditure (MME) and risk of job loss for tofacitinib treatment vs placebo. Methods. Data analysed were from two randomized phase 3 studies of RA patients (n = 1115) with inadequate response to MTX or TNF inhibitors (TNFi) receiving tofacitinib 5 or 10 mg twice daily, adalimumab (one study only) or placebo, in combination with MTX. Short Form 36 version 2 Health Survey physical and mental component summary scores were translated into predicted MME via an algorithm and concurrent inability to work and job loss risks at 6, 12 and 24 months, using Medical Outcomes Study data. Results. MME reduction by month 3 was $100 greater for tofacitinib- than placebo-treated TNFi inadequate responders (P < 0.001); >20 and 6% reductions from baseline, respectively. By month 3 of tofacitinib treatment, the odds of inability to work decreased ⩾16%, and risk of future job loss decreased ∼20% (P < 0.001 vs placebo). MME reduction by month 3 was $70 greater for tofacitinib- than placebo-treated MTX inadequate responders (P < 0.001); ⩾23 and 13% reductions from baseline, respectively. By month 3 of tofacitinib treatment, the odds of inability to work decreased ⩾31% and risk of future job loss decreased ⩾25% (P < 0.001 vs placebo). Conclusion. Tofacitinib treatment had a positive impact on estimated medical expenditure and risk of job loss for RA patients with inadequate response to MTX or TNFi. PMID:28460083

Pre- and postnatal exposure to intimate partner violence among South African HIV-infected mothers and infant developmental functioning at 12 months of age.

PubMed

Rodriguez, Violeta J; Peltzer, Karl; Matseke, Gladys; Weiss, Stephen M; Shine, Agnes; Jones, Deborah L

2018-05-23

In rural South Africa, pregnant HIV-infected women report high rates of psychological (55%) and physical (20%) intimate partner violence (IPV). IPV increases the risk of infant developmental delays. Such delays may have negative socioemotional and cognitive outcomes throughout the lifespan. This paper assesses the relationship between IPV and infant development in rural South Africa. The present investigation was a cross-sectional add-on follow-up designed retrospectively. A randomly selected sub-sample of mothers from the main randomized controlled trial (n = 72) were asked to participate with their infants at 12 months of age; all women invited agreed to participate. Women were 18.35 ± 5.47 weeks pregnant; demographics, HIV disclosure status, and pre- and postnatal IPV measured via the Conflict Tactics Scale during pregnancy at baseline and 12 months post-partum were assessed. Infant HIV serostatus and developmental functioning at 12 months of age were assessed. Women were a mean age of 29 ± 2 years. One third had completed at least 12 years of education and had a monthly income of ~ US$76. At 12 months post-partum, 6% of infants tested HIV seropositive. Postnatal physical IPV was associated with delays in cognitive and receptive language development p < 0.05, but only in unadjusted analyses. This study identified an association between early IPV exposure and infant cognitive and receptive communication delays. Given the small sample size, findings support replication. Longitudinal studies are needed to confirm temporal order and identify appropriate timing for interventions in HIV-exposed infants.

Vocational Training with HIV Prevention for Ugandan Youth

PubMed Central

Rotheram-Borus, Mary Jane; Lightfoot, Marguerita; Kasirye, Rogers; Desmond, Katherine

2013-01-01

In a pilot study, young people in slums in Kampala, Uganda received an HIV prevention program (Street Smart) and were randomized to receive vocational training immediately (Immediate) or four months later (Delayed). Youth were monitored at recruitment, 4 months (85% retention), and 24 months (74% retention). Employment increased dramatically: Only 48% had ever been employed at recruitment, 86% were employed from months 21 to 24 post recruitment. Over two years, decreases were recorded in the number of sexual partners, mental health symptoms, delinquent acts, and drug use; condom use increased. Providing employment in low income countries, in conjunction with HIV prevention, may provide sustained support to young people to prevent HIV acquisition. PMID:21800180

Evaluation of a standardized treatment regimen of anti-tuberculosis drugs for patients with multi-drug-resistant tuberculosis (STREAM): study protocol for a randomized controlled trial.

PubMed

Nunn, Andrew J; Rusen, I D; Van Deun, Armand; Torrea, Gabriela; Phillips, Patrick P J; Chiang, Chen-Yuan; Squire, S Bertel; Madan, Jason; Meredith, Sarah K

2014-09-09

In contrast to drug-sensitive tuberculosis, the guidelines for the treatment of multi-drug-resistant tuberculosis (MDR-TB) have a very poor evidence base; current recommendations, based on expert opinion, are that patients should be treated for a minimum of 20 months. A series of cohort studies conducted in Bangladesh identified a nine-month regimen with very promising results. There is a need to evaluate this regimen in comparison with the currently recommended regimen in a randomized controlled trial in a variety of settings, including patients with HIV-coinfection. STREAM is a multi-centre randomized trial of non-inferiority design comparing a nine-month regimen to the treatment currently recommended by the World Health Organization in patients with MDR pulmonary TB with no evidence on line probe assay of fluoroquinolone or kanamycin resistance. The nine-month regimen includes clofazimine and high-dose moxifloxacin and can be extended to 11 months in the event of delay in smear conversion. The primary outcome is based on the bacteriological status of the patients at 27 months post-randomization. Based on the assumption that the nine-month regimen will be slightly more effective than the control regimen and, given a 10% margin of non-inferiority, a total of 400 patients are required to be enrolled. Health economics data are being collected on all patients in selected sites. The results from the study in Bangladesh and cohorts in progress elsewhere are encouraging, but for this regimen to be recommended more widely than in a research setting, robust evidence is needed from a randomized clinical trial. Results from the STREAM trial together with data from ongoing cohorts should provide the evidence necessary to revise current recommendations for the treatment for MDR-TB. This trial was registered with clincaltrials.gov (registration number: ISRCTN78372190) on 14 October 2010.

HIV Self-Testing Increases HIV Testing Frequency in High Risk Men Who Have Sex with Men: A Randomized Controlled Trial.

PubMed

Katz, David A; Golden, Matthew R; Hughes, James P; Farquhar, Carey; Stekler, Joanne D

2018-04-24

Self-testing may increase HIV testing and decrease the time people with HIV are unaware of their status, but there is concern that absence of counseling may result in increased HIV risk. Seattle, Washington. We randomly assigned 230 high-risk HIV-negative men who have sex with men (MSM) to have access to oral fluid HIV self-tests at no cost versus testing as usual .for 15 months. The primary outcome was self-reported number of HIV tests during follow-up. To evaluate self-testing's impact on sexual behavior, we compared the following between arms: non-HIV-concordant condomless anal intercourse (CAI) and number of male CAI partners in the last 3 months (measured at 9 and 15 months) and diagnosis with a bacterial sexually transmitted infection (STI: early syphilis, gonorrhea, chlamydial infection) at the final study visit (15 months). A post hoc analysis compared the number of STI tests reported during follow-up. Men randomized to self-testing reported significantly more HIV tests during follow-up (mean=5.3, 95%CI=4.7-6.0) than those randomized to testing as usual (3.6, 3.2-4.0; p<.0001), representing an average increase of 1.7 tests per participant over 15 months. Men randomized to self-testing reported using an average of 3.9 self-tests. Self-testing was non-inferior with respect to all markers of HIV risk. Men in the self-testing arm reported significantly fewer STI tests during follow-up (mean=2.3, 95%CI=1.9-2.7) than men in the control arm (3.2, 2.8-3.6; p=0.0038). Access to free HIV self-testing increased testing frequency among high-risk MSM and did not impact sexual behavior or STI acquisition.

''Playstation eyetoy games'' improve upper extremity-related motor functioning in subacute stroke: a randomized controlled clinical trial.

PubMed

Yavuzer, G; Senel, A; Atay, M B; Stam, H J

2008-09-01

To evaluate the effects of ''Playstation EyeToy Games'' on upper extremity motor recovery and upper extremity-related motor functioning of patients with subacute stroke. The authors designed a randomized, controlled, assessor-blinded, 4-week trial, with follow-up at 3 months. A total of 20 hemiparetic inpatients (mean age 61.1 years), all within 12 months post-stroke, received 30 minutes of treatment with ''Playstation EyeToy Games'' per day, consisting of flexion and extension of the paretic shoulder, elbow and wrist as well as abduction of the paretic shoulder or placebo therapy (watching the games for the same duration without physical involvement into the games) in addition to conventional program, 5 days a week, 2-5 hours/day for 4 weeks. Brunnstrom's staging and self-care sub-items of the functional independence measure (FIM) were performed at 0 month (baseline), 4 weeks (post-treatment), and 3 months (follow-up) after the treatment. The mean change score (95% confidence interval) of the FIM self-care score (5.5 [2.9-8.0] vs 1.8 [0.1-3.7], P=0.018) showed significantly more improvement in the EyeToy group compared to the control group. No significant differences were found between the groups for the Brunnstrom stages for hand and upper extremity. ''Playstation EyeToy Games'' combined with a conventional stroke rehabilitation program have a potential to enhance upper extremity-related motor functioning in subacute stroke patients.

A cluster randomized controlled platform trial comparing group MEmory specificity training (MEST) to group psychoeducation and supportive counselling (PSC) in the treatment of recurrent depression.

PubMed

Werner-Seidler, Aliza; Hitchcock, Caitlin; Bevan, Anna; McKinnon, Anna; Gillard, Julia; Dahm, Theresa; Chadwick, Isobel; Panesar, Inderpal; Breakwell, Lauren; Mueller, Viola; Rodrigues, Evangeline; Rees, Catrin; Gormley, Siobhan; Schweizer, Susanne; Watson, Peter; Raes, Filip; Jobson, Laura; Dalgleish, Tim

2018-06-01

Impaired ability to recall specific autobiographical memories is characteristic of depression, which when reversed, may have therapeutic benefits. This cluster-randomized controlled pilot trial investigated efficacy and aspects of acceptability, and feasibility of MEmory Specificity Training (MEST) relative to Psychoeducation and Supportive Counselling (PSC) for Major Depressive Disorder (N = 62). A key aim of this study was to determine a range of effect size estimates to inform a later phase trial. Assessments were completed at baseline, post-treatment and 3-month follow-up. The cognitive process outcome was memory specificity. The primary clinical outcome was symptoms on the Beck Depression Inventory-II at 3-month follow-up. The MEST group demonstrated greater improvement in memory specificity relative to PSC at post-intervention (d = 0.88) and follow-up (d = 0.74), relative to PSC. Both groups experienced a reduction in depressive symptoms at 3-month follow-up (d = 0.67). However, there was no support for a greater improvement in depressive symptoms at 3 months following MEST relative to PSC (d = -0.04). Although MEST generated changes on memory specificity and improved depressive symptoms, results provide no indication that MEST is superior to PSC in the resolution of self-reported depressive symptoms. Implications for later-phase definitive trials of MEST are discussed. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

Specific Phobias in Youth: A Randomized Controlled Trial Comparing One-Session Treatment to a Parent-Augmented One-Session Treatment

PubMed Central

Ollendick, Thomas H.; Halldorsdottir, Thorhildur; Fraire, Maria G; Austin, Kristin E.; Noguchi, Ryoichi J. P.; Lewis, Krystal M.; Jarrett, Matthew A.; Cunningham, Natoshia R.; Canavera, Kristin; Allen, Kristy B.; Whitmore, Maria J.

2015-01-01

Objective Examine the efficacy of a parent-augmented One Session Treatment (A-OST) in treating specific phobias (SP) in youth by comparing this novel treatment to child-focused OST, a well-established treatment. Method A total of 97 youth (ages 6–15, 51.5% female, 84.5% white) who fulfilled diagnostic criteria for SP were randomized to either A-OST or OST. SPs were assessed with semi-structured diagnostic interviews, clinician improvement ratings, and parent and child improvement ratings. In addition, measures of treatment satisfaction and parental self-efficacy were obtained. Blind assessments were completed pretreatment, post-treatment, and 1-month and 6-months following treatment. Analyses were undertaken using mixed models. In addition, gender, age, internalizing/externalizing problems, parent overprotection, and parent anxiety were examined as potential predictors and moderators of treatment outcome. Results Both treatment conditions produced similar outcomes with approximately 50% of youth in both treatments diagnosis free and judged to be much or very much improved at post-treatment and 1-month follow up. At 6-month follow up, however, the treatments diverged with OST resulting in marginally superior outcomes to A-OST, contrary to predictions. Only age of child predicted treatment outcome across the two treatments (older children did better); unexpectedly, none of the variables moderated treatment outcomes. Conclusions Parent augmentation of OST produced no appreciable gains in treatment outcomes. Directions for future research are highlighted. PMID:25645164

Survey of Recipients of WAP Services Assessment of Household Budget and Energy Behaviors Pre to Post Weatherization DOE

DOE Office of Scientific and Technical Information (OSTI.GOV)

Tonn, Bruce Edward; Rose, Erin M.; Hawkins, Beth A.

This report presents results from the national survey of weatherization recipients. This research was one component of the retrospective and Recovery Act evaluations of the U.S. Department of Energy s Weatherization Assistance Program. Survey respondents were randomly selected from a nationally representative sample of weatherization recipients. The respondents and a comparison group were surveyed just prior to receiving their energy audits and then again approximately 18 months post-weatherization. This report focuses on budget issues faced by WAP households pre- and post-weatherization, whether household energy behaviors changed from pre- to post, the effectiveness of approaches to client energy education, and usemore » and knowledge about thermostats.« less

Early Intervention for Post-Traumatic Stress Disorder, Depression, and Quality of Life in Mortuary Affairs Soldiers Postdeployment.

PubMed

Biggs, Quinn M; Fullerton, Carol S; McCarroll, James E; Liu, Xian; Wang, Leming; Dacuyan, Nicole M; Zatzick, Douglas F; Ursano, Robert J

2016-11-01

U.S. Army mortuary affairs (MA) soldiers experience stressors of deployment and exposure to the dead, increasing risk for post-traumatic stress and depression. This study examines Troop Education for Army Morale, a postdeployment early intervention based on Psychological First Aid. MA soldiers (N = 126) were randomized to intervention or comparison groups 1-month postdeployment. Intervention sessions were held at 2, 3, 4, and 7 months. Assessments of post-traumatic stress disorder (PTSD), depression, and quality of life (QOL) were conducted at 1, 2, 3, 4, 7, and 10 months for both groups. At baseline, 25.0% of the total sample had probable PTSD (17-item PTSD Checklist M = 35.4, SD = 16.9) and 23.6% had probable depression (9-item Patient Health Questionnaire Depression Scale M = 7.8, SD = 6.9). Over 10 months, PTSD and depression symptoms decreased and QOL improved for the total sample. At study conclusion, intervention and comparison groups were not different. Intervention group males showed a transient symptom increase at 2 to 3 months. Males attended fewer intervention sessions than females. Lower attendance was associated with more symptoms and lower QOL. Higher attendance was associated with greater intervention benefits. Findings highlight the need for better understanding postdeployment interventions and facilitating attendance. Further intervention for MA soldiers is indicated. Reprint & Copyright © 2016 Association of Military Surgeons of the U.S.

Mexican/Mexican American Adolescents and "Keepin' It REAL": An Evidence-Based Substance Use Prevention Program

ERIC Educational Resources Information Center

Kulis, Stephen; Marsiglia, Flavio F.; Elek, Elvira; Dustman, Patricia; Wagstaff, David A.; Hecht, Michael L.

2005-01-01

A randomized trial tested the efficacy of three curriculum versions teaching drug resistance strategies, one modeled on Mexican American culture; another modeled on European American and African American culture; and a multicultural version. Self-report data at baseline and 14 months post-intervention were obtained from 3,402 Mexican heritage…

Behavioral Economic Predictors of Brief Alcohol Intervention Outcomes

PubMed Central

Murphy, James G.; Dennhardt, Ashley A.; Martens, Matthew P.; Yurasek, Ali M.; Skidmore, Jessica R.; MacKillop, James; McDevitt-Murphy, Meghan E.

2015-01-01

Objective The present study attempted to determine if behavioral economic indices of elevated alcohol reward value, measured before and immediately after a brief alcohol intervention, predict treatment response. Method Participants were 133 heavy drinking college students (49.6% female, 51.4% male; 64.3% Caucasian, 29.5% African American) who were randomized to one of three conditions: motivational interviewing plus personalized feedback (BMI), computerized personalized feedback intervention (e-CHUG), and assessment only. Results Baseline levels of alcohol demand significantly predicted drinks per week and alcohol problems at 1-month (demand intensity= maximum expenditure) and 6-month (relative discretionary expenditures on alcohol) follow-up. BMI and e-CHUG were associated with an immediate post-session reduction in alcohol demand (p < .001, ηρ2 = .29) that persisted at the 1-month follow-up, with greater post-session reductions in the BMI condition (p = .02, ηρ2 = .06). Reductions in demand intensity and Omax (maximum expenditure) immediately post-intervention significantly predicted drinking reductions at one-month follow up (p = .04, ΔR2 = .02 & p = .01, ΔR2 = .03, respectively). Reductions in relative discretionary expenditures on alcohol at 1-month significantly predicted drinking (p = .002, ΔR2 = .06,) and alcohol problem (p < .001, ΔR2 = .13) reductions at the 6-month follow-up. Conclusions These results suggest that behavioral economic reward value indices may function as risk factors for poor intervention response and as clinically-relevant markers of change in heavy drinkers. PMID:26167945

VATS versus intrapleural streptokinase: A prospective, randomized, controlled clinical trial for optimum treatment of post-traumatic Residual Hemothorax.

PubMed

Kumar, S; Rathi, V; Rattan, A; Chaudhary, S; Agarwal, N

2015-09-01

Post-traumatic residual haemothorax (RH) is common and carries significant morbidity. However, its optimal treatment is not clear. The aim of this study was to find the extent of this problem and the choice of treatment between VATS and intra-pleural streptokinase instillation (IPSI). This RCT, conducted over 18 months period, included all patients of chest trauma between 18 and 70 years of age, admitted with haemothorax or haemopneumothorax requiring inter-costal drain (ICD) insertion. 154 events of haemothorax/haemopneumothorax requiring ICD insertion were enrolled. RH was seen in 48 (31%) patients: 13 patients were excluded from RCT after refusal for treatment. Seventeen (49%) patients of remaining 35 RH cases were randomized to IPSI group and 18 (51%) patients were randomized to VATS group. The outcome parameters were resolution of RH and treatment related complications. RH resolved equally well in VATS and IPSI group [13 patients (72%) versus 12 patients (71%), respectively; continuity-adjusted p=1]. Morbidity wise no difference (p-value 0.529) was seen in the two groups. Post-traumatic RH is seen in 1/3rd patients and is equally well treated by VATS and IPSI. Copyright © 2015 Elsevier Ltd. All rights reserved.

A Multicenter Randomized Controlled Trial of Rituximab versus Cyclosporine in the Treatment of Idiopathic Membranous Nephropathy (MENTOR).

PubMed

Fervenza, Fernando C; Canetta, Pietro A; Barbour, Sean J; Lafayette, Richard A; Rovin, Brad H; Aslam, Nabeel; Hladunewich, Michelle A; Irazabal, Maria V; Sethi, Sanjeev; Gipson, Debbie S; Reich, Heather N; Brenchley, Paul; Kretzler, Matthias; Radhakrishnan, Jai; Hebert, Lee A; Gipson, Patrick E; Thomas, Leslie F; McCarthy, Ellen T; Appel, Gerald B; Jefferson, J Ashley; Eirin, Alfonso; Lieske, John C; Hogan, Marie C; Greene, Eddie L; Dillon, John J; Leung, Nelson; Sedor, John R; Rizk, Dana V; Blumenthal, Samuel S; Lasic, Lada B; Juncos, Luis A; Green, Dollie F; Simon, James; Sussman, Amy N; Philibert, David; Cattran, Daniel C

2015-01-01

Idiopathic membranous nephropathy remains the leading cause of nephrotic syndrome in Caucasian adults. Immunosuppressive therapy with cyclosporine (CSA) is often successful in reducing proteinuria, but its use is associated with a high relapse rate. Rituximab, a monoclonal antibody that specifically targets CD20 on the surface of B-cells, is effective in achieving a complete remission of proteinuria in patients with idiopathic membranous nephropathy. However, whether rituximab is as effective as CSA in inducing and maintaining complete or partial remission of proteinuria in these patients is unknown. The membranous nephropathy trial of rituximab (MENTOR) hypothesizes that B-cell targeting with rituximab is non-inferior to CSA in inducing long-term remission of proteinuria. Patients with idiopathic membranous nephropathy, proteinuria ≥5 g/24 h, and a minimum of 3 months of Angiotensin-II blockade will be randomized into a 12-month treatment period with i.v. rituximab, 1,000 mg (2 infusions, 14 days apart; repeated at 6 months if a substantial reduction in proteinuria (equal to or >25%) is seen at 6 months) or oral CSA 3.5-5 mg/kg/day for 6 months (continued for another 6 months if a substantial reduction in proteinuria (equal to or >25%) is seen at 6 months). The efficacy of treatment will be assessed by the remission status (based on changes in proteinuria) at 24 months from randomization. Patient safety will be assessed via collection of adverse event data and evaluation of pre- and posttreatment laboratory data. At the 6-month post-randomization visit, patients who have been randomized to either CSA or rituximab but who do not have a reduction in proteinuria ≥25% (confirmed on repeat measurements within 2 weeks) will be considered treatment failures and exit the study. This study will test for the first time whether treatment with rituximab is non-inferior to CSA in inducing long-term remission (complete or partial) of proteinuria in patients with idiopathic membranous nephropathy. 2015 S. Karger AG, Basel.

Diminishing the self-stigma of mental illness by coming out proud.

PubMed

Corrigan, Patrick W; Larson, Jonathon E; Michaels, Patrick J; Buchholz, Blythe A; Rossi, Rachel Del; Fontecchio, Malia Javier; Castro, David; Gause, Michael; Krzyżanowski, Richard; Rüsch, Nicolas

2015-09-30

This randomized controlled trial examined the impact of the Coming Out Proud (COP) program on self-stigma, stigma stress, and depression. Research participants who experienced mental health challenges were randomly assigned to a three session COP program (n=51) or a waitlist control (n=75). Outcome measures that assessed the progressively harmful stages of self-stigma, stigma stress appraisals, and depression were administered at pre-test, post-test, and one-month follow-up. People completing COP showed significant improvement at post-test and follow-up in the more harmful aspects of self-stigma compared to the control group. COP participants also showed improvements in stigma stress appraisals. Women participating in COP showed significant post-test and follow-up reductions in depression after COP compared to the control group. Men did not show this effect. Future research should determine whether these benefits also enhance attitudes related to recovery, empowerment, and self-determination. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Increasing the effectiveness of the Diabetes Prevention Program through if-then plans: study protocol for the randomized controlled trial of the McGill CHIP Healthy Weight Program.

PubMed

Knäuper, Bärbel; Ivanova, Elena; Xu, Zhen; Chamandy, Melodie; Lowensteyn, Ilka; Joseph, Lawrence; Luszczynska, Aleksandra; Grover, Steven

2014-05-18

The Diabetes Prevention Program (DPP) is highly effective in promoting weight loss in overweight and obese individuals. However, one-on-one DPP sessions are costly. As a cost-saving alternative, a group version of the DPP, called Group Lifestyle Balance program (GLB), has been developed but has been shown to be less effective. The aim of this two-arm parallel randomized controlled trial is to increase the effectiveness of the GLB by integrating habit formation techniques, namely if-then plans and their mental practice, into the program. A total of 154 participants will be randomized to a standard or enriched GLB program. For the enriched GLB program, if-then plans and their mental practice will be integrated into the standard GLB program. Participants will be overweight or obese men and women (BMI of 28 to 45 kg/m2, waist circumference ≥ 88 for women, ≥ 102 for men, 18 to 75 years of age) who do less than 200 minutes of self-reported moderate or vigorous exercise per week. Measures will be completed at baseline, 3 months, post-intervention (12 months), and 12 months post-intervention (24 months). The primary outcome measure is weight loss at 3, 12, and 24 months. Secondary outcomes include percent reaching weight loss goal, physical activity at 3, 12, and 24 months, and weight-related risk factors (waist circumference, hemoglobin A1c, systolic/diastolic blood pressure, total cholesterol/HDL ratio). Standardized training of the life-style coaches, use of standardized manuals, and audio taping and reviewing of the sessions will ensure intervention fidelity. The study will provide evidence-based data on the effectiveness of an enhanced GLB intervention in promoting weight loss and in reducing weight-related risk factors for chronic health problems. Ethical clearance has been received from the Research Ethics and Compliance Board of the Faculty of Medicine Research and Graduate Studies Office at McGill University (Montreal, Canada). ClinicalTrials.gov Identifier: NCT02008435. Registered 6 December 2013.

The dose-response effects of aerobic exercise on musculoskeletal injury: a post hoc analysis of a randomized trial.

PubMed

Brown, Justin C; Schmitz, Kathryn H

2017-01-01

In a post hoc analysis, we quantified the risk of musculoskeletal injury (MSI) associated with different volumes of aerobic exercise in a randomized trial. Premenopausal women (n = 119) were randomized to one of three groups: low-dose aerobic exercise (150 min·per week), high-dose aerobic exercise (300 min·per week) or control (usual activity) for 5 months. Compared to the control group, the risk of reporting an acute MSI increased with higher volumes of aerobic exercise, with a similar pattern observed for recurrent MSI. The risk of reporting an MSI severe enough to impair activities of daily living did not increase with higher volumes of aerobic exercise. Approximately half of MSI were causally attributed to aerobic exercise. The risk of experiencing an acute or recurrent MSI increases with higher volumes of aerobic exercise; however, the risk of experiencing an MSI severe enough to impair activities of daily living does not increase with higher volumes of aerobic exercise.

Post-operative ovarian adhesion formation after ovarian drilling: a randomized study comparing conventional laparoscopy and transvaginal hydrolaparoscopy.

PubMed

Giampaolino, Pierluigi; Morra, Ilaria; Tommaselli, Giovanni Antonio; Di Carlo, Costantino; Nappi, Carmine; Bifulco, Giuseppe

2016-10-01

To compare conventional laparoscopic ovarian drilling (LOD) with transvaginal hydrolaparoscopy (THL) ovarian drilling in terms of ovarian adhesion formation, evaluated using office THL during follow-up in CC-resistant anovulatory patients affected by PCOS. Prospective randomized study on 246 CC-resistant women with PCOS. The patients enrolled were divided into two groups, 123 were scheduled to undergo LOD and 123 to undergo THL ovarian drilling. Six months after the procedure all patients were offered office transvaginal hydrolaparoscopy (THL) follow-up, under local anesthesia to evaluate adhesion formation. Duration of the procedure was significantly shorter in the THL group in comparison with LOD group (p < 0.0001). No intra- or post-operative complication was observed in any of the patients in both groups. Post-operative THL follow-up after 6 months showed that 15 (15.5 %) patients in the THL group and 73 (70.2 %) in the LOD group showed the presence of ovarian adhesion. This difference was highly significant with a p value <0.0001 and a relative risk of 0.22 [95 % IC 0.133-0.350]. This study seems to indicate that THL ovarian drilling may reduce the risk of ovarian adhesion formation and could be used as a safe and effective option to reduce ovarian adhesion formation in patients undergoing ovarian drilling.

Economic evaluation of a bio-psycho-social intervention for comorbid disorders in a traumatized population in post-war Kosovo.

PubMed

Chang, Wei-Lun; Andersen, Carit Jacques; Berisha, Besa Shatri; Estrup, Olena; Wang, Shr-Jie

2018-05-08

Post-hoc economic evaluation of a bio-psycho-social intervention in post-war Kosovo from a societal perspective. Cost-effectiveness analysis, cost-utility analysis, and partial cost-benefit analysis using data from a randomized controlled trial. Thirty-four torture/war victims with comorbid conditions enrolled in 2012-2013. Participants were randomly assigned to an "intervention" and a "waiting-list" group. Changes in mental, emotional and physical health and functional impairment were assessed before and after treatment, along with increase in labour income as a proxy for productivity gain. The cost of an extra unit of effectiveness and an additional quality-adjusted life year were calculated. The total cost per participant was €1,322 including, or €1,019 excluding, research costs. Wide variations in costs of changes in mental, emotional and physical effectiveness were demonstrated. Multidisciplinary intervention resulted in functional improvement at a cost of €10,508 per quality-adjusted life year gained. With a mean monthly income increase to €133 (18%) after intervention, the intervention cost per participant would be equal to the total increase in monthly income after 4-5 years, assuming the increased level is maintained. Socio-economic benefit associated with quality-adjusted life year gain is shown, although the cost of an additional quality-adjusted life year is above the World Health Organization cost-effectiveness threshold.

Lack of benefit from percutaneous intervention of persistently occluded infarct arteries after the acute phase of myocardial infarction is time independent: insights from Occluded Artery Trial

PubMed Central

Menon, Venu; Pearte, Camille A.; Buller, Christopher E.; Steg, Ph.Gabriel; Forman, Sandra A.; White, Harvey D.; Marino, Paolo N.; Katritsis, Demosthenes G.; Caramori, Paulo; Lasevitch, Ricardo; Loboz-Grudzien, Krystyna; Zurakowski, Aleksander; Lamas, Gervasio A.; Hochman, Judith S.

2009-01-01

Aims The Occluded Artery Trial (OAT) (n = 2201) showed no benefit for routine percutaneous intervention (PCI) (n = 1101) over medical therapy (MED) (n = 1100) on the combined endpoint of death, myocardial infarction (MI), and class IV heart failure (congestive heart failure) in stable post-MI patients with late occluded infarct-related arteries (IRAs). We evaluated the potential for selective benefit with PCI over MED for patients enrolled early in OAT. Methods and results We explored outcomes with PCI over MED in patients randomized to the ≤3 calendar days and ≤7 calendar days post-MI time windows. Earlier, times to randomization in OAT were associated with higher rates of the combined endpoint (adjusted HR 1.04/day: 99% CI 1.01–1.06; P < 0.001). The 48-month event rates for ≤3 days, ≤7 days post-MI enrolled patients were similar for PCI vs. MED for the combined and individual endpoints. There was no interaction between time to randomization defined as a continuous (P = 0.55) or categorical variable with a cut-point of 3 days (P = 0.98) or 7 days (P = 0.64) post-MI and treatment effect. Conclusion Consistent with overall OAT findings, patients enrolled in the ≤3 day and ≤7 day post-MI time windows derived no benefit with PCI over MED with no interaction between time to randomization and treatment effect. Our findings do not support routine PCI of the occluded IRA in trial-eligible patients even in the earliest 24–72 h time window. PMID:19028780

A pilot randomized controlled trial of mindfulness-based stress reduction for caregivers of family members with dementia.

PubMed

Brown, Kirk Warren; Coogle, Constance L; Wegelin, Jacob

2016-11-01

The majority of care for those with Alzheimer's disease and other age-related dementias is provided in the home by family members. To date, there is no consistently effective intervention for reducing the significant stress burden of many family caregivers. The present pilot randomized controlled trial tested the efficacy of an adapted, eight-week mindfulness-based stress reduction (MBSR) program, relative to a near structurally equivalent, standard social support (SS) control condition for reducing caregiver stress and enhancing the care giver-recipient relationship. Thirty-eight family caregivers were randomized to MBSR or SS, with measures of diurnal salivary cortisol, and perceived stress, mental health, experiential avoidance, caregiver burden, and relationship quality collected pre- and post-intervention and at three-month follow-up. MBSR participants reported significantly lower levels of perceived stress and mood disturbance at post-intervention relative to SS participants. At three-month follow-up, participants in both treatment conditions reported improvements on several psychosocial outcomes. At follow-up, there were no condition differences on these outcomes, nor did MBSR and SS participants differ in diurnal cortisol response change over the course of the study. Both MBSR and SS showed stress reduction effects, and MBSR showed no sustained neuroendocrine and psychosocial advantages over SS. The lack of treatment condition differences could be attributable to active ingredients in both interventions, and to population-specific and design factors.

Gait mechanics and tibiofemoral loading in men of the ACL-SPORTS randomized control trial.

PubMed

Capin, Jacob J; Khandha, Ashutosh; Zarzycki, Ryan; Arundale, Amelia J H; Ziegler, Melissa L; Manal, Kurt; Buchanan, Thomas S; Snyder-Mackler, Lynn

2018-03-25

The risk for post-traumatic osteoarthritis is elevated after anterior cruciate ligament reconstruction (ACLR), and may be especially high among individuals with aberrant walking mechanics, such as medial tibiofemoral joint underloading 6 months postoperatively. Rehabilitation training programs have been proposed as one strategy to address aberrant gait mechanics. We developed the anterior cruciate ligament specialized post-operative return-to-sports (ACL-SPORTS) randomized control trial to test the effect of 10 post-operative training sessions consisting of strength, agility, plyometric, and secondary prevention exercises (SAPP) or SAPP plus perturbation (SAPP + PERT) training on gait mechanics after ACLR. A total of 40 male athletes (age 23 ± 7 years) after primary ACLR were randomized to SAPP or SAPP + PERT training and tested at three distinct, post-operative time points: 1) after impairment resolution (Pre-training); 2) following 10 training sessions (Post-training); and 3) 2 years after ACLR. Knee kinematic and kinetic variables as well as muscle and joint contact forces were calculated via inverse dynamics and a validated electromyography-informed musculoskeletal model. There were no significant improvements from Pre-training to Post-training in either intervention group. Smaller peak knee flexion angles, extension moments, extensor muscle forces, medial compartment contact forces, and tibiofemoral contact forces were present across group and time, however the magnitude of interlimb differences were generally smaller and likely not meaningful 2 years postoperatively. Neither SAPP nor SAPP + PERT training appears effective at altering gait mechanics in men in the short-term; however, meaningful gait asymmetries mostly resolved between post-training and 2 years after ACLR regardless of intervention group. © 2018 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res. © 2018 Orthopaedic Research Society. Published by Wiley Periodicals, Inc.

FCET2EC (From controlled experimental trial to = 2 everyday communication): How effective is intensive integrative therapy for stroke-induced chronic aphasia under routine clinical conditions? A study protocol for a randomized controlled trial.

PubMed

Baumgaertner, Annette; Grewe, Tanja; Ziegler, Wolfram; Floel, Agnes; Springer, Luise; Martus, Peter; Breitenstein, Caterina

2013-09-23

Therapy guidelines recommend speech and language therapy (SLT) as the "gold standard" for aphasia treatment. Treatment intensity (i.e., ≥5 hours of SLT per week) is a key predictor of SLT outcome. The scientific evidence to support the efficacy of SLT is unsatisfactory to date given the lack of randomized controlled trials (RCT), particularly with respect to chronic aphasia (lasting for >6 months after initial stroke). This randomized waiting list-controlled multi-centre trial examines whether intensive integrative language therapy provided in routine in- and outpatient clinical settings is effective in improving everyday communication in chronic post-stroke aphasia. Participants are men and women aged 18 to 70 years, at least 6 months post an ischemic or haemorrhagic stroke resulting in persisting language impairment (i.e., chronic aphasia); 220 patients will be screened for participation, with the goal of including at least 126 patients during the 26-month recruitment period. Basic language production and comprehension abilities need to be preserved (as assessed by the Aachen Aphasia Test).Therapy consists of language-systematic and communicative-pragmatic exercises for at least 2 hours/day and at least 10 hours/week, plus at least 1 hour self-administered training per day, for at least three weeks. Contents of therapy are adapted to patients' individual impairment profiles.Prior to and immediately following the therapy/waiting period, patients' individual language abilities are assessed via primary and secondary outcome measures. The primary (blinded) outcome measure is the A-scale (informational content, or 'understandability', of the message) of the Amsterdam-Nijmegen Everyday Language Test (ANELT), a standardized measure of functional communication ability. Secondary (unblinded) outcome measures are language-systematic and communicative-pragmatic language screenings and questionnaires assessing life quality as viewed by the patient as well as a relative.The primary analysis tests for differences between the therapy group and an untreated (waiting list) control group with respect to pre- versus post 3-week-therapy (or waiting period, respectively) scores on the ANELT A-scale. Statistical between-group comparisons of primary and secondary outcome measures will be conducted in intention-to-treat analyses.Long-term stability of treatment effects will be assessed six months post intensive SLT (primary and secondary endpoints). Registered in ClinicalTrials.gov with the Identifier NCT01540383.

Efficacy of a Community-Based Physical Activity Program KM2H2 for Stroke and Heart Attack Prevention among Senior Hypertensive Patients: A Cluster Randomized Controlled Phase-II Trial

PubMed Central

Gong, Jie; Chen, Xinguang; Li, Sijian

2015-01-01

Objective To evaluate the efficacy of the program Keep Moving toward Healthy Heart and Healthy Brain (KM2H2) in encouraging physical activities for the prevention of heart attack and stroke among hypertensive patients enrolled in the Community-Based Hypertension Control Program (CBHCP). Design Cluster randomized controlled trial with three waves of longitudinal assessments at baseline, 3 and 6 months post intervention. Setting Community-based and patient-centered self-care for behavioral intervention in urban settings of China. Participants A total of 450 participants diagnosed with hypertension from 12 community health centers in Wuhan, China were recruited, and were randomly assigned by center to receive either KM2H2 plus standard CBHCP care (6 centers and 232 patients) or the standard care only (6 centers and 218 patients). Intervention KM2H2 is a behavioral intervention guided by the Transtheoretical Model, the Model of Personalized Medicine and Social Capital Theory. It consists of six intervention sessions and two booster sessions engineered in a progressive manner. The purpose is to motivate and maintain physical activities for the prevention of heart attack and stroke. Outcome Measures Heart attack and stroke (clinically diagnosed, primary outcome), blood pressure (measured, secondary outcome), and physical activity (self-report, tertiary outcome) were assessed at the individual level during the baseline, 3- and 6-month post-intervention. Results Relative to the standard care, receiving KM2H2 was associated with significant reductions in the incidence of heart attack (3.60% vs. 7.03%, p < .05) and stroke (5.11% vs. 9.90%, p<0.05), and moderate reduction in blood pressure (-3.72mmHg in DBP and -2.92 mmHg in DBP) at 6-month post-intervention; and significant increases in physical activity at 3- (d = 0.53, 95% CI: 0.21, 0.85) and 6-month (d = 0.45, 95% CI: 0.04, 0.85) post-intervention, respectively. Conclusion The program KM2H2 is efficacious to reduce the risk of heart attack and stroke among senior patients who are on anti-hypertensive medication. Findings of this study provide solid data supporting a formal phase-III trial to establish the effectiveness of KM2H2 for use in community settings for prevention. Trial Registration ISRCTN Register ISRCTN12608966 PMID:26426421

Effectiveness of a facebook-delivered physical activity intervention for post-partum women: a randomized controlled trial protocol.

PubMed

Kernot, Jocelyn; Olds, Tim; Lewis, Lucy K; Maher, Carol

2013-05-29

Physical activity is reduced during the post-partum period. Facebook is frequently used by Australian mothers, and offers flexibility, high levels of engagement and the ability to disseminate information and advice via social contacts. The Mums Step it Up Program is a newly developed 50 day team-based physical activity intervention delivered via a Facebook app. The program involves post-partum women working in teams of 4-8 friends aiming to achieve 10,000 steps per day measured by a pedometer. Women are encouraged to use the app to log their daily steps and undertake social and supportive interactions with their friends and other participants. This study aims to determine the effectiveness of the Mums Step it Up Program. A sample of 126 women up to 12 months post-partum will be recruited through community-based health and family services. Participants will be randomly allocated into one of three groups: control, pedometer only and the Mums Step it Up Program. Assessments will be completed at baseline, 6 weeks and 6 months. The primary outcome (objective physical activity) and the secondary outcomes (sleep quality and quantity, depressive symptoms, weight and quality of life) will be used to determine the effectiveness of the Mums Step it Up Program compared with the control and pedometer only groups. Analyses will be undertaken on an intention-to-treat-basis using random effects mixed modeling. The effect of theorized mediators (physical activity attitudes, subjective norms and perceived behavioral control) will also be examined. This study will provide information about the potential of a Facebook app for the delivery of health behavior interventions. If this intervention proves to be effective it will be released on a mass scale and promoted to the general public. Australia and New Zealand Clinical Trials Register: ACTRN12613000069752.

Comparison of two psycho-educational family group interventions for improving psycho-social outcomes in persons with spinal cord injury and their caregivers: a randomized-controlled trial of multi-family group intervention versus an active education control condition.

PubMed

Dyck, Dennis G; Weeks, Douglas L; Gross, Sarah; Lederhos Smith, Crystal; Lott, Hilary A; Wallace, Aimee J; Wood, Sonya M

2016-07-26

Over 12,000 individuals suffer a spinal cord injury (SCI) annually in the United States, necessitating long-term, complex adjustments and responsibilities for patients and their caregivers. Despite growing evidence that family education and support improves the management of chronic conditions for care recipients as well as caregiver outcomes, few systematic efforts have been made to involve caregivers in psycho-educational interventions for SCI. As a result, a serious gap exists in accumulated knowledge regarding effective, family-based treatment strategies for improving outcomes for individuals with SCI and their caregivers. The proposed research aims to fill this gap by evaluating the efficacy of a structured adaptation of an evidence-based psychosocial group treatment called Multi-Family Group (MFG) intervention. The objective of this study is to test, in a randomized-controlled design, an MFG intervention for the treatment of individuals with SCI and their primary caregivers. Our central hypothesis is that by providing support in an MFG format, we will improve coping skills of persons with SCI and their caregivers as well as supportive strategies employed by caregivers. We will recruit 32 individuals with SCI who have been discharged from inpatient rehabilitation within the previous 3 years and their primary caregivers. Patient/caregiver pairs will be randomized to the MFG intervention or an active SCI education control (SCIEC) condition in a two-armed randomized trial design. Participants will be assessed pre- and post-program and 6 months post-program. Intent to treat analyses will test two a priori hypotheses: (1) MFG-SCI will be superior to SCIEC for SCI patient activation, health status, and emotion regulation, caregiver burden and health status, and relationship functioning, and (2) MFG will be more effective for individuals with SCI and their caregivers when the person with SCI is within 18 months of discharge from inpatient rehabilitation compared to when the person is between 19 and 36 months post discharge. Support for our hypotheses will indicate that MFG-SCI is superior to specific education for assisting patients and their caregivers in the management of difficult, long-term, life adjustments in the months and years after SCI, with increased efficacy closer in time to the injury. ClinicalTrials.gov NCT02161913 . Registered 10 June 2014.

A comparison of three different surgical procedures in the treatment of type A thoracolumbar fractures: a randomized controlled trial.

PubMed

Lyu, Jianhua; Chen, Kai; Tang, Zhaohui; Chen, Yu; Li, Ming; Zhang, Qiulin

2016-06-01

The aim of the study was to evaluate the efficacy of three different surgical procedures in the treatment of type A thoracolumbar fractures. Between September 2012 and January 2015, a total of 90 patients with type A thoracolumbar fractures were randomly assigned into three groups of 30 each. Patients in group A, B, and C were treated with three-level percutaneous fixation, two-level percutaneous fixation, and three-level open fixation, respectively. Blood loss, duration of surgery, VAS scores, Cobb angles, and anterior height ratios of fractured vertebrae were collected for statistical analysis. The average follow-up was 17.7 months. Post-operative Cobb angles were significantly corrected and anterior height ratios of fractured vertebrae were well restored in all three groups (p < 0.01). Back pain was efficiently relieved according to VAS score change (p < 0.01). There were significant differences in values of blood loss and post-operative VAS scores (at three months) between group A and group C (p < 0.01). No significant difference concerning post-operative anterior height ratios of fractured vertebrae, Cobb angles and correction losses was observed between group A and group B (p = 0.580, 0.840, 0.215, respectively). Percutaneous fixation not only provides the same reduction effect as open fixation, but also has an advantage of causing less operation related trauma which is beneficial to post-operative rehabilitation. The efficacy of three-level percutaneous fixation and two-level percutaneous fixation in the treatment of type A thoracolumbar fractures is not significantly different.

The effects of Pilates method on pelvic floor muscle strength in patients with post-prostatectomy urinary incontinence: A randomized clinical trial.

PubMed

Gomes, Cíntia S; Pedriali, Fabiana R; Urbano, Mariana R; Moreira, Eliane H; Averbeck, Marcio A; Almeida, Silvio Henrique M

2018-01-01

To assess the effects of a Pilates exercise program compared to conventional pelvic floor muscle training (PFMT) protocol on pelvic floor muscle strength (PFMS) in patients with post-prostatectomy urinary incontinence. Patients were randomized into three treatment groups (G1: Pilates, G2: electrical stimulation combined with PFMT, and G3: control group). Duration of therapy was 10 weeks. Baseline assessment included the 24 h pad-test and the ICI-Q questionnaire. PFMS was measured using a manometric perineometry device at baseline and 4 months after radical prostatectomy (RP). The level of significance was P < 0.05. One hundred twenty three patients were randomized and 104 patients completed the study protocol (G1: n = 34; G2: n = 35; G3: n = 35). Post-treatment assessment showed statistically significant improvements in maximum strength in G2, increased endurance in G1 and G2, and increment of muscle power in all three groups (P < 0.05). However, there were no significant differences in the mean changes of maximum strength, endurance, and muscle power between groups after treatment (P > 0.05). G1 and G2 achieved a higher number of fully continent patients than G3 (P < 0.05). At the end of treatment, 59% of patients in G1, 54% in G2, and 26% in G3 were continent (no pads/day). Improvements in PFMS parameters were distinct among active treatment groups versus controls, but did not predict recovery of urinary continence at final assessment. The Pilates method promoted similar outcomes in the proportion of fully continent patients when compared to conventional PFMT 4 months after RP. © 2017 Wiley Periodicals, Inc.

Does mode of follow-up influence contraceptive use after medical abortion in a low-resource setting? Secondary outcome analysis of a non-inferiority randomized controlled trial.

PubMed

Paul, Mandira; Iyengar, Sharad D; Essén, Birgitta; Gemzell-Danielsson, Kristina; Iyengar, Kirti; Bring, Johan; Klingberg-Allvin, Marie

2016-10-17

Post-abortion contraceptive use in India is low and the use of modern methods of contraception is rare, especially in rural areas. This study primarily compares contraceptive use among women whose abortion outcome was assessed in-clinic with women who assessed their abortion outcome at home, in a low-resource, primary health care setting. Moreover, it investigates how background characteristics and abortion service provision influences contraceptive use post-abortion. A randomized controlled, non-inferiority, trial (RCT) compared clinic follow-up with home-assessment of abortion outcome at 2 weeks post-abortion. Additionally, contraceptive-use at 3 months post-abortion was investigated through a cross-sectional follow-up interview with a largely urban sub-sample of women from the RCT. Women seeking abortion with a gestational age of up to 9 weeks and who agreed to a 2-week follow-up were included (n = 731). Women with known contraindications to medical abortions, Hb < 85 mg/l and aged below 18 were excluded. Data were collected between April 2013 and August 2014 in six primary health-care clinics in Rajasthan. A computerised random number generator created the randomisation sequence (1:1) in blocks of six. Contraceptive use was measured at 2 weeks among women successfully followed-up (n = 623) and 3 months in the sub-set of women who were included if they were recruited at one of the urban study sites, owned a phone and agreed to a 3-month follow-up (n = 114). There were no differences between contraceptive use and continuation between study groups at 3 months (76 % clinic follow-up, 77 % home-assessment), however women in the clinic follow-up group were most likely to adopt a contraceptive method at 2 weeks (62 ± 12 %), while women in the home-assessment group were most likely to adopt a method after next menstruation (60 ± 13 %). Fifty-two per cent of women who initiated a method at 2 weeks chose the 3-month injection or the copper intrauterine device. Only 4 % of women preferred sterilization. Caste, educational attainment, or type of residence did not influence contraceptive use. Simplified follow-up after early medical abortion will not change women's opportunities to access contraception in a low-resource setting, if contraceptive services are provided as intra-abortion services as early as on day one. Women's postabortion contraceptive use at 3 months is unlikely to be affected by mode of followup after medical abortion, also in a low-resource setting. Clinical guidelines need to encourage intra-abortion contraception, offering the full spectrum of evidence-based methods, especially long-acting reversible methods. Clinicaltrials.gov NCT01827995.

Two-year follow-up of an adolescent behavioral weight control intervention.

PubMed

Lloyd-Richardson, Elizabeth E; Jelalian, Elissa; Sato, Amy F; Hart, Chantelle N; Mehlenbeck, Robyn; Wing, Rena R

2012-08-01

This study examined the 24-month outcomes of a randomized controlled trial of a group-based behavioral weight control (BWC) program combined with either activity-based peer intervention or aerobic exercise. At baseline, 118 obese adolescents (68% female; BMI = 31.41 ± 3.33) ages 13 to 16 years (mean = 14.33; SD = 1.02) were randomized to receive 1 of 2 weight loss interventions. Both interventions received the same 16-week group-based cognitive-behavioral treatment, combined with either aerobic exercise or peer-based adventure therapy. Eighty-nine adolescents (75% of original sample) completed the 24-month follow-up. Anthropometric and psychosocial measures were obtained at baseline, at the end of the 16-week intervention, and at 12 and 24 months following randomization. An intent-to-treat mixed factor analysis of variance indicated a significant effect for time on both percent over 50th percentile BMI for age and gender and standardized BMI score, with no differences by intervention group. Post hoc comparisons showed a significant decrease in percent overweight at 4 months (end of treatment), which was maintained at both 12- and 24-month follow-up visits. Significant improvements on several dimensions of self-concept were noted, with significant effects on physical appearance self-concept that were maintained through 24 months. Both BWC conditions were effective at maintaining reductions in adolescent obesity and improvements in physical appearance self-concept through 24-month follow-up. This study is one of the first to document long-term outcomes of BWC intervention among adolescents.

Long-term titrated IOP control with one, two, or three trabecular micro-bypass stents in open-angle glaucoma subjects on topical hypotensive medication: 42-month outcomes

PubMed Central

Erb, Carl; Carceller Guillamet, Amadeu; Fea, Antonio M; Voskanyan, Lilit; Giamporcaro, Jane Ellen; Hornbeak, Dana M

2018-01-01

Purpose Evaluate long-term outcomes after one, two, or three trabecular micro-bypass stents implanted in a standalone procedure in eyes with open-angle glaucoma taking ocular hypotensive medication. Patients and methods Prospective randomized ongoing study of 119 subjects (109 with 42-month follow-up) with open-angle glaucoma, preoperative intraocular pressure (IOP) 18–30 mmHg on one to three glaucoma medications, and unmedicated (post-washout) IOP 22–38 mmHg. Subjects were randomized to receive one (n=38), two (n=41), or three (n=40) iStent trabecular micro-bypass stents in a standalone procedure. Postoperatively, IOP was measured with medication and annually following washout. Data included IOP, medications, gonioscopy, pachymetry, visual field, visual acuity, adverse events, and slit-lamp and fundus examinations. Results Preoperative mean medicated IOP was 19.8±1.3 mmHg on 1.71 medications in one-stent eyes, 20.1±1.6 mmHg on 1.76 medications in two-stent eyes, and 20.4±1.8 mmHg on 1.53 medications in three-stent eyes. Post-washout IOP prior to stent implantation was 25.0±1.2, 25.0±1.7, and 25.1±1.9 mmHg in the three groups, respectively. Postoperatively, Month 42 medicated IOP was 15.0±2.8, 15.7±1.0 and 14.8±1.3 mmHg in the three groups, and post-washout IOP (Months 36–37) was 17.4±0.9, 15.8±1.1 and 14.2±1.5 mmHg, respectively. IOP reduction ≥20% without medication was achieved in 89%, 90%, and 92% of one-, two-, and three-stent eyes, respectively, at Month 12; and in 61%, 91%, and 91% of eyes, respectively, at Month 42. The need for additional medication remained consistent at Months 12 and 42 in multi-stent eyes (four two-stent eyes and three three-stent eyes at both time points), whereas it increased in single-stent eyes (four eyes at Month 12 versus 18 eyes at Month 42). Safety parameters were favorable in all groups. Conclusion The standalone implantation of either single or multiple iStent® device(s) produced safe, clinically meaningful IOP and medication reductions through 42 months postoperatively, with incrementally greater and more sustained reductions in multi-stent eyes. PMID:29440867

Predictors of physical activity at 12 month follow-up after a supervised exercise intervention in postmenopausal women.

PubMed

Aparicio-Ting, Fabiola E; Farris, Megan; Courneya, Kerry S; Schiller, Ashley; Friedenreich, Christine M

2015-05-05

Few studies have examined recreational physical activity (RPA) after participating in a structured exercise intervention. More specifically, little is known about the long-term effects of exercise interventions in post-menopausal women. This study had two objectives: 1) To compare RPA in postmenopausal women in the exercise group and the control group 12 months after the end of the Alberta Physical Activity and Breast Cancer Prevention (ALPHA) Trial; and 2) To apply the Theory of Planned Behaviour (TPB) to identify predictors of RPA 12 months post-intervention among women in the exercise group. Self-reported RPA 12-months post-intervention from a validated questionnaire was used to estimate RPA levels for control group (118/160, 74% response) and exercise group participants (126/160, 79% response). Bivariate analysis was used to compare RPA between exercise and control group participants and to identify TPB variables for multivariate analysis. Logistic regression was applied to TPB data collected from self- administered questionnaires at end of trial by exercise group participants (126/160, 79% response) to identify predictors of long-term RPA. At 12 months post-intervention, 62% of women in the exercise group were active compared to 58% of controls (p = 0.52). Of the TPB constructs examined, self-efficacy (OR =2.98 (1.08-8.20)) and behavioural beliefs (OR = 1.46 (1.03-2.06)) were identified as predictors of RPA for exercise group participants. Levels of RPA in the exercise and control groups were comparable 12 months post intervention, indicating that participation in the ALPHA trial was associated with increased physical activity in previously inactive women, regardless of randomization into either the exercise group or in the control group. Exercise interventions that promote self-efficacy and positive behavioural beliefs have the potential to have long-term impacts on physical activity behaviour, although further research is needed to examine additional psychological, social and environmental predictors of long-term RPA in post-menopausal women. ClinicalTrials.gov NCT00522262.

A Randomized Controlled Trial of Personalized Text Message Reminders to Promote Medication Adherence Among HIV-Positive Adolescents and Young Adults.

PubMed

Garofalo, Robert; Kuhns, Lisa M; Hotton, Anna; Johnson, Amy; Muldoon, Abigail; Rice, Dion

2016-05-01

HIV-positive adolescents and young adults often experience suboptimal medication adherence, yet few interventions to improve adherence in this group have shown evidence of efficacy. We conducted a randomized trial of a two-way, personalized daily text messaging intervention to improve adherence to antiretroviral therapy (ART) among N = 105 poorly adherent HIV-positive adolescents and young adults, ages 16-29. Adherence to ART was assessed via self-reported visual analogue scale (VAS; 0-100 %) at 3 and 6-months for mean adherence level and proportion ≥90 % adherent. The average effect estimate over the 6-month intervention period was significant for ≥90 % adherence (OR = 2.12, 95 % CI 1.01-4.45, p < .05) and maintained at 12-months (6 months post-intervention). Satisfaction scores for the intervention were very high. These results suggest both feasibility and initial efficacy of this approach. Given study limitations, additional testing of this intervention as part of a larger clinical trial with objective and/or clinical outcome measures of adherence is warranted.

Does extended proactive telephone support increase smoking cessation among low-income women using nicotine patches?

PubMed

Solomon, Laura J; Marcy, Theodore W; Howe, Kathleen D; Skelly, Joan M; Reinier, Kyndaron; Flynn, Brian S

2005-03-01

It is unclear whether proactive telephone support enhances smoking cessation beyond the provision of nicotine replacement therapy alone. We randomly assigned 330 low-income women smokers to receive either free nicotine patches (control condition) or free nicotine patches with up to 16 weeks of proactive telephone support (experimental condition). All participants were assessed by telephone at baseline and at 2 weeks, 3 months, and 6 months post-baseline to determine smoking status. Results revealed a significant effect for the telephone support at 3 months, with 43% of experimental versus 26% of control condition women reporting 30-day point prevalent abstinence (P = 0.002). The difference was no longer significant at 6 months. A metaanalysis conducted with five randomized studies revealed a slight but non-significant long-term benefit of proactive telephone support when added to the provision of free nicotine patches for smoking cessation. This is the second study to demonstrate a short-term effect for proactive telephone support added to free nicotine replacement therapy; however, neither the current study, nor the metaanalysis including the four other published trials, confirmed a longer-term benefit.

A pilot study examining functional brain activity 6 months after memory retraining in MS: the MEMREHAB trial.

PubMed

Dobryakova, Ekaterina; Wylie, Glenn R; DeLuca, John; Chiaravalloti, Nancy D

2014-09-01

Cognitive impairment in individuals with multiple sclerosis (MS) is now well recognized. One of the most common cognitive deficits is found in memory functioning, largely due to impaired acquisition. We examined functional brain activity 6 months after memory retraining in individuals with MS. The current report presents long term follow-up results from a randomized clinical trial on a memory rehabilitation protocol known as the modified Story Memory Technique. Behavioral memory performance and brain activity of all participants were evaluated at baseline, immediately after treatment, and 6 months after treatment. Results revealed that previously observed increases in patterns of cerebral activation during learning immediately after memory training were maintained 6 months post training.

Comparison of Insecticide-Treated Nets and Indoor Residual Spraying to Control the Vector of Visceral Leishmaniasis in Mymensingh District, Bangladesh

PubMed Central

Chowdhury, Rajib; Dotson, Ellen; Blackstock, Anna J.; McClintock, Shannon; Maheswary, Narayan P.; Faria, Shyla; Islam, Saiful; Akter, Tangin; Kroeger, Axel; Akhter, Shireen; Bern, Caryn

2011-01-01

Integrated vector management is a pillar of the South Asian visceral leishmaniasis (VL) elimination program, but the best approach remains a matter of debate. Sand fly seasonality was determined in 40 houses sampled monthly. The impact of interventions on Phlebotomus argentipes density was tested from 2006–2007 in a cluster-randomized trial with four arms: indoor residual spraying (IRS), insecticide-treated nets (ITNs), environmental management (EVM), and no intervention. Phlebotomus argentipes density peaked in March with the highest proportion of gravid females in May. The EVM (mud plastering of wall and floor cracks) showed no impact. The IRS and ITNs were associated with a 70–80% decrease in male and female P. argentipes density up to 5 months post intervention. Vector density rebounded by 11 months post-IRS, whereas ITN-treated households continued to show significantly lower density compared with households without intervention. Our data suggest that both IRS and ITNs may help to improve VL control in Bangladesh. PMID:21540372

Developing an intervention to overcome procrastination.

PubMed

Otermin-Cristeta, Solange; Hautzinger, Martin

2018-01-01

The main goal of this study was the development of a reliable intervention to overcome general procrastination orientated to college students, designed to be used in practical clinical work. The workshops involved six meetings based on behavioral and cognitive techniques, paradox intervention, and psychoeducation. 175 students participated voluntarily. Their procrastination levels were measured in a pretest, post-test, and a 3-month follow-up. After the first interview, the participants were randomly divided into three groups (Intervention A, Intervention B, and a control group with no intervention). There was a significant improvement after the intervention. After 3 months, the average score was still significantly lower than in the pretest, whereas the score of the control group remained unchanged. The participants in Workshop A scored significantly lower in the post-test than the ones in Workshop B. After 3 months, the participants in Workshop B scored significantly lower in the follow up. So both interventions resulted to be effective in reducing procrastination sustainably.

Preventing patient-to-worker violence in hospitals: outcome of a randomized controlled intervention

PubMed Central

Arnetz, Judith E.; Hamblin, Lydia; Russell, Jim; Upfal, Mark J.; Luborsky, Mark; Janisse, James; Essenmacher, Lynnette

2016-01-01

Objective To evaluate the effects of a randomized controlled intervention on the incidence of patient-to-worker (Type II) violence and related injury in hospitals. Methods Forty-one units across 7 hospitals were randomized into intervention (n=21) and control (n=20) groups. Intervention units received unit-level violence data to facilitate development of an action plan for violence prevention; no data were presented to control units. Main outcomes were rates of violent events and injuries across study groups over time. Results Six months post-intervention, incident rate ratios of violent events were significantly lower on intervention units compared to controls (IRR 0.48, 95% CI 0.29-0.80). At 24 months, the risk for violence-related injury was lower on intervention units, compared to controls (IRR 0.37, 95% CI 0.17-0.83). Conclusion This data-driven, worksite-based intervention was effective in decreasing risks of patient-to-worker violence and related injury. PMID:28045793

A randomized-control trial for the teachers' diploma programme on psychosocial care, support and protection in Zambian government primary schools.

PubMed

Kaljee, Linda; Zhang, Liying; Langhaug, Lisa; Munjile, Kelvin; Tembo, Stephen; Menon, Anitha; Stanton, Bonita; Li, Xiaoming; Malungo, Jacob

2017-04-01

Orphaned and vulnerable children (OVC) experience poverty, stigma, and abuse resulting in poor physical, emotional, and psychological outcomes. The Teachers' Diploma Programme on Psychosocial Care, Support, and Protection is a child-centered 15-month long-distance learning program focused on providing teachers with the knowledge and skills to enhance their school environments, foster psychosocial support, and facilitate school-community relationships. A randomized controlled trial was implemented in 2013-2014. Both teachers (n=325) and students (n=1378) were assessed at baseline and 15-months post-intervention from randomly assigned primary schools in Lusaka and Eastern Provinces, Zambia. Multilevel linear mixed models (MLM) indicate positive significant changes for intervention teachers on outcomes related to self-care, teaching resources, safety, social support, and gender equity. Positive outcomes for intervention students related to future orientation, respect, support, safety, sexual abuse, and bullying. Outcomes support the hypothesis that teachers and students benefit from a program designed to enhance teachers' psychosocial skills and knowledge.

Incorporating tailored interactive patient solutions using interactive voice response technology to improve statin adherence: results of a randomized clinical trial in a managed care setting.

PubMed

Stacy, Jane N; Schwartz, Steven M; Ershoff, Daniel; Shreve, Marilyn Standifer

2009-10-01

The current study presents the impact of a behavior change program to increase statin adherence using interactive voice response (IVR) technology. Subjects were affiliated with a large health benefit company, were prescribed a statin (index) and had no lipid-lowering pharmacy claims in the previous 6 months, and were continuously enrolled in the plan for 12 months prior and 6 months post index statin. Potential subjects (1219) were contacted by the IVR system; 497 gave informed consent. Subjects were asked to respond to 15 questions from the IVR that were guided by several behavior change theories. At the conclusion of the questions, subjects were randomly assigned to either a control group (n = 244), who received generic feedback at the conclusion of the call and were then mailed a generic cholesterol guide, or an experimental group (n = 253), who received tailored feedback based on their cholesterol-related knowledge, attitudes, beliefs, and perceived barriers to medication adherence, and were mailed a tailored guide that reinforced similar themes. Subjects in the experimental group had the opportunity to participate in 2 additional tailored IVR support calls. The primary dependent variable was 6-month point prevalence, defined as claims evidence of a statin on days 121-180 post index statin. Subjects in the experimental group had a significantly higher 6-month point prevalence than the controls (70.4% vs. 60.7%, P < 0.05). Results of this study suggest that a behavioral support program using IVR technology can be a cost-effective modality to address the important public health problem of patient nonadherence with statin medication.

Automatic remote monitoring utilizing daily transmissions: transmission reliability and implantable cardioverter defibrillator battery longevity in the TRUST trial.

PubMed

Varma, Niraj; Love, Charles J; Schweikert, Robert; Moll, Philip; Michalski, Justin; Epstein, Andrew E

2018-04-01

Benefits of automatic remote home monitoring (HM) among implantable cardioverter defibrillator (ICD) patients may require high transmission frequency. However, transmission reliability and effects on battery longevity remain uncertain. We hypothesized that HM would have high transmission success permitting punctual guideline based follow-up, and improve battery longevity. This was tested in the prospective randomized TRUST trial. Implantable cardioverter defibrillator patients were randomized post-implant 2:1 to HM (n = 908) (transmit daily) or to Conventional in-person monitoring [conventional management (CM), n = 431 (HM disabled)]. In both groups, five evaluations were scheduled every 3 months for 15 months. Home Monitoring technology performance was assessed by transmissions received vs. total possible, and number of scheduled HM checks failing because of missed transmissions. Battery longevity was compared in HM vs. CM at 15 months, and again in HM 3 years post-implant using continuously transmitted data. Transmission success per patient was 91% (median follow-up of 434 days). Overall, daily HM transmissions were received in 315 795 of a potential 363 450 days (87%). Only 55/3759 (1.46%) of unsuccessful scheduled evaluations in HM were attributed to transmission loss. Shock frequency and pacing percentage were similar in HM vs. CM. Fifteen month battery longevity was 12% greater in HM (93.2 ± 8.8% vs. 83.5 ± 6.0% CM, P < 0.001). In extended follow-up of HM patients, estimated battery longevity was 50.9 ± 9.1% (median 52%) at 36 months. Automatic remote HM demonstrated robust transmission reliability. Daily transmission load may be sustained without reducing battery longevity. Home Monitoring conserves battery longevity and tracks long term device performance. ClinicalTrials.gov; NCT00336284.

Combined cognitive-strategy and task-specific training improves transfer to untrained activities in sub-acute stroke: An exploratory randomized controlled trial

PubMed Central

McEwen, Sara; Polatajko, Helene; Baum, Carolyn; Rios, Jorge; Cirone, Dianne; Doherty, Meghan; Wolf, Timothy

2014-01-01

Purpose The purpose of this study was to estimate the effect of the Cognitive Orientation to daily Occupational Performance (CO-OP) approach compared to usual outpatient rehabilitation on activity and participation in people less than 3 months post stroke. Methods An exploratory, single blind, randomized controlled trial with a usual care control arm was conducted. Participants referred to 2 stroke rehabilitation outpatient programs were randomized to receive either Usual Care or CO-OP. The primary outcome was actual performance of trained and untrained self-selected activities, measured using the Performance Quality Rating Scale (PQRS). Additional outcomes included the Canadian Occupational Performance Measure (COPM), the Stroke Impact Scale Participation Domain, the Community Participation Index, and the Self Efficacy Gauge. Results Thirty-five (35) eligible participants were randomized; 26 completed the intervention. Post-intervention, PQRS change scores demonstrated CO-OP had a medium effect over Usual Care on trained self-selected activities (d=0.5) and a large effect on untrained (d=1.2). At a 3 month follow-up, PQRS change scores indicated a large effect of CO-OP on both trained (d=1.6) and untrained activities (d=1.1). CO-OP had a small effect on COPM and a medium effect on the Community Participation Index perceived control and the Self-Efficacy Gauge. Conclusion CO-OP was associated with a large treatment effect on follow up performances of self-selected activities, and demonstrated transfer to untrained activities. A larger trial is warranted. PMID:25416738

A phase II randomized trial of Observation versus stereotactic ablative RadiatIon for OLigometastatic prostate CancEr (ORIOLE).

PubMed

Radwan, Noura; Phillips, Ryan; Ross, Ashley; Rowe, Steven P; Gorin, Michael A; Antonarakis, Emmanuel S; Deville, Curtiland; Greco, Stephen; Denmeade, Samuel; Paller, Channing; Song, Daniel Y; Diehn, Maximilian; Wang, Hao; Carducci, Michael; Pienta, Kenneth J; Pomper, Martin G; DeWeese, Theodore L; Dicker, Adam; Eisenberger, Mario; Tran, Phuoc T

2017-06-29

We describe a randomized, non-blinded Phase II interventional study to assess the safety and efficacy of stereotactic ablative radiotherapy (SABR) for hormone-sensitive oligometastatic prostate adenocarcinoma, and to describe the biology of the oligometastatic state using immunologic, cellular, molecular, and functional imaging correlates. 54 men with oligometastatic prostate adenocarcinoma will be accrued. The primary clinical endpoint will be progression at 6 months from randomization with the hypothesis that SABR to all metastases will forestall progression by disrupting the metastatic process. Secondary clinical endpoints will include local control at 6 months post-SABR, toxicity and quality of life, and androgen deprivation therapy (ADT)-free survival (ADT-FS). Further fundamental analysis of the oligometastatic state with be achieved through correlation with investigational 18 F-DCFPyL PET/CT imaging and measurement of circulating tumor cells, circulating tumor DNA, and circulating T-cell receptor repertoires, facilitating an unprecedented opportunity to characterize, in isolation, the effects of SABR on the dynamics of and immunologic response to oligometastatic disease. Patients will be randomized 2:1 to SABR or observation with minimization to balance assignment by primary intervention, prior hormonal therapy, and PSA doubling time. Progression after 6 months will be compared using Fisher's exact test. Hazard ratios and Kaplan-Meier estimates of progression free survival (PFS), ADT free survival (ADT-FS), time to locoregional progression (TTLP) and time to distant progression (TTDP) will be calculated based on an intention-to-treat. Local control will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Withdrawal from the study prior to 6 months will be counted as progression. Adverse events will be summarized by type and grade. Quality of life pre- and post- SABR will be measured by Brief Pain Inventory. The ORIOLE trial is the first randomized, non-blinded Phase II interventional study in the North America evaluating the safety and efficacy of SABR in oligometastatic hormone-sensitive prostate cancer. Leading-edge laboratory and imaging correlates will provide unique insight into the effects of SABR on the oligometastatic state. ClinicalTrials.gov Identifier: NCT02680587. URL of Registry: https://clinicaltrials.gov/show/NCT02680587 Date of Registration: 02/08/2016. Date of First Participant Enrollment: 05/23/2016.

Remission and recovery associated with lurasidone in the treatment of major depressive disorder with subthreshold hypomanic symptoms (mixed features): post-hoc analysis of a randomized, placebo-controlled study with longer-term extension.

PubMed

Goldberg, Joseph F; Ng-Mak, Daisy; Siu, Cynthia; Chuang, Chien-Chia; Rajagopalan, Krithika; Loebel, Antony

2017-04-01

This post-hoc analysis assessed rates of symptomatic and functional remission, as well as recovery (combination of symptomatic and functional remission), in patients treated with lurasidone for major depressive disorder (MDD) associated with subthreshold hypomanic symptoms (mixed features). Patients with MDD plus two or three manic symptoms (defined as per the DSM-5 mixed-features specifier) were randomly assigned to flexible-dose lurasidone 20-60 mg/day (n=109) or placebo (n=100) for 6 weeks, followed by a 3-month open-label, flexible-dose extension study for U.S. sites only (n=48). Cross-sectional recovery was defined as the presence of both symptomatic remission (Montgomery-Åsberg Depression Rating Scale score ≤ 12) and functional remission (all Sheehan Disability Scale [SDS] domain scores ≤3) at week 6, and at both months 1 and 3 of the extension study ("sustained recovery"). A significantly higher proportion of lurasidone-treated patients (31.3%) achieved recovery (assessed cross-sectionally) compared to placebo (12.2%, p=0.002) at week 6. The number of manic symptoms at baseline moderated the effect size for attaining cross-sectional recovery for lurasidone treatment (vs. placebo) (p=0.028). Sustained recovery rates were higher in patients initially treated with lurasidone (20.8%) versus placebo (12.5%). In this post-hoc analysis of a placebo-controlled study with open-label extension that involved patients with MDD and mixed features, lurasidone was found to significantly improve the rate of recovery at 6 weeks (vs. placebo) that was sustained at month 3 of the extension study. The presence of two (as opposed to three) manic symptoms moderated recovery at the acute study endpoint.

Efficacy and retention of Basic Life Support education including Automated External Defibrillator usage during a physical education period.

PubMed

Watanabe, Kae; Lopez-Colon, Dalia; Shuster, Jonathan J; Philip, Joseph

2017-03-01

The American Heart Association (AHA) advocates for CPR education as a requirement of secondary school curriculum. Unfortunately, many states have not adopted CPR education. Our aim was to investigate a low-cost, time effective method to educate students on Basic Life Support (BLS), including reeducation. This is a prospective, randomized study. Retention was assessed at 4 months post-initial education. Education was performed by AHA-certified providers during a 45-minute physical education class in a middle school in Florida. This age provides opportunities for reinforcement through high school, with ability for efficient learning. The study included 41 Eighth grade students. Students were randomized into two groups; one group received repeat education 2 months after the first education, the second group did not. All students received BLS education limited to chest compressions and usage of an Automated External Defibrillator. Students had skills and knowledge tests administered pre- and post-education after initial education, and repeated 2 and 4 months later to assess retention. There was a significant increase in CPR skills and knowledge when comparing pre- and post-education results for all time-points ( p  < 0.001). When assessing reeducation, a significant improvement was noted in total knowledge scores but not during the actual steps of CPR. Our study indicates significant increase in CPR knowledge and skills following a one-time 45-minute session. Reeducation may be useful, but the interval needs further investigation. If schools across the United States invested one 45-60-minute period every school year, this would ensure widespread CPR knowledge with minimal cost and loss of school time.

A Randomized Clinical Trial Examining the Effect of Video-Based Prevention of Alcohol and Marijuana Use Among Recent Sexual Assault Victims.

PubMed

Walsh, Kate; Gilmore, Amanda K; Frazier, Patricia; Ledray, Linda; Acierno, Ron; Ruggiero, Kenneth J; Kilpatrick, Dean G; Resnick, Heidi S

2017-12-01

This study examined whether a brief video intervention (Prevention of Post-Rape Stress [PPRS]) delivered in the emergency department to recent sexual assault (SA) victims reduced alcohol and marijuana use at 3 points over the course of a 6-month follow-up compared to treatment as usual (TAU) and an active control condition (Pleasant Imagery and Relaxation Instruction [PIRI]). Prior assault history, minority status, and pre-SA substance use also were examined as moderators of intervention efficacy. Women aged 15 and older (N = 154) who participated in a post-SA medical forensic examination were randomly assigned to watch the PPRS video (n = 54) or the PIRI video (n = 48) or receive TAU (n = 52) and completed at least 1 follow-up assessment targeted at 1.5 (T1), 3 (T2), or 6 (T3) months following the examination. Regression analyses revealed that, relative to TAU, PPRS was associated with less frequent alcohol use at 6 months post-SA among women reporting pre-SA binge drinking and minority women. Relative to TAU, PPRS also was associated with fewer days of marijuana use at T1 among those who did not report pre-SA marijuana use and prior SA. Findings for pre-SA marijuana use were maintained at T3; however, findings for prior SA shifted such that PPRS was associated with fewer days of marijuana use at T3 for women with a prior SA. PPRS may be effective at reducing substance use for some recent SA victims, including those with a prior SA history, a prior substance use history, and minority women. Copyright © 2017 by the Research Society on Alcoholism.

Train the trainer? A randomized controlled trial of a multi-tiered oral health education programme in community-based residential services for adults with intellectual disability.

PubMed

Mac Giolla Phadraig, Caoimhin; Guerin, Suzanne; Nunn, June

2013-04-01

To assess the impact of a multi-tiered oral health education programme on care staff caring for people with intellectual disability (ID). Postal questionnaires were sent to all care staff of a community-based residential care service for adults, randomly assigned to control and intervention groups. A specifically developed training programme was delivered to residential staff nominees, who then trained all staff within the intervention group. The control group received no training. Post-test questionnaires were sent to both groups. Paired-samples t-test was used to compare oral health-related knowledge (K) and behaviour, attitude and self-efficacy (BAS) scores. Of the initial 219 respondents, 154 (response rate between 40% and 35.8%, with attrition rate of 29.7% from baseline to repeat) returned completed questionnaires at post-test (M=8.5 months, range=6.5-11 months). Control and intervention groups were comparable for general training, employment and demographic variables. In the intervention group, mean Knowledge Index score rose from K=7.2 to K=7.9 (P<0.001) and mean BAS scale score rose from BAS=4.7 to BAS=5.4 (P<0.001). There was no statistically significant increase in mean scores from test (K=7.0, BAS=4.7) to post-test (K=7.2, BAS=4.9) for the control group. Mean scores regarding knowledge, attitude, self-efficacy and reported behaviour increased significantly at 8.5 months in staff where training was provided. The results indicate that a multi-tiered training programme improved knowledge, attitude, self-efficacy and reported behaviour amongst staff caring for people with ID. © 2012 John Wiley & Sons A/S.

Changes of attachment characteristics during psychotherapy of patients with social anxiety disorder: Results from the SOPHO-Net trial

PubMed Central

Strauß, Bernhard; Altmann, Uwe; Manes, Susanne; Tholl, Anne; Koranyi, Susan; Nolte, Tobias; Beutel, Manfred E.; Wiltink, Jörg; Herpertz, Stephan; Hiller, Wolfgang; Hoyer, Jürgen; Joraschky, Peter; Nolting, Björn; Ritter, Viktoria; Stangier, Ulrich; Willutzki, Ulrike; Salzer, Simone; Leibing, Eric; Leichsenring, Falk; Kirchmann, Helmut

2018-01-01

Objectives Within a randomized controlled trial contrasting the outcome of manualized cognitive-behavioral (CBT) and short term psychodynamic therapy (PDT) compared to a waiting list condition (the SOPHO-Net trial), we set out to test whether self-reported attachment characteristics change during the treatments and if these changes differ between treatments. Research design and methods 495 patients from the SOPHO-Net trial (54.5% female, mean age 35.2 years) who were randomized to either CBT, PDT or waiting list (WL) completed the partner-related revised Experiences in Close Relationships Questionnaire (ECR-R) before and after treatment and at 6 and 12 months follow-up. The Liebowitz Social Anxiety Scale (LSAS) was administered at pre-treatment, post-treatment, and at 6-month and 1-year follow-up. ECR-R scores were first compared to a representative healthy sample (n = 2508) in order to demonstrate that the clinical sample differed significantly from the non-clinical sample with respect to attachment anxiety and avoidance. Results LSAS scores correlated significantly with both ECR-R subscales. Post-therapy, patients treated with CBT revealed significant changes in attachment anxiety and avoidance whereas patients treated with PDT showed no significant changes. Changes between post-treatment and the two follow-ups were significant in both conditions, with minimal (insignificant) differences between treatments at the 12- month follow-up. Conclusions The current study supports recent reviews of mostly naturalistic studies indicating changes in attachment as a result of psychotherapy. Although there were differences between conditions at the end of treatment, these largely disappeared during the follow-up period which is line with the other results of the SOPHO-NET trial. Trial registration Controlled-trials.com ISRCTN53517394 PMID:29518077

Outcomes of three universal eating disorder risk reduction programs by participants with higher and lower baseline shape and weight concern.

PubMed

Wilksch, Simon M; Paxton, Susan J; Byrne, Susan M; Austin, S Bryn; O'Shea, Anne; Wade, Tracey D

2017-01-01

To investigate if baseline shape and weight concern (SWC) moderated outcomes in Prevention Across the Spectrum, a randomized-controlled trial (RCT) of 3 school-based programs aimed at reducing eating disorder and obesity risk factors. N = 1,316 Grade 7 and 8 girls and boys (M age = 13.21 years) across three Australian states were randomly allocated to: Media Smart; Life Smart; Helping, Encouraging, Listening and Protecting Peers Initiative (HELPP) or control (usual school class). Moderation was explored by testing interaction effects for group (Media Smart; Life Smart; HELPP; Control) × moderator (SWC: higher-SWC; lower-SWC) × time (post-program; 6-month follow-up; 12-month follow-up), with baseline risk factor scores entered as covariates. Moderation effects were found for shape concern, weight concern, eating concern, regular eating (i.e., meal skipping), physical activity, body dissatisfaction, dieting, and perfectionism. Post-hoc testing found eating concern at post-program was the only variable where higher-SWC Media Smart participants experienced a reduction in risk relative to controls. Both higher-SWC Life Smart and HELPP participants reported an increase in eating concern relative to controls and both groups were skipping more meals than controls at 12-month follow-up. Amongst lower-SWC participants, Media Smart was the only group to experience a benefit relative to controls (physical activity). This study highlights the need for moderator analyses to become more routinely conducted in universal trials, to ensure that participants across baseline risk levels are benefiting and not harmed from program participation. © 2016 Wiley Periodicals, Inc. (Int J Eat Disord 2017; 50:66-75). © 2016 Wiley Periodicals, Inc.

Sustained Uptake of a Hospital-Based Handwashing with Soap and Water Treatment Intervention (Cholera-Hospital-Based Intervention for 7 Days [CHoBI7]): A Randomized Controlled Trial

PubMed Central

George, Christine Marie; Jung, Danielle S.; Saif-Ur-Rahman, K. M.; Monira, Shirajum; Sack, David A.; Rashid, Mahamud-ur; Mahmud, Md. Toslim; Mustafiz, Munshi; Rahman, Zillur; Bhuyian, Sazzadul Islam; Winch, Peter J.; Leontsini, Elli; Perin, Jamie; Begum, Farzana; Zohura, Fatema; Biswas, Shwapon; Parvin, Tahmina; Bradley Sack, R.; Alam, Munirul

2016-01-01

Diarrhea is the second leading cause of death in children under 5 years of age globally. The time patients and caregivers spend at a health facility for severe diarrhea presents the opportunity to deliver water, sanitation, and hygiene (WASH) interventions. We recently developed Cholera-Hospital-Based Intervention for 7 days (CHoBI7), a 1-week hospital-based handwashing with soap and water treatment intervention, for household members of cholera patients. To investigate if this intervention could lead to sustained WASH practices, we conducted a follow-up evaluation of 196 intervention household members and 205 control household members enrolled in a randomized controlled trial of the CHoBI7 intervention 6 to 12 months post-intervention. Compared with the control arm, the intervention arm had four times higher odds of household members' handwashing with soap at a key time during 5-hour structured observation (odds ratio [OR]: 4.71, 95% confidence interval [CI]: 2.61, 8.49) (18% versus 50%) and a 41% reduction in households in the World Health Organization very high-risk category for stored drinking water (OR: 0.38, 95% CI: 0.15, 0.96) (58% versus 34%) 6 to 12 months post-intervention. Furthemore, 71% of observed handwashing with soap events in the intervention arm involved the preparation and use of soapy water, which was promoted during the intervention, compared to 9% of control households. These findings demonstrate that the hospital-based CHoBI7 intervention can lead to significant increases in handwashing with soap practices and improved stored drinking water quality 6 to 12 months post-intervention. PMID:26728766

Efficacy, safety and immunogenicity of a human rotavirus vaccine (RIX4414) in Hong Kong children up to three years of age: a randomized, controlled trial.

PubMed

Lau, Yu-Lung; Nelson, E Anthony S; Poon, Kin-Hung; Chan, Paul K S; Chiu, Susan; Sung, Rita; Leung, Chi Wai; Ng, Daniel; Ma, Yee Man; Chan, Desmond; Lee, Tsz Leung; Tang, Joyce; Kwan, Yat Wah; Ip, Patricia; Ho, Marco; Fung, Lai-Wah Eva; Tang, Haiwen; Suryakiran, P V; Han, Htay Htay; Bock, Hans

2013-04-26

A phase III, double-blind, randomized, controlled trial was conducted in Hong Kong to evaluate the efficacy, safety and immunogenicity of a human rotavirus vaccine, RIX4414 (Rotarix) against severe rotavirus gastroenteritis in children up to three years of age. Healthy infants aged 6-12 weeks were enrolled between 08-December-2003 and 31-August-2005 and received two oral doses of either RIX4414 vaccine (N=1513) or placebo (N=1512) given 2 months apart. Vaccine efficacy was assessed from two weeks post-Dose 2 until the children were two and three years of age. Anti-rotavirus IgA seroconversion rate was calculated pre-vaccination and 1-2 months post-Dose 2 using ELISA (cut-off=20 U/mL) for 100 infants. Safety was assessed until the children were two years of age; serious adverse events (SAEs) were recorded throughout the study period. In children aged two and three years of life, vaccine efficacy against severe rotavirus gastroenteritis was 95.6% (95% CI: 73.1%-99.9%) and 96.1% (95% CI: 76.5%-99.9%), respectively. The seroconversion rate 1-2 months after the second dose of RIX4414 was 97.5% (95% CI: 86.8%-99.9%). At least one SAE was recorded in 439 and 477 infants who were administered RIX4414 and placebo, respectively (p-value=0.130). Six intussusception cases were reported (RIX4414=4; placebo=2) and none was assessed to be vaccine-related. RIX4414 was efficacious, immunogenic and safe in the prevention of rotavirus gastroenteritis for at least two years post-vaccination in Hong Kong children. Copyright © 2013 Elsevier Ltd. All rights reserved.

Sustained Uptake of a Hospital-Based Handwashing with Soap and Water Treatment Intervention (Cholera-Hospital-Based Intervention for 7 Days [CHoBI7]): A Randomized Controlled Trial.

PubMed

George, Christine Marie; Jung, Danielle S; Saif-Ur-Rahman, K M; Monira, Shirajum; Sack, David A; Mahamud-ur Rashid; Mahmud, Md Toslim; Mustafiz, Munshi; Rahman, Zillur; Bhuyian, Sazzadul Islam; Winch, Peter J; Leontsini, Elli; Perin, Jamie; Begum, Farzana; Zohura, Fatema; Biswas, Shwapon; Parvin, Tahmina; Sack, R Bradley; Alam, Munirul

2016-02-01

Diarrhea is the second leading cause of death in children under 5 years of age globally. The time patients and caregivers spend at a health facility for severe diarrhea presents the opportunity to deliver water, sanitation, and hygiene (WASH) interventions. We recently developed Cholera-Hospital-Based Intervention for 7 days (CHoBI7), a 1-week hospital-based handwashing with soap and water treatment intervention, for household members of cholera patients. To investigate if this intervention could lead to sustained WASH practices, we conducted a follow-up evaluation of 196 intervention household members and 205 control household members enrolled in a randomized controlled trial of the CHoBI7 intervention 6 to 12 months post-intervention. Compared with the control arm, the intervention arm had four times higher odds of household members' handwashing with soap at a key time during 5-hour structured observation (odds ratio [OR]: 4.71, 95% confidence interval [CI]: 2.61, 8.49) (18% versus 50%) and a 41% reduction in households in the World Health Organization very high-risk category for stored drinking water (OR: 0.38, 95% CI: 0.15, 0.96) (58% versus 34%) 6 to 12 months post-intervention. Furthemore, 71% of observed handwashing with soap events in the intervention arm involved the preparation and use of soapy water, which was promoted during the intervention, compared to 9% of control households. These findings demonstrate that the hospital-based CHoBI7 intervention can lead to significant increases in handwashing with soap practices and improved stored drinking water quality 6 to 12 months post-intervention. © The American Society of Tropical Medicine and Hygiene.

Interaction between a tannin-containing legume and endophyte-infected tall fescue seed on lambs’ feeding behavior and physiology

USDA-ARS?s Scientific Manuscript database

It was hypothesized that a tannin-rich legume like sainfoin reduces the negative post-ingestive effects of ergot alkaloids in tall fescue. Thirty-two 4-month-old lambs were individually penned and randomly assigned to a 2X2 factorial arrangement with two legume species (1-sainfoin [SAN; ' 3% condens...

Comparison of Radiofrequency Thermal Ablation and Microdebrider-Assisted Turbinoplasty in Inferior Turbinate Hypertrophy: A Prospective, Randomized, and Clinical Study

PubMed Central

Akagün, Fatih; İmamoğlu, Mehmet; Çobanoğlu, Hatice Bengü; Ural, Ahmet

2016-01-01

Objective To compare the effectiveness of radiofrequency thermal ablation with those of microdebrider-assisted turbinoplasty, we designed a prospective, randomized clinical study. Methods Forty patients suffering from nasal obstruction due to bilateral inferior turbinate hypertrophy were enrolled. Half of the patients were operated by radiofrequency thermal ablation, while the other half underwent microdebrider-assisted turbinoplasty. The outcomes of both techniques were compared in terms of symptomatology, nasal patency, and mucociliary transport. Results A statistically significant difference existed between the two groups with respect to nasal obstruction and the frequency of obstruction at the first post-operative week and first and third post-operative months (p<0.05). Rhinomanometry detected a significant decrease in nasal resistance values in both surgical groups compared to the preoperative values. The mucociliary transport time was significantly prolonged in the first postoperative week and first postoperative month in microdebrider-assisted inferior turbinoplasty group. Conclusion Both radiofrequency thermal ablation and microdebrider-assisted turbinoplasty are effective techniques for treating inferior turbinate hypertrophy. The treatment modality should be individually determined, and parameters such as tissue healing, volume reduction, and mucociliary activity must be taken into account. PMID:29392030

A comparison of online versus workbook delivery of a self-help positive parenting program.

PubMed

Sanders, Matthew R; Dittman, Cassandra K; Farruggia, Susan P; Keown, Louise J

2014-06-01

A noninferiority randomized trial design compared the efficacy of two self-help variants of the Triple P-Positive Parenting Program: an online version and a self-help workbook. We randomly assigned families of 193 children displaying early onset disruptive behavior difficulties to the online (N = 97) or workbook (N = 96) interventions. Parents completed questionnaire measures of child behavior, parenting, child maltreatment risk, personal adjustment and relationship quality at pre- and post-intervention and again at 6-month follow up. The short-term intervention effects of the Triple P Online program were not inferior to the workbook on the primary outcomes of disruptive child behavior and dysfunctional parenting as reported by both mothers and fathers. Both interventions were associated with significant and clinically meaningful declines from pre- to post-intervention in levels of disruptive child behavior, dysfunctional parenting styles, risk of child maltreatment, and inter-parental conflict on both mother and father report measures. Intervention effects were largely maintained at 6-month follow up, thus supporting the use of self-help parenting programs within a comprehensive population-based system of parenting support to reduce child maltreatment and behavioral problems in children.

Acupuncture in the management of chronic low back pain: a blinded randomized controlled trial.

PubMed

Kerr, Daniel P; Walsh, Deirdre M; Baxter, David

2003-01-01

To assess the efficacy of acupuncture in the treatment of chronic low back pain. Patients (n = 60) with chronic low back pain were recruited and randomly allocated to either Acupuncture therapy or Placebo transcutaneous electrical nerve stimulation (TENS) groups. Patients were treated weekly for 6 weeks, and blinded assessments were carried out pre- and post-treatment using the McGill Pain Questionnaire (MPQ) and visual analog scales (VAS) for pain, the Short-form 36 quality-of-life questionnaire, and a simple range of motion measurement. A total of 46 patients completed the trial and were followed up at 6 months. Analysis of results using t tests showed that in both groups there were significant pre-post improvements for all scores, except for MPQ scores in the Placebo-TENS group. There was no significant difference between the 2 groups for any of the outcome measures at the end of treatment. Results from the 6-month follow-up would suggest that the response was better in the acupuncture group. Further research is necessary to fully assess the efficacy of this treatment in combating chronic low back pain using larger sample sizes or alternative control groups.

Examination of a brief anxiety sensitivity cognitive concerns intervention on suicidality among individuals with obsessive-compulsive symptoms.

PubMed

Raines, Amanda M; Short, Nicole A; Allan, Nicholas P; Oglesby, Mary E; Schmidt, Norman B

2015-11-01

A growing body of research has demonstrated elevated rates of suicidality among individuals with obsessive-compulsive disorder (OCD). Recently, it has been proposed that the cognitive concerns component of anxiety sensitivity (AS) may be one factor contributing to this association. AS cognitive concerns, which reflect fears of mental incapacitation, has been found to be associated with OCD and increased suicidality in a number of populations. However, questions remain as to whether reductions in AS cognitive concerns will lead to subsequent reductions in suicidality among individuals with OCD symptoms. In the current study, the sample (N=54) was comprised of individuals with elevated OCD symptoms recruited from the community who were participating in a larger randomized clinical trial. Individuals were randomly assigned to a one-session AS cognitive concerns intervention or a health information control intervention and assessed at post-treatment and one-month follow-up. Results indicated that the active intervention produced significantly greater reductions in AS cognitive concerns immediately post-intervention. Moreover, changes in AS cognitive concerns following the intervention mediated changes in suicidality at one-month follow-up. Findings are discussed in regard to adjunct interventions for OCD. Copyright © 2015 Elsevier Inc. All rights reserved.

A Randomized Controlled Trial of an Intensive Nutrition Intervention Versus Standard Nutrition Care to Avoid Excess Weight Gain After Kidney Transplantation: The INTENT Trial.

PubMed

Henggeler, Cordula K; Plank, Lindsay D; Ryan, Kristin J; Gilchrist, Emily L; Casas, Jessie M; Lloyd, Lyn E; Mash, Laura E; McLellan, Sandra L; Robb, Jennifer M; Collins, Michael G

2018-05-02

Excessive weight gain is common after kidney transplantation and increases cardiovascular risk. The aim of this randomized controlled trial was to determine whether an intensive nutrition and exercise intervention delivered alongside routine post-transplant care would reduce post-transplant weight gain. Single-blind, randomized controlled trial. Adult kidney transplant recipients at a regional transplant center were recruited during routine outpatient clinic visits in the first month after transplant. Patients with a body mass index >40 kg/m 2 or <18.5 kg/m 2 , severe malnutrition, or ongoing medical complications were excluded. Participants were randomized to intensive nutrition intervention (individualized nutrition and exercise counselling; 12 dietitian visits; 3 exercise physiologist visits over 12 months) or to standard nutrition care (guideline based; 4 dietitian visits). The primary outcome was weight at 6 months after transplant adjusted for baseline weight, obesity, and gender, analyzed using analysis of covariance. The secondary outcomes included body composition, biochemistry, quality of life, and physical function. Thirty-seven participants were randomized to the intensive intervention (n = 19) or to standard care (n = 18); one intensive group participant withdrew before baseline. Weight increased between baseline, 6 and 12 months (78.0 ± 13.7 [standard deviation], 79.6 ± 13.0 kg, 81.6 ± 12.9 kg; mean change 4.6% P < .001) but at 6 months did not differ significantly between the groups: 77.0 ± 12.4 kg (intensive); 82.2 ± 13.4 kg (standard); difference in adjusted means 0.4 kg (95% confidence interval: -2.2 to 3.0 kg); analysis of covariance P = .7. No between-group differences in secondary outcomes were observed. Across the whole cohort, total body protein and physical function (gait speed, sit to stand, grip strength, physical activity, and quality of life [all but 2 domains]) improved. However, adverse changes were seen for total body fat, HbA1c, and fasting glucose across the cohort. Kidney transplant recipients in the first year after transplant did not benefit from an intensive nutrition intervention compared with standard nutrition care, although weight gain was relatively modest in both groups. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Pharmacomechanical Catheter-Directed Thrombolysis for Deep-Vein Thrombosis.

PubMed

Vedantham, Suresh; Goldhaber, Samuel Z; Julian, Jim A; Kahn, Susan R; Jaff, Michael R; Cohen, David J; Magnuson, Elizabeth; Razavi, Mahmood K; Comerota, Anthony J; Gornik, Heather L; Murphy, Timothy P; Lewis, Lawrence; Duncan, James R; Nieters, Patricia; Derfler, Mary C; Filion, Marc; Gu, Chu-Shu; Kee, Stephen; Schneider, Joseph; Saad, Nael; Blinder, Morey; Moll, Stephan; Sacks, David; Lin, Judith; Rundback, John; Garcia, Mark; Razdan, Rahul; VanderWoude, Eric; Marques, Vasco; Kearon, Clive

2017-12-07

The post-thrombotic syndrome frequently develops in patients with proximal deep-vein thrombosis despite treatment with anticoagulant therapy. Pharmacomechanical catheter-directed thrombolysis (hereafter "pharmacomechanical thrombolysis") rapidly removes thrombus and is hypothesized to reduce the risk of the post-thrombotic syndrome. We randomly assigned 692 patients with acute proximal deep-vein thrombosis to receive either anticoagulation alone (control group) or anticoagulation plus pharmacomechanical thrombolysis (catheter-mediated or device-mediated intrathrombus delivery of recombinant tissue plasminogen activator and thrombus aspiration or maceration, with or without stenting). The primary outcome was development of the post-thrombotic syndrome between 6 and 24 months of follow-up. Between 6 and 24 months, there was no significant between-group difference in the percentage of patients with the post-thrombotic syndrome (47% in the pharmacomechanical-thrombolysis group and 48% in the control group; risk ratio, 0.96; 95% confidence interval [CI], 0.82 to 1.11; P=0.56). Pharmacomechanical thrombolysis led to more major bleeding events within 10 days (1.7% vs. 0.3% of patients, P=0.049), but no significant difference in recurrent venous thromboembolism was seen over the 24-month follow-up period (12% in the pharmacomechanical-thrombolysis group and 8% in the control group, P=0.09). Moderate-to-severe post-thrombotic syndrome occurred in 18% of patients in the pharmacomechanical-thrombolysis group versus 24% of those in the control group (risk ratio, 0.73; 95% CI, 0.54 to 0.98; P=0.04). Severity scores for the post-thrombotic syndrome were lower in the pharmacomechanical-thrombolysis group than in the control group at 6, 12, 18, and 24 months of follow-up (P<0.01 for the comparison of the Villalta scores at each time point), but the improvement in quality of life from baseline to 24 months did not differ significantly between the treatment groups. Among patients with acute proximal deep-vein thrombosis, the addition of pharmacomechanical catheter-directed thrombolysis to anticoagulation did not result in a lower risk of the post-thrombotic syndrome but did result in a higher risk of major bleeding. (Funded by the National Heart, Lung, and Blood Institute and others; ATTRACT ClinicalTrials.gov number, NCT00790335 .).

Comparing glycaemic benefits of Active Versus passive lifestyle Intervention in kidney Allograft Recipients (CAVIAR): study protocol for a randomised controlled trial.

PubMed

Wilcox, Joanne; Waite, Chantelle; Tomlinson, Lyndsey; Driscoll, Joanne; Karim, Asra; Day, Edward; Sharif, Adnan

2016-08-22

Lifestyle modification is widely recommended to kidney allograft recipients post transplantation due to the cardiometabolic risks associated with immunosuppression including new-onset diabetes, weight gain and cardiovascular events. However, we have no actual evidence that undertaking lifestyle modification protects from any adverse outcomes post transplantation. The aim of this study is to compare whether a more proactive versus passive interventional approach to modify lifestyle is associated with superior outcomes post kidney transplantation. We designed this prospective, single-centre, open-label, randomised controlled study to compare the efficacy of active versus passive lifestyle intervention for kidney allograft recipients early post transplantation. A total of 130 eligible patients, who are stable, nondiabetic and between 3 and 24 months post kidney transplantation, will be recruited. Randomisation is being undertaken by random block permutations into passive (n = 65, leaflet guidance only) versus active lifestyle modification (n = 65, supervised intervention) over a 6-month period. Supervised intervention is being facilitated by two dietitians during the 6-month intervention period to provide continuous lifestyle intervention guidance, support and encouragement. Both dietitians are accredited with behavioural intervention skills and will utilise motivational aids to support study recruits randomised to active intervention. The primary outcome is change in abnormal glucose metabolism parameters after 6 months of comparing active versus passive lifestyle intervention. Secondary outcomes include changes in a wide array of cardiometabolic parameters, kidney allograft function and patient-reported outcome measures. Long-term tracking of patients via data linkage to electronic patient records and national registries will facilitate long-term comparison of outcomes after active versus passive lifestyle intervention beyond the 6-month intervention period. This is the first randomised controlled study to investigate the benefits of active versus passive lifestyle intervention in kidney allograft recipients for the prevention of abnormal cardiometabolic outcomes. In addition, this is the first example of utilising behaviour therapy intervention post kidney transplantation to achieve clinically beneficial outcomes, which has potential implications on many spheres of post-transplant care. This study was registered with the Clinical Trials Registry on 27 August 2014 (ClinicalTrials.org Identifier: NCT02233491 ).

A randomized prospective long-term (>1 year) clinical trial comparing the efficacy and safety of radiofrequency ablation to 980 nm laser ablation of the great saphenous vein.

PubMed

Sydnor, Malcolm; Mavropoulos, John; Slobodnik, Natalia; Wolfe, Luke; Strife, Brian; Komorowski, Daniel

2017-07-01

Purpose To compare the short- and long-term (>1 year) efficacy and safety of radiofrequency ablation (ClosureFAST™) versus endovenous laser ablation (980 nm diode laser) for the treatment of superficial venous insufficiency of the great saphenous vein. Materials and methods Two hundred patients with superficial venous insufficiency of the great saphenous vein were randomized to receive either radiofrequency ablation or endovenous laser ablation (and simultaneous adjunctive therapies for surface varicosities when appropriate). Post-treatment sonographic and clinical assessment was conducted at one week, six weeks, and six months for closure, complications, and patient satisfaction. Clinical assessment of each patient was conducted at one year and then at yearly intervals for patient satisfaction. Results Post-procedure pain ( p < 0.0001) and objective post-procedure bruising ( p = 0.0114) were significantly lower in the radiofrequency ablation group. Improvements in venous clinical severity score were noted through six months in both groups (endovenous laser ablation 6.6 to 1; radiofrequency ablation 6.2 to 1) with no significant difference in venous clinical severity score ( p = 0.4066) or measured adverse effects; 89 endovenous laser ablation and 87 radiofrequency patients were interviewed at least 12 months out with a mean long-term follow-up of 44 and 42 months ( p = 0.1096), respectively. There were four treatment failures in each group, and every case was correctable with further treatment. Overall, there were no significant differences with regard to patient satisfaction between radiofrequency ablation and endovenous laser ablation ( p = 0.3009). There were no cases of deep venous thrombosis in either group at any time during this study. Conclusions Radiofrequency ablation and endovenous laser ablation are highly effective and safe from both anatomic and clinical standpoints over a multi-year period and neither modality achieved superiority over the other.

A randomized controlled trial of cognitive-behavior therapy plus bright light therapy for adolescent delayed sleep phase disorder.

PubMed

Gradisar, Michael; Dohnt, Hayley; Gardner, Greg; Paine, Sarah; Starkey, Karina; Menne, Annemarie; Slater, Amy; Wright, Helen; Hudson, Jennifer L; Weaver, Edward; Trenowden, Sophie

2011-12-01

To evaluate cognitive-behavior therapy plus bright light therapy (CBT plus BLT) for adolescents diagnosed with delayed sleep phase disorder (DSPD). Randomized controlled trial of CBT plus BLT vs. waitlist (WL) control with comparisons at pre- and post-treatment. There was 6-month follow-up for the CBT plus BLT group only. Flinders University Child & Adolescent Sleep Clinic, Adelaide, South Australia. 49 adolescents (mean age 14.6 ± 1.0 y, 53% males) diagnosed with DSPD; mean chronicity 4 y 8 months; 16% not attending school. Eighteen percent of adolescents dropped out of the study (CBT plus BLT: N = 23 vs. WL: N = 17). CBT plus BLT consisted of 6 individual sessions, including morning bright light therapy to advance adolescents' circadian rhythms, and cognitive restructuring and sleep education to target associated insomnia and sleep hygiene. DSPD diagnosis was performed via a clinical interview and 7-day sleep diary. Measurements at each time-point included online sleep diaries and scales measuring sleepiness, fatigue, and depression symptoms. Compared to WL, moderate-to-large improvements (d = 0.65-1.24) were found at post-treatment for CBT plus BLT adolescents, including reduced sleep latency, earlier sleep onset and rise times, total sleep time (school nights), wake after sleep onset, sleepiness, and fatigue. At 6-month follow-up (N = 15), small-to-large improvements (d = 0.24-1.53) continued for CBT plus BLT adolescents, with effects found for all measures. Significantly fewer adolescents receiving CBT plus BLT met DPSD criteria at post-treatment (WL = 82% vs. CBT plus BLT = 13%, P < 0.0001), yet 13% still met DSPD criteria at the 6-month follow-up. CBT plus BLT for adolescent DSPD is effective for improving multiple sleep and daytime impairments in the immediate and long-term. Studies evaluating the treatment effectiveness of each treatment component are needed. Australia-New Zealand Trials Registry Number: ACTRN12610001041044.

Tailored interventions for screening mammography among a sample of initially non-adherent women: when is a booster dose important?

PubMed

Skinner, Celette Sugg; Kobrin, Sarah C; Monahan, Patrick O; Daggy, Joanne; Menon, Usha; Todora, Helen Smith; Champion, Victoria L

2007-01-01

To assess added value of a booster dose of a tailored mammography intervention. Participants, non-adherent at baseline, were randomly assigned to usual care or one of three tailored interventions. Intervention group members (n=657) were further randomly assigned to receive/not receive a booster intervention dose. Electronic record mammography data were collected following initial intervention and at 6 and 15 months post-booster. Booster had no effect among women not screened after first intervention dose (n=337). Among women screened after initial dose (n=320), booster predicted re-screening at 6 but not 15 months. A boosterxrace interaction showed a booster effect at 6 months for African Americans (OR=4.66, p=.0005) but not Caucasians (OR=0.74, p=.44). Findings suggest if a first-dose intervention does not facilitate screening, neither will a booster dose. However, among women for whom a first dose is effective, boosters can facilitate timely repeat adherence, especially among African Americans. At 6 months booster recipients were less likely to be off-schedule but, by 15 months, the groups were similar. Boosters may effect when, but not whether, women continue screening.

Financial incentive strategies for maintenance of weight loss: results from an internet-based randomized controlled trial.

PubMed

Yancy, William S; Shaw, Pamela A; Wesby, Lisa; Hilbert, Victoria; Yang, Lin; Zhu, Jingsan; Troxel, Andrea; Huffman, David; Foster, Gary D; Wojtanowski, Alexis C; Volpp, Kevin G

2018-05-25

Financial incentives can improve initial weight loss; we examined whether financial incentives can improve weight loss maintenance. Participants aged 30-80 years who lost at least 5 kg during the first 4-6 months in a nationally available commercial weight loss program were recruited via the internet into a three-arm randomized trial of two types of financial incentives versus active control during months 1-6 (Phase I) followed by passive monitoring during months 7-12 (Phase II). Interventions were daily self-weighing and text messaging feedback alone (control) or combined with a lottery-based incentive or a direct incentive. The primary outcome was weight change 6 months after initial weight loss. Secondary outcomes included weight change 12 months after initial weight loss (6 months after cessation of maintenance intervention), and self-reported physical activity and eating behaviors. Of 191 participants randomized, the mean age was 49.0 (SD = 10.5) years and weight loss prior to randomization was 11.4 (4.7) kg; 92% were women and 89% were White. Mean weight changes during the next 6 months (Phase I) were: lottery -3.0 (5.8) kg; direct -2.8 (5.8) kg; and control -1.4 (5.8) kg (all pairwise comparisons p > 0.1). Weight changes through the end of 12 months post-weight loss (Phase II) were: lottery -1.8 (10.5) kg; direct -0.7 (10.7) kg; and control -0.3 (9.4) kg (all pairwise comparisons p > 0.1). The percentages of participants who maintained their weight loss (defined as gaining ≤1.36 kg) were: lottery 79%, direct 76%, and control 67% at 6 months and lottery 66%, direct 62%, and control 59% at 12 months (all pairwise comparisons p > 0.1). At 6 and 12 months after initial weight loss, changes in self-reported physical activity or eating behaviors did not differ across arms. Compared with the active control of daily texting based on daily home weighing, lottery-based and direct monetary incentives provided no additional benefit for weight loss maintenance.

Effectiveness of school- and family-based interventions to prevent gaming addiction among grades 4–5 students in Bangkok, Thailand

PubMed Central

Apisitwasana, Nipaporn; Perngparn, Usaneya; Cottler, Linda B

2018-01-01

Purpose This study aimed to assess the effectiveness of Participatory Learning School and Family Based Intervention Program for Preventing Game Addiction by Developing Self-Regulation of gaming addiction among students of grades 4 and 5 in Bangkok. Methods A quasi-experimental study was implemented among students of grades 4 and 5 at primary schools in Bangkok selected through multistage random sampling. Two comparable schools were randomly assigned to either the intervention or control group. Then, 310 students in the randomly selected classrooms were allocated to each group. The intervention group received the self-regulation program with school and family involvement to prevent gaming addiction. Master teachers attended in-house training on prevention of gaming addiction in children. Parents of these children received a gaming addiction prevention manual and guidelines. The program lasted 8 weeks. The control group received no intervention. Knowledge and Attitude About Gaming Questionnaire, Game Addiction Screening Test (GAST), and Game Addiction Protection Scale were utilized to assess subjects at baseline, immediately after, and 3 months post-intervention. Descriptive statistics, chi-square, and independent t-test were used to describe characteristics of the participants, and repeated measures ANOVA was analyzed to test the effectiveness of the intervention. Results The findings revealed that there were significant differences in knowledge, attitude, self-regulation, and gaming addiction behaviors (p < 0.05) immediately and 3 months post-intervention. Positive effects of the intervention included increase in knowledge, attitude, and self-regulation, whereas the GAST score was significantly decreased (p < 0.05) immediately and 3 months after the program. Conclusion The program based on self-regulation and school and family participation is effective for preventing gaming addiction in students of grades 4 and 5 in Bangkok, Thailand. PMID:29695939

Modifying mental health help-seeking stigma among undergraduates with untreated psychiatric disorders: A pilot randomized trial of a novel cognitive bias modification intervention.

PubMed

Stanley, Ian H; Hom, Melanie A; Joiner, Thomas E

2018-04-01

Help-seeking stigma is a potent barrier to the utilization of mental health services. This study aimed to determine if, compared to a psychoeducation condition, individuals randomized to a novel cognitive bias modification intervention for help-seeking stigma (CBM-HS) demonstrate greater reductions in help-seeking stigma, as well as increases in readiness to change and help-seeking behaviors. Participants included 32 undergraduates with a DSM-5 psychiatric disorder who denied past-year mental health treatment. Post-randomization, three intervention sessions were delivered in one-week intervals (45 min total). Participants were assessed at baseline, mid-intervention, one-week post-intervention, and two-month follow-up. RM-ANOVAs were utilized among the intent-to-treat sample. There were no significant differences across time points between the intervention groups for help-seeking stigma and readiness to change. At two-month follow-up, 25% of participants initiated mental health treatment (29.4% CBM-HS, 20.0% psychoeducation). Strikingly, across groups, there was a statistically significant reduction in help-seeking self-stigma (F[2.214,66.418] = 5.057, p = 0.007, η p 2  = 0.144) and perceived public stigma (F[3,90] = 6.614, p < 0.001, η p 2  = 0.181) from baseline to two-month follow-up, indicating large effects; 18.8% achieved clinically significant change, among whom two-thirds were in the CBM-HS condition. Two brief, scalable interventions appear to reduce help-seeking stigma among undergraduates with untreated psychiatric disorders. Studies are needed to evaluate these interventions against an inactive control. Copyright © 2018 Elsevier Ltd. All rights reserved.

Effectiveness of school- and family-based interventions to prevent gaming addiction among grades 4-5 students in Bangkok, Thailand.

PubMed

Apisitwasana, Nipaporn; Perngparn, Usaneya; Cottler, Linda B

2018-01-01

This study aimed to assess the effectiveness of Participatory Learning School and Family Based Intervention Program for Preventing Game Addiction by Developing Self-Regulation of gaming addiction among students of grades 4 and 5 in Bangkok. A quasi-experimental study was implemented among students of grades 4 and 5 at primary schools in Bangkok selected through multistage random sampling. Two comparable schools were randomly assigned to either the intervention or control group. Then, 310 students in the randomly selected classrooms were allocated to each group. The intervention group received the self-regulation program with school and family involvement to prevent gaming addiction. Master teachers attended in-house training on prevention of gaming addiction in children. Parents of these children received a gaming addiction prevention manual and guidelines. The program lasted 8 weeks. The control group received no intervention. Knowledge and Attitude About Gaming Questionnaire, Game Addiction Screening Test (GAST), and Game Addiction Protection Scale were utilized to assess subjects at baseline, immediately after, and 3 months post-intervention. Descriptive statistics, chi-square, and independent t -test were used to describe characteristics of the participants, and repeated measures ANOVA was analyzed to test the effectiveness of the intervention. The findings revealed that there were significant differences in knowledge, attitude, self-regulation, and gaming addiction behaviors ( p < 0.05) immediately and 3 months post-intervention. Positive effects of the intervention included increase in knowledge, attitude, and self-regulation, whereas the GAST score was significantly decreased ( p < 0.05) immediately and 3 months after the program. The program based on self-regulation and school and family participation is effective for preventing gaming addiction in students of grades 4 and 5 in Bangkok, Thailand.

MAGNETIC VT study: a prospective, multicenter, post-market randomized controlled trial comparing VT ablation outcomes using remote magnetic navigation-guided substrate mapping and ablation versus manual approach in a low LVEF population.

PubMed

Di Biase, Luigi; Tung, Roderick; Szili-Torok, Tamás; Burkhardt, J David; Weiss, Peter; Tavernier, Rene; Berman, Adam E; Wissner, Erik; Spear, William; Chen, Xu; Neužil, Petr; Skoda, Jan; Lakkireddy, Dhanunjaya; Schwagten, Bruno; Lock, Ken; Natale, Andrea

2017-04-01

Patients with ischemic cardiomyopathy (ICM) are prone to scar-related ventricular tachycardia (VT). The success of VT ablation depends on accurate arrhythmogenic substrate localization, followed by optimal delivery of energy provided by constant electrode-tissue contact. Current manual and remote magnetic navigation (RMN)-guided ablation strategies aim to identify a reentry circuit and to target a critical isthmus through activation and entrainment mapping during ongoing tachycardia. The MAGNETIC VT trial will assess if VT ablation using the Niobe™ ES magnetic navigation system results in superior outcomes compared to a manual approach in subjects with ischemic scar VT and low ejection fraction. This is a randomized, single-blind, prospective, multicenter post-market study. A total of 386 subjects (193 per group) will be enrolled and randomized 1:1 between treatment with the Niobe ES system and treatment via a manual procedure at up to 20 sites. The study population will consist of patients with ischemic cardiomyopathy with left ventricular ejection fraction (LVEF) of ≤35% and implantable cardioverter defibrillator (ICD) who have sustained monomorphic VT. The primary study endpoint is freedom from any recurrence of VT through 12 months. The secondary endpoints are acute success; freedom from any VT at 1 year in a large-scar subpopulation; procedure-related major adverse events; and mortality rate through 12-month follow-up. Follow-up will consist of visits at 3, 6, 9, and 12 months, all of which will include ICD interrogation. The MAGNETIC VT trial will help determine whether substrate-based ablation of VT with RMN has clinical advantages over manual catheter manipulation. Clinicaltrials.gov identifier: NCT02637947.

A randomized trial comparing live and telemedicine deliveries of an imagery-based behavioral intervention for breast cancer survivors: reducing symptoms and barriers to care.

PubMed

Freeman, Lyn W; White, Rebecca; Ratcliff, Chelsea G; Sutton, Sue; Stewart, Mary; Palmer, J Lynn; Link, Judith; Cohen, Lorenzo

2015-08-01

This multi-site randomized trial evaluates the quality of life (QOL) benefits of an imagery-based group intervention titled 'Envision the Rhythms of Life'(ERL). Breast cancer survivors >6 weeks post-treatment were randomized to attend five weekly 4-h group sessions at a community center with therapist present (live delivery (LD), n = 48), therapist streamed via telemedicine (telemedicine delivery (TD), n = 23), or to a waitlist control (WL) group (n = 47). Weekly individual phone calls to encourage at-home practice began at session one and continued until the 3-month follow-up. Seven self-report measures of QOL were examined at baseline, 1-month and 3-month post-treatments including health-related and breast cancer-specific QOL, fatigue, cognitive function, spirituality, distress, and sleep. The Bonferroni method was used to correct for multiple comparisons, and alpha was adjusted to 0.01. Linear multilevel modeling analyses revealed less fatigue, cognitive dysfunction, and sleep disturbance for LD and TD compared with WL across the follow-up (p's < 0.01). Changes in fatigue, cognitive dysfunction, sleep disturbance, and health-related and breast cancer-related QOL were clinically significant. There were no differences between LD and TD. Both the live and telemedicine delivered ERL intervention resulted in improvements in multiple QOL domains for breast cancer survivors compared with WL. Further, there were no significant differences between LD and TD, suggesting telemedicine delivered ERL intervention may represent an effective and viable option for cancer survivors in remote areas. Copyright © 2014 John Wiley & Sons, Ltd.

Cognitive rehabilitation for individuals with opioid use disorder: A randomized controlled trial.

PubMed

Rezapour, Tara; Hatami, Javad; Farhoudian, Ali; Sofuoglu, Mehmet; Noroozi, Alireza; Daneshmand, Reza; Samiei, Ahmadreza; Ekhtiari, Hamed

2017-11-21

To examine the efficacy of cognitive rehabilitation treatment (CRT) for people with opioid use disorder who were recruited into a methadone maintenance treatment (MMT) programme. 120 male subjects were randomly assigned to (1) MMT plus CRT in two months or (2) MMT plus a control intervention. Subjects were assessed at the beginning, mid-point and post-intervention as well as at 1-, 3- and 6-month follow-up time points. Analysis with repeated measure ANOVA showed that the CRT group performed significantly better in tests of learning, switching, processing speed, working memory and memory span. Moreover, the CRT group had significantly lower opiate use over the control group during 3-months follow-up. Analysis including only those with a history of methamphetamine use showed that the CRT group had significantly lower amphetamine use. No group differences were observed for treatment retention. Our findings provide evidence that adding CRT as an adjunct intervention to MMT can improve cognitive performance as well as abstinence from both opiates and stimulants.

The long-term effect of being treated in a geriatric ward compared to an orthopaedic ward on six measures of free-living physical behavior 4 and 12 months after a hip fracture - a randomised controlled trial.

PubMed

Taraldsen, Kristin; Thingstad, Pernille; Sletvold, Olav; Saltvedt, Ingvild; Lydersen, Stian; Granat, Malcolm H; Chastin, Sebastien; Helbostad, Jorunn L

2015-12-04

This study is part of the Trondheim Hip Fracture Trial, where we compared free-living physical behavior in daily life 4 and 12 months following hip surgery for patients managed with comprehensive geriatric care (CGC) in a geriatric ward with those managed with orthopedic care (OC) in an orthopedic ward. This is a single centre, prospective, randomized controlled trial. 397 hip fracture patients were randomized to CGC (n = 199) or OC (n = 198) in the Emergency Department with follow-up assessments performed four and 12 months post-surgery. Outcomes were mean upright time, number and length of upright events recorded continuously for four days at four and 12 months post-surgery by an accelerometer-based activity monitor. Missing data were handled by multiple imputation and group differences assessed by linear regression with adjustments for gender, age and fracture type. There were no group differences in participants' pre-fracture characteristics. Estimated group difference in favor of CGC in upright time at 4 months was 34.6 min (17.4 %, CI 9.6 to 59.6, p = .007) and at 12 months, 27.7 min (13.9 %, CI 3.5 to 51.8, p = .025). Average and maximum length of upright events was longer in the CGC (p's < .042). No group difference was found for number of upright events (p's > .452). Participants treated with CGC during the hospital stay improved free-living physical behavior more than those treated with OC both 4 and 12 months after surgery, with more time and longer periods spent in upright. Results support findings from the same study for functional outcomes, and demonstrate that CGC impacts daily life as long as one year after surgery. ClinicalTrials.gov, NCT00667914 , April 18, 2008.

Bad Dream Frequency in Older Adults with Generalized Anxiety Disorder: Prevalence, Correlates, and Effect of Cognitive Behavioral Treatment for Anxiety

PubMed Central

Nadorff, Michael R.; Porter, Ben; Rhoades, Howard M.; Greisinger, Anthony J.; Kunik, Mark E.; Stanley, Melinda A.

2012-01-01

This study investigated the relation between generalized anxiety disorder (GAD) and frequency of bad dreams in older adults. A secondary analysis from a randomized clinical trial comparing cognitive behavioral therapy for anxiety (CBT) to enhanced usual care (EUC), it assessed bad dream frequency at baseline, post-treatment (3 months), and 6, 9, 12 and 15 months. Of 227 participants (mean age = 67.4), 134 met GAD diagnostic criteria (CBT = 70, EUC = 64), with the remaining 93 serving as a comparison group. Patients with GAD had significantly more bad dreams than those without, and bad dream frequency was significantly associated with depression, anxiety, worry, and poor quality of life. CBT for anxiety significantly reduced bad dream frequency at post-treatment and throughout follow-up compared to EUC. PMID:23470116

A Randomized Controlled Trial of 7-Day Intensive and Standard Weekly Cognitive Therapy for PTSD and Emotion-Focused Supportive Therapy

PubMed Central

Ehlers, Anke; Hackmann, Ann; Grey, Nick; Wild, Jennifer; Liness, Sheena; Albert, Idit; Deale, Alicia; Stott, Richard; Clark, David M.

2014-01-01

Objective Psychological treatments for posttraumatic stress disorder (PTSD) are usually delivered once or twice weekly over several months. It is unclear whether they can be successfully delivered over a shorter period of time. This clinical trial had two goals, (1) to investigate the acceptability and efficacy of a 7-day intensive version of cognitive therapy for PTSD, and (2) to investigate whether cognitive therapy has specific treatment effects by comparing intensive and standard weekly cognitive therapy with an equally credible alternative treatment. Method Patients with chronic PTSD (N=121) were randomly allocated to 7-day intensive or standard 3-month weekly cognitive therapy for PTSD, 3-month weekly emotion-focused supportive therapy, or a 14-week waitlist condition. Primary outcomes were PTSD symptoms and diagnosis as assessed by independent assessors and self-report. Secondary outcomes were disability, anxiety, depression, and quality of life. Measures were taken at initial assessment, 6 weeks and 14 weeks (post-treatment/wait). For groups receiving treatment, measures were also taken at 3 weeks, and follow-ups at 27 and 40 weeks after randomization. All analyses were intent-to-treat. Results At post-treatment/wait assessment, 73%, 77%, 43%, 7% of the intensive cognitive therapy, standard cognitive therapy, supportive therapy, and waitlist groups, respectively, had recovered from PTSD. All treatments were well tolerated and were superior to waitlist on all outcome measures, with the exception of no difference between supportive therapy and waitlist on quality of life. For primary outcomes, disability and general anxiety, intensive and standard cognitive therapy were superior to supportive therapy. Intensive cognitive therapy achieved faster symptom reduction and comparable overall outcomes to standard cognitive therapy. Conclusions Cognitive therapy for PTSD delivered intensively over little more than a week is as effective as cognitive therapy delivered over 3 months. Both had specific effects and were superior to supportive therapy. Intensive cognitive therapy for PTSD is a feasible and promising alternative to traditional weekly treatment. PMID:24480899

The effects of mindfulness-based stress reduction on psychosocial outcomes and quality of life in early-stage breast cancer patients: a randomized trial

PubMed Central

Henderson, Virginia P.; Clemow, Lynn; Massion, Ann O.; Hurley, Thomas G.; Druker, Susan

2013-01-01

The aim of this study was determine the effectiveness of a mindfulness-based stress-reduction (MBSR) program on quality of life (QOL) and psychosocial outcomes in women with early-stage breast cancer, using a three-arm randomized controlled clinical trial (RCT). This RCT consisting of 172 women, aged 20–65 with stage I or II breast cancer consisted of the 8-week MBSR, which was compared to a nutrition education program (NEP) and usual supportive care (UC). Follow-up was performed at three post-intervention points: 4 months, 1, and 2 years. Standardized, validated self-administered questionnaires were adopted to assess psychosocial variables. Statistical analysis included descriptive and regression analyses incorporating both intention-to-treat and post hoc multivariable approaches of the 163 women with complete data at baseline, those who were randomized to MBSR experienced a significant improvement in the primary measures of QOL and coping outcomes compared to the NEP, UC, or both, including the spirituality subscale of the FACT-B as well as dealing with illness scale increases in active behavioral coping and active cognitive coping. Secondary outcome improvements resulting in significant between-group contrasts favoring the MBSR group at 4 months included meaningfulness, depression, paranoid ideation, hostility, anxiety, unhappiness, and emotional control. Results tended to decline at 12 months and even more at 24 months, though at all times, they were as robust in women with lower expectation of effect as in those with higher expectation. The MBSR intervention appears to benefit psychosocial adjustment in cancer patients, over and above the effects of usual care or a credible control condition. The universality of effects across levels of expectation indicates a potential to utilize this stress reduction approach as complementary therapy in oncologic practice. PMID:21901389

A Randomized Trial of MBSR Versus Aerobic Exercise for Social Anxiety Disorder*

PubMed Central

Jazaieri, Hooria; Goldin, Philippe R.; Werner, Kelly; Ziv, Michal; Gross, James J.

2014-01-01

OBJECTIVE Effective treatments for social anxiety disorder (SAD) exist, but additional treatment options are needed for non-responders as well as those who are either unable or unwilling to engage in traditional treatments. Mindfulness-Based Stress Reduction (MBSR) is one non-traditional treatment that has demonstrated efficacy in treating other mood and anxiety disorders, and preliminary data suggest its efficacy in SAD as well. METHOD Fifty-six adults (52% female; 41% Caucasian; Age (M ± SD): 32.8 ± 8.4) with SAD were randomized to MBSR or an active comparison condition, aerobic exercise (AE). At baseline and post-intervention, participants completed measures of clinical symptoms (Liebowitz Social Anxiety Scale, Social Interaction Anxiety Scale, Beck Depression Inventory-II, and Perceived Stress Scale) and subjective well-being (Rosenberg Self-Esteem Scale, Satisfaction with Life Scale, Self-Compassion Scale and UCLA-8 Loneliness Scale). At 3-months post intervention, a subset of these measures were re-administered. For clinical significance analyses, 48 healthy adults (52.1% female; 56.3% Caucasian; Age (M ± SD): 33.9 ± 9.8) were recruited. MBSR and AE participants were also compared to a separate untreated group of 29 adults (44.8% female; 48.3% Caucasian; Age (M ± SD): 32.3 ± 9.4) with generalized SAD who completed assessments over a comparable time period with no intervening treatment. RESULTS A 2 (Group) × 2 (Time) repeated-measures analyses of variance (ANOVAs) on measures of clinical symptoms and well-being were conducted to examine pre to post and pre- to 3-month follow-up. MBSR and AE were both associated with reductions in social anxiety and depression and increases in subjective well-being, both immediately post intervention and at 3-months post intervention. When participants in the RCT were compared to the untreated SAD group, participants in both interventions exhibited improvements on measures of clinical symptoms and well-being. CONCLUSION Non-traditional interventions such as MBSR and AE merit further exploration as alternative or complementary treatments for SAD. PMID:22623316

Postmenarche growth: cohort study among indigenous and non-indigenous Chilean adolescents.

PubMed

Amigo, Hugo; Lara, Macarena; Bustos, Patricia; Muñoz, Sergio

2015-01-31

In Chile, indigenous and non-indigenous schoolchildren have the same stature when they begin school but indigenous adults are shorter, indicating the importance of analyzing growth during puberty. The aim of this study was to compare the growth of indigenous and non-indigenous girls during the 36 months after menarche in Chile's Araucanía Region. A concurrent cohort study was conducted to compare growth in the two ethnic groups, which were comprised of 114 indigenous and 126 non-indigenous girls who recently experienced menarche and were randomly selected. Height was measured at menarche and at 6, 12, 18, 24 and 36 months post-menarche. General linear models were used to analyze growth and a generalized estimating equation model was used to compare height at 36 months post-menarche. At menarche, the Z-score of height/age was less for indigenous than non-indigenous girls (-0.01 vs. -0.61, p < 0.001). Indigenous girls grew at a slower rate than non-indigenous girls (6.5 vs. 7.2 cm, p = 0.02), and height at 36-months post-menarche reached -0.82 vs. -0.35 cm (p <0.001). In an adjusted model at 36 months post-menarche, indigenous girls were 1.6 cm shorter than non-indigenous girls (95% confidence interval: -3.13 to -0.04). The height of indigenous girls at menarche was lower than that of non-indigenous girls and they subsequently grew less, maintaining the gap between the two groups. At the end of the follow-up period, the indigenous girls were shorter than their non-indigenous peers.

Fluoroscopic Caudal Epidural Injections in Managing Post Lumbar Surgery Syndrome: Two-Year Results of a Randomized, Double-Blind, Active-Control Trial

PubMed Central

Manchikanti, Laxmaiah; Singh, Vijay; Cash, Kimberly A.; Pampati, Vidyasagar; Datta, Sukdeb

2012-01-01

Study Design: A randomized, active control, double-blind trial. Objective: To evaluate the effectiveness of fluoroscopically directed caudal epidural injections with or without steroids in managing chronic low back and lower extremity pain secondary to post lumbar surgery syndrome. Summary of Background Data: There is a paucity of evidence concerning caudal epidural injections for managing chronic persistent low back pain with or without lower extremity pain caused by post lumbar surgery syndrome. Methods: This active control randomized study included 140 patients with 70 patients in each group. Group I received 0.5% lidocaine, 10 mL; Group II received 9 mL of 0.5% lidocaine mixed with 1 mL of 6 mg of nonparticulate betamethasone. The multiple outcome measures included the numeric rating scale, the Oswestry Disability Index 2.0, employment status, and opioid intake with assessments at 3, 6, 12, 18, and 24 months posttreatment. Primary outcome was defined as at least 50% improvement in pain and Oswestry Disability Index scores. Patients with a positive response to the first 2 procedures with at least 3 weeks of relief were considered to be successful. All others were considered as failures. Results: Overall in Group I, 53% and 47% of the patients and in Group II, 59% and 58% of the patients, showed significant improvement with reduction in pain scores and disability index at 12 months and 24 months. In contrast, in the successful groups, significant pain relief and improvement in function were observed in 70% and 62% of Group I at one and 2 years; in 75% and 69% of Group II at one and 2 years. The results in the successful group showed that at the end of the first year patients experienced approximately 38 weeks of relief and at the end of 2 years Group I had 62 weeks and Group II had 68 weeks of relief. Overall total relief for 2 years was 48 weeks in Group I and 54 weeks in Group II. The average procedures in the successful groups were at 4 in one year and 6 at the end of 2 years. Conclusion: Caudal epidural injections of local anesthetic with or without steroid might be effective in patients with chronic persistent low back and/or lower extremity pain in patients with post lumbar surgery syndrome. PMID:23028241

Brief Motivational and Parent Interventions For College Students: A Randomized Factorial Study

PubMed Central

Wood, Mark D.; Fairlie, Anne M.; Fernandez, Anne C.; Borsari, Brian; Capone, Christy; Laforge, Robert; Carmona-Barros, Rosa

2010-01-01

Objective Using a randomized factorial design, we examined the efficacy of a Brief Motivational Intervention (BMI) and Parent-based Intervention (PBI) as universal preventive interventions to reduce alcohol use among incoming college students. Method Participants (N = 1,014) were assessed prior to matriculation and at 10-months and 22-months post-baseline. Two-part latent growth modeling was used to simultaneously examine initiation and growth in heavy episodic drinking and alcohol-related consequences. Results This study retained 90.8% (n = 921) of randomized students at the 10 month follow-up and 84.0% (n = 852) at the 22-month follow-up. BMI participants were significantly less likely than non-BMI participants to initiate heavy episodic drinking and to begin experiencing alcohol-related consequences. Effect sizes were minimal at 10-months (Cohen’s h ranged from 0.02–0.07) and small at 22-months (h’s from 0.15–0.22). A significant BMI X PBI interaction revealed that students receiving both the BMI and PBI were significantly less likely to report the onset of consequences beyond the sum of the individual intervention effects (h = 0.08 at 10-month and 0.21 at 22-month). Hypothesized direct BMI effects for reductions in heavy episodic drinking and consequences were not observed. Significant mediated effects via changes in descriptive norms were present for both growth and initiation of heavy episodic drinking and consequences. Conclusions To our knowledge, the current study is the first to provide support for BMI as a universal preventive intervention for incoming college students. While hypothesized PBI main effects were not found, mediation analyses suggest future refinements could enhance PBI effectiveness. PMID:20515210

Feasibility of an expressive-disclosure group intervention for post-treatment colorectal cancer patients: results of the Healthy Expressions study.

PubMed

Carmack, Cindy L; Basen-Engquist, Karen; Yuan, Ying; Greisinger, Anthony; Rodriguez-Bigas, Miguel; Wolff, Robert A; Barker, Trina; Baum, George; Pennebaker, James W

2011-11-01

Adjusting to cancer requires effective cognitive and emotional processing. Written and verbal disclosure facilitate processing and have been studied independently in cancer survivors. Combined written and verbal expression may be more effective than either alone, particularly for patients with difficult to discuss or embarrassing side effects. Thus, the authors developed and tested the efficacy of a 12-session combined written and verbal expression group program for psychologically distressed colorectal cancer (CRC) patients. Forty post-treatment patients with CRC (stages I-III) identified as psychologically distressed using the Brief Symptom Inventory (BSI) were randomized to an intervention group (Healthy Expressions; n = 25) or standard care (control group; n = 15). Assessments were completed at baseline, Month 2, and Month 4 (postintervention). Primary outcomes were psychological functioning and quality of life (QOL). Most participants were women (63%), white (63%), and non-Hispanic (75%). The Healthy Expressions group demonstrated significantly greater changes in distress compared with the control group at Month 2 on the BSI Global Severity Index (GSI) and the Centers for Epidemiologic Studies Depression scale (CES-D) scores (P < .05 for each); differences in the European Organization for Research and Treatment of Cancer (EORTC) global QOL scores approached significance (P = .063). The BSI GSI and Positive Symptom Total, CES-D, and EORTC emotional functioning subscale scores were all significant at Month 4 (P < .05 for each). The Healthy Expressions program improved psychological functioning in CRC patients who reported experiencing distress. Findings demonstrate the program's feasibility and provide strong support for conducting a larger randomized trial. Copyright © 2011 American Cancer Society.

Experimental protocol of a randomized controlled clinical trial investigating the effects of personalized exercise rehabilitation on kidney transplant recipients' outcomes.

PubMed

Kastelz, Alexandra; Tzvetanov, Ivo G; Fernhall, Bo; Shetty, Aneesha; Gallon, Lorenzo; West-Thielke, Patricia; Hachaj, Greg; Grazman, Mark; Benedetti, Enrico

2015-11-01

This randomized controlled trial (RCT) will investigate the effects of a personalized exercise rehabilitation regimen on return to work and find work rate, vascular health, functional capacity, quality of life, kidney function, and body composition in kidney transplant (KT) recipients. This RCT will recruit 120 men and/or women who have had a KT to participate in a 12 month exercise intervention or control (standard clinical care only) group. The 12 month exercise intervention will consist of one-on-one, progressive exercise rehabilitation sessions twice a week, for 60 min each session. The control group will continue standard clinical care as recommended by their post-transplant medical team without any intervention. The primary outcomes will be assessments of vascular structure and function, walking and strength measures to assess functional capacity, blood markers to assess kidney function, questionnaires to assess quality of life, DXA body scan to assess body composition, and a 1-week free living physical activity assessment. Additionally, employment status will be assessed. These assessments will be performed at baseline, 6 months, and 12 months. This investigation will increase the understanding of the role exercise rehabilitation has on managing the physiological and psychological health of the individual as well as on the individual's personal economic impact (via employment status). This study design has the potential to assist in constructing an effective exercise rehabilitation program that can be incorporated into part of standard post-transplant care. Copyright © 2015 Elsevier Inc. All rights reserved.

Effect of lung volume reduction surgery on resting pulmonary hemodynamics in severe emphysema.

PubMed

Criner, Gerard J; Scharf, Steven M; Falk, Jeremy A; Gaughan, John P; Sternberg, Alice L; Patel, Namrata B; Fessler, Henry E; Minai, Omar A; Fishman, Alfred P

2007-08-01

To determine the effect of medical treatment versus lung volume reduction surgery (LVRS) on pulmonary hemodynamics. Three clinical centers of the National Emphysema Treatment Trial (NETT) screened patients for additional inclusion into a cardiovascular (CV) substudy. Demographics were determined, and lung function testing, six-minute-walk distance, and maximum cardiopulmonary exercise testing were done at baseline and 6 months after medical therapy or LVRS. CV substudy patients underwent right heart catheterization at rest prerandomization (baseline) and 6 months after treatment. A total of 110 of the 163 patients evaluated for the CV substudy were randomized in NETT (53 were ineligible), 54 to medical treatment and 56 to LVRS. Fifty-five of these patients had both baseline and repeat right heart catheterization 6 months postrandomization. Baseline demographics and lung function data revealed CV substudy patients to be similar to the remaining 1,163 randomized NETT patients in terms of age, sex, FEV(1), residual volume, diffusion capacity of carbon monoxide, Pa(O(2)), Pa(CO(2)), and six-minute-walk distance. CV substudy patients had moderate pulmonary hypertension at rest (Ppa, 24.8 +/- 4.9 mm Hg); baseline hemodynamic measurements were similar across groups. Changes from baseline pressures to 6 months post-treatment were similar across treatment groups, except for a smaller change in pulmonary capillary wedge pressure at end-expiration post-LVRS compared with medical treatment (-1.8 vs. 3.5 mm Hg, p = 0.04). In comparison to medical therapy, LVRS was not associated with an increase in pulmonary artery pressures.

Effect of platelet-rich plasma on patients after blepharoplasty surgery.

PubMed

Parra, Fidelina; Morales-Rome, David Enrique; Campos-Rodríguez, Rafael; Cruz-Hernández, Teresita Rocío; Drago-Serrano, Maria Elisa

2018-04-01

To evaluate the effect of platelet-rich plasma (PRP) treatment on patients after blepharoplasty surgery. After undergoing blepharoplasty, 20 patients were randomly divided into two groups (n = 10 each). One was treated with autologous PRP and the other was not given any post-surgery treatment (basal group). Autologous PRP application was performed intradermically 24 h, 1 month, and 2 months post-surgery, and the outcome of the applications was assessed 1, 2, and 3 months post-surgery. The postoperative wound was assessed on a patient and observer scar assessment scale (POSAS) by patients and by an unblinded clinical observer. Statistical comparison between the two groups was analyzed by using the Mann-Whitney unpaired, two-tailed test. Significant differences were considered with P ≤ 0.05. Patient-reported data indicate that compared to the basal group, the PRP group showed no significant differences regarding pain, itching, or color, but had better values for stiffness and thickness (months 1 and 2) as well as scar irregularity (month 1). Data reported by the clinical observer showed that in comparison with the basal group, the PRP group showed no differences in vascularization or pigmentation, but had lower (better) scores regarding thickness, relief, and pliability (at all assessment times). The total assessment values from patients and the observer were significantly better for the PRP than the basal group. Autologous PRP treatment enhanced some parameters associated with healing properties, suggesting a potential therapeutic value after blepharoplasty surgery.

Recovery from DSM-IV post-traumatic stress disorder in the WHO World Mental Health surveys.

PubMed

Rosellini, A J; Liu, H; Petukhova, M V; Sampson, N A; Aguilar-Gaxiola, S; Alonso, J; Borges, G; Bruffaerts, R; Bromet, E J; de Girolamo, G; de Jonge, P; Fayyad, J; Florescu, S; Gureje, O; Haro, J M; Hinkov, H; Karam, E G; Kawakami, N; Koenen, K C; Lee, S; Lépine, J P; Levinson, D; Navarro-Mateu, F; Oladeji, B D; O'Neill, S; Pennell, B-E; Piazza, M; Posada-Villa, J; Scott, K M; Stein, D J; Torres, Y; Viana, M C; Zaslavsky, A M; Kessler, R C

2018-02-01

Research on post-traumatic stress disorder (PTSD) course finds a substantial proportion of cases remit within 6 months, a majority within 2 years, and a substantial minority persists for many years. Results are inconsistent about pre-trauma predictors. The WHO World Mental Health surveys assessed lifetime DSM-IV PTSD presence-course after one randomly-selected trauma, allowing retrospective estimates of PTSD duration. Prior traumas, childhood adversities (CAs), and other lifetime DSM-IV mental disorders were examined as predictors using discrete-time person-month survival analysis among the 1575 respondents with lifetime PTSD. 20%, 27%, and 50% of cases recovered within 3, 6, and 24 months and 77% within 10 years (the longest duration allowing stable estimates). Time-related recall bias was found largely for recoveries after 24 months. Recovery was weakly related to most trauma types other than very low [odds-ratio (OR) 0.2-0.3] early-recovery (within 24 months) associated with purposefully injuring/torturing/killing and witnessing atrocities and very low later-recovery (25+ months) associated with being kidnapped. The significant ORs for prior traumas, CAs, and mental disorders were generally inconsistent between early- and later-recovery models. Cross-validated versions of final models nonetheless discriminated significantly between the 50% of respondents with highest and lowest predicted probabilities of both early-recovery (66-55% v. 43%) and later-recovery (75-68% v. 39%). We found PTSD recovery trajectories similar to those in previous studies. The weak associations of pre-trauma factors with recovery, also consistent with previous studies, presumably are due to stronger influences of post-trauma factors.

Using Behavioral Analytics to Increase Exercise: A Randomized N-of-1 Study.

PubMed

Yoon, Sunmoo; Schwartz, Joseph E; Burg, Matthew M; Kronish, Ian M; Alcantara, Carmela; Julian, Jacob; Parsons, Faith; Davidson, Karina W; Diaz, Keith M

2018-04-01

This intervention study used mobile technologies to investigate whether those randomized to receive a personalized "activity fingerprint" (i.e., a one-time tailored message about personal predictors of exercise developed from 6 months of observational data) increased their physical activity levels relative to those not receiving the fingerprint. A 12-month randomized intervention study. From 2014 to 2015, 79 intermittent exercisers had their daily physical activity assessed by accelerometry (Fitbit Flex) and daily stress experience, a potential predictor of exercise behavior, was assessed by smartphone. Data collected during the first 6 months of observation were used to develop a person-specific "activity fingerprint" (i.e., N-of-1) that was subsequently sent via email on a single occasion to randomized participants. Pre-post changes in the percentage of days exercised were analyzed within and between control and intervention groups. The control group significantly decreased their proportion of days exercised (10.5% decrease, p<0.0001) following randomization. By contrast, the intervention group showed a nonsignificant decrease in the proportion of days exercised (4.0% decrease, p=0.14). Relative to the decrease observed in the control group, receipt of the activity fingerprint significantly increased the likelihood of exercising in the intervention group (6.5%, p=0.04). This N-of-1 intervention study demonstrates that a one-time brief message conveying personalized exercise predictors had a beneficial effect on exercise behavior among urban adults. Copyright © 2018 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

A Randomized Controlled Trial of Cognitive-Behavior Therapy Plus Bright Light Therapy for Adolescent Delayed Sleep Phase Disorder

PubMed Central

Gradisar, Michael; Dohnt, Hayley; Gardner, Greg; Paine, Sarah; Starkey, Karina; Menne, Annemarie; Slater, Amy; Wright, Helen; Hudson, Jennifer L.; Weaver, Edward; Trenowden, Sophie

2011-01-01

Objective: To evaluate cognitive-behavior therapy plus bright light therapy (CBT plus BLT) for adolescents diagnosed with delayed sleep phase disorder (DSPD). Design: Randomized controlled trial of CBT plus BLT vs. waitlist (WL) control with comparisons at pre- and post-treatment. There was 6-month follow-up for the CBT plus BLT group only. Setting: Flinders University Child & Adolescent Sleep Clinic, Adelaide, South Australia. Patients: 49 adolescents (mean age 14.6 ± 1.0 y, 53% males) diagnosed with DSPD; mean chronicity 4 y 8 months; 16% not attending school. Eighteen percent of adolescents dropped out of the study (CBT plus BLT: N = 23 vs WL: N = 17). Interventions: CBT plus BLT consisted of 6 individual sessions, including morning bright light therapy to advance adolescents' circadian rhythms, and cognitive restructuring and sleep education to target associated insomnia and sleep hygiene. Measurements and Results: DSPD diagnosis was performed via a clinical interview and 7-day sleep diary. Measurements at each time-point included online sleep diaries and scales measuring sleepiness, fatigue, and depression symptoms. Compared to WL, moderate-to-large improvements (d = 0.65-1.24) were found at post-treatment for CBT plus BLT adolescents, including reduced sleep latency, earlier sleep onset and rise times, total sleep time (school nights), wake after sleep onset, sleepiness, and fatigue. At 6-month follow-up (N = 15), small-to-large improvements (d = 0.24-1.53) continued for CBT plus BLT adolescents, with effects found for all measures. Significantly fewer adolescents receiving CBT plus BLT met DPSD criteria at post-treatment (WL = 82% vs. CBT plus BLT = 13%, P < 0.0001), yet 13% still met DSPD criteria at the 6-month follow-up. Conclusions: CBT plus BLT for adolescent DSPD is effective for improving multiple sleep and daytime impairments in the immediate and long-term. Studies evaluating the treatment effectiveness of each treatment component are needed. Clinical Trial Information: Australia – New Zealand Trials Registry Number: ACTRN12610001041044. Citation: Gradisar M; Dohnt H; Gardner G; Paine S; Starkey K; Menne A; Slater A; Wright H; Hudson JL; Weaver E; Trenowden S. A randomized controlled trial of cognitive-behavior therapy plus bright light therapy for adolescent delayed sleep phase disorder. SLEEP 2011;34(12):1671-1680. PMID:22131604

Randomized controlled evaluation of an early intervention to prevent post-rape psychopathology.

PubMed

Resnick, Heidi; Acierno, Ron; Waldrop, Angela E; King, Lynda; King, Daniel; Danielson, Carla; Ruggiero, Kenneth J; Kilpatrick, Dean

2007-10-01

A randomized between-group design was used to evaluate the efficacy of a video intervention to reduce post-traumatic stress disorder (PTSD) and other mental health problems, implemented prior to the forensic medical examination conducted within 72 h post-sexual assault. Participants were 140 female victims of sexual assault (68 video/72 nonvideo) aged 15 years or older. Assessments were targeted for 6 weeks (Time 1) and 6 months (Time 2) post-assault. At Time 1, the intervention was associated with lower scores on measures of PTSD and depression among women with a prior rape history relative to scores among women with a prior rape history in the standard care condition. At Time 2, depression scores were also lower among those with a prior rape history who were in the video relative to the standard care condition. Small effects indicating higher PTSD and Beck Anxiety Inventory (BAI) scores among women without a prior rape history in the video condition were observed at Time 1. Accelerated longitudinal growth curve analysis indicated a videoxprior rape history interaction for PTSD, yielding four patterns of symptom trajectory over time. Women with a prior rape history in the video condition generally maintained the lowest level of symptoms.

A Randomized Study Comparing the Shaker Exercise with Traditional Therapy: A Preliminary Study

PubMed Central

Rademaker, Alfred; Pauloski, Barbara Roa; Kelly, Amy; Stangl-McBreen, Carrie; Antinoja, Jodi; Grande, Barbara; Farquharson, Julie; Kern, Mark; Easterling, Caryn; Shaker, Reza

2010-01-01

Seven institutions participated in this small clinical trial that included 19 patients who exhibited oropharyngeal dysphagia on videofluorography (VFG) involving the upper esophageal sphincter (UES) and who had a 3-month history of aspiration. All patients were randomized to either traditional swallowing therapy or the Shaker exercise for 6 weeks. Each patient received a modified barium swallow pre- and post-therapy, including two swallows each of 3 ml and 5 ml liquid barium and 3 ml barium pudding. Each videofluorographic study was sent to a central laboratory and digitized in order to measure hyoid and larynx movement as well as UES opening. Fourteen patients received both pre-and post-therapy VFG studies. There was significantly less aspiration post-therapy in patients in the Shaker group. Residue in the various oral and pharyngeal locations did not differ between the groups. With traditional therapy, there were several significant increases from pre- to post-therapy, including superior laryngeal movement and superior hyoid movement on 3-ml pudding swallows and anterior laryngeal movement on 3-ml liquid boluses, indicating significant improvement in swallowing physiology. After both types of therapy there is a significant increase in UES opening width on 3-ml paste swallows. PMID:19472007

Immunogenicity and safety of the candidate RTS,S/AS01 vaccine in young Nigerian children: a randomized, double-blind, lot-to-lot consistency trial.

PubMed

Umeh, Rich; Oguche, Stephen; Oguonu, Tagbo; Pitmang, Simon; Shu, Elvis; Onyia, Jude-Tony; Daniyam, Comfort A; Shwe, David; Ahmad, Abdullahi; Jongert, Erik; Catteau, Grégory; Lievens, Marc; Ofori-Anyinam, Opokua; Leach, Amanda

2014-11-12

For regulatory approval, consistency in manufacturing of vaccine lots is expected to be demonstrated in confirmatory immunogenicity studies using two-sided equivalence trials. This randomized, double-blind study (NCT01323972) assessed consistency of three RTS,S/AS01 malaria vaccine batches formulated from commercial-scale purified antigen bulk lots in terms of anti-CS-responses induced. Healthy children aged 5-17 months were randomized (1:1:1:1) to receive RTS,S/AS01 at 0-1-2 months from one of three commercial-scale purified antigen bulk lots (1600 litres-fermentation scale; commercial-scale lots), or a comparator vaccine batch made from pilot-scale purified antigen bulk lot (20 litres-fermentation scale; pilot-scale lot). The co-primary objectives were to first demonstrate consistency of antibody responses against circumsporozoite (CS) protein at one month post-dose 3 for the three commercial-scale lots and second demonstrate non-inferiority of anti-CS antibody responses at one month post-dose 3 for the commercial-scale lots compared to the pilot-scale lot. Safety and reactogenicity were evaluated as secondary endpoints. One month post-dose-3, anti-CS antibody geometric mean titres (GMT) for the 3 commercial scale lots were 319.6 EU/ml (95% confidence interval (CI): 268.9-379.8), 241.4 EU/ml (207.6-280.7), and 302.3 EU/ml (259.4-352.3). Consistency for the RTS,S/AS01 commercial-scale lots was demonstrated as the two-sided 95% CI of the anti-CS antibody GMT ratio between each pair of lots was within the range of 0.5-2.0. GMT of the pooled commercial-scale lots (285.8 EU/ml (260.7-313.3)) was non-inferior to the pilot-scale lot (271.7 EU/ml (228.5-323.1)). Each RTS,S/AS01 lot had an acceptable tolerability profile, with infrequent reports of grade 3 solicited symptoms. No safety signals were identified and no serious adverse events were considered related to vaccination. RTS,S/AS01 lots formulated from commercial-scale purified antigen bulk batches induced a consistent anti-CS antibody response, and the anti-CS GMT of pooled commercial-scale lots was non-inferior to that of a lot formulated from a pilot-scale antigen bulk batch. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

POWER for reproductive health: results from a social marketing campaign promoting female and male condoms.

PubMed

Bull, Sheana S; Posner, Samuel F; Ortiz, Charlene; Beaty, Brenda; Benton, Kathryn; Lin, Lillian; Pals, Sherri L; Evans, Tom

2008-07-01

To evaluate effects of a 6-month social marketing campaign on awareness of, attitudes toward and use of female as well as male condoms for 15-25 year-old-women. Using a time-space sampling methodology, we conducted a cross-sectional survey of 3407 women at pre-campaign in 12 western U.S. neighborhoods on female and male condom awareness, attitudes, and use. Six of the 12 study neighborhoods were randomly selected to receive the POWER social marketing campaign designed to impact condom knowledge, attitudes, and use. The campaign was followed with another cross-sectional survey of 3,003 women in all 12 study neighborhoods on condom knowledge, attitudes, use and awareness of POWER materials. We compared pre-and post-campaign surveys to determine the efficacy of POWER and conducted post hoc analyses on post-campaign data to determine if exposure to POWER was related to higher levels of positive condom attitudes and norms and condom use. We found no differences between neighborhoods with and without the POWER campaign with regard to our primary outcomes. To diagnose reasons for this null effect, we examined outcomes post hoc examining the influence of POWER exposure. Post hoc analyses show some evidence that exposure to POWER was associated with condom use. In the context of the nested trial, this raises concerns that post test only evaluations are limited. Establishing the efficacy of a social marketing campaign is challenging. This group randomized trial showed a null effect. Social marketing campaigns may need to have more media channels and saturation before they can show behavioral effects. Using a nested design with randomization at the community level and probability sampling introduces rigor not commonly seen in evaluations of social marketing campaigns.

Tai Chi Chih Compared With Cognitive Behavioral Therapy for the Treatment of Insomnia in Survivors of Breast Cancer: A Randomized, Partially Blinded, Noninferiority Trial

PubMed Central

Olmstead, Richard; Carrillo, Carmen; Sadeghi, Nina; Nicassio, Perry; Ganz, Patricia A.; Bower, Julienne E.

2017-01-01

Purpose Cognitive behavioral therapy for insomnia (CBT-I) and Tai Chi Chih (TCC), a movement meditation, improve insomnia symptoms. Here, we evaluated whether TCC is noninferior to CBT-I for the treatment of insomnia in survivors of breast cancer. Patients and Methods This was a randomized, partially blinded, noninferiority trial that involved survivors of breast cancer with insomnia who were recruited from the Los Angeles community from April 2008 to July 2012. After a 2-month phase-in period with repeated baseline assessment, participants were randomly assigned to 3 months of CBT-I or TCC and evaluated at months 2, 3 (post-treatment), 6, and 15 (follow-up). Primary outcome was insomnia treatment response—that is, marked clinical improvement of symptoms by the Pittsburgh Sleep Quality Index—at 15 months. Secondary outcomes were clinician-assessed remission of insomnia; sleep quality; total sleep time, sleep onset latency, sleep efficiency, and awake after sleep onset, derived from sleep diaries; polysomnography; and symptoms of fatigue, sleepiness, and depression. Results Of 145 participants who were screened, 90 were randomly assigned (CBT-I: n = 45; TCC: n = 45). The proportion of participants who showed insomnia treatment response at 15 months was 43.7% and 46.7% in CBT-I and TCC, respectively. Tests of noninferiority showed that TCC was noninferior to CBT-I at 15 months (P = .02) and at months 3 (P = .02) and 6 (P < .01). For secondary outcomes, insomnia remission was 46.2% and 37.9% in CBT-I and TCC, respectively. CBT-I and TCC groups showed robust improvements in sleep quality, sleep diary measures, and related symptoms (all P < .01), but not polysomnography, with similar improvements in both groups. Conclusion CBT-I and TCC produce clinically meaningful improvements in insomnia. TCC, a mindful movement meditation, was found to be statistically noninferior to CBT-I, the gold standard for behavioral treatment of insomnia. PMID:28489508

Renal, efficacy and safety outcomes following late conversion of kidney transplant patients from calcineurin inhibitor therapy to everolimus: the randomized APOLLO study.

PubMed

Budde, Klemens; Rath, Thomas; Sommerer, Claudia; Haller, Hermann; Reinke, Petra; Witzke, Oliver; Suwelack, Barbara; Baeumer, Daniel; May, Christoph; Porstner, Martina; Arns, Wolfgang

2015-01-01

The primary objective of this trial was to demonstrate, based on the estimated glomerular filtration rate (eGFR), superior renal function at month 12 after conversion of maintenance kidney transplant patients from calcineurin inhibitor (CNI) therapy to everolimus, compared to continuing a standard CNI regimen. APOLLO was an open-label, 12-month, prospective, multicenter study in which 93 maintenance kidney transplant patients were randomized to convert from CNI to everolimus (n = 46) or remain on standard CNI-based immunosuppression (n = 47). The primary efficacy variable was eGFR (Nankivell formula) 12 months after randomization. The study was terminated prematurely due to slow recruitment and was thus underpowered. Mean time post-transplant was 83.5 months with everolimus and 70.1 months with CNI. Adjusted values for eGFR (Nankivell) at month 12 were 61.6 (95% CI 58.1, 65.1) mL/ min/1.73 m² with everolimus and 58.8 (95% CI 55.2, 62.3) mL/min/1.73 m² with CNI, a difference of 2.8 (95% CI -1.0, 6.7) mL/ min/1.73 m² (p = 0.145) i.e., the primary objective was not met. Using the modification of diet in renal disease (MDRD) formula, adjusted eGFR at month 12 was significantly higher with everolimus (p = 0.030). In the subpopulation who remained on the study drug (n = 52), the difference in the adjusted change from randomization was 6.6 (95% CI 1.5, 11.6) mL/min/1.73 m² (p = 0.013) in favor of everolimus. There was no biopsyproven acute rejection and no graft losses. Adverse events led to discontinuation of everolimus and CNI in 32.6% and 10.6% of patients, respectively. Conversion from CNI to everolimus to preserve renal function can be considered several years after kidney transplantation and does not compromise immunosuppressive efficacy.

A Randomized, Controlled Trial of Emotional Disclosure in Rheumatoid Arthritis: Can Clinician Assistance Enhance the Effects?

PubMed Central

Keefe, Francis J.; Anderson, Timothy; Lumley, Mark; Caldwell, David; Stainbrook, David; Mckee, Daphne; Waters, Sandra J.; Connelly, Mark; Affleck, Glenn; Pope, Mary Susan; Weiss, Marianne; Riordan, Paul A.; Uhlin, Brian D.

2008-01-01

Emotional disclosure by writing or talking about stressful life experiences improves health status in non-clinical populations, but its success in clinical populations, particularly rheumatoid arthritis (RA), has been mixed. In this randomized, controlled trial, we attempted to increase the efficacy of emotional disclosure by having a trained clinician help patients emotionally disclose and process stressful experiences. We randomized 98 adults with RA to one of four conditions: a) private verbal emotional disclosure; b) clinician-assisted verbal emotional disclosure; c) arthritis information control (all of which engaged in four, 30-minute laboratory sessions); or d) no-treatment, standard care only control group. Outcome measures (pain, disability, affect, stress) were assessed at baseline, 2 months following treatment (2-month follow-up), and at 5-month, and 15-month follow-ups. A manipulation check demonstrated that, as expected, both types of emotional disclosure led to immediate (post-session) increases in negative affect compared with arthritis information. Outcome analyses at all three follow-ups revealed no clear pattern of effects for either clinician-assisted or private emotional disclosure compared with the two control groups. There were some benefits in terms of a reduction in pain behavior with private disclosure versus clinician-assisted disclosure at the 2 month follow-up, but no other significant between group differences. We conclude that verbal emotional disclosure about stressful experiences, whether conducted privately or assisted by a clinician, has little or no benefit for people with RA. PMID:17923329

Treatment of Periodontal Disease with an Octenidine-based Antiseptic in HIV-positive Patients.

PubMed

Gušić, I; Medić, D; Radovanović Kanjuh, M; Ðurić, M; Brkić, S; Turkulov, V; Predin, T; Mirnić, J

2016-05-01

To evaluate the effects of a periodontal therapy with subsequent application of an octenidine (OCT)-based antiseptic in HIV-positive patients receiving highly active antiretroviral therapy. HIV-positive patients with a clinically diagnosed periodontal disease were randomly divided into two groups (n = 30/group). Both groups initially received a periodontal therapy. Patients in the OCT group additionally used an OCT-based mouthwash. Subgingival plaque samples and periodontal indices were analysed prior to treatment onset as well as one and 3 months post-treatment. Periodontal therapy has resulted in a significant decrease in the values of all periodontal indices one and 3 months following the therapy completion (P = 0.000). The effects of the two applied therapeutic protocols differed significantly in terms of the variation in the PBI (F = 4.617; P = 0.017) and the PD (F = 3.203; P = 0.044) value. In the patients in the OCT group, a more pronounced decrease in the PBI and PD was noted at 1-month follow-up as well as a greater increase in the PD value 3 months upon treatment completion. In the OCT group, no more atypical microorganisms were detectable 1 month post-treatment, while in the control group they were found in 34.5% of patients. The periodontal therapy bears good results in HIV-positive patients. Additional administration of OCT contributes to the significant decline in the PBI and DS values and eliminates atypical microorganisms within 1 month post-treatment. However, more favourable results were not noted in the OCT group at the 3-month assessment. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Pathways to Preventing Substance Use Among Youth in Foster Care.

PubMed

Kim, Hyoun K; Buchanan, Rohanna; Price, Joseph M

2017-07-01

Substance use problems are highly prevalent among youth in foster care. Such problems in adolescence have long-lasting implications for subsequent adjustment throughout adulthood and even across generations. Although several programs have demonstrated positive results in reducing substance use in at-risk youth, few studies have systemically examined how such programs work for foster youth and whether they are effective for both genders. This study examined the efficacy of KEEP SAFE, a family-based and skill-focused program designed to prevent substance use and other related health risking behaviors among youth in foster care. We hypothesized that improving the caregiver-youth relationship would lead to later reductions in youths' involvement with deviant peers, which subsequently would lead to less substance use, and that this mechanism would work comparably for both genders. A sample of 259 youth (154 girls, ages 11-17 years) in foster care and their caregivers participated in a randomized controlled trial and was followed for 18 months post-baseline. Results indicated that the intervention significantly reduced substance use in foster youth at 18 months post-baseline and that the intervention influenced substance use through two processes: youths' improved quality of relationships with caregivers at 6 months post-baseline and fewer associations with deviant peers at 12 months post-baseline. This suggests that these two processes may be fruitful immediate targets in substance use prevention programs for foster youth. We also found little gender differences in direct and mediating effects of the intervention, suggesting KEEP SAFE may be effective for both genders in foster care.

The Mediating Role of Partner Communication Frequency on Condom Use Among African-American Adolescent Females Participating in an HIV Prevention Intervention

PubMed Central

Sales, Jessica M.; Lang, Delia L.; DiClemente, Ralph J.; Latham, Teaniese P; Wingood, Gina M.; Hardin, James W.; Rose, Eve S.

2011-01-01

Objective Although effective HIV prevention interventions have been developed for adolescents, few interventions have explored whether components of the intervention are responsible for the observed changes in behaviors post-intervention. This study examined the mediating role of partner communication frequency on African-American adolescent females’ condom use post-participation in a demonstrated efficacious HIV risk-reduction intervention. Main Outcome Measures Percent condom use in the past 60 days and consistent condom use in the past 6o days across the 12-month follow-up period. Design As part of a randomized controlled trial of African-American adolescent females (N=715), 15-21 years, seeking sexual health services, completed a computerized interview at baseline (prior to intervention) and again 6- and 12-month follow-up post-intervention participation. The interview assessed adolescents’ sexual behavior and partner communication skills, among other variables, at each time point. Using generalized estimating equation (GEE) techniques, both logistic and linear regression models were employed to test mediation over the 12-month follow-up period. Additional tests were conducted to assess the significance of the mediated models. Results Mediation analyses observed that partner communication frequency was a significant partial mediator of both proportion condom-protected sex acts (p =.001) and consistent condom use (p = .001). Conclusion Partner communication frequency, an integral component of this HIV intervention, significantly increased as a function of participating in the intervention partially explaining the change in condom use observed 12-months post-intervention. Understanding what intervention components are associated with behavior change is important for future intervention development. PMID:21843001

Does Prolonged Enteral Feeding With Supplemental Omega-3 Fatty Acids Impact on Recovery Post-esophagectomy: Results of a Randomized Double-Blind Trial.

PubMed

Healy, Laura A; Ryan, Aoife; Doyle, Suzanne L; Ní Bhuachalla, Éadaoin Bríd; Cushen, Samantha; Segurado, Ricardo; Murphy, Thomas; Ravi, Narayanasamy; Donohoe, Claire L; Reynolds, John V

2017-11-01

This randomized controlled trial (RCT) hypothesized that prolonged enteral nutrition (EN) with supplemental eicosapentanoic acid (EPA), an omega-3 fatty acid with immune and anabolic properties, may impact on clinical and nutritional outcomes. Esophagectomy is associated with significant weight loss and catabolism, and negatively impacts quality of life (QL). Strategies to counter sustained catabolism have therapeutic rationale. This multicenter, double-blind, placebo-controlled RCT was powered on a 5% difference in lean body mass (LBM) at 1 month. Patients were randomly assigned to receive either EN-EPA (2.2 g EPA/day) (n = 97) or isocaloric isonitrogenous standard EN (EN-S) (n = 94), preoperatively (5 days orally), and postoperatively via a jejunostomy until 1 month postdischarge. Assessments perioperatively, and at 1, 3, and 6 months included weight, body mass index (BMI), body composition, muscle strength, cytokines, complications, and QL. The median (range) nutrition support was for 51 (36 to 78) days, and overall compliance was 96%. For the entire cohort, a significant (P < 0.005) decrease in weight (-7.4 ± 6.6 kg), BMI (-2.6 ± 2.2 kg/m), LBM (-2.5 ± 8.7 kg), and fat mass (-3.4 ± 5.8 kg) was evident from preoperatively to 6 months. The mean (±SD) loss of LBM (kg) at 1 month was -3.7 ± 8.7 in the EN-S group, compared with -5.6 ± 12.1 in the EN-EPA group (P = 0.355). Per-protocol analysis revealed no difference between the EN-EPA and EN-S in any clinical, nutritional, functional, QL or immune parameter at any time point. The thesis that EPA impacts on anabolism, immune function, and clinical outcomes post-esophagectomy was not supported. Compliance with home EN was excellent, but weight, muscle, and fat loss was significant in 30% of patients, highlighting the complexity of postoperative weight loss.

Treatment seeking as a mechanism of change in a randomized controlled trial of a mobile health intervention to support recovery from alcohol use disorders.

PubMed

Glass, Joseph E; McKay, James R; Gustafson, David H; Kornfield, Rachel; Rathouz, Paul J; McTavish, Fiona M; Atwood, Amy K; Isham, Andrew; Quanbeck, Andrew; Shah, Dhavan

2017-06-01

We estimated the efficacy of the Addiction-Comprehensive Health Enhancement Support System (A-CHESS) in increasing the use of services for addiction and examined the extent to which this use of services mediated the effects of A-CHESS on risky drinking days and abstinence from drinking. We conducted secondary data analyses of the A-CHESS randomized controlled trial. Recruitment occurred in five residential treatment programs operated by two addiction treatment organizations. Participants were 349 adults with alcohol use disorders recruited two weeks before discharge from residential treatment. We provided intervention arm participants with a smartphone, the A-CHESS application, and an 8-month service plan. Control arm participants received treatment as usual. Telephone interviews at 4, 8, and 12-month follow-ups assessed past-month risky drinking days, past-month abstinence, and post-discharge service utilization (past-month outpatient addiction treatment and past-week mutual help including Alcoholics Anonymous and Narcotics Anonymous). Using mixed effects latent variable models, we estimated the indirect effects of A-CHESS on drinking outcomes, as mediated by post-discharge service utilization. Approximately 50.5% of participants reported outpatient addiction treatment and 75.5% reported mutual help at any follow-up interview in the year following randomization. Assignment to the A-CHESS intervention was associated with an increased odds of outpatient addiction treatment across follow-ups, but not mutual help. This use of outpatient addiction treatment mediated the effect of A-CHESS on risky drinking days, but not abstinence. The effect of A-CHESS through outpatient addiction treatment appeared to reduce the expected number of risky drinking days across follow-ups by 11%. The mobile health (mHealth) intervention promoted the use of outpatient addiction treatment, which appeared to contribute to its efficacy in reducing risky drinking. Future research should investigate how mHealth interventions could link patients to needed treatment services and promote the sustained use of these services. Copyright © 2017 Elsevier Inc. All rights reserved.

A pilot randomized controlled trial of on-line interventions to improve sleep quality in adults after mild or moderate traumatic brain injury.

PubMed

Theadom, Alice; Barker-Collo, Suzanne; Jones, Kelly; Dudley, Margaret; Vincent, Norah; Feigin, Valery

2018-05-01

To explore feasibility and potential efficacy of on-line interventions for sleep quality following a traumatic brain injury (TBI). A two parallel-group, randomized controlled pilot study. Community-based. In all, 24 participants (mean age: 35.9 ± 11.8 years) who reported experiencing sleep difficulties between 3 and 36 months after a mild or moderate TBI. Participants were randomized to receive either a cognitive behaviour therapy or an education intervention on-line. Both interventions were self-completed for 20-30 minutes per week over a six-week period. The Pittsburgh Sleep Quality Index assessed self-reported sleep quality with actigraphy used as an objective measure of sleep quality. The CNS Vital Signs on-line neuropsychological test assessed cognitive functioning and the Rivermead Post-concussion Symptoms and Quality of Life after Brain Injury questionnaires were completed pre and post intervention. Both programmes demonstrated feasibility for use post TBI, with 83.3% of participants completing the interventions. The cognitive behaviour therapy group experienced significant reductions ( F = 5.47, p = 0.04) in sleep disturbance (mean individual change = -4.00) in comparison to controls post intervention (mean individual change = -1.50) with a moderate effect size of 1.17. There were no significant group differences on objective sleep quality, cognitive functioning, post-concussion symptoms or quality of life. On-line programmes designed to improve sleep are feasible for use for adults following mild-to-moderate TBI. Based on the effect size identified in this pilot study, 128 people (64 per group) would be needed to determine clinical effectiveness.

Study design to evaluate cognitive behavioral therapy among a diverse sample of adults with a first-time DUI offense.

PubMed

Chan Osilla, Karen; Watkins, Katherine E; Kulesza, Magdalena; Flórez, Karen; Lara-Greenberg, Marielena; Miles, Jeremy N V

2016-03-31

Driving under the influence (DUI) of alcohol is a major public health concern, and many individuals continue to drink and drive even after being convicted of a DUI offense. Latinos, in particular, are disproportionately likely to be arrested for a DUI, have higher rates of recidivism, and are more likely to die in alcohol-related accidents than non-Latino Whites. Latinos also experience significant disparities in accessing alcohol-related treatment. This study protocol paper describes a randomized trial of cognitive behavioral therapy (CBT) compared to usual care in DUI programs for individuals with a first-time offense and at-risk drinking. We will utilize a two-group randomized design where individuals enrolled in a DUI program with a first-time conviction will be randomized to CBT (n = 150) or usual care (n = 150). Participants will be assessed at baseline, immediately post-treatment, and 6-months post-treatment. Recidivism data will be collected using administrative data within 2 years post-treatment. This project has the potential to benefit a large population of vulnerable individuals who are at risk of DUI recidivism. It also develops a new model of care by providing treatment in DUI programs to reduce disparities associated with poor treatment access. Trial registration NCT02588703.

Implementation of a Nutrition Program Reduced Post-Discharge Growth Restriction in Thai Very Low Birth Weight Preterm Infants.

PubMed

Japakasetr, Suchada; Sirikulchayanonta, Chutima; Suthutvoravut, Umaporn; Chindavijak, Busba; Kagawa, Masaharu; Nokdee, Somjai

2016-12-17

Very low birth weight (VLBW) preterm infants are vulnerable to growth restriction after discharge due to cumulative protein and energy deficits during their hospital stay and early post-discharge period. The current study evaluated the effectiveness of the preterm infant, post-discharge nutrition (PIN) program to reduce post-discharge growth restriction in Thai VLBW preterm infants. A prospective, non-randomized interventional cohort study was undertaken to assess the growth of 22 VLBW preterm infants who received the PIN program and compared them with 22 VLBW preterm infants who received conventional nutrition services. Infant's growth was recorded monthly until the infants reached six months' corrected age (6-moCA). Intervention infants had significantly greater body weights ( p = 0.013) and head circumferences ( p = 0.009). Also, a greater proportion of the intervention group recovered their weight to the standard weight at 4-moCA ( p = 0.027) and at 6-moCA ( p = 0.007) and their head circumference to the standard head circumference at 6-moCA ( p = 0.004) compared to their historical comparison counterparts. Enlistment in the PIN program thus resulted in significantly reduced post-discharge growth restriction in VLBW preterm infants. Further research on longer term effects of the program on infant's growth and development is warranted.

The efficacy of proanthocyanidins and secnidazole in the treatment of chronic periodontitis after scaling and root planing therapy.

PubMed

Li, M; Li, R; Jin, Q; Pang, J; Xu, Z

2017-01-01

The aim of this study is to evaluate the clinical and microbiological effect of the systemic antibiotic therapy of proanthocyanidins and secnidazole on periodontitis. Seventy-five subjects with chronic periodontitis were randomly divided into two treatment groups (secnidazole or proanthocyanidins) and one placebo control group (25 cases each). Plaque index (PI), gingival index (GI), gingival bleeding index (BI), probing pocket depth (PPD), and clinical attachment level (CAL) were carried out at baseline, post-treatment and 3 months after treatment. Microbial analysis was performed at baseline and post-treatment. The results show that the two treatment groups had greater mean reduction in BI, GI, and PPD evaluated at both post-treatment and 3 months after treatment compared to the control group (p less than 0.05), but there were no significant differences in those of PI and CAL (except CAL evaluated at post-treatment, p 0.05). After treatment, culturable bacteria counts significantly decreased. In conclusion, the adjunctive use of proanthocyanidins or secnidazole in combination with scaling and root planing in adults with periodontitis is effective in reducing the pathogenic flora and achieves significantly better clinical results to a certain degree.

Effects of horticultural therapy on elderly' health: protocol of a randomized controlled trial.

PubMed

Chan, Hui Yu; Ho, Roger Chun-Man; Mahendran, Rathi; Ng, Kheng Siang; Tam, Wilson Wai-San; Rawtaer, Iris; Tan, Chay Hoon; Larbi, Anis; Feng, Lei; Sia, Angelia; Ng, Maxel Kian-Wee; Gan, Goh Lee; Kua, Ee Heok

2017-08-29

Due to a rapidly ageing population in the world, it is increasingly pertinent to promote successful ageing strategies which are cost-effective, easily accessible, and more likely to be acceptable to the elderly. Past research associates exposure to natural environments and horticultural therapy (HT) with positive psychological, social and physical health benefits. This Randomized Controlled Trial (RCT) is designed to evaluate the efficacy of HT in promoting Asian elderly' mental health, cognitive functioning and physical health. 70 elderly participants aged 60 to 85 years old will be randomized to participate in either the active horticultural therapy group or be in the waitlist control. Sessions will be weekly for 12 weeks, and monthly for 3 months. Mental health will be assessed through self-reports of depressive and anxiety symptomatology, life satisfaction, social connectedness and psychological well-being, collaborated with immunological markers. Outcome measures of cognitive functioning and physical health include neuropsychological tests of cognitive function and basic health screening. Outcomes will be assessed at baseline, 3 months and 6 months post-intervention. This RCT comprehensively investigates the efficacy of a non-invasive intervention, HT, in enhancing mental health, cognitive functioning and physical health. The results have tremendous potential for supporting future successful ageing programs and applicability to larger populations. ClinicalTrials.gov NCT02495194 . Trial registration date: July 13, 2015. Retrospectively registered.

Placental transfusion in preterm neonates of 30-33 weeks' gestation: a randomized controlled trial.

PubMed

Das, Bikramjit; Sundaram, Venkataseshan; Tarnow-Mordi, William; Ghadge, Alpana; Dhaliwal, Lakhbir Kaur; Kumar, Praveen

2018-02-06

To compare effect of placental transfusion by delayed cord clamping (DCC) or cord milking (CM) with early cord clamping (ECC) on a composite of mortality or abnormal neurological status at 40 weeks' post-menstrual age (PMA) and 24-30 months' chronological age in neonates of 30-33 weeks' gestation. Randomized, controlled trial. A composite of mortality or abnormal neurological status at 40 weeks PMA and survival free of neurodevelopmental abnormalities at 24-30 months' chronological age. A total of 461 neonates were randomized to placental transfusion (n = 233) or to ECC (n = 228). Among those assigned to placental transfusion group, 173 underwent DCC while in the remaining 60, CM was done. Incidence of mortality or abnormal neurological status at 40 weeks PMA (43 (18%) vs 35 (15%), RR (95% CI) 1.2 (0.8, 1.8), p = 0.4) and survival free of neurodevelopmental impairment at 24-30 months of chronological age (99 (47%) vs. 100 (50%); RR (95% CI): 0.9 (0.8, 1.2); P = 0.9) was similar between the study groups. The placental transfusion group showed a trend towards lower incidence of necrotizing enterocolitis. In 30-33 weeks' gestation preterm neonates, placental transfusion as compared to early cord clamping resulted in similar mortality or abnormal neurological status at 40 weeks PMA and at 24-30 months of chronological age.

What Effect Does Story Time Have on Toddlers' Social and Emotional Skills

ERIC Educational Resources Information Center

Betawi, I. A.

2015-01-01

The purpose of this study is to investigate the effect of story time and reading stories on the development of toddlers' social and emotional skills between 24 and 36 months of age. A sample of 10 toddlers was randomly selected from three different classes at the laboratory nursery of The University of Jordan. A pre-test and post-test were…

Sustained impact of the "Healthy Habits, Healthy Girls – Brazil" school-based randomized controlled trial for adolescents living in low-income communities

USDA-ARS?s Scientific Manuscript database

Pediatric obesity is a major public health concern in low- and middle-income countries, such as Brazil. There is an urgent need for preventive programs for adolescents and, the assessment of their sustained impact. This paper reports the longer-term (6-month post intervention) effects of the "H3G-Br...

Randomized Effectiveness Study of Four Therapeutic Strategies for TMJ Closed Lock

PubMed Central

Schiffman, E.L.; Look, J.O.; Hodges, J.S.; Swift, J.Q.; Decker, K.L.; Hathaway, K.M.; Templeton, R.B.; Fricton, J.R.

2008-01-01

For individuals with temporomandibular joint (TMJ) disc displacement without reduction with limited mouth opening (closed lock), interventions vary from minimal treatment to surgery. In a single-blind trial, 106 individuals with TMJ closed lock were randomized among medical management, rehabilitation, arthroscopic surgery with post-operative rehabilitation, or arthroplasty with post-operative rehabilitation. Evaluations at baseline, 3, 6, 12, 18, 24, and 60 months used the Craniomandibular Index (CMI) and Symptom Severity Index (SSI) for jaw function and TMJ pain respectively. Using an intention-to-treat analysis, we observed no between-group difference at any follow-up for CMI (p ≥ 0.33) or SSI (p ≥ 0.08). Both outcomes showed within-group improvement (p < 0.0001) for all groups. The findings of this study suggest that primary treatment for individuals with TMJ closed lock should consist of medical management or rehabilitation. The use of this approach will avoid unnecessary surgical procedures. PMID:17189464

A randomized, comparative pilot trial of family-based interpersonal psychotherapy for reducing psychosocial symptoms, disordered-eating, and excess weight gain in at-risk preadolescents with loss-of-control-eating.

PubMed

Shomaker, Lauren B; Tanofsky-Kraff, Marian; Matherne, Camden E; Mehari, Rim D; Olsen, Cara H; Marwitz, Shannon E; Bakalar, Jennifer L; Ranzenhofer, Lisa M; Kelly, Nichole R; Schvey, Natasha A; Burke, Natasha L; Cassidy, Omni; Brady, Sheila M; Dietz, Laura J; Wilfley, Denise E; Yanovski, Susan Z; Yanovski, Jack A

2017-09-01

Preadolescent loss-of-control-eating (LOC-eating) is a risk factor for excess weight gain and binge-eating-disorder. We evaluated feasibility and acceptability of a preventive family-based interpersonal psychotherapy (FB-IPT) program. FB-IPT was compared to family-based health education (FB-HE) to evaluate changes in children's psychosocial functioning, LOC-eating, and body mass. A randomized, controlled pilot trial was conducted with 29 children, 8 to 13 years who had overweight/obesity and LOC-eating. Youth-parent dyads were randomized to 12-week FB-IPT (n = 15) or FB-HE (n = 14) and evaluated at post-treatment, six-months, and one-year. Changes in child psychosocial functioning, LOC-eating, BMI, and adiposity by dual-energy-X-ray-absorptiometry were assessed. Missing follow-up data were multiply imputed. FB-IPT feasibility and acceptability were indicated by good attendance (83%) and perceived benefits to social interactions and eating. Follow-up assessments were completed by 73% FB-IPT and 86% FB-HE at post-treatment, 60% and 64% at six-months, and 47% and 57% at one-year. At post-treatment, children in FB-IPT reported greater decreases in depression (95% CI -7.23, -2.01, Cohen's d = 1.23) and anxiety (95% CI -6.08, -0.70, Cohen's d = .79) and less odds of LOC-eating (95% CI -3.93, -0.03, Cohen's d = .38) than FB-HE. At six-months, children in FB-IPT had greater reductions in disordered-eating attitudes (95% CI -0.72, -0.05, Cohen's d = .66) and at one-year, tended to have greater decreases in depressive symptoms (95% CI -8.82, 0.44, Cohen's d = .69) than FB-HE. There was no difference in BMI gain between the groups. Family-based approaches that address interpersonal and emotional underpinnings of LOC-eating in preadolescents with overweight/obesity show preliminary promise, particularly for reducing internalizing symptoms. Whether observed psychological benefits translate into sustained prevention of disordered-eating or excess weight gain requires further study. © 2017 Wiley Periodicals, Inc.

Protocol for a randomized controlled trial of a specialized health coaching intervention to prevent excessive gestational weight gain and postpartum weight retention in women: the HIPP study.

PubMed

Skouteris, Helen; McCabe, Marita; Milgrom, Jeannette; Kent, Bridie; Bruce, Lauren J; Mihalopoulos, Cathrine; Herring, Sharon J; Barnett, Malcolm; Patterson, Denise; Teale, Glyn; Gale, Janette

2012-01-25

Pregnancy is a time of significant physiological and physical change for women. In particular, it is a time at which many women are at risk of gaining excessive weight. We describe the rationale and methods of the Health in Pregnancy and Post-birth (HIPP) Study, a study which aims primarily to determine the effectiveness of a specialized health coaching (HC) intervention during pregnancy, compared to education alone, in preventing excessive gestational weight gain and postpartum weight retention 12 months post birth. A secondary aim of this study is to evaluate the mechanisms by which our HC intervention impacts on weight management both during pregnancy and post birth. The randomized controlled trial will be conducted with 220 women who have a BMI > 18.5 (American IOM cut-off for normal weight), are 18 years of age or older, English speaking, no history of disordered eating or diabetes and are less than 18 weeks gestation at recruitment. Women will be randomly allocated to either a specialized HC intervention group or an Education Alone group. Our specialized HC intervention has two components: (1) one-on-one sessions with a Health Coach, and (2) two by two hour educational group sessions led by a Health Coach. Women in the Education Alone group will receive two by two hour educational group sessions with no HC components. Body Mass Index, waist circumference, and psychological factors including motivation, readiness to change, symptoms of depression and anxiety, and body dissatisfaction will be assessed at baseline (14-16 weeks gestation), and again at follow-up: 32 weeks gestation, 6 weeks, 6 months and 12 months postpartum. Our study responds to the urgent need to design effective interventions in pregnancy to prevent excessive gestational weight gain and postpartum weight retention. Our pregnancy HC intervention is novel and innovative and has been designed to be easily adopted by health professionals who work with pregnant women, such as obstetricians, midwives, allied health professionals and health psychologists. Australian New Zealand Clinical Trials Registry ACTRN12611000331932.

World Health Organization "School Mental Health Manual"-based training for school teachers in Urban Lahore, Pakistan: study protocol for a randomized controlled trial.

PubMed

Imran, Nazish; Rahman, Atif; Chaudhry, Nakhshab; Asif, Aftab

2018-05-24

The teacher's role in school mental health initiatives cannot be overemphasized. Despite global evidence of educational interventions in improving teachers' knowledge and attitudes regarding mental health, this area remains under researched in Pakistan. This paper presents a study protocol of a pilot randomized controlled trial to examine the effectiveness of a teacher training intervention for improving mental health literacy and self-efficacy among school teachers in urban Lahore, Pakistan. The randomized controlled trial will follow the CONSORT guidelines. Participants will be allocated to the Intervention group (receiving the World Health Organization, Eastern Mediterranean Region (WHO-EMRO) School Mental Health Manual-based intervention in three 6-h, face-to-face sessions) or a waitlist control group (not receiving training during the study period). Participants will be teachers of private schools with similar broad demographic characteristics in an inner city area of Lahore. The primary outcome measures for the trial is teachers' mental health literacy. It will be assessed by using the previously applied (during WHO training of Master Trainers) self-administered questionnaire in both groups pre and post training and at 3 months' follow-up. Secondary outcomes include: for teachers: Teachers' self-efficacy (assessed by the Teachers' Sense of Self Efficacy Scale (TSES) short form.); for students (11-16 years): socio-emotional skills and psychological problems measured by the Strengths and Difficulties Questionnaire (assessed at baseline and 3 months post intervention); for schools: the WHO School Psychosocial Profile Questionnaire (baseline and 3 months post intervention). Given the high prevalence of child mental health problems, stigma and lack of services, it is important to consider alternate avenues for promoting positive mental health among youth. This pilot study should establish the effectiveness of the WHO-EMRO School Mental Health Manual-based Intervention improving teacher's mental health literacy and helping them to learn practical steps that can be implemented at low cost in school settings. It will also provide information regarding intervention implementation and sustainability. ClinicalTrials.gov, ID: NCT02937714 . Registered on 18 October 2016.

Functional weight-bearing mobilization after Achilles tendon rupture enhances early healing response: a single-blinded randomized controlled trial.

PubMed

Valkering, Kars P; Aufwerber, Susanna; Ranuccio, Francesco; Lunini, Enricomaria; Edman, Gunnar; Ackermann, Paul W

2017-06-01

Functional weight-bearing mobilization may improve repair of Achilles tendon rupture (ATR), but the underlying mechanisms and outcome were unknown. We hypothesized that functional weight-bearing mobilization by means of increased metabolism could improve both early and long-term healing. In this prospective randomized controlled trial, patients with acute ATR were randomized to either direct post-operative functional weight-bearing mobilization (n = 27) in an orthosis or to non-weight-bearing (n = 29) plaster cast immobilization. During the first two post-operative weeks, 15°-30° of plantar flexion was allowed and encouraged in the functional weight-bearing mobilization group. At 2 weeks, patients in the non-weight-bearing cast immobilization group received a stiff orthosis, while the functional weight-bearing mobilization group continued with increased range of motion. At 6 weeks, all patients discontinued immobilization. At 2 weeks, healing metabolites and markers of procollagen type I (PINP) and III (PIIINP) were examined using microdialysis. At 6 and 12 months, functional outcome using heel-rise test was assessed. Healing tendons of both groups exhibited increased levels of metabolites glutamate, lactate, pyruvate, and of PIIINP (all p < 0.05). Patients in functional weight-bearing mobilization group demonstrated significantly higher concentrations of glutamate compared to the non-weight-bearing cast immobilization group (p = 0.045).The upregulated glutamate levels were significantly correlated with the concentrations of PINP (r = 0.5, p = 0.002) as well as with improved functional outcome at 6 months (r = 0.4; p = 0.014). Heel-rise tests at 6 and 12 months did not display any differences between the two groups. Functional weight-bearing mobilization enhanced the early healing response of ATR. In addition, early ankle range of motion was improved without the risk of Achilles tendon elongation and without altering long-term functional outcome. The relationship between functional weight-bearing mobilization-induced upregulation of glutamate and enhanced healing suggests novel opportunities to optimize post-operative rehabilitation.

Efficacy and Safety of Ranibizumab 0.5 mg for the Treatment of Macular Edema Resulting from Uncommon Causes: Twelve-Month Findings from PROMETHEUS.

PubMed

Staurenghi, Giovanni; Lai, Timothy Y Y; Mitchell, Paul; Wolf, Sebastian; Wenzel, Andreas; Li, Jun; Bhaumik, Amitabha; Hykin, Philip G

2018-06-01

To evaluate the efficacy and safety of ranibizumab 0.5 mg in adult patients with macular edema (ME) resulting from any cause other than diabetes, retinal vein occlusion, or neovascular age-related macular degeneration. A phase 3, 12-month, double-masked, randomized, sham-controlled, multicenter study. One hundred seventy-eight eligible patients aged ≥18 years. Patients were randomized 2:1 to receive either ranibizumab 0.5 mg (n = 118) or sham (n = 60) at baseline and month 1. From month 2, patients in both arms received open-label individualized ranibizumab treatment based on disease activity. A preplanned subgroup analysis was conducted on the primary end point on 5 predefined baseline ME etiologies (inflammatory/post-uveitis, pseudophakic or aphakic, central serous chorioretinopathy, idiopathic, and miscellaneous). Changes in best-corrected visual acuity (BCVA; Early Treatment Diabetic Retinopathy Study letters) from baseline to month 2 (primary end point) and month 12 and safety over 12 months. Overall, 156 patients (87.6%) completed the study. The baseline characteristics were well balanced between the treatment arms. Overall, ranibizumab showed superior efficacy versus sham from baseline to month 2 (least squares mean BCVA, +5.7 letters vs. +2.9 letters; 1-sided P = 0.0111), that is, a treatment effect (TE) of +2.8 letters. The mean BCVA gain from baseline to month 12 was 9.6 letters with ranibizumab. The TE at month 2 was variable in the 5 predefined etiology subgroups, ranging from >5-letter gain to 0.5-letter loss. The safety findings were consistent with the well-established safety profile of ranibizumab. The primary end point was met and ranibizumab showed superiority in BCVA gain over sham in treating ME due to uncommon causes, with a TE of +2.8 letters versus sham at month 2. At month 12, the mean BCVA gain was high (9.6 letters) in the ranibizumab arm; however, the TE was observed to be variable across the different etiology subgroups, reaching a >1-line TE in BCVA in patients with ME resulting from inflammatory conditions/post-uveitis or after cataract surgery. Overall, ranibizumab was well tolerated with no new safety findings up to month 12. Copyright © 2018 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Acceptability and feasibility of an e-mental health intervention for parents of childhood cancer survivors: "Cascade".

PubMed

Wakefield, Claire E; Sansom-Daly, Ursula M; McGill, Brittany C; Ellis, Sarah J; Doolan, Emma L; Robertson, Eden G; Mathur, Sanaa; Cohn, Richard J

2016-06-01

The aim of this study was to evaluate the feasibility and acceptability of "Cascade": an online, group-based, cognitive behavioral therapy intervention, delivered "live" by a psychologist, to assist parents of children who have completed cancer treatment. Forty-seven parents were randomized to Cascade (n = 25) or a 6-month waitlist (n = 22). Parents completed questionnaires at baseline, 1-2 weeks and 6 months post-intervention. Thirty parents completed full evaluations of the Cascade program (n = 21 randomized to Cascade, n = 9 completed Cascade post-waitlist). Ninety-six percent of Cascade participants completed the intervention (n = 24/25). Eighty percent of parents completed every questionnaire (mean completion time 25 min (SD = 12)). Cascade was described as at least "somewhat" helpful by all parents. None rated Cascade as "very/quite" burdensome. Parents reported that the "online format was easy to use" (n = 28, 93.3 %), "I learnt new skills" (n = 28, 93.3 %), and "I enjoyed talking to others" (n = 29, 96.7 %). Peer-to-peer benefits were highlighted by good group cohesion scores. Cascade is highly acceptable and feasible. Its online delivery mechanism may address inequities in post-treatment support for parents, a particularly acute concern for rural/remote families. Future research needs to establish the efficacy of the intervention. ACTRN12613000270718, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12613000270718.

Zonisamide and renal calculi in patients with epilepsy: how big an issue?

PubMed

Wroe, Stephen

2007-08-01

To determine the prevalence of renal calculi in patients treated with zonisamide during randomized, controlled and open-label clinical trials, and from post-marketing surveillance data. Reports of renal calculi from four placebo-controlled double-blind trials of zonisamide, their long-term open-label treatment extension phases, and the US/European zonisamide clinical trial programme were reviewed. One double-blind study and its extension included routine ultrasound screening to identify asymptomatic calculi. Post-marketing surveillance data were also investigated, as was concomitant treatment with topiramate. No symptomatic renal calculi were reported during four randomized double-blind, placebo-controlled trials involving 848 subjects (including 498 zonisamide recipients) treated for up to 3 months. In long-term extension studies with treatment for up to 24 months, symptomatic renal calculi were reported in 9/626 (1.4%) patients. Pooled safety data from all US/European clinical trials identified 15/1296 (1.2%) patients with symptomatic renal calculi during treatment for up to 8.7 years. Post-marketing surveillance revealed nine cases from 59 667 patient-years of exposure in the USA, and 14 from 709 294 patient-years of exposure in Japan; only one case occurred during concomitant topiramate and zonisamide treatment. No imbalance in electrolyte levels was found from 35 patients receiving such co-treatment in clinical trials. The available data suggest that the risk of developing renal calculi during zonisamide treatment is low. Data are insufficient to determine whether concomitant treatment with topiramate increases the risk of renal stones.

Race-ethnicity on blood pressure control after ischemic stroke: a prospective cohort study.

PubMed

Nguyen-Huynh, Mai N; Hills, Nancy K; Sidney, Stephen; Klingman, Jeffrey G; Johnston, S Claiborne

2017-01-01

Disparities in health care access and socioeconomic status (SES) have been associated with racial-ethnic differences in blood pressure (BP) control. We examined post-ischemic stroke BP in a multiethnic cohort with good health care access. We included all hypertensive patients (n = 2972) from a randomized quality improvement trial on secondary stroke prevention, conducted in 14 Kaiser Permanente hospitals in Northern California from 2004-2006 (QUISP). Average age 73.2 ± 12.2 years; 52% female, 66% non-Hispanic white, 14% African-American, 11% Asian, 8% Hispanic, and 1% other. Demographics, diagnoses, health care utilization, BP measurements, and medications were obtained as part of routine care. We used random effects logistic regression models to examine race as a predictor of blood pressure control (<140/90 mm Hg) at 6 months post-discharge, adjusted for SES, age, gender, dementia, antihypertensive therapy, and attendance at follow-up visits. At 6 months, BP was controlled in 52.7% of blacks compared to 61.4% of whites (OR = 0.63, 95% CI, 0.48-0.82, P = .001). Black race remained independently associated with poorer BP control in adjusted analysis, although blacks were as likely to attend post-discharge visits, and more likely to be on any antihypertensive therapy than whites. Greater difficulty in controlling BP and lifestyle differences may account for this difference. Copyright © 2016 American Society of Hypertension. Published by Elsevier Inc. All rights reserved.

Dentin-like versus Rigid Endodontic Post: 11-year Randomized Controlled Pilot Trial on No-wall to 2-wall Defects.

PubMed

Naumann, Michael; Sterzenbach, Guido; Dietrich, Thomas; Bitter, Kerstin; Frankenberger, Roland; von Stein-Lausnitz, Manja

2017-11-01

This is the first long-term randomized controlled trial to evaluate dentin-like glass fiber posts (GFPs) compared with rather rigid titanium posts (TPs) for post-endodontic restoration of severely damaged endodontically treated teeth with 2 or fewer remaining cavity walls. Ninety-one subjects in need of post-endodontic restorations were randomly assigned to receive either a tapered GFP (n = 45) or TP (n = 46). Posts were adhesively luted by using self-adhesive resin cement, followed by composite core build-up and preparation of 2-mm ferrule design. Primary end point was loss of restoration for any reason. Kaplan-Meier curves were constructed, and log-rank test was calculated (P < .05). After a follow-up of 132 months, 17 GFP and 20 TP restorations survived, and 19 failed (12 GFP, 7 TP). Failure modes for GFP were root fracture (n = 4), core fracture (n = 1), secondary caries (n = 1), endodontic failure (n = 2), extraction because of tooth mobility grade III associated with insufficient design of removable partial denture (n = 1), tooth fracture (n = 1), and changes in treatment plan (n = 2); failure modes for TP were endodontic failure (n = 5), root fracture (n = 1), and 1 extraction for other reasons. Cumulative survival probability was 58.7% for GFP and 74.2% for TP. When using self-adhesively luted prefabricated posts, resin composite core build-up, and 2-mm ferrule to reconstruct severely damaged endodontically treated teeth, tooth survival is not influenced by post rigidity. Survival decreased rapidly after 8 years of observation in both groups. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Increased Hospital-Based Physical Rehabilitation and Information Provision After Intensive Care Unit Discharge: The RECOVER Randomized Clinical Trial.

PubMed

Walsh, Timothy S; Salisbury, Lisa G; Merriweather, Judith L; Boyd, Julia A; Griffith, David M; Huby, Guro; Kean, Susanne; Mackenzie, Simon J; Krishan, Ashma; Lewis, Stephanie C; Murray, Gordon D; Forbes, John F; Smith, Joel; Rattray, Janice E; Hull, Alastair M; Ramsay, Pamela

2015-06-01

Critical illness results in disability and reduced health-related quality of life (HRQOL), but the optimum timing and components of rehabilitation are uncertain. To evaluate the effect of increasing physical and nutritional rehabilitation plus information delivered during the post-intensive care unit (ICU) acute hospital stay by dedicated rehabilitation assistants on subsequent mobility, HRQOL, and prevalent disabilities. A parallel group, randomized clinical trial with blinded outcome assessment at 2 hospitals in Edinburgh, Scotland, of 240 patients discharged from the ICU between December 1, 2010, and January 31, 2013, who required at least 48 hours of mechanical ventilation. Analysis for the primary outcome and other 3-month outcomes was performed between June and August 2013; for the 6- and 12-month outcomes and the health economic evaluation, between March and April 2014. During the post-ICU hospital stay, both groups received physiotherapy and dietetic, occupational, and speech/language therapy, but patients in the intervention group received rehabilitation that typically increased the frequency of mobility and exercise therapies 2- to 3-fold, increased dietetic assessment and treatment, used individualized goal setting, and provided greater illness-specific information. Intervention group therapy was coordinated and delivered by a dedicated rehabilitation practitioner. The Rivermead Mobility Index (RMI) (range 0-15) at 3 months; higher scores indicate greater mobility. Secondary outcomes included HRQOL, psychological outcomes, self-reported symptoms, patient experience, and cost-effectiveness during a 12-month follow-up (completed in February 2014). Median RMI at randomization was 3 (interquartile range [IQR], 1-6) and at 3 months was 13 (IQR, 10-14) for the intervention and usual care groups (mean difference, -0.2 [95% CI, -1.3 to 0.9; P = .71]). The HRQOL scores were unchanged by the intervention (mean difference in the Physical Component Summary score, -0.1 [95% CI, -3.3 to 3.1; P = .96]; and in the Mental Component Summary score, 0.2 [95% CI, -3.4 to 3.8; P = .91]). No differences were found for self-reported symptoms of fatigue, pain, appetite, joint stiffness, or breathlessness. Levels of anxiety, depression, and posttraumatic stress were similar, as were hand grip strength and the timed Up & Go test. No differences were found at the 6- or 12-month follow-up for any outcome measures. However, patients in the intervention group reported greater satisfaction with physiotherapy, nutritional support, coordination of care, and information provision. Post-ICU hospital-based rehabilitation, including increased physical and nutritional therapy plus information provision, did not improve physical recovery or HRQOL, but improved patient satisfaction with many aspects of recovery. isrctn.com Identifier: ISRCTN09412438.

Randomized controlled trial of accelerated resolution therapy (ART) for symptoms of combat-related post-traumatic stress disorder (PTSD).

PubMed

Kip, Kevin E; Rosenzweig, Laney; Hernandez, Diego F; Shuman, Amy; Sullivan, Kelly L; Long, Christopher J; Taylor, James; McGhee, Stephen; Girling, Sue Ann; Wittenberg, Trudy; Sahebzamani, Frances M; Lengacher, Cecile A; Kadel, Rajendra; Diamond, David M

2013-12-01

Therapies for post-traumatic stress disorder (PTSD) endorsed by the Department of Defense and Veterans Administration are relatively lengthy, costly, and yield variable success. We evaluated Accelerated Resolution Therapy (ART) for the treatment of combat-related psychological trauma. A randomized controlled trial of ART versus an Attention Control (AC) regimen was conducted among 57 U.S. service members/veterans. After random assignment, those assigned to AC were offered crossover to ART, with 3-month follow-up on all participants. Self-report symptoms of PTSD and comorbidities were analyzed among study completers and by the intention-to-treat principle. Mean age was 41 ± 13 years with 19% female, 54% Army, and 68% with prior PTSD treatment. The ART was delivered in 3.7 ± 1.1 sessions with a 94% completion rate. Mean reductions in symptoms of PTSD, depression, anxiety, and trauma-related guilt were significantly greater (p < 0.001) with ART compared to AC. Favorable results for those treated with ART persisted at 3 months, including reduction in aggression (p < 0.0001). Adverse treatment-related events were rare and not serious. ART appears to be a safe and effective treatment for symptoms of combat-related PTSD, including refractory PTSD, and is delivered in significantly less time than therapies endorsed by the Department of Defense and Veterans Administration. Reprint & Copyright © 2013 Association of Military Surgeons of the U.S.

Mindfulness vs psychoeducation in adult ADHD: a randomized controlled trial.

PubMed

Hoxhaj, E; Sadohara, C; Borel, P; D'Amelio, R; Sobanski, E; Müller, H; Feige, B; Matthies, S; Philipsen, Alexandra

2018-06-01

Mindfulness training is a promising treatment approach in adult ADHD. However, there has not yet been a randomized controlled trial comparing mindfulness to an active control condition. In this study, we assessed the efficacy of a mindfulness training program (MAP) compared to structured psychoeducation (PE). After randomization 81 medication-free adult ADHD patients participated either in an 8-week MAP or PE group program. At baseline (T1), after 8 weeks (T2) and after 8 months (T3), severity of ADHD and associated symptoms (depression, general psychopathology, quality of life) were measured with the Conner's ADHD Rating Scales (CAARS), the Beck Depression Inventory (BDI), the Brief Symptom Inventory (BSI) and the SF-36 by self and blind observer ratings. Both groups showed significant pre-post improvements in observer-rated Inattention scale (p < .001, partial η 2  = 0.18) and in associated symptomatology, which persisted through 6 months of follow-up. There were no significant differences regarding symptom reduction between the treatment groups. Women benefited more compared to men irrespective of treatment group. Men showed the most pronounced changes under MAP. In the current study, MAP was not superior to PE regarding symptom reduction in adult ADHD. Both interventions, mindfulness meditation and PE, were efficacious in reducing symptom load in adult ADHD. Furthermore in exploratory post hoc tests the study provides evidence for a potential gender-specific treatment response in adult ADHD.

Mediation Analysis of the Efficacy of the Eban HIV/STD Risk-Reduction Intervention for African American HIV Serodiscordant Couples.

PubMed

El-Bassel, Nabila; Jemmott, John B; Bellamy, Scarlett L; Pequegnat, Willo; Wingood, Gina M; Wyatt, Gail E; Landis, J Richard; Remien, Robert H

2016-06-01

Targeting couples is a promising behavioral HIV risk-reduction strategy, but the mechanisms underlying the effects of such interventions are unknown. We report secondary analyses testing whether Social-Cognitive-Theory variables mediated the Eban HIV-risk-reduction intervention's effects on condom-use outcomes. In a multisite randomized controlled trial conducted in four US cities, 535 African American HIV-serodiscordant couples were randomized to the Eban HIV risk-reduction intervention or attention-matched control intervention. Outcomes were proportion condom-protected sex, consistent condom use, and frequency of unprotected sex measured pre-, immediately post-, and 6 and 12 months post-intervention. Potential mediators included Social-Cognitive-Theory variables: outcome expectancies and self-efficacy. Mediation analyses using the product-of-coefficients approach in a generalized-estimating-equations framework revealed that condom-use outcome expectancy, partner-reaction outcome expectancy, intention, self-efficacy, and safer-sex communication improved post-intervention and mediated intervention-induced improvements in condom-use outcomes. These findings underscore the importance of targeting outcome expectancies, self-efficacy, and safer-sex communication in couples-level HIV risk-reduction interventions.

Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Gestational diabetes mellitus (GDM) is defined as glucose intolerance with its onset or first recognition during pregnancy. Post-GDM women have a life-time risk exceeding 70% of developing type 2 diabetes mellitus (T2DM). Lifestyle modifications reduce the incidence of T2DM by up to 58% for high-risk individuals. Methods/Design The Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) is a randomized controlled trial aiming to assess the effectiveness of a structured diabetes prevention intervention for post-GDM women. This trial has an intervention group participating in a diabetes prevention program (DPP), and a control group receiving usual care from their general practitioners during the same time period. The 12-month intervention comprises an individual session followed by five group sessions at two-week intervals, and two follow-up telephone calls. A total of 574 women will be recruited, with 287 in each arm. The women will undergo blood tests, anthropometric measurements, and self-reported health status, diet, physical activity, quality of life, depression, risk perception and healthcare service usage, at baseline and 12 months. At completion, primary outcome (changes in diabetes risk) and secondary outcome (changes in psychosocial and quality of life measurements and in cardiovascular disease risk factors) will be assessed in both groups. Discussion This study aims to show whether MAGDA-DPP leads to a reduction in diabetes risk for post-GDM women. The characteristics that predict intervention completion and improvement in clinical and behavioral measures will be useful for further development of DPPs for this population. Trial registration Australian New Zealand Clinical Trials Registry ANZCTRN 12610000338066 PMID:24135085

A Randomized, Double-blind Evaluation of D-cycloserine or Alprazolam Combined with Virtual Reality Exposure Therapy for Posttraumatic Stress Disorder (PTSD) in Iraq and Afghanistan War Veterans

PubMed Central

Rothbaum, Barbara Olasov; Price, Matthew; Jovanovic, Tanja; Norrholm, Seth D.; Gerardi, Maryrose; Dunlop, Boadie; Davis, Michael; Bradley, Bekh; Duncan, Erica; Rizzo, Albert “Skip”; Ressler, Kerry J.

2014-01-01

Objective To determine the effectiveness of Virtual Reality Exposure (VRE) augmented with D-cycloserine (50mg) or alprazolam (0.25mg), compared to placebo, in reducing PTSD due to military trauma in Iraq and Afghanistan. Method A double-blind, placebo-controlled randomized clinical trial comparing augmentation methods for VRE for subjects (n= 156) with PTSD was conducted. Results PTSD symptoms significantly improved from pre- to post-treatment over the 6-session VRE treatment (p<.001) across all conditions and were maintained at 3, 6, and 12 months follow-up. There were no overall differences between the D-cycloserine group on symptoms at any time-point. The alprazolam and placebo conditions significantly differed on the post-treatment Clinician Administered PTSD scale (p = .006) and the 3-month post-treatment PTSD diagnosis, such that the alprazolam group showed greater rates of PTSD (79.2% alprazolam vs. 47.8% placebo). Between-session extinction learning was a treatment-specific enhancer of outcome for the D-cycloserine group only (p<.005). At post-treatment, the D-cycloserine group was the lowest on cortisol reactivity (p<.05) and startle response during VR scenes (p<.05). Conclusions A small number of VRE sessions were associated with reduced PTSD diagnosis and symptoms in Iraq/Afghanistan veterans, although there was no control condition for the VRE. Overall, there was no advantage of D-cycloserine on PTSD symptoms in primary analyses. In secondary analyses, benzodiazepine use during treatment may impair recovery, and D-cycloserine may enhance VRE in patients who demonstrate within-session learning. D-cycloserine augmentation treatment in PTSD patients may reduce cortisol and startle reactivity compared to the alprazolam and placebo treatment, consistent with the animal literature. PMID:24743802

Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: study protocol for a randomized controlled trial.

PubMed

Shih, Sophy T F; Davis-Lameloise, Nathalie; Janus, Edward D; Wildey, Carol; Versace, Vincent L; Hagger, Virginia; Asproloupos, Dino; O'Reilly, Sharleen; Phillips, Paddy A; Ackland, Michael; Skinner, Timothy; Oats, Jeremy; Carter, Rob; Best, James D; Dunbar, James A

2013-10-17

Gestational diabetes mellitus (GDM) is defined as glucose intolerance with its onset or first recognition during pregnancy. Post-GDM women have a life-time risk exceeding 70% of developing type 2 diabetes mellitus (T2DM). Lifestyle modifications reduce the incidence of T2DM by up to 58% for high-risk individuals. The Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) is a randomized controlled trial aiming to assess the effectiveness of a structured diabetes prevention intervention for post-GDM women. This trial has an intervention group participating in a diabetes prevention program (DPP), and a control group receiving usual care from their general practitioners during the same time period. The 12-month intervention comprises an individual session followed by five group sessions at two-week intervals, and two follow-up telephone calls. A total of 574 women will be recruited, with 287 in each arm. The women will undergo blood tests, anthropometric measurements, and self-reported health status, diet, physical activity, quality of life, depression, risk perception and healthcare service usage, at baseline and 12 months. At completion, primary outcome (changes in diabetes risk) and secondary outcome (changes in psychosocial and quality of life measurements and in cardiovascular disease risk factors) will be assessed in both groups. This study aims to show whether MAGDA-DPP leads to a reduction in diabetes risk for post-GDM women. The characteristics that predict intervention completion and improvement in clinical and behavioral measures will be useful for further development of DPPs for this population. Australian New Zealand Clinical Trials Registry ANZCTRN 12610000338066.

Estimated medical expenditure and risk of job loss among rheumatoid arthritis patients undergoing tofacitinib treatment: post hoc analyses of two randomized clinical trials.

PubMed

Rendas-Baum, Regina; Kosinski, Mark; Singh, Amitabh; Mebus, Charles A; Wilkinson, Bethany E; Wallenstein, Gene V

2017-08-01

RA causes high disability levels and reduces health-related quality of life, triggering increased costs and risk of unemployment. Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. These post hoc analyses of phase 3 data aimed to assess monthly medical expenditure (MME) and risk of job loss for tofacitinib treatment vs placebo. Data analysed were from two randomized phase 3 studies of RA patients (n = 1115) with inadequate response to MTX or TNF inhibitors (TNFi) receiving tofacitinib 5 or 10 mg twice daily, adalimumab (one study only) or placebo, in combination with MTX. Short Form 36 version 2 Health Survey physical and mental component summary scores were translated into predicted MME via an algorithm and concurrent inability to work and job loss risks at 6, 12 and 24 months, using Medical Outcomes Study data. MME reduction by month 3 was $100 greater for tofacitinib- than placebo-treated TNFi inadequate responders (P < 0.001); >20 and 6% reductions from baseline, respectively. By month 3 of tofacitinib treatment, the odds of inability to work decreased ⩾16%, and risk of future job loss decreased ∼20% (P < 0.001 vs placebo). MME reduction by month 3 was $70 greater for tofacitinib- than placebo-treated MTX inadequate responders (P < 0.001); ⩾23 and 13% reductions from baseline, respectively. By month 3 of tofacitinib treatment, the odds of inability to work decreased ⩾31% and risk of future job loss decreased ⩾25% (P < 0.001 vs placebo). Tofacitinib treatment had a positive impact on estimated medical expenditure and risk of job loss for RA patients with inadequate response to MTX or TNFi. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology.

Efficacy and safety of trabectedin or dacarbazine in patients with advanced uterine leiomyosarcoma after failure of anthracycline-based chemotherapy: Subgroup analysis of a phase 3, randomized clinical trial.

PubMed

Hensley, Martee L; Patel, Shreyaskumar R; von Mehren, Margaret; Ganjoo, Kristen; Jones, Robin L; Staddon, Arthur; Rushing, Daniel; Milhem, Mohammed; Monk, Bradley; Wang, George; McCarthy, Sharon; Knoblauch, Roland E; Parekh, Trilok V; Maki, Robert G; Demetri, George D

2017-09-01

Trabectedin demonstrated significantly improved disease control in leiomyosarcoma and liposarcoma patients in a global phase 3 trial (NCT01343277). A post hoc analysis was conducted to assess the efficacy and safety of trabectedin or dacarbazine in women with uterine leiomyosarcoma (uLMS), the largest subgroup of enrolled patients (40%). Of 577 patients randomized 2:1 to receive trabectedin 1.5mg/m 2 by 24-hour IV infusion or dacarbazine 1g/m 2 by 20-120-minute IV infusion once every three weeks, 232 had uLMS (trabectedin: 144; dacarbazine: 88). The primary endpoint was overall survival (OS); secondary endpoints were progression-free survival (PFS), objective response rate (ORR), clinical benefit rate (CBR: complete responses+partial responses+stable disease [SD] for at least 18weeks), duration of response (DOR), and safety. PFS for trabectedin was 4.0months compared with 1.5months for dacarbazine (hazard ratio [HR]=0.57; 95% CI 0.41-0.81; P=0.0012). OS was similar (trabectedin 13.4months vs. dacarbazine 12.9months, HR=0.89; 95% CI 0.65-1.24; P=0.51) between groups. ORR was 11% with trabectedin vs. 9% with dacarbazine (P=0.82). CBR for trabectedin was 31% vs. 18% with dacarbazine (P=0.05); median DOR was 6.5months for trabectedin vs. 4.1months for dacarbazine (P=0.32). Grade 3/4 treatment-emergent adverse events observed in ≥10% of patients in the trabectedin group included transient aminotransferase (aspartate/alanine) elevations, anemia, leukopenia, and thrombocytopenia. In this post hoc subset analysis of patients with uLMS who had received prior anthracycline therapy, trabectedin treatment resulted in significantly longer PFS versus dacarbazine, with an acceptable safety profile. There was no difference in OS. Copyright © 2017. Published by Elsevier Inc.

Effect of Deploying Trained Community Based Reproductive Health Nurses (CORN) on Long-Acting Reversible Contraception (LARC) Use in Rural Ethiopia: A Cluster Randomized Community Trial.

PubMed

Zerfu, Taddese Alemu; Ayele, Henok Taddese; Bogale, Tariku Nigatu

2018-06-01

To investigate the effect of innovative means to distribute LARC on contraceptive use, we implemented a three arm, parallel groups, cluster randomized community trial design. The intervention consisted of placing trained community-based reproductive health nurses (CORN) within health centers or health posts. The nurses provided counseling to encourage women to use LARC and distributed all contraceptive methods. A total of 282 villages were randomly selected and assigned to a control arm (n = 94) or 1 of 2 treatment arms (n = 94 each). The treatment groups differed by where the new service providers were deployed, health post or health center. We calculated difference-in-difference (DID) estimates to assess program impacts on LARC use. After nine months of intervention, the use of LARC methods increased significantly by 72.3 percent, while the use of short acting methods declined by 19.6 percent. The proportion of women using LARC methods increased by 45.9 percent and 45.7 percent in the health post and health center based intervention arms, respectively. Compared to the control group, the DID estimates indicate that the use of LARC methods increased by 11.3 and 12.3 percentage points in the health post and health center based intervention arms. Given the low use of LARC methods in similar settings, deployment of contextually trained nurses at the grassroots level could substantially increase utilization of these methods. © 2018 The Population Council, Inc.

Vildagliptin compared to glimepiride on post-prandial lipemia and on insulin resistance in type 2 diabetic patients.

PubMed

Derosa, Giuseppe; Bonaventura, Aldo; Bianchi, Lucio; Romano, Davide; Fogari, Elena; D'Angelo, Angela; Maffioli, Pamela

2014-07-01

To evaluate the effects of vildagliptin compared to glimepiride on glycemic control, insulin resistance and post-prandial lipemia. 167 type 2 diabetic patients, not adequately controlled by metformin, were randomized to vildagliptin 50 mg twice a day or glimepiride 2 mg three times a day for 6 months, in a double blind, randomized clinical trial. We evaluated: body mass index (BMI), glycemic control, fasting plasma insulin (FPI), homeostasis model assessment insulin resistance index (HOMA-IR), fasting plasma proinsulin (FPPr), glucagon, lipid profile, resistin, retinol binding protein-4 (RBP-4), visfatin and vaspin. Furthermore, at the randomization and at the end of the study all patients underwent an euglycemic hyperinsulinemic clamp to evaluate M value and an oral fat load. Despite a similar decrease of glycated hemoglobin, there were an increase of body weight with glimepiride + metformin and a decrease with vildagliptin + metformin. Fasting plasma insulin increased with glimepiride + metformin, while it did not change with vildagliptin + metformin. Vildagliptin + metformin improved lipid profile. Regarding insulin sensitivity, vildagliptin + metformin increased M value. Resistin, RBP-4, vaspin and visfatin were decreased by vildagliptin + metformin, but in group to group comparison, only vaspin reduction resulted statistically significant. Vildagliptin + metformin reduced post-prandial lipemia and insulinemia compared to glimepiride + metformin. Vildagliptin, in addition to metformin, was more effective than glimepiride + metformin in reducing insulin resistance and post-prandial lipemia. Copyright © 2014 Elsevier Inc. All rights reserved.

Provider training to screen and initiate evidence-based pediatric obesity treatment in routine practice settings: A randomized pilot trial

PubMed Central

Kolko, Rachel P.; Kass, Andrea E.; Hayes, Jacqueline F.; Levine, Michele D.; Garbutt, Jane M.; Proctor, Enola K.; Wilfley, Denise E.

2016-01-01

Introduction This randomized pilot trial evaluated two training modalities for first-line, evidence-based pediatric obesity services (screening and goal-setting) among nursing students. Method Participants (N=63) were randomized to Live Interactive Training (Live) or Web-facilitated Self-study Training (Web). Pre-training, post-training, and one-month follow-up assessments evaluated training feasibility, acceptability, and impact (knowledge, and skill via simulation). Moderator (previous experience) and predictor (content engagement) analyses were conducted. Results Nearly-all (98%) participants completed assessments. Both trainings were acceptable, with higher ratings for Live and participants with previous experience (p’s<.05). Knowledge and skill improved from pre-training to post-training and follow-up in both conditions (p’s<.001). Live demonstrated greater content engagement (p’s<.01). Conclusions The training package was feasible, acceptable, and efficacious among nursing students. Given that Live had higher acceptability and engagement, and online training offers greater scalability, integrating interactive Live components within Web-based training may optimize outcomes, which may enhance practitioners’ delivery of pediatric obesity services. PMID:26873293

Online Versus Face-To-Face Training of Critical Time Intervention: A Matching Cluster Randomized Trial

PubMed Central

Olivet, Jeffrey; Zerger, Suzanne; Greene, R. Neil; Kenney, Rachael R.; Herman, Daniel B.

2017-01-01

This study examined the effectiveness of online education to providers who serve people experiencing homelessness, comparing online and face-to-face training of Critical Time Intervention (CTI), an evidence-based case management model. The authors recruited 184 staff from 19 homeless service agencies to participate in one of two training conditions: (a) Online Training + Community of Practice or (b) Face-to-Face Training + Telephone Consultation. Each group received 24 hours of instruction and support. Through baseline, follow-up, and nine-month post-training surveys, the authors examined satisfaction, knowledge gains, knowledge retention, and readiness to implement CTI. While satisfaction rates were higher among participants in the face-to-face group, the two training conditions produced comparable pre/post knowledge gains. Furthermore, both groups showed increased knowledge retention scores at nine-month follow up, with the online group scoring higher than the face-to-face group. PMID:28919668

Alveolar ridge augmentation by connective tissue grafting using a pouch method and modified connective tissue technique: A prospective study.

PubMed

Agarwal, Ashish; Gupta, Narinder Dev

2015-01-01

Localized alveolar ridge defect may create physiological and pathological problems. Developments in surgical techniques have made it simpler to change the configuration of a ridge to create a more aesthetic and more easily cleansable shape. The purpose of this study was to compare the efficacy of alveolar ridge augmentation using a subepithelial connective tissue graft in pouch and modified connective tissue graft technique. In this randomized, double blind, parallel and prospective study, 40 non-smoker individuals with 40 class III alveolar ridge defects in maxillary anterior were randomly divided in two groups. Group I received modified connective tissue graft, while group II were treated with subepithelial connective tissue graft in pouch technique. The defect size was measured in its horizontal and vertical dimension by utilizing a periodontal probe in a stone cast at base line, after 3 months, and 6 months post surgically. Analysis of variance and Bonferroni post-hoc test were used for statistical analysis. A two-tailed P < 0.05 was considered to be statistically significant. Mean values in horizontal width after 6 months were 4.70 ± 0.87 mm, and 4.05 ± 0.89 mm for group I and II, respectively. Regarding vertical heights, obtained mean values were 4.75 ± 0.97 mm and 3.70 ± 0.92 mm for group I and group II, respectively. Within the limitations of this study, connective tissue graft proposed significantly more improvement as compare to connective tissue graft in pouch.

Design and outcomes of a Mothers In Motion behavioral intervention pilot study.

PubMed

Chang, Mei-Wei; Nitzke, Susan; Brown, Roger

2010-01-01

This paper describes the design and findings of a pilot Mothers In Motion (P-MIM) program. A randomized controlled trial that collected data via telephone interviews and finger stick at 3 time points: baseline and 2 and 8 months post-intervention. Three Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) sites in southern Michigan. One hundred and twenty nine overweight and obese African-American and white mothers, 18-34 years old. The 10-week, theory-based, culturally sensitive intervention messages were delivered via a series of 5 chapters on a DVD and complemented by 5 peer support group teleconferences. Dietary fat, fruit, and vegetable intake; physical activity; stress; feelings; body weight; and blood glucose. General linear mixed model was applied to assess treatment effects across 2 and 8 months post-intervention. No significant effect sizes were found in primary and secondary outcome variables at 2 and 8 months post-intervention. However, changes in body weight and blood glucose showed apparent trends consistent with the study's hypotheses. The P-MIM showed promise for preventing weight gain in low-income overweight and obese women. However, a larger experimental trial is warranted to determine the effectiveness of this intervention. Copyright 2010 Society for Nutrition Education. Published by Elsevier Inc. All rights reserved.

The long-term effects of a primary care physical activity intervention on mental health in low-active, community-dwelling older adults.

PubMed

Patel, Asmita; Keogh, Justin W L; Kolt, Gregory S; Schofield, Grant M

2013-01-01

To examine the effect that physical activity delivered via two different versions of the Green Prescription (a primary care physical activity scripting program) had on depressive symptomatology and general mental health functioning over a 12-month period in non-depressed, low-active, community-dwelling older adults. Two hundred and twenty-five participants from the Healthy Steps study took part in the present study. Healthy Steps participants were randomized to receive either the standard time-based or a modified pedometer-based Green Prescription. Depression, mental health functioning and physical activity were measured at baseline, post-intervention (3 months post-baseline) and at the 9-month follow-up period. At post-intervention, a positive association was found between increases in leisure-time physical activity and total walking physical activity and a decrease in depressive symptomatology (within the non-depressed range of the GDS-15) and an increase in perceived mental health functioning, regardless of intervention allocation. These improvements were also evident at the follow-up period for participants in both intervention allocation groups. Our findings suggest that the standard time-based Green Prescription and a modified pedometer-based Green Prescription are both effective in maintaining and improving mental health in non-depressed, previously low-active older adults.

Cost-Effectiveness of Integrating Tobacco Cessation Into Post-Traumatic Stress Disorder Treatment.

PubMed

Barnett, Paul G; Jeffers, Abra; Smith, Mark W; Chow, Bruce K; McFall, Miles; Saxon, Andrew J

2016-03-01

We examined the cost-effectiveness of smoking cessation integrated with treatment for post-traumatic stress disorder (PTSD). Smoking veterans receiving care for PTSD (N = 943) were randomized to care integrated with smoking cessation versus referral to a smoking cessation clinic. Smoking cessation services, health care cost and utilization, quality of life, and biochemically-verified abstinence from cigarettes were assessed over 18-months of follow-up. Clinical outcomes were combined with literature on changes in smoking status and the effect of smoking on health care cost, mortality, and quality of life in a Markov model of cost-effectiveness over a lifetime horizon. We discounted cost and outcomes at 3% per year and report costs in 2010 US dollars. The mean of smoking cessation services cost was $1286 in those randomized to integrated care and $551 in those receiving standard care (P < .001). There were no significant differences in the cost of mental health services or other care. After 12 months, prolonged biochemically verified abstinence was observed in 8.9% of those randomized to integrated care and 4.5% of those randomized to standard care (P = .004). The model projected that Integrated Care added $836 in lifetime cost and generated 0.0259 quality adjusted life years (QALYs), an incremental cost-effectiveness ratio of $32 257 per QALY. It was 86.0% likely to be cost-effective compared to a threshold of $100 000/QALY. Smoking cessation integrated with treatment for PTSD was cost-effective, within a broad confidence region, but less cost-effective than most other smoking cessation programs reported in the literature. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco 2015. This work is written by (a) US Government employee(s) and is in the public domain in the US.

Cost-Effectiveness of Integrating Tobacco Cessation Into Post-Traumatic Stress Disorder Treatment

PubMed Central

Jeffers, Abra; Smith, Mark W.; Chow, Bruce K.; McFall, Miles; Saxon, Andrew J.

2016-01-01

Abstract Introduction: We examined the cost-effectiveness of smoking cessation integrated with treatment for post-traumatic stress disorder (PTSD). Methods: Smoking veterans receiving care for PTSD ( N = 943) were randomized to care integrated with smoking cessation versus referral to a smoking cessation clinic. Smoking cessation services, health care cost and utilization, quality of life, and biochemically-verified abstinence from cigarettes were assessed over 18-months of follow-up. Clinical outcomes were combined with literature on changes in smoking status and the effect of smoking on health care cost, mortality, and quality of life in a Markov model of cost-effectiveness over a lifetime horizon. We discounted cost and outcomes at 3% per year and report costs in 2010 US dollars. Results: The mean of smoking cessation services cost was $1286 in those randomized to integrated care and $551 in those receiving standard care ( P < .001). There were no significant differences in the cost of mental health services or other care. After 12 months, prolonged biochemically verified abstinence was observed in 8.9% of those randomized to integrated care and 4.5% of those randomized to standard care ( P = .004). The model projected that Integrated Care added $836 in lifetime cost and generated 0.0259 quality adjusted life years (QALYs), an incremental cost-effectiveness ratio of $32 257 per QALY. It was 86.0% likely to be cost-effective compared to a threshold of $100 000/QALY. Conclusions: Smoking cessation integrated with treatment for PTSD was cost-effective, within a broad confidence region, but less cost-effective than most other smoking cessation programs reported in the literature. PMID:25943761

Mediators and Moderators of a School-Based Cognitive-Behavioral Depression Prevention Program.

PubMed

Duong, Mylien T; Kelly, Brynn M; Haaland, Wren L; Matsumiya, Brandon; Huey, Stanley J; McCarty, Carolyn A

2016-10-01

This study tested potential moderators and mediators of an indicated depression prevention program for middle school students, Positive Thoughts and Actions (PTA). Participants were 120 students randomly assigned to PTA, or a brief, individually administered supportive intervention (Individual Support Program, or ISP). Youths completed measures of depressive symptoms at baseline, post-intervention, and 12-month follow-up. Hierarchical regression was used to test three moderators-ethnic minority status, gender, and baseline depressive symptoms-and three mediators representing functional outcomes targeted by PTA-parent-child communication, attitude towards school, and health behavior. Ethnic minority status did not moderate PTA effects at post-intervention but did moderate PTA effects at 12-month follow-up. At 12 months, PTA appeared to be more effective for White participants than ethnic minority youth. Follow-up analyses suggested this moderation effect was due to the tendency of ethnic minority youth, especially those with fewer symptoms at baseline, to drop out by 12 months. Neither gender nor baseline depressive symptoms moderated the effects of PTA. Although PTA improved health behavior and attitudes toward school, there was no evidence that any of these functional outcomes measured mediated the impact of PTA on depressive symptoms. Future directions are discussed.

Pilot Randomized Controlled Trial of Internet-delivered Cognitive-Behavioral Treatment for Pediatric Headache

PubMed Central

Law, Emily F.; Beals-Erickson, Sarah E.; Noel, Melanie; Claar, Robyn; Palermo, Tonya M.

2015-01-01

Objective To evaluate the feasibility and preliminary effectiveness of an Internet-delivered cognitive-behavioral therapy (CBT) intervention for adolescents with chronic headache. Background Headache is among the most common pain complaints of childhood. Cognitive-behavioral interventions are efficacious for improving pain among youth with headache. However, many youth do not receive psychological treatment for headache due to poor access, which has led to consideration of alternative delivery modalities such as the Internet. Methods We used a parallel arm randomized controlled trial design to evaluate the feasibility and preliminary effectiveness of an Internet-delivered family-based CBT intervention, Web-Based Management of Adolescent Pain (Web-MAP). Adolescents were eligible for the trial if they were a new patient being evaluated in a specialized headache clinic, between the ages of 11–17 years old, and had recurrent headache for three months or more as diagnosed by a pediatric neurologist. Eighty-three youth enrolled in the trial. An online random number generator was used to randomly assign participants to receive Internet CBT adjunctive to specialized headache treatment (n = 44) or specialized headache treatment alone (n = 39). The primary treatment outcome was headache days. Results Youth and parents in the Internet CBT group demonstrated high levels of engagement with the web program and reported satisfaction with the intervention. Multi-level modeling was used to conduct hypothesis testing for continuous outcomes. For our primary treatment outcome of headache days, adolescents reported a statistically significant reduction in headache days from baseline to post-treatment and baseline to three-month follow-up in both treatment conditions (main effect for time F(2, 136) = 19.70, p < .001). However, there was no statistically significant difference between the Internet CBT group and the specialized headache treatment group at post-treatment or follow-up (group x time interaction F(2, 134) = .94, p = .395). For our secondary treatment outcomes, findings from multilevel modeling (MLM) showed that adolescents in both groups demonstrated statistically significant improvement headache pain intensity, activity limitations, depressive symptoms and parent protective behaviors from baseline to post-treatment and these gains were maintained at three-month follow-up. Adolescent anxiety symptoms and sleep did not change during the study period for either group. There were no statistically significant group differences on any secondary outcomes at post-treatment or follow-up (p > 0.05 for all outcomes). No adverse events were reported. Conclusion Although adjunctive Internet CBT did not lead to additional benefit in this population, future research should evaluate whether it is an effective intervention for adolescents with headache who are unable to access specialized headache treatment. PMID:26316194

Factors contributing to practice variation in post-stroke rehabilitation.

PubMed Central

Lee, A J; Huber, J H; Stason, W B

1997-01-01

OBJECTIVE: To analyze geographic variability in the utilization and cost of post-stroke medical care using multiple linear regression. DATA SOURCES/STUDY SETTING: A 20 percent random sample of Medicare beneficiaries with an admission to an acute care hospital for stroke during the first six months of 1991, supplemented by data from their Medicare claims and beneficiary records, the Medicare Cost Reports for hospitals and nursing homes, and the Area Resource File. STUDY DESIGN: Weighted least squares regression is used to analyze variations in post-stroke practice patterns across 151 MSAs (Metropolitan Statistical Areas). Average post-stroke costs, utilization rates, and facility lengths of stay are regressed on patient and market characteristics. DATA COLLECTION/EXTRACTION METHODS: For a six-month post-stroke interval, beneficiary-level post-stroke costs and service utilization are averaged by MSA. Variables describing market conditions are then added to these MSA-level records. PRINCIPAL FINDINGS: Patient variables rarely explain more than a third of practice variation, and often they explain substantially less than that. Market variables (with some exception) tend to be relatively less important. Finally, one-half to two-thirds of the practice variation across MSAs is unexplained by the patient and market factors measured in our data. CONCLUSIONS: A substantial portion of inter-MSA variability in utilization and intensity of post-stroke rehabilitation services cannot be explained by differences in patient characteristics. Given the large practice differences observed across MSAs, it seems unlikely that unmeasured patient differences can account for much more of the practice differences. PMID:9180616

A randomized controlled trial of treatments for co-occurring substance use disorders and post-traumatic stress disorder.

PubMed

McGovern, Mark P; Lambert-Harris, Chantal; Xie, Haiyi; Meier, Andrea; McLeman, Bethany; Saunders, Elizabeth

2015-07-01

Post-traumatic stress disorder (PTSD) is common among people with substance use disorders, and the comorbidity is associated with negative outcomes. We report on a randomized controlled trial comparing the effect of integrated cognitive-behavioral therapy (ICBT) plus standard care, individual addiction counseling plus standard care and standard care alone on substance use and PTSD symptoms. Three-group, multi-site randomized controlled trial. Seven addiction treatment programs in Vermont and New Hampshire, USA. Recruitment took place between December 2010 and January 2013. In this single-blind study, 221 participants were randomized to one of three conditions: ICBT plus standard care (SC) (n = 73), individual addiction counseling (IAC) plus SC (n = 75) or SC only (n = 73). One hundred and seventy-two patients were assessed at 6-month follow-up (58 ICBT; 61 IAC; 53 SC). Intervention and comparators: ICBT is a manual-guided therapy focused on PTSD and substance use symptom reduction with three main components: patient education, mindful relaxation and flexible thinking. IAC is a manual-guided therapy focused exclusively on substance use and recovery with modules organized in a stage-based approach: treatment initiation, early abstinence, maintaining abstinence and recovery. SC are intensive out-patient program services that include 9-12 hours of face-to-face contact per week over 2-4 days of group and individual therapies plus medication management. Primary outcomes were PTSD severity and substance use severity at 6 months. Secondary outcomes were therapy retention. PTSD symptoms reduced in all conditions with no difference between them. In analyses of covariance, ICBT produced more favorable outcomes on toxicology than IAC or SC [comparison with IAC, parameter estimate: 1.10; confidence interval (CI) = 0.17-2.04; comparison with SC, parameter estimate: 1.13; CI = 0.18-2.08] and had a greater reduction in reported drug use than SC (parameter estimate: -9.92; CI = -18.14 to -1.70). ICBT patients had better therapy continuation versus IAC (P<0.001). There were no unexpected or study-related adverse events. Integrated cognitive behavioral therapy may improve drug-related outcomes in post-traumatic stress disorder sufferers with substance use disorder more than drug-focused counseling, but probably not by reducing post-traumatic stress disorder symptoms to a greater extent. © 2015 Society for the Study of Addiction.

Effects of pediatric first aid training on preschool teachers: a longitudinal cohort study in China.

PubMed

Li, Feng; Sheng, Xiaoyang; Zhang, Jinsong; Jiang, Fan; Shen, Xiaoming

2014-08-24

Unintentional injuries are a major cause of death among children. Data suggest that the retention of knowledge and skills about first aid declined over time. The purpose of this study was to assess the effects of pediatric first aid training among teachers. A stratified random sampling method was used to select 1,067 teachers. The selected trainees received pediatric first aid training. Follow-up assessments were conducted 6 months, 9 months and 4 years following the training. A standardized collection of demographics was performed, and participants were given a questionnaire to indicate knowledge of and emotions about first aid. In the pretest, 1067 people responded with a mean of 21.0 correct answers to 37 questions, whereas in the post-test period, the mean score increased to 32.2 correct answers of 37 questions (P <0.001). There was a decrease in scores from post-test to 6 months, 9 months and 4 years after the training. However, the mean at the 6-month, 9-month and 4-year marks were higher than the pretest mean (P < 0.001). A total of 82.8% of the participants achieved a pass mark of 80% or above; 42.8% of participants achieved the pass mark at 6 months, 41.7% at 9 months and 11.7% at 4 years (compared with pre-test, P < 0.001). The mean score of the subjects' emotions in the post-test period increased to 81 (P < 0.001). The mean scores of emotions at 9 months or 4 years were higher than the pretest mean (P < 0.001). At the 4-year mark, the majority of preschool staff (>70%) had administered correct first aid for injuries. This study demonstrated that the acquisition of knowledge, both short and long term, significantly improves. Despite appreciable decreases in knowledge long term, knowledge retention was modest but stable.

Efficacy of an activated charcoal-simethicone combination in dyspeptic syndrome: results of a randomized prospective study in general practice.

PubMed

Lecuyer, M; Cousin, T; Monnot, M-N; Coffin, B

2009-01-01

The aim of this prospective, multicenter, randomized, placebo-controlled trial was to evaluate the efficacy of a commercial combination of simethicone and activated charcoal (Carbosylane) on dyspeptic symptoms in patients consulting a general practitioner. A total of 132 patients were studied. Treatment duration was 3 months, followed by a 2 months follow-up period. At the end of the treatment period, the percentage of patients with a reduction of at least two points on the symptom intensity scale was significantly higher with Carbosylane than with a placebo (P=0.043). Compared with placebo, the intensity of three symptoms (abdominal fullness, bloating and the sensation of slow digestion) was significantly decreased after 90 days of Carbosylane (P<0.05). At the end of the post-treatment follow-up, the percentages of patients with moderate or severe global complaints were 6.78% and 21.43% in the Carbosylane and placebo groups, respectively (P<0.03). Among patients consulting a general practitioner for dyspeptic syndrome, 3 months of treatment with Carbosylane resulted in significant symptomatic improvement. The improvement was still evident 2 months after the end of treatment.

Effectiveness of psychological interventions to improve quality of life in people with long-term conditions: rapid systematic review of randomised controlled trials.

PubMed

Anderson, Niall; Ozakinci, Gozde

2018-03-27

Long-term conditions may negatively impact multiple aspects of quality of life including physical functioning and mental wellbeing. The rapid systematic review aimed to examine the effectiveness of psychological interventions to improve quality of life in people with long-term conditions to inform future healthcare provision and research. EBSCOhost and OVID were used to search four databases (PsychInfo, PBSC, Medline and Embase). Relevant papers were systematically extracted by one researcher using the predefined inclusion/exclusion criteria based on titles, abstracts, and full texts. Randomized controlled trial psychological interventions conducted between 2006 and February 2016 to directly target and assess people with long-term conditions in order to improve quality of life were included. Interventions without long-term condition populations, psychological intervention and/or patient-assessed quality of life were excluded. From 2223 citations identified, 6 satisfied the inclusion/exclusion criteria. All 6 studies significantly improved at least one quality of life outcome immediately post-intervention. Significant quality of life improvements were maintained at 12-months follow-up in one out of two studies for each of the short- (0-3 months), medium- (3-12 months), and long-term (≥ 12 months) study duration categories. All 6 psychological intervention studies significantly improved at least one quality of life outcome immediately post-intervention, with three out of six studies maintaining effects up to 12-months post-intervention. Future studies should seek to assess the efficacy of tailored psychological interventions using different formats, durations and facilitators to supplement healthcare provision and practice.

Short-Term Effects of Pulsed Radiofrequency on Chronic Refractory Cervical Radicular Pain

PubMed Central

Choi, Gyu-Sik; Cho, Yun-Woo; Lee, Dong-Kyu

2011-01-01

Objective To evaluate the short-term effectiveness of pulsed radiofrequency on the dorsal root ganglion (DRG) in patients with chronic refractory cervical radicular pain. Method Fifteen patients (13 males, 2 females; mean age, 55.9 years) with chronic radicular pain due to cervical disc herniation or foraminal stenosis refractory to active rehabilitative management, including transforaminal cervical epidural steroid injection and exercise, were selected. All patients received pulsed radiofrequency on the symptomatic cervical dorsal root ganglion and were carefully evaluated for neurologic deficits and side effects. The clinical outcomes were measured using a visual analogue scale (VAS) and a neck disability index (NDI) before treatment, one and three months after treatment. Successful pain relief was defined as a 50% or greater reduction in the VAS score as compared with the pre-treatment score. After three months, we categorized the patients' satisfaction. Results The average VAS for radicular pain was reduced significantly from 5.3 at pretreatment to 2.5 at 3 months post-treatment (p<0.05). Eleven of 15 patients (77.3%) after cervical pulsed RF stimulation reported pain relief of 50% or more at the 3 month follow-up. The average NDI was significantly reduced from 44.0% at pretreatment to 35.8% 3 months post-treatment (p<0.05). At 3 months post-treatment, eleven of fifteen patients (73.3%) were satisfied with their status. No adverse effects were observed. Conclusion The results demonstrate that the application of pulsed radiofrequency on DRG might be an effective short-term intervention for chronic refractory cervical radicular pain. Further studies, including a randomized controlled trial with long-term follow-up, are now needed. PMID:22506211

Concordance and discordance between measured and perceived balance and the effect on gait speed and falls following stroke

PubMed Central

Liphart, Jodi; Gallichio, Joann; Tilson, Julie K; Pei, Qinglin; Wu, Samuel S; Duncan, Pamela W

2016-01-01

Objective To ascertain the existence of discordance between perceived and measured balance in persons with stroke and to examine the impact on walking speed and falls. Design A secondary analysis of a phase three, multicentered randomized controlled trial examining walking recovery following stroke. Subjects A total of 352 participants from the Locomotor Experience Applied Post-Stroke (LEAPS) trial. Methods Participants were categorized into four groups: two concordant and two discordant groups in relation to measured and perceived balance. Number and percentage of individuals with concordance and discordance were evaluated at two and 12 months. Walking speed and fall incidence between groups were examined. Main measures Perceived balance was measured by the Activity-specific Balance Confidence scale, measured balance was determined by the Berg Balance Scale and gait speed was measured by the 10-meter walk test. Results Discordance was present for 35.8% of participants at two months post-stroke with no statistically significant change in proportion at 12 months. Discordant participants with high perceived balance and low measured balance walked 0.09 m/s faster at two months than participants with concordant low perceived and measured balance (p < 0.05). Discordant participants with low perceived balance and high measured balance walked 0.15 m/s slower than those that were concordant with high perceived and measured balance (p ⩽ 0.0001) at 12 months. Concordant participants with high perceived and measured balance walked fastest and had fewer falls. Conclusions Discordance existed between perceived and measured balance in one-third of individuals at two and 12 months post-stroke. Perceived balance impacted gait speed but not fall incidence. PMID:25810426

Change in clinical indices following laser or scalpel treatment for periodontitis: A split-mouth, randomized, multi-center trial

NASA Astrophysics Data System (ADS)

Harris, David M.; Nicholson, Dawn M.; McCarthy, Delwin; Yukna, Raymond A.; Reynolds, Mark A.; Greenwell, Henry; Finley, James; McCawley, Thomas K.; Xenoudi, Pinelopi; Gregg, Robert H.

2014-02-01

Data are presented from a multi-center, prospective, longitudinal, clinical trial comparing four different treatments for periodontitis, (1) the LANAPTM protocol utilizing a FR pulsed-Nd:YAG laser; (2) flap surgery using the Modified Widman technique (MWF); (3) traditional scaling and root planing (SRP); and (4) coronal debridement (CD). Each treatment was randomized to a different quadrant. Fifty-one (54) subjects were recruited at five centers that included both private practice and university-based investigators. At 6-months and 12 months post-treatment the LANAPTM protocol and MWF yielded equivalent results based on changes in probing depths. The major difference observed between the two procedures was that patients reported significantly greater comfort following the LANAP™ procedure than following the MWF (P<0.001). There was greater reduction in bleeding in the LANAPTM quadrant than in the other three at both 6 and 12 months. Improvements following SRP were better than expected at 6 months and continued to improve, providing outcomes that were equivalent to both LANAPTM and MWF at 12 months. The improvement in the SRP quadrants suggests the hypothesis that an aspect of the LANAPTM protocol generated a significant, positive and unanticipated systemic (or trans-oral) effect on sub-gingival wound healing.

The impact of an online social network with wireless monitoring devices on physical activity and weight loss.

PubMed

Greene, Jessica; Sacks, Rebecca; Piniewski, Brigitte; Kil, David; Hahn, Jin S

2013-07-01

Online social networks (OSNs) are a new, promising approach for catalyzing health-related behavior change. To date, the empirical evidence on their impact has been limited. Using a randomized trial, we assessed the impact of a health-oriented OSN with accelerometer and scales on participant's physical activity, weight, and clinical indicators. A sample of 349 PeaceHealth Oregon employees and family members were randomized to the iWell OSN or a control group and followed for 6 months in 2010-2011. The iWell OSN enabled participants to connect with "friends," make public postings, view contacts' postings, set goals, download the number of their steps from an accelerometer and their weight from a scale, view trends in physical activity and weight, and compete against others in physical activity. Both control and intervention participants received traditional education material on diet and physical activity. Laboratory data on weight and clinical indicators (triglycerides, high-density lipoprotein, or low-density lipoprotein), and self-reported data on physical activity, were collected at baseline, 3 months, and 6 months. At 6 months, the intervention group increased leisure walking minutes by 164% compared with 47% in the control group. The intervention group also lost more weight than the controls (5.2 pounds compared with 1.5 pounds). There were no observed significant differences in vigorous exercise or clinical indicators between the 2 groups. Among intervention participants, greater OSN use, as measured by number of private messages sent, was associated with a greater increase in leisure walking and greater weight reduction over the study period. The study provides evidence that interventions using OSNs can successfully promote increases in physical activity and weight loss.

Mineralocorticoid receptor antagonist pretreatment to MINIMISE reperfusion injury after ST-elevation myocardial infarction (the MINIMISE STEMI Trial): rationale and study design.

PubMed

Bulluck, Heerajnarain; Fröhlich, Georg M; Mohdnazri, Shah; Gamma, Reto A; Davies, John R; Clesham, Gerald J; Sayer, Jeremy W; Aggarwal, Rajesh K; Tang, Kare H; Kelly, Paul A; Jagathesan, Rohan; Kabir, Alamgir; Robinson, Nicholas M; Sirker, Alex; Mathur, Anthony; Blackman, Daniel J; Ariti, Cono; Krishnamurthy, Arvindra; White, Steven K; Meier, Pascal; Moon, James C; Greenwood, John P; Hausenloy, Derek J

2015-05-01

Novel therapies capable of reducing myocardial infarct (MI) size when administered prior to reperfusion are required to prevent the onset of heart failure in ST-segment elevation myocardial infarction (STEMI) patients treated by primary percutaneous coronary intervention (PPCI). Experimental animal studies have demonstrated that mineralocorticoid receptor antagonist (MRA) therapy administered prior to reperfusion can reduce MI size, and MRA therapy prevents adverse left ventricular (LV) remodeling in post-MI patients with LV impairment. With these 2 benefits in mind, we hypothesize that initiating MRA therapy prior to PPCI, followed by 3 months of oral MRA therapy, will reduce MI size and prevent adverse LV remodeling in STEMI patients. The MINIMISE-STEMI trial is a prospective, randomized, double-blind, placebo-controlled trial that will recruit 150 STEMI patients from four centers in the United Kingdom. Patients will be randomized to receive either an intravenous bolus of MRA therapy (potassium canrenoate 200 mg) or matching placebo prior to PPCI, followed by oral spironolactone 50 mg once daily or matching placebo for 3 months. A cardiac magnetic resonance imaging scan will be performed within 1 week of PPCI and repeated at 3 months to assess MI size and LV remodeling. Enzymatic MI size will be estimated by the 48-hour area-under-the-curve serum cardiac enzymes. The primary endpoint of the study will be MI size on the 3-month cardiac magnetic resonance imaging scan. The MINIMISE STEMI trial will investigate whether early MRA therapy, initiated prior to reperfusion, can reduce MI size and prevent adverse post-MI LV remodeling. © 2015 The Authors. Clinical Cardiology published by Wiley Periodicals, Inc.

Teen Online Problem Solving for Teens With Traumatic Brain Injury: Rationale, Methods, and Preliminary Feasibility of a Teen Only Intervention

PubMed Central

Wade, Shari L.; Narad, Megan E.; Kingery, Kathleen M.; Taylor, H. Gerry; Stancin, Terry; Kirkwood, Michael W.; Yeates, Keith O.

2017-01-01

Purpose/Objective To describe the Teen Online Problem Solving—Teen Only (TOPS-TO) intervention relative to the original Teen Online Problem Solving—Family (TOPS-F) intervention, to describe a randomized controlled trial to assess intervention efficacy, and to report feasibility and acceptability of the TOPS-TO intervention. Research method and design This is a multisite randomized controlled trial, including 152 teens (49 TOPS-F, 51 TOPS-TO, 52 IRC) between the ages of 11–18 who were hospitalized for a moderate to severe traumatic brain injury in the previous 18 months. Assessments were completed at baseline, 6-months post baseline, and 12-months post baseline. Data discussed include adherence and satisfaction data collected at the 6-month assessment (treatment completion) for TOPS-F and TOPS-TO. Results Adherence measures (sessions completed, dropout rates, duration of treatment engagement, and rates of program completion) were similar across treatment groups. Overall, teen and parent reported satisfaction was high and similar across groups. Teens spent a similar amount of time on the TOPS website across groups, and parents in the TOPS-F spent more time on the TOPS website than those in the TOPS-TO group (p = .002). Parents in the TOPS-F group rated the TOPS website as more helpful than those in the TOPS-TO group (p = .05). Conclusions/Implications TOPS-TO intervention is a feasible and acceptable intervention approach. Parents may perceive greater benefit from the family based intervention. Further examination is required to understand the comparative efficacy in improving child and family outcomes, and who is likely to benefit from each approach. PMID:28836809

Social Cognitive Constructs Did Not Mediate the BEAT Cancer Intervention Effects on Objective Physical Activity Behavior Based on Multivariable Path Analysis.

PubMed

Rogers, Laura Q; Courneya, Kerry S; Anton, Phillip M; Hopkins-Price, Patricia; Verhulst, Steven; Robbs, Randall S; Vicari, Sandra K; McAuley, Edward

2017-04-01

Most breast cancer survivors do not meet physical activity recommendations. Understanding mediators of physical activity behavior change can improve interventions designed to increase physical activity in this at-risk population. Study aims were to determine the 3-month Better Exercise Adherence after Treatment for Cancer (BEAT Cancer) behavior change intervention effects on social cognitive theory constructs and the mediating role of any changes on the increase in accelerometer-measured physical activity previously reported. Post-treatment breast cancer survivors (N = 222) were randomized to BEAT Cancer or usual care. Assessments occurred at baseline, 3 months (M3), and 6 months (M6). Adjusted linear mixed model analysis of variance determined intervention effects on walking self-efficacy, outcome expectations, goal setting, and perceived barrier interference at M3. Path analysis determined mediation of intervention effects on physical activity at M6 by changes in social cognitive constructs during the intervention (i.e., baseline to M3). BEAT Cancer significantly improved self-efficacy, goals, negative outcome expectations, and barriers. Total path analysis model explained 24 % of the variance in M6 physical activity. There were significant paths from randomized intervention group to self-efficacy (β = 0.15, p < .05) and barriers (β = -0.22, p < .01). Barriers demonstrated a borderline significant association with M6 physical activity (β = -0.24, p = .05). No statistically significant indirect effects were found. Although BEAT Cancer significantly improved social cognitive constructs, no significant indirect effects on physical activity improvements 3 months post-intervention were observed (NCT00929617).

Comprehensive self-control training benefits depressed college students: A six-month randomized controlled intervention trial.

PubMed

Yang, Xueling; Zhao, Jiubo; Chen, Yu; Zu, Simeng; Zhao, Jingbo

2018-01-15

Depressive disorder was associated with dysfunctional self-regulation. The current study attempted to design and test a comprehensive self-control training (CSCT) program with an overall emphasis on behaviral activation in depressed Chinese college students. Participants included 74 students who had diagnosed with major depression, they were randomly assigned to one of the two groups: intervention group (n=37), and control group (n=37). The intervention participants received an eight-week CSCT and four-month follow-up consolidation program, as compared to the control group who received only pre-post-and-follow-up measurements. All participants measured Beck Depression Inventory (BDI-Ⅱ) and Self-control Scale (SCS) at three time points: baseline, post-training, and four-month follow-up. The dropout rates were 6 (8.1%) in the intervention group and 3 (4.1%) in the control group at the end of six-month intervention. The general linear model repeated measures analysis of variance revealed that comparing with the control group, the intervention group participants had more increase in their trait self-control score, at the meantime, their depressive symptoms had significantly improved. Univariate and logistic regression analyses revealed that participants with milder baseline depressive symptoms were more likely to benefit from CSCT interventions; depression improvement was also associated with the number of sessions attended. The main limitation was related to the small sample size which consisted of college students who were relatively young and well educated. The current study demonstrates that CSCT program could temporarily enhance self-control capacity as well as improve depressive symptoms; participants who are mildly to moderately depressed, and who could adhere to the training protocol are more likely to benefit from the intervention. Copyright © 2017 Elsevier B.V. All rights reserved.

Teen online problem solving for teens with traumatic brain injury: Rationale, methods, and preliminary feasibility of a teen only intervention.

PubMed

Wade, Shari L; Narad, Megan E; Kingery, Kathleen M; Taylor, H Gerry; Stancin, Terry; Kirkwood, Michael W; Yeates, Keith O

2017-08-01

To describe the Teen Online Problem Solving-Teen Only (TOPS-TO) intervention relative to the original Teen Online Problem Solving-Family (TOPS-F) intervention, to describe a randomized controlled trial to assess intervention efficacy, and to report feasibility and acceptability of the TOPS-TO intervention. Research method and design: This is a multisite randomized controlled trial, including 152 teens (49 TOPS-F, 51 TOPS-TO, 52 IRC) between the ages of 11-18 who were hospitalized for a moderate to severe traumatic brain injury in the previous 18 months. Assessments were completed at baseline, 6-months post baseline, and 12-months post baseline. Data discussed include adherence and satisfaction data collected at the 6-month assessment (treatment completion) for TOPS-F and TOPS-TO. Adherence measures (sessions completed, dropout rates, duration of treatment engagement, and rates of program completion) were similar across treatment groups. Overall, teen and parent reported satisfaction was high and similar across groups. Teens spent a similar amount of time on the TOPS website across groups, and parents in the TOPS-F spent more time on the TOPS website than those in the TOPS-TO group (p = .002). Parents in the TOPS-F group rated the TOPS website as more helpful than those in the TOPS-TO group (p = .05). TOPS-TO intervention is a feasible and acceptable intervention approach. Parents may perceive greater benefit from the family based intervention. Further examination is required to understand the comparative efficacy in improving child and family outcomes, and who is likely to benefit from each approach. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Randomized Pilot of an Anxiety Sensitivity-Based Intervention for Individuals in a Substance Use Day Program.

PubMed

Worden, Blaise L; Genova, Marla; Tolin, David F

2017-01-01

Anxiety sensitivity (AS), or the tendency to appraise physical symptoms as intolerable or dangerous, may maintain the cycle between co-occurring anxiety and substance use disorders. This study examined preliminary efficacy of a brief intervention targeting AS for individuals with heterogeneous substance use disorders. Forty-one patients with high AS entering an addictions day program were randomized to treatment as usual (TAU) or to TAU plus a nine-hour AS-focused intervention that consisted of interoceptive exposures, psychoeducation about the cycle of problematic substance use and anxiety, and a single session of cognitive challenging (e.g., reviewing common cognitive distortions and decatastrophizing anxiety symptoms). Mixed-effects intent-to-treat models suggested that participants in the AS condition showed greater decreases in AS at post-treatment, but this effect was lost at follow-up three months later. Intervention conditions did not differ in change in percent days abstinent or self-reported anxiety, with both conditions showing significant improvement at post-treatment. Results suggest that the nine-hour AS-focused intervention led to a short-term benefit over TAU alone, but this benefit was not sustained at three months' follow-up. Future AS interventions may need to target specific subconstructs of AS for selected populations, or target emotional distress tolerance more broadly.

Two parallel, pragmatic, UK multicentre, randomised controlled trials comparing surgical options for upper compartment (vault or uterine) pelvic organ prolapse (the VUE Study): study protocol for a randomised controlled trial.

PubMed

Glazener, Cathryn; Constable, Lynda; Hemming, Christine; Breeman, Suzanne; Elders, Andrew; Cooper, Kevin; Freeman, Robert; Smith, Anthony R B; Hagen, Suzanne; McDonald, Alison; McPherson, Gladys; Montgomery, Isobel; Kilonzo, Mary; Boyers, Dwayne; Goulao, Beatriz; Norrie, John

2016-09-08

One in three women who have a prolapse operation will go on to have another operation, though not necessarily in the same compartment. Surgery can result in greater impairment of quality of life than the original prolapse itself (such as the development of new-onset urinary incontinence, or prolapse at a different site). Anterior and posterior prolapse surgery is most common (90 % of operations), but around 43 % of women also have a uterine (34 %) or vault (9 %) procedure at the same time. There is not enough evidence from randomised controlled trials (RCTs) to guide management of vault or uterine prolapse. The Vault or Uterine prolapse surgery Evaluation (VUE) study aims to assess the surgical management of upper compartment pelvic organ prolapse (POP) in terms of clinical effectiveness, cost-effectiveness and adverse events. VUE is two parallel, pragmatic, UK multicentre, RCTs (Uterine Trial and Vault Trial). Eligible for inclusion are women with vault or uterine prolapse: requiring a surgical procedure, suitable for randomisation and willing to be randomised. Randomisation will be computer-allocated separately for each trial, minimised on: requiring concomitant anterior and/or posterior POP surgery or not, concomitant incontinence surgery or not, age (under 60 years or 60 years and older) and surgeon. Participants will be randomly assigned, with equal probability to intervention or control arms in either the Uterine Trial or the Vault Trial. Uterine Trial participants will receive either a vaginal hysterectomy or a uterine preservation procedure. Vault Trial participants will receive either a vaginal sacrospinous fixation or an abdominal sacrocolpopexy. Participants will be followed up by postal questionnaires (6 months post surgery and 12 months post randomisation) and also reviewed in clinic 12 months post surgery. The primary outcome is the participant-reported Pelvic Organ Prolapse Symptom Score (POP-SS) at 12 months post randomisation. Demonstrating the efficacy of vault and uterine prolapse surgeries is relevant not only to patients and clinicians but also to health care providers, both in the UK and globally. Current controlled trials ISRCTN86784244 (assigned 19 October 2012), and the first subject was randomly assigned on 1 May 2013.

Development and pilot testing of daily Interactive Voice Response (IVR) calls to support antiretroviral adherence in India: A mixed-methods pilot study

PubMed Central

Swendeman, Dallas; Jana, Smarajit; Ray, Protim; Mindry, Deborah; Das, Madhushree; Bhakta, Bhumi

2015-01-01

This two-phase pilot study aimed to design, pilot, and refine an automated Interactive Voice Response (IVR) intervention to support antiretroviral adherence for people living with HIV (PLH), in Kolkata, India. Mixed-methods formative research included a community advisory board (CAB) for IVR message development, one-month pre-post pilot, post-pilot focus groups, and further message development. Two IVR calls are made daily, timed to patients’ dosing schedules, with brief messages (<1-minute) on strategies for self-management of three domains: medical (adherence, symptoms, co-infections), mental health (social support, stress, positive cognitions), and nutrition and hygiene (per PLH preferences). Three ART appointment reminders are also sent each month. One-month pilot results (n=46, 80% women, 60% sex workers) found significant increases in self-reported ART adherence, both within past three days (p=0.05) and time since missed last dose (p=0.015). Depression was common. Messaging content and assessment domains were expanded for testing in a randomized trial is currently underway. PMID:25638037

Development and Pilot Testing of Daily Interactive Voice Response (IVR) Calls to Support Antiretroviral Adherence in India: A Mixed-Methods Pilot Study.

PubMed

Swendeman, Dallas; Jana, Smarajit; Ray, Protim; Mindry, Deborah; Das, Madhushree; Bhakta, Bhumi

2015-06-01

This two-phase pilot study aimed to design, pilot, and refine an automated interactive voice response (IVR) intervention to support antiretroviral adherence for people living with HIV (PLH), in Kolkata, India. Mixed-methods formative research included a community advisory board for IVR message development, 1-month pre-post pilot, post-pilot focus groups, and further message development. Two IVR calls are made daily, timed to patients' dosing schedules, with brief messages (<1-min) on strategies for self-management of three domains: medical (adherence, symptoms, co-infections), mental health (social support, stress, positive cognitions), and nutrition and hygiene (per PLH preferences). Three ART appointment reminders are also sent each month. One-month pilot results (n = 46, 80 % women, 60 % sex workers) found significant increases in self-reported ART adherence, both within past three days (p = 0.05) and time since missed last dose (p = 0.015). Depression was common. Messaging content and assessment domains were expanded for testing in a randomized trial currently underway.

Impact of Sustained Use of a Multifaceted Computerized Quality Improvement Intervention for Cardiovascular Disease Management in Australian Primary Health Care.

PubMed

Patel, Bindu; Peiris, David; Usherwood, Tim; Li, Qiang; Harris, Mark; Panaretto, Kathryn; Zwar, Nicholas; Patel, Anushka

2017-10-24

We evaluated a multifaceted, computerized quality improvement intervention for management of cardiovascular disease (CVD) risk in Australian primary health care. After completion of a cluster randomized controlled trial, the intervention was made available to both trial arms. Our objective was to assess intervention outcomes in the post-trial period and any heterogeneity based on original intervention allocation. Data from 41 health services were analyzed. Outcomes were (1) proportion of eligible population with guideline-recommended CVD risk factor measurements; and (2) the proportion at high CVD risk with current prescriptions for guideline-recommended medications. Patient-level analyses were conducted using generalized estimating equations to account for clustering and time effects and tests for heterogeneity were conducted to assess impact of original treatment allocation. Median follow-up for 22 809 patients (mean age, 64.2 years; 42.5% men, 26.5% high CVD risk) was 17.9 months post-trial and 35 months since trial inception. At the end of the post-trial period there was no change in CVD risk factor screening overall when compared with the end of the trial period (64.7% versus 63.5%, P =0.17). For patients at high CVD risk, there were significant improvements in recommended prescriptions at end of the post-trial period when compared with the end of the trial period (65.2% versus 56.0%, P <0.001). There was no heterogeneity of treatment effects on the outcomes based on original randomization allocation. CVD risk screening improvements were not observed in the post-trial period. Conversely, improvements in prescribing continued, suggesting that changes in provider and patient actions may take time when initiating medications. URL: http://www.anzctr.org.au. Unique identifier: 12611000478910. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

Randomized controlled trial of video self-modeling following speech restructuring treatment for stuttering.

PubMed

Cream, Angela; O'Brian, Sue; Jones, Mark; Block, Susan; Harrison, Elisabeth; Lincoln, Michelle; Hewat, Sally; Packman, Ann; Menzies, Ross; Onslow, Mark

2010-08-01

In this study, the authors investigated the efficacy of video self-modeling (VSM) following speech restructuring treatment to improve the maintenance of treatment effects. The design was an open-plan, parallel-group, randomized controlled trial. Participants were 89 adults and adolescents who undertook intensive speech restructuring treatment. Post treatment, participants were randomly assigned to 2 trial arms: standard maintenance and standard maintenance plus VSM. Participants in the latter arm viewed stutter-free videos of themselves each day for 1 month. The addition of VSM did not improve speech outcomes, as measured by percent syllables stuttered, at either 1 or 6 months postrandomization. However, at the latter assessment, self-rating of worst stuttering severity by the VSM group was 10% better than that of the control group, and satisfaction with speech fluency was 20% better. Quality of life was also better for the VSM group, which was mildly to moderately impaired compared with moderate impairment in the control group. VSM intervention after treatment was associated with improvements in self-reported outcomes. The clinical implications of this finding are discussed.

A randomized controlled trial comparing EMDR and CBT for obsessive-compulsive disorder.

PubMed

Marsden, Zoe; Lovell, Karina; Blore, David; Ali, Shehzad; Delgadillo, Jaime

2018-01-01

This study aimed to evaluate eye movement desensitization and reprocessing (EMDR) as a treatment for obsessive-compulsive disorder (OCD), by comparison to cognitive behavioural therapy (CBT) based on exposure and response prevention. This was a pragmatic, feasibility randomized controlled trial in which 55 participants with OCD were randomized to EMDR (n = 29) or CBT (n = 26). The Yale-Brown obsessive-compulsive scale was completed at baseline, after treatment and at 6 months follow-up. Treatment completion and response rates were compared using chi-square tests. Effect size was examined using Cohen's d and multilevel modelling. Overall, 61.8% completed treatment and 30.2% attained reliable and clinically significant improvement in OCD symptoms, with no significant differences between groups (p > .05). There were no significant differences between groups in Yale-Brown obsessive-compulsive scale severity post-treatment (d = -0.24, p = .38) or at 6 months follow-up (d = -0.03, p = .90). EMDR and CBT had comparable completion rates and clinical outcomes. Copyright © 2017 John Wiley & Sons, Ltd.

A randomized trial testing the superiority of a post-discharge care management model for stroke survivors

PubMed Central

Allen, Kyle; Hazelett, Susan; Jarjoura, David; Hua, Keding; Wright, Kathy; Weinhardt, Janice; Kropp, Denise

2009-01-01

Objective To evaluate whether comprehensive post-discharge care management for stroke survivors is superior to organized acute stroke unit care with enhanced discharge planning in improving a profile of health and well-being. Methods This was a randomized trial of a comprehensive post-discharge care management intervention for ischemic stroke patients with NIH Stroke Scale scores ≥1 discharged from an acute stroke unit. An Advanced Practice Nurse (APN) performed an in-home assessment for the intervention group from which an Interdisciplinary Team developed patient-specific care plans. The APN worked with the primary care physician (PCP) and patient to implement the plan over the next 6 months. Main outcome measures The intervention and usual care groups were compared using a global and closed hypothesis testing strategy. Outcomes fell into 5 domains: 1) Neuromotor Function, 2) Institution Time or Death, 3) Quality of Life, 4) Management of Risk, and 5) Stroke Knowledge and Lifestyle. Results Treatment effect was near zero standard deviations for all but the stroke knowledge and lifestyle domain which showed a significant effect of the intervention (p=0.0003). Conclusions Post discharge care management was not more effective than organized stroke unit care with enhanced discharge planning in most domains in this population. The intervention did, however, fill a post-discharge knowledge gap. PMID:19900646

Investigating the influence of nitrate nitrogen on post-smolt Atlantic salmon Salmo salar reproductive physiology in water recirculation aquaculture systems

USGS Publications Warehouse

Good, Christopher; Davidson, John; Iwanowicz, Luke R.; Meyer, Michael T.; Dietze, Julie E.; Kolpin, Dana W.; Marancik, David; Birkett, Jill; Williams, Christina; Summerfelt, Steven T.

2017-01-01

A major issue affecting land-based, closed containment Atlantic salmon Salmo salar growout production in water recirculation aquaculture systems (RAS) is precocious male maturation, which can negatively impact factors such as feed conversion, fillet yield, and product quality. Along with other water quality parameters, elevated nitrate nitrogen (NO3-N) has been shown to influence the reproductive development and endogenous sex steroid production in a number of aquatic animal species, including Atlantic salmon. We sought to determine whether elevated NO3-N in RAS can influence early maturation in post-smolt Atlantic salmon in an 8-month trial in replicated freshwater RAS. Post-smolt Atlantic salmon (102 ± 1 g) were stocked into six RAS, with three RAS randomly selected for dosing with high NO3-N (99 ± 1 mg/L) and three RAS set for low NO3-N (10 ± 0 mg/L). At 2-, 4-, 6-, and 8-months post-stocking, 5 fish were randomly sampled from each RAS, gonadosomatic index(GSI) data were collected, and plasma was sampled for 11-ketotestosterone(11-KT) quantification. At 4- and 8-months post-stocking, samples of culture tank and spring water (used as “makeup” or replacement water) were collected and tested for a suite of 42 hormonally active compounds using liquid chromatography/mass spectrometry, as well as for estrogenicity using the bioluminescent yeast estrogen screen (BLYES) reporter system. Finally, at 8-months post-stocking 8–9 salmon were sampled from each RAS for blood gas and chemistry analyses, and multiple organ tissues were sampled for histopathology evaluation. Overall, sexually mature males were highly prevalent in both NO3-N treatment groups by study’s end, and there did not appear to be an effect of NO3-N on male maturation prevalence based on grilse identification, GSI, and 11-KT results, indicating that other culture parameters likely instigated early maturation. No important differences were noted between treatment groups for whole blood gas and chemistry parameters, and no significant tissue changes were noted on histopathology. No hormones, hormone conjugates, or mycotoxins were detected in any water samples; phytoestrogens were generally detected at low levels but were unrelated to NO3-N treatment. Finally, low-level estrogenicity was detected in RAS water, but a NO3-N treatment effect could not be determined. The major findings of this study are i) the NO3-N treatments did not appear to be related to the observed male maturation, and ii) the majority of hormonally active compounds were not detectable in RAS water.

Characterization and longitudinal monitoring of serum androgens and glucocorticoids during normal pregnancy in the killer whale (Orcinus orca).

PubMed

Robeck, Todd R; Steinman, Karen J; O'Brien, Justine K

2017-06-01

The secretory patterns of testosterone (T), androstenedione (A4), dehydroepiandrosterone (DHEA), cortisol (C), and corticosterone (Co) were characterized throughout 28 normal pregnancies until two-months post-partum in eleven killer whales. Effects of fetal sex, dam parity or age, and season were evaluated across either day post-conception (DPC), stage of pregnancy (PRE, EARLY, MID, LATE, POST) or indexed month post-conception (IMPC) using a mixed model linear regression with animal ID and pregnancy number as the random variables. Across DPC, DHEA, A4 and T concentrations were affected (P<0.05) by season, with highest concentrations during spring (DHEA, A4, & T) and summer (A4) as compared to the fall. A significant effect of parity on androgen production was observed only for DHEA, with multiparous females having higher (P=0.01) concentrations than nulliparous females. All three androgens significantly increased with each successive pregnancy stage and IMPC with peak concentrations occurring during IMPC 10 (DHEA), 13 (A4) and 14 (T), respectively. Cortisol was affected by season (P=0.03) with highest concentrations being detected during the months of fall, while Co was only affected by parity (P=0.003) with significant increases observed for primiparous females as compared to nulliparous females. Cortisol and Co concentrations peaked (P<0.05) during IMPC 17 (i.e., the month prior to parturition). The C to Co ratio during pregnancy was 7.4 to 1, indicating that cortisol is the major circulating glucocorticoid studied to date in pregnant killer whales. The significant increase in concentrations of maternal androgens throughout pregnancy, which were unrelated to fetal sex, indicates that they play an important role during killer whale fetal development. Copyright © 2017 Elsevier Inc. All rights reserved.

Use of Oral Steroid and its Effects on Atrial Fibrillation Recurrence and Inflammatory Cytokines Post Ablation - The Steroid AF Study.

PubMed

Iskandar, Sandia; Reddy, Madhu; Afzal, Muhammad R; Rajasingh, Johnson; Atoui, Moustapha; Lavu, Madhav; Atkins, Donita; Bommana, Sudha; Umbarger, Linda; Jaeger, Misty; Pimentel, Rhea; Dendi, Raghuveer; Emert, Martin; Turagam, Mohit; Di Biase, Luigi; Natale, Andrea; Lakkireddy, Dhanunjaya

2017-01-01

Use of corticosteroids before and after atrial fibrillation (AF) ablation can decrease acute inflammation and reduce AF recurrence. To assess the efficacy of oral prednisone in improving the outcomes of pulmonary vein isolation with radiofrequency ablation and its effect on inflammatory cytokine. A total of 60 patients with paroxysmal AF undergoing radiofrequency ablation were randomized (1:1) to receive either 3 doses of 60 mg daily of oral prednisone or a placebo. Inflammatory cytokine levels (TNF-α, IL-1, IL6, IL-8) were measured at baseline, prior to ablation, immediately after ablation, and 24 hours post ablation. Patients underwent 30 day event monitoring at 3 months, 6 months and 12 months post procedure. Immediate post ablation levels of inflammatory cytokines were lower in the steroid group when compared to the placebo group; IL-6: 9.0 ±7 vs 15.8 ±13 p=0.031; IL-8: 10.5 ±9 vs 15.3 ±8; p=0.047 respectively. Acute PV reconnection rates during the procedure (7/23% vs 10/36%; p = 0.39), and RF ablation time (51±13 vs 56±11 min, p = 0.11) trended to be lower in the placebo group than the steroid group. There was no difference in the incidence of early recurrence of AF during the blanking period and freedom from AF off AAD at 12 months between both groups (5/17% vs 8/27%; p = 0.347 and 21/70% vs 18/60%; p=0.417 in placebo and steroid groups respectively). Although oral corticosteroids have significant effect in lowering certain cytokines, it did not impact the clinical outcomes of AF ablation.

Time course of upper limb function and return-to-work post-radiotherapy in young adults with breast cancer: a pilot randomized control trial on effects of targeted exercise program.

PubMed

Ibrahim, Marize; Muanza, Thierry; Smirnow, Nadia; Sateren, Warren; Fournier, Beatrice; Kavan, Petr; Palumbo, Michael; Dalfen, Richard; Dalzell, Mary-Ann

2017-12-01

Breast cancer (BC) diagnosis in young adults (YA) is rising, and both disease and treatments are aggressive in this population. Evidence supports the use of physical activity in reducing shoulder dysfunction, which is common among BC survivors. A pilot randomized clinical trial was performed to determine the effectiveness of a 12-week post-radiation exercise program in minimizing upper extremity dysfunction in YA with BC. Participants were randomized to either an exercise arm or a control arm receiving standard care. Data was collected over six time points using: the Disability of Arm, Shoulder, and Hand (DASH); the Metabolic Equivalent of Task-hours per week (MET-hours/week), and a post hoc questionnaire on return to work. In total, 59 young women participated in the study (n = 29 exercise; n = 30 control). No statistically significant differences were found in overall DASH results between groups; however, those who underwent total mastectomy had residual upper limb dysfunction (p < 0.05). Both groups returned to pre-diagnosis activity levels by 18 months. Final evaluation showed that 86% of the women returned to work, and 89% resumed prior work activities with a decrease of 8.5 h/week. Although the short-term targeted exercise program had no effect on long-term upper limb function post-radiation, timing and program specificity may require consideration of tissue healing post-radiation and surgery type. The majority of participants returned to work, however not returning to pre-diagnosis work hours. Exercise interventions alone may not reverse the long-term sequelae of breast cancer treatment and allow young adult patients to return to work.

Anterior cruciate ligament- specialized post-operative return-to-sports (ACL-SPORTS) training: a randomized control trial

PubMed Central

2013-01-01

Background Anterior cruciate ligament reconstruction (ACLR) is standard practice for athletes that wish to return to high-level activities; however functional outcomes after ACLR are poor. Quadriceps strength weakness, abnormal movement patterns and below normal knee function is reported in the months and years after ACLR. Second ACL injuries are common with even worse outcomes than primary ACLR. Modifiable limb-to-limb asymmetries have been identified in individuals who re-injure after primary ACLR, suggesting a neuromuscular training program is needed to improve post-operative outcomes. Pre-operative perturbation training, a neuromuscular training program, has been successful at improving limb symmetry prior to surgery, though benefits are not lasting after surgery. Implementing perturbation training after surgery may be successful in addressing post-operative deficits that contribute to poor functional outcomes and second ACL injury risk. Methods/Design 80 athletes that have undergone a unilateral ACLR and wish to return to level 1 or 2 activities will be recruited for this study and randomized to one of two treatment groups. A standard care group will receive prevention exercises, quadriceps strengthening and agility exercises, while the perturbation group will receive the same exercise program with the addition of perturbation training. The primary outcomes measures will include gait biomechanics, clinical and functional measures, and knee joint loading. Return to sport rates, return to pre-injury level of activity rates, and second injury rates will be secondary measures. Discussion The results of this ACL-Specialized Post-Operative Return To Sports (ACL-SPORTS) Training program will help clinicians to better determine an effective post-operative treatment program that will improve modifiable impairments that influence outcomes after ACLR. Trial registration Randomized Control Trial NIH 5R01AR048212-07. ClinicalTrials.gov: NCT01773317 PMID:23522373

Attachment-focused integrative reminiscence with older African Americans: a randomized controlled intervention study.

PubMed

Sabir, Myra; Henderson, Charles R; Kang, Suk-Young; Pillemer, Karl

2016-01-01

Prior integrative reminiscence interventions have had a limited focus on attachment themes. The attachment-focused integrative reminiscence (AFIR) intervention differs from these in its central emphasis on attachment themes. The wide range of health benefits resulting from integrative reminiscence may be due in part to reminiscing about, mourning, and integrating unresolved attachment experiences. Participants were randomized into treatment and wait-list control conditions, completed a pre-test, met for eight consecutive weekly two-hour sessions of largely attachment-focused reminiscence, then completed post-tests immediately following the intervention and again six months later. Results show treatment effects for depression (p = .01 and .05 at eight weeks and six months), perceived stress (p = .01 and .04), and emergency room (ER) visits at six months (p = .04), with the intervention group showing lower depression and stress and fewer ER visits. Integrative reminiscence interventions are cost effective, have rapid impact, and carry a certain appeal to older adults. Augmenting such interventions with a focus on attachment experiences may reduce perceived stress, an important health risk factor. Wider application of AFIRs may further reduce health disparities among US older adults.

Randomized controlled trial comparing esophageal dilation to no dilation among adults with esophageal eosinophilia and dysphagia.

PubMed

Kavitt, R T; Ates, F; Slaughter, J C; Higginbotham, T; Shepherd, B D; Sumner, E L; Vaezi, M F

2016-11-01

The role of esophageal dilation in patients with esophageal eosinophilia with dysphagia remains unknown. The practice of dilation is currently based on center preferences and expert opinion. The aim of this study is to determine if, and to what extent, dysphagia improves in response to initial esophageal dilation followed by standard medical therapies. We conducted a randomized, blinded, controlled trial evaluating adult patients with dysphagia and newly diagnosed esophageal eosinophilia from 2008 to 2013. Patients were randomized to dilation or no dilation at time of endoscopy and blinded to dilation status. Endoscopic features were graded as major and minor. Subsequent to randomization and endoscopy, all patients received fluticasone and dexlansoprazole for 2 months. The primary study outcome was reduction in overall dysphagia score, assessed at 30 and 60 days post-intervention. Patients with severe strictures (less than 7-mm esophageal diameter) were excluded from the study. Thirty-one patients were randomized and completed the protocol: 17 randomized to dilation and 14 to no dilation. Both groups were similar with regard to gender, age, eosinophil density, endoscopic score, and baseline dysphagia score. The population exhibited moderate to severe dysphagia and moderate esophageal stricturing at baseline. Overall, there was a significant (P < 0.001) but similar reduction in mean dysphagia score at 30 and 60 days post-randomization compared with baseline in both groups. No significant difference in dysphagia scores between treatment groups after 30 (P = 0.93) or 60 (P = 0.21) days post-intervention was observed. Esophageal dilation did not result in additional improvement in dysphagia score compared with treatment with proton pump inhibitor and fluticasone alone. In patients with symptomatic esophageal eosinophilia without severe stricture, dilation does not appear to be a necessary initial treatment strategy. © 2015 International Society for Diseases of the Esophagus.

Treatment of myofascial pain syndrome with lidocaine injection and physical therapy, alone or in combination: a single blind, randomized, controlled clinical trial.

PubMed

Lugo, Luz Helena; García, Hector Ivan; Rogers, Heather L; Plata, Jesús Alberto

2016-02-24

Myofascial pain syndrome (MPS) of the shoulder girdle and cervical region is a common musculoskeletal problem that is often chronic or recurrent. Physical therapy (PT) and lidocaine injections (LI) are two treatments with demonstrated effectiveness compared to a control group, however little is known about their combined value. The objective of this study was to determine whether LI into trigger points combined with a PT program would be more effective than each separate treatment alone in improving pain, function, and quality of life in a group of patients with MPS of the shoulder girdle and cervical region. A single-blind, randomized, controlled clinical trial (RCT) was conducted with three parallel groups in the Departments of Physical Medicine and Rehabilitation of two urban hospitals in Medellin, Colombia. One hundred and twenty seven patients with shoulder girdle MPS for more than 6 weeks and pain greater than 40 mm on the visual analog scale (VAS) were assigned to 1 of 3 intervention groups: PT, LI, or the combination of both (PT + LI). The primary outcome was VAS pain rating at 1-month post-treatment. The secondary outcomes included VAS pain rating at 3 months, and, at both 1 and 3 months post-treatment: (a) function, evaluated by hand-back maneuver and the hand-mouth maneuver, (b) quality of life, as measured by sub-scales of the Short Form - 36 (SF-36), and (c) depressive symptoms, as measured by the Patient Health Questionnaire - 9 (PHQ-9). Independent t-tests were used to compare outcomes between groups at 1 month and 3 months post-treatment. In the per protocol analysis, there were no significant intergroup differences in VAS at 1 month PT + LI, 40.8 [25.3] vs. PT, 37.8 [21.9], p = 0.560 and vs. LI, 44.2 [24.9], p = 0.545. There were also no differences between groups on secondary outcomes except that the PT and PT + LI groups had higher right upper limb hand-back maneuver scores compared to the LI alone group at both 1 and 3 months (p = 0.013 and p = 0.016 respectively). The results of this RCT showed that no differences in pain ratings were observed between the individual treatments (PT or LI) compared to the combined treatment of PT and LI. In general, no difference in primary or secondary outcomes was observed between treatments. NTC01250184 November 27, 2010.

Cytokine and neuropeptide levels are associated with pain relief in patients with chronically painful total knee arthroplasty: a pilot study.

PubMed

Singh, Jasvinder A; Noorbaloochi, Siamak; Knutson, Keith L

2017-01-14

There are few studies with an assessment of the levels of cytokines or neuropeptides as correlates of pain and pain relief in patients with painful joint diseases. Our objective was to assess whether improvements from baseline to 2-months in serum cytokine, chemokine and substance P levels were associated with clinically meaningful pain relief at 2-months post-injection in patients with painful total knee arthroplasty (TKA). Using data from randomized trial of 60 TKAs, we assessed the association of change in cytokine/chemokine/Substance P levels with primary study outcome, clinically important improvement in Western Ontario McMaster Osteoarthritis Index (WOMAC) pain subscale at 2-months post-injection using Student's t-tests and Spearman's correlation coefficient (non-parametric). Patients were categorized as pain responders (20-point reduction or more on 0-100 WOMAC pain) vs. pain non-responders. Sensitivity analysis used 0-10 daytime pain numeric rating scale (NRS) instead of WOMAC pain subscale. In a pilot study, compared to non-responders (n = 23) on WOMAC pain scale at 2-months, pain responders (n = 12) had significantly greater increase in serum levels of IL-7, IL-10, IL-12, eotaxin, interferon gamma and TNF-α from baseline to 2-months post-injection (p < 0.05 for all). Change in several cytokine/chemokine and substance P levels from pre-injection to 2-month follow-up correlated significantly with change in WOMAC pain with correlation coefficients ranging -0.37 to -0.51: IL-2, IL-7, IL-8, IL-9, IL-16, IL-12p, GCSF, IFN gamma, IP-10, MCP, MIP1b, TNF-α and VEGF (n = 35). Sensitivity analysis showed that substance P decreased significantly more from baseline to 2-months in the pain responders (0.54 ± 0.53; n = 10) than in the pain non-responders (0.48 ± 1.18; n = 9; p = 0.023) and that this change in serum substance P correlated significantly with change in daytime NRS pain, correlation coefficient was 0.53 (p = 0.021; n = 19). Findings should be interpreted with caution, since cytokine analyses were performed for a sub-group of the entire trial population. Serum cytokine, chemokine and Substance P levels correlated with pain response in patients with painful TKA after an intra-articular injection in a randomized trial.

A Randomized Controlled Trial of Clinician-Supported Problem-Solving Bibliotherapy for Family Caregivers of People With First-Episode Psychosis.

PubMed

Chien, Wai Tong; Thompson, David R; Lubman, Dan I; McCann, Terence V

2016-11-01

Family interventions for first-episode psychosis (FEP) are an integral component of treatment, with positive effects mainly on patients' mental state and relapse rate. However, comparatively little attention has been paid to the effects of family interventions on caregivers' stress coping and well-being, especially in non-Western countries. We aimed to test the effects of a 5-month clinician-supported problem-solving bibliotherapy (CSPSB) for Chinese family caregivers of people with FEP in improving family burden and carers' problem-solving and caregiving experience, and in reducing psychotic symptoms and duration of re-hospitalizations, compared with those only received usual outpatient family support (UOFS). A randomized controlled trial was conducted across 2 early psychosis clinics in Hong Kong, where there might be inadequate usual family support services for FEP patients. A total of 116 caregivers were randomly selected, and after baseline measurement, randomly assigned to the CSPSB or UOFS. They were also assessed at 1-week and 6- and 12-month post-intervention. Intention-to-treat analyses were applied and indicated that the CSPSB group reported significantly greater improvements in family burden and caregiving experience, and reductions in severity of psychotic symptoms and duration of re-hospitalizations, than the UOFS group at 6- and 12-month follow-up. CSPSB produces moderate long-term benefits to caregivers and FEP patients, and is a low-cost adjunct to UOFS. © The Author 2016. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center.

Theory-based behavioral intervention increases self-reported physical activity in South African men: a cluster-randomized controlled trial.

PubMed

Jemmott, John B; Jemmott, Loretta S; Ngwane, Zolani; Zhang, Jingwen; Heeren, G Anita; Icard, Larry D; O'Leary, Ann; Mtose, Xoliswa; Teitelman, Anne; Carty, Craig

2014-07-01

To determine whether a health-promotion intervention increases South African men's adherence to physical-activity guidelines. We utilized a cluster-randomized controlled trial design. Eligible clusters, residential neighborhoods near East London, South Africa, were matched in pairs. Within randomly selected pairs, neighborhoods were randomized to theory-based, culturally congruent health-promotion intervention encouraging physical activity or attention-matched HIV/STI risk-reduction control intervention. Men residing in the neighborhoods and reporting coitus in the previous 3 months were eligible. Primary outcome was self-reported individual-level adherence to physical-activity guidelines averaged over 6-month and 12-month post-intervention assessments. Data were collected in 2007-2010. Data collectors, but not facilitators or participants, were blind to group assignment. Primary outcome intention-to-treat analysis included 22 of 22 clusters and 537 of 572 men in the health-promotion intervention and 22 of 22 clusters and 569 of 609 men in the attention-control intervention. Model-estimated probability of meeting physical-activity guidelines was 51.0% in the health-promotion intervention and 44.7% in attention-matched control (OR=1.34; 95% CI, 1.09-1.63), adjusting for baseline prevalence and clustering from 44 neighborhoods. A theory-based culturally congruent intervention increased South African men's self-reported physical activity, a key contributor to deaths from non-communicable diseases in South Africa. ClinicalTrials.gov Identifier: NCT01490359. Copyright © 2014 Elsevier Inc. All rights reserved.

The EXCITE Trial: Retention of Improved Upper Extremity Function Among Stroke Survivors Receiving CI Movement Therapy

PubMed Central

Wolf, Steven L.; Winstein, Carolee J.; Miller, J Phillip; Thompson, Paul A.; Taub, Edward; Uswatte, Gitendra; Morris, David; Blanton, Sarah; Nichols-Larsen, Deborah; Clark, Patricia C.

2008-01-01

Summary Background Constraint-Induced Movement therapy (CIMT) uses a variety of treatment components, including restricted use of the better upper extremity, to promote increased use of the contralesional limb for many hours each weekday over two consecutive weeks. The EXCITE Trial demonstrated the efficacy of this intervention for patients 3-9 months post-stroke who were followed for the next 12 months. We assessed the retention of improvements through 24 months. Method Measurements were made every four months for impaired upper extremity function (Wolf Motor Function Test - WMFT and Motor Activity Log - MAL) and health related quality of life (Stroke Impact Scale - SIS) amongst 106/222 participants randomized into one arm of the EXCITE Trial in which they received CIMT rather than usual and customary care. Findings There was no observed regression from the treatment effects observed at 12 months after treatment during the next 12 months for the primary outcome measures of WMFT and MAL. In fact, the additional changes were in the direction of increased therapeutic effect. For the strength components of the WMFT the changes were significant (P < .05) Secondary outcome variables, including the SIS, exhibited a similar pattern. Interpretation Mild to moderately impaired patients who are 3-9 months post-stroke demonstrate substantial improvement in functional use of the paretic upper extremity and quality of life 2 years after receiving a 2-week CIMT intervention. Thus this intervention has persistent benefits. PMID:18077218

Patient satisfaction and efficacy of accent radiofrequency for facial skin wrinkle reduction

PubMed Central

Jaffary, Fariba; Nilforoushzadeh, Mohammad Ali; Zarkoob, Hajar

2013-01-01

Background: Radiofrequency (RF) is a new technique to treat facial wrinkles. This study was designed to assess the efficacy of Accent RF in wrinkle reduction of different areas of the face. Materials and Methods: Patients with mild to severe facial wrinkles were treated with Accent using RF energies of 35-145 W. The average energy used in this study was 83.11 W. Patients received four subsequent weekly RF sessions. Wrinkle improvement was rated by two physicians comparing 6-month post treatment photographs with pretreatment photos. Moreover, patient satisfaction was assessed at 1 and 6 months after the last session of the treatment. Results: A total of 45 women participated in this study. In terms of patient satisfaction one month after the last treatment, 8.9% of the patients declared their dissatisfaction, 53.3% were somehow satisfied, 33.3% were satisfied, and 4.4% were very satisfied. At 6 months, patient satisfaction was as follows: 4.4% dissatisfied, 31.1% somehow satisfied, 46.7% satisfied, and 17.8% very satisfied. Patient satisfaction 6 months after the last treatment was significantly higher than 1 month post treatment (P = 0.006). At 6 months, patient satisfaction was not more than 75% in any treatment areas of the face. Conclusion: The results of this study suggest that Accent RF may be considered as a possible effective option for facial skin rejuvenation although its efficacy and safety needs to be evaluated further in randomized controlled trials. PMID:24523783

Double hemibody irradiation (DHBI) in the management of relapsed and primary chemoresistant multiple myeloma.

PubMed

McSweeney, E N; Tobias, J S; Blackman, G; Goldstone, A H; Richards, J D

1993-01-01

In view of increasing controversy regarding the role of double hemibody irradiation (DHBI) in the treatment of multiple myeloma, we have analysed the use of this technique at our institution over a 6-year period. Fifty-five patients with multiple myeloma were treated with both upper and lower hemibody irradiation between January 1985 and January 1991; 42 had relapsed post-plateau and 13 were chemoresistant to initial therapy. Fifteen patients received alpha IFN-2b maintenance therapy post-DHBI, at a dose of 3 Mu three times per week, as part of a randomized trial. Ninety-five per cent of patients experienced symptomatic improvement in bone pain post-DHBI, 21% of whom discontinued opiate analgesics altogether; 63% had a minor biochemical response and 38% had a partial biochemical response. The overall survival (OS) and progression free survivals (PFS) in all patients were 11 months and 8 months respectively. No significant difference was noted in either OS or PFS, according to whether patients were chemoresistant or had relapsed post-plateau. alpha IFN did not appear to prolong survival (OS or PFS) post-DHBI. Cytopenia was a significant problem, such that only 60% of patients had counts adequate enough to be eligible for alpha IFN. We conclude that DHBI is an effective treatment in patients with relapsed multiple myeloma and in those who are chemoresistant to initial therapy.(ABSTRACT TRUNCATED AT 250 WORDS)

An acceptance-oriented cognitive-behavioral therapy in multimodal rehabilitation: a pre-post test evaluation in highly distressed patients with rheumatic diseases.

PubMed

Vriezekolk, Johanna E; Eijsbouts, Agnes M M; van Lankveld, Wim G J M; Beenackers, Hanneke; Geenen, Rinie; van den Ende, Cornelia H M

2013-06-01

To examine the potential effectiveness of a multimodal rehabilitation program including an acceptance-oriented cognitive-behavioral therapy for highly distressed patients with rheumatic diseases. An observational study employing a one-group pre-post test design (N=25). The primary outcome was psychological distress. Secondary outcomes were quality of life, illness acceptance, and coping flexibility. Group pre-to-post and pre-to-12 months follow-up treatment changes were evaluated by paired-samples t-tests and Cohen's effect sizes (d). Individual changes were evaluated by the reliable change index (RCI) and clinically significant change (CSC) parameters. Significant effects were found post-treatment and maintained at 12 months in psychological distress (d>0.80), illness acceptance (d=1.48) and the SF-36 subscales role physical, vitality, and mental health (d ≥ 0.65). No significant effects were found for coping flexibility and the SF-36 subscales physical functioning, bodily pain, social functioning, and role emotional. Both a reliable (RCI) and clinically significant (CSC) improvement was observed for almost half of the highly distressed patients. The patients enrolled in the multimodal rehabilitation program showed improved psychological health status from pre to post-treatment. A randomized clinical trial is needed to confirm or refute the added value of an acceptance-oriented cognitive-behavioral therapy for highly distressed patients in rehabilitation. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

A novel cognitive behaviour therapy for bipolar disorders (Think Effectively About Mood Swings or TEAMS): study protocol for a randomized controlled trial.

PubMed

Mansell, Warren; Tai, Sara; Clark, Alexandra; Akgonul, Savas; Dunn, Graham; Davies, Linda; Law, Heather; Morriss, Richard; Tinning, Neil; Morrison, Anthony P

2014-10-24

Existing psychological therapies for bipolar disorders have been found to have mixed results, with a consensus that they provide a significant, but modest, effect on clinical outcomes. Typically, these approaches have focused on promoting strategies to prevent future relapse. An alternative treatment approach, termed 'Think Effectively About Mood Swings' (TEAMS) addresses current symptoms, including subclinical hypomania, depression and anxiety, and promotes long-term recovery. Following the publication of a theoretical model, a range of research studies testing the model and a case series have demonstrated positive results. The current study reports the protocol of a feasibility randomized controlled trial to inform a future multi-centre trial. A target number of 84 patients with a diagnosis of bipolar I or II disorder, or bipolar disorder not-otherwise-specified are screened, allocated to a baseline assessment and randomized to either 16 sessions of TEAMS therapy plus treatment-as-usual (TAU) or TAU. Patients complete self-report inventories of depression, anxiety, recovery status and bipolar cognitions targeted by TEAMS. Assessments of diagnosis, bipolar symptoms, medication, access to services and quality of life are conducted by assessors blind to treatment condition at 3, 6, 12 and 18 months post-randomization. The main aim is to evaluate recruitment and retention of participants into both arms of the study, as well as adherence to therapy, to determine feasibility and acceptability. It is predicted that TEAMS plus TAU will reduce self-reported depression in comparison to TAU alone at six months post-randomization. The secondary hypotheses are that TEAMS will reduce the severity of hypomanic symptoms and anxiety, reduce bipolar cognitions, improve social functioning and promote recovery compared to TAU alone at post-treatment and follow-up. The study also incorporates semi-structured interviews about the experiences of previous treatment and the experience of TEAMS therapy that will be subject to qualitative analyses to inform future developments of the approach. The design will provide preliminary evidence of efficacy, feasibility, acceptability, uptake, attrition and barriers to treatment to design a definitive trial of this novel intervention compared to treatment as usual. This trial was registered with Current Controlled Trials (ISRCTN83928726) on registered 25 July 2014.

Improving Social Support for Older Adults Through Technology: Findings From the PRISM Randomized Controlled Trial.

PubMed

Czaja, Sara J; Boot, Walter R; Charness, Neil; Rogers, Wendy A; Sharit, Joseph

2018-05-08

Information and communication technology holds promise in terms of providing support and reducing isolation among older adults. We evaluated the impact of a specially designed computer system for older adults, the Personal Reminder Information and Social Management (PRISM) system. The trial was a multisite randomized field trial conducted at 3 sites. PRISM was compared to a Binder condition wherein participants received a notebook that contained paper content similar to that contained in PRISM. The sample included 300 older adults at risk for social isolation who lived independently in the community (Mage = 76.15 years). Primary outcome measures included indices of social isolation, social support, loneliness, and well-being. Secondary outcome measures included indices of computer proficiency and attitudes toward technology. Data were collected at baseline and at 6 and 12 months post-randomization. The PRISM group reported significantly less loneliness and increased perceived social support and well-being at 6 months. There was a trend indicating a decline in social isolation. Group differences were not maintained at 12 months, but those in the PRISM condition still showed improvements from baseline. There was also an increase in computer self-efficacy, proficiency, and comfort with computers for PRISM participants at 6 and 12 months. The findings suggest that access to technology applications such as PRISM may enhance social connectivity and reduce loneliness among older adults and has the potential to change attitudes toward technology and increase technology self-efficacy.

The Smoker’s Health Project: A self-determination theory intervention to facilitate maintenance of tobacco abstinence

PubMed Central

Williams, Geoffrey C.; Patrick, Heather; Niemiec, Christopher P.; Ryan, Richard M.; Deci, Edward L.; Lavigne, Holly McGregor

2011-01-01

A previous randomized clinical trial based on self-determination theory (SDT) and consistent with the Public Health Service (PHS) Guideline for Treating Tobacco Use and Dependence demonstrated that an intensive intervention could change autonomous self-regulation and perceived competence which in part facilitated long-term tobacco abstinence. The current article describes a pragmatic comparative effectiveness trial of three SDT-based intensive tobacco-dependence interventions. Eligible participants are randomized to one of three treatment conditions designed to facilitate long-term maintenance of tobacco abstinence, namely, Community Care (CC), which includes the 6-month SDT-based intervention previously shown to promote autonomous self-regulation, perceived competence, medication use, and tobacco abstinence; Extended Need Support (ENS), which extends the 6-month SDT-based intervention to 12 months and trains an important other to provide support for smokers’ basic psychological needs; and Harm Reduction (HR), which provides extended need support and recommends medication use for participants who do not want to stop smoking completely within 30 days but who are willing to reduce their cigarette use by half. The primary outcome is 12-month prolonged abstinence from tobacco, which is assessed one year following termination of treatment (two years post-randomization). Secondary outcomes include 7- and 30-day point prevalence tobacco abstinence, number of days using smoking-cessation medication, change in autonomous self-regulation and perceived competence, and perceived need support from important others. PMID:21382516

The smoker's health project: a self-determination theory intervention to facilitate maintenance of tobacco abstinence.

PubMed

Williams, Geoffrey C; Patrick, Heather; Niemiec, Christopher P; Ryan, Richard M; Deci, Edward L; Lavigne, Holly McGregor

2011-07-01

A previous randomized clinical trial based on self-determination theory (SDT) and consistent with the Public Health Service (PHS) Guideline for Treating Tobacco Use and Dependence demonstrated that an intensive intervention could change autonomous self-regulation and perceived competence, which in part facilitated long-term tobacco abstinence. The current article describes a pragmatic comparative effectiveness trial of three SDT-based intensive tobacco-dependence interventions. Eligible participants are randomized to one of the three treatment conditions designed to facilitate long-term maintenance of tobacco abstinence, namely, Community Care (CC), which includes the 6 month SDT-based intervention previously shown to promote autonomous self-regulation, perceived competence, medication use, and tobacco abstinence; Extended Need Support (ENS), which extends the 6 month SDT-based intervention to 12 months and trains an important other to provide support for smokers' basic psychological needs; and Harm Reduction (HR), which provides extended need support and recommends medication use for participants who do not want to stop smoking completely within 30 days but who are willing to reduce their cigarette use by half. The primary outcome is 12 month prolonged abstinence from tobacco, which is assessed one year following termination of treatment (two years post-randomization). Secondary outcomes include 7- and 30 day point prevalence tobacco abstinence, number of days using smoking-cessation medication, change in autonomous self-regulation and perceived competence, and perceived need support from important others. Copyright © 2011 Elsevier Inc. All rights reserved.

Family Economic Strengthening and Parenting Stress Among Caregivers of AIDS-Orphaned Children: Results from a Cluster Randomized Clinical Trial in Uganda.

PubMed

Nabunya, Proscovia; Ssewamala, Fred M; Ilic, Vilma

2014-09-01

This study examines the impact of a family economic strengthening intervention on parenting stress among caregivers of AIDS-orphaned children in Uganda. The study uses data from a 4-year (2008-2012) NIMH randomized clinical trial for AIDS-orphaned children known as Suubi-Maka (N=346 dyads). Child-caregiver dyads from 10 comparable primary schools were randomly assigned to either the control group (n=167 dyads) receiving usual care for school-going orphaned children (such as food aid and scholastic materials) or the treatment group (n=179 dyads) receiving a family economic strengthening intervention (focused on a matched savings account), financial planning and management workshops over and above the usual care. Interviews were conducted at baseline, 12 months and 24 months follow-up. This study uses data from baseline and 24 months post-intervention. We use multivariate regression methods, controlling for socioeconomic characteristics. At 24 months, caregivers in the treatment group reported significantly lower levels of parenting stress compared to caregivers in the control group. Findings from this study point to the potential of a family economic strengthening intervention to improve caregiver's psychosocial wellbeing and that of their families. We conclude that programs and policies aimed at improving the psychosocial wellbeing of families caring for AIDS-orphaned children may consider incorporating economic strengthening components in their programming to help support these kinds of families, caregivers of AIDS-orphaned children especially those residing in developing countries.

Outcome Evaluation of Family Eats.

PubMed

Cullen, Karen Weber; Thompson, Debbe; Chen, Tzu-An

2017-02-01

This article presents the results of a randomized clinical trial evaluating the eight-session Family Eats web-based intervention promoting healthy home food environments for African American families. African American families ( n = 126) with 8- to 12-year-old children completed online baseline questionnaires and were randomized into intervention or control groups. Data collection occurred at baseline, immediately postintervention (Post 1), and 4 months later (Post 2), for parents and children, separately. There were two group by time intervention effects: Control group parents reported a significantly greater frequency of drinking 100% fruit juice at Post 1 compared with intervention group parents. Parent menu planning skills were significantly higher at Post 2 for the intervention group compared with the control group. Significant positive changes overtime were noted for both groups for home fruit/vegetable availability, food preparation practices, and healthy restaurant selection. Intervention group children reported a significant increase in home juice availability at Post 1 compared with the control group; home fruit availability improved for both groups. There was no difference in log on rates by group: 84% and 86% for those who completed Post 1 and Post 2 measurements, respectively. Sixty-four participants completed the evaluation survey: 17 control (50%) and 47 intervention (51%) participants. All participants reported liking the program components; all but one gave it an A or B grade. An Internet-delivered nutrition intervention for families was successful in achieving change in some mediating variables, with good log on rates. Future research with Family Eats should include larger sample sizes, with longer follow-up and a more objective measure of diet.

Pilot randomized controlled trial of a mindfulness-based group intervention in adolescent girls at risk for type 2 diabetes with depressive symptoms.

PubMed

Shomaker, Lauren B; Bruggink, Stephanie; Pivarunas, Bernadette; Skoranski, Amanda; Foss, Jillian; Chaffin, Ella; Dalager, Stephanie; Annameier, Shelly; Quaglia, Jordan; Brown, Kirk Warren; Broderick, Patricia; Bell, Christopher

2017-06-01

(1) Evaluate feasibility and acceptability of a mindfulness-based group in adolescent girls at-risk for type 2 diabetes (T2D) with depressive symptoms, and (2) compare efficacy of a mindfulness-based versus cognitive-behavioral group for decreasing depressive symptoms and improving insulin resistance. Parallel-group, randomized controlled pilot trial conducted at a university. Thirty-three girls 12-17y with overweight/obesity, family history of diabetes, and elevated depressive symptoms were randomized to a six-week mindfulness-based (n=17) or cognitive-behavioral program (n=16). Both interventions included six, one-hour weekly group sessions. The mindfulness-based program included guided mindfulness awareness practices. The cognitive-behavioral program involved cognitive restructuring and behavioral activation. Adolescents were evaluated at baseline, post-intervention, and six-months. Feasibility/acceptability were measured by attendance and program ratings. Depressive symptoms were assessed by validated survey. Insulin resistance was determined from fasting insulin and glucose, and dual energy x-ray absorptiometry was used to assess body composition. Most adolescents attended ≥80% sessions (mindfulness: 92% versus cognitive-behavioral: 87%, p=1.00). Acceptability ratings were strong. At post-treatment and six-months, adolescents in the mindfulness condition had greater decreases in depressive symptoms than adolescents in the cognitive-behavioral condition (ps<.05). Compared to the cognitive-behavioral condition, adolescents in the mindfulness-based intervention also had greater decreases in insulin resistance and fasting insulin at post-treatment, adjusting for fat mass and other covariates (ps<.05). A mindfulness-based intervention shows feasibility and acceptability in girls at-risk for T2D with depressive symptoms. Compared to a cognitive-behavioral program, after the intervention, adolescents who received mindfulness showed greater reductions in depressive symptoms and better insulin resistance. ClinicalTrials.gov identifier: NCT02218138 clinicaltrials.gov. Copyright © 2017 Elsevier Ltd. All rights reserved.

Preventing Depression in Final Year Secondary Students: School-Based Randomized Controlled Trial

PubMed Central

Perry, Yael; Werner-Seidler, Aliza; Calear, Alison; Mackinnon, Andrew; King, Catherine; Scott, Jan; Merry, Sally; Fleming, Theresa; Stasiak, Karolina; Batterham, Philip J

2017-01-01

Background Depression often emerges for the first time during adolescence. There is accumulating evidence that universal depression prevention programs may have the capacity to reduce the impact of depression when delivered in the school environment. Objective This trial investigated the effectiveness of SPARX-R, a gamified online cognitive behavior therapy intervention for the prevention of depression relative to an attention-matched control intervention delivered to students prior to facing a significant stressor—final secondary school exams. It was hypothesized that delivering a prevention intervention in advance of a stressor would reduce depressive symptoms relative to the control group. Methods A cluster randomized controlled trial was conducted in 10 government schools in Sydney, Australia. Participants were 540 final year secondary students (mean 16.7 [SD 0.51] years), and clusters at the school level were randomly allocated to SPARX-R or the control intervention. Interventions were delivered weekly in 7 modules, each taking approximately 20 to 30 minutes to complete. The primary outcome was symptoms of depression as measured by the Major Depression Inventory. Intention-to-treat analyses were performed. Results Compared to controls, participants in the SPARX-R condition (n=242) showed significantly reduced depression symptoms relative to the control (n=298) at post-intervention (Cohen d=0.29) and 6 months post-baseline (d=0.21) but not at 18 months post-baseline (d=0.33). Conclusions This is the first trial to demonstrate a preventive effect on depressive symptoms prior to a significant and universal stressor in adolescents. It demonstrates that an online intervention delivered in advance of a stressful experience can reduce the impact of such an event on the potential development or exacerbation of depression. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12614000316606; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=365986 (Archived by WebCite at http://www.webcitation.org/ 6u7ou1aI9) PMID:29097357

PreSERVE-AMI: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Intracoronary Administration of Autologous CD34+ Cells in Patients With Left Ventricular Dysfunction Post STEMI.

PubMed

Quyyumi, Arshed A; Vasquez, Alejandro; Kereiakes, Dean J; Klapholz, Marc; Schaer, Gary L; Abdel-Latif, Ahmed; Frohwein, Stephen; Henry, Timothy D; Schatz, Richard A; Dib, Nabil; Toma, Catalin; Davidson, Charles J; Barsness, Gregory W; Shavelle, David M; Cohen, Martin; Poole, Joseph; Moss, Thomas; Hyde, Pamela; Kanakaraj, Anna Maria; Druker, Vitaly; Chung, Amy; Junge, Candice; Preti, Robert A; Smith, Robin L; Mazzo, David J; Pecora, Andrew; Losordo, Douglas W

2017-01-20

Despite direct immediate intervention and therapy, ST-segment-elevation myocardial infarction (STEMI) victims remain at risk for infarct expansion, heart failure, reinfarction, repeat revascularization, and death. To evaluate the safety and bioactivity of autologous CD34+ cell (CLBS10) intracoronary infusion in patients with left ventricular dysfunction post STEMI. Patients who underwent successful stenting for STEMI and had left ventricular dysfunction (ejection fraction≤48%) ≥4 days poststent were eligible for enrollment. Subjects (N=161) underwent mini bone marrow harvest and were randomized 1:1 to receive (1) autologous CD34+ cells (minimum 10 mol/L±20% cells; N=78) or (2) diluent alone (N=83), via intracoronary infusion. The primary safety end point was adverse events, serious adverse events, and major adverse cardiac event. The primary efficacy end point was change in resting myocardial perfusion over 6 months. No differences in myocardial perfusion or adverse events were observed between the control and treatment groups, although increased perfusion was observed within each group from baseline to 6 months (P<0.001). In secondary analyses, when adjusted for time of ischemia, a consistently favorable cell dose-dependent effect was observed in the change in left ventricular ejection fraction and infarct size, and the duration of time subjects was alive and out of hospital (P=0.05). At 1 year, 3.6% (N=3) and 0% deaths were observed in the control and treatment group, respectively. This PreSERVE-AMI (Phase 2, randomized, double-blind, placebo-controlled trial) represents the largest study of cell-based therapy for STEMI completed in the United States and provides evidence supporting safety and potential efficacy in patients with left ventricular dysfunction post STEMI who are at risk for death and major morbidity. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01495364. © 2016 American Heart Association, Inc.

Pilot Randomized Controlled Trial of a Mindfulness-Based Group Intervention in Adolescent Girls at Risk for Type 2 Diabetes with Depressive Symptoms

PubMed Central

Shomaker, Lauren B.; Bruggink, Stephanie; Pivarunas, Bernadette; Skoranski, Amanda; Foss, Jillian; Chaffin, Ella; Dalager, Stephanie; Annameier, Shelly; Quaglia, Jordan; Brown, Kirk Warren; Broderick, Patricia; Bell, Christopher

2017-01-01

Objective (1) Evaluate feasibility and acceptability of a mindfulness-based group in adolescent girls at-risk for type 2 diabetes (T2D) with depressive symptoms, and (2) compare efficacy of a mindfulness-based versus cognitive-behavioral group for decreasing depressive symptoms and improving insulin resistance. Design and setting Parallel-group, randomized controlled pilot trial conducted at a university. Participants Thirty-three girls 12-17y with overweight/obesity, family history of diabetes, and elevated depressive symptoms were randomized to a six-week mindfulness-based (n=17) or cognitive-behavioral program (n=16). Interventions Both interventions included six, one-hour weekly group sessions. The mindfulness-based program included guided mindfulness awareness practices. The cognitive-behavioral program involved cognitive restructuring and behavioral activation. Main outcome measures Adolescents were evaluated at baseline, post-intervention, and six-months. Feasibility/acceptability were measured by attendance and program ratings. Depressive symptoms were assessed by validated survey. Insulin resistance was determined from fasting insulin and glucose, and dual energy x-ray absorptiometry was used to assess body composition. Results Most adolescents attended ≥80% sessions (mindfulness:92% versus cognitive-behavioral:87%, p=1.00). Acceptability ratings were strong. At post-treatment and six-months, adolescents in the mindfulness condition had greater decreases in depressive symptoms than adolescents in the cognitive-behavioral condition (ps<.05). Compared to the cognitive-behavioral condition, adolescents in the mindfulness-based intervention also had greater decreases in insulin resistance and fasting insulin at post-treatment, adjusting for fat mass and other covariates (ps<.05). Conclusions A mindfulness-based intervention shows feasibility and acceptability in girls at-risk for T2D with depressive symptoms. Compared to a cognitive-behavioral program, after the intervention, adolescents who received mindfulness showed greater reductions in depressive symptoms and better insulin resistance. PMID:28619307

Effectiveness of a web-based personalized rheumatoid arthritis risk tool with or without a health educator for knowledge of RA risk factors.

PubMed

Prado, Maria G; Iversen, Maura D; Yu, Zhi; Miller Kroouze, Rachel; Triedman, Nellie A; Kalia, Sarah S; Lu, Bing; Green, Robert C; Karlson, Elizabeth W; Sparks, Jeffrey A

2018-01-05

To assess knowledge of rheumatoid arthritis (RA) risk factors among unaffected first-degree relatives (FDRs) and to study whether a personalized RA education tool increases risk factor knowledge. We performed a randomized controlled trial assessing RA educational interventions among 238 FDRs. The web-based Personalized Risk Estimator for RA (PRE-RA) tool displayed personalized RA risk results (genetics, autoantibodies, demographics, and behaviors) and educated about risk factors. Subjects were randomly assigned to: Comparison arm (standard RA education, n=80), PRE-RA arm (PRE-RA alone, n=78), or PRE-RA Plus arm (PRE-RA and a one-on-one session with a trained health educator, n=80). The RA Knowledge Score (RAKS, the number of 8 established RA risk factors identified as related to RA) was calculated at baseline and post-education (immediate/6 weeks/6 months/12 months). We compared RAKS and its components at each post-education point by randomization arm. At baseline before education, few FDRs identified behavioral RA risk factors (15.9% for dental health, 31.9% for smoking, 47.5% for overweight/obesity, and 54.2% for diet). After education, RAKS increased in all arms, higher in PRE-RA and PRE-RA Plus than Comparison at all post-education points (p<0.05). PRE-RA were more likely to identify risk factors than those that received standard education (proportion agreeing smoking is a risk factor at 6 weeks: 83.1% in PRE-RA Plus arm, 71.8% in PRE-RA, and 43.1% in Comparison arms, p<0.05 for PRE-RA vs. Comparison). Despite being both familiar with RA and at increased risk, FDRs had low knowledge about RA risk factors. A web-based personalized RA education tool successfully increased RA risk factor knowledge. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Music therapy as an adjunct to standard treatment for obsessive compulsive disorder and co-morbid anxiety and depression: A randomized clinical trial.

PubMed

Shiranibidabadi, Shahrzad; Mehryar, Amirhooshang

2015-09-15

Previous studies have highlighted the potential therapeutic benefits of music therapy as an adjunct to standard care, in a variety of psychiatric ailments including mood and anxiety disorders. However, the role of music in the treatment of obsessive-compulsive disorder (OCD) have not been investigated to date. In a single-center, parallel-group, randomized clinical trial (NCT02314195) 30 patients with OCD were randomly assigned to standard treatment (pharmacotherapy and cognitive-behavior therapy) plus 12 sessions of individual music therapy (n = 15) or standard treatment only (n = 15) for one month. Maudsley Obsessive-Compulsive Inventory, Beck Anxiety Inventory, and Beck Depression Inventory-Short Form were administered baseline and after one month. Thirty patients completed the study. Music therapy resulted in a greater decrease in total obsessive score (post-intervention score: music therapy+standard treatment: 12.4 ± 1.9 vs standard treatment only: 15.1 ± 1.7, p < 0.001, effect size = 56.7%). For subtypes, significant between-group differences were identified for checking (p = 0.004), and slowness (p = 0.019), but not for washing or responsibility. Music therapy was significantly more effective in reducing anxiety (post-intervention score: music therapy + standard treatment: 16.9 ± 7.4 vs standard treatment only: 22.9 ± 4.6, p < 0.001, effect size = 47.0%), and depressive symptoms (post-intervention score: music therapy + standard treatment: 10.8 ± 3.8 vs standard treatment: 17.1 ± 3.7, p < 0.001, effect size = 47.0%). Inclusion of a small sample size, lack of blinding due to the nature of the intervention, short duration of follow-up. In patients with OCD, music therapy, as an adjunct to standard care, seems to be effective in reducing obsessions, as well as co-morbid anxiety and depressive symptoms. Copyright © 2015. Published by Elsevier B.V.

Feasibility and effectiveness of an evidence-based asthma service in Australian community pharmacies: a pragmatic cluster randomized trial.

PubMed

Armour, Carol L; Reddel, Helen K; LeMay, Kate S; Saini, Bandana; Smith, Lorraine D; Bosnic-Anticevich, Sinthia Z; Song, Yun Ju Christine; Alles, M Chehani; Burton, Deborah L; Emmerton, Lynne; Stewart, Kay; Krass, Ines

2013-04-01

To test the feasibility, effectiveness, and sustainability of a pharmacy asthma service in primary care. A pragmatic cluster randomized trial in community pharmacies in four Australian states/territories in 2009. Specially trained pharmacists were randomized to deliver an asthma service in two groups, providing three versus four consultations over 6 months. People with poorly controlled asthma or no recent asthma review were included. Follow-up for 12 months after service completion occurred in 30% of randomly selected completing patients. Outcomes included change in asthma control (poor and fair/good) and Asthma Control Questionnaire (ACQ) score, inhaler technique, quality of life, perceived control, adherence, asthma knowledge, and asthma action plan ownership. Ninety-six pharmacists enrolled 570 patients, with 398 (70%) completing. Asthma control significantly improved with both the three- and four-visit service, with no significant difference between groups (good/fair control 29% and 21% at baseline, 61% and 59% at end, p = .791). Significant improvements were also evident in the ACQ (mean change 0.56), inhaler technique (17-33% correct baseline, 57-72% end), asthma action plan ownership (19% baseline, 56% end), quality of life, adherence, perceived control, and asthma knowledge, with no significant difference between groups for any variable. Outcomes were sustained at 12 months post-service. The pharmacy asthma service delivered clinically important improvements in both a three-visit and four-visit service. Pharmacists were able to recruit and deliver the service with minimal intervention, suggesting it is practical to implement in practice. The three-visit service would be feasible and effective to implement, with a review at 12 months.

Abstinence Reinforcement Therapy (ART) for Rural Veterans: Methodology for an mHealth Smoking Cessation Intervention

PubMed Central

Wilson, Sarah M.; Hair, Lauren P.; Hertzberg, Jeffrey S.; Kirby, Angela C.; Olsen, Maren K.; Lindquist, Jennifer H.; Maciejewski, Matthew L.; Beckham, Jean C.; Calhoun, Patrick S.

2016-01-01

Introduction Smoking is the most preventable cause of morbidity and mortality in U.S. veterans. Rural veterans in particular have elevated risk for smoking and smoking-related illness. However, these veterans underutilize smoking cessation treatment, which suggests that interventions for rural veterans should optimize efficacy and reach. Objective The primary goal of the current study is to evaluate the effectiveness of an intervention that combines evidenced based treatment for smoking cessation with smart-phone based, portable contingency management on smoking rates compared to a contact control intervention in a randomized controlled trial among rural Veteran smokers. Specifically, Veterans will be randomized to receive Abstinence Reinforcement Therapy (ART) which combines evidenced based cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for access to nicotine replacement (NRT), and mobile contingency management (mCM) or a control condition (i.e., TC and NRT alone) that will provide controls for therapist, medication, time and attention effects. Methods Smokers were identified using VHA electronic medical records and recruited proactively via telephone. Participants (N = 310) are randomized to either ART or a best practice control consisting of telephone counseling and telemedicine. Participating patients will be surveyed at 3-months, 6-months and 12-months post-randomization. The primary outcome measure is self-reported and biochemically validated prolonged abstinence at 6-month follow-up. Discussion This trial is designed to test the relative effectiveness of ART compared to a telehealth-only comparison group. Dissemination of this mHealth intervention for veterans in a variety of settings would be warranted if ART improves smoking outcomes for rural veterans and is cost-effective. PMID:27521811

A randomized controlled trial evaluating the erythropoiesis stimulating agent sparing potential of a vitamin E-bonded polysulfone dialysis membrane

PubMed Central

Lines, Simon W.; Carter, Angela M.; Dunn, Emma J.; Lindley, Elizabeth J.; Tattersall, James E.; Wright, Mark J.

2014-01-01

Background Vitamin E (VE) bonded polysulfone dialysis membranes have putative erythropoiesis stimulating agent (ESA)-sparing and anti-inflammatory properties based on data from a small number of studies. We sought to investigate this in a large, prospective 12-month randomized controlled trial. Methods Two-hundred and sixty prevalent haemodialysis (HD) patients were randomized to dialysis with VE-bonded polysulfone membranes or non-VE-bonded equivalents. All ESA-dosing was performed by means of a computer-based anaemia management decision support system. Monthly data were used to calculate the ESA resistance index (ERI) and blood tests were performed at baseline, 6 and 12 months for measurement of C-reactive protein (CRP) levels. Results Of the 260 patients, 123 were randomized to dialysis with the VE-membrane and 12-month data was available for 220 patients. At the study population level, no beneficial effect of the VE membranes on the ERI or CRP levels was observed. Post hoc analyses indicated that there was a significant fall in ERI for patients with the highest baseline ESA resistance dialysed with the VE (9.28 [7.70–12.5] versus 7.70 [5.34–12.7] IU/week/kg/g/dL Hb, P = 0.01) but not the control membranes (9.45 [7.62–12.3] versus 8.14 [4.44–15.6] IU/week/kg/g/dL Hb, P = 0.41); this was not attributable to changes in CRP levels. Conclusions Wholesale switching of all chronic HD patients to dialysis with VE-bonded polysulfone membranes appears not to be associated with improvements in ESA-responsiveness or CRP. These membranes may have utility in patients with heightened ESA resistance. PMID:24293660

Maintained intentional weight loss reduces cardiovascular outcomes: results from the Sibutramine Cardiovascular OUTcomes (SCOUT) trial.

PubMed

Caterson, I D; Finer, N; Coutinho, W; Van Gaal, L F; Maggioni, A P; Torp-Pedersen, C; Sharma, A M; Legler, U F; Shepherd, G M; Rode, R A; Perdok, R J; Renz, C L; James, W P T

2012-06-01

The Sibutramine Cardiovascular OUTcomes trial showed that sibutramine produced greater mean weight loss than placebo but increased cardiovascular morbidity but not mortality. The relationship between 12-month weight loss and subsequent cardiovascular outcomes is explored. Overweight/obese subjects (N = 10 744), ≥55 years with cardiovascular disease and/or type 2 diabetes mellitus, received sibutramine plus weight management during a 6-week Lead-in Period before randomization to continue sibutramine (N = 4906) or to receive placebo (N = 4898). The primary endpoint was the time from randomization to first occurrence of a primary outcome event (non-fatal myocardial infarction, non-fatal stroke, resuscitated cardiac arrest or cardiovascular death). For the total population, mean weight change during Lead-in Period (sibutramine) was -2.54 kg. Post-randomization, mean total weight change to Month 12 was -4.18 kg (sibutramine) or -1.87 kg (placebo). Degree of weight loss during Lead-in Period or through Month 12 was associated with a progressive reduction in risk for the total population in primary outcome events and cardiovascular mortality over the 5-year assessment. Although more events occurred in the randomized sibutramine group, on an average, a modest weight loss of approximately 3 kg achieved in the Lead-in Period appeared to offset this increased event rate. Moderate weight loss (3-10 kg) reduced cardiovascular deaths in those with severe, moderate or mild cardiovascular disease. Modest weight loss over short-term (6 weeks) and longer-term (6-12 months) periods is associated with reduction in subsequent cardiovascular mortality for the following 4-5 years even in those with pre-existing cardiovascular disease. While the sibutramine group experienced more primary outcome events than the placebo group, greater weight loss reduced overall risk of these occurring in both groups. © 2011 Blackwell Publishing Ltd.

The Association Between Nutritional Adequacy and Long-Term Outcomes in Critically Ill Patients Requiring Prolonged Mechanical Ventilation: A Multicenter Cohort Study.

PubMed

Wei, Xuejiao; Day, Andrew G; Ouellette-Kuntz, Hélène; Heyland, Daren K

2015-08-01

To examine the association between short-term nutritional adequacy received while in the ICU and long-term outcomes including 6-month survival and health-related quality of life in critically ill patients requiring prolonged mechanical ventilation. Retrospective analysis of data prospectively collected in the context of a multicenter randomized controlled trial. An international sample of ICUs. Adult patients who were mechanically ventilated for more than 8 days in the ICU. None. Nutritional adequacy was obtained from the average proportion of prescribed calories received over the amount prescribed during the first 8 days. Survival status and health-related quality of life as assessed using the Short-Form 36 v2 were obtained at 3- and 6 months post ICU admission. Of the 1,223 patients enrolled in the randomized controlled trial, 475 met the inclusion criteria for this study. At 6-month follow-up, 302 of the 475 patients (64%) were alive. Survival time in those who received low nutritional adequacy was significantly shorter than those who received high nutritional adequacy while adjusting for important covariates (adjusted hazard ratio, 1.7; 95% CI, 1.1-2.6). At 3-month follow-up, a 25% increase in nutritional adequacy was associated with improvements in Physical Functioning and Role Physical of 7.3 (p = 0.02) and 8.3 (p = 0.004) points, respectively. At 6-month follow-up, adjusted increases in Physical Functioning and Role Physical scores for every 25% increase in nutrition adequacy became smaller and were no longer statistically significant (adjusted estimate for Physical Functioning = 4.2, p = 0.14; for Role Physical = 3.2, p = 0.25). Greater amounts of nutritional intake received during the first week in the ICU were associated with longer survival time and faster physical recovery to 3 months but not 6 months post ICU discharge in critically ill patients requiring prolonged mechanical ventilation. Current recommendations to underfeed critically ill patients may cause harm in some long-stay patients.

Phase II, randomized, open, controlled study of AS03-adjuvanted H5N1 pre-pandemic influenza vaccine in children aged 3 to 9 years: follow-up of safety and immunogenicity persistence at 24 months post-vaccination.

PubMed

Díez-Domingo, Javier; Baldó, José-María; Planelles-Catarino, Maria Victoria; Garcés-Sánchez, María; Ubeda, Isabel; Jubert-Rosich, Angels; Marès, Josep; Garcia-Corbeira, Pilar; Moris, Philippe; Teko, Maurice; Vanden Abeele, Carline; Gillard, Paul

2015-03-01

An AS03-adjuvanted H5N1 influenza vaccine elicited broad and persistent immune responses with an acceptable safety profile up to 6 months following the first vaccination in children aged 3-9 years. In this follow-up of the Phase II study, we report immunogenicity persistence and safety at 24 months post-vaccination in children aged 3-9 years. The randomized, open-label study assessed two doses of H5N1 A/Vietnam/1194/2004 influenza vaccine (1·9 μg or 3·75 μg hemagglutinin antigen) formulated with AS03A or AS03B (11·89 mg or 5·93 mg tocopherol, respectively). Control groups received seasonal trivalent influenza vaccine. Safety was assessed prospectively and included potential immune-mediated diseases (pIMDs). Immunogenicity was assessed by hemagglutination-inhibition assay 12 and 24 months after vaccination; cross-reactivity and cell-mediated responses were also assessed. (NCT00502593). The safety population included 405 children. Over 24 months, five events fulfilled the criteria for pIMDs, of which four occurred in H5N1 vaccine recipients, including uveitis (n = 1) and autoimmune hepatitis (n = 1), which were considered to be vaccine-related. Overall, safety profiles of the vaccines were clinically acceptable. Humoral immune responses at 12 and 24 months were reduced versus those observed after the second dose of vaccine, although still within the range of those observed after the first dose. Persistence of cell-mediated immunity was strong, and CD4(+) T cells with a TH 1 profile were observed. Two doses of an AS03-adjuvanted H5N1 influenza vaccine in children showed low but persistent humoral immune responses and a strong persistence of cell-mediated immunity, with clinically acceptable safety profiles up to 24 months following first vaccination. © 2014 The Authors. Influenza and Other Respiratory Viruses Published by John Wiley & Sons Ltd.

Improving Post-Discharge Medication Adherence in Patients with CVD: A Pilot Randomized Trial

PubMed Central

Oliveira-Filho, Alfredo D.; Morisky, Donald E.; Costa, Francisco A.; Pacheco, Sara T.; Neves, Sabrina F.; Lyra-Jr, Divaldo P.

2014-01-01

Background Effective interventions to improve medication adherence are usually complex and expensive. Objective To assess the impact of a low-cost intervention designed to improve medication adherence and clinical outcomes in post-discharge patients with CVD. Method A pilot RCT was conducted at a teaching hospital. Intervention was based on the four-item Morisky Medication Adherence Scale (MMAS-4). The primary outcome measure was medication adherence assessed using the eight-item MMAS at baseline, at 1 month post hospital discharge and re-assessed 1 year after hospital discharge. Other outcomes included readmission and mortality rates. Results 61 patients were randomized to intervention (n = 30) and control (n = 31) groups. The mean age of the patients was 61 years (SD 12.73), 52.5% were males, and 57.4% were married or living with a partner. Mean number of prescribed medications per patient was 4.5 (SD 3.3). Medication adherence was correlated to intervention (p = 0.04) and after 1 month, 48.4% of patients in the control group and 83.3% in the intervention group were considered adherent. However, this difference decreased after 1 year, when adherence was 34.8% and 60.9%, respectively. Readmission and mortality rates were related to low adherence in both groups. Conclusion The intervention based on a validated patient self-report instrument for assessing adherence is a potentially effective method to improve adherent behavior and can be successfully used as a tool to guide adherence counseling in the clinical visit. However, a larger study is required to assess the real impact of intervention on these outcomes. PMID:25590930

The effect of peer-led education on the life quality of mastectomy patients referred to breast cancer-clinics in Shiraz, Iran 2009.

PubMed

Sharif, Farkhondeh; Abshorshori, Narjes; Tahmasebi, Sedigheh; Hazrati, Maryam; Zare, Najaf; Masoumi, Sarah

2010-07-23

Breast cancer among women is a relatively common with a more favorable expected survival rates than other forms of cancers. This study aimed to determine the improved quality of life for post-mastectomy women through peer education. Using pre and post test follow up and control design approach, 99 women with stage I and II of breast cancer diagnosis were followed one year after modified radical mastectomy. To measure the quality of life an instrument designed by the European organization for research and treatment of cancer, known as the Quality of Life Question (QLQ-30) and its breast cancer supplementary measure (QLQ-BR23) at three points in time (before, immediately and two months after intervention) for both groups were used. The participant selection was a convenient sampling method and women were randomly assigned into two experimental and control groups. The experimental group was randomly assigned to five groups and peer educators conducted weekly educational programs for one month. Tabulated data were analyzed using chi square, t test, and repeated measurement multivariate to compare the quality of life differences over time. For the experimental group, the results showed statistically significant improvement in all performance aspects of life quality and symptom reduction (P < 0.001), while the control group had no significant differences in all aspects of life quality. The findings of this study suggest that peer led education is a useful intervention for post-mastectomy women to improve their quality of life.

The use of low-level laser therapy (LLLT) in the treatment of trigger points that are associated with rotator cuff tendonitis

NASA Astrophysics Data System (ADS)

Al-Shenqiti, A.; Oldham, J.

2003-12-01

The purpose of this study was to investigate the efficacy of LLLT in the treatment of trigger points (TrPs) that are associated with rotator cuff tendonitis. A double-blind randomized controlled trail was conducted. Sixty patients were randomly allocated to one of two groups: sham or laser therapy. The laser (Excel, Omega Universal Technologies Ltd, London, UK) parameters used were a wavelength of 820 nm, a power output of 100 mW, a frequency of 5000 Hz (modulated) and energy density of 32 J/cm2. The two groups received a course of 12 treatment sessions for four weeks (3 sessions per week). Pain, functional activities (as measured using the Shoulder Pain and Disability Index, SPADI), pressure pain threshold (PPT) and range of motion (ROM) were assessed pre and post treatment, with a three month follow-up assessment. Significant improvements in pain (p < 0.001) were observed for the laser group (6 cm median improvement on a 10 cm VAS) compared to the sham group (2 cm median improvement) immediately post treatment. The improvements in the laser group continued post treatment with a 7 cm median improvement observed at three month follow-up. Similar between group differences were observed for ROM (p < 0.01), functional activities (p <= 0.001) and PPT (p <= 0.05). The findings of the current study suggested that LLLT is effective in treating patients with TrPs associated with rotator cuff tendonitis, when using the parameters described. However, the mechanism of its action is not yet clear, and will require further investigation.

Enhancing Web-based mindfulness training for mental health promotion with the health action process approach: randomized controlled trial.

PubMed

Mak, Winnie W S; Chan, Amy T Y; Cheung, Eliza Y L; Lin, Cherry L Y; Ngai, Karin C S

2015-01-19

With increasing evidence demonstrating the effectiveness of Web-based interventions and mindfulness-based training in improving health, delivering mindfulness training online is an attractive proposition. The aim of this study was to evaluate the efficacy of two Internet-based interventions (basic mindfulness and Health Action Process Approach enhanced mindfulness) with waitlist control. Health Action Process Approach (HAPA) principles were used to enhance participants' efficacy and planning. Participants were recruited online and offline among local universities; 321 university students and staff were randomly assigned to three conditions. The basic and HAPA-enhanced groups completed the 8-week fully automated mindfulness training online. All participants (including control) were asked to complete an online questionnaire pre-program, post-program, and at 3-month follow-up. Significant group by time interaction effect was found. The HAPA-enhanced group showed significantly higher levels of mindfulness from pre-intervention to post-intervention, and such improvement was sustained at follow-up. Both the basic and HAPA-enhanced mindfulness groups showed better mental well-being from pre-intervention to post-intervention, and improvement was sustained at 3-month follow-up. Online mindfulness training can improve mental health. An online platform is a viable medium to implement and disseminate evidence-based interventions and is a highly scalable approach to reach the general public. Chinese Clinical Trial Registry (ChiCTR): ChiCTR-TRC-12002954; http://www.chictr.org/en/proj/show.aspx?proj=3904 (Archived by WebCite at http://www.webcitation.org/6VCdG09pA).

Safety of a quadrivalent meningococcal serogroups A, C, W and Y conjugate vaccine (MenACWY-CRM) administered with routine infant vaccinations: results of an open-label, randomized, phase 3b controlled study in healthy infants.

PubMed

Abdelnour, Arturo; Silas, Peter E; Lamas, Marta Raquel Valdés; Aragón, Carlos Fernándo Grazioso; Chiu, Nan-Chang; Chiu, Cheng-Hsun; Acuña, Teobaldo Herrera; Castrejón, Tirza De León; Izu, Allen; Odrljin, Tatjana; Smolenov, Igor; Hohenboken, Matthew; Dull, Peter M

2014-02-12

The highest risk for invasive meningococcal disease (IMD) is in infants aged <1 year. Quadrivalent meningococcal conjugate vaccination has the potential to prevent IMD caused by serogroups A, C, W and Y. This phase 3b, multinational, open-label, randomized, parallel-group, multicenter study evaluated the safety of a 4-dose series of MenACWY-CRM, a quadrivalent meningococcal conjugate vaccine, concomitantly administered with routine vaccinations to healthy infants. Two-month-old infants were randomized 3:1 to receive MenACWY-CRM with routine vaccines or routine vaccines alone at ages 2, 4, 6 and 12 months. Adverse events (AEs) that were medically attended and serious adverse events (SAEs) were collected from all subjects from enrollment through 18 months of age. In a subset, detailed safety data (local and systemic solicited reactions and all AEs) were collected for 7 days post vaccination. The primary objective was a non-inferiority comparison of the percentages of subjects with ≥1 severe systemic reaction during Days 1-7 after any vaccination of MenACWY-CRM plus routine vaccinations versus routine vaccinations alone (criterion: upper limit of 95% confidence interval [CI] of group difference <6%). A total of 7744 subjects were randomized with 1898 in the detailed safety arm. The percentage of subjects with severe systemic reactions was 16% after MenACWY-CRM plus routine vaccines and 13% after routine vaccines alone (group difference 3.0% (95% CI -0.8, 6.4%). Although the non-inferiority criterion was not met, post hoc analysis controlling for significant center and group-by-center differences revealed that MenACWY-CRM plus routine vaccinations was non-inferior to routine vaccinations alone (group difference -0.1% [95% CI -4.9%, 4.7%]). Rates of solicited AEs, medically attended AEs, and SAEs were similar across groups. In a large multinational safety study, a 4-dose series of MenACWY-CRM concomitantly administered with routine vaccines was clinically acceptable with a similar safety profile to routine vaccines given alone. Copyright © 2013 Elsevier Ltd. All rights reserved.

Safety of Russian-backbone seasonal trivalent, live-attenuated influenza vaccine in a phase II randomized placebo-controlled clinical trial among children in urban Bangladesh.

PubMed

Ortiz, Justin R; Goswami, Doli; Lewis, Kristen D C; Sharmeen, Amina Tahia; Ahmed, Moshtaq; Rahman, Mustafizur; Rahman, Mohammed Z; Feser, Jodi; Neuzil, Kathleen M; Brooks, W Abdullah

2015-06-26

Live-attenuated influenza vaccines (LAIVs) have the potential to be affordable, effective, and logistically feasible for immunization of children in low-resource settings. We conducted a phase II, randomized, double-blind, parallel group, placebo-controlled trial on the safety of the Russian-backbone, seasonal trivalent LAIV among children aged 24 through 59 months in Dhaka, Bangladesh in 2012. After vaccination, we monitored participants for six months with weekly home visits and study clinic surveillance for solicited and unsolicited adverse events, protocol-defined wheezing illness (PDWI), and serious adverse events (SAEs), including all cause hospitalizations. Three hundred children were randomized and administered LAIV (n=150) or placebo (n=150). No immediate post-vaccination reactions occurred in either group. Solicited reactions were similar between vaccine and placebo groups during the first 7 days post-vaccination and throughout the entire trial. There were no statistically significant differences in participants experiencing PDWI between LAIV and placebo groups throughout the trial (n=13 vs. n=16, p=0.697). Of 131 children with a history of medical treatment or hospitalization for asthma or wheezing at study entry, 65 received LAIV and 66 received placebo. Among this subset, there was no statistical difference in PDWI occurring throughout the trial between the LAIV or placebo groups (7.7% vs. 19.7%, p=0.074). While there were no related SAEs, LAIV recipients had six unrelated SAEs and placebo recipients had none. These SAEs included three due to traumatic injury and bone fracture, and one each due to accidental overdose of paracetamol, abdominal pain, and acute gastroenteritis. None of the participants with SAEs had laboratory-confirmed influenza, wheezing illness, or other signs of acute respiratory illness at the time of their events. In this randomized, controlled trial among 300 children aged 24 through 59 months in urban Bangladesh, Russian-backbone LAIV was safe and well tolerated. Further evaluation of LAIV safety and efficacy in a larger cohort is warranted. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

Efficacy of a workplace osteoporosis prevention intervention: a cluster randomized trial.

PubMed

Tan, Ai May; LaMontagne, Anthony D; English, Dallas R; Howard, Peter

2016-08-24

Osteoporosis is a debilitating disease. Adequate calcium consumption and physical activity are the two major modifiable risk factors. This paper describes the major outcomes and efficacy of a workplace-based targeted behaviour change intervention to improve the dietary and physical activity behaviours of working women in sedentary occupations in Singapore. A cluster-randomized design was used, comparing the efficacy of a tailored intervention to standard care. Workplaces were the units of randomization and intervention. Sixteen workplaces were recruited from a pool of 97, and randomly assigned to intervention and control arms (eight workplaces in each). Women meeting specified inclusion criteria were then recruited to participate. Workplaces in the intervention arm received three participatory workshops and organization-wide educational activities. Workplaces in the control/standard care arm received print resources. Outcome measures were calcium intake (milligrams/day) and physical activity level (duration: minutes/week), measured at baseline, 4 weeks and 6 months post intervention. Adjusted cluster-level analyses were conducted comparing changes in intervention versus control groups, following intention-to-treat principles and CONSORT guidelines. Workplaces in the intervention group reported a significantly greater increase in calcium intake and duration of load-bearing moderate to vigorous physical activity (MVPA) compared with the standard care control group. Four weeks after intervention, the difference in adjusted mean calcium intake was 343.2 mg/day (95 % CI = 337.4 to 349.0, p < .0005) and the difference in adjusted mean load-bearing MVPA was 55.6 min/week (95 % CI = 54.5 to 56.6, p < .0005). Six months post intervention, the mean differences attenuated slightly to 290.5 mg/day (95 % CI = 285.3 to 295.7, p < .0005) and 50.9 min/week (95 % CI =49.3 to 52.6, p < .0005) respectively. This workplace-based intervention substantially improved calcium intake and load-bearing moderate to vigorous physical activity 6 months after the intervention began. Australia New Zealand Clinical Trial Registry ACTRN12616000079448 . Registered 25 January 2016 (retrospectively registered).

Impact of a hands-on component on learning in the Fundamental Use of Surgical Energy™ (FUSE) curriculum: a randomized-controlled trial in surgical trainees.

PubMed

Madani, Amin; Watanabe, Yusuke; Vassiliou, Melina C; Fuchshuber, Pascal; Jones, Daniel B; Schwaitzberg, Steven D; Fried, Gerald M; Feldman, Liane S

2014-10-01

While energy devices are ubiquitous in the operating room, they remain poorly understood and can result in significant complications. The purpose of this study was to estimate the extent to which adding a novel bench-top component improves learning of SAGES' Fundamental Use of Surgical Energy™ (FUSE) electrosurgery curriculum among surgical trainees. Surgical residents participated in a 1-h didactic electrosurgery (ES) course, based on the FUSE curriculum. They were then randomized to one of two groups: an unstructured hands-on session where trainees used ES devices (control group) or a goal-directed hands-on training session (Sim group). Pre- and post-curriculum (immediate and at 3 months) assessments included knowledge of ES (multiple-choice examination), self-perceived competence for each of the 35 course objectives (questionnaire), and self-perceived comfort with performance of seven tasks related to safe use of ES. Data expressed as median[interquartile range], *p < 0.05. 56 (29 control; 27 Sim) surgical trainees completed the curriculum and assessments. Baseline characteristics, including pre-curriculum exam and questionnaire scores, were similar. Total score on the exam improved from 46%[40;54] to 84%[77;91]* for the entire cohort, with higher immediate post-curriculum scores in the Sim group compared to controls (89%[83;94] vs. 83%[71;86]*). At 3 months, performance on the exam declined in both groups, but remained higher in the Sim group (77%[69;90] vs 60%[51;80]*). Participants in both groups reported feeling greater comfort and competence post-curriculum (immediate and at 3 months) compared to baseline. This improvement was greater in the Sim group with a higher proportion feeling "Very Comfortable" or "Fully Competent" (Sim: 3/7 tasks and 28/35 objectives; control: 0/7 tasks and 10/35 objectives). A FUSE-based curriculum improved surgical trainees' knowledge and comfort in the safe use of electrosurgical devices. The addition of a structured interactive bench-top simulation component further improved learning and retention at 3 months.

Effectiveness of medical taping concept in primary dysmenorrhoea: a two-armed randomized trial

PubMed Central

Tomás-Rodríguez, María Isabel; Palazón-Bru, Antonio; Martínez-St. John, Damian Robert James; Toledo-Marhuenda, José Vicente; Asensio-García, María del Rosario; Gil-Guillén, Vicente Francisco

2015-01-01

In 2014, we assessed the effectiveness of Medical Taping Concept (MTC) in Primary Dysmenorrhoea (PD) with a single-blind, two-armed clinical trial (NCT02114723, ClinicalTrials.gov) with a follow-up of 4 menstrual cycles (pre-intervention: 2 months; post-intervention: 2 months) in a sample formed by 129 Spanish women aged 18–30 years with PD. We had two groups: intervention group (75), MTC covering T-11 and T-12 dermatomes; control group (54), another taping in both greater trochanter areas. Our main outcome measures were: pre-intervention and post-intervention increase in pain difference measured 2 hours after commencement (2-h pain — 0-h pain); difference between the number of tablets ingested post-intervention and pre-intervention; and associated symptoms in post-intervention (fatigue, vomiting, diarrhoea, nausea and others). Pain was assessed in: abdomen, legs, head and lower back. We found significant differences (p < 0.05) for number of tablets, abdominal and leg pain. In conclusion, the intervention group had less abdominal and leg pain when pharmacological therapy was not started. Furthermore, the intervention resulted in a lower intake of tablets. Nevertheless, more studies are needed to corroborate our results and to analyze the MTC effectiveness if women do not take any tablets during the entire menstrual period. PMID:26564807

Effectiveness of medical taping concept in primary dysmenorrhoea: a two-armed randomized trial.

PubMed

Tomás-Rodríguez, María Isabel; Palazón-Bru, Antonio; Martínez-St John, Damian Robert James; Toledo-Marhuenda, José Vicente; Asensio-García, María del Rosario; Gil-Guillén, Vicente Francisco

2015-11-13

In 2014, we assessed the effectiveness of Medical Taping Concept (MTC) in Primary Dysmenorrhoea (PD) with a single-blind, two-armed clinical trial (NCT02114723, ClinicalTrials.gov) with a follow-up of 4 menstrual cycles (pre-intervention: 2 months; post-intervention: 2 months) in a sample formed by 129 Spanish women aged 18-30 years with PD. We had two groups: intervention group (75), MTC covering T-11 and T-12 dermatomes; control group (54), another taping in both greater trochanter areas. Our main outcome measures were: pre-intervention and post-intervention increase in pain difference measured 2 hours after commencement (2-h pain - 0-h pain); difference between the number of tablets ingested post-intervention and pre-intervention; and associated symptoms in post-intervention (fatigue, vomiting, diarrhoea, nausea and others). Pain was assessed in: abdomen, legs, head and lower back. We found significant differences (p < 0.05) for number of tablets, abdominal and leg pain. In conclusion, the intervention group had less abdominal and leg pain when pharmacological therapy was not started. Furthermore, the intervention resulted in a lower intake of tablets. Nevertheless, more studies are needed to corroborate our results and to analyze the MTC effectiveness if women do not take any tablets during the entire menstrual period.

Direct versus Indirect Treatment for Preschool Children who Stutter: The RESTART Randomized Trial

PubMed Central

de Sonneville-Koedoot, Caroline; Stolk, Elly; Rietveld, Toni; Franken, Marie-Christine

2015-01-01

Objective Stuttering is a common childhood disorder. There is limited high quality evidence regarding options for best treatment. The aim of the study was to compare the effectiveness of direct treatment with indirect treatment in preschool children who stutter. Methods In this multicenter randomized controlled trial with an 18 month follow-up, preschool children who stutter who were referred for treatment were randomized to direct treatment (Lidcombe Program; n = 99) or indirect treatment (RESTART-DCM treatment; n = 100). Main inclusion criteria were age 3–6 years, ≥3% syllables stuttered (%SS), and time since onset ≥6 months. The primary outcome was the percentage of non-stuttering children at 18 months. Secondary outcomes included stuttering frequency (%SS), stuttering severity ratings by the parents and therapist, severity rating by the child, health-related quality of life, emotional and behavioral problems, and speech attitude. Results Percentage of non-stuttering children for direct treatment was 76.5% (65/85) versus 71.4% (65/91) for indirect treatment (Odds Ratio (OR), 0.6; 95% CI, 0.1–2.4, p = .42). At 3 months, children treated by direct treatment showed a greater decline in %SS (significant interaction time x therapy: β = -1.89; t(282.82) = -2.807, p = .005). At 18 months, stuttering frequency was 1.2% (SD 2.1) for direct treatment and 1.5% (SD 2.1) for indirect treatment. Direct treatment had slightly better scores on most other secondary outcome measures, but no differences between treatment approaches were significant. Conclusions Direct treatment decreased stuttering more quickly during the first three months of treatment. At 18 months, however, clinical outcomes for direct and indirect treatment were comparable. These results imply that at 18 months post treatment onset, both treatments are roughly equal in treating developmental stuttering in ways that surpass expectations of natural recovery. Follow-up data are needed to confirm these findings in the longer term. Trial Registration isrctn.org ISRCTN24362190 PMID:26218228

Direct versus Indirect Treatment for Preschool Children who Stutter: The RESTART Randomized Trial.

PubMed

de Sonneville-Koedoot, Caroline; Stolk, Elly; Rietveld, Toni; Franken, Marie-Christine

2015-01-01

Stuttering is a common childhood disorder. There is limited high quality evidence regarding options for best treatment. The aim of the study was to compare the effectiveness of direct treatment with indirect treatment in preschool children who stutter. In this multicenter randomized controlled trial with an 18 month follow-up, preschool children who stutter who were referred for treatment were randomized to direct treatment (Lidcombe Program; n = 99) or indirect treatment (RESTART-DCM treatment; n = 100). Main inclusion criteria were age 3-6 years, ≥3% syllables stuttered (%SS), and time since onset ≥6 months. The primary outcome was the percentage of non-stuttering children at 18 months. Secondary outcomes included stuttering frequency (%SS), stuttering severity ratings by the parents and therapist, severity rating by the child, health-related quality of life, emotional and behavioral problems, and speech attitude. Percentage of non-stuttering children for direct treatment was 76.5% (65/85) versus 71.4% (65/91) for indirect treatment (Odds Ratio (OR), 0.6; 95% CI, 0.1-2.4, p = .42). At 3 months, children treated by direct treatment showed a greater decline in %SS (significant interaction time x therapy: β = -1.89; t(282.82) = -2.807, p = .005). At 18 months, stuttering frequency was 1.2% (SD 2.1) for direct treatment and 1.5% (SD 2.1) for indirect treatment. Direct treatment had slightly better scores on most other secondary outcome measures, but no differences between treatment approaches were significant. Direct treatment decreased stuttering more quickly during the first three months of treatment. At 18 months, however, clinical outcomes for direct and indirect treatment were comparable. These results imply that at 18 months post treatment onset, both treatments are roughly equal in treating developmental stuttering in ways that surpass expectations of natural recovery. Follow-up data are needed to confirm these findings in the longer term. isrctn.org ISRCTN24362190.

The Efficacy of a Group Cognitive Behavioral Therapy for War-Affected Young Migrants Living in Australia: A Cluster Randomized Controlled Trial

PubMed Central

Ooi, Chew S.; Rooney, Rosanna M.; Roberts, Clare; Kane, Robert T.; Wright, Bernadette; Chatzisarantis, Nikos

2016-01-01

Background: Preventative and treatment programs for people at risk of developing psychological problems after exposure to war trauma have mushroomed in the last decade. However, there is still much contention about evidence-based and culturally sensitive interventions for children. The aim of this study was to examine the efficacy of the Teaching Recovery Techniques in improving the emotional and behavioral outcomes of war-affected children resettled in Australia. Methods and Findings: A cluster randomized controlled trial with pre-test, post-test, and 3-month follow-up design was employed. A total of 82 participants (aged 10–17 years) were randomized by school into the 8-week intervention (n = 45) or the waiting list (WL) control condition (n = 37). Study outcomes included symptoms of post-traumatic stress disorder, depression, internalizing and externalizing problems, as well as psychosocial functioning. A medium intervention effect was found for depression symptoms. Participants in the intervention condition experienced a greater symptom reduction than participants in the WL control condition, F(1, 155) = 5.20, p = 0.024, partial η2 = 0.07. This improvement was maintained at the 3-month follow-up, F(2, 122) = 7.24, p = 0.001, partial η2 = 0.20. Conclusions: These findings suggest the potential benefit of the school and group-based intervention on depression symptoms but not on other outcomes, when compared to a waiting list control group. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12611000 948998. PMID:27843435

A randomized controlled trial of mindfulness-based stress reduction for women with early-stage breast cancer receiving radiotherapy.

PubMed

Henderson, Virginia P; Massion, Ann O; Clemow, Lynn; Hurley, Thomas G; Druker, Susan; Hébert, James R

2013-09-01

To testthe relative effectiveness of a mindfulness-based stress reduction program (MBSR) compared with a nutrition education intervention (NEP) and usual care (UC) in women with newly diagnosed early-stage breast cancer (BrCA)undergoing radiotherapy. Datawere available from a randomized controlled trialof 172 women, 20 to 65 years old, with stage I or II BrCA. Data from women completing the 8-week MBSR program plus 3 additional sessions focuses on special needs associated with BrCA were compared to women receiving attention control NEP and UC. Follow-up was performed at 3 post-intervention points: 4 months, and 1 and 2 years. Standardized, validated self-administered questionnaires were used to assess psychosocial variables. Descriptive analyses compared women by randomization assignment. Regression analyses, incorporating both intention-to-treat and post hoc multivariable approaches, were used to control for potential confounding variables. A subset of 120 women underwent radiotherapy; 77 completed treatment prior to the study, and 40 had radiotherapy during the MBSR intervention. Women who actively received radiotherapy (art) while participating in the MBSR intervention (MBSR-art) experienced a significant (P < .05) improvement in 16 psychosocial variables compared with the NEP-art, UC-art, or both at 4 months. These included health-related, BrCA-specific quality of life and psychosocial coping, which were the primary outcomes, and secondary measures, including meaningfulness, helplessness, cognitive avoidance, depression, paranoid ideation, hostility, anxiety, global severity, anxious preoccupation, and emotional control. MBSR appears to facilitate psychosocial adjustment in BrCA patients receiving radiotherapy, suggesting applicability for MBSR as adjunctive therapy in oncological practice.

Virtual reality for upper extremity rehabilitation in early stroke: a pilot randomized controlled trial.

PubMed

Yin, Chan Wai; Sien, Ng Yee; Ying, Low Ai; Chung, Stephanie Fook-Chong Man; Tan May Leng, Dawn

2014-11-01

To investigate the effect of virtual reality (VR) rehabilitation on upper extremity motor performance of patients with early stroke. Pilot randomized controlled trial. Rehabilitation wards. Twenty three adults with stroke (mean age (SD) = 58.35 (13.45) years and mean time since stroke (SD) = 16.30 (7.44) days). Participants were randomly assigned to VR group (n=11) or control group (n=12). VR group received nine 30 minutes upper extremity VR therapy in standing (five weekdays in two weeks) plus conventional therapy, which included physical and occupational therapy. Control group received only conventional therapy, which was comparable to total training time received by VR group (mean training hours (SD):VR = 17.07 (2.86); control = 15.50 (2.79)). The main outcome measure was the Fugl-Meyer Assessment (FMA). Secondary outcomes included Action Research Arm Test, Motor Activity Log and Functional Independence Measure. Results were taken at baseline, post intervention and 1-month post intervention. Participants' feedback and adverse effects were recorded. All participants improved in FMA scores (mean change (SD) = 11.65 (8.56), P<.001). These effects were sustained at one month after intervention (mean (SD) change from baseline = 18.67 (13.26), P<.001). All other outcome measures showed similar patterns. There were no significant differences in improvement between both groups. Majority of the participants found VR training useful and enjoyable, with no serious adverse effects reported. Although additional VR training was not superior to conventional therapy alone, this study demonstrates the feasibility of VR training in early stroke. © The Author(s) 2014.

A Randomized Trial Comparing Live and Telemedicine Delivery of an Imagery-based Behavioral Intervention for Breast Cancer Survivors: Reducing Symptoms and Barriers to Care

PubMed Central

Freeman, Lyn W.; White, Rebecca; Ratcliff, Chelsea G.; Sutton, Sue; Stewart, Mary; Palmer, J. Lynn; Link, Judith; Cohen, Lorenzo

2015-01-01

Objective This multi-site randomized trial evaluates the quality of life (QOL) benefits of an imagery-based group intervention titled “Envision the Rhythms of Life” (ERL). Methods Breast cancer survivors >6 weeks post-treatment were randomized to attend five weekly 4-hour group sessions at a community center with therapist present (live-delivery; LD, n=48); therapist streamed via telemedicine (telemedicine-delivery; TD, n=23); or to a waitlist control group (WL, n=47). Weekly individual phone calls to encourage at-home practice began at session one and continued until the 3-month follow-up. Seven self-report measures of QOL were examined at baseline, 1 and 3 months post-treatment including health-related and breast cancer-specific QOL, fatigue, cognitive function, spirituality, distress, and sleep. Results The Bonferroni method was used to correct for multiple comparisons, and alpha was adjusted to 0.01. LMM analyses revealed less fatigue, cognitive dysfunction, and sleep disturbance for LD and TD compared to WL across the follow-up (p’s <0.01). Changes in fatigue, cognitive dysfunction, sleep disturbance, and health-related and breast cancer-related QOL were clinically significant. There were no differences between LD and TD. Conclusions Both the live and telemedicine delivered ERL intervention resulted in improvements in multiple QOL domains for breast cancer survivors compared to a waitlist control. Further, there were no significant differences between live- and telemedicine-delivery, suggesting telemedicine delivered ERL intervention may represent an effective and viable option for cancer survivors in remote areas. PMID:25146413

A randomized clinical trial of buprenorphine for prisoners: Findings at 12-months post-release

PubMed Central

Gordon, Michael S.; Kinlock, Timothy W.; Schwartz, Robert P.; O’Grady, Kevin E.; Fitzgerald, Terrence T.; Vocci, Frank J.

2017-01-01

Background This study examined whether starting buprenorphine treatment prior to prison and after release from prison would be associated with better drug treatment outcomes and whether males and females responded differently to the combination of in-prison treatment and post-release service setting. Methods Study design was a 2 (In-Prison Treatment Condition: Buprenorphine Treatment Vs. Counseling Only) X 2 [Post-Release Service Setting Condition: Opioid Treatment Program (OTP) Vs. Community Health Center (CHC)] X 2 (Gender) factorial design. The trial was conducted between September 2008 and July 2012. Follow-up assessments were completed in 2014. Participants were recruited from two Baltimore prerelease prisons (one for men and one for women). Adult pre-release prisoners who were heroin-dependent during the year prior to incarceration were eligible. Post-release assessments were conducted at 1, 3, 6, and 12-month following prison release. Results Participants (N=211) in the in-prison treatment condition effect had a higher mean number of days of community buprenorphine treatment compared to the condition in which participants initiated medication after release (P=.005). However, there were no statistically significant hypothesized effects for the in-prison treatment condition in terms of: days of heroin use and crime, and opioid and cocaine positive urine screening test results (all Ps>.14) and no statistically significant hypothesized gender effects (all Ps>.18). Conclusions Although initiating buprenorphine treatment in prison compared to after-release was associated with more days receiving buprenorphine treatment in the designated community treatment program during the 12-months post-release assessment, it was not associated with superior outcomes in terms of heroin and cocaine use and criminal behavior. PMID:28107680

A randomized clinical trial of buprenorphine for prisoners: Findings at 12-months post-release.

PubMed

Gordon, Michael S; Kinlock, Timothy W; Schwartz, Robert P; O'Grady, Kevin E; Fitzgerald, Terrence T; Vocci, Frank J

2017-03-01

This study examined whether starting buprenorphine treatment prior to prison and after release from prison would be associated with better drug treatment outcomes and whether males and females responded differently to the combination of in-prison treatment and post-release service setting. Study design was a 2 (In-Prison Treatment: Condition: Buprenorphine Treatment: vs. Counseling Only)×2 [Post-Release Service Setting Condition: Opioid Treatment: Program (OTP) vs. Community Health Center (CHC)]×2 (Gender) factorial design. The trial was conducted between September 2008 and July 2012. Follow-up assessments were completed in 2014. Participants were recruited from two Baltimore pre-release prisons (one for men and one for women). Adult pre-release prisoners who were heroin-dependent during the year prior to incarceration were eligible. Post-release assessments were conducted at 1, 3, 6, and 12-month following prison release. Participants (N=211) in the in-prison treatment condition effect had a higher mean number of days of community buprenorphine treatment compared to the condition in which participants initiated medication after release (P=0.005). However, there were no statistically significant hypothesized effects for the in-prison treatment condition in terms of: days of heroin use and crime, and opioid and cocaine positive urine screening test results (all Ps>0.14) and no statistically significant hypothesized gender effects (all Ps>0.18). Although initiating buprenorphine treatment in prison compared to after-release was associated with more days receiving buprenorphine treatment in the designated community treatment program during the 12-months post-release assessment, it was not associated with superior outcomes in terms of heroin and cocaine use and criminal behavior. Copyright © 2017 Elsevier B.V. All rights reserved.

Effectiveness of a selective intervention program targeting personality risk factors for alcohol misuse among young adolescents: results of a cluster randomized controlled trial.

PubMed

Lammers, Jeroen; Goossens, Ferry; Conrod, Patricia; Engels, Rutger; Wiers, Reinout W; Kleinjan, Marloes

2015-07-01

The effectiveness of Preventure was tested on drinking behaviour of young adolescents in secondary education in the Netherlands. A cluster randomized controlled trial was carried out, with participants assigned randomly to a two-session coping skills intervention or a control no-intervention condition. Fifteen secondary schools throughout the Netherlands; seven schools in the intervention and eight schools in the control condition. A total of 699 adolescents aged 13-15 years participated, 343 allocated to the intervention and 356 to the control condition, with drinking experience and elevated scores in either negative thinking, anxiety sensitivity, impulsivity or sensation-seeking. Preventure is a selective school-based alcohol prevention programme targeting personality risk factors. The comparator was a no-intervention control. The effects of the intervention on the primary outcome past-month binge drinking, and the secondary outcomes binge drinking frequency, alcohol use, alcohol frequency and problem drinking, were examined. The primary analyses of interest were intervention main effects at 12 months post-intervention. In addition, intervention effects on the linear development of binge drinking using a latent-growth curve approach were examined. Binge drinking rates were not significantly different between the intervention (42.9%) and control group (49.2%) at 12 months follow-up [odds ratio (OR) = 1.05, confidence interval (CI) = 0.99, 1.11]. Intention-to-treat analyses revealed no significant intervention effects on alcohol use (53.9 versus 61.5%; OR = 0.99, CI = 0.86, 1.14) and problem drinking (37.0 versus 44.7%; OR = 1.03, CI = 0.92, 1.10) at 12 months follow-up. The post-hoc latent-growth analyses revealed significant effects on the development of binge drinking (β = -0.16, P = 0.05), and binge drinking frequency (β = -0.14, P = 0.05). The alcohol prevention programme, Preventure, appears to have little or no effect on overall prevalence of binge drinking in adolescents in the Netherlands but may reduce the development of binge drinking over time. © 2015 Society for the Study of Addiction.

Mass drug administration for malaria

PubMed Central

Poirot, Eugenie; Skarbinski, Jacek; Sinclair, David; Kachur, S Patrick; Slutsker, Laurence; Hwang, Jimee

2013-01-01

Background Mass drug administration (MDA), defined as the empiric administration of a therapeutic antimalarial regimen to an entire population at the same time, has been a historic component of many malaria control and elimination programmes, but is not currently recommended. With renewed interest in MDA and its role in malaria elimination, this review aims to summarize the findings from existing research studies and program experiences of MDA strategies for reducing malaria burden and transmission. Objectives To assess the impact of antimalarial MDA on population asexual parasitaemia prevalence, parasitaemia incidence, gametocytaemia prevalence, anaemia prevalence, mortality and MDA-associated adverse events. Search methods We searched the Cochrane Infectious Disease Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE+, EMBASE, to February 2013. We also searched CABS Abstracts, LILACS, reference lists, and recent conference proceedings. Selection criteria Cluster-randomized trials and non-randomized controlled studies comparing therapeutic MDA versus placebo or no MDA, and uncontrolled before-and-after studies comparing post-MDA to baseline data were selected. Studies administering intermittent preventive treatment (IPT) to sub-populations (for example, pregnant women, children or infants) were excluded. Data collection and analysis Two authors independently reviewed studies for inclusion, extracted data and assessed risk of bias. Studies were stratified by study design and then subgrouped by endemicity, by co-administration of 8-aminoquinoline plus schizonticide drugs and by plasmodium species. The quality of evidence was assessed using the GRADE approach. Main results Two cluster-randomized trials, eight non-randomized controlled studies and 22 uncontrolled before-and-after studies are included in this review. Twenty-two studies (29 comparisons) compared MDA to placebo or no intervention of which two comparisons were conducted in areas of low endemicity (≤5%), 12 in areas of moderate endemicity (6-39%) and 15 in areas of high endemicity (≥ 40%). Ten studies evaluated MDA plus other vector control measures. The studies used a wide variety of MDA regimens incorporating different drugs, dosages, timings and numbers of MDA rounds. Many of the studies are now more than 30 years old. Areas of low endemicity (≤5%) Within the first month post-MDA, a single uncontrolled before-and-after study conducted in 1955 on a small Taiwanese island reported a much lower prevalence of parasitaemia following a single course of chloroquine compared to baseline (1 study, very low quality evidence). This lower parasite prevalence was still present after more than 12 months (one study, very low quality evidence). In addition, one cluster-randomized trial evaluating MDA in a low endemic setting reported zero episodes of parasitaemia at baseline, and throughout five months of follow-up in both the control and intervention arms (one study, very low quality evidence). Areas of moderate endemicity (6-39%) Within the first month post-MDA, the prevalence of parasitaemia was much lower in three non-randomized controlled studies from Kenya and India in the 1950s (RR 0.03, 95% CI 0.01 to 0.08, three studies, moderate quality evidence), and in three uncontrolled before-and-after studies conducted between 1954 and 1961 (RR 0.29, 95% CI 0.17 to 0.48, three studies,low quality evidence). The longest follow-up in these settings was four to six months. At this time point, the prevalence of parasitaemia remained substantially lower than controls in the two non-randomized controlled studies (RR 0.18, 95% CI 0.10 to 0.33, two studies, low quality evidence). In contrast, the two uncontrolled before-and-after studies found mixed results: one found no difference and one found a substantially higher prevalence compared to baseline (not pooled, two studies, very low quality evidence). Areas of high endemicity (≥40%) Within the first month post-MDA, the single cluster-randomized trial from the Gambia in 1999 found no significant difference in parasite prevalence (one study, low quality evidence). However, prevalence was much lower during the MDA programmes in three non-randomized controlled studies conducted in the 1960s and 1970s (RR 0.17, 95% CI 0.11 to 0.27, three studies, moderate quality evidence), and within one month of MDA in four uncontrolled before-and-after studies (RR 0.37, 95% CI 0.28 to 0.49, four studies,low quality evidence). Four trials reported changes in prevalence beyond three months. In the Gambia, the single cluster-randomized trial found no difference at five months (one trial, moderate quality evidence). The three uncontrolled before-and-after studies had mixed findings with large studies from Palestine and Cambodia showing sustained reductions at four months and 12 months, respectively, and a small study from Malaysia showing no difference after four to six months of follow-up (three studies,low quality evidence). 8-aminoquinolines We found no studies directly comparing MDA regimens that included 8-aminoquinolines with regimens that did not. In a crude subgroup analysis with a limited number of studies, we were unable to detect any evidence of additional benefit of primaquine in moderate- and high-transmission settings. Plasmodium species In studies that reported species-specific outcomes, the same interventions resulted in a larger impact on Plasmodium falciparum compared to P. vivax. Authors' conclusions MDA appears to reduce substantially the initial risk of malaria parasitaemia. However, few studies showed sustained impact beyond six months post-MDA, and those that did were conducted on small islands or in highland settings. To assess whether there is an impact of MDA on malaria transmission in the longer term requires more quasi experimental studies with the intention of elimination, especially in low- and moderate-transmission settings. These studies need to address any long-term outcomes, any potential barriers for community uptake, and contribution to the development of drug resistance. PLAIN LANGUAGE SUMMARY Administration of antimalarial drugs to whole populations Malaria is the most important mosquito-borne disease caused by a parasite, accounting for an estimated 660,000 deaths annually. Fortunately, malaria is both preventable and treatable. Several malaria control tools currently exist, and new and innovative approaches are continually under development. The administration of drugs against malaria to whole populations, termed mass drug administration (MDA), was a component of many malaria elimination programmes in the 1950s, and is once again attracting interest as a malaria elimination tool. As a consequence, it is important to review the currently available literature in order to assess the potential for this strategy to reduce malaria burden and transmission, and to identify gaps in our understanding. This review assessed the impact of MDA on several malaria-specific outcome measures. Thirty-two studies were included in this review, from sites in Asia, Africa, Europe and the Americas. The review found that although MDA can reduce the initial risk of malaria-specific outcomes, these reductions are often not sustained. However, a few studies conducted on small islands or in highland areas did show sustained impact more than six months after MDA. Adverse events were inadequately addressed in most studies. Notable severe drug reactions, including haemolysis, haemoglobinuria, severe anaemia and death, were reported with 8-aminoquinoline plus schizonticide drug co-administration, while severe skin reactions were reported with sulphadoxine-pyrimethamine plus artesunate plus primaquine. Assessing the true impact of MDA programmes can be a challenge due to the heterogeneity of the study methods employed. Nonetheless, this review can help guide future antimalarial MDA interventions and their evaluation. PMID:24318836

Socket grafting with or without buccal augmentation with anorganic bovine bone at immediate post-extractive implants: 6-month after loading results from a multicenter randomised controlled clinical trial.

PubMed

Zuffetti, Francesco; Esposito, Marco; Capelli, Matteo; Galli, Fabio; Testori, Tiziano; Del Fabbro, Massimo

2013-01-01

To evaluate whether grafting with additional anorganic bovine bone to augment horizontally the buccal plate (internal and external grafting [IEG]) at single post-extractive implants preserves the alveolar ridge, improving aesthetics, better than internal socket grafting alone (ISGA). A total of 78 patients, treated in four Italian private practices, requiring a single immediate post-extractive implant, having at least 1 mm of implant-to-buccal bone gap after implant insertion and a preserved buccal bone, had the residual bone-to-implant gap filled with anorganic bovine bone. Thirty-nine randomly allocated patients received additional buccal horizontal augmentation of about 2 mm thickness with the same bone substitute (IEG group) covered with collagen resorbable membranes. Implants were submerged for 4 months before being loaded with provisional acrylic crowns. Definitive crowns were delivered after 6 months. Outcome measures were crown/implant failures, complications and aesthetics recorded by blinded assessors 6 months after initial loading, at delivery of definitive crowns. Six months after initial loading, 8 patients dropped out, did not complete the treatment or were treated twice and therefore had to be excluded (4 from each group). There were no statistically significant differences for implant failures and complications between the two groups. Two implants failed in the IEG group versus 1 in the ISGA group. Four complications occurred, 2 in each group. The mean implant aesthetic score (IAS) was 7.8 at ISGA sites and 8.0 at IEG sites. There were no statistically significant differences between the two groups (P = 0.492; difference 0.2 mm; 95% CI -0.769, 0.369) for IAS score. There were no statistically significant differences in the outcomes between the centres. The use of adjunctive anorganic bovine bone placed buccally at preserved buccal sites of immediate post-extractive implants may not improve the aesthetic outcome, however additional research is needed to confirm or reject these preliminary findings.

Randomized Trial of a Group Music and Imagery Method (GrpMI) for Women with Fibromyalgia.

PubMed

Torres, Esperanza; Pedersen, Inge N; Pérez-Fernández, José I

2018-06-07

Fibromyalgia (FM) affects about 2-4% of the world population. Patients, mostly women, experience chronic widespread pain, fatigue, stiffness, sleep disturbances, and psychological disorders, especially depression and anxiety. The aim of this study was to examine preliminary efficacy of a Group Music and Imagery (GrpMI) intervention, which included relaxation, music listening, and spontaneous imagery, to improve subjective psychological well-being, functional capacity and health, pain perception, anxiety, and depression in women with FM. Fifty-six women aged 35 to 65 years (M = 51.3) diagnosed with FM were randomly assigned to either GrpMI treatment (n = 33) or control (n = 26) condition. Experimental group participants received 12 weekly GrpMI sessions, and control group participants who did not receive any additional service completed measures at the same time points as the experimental group. Intra-group analyses showed that GrpMI participants had a significant increase in psychological well-being and significant decrease in the impact of FM on functional capacity and health, pain perception, anxiety, and depression post-treatment, with sustained benefit at three-month follow-up for all variables except psychological well-being. Control group participants showed decreases in trait anxiety and depression at post-treatment, with no significant benefit at three-month follow-up. Inter-group analyses showed that compared with control participants, GRpMI participants had significantly higher scores for psychological well-being and lower-state anxiety post-treatment; however, no differences were observed between groups at three-month follow-up. Findings offer preliminary evidence for the benefit of GrpMI to improve well-being and reduce anxiety in women with FM. Findings also suggest that GrpMI may help diminish pain intensity, state depression, and the impact of FM on functional capacity and health, but further studies are needed to establish efficacy.

Effect of cognitive behavioral group therapy for recovery of self-esteem on community-living individuals with mental illness: Non-randomized controlled trial.

PubMed

Kunikata, Hiroko; Yoshinaga, Naoki; Nakajima, Kazuo

2016-10-01

The aim of this study was to examine over a 12-month post-intervention period whether the participation of community-living individuals with mental illness in cognitive behavioral group therapy for recovery of self-esteem (CBGTRS) resulted in improved outcomes. This was a non-randomized controlled trial. The participants were persons with mental illness who resided in communities in the Chugoku region of Japan. In total, 41 were assigned to an experimental group (CBGTRS intervention, 12 group sessions), and 21 to a control group. Outcome indices (self-esteem, moods, cognition, subjective well-being, psychiatric symptoms) were measured for the experimental group prior to intervention (T0), immediately post-intervention (T1), and at 3 (T2) and 12 (T3) months post-intervention. The control group was measured at the same intervals. For the experimental group, self-esteem scores at T1, T2, and T3 were significantly higher than at T0. Moods and cognition scores remained significantly low until T2. Scores for Inadequate Mental Mastery in the subjective well-being index had not decreased by T3. Confidence in Coping remained significantly high until T2. Psychiatric symptoms scores at T0, T1, T2, and T3 were significantly lower than at T0. The means and standard errors for self-esteem and Inadequate Mental Mastery increased until T3, and those for Tension-Anxiety, Depression-Dejection, and Confusion decreased until T2. From within-group trends and between-group differences in self-esteem, we conclude that CBGTRS may have a relatively long-term effect on self-esteem recovery. T2 is the turning point for moods and cognition; thus, follow-up is needed 3 months following the initial program. © 2016 The Authors. Psychiatry and Clinical Neurosciences © 2016 Japanese Society of Psychiatry and Neurology.

Safety and adherence to intermittent pre-exposure prophylaxis (PrEP) for HIV-1 in African men who have sex with men and female sex workers.

PubMed

Mutua, Gaudensia; Sanders, Eduard; Mugo, Peter; Anzala, Omu; Haberer, Jessica E; Bangsberg, David; Barin, Burc; Rooney, James F; Mark, David; Chetty, Paramesh; Fast, Patricia; Priddy, Frances H

2012-01-01

Little is known about safety of and adherence to intermittent HIV PrEP regimens, which may be more feasible than daily dosing in some settings. We present safety and adherence data from the first trial of an intermittent PrEP regimen among Kenyan men who have sex with men (MSM) and female sex workers (FSW). MSM and FSW were randomized to daily oral FTC/TDF or placebo, or intermittent (Monday, Friday and within 2 hours after sex, not to exceed one dose per day) oral FTC/TDF or placebo in a 2:1:2:1 ratio; volunteers were followed monthly for 4 months. Adherence was assessed with the medication event monitoring system (MEMS). Sexual activity data were collected via daily text message (SMS) queries and timeline followback interviews with a one-month recall period. Sixty-seven men and 5 women were randomized into the study. Safety was similar among all groups. Median MEMS adherence rates were 83% [IQR: 63-92] for daily dosing and 55% [IQR:28-78] for fixed intermittent dosing (p = 0.003), while adherence to any post-coital doses was 26% [IQR:14-50]. SMS response rates were low, which may have impaired measurement of post-coital dosing adherence. Acceptability of PrEP was high, regardless of dosing regimen. Adherence to intermittent dosing regimens, fixed doses, and in particular coitally-dependent doses, may be more difficult than adherence to daily dosing. However, intermittent dosing may still be appropriate for PrEP if intracellular drug levels, which correlate with prevention of HIV acquisition, can be attained with less than daily dosing and if barriers to adherence can be addressed. Additional drug level data, qualitative data on adherence barriers, and better methods to measure sexual activity are necessary to determine whether adherence to post-coital PrEP could be comparable to more standard regimens. ClinicalTrials.gov NCT00971230.

Post-partum weight loss and glucose metabolism in women with gestational diabetes: the DEBI Study.

PubMed

Ehrlich, S F; Hedderson, M M; Quesenberry, C P; Feng, J; Brown, S D; Crites, Y; Ferrara, A

2014-07-01

Women with gestational diabetes are at high risk for developing diabetes; post-partum weight loss may reduce the risk of diabetes. We evaluated the association of post-partum weight change with changes in glucose, insulin and homeostasis model assessment of insulin resistance in a subsample (n = 72) of participants from Diet Exercise and Breastfeeding Intervention (DEBI), a randomized pilot trial of lifestyle intervention for women with gestational diabetes. Glucose and insulin were measured fasting and 2 h after an oral glucose tolerance test at 6 weeks and 12 months post-partum. Women were categorized by weight change (lost > 2 kg vs. maintained/gained) between 6 weeks and 12 months post-partum. Compared with women who maintained or gained weight, women who lost > 2 kg experienced significantly lower increases in fasting glucose [age-adjusted means: 0.1 mmol/l (95% CI -0.03 to 0.3) vs. 0.4 mmol/l (95% CI 0.3-0.6); P < 0.01] and 2-h insulin [10.0 pmol/l (95% CI -56.9 to 76.9) vs. 181.2 pmol/l (95% CI 108.3-506.9); P < 0.01] and a significant reduction in 2-h glucose [-0.9 mmol/l (95% CI -1.4 to -0.3) vs. 0.3 mmol/l (95% CI -0.3 to 0.9); P < 0.01]. In multiple linear regression models adjusted for age, Hispanic ethnicity, medication use, meeting the Institute of Medicine's recommendations for gestational weight gain, breastfeeding and randomized group, a 1-kg increase in weight was significantly associated with increases in fasting and 2-h glucose (P < 0.05), but was not associated with insulin or homeostasis model assessment of insulin resistance. In women with gestational diabetes, modest post-partum weight loss may be associated with improvements in glucose metabolism. © 2014 The Authors. Diabetic Medicine © 2014 Diabetes UK.

Efficacy of GP referral of insufficiently active patients for expert physical activity counseling: protocol for a pragmatic randomized trial (The NewCOACH trial).

PubMed

James, Erica L; Ewald, Ben; Johnson, Natalie; Brown, Wendy; Stacey, Fiona G; Mcelduff, Patrick; Booth, Angela; Yang, Fan; Hespe, Charlotte; Plotnikoff, Ronald C

2014-12-29

Physical inactivity is fourth in the list of risk factors for global mortality. General practitioners are well placed to offer physical activity counseling but insufficient time is a barrier. Although referral to an exercise specialist is an alternative, in Australia, these allied health professionals are only publicly funded to provide face-to-face counseling to patients who have an existing chronic illness. Accordingly, this trial aims to determine the efficacy of GP referral of insufficiently active patients (regardless of their chronic disease status) for physical activity counseling (either face-to-face or predominately via telephone) by exercise specialists, based on patients' objectively assessed physical activity levels, compared with usual care. If the trial is efficacious, the equivalence and cost-effectiveness of face-to-face counseling versus telephone counseling will be assessed. This three arm pragmatic randomized trial will involve the recruitment of 261 patients from primary care clinics in metropolitan and regional areas of New South Wales, Australia. Insufficiently active (less than 7000 steps/day) consenting adult patients will be randomly assigned to: 1) five face-to-face counseling sessions, 2) one face-to-face counseling session followed by four telephone calls, or 3) a generic mailed physical activity brochure (usual care). The interventions will operationalize social cognitive theory via a behavior change counseling framework. Participants will complete a survey and seven days of pedometry at baseline, and at three and 12 months post-randomization. The primary analyses will be based on intention-to-treat principles and will compare: (i) mean change in average daily step counts between baseline and 12 months for the combined intervention group (Group 1: face-to-face, and Group 2: telephone) and usual care (Group 3); (ii) step counts at 3 months post-randomization. Secondary outcomes include: self-reported physical activity, sedentary behavior, quality of life, and depression. If referral of primary care patients to exercise specialists increases physical activity, this process offers the prospect of systematically and sustainably reaching a large proportion of insufficiently active adults. If shown to be efficacious this trial provides evidence to expand public funding beyond those with a chronic disease and for delivery via telephone as well as face-to-face consultations. Australian New Zealand Clinical Trials Registry ACTRN12611000884909 .

Effectiveness and cost-effectiveness of a group-based pain self-management intervention for patients undergoing total hip replacement: feasibility study for a randomized controlled trial.

PubMed

Wylde, Vikki; Marques, Elsa; Artz, Neil; Blom, Ashley; Gooberman-Hill, Rachael

2014-05-20

Total hip replacement (THR) is a common elective surgical procedure and can be effective for reducing chronic pain. However, waiting times can be considerable. A pain self-management intervention may provide patients with skills to more effectively manage their pain and its impact during their wait for surgery. This study aimed to evaluate the feasibility of conducting a randomized controlled trial to assess the effectiveness and cost-effectiveness of a group-based pain self-management course for patients undergoing THR. Patients listed for a THR at one orthopedic center were posted a study invitation pack. Participants were randomized to attend a pain self-management course plus standard care or standard care only. The lay-led course was delivered by Arthritis Care and consisted of two half-day sessions prior to surgery and one full-day session after surgery. Participants provided outcome and resource-use data using a diary and postal questionnaires prior to surgery and one month, three months and six months after surgery. Brief telephone interviews were conducted with non-participants to explore barriers to participation. Invitations were sent to 385 eligible patients and 88 patients (23%) consented to participate. Interviews with 57 non-participants revealed the most common reasons for non-participation were views about the course and transport difficulties. Of the 43 patients randomized to the intervention group, 28 attended the pre-operative pain self-management sessions and 11 attended the post-operative sessions. Participant satisfaction with the course was high, and feedback highlighted that patients enjoyed the group format. Retention of participants was acceptable (83% of recruited patients completed follow-up) and questionnaire return rates were high (72% to 93%), with the exception of the pre-operative resource-use diary (35% return rate). Resource-use completion rates allowed for an economic evaluation from the health and social care payer perspective. This study highlights the importance of feasibility work prior to a randomized controlled trial to assess recruitment methods and rates, barriers to participation, logistics of scheduling group-based interventions, acceptability of the intervention and piloting resource use questionnaires to improve data available for economic evaluations. This information is of value to researchers and funders in the design and commissioning of future research. Current Controlled Trials ISRCTN52305381.

Effect of Educational Outreach Timing and Duration on Facility Performance for Infectious Disease Care in Uganda: A Trial with Pre-Post and Cluster Randomized Controlled Components

PubMed Central

Burnett, Sarah M.; Mbonye, Martin K.; Naikoba, Sarah; Zawedde-Muyanja, Stella; Kinoti, Stephen N.; Ronald, Allan; Rubashembusya, Timothy; Willis, Kelly S.; Colebunders, Robert; Manabe, Yukari C.; Weaver, Marcia R.

2015-01-01

Background Classroom-based learning is often insufficient to ensure high quality care and application of health care guidelines. Educational outreach is garnering attention as a supplemental method to enhance health care worker capacity, yet there is little information about the timing and duration required to improve facility performance. We sought to evaluate the effects of an infectious disease training program followed by either immediate or delayed on-site support (OSS), an educational outreach approach, on nine facility performance indicators for emergency triage, assessment, and treatment; malaria; and pneumonia. We also compared the effects of nine monthly OSS visits to extended OSS, with three additional visits over six months. Methods This study was conducted at 36 health facilities in Uganda, covering 1,275,960 outpatient visits over 23 months. From April 2010 to December 2010, 36 sites received infectious disease training; 18 randomly selected sites in arm A received nine monthly OSS visits (immediate OSS) and 18 sites in arm B did not. From March 2011 to September 2011, arm A sites received three additional visits every two months (extended OSS), while the arm B sites received eight monthly OSS visits (delayed OSS). We compared the combined effect of training and delayed OSS to training followed by immediate OSS to determine the effect of delaying OSS implementation by nine months. We also compared facility performance in arm A during the extended OSS to immediate OSS to examine the effect of additional, less frequent OSS. Results Delayed OSS, when combined with training, was associated with significant pre/post improvements in four indicators: outpatients triaged (44% vs. 87%, aRR = 1.54, 99% CI = 1.11, 2.15); emergency and priority patients admitted, detained, or referred (16% vs. 31%, aRR = 1.74, 99% CI = 1.10, 2.75); patients with a negative malaria test result prescribed an antimalarial (53% vs. 34%, aRR = 0.67, 99% CI = 0.55, 0.82); and pneumonia suspects assessed for pneumonia (6% vs. 27%, aRR = 2.97, 99% CI = 1.44, 6.17). Differences between the delayed OSS and immediate OSS arms were not statistically significant for any of the nine indicators (all adjusted relative RR (aRRR) between 0.76–1.44, all p>0.06). Extended OSS was associated with significant improvement in two indicators (outpatients triaged: aRR = 1.09, 99% CI = 1.01; emergency and priority patients admitted, detained, or referred: aRR = 1.22, 99% CI = 1.01, 1.38) and decline in one (pneumonia suspects assessed for pneumonia: aRR: 0.93; 99% CI = 0.88, 0.98). Conclusions Educational outreach held up to nine months after training had similar effects on facility performance as educational outreach started within one month post-training. Six months of bi-monthly educational outreach maintained facility performance gains, but incremental improvements were heterogeneous. PMID:26352257

Alveolar ridge augmentation by connective tissue grafting using a pouch method and modified connective tissue technique: A prospective study

PubMed Central

Agarwal, Ashish; Gupta, Narinder Dev

2015-01-01

Background: Localized alveolar ridge defect may create physiological and pathological problems. Developments in surgical techniques have made it simpler to change the configuration of a ridge to create a more aesthetic and more easily cleansable shape. The purpose of this study was to compare the efficacy of alveolar ridge augmentation using a subepithelial connective tissue graft in pouch and modified connective tissue graft technique. Materials and Methods: In this randomized, double blind, parallel and prospective study, 40 non-smoker individuals with 40 class III alveolar ridge defects in maxillary anterior were randomly divided in two groups. Group I received modified connective tissue graft, while group II were treated with subepithelial connective tissue graft in pouch technique. The defect size was measured in its horizontal and vertical dimension by utilizing a periodontal probe in a stone cast at base line, after 3 months, and 6 months post surgically. Analysis of variance and Bonferroni post-hoc test were used for statistical analysis. A two-tailed P < 0.05 was considered to be statistically significant. Results: Mean values in horizontal width after 6 months were 4.70 ± 0.87 mm, and 4.05 ± 0.89 mm for group I and II, respectively. Regarding vertical heights, obtained mean values were 4.75 ± 0.97 mm and 3.70 ± 0.92 mm for group I and group II, respectively. Conclusion: Within the limitations of this study, connective tissue graft proposed significantly more improvement as compare to connective tissue graft in pouch. PMID:26759591

Effects of a post-deworming health hygiene education intervention on absenteeism in school-age children of the Peruvian Amazon.

PubMed

Thériault, François L; Maheu-Giroux, Mathieu; Blouin, Brittany; Casapía, Martin; Gyorkos, Theresa W

2014-08-01

Soil-transmitted helminth (STH) infections are a leading cause of disability and disease burden in school-age children of worm-endemic regions. Their effect on school absenteeism, however, remains unclear. The World Health Organization currently recommends delivering mass deworming and health hygiene education through school-based programs, in an effort to control STH-related morbidity. In this cluster-RCT, the impact of a health hygiene education intervention on absenteeism was measured. From April to June 2010, all Grade 5 students at 18 schools in a worm-endemic region of the Peruvian Amazon were dewormed. Immediately following deworming, nine schools were randomly assigned to the intervention arm of the trial using a matched-pair design. The Grade 5 students attending intervention schools (N = 517) received four months of health hygiene education aimed at increasing knowledge of STH prevention. Grade 5 students from the other nine schools (N = 571) served as controls. Absenteeism was measured daily through teachers' attendance logs. After four months of follow-up, overall absenteeism rates at intervention and control schools were not statistically significantly different. However, post-trial non-randomized analyses have shown that students with moderate-to-heavy Ascaris infections and light hookworm infections four months after deworming had, respectively, missed 2.4% (95% CI: 0.1%, 4.7%) and 4.6% (95% CI: 1.9%, 7.4%) more schooldays during the follow-up period than their uninfected counterparts. These results provide empirical evidence of a direct effect of STH infections on absenteeism in school-age children.

Effects of a Post-Deworming Health Hygiene Education Intervention on Absenteeism in School-Age Children of the Peruvian Amazon

PubMed Central

Thériault, François L.; Maheu-Giroux, Mathieu; Blouin, Brittany; Casapía, Martin; Gyorkos, Theresa W.

2014-01-01

Soil-transmitted helminth (STH) infections are a leading cause of disability and disease burden in school-age children of worm-endemic regions. Their effect on school absenteeism, however, remains unclear. The World Health Organization currently recommends delivering mass deworming and health hygiene education through school-based programs, in an effort to control STH-related morbidity. In this cluster-RCT, the impact of a health hygiene education intervention on absenteeism was measured. From April to June 2010, all Grade 5 students at 18 schools in a worm-endemic region of the Peruvian Amazon were dewormed. Immediately following deworming, nine schools were randomly assigned to the intervention arm of the trial using a matched-pair design. The Grade 5 students attending intervention schools (N = 517) received four months of health hygiene education aimed at increasing knowledge of STH prevention. Grade 5 students from the other nine schools (N = 571) served as controls. Absenteeism was measured daily through teachers' attendance logs. After four months of follow-up, overall absenteeism rates at intervention and control schools were not statistically significantly different. However, post-trial non-randomized analyses have shown that students with moderate-to-heavy Ascaris infections and light hookworm infections four months after deworming had, respectively, missed 2.4% (95% CI: 0.1%, 4.7%) and 4.6% (95% CI: 1.9%, 7.4%) more schooldays during the follow-up period than their uninfected counterparts. These results provide empirical evidence of a direct effect of STH infections on absenteeism in school-age children. PMID:25122469

The Memory Support System for Mild Cognitive Impairment: Randomized trial of a cognitive rehabilitation intervention

PubMed Central

Greenaway, M. C.; Duncan, N. L.; Smith, G. E.

2013-01-01

Objective Individuals with amnestic Mild Cognitive Impairment (MCI) have few empirically-based treatment options for combating their memory loss. This study sought to examine the efficacy of a calendar/notebook rehabilitation intervention, the Memory Support System (MSS), for individuals with amnestic MCI. Methods Forty individuals with single domain amnestic MCI and their program partners were randomized to receive the MSS, either with training or without (controls). Measures of adherence, activities of daily living, and emotional impact were completed at the first and last intervention session and again at 8-weeks and 6 months post intervention. Results Training in use of a notebook/calendar system significantly improved adherence over those who received the calendars but no training. Functional ability and memory self efficacy significantly improved for those who received MSS training. Change in functional ability remained significantly better in the intervention group than in the control group out to 8 week follow up. Care partners in the intervention group demonstrated improved mood by 8 week and 6 month follow-up, while control care partners reported worse caregiver burden by 6 month follow up. Conclusions MSS training resulted in improvement in ADLs and sense of memory self efficacy for individuals with MCI. While ADL benefits were maintained out to 8 weeks post intervention, future inclusion of booster sessions may help extend the therapeutic effect out even further. Improved mood of care partners of trained individuals and worsening sense of caregiver burden over time for partners of untrained individuals further supports the efficacy of the MSS for MCI. PMID:22678947

Increased physical activity improves sleep and mood outcomes in inactive people with insomnia: a randomized controlled trial.

PubMed

Hartescu, Iuliana; Morgan, Kevin; Stevinson, Clare D

2015-10-01

While high levels of activity and exercise training have been associated with improvements in sleep quality, minimum levels of activity likely to improve sleep outcomes have not been explored. A two-armed parallel randomized controlled trial (N=41; 30 females) was designed to assess whether increasing physical activity to the level recommended in public health guidelines can improve sleep quality among inactive adults meeting research diagnostic criteria for insomnia. The intervention consisted of a monitored program of ≥150 min of moderate- to vigorous-intensity physical activity per week, for 6 months. The principal end-point was the Insomnia Severity Index at 6 months post-baseline. Secondary outcomes included measures of mood, fatigue and daytime sleepiness. Activity and light exposure were monitored throughout the trial using accelerometry and actigraphy. At 6 months post-baseline, the physical activity group showed significantly reduced insomnia symptom severity (F(8,26) = 5.16, P = 0.03), with an average reduction of four points on the Insomnia Severity Index; and significantly reduced depression and anxiety scores (F(6,28) = 5.61, P = 0.02; and F(6,28) = 4.41, P = 0.05, respectively). All of the changes were independent of daily light exposure. Daytime fatigue showed no significant effect of the intervention (F(8,26) = 1.84, P = 0.18). Adherence and retention were high. Internationally recommended minimum levels of physical activity improve daytime and night-time symptoms of chronic insomnia independent of daily light exposure levels. © 2015 European Sleep Research Society.

Mindfulness instruction for HIV-infected youth: a randomized controlled trial.

PubMed

Webb, Lindsey; Perry-Parrish, Carisa; Ellen, Jonathan; Sibinga, Erica

2018-06-01

HIV-infected youth experience many stressors, including stress related to their illness, which can negatively impact their mental and physical health. Therefore, there is a significant need to identify potentially effective interventions to improve stress management, coping, and self-regulation. The object of the study was to assess the effect of a mindfulness-based stress reduction (MBSR) program compared to an active control group on psychological symptoms and HIV disease management in youth utilizing a randomized controlled trial. Seventy-two HIV-infected adolescents, ages 14-22 (mean age 18.71 years), were enrolled from two urban clinics and randomized to MBSR or an active control. Data were collected on mindfulness, stress, self-regulation, psychological symptoms, medication adherence, and cognitive flexibility at baseline, post-program, and 3-month follow-up. CD4+ T lymphocyte and HIV viral load (HIV VL) counts were also pulled from medical records. HIV-infected youth in the MBSR group reported higher levels of mindfulness (P = .03), problem-solving coping (P = .03), and life satisfaction (P = .047), and lower aggression (P = .002) than those in the control group at the 3-month follow-up. At post-program, MBSR participants had higher cognitive accuracy when faced with negative emotion stimuli (P = .02). Also, those in the MBSR study arm were more likely to have or maintain reductions in HIV VL at 3-month follow-up than those in the control group (P = .04). In our sample, MBSR instruction proved beneficial for important psychological and HIV-disease outcomes, even when compared with an active control condition. Lower HIV VL levels suggest improved HIV disease control, possibly due to higher levels of HIV medication adherence, which is of great significance in both HIV treatment and prevention. Additional research is needed to explore further the role of MBSR for improving the psychological and physical health of HIV-positive youth.

Multicomponent interdisciplinary group intervention for self-management of fibromyalgia: a mixed-methods randomized controlled trial.

PubMed

Bourgault, Patricia; Lacasse, Anaïs; Marchand, Serge; Courtemanche-Harel, Roxanne; Charest, Jacques; Gaumond, Isabelle; Barcellos de Souza, Juliana; Choinière, Manon

2015-01-01

This study evaluated the efficacy of the PASSAGE Program, a structured multicomponent interdisciplinary group intervention for the self-management of FMS. A mixed-methods randomized controlled trial (intervention (INT) vs. waitlist (WL)) was conducted with patients suffering from FMS. Data were collected at baseline (T0), at the end of the intervention (T1), and 3 months later (T2). The primary outcome was change in pain intensity (0-10). Secondary outcomes were fibromyalgia severity, pain interference, sleep quality, pain coping strategies, depression, health-related quality of life, patient global impression of change (PGIC), and perceived pain relief. Qualitative group interviews with a subset of patients were also conducted. Complete data from T0 to T2 were available for 43 patients. The intervention had a statistically significant impact on the three PGIC measures. At the end of the PASSAGE Program, the percentages of patients who perceived overall improvement in their pain levels, functioning and quality of life were significantly higher in the INT Group (73%, 55%, 77% respectively) than in the WL Group (8%, 12%, 20%). The same differences were observed 3 months post-intervention (Intervention group: 62%, 43%, 38% vs Waitlist Group: 13%, 13%, 9%). The proportion of patients who reported ≥ 50% pain relief was also significantly higher in the INT Group at the end of the intervention (36% vs 12%) and 3 months post-intervention (33% vs 4%). Results of the qualitative analysis were in line with the quantitative findings regarding the efficacy of the intervention. The improvement, however, was not reflected in the primary outcome and other secondary outcome measures. The PASSAGE Program was effective in helping FMS patients gain a sense of control over their symptoms. We suggest including PGIC in future clinical trials on FMS as they appear to capture important aspects of the patients' experience. International Standard Randomized Controlled Trial Number Register ISRCTN14526380.

Repetitive TMS to augment cognitive processing therapy in combat veterans of recent conflicts with PTSD: A randomized clinical trial.

PubMed

Kozel, F Andrew; Motes, Michael A; Didehbani, Nyaz; DeLaRosa, Bambi; Bass, Christina; Schraufnagel, Caitlin D; Jones, Penelope; Morgan, Cassie Rae; Spence, Jeffrey S; Kraut, Michael A; Hart, John

2018-03-15

The objective was to test whether repetitive Transcranial Magnetic Stimulation (rTMS) just prior to Cognitive Processing Therapy (CPT) would significantly improve the clinical outcome compared to sham rTMS prior to CPT in veterans with PTSD. Veterans 18-60 years of age with current combat-related PTSD symptoms were randomized, using a 1:1 ratio in a parallel design, to active (rTMS+CPT) versus sham (sham+CPT) rTMS just prior to weekly CPT for 12-15 sessions. Blinded raters evaluated veterans at baseline, after the 5th and 9th treatments, and at 1, 3, and 6 months post-treatment. Clinician Administered PTSD Scale (CAPS) was the primary outcome measure with the PTSD Checklist (PCL) as a secondary outcome measure. The TMS coil (active or sham) was positioned over the right dorsolateral prefrontal cortex (110% MT, 1Hz continuously for 30min, 1800 pulses/treatment). Of the 515 individuals screened for the study, 103 participants were randomized to either active (n = 54) or sham rTMS (n = 49). Sixty-two participants (60%) completed treatment and 59 (57%) completed the 6-month assessment. The rTMS+CPT group showed greater symptom reductions from baseline on both CAPS and PCL across CPT sessions and follow-up assessments, t(df ≥ 325) ≤ -2.01, p ≤ 0.023, one-tailed and t(df ≥ 303) ≤ -2.14, p ≤ 0.017, one-tailed, respectively. Participants were predominantly male and limited to one era of conflicts as well as those who could safely undergo rTMS. The addition of rTMS to CPT compared to sham with CPT produced significantly greater PTSD symptom reduction early in treatment and was sustained up to six months post-treatment. Copyright © 2017 Elsevier B.V. All rights reserved.

Randomized Clinical Trial of Thrice-Weekly 4-Month Moxifloxacin or Gatifloxacin Containing Regimens in the Treatment of New Sputum Positive Pulmonary Tuberculosis Patients

PubMed Central

Jawahar, Mohideen S.; Banurekha, Vaithilingam V.; Paramasivan, Chinnampedu N.; Rahman, Fathima; Ramachandran, Rajeswari; Venkatesan, Perumal; Balasubramanian, Rani; Selvakumar, Nagamiah; Ponnuraja, Chinnaiyan; Iliayas, Allaudeen S.; Gangadevi, Navaneethapandian P.; Raman, Balambal; Baskaran, Dhanaraj; Kumar, Santhanakrishnan R.; Kumar, Marimuthu M.; Mohan, Victor; Ganapathy, Sudha; Kumar, Vanaja; Shanmugam, Geetha; Charles, Niruparani; Sakthivel, Murugesan R.; Jagannath, Kannivelu; Chandrasekar, Chockalingam; Parthasarathy, Ramavaram T.; Narayanan, Paranji R.

2013-01-01

Background Shortening tuberculosis (TB) treatment duration is a research priority. This paper presents data from a prematurely terminated randomized clinical trial, of 4-month moxifloxacin or gatifloxacin regimens, in South India. Methods Newly diagnosed, sputum-positive HIV-negative pulmonary TB patients were randomly allocated to receive gatifloxacin or moxifloxacin, along with isoniazid and rifampicin for 4 months with pyrazinamide for first 2 months (G or M) or isoniazid and rifampicin for 6 months with ethambutol and pyrazinamide for first 2 months (C). All regimens were administered thrice-weekly. Clinical and bacteriological assessments were done monthly during treatment and for 24 months post-treatment. The Data and Safety Monitoring Board recommended termination of the trial due to high TB recurrence rates in the G and M regimens. Results Of 416 patients in intent-to-treat analysis, 6 (5%) of 124, 2 (2%) of 110 and 2 (2%) of 137 patients with drug-susceptible TB in the G, M and C arms respectively had unfavorable response at the end of treatment; during the next 24 months, 17 (15%) of 115, 11 (11%) of 104 and 8 (6%) of 132 patients respectively, had TB recurrence. Of 38 drug-resistant patients 1 of 8 and 3 of 26 in the G and C arms respectively had unfavourable response at the end of treatment; and TB recurrence occurred in 2 of 7 and 2 of 23 patients, respectively. The differences in TB recurrence rates between the G and C arms was statistically significant (p = 0.02). Gastro-intestinal symptoms occurred in 23%, 22% and 9% of patients in the G, M and C arms respectively, but most reactions were mild and manageable with symptomatic measures; 1% required regimen modification. Conclusions 4-month thrice-weekly regimens of gatifloxacin or moxifloxacin with isoniazid, rifampicin and pyrazinamide, were inferior to standard 6-month treatment, in patients with newly diagnosed sputum positive pulmonary TB. Trial Registration Clinical Trials Registry of India CTRI/2012/10/003060 PMID:23843980

Efficacy of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine against acute otitis media and nasopharyngeal carriage in Panamanian children – A randomized controlled trial

PubMed Central

Sáez-Llorens, Xavier; Rowley, Stella; Wong, Digna; Rodríguez, Mirna; Calvo, Arlene; Troitiño, Marisol; Salas, Albino; Vega, Vielka; Castrejón, Maria Mercedes; Lommel, Patricia; Pascal, Thierry G.; Hausdorff, William P.; Borys, Dorota; Ruiz-Guiñazú, Javier; Ortega-Barría, Eduardo; Yarzabal, Juan Pablo; Schuerman, Lode

2017-01-01

ABSTRACT We previously reported 10-valent pneumococcal non-typeable Haemophilus influenzae (NTHi) protein D conjugate vaccine (PHiD-CV) efficacy in a double-blind randomized trial (ClinicalTrials.gov: NCT00466947) against various diseases, including acute otitis media (AOM). Here, we provide further analyses. In the Panamanian subset, 7,359 children were randomized (1:1) to receive PHiD-CV or control vaccine at age 2/4/6 and 15–18 months. Of these, 2,000 had nasopharyngeal swabs collected. AOM cases were captured when parents sought medical attention for children with AOM symptoms; surveillance was enhanced approximately 2 y into the study through regular telephone calls or home visits by study personnel, who advised parents to visit the clinic if their child had AOM symptoms. Mean follow-up was 31.4 months. Clinical AOM (C-AOM) cases were assessed by physicians and confirmed by otorhinolaryngologists. Middle ear fluid samples, taken from children with C-AOM after specific informed consent, and nasopharyngeal samples were cultured for pathogen identification. For 7,359 children, 2,574 suspected AOM cases were assessed by a primary healthcare physician; 649 cases were C-AOM cases as per protocol definition. From the 503 MEF samples collected, 158 resulted in a positive culture. In the intent-to-treat cohort (7,214 children), PHiD-CV showed VE against first C-AOM (24.0% [95% CI: 8.7, 36.7]) and bacterial (B-AOM) episodes (48.0% [20.3, 66.1]) in children <24 months, which declined thereafter with age. Pre-booster VE against C-AOM was 30.7% [12.9, 44.9]; post-booster, −6.7% [−36.4, 16.6]. PHiD-CV VE was 17.7% [−6.1, 36.2] against moderate and 32.7% [−20.5, 62.4] against severe C-AOM. VE against vaccine-serotype pneumococcal NPC was 31.2% [5.3, 50.3] 3 months post-booster, and 25.6% [12.7, 36.7] across all visits. NTHi colonization rates were low and no significant reduction was observed. PHiD-CV showed efficacy against C-AOM and B-AOM in children younger than 24 months, and reduced vaccine-serotype NPC. PMID:28368738

The Effectiveness of the Harm Reduction Group Therapy Based on Bandura's Self-Efficacy Theory on Risky Behaviors of Drug-Dependent Sex Worker Women.

PubMed

Rabani-Bavojdan, Marjan; Rabani-Bavojdan, Mozhgan; Rajabizadeh, Ghodratollah; Kaviani, Nahid; Bahramnejad, Ali; Ghaffari, Zohreh; Shafiei-Bafti, Mehdi

2017-07-01

The aim of this study was to investigate the effectiveness of the harm reduction group therapy based on Bandura's self-efficacy theory on risky behaviors of sex workers in Kerman, Iran. A quasi-experimental two-group design (a random selection with pre-test and post-test) was used. A risky behaviors questionnaire was used to collect. The sample was selected among sex workers referring to drop-in centers in Kerman. Subjects were allocated to two groups and were randomly classified into two experimental and control groups. The sample group consisted of 56 subjects. The experimental design was carried out during 12 sessions, and the post-test was performed one month and two weeks after the completion of the sessions. The results were analyzed statistically. By reducing harm based on Bandura's self-efficacy theory, the risky behaviors of the experimental group, including injection behavior, sexual behavior, violence, and damage to the skin, were significantly reduced in the pre-test compared to the post-test (P < 0.010). The harm reduction group therapy based on Bandura's self-efficacy theory can reduce the risky behaviors of sex workers.

Randomized Controlled Evaluation of an Early Intervention to Prevent Post-Rape Psychopathology

PubMed Central

Resnick, Heidi; Acierno, Ron; Waldrop, Angela E.; King, Lynda; King, Daniel; Danielson, Carla; Ruggiero, Kenneth J.; Kilpatrick, Dean

2007-01-01

A randomized between-group design was used to evaluate efficacy of a video intervention to reduce PTSD and other mental health problems, implemented prior to the forensic medical exam conducted within 72 hours post-sexual assault. Participants were 140 female victims of sexual assault (68 video/72 nonvideo) ages 15 or older. Assessments were targeted for 6 weeks (Time 1) and 6 months (Time 2) post-assault. At Time 1, the intervention was associated with lower scores on measures of PTSD and depression among women with prior rape history relative to scores among women with prior rape history in the standard care condition. At Time 2, depression scores were also lower among those with a prior history who were in the video relative to standard care condition. Small effects indicating higher PTSD and BAI scores among women without a prior history in the video condition were observed at Time 1. Accelerated longitudinal growth curve analysis indicated a video x prior rape history interaction for PTSD, yielding four patterns of symptom trajectory over time. Women with a prior rape history in the video condition generally maintained the lowest level of symptoms. PMID:17585872

Deep peeling using phenol versus percutaneous collagen induction combined with trichloroacetic acid 20% in atrophic post-acne scars; a randomized controlled trial.

PubMed

Leheta, Tahra Mohamed; Abdel Hay, Rania Mounir; El Garem, Yehia Farouk

2014-04-01

Deep peeling using phenol and percutaneous collagen induction (PCI) are used in treating acne scars. To compare deep peeling using phenol and PCI combined with trichloroacetic acid (TCA) 20% in treating atrophic acne scars. 24 patients with post-acne atrophic scars were randomly divided into two groups; group 1 was subjected to one session of deep peeling using phenol, and group 2 was subjected to four sessions of PCI combined with TCA 20%. As a secondary outcome measure, side effects were recorded and patients were asked to assess their % of improvement by a questionnaire completed 8 months after the procedure. Scar severity scores improved by a mean of 75.12% (p < 0.001) in group 1 and a mean of 69.43% (p < 0.001) in group 2. Comparing the degree of improvement in different types of scars, within the same group after treatment, revealed a significant highest degree of improvement in the rolling type (p = 0.005) in group 2. Deep peeling using phenol and PCI with TCA 20% were effective in treating post-acne atrophic scars.

Acceptance and commitment therapy in youth with neurofibromatosis type 1 (NF1) and chronic pain and their parents: A pilot study of feasibility and preliminary efficacy.

PubMed

Martin, Staci; Wolters, Pamela L; Toledo-Tamula, Mary Anne; Schmitt, Shawn Nelson; Baldwin, Andrea; Starosta, Amy; Gillespie, Andrea; Widemann, Brigitte

2016-06-01

Neurofibromatosis type 1 (NF1) is an autosomal dominant genetic disorder affecting about 1 in 3,500 individuals. Chronic pain is commonly reported among individuals with NF1 and plexiform neurofibroma tumors (PNs). Acceptance and Commitment Therapy (ACT), an empirically supported method for addressing chronic pain, helps individuals re-focus on valued relationships and activities. This pilot study investigated the feasibility and preliminary efficacy of a brief ACT workshop in the NF1 population. Eligible participants included adolescents and young adults (AYA; 12-21 years) with NF1 and chronic pain that interfered with daily functioning and their parents. Patients and parents completed baseline measures of pain interference, pain intensity, functional disability, pain acceptance, depression, and anxiety. Then, AYA and parents participated separately in a 2-day small-group ACT workshop. A telephone booster session occurred 1 month post-intervention. Three-month post-treatment measures were completed by mail. Ten adolescents (4 males; M age = 16.9 years) and seven parents provided baseline and 3-month data. Mean satisfaction with the study was moderate to high (3.9 for patients and 4.6 for parents on a 1-5 scales). Patients and parents reported significant declines in patients' pain interference at 3 months post-treatment. Patient-reported pain intensity significantly declined from baseline to 3 months. Parents reported marginally greater acceptance of their child's pain. No changes emerged in functional ability or mood. Preliminary findings suggest that a brief ACT group intervention is feasible and may help AYA with NF1 and PNs cope with their chronic pain, although larger randomized studies are needed to confirm treatment efficacy. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Impact of time to therapy and reperfusion modality on the efficacy of adenosine in acute myocardial infarction: the AMISTAD-2 trial.

PubMed

Kloner, Robert A; Forman, Mervyn B; Gibbons, Raymond J; Ross, Allan M; Alexander, R Wayne; Stone, Gregg W

2006-10-01

The purpose of this analysis was to determine whether the efficacy of adenosine vs. placebo was dependent on the timing of reperfusion therapy in the second Acute Myocardial Infarction Study of Adenosine (AMISTAD-II). Patients presenting with ST-segment elevation anterior AMI were randomized to receive placebo vs. adenosine (50 or 70 microg/kg/min) for 3 h starting within 15 min of reperfusion therapy. In the present post hoc hypothesis generating study, the results were stratified according to the timing of reperfusion, i.e. > or = or < the median 3.17 h, and by reperfusion modality. In patients receiving reperfusion < 3.17 h, adenosine compared with placebo significantly reduced 1-month mortality (5.2 vs. 9.2%, respectively, P = 0.014), 6-month mortality (7.3 vs. 11.2%, P = 0.033), and the occurrence of the primary 6-month composite clinical endpoint of death, in-hospital CHF, or rehospitalization for CHF at 6 months (12.0 vs. 17.2%, P = 0.022). Patients reperfused beyond 3 h did not benefit from adenosine. In this post hoc analysis, 3 h adenosine infusion administered as an adjunct to reperfusion therapy within the first 3.17 h onset of evolving anterior ST-segment elevation AMI enhanced early and late survival, and reduced the composite clinical endpoint of death or CHF at 6 months.

Personal financial incentives for changing habitual health-related behaviors: A systematic review and meta-analysis.

PubMed

Mantzari, Eleni; Vogt, Florian; Shemilt, Ian; Wei, Yinghui; Higgins, Julian P T; Marteau, Theresa M

2015-06-01

Uncertainty remains about whether personal financial incentives could achieve sustained changes in health-related behaviors that would reduce the fast-growing global non-communicable disease burden. This review aims to estimate whether: i. financial incentives achieve sustained changes in smoking, eating, alcohol consumption and physical activity; ii. effectiveness is modified by (a) the target behavior, (b) incentive value and attainment certainty, (c) recipients' deprivation level. Multiple sources were searched for trials offering adults financial incentives and assessing outcomes relating to pre-specified behaviors at a minimum of six months from baseline. Analyses included random-effects meta-analyses and meta-regressions grouped by timed endpoints. Of 24,265 unique identified articles, 34 were included in the analysis. Financial incentives increased behavior-change, with effects sustained until 18months from baseline (OR: 1.53, 95% CI 1.05-2.23) and three months post-incentive removal (OR: 2.11, 95% CI 1.21-3.67). High deprivation increased incentive effects (OR: 2.17; 95% CI 1.22-3.85), but only at >6-12months from baseline. Other assessed variables did not independently modify effects at any time-point. Personal financial incentives can change habitual health-related behaviors and help reduce health inequalities. However, their role in reducing disease burden is potentially limited given current evidence that effects dissipate beyond three months post-incentive removal. Copyright © 2015. Published by Elsevier Inc.

Letrozole in advanced breast cancer: the PO25 trial

PubMed Central

2007-01-01

Tamoxifen has been a standard first-line endocrine therapy for post-menopausal women with hormone-responsive advanced breast cancer, but more than half of patients fail to respond and time to progression is less than 12 months in responders. The third-generation aromatase inhibitors were developed to provide more effective alternatives to tamoxifen. In the Femara Study PO25, post-menopausal women with advanced breast cancer were randomized to receive letrozole 2.5 mg (n = 453) or tamoxifen 20 mg (n = 454) given orally daily until progressive disease occurred. Patients were permitted to cross over to the other treatment at progression. In the primary efficacy analysis, median time to progression (TTP) was significantly longer with letrozole than with tamoxifen (9.4 months vs. 6.0 months, respectively; P < 0.0001). The objective response rate (ORR) was significantly higher for letrozole than for tamoxifen (32% vs. 21%; P = 0.0002). Prospectively planned analyses of the intent-to-treat population showed that letrozole significantly improved overall survival (OS) compared with tamoxifen over the first 24 months of the trial. An exploratory analysis of patients, who did not cross over, indicated a median OS benefit of 14 months for letrozole compared with tamoxifen. Letrozole is the only third-generation aromatase inhibitor that has demonstrated significant improvements in ORR, TTP, and early OS. PMID:17333340

Chymotrypsin with sialendoscopy-assisted surgery for the treatment of chronic obstructive parotitis.

PubMed

Sun, H-J; Xiao, J-Q; Qiao, Q-H; Bao, X; Wu, C-B; Zhou, Q

2017-07-01

Chronic obstructive parotitis (COP) is a common disease of the parotid gland. A total of 104 patients with COP were identified and randomized into a treatment group (52 cases) and a control group (52 cases). All patients underwent sialography and salivary gland scintigraphy (SGS) examinations before surgery. The patients in the treatment group received chymotrypsin combined with gentamicin via interventional sialendoscopy to irrigate the duct, and the control group received gentamicin alone. All patients were asked to record their pain on a visual analogue scale (VAS) before treatment and at 1 week, 2 weeks, 1 month, 3 months, and 6 months after surgery. The VAS score for pain intensity was decreased at 1 week post-treatment in both groups (P<0.05). Compared to the control group, the VAS score was lower in the treatment group at 1 week, 2 weeks, and 1 month post-treatment (P<0.05). The 6-month postoperative SGS results showed improved uptake and excretion in both groups (P<0.05). The treatment group exhibited higher scores for postoperative SGS excretion than the control group (P<0.05). The administration of chymotrypsin combined with gentamicin by sialendoscopy is effective for the treatment of non-stone-related COP and specifically improves the excretion function of the parotid gland. Copyright © 2017 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Pilot randomized controlled trial of dialectical behavior therapy group skills training for ADHD among college students.

PubMed

Fleming, Andrew P; McMahon, Robert J; Moran, Lyndsey R; Peterson, A Paige; Dreessen, Anthony

2015-03-01

ADHD affects between 2% and 8% of college students and is associated with broad functional impairment. No prior randomized controlled trials with this population have been published. The present study is a pilot randomized controlled trial evaluating dialectical behavior therapy (DBT) group skills training adapted for college students with ADHD. Thirty-three undergraduates with ADHD between ages 18 and 24 were randomized to receive either DBT group skills training or skills handouts during an 8-week intervention phase. ADHD symptoms, executive functioning (EF), and related outcomes were assessed at baseline, post-treatment, and 3-month follow-up. Participants receiving DBT group skills training showed greater treatment response rates (59-65% vs. 19-25%) and clinical recovery rates (53-59% vs. 6-13%) on ADHD symptoms and EF, and greater improvements in quality of life. DBT group skills training may be efficacious, acceptable, and feasible for treating ADHD among college students. A larger randomized trial is needed for further evaluation. © 2014 SAGE Publications.

The effect of a computer-related ergonomic intervention program on learners in a school environment.

PubMed

Sellschop, Ingrid; Myezwa, Hellen; Mudzi, Witness; Mbambo-Kekana, Nonceba

2015-01-01

The interest in school ergonomic intervention programs and their effects on musculoskeletal pain is increasing around the world. The objective of this longitudinal randomized control trial was to implement and measure the effects of a computer-related ergonomics intervention on grade eight learners in a school environment in Johannesburg South Africa (a developing country). The sample comprised of a control group (n= 66) and an intervention group (n= 61). The outcome measures used were posture assessment using the Rapid Upper Limb Assessment tool (RULA) and the prevalence of musculoskeletal pain using a visual analogue scale (VAS). Measurements were done at baseline, three months and six months post intervention. The results showed that the posture of the intervention group changed significantly from an Action Level 4 to an Action level 2 and Action level 3, indicating a sustained improvement of learners' postural positions whilst using computers. The intervention group showed a significant reduction in the prevalence of musculoskeletal pain from 42.6% at baseline to 18% six months post intervention (p< 0.003). In conclusion, the results indicated that a computer-related intervention program for grade eight learners in a school environment is effective and that behavioural changes can be made that are sustainable over a period of six months.

A comparative evaluation of subepithelial connective tissue graft (SCTG) versus platelet concentrate graft (PCG) in the treatment of gingival recession using coronally advanced flap technique: A 12-month study

PubMed Central

Kumar, G. Naveen Vital; Murthy, K. Raja Venkatesh

2013-01-01

Objective: The objective of this study was to clinically evaluate and compare the efficacy of platelet concentrate graft (PCG) with that of subepithelial connective tissue graft (SCTG) using a coronally advanced flap technique in the treatment of gingival recession. Materials and Methods: Twelve patients with a total of 24 gingival recession defects were selected and randomly assigned either to experimental site-A (SCTG) or experimental site-B (PCG). The clinical parameters were recorded at baseline up to 12 months post-operatively and compared. Results: The mean vertical recession depth (VRD) statistically significantly decreased from 2.50 ± 0.48 mm to 0.54 ± 0.50 mm with PCG and from 2.75 ± 0.58 mm to 0.54 ± 0.45 mm with SCTG at 12 months. No statistically significant differences between the treatments were found for VRD and clinical attachment level (CAL), while keratinized tissue width (KTW) gain was statistically significant. Conclusion: Both the SCTG and the PCG group resulted in a significant amount of root coverage. The PCG technique was less invasive and required minimal time and clinical maneuver. It resulted in superior aesthetic outcome and lower post-surgical discomfort at the 12 months follow-up. PMID:24554889

The association between the nature of the goal committed to and quitting smoking.

PubMed

Borland, Ron; Li, Lin; Balmford, James

2017-12-01

Commitments to goals are theorized to affect behavior change outcomes, but competing theories argue for hard to achieve goals and strategic sub-goals as optimum strategies for success. This study aimed to explore whether the nature of the goal affects smoking cessation outcomes. A total of 1043 participants in a randomized controlled trial of variations to an automated computer generated cessation advice program, who had made a quit attempt were asked at 1 month post quit about the initial goal they had set at the time of making the attempt. They were also followed up at 6 months post quit. Compared with those reporting 'seeing how it will go', those who reported the goal of 'taking it a cigarette at a time' were less likely to be quit at 1 month, while those with the most ambitious goal, to 'never smoke again', were more likely to be quit, and were more likely to maintain abstinence for 6 months. Indeed, 'taking it a cigarette at a time' was associated with greater short-term relapse. There is likely to be a benefit in encouraging smokers to set ambitious long-term goals rather than setting intermediate or non-specific goals. © The Author 2017. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Provider Training to Screen and Initiate Evidence-Based Pediatric Obesity Treatment in Routine Practice Settings: A Randomized Pilot Trial.

PubMed

Kolko, Rachel P; Kass, Andrea E; Hayes, Jacqueline F; Levine, Michele D; Garbutt, Jane M; Proctor, Enola K; Wilfley, Denise E

This randomized pilot trial evaluated two training modalities for first-line, evidence-based pediatric obesity services (screening and goal setting) among nursing students. Participants (N = 63) were randomized to live interactive training or Web-facilitated self-study training. Pretraining, post-training, and 1-month follow-up assessments evaluated training feasibility, acceptability, and impact (knowledge and skill via simulation). Moderator (previous experience) and predictor (content engagement) analyses were conducted. Nearly all participants (98%) completed assessments. Both types of training were acceptable, with higher ratings for live training and participants with previous experience (ps < .05). Knowledge and skill improved from pretraining to post-training and follow-up in both conditions (ps < .001). Live training demonstrated greater content engagement (p < .01). The training package was feasible, acceptable, and efficacious among nursing students. Given that live training had higher acceptability and engagement and online training offers greater scalability, integrating interactive live training components within Web-based training may optimize outcomes, which may enhance practitioners' delivery of pediatric obesity services. Copyright © 2016 National Association of Pediatric Nurse Practitioners. Published by Elsevier Inc. All rights reserved.

Determining the feasibility and preliminary efficacy of a stroke instructional and educational DVD in a multinational context: a randomized controlled pilot study.

PubMed

Jones, Kelly M; Bhattacharjee, Rohit; Krishnamurthi, Rita; Blanton, Sarah; Barker-Collo, Suzanne; Theadom, Alice; Thrift, Amanda G; Wolf, Steven L; Venketasubramanian, Narayanaswamy; Parmar, Priya; Maujean, Annick; Ranta, Annemarei; Cadilhac, Dominique; Sanya, Emmanuel O; MacKay-Lyons, Marilyn; Pandian, Jeyaraj D; Arora, Deepti; Obiako, Reginald O; Saposnik, Gustavo; Balalla, Shivanthi; Bornstein, Natan M; Langhorne, Peter; Norrving, Bo; Brown, Nita; Brainin, Michael; Taylor, Denise; Feigin, Valery L

2018-05-01

To assess the feasibility of conducting a randomized controlled trial of an instructional and educational stroke DVD and determine the feasibility and preliminary efficacy of this intervention in a multinational context. Non-funded, pilot randomized controlled trial of intervention versus usual care. International, multicentre, community-based. Community-living adults up to three years post stroke with moderate to severe disability and their nominated informal caregivers. Intervention patients viewed and practised rehabilitation techniques demonstrated in the DVD over six weeks. Trial feasibility by number of active recruitment sites, recruitment efficiency, randomization and follow-up. Intervention feasibility by patient and caregiver impressions. Preliminary efficacy by the quality of life - 5-level EuroQol-5D (EQ-5D) health status measure, General Health Questionnaire and Centre for Epidemiological Studies-Depression at two months. In total, 14 recruitment sites were established across eight countries. Recruitment was achieved at nine (64%) sites. Over 16 months, 66 participants were recruited (mean (SD) age = 63.5 (12.47) years) and randomized to intervention ( n = 34) and control ( n = 32) groups. In total, 54 (82%) completed a follow-up assessment. Patient and/or caregiver comments about the benefits and barriers to accessing the intervention were mixed. There were no significant between-group differences in outcomes at two months ( P > 0.05). Conducting a multinational trial of a stroke DVD requires full funding. The intervention was acceptable to some patients and their caregivers, yet a generalized education approach did not fully meet their needs and/or expectations. A more individualized method may be required to meet peoples' changing needs during stroke recovery.

Preoperative exercise training prevents functional decline after lung resection surgery: a randomized, single-blind controlled trial.

PubMed

Sebio García, Raquel; Yáñez-Brage, Maria Isabel; Giménez Moolhuyzen, Esther; Salorio Riobo, Marta; Lista Paz, Ana; Borro Mate, Jose María

2017-08-01

To investigate the effects of a preoperative pulmonary rehabilitation programme in patients with lung cancer undergoing video-assisted thoracic surgery. Randomized, single-blind controlled trial. Teaching hospital. Patients with suspected or confirmed lung cancer undergoing video-assisted thoracic surgery. Participants were randomized to either a prehabilitation group or a control group. Participants in the prehabilitation group underwent a combination of moderate endurance and resistance training plus breathing exercises three to five times per week. The primary outcome of the study was exercise capacity. Secondary outcomes were muscle strength (Senior Fitness Test), health-related quality of life (Short-Form 36) and the postoperative outcomes. Patients were evaluated at baseline (before randomization), presurgery (only the prehabilitation group), after surgery and three months post-operatively. A total of 40 patients were randomized and 22 finished the study (10 in the prehabilitation group and 12 in the control group). Three patients were lost to follow-up at three months. After the training, there was a statistically significant improvement in exercise tolerance (+397 seconds, p = 0.0001), the physical summary component of the SF-36 (+4.4 points, p = 0.008) and muscle strength ( p < 0.01). There were no significant differences between groups after surgery. However, three months postoperatively, significant differences were found in the mean change of exercise capacity ( p = 0.005), physical summary component ( p = 0.001) and upper and lower body strength ( p = 0.045 and p = 0.002). A pulmonary rehabilitation programme before video-assisted thoracic surgery seems to improve patients' preoperative condition and may prevent functional decline after surgery. Clinical Registration Number: NCT01963923 (Registration date 10/10/2013).

[Training of resident physicians in the recognition and treatment of an anaphylaxis case in pediatrics with simulation models].

PubMed

Enríquez, Diego; Lamborizio, María J; Firenze, Lorena; Jaureguizar, María de la P; Díaz Pumará, Estanislao; Szyld, Edgardo

2017-08-01

To evaluate the performance of resident physicians in diagnosing and treating a case of anaphylaxis, six months after participating in simulation training exercises. Initially, a group of pediatric residents were trained using simulation techniques in the management of critical pediatric cases. Based on their performance in this exercise, participants were assigned to one of 3 groups. At six months post-training, 4 residents were randomly chosen from each group to be re-tested, using the same performance measure as previously used. During the initial training session, 56 of 72 participants (78%) correctly identified and treated the case. Six months after the initial training, all 12 (100%) resident physicians who were re-tested successfully diagnosed and treated the simulated anaphylaxis case. The training through simulation techniques allowed correction or optimization of the treatment of simulated anaphylaxis cases in resident physicians evaluated after 6 months of the initial training.

Nurse-led cognitive-behavioral group therapy for recovery of self-esteem in patients with mental disorders: A pilot study.

PubMed

Kunikata, Hiroko; Yoshinaga, Naoki; Shiraishi, Yuko; Okada, Yoshie

2016-07-01

To design a program targeting recovery of self-esteem in patients with mental disorders, and to clarify the changes after the program to determine its effectiveness. This study employed a one group pre- and post design, which comprised baseline, post-intervention, and 3 month follow-up phases, and recruited 41 Japanese patients with mental disorders living in the community. The authors administered the nurse-led group cognitive-behavioral therapy program for the recovery of self-esteem, which comprised 12 sessions, to the participants. The follow-up investigations were conducted immediately and 3 months after the program. The present authors used the Rosenberg Self-Esteem Scale (RSES), Profile of Mood States (POMS), Subjective Well-Being Inventory (SUBI), and Test to Determine the Characteristics of Ideas as subjective measures and the Brief Psychiatric Rating Scale (BPRS) as an objective measure. After controlling for the factors of medication and use of social services, improvement was observed in all measures of evaluation. The authors identified improvement at post-intervention and follow up. The scores for the RSES, BPRS, confidence in coping, and inadequate mental mastery at post-intervention and follow up were significantly higher than those at baseline, and these beneficial effects were maintained 3 months after the program. The program may aid in recovering and maintaining self-esteem of patients suffering from mental disorders. However, it is necessary to conduct a randomized controlled clinical trial to confirm these findings. © 2016 Japan Academy of Nursing Science.

A new methodology based on functional principal component analysis to study postural stability post-stroke.

PubMed

Sánchez-Sánchez, M Luz; Belda-Lois, Juan-Manuel; Mena-Del Horno, Silvia; Viosca-Herrero, Enrique; Igual-Camacho, Celedonia; Gisbert-Morant, Beatriz

2018-05-05

A major goal in stroke rehabilitation is the establishment of more effective physical therapy techniques to recover postural stability. Functional Principal Component Analysis provides greater insight into recovery trends. However, when missing values exist, obtaining functional data presents some difficulties. The purpose of this study was to reveal an alternative technique for obtaining the Functional Principal Components without requiring the conversion to functional data beforehand and to investigate this methodology to determine the effect of specific physical therapy techniques in balance recovery trends in elderly subjects with hemiplegia post-stroke. A randomized controlled pilot trial was developed. Thirty inpatients post-stroke were included. Control and target groups were treated with the same conventional physical therapy protocol based on functional criteria, but specific techniques were added to the target group depending on the subjects' functional level. Postural stability during standing was quantified by posturography. The assessments were performed once a month from the moment the participants were able to stand up to six months post-stroke. The target group showed a significant improvement in postural control recovery trend six months after stroke that was not present in the control group. Some of the assessed parameters revealed significant differences between treatment groups (P < 0.05). The proposed methodology allows Functional Principal Component Analysis to be performed when data is scarce. Moreover, it allowed the dynamics of recovery of two different treatment groups to be determined, showing that the techniques added in the target group increased postural stability compared to the base protocol. Copyright © 2018 Elsevier Ltd. All rights reserved.

Metformin and sitAgliptin in patients with impAired glucose tolerance and a recent TIA or minor ischemic Stroke (MAAS): study protocol for a randomized controlled trial.

PubMed

Osei, Elizabeth; Fonville, Susanne; Zandbergen, Adrienne A M; Brouwers, Paul J A M; Mulder, Laus J M M; Lingsma, Hester F; Dippel, Diederik W J; Koudstaal, Peter J; den Hertog, Heleen M

2015-08-05

Impaired glucose tolerance is present in one third of patients with a TIA or ischemic stroke and is associated with a two-fold risk of recurrent stroke. Metformin improves glucose tolerance, but often leads to side effects. The aim of this study is to explore the feasibility, safety, and effects on glucose metabolism of metformin and sitagliptin in patients with TIA or minor ischemic stroke and impaired glucose tolerance. We will also assess whether a slow increase in metformin dose and better support and information on this treatment will reduce the incidence of side effects in these patients. The Metformin and sitAgliptin in patients with impAired glucose tolerance and a recent TIA or minor ischemic Stroke trial (MAAS trial) is a phase II, multicenter, randomized, controlled, open-label trial with blinded outcome assessment. Non-diabetic patients (n = 100) with a recent (<6 months) TIA, amaurosis fugax or minor ischemic stroke (modified Rankin scale ≤ 3) and impaired glucose tolerance, defined as 2-hour post-load glucose levels between 7.8 and 11.0 mmol/L after repeated standard oral glucose tolerance test, will be included. Patients with renal or liver impairment, heart failure, chronic hypoxic lung disease stage III-IV, history of lactate acidosis or diabetic ketoacidosis, pregnancy or breastfeeding, pancreatitis and use of digoxin will be excluded. The patients will be randomly assigned in a 1:1:2 ratio to metformin, sitagliptin or "no treatment." Patients allocated to metformin will start with 500 mg twice daily, which will be slowly increased during a 6-week period to a twice daily dose of 1000 mg. Patients allocated to sitagliptin will be treated with a daily fixed dose of 100 mg. The study has been registered as NTR 3196 in The Netherlands Trial Register. Primary outcomes include percentage still on treatment, percentage of (serious) adverse events, and the baseline adjusted difference in 2-hour post-load glucose levels at 6 months. This study will give more information about the feasibility and safety of metformin and sitagliptin as well as the effect on 2-hour post-load glucose levels at 6 months in patients with TIA or ischemic stroke and impaired glucose tolerance. NTR3196 , Date of registration: 15 December 2011.

A Randomized, Comparative Pilot Trial of Family-Based Interpersonal Psychotherapy for Reducing Psychosocial Symptoms, Disordered-eating, and Excess Weight Gain in At-Risk Preadolescents with Loss-of-control-eating

PubMed Central

Shomaker, Lauren B.; Tanofsky-Kraff, Marian; Matherne, Camden E.; Mehari, Rim D.; Olsen, Cara H.; Marwitz, Shannon E.; Bakalar, Jennifer L.; Ranzenhofer, Lisa M.; Kelly, Nichole R.; Schvey, Natasha A.; Burke, Natasha L.; Cassidy, Omni; Brady, Sheila M.; Dietz, Laura J.; Wilfley, Denise E.; Yanovski, Susan Z.; Yanovski, Jack A.

2018-01-01

Objective Preadolescent loss-of-control-eating (LOC-eating) is a risk factor for excess weight gain and binge-eating-disorder. We evaluated feasibility and acceptability of a preventive family-based interpersonal psychotherapy (FB-IPT) program. FB-IPT was compared to family-based health education (FB-HE) to evaluate changes in children’s psychosocial functioning, LOC-eating, and body mass. Method A randomized, controlled pilot trial was conducted with 29 children, 8 to 13 years who had overweight/obesity and LOC-eating. Youth-parent dyads were randomized to 12-week FB-IPT (n=15) or FB-HE (n=14) and evaluated at post-treatment, six-months, and one-year. Changes in child psychosocial functioning, LOC-eating, BMI, and adiposity by dual-energy-X-ray-absorptiometry were assessed. Missing follow-up data were multiply imputed. Results FB-IPT feasibility and acceptability were indicated by good attendance (83%) and perceived benefits to social interactions and eating. Follow-up assessments were completed by 73% FB-IPT and 86% FB-HE at post-treatment, 60% and 64% at six-months, and 47% and 57% at one-year. At post-treatment, children in FB-IPT reported greater decreases in depression (95% CI −7.23, −2.01, Cohen’s d=1.23) and anxiety (95% CI −6.08, −0.70, Cohen’s d=.79) and less odds of LOC-eating (95% CI −3.93, −0.03, Cohen’s d=.38) than FB-HE. At six-months, children in FB-IPT had greater reductions in disordered-eating attitudes (95% CI −0.72, −0.05, Cohen’s d=.66) and at one-year, tended to have greater decreases in depressive symptoms (95% CI −8.82, 0.44, Cohen’s d=.69) than FB-HE. There was no difference in BMI gain between the groups. Discussion Family-based approaches that address interpersonal and emotional underpinnings of LOC-eating in preadolescents with overweight/obesity show preliminary promise, particularly for reducing internalizing symptoms. Whether observed psychological benefits translate into sustained prevention of disordered-eating or excess weight gain requires further study. PMID:28714097

Effectiveness of a psycho-educational group program for major depression in primary care: a randomized controlled trial

PubMed Central

2012-01-01

Background Studies show the effectiveness of group psychoeducation in reducing symptoms in people with depression. However, few controlled studies that have included aspects of personal care and healthy lifestyle (diet, physical exercise, sleep) together with cognitive-behavioral techniques in psychoeducation are proven to be effective. The objective of this study is to assess the effectiveness of a psychoeducational program, which includes aspects of personal care and healthy lifestyle, in patients with mild/moderate depression symptoms in Primary Care (PC). Methods In a randomized, controlled trial, 246 participants over 20 years old with ICD-10 major depression were recruited through nurses/general practitioners at 12 urban Primary Care Centers (PCCs) in Barcelona. The intervention group (IG) (n=119) received a group psychoeducational program (12 weekly, 1.5 h sessions led by two nurses) and the control group (CG) (n=112) received usual care. Patients were assessed at baseline and at, 3, 6 and 9 months. The main outcome measures were the BDI, EQ-5D and remission based upon the BDI. Results 231 randomized patients were included, of whom 85 had mild depression and 146 moderate depression. The analyses showed significant differences between groups in relation to remission of symptoms, especially in the mild depression group with a high rate of 57% (p=0.009) at post-treatment and 65% (p=0.006) at 9 month follow up, and only showed significant differences on the BDI at post-treatment (p=0.016; effect size Cohen’s d’=.51) and at 6 and 9 month follow-up (p= 0.048; d’=.44). In the overall and moderate sample, the analyses only showed significant differences between groups on the BDI at post-treatment, p=0.02 (d’=.29) and p=0.010 (d’=.47), respectively. The psychoeducation group improved significantly on the EQ-5D at short and long-term. Conclusions This psychoeducational intervention is a short and long-term effective treatment for patients with mild depression symptoms. It results in a high remission rate, is recommended in PC and can be carried out by nurses with previous training. In moderate patients, group psychoeducation is effective in the short-term. Trial registration Clinical Trials.gov identifier NCT00841737 PMID:23249399

Retention of cardiopulmonary resuscitation skills after hands-only training versus conventional training in novices: a randomized controlled trial.

PubMed

Kim, Young Joon; Cho, Youngsuk; Cho, Gyu Chong; Ji, Hyun Kyung; Han, Song Yi; Lee, Jin Hyuck

2017-06-01

Cardiopulmonary resuscitation (CPR) training can improve performance during simulated cardiac arrest; however, retention of skills after training remains uncertain. Recently, hands-only CPR has been shown to be as effective as conventional CPR. The purpose of this study is to compare the retention rate of CPR skills in laypersons after hands-only or conventional CPR training. Participants were randomly assigned to 1 of 2 CPR training methods: 80 minutes of hands-only CPR training or 180 minutes of conventional CPR training. Each participant's CPR skills were evaluated at the end of training and 3 months thereafter using the Resusci Anne manikin with a skill-reporting software. In total, 252 participants completed training; there were 125 in the hands-only CPR group and 127 in the conventional CPR group. After 3 months, 118 participants were randomly selected to complete a post-training test. The hands-only CPR group showed a significant decrease in average compression rate (P=0.015), average compression depth (P=0.031), and proportion of adequate compression depth (P=0.011). In contrast, there was no difference in the skills of the conventional CPR group after 3 months. Conventional CPR training appears to be more effective for the retention of chest compression skills than hands-only CPR training; however, the retention of artificial ventilation skills after conventional CPR training is poor.

Comparative study between surgical and non-surgical treatment of anismus in patients with symptoms of obstructed defecation: a prospective randomized study.

PubMed

Faried, Mohamed; El Nakeeb, Ayman; Youssef, Mohamed; Omar, Waleed; El Monem, Hisham Abd

2010-08-01

This study came to compare the results of biofeedback retraining biofeedback (BFB), botulinum toxin botulinum type A (BTX-A) injection and partial division of puborectalis (PDPR) in the treatment of anismus patients. Consecutive patients treated for anismus fulfilled Rome II criteria for functional constipation at our institution were evaluated for inclusion. Participants were randomly allocated to receive BFB, BTX-A injection, and PDPR. All patients underwent anorectal manometry, balloon expulsion test, defecography, and electromyography activity of the anal sphincter. Follow up was conducted weekly in the first month then monthly for about 1 year. Study variables included clinical improvement, patient satisfaction, and objective improvement. Sixty patients with anismus were randomized and completed the study. The groups differed significantly regarding clinical improvement at 1 month (50% for BFB, 75%BTX-A injection, and 95% for PDPR, P = 0.006) and differences persisted at 1 year (30% for BFB, 35%BTX-A injection, and 70% for PDPR, P = 0.02). Constipation score of the patients significantly improved postPDPR and BTX-A injection. Manometric relaxation was achieved significantly in the three groups. Biofeedback retraining has a limited therapeutic effect, BTX-A injection seems to be successful for temporary treatment but PDPR is found to be an effective with lower morbidity in contrast to its higher success rate in treating anismus.

Effect of apical clearing technique on the treatment outcome of teeth with asymptomatic apical periodontitis: A randomized clinical trial.

PubMed

Mittal, Priya; Logani, Ajay; Shah, Naseem; Pandey, R M

2016-01-01

This study aims to compare the periapical healing of teeth with asymptomatic apical periodontitis treated either by conventional apical preparation (CAP) or apical clearing technique (ACT). Twenty subjects with bilateral nonvital similar teeth exhibiting comparable periapical index (PAI) score were enrolled and randomly allocated. Group I (CAP, n = 20): Apical preparation three sizes greater (master apical file [MAF]) than the first binding file at the established working length. Group II (ACT, n = 20): Apical preparation three sizes greater than the MAF that was followed by dry reaming. Root canal therapy was accomplished in single-visit for all the teeth. They were pursued radiographically at 3, 6, 9 and 12 months. Pre- and post-treatment PAI scores were compared. To ascertain the proportion of healed teeth between the two groups, McNemar Chi-square test was applied. At 3, 6, and 9 months' time interval the proportion of healed teeth for Group II (ACT) was greater in comparison to Group I (CAP) (P < 0.05). However, at 12 months follow-up period this difference was not significant (P = 0.08). ACT enhanced the healing kinetics. However, the long-term (12 months) radiographic outcome was similar for either technique.

Anti-Vascular Endothelial Growth Factor Comparative Effectiveness Trial for Diabetic Macular Edema: Additional Efficacy Post Hoc Analyses of a Randomized Clinical Trial.

PubMed

Jampol, Lee M; Glassman, Adam R; Bressler, Neil M; Wells, John A; Ayala, Allison R

2016-12-01

Post hoc analyses from the Diabetic Retinopathy Clinical Research Network randomized clinical trial comparing aflibercept, bevacizumab, and ranibizumab for diabetic macular edema (DME) might influence interpretation of study results. To provide additional outcomes comparing 3 anti-vascular endothelial growth factor (VEGF) agents for DME. Post hoc analyses performed from May 3, 2016, to June 21, 2016, of a randomized clinical trial performed from August 22, 2012, to September 23, 2015, of 660 participants comparing 3 anti-VEGF treatments in eyes with center-involved DME causing vision impairment. Randomization to intravitreous aflibercept (2.0 mg), bevacizumab (1.25 mg), or ranibizumab (0.3 mg) administered up to monthly based on a structured retreatment regimen. Focal/grid laser treatment was added after 6 months for the treatment of persistent DME. Change in visual acuity (VA) area under the curve and change in central subfield thickness (CST) within subgroups based on whether an eye received laser treatment for DME during the study. Post hoc analyses were performed for 660 participants (mean [SD] age, 61 [10] years; 47% female, 65% white, 16% black or African American, 16% Hispanic, and 3% other). For eyes with an initial VA of 20/50 or worse, VA improvement was greater with aflibercept than the other agents at 1 year but superior only to bevacizumab at 2 years. Mean (SD) letter change in VA over 2 years (area under curve) was greater with aflibercept (+17.1 [9.7]) than with bevacizumab (+12.1 [9.4]; 95% CI, +1.6 to +7.3; P < .001) or ranibizumab (+13.6 [8.5]; 95% CI, +0.7 to +6.0; P = .009). When VA was 20/50 or worse at baseline, bevacizumab reduced CST less than the other agents at 1 year, but at 2 years the differences had diminished. In subgroups stratified by baseline VA, anti-VEGF agent, and whether focal/grid laser treatment was performed for DME, the only participants to have a substantial reduction in mean CST between 1 and 2 years were those with a baseline VA of 20/50 or worse receiving bevacizumab and laser treatment (mean [SD], -55 [108] µm; 95% CI, -82 to -28 µm; P < .001). Although post hoc analyses should be viewed with caution given the potential for bias, in eyes with a VA of 20/50 or worse, aflibercept has the greatest improvement in VA over 2 years. Focal/grid laser treatment, ceiling and floor effects, or both may account for mean thickness reductions noted only in bevacizumab-treated eyes between 1 and 2 years. clinicaltrials.gov Identifier NCT01627249.

Associations of contextual risk and protective factors with fathers’ parenting practices in the post-deployment environment

PubMed Central

Davis, Laurel; Hanson, Sheila K.; Zamir, Osnat; Gewirtz, Abigail H.; DeGarmo, David S.

2015-01-01

Deployment separation and reunifications are salient contexts that directly impact effective family functioning and parenting for military fathers. Yet, we know very little about determinants of post-deployed father involvement and effective parenting. The present study examined hypothesized risk and protective factors of observed parenting for 282 post-deployed fathers who served in the Army National Guard/Reserves. Pre-intervention data were employed from fathers participating in the After Deployment, Adaptive Parenting Tools (ADAPT) randomized control trial. Parenting practices were obtained from direct observation of father-child interaction and included measures of problem solving, harsh discipline, positive involvement, encouragement, and monitoring. Risk factors included combat exposure, negative life events, months deployed, and PTSD symptoms. Protective factors included education, income, dyadic adjustment, and social support. Results of a structural equation model predicting an effective parenting construct indicated that months deployed, income, and father age were most related to observed parenting, explaining 16% of the variance. We are aware of no other study utilizing direct parent-child observations of father’s parenting skills following overseas deployment. Implications for practice and preventive intervention are discussed. PMID:26213794

Gait Retraining From Rearfoot Strike to Forefoot Strike does not change Running Economy.

PubMed

Roper, Jenevieve Lynn; Doerfler, Deborah; Kravitz, Len; Dufek, Janet S; Mermier, Christine

2017-12-01

Gait retraining is a method for management of patellofemoral pain, which is a common ailment among recreational runners. The present study investigated the effects of gait retraining from rearfoot strike to forefoot strike on running economy, heart rate, and respiratory exchange ratio immediately post-retraining and one-month post-retraining in recreational runners with patellofemoral pain. Knee pain was also measured. Sixteen participants (n=16) were randomly placed in the control (n=8) or experimental (n=8) group. A 10-minute treadmill RE test was performed by all subjects. The experimental group performed eight gait retraining running sessions where foot strike pattern was switched from rearfoot strike to forefoot strike, while the control group received no intervention. There were no significant differences for running economy (p=0.26), respiratory exchange ratio (p=0.258), or heart rate (p=0.248) between the groups. Knee pain reported on a visual analog scale was also significantly reduced (p<0.05) as a result of retraining. The present study demonstrates that retraining from rearfoot strike to forefoot strike did not affect running economy up to one-month post-retraining while reducing running-related patellofemoral pain. © Georg Thieme Verlag KG Stuttgart · New York.

Social Norms and Financial Incentives to Promote Employees’ Healthy Food Choices: A Randomized Controlled Trial

PubMed Central

Thorndike, Anne N.; Riis, Jason; Levy, Douglas E.

2016-01-01

Population-level strategies to improve healthy food choices are needed for obesity prevention. We conducted a randomized controlled trial of 2,672 employees at Massachusetts General Hospital who were regular customers of the hospital cafeteria with all items labeled green (healthy), yellow (less healthy), or red (unhealthy) to determine if social norm (peer-comparison) feedback with or without financial incentives increased employees’ healthy food choices. Participants were randomized in 2012 to three arms: 1) monthly letter with social norm feedback about healthy food purchases, comparing employee to “all” and to “healthiest” customers (feedback-only); 2) monthly letter with social norm feedback plus small financial incentive for increasing green purchases (feedback-incentive); or 3) no contact (control). The main outcome was change in proportion of green-labeled purchases at end of 3-month intervention. Post-hoc analyses examined linear trends. At baseline, the proportion of green-labeled purchases (50%) did not differ between arms. At end of the 3-month intervention, the percentage increase in green-labeled purchases was larger in the feedback-incentive arm compared to control (2.2% vs. 0.1%, P=0.03), but the two intervention arms were not different. The rate of increase in green-labeled purchases was higher in both feedback-only (P=0.04) and feedback-incentive arms (P=0.004) compared to control. At end of a 3-month wash-out, there were no differences between control and intervention arms. Social norms plus small financial incentives increased employees’ healthy food choices over the short-term. Future research will be needed to assess the impact of this relatively low-cost intervention on employees’ food choices and weight over the long-term. Trial Registration: Clinical Trials.gov NCT01604499 PMID:26827617

Social norms and financial incentives to promote employees' healthy food choices: A randomized controlled trial.

PubMed

Thorndike, Anne N; Riis, Jason; Levy, Douglas E

2016-05-01

Population-level strategies to improve healthy food choices are needed for obesity prevention. We conducted a randomized controlled trial of 2672 employees at the Massachusetts General Hospital who were regular customers of the hospital cafeteria with all items labeled green (healthy), yellow (less healthy), or red (unhealthy) to determine if social norm (peer-comparison) feedback with or without financial incentives increased employees' healthy food choices. Participants were randomized in 2012 to three arms: 1) monthly letter with social norm feedback about healthy food purchases, comparing employee to "all" and to "healthiest" customers (feedback-only); 2) monthly letter with social norm feedback plus small financial incentive for increasing green purchases (feedback-incentive); or 3) no contact (control). The main outcome was change in proportion of green-labeled purchases at the end of 3-month intervention. Post-hoc analyses examined linear trends. At baseline, the proportion of green-labeled purchases (50%) did not differ between arms. At the end of the 3-month intervention, the percentage increase in green-labeled purchases was larger in the feedback-incentive arm compared to control (2.2% vs. 0.1%, P=0.03), but the two intervention arms were not different. The rate of increase in green-labeled purchases was higher in both feedback-only (P=0.04) and feedback-incentive arms (P=0.004) compared to control. At the end of a 3-month wash-out, there were no differences between control and intervention arms. Social norms plus small financial incentives increased employees' healthy food choices over the short-term. Future research will be needed to assess the impact of this relatively low-cost intervention on employees' food choices and weight over the long-term. Clinical Trials.gov: NCT01604499. Copyright © 2016 Elsevier Inc. All rights reserved.

Clinical and microbiological effectiveness of photodynamic therapy on primary endodontic infections: a 6-month randomized clinical trial.

PubMed

de Miranda, Rachel Garcia; Colombo, Ana Paula Vieira

2018-05-01

This short-term randomized controlled trial evaluated the effectiveness of photodynamic therapy (PDT) on clinical success (periapical healing) and on the microbiota of primary endodontic infections. Thirty-two patients presenting mandibular molars with apical periodontitis (one tooth/patient) were selected and randomly allocated into two therapeutic groups: control (chemo-mechanical debridement [CMD]; n = 16) and PDT (CMD + PDT; n = 16). All teeth in both groups had intracanal medication with calcium hydroxide for 7 days before final obturation. Follow-up radiographs were made at 3 and 6 months. Periapical healing was evaluated by the periapical index (PAI). Samples were obtained at baseline, after CMD with or without PDT, and just before root filling to determine the frequency and levels of 37 taxa by checkerboard. Significant decreases in PAI scores were observed in both groups over time, although at 6 months, the PDT group presented a significantly better healing score than the control (p < 0.05). At baseline, the most prevalent species in all samples were Candida albicans (46.9%), Dialister pneumosintes (31.2%), Prevotella nigrescens (28.2%), Prevotella tannerae (28.1%), and Peptostreptococcus anaerobius (25%). Most species reduced over time in both groups, and no significant differences in frequency and levels of the tested species were observed between groups in any time point evaluated. C. albicans and D. pneumosintes were still detected in high frequency in both groups at 3 months post-therapy. Conventional endodontic therapy with or without PDT is effective in reducing microbial load, resulting in periapical healing. Nevertheless, adjunctive PDT provides better periapical healing at 6-month follow-up. Teeth with apical periodontitis treated with PDT adjunct to conventional treatment would demonstrate superior healing and reduction of microorganisms.

A pilot study of randomized clinical controlled trial of gait training in subacute stroke patients with partial body-weight support electromechanical gait trainer and functional electrical stimulation: six-month follow-up.

PubMed

Ng, Maple F W; Tong, Raymond K Y; Li, Leonard S W

2008-01-01

This study aimed to assess the effectiveness of gait training using an electromechanical gait trainer with or without functional electrical stimulation for people with subacute stroke. This was a nonblinded randomized controlled trial with a 6-month follow-up. Fifty-four subjects were recruited within 6 weeks after stroke onset and were randomly assigned to 1 of 3 gait intervention groups: conventional overground gait training treatment (CT, n=21), electromechanical gait trainer (GT, n=17) and, electromechanical gait trainer with functional electrical stimulation (GT-FES, n=16). All subjects were to undergo an assigned intervention program comprising a 20-minute session every weekday for 4 weeks. The outcome measures were Functional Independence Measure, Barthel Index, Motricity Index leg subscale, Elderly Mobility Scale (EMS), Berg Balance Scale, Functional Ambulatory Category (FAC), and 5-meter walking speed test. Assessments were made at baseline, at the end of the 4-week intervention program, and 6 months after the program ended. By intention-to-treat and multivariate analysis, statistically significant differences showed up in EMS (Wilks' lambda=0.743, P=0.005), FAC (Wilks' lambda=0.744, P=0.005) and gait speed (Wilks' lambda=0.658, P<0.0001). Post hoc analysis (univariate 2-way ANCOVA) revealed that the GT and GT-FES groups showed significantly better improvement in comparison with the CT group at the end of the 4 weeks of training and in the 6-month follow-up. For the early stage after stroke, this study indicated a higher effectiveness in poststroke gait training that used an electromechanical gait trainer compared with conventional overground gait training. The training effect was sustained through to the 6-month follow-up after the intervention.

A Social Media Peer Group for Mothers To Prevent Obesity from Infancy: The Grow2Gether Randomized Trial.

PubMed

Fiks, Alexander G; Gruver, Rachel S; Bishop-Gilyard, Chanelle T; Shults, Justine; Virudachalam, Senbagam; Suh, Andrew W; Gerdes, Marsha; Kalra, Gurpreet K; DeRusso, Patricia A; Lieberman, Alexandra; Weng, Daniel; Elovitz, Michal A; Berkowitz, Robert I; Power, Thomas J

2017-10-01

Few studies have addressed obesity prevention among low-income families whose infants are at increased obesity risk. We tested a Facebook peer-group intervention for low-income mothers to foster behaviors promoting healthy infant growth. In this randomized controlled trial, 87 pregnant women (Medicaid insured, BMI ≥25 kg/m 2 ) were randomized to the Grow2Gether intervention or text message appointment reminders. Grow2Gether participants joined a private Facebook group of 9-13 women from 2 months before delivery until infant age 9 months. A psychologist facilitated groups featuring a curriculum of weekly videos addressing feeding, sleep, parenting, and maternal well-being. Feasibility was assessed using the frequency and content of participation, and acceptability using surveys. Maternal beliefs and behaviors and infant growth were assessed at birth, 2, 4, 6, and 9 months. Differences in infant growth between study arms were explored. We conducted intention-to-treat analyses using quasi-least-squares regression. Eighty-eight percent (75/85) of intervention participants (42% (36/85) food insecure, 88% (75/85) black) reported the group was helpful. Participants posted 30 times/group/week on average. At 9 months, the intervention group had significant improvement in feeding behaviors (Infant Feeding Style Questionnaire) compared to the control group (p = 0.01, effect size = 0.45). Intervention group mothers were significantly less likely to pressure infants to finish food and, at age 6 months, give cereal in the bottle. Differences were not observed for other outcomes, including maternal feeding beliefs or infant weight-for-length. A social media peer-group intervention was engaging and significantly impacted certain feeding behaviors in families with infants at high risk of obesity.

Effect of cup feeding and bottle feeding on breastfeeding in late preterm infants: a randomized controlled study.

PubMed

Yilmaz, Gonca; Caylan, Nilgun; Karacan, Can Demir; Bodur, İlknur; Gokcay, Gulbin

2014-05-01

Cup feeding has been used as an alternative feeding method for preterm infants. The purpose of this study was to determine the effect of bottle and cup feeding on exclusive breastfeeding rates at hospital discharge and 3 and 6 months post-discharge in late preterm infants. Included in the study were preterm infants of 32 to 35 weeks' gestation fed only by intermittent gastric tube at the time of recruitment; 522 infants were randomly assigned to 2 groups: the cup-fed group (n = 254) and bottle-fed group (n = 268). Main outcomes were prevalence of exclusive breastfeeding at discharge and 3 and 6 months after discharge, and length of hospital stay. Infants randomized to cup versus bottle feeding were more likely to be exclusively breastfed at discharge home (relative risk [RR], 1.58; 95% confidence interval [CI], 1.36-1.83), 3 months after discharge (RR, 1.64; 95% CI, 1.42-1.89), and 6 months after discharge (RR, 1.36; 95% CI, 1.14-1.63). There was no significant difference between groups for length of hospital stay. The mean hospital stay was 25.96 ± 2.20 days in the bottle-fed group and 25.68 ± 2.22 days in the cup-fed group. There was no significant difference between groups for time spent feeding, feeding problems, or weight gain in hospital. Cup feeding significantly increased the likelihood of late preterm infants being exclusively breastfed at discharge and 3 and 6 months after discharge, and cup feeding did not increase the length of hospital stay. Overall, we recommend cup feeding as a transitional method prior to breastfeeding for late preterm infants during hospitalization.

Clinical efficacy of a xenogeneic collagen matrix in augmenting keratinized mucosa around implants: a randomized controlled prospective clinical trial.

PubMed

Lorenzo, Ramón; García, Virginia; Orsini, Marco; Martin, Conchita; Sanz, Mariano

2012-03-01

The aim of this controlled randomized clinical trial was to evaluate the efficacy of a xenogeneic collagen matrix (CM) to augment the keratinized tissue around implants supporting prosthetic restorations at 6 months when compared with the standard treatment, the connective tissue autograft, CTG). This randomized longitudinal parallel controlled clinical trial studied 24 patients with at least one location with minimal keratinized tissue (≤1 mm). The 6-month width of keratinized tissue. As secondary outcomes the esthetic outlook, the maintenance of peri-implant mucosal health and the patient morbidity were assessed pre-operatively and 1, 3, and 6 months post-operatively. At 6 months, Group CTG attained a mean width of keratinized tissue of 2.75 (1.5) mm, while the corresponding figure in Group CM was 2.8 (0.4) mm, the inter-group differences not being statistically significant. The surgical procedure in both groups did not alter significantly the mucosal health in the affected abutments. There was a similar esthetic result and significant increase in the vestibular depth in both groups as a result of the surgery. In the CM group it changed from 2.2 (3.3) to 5.1 (2.5) mm at 6 months. The patients treated with the CM referred less pain, needed less pain medication, and the surgical time was shorter, although these differences were not statistically significant when compared with the CTG group. These results prove that this new CM was as effective and predictable as the CTG for attaining a band of keratinized tissue. © 2011 John Wiley & Sons A/S.

Surgical treatment of adhesion-related chronic abdominal and pelvic pain after gynaecological and general surgery: a systematic review and meta-analysis.

PubMed

van den Beukel, Barend A; de Ree, Roy; van Leuven, Suzanne; Bakkum, Erica A; Strik, Chema; van Goor, Harry; Ten Broek, Richard P G

2017-05-01

Chronic pain is a frequent post-operative complication, affecting ~20-40% of patients who have undergone surgery of the female genital or alimentary tract. Chronic pain is an important risk factor for diminished quality of life after surgery. Adhesions are frequently associated with chronic post-operative pain; however, surgical treatment of adhesion-related pain is controversial. The aim of this study was to investigate the efficacy and harms of surgical interventions for chronic post-operative pain attributable to adhesions. A search was conducted using PubMed, EMBASE and CENTRAL, without restrictions pertaining to date, publication status or language. Randomized trials and cohort studies from all surgical interventions for chronic post-operative pain were considered eligible. Patients with a concomitant diagnosis that could cause chronic pain (e.g. endometriosis or inflammatory conditions) were excluded. Outcome measures were graded according to clinical relevance, with improvement of pain at long-term follow-up regarded as most clinically relevant. A total of 4294 unique citations were identified, of which 13 studies met the criteria for inclusion. Two of the analysed studies were randomized trials, of which one had a low risk of bias. Only one trial, randomizing between laparoscopic adhesiolysis without an adhesion barrier and diagnostic laparoscopy, reported improvement of pain at long-term follow-up. In this trial, pain improved in 55.8% of patients after adhesiolysis and in 41.7% of patients in the control group; however, the difference was not significant (relative risk (RR) 1.34; 95% CI: 0.89-2.02). Most non-randomized studies had mid-length follow-up (6-12 months). In pooled analyses of trials and non-randomized studies, improvement of pain was reported in 72% of patients who underwent adhesiolysis (95% CI: 61-83%) at any follow-up longer than 3 months. The incidence of negative laparoscopies was 20% (95% CI: 10-30%). The overall incidence of complications following laparoscopic adhesiolysis was 4% (95% CI: 1-6%). Laparoscopic adhesiolysis reduces pain from adhesions in ~70% of patients in the initial phase after treatment. However, there is little evidence for long-term efficacy of adhesiolysis for chronic pain. Other drawbacks of laparoscopic adhesiolysis are the high rate of negative laparoscopies and the risk of bowel injury. At present, there is little evidence to support routine use of adhesiolysis in treatment for chronic pain. New research is needed to investigate whether the results of adhesiolysis can be improved with new techniques for diagnosis and prevention of adhesion reformation. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com

The Study of Mental and Resistance Training (SMART) study—resistance training and/or cognitive training in mild cognitive impairment: a randomized, double-blind, double-sham controlled trial.

PubMed

Fiatarone Singh, Maria A; Gates, Nicola; Saigal, Nidhi; Wilson, Guy C; Meiklejohn, Jacinda; Brodaty, Henry; Wen, Wei; Singh, Nalin; Baune, Bernhard T; Suo, Chao; Baker, Michael K; Foroughi, Nasim; Wang, Yi; Sachdev, Perminder S; Valenzuela, Michael

2014-12-01

Mild cognitive impairment (MCI) increases dementia risk with no pharmacologic treatment available. The Study of Mental and Resistance Training was a randomized, double-blind, double-sham controlled trial of adults with MCI. Participants were randomized to 2 supervised interventions: active or sham physical training (high intensity progressive resistance training vs seated calisthenics) plus active or sham cognitive training (computerized, multidomain cognitive training vs watching videos/quizzes), 2-3 days/week for 6 months with 18-month follow-up. Primary outcomes were global cognitive function (Alzheimer's Disease Assessment Scale-cognitive subscale; ADAS-Cog) and functional independence (Bayer Activities of Daily Living). Secondary outcomes included executive function, memory, and speed/attention tests, and cognitive domain scores. One hundred adults with MCI [70.1 (6.7) years; 68% women] were enrolled and analyzed. Resistance training significantly improved the primary outcome ADAS-Cog; [relative effect size (95% confidence interval) -0.33 (-0.73, 0.06); P < .05] at 6 months and executive function (Wechsler Adult Intelligence Scale Matrices; P = .016) across 18 months. Normal ADAS-Cog scores occurred in 48% (24/49) after resistance training vs 27% (14/51) without resistance training [P < .03; odds ratio (95% confidence interval) 3.50 (1.18, 10.48)]. Cognitive training only attenuated decline in Memory Domain at 6 months (P < .02). Resistance training 18-month benefit was 74% higher (P = .02) for Executive Domain compared with combined training [z-score change = 0.42 (0.22, 0.63) resistance training vs 0.11 (-0.60, 0.28) combined] and 48% higher (P < .04) for Global Domain [z-score change = .0.45 (0.29, 0.61) resistance training vs 0.23 (0.10, 0.36) combined]. Resistance training significantly improved global cognitive function, with maintenance of executive and global benefits over 18 months. Copyright © 2014 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

Randomized Trial of Communication Facilitators to Reduce Family Distress and Intensity of End-of-Life Care.

PubMed

Curtis, J Randall; Treece, Patsy D; Nielsen, Elizabeth L; Gold, Julia; Ciechanowski, Paul S; Shannon, Sarah E; Khandelwal, Nita; Young, Jessica P; Engelberg, Ruth A

2016-01-15

Communication with family of critically ill patients is often poor and associated with family distress. To determine if an intensive care unit (ICU) communication facilitator reduces family distress and intensity of end-of-life care. We conducted a randomized trial at two hospitals. Eligible patients had a predicted mortality greater than or equal to 30% and a surrogate decision maker. Facilitators supported communication between clinicians and families, adapted communication to family needs, and mediated conflict. Outcomes included depression, anxiety, and post-traumatic stress disorder (PTSD) among family 3 and 6 months after ICU and resource use. We identified 488 eligible patients and randomized 168. Of 352 eligible family members, 268 participated (76%). Family follow-up at 3 and 6 months ranged from 42 to 47%. The intervention was associated with decreased depressive symptoms at 6 months (P = 0.017), but there were no significant differences in psychological symptoms at 3 months or anxiety or PTSD at 6 months. The intervention was not associated with ICU mortality (25% control vs. 21% intervention; P = 0.615) but decreased ICU costs among all patients (per patient: $75,850 control, $51,060 intervention; P = 0.042) and particularly among decedents ($98,220 control, $22,690 intervention; P = 0.028). Among decedents, the intervention reduced ICU and hospital length of stay (28.5 vs. 7.7 d and 31.8 vs. 8.0 d, respectively; P < 0.001). Communication facilitators may be associated with decreased family depressive symptoms at 6 months, but we found no significant difference at 3 months or in anxiety or PTSD. The intervention reduced costs and length of stay, especially among decedents. This is the first study to find a reduction in intensity of end-of-life care with similar or improved family distress. Clinical trial registered with www.clinicaltrials.gov (NCT 00720200).

Interventions to increase physical activity in middle-age women at the workplace: a randomized controlled trial.

PubMed

Ribeiro, Marcos Ausenka; Martins, Milton Arruda; Carvalho, Celso R F

2014-01-01

A four-group randomized controlled trial evaluated the impact of distinct workplace interventions to increase the physical activity (PA) and to reduce anthropometric parameters in middle-age women. One-hundred and ninety-five women age 40-50 yr who were employees from a university hospital and physically inactive at their leisure time were randomly assigned to one of four groups: minimal treatment comparator (MTC; n = 47), pedometer-based individual counseling (PedIC; n = 53), pedometer-based group counseling (PedGC; n = 48), and aerobic training (AT; n = 47). The outcomes were total number of steps (primary outcome), those performed at moderate intensity (≥ 110 steps per minute), and weight and waist circumference (secondary outcomes). Evaluations were performed at baseline, at the end of a 3-month intervention, and 3 months after that. Data were presented as delta [(after 3 months-baseline) or (after 6 months-baseline)] and 95% confidence interval. To detect the differences among the groups, a one-way ANOVA and a Holm-Sidak post hoc test was used (P < 0.05). The Cohen effect size was calculated, and an intention-to-treat approach was performed. Only groups using pedometers (PedIC and PedGC) increased the total number of steps after 3 months (P < 0.05); however, the increase observed in PedGC group (1475 steps per day) was even higher than that in PedIC (512 steps per day, P < 0.05) with larger effect size (1.4). The number of steps performed at moderate intensity also increased only in the PedGC group (845 steps per day, P < 0.05). No PA benefit was observed at 6 months. Women submitted to AT did not modify PA daily life activity but reduced anthropometric parameters after 3 and 6 months (P < 0.05). Our results show that in the workplace setting, pedometer-based PA intervention with counseling is effective increasing daily life number of steps, whereas AT is effective for weight loss.

Superstition and post-tonsillectomy hemorrhage.

PubMed

Kumar, Veena V; Kumar, Naveen V; Isaacson, Glenn

2004-11-01

The objective was to determine whether post-tonsillectomy hemorrhages occur more frequently in redheaded children, in patterns of threes, on Friday-the-13th days, or with the full moon. Case-control analysis. The authors performed multiple statistical analyses of all children undergoing tonsillectomy at Temple University Children's Medical Center (Philadelphia, PA) during a 29-month period. Children readmitted to the hospital with or without surgical control of bleeding were compared with children who did not bleed. Relation of post-tonsillectomy hemorrhages to the phase of the moon was evaluated using a standard normal deviate. The frequency of surgery performed on Friday-the-13th days was compared with a differently dated Friday chosen at random. Clusters of three hemorrhages in a 7-day period were recorded. Families of children were contacted and asked whether their child had red hair. A chi analysis compared redheaded and non-redheaded tonsillectomy patients. Twenty-eight of 589 tonsillectomy cases performed required readmission for bleeding events. Twenty tonsillectomies occurred on a full-moon day, resulting in one bleeding event. One cluster of three post-tonsillectomy hemorrhages occurred in a 7-day period. Four of the children who bled had red hair. Two tonsillectomies occurred on Friday the 13th, with no associated hemorrhage. Statistical analysis revealed a random pattern to post-tonsillectomy hemorrhage. Post-tonsillectomy hemorrhages do not occur in clusters of three and are not more frequent with the full moon or on Friday the 13th. The bleeding rate among children with red hair is similar to that of non-redheaded children.

Hip Osteoarthritis in Dogs: A Randomized Study Using Mesenchymal Stem Cells from Adipose Tissue and Plasma Rich in Growth Factors

PubMed Central

Cuervo, Belen; Rubio, Monica; Sopena, Joaquin; Dominguez, Juan Manuel; Vilar, Jose; Morales, Manuel; Cugat, Ramón; Carrillo, Jose Maria

2014-01-01

Purpose: The aim of this study was to compare the efficacy and safety of a single intra-articular injection of adipose mesenchymal stem cells (aMSCs) versus plasma rich in growth factors (PRGF) as a treatment for reducing symptoms in dogs with hip osteoarthritis (OA). Methods: This was a randomized, multicenter, blinded, parallel group. Thirty-nine dogs with symptomatic hip OA were assigned to one of the two groups, to receive aMSCs or PRGF. The primary outcome measures were pain and function subscales, including radiologic assessment, functional limitation and joint mobility. The secondary outcome measures were owners’ satisfaction questionnaire, rescue analgesic requirement and overall safety. Data was collected at baseline, then, 1, 3 and 6 months post-treatment. Results: OA degree did not vary within groups. Functional limitation, range of motion (ROM), owner’s and veterinary investigator visual analogue scale (VAS), and patient’s quality of life improved from the first month up to six months. The aMSCs group obtained better results at 6 months. There were no adverse effects during the study. Our findings show that aMSCs and PRGF are safe and effective in the functional analysis at 1, 3 and 6 months; provide a significant improvement, reducing dog’s pain, and improving physical function. With respect to basal levels for every parameter in patients with hip OA, aMSCs showed better results at 6 months. PMID:25089877

Effect of Subgingivally Delivered 10% Emblica officinalis Gel as an Adjunct to Scaling and Root Planing in the Treatment of Chronic Periodontitis - A Randomized Placebo-controlled Clinical Trial.

PubMed

Grover, Shilpa; Tewari, Shikha; Sharma, Rajinder K; Singh, Gajendra; Yadav, Aparna; Naula, Satish C

2016-06-01

Emblica officinalis fruit possesses varied medicinal properties including cytoprotective antimicrobial, antioxidant, antiresorptive and antiinflammatory activity. The present study aimed to investigate the effect of subgingival application of indigenously prepared E. officinalis (Amla) sustained-release gel adjunctive to scaling and root planing (SRP) on chronic periodontitis. Forty-six patients (528 sites) were randomly assigned to control group (23;264): SRP +placebo gel and test group (23;264): SRP + 10% E. officinalis gel application. Periodontal parameters: plaque index, gingival index, probing pocket depth (PPD), clinical attachment level (CAL) and modified sulcus bleeding index (mSBI) were assessed at baseline, 2 and 3-month post-therapy. Forty patients (470 sites) completed the trial. When test and control sites were compared, significantly more reduction in mean PPD, mSBI, number of sites with PPD = 5-6 mm, PPD ≥ 7 mm, CAL ≥ 6 mm and greater CAL gain were achieved in test sites at 2- and 3-month post-therapy (p < 0.05). Locally delivered 10% E. officinalis sustained-release gel used as an adjunct to SRP may be more effective in reducing inflammation and periodontal destruction in patients with chronic periodontitis when compared with SRP alone. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Feasibility of a Grocery Store Tour for Parents and Their Adolescents: A Randomized Controlled Pilot Study.

PubMed

Nikolaus, Cassandra J; Graziose, Matthew M; Nickols-Richardson, Sharon M

To evaluate the feasibility of a grocery store tour for parents and their adolescents being led by adults or adolescent peers. Randomized controlled pilot study with surveys at baseline and post-program, and at 3- and 6-month follow-up. Midwestern midsized grocery stores. Sixty-one parents and their 71 11- to 14-year-old adolescents. Nutrition education during 1 90-minute grocery store tour. Process observations and participants' tour perceptions provided fidelity outcomes. Questionnaires quantitatively assessed participants' knowledge, self-efficacy, and tour strategy use. Chi-square and McNemar tests were used to analyze categorical data, and Kruskal-Wallis, Wilcoxon signed-rank, and Mann-Whitney U tests were employed for continuous variables (significance at P < .05). Over 90% of tour tasks were rated as completed well for adult and peer leaders. Participants had positive tour perceptions but noted deficiencies in teen leaders' knowledge and leadership skills. Overall, parents and adolescents retained increased self-efficacy from pre-tour to post-tour intervals. Despite limited knowledge retention, parents reported they had increased (6.5 ± 4.19) healthful grocery shopping behaviors in the 6 months after the intervention. Peers may feasibly lead grocery store tours but they may need additional resources and support to be highly effective. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Generic versus disorder specific cognitive behavior therapy for social anxiety disorder in youth: A randomized controlled trial using internet delivery.

PubMed

Spence, Susan H; Donovan, Caroline L; March, Sonja; Kenardy, Justin A; Hearn, Cate S

2017-03-01

The study examined whether the efficacy of cognitive behavioral treatment for Social Anxiety Disorder for children and adolescents is increased if intervention addresses specific cognitive and behavioral factors linked to the development and maintenance of SAD in young people, over and above the traditional generic CBT approach. Participants were 125 youth, aged 8-17 years, with a primary diagnosis of SAD, who were randomly assigned to generic CBT (CBT-GEN), social anxiety specific CBT (CBT-SAD) or a wait list control (WLC). Intervention was delivered using a therapist-supported online program. After 12-weeks, participants who received treatment (CBT-SAD or CBT-GEN) showed significantly greater reduction in social anxiety and post-event processing, and greater improvement in global functioning than the WLC but there was no significant difference between CBT-SAD and CBT-GEN on any outcome variable at 12-weeks or 6-month follow-up. Despite significant reductions in anxiety, the majority in both treatment conditions continued to meet diagnostic criteria for SAD at 6-month follow-up. Decreases in social anxiety were associated with decreases in post-event processing. Future research should continue to investigate disorder-specific interventions for SAD in young people, drawing on evidence regarding causal or maintaining factors, in order to enhance treatment outcomes for this debilitating condition. Copyright © 2016 Elsevier Ltd. All rights reserved.