Trial of infographics in Northern Ireland (TINI): Preliminary evaluation and results of a randomized controlled trial comparing infographics with text.

PubMed

McCrorie, Alan David; Chen, Jingwen Jessica; Weller, Ross; McGlade, Kieran John; Donnelly, Conan

2018-06-01

Infographics represent a potential means of improving public knowledge about cancer. However, there is little experimental evidence of their efficacy. This preliminary study investigates whether infographics are superior to text for the communication of information about cancer risk in old age via a three armed randomized controlled trial. Trial involved allocation concealment and block randomization of 30 male participants aged over 50 to receive text information (control) or one of two infographics (interventions). Participants who viewed an infographic were more likely to know the correct association between cancer risk and old age compared with those viewing text information (risk ratio = 3.0, 95% confidence interval 0.82-10.90). Participants had limited understanding of the phrases "cancer incidence" and "cancer prevalence" but good understanding of the phrases "cancer risk factor" and "cancer stage." Possession of good numerical skills appears to be a key determinant of ability to extract meaning from statistical information provided; regardless of format. Initial results suggest icon array infographics may be more effective communication mediums than text but further study with more participants and an updated infographic is necessary to confirm this finding. ISRCTN33951209.

Preliminary evaluation of a self-directed video-based 1-2-3 Magic parenting program: a randomized controlled trial.

PubMed

Porzig-Drummond, Renata; Stevenson, Richard J; Stevenson, Caroline

2015-03-01

The current study examined the effectiveness of a self-directed video-based format of the 1-2-3 Magic parenting program in reducing dysfunctional parenting and child problem behaviors. Eighty-four parents of children aged 2-10 were randomly assigned to either the intervention group (n = 43) or the waitlist control group (n = 41). Participants in the intervention group reported significantly less problem behaviors for their children, and significantly less dysfunctional parenting, at post-intervention when compared to the control group. The results were maintained at 6-month follow-up. There was no significant change on measures of parental adjustment for either group. The current results provide preliminary support for the conclusion that the video-based self-directed format of the 1-2-3 Magic parenting program is suitable as an entry-level intervention in a multi-level intervention model and is suitable for inclusion in a population approach to parenting program delivery. Copyright © 2015 Elsevier Ltd. All rights reserved.

Impact of Cognitive Behavioral Therapy on Observed Autism Symptom Severity during School Recess: A Preliminary Randomized, Controlled Trial

ERIC Educational Resources Information Center

Wood, Jeffrey J.; Fujii, Cori; Renno, Patricia; Van Dyke, Marilyn

2014-01-01

This study compared cognitive behavioral therapy (CBT) and treatment-as-usual (TAU) in terms of effects on observed social communication-related autism symptom severity during unstructured play time at school for children with autism spectrum disorders (ASD). Thirteen children with ASD (7-11 years old) were randomly assigned to 32 sessions of CBT…

Some New Possibilities to Control Kudzu

Treesearch

Jerry L. Michael

1982-01-01

Six chemicals were tested at random with 3 replications at 3 rates for foliar activity on kudzu [Pueraria lobata (Willd.) Ohwi]. All chemicals gave some degree of control. DPX-6376, XRM-3972 (Lontrel), and Oust(TM) Weed Killer (formerly known as DPX-5648) gave more than 99% topkill for 3 l/2 months. Preliminary results...

The Preliminary Effects of Massage and Inhalation Aromatherapy on Chemotherapy-Induced Acute Nausea and Vomiting: A Quasi-Randomized Controlled Pilot Trial.

PubMed

Zorba, Pinar; Ozdemir, Leyla

2017-04-20

Despite pharmacological treatment, chemotherapy-induced nausea and vomiting (CINV) are observed in patients. This quasi-randomized controlled pilot study evaluated the feasibility and preliminary effects of massage and inhalation aromatherapies on chemotherapy-induced acute nausea/vomiting. Seventy-five patients with breast cancer were randomly grouped into 1 of 3 groups: massage (n = 25), inhalation (n = 25), and control (n = 25). The patients in the massage group received 20-minute aromatherapy foot massage, whereas those in the inhalation group received 3-minute inhalation aromatherapy before their second, third, and fourth chemotherapy cycles. The control group underwent only the routine treatment. A nausea, vomiting, and retching patient follow-up form was used to evaluate nausea severity by visual analog scale and frequency of vomiting and retching. The incidence of nausea and retching was significantly higher in the control group than in the other groups in the third and fourth chemotherapy cycles (P < .001). Furthermore, in these 2 cycles, the incidence of nausea and retching was significantly lower in the massage group than in the inhalation group (P < .001). Nausea severity was significantly lower among patients in the massage and inhalation groups than in the control group in all 3 cycles (P < .001). Nausea severity was significantly lower in the massage and inhalation aromatherapy groups than in the control group. Nausea and retching incidence was reduced in the aromatherapy groups compared with that in the control group. Nonpharmacological approaches are recommended for managing CINV. Massage and inhalation aromatherapy seems promising regarding the management of CINV.

Environmental Exposures, Genetic Polymorphisms and p53 Mutational Spectra in a Case-Control Study of Breast Cancer.

DTIC Science & Technology

1998-01-01

Further, preliminary clinical data suggest that serotonin reuptake inhibitors , such as fluoxetinc hydrochloride, may promote smoking cessation (15,16...benefits of serotonin reuptake inhibitors in smoking cessation (16) suggested that this gene may be a plausible candidate for predisposition to... used for random selection of women under age 65; women age 65 and over were randomly selected from the listing of the Health Care Finance

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.

Effectiveness of Aerobic Exercise as an Augmentation Therapy for Inpatients with Major Depressive Disorder: A Preliminary Randomized Controlled Trial.

PubMed

Shachar-Malach, Tal; Cooper Kazaz, Rena; Constantini, Naama; Lifschytz, Tzuri; Lerer, Bernard

2015-01-01

Physical exercise has been shown to reduce depressive symptoms when used in combination with antidepressant medication. We report a randomized controlled trial of aerobic exercise compared to stretching as an augmentation strategy for hospitalized patients with major depression. Male or female patients, 18-80 years, diagnosed with a Major Depressive Episode, were randomly assigned to three weeks of augmentation therapy with aerobic (n=6) or stretching exercise (n=6). Depression was rated, at several time points using the 21-item Hamilton Depression Scale (HAM-D), Beck Depression Inventory (BDI) and other scales. According to the HAM-D, there were four (out of six) responders in the aerobic group, two of whom achieved remission, and none in the stretching group. According to the BDI, there were two responders in the aerobic group who were also remitters and none in the stretching group. The results of this small study suggest that aerobic exercise significantly improves treatment outcome when added to antidepressant medication. However, due to the small sample size the results must be regarded as preliminary and further studies are needed to confirm the findings.

Soft Tissue Response to Titanium Abutments with Different Surface Treatment: Preliminary Histologic Report of a Randomized Controlled Trial.

PubMed

Canullo, Luigi; Dehner, Jan Friedrich; Penarrocha, David; Checchi, Vittorio; Mazzoni, Annalisa; Breschi, Lorenzo

2016-01-01

The aim of this preliminary prospective RCT was to histologically evaluate peri-implant soft tissues around titanium abutments treated using different cleaning methods. Sixteen patients were randomized into three groups: laboratory customized abutments underwent Plasma of Argon treatment (Plasma Group), laboratory customized abutments underwent cleaning by steam (Steam Group), and abutments were used as they came from industry (Control Group). Seven days after the second surgery, soft tissues around abutments were harvested. Samples were histologically analyzed. Soft tissues surrounding Plasma Group abutments predominantly showed diffuse chronic infiltrate, almost no acute infiltrate, with presence of few polymorphonuclear neutrophil granulocytes, and a diffuse presence of collagenization bands. Similarly, in Steam Group, the histological analysis showed a high variability of inflammatory expression factors. Tissues harvested from Control Group showed presence of few neutrophil granulocytes, moderate presence of lymphocytes, and diffuse collagenization bands in some sections, while they showed absence of acute infiltrate in 40% of sections. However, no statistical difference was found among the tested groups for each parameter (p > 0.05). Within the limit of the present study, results showed no statistically significant difference concerning inflammation and healing tendency between test and control groups.

Safety and preliminary efficacy of deep transcranial magnetic stimulation in MS-related fatigue

PubMed Central

Gaede, Gunnar; Tiede, Marina; Lorenz, Ina; Brandt, Alexander U.; Pfueller, Caspar; Dörr, Jan; Bellmann-Strobl, Judith; Piper, Sophie K.; Roth, Yiftach; Zangen, Abraham; Schippling, Sven

2017-01-01

Objective: To conduct a randomized, sham-controlled phase I/IIa study to evaluate the safety and preliminary efficacy of deep brain H-coil repetitive transcranial magnetic stimulation (rTMS) over the prefrontal cortex (PFC) and the primary motor cortex (MC) in patients with MS with fatigue or depression (NCT01106365). Methods: Thirty-three patients with MS were recruited to undergo 18 consecutive rTMS sessions over 6 weeks, followed by follow-up (FU) assessments over 6 weeks. Patients were randomized to receive high-frequency stimulation of the left PFC, MC, or sham stimulation. Primary end point was the safety of stimulation. Preliminary efficacy was assessed based on changes in Fatigue Severity Scale (FSS) and Beck Depression Inventory scores. Randomization allowed only analysis of preliminary efficacy for fatigue. Results: No serious adverse events were observed. Five patients terminated participation during treatment due to mild side effects. Treatment resulted in a significant median FSS decrease of 1.0 point (95%CI [0.45,1.65]), which was sustained during FU. Conclusions: H-coil rTMS is safe and well tolerated in patients with MS. The observed sustained reduction in fatigue after subthreshold MC stimulation warrants further investigation. ClinicalTrials.gov identifier: NCT01106365. Classification of evidence: This study provides Class III evidence that rTMS of the prefrontal or primary MC is not associated with serious adverse effects, although this study is underpowered to state this with any precision. PMID:29259998

Effects of Brain Gym on Overhand Throwing in First Grade Students: A Preliminary Investigation

ERIC Educational Resources Information Center

Maskell, Bronwen; Shapiro, Deborah R.; Ridley, Christopher

2004-01-01

The purpose was to examine the effect of Brain Gym on learning the overhand throw among 42 first grade students. Participants from two intact classes were randomly assigned to an experimental or control condition. Students were tested before and after a 5-week intervention using the object control subtest from the Test of Gross Motor Development-2…

Game-Based Virtual Reality Canoe Paddling Training to Improve Postural Balance and Upper Extremity Function: A Preliminary Randomized Controlled Study of 30 Patients with Subacute Stroke.

PubMed

Lee, Myung Mo; Lee, Kyeong Jin; Song, Chang Ho

2018-04-27

BACKGROUND Virtual reality (VR) training with motion-controlled console games can be incorporated into stroke rehabilitation programs. The use of a variety of gaming software can provide the patient with an opportunity to perform activities that are exciting, entertaining, and that may not be feasible in clinical environments. The aim of this preliminary randomized controlled study was to investigate the effects of game-based VR canoe paddling training, when combined with conventional physical rehabilitation programs, on postural balance and upper extremity function in 30 patients with subacute stroke. MATERIAL AND METHODS Thirty patients, who were within six months following the diagnosis of stroke, were randomly allocated to either the experimental group (n=15) or the control group (n=15). All participants participated in a conventional rehabilitation program. Also, the experimental group (n=15) performed the VR canoe paddling training for 30 minutes each day, three times per week, for five weeks. After five weeks, outcomes of changes in postural balance and upper extremity function were evaluated and compared between the two groups. RESULTS At five weeks, postural balance and upper extremity function showed significant improvements in both patients groups when compared with the baseline measurements (p<0.05). However, postural balance and upper extremity function were significantly improved in the experimental group when compared with the control group (p<0.05). CONCLUSIONS Game-based VR canoe paddling training is an effective rehabilitation therapy that enhances postural balance and upper extremity function in patients with subacute stroke when combined with conventional physical rehabilitation programs.

A Preliminary Investigation of a Randomized Dependent Group Contingency for Hallway Transitions

ERIC Educational Resources Information Center

Deshais, Meghan A.; Fisher, Alyssa B.; Kahng, SungWoo

2018-01-01

We conducted a preliminary investigation of a randomized dependent group contingency to decrease disruptive behavior during hallway transitions. Two first-graders, identified by their classroom teacher, participated in this study. A multiple baseline across transitions was used to evaluate the effects of the randomized dependent group contingency…

Effects of psychoeducation on helpful support for complicated grief: a preliminary randomized controlled single-blind study.

PubMed

Nam, I S

2016-01-01

Complicated grief is a distinct psychological response of individuals facing the loss of a loved one and can lead to many types of adverse health outcomes. Although social support may be beneficial, few studies have examined the beneficial effects of helpful support on complicated grief following bereavement. A randomized controlled trial was conducted. Bereaved participants and supporters were randomized to psychoeducation on complicated grief and helpful social support or psychoeducation on complicated grief. The primary outcome was the Inventory of Complicated Grief. The results showed that psychoeducation of supporters of bereaved individuals has significant beneficial effects. Particularly, symptoms of complicated grief were decreased in bereaved individuals with supporters that received psychoeducation. The results highlight the potential of psychoeducation to facilitate helpful social support and reduce complicated grief.

Aromatherapy and behaviour disturbances in dementia: a randomized controlled trial.

PubMed

Smallwood, J; Brown, R; Coulter, F; Irvine, E; Copland, C

2001-10-01

A random controlled trial of the relaxing effects of an aromatherapy massage on disordered behaviour in dementia was conducted. Twenty-one patients were randomly allocated into one of three conditions, aromatherapy and massage (AM), conversation and aromatherapy (CA) and massage only (M). AM showed the greatest reduction in the frequency of excessive motor behaviour of all three conditions. This reached statistical significance between the hours of three and four pm (p < 0.05). Post hoc analysis suggested that at this time of day the AM consistently reduced motor behaviour when compared with CA (p = 0.05). This provides preliminary evidence of a measurable sedative effect of aromatherapy massage on dementia within a robust scientific paradigm. Further research is recommended with an expanded sample size. Copyright 2001 John Wiley & Sons, Ltd.

Mindfulness Therapy for Maladaptive Interpersonal Dependency: A Preliminary Randomized Controlled Trial.

PubMed

McClintock, Andrew S; Anderson, Timothy; Cranston, Saryn

2015-11-01

Existing treatments for maladaptive interpersonal dependency and dependent personality disorder do not meet basic scientific standards for effectiveness. The present investigation tested the efficacy of a mindfulness-based approach: mindfulness therapy for maladaptive interpersonal dependency (MT-MID). Forty-eight participants who reported consistently high levels of maladaptive dependency (i.e., scored higher than 1 standard deviation above the mean on the Interpersonal Dependency Inventory at two separate assessments) were randomized to either 5 sessions of MT-MID or a minimal contact control. Five self-reported outcomes (mindfulness, maladaptive interpersonal dependency, helplessness, fears of negative evaluation, and excessive reassurance seeking) were assessed at pretreatment, posttreatment, and a 4-week follow-up. Intent-to-treat analyses indicated that MT-MID yielded greater improvements than the control on all 5 outcomes at posttreatment (median d=1.61) and follow-up (median d=1.51). Participants assigned to MT-MID were more likely than control participants to meet criteria for clinically significant change at posttreatment (56.5% vs. 0%) and follow-up (42.9% vs. 0%). There was also evidence that increases in mindfulness mediated the dependency-related improvements. These results provide preliminary support for the efficacy of a mindfulness-based approach for treating the symptoms of maladaptive dependency. Copyright © 2015. Published by Elsevier Ltd.

A Randomized Controlled Trial of the Child Anxiety Multi-Day Program (CAMP) for Separation Anxiety Disorder

ERIC Educational Resources Information Center

Santucci, Lauren C.; Ehrenreich-May, Jill

2013-01-01

While the efficacy of cognitive behavior therapy for childhood anxiety disorders, including separation anxiety disorder (SAD), has been established, tailoring such treatments to particular interests and needs may enhance uptake of evidence-based interventions. The current investigation evaluates the feasibility and preliminary efficacy of an…

Motivational Enhancement Therapy for Adolescent Marijuana Users: A Preliminary Randomized Controlled Trial

ERIC Educational Resources Information Center

Walker, Denise D.; Roffman, Roger A.; Stephens, Robert S.; Wakana, Kim; Berghuis, James

2006-01-01

This study's aims were (a) to investigate the feasibility of a school-based motivational enhancement therapy (MET) intervention in voluntarily attracting adolescents who smoke marijuana regularly but who are not seeking formal treatment and (b) to evaluate the efficacy of the intervention in reducing marijuana use. Ninety-seven adolescents who had…

An Intervention for Relational and Physical Aggression in Early Childhood: A Preliminary Study

ERIC Educational Resources Information Center

Ostrov, Jamie M.; Massetti, Greta M.; Stauffacher, Kirstin; Godleski, Stephanie A.; Hart, Katie C.; Karch, Kathryn M.; Mullins, Adam D.; Ries, Emily E.

2009-01-01

A preventive intervention for reducing physical and relational aggression, peer victimization, and increasing prosocial behavior was developed for use in early childhood classrooms. Nine classrooms were randomly assigned to be intervention rooms (N = 202 children) and nine classrooms were control rooms (N = 201 children). Classroom was the unit of…

Feasibility, Acceptability, and Preliminary Effects of the COPE Online Cognitive-Behavioral Skill-Building Program on Mental Health Outcomes and Academic Performance in Freshmen College Students: A Randomized Controlled Pilot Study.

PubMed

Melnyk, Bernadette Mazurek; Amaya, Megan; Szalacha, Laura A; Hoying, Jacqueline; Taylor, Tiffany; Bowersox, Kristen

2015-08-01

Despite the increasing prevalence of mental health disorders in university students, few receive needed evidence-based treatment. The purpose of this study was to assess the feasibility and preliminary effects of a seven-session online cognitive-behavioral skill-building intervention (i.e., COPE, Creating Opportunities for Personal Empowerment) versus a comparison group on their anxiety, depressive symptoms, and grade performance. A randomized controlled pilot study was conducted from September 2012 to May 2013 with 121 college freshmen enrolled in a required one credit survey course. Although there were no significant differences in anxiety and depressive symptoms between the groups, only COPE students with an elevated level of anxiety at baseline had a significant decline in symptoms. Grade point average was higher in COPE versus comparison students. Evaluations indicated that COPE was a positive experience for students. COPE is a promising brief intervention that can be integrated effectively into a required freshman course. © 2015 Wiley Periodicals, Inc.

Computer-based attention training in the schools for children with attention deficit/hyperactivity disorder: a preliminary trial.

PubMed

Steiner, Naomi J; Sheldrick, Radley Christopher; Gotthelf, David; Perrin, Ellen C

2011-07-01

Objective. This study examined the efficacy of 2 computer-based training systems to teach children with attention deficit/hyperactivity disorder (ADHD) to attend more effectively. Design/methods. A total of 41 children with ADHD from 2 middle schools were randomly assigned to receive 2 sessions a week at school of either neurofeedback (NF) or attention training through a standard computer format (SCF), either immediately or after a 6-month wait (waitlist control group). Parents, children, and teachers completed questionnaires pre- and postintervention. Results. Primary parents in the NF condition reported significant (P < .05) change on Conners's Rating Scales-Revised (CRS-R) and Behavior Assessment Scales for Children (BASC) subscales; and in the SCF condition, they reported significant (P < .05) change on the CRS-R Inattention scale and ADHD index, the BASC Attention Problems Scale, and on the Behavioral Rating Inventory of Executive Functioning (BRIEF). Conclusion. This randomized control trial provides preliminary evidence of the effectiveness of computer-based interventions for ADHD and supports the feasibility of offering them in a school setting.

The Acceptability and Potential Utility of Cognitive Training to Improve Working Memory in Persons Living With HIV: A Preliminary Randomized Trial.

PubMed

Towe, Sheri L; Patel, Puja; Meade, Christina S

HIV-associated neurocognitive impairments that impact daily function persist in the era of effective antiretroviral therapy. Cognitive training, a promising low-cost intervention, has been shown to improve neurocognitive functioning in some clinical populations. We tested the feasibility, acceptability, and preliminary effects of computerized cognitive training to improve working memory in persons living with HIV infection (PLWH) and working memory impairment. In this randomized clinical trial, we assigned 21 adult PLWH to either an experimental cognitive training intervention or an attention-matched control training intervention. Participants completed 12 training sessions across 10 weeks with assessments at baseline and post-training. Session attendance was excellent and participants rated the program positively. Participants in the experimental arm demonstrated improved working memory function over time; participants in the control arm showed no change. Our results suggest that cognitive training may be a promising intervention for working memory impairment in PLWH and should be evaluated further. Copyright © 2017 Association of Nurses in AIDS Care. Published by Elsevier Inc. All rights reserved.

A preliminary randomized clinical trial comparing diode laser and scalpel periosteal incision during implant surgery: impact on postoperative morbidity and implant survival.

PubMed

Shahnaz, Aysan; Jamali, Raika; Mohammadi, Farnush; Khorsand, Afshin; Moslemi, Neda; Fekrazad, Reza

2018-01-01

The aim of this preliminary randomized clinical trial was to compare: (1) post-operative morbidity after application of laser or scalpel incision for flap advancement during implant surgery and bone grafting and (2) implant survival rate following flap advancement with laser or scalpel incision after 6 months of loading. Eighteen patients who were scheduled for dental implant placement and simultaneous bone grafting were randomly assigned to test or control groups. Diode laser (810 nm, 2 W, pulse interval 200 μs; pulse length 100 μs, 400-μm initiated fiber tip), or scalpel (control) was used to sever the periosteum to create a tension-free flap. Visual analogue scale (VAS) pain score, rate of nonsteroid anti-inflammatory drug (NSAID) consumption, intensity of swelling, and ecchymosis were measured for the six postsurgical days. Six months after loading, implant survival was assessed. VAS pain score (during the first four postoperative days), rate of NSAID consumption (during the first three postoperative days), and intensity of swelling (during the first five postoperative days) were significantly lower in the test group compared to the control group (All P values < 0.05). One patient in the control group experienced ecchymosis. All implants were successful in function. Application of laser for performing periosteal releasing incision reduced the incidence and severity of postoperative morbidity of the patients undergone implant surgery in conjunction with bone augmentation procedure. We did not find any detrimental effect of laser incision on the implant survival within 6 months of loading.

Preliminary efficacy and safety of an oromucosal standardized cannabis extract in chemotherapy-induced nausea and vomiting.

PubMed

Duran, Marta; Pérez, Eulàlia; Abanades, Sergio; Vidal, Xavier; Saura, Cristina; Majem, Margarita; Arriola, Edurne; Rabanal, Manel; Pastor, Antoni; Farré, Magí; Rams, Neus; Laporte, Joan-Ramon; Capellà, Dolors

2010-11-01

Despite progress in anti-emetic treatment, many patients still suffer from chemotherapy-induced nausea and vomiting (CINV). This is a pilot, randomized, double-blind, placebo-controlled phase II clinical trial designed to evaluate the tolerability, preliminary efficacy, and pharmacokinetics of an acute dose titration of a whole-plant cannabis-based medicine (CBM) containing delta-9-tetrahydrocannabinol and cannabidiol, taken in conjunction with standard therapies in the control of CINV. Patients suffering from CINV despite prophylaxis with standard anti-emetic treatment were randomized to CBM or placebo, during the 120 h post-chemotherapy period, added to standard anti-emetic treatment. Tolerability was measured as the number of withdrawals from the study during the titration period because of adverse events (AEs). The endpoint for the preliminary efficacy analysis was the proportion of patients showing complete or partial response. Seven patients were randomized to CBM and nine to placebo. Only one patient in the CBM arm was withdrawn due to AEs. A higher proportion of patients in the CBM group experienced a complete response during the overall observation period [5/7 (71.4%) with CMB vs. 2/9 (22.2%) with placebo, the difference being 49.2% (95% CI 1%, 75%)], due to the delayed period. The incidence of AEs was higher in the CBM group (86% vs. 67%). No serious AEs were reported. The mean daily dose was 4.8 sprays in both groups. Compared with placebo, CBM added to standard antiemetic therapy was well tolerated and provided better protection against delayed CINV. These results should be confirmed in a phase III clinical trial. © 2010 Department of Health, Generalitat of Catalonia. British Journal of Clinical Pharmacology © 2010 The British Pharmacological Society.

Prospective randomized controlled trial of conventional laparoscopic versus laparoendoscopic single-site radical nephrectomy for localized renal cell carcinoma: a preliminary report regarding quality of life.

PubMed

Park, Yong Hyun; Kim, Kwang Taek; Ko, Kyungtae; Kim, Hyeon Hoe

2015-03-01

The safety and efficacy of laparoendoscopic single-site surgery (LESS) for renal cell carcinoma (RCC) have not been clearly demonstrated. We aimed to present preliminary data from a prospective randomized controlled trial of LESS versus conventional laparoscopic radical nephrectomy for localized RCC. Patients with cT1-2 RCC were randomized to LESS (n = 17) or conventional laparoscopy (n = 18) group. The short-term outcome measures assessed were perioperative morbidity, postoperative pain, and quality of recovery as determined using QoR-40. No significant differences were observed between the LESS and conventional laparoscopy groups with respect to operative time (143.5 vs. 126.1 min, p = 0.218), blood loss (143.6 vs. 118.2 ml, p = 0.121), hospital stay (3.8 vs. 3.1 day s, p = 0.170), analgesic requirements (63.2 vs. 60.0 mg, p = 0.956), and complication rates (26.7 vs. 22.2 %, p = 0.767). However, postoperative quality of recovery was better in the LESS group (176.4 vs. 152.6, p = 0.005). Furthermore, quality of recovery, as measured using the QoR-40 dimensions of emotional state (39.9 vs. 34.0, p = 0.003), physical comfort (51.9 vs. 46.7, p = 0.034), psychological support (32.2 vs. 25.8, p = 0.003), and physical independence (20.7 vs. 17.5, p = 0.047), but not pain (31.8 vs. 29.6, p = 0.259), was significantly better in the LESS group. The preliminary results from this prospective trial suggest that LESS could be a safe and effective treatment option for localized RCC with equivalent surgical outcomes and improved postoperative quality of recovery compared with conventional laparoscopic surgery.

Game-Based Virtual Reality Canoe Paddling Training to Improve Postural Balance and Upper Extremity Function: A Preliminary Randomized Controlled Study of 30 Patients with Subacute Stroke

PubMed Central

Lee, Myung Mo; Lee, Kyeong Jin

2018-01-01

Background Virtual reality (VR) training with motion-controlled console games can be incorporated into stroke rehabilitation programs. The use of a variety of gaming software can provide the patient with an opportunity to perform activities that are exciting, entertaining, and that may not be feasible in clinical environments. The aim of this preliminary randomized controlled study was to investigate the effects of game-based VR canoe paddling training, when combined with conventional physical rehabilitation programs, on postural balance and upper extremity function in 30 patients with subacute stroke. Material/Methods Thirty patients, who were within six months following the diagnosis of stroke, were randomly allocated to either the experimental group (n=15) or the control group (n=15). All participants participated in a conventional rehabilitation program. Also, the experimental group (n=15) performed the VR canoe paddling training for 30 minutes each day, three times per week, for five weeks. After five weeks, outcomes of changes in postural balance and upper extremity function were evaluated and compared between the two groups. Results At five weeks, postural balance and upper extremity function showed significant improvements in both patients groups when compared with the baseline measurements (p<0.05). However, postural balance and upper extremity function were significantly improved in the experimental group when compared with the control group (p<0.05). Conclusions Game-based VR canoe paddling training is an effective rehabilitation therapy that enhances postural balance and upper extremity function in patients with subacute stroke when combined with conventional physical rehabilitation programs. PMID:29702630

Feasibility, acceptability and preliminary psychological benefits of mindfulness meditation training in a sample of men diagnosed with prostate cancer on active surveillance: results from a randomized controlled pilot trial.

PubMed

Victorson, David; Hankin, Vered; Burns, James; Weiland, Rebecca; Maletich, Carly; Sufrin, Nathaniel; Schuette, Stephanie; Gutierrez, Bruriah; Brendler, Charles

2017-08-01

In a pilot randomized controlled trial, examine the feasibility and preliminary efficacy of an 8-week, mindfulness training program (Mindfulness Based Stress Reduction) in a sample of men on active surveillance on important psychological outcomes including prostate cancer anxiety, uncertainty intolerance and posttraumatic growth. Men were randomized to either mindfulness (n = 24) or an attention control arm (n = 19) and completed self-reported measures of prostate cancer anxiety, uncertainty intolerance, global quality of life, mindfulness and posttraumatic growth at baseline, 8 weeks, 6 months and 12 months. Participants in the mindfulness arm demonstrated significant decreases in prostate cancer anxiety and uncertainty intolerance, and significant increases in mindfulness, global mental health and posttraumatic growth. Participants in the control condition also demonstrated significant increases in mindfulness over time. Longitudinal increases in posttraumatic growth were significantly larger in the mindfulness arm than they were in the control arm. While mindfulness training was found to be generally feasible and acceptable among participants who enrolled in the 8-week intervention as determined by completion rates and open-ended survey responses, the response rate between initial enrollment and the total number of men approached was lower than desired (47%). While larger sample sizes are necessary to examine the efficacy of mindfulness training on important psychological outcomes, in this pilot study posttraumatic growth was shown to significantly increase over time for men in the treatment group. Mindfulness training has the potential to help men cope more effectively with some of the stressors and uncertainties associated with active surveillance. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Feasibility, safety and preliminary evidence of the effectiveness of a home-based exercise programme for older people with Alzheimer's disease: a pilot randomized controlled trial.

PubMed

Suttanon, Plaiwan; Hill, Keith D; Said, Catherine M; Williams, Susan B; Byrne, Karin N; LoGiudice, Dina; Lautenschlager, Nicola T; Dodd, Karen J

2013-05-01

To evaluate the feasibility and safety of a home-based exercise programme for people with Alzheimer's disease, and to provide preliminary evidence of programme effectiveness in improving balance and mobility and reducing falls risk. A randomized controlled trial. Community. Forty people with mild to moderate Alzheimer's disease (mean age 81.9, SD 5.72; 62.5% female). Participants were randomized to a six-month home-based individually tailored balance, strengthening and walking exercise programme (physiotherapist) or a six-month home-based education programme (control) (occupational therapist). Both programmes provided six home-visits and five follow-up phone calls. Balance, mobility, falls and falls risk were measured at baseline and programme completion. Intention-to-treat analysis using a generalized linear model with group allocation as a predictor variable was performed to evaluate programme effectiveness. Feasibility and adverse events were systematically recorded at each contact. Fifty-eight per cent of the exercise group finished the programme, completing an average of 83% of prescribed sessions, with no adverse events reported. Functional Reach improved significantly (P = 0.002) in the exercise group (mean (SD), 2.28 (4.36)) compared to the control group (-2.99 (4.87)). Significant improvement was also observed for the Falls Risk for Older People - Community score (P = 0.008) and trends for improvement on several other balance, mobility, falls and falls risk measures for the exercise group compared to the control group. The exercise programme was feasible and safe and may help improve balance and mobility performance and reduce falls risk in people with Alzheimer's disease.

Feasibility and preliminary efficacy of a web-based smoking cessation intervention for HIV-infected smokers: a randomized controlled trial.

PubMed

Shuter, Jonathan; Morales, Daniela A; Considine-Dunn, Shannon E; An, Lawrence C; Stanton, Cassandra A

2014-09-01

To evaluate the feasibility and preliminary efficacy of a Web-based tobacco treatment for persons living with HIV (PLWH). Prospective, randomized controlled trial. HIV-care center in the Bronx, New York. Eligibility criteria included HIV infection, current tobacco usage, interest in quitting, and access to a computer with internet. One hundred thirty-eight subjects enrolled, and 134 completed the study. Positively Smoke Free on the Web (PSFW), an 8-session, 7-week targeted tobacco treatment program for PLWH, was compared with standard care (brief advice to quit and self-help brochure). All subjects were offered nicotine patches. The main feasibility outcomes were number of sessions logged into, number of Web pages visited, number of interactive clicks, and total time logged in. The main efficacy outcome was biochemically verified, 7-day point prevalence abstinence 3 months after intervention. PSFW subjects logged into a mean of 5.5 of 8 sessions and 26.2 of 41 pages. They executed a mean of 10 interactive clicks during a mean total of 59.8 minutes logged in. Most required reminder phone calls to complete the sessions. Educational level, anxiety score, and home access of the Web site were associated with Web site usage. Ten percent of the PSFW group vs. 4.3% of controls achieved the abstinence end point. Among those who completed all 8 sessions, 17.9% were abstinent, and among women completers, 30.8% were abstinent. Web-based treatment is a feasible strategy for PLWH smokers, and preliminary findings suggest therapeutic efficacy.

Online Activities for Enhancing Sex Education Curricula: Preliminary Evidence on the Effectiveness of the Abstinence and Contraception Education Storehouse

PubMed Central

Raghupathy, Shobana; Klein, Charles; Card, Josefina

2013-01-01

The purpose of this research was to conduct a preliminary evaluation of the Abstinence and Contraception Education Storehouse (ACES), a digital, classroom-based resource designed to supplement existing sex education curricula with highly interactive materials such as video clips, multimedia polls and quizzes, and audiovisual demonstrations. 335 students ages 14–19 were randomly assigned to an ACES–based (treatment) or a standard (control) sex education curriculum. Data were collected at the onset of the intervention and 3-months after the completion of the intervention. Preliminary results were highly encouraging, with ACES participants who were sexually initiated at baseline reporting at the 3-month follow-up significant reductions in the number of times they had sex in the past four weeks. Both sexually initiated and non-sexually initiated youth who experienced the ACES curriculum also demonstrated greater intent to abstain from the sex during the follow-up period than those in the control group. PMID:24078799

Online Activities for Enhancing Sex Education Curricula: Preliminary Evidence on the Effectiveness of the Abstinence and Contraception Education Storehouse.

PubMed

Raghupathy, Shobana; Klein, Charles; Card, Josefina

2013-01-01

The purpose of this research was to conduct a preliminary evaluation of the Abstinence and Contraception Education Storehouse (ACES), a digital, classroom-based resource designed to supplement existing sex education curricula with highly interactive materials such as video clips, multimedia polls and quizzes, and audiovisual demonstrations. 335 students ages 14-19 were randomly assigned to an ACES-based (treatment) or a standard (control) sex education curriculum. Data were collected at the onset of the intervention and 3-months after the completion of the intervention. Preliminary results were highly encouraging, with ACES participants who were sexually initiated at baseline reporting at the 3-month follow-up significant reductions in the number of times they had sex in the past four weeks. Both sexually initiated and non-sexually initiated youth who experienced the ACES curriculum also demonstrated greater intent to abstain from the sex during the follow-up period than those in the control group.

Perioperative ketorolac in high risk breast cancer patients. Rationale, feasibility and methodology of a prospective randomized placebo-controlled trial.

PubMed

Forget, Patrice; Berlière, Martine; van Maanen, Aline; Duhoux, Francois P; Machiels, Jean-Pascal; Coulie, Pierre G; Bouche, Gauthier; De Kock, Marc

2013-10-01

Ketorolac, a NSAID routinely used during surgery proposed to have anticancer effects, is a promising way to improve postoperative oncological outcome. This effect may be particularly prominent in patients with elevated preoperative inflammatory scores, like the neutrophil:lymphocyte ratio. In this paper, we describe the rationale, the preliminary analyses in our patients, the feasibility and the methodology of a prospective randomized trial called "Ketorolac in Breast Cancer trial" (KBCt) (NCT01806259). Copyright © 2013 Elsevier Ltd. All rights reserved.

Reading Intervention Using Interactive Metronome in Children with Language and Reading Impairment: A Preliminary Investigation

ERIC Educational Resources Information Center

Ritter, Michaela; Colson, Karen A.; Park, Jungjun

2013-01-01

This exploratory study examined the effects of Interactive Metronome (IM) when integrated with a traditional language and reading intervention on reading achievement. Forty-nine school-age children with language and reading impairments were assigned randomly to either an experimental group who received the IM treatment or to a control group who…

Transitioning Together: A Multi-Family Group Psychoeducation Program for Adolescents with ASD and Their Parents

ERIC Educational Resources Information Center

DaWalt, Leann Smith; Greenberg, Jan S.; Mailick, Marsha R.

2018-01-01

Currently there are few evidence-based programs available for families of individuals with ASD during the transition to adulthood. The present study provided a preliminary evaluation of a multi-family group psychoeducation intervention using a randomized waitlist control design (n = 41). Families in the intervention condition participated in…

Is Homeopathy Effective for Hot Flashes and Other Estrogen-Withdrawal Symptoms in Breast Cancer Survivors? A Preliminary Randomized Controlled Trial

DTIC Science & Technology

2003-04-01

homeopathy may be effective in improving hot flashes and quality of life in breast cancer survivors with symptoms of estrogen withdrawal. Methods- A...scores improved significantly in both homeopathy groups compared to placebo. Results of this study suggest that a larger study should be done.

Effectiveness of Mindfulness-Based Stress Reduction Bibliotherapy: A Preliminary Randomized Controlled Trial.

PubMed

Hazlett-Stevens, Holly; Oren, Yelena

2017-06-01

This randomized controlled investigation examined the effectiveness of a self-help bibliotherapy format of the evidence-based mindfulness-based stress reduction (MBSR) intervention. College students seeking stress reduction were randomly assigned to a 10-week MBSR bibliotherapy intervention group (n = 47) or a no-treatment control group (n = 45). Self-report measures were collected at baseline and postintervention. A total of 25 bibliotherapy and 43 control group participants provided final data following the intervention period. Compared to the control group, bibliotherapy participants reported increased mindfulness following the intervention. Significant decreases on measures of depression, anxiety, stress, perceived stress, and anxiety sensitivity also were reported postintervention as well as increased quality of life in physical health, psychological, and environmental domains. No statistically significant group effects were found for social relationships quality of life domain, worry, and experiential avoidance measures. This MBSR workbook may provide an acceptable and effective alternative for motivated individuals seeking to reduce stress, at least for a select group of individuals who are willing and able to sustain participation in the intervention. © 2016 Wiley Periodicals, Inc.

Oncosurgical Management of Liver Limited Stage IV Colorectal Cancer: Preliminary Data and Protocol for a Randomized Controlled Trial.

PubMed

Sutton, Paul; Vimalachandran, Dale; Poston, Graeme; Fenwick, Stephen; Malik, Hassan

2018-05-09

Colorectal cancer is the fourth commonest cancer and second commonest cause of cancer-related death in the United Kingdom. Almost 15% of patients have metastases on presentation. An increasing number of surgical strategies and better neoadjuvant treatment options are responsible for more patients undergoing resection of liver metastases, with prolonged survival in a select group of patients who present with synchronous disease. It is clear that the optimal strategy for the management of these patients remains unclear, and there is certainly a complete absence of Level 1 evidence in the literature. The objective of this study is to undertake preliminary work and devise an outline trial protocol to inform the future development of clinical studies to investigate the management of patients with liver limited stage IV colorectal cancer. We have undertaken some preliminary work and begun the process of designing a randomized controlled trial and present a draft trial protocol here. This study is at the protocol development stage only, and as such no results are available. There is no funding in place for this study, and no anticipated start date. We have presented preliminary work and an outline trial protocol which we anticipate will inform the future development of clinical studies to investigate the management of patients with liver limited stage IV colorectal cancer. We do not believe that the trial we have designed will answer the most significant clinical questions, nor that it is feasible to be delivered within the United Kingdom's National Health Service at this current time. ©Paul Sutton, Dale Vimalachandran, Graeme Poston, Stephen Fenwick, Hassan Malik. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 09.05.2018.

The Efficacy and Acceptability of Third-Wave Behavioral and Cognitive eHealth Treatments: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

PubMed

O'Connor, Martin; Munnelly, Anita; Whelan, Robert; McHugh, Louise

2018-05-01

eHealth is an innovative method of delivering therapeutic content with the potential to improve access to third-wave behaviural and cognitive therapies. This systematic review and meta-analysis aimed to determine the efficacy and acceptability of third-wave eHealth treatments in improving mental health outcomes. A comprehensive search of electronic bibliographic databases including PubMed, PsycINFO, Web of Science, and CENTRAL was conducted to identify randomized controlled trials of third-wave treatments in which eHealth was the main component. Twenty-one studies were included in the review. Meta-analyses revealed that third-wave eHealth significantly outperformed inactive control conditions in improving anxiety, depression, and quality-of-life outcomes and active control conditions in alleviating anxiety and depression with small to medium effect sizes. No statistically significant differences were found relative to comparison interventions. Findings from a narrative synthesis of participant evaluation outcomes and meta-analysis of participant attrition rates provided preliminary support for the acceptability of third-wave eHealth. Third-wave eHealth treatments are efficacious in improving mental health outcomes including anxiety, depression, and quality of life, but not more so than comparison interventions. Preliminary evidence from indices of participant evaluation and attrition rates supports the acceptability of these treatments. Copyright © 2017. Published by Elsevier Ltd.

Systematic review of physiotherapy interventions to improve gross motor capacity and performance in children and adolescents with an acquired brain injury.

PubMed

Baque, Emmah; Sakzewski, Leanne; Barber, Lee; Boyd, Roslyn N

2016-01-01

To systematically review the efficacy of physiotherapy interventions to improve gross motor capacity, performance and societal participation in children aged 5-17 years with an acquired brain injury (ABI). Randomized and non-randomized controlled trials, cohort, case series, case-control and case studies were included and classified according to grades of evidence. Methodological quality of studies was assessed using the Downs and Black (D&B) scale and quantitative data was analysed using effect sizes. Two home-based studies investigated functional strength training (one randomized controlled trial, n = 20, level 2b, D&B = 16/32 and one non-randomized self-control study, n = 19, level 4, D&B = 15/32). Four studies evaluated virtual reality including: one pilot study, n = 50, level 4, D&B = 22/32; one single-subject, non-concurrent, randomized multiple baseline study, n = 3, level 4, D&B = 15/32; one case series study, n = 2, level 4, D&B = 15/32; one case study, n = 1, level 4, D&B = 15/32. Effect sizes for the randomized controlled trial ranged between 0.30-1.29 for the Functional Reach and Timed Up and Go outcome measures. There is preliminary evidence to support the efficacy of physiotherapy interventions to improve gross motor outcomes in children with an ABI. Both functional strength training and virtual-reality based therapy are potential treatment options for clinicians to prescribe in either home or clinical settings.

The Effects of the Bali Yoga Program for Breast Cancer Patients on Chemotherapy-Induced Nausea and Vomiting: Results of a Partially Randomized and Blinded Controlled Trial.

PubMed

Anestin, Annélie S; Dupuis, Gilles; Lanctôt, Dominique; Bali, Madan

2017-10-01

Complementary and alternative medicine has been shown to be beneficial in reducing chemotherapy-induced nausea and vomiting. However, conclusive results are lacking in order to confirm its usefulness. The purpose of this study was to determine whether a standardized yoga intervention could reduce these adverse symptoms. This was a partially randomized and blinded controlled trial comparing a standardized yoga intervention with standard care. Eligible patients were adults diagnosed with stages I to III breast cancer receiving chemotherapy. Patients randomized to the experimental group participated in an 8-week yoga program. There was no significant difference between the experimental and control groups on chemotherapy-induced nausea and vomiting after 8 weeks. Results suggest the yoga program is not beneficial in managing these adverse symptoms. However, considering preliminary evidence suggesting yoga's beneficial impact in cancer symptom management, methodological limitations should be explored and additional studies should be conducted.

A Multicenter, Prospective, Randomized Controlled Trial Evaluating the Efficacy of Rectal Diclofenac and Sublingual Nitroglycerin as a Combined Prophylactic Treatment for Post-ERCP Pancreatitis.

PubMed

Tomoda, Takeshi; Kato, Hironari; Mizukawa, Sho; Muro, Shinichiro; Akimoto, Yutaka; Uchida, Daisuke; Matsumoto, Kazuyuki; Yamamoto, Naoki; Horiguchi, Shigeru; Tsutsumi, Koichiro; Okada, Hiroyuki

2016-01-01

Acute pancreatitis is the major complication of endoscopic retrograde cholangiopancreatography (ERCP). A preliminary research suggested that the administration of nonsteroidal anti-inflammatory drugs (NSAIDs) with nitroglycerin might reduce the incidence of post-ERCP pancreatitis (PEP) more effectively than NSAIDs alone. We conduct a two-arm, multicenter, prospective, randomized, superiority trial to evaluate the additional effect of nitroglycerin for prevention of PEP. A total of 900 patients randomly receive 50 mg diclofenac suppository either alone or with 5 mg isosorbide dinitrate sublingual tablet. The primary endpoint is the occurrence of PEP. This study will clarify whether NSAIDs plus nitroglycerin can prevent PEP.

Positive psychotherapy for smoking cessation enhanced with text messaging: Protocol for a randomized controlled trial.

PubMed

Kahler, Christopher W; Surace, Anthony; Rebecca, E F; Gordon, B A; Cioe, Patricia A; Spillane, Nichea S; Parks, Acacia; Bock, Beth C; Brown, Richard A

2018-06-21

Despite reductions in cigarette smoking in the U.S., improvements in the efficacy of smoking cessation treatments are needed, as rates of sustained abstinence remain disappointingly low. Both low positive affect and high negative affect contribute to smoking relapse and constitute viable targets for smoking cessation interventions. Although some clinical trials have evaluated interventions to address depression as a smoking relapse risk factor, very few have focused on positive affect. Recently, we developed and conducted a preliminary clinical trial of a smoking cessation treatment that targets positive affect and cognitions by incorporating interventions rooted in positive psychology. The current randomized controlled trial will expand upon this preliminary trial to test whether this positive psychology-informed approach results in higher smoking cessation rates compared to a time-matched standard smoking cessation treatment control. Three hundred and forty adult daily smokers will be randomly assigned to either positive psychotherapy for smoking cessation or standard behavioral smoking cessation counseling. Participants will meet weekly with a study counselor for 6 weeks and will receive transdermal nicotine patch and text messaging smoking cessation support. Additionally, text messaging in the positive psychotherapy condition will encourage engagement in positive psychology-specific strategies for boosting mood and staying smoke free. Smoking cessation outcomes will be measured at 12, 26, and 52 weeks following target quit date. Results from this study will provide evidence on whether incorporating positive psychology interventions into smoking cessation treatment can improve smoking cessation outcomes relative to standard behavioral counseling with nicotine patch and text messaging. Copyright © 2018. Published by Elsevier Inc.

Infant-mother attachment can be improved through group intervention: a preliminary evaluation in Spain in a non-randomized controlled trial.

PubMed

Torres, Bárbara; Alonso-Arbiol, Itziar; Cantero, María José; Abubakar, Amina

2011-11-01

The quality of infant-mother attachment has been linked to competence in different domains of child development. Research indicates that early intervention can enhance the quality of infant-mother attachment, though its efficacy in a group format has yet to be evaluated. The current study is aimed at examining the usefulness of a group intervention in enhancing infant-mother attachment. An intervention aimed at addressing aspects such as maternal responsivity, sensitivity and childrearing behaviour was developed by the researchers and experienced psychologists. The intervention spanned a period of 14 months starting from the third quarter of pregnancy. The intervention was evaluated among 24 mothers from the Basque region of Spain. The sample consisted of children of both genders in a similar proportion: 45.8% were boys and 54.2% were girls. The children in this sample were full-term born and did not present symptoms of any serious pre- or postnatal complications. The intervention had a statistically non-significant medium effect. Infants whose mothers had received the intervention showed higher rates of secure attachment compared to children from the control group, as assessed by the Strange Situation observation procedure. A potentially significant confounding variable, maternal attachment, was balanced across the intervention and comparison groups. We can tentatively point out that a group intervention may enhance the quality of infant-mother attachment. Nevertheless, because the study design was not randomized, the results of this study remain preliminary and need replication in a full randomized controlled trial designed study.

Increasing discomfort tolerance predicts incentive senitization of exercise reinforcement: Preliminary results from a randomized controlled intervention to increase the reinforcing value of exercise in overweight to obese adu

USDA-ARS?s Scientific Manuscript database

Objective: The reinforcing (motivating) value of exercise/physical activity (RRVex) predicts usual exercise behavior and meeting of physical activity guidelines. Recent cross-sectional evidence suggests, for the first time, that greater tolerance for the discomfort experienced during exercise is ass...

Treatment of female pattern hair loss.

PubMed

Hassani, Masoumeh; Gorouhi, Farzam; Babakoohi, Shahab; Moghadam-Kia, Siamak; Firooz, Alireza

2012-01-01

Female pattern hair loss (FPHL) as a distinctive entity was first described about 30 years ago. The objective of this study was to perform a systematic review of all randomized controlled trials for treatment of FPHL. A preliminary search was carried out in several databases up to August 2008 to identify all randomized controlled trials on nonsurgical interventions for treatment of FPHL. Studies reporting fewer than 10 patients and non-English articles were excluded. Additionally, references of relevant articles and reviews were checked manually in search for additional sources. Among 238 citations found in the preliminary search, 12 fulfilled all criteria to be included in the systematic review. Topical minoxidil 1% to 5% for 24 to 48 weeks was shown to be effective in FPHL and its effect was not related to age or androgen level of patients. In addition, it may be effective in women with FPHL, both with and without hyperandrogenism, and in young and old premenopausal or postmenopausal. In patients with increased serum androgens, oral flutamide but not finasteride or cyproterone acetate was more effective than no treatment. Topical minoxidil is effective in patients with FPHL, with or without hyperandrogenism, but there is limited evidence for the efficacy of antiandrogens.

Acceptability and preliminary efficacy of a tailored online HIV/STI testing intervention for young men who have sex with men: the Get Connected! program.

PubMed

Bauermeister, José A; Pingel, Emily S; Jadwin-Cakmak, Laura; Harper, Gary W; Horvath, Keith; Weiss, Gretchen; Dittus, Patricia

2015-10-01

Southeast Michigan accounts for over 70 % of all HIV/STI cases in the state, with young men who have sex with men (YMSM) between the ages of 13 and 24 encumbering the largest burden in HIV/STI incidence. Using community-based participatory research principles, we developed and pilot tested a web-based, randomized control trial seeking to promote HIV/STI testing ("Get Connected!") among YMSM (N = 130; ages 15-24). Randomized participants completed a baseline assessment and shown a test-locator condition (control) or a tailored, personalized site (treatment). At 30-day follow-up, we found high acceptability among YMSM in both conditions, yet higher credibility of intervention content among YMSM in the treatment group (d = .55). Furthermore, 30 participants reported testing by following, with the majority of these participants (73.3 %; n = 22) completing the treatment condition, a clinically meaningful effect (d = .34) suggesting preliminary efficacy for the intervention. These results demonstrate the potential of the intervention, and suggest that a larger efficacy trial may be warranted.

Control of Networked Traffic Flow Distribution - A Stochastic Distribution System Perspective

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

Wang, Hong; Aziz, H M Abdul; Young, Stan

Networked traffic flow is a common scenario for urban transportation, where the distribution of vehicle queues either at controlled intersections or highway segments reflect the smoothness of the traffic flow in the network. At signalized intersections, the traffic queues are controlled by traffic signal control settings and effective traffic lights control would realize both smooth traffic flow and minimize fuel consumption. Funded by the Energy Efficient Mobility Systems (EEMS) program of the Vehicle Technologies Office of the US Department of Energy, we performed a preliminary investigation on the modelling and control framework in context of urban network of signalized intersections.more » In specific, we developed a recursive input-output traffic queueing models. The queue formation can be modeled as a stochastic process where the number of vehicles entering each intersection is a random number. Further, we proposed a preliminary B-Spline stochastic model for a one-way single-lane corridor traffic system based on theory of stochastic distribution control.. It has been shown that the developed stochastic model would provide the optimal probability density function (PDF) of the traffic queueing length as a dynamic function of the traffic signal setting parameters. Based upon such a stochastic distribution model, we have proposed a preliminary closed loop framework on stochastic distribution control for the traffic queueing system to make the traffic queueing length PDF follow a target PDF that potentially realizes the smooth traffic flow distribution in a concerned corridor.« less

Android Robot-Mediated Mock Job Interview Sessions for Young Adults with Autism Spectrum Disorder: A Pilot Study

PubMed Central

Kumazaki, Hirokazu; Warren, Zachary; Corbett, Blythe A.; Yoshikawa, Yuichiro; Matsumoto, Yoshio; Higashida, Haruhiro; Yuhi, Teruko; Ikeda, Takashi; Ishiguro, Hiroshi; Kikuchi, Mitsuru

2017-01-01

The feasibility and preliminary efficacy of an android robot-mediated mock job interview training in terms of both bolstering self-confidence and reducing biological levels of stress in comparison to a psycho-educational approach human interview was assessed in a randomized study. Young adults (ages 18–25 years) with autism spectrum disorder (ASD) were randomized to participate either in a mock job interview training with our android robot system (n = 7) or a self-paced review of materials about job-interviewing skills (n = 8). Baseline and outcome measurements of self-reported performance/efficacy and salivary cortisol were obtained after a mock job interview with a human interviewer. After training sessions, individuals with ASD participating in the android robot-mediated sessions reported marginally improved self-confidence and demonstrated significantly lower levels of salivary cortisol as compared to the control condition. These results provide preliminary support for the feasibility and efficacy of android robot-mediated learning. PMID:28955254

Android Robot-Mediated Mock Job Interview Sessions for Young Adults with Autism Spectrum Disorder: A Pilot Study.

PubMed

Kumazaki, Hirokazu; Warren, Zachary; Corbett, Blythe A; Yoshikawa, Yuichiro; Matsumoto, Yoshio; Higashida, Haruhiro; Yuhi, Teruko; Ikeda, Takashi; Ishiguro, Hiroshi; Kikuchi, Mitsuru

2017-01-01

The feasibility and preliminary efficacy of an android robot-mediated mock job interview training in terms of both bolstering self-confidence and reducing biological levels of stress in comparison to a psycho-educational approach human interview was assessed in a randomized study. Young adults (ages 18-25 years) with autism spectrum disorder (ASD) were randomized to participate either in a mock job interview training with our android robot system ( n  = 7) or a self-paced review of materials about job-interviewing skills ( n  = 8). Baseline and outcome measurements of self-reported performance/efficacy and salivary cortisol were obtained after a mock job interview with a human interviewer. After training sessions, individuals with ASD participating in the android robot-mediated sessions reported marginally improved self-confidence and demonstrated significantly lower levels of salivary cortisol as compared to the control condition. These results provide preliminary support for the feasibility and efficacy of android robot-mediated learning.

The preliminary effect of a parenting program for Korean American mothers: a randomized controlled experimental study.

PubMed

Kim, Eunjung; Cain, Kevin C; Webster-Stratton, Carolyn

2008-09-01

Traditional Korean American discipline is characterized by a lack of expression of affection and use of harsh discipline. The purpose of this study was to pilot test the effect of the Incredible Years Parenting Program among Korean American mothers. A randomized controlled experimental study design was used; 29 first-generation Korean American mothers of young children (3-8 years old) were randomly assigned to intervention (n=20) and control (n=9) groups. Intervention group mothers received a 12-week parenting program. Control group mothers did not receive the intervention. Mothers reported on discipline styles (positive, appropriate, and harsh), level of acculturation, and their child's outcomes (behavioral problems and social competence) at pre-, post-, and 1-year follow-up intervals. After completing the program, intervention group mothers significantly increased use of positive discipline as compared to control group mothers. Among intervention group mothers, high-acculturated mothers significantly increased appropriate discipline whereas low-acculturated mothers significantly decreased harsh discipline. In the 1-year follow-up, intervention group mothers maintained the significant effect for positive discipline. Providing this program appears to be a promising way of promoting positive discipline among Korean American mothers.

Brief narrative exposure therapy for posttraumatic stress in Iraqi refugees: a preliminary randomized clinical trial.

PubMed

Hijazi, Alaa M; Lumley, Mark A; Ziadni, Maisa S; Haddad, Luay; Rapport, Lisa J; Arnetz, Bengt B

2014-06-01

Many Iraqi refugees suffer from posttraumatic stress. Efficient, culturally sensitive interventions are needed, and so we adapted narrative exposure therapy into a brief version (brief NET) and tested its effects in a sample of traumatized Iraqi refugees. Iraqi refugees in the United States reporting elevated posttraumatic stress (N = 63) were randomized to brief NET or waitlist control conditions in a 2:1 ratio; brief NET was 3 sessions, conducted individually, in Arabic. Positive indicators (posttraumatic growth and well-being) and symptoms (posttraumatic stress, depressive, and somatic) were assessed at baseline and 2- and 4-month follow-up. Treatment participation (95.1% completion) and study retention (98.4% provided follow-up data) were very high. Significant condition by time interactions showed that those receiving brief NET had greater posttraumatic growth (d = 0.83) and well-being (d = 0.54) through 4 months than controls. Brief NET reduced symptoms of posttraumatic stress (d = -0.48) and depression (d = -0.46) more, but only at 2 months; symptoms of controls also decreased from 2 to 4 months, eliminating condition differences at 4 months. Three sessions of brief NET increased growth and well-being and led to symptom reduction in highly traumatized Iraqi refugees. This preliminary study suggests that brief NET is both acceptable and potentially efficacious in traumatized Iraqi refugees. Copyright © 2014 International Society for Traumatic Stress Studies.

Long-Term Chamomile Therapy of Generalized Anxiety Disorder: A Study Protocol for a Randomized, Double-Blind, Placebo- Controlled Trial.

PubMed

Mao, Jun J; Li, Qing S; Soeller, Irene; Rockwell, Kenneth; Xie, Sharon X; Amsterdam, Jay D

2014-11-01

Anxiety symptoms are among the most common reasons for consumers to use Complementary and Alternative Medicine (CAM) therapy. Although many botanicals have been proposed as putative remedies for anxiety symptoms, there has been a paucity of controlled trials of these remedies. A preliminary study of the anxiolytic effect of Chamomile ( Matricaria recutita ) in humans suggests that chamomile may have anxiolytic and antidepressant activity. We now seek to conduct a 5-year randomized, double-blind, placebo-substitution study to examine the short and long-term safety and efficacy of chamomile extract in Generalized Anxiety Disorder (GAD). 180 subjects with moderate to severe GAD will receive initial open-label pharmaceutical-grade chamomile extract 500-1,500 mg daily for 8 weeks. Responders to treatment who remain well for an additional 4 weeks of consolidation therapy, will be randomized to double-blind continuation therapy with either chamomile extract 500-1,500 mg daily or placebo for an additional 26 weeks. The primary outcome will be the time to relapse during study continuation therapy in each treatment condition. Secondary outcomes will include the proportion of subjects in each treatment condition who relapse, as well as the proportion of subjects with treatment-emergent adverse events. Quality of life ratings will also be compared between treatment conditions during short and long-term therapy. Many individuals with mental disorders decline conventional therapy and seek CAM therapies for their symptoms. Thus, the identification of effective CAM therapy is of relevance to reducing the burden of mental illness. This study builds upon our prior findings of significant superiority of chamomile versus placebo in reducing GAD symptoms. We now extend these preliminary findings by conducting a randomized long-term safety and efficacy study of chamomile in GAD.

A preliminary path analysis of expectancy and patient-provider encounter in an open-label randomized controlled trial of spinal manipulation for cervicogenic headache.

PubMed

Haas, Mitchell; Aickin, Mikel; Vavrek, Darcy

2010-01-01

The purpose of this article was to present a preliminary model to identify the effects of expectancy of treatment success and the patient-provider encounter (PPE) on outcomes in an open-label randomized trial. Eighty participants with chronic cervicogenic headache (CGH) were randomized to 4 groups: 2 levels of treatment dose (8 or 16) and 2 levels of therapy from a chiropractor (spinal manipulation or light massage). Providers were instructed to have equal enthusiasm for all care. Structural equation modeling with standardized path coefficients (beta) was used in a path analysis to identify the effects of patient expectancy and the PPE on CGH pain. The model included monthly pain from baseline to 12 weeks. Expectancy and PPE were evaluated on Likert scales. The patient-provider encounter was measured as patient perception of chiropractor enthusiasm, confidence, and comfort with care. Baseline patient expectancy was balanced across groups. The PPE measures were balanced across groups and consistent over the 8-week treatment period. Treatment and baseline pain had the strongest effects on pain outcomes (|beta| = .46-.59). Expectations had little effect on pain (abs value(beta) < .15). The patient-provider encounter had a weak effect on pain (abs value(beta)= .03-.27) and on subsequent confidence in treatment success (abs value(beta)= .09 and .12). Encouraging equipoise in the PPE and balancing expectancy across treatment groups may protect against some confounding related to the absence of blinding in a randomized controlled trial of pain. In this trial, their effects were found to be small relative to the effects of treatment and baseline values. Copyright 2010 National University of Health Sciences. Published by Mosby, Inc. All rights reserved.

Preliminary evidence that cinnamon improves menstrual cyclicity in women with polycystic ovary syndrome: a randomized controlled trial.

PubMed

Kort, Daniel H; Lobo, Roger A

2014-11-01

To determine the effect of cinnamon on menstrual cyclicity and metabolic dysfunction in women with polycystic ovary syndrome (PCOS). In a prospective, placebo controlled, double-blinded randomized trial, 45 women with PCOS were randomized (1:1) to receive cinnamon supplements (1.5 g/d) or placebo for 6 months. Menstrual cyclicity (average cycles/month) during the 6 months study period was compared between the 2 groups using the Mann-Whitney U test. Changes in menstrual cyclicity and insulin resistance between baseline and the 6 month study period were compared between the 2 groups using Wilcoxon signed rank tests. The 45 women were randomized, 26 women completed 3 months of the study, and 17 women completed the entire 6 months of the study. During the 6 month intervention, menstrual cycles were more frequent in patients taking cinnamon compared with patients taking placebo (median, 0.75; interquartile range, 0.5-0.83 vs median, 0.25; interquartile range, 0-0.54; P = .0085; Mann Whitney U). In patients taking cinnamon, menstrual cyclicity improved from baseline (+ 0.23 cycles/month 95% confidence interval, 0.099-0.36), yet did not improve for women taking placebo. (P = .0076, Wilcoxon signed rank). Samples (n = 5) of serum from the luteal phase in different patients within the cinnamon group were thawed and ovulatory progesterone levels (>3 ng/mL) confirmed. Luteal phase progesterone levels (>3 ng/mL, n = 5) confirmed ovulatory menses. Measures of insulin resistance or serum androgen levels did not change for either group. These preliminary data suggest that cinnamon supplementation improves menstrual cyclicity and may be an effective treatment option for some women with PCOS. Copyright © 2014 Elsevier Inc. All rights reserved.

Working Memory Training in ADHD: Controlling for Engagement, Motivation, and Expectancy of Improvement (Pilot Study).

PubMed

Mawjee, Karizma; Woltering, Steven; Lai, Nathan; Gotlieb, Howell; Kronitz, Reena; Tannock, Rosemary

2017-09-01

The aim of this study was to evaluate whether a shortened-length session of CogMed Working Memory Training (CWMT) would be a suitable active control group and evaluate study protocol to aid in design refinements for a larger randomized controlled trial (RCT). Thirty-eight post-secondary students diagnosed with ADHD were randomized into 25 sessions of standard (45 min/session) or shortened (15 min/session) CWMT, or into a waitlist control group. There was no significant difference in completion rate or training index score between the standard- and shortened-length groups indicating that both groups showed improvement and put forth good effort during training. Preliminary findings suggest that shorter training sessions may induce similar levels of engagement, motivation, and expectancy of improvement in participants. We conclude that a larger scale RCT that utilizes shortened-length training as an active control group is warranted, but that a few modifications to the study protocol will be required.

Turbulence flight director analysis and preliminary simulation

NASA Technical Reports Server (NTRS)

Johnson, D. E.; Klein, R. E.

1974-01-01

A control column and trottle flight director display system is synthesized for use during flight through severe turbulence. The column system is designed to minimize airspeed excursions without overdriving attitude. The throttle system is designed to augment the airspeed regulation and provide an indication of the trim thrust required for any desired flight path angle. Together they form an energy management system to provide harmonious display indications of current aircraft motions and required corrective action, minimize gust upset tendencies, minimize unsafe aircraft excursions, and maintain satisfactory ride qualities. A preliminary fixed-base piloted simulation verified the analysis and provided a shakedown for a more sophisticated moving-base simulation to be accomplished next. This preliminary simulation utilized a flight scenario concept combining piloting tasks, random turbulence, and discrete gusts to create a high but realistic pilot workload conducive to pilot error and potential upset. The turbulence director (energy management) system significantly reduced pilot workload and minimized unsafe aircraft excursions.

Randomized Controlled Trial: Multimodal Anxiety and Social Skill Intervention for Adolescents with Autism Spectrum Disorder

PubMed Central

White, Susan W.; Ollendick, Thomas; Albano, Anne Marie; Oswald, Donald; Johnson, Cynthia; Southam-Gerow, Michael A.; Kim, Inyoung; Scahill, Lawrence

2012-01-01

Anxiety is common among adolescents with autism spectrum disorders (ASD) and may amplify the core social disability, thus necessitating combined treatment approaches. This pilot, randomized controlled trial (RCT) evaluated the feasibility and preliminary outcomes of the Multimodal Anxiety and Social Skills Intervention (MASSI) program in a sample of 30 adolescents with ASD and anxiety symptoms of moderate or greater severity. The treatment was acceptable to families, subject adherence was high, and therapist fidelity was high. A 16% improvement in ASD social impairment (within-group effect size = 1.18) was observed on a parent-reported scale. Although anxiety symptoms declined by 26%, the change was not statistically significant. These findings suggest MASSI is a feasible treatment program and further evaluation is warranted. PMID:22735897

A Preliminary Randomized Controlled Trial of a Behavioral Exercise Intervention for Smoking Cessation

PubMed Central

Bloom, Erika Litvin; Strong, David R.; Riebe, Deborah; Marcus, Bess H.; Desaulniers, Julie; Fokas, Kathryn; Brown, Richard A.

2014-01-01

Introduction: Previous exercise intervention studies for smoking cessation have been challenged by a number of methodological limitations that confound the potential efficacy of aerobic exercise for smoking cessation. Methods: The preliminary efficacy of a behavioral exercise intervention that incorporated features designed to address prior limitations was tested in a randomized controlled trial (RCT). Sixty-one smokers (65.6% female, mean age = 47.3 years, smoked a mean of 19.7 cigarettes/day) were randomized to receive either a 12-week exercise intervention or a 12-week health education contact control. Participants in both conditions received an 8-week telephone-delivered, standard smoking cessation protocol (with the transdermal nicotine patch). Follow-ups were conducted at the end of treatment (EOT), 6- and 12-month timepoints. Results: There were no differences between conditions with respect to the number of weekly exercise or health education sessions attended (9.3±2.8 vs. 9.3±3.0, respectively). While not statistically significant, participants in the exercise condition demonstrated higher verified abstinence rates (EOT: 40% vs. 22.6%, odds ratio [OR] = 2.28; 6- and 12-month follow-ups: 26.7% vs. 12.9%, OR = 2.46). Irrespective of treatment condition, higher levels of moderate-to-vigorous exercise were associated with lower levels of depressive symptoms during the intervention. Conclusions: The results of this small RCT point toward the benefit of a behavioral exercise intervention designed to address previous methodological limitations for smoking cessation. Given the potential public health impact of the demonstrated efficacy of exercise for smoking cessation, the continued development and optimization of exercise interventions for smokers through larger RCTs merits pursuit. PMID:24812023

A multicenter, randomized, controlled trial of osteopathic manipulative treatment on preterms.

PubMed

Cerritelli, Francesco; Pizzolorusso, Gianfranco; Renzetti, Cinzia; Cozzolino, Vincenzo; D'Orazio, Marianna; Lupacchini, Mariacristina; Marinelli, Benedetta; Accorsi, Alessandro; Lucci, Chiara; Lancellotti, Jenny; Ballabio, Silvia; Castelli, Carola; Molteni, Daniela; Besana, Roberto; Tubaldi, Lucia; Perri, Francesco Paolo; Fusilli, Paola; D'Incecco, Carmine; Barlafante, Gina

2015-01-01

Despite some preliminary evidence, it is still largely unknown whether osteopathic manipulative treatment improves preterm clinical outcomes. The present multi-center randomized single blind parallel group clinical trial enrolled newborns who met the criteria for gestational age between 29 and 37 weeks, without any congenital complication from 3 different public neonatal intensive care units. Preterm infants were randomly assigned to usual prenatal care (control group) or osteopathic manipulative treatment (study group). The primary outcome was the mean difference in length of hospital stay between groups. A total of 695 newborns were randomly assigned to either the study group (n= 352) or the control group (n=343). A statistical significant difference was observed between the two groups for the primary outcome (13.8 and 17.5 days for the study and control group respectively, p<0.001, effect size: 0.31). Multivariate analysis showed a reduction of the length of stay of 3.9 days (95% CI -5.5 to -2.3, p<0.001). Furthermore, there were significant reductions with treatment as compared to usual care in cost (difference between study and control group: 1,586.01€; 95% CI 1,087.18 to 6,277.28; p<0.001) but not in daily weight gain. There were no complications associated to the intervention. Osteopathic treatment reduced significantly the number of days of hospitalization and is cost-effective on a large cohort of preterm infants.

A Yoga Intervention for Posttraumatic Stress: A Preliminary Randomized Control Trial.

PubMed

Jindani, Farah; Turner, Nigel; Khalsa, Sat Bir S

2015-01-01

Yoga may be effective in the reduction of PTSD symptomology. The purpose of this study was to evaluate the impact of a Kundalini Yoga (KY) treatment on PTSD symptoms and overall wellbeing. To supplement the current field of inquiry, a pilot randomized control trial (RCT) was conducted comparing an 8-session KY intervention with a waitlist control group. 80 individuals with current PTSD symptoms participated. Both groups demonstrated changes in PTSD symptomology but yoga participants showed greater changes in measures of sleep, positive affect, perceived stress, anxiety, stress, and resilience. Between-groups effect sizes were small to moderate (0.09-0.25). KY may be an adjunctive or alternative intervention for PTSD. Findings indicate the need for further yoga research to better understand the mechanism of yoga in relation to mental and physical health, gender and ethnic comparisons, and short- and long-term yoga practice for psychiatric conditions.

A Yoga Intervention for Posttraumatic Stress: A Preliminary Randomized Control Trial

PubMed Central

Jindani, Farah; Turner, Nigel; Khalsa, Sat Bir S.

2015-01-01

Yoga may be effective in the reduction of PTSD symptomology. The purpose of this study was to evaluate the impact of a Kundalini Yoga (KY) treatment on PTSD symptoms and overall wellbeing. To supplement the current field of inquiry, a pilot randomized control trial (RCT) was conducted comparing an 8-session KY intervention with a waitlist control group. 80 individuals with current PTSD symptoms participated. Both groups demonstrated changes in PTSD symptomology but yoga participants showed greater changes in measures of sleep, positive affect, perceived stress, anxiety, stress, and resilience. Between-groups effect sizes were small to moderate (0.09–0.25). KY may be an adjunctive or alternative intervention for PTSD. Findings indicate the need for further yoga research to better understand the mechanism of yoga in relation to mental and physical health, gender and ethnic comparisons, and short- and long-term yoga practice for psychiatric conditions. PMID:26366179

A Method for the Control of Multigrasp Myoelectric Prosthetic Hands

PubMed Central

Dalley, Skyler Ashton; Varol, Huseyin Atakan; Goldfarb, Michael

2012-01-01

This paper presents the design and preliminary experimental validation of a multigrasp myoelectric controller. The described method enables direct and proportional control of multigrasp prosthetic hand motion among nine characteristic postures using two surface electromyography electrodes. To assess the efficacy of the control method, five nonamputee subjects utilized the multigrasp myoelectric controller to command the motion of a virtual prosthesis between random sequences of target hand postures in a series of experimental trials. For comparison, the same subjects also utilized a data glove, worn on their native hand, to command the motion of the virtual prosthesis for similar sequences of target postures during each trial. The time required to transition from posture to posture and the percentage of correctly completed transitions were evaluated to characterize the ability to control the virtual prosthesis using each method. The average overall transition times across all subjects were found to be 1.49 and 0.81 s for the multigrasp myoelectric controller and the native hand, respectively. The average transition completion rates for both were found to be the same (99.2%). Supplemental videos demonstrate the virtual prosthesis experiments, as well as a preliminary hardware implementation. PMID:22180515

Processing speed and working memory training in multiple sclerosis: a double-blind randomized controlled pilot study.

PubMed

Hancock, Laura M; Bruce, Jared M; Bruce, Amanda S; Lynch, Sharon G

2015-01-01

Between 40-65% of multiple sclerosis patients experience cognitive deficits, with processing speed and working memory most commonly affected. This pilot study investigated the effect of computerized cognitive training focused on improving processing speed and working memory. Participants were randomized into either an active or a sham training group and engaged in six weeks of training. The active training group improved on a measure of processing speed and attention following cognitive training, and data trended toward significance on measures of other domains. Results provide preliminary evidence that cognitive training with multiple sclerosis patients may produce moderate improvement in select areas of cognitive functioning.

Lifestyle interventions to reduce risk of diabetes among women with prior gestational diabetes mellitus.

PubMed

Chasan-Taber, Lisa

2015-01-01

While lifestyle interventions involving exercise and a healthy diet in high-risk adults have been found to reduce progression to type 2 diabetes by >50%, little attention has been given to the potential benefits of such strategies in women with a history of gestational diabetes mellitus (GDM). We conducted a literature search of PubMed for English language studies of randomized controlled trials of lifestyle interventions among women with a history of GDM. In total, nine studies were identified which fulfilled the eligibility criteria. The majority of randomized trials of lifestyle interventions in women with GDM have been limited to pilot or feasibility studies. However, preliminary findings suggest that such interventions can improve diabetes risk factors in women with a history of GDM. Larger, well-designed controlled randomized trials are needed to assess the effects of lifestyle interventions on preventing subsequent progression to type 2 diabetes among women with GDM. Copyright © 2014 Elsevier Ltd. All rights reserved.

Promoting a Positive Middle School Transition: A Randomized-Controlled Treatment Study Examining Self-Concept and Self-Esteem.

PubMed

Coelho, Vitor Alexandre; Marchante, Marta; Jimerson, Shane R

2017-03-01

The middle school transition is a salient developmental experience impacting adolescents around the world. This study employed a randomized-controlled treatment design, with randomization at the school level, to investigate the impact of a school adjustment program for middle school transition and potential gender differences. Participants included 1147 students (M age  = 9.62; SD = 0.30, 45.7 % girls), who were assessed at four time points during the transition, regarding five dimensions of self-concept (academic, social, emotional, physical and family) and self-esteem. Parallel growth curves were employed to analyze the evolution of self-concept. Following the transition to middle school, students reported lower levels of self-concept (academic, emotional and physical) and self-esteem, while participation in the intervention led to increases in self-esteem and gains in social self-concept. No gender differences were found. These results provide preliminary evidence supporting such interventions in early middle school transitions.

A telephonic mindfulness-based intervention for persons with sickle cell disease: study protocol for a randomized controlled trial.

PubMed

Williams, Hants; Silva, Susan; Simmons, Leigh Ann; Tanabe, Paula

2017-05-15

One of the most difficult symptoms for persons with sickle cell disease (SCD) to manage is chronic pain. Chronic pain impacts approximately one-third of persons with SCD and is associated with increased pain intensity, pain behavior, and frequency and duration of hospital visits. A promising category of nonpharmacological interventions for managing both physical and affective components of pain are mindfulness-based interventions (MBIs). The primary aim of this study is to conduct a randomized controlled study to evaluate the acceptability and feasibility, as well as to determine the preliminary efficacy, of a telephonic MBI for adults with SCD who have chronic pain. We will enroll 60 adult patients with SCD and chronic pain at an outpatient comprehensive SCD center in the southeastern United States. Patients will be randomized to either an MBI or a wait-listed control group. The MBI group will complete a six-session (60 minutes), telephonically delivered, group-based MBI program. The feasibility, acceptability, and efficacy of the MBI regarding pain catastrophizing will be assessed by administering questionnaires at baseline and weeks 1, 3, and 6. In addition, ten randomly selected MBI participants will complete semistructured interviews to help determine intervention acceptability. In this study protocol, we report detailed methods of the randomized controlled trial. Findings of this study will be useful to determine the acceptability, feasibility, and efficacy of an MBI for persons with SCD and chronic pain. ClinicalTrials.gov identifier: NCT02394587 . Registered on 9 February 2015.

Cervical epidural injections in chronic discogenic neck pain without disc herniation or radiculitis: preliminary results of a randomized, double-blind, controlled trial.

PubMed

Manchikanti, Laxmaiah; Cash, Kimberly A; Pampati, Vidyasagar; Wargo, Bradley W; Malla, Yogesh

2010-01-01

Chronic neck pain is a common problem in the adult population with a typical 12-month prevalence of 30% to 50%. However, there is a lack of consensus regarding the causes and treatments of chronic neck pain. Despite limited evidence, cervical epidural injections are one of the commonly performed non-surgical interventions in the management of chronic neck pain. A randomized, double-blind, active control trial. An interventional pain management practice, a specialty referral center, a private practice setting in the United States. To evaluate the effectiveness of cervical interlaminar epidural injections with local anesthetic with or without steroids in the management of chronic neck pain with or without upper extremity pain in patients without disc herniation or radiculitis or facet joint pain. Patients without disc herniation or radiculitis and negative for facet joint pain by means of controlled diagnostic medial branch blocks were randomly assigned to one of 2 groups: injection of local anesthetic only or local anesthetic mixed with non-particulate betamethasone. Seventy patients were included in this analysis. Randomization was performed by computer-generated random allocation sequence by simple randomization. Multiple outcome measures were utilized including the Numeric Rating Scale (NRS), the Neck Disability Index (NDI), employment status, and opioid intake with assessment at 3, 6, and 12 months post-treatment. Significant pain relief or functional status was defined as a 50% or more reduction. Significant pain relief (> or = 50%) was demonstrated in 80% of patients in both groups and functional status improvement (> or = 50%) in 69% of Group I and 80% of Group II. The overall average procedures per year were 3.9 +/- 1.01 in Group I and 3.9 +/- 0.8 in Group II with an average total relief per year of 40.3 +/- 14.1 weeks in Group I and 42.1 +/- 9.9 weeks in Group II over a period of 52 weeks in the successful group. The results of this study are limited by the lack of a placebo group and a preliminary report of 70 patients, with 35 patients in each group. Cervical interlaminar epidural injections with local anesthetic with or without steroids may be effective in patients with chronic function-limiting discogenic.

Randomized clinical trial of bright light therapy for antepartum depression: preliminary findings.

PubMed

Epperson, C Neill; Terman, Michael; Terman, Jiuan Su; Hanusa, Barbara H; Oren, Dan A; Peindl, Kathleen S; Wisner, Katherine L

2004-03-01

Bright light therapy was shown to be a promising treatment for depression during pregnancy in a recent open-label study. In an extension of this work, we report findings from a double-blind placebo-controlled pilot study. Ten pregnant women with DSM-IV major depressive disorder were randomly assigned from April 2000 to January 2002 to a 5-week clinical trial with either a 7000 lux (active) or 500 lux (placebo) light box. At the end of the randomized controlled trial, subjects had the option of continuing in a 5-week extension phase. The Structured Interview Guide for the Hamilton Depression Scale-Seasonal Affective Disorder Version was administered to assess changes in clinical status. Salivary melatonin was used to index circadian rhythm phase for comparison with antidepressant results. Although there was a small mean group advantage of active treatment throughout the randomized controlled trial, it was not statistically significant. However, in the longer 10-week trial, the presence of active versus placebo light produced a clear treatment effect (p =.001) with an effect size (0.43) similar to that seen in antidepressant drug trials. Successful treatment with bright light was associated with phase advances of the melatonin rhythm. These findings provide additional evidence for an active effect of bright light therapy for antepartum depression and underscore the need for an expanded randomized clinical trial.

Task-oriented training with computer gaming in people with rheumatoid arthritisor osteoarthritis of the hand: study protocol of a randomized controlled pilot trial.

PubMed

Srikesavan, Cynthia Swarnalatha; Shay, Barbara; Robinson, David B; Szturm, Tony

2013-03-09

Significant restriction in the ability to participate in home, work and community life results from pain, fatigue, joint damage, stiffness and reduced joint range of motion and muscle strength in people with rheumatoid arthritis or osteoarthritis of the hand. With modest evidence on the therapeutic effectiveness of conventional hand exercises, a task-oriented training program via real life object manipulations has been developed for people with arthritis. An innovative, computer-based gaming platform that allows a broad range of common objects to be seamlessly transformed into therapeutic input devices through instrumentation with a motion-sense mouse has also been designed. Personalized objects are selected to target specific training goals such as graded finger mobility, strength, endurance or fine/gross dexterous functions. The movements and object manipulation tasks that replicate common situations in everyday living will then be used to control and play any computer game, making practice challenging and engaging. The ongoing study is a 6-week, single-center, parallel-group, equally allocated and assessor-blinded pilot randomized controlled trial. Thirty people with rheumatoid arthritis or osteoarthritis affecting the hand will be randomized to receive either conventional hand exercises or the task-oriented training. The purpose is to determine a preliminary estimation of therapeutic effectiveness and feasibility of the task-oriented training program. Performance based and self-reported hand function, and exercise compliance are the study outcomes. Changes in outcomes (pre to post intervention) within each group will be assessed by paired Student t test or Wilcoxon signed-rank test and between groups (control versus experimental) post intervention using unpaired Student t test or Mann-Whitney U test. The study findings will inform decisions on the feasibility, safety and completion rate and will also provide preliminary data on the treatment effects of the task-oriented training compared with conventional hand exercises in people with rheumatoid arthritis or osteoarthritis of the hand. ClinicalTrials.gov: NCT01635582.

Role of exercise training in polycystic ovary syndrome: a systematic review and meta-analysis.

PubMed

Benham, J L; Yamamoto, J M; Friedenreich, C M; Rabi, D M; Sigal, R J

2018-06-12

Preliminary evidence suggests exercise in polycystic ovary syndrome (PCOS) may improve reproductive and cardiometabolic parameters. Our primary aim was to determine the impact of exercise training on reproductive health in women with PCOS. Our secondary aim was to determine the effect of exercise training on cardiometabolic indices. A systematic review of published literature was conducted using MEDLINE and EMBASE based on a pre-published protocol (PROSPERO CRD42017065324). The search was not limited by year. Randomized controlled trials, non-randomized controlled trials and uncontrolled trials that evaluated an exercise intervention in women with PCOS and reported reproductive outcomes were included. Reproductive outcomes were analysed semi-quantitatively and a meta-analysis was conducted for reported cardiometabolic outcomes. Of 517 screened abstracts, 14 studies involving 617 women with PCOS were included: seven randomized controlled trials, one non-randomized controlled trial and six uncontrolled trials. There were insufficient published data to describe the effect of exercise interventions on ovulation quantitatively, but semi-quantitative analysis suggested that exercise interventions may improve menstrual regularity, pregnancy and ovulation rates. Our meta-analysis found that exercise improved lipid profiles and decreased waist circumference, systolic blood pressure and fasting insulin. The impact of exercise interventions on reproductive function remains unclear. However, our meta-analysis suggests that exercise interventions may improve cardiometabolic profiles in women with PCOS. © 2018 World Obesity Federation.

Preliminary examination of the efficacy and safety of a standardized chamomile extract for chronic primary insomnia: a randomized placebo-controlled pilot study.

PubMed

Zick, Suzanna M; Wright, Benjamin D; Sen, Ananda; Arnedt, J Todd

2011-09-22

Despite being the most commonly used herbal for sleep disorders, chamomile's (Matricaria recutita) efficacy and safety for treating chronic primary insomnia is unknown. We examined the preliminary efficacy and safety of chamomile for improving subjective sleep and daytime symptoms in patients with chronic insomnia. We performed a randomized, double-blind, placebo-controlled pilot trial in 34 patients aged 18-65 years with DSM-IV primary insomnia for ≥ 6-months. Patients were randomized to 270 mg of chamomile twice daily or placebo for 28-days. The primary outcomes were sleep diary measures. Secondary outcomes included daytime symptoms, safety assessments, and effect size of these measures. There were no significant differences between groups in changes in sleep diary measures, including total sleep time (TST), sleep efficiency, sleep latency, wake after sleep onset (WASO), sleep quality, and number of awakenings. Chamomile did show modest advantage on daytime functioning, although these did not reach statistical significance. Effect sizes were generally small to moderate (Cohen's d ≤ 0.20 to < 0.60) with sleep latency, night time awakenings, and Fatigue Severity Scale (FSS), having moderate effect sizes in favor of chamomile. However, TST demonstrated a moderate effect size in favor of placebo. There were no differences in adverse events reported by the chamomile group compared to placebo. Chamomile could provide modest benefits of daytime functioning and mixed benefits on sleep diary measures relative to placebo in adults with chronic primary insomnia. However, further studies in select insomnia patients would be needed to investigate these conclusions.

Implantable hemodynamic monitoring (the Chronicle IHM system): remote telemonitoring for patients with heart failure.

PubMed

Ho, C

2008-01-01

(1) Remote monitoring for ambulatory heart failure patients uses an implantable device to record hemodynamic data and transmit it to a central server for continuous assessment. (2) Preliminary evidence from observational studies suggests a potential for reducing hospitalizations with the use of right ventricle implantable hemodynamic monitoring (IHM). However, although a multicentre, randomized controlled trial (COMPASS-HF) showed a reduction in hospitalizations in the IHM group the results were not statistically significant and the US Food and Drug Administration panel concluded the trial failed to meet its primary efficacy endpoint. (3) In the COMPASS-HF study the most common device-related complication was lead dislodgement. (4) Large randomized controlled trials are needed to demonstrate the clinical utility of IHM, particularly in terms of its impact on reducing hospitalization and improving patient outcomes.

A Preliminary Study for Evaluating the Dose-Dependent Effect of d-Allulose for Fat Mass Reduction in Adult Humans: A Randomized, Double-Blind, Placebo-Controlled Trial.

PubMed

Han, Youngji; Kwon, Eun-Young; Yu, Mi Kyeong; Lee, Seon Jeong; Kim, Hye-Jin; Kim, Seong-Bo; Kim, Yang Hee; Choi, Myung-Sook

2018-01-31

d-allulose is a rare sugar with zero energy that can be consumed by obese/overweight individuals. Many studies have suggested that zero-calorie d-allulose has beneficial effects on obesity-related metabolism in mouse models, but only a few studies have been performed on human subjects. Therefore, we performed a preliminary study with 121 Korean subjects (aged 20-40 years, body mass index ≥ 23 kg/m²). A randomized controlled trial involving placebo control (sucralose, 0.012 g × 2 times/day), low d-allulose (d-allulose, 4 g × 2 times/day), and high d-allulose (d-allulose, 7 g × 2 times/day) groups was designed. Parameters for body composition, nutrient intake, computed tomography (CT) scan, and plasma lipid profiles were assessed. Body fat percentage and body fat mass were significantly decreased following d-allulose supplementation. The high d-allulose group revealed a significant decrease in not only body mass index (BMI), but also total abdominal and subcutaneous fat areas measured by CT scans compared to the placebo group. There were no significant differences in nutrient intake, plasma lipid profiles, markers of liver and kidney function, and major inflammation markers among groups. These results provide useful information on the dose-dependent effect of d-allulose for overweight/obese adult humans. Based on these results, the efficacy of d-allulose for body fat reduction needs to be validated using dual energy X-ray absorption.

The Efficacy of Adapted MBCT on Core Symptoms and Executive Functioning in Adults With ADHD: A Preliminary Randomized Controlled Trial.

PubMed

Hepark, Sevket; Janssen, Lotte; de Vries, Alicia; Schoenberg, Poppy L A; Donders, Rogier; Kan, Cornelis C; Speckens, Anne E M

2015-11-20

The aim of this study was to examine the effectiveness of mindfulness as a treatment for adults diagnosed with ADHD. A 12-week-adapted mindfulness-based cognitive therapy (MBCT) program is compared with a waiting list (WL) group. Adults with ADHD were randomly allocated to MBCT (n = 55) or waitlist (n = 48). Outcome measures included investigator-rated ADHD symptoms (primary), self-reported ADHD symptoms, executive functioning, depressive and anxiety symptoms, patient functioning, and mindfulness skills. MBCT resulted in a significant reduction of ADHD symptoms, both investigator-rated and self-reported, based on per-protocol and intention-to-treat analyses. Significant improvements in executive functioning and mindfulness skills were found. Additional analyses suggested that the efficacy of MBCT in reducing ADHD symptoms and improving executive functioning is partially mediated by an increase in the mindfulness skill "Act With Awareness." No improvements were observed for depressive and anxiety symptoms, and patient functioning. This study provides preliminary support for the effectiveness of MBCT for adults with ADHD. © The Author(s) 2015.

Preliminary Effectiveness Study of Coping Power Program for Aggressive Children in Pakistan.

PubMed

Mushtaq, Asia; Lochman, John E; Tariq, Pervaiz N; Sabih, Fazaila

2017-10-01

Aggression is a characteristic feature of many psychiatric disorders. To address the scarceness for evidence-based interventions for behavioral problems in Pakistan, we evaluated the effectiveness of culturally adapted version of Coping Power Program. The purpose of the study was to determine the extent to which Coping Power Program is capable of reducing aggressive behavior and improving competent behavior, when delivered in a different culture, i.e., Pakistan. With randomized control trial (RCT) of pre- and post-testing, 112 fourth grade boys were allocated to Coping Power intervention condition and waitlist control condition. The intervention group showed significant reduction in aggression at post assessment, in comparison to control group. Boys who received Coping Power intervention also showed improvements in behavior, social skills, and social cognitive processes, with better anger control and problem solving strategies, in comparison to the control group. The results of the study provide preliminary evidence, supporting the effectiveness of Coping Power Program for Pakistani children. Despite its limitations, the results of this study are promising and suggest that Coping Power is an effective intervention to reduce behavioral problems and promote healthy and positive behaviors in children, even when implemented in different contexts with greater potential for violence exposure.

Clinical effects of an avocado-soybean unsaponifiable extract on arthralgia and osteoarthritis of the temporomandibular joint: preliminary study.

PubMed

Catunda, I S; Vasconcelos, B C do E; Andrade, E S de S; Costa, D F N

2016-08-01

The aim of the present preliminary study was to investigate the effectiveness of an avocado-soybean unsaponifiable extract (ASU) in patients with arthralgia and osteoarthritis of the temporomandibular joint (TMJ). A randomized, double-blind, placebo-controlled trial was carried out. Fourteen women diagnosed with arthralgia and osteoarthritis of the TMJ using the Research Diagnostic Criteria for Temporomandibular Disorders were included in the statistical analysis. The women were allocated randomly to two groups: ASU group and placebo group. Pain was measured using a visual analogue scale and pressure algometer. Mandibular function was evaluated through measurement of mandibular movements. Quality of life was measured using the Oral Health Impact Profile (OHIP-14). The medication (ASU capsules or placebo capsules) was used for 4 months and the total follow-up was 6 months. Those taking the ASU extract had a decrease in pain symptoms and an improvement in quality of life. Moreover, a significant reduction in the use of rescue medication was found in the ASU group compared to the placebo group. This preliminary study provides strong evidence of the effectiveness of an avocado-soybean unsaponifiable extract in patients with degenerative joint diseases and arthralgia in the TMJ. Further studies with larger samples should be performed. Copyright © 2016 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

A Multicenter, Randomized, Controlled Trial of Osteopathic Manipulative Treatment on Preterms

PubMed Central

Cerritelli, Francesco; Pizzolorusso, Gianfranco; Renzetti, Cinzia; Cozzolino, Vincenzo; D’Orazio, Marianna; Lupacchini, Mariacristina; Marinelli, Benedetta; Accorsi, Alessandro; Lucci, Chiara; Lancellotti, Jenny; Ballabio, Silvia; Castelli, Carola; Molteni, Daniela; Besana, Roberto; Tubaldi, Lucia; Perri, Francesco Paolo; Fusilli, Paola; D’Incecco, Carmine; Barlafante, Gina

2015-01-01

Background Despite some preliminary evidence, it is still largely unknown whether osteopathic manipulative treatment improves preterm clinical outcomes. Materials and Methods The present multi-center randomized single blind parallel group clinical trial enrolled newborns who met the criteria for gestational age between 29 and 37 weeks, without any congenital complication from 3 different public neonatal intensive care units. Preterm infants were randomly assigned to usual prenatal care (control group) or osteopathic manipulative treatment (study group). The primary outcome was the mean difference in length of hospital stay between groups. Results A total of 695 newborns were randomly assigned to either the study group (n= 352) or the control group (n=343). A statistical significant difference was observed between the two groups for the primary outcome (13.8 and 17.5 days for the study and control group respectively, p<0.001, effect size: 0.31). Multivariate analysis showed a reduction of the length of stay of 3.9 days (95% CI -5.5 to -2.3, p<0.001). Furthermore, there were significant reductions with treatment as compared to usual care in cost (difference between study and control group: 1,586.01€; 95% CI 1,087.18 to 6,277.28; p<0.001) but not in daily weight gain. There were no complications associated to the intervention. Conclusions Osteopathic treatment reduced significantly the number of days of hospitalization and is cost-effective on a large cohort of preterm infants. PMID:25974071

Alpha Lipoic Acid (ALA) effects on subchorionic hematoma: preliminary clinical results.

PubMed

Porcaro, G; Brillo, E; Giardina, I; Di Iorio, R

2015-09-01

The clinic use of alpha Lipoic Acid (ALA) is linked to its capability to exert antioxidant effects and, more interestingly, to counteract the pathologic changes of complex networks of cytokines, chemokines and growth factors, restoring their physiological state. The aim of this randomized controlled clinical trial was to test the contribution of oral supplementation of ALA to the standard treatment with Progesterone vaginal suppositories, in healing subchorionic hematomas in patients with threatened miscarriage. Controls were administered only Progesterone suppositories. Nineteen pregnant women in the first trimester of gestation, with threatened miscarriage and ultrasound evidence of subchorionic hematoma, were included in the trial and randomly divided in two groups: controls, treated with 400 mg Progesterone (200 mg 2 times per day), given by vaginal suppositories, and case study treated with the same Progesterone dosage, plus ALA, given orally at the dose of 600 mg (300 mg 2 times per day, DAV®, Lo.Li. Pharma srl, Italy). Sixteen patients completed the trial. Treatment was performed until complete resolution of the clinical picture. In both groups, the subjects improved significantly but, in general, a better and faster evolution in the major signs of threatened miscarriage was observed in the subjects treated with ALA and Progesterone. In these patients, the speed of resorption of subchorionic hematoma was significantly (p ≤ 0.05) superior compared to controls. The ALA and Progesterone group showed a faster decrease or disappearance of all symptoms than that observed in the control group, however the difference was not significant. These preliminary results suggest that ALA supplementation significantly contributes to speed up the process of restoration of physiological conditions in threatened miscarriage and ameliorates the medical conditions of both the mothers and the foetus, probably modulating the networks of cytokines, growth factors and other molecules.

Safety and feasibility of transcranial direct current stimulation in pediatric hemiparesis: randomized controlled preliminary study.

PubMed

Gillick, Bernadette T; Feyma, Tim; Menk, Jeremiah; Usset, Michelle; Vaith, Amy; Wood, Teddi Jean; Worthington, Rebecca; Krach, Linda E

2015-03-01

Transcranial direct current stimulation (tDCS) is a form of noninvasive brain stimulation that has shown improved adult stroke outcomes. Applying tDCS in children with congenital hemiparesis has not yet been explored. The primary objective of this study was to explore the safety and feasibility of single-session tDCS through an adverse events profile and symptom assessment within a double-blind, randomized placebo-controlled preliminary study in children with congenital hemiparesis. A secondary objective was to assess the stability of hand and cognitive function. A double-blind, randomized placebo-controlled pretest/posttest/follow-up study was conducted. The study was conducted in a university pediatric research laboratory. Thirteen children, ages 7 to 18 years, with congenital hemiparesis participated. Adverse events/safety assessment and hand function were measured. Participants were randomly assigned to either an intervention group or a control group, with safety and functional assessments at pretest, at posttest on the same day, and at a 1-week follow-up session. An intervention of 10 minutes of 0.7 mA tDCS was applied to bilateral primary motor cortices. The tDCS intervention was considered safe if there was no individual decline of 25% or group decline of 2 standard deviations for motor evoked potentials (MEPs) and behavioral data and no report of adverse events. No major adverse events were found, including no seizures. Two participants did not complete the study due to lack of MEP and discomfort. For the 11 participants who completed the study, group differences in MEPs and behavioral data did not exceed 2 standard deviations in those who received the tDCS (n=5) and those in the control group (n=6). The study was completed without the need for stopping per medical monitor and biostatisticial analysis. A limitation of the study was the small sample size, with data available for 11 participants. Based on the results of this study, tDCS appears to be safe, feasible, and well tolerated in most children with hemiparesis. Future investigations of serial sessions of tDCS in conjunction with rehabilitation in pediatric hemiparesis are indicated to explore the benefit of a synergistic approach to improving hand function. © 2015 American Physical Therapy Association.

Safety and Feasibility of Transcranial Direct Current Stimulation in Pediatric Hemiparesis: Randomized Controlled Preliminary Study

PubMed Central

Feyma, Tim; Menk, Jeremiah; Usset, Michelle; Vaith, Amy; Wood, Teddi Jean; Worthington, Rebecca; Krach, Linda E.

2015-01-01

Background Transcranial direct current stimulation (tDCS) is a form of noninvasive brain stimulation that has shown improved adult stroke outcomes. Applying tDCS in children with congenital hemiparesis has not yet been explored. Objective The primary objective of this study was to explore the safety and feasibility of single-session tDCS through an adverse events profile and symptom assessment within a double-blind, randomized placebo-controlled preliminary study in children with congenital hemiparesis. A secondary objective was to assess the stability of hand and cognitive function. Design A double-blind, randomized placebo-controlled pretest/posttest/follow-up study was conducted. Setting The study was conducted in a university pediatric research laboratory. Participants Thirteen children, ages 7 to 18 years, with congenital hemiparesis participated. Measurements Adverse events/safety assessment and hand function were measured. Intervention Participants were randomly assigned to either an intervention group or a control group, with safety and functional assessments at pretest, at posttest on the same day, and at a 1-week follow-up session. An intervention of 10 minutes of 0.7 mA tDCS was applied to bilateral primary motor cortices. The tDCS intervention was considered safe if there was no individual decline of 25% or group decline of 2 standard deviations for motor evoked potentials (MEPs) and behavioral data and no report of adverse events. Results No major adverse events were found, including no seizures. Two participants did not complete the study due to lack of MEP and discomfort. For the 11 participants who completed the study, group differences in MEPs and behavioral data did not exceed 2 standard deviations in those who received the tDCS (n=5) and those in the control group (n=6). The study was completed without the need for stopping per medical monitor and biostatisticial analysis. Limitations A limitation of the study was the small sample size, with data available for 11 participants. Conclusions Based on the results of this study, tDCS appears to be safe, feasible, and well tolerated in most children with hemiparesis. Future investigations of serial sessions of tDCS in conjunction with rehabilitation in pediatric hemiparesis are indicated to explore the benefit of a synergistic approach to improving hand function. PMID:25413621

Use of a knowledge-attitude-behaviour education programme for Chinese adults undergoing maintenance haemodialysis: Randomized controlled trial.

PubMed

Liu, Li; Liu, Yue-Ping; Wang, Jing; An, Li-Wei; Jiao, Jian-Mei

2016-06-01

To investigate the effects of a knowledge-attitude-behaviour health education model on acquisition of disease-related knowledge and self-management behaviour by patients undergoing maintenance haemodialysis. Patients recently prescribed MHD were randomly assigned to a control group or an intervention group. Control group patients were treated with usual care and general education models. A specialist knowledge-attitude-behaviour health education model was applied to patients in the intervention group. Eighty-six patients were included (n = 43 per group). Before intervention, there were no significant between-group differences in disease knowledge and self-management behaviour. After 6 months' intervention, a significant between-group difference in acquisition of disease knowledge was observed. Self-management behaviour scores (control of body mass, reasonable diet, correct drug intake, physical activity, correct fistula care, disease condition monitoring, psychological and social behaviours) for the intervention group were also higher than those for the control group. These preliminary findings suggest that the knowledge-attitude-behaviour model appears to be a valuable tool for the health education of MHD patients. © The Author(s) 2016.

Use of a knowledge-attitude-behaviour education programme for Chinese adults undergoing maintenance haemodialysis: Randomized controlled trial

PubMed Central

Liu, Li; Wang, Jing; An, Li-Wei; Jiao, Jian-Mei

2016-01-01

Objective To investigate the effects of a knowledge-attitude-behaviour health education model on acquisition of disease-related knowledge and self-management behaviour by patients undergoing maintenance haemodialysis. Methods Patients recently prescribed MHD were randomly assigned to a control group or an intervention group. Control group patients were treated with usual care and general education models. A specialist knowledge-attitude-behaviour health education model was applied to patients in the intervention group. Results Eighty-six patients were included (n = 43 per group). Before intervention, there were no significant between-group differences in disease knowledge and self-management behaviour. After 6 months’ intervention, a significant between-group difference in acquisition of disease knowledge was observed. Self-management behaviour scores (control of body mass, reasonable diet, correct drug intake, physical activity, correct fistula care, disease condition monitoring, psychological and social behaviours) for the intervention group were also higher than those for the control group. Conclusion These preliminary findings suggest that the knowledge-attitude-behaviour model appears to be a valuable tool for the health education of MHD patients. PMID:26951842

Dual ovarian stimulation and random start in assisted reproductive technologies: from ovarian biology to clinical application.

PubMed

Vaiarelli, Alberto; Venturella, Roberta; Vizziello, Damiano; Bulletti, Francesco; Ubaldi, Filippo M

2017-06-01

The opportunity to use gonadotropins to stimulate the growth of antral follicles coming from different follicular waves available in different moment of the menstrual cycle allowed the implementation of innovative protocols in assisted reproductive technologies. The purpose of this review is to explore the possible advantages related to these new controlled ovarian stimulation (COS) strategies. Women exhibit major and minor wave patterns of ovarian follicular development during the menstrual cycle, as it is in animal species. These observations led to the introduction of two new strategies for COS: the random start and the double ovarian stimulation within a single menstrual cycle. The use of gonadotropin-releasing hormone antagonist COS protocols, started randomly at any day of the menstrual cycle, is today a standard procedure in those cases where obtaining oocytes is an urgent task, such as in case of fertility preservation for malignant diseases or other medical indications.On the other hand, in poor prognosis patients, double ovarian stimulation has been suggested with the aim of maximizing the number of oocytes retrieved within a single menstrual cycle and, in turn increasing the chance to obtain a reproductively competent embryo. Randomized control trials are necessary to confirm these preliminary findings.

Aquatic physical therapy for children with developmental coordination disorder: a pilot randomized controlled trial.

PubMed

Hillier, Susan; McIntyre, Auburn; Plummer, Leanne

2010-05-01

Aquatic therapy is an intervention for children with Developmental Coordination Disorder (DCD) that has not been investigated formally. This was a pilot randomized controlled trial to investigate the feasibility and preliminary effectiveness of an aquatic therapy program to improve motor skills of children with DCD. Thirteen children (mean age 7 years 1 month; 10 males) with DCD were randomly allocated to receive either six sessions of aquatic therapy (once weekly session of 30 min for 6-8 weeks) or to a wait-list (control group). The intervention and measures were demonstrated to be feasible, but barriers, such as limited appointment times and accessibility, were encountered. Analysis of covariance indicated that at posttest, mean scores on the Movement Assessment Battery were higher for children who received aquatic therapy compared to those on the wait-list (p = .057). Similar trends were noted on the physical competence portion of the Pictorial Scale of Perceived Competence and Social Acceptance (p = .058). Participation levels, as measured by a parent questionnaire, showed improvement for both groups. Potential facilitators and barriers to implementation of an aquatic therapy for children with DCD are discussed.

A randomized, controlled trial of massage therapy as a treatment for migraine.

PubMed

Lawler, Sheleigh P; Cameron, Linda D

2006-08-01

Migraine is a distressing disorder that is often triggered by stress and poor sleep. Only one randomized controlled trial (RCT) has assessed the effects of massage therapy on migraine experiences, which yielded some promising findings. An RCT was designed to replicate and extend the earlier findings using a larger sample, additional stress-related indicators, and assessments past the final session to identify longer-term effects of massage therapy on stress and migraine experiences. Migraine sufferers (N = 47) who were randomly assigned to massage or control conditions completed daily assessments of migraine experiences and sleep patterns for 13 weeks. Massage participants attended weekly massage sessions during Weeks 5 to 10. State anxiety, heart rates, and salivary cortisol were assessed before and after the sessions. Perceived stress and coping efficacy were assessed at Weeks 4, 10, and 13. Compared to control participants, massage participants exhibited greater improvements in migraine frequency and sleep quality during the intervention weeks and the 3 follow-up weeks. Trends for beneficial effects of massage therapy on perceived stress and coping efficacy were observed. During sessions, massage induced decreases in state anxiety, heart rate, and cortisol. The findings provide preliminary support for the utility of massage therapy as a nonpharmacologic treatment for individuals suffering from migraines.

Emergency department-initiated palliative care for advanced cancer patients: protocol for a pilot randomized controlled trial.

PubMed

Kandarian, Brandon; Morrison, R Sean; Richardson, Lynne D; Ortiz, Joanna; Grudzen, Corita R

2014-06-25

For patients with advanced cancer, visits to the emergency department (ED) are common. Such patients present to the ED with a specific profile of palliative care needs, including burdensome symptoms such as pain, dyspnea, or vomiting that cannot be controlled in other settings and a lack of well-defined goals of care. The goals of this study are: i) to test the feasibility of recruiting, enrolling, and randomizing patients with serious illness in the ED; and ii) to evaluate the impact of ED-initiated palliative care on health care utilization, quality of life, and survival. This is a protocol for a single center parallel, two-arm randomized controlled trial in ED patients with metastatic solid tumors comparing ED-initiated palliative care referral to a control group receiving usual care. We plan to enroll 125 to 150 ED-advanced cancer patients at Mount Sinai Hospital in New York, USA, who meet the following criteria: i) pass a brief cognitive screen; ii) speak fluent English or Spanish; and iii) have never been seen by palliative care. We will use balanced block randomization in groups of 50 to assign patients to the intervention or control group after completion of a baseline questionnaire. All research staff performing assessment or analysis will be blinded to patient assignment. We will measure the impact of the palliative care intervention on the following outcomes: i) timing and rate of palliative care consultation; ii) quality of life and depression at 12 weeks, measured using the FACT-G and PHQ-9; iii) health care utilization; and iv) length of survival. The primary analysis will be based on intention-to-treat. This pilot randomized controlled trial will test the feasibility of recruiting, enrolling, and randomizing patients with advanced cancer in the ED, and provide a preliminary estimate of the impact of palliative care referral on health care utilization, quality of life, and survival. Clinical Trials.gov identifier: NCT01358110 (Entered 5/19/2011).

A randomized controlled trial of an Internet delivered dialectical behavior therapy skills training for suicidal and heavy episodic drinkers.

PubMed

Wilks, Chelsey R; Lungu, Anita; Ang, Sin Yee; Matsumiya, Brandon; Yin, Qingqing; Linehan, Marsha M

2018-05-01

Given that alcohol misuse elevates risk of suicide death among ideators, the paucity of treatment outcome research for individuals presenting with both suicide ideation and problem drinking is particularly troubling. Dialectical behavior therapy (DBT) skills training, which effectively targets behaviors associated with emotion dysregulation including addictive and suicidal behaviors, provides a fitting model amenable to computerization. As stigma and scarcity stand as potential barriers to treatment, online dissemination platforms provide means for efficient treatment delivery that can augment the utility of suitable interventions. This pilot RCT sought to evaluate the feasibility, acceptability, and preliminary efficacy of an Internet-delivered DBT skills training intervention (iDBT-ST) for suicidal individuals who engage in heavy episodic drinking METHODS: Participants (N = 59) were randomized to receive iDBT-ST immediately or after an 8-week waiting period. Clinical outcomes were suicide ideation, alcohol use, and emotion dysregulation. Participants on average saw a significant reduction in all outcomes over the four-month study period. Compared to waitlist controls, individuals who received iDBT-ST immediately showed faster reductions in alcohol consumption. Preliminary results suggest that iDBT-ST may be a viable resource for the high-risk and underserved group represented in this study, and pathways for future development are suggested. There was difficulty retaining and engaging participants due to technological barriers. Copyright © 2018 Elsevier B.V. All rights reserved.

Group cognitive behavioural therapy and group recreational activity for adults with autism spectrum disorders: A preliminary randomized controlled trial

PubMed Central

Plenty, Stephanie; Bejerot, Susanne

2014-01-01

Although adults with autism spectrum disorder are an increasingly identified patient population, few treatment options are available. This preliminary randomized controlled open trial with a parallel design developed two group interventions for adults with autism spectrum disorders and intelligence within the normal range: cognitive behavioural therapy and recreational activity. Both interventions comprised 36 weekly 3-h sessions led by two therapists in groups of 6–8 patients. A total of 68 psychiatric patients with autism spectrum disorders participated in the study. Outcome measures were Quality of Life Inventory, Sense of Coherence Scale, Rosenberg Self-Esteem Scale and an exploratory analysis on measures of psychiatric health. Participants in both treatment conditions reported an increased quality of life at post-treatment (d = 0.39, p < 0.001), with no difference between interventions. No amelioration of psychiatric symptoms was observed. The dropout rate was lower with cognitive behavioural therapy than with recreational activity, and participants in cognitive behavioural therapy rated themselves as more generally improved, as well as more improved regarding expression of needs and understanding of difficulties. Both interventions appear to be promising treatment options for adults with autism spectrum disorder. The interventions’ similar efficacy may be due to the common elements, structure and group setting. Cognitive behavioural therapy may be additionally beneficial in terms of increasing specific skills and minimizing dropout. PMID:24089423

Group cognitive behavioural therapy and group recreational activity for adults with autism spectrum disorders: a preliminary randomized controlled trial.

PubMed

Hesselmark, Eva; Plenty, Stephanie; Bejerot, Susanne

2014-08-01

Although adults with autism spectrum disorder are an increasingly identified patient population, few treatment options are available. This preliminary randomized controlled open trial with a parallel design developed two group interventions for adults with autism spectrum disorders and intelligence within the normal range: cognitive behavioural therapy and recreational activity. Both interventions comprised 36 weekly 3-h sessions led by two therapists in groups of 6-8 patients. A total of 68 psychiatric patients with autism spectrum disorders participated in the study. Outcome measures were Quality of Life Inventory, Sense of Coherence Scale, Rosenberg Self-Esteem Scale and an exploratory analysis on measures of psychiatric health. Participants in both treatment conditions reported an increased quality of life at post-treatment (d = 0.39, p < 0.001), with no difference between interventions. No amelioration of psychiatric symptoms was observed. The dropout rate was lower with cognitive behavioural therapy than with recreational activity, and participants in cognitive behavioural therapy rated themselves as more generally improved, as well as more improved regarding expression of needs and understanding of difficulties. Both interventions appear to be promising treatment options for adults with autism spectrum disorder. The interventions' similar efficacy may be due to the common elements, structure and group setting. Cognitive behavioural therapy may be additionally beneficial in terms of increasing specific skills and minimizing dropout. © The Author(s) 2013.

Emotional Freedom Techniques in the Treatment of Unhealthy Eating Behaviors and Related Psychological Constructs in Adolescents: A Randomized Controlled Pilot Trial.

PubMed

Stapleton, Peta; Chatwin, Hannah; William, Mary; Hutton, Amanda; Pain, Amanda; Porter, Brett; Sheldon, Terri

2016-01-01

In Australia and throughout much of the world, rates of obesity continue to climb as do the prevalence of eating disorders, particularly in adolescents. Psychological consequences of childhood obesity include low self-esteem, depression, body dissatisfaction, and social maladjustment (Young-Hyman et al., 2012). This feasibility study sought to examine the impact of a six-week Emotional Freedom Techniques (EFT) group treatment program upon eating behaviours, self-esteem, compassion, and psychological symptoms. Forty-four students were randomly allocated to either the EFT group or the waitlist control group. Results revealed a delayed effect for both groups at post-intervention, with improved eating habits, self-esteem, and compassion at follow-up. Findings provide preliminary support for EFT as an effective treatment strategy for increasing healthy eating behaviours and improving associated weight-related psychopathology. Copyright © 2016 Elsevier Inc. All rights reserved.

Treatment of eating disorders in child and adolescent psychiatry.

PubMed

Herpertz-Dahlmann, Beate

2017-11-01

Recent research on the multimodal treatment of eating disorders in child and adolescent psychiatry has yielded a significant increase in randomized controlled trials and systematic reviews. This review aims to present relevant findings published during the last 2 years related to medical and psychological treatment of anorexia nervosa, bulimia nervosa and avoidant/restrictive food intake disorder (ARFID). For anorexia nervosa, recent reports described the efficacy of different treatment settings, lengths of hospital stay and high vs. low-calorie refeeding programmes. For both anorexia and bulimia nervosa, a number of randomized controlled trials comparing individual and family-oriented treatment approaches were published. For the newly defined ARFID, only very preliminary results on possible treatment approaches implying a multidisciplinary treatment programme were obtained. Although there is some evidence of the effectiveness of new child and adolescent psychiatric treatment approaches to eating disorders, the relapse rate remains very high, and there is an urgent need for ongoing intensive research.

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.

Online prevention of postpartum depression for Spanish- and English-speaking pregnant women: A pilot randomized controlled trial

PubMed Central

Barrera, Alinne Z.; Wickham, Robert E.; Muñoz, Ricardo F.

2015-01-01

Background Postpartum depression (PPD) is a maternal mental health problem that affects women from all regions of the world. Unfortunately, even in developed countries, half of the cases go undetected and, consequently, untreated. Individuals from low and middle income countries trend toward underutilization of mental health services, partly due to the limited number of available psychological resources. The primary aims of this pilot randomized controlled trial were to adapt to the Internet the Mothers and Babies Course/Curso Mamás y Bebés, a prevention of PPD intervention, to describe the characteristics of the pregnant women who engaged in the intervention site, and to obtain preliminary data on the efficacy of the Internet intervention to reduce the risk of PPD. Methods Pregnant women, 18 years or older who were interested in using the site for themselves were recruited and randomly assigned to a fully-automated self-help Internet intervention or to an information-only control condition. Randomized participants were invited to complete monthly depression assessments up to six months postpartum. To examine the prevention effects of the Internet intervention, pregnant women who did not meet current criteria for a major depressive episode, who engaged with the study website, and who provided depression data during the postpartum follow-up period were included in the study analyses. Results Participants were 111 predominantly Spanish-speaking (82.9%) and Latino/Hispanic (71.3%) pregnant women residing in 23 countries worldwide. The effect of the prevention intervention condition failed to reach significance at the a priori alpha-level. However, the observed coefficient trended in the hypothesized direction (b = −0.514, χ2 (1) = 3.43, p = .061; HR = 0.598). The benefits of receiving the e-MB Internet intervention was greater for pregnant women reporting high (vs. low) levels of prenatal depression symptoms (b = −0.605, χ2 (1) = 5.20, p =.023). Conclusions This study provides preliminary evidence that Internet interventions are a promising method toward expanding the reach of psychological resources to perinatal women at-risk for PPD. PMID:26273567

Cognitive control training for emotion-related impulsivity.

PubMed

Peckham, Andrew D; Johnson, Sheri L

2018-06-01

Many forms of psychopathology are tied to a heightened tendency to respond impulsively to strong emotions, and this tendency, in turn, is closely tied to problems with cognitive control. The goal of the present study was to test whether a two-week, six-session cognitive control training program is efficacious in reducing emotion-related impulsivity. Participants (N = 52) reporting elevated scores on an emotion-related impulsivity measure completed cognitive control training targeting working memory and response inhibition. A subset of participants were randomized to a waitlist control group. Impulsivity, emotion regulation, and performance on near and far-transfer cognitive tasks were assessed at baseline and after completion of training. Emotion-related impulsivity declined significantly from pre-training to post-training and at two-week follow-up; improvements were not observed in the waitlist control group. A decrease in brooding rumination and an increase in reappraisal were also observed. Participants showed significant improvements on trained versions of the working memory and inhibition tasks as well as improvements on an inhibition transfer task. In sum, these preliminary findings show that cognitive training appears to be well-tolerated for people with significant emotion-driven impulsivity. Results provide preliminary support for the efficacy of cognitive training interventions as a way to reduce emotion-related impulsivity. Copyright © 2018 Elsevier Ltd. All rights reserved.

Long-Term Chamomile Therapy of Generalized Anxiety Disorder: A Study Protocol for a Randomized, Double-Blind, Placebo- Controlled Trial

PubMed Central

Mao, Jun J; Li, Qing S.; Soeller, Irene; Rockwell, Kenneth; Xie, Sharon X; Amsterdam, Jay D.

2017-01-01

Background Anxiety symptoms are among the most common reasons for consumers to use Complementary and Alternative Medicine (CAM) therapy. Although many botanicals have been proposed as putative remedies for anxiety symptoms, there has been a paucity of controlled trials of these remedies. A preliminary study of the anxiolytic effect of Chamomile (Matricaria recutita) in humans suggests that chamomile may have anxiolytic and antidepressant activity. We now seek to conduct a 5-year randomized, double-blind, placebo-substitution study to examine the short and long-term safety and efficacy of chamomile extract in Generalized Anxiety Disorder (GAD). Methods/Design 180 subjects with moderate to severe GAD will receive initial open-label pharmaceutical-grade chamomile extract 500–1,500 mg daily for 8 weeks. Responders to treatment who remain well for an additional 4 weeks of consolidation therapy, will be randomized to double-blind continuation therapy with either chamomile extract 500–1,500 mg daily or placebo for an additional 26 weeks. The primary outcome will be the time to relapse during study continuation therapy in each treatment condition. Secondary outcomes will include the proportion of subjects in each treatment condition who relapse, as well as the proportion of subjects with treatment-emergent adverse events. Quality of life ratings will also be compared between treatment conditions during short and long-term therapy. Discussion Many individuals with mental disorders decline conventional therapy and seek CAM therapies for their symptoms. Thus, the identification of effective CAM therapy is of relevance to reducing the burden of mental illness. This study builds upon our prior findings of significant superiority of chamomile versus placebo in reducing GAD symptoms. We now extend these preliminary findings by conducting a randomized long-term safety and efficacy study of chamomile in GAD. PMID:29057164

Clinical evaluation of a novel herbal dental cream in plaque formation: a double-blind, randomized, controlled clinical trial

PubMed Central

Amrutesh, Sunita; Malini, J; Tandur, Prakash S; Patki, Pralhad S

2010-01-01

Background The aim of this study was to evaluate the efficacy and safety of herbal dental cream in comparison to fluoride dental cream. Objectives Clinical evaluation of a novel herbal dental cream in plaque formation: a double-blind, randomized, controlled clinical trial. Methods One hundred and two patients with established dental plaque were randomly assigned to either herbal dental group or fluoride dental group for six weeks in a double-blind design. Improvement in plaque index, oral hygiene status, bleeding index, and gingival index was evaluated in these patients along with microbiological study. Results Results indicated a significant reduction in plaque index, gingival index, oral hygiene index, and microbial growth in both groups. Difference between the groups was not significant. There was no significant change in bleeding index. No adverse events were reported and both the dental creams were well tolerated. Conclusion The finding of this preliminary study indicates that herbal dental cream is as safe and effective as fluoride dental cream, but not superior to it. PMID:27186096

Preliminary examination of the efficacy and safety of a standardized chamomile extract for chronic primary insomnia: A randomized placebo-controlled pilot study

PubMed Central

2011-01-01

Background Despite being the most commonly used herbal for sleep disorders, chamomile's (Matricaria recutita) efficacy and safety for treating chronic primary insomnia is unknown. We examined the preliminary efficacy and safety of chamomile for improving subjective sleep and daytime symptoms in patients with chronic insomnia. Methods We performed a randomized, double-blind, placebo-controlled pilot trial in 34 patients aged 18-65 years with DSM-IV primary insomnia for ≥ 6-months. Patients were randomized to 270 mg of chamomile twice daily or placebo for 28-days. The primary outcomes were sleep diary measures. Secondary outcomes included daytime symptoms, safety assessments, and effect size of these measures. Results There were no significant differences between groups in changes in sleep diary measures, including total sleep time (TST), sleep efficiency, sleep latency, wake after sleep onset (WASO), sleep quality, and number of awakenings. Chamomile did show modest advantage on daytime functioning, although these did not reach statistical significance. Effect sizes were generally small to moderate (Cohen's d ≤ 0.20 to < 0.60) with sleep latency, night time awakenings, and Fatigue Severity Scale (FSS), having moderate effect sizes in favor of chamomile. However, TST demonstrated a moderate effect size in favor of placebo. There were no differences in adverse events reported by the chamomile group compared to placebo. Conclusion Chamomile could provide modest benefits of daytime functioning and mixed benefits on sleep diary measures relative to placebo in adults with chronic primary insomnia. However, further studies in select insomnia patients would be needed to investigate these conclusions. Trial Registration ClinicalTrials.gov Identifier NCT01286324 PMID:21939549

Effect of Intravenous Iron Supplementation on Acute Mountain Sickness: A Preliminary Randomized Controlled Study

PubMed Central

Ren, Xuewen; Zhang, Qiuying; Wang, Hao; Man, Chunyan; Hong, Heng; Chen, Li; Li, Tanshi; Ye, Ping

2015-01-01

Background The aim of this study was to assess the role of intravenous iron supplementation in the prevention of AMS. Material/Methods This was a randomized, double-blinded, placebo-controlled study. Forty-one (n=41) healthy Chinese low-altitude inhabitants living in Beijing, China (altitude of about 50 meters) were randomly assigned into intravenous iron supplementation (ISS group; n=21) and placebo (CON group; n=20) groups. Participants in the ISS group received iron sucrose supplement (200 mg) before flying to Lhasa, China (altitude of 4300 meters). Acute mountain sickness (AMS) severity was assessed with the Lake Louise scoring (LLS) system within 5 days after landing on the plateau (at high altitude). Routine check-ups, clinical biochemistry, and blood tests were performed before departure and 24 h after arrival. Results A total of 38 participants completed the study (ISS group: n=19; CON group: n=19). The rate of subjects with AMS (LLS>3) was lower in the ISS group compared with the CON group, but no significant differences were obtained (P>0.05). There were no differences in patients’ baseline characteristics. The physiological indices were similar in both groups except for serum iron concentrations (19.44±10.02 vs. 85.10±26.78 μmol/L) and transferrin saturation rates (28.20±12.14 vs. 68.34±33.12%), which were significantly higher in the ISS group (P<0.05). Finally, heart rate was identified as a contributing factor of LLS. Conclusions These preliminary findings suggest that intravenous iron supplementation has no significant protective effect on AMS in healthy Chinese low-altitude inhabitants. PMID:26175087

Randomized controlled trial of dexamphetamine maintenance for the treatment of methamphetamine dependence.

PubMed

Longo, Marie; Wickes, Wendy; Smout, Matthew; Harrison, Sonia; Cahill, Sharon; White, Jason M

2010-01-01

To investigate the safety and efficacy of once-daily supervised oral administration of sustained-release dexamphetamine in people dependent on methamphetamine. Randomized, double-blind, placebo-controlled trial. Forty-nine methamphetamine-dependent drug users from Drug and Alcohol Services South Australia (DASSA) clinics. Participants were assigned randomly to receive up to 110 mg/day sustained-release dexamphetamine (n = 23) or placebo (n = 26) for a maximum of 12 weeks, with gradual reduction of the study medication over an additional 4 weeks. Medication was taken daily under pharmacist supervision. Primary outcome measures included treatment retention, measures of methamphetamine consumption (self-report and hair analysis), degree of methamphetamine dependence and severity of methamphetamine withdrawal. Hair samples were analysed for methamphetamine using liquid chromatography-mass spectrometry. Treatment retention was significantly different between groups, with those who received dexamphetamine remaining in treatment for an average of 86.3 days compared with 48.6 days for those receiving placebo (P = 0.014). There were significant reductions in self-reported methamphetamine use between baseline and follow-up within each group (P < 0.0001), with a trend to a greater reduction among the dexamphetamine group (P = 0.086). Based on hair analysis, there was a significant decrease in methamphetamine concentration for both groups (P < 0.0001). At follow-up, degree of methamphetamine dependence was significantly lower in the dexamphetamine group (P = 0.042). Dexamphetamine maintenance was not associated with serious adverse events. The results of this preliminary study have demonstrated that a maintenance pharmacotherapy programme of daily sustained-release amphetamine dispensing under pharmacist supervision is both feasible and safe. The increased retention in the dexamphetamine group, together with the general decreases in methamphetamine use, degree of dependence and withdrawal symptom severity, provide preliminary evidence that this may be an efficacious treatment option for methamphetamine dependence.

The impact of two workplace-based health risk appraisal interventions on employee lifestyle parameters, mental health and work ability: results of a randomized controlled trial.

PubMed

Addley, K; Boyd, S; Kerr, R; McQuillan, P; Houdmont, J; McCrory, M

2014-04-01

Health risk appraisals (HRA) are a common type of workplace health promotion programme offered by American employers. In the United Kingdom, evidence of their effectiveness for promoting health behaviour change remains inconclusive. This randomized controlled trial examined the effects of two HRA interventions on lifestyle parameters, mental health and work ability in a UK context. A total of 180 employees were randomized into one of three groups: Group A (HRA augmented with health promotion and education activities), Group B (HRA only) and Group C (control, no intervention). After 12 months, changes in mean scoring in 10 lifestyle, mental health and work ability indices were compared, Groups A and B demonstrated non-significant improvements in 70% and 80%, respectively, compared with controls (40%). Odds ratios revealed that, compared with the control group, Group A was 29.2 (95% CI: 9.22-92.27) times more likely to report a perceived change in lifestyle behaviour; Group B 4.4 times (95% CI: 1.65-11.44). In conclusion, participation in the HRA was associated with a higher likelihood of perceived lifestyle behaviour change which was further increased in the augmented HRA group, thereby providing preliminary evidence that HRA and augmented HRA in particular may help UK employees make positive healthy lifestyle changes.

Effects of periodontal treatment on lung function and exacerbation frequency in patients with chronic obstructive pulmonary disease and chronic periodontitis: a 2-year pilot randomized controlled trial.

PubMed

Zhou, Xuan; Han, Jing; Liu, Zhiqiang; Song, Yiqing; Wang, Zuomin; Sun, Zheng

2014-06-01

To evaluate the direct effects of periodontal therapy in Chronic Obstructive Pulmonary Disease (COPD) patients with chronic periodontitis (CP). In a pilot randomized controlled trial, 60 COPD patients with CP were randomly assigned to receive scaling and root planing (SRP) treatment, supragingival scaling treatment, or oral hygiene instructions only with no periodontal treatment. We evaluated their periodontal indexes, respiratory function, and COPD exacerbations at baseline, 6 months, 1, and 2 years. Compared with the control group, measurements of periodontal indexes were significantly improved in patients in two treatment groups at 6-month, 1-year, and 2-year follow-up (all p < 0.05). Overall, the means of forced expiratory volume in the first second/forced vital capacity (FEV1/FVC) and FEV1 were significantly higher in the two therapy groups compared with the control group during the follow-up (p < 0.05). In addition, the frequencies of COPD exacerbation were significantly lower in the two therapy groups than in the control group at 2-year follow-up (p < 0.05). Our preliminary results from this pilot trial suggest that periodontal therapy in COPD patients with CP may improve lung function and decrease the frequency of COPD exacerbation. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Effectiveness of peer-led dissonance-based eating disorder prevention groups: results from two randomized pilot trials.

PubMed

Stice, Eric; Rohde, Paul; Durant, Shelley; Shaw, Heather; Wade, Emily

2013-05-01

The present preliminary trials tested whether undergraduate peer leaders can effectively deliver a dissonance-based eating disorder prevention program, which could facilitate broad dissemination of this efficacious intervention. In Study 1, female undergraduates (N=171) were randomized to peer-led groups, clinician-led groups, or an educational brochure control condition. In Study 2, which improved a design limitation of Study 1 by using completely parallel outcome measures across conditions, female undergraduates (N=148) were randomized to either immediate peer-led groups or a waitlist control condition. In Study 1, participants in peer- and clinician-led groups showed significantly greater pre-post reductions in risk factors and eating disorder symptoms than controls (M d=.64 and .98 respectively), though clinician- versus peer-led groups had higher attendance and competence ratings, and produced stronger effects at posttest (M d=.32) and at 1-year follow-up (M d=.26). In Study 2, participants in peer-led groups showed greater pre-post reductions in all outcomes than waitlist controls (M d=.75). Results provide novel evidence that dissonance-based eating disorder prevention groups led by undergraduate peers are feasible and produce greater reductions in eating disorder risk factors and symptoms than minimal-intervention control conditions, but indicate that effects are smaller for peer- versus clinician-led groups. Copyright © 2013 Elsevier Ltd. All rights reserved.

Feasibility, acceptability, and preliminary effectiveness of patient advocates for improving adult asthma outcomes

PubMed Central

Apter, Andrea J.; Wan, Fei; Reisine, Susan; Bogen, Daniel K.; Rand, Cynthia; Bender, Bruce; Bennett, Ian M.; Gonzalez, Rodalyn; Priolo, Chantel; Sonnad, Seema S.; Bryant-Stephens, Tyra; Ferguson, Monica; Boyd, Rhonda C.; Have, Thomas Ten; Roy, Jason

2014-01-01

Background Asthmatic adults from low-income urban neighborhoods have inferior health outcomes which in part may be due to barriers accessing care and with patient-provider communication. We adapted a patient advocate (PA) intervention to overcome these barriers. Objective To conduct a pilot study to assess feasibility, acceptability, and preliminary evidence of effectiveness. Methods A prospective randomized design was employed with mixed methods evaluation. Adults with moderate or severe asthma were randomized to 16 weeks of PA or a minimal intervention (MI) comparison condition. The PA, a nonprofessional, modeled preparations for a medical visit, attended the visit, and confirmed understanding. The PA facilitated scheduling, obtaining insurance coverage, and overcoming barriers to implementing medical advice. Outcomes included electronically-monitored inhaled corticosteroid adherence, asthma control, quality of life, FEV1, ED visits, and hospitalizations. Mixed-effects models guided an intention-to-treat analysis. Results 100 adults participated: age 47±14 years, 75% female, 71% African American, 16% white, baseline FEV1 69% ± 18%, 36% experiencing hospitalizations and 56% ED visits for asthma in the prior year. Ninety-three subjects completed all visits; 36 of 53 PA-assigned had a PA visit. Adherence declined significantly in the control (p= 0.001) but not significantly in the PA group (p=.30). Both PA and MI groups demonstrated improved asthma control (p=0.01 in both) and quality of life (p=0.001, p=0.004). Hospitalizations and ED visits for asthma did not differ between groups. The observed changes over time tended to favor the PA group, but this study was underpowered to detect differences between groups. Conclusion The PA intervention was feasible and acceptable and demonstrated potential for improving asthma control and quality of life. PMID:23800333

Preliminary examination of metabolic syndrome response to motivational interviewing for weight loss as compared to an attentional control and usual care in primary care for individuals with and without binge-eating disorder.

PubMed

Barnes, Rachel D; Barber, Jessica A

2017-08-01

Motivational interviewing (MI) treatment for weight loss is being studied in primary care. The effect of such interventions on metabolic syndrome or binge eating disorder (BED), both highly related to excess weight, has not been examined in primary care. This study conducted secondary analyses from a randomized controlled trial to test the impact of MI for weight loss in primary care on metabolic syndrome. 74 adult participants with overweight/obesity recruited through primary care were randomized to 12weeks of either MI, an attentional control, or usual care. Participants completed measurements for metabolic syndrome at pre- and post-treatment. There were no statistically significant differences in metabolic syndrome rates at pre-, X 2 (2)=0.16, p=0.921, or post-, X 2 (2)=0.852, p=0.653 treatment. The rates in metabolic syndrome, however, decreased for MI (10.2%) and attentional control (13.8%) participants, but not for usual care. At baseline, metabolic syndrome rates did not differ significantly between participants with BED or without BED across treatments. At post-treatment, participants with BED were significantly more likely to meet criteria for metabolic syndrome than participants without BED, X 2 (1)=5.145, p=0.023, phi=0.273. Across treatments, metabolic syndrome remitted for almost a quarter of participants without BED (23.1%) but for 0% of those with BED. These preliminary results are based on a small sample and should be interpreted with caution, but they are the first to suggest that relatively low intensity MI weight loss interventions in primary care may decrease metabolic syndrome rates but not for individuals with BED. Copyright © 2017 Elsevier Ltd. All rights reserved.

Nurse leader mindfulness meditation program for stress management: a randomized controlled trial.

PubMed

Pipe, Teri Britt; Bortz, Jennifer J; Dueck, Amylou; Pendergast, Debra; Buchda, Vicki; Summers, Jay

2009-03-01

The aim of this study was to rigorously evaluate a brief stress management intervention for nurse leaders. Despite the nursing shortage, evidence-based workplace approaches addressing nurse stress have not been well studied. Nurse leaders (n = 33) were randomly assigned to brief mindfulness meditation course (MMC) or leadership course (control). Self-report measures of stress were administered at baseline and within 1 week of course completion. Among MMC participants, change scores (from baseline to postintervention) on several subscales of the Symptom Checklist 90-Revised showed significantly more improvement in self-reported stress symptoms relative to controls. Mindfulness meditation course participants had significantly more improvement in Positive Symptom Distress Index (P = 0.010; confidence interval [CI] = -0.483 to -0.073) and Global Severity Index (P = 0.019; CI = -0.475 to -0.046) and nearly significantly more improvement in Positive Symptom Total (P = 0.066; CI = -16.66 to 0.581) compared with controls. Results support preliminary effectiveness of a 4-week MMC in reducing self-reported stress symptoms among nursing leaders.

A preliminary randomized controlled trial of a behavioral exercise intervention for smoking cessation.

PubMed

Abrantes, Ana M; Bloom, Erika Litvin; Strong, David R; Riebe, Deborah; Marcus, Bess H; Desaulniers, Julie; Fokas, Kathryn; Brown, Richard A

2014-08-01

Previous exercise intervention studies for smoking cessation have been challenged by a number of methodological limitations that confound the potential efficacy of aerobic exercise for smoking cessation. The preliminary efficacy of a behavioral exercise intervention that incorporated features designed to address prior limitations was tested in a randomized controlled trial (RCT). Sixty-one smokers (65.6% female, mean age = 47.3 years, smoked a mean of 19.7 cigarettes/day) were randomized to receive either a 12-week exercise intervention or a 12-week health education contact control. Participants in both conditions received an 8-week telephone-delivered, standard smoking cessation protocol (with the transdermal nicotine patch). Follow-ups were conducted at the end of treatment (EOT), 6- and 12-month timepoints. There were no differences between conditions with respect to the number of weekly exercise or health education sessions attended (9.3±2.8 vs. 9.3±3.0, respectively). While not statistically significant, participants in the exercise condition demonstrated higher verified abstinence rates (EOT: 40% vs. 22.6%, odds ratio [OR] = 2.28; 6- and 12-month follow-ups: 26.7% vs. 12.9%, OR = 2.46). Irrespective of treatment condition, higher levels of moderate-to-vigorous exercise were associated with lower levels of depressive symptoms during the intervention. The results of this small RCT point toward the benefit of a behavioral exercise intervention designed to address previous methodological limitations for smoking cessation. Given the potential public health impact of the demonstrated efficacy of exercise for smoking cessation, the continued development and optimization of exercise interventions for smokers through larger RCTs merits pursuit. © The Author 2014. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Feasibility and Preliminary Efficacy of Visual Cue Training to Improve Adaptability of Walking after Stroke: Multi-Centre, Single-Blind Randomised Control Pilot Trial.

PubMed

Hollands, Kristen L; Pelton, Trudy A; Wimperis, Andrew; Whitham, Diane; Tan, Wei; Jowett, Sue; Sackley, Catherine M; Wing, Alan M; Tyson, Sarah F; Mathias, Jonathan; Hensman, Marianne; van Vliet, Paulette M

2015-01-01

Given the importance of vision in the control of walking and evidence indicating varied practice of walking improves mobility outcomes, this study sought to examine the feasibility and preliminary efficacy of varied walking practice in response to visual cues, for the rehabilitation of walking following stroke. This 3 arm parallel, multi-centre, assessor blind, randomised control trial was conducted within outpatient neurorehabilitation services. Community dwelling stroke survivors with walking speed <0.8m/s, lower limb paresis and no severe visual impairments. Over-ground visual cue training (O-VCT), Treadmill based visual cue training (T-VCT), and Usual care (UC) delivered by physiotherapists twice weekly for 8 weeks. Participants were randomised using computer generated random permutated balanced blocks of randomly varying size. Recruitment, retention, adherence, adverse events and mobility and balance were measured before randomisation, post-intervention and at four weeks follow-up. Fifty-six participants participated (18 T-VCT, 19 O-VCT, 19 UC). Thirty-four completed treatment and follow-up assessments. Of the participants that completed, adherence was good with 16 treatments provided over (median of) 8.4, 7.5 and 9 weeks for T-VCT, O-VCT and UC respectively. No adverse events were reported. Post-treatment improvements in walking speed, symmetry, balance and functional mobility were seen in all treatment arms. Outpatient based treadmill and over-ground walking adaptability practice using visual cues are feasible and may improve mobility and balance. Future studies should continue a carefully phased approach using identified methods to improve retention. Clinicaltrials.gov NCT01600391.

A randomized clinical trial aimed at preventing poor psychosocial and glycemic outcomes in teens with type 1 diabetes (T1D)

PubMed Central

Weissberg-Benchell, Jill; Rausch, Joseph; Iturralde, Esti; Jedraszko, Aneta; Hood, Korey

2016-01-01

Adolescents with type 1 diabetes have an increased risk for a variety of emotional and behavioral challenges as well as negative diabetes outcomes. This study was designed to compare the effectiveness of a depression-prevention, resilience promotion program with an advanced diabetes education program. Each program consisted of 9 group-based sessions. There were 264 adolescents enrolled in this multi-site randomized clinical trial. The primary outcomes were depressive symptoms and glycemic control; secondary outcomes included resilience skills, diabetes management and adherence, and diabetes-specific distress. The goal of the present paper is to describe the study design, the intervention, and the baseline characteristics of the sample. Preliminary data suggests that enrollment, randomization and retention were successful. Longitudinal follow-up and examination of mechanisms of action as they relate to psychosocial and glycemic outcomes will be explored in the future. PMID:27267154

Is Homepathy Effective for Hot Flashes and other Estrogen-Withdrawal Symptoms in Breast Cancer Survivors? A Preliminary Randomized Controlled Trial

DTIC Science & Technology

2000-04-01

AD__________ Award Number: DAMD17-99-1-9438 TITLE: Is Homeopathy Effective for Hot Flashes and Other Estrogen-Withdrawal Symptoms in Breast Cancer...Mar 00) 4. TITLE AND SUBTITLE 5. FUNDING NUMBERS Is Homeopathy Effective for Hot Flashes and Other Estrogen- DAMD17-99-1-9438 Withdrawal Symptoms in...there is evidence that homeopathy is an effective treatment to improve the quality of life in breast cancer survivors who are experiencing hot flashes

Effectiveness of Healthy Relationships Video-Group—A Videoconferencing Group Intervention for Women Living with HIV: Preliminary Findings from a Randomized Controlled Trial

PubMed Central

Buhi, Eric R.; Baldwin, Julie; Chen, Henian; Johnson, Ayesha; Lynn, Vickie; Glueckauf, Robert

2014-01-01

Abstract Introduction: Expanded access to efficacious interventions is needed for women living with human immunodeficiency virus (WLH) in the United States. Availability of “prevention with (human immunodeficiency virus [HIV)] positives” interventions in rural/remote and low HIV prevalence areas remains limited, leaving WLH in these communities few options for receiving effective behavioral interventions such as Healthy Relationships (HR). Offering such programs via videoconferencing groups (VGs) may expand access. This analysis tests the effectiveness of HR-VG (versus wait-list control) for reducing sexual risk behavior among WLH and explores intervention satisfaction. Subjects and Methods: In this randomized controlled trial unprotected vaginal/anal sex occasions over the prior 3 months reported at the 6-month follow-up were compared across randomization groups through zero-inflated Poisson regression modeling, controlling for unprotected sex at baseline. Seventy-one WLH were randomized and completed the baseline assessment (n=36 intervention and n=35 control); 59 (83% in each group) had follow-up data. Results: Among those who engaged in unprotected sex at 6-month follow-up, intervention participants had approximately seven fewer unprotected occasions than control participants (95% confidence interval 5.43–7.43). Intervention participants reported high levels of satisfaction with HR-VG; 84% reported being “very satisfied” overall. Conclusions: This study found promising evidence for effective dissemination of HIV risk reduction interventions via VGs. Important next steps will be to determine whether VGs are effective with other subpopulations of people living with HIV (i.e., men and non-English speakers) and to assess cost-effectiveness. Possibilities for using VGs to expand access to other psychosocial and behavioral interventions and reduce stigma are discussed. PMID:24237482

Task-oriented training with computer gaming in people with rheumatoid arthritisor osteoarthritis of the hand: study protocol of a randomized controlled pilot trial

PubMed Central

2013-01-01

Background Significant restriction in the ability to participate in home, work and community life results from pain, fatigue, joint damage, stiffness and reduced joint range of motion and muscle strength in people with rheumatoid arthritis or osteoarthritis of the hand. With modest evidence on the therapeutic effectiveness of conventional hand exercises, a task-oriented training program via real life object manipulations has been developed for people with arthritis. An innovative, computer-based gaming platform that allows a broad range of common objects to be seamlessly transformed into therapeutic input devices through instrumentation with a motion-sense mouse has also been designed. Personalized objects are selected to target specific training goals such as graded finger mobility, strength, endurance or fine/gross dexterous functions. The movements and object manipulation tasks that replicate common situations in everyday living will then be used to control and play any computer game, making practice challenging and engaging. Methods/Design The ongoing study is a 6-week, single-center, parallel-group, equally allocated and assessor-blinded pilot randomized controlled trial. Thirty people with rheumatoid arthritis or osteoarthritis affecting the hand will be randomized to receive either conventional hand exercises or the task-oriented training. The purpose is to determine a preliminary estimation of therapeutic effectiveness and feasibility of the task-oriented training program. Performance based and self-reported hand function, and exercise compliance are the study outcomes. Changes in outcomes (pre to post intervention) within each group will be assessed by paired Student t test or Wilcoxon signed-rank test and between groups (control versus experimental) post intervention using unpaired Student t test or Mann–Whitney U test. Discussion The study findings will inform decisions on the feasibility, safety and completion rate and will also provide preliminary data on the treatment effects of the task-oriented training compared with conventional hand exercises in people with rheumatoid arthritis or osteoarthritis of the hand. Trial registration ClinicalTrials.gov: NCT01635582 PMID:23497529

Rhodiola rosea therapy for major depressive disorder: a study protocol for a randomized, double-blind, placebo- controlled trial

PubMed Central

Mao, Jun J; Li, Qing S.; Soeller, Irene; Xie, Sharon X; Amsterdam, Jay D.

2014-01-01

Background Rhodiola rosea (R. rosea), a botanical of both western and traditional Chinese medicine, has been used as a folk remedy for improving stamina and reducing stress. However, few controlled clinical trials have examined the safety and efficacy of R. rosea for the treatment of major depressive disorder (MDD). This study seeks to evaluate the safety and efficacy of R. rosea in a 12-week, randomized, double-blind, placebo-controlled, parallel group study design. Methods / Design Subjects with MDD not receiving antidepressant therapy will be randomized to either R. rosea extract 340–1,360 mg daily; sertraline 50–200 mg daily, or placebo for 12 weeks. The primary outcome measure will be change over time in the mean 17-item Hamilton Depression Rating score. Secondary outcome measures will include safety and quality of life ratings. Statistical procedures will include mixed-effects models to assess efficacy for primary and secondary outcomes. Discussion This study will provide valuable preliminary information on the safety and efficacy data of R. rosea versus conventional antidepressant therapy of MDD. It will also inform additional hypotheses and study design of future, fully powered, phase III clinical trials with R. rosea to determine its safety and efficacy in MDD. PMID:25610752

Taking immunosuppressive medications effectively (TIMELink): a pilot randomized controlled trial in adult kidney transplant recipients.

PubMed

Russell, Cynthia; Conn, Vicki; Ashbaugh, Catherine; Madsen, Richard; Wakefield, Mark; Webb, Andrew; Coffey, Deanna; Peace, Leanne

2011-01-01

Immunosuppressive medication non-adherence is one of the most prevalent but preventable causes of poor outcomes in adult renal transplant recipients, yet there is a paucity of studies testing interventions in this area. Using a randomized controlled trial design, 30 adult renal transplant recipients were screened for medication non-adherence using electronic monitoring. Fifteen non-adherent participants were randomized to receive either a continuous self-improvement intervention or attention control management. The six-month continuous self-improvement intervention involved the participant and clinical nurse specialist collaboratively identifying the person's life routines, important people, and possible solutions to enhance medication taking. The participant then received individual monthly medication taking feedback delivered via a graphic printout of daily medication taking generated from electronic monitoring. The mean medication adherence score for the continuous self-improvement intervention group (n = 8) was statistically significantly higher than the attention control group's (n = 5) mean medication adherence score (p = 0.03). The continuous self-improvement intervention effect size (Cohen's d) was large at 1.4. Participants' perceptions of the intervention were highly favorable. The continuous self-improvement intervention shows promise as an effective and feasible approach to improve medication adherence in adult renal transplant recipients. A fully-powered study with a diverse sample is needed to confirm these preliminary findings. © 2010 John Wiley & Sons A/S.

Augmenting Prolonged Exposure therapy for PTSD with intranasal oxytocin: A randomized, placebo-controlled pilot trial.

PubMed

Flanagan, Julianne C; Sippel, Lauren M; Wahlquist, Amy; Moran-Santa Maria, Megan M; Back, Sudie E

2018-03-01

Posttraumatic stress disorder (PTSD) is a chronic, debilitating condition for which Prolonged Exposure (PE) therapy is highly efficacious. However, for some individuals, premature dropout and residual PTSD symptoms remain obstacles. The neuropeptide oxytocin is a promising candidate to enhance PE due to its ability to enhance 1) prosocial cognition and behavior, which are theorized to promote positive working alliance, and 2) extinction learning, which is the central mechanism of action underlying successful PE treatment. Despite a robust theoretical rationale, no studies to date have combined evidence-based psychotherapy for PTSD with oxytocin. This randomized, placebo-controlled, double-blind pilot trial examined the feasibility, safety, and preliminary efficacy of augmenting PE with oxytocin. Participants were 17 individuals with diverse index traumas. Participants self-administered intranasal oxytocin (40 IU) or matching placebo 45 min prior to each weekly PE therapy session. One adverse event occurred in the placebo group and three individuals dropped out (17.6%; 2 oxytocin group and 1 placebo group). The oxytocin group demonstrated lower PTSD and depression symptoms during PE, and had higher working alliance scores, although these differences did not reach statistical significance. Although preliminary, the findings support the feasibility of oxytocin combined with PE. Adequately powered studies are necessary to determine whether oxytocin enhances PE treatment outcomes and to examine potential mechanisms, such as accelerating extinction learning, enhancing early response, and preventing premature dropout. NCT03238924. Copyright © 2017. Published by Elsevier Ltd.

The Aspirin Regimens in Essential Thrombocythemia (ARES) phase II randomized trial design: Implementation of the serum thromboxane B2 assay as an evaluation tool of different aspirin dosing regimens in the clinical setting.

PubMed

De Stefano, Valerio; Rocca, Bianca; Tosetto, Alberto; Soldati, Denise; Petrucci, Giovanna; Beggiato, Eloise; Bertozzi, Irene; Betti, Silvia; Carli, Giuseppe; Carpenedo, Monica; Cattaneo, Daniele; Cavalca, Viviana; Dragani, Alfredo; Elli, Elena; Finazzi, Guido; Iurlo, Alessandra; Lanzarone, Giuseppe; Lissandrini, Laura; Palandri, Francesca; Paoli, Chiara; Rambaldi, Alessandro; Ranalli, Paola; Randi, Maria Luigia; Ricco, Alessandra; Rossi, Elena; Ruggeri, Marco; Specchia, Giorgina; Timillero, Andrea; Turnu, Linda; Vianelli, Nicola; Vannucchi, Alessandro M; Rodeghiero, Francesco; Patrono, Carlo

2018-06-01

Once-daily (od), low-dose aspirin (75-100 mg) is recommended to reduce the thrombotic risk of patients with essential thrombocytemia (ET). This practice is based on data extrapolated from other high-risk patients and an aspirin trial in polycythemia vera, with the assumption of similar aspirin pharmacodynamics in the two settings. However, the pharmacodynamics of low-dose aspirin is impaired in ET, reflecting accelerated renewal of platelet cyclooxygenase (COX)-1. ARES is a parallel-arm, placebo-controlled, randomized, dose-finding, phase II trial enrolling 300 ET patients to address two main questions. First, whether twice or three times 100 mg aspirin daily dosing is superior to the standard od regimen in inhibiting platelet thromboxane (TX)A 2 production, without inhibiting vascular prostacyclin biosynthesis. Second, whether long-term persistence of superior biochemical efficacy can be safely maintained with multiple vs. single dosing aspirin regimen. Considering that the primary study end point is serum TXB 2 , a surrogate biomarker of clinical efficacy, a preliminary exercise of reproducibility and validation of this biomarker across all the 11 participating centers was implemented. The results of this preliminary phase demonstrate the importance of controlling reproducibility of biomarkers in multicenter trials and the feasibility of using serum TXB 2 as a reliable end point for dose-finding studies of novel aspirin regimens.

A preliminary, controlled investigation of magnesium L-aspartate hydrochloride for illicit cocaine and opiate use in methadone-maintained patients.

PubMed

Margolin, Arthur; Kantak, Kathleen; Copenhaver, Michael; Avants, S Kelly

2003-01-01

Based on pre-clinical studies suggesting that magnesium (Mg) reduces cocaine self-administration and potentiates the antinociceptive effects of morphine, we conducted a preliminary randomized clinical trial investigating Mg for the treatment of illicit cocaine and opiate use. Eighteen methadone-maintained patients who used illicit opiates and cocaine received either Mg (732 mg/day) or placebo for 12 weeks. Overall, findings showed that the percentage of urine screens testing positive for opiates in the Mg group (22.6%) was half that of the placebo group (46.4%), p = .04; the difference was even greater in the "medication compliant" sample (Mg: 16.3%, placebo: 47.9%), p = .02. Cocaine craving was lower in the Mg compared to the placebo group, but there was no difference between groups in cocaine use. These preliminary findings suggest that Mg may have a beneficial effect for reducing illicit opiate use. It is possible that a higher dose of Mg than was used in this study may be needed to decrease cocaine use.

Cognitive-behavioural group therapy versus guided self-help for compulsive buying disorder: a preliminary study.

PubMed

Müller, A; Arikian, A; de Zwaan, M; Mitchell, J E

2013-01-01

Compulsive buying (CB) is defined as extreme preoccupation with buying/shopping and frequent buying that causes substantial negative psychological, social, occupational and financial consequences. There exists preliminary evidence that group cognitive-behavioural therapy (CBT) is effective in the treatment of CB. The present pilot study made a first attempt to compare group CBT for CB with telephone-guided self-help (GSH). Fifty-six patients were allocated randomly to one of the three conditions: (1) group CBT (n = 22); (2) GSH (n = 20); and (3) a waiting list condition (n = 14). The results indicate that face-to-face group CBT is superior not only to the waiting list condition but also to GSH. Patients who received GSH tended to have more success in overcoming CB compared with the waiting list controls. Given the sample size, the results must be considered as preliminary and further research is needed to address the topic whether GSH also could be a helpful intervention in reducing CB. Copyright © 2011 John Wiley & Sons, Ltd.

[Prevention of post-operative pain and haemorrhage in PPH (Procedure for Prolapse and Hemorrhoids) and STARR (Stapled Trans-Anal Rectal Resection). Preliminary results in 261 cases].

PubMed

Mongardini, M; Custureri, F; Schillaci, F; Cola, A; Maturo, A; Fanello, G; Corelli, S; Pappalardo, G

2005-04-01

Intra- and early (first week) post-operative haemorrhages are the most common complications in stapled hemorrhoidectomy PPH (Procedure for Prolapse and Hemorrhoids) and in circumferential resection of the rectal prolapse STARR (Stapled Trans Anal Rectal Resection). Performing PPH and STARR we employed a gelatin based haemostatic sealant with thrombin component (FloSeal) to control intra-operative bleeding and to reduce post-operative bleeding avoiding haemostatic stitches on suture line. We report the preliminary results on 197 PPH and 64 STARR; 44 PPH (22.4%) and 27 STARR (42.2%) were treated by FloSeal. No major post-operative bleeding was observed in all patients treated by FloSeal, compared to 1.3% and 2.7% of hemorrhage respectively in PPH and STARR patients treated without sealant. Post-operative pain was less severe in patients treated by FloSeal, without a difference statistically significant. The data are preliminary and must be confirmed in prospective randomized trials in larger series.

Emerging Therapies for Diabetic Nephropathy Patients: Beyond Blockade of the Renin-Angiotensin System

PubMed Central

Tanios, Bassem Y.; Ziyadeh, Fuad N.

2012-01-01

Diabetic nephropathy is a leading cause of end-stage renal disease worldwide. The mainstay of treatment has been glycemic control and blood pressure lowering using agents blocking the renin-angiotensin system. Clinical trials are currently under way using novel agents for the treatment of patients with diabetic nephropathy. Promising agents emerging from some of the completed trials include pirfenidone and bardoxolone methyl, which have been shown in two recent randomized controlled trials in patients with diabetic nephropathy to result in an improved estimated glomerular filtration rate compared to placebo. Also, paricalcitol has been shown to decrease the urinary albumin-to-creatinine ratio, whereas sulodexide failed to do so in a large randomized double-blind placebo-controlled trial. Of note, pyridoxamine has also shown promise in the treatment of diabetic nephropathy if started early in the disease course. These preliminary trials have shown significant promise for managing patients with diabetic nephropathy, sparking active research in this field and providing the rationale for further clinical testing in long-term, hard-outcomes trials. PMID:23599705

'On Your Feet to Earn Your Seat', a habit-based intervention to reduce sedentary behaviour in older adults: study protocol for a randomized controlled trial.

PubMed

Gardner, Benjamin; Thuné-Boyle, Ingela; Iliffe, Steve; Fox, Kenneth R; Jefferis, Barbara J; Hamer, Mark; Tyler, Nick; Wardle, Jane

2014-09-20

Many older adults are both highly sedentary (that is, spend considerable amounts of time sitting) and physically inactive (that is, do little physical activity). This protocol describes an exploratory trial of a theory-based behaviour change intervention in the form of a booklet outlining simple activities ('tips') designed both to reduce sedentary behaviour and to increase physical activity in older adults. The intervention is based on the 'habit formation' model, which proposes that consistent repetition leads to behaviour becoming automatic, sustaining activity gains over time. The intervention is being developed iteratively, in line with Medical Research Council complex intervention guidelines. Selection of activity tips was informed by semi-structured interviews and focus groups with older adults, and input from a multidisciplinary expert panel. An ongoing preliminary field test of acceptability among 25 older adults will inform further refinement. An exploratory randomized controlled trial will be conducted within a primary care setting, comparing the tips booklet with a control fact sheet. Retired, inactive and sedentary adults (n = 120) aged 60 to 74 years, with no physical impairments precluding light physical activity, will be recruited from general practices in north London, UK. The primary outcomes are recruitment and attrition rates. Secondary outcomes are changes in behaviour, habit, health and wellbeing over 12 weeks. Data will be used to inform study procedures for a future, larger-scale definitive randomized controlled trial. Current Controlled Trials ISRCTN47901994.

Heated hatha yoga to target cortisol reactivity to stress and affective eating in women at risk for obesity-related illnesses: A randomized controlled trial.

PubMed

Hopkins, Lindsey B; Medina, Johnna L; Baird, Scarlett O; Rosenfield, David; Powers, Mark B; Smits, Jasper A J

2016-06-01

Cortisol reactivity to stress is associated with affective eating, an important behavioral risk factor for obesity and related metabolic diseases. Yoga practice is related to decreases in stress and cortisol levels, thus emerging as a potential targeted complementary intervention for affective eating. This randomized controlled trial examined the efficacy of a heated, hatha yoga intervention for reducing cortisol reactivity to stress and affective eating. Females (N = 52; ages 25-46 years; 75% White) at risk for obesity and related illnesses were randomly assigned to 8 weeks of Bikram Yoga practice or to waitlist control. Cortisol reactivity to a laboratory stress induction were measured at Weeks 0 (pretreatment) and 9 (posttreatment). Self-reported binge eating frequency and coping motives for eating were assessed at Weeks 0, 3, 6, and 9. Among participants with elevated cortisol reactivity at pretreatment ("high reactors"), those randomized to the yoga condition evidenced greater pre- to posttreatment reductions in cortisol reactivity (p = .042, d = .85), but there were not significant condition differences for the "low reactors" (p = .178, d = .53). Yoga participants reported greater decreases in binge eating frequency (p = .040, d = .62) and eating to cope with negative affect (p = .038, d = .54). This study provides preliminary support for the efficacy of heated hatha yoga for treating physiological stress reactivity and affective eating among women at risk for obesity-related illnesses. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Treatment for Insomnia in Combat-Exposed OEF/OIF/OND Military Veterans: Preliminary Randomized Controlled Trial

PubMed Central

Germain, Anne; Richardson, Robin; Stocker, Ryan; Mammen, Oommen; Hall, Martica; Bramoweth, Adam D.; Begley, Amy; Rode, Noelle; Frank, Ellen; Haas, Gretchen; Buysse, Daniel J.

2014-01-01

Objective Chronic insomnia is highly prevalent among military personnel returning from Iraq and Afghanistan. We evaluated the effects of a military version of a brief behavioral treatment of insomnia (BBTI-MV) compared to an information only control (IC) condition in combat-exposed Veterans of Operations Enduring/Iraqi Freedom or Operation New Dawn (OEF/OIF/OND) on insomnia, sleep quality, and daytime symptoms of anxiety and depression. Method Forty OEF/OIF/OND Veterans (Mean age = 38.4 years old, s.d. = 11.69; 85% men; 77.5% white) were randomized to one of two conditions. BBTI-MV consisted of two in-person sessions and two telephone contacts delivered over four weeks, and included personalized recommendations to reduce insomnia. The IC condition also consisted of 2 in-person sessions two telephone contacts delivered over four weeks, and Veterans were encouraged to read written information about sleep-promoting behaviors. The Insomnia Severity Index, Pittsburgh Sleep Quality Index, PTSD Checklist, and Beck Depression and Anxiety Inventories were completed at baseline, post-treatment, and at the six-month follow-up. Results Both interventions were associated with clinically significant improvements in insomnia, although the magnitude of improvements in sleep and rates of treatment response and remission were greater for BBTI-MV compared to IC from pre- to post-treatment. Conclusion Both BBTI-MV and the provision of information were associated with clinically significant improvements in insomnia among Veterans. Despite the preliminary nature of the findings and limitations inherent to small controlled trials, the findings suggest that both approaches may provide viable options in a stepped-care approach to the treatment of insomnia in retuning combat-exposed Veterans. Larger, confirmatory effectiveness trials are required. PMID:25194223

Feasibility and Preliminary Efficacy of Visual Cue Training to Improve Adaptability of Walking after Stroke: Multi-Centre, Single-Blind Randomised Control Pilot Trial

PubMed Central

Hollands, Kristen L.; Pelton, Trudy A.; Wimperis, Andrew; Whitham, Diane; Tan, Wei; Jowett, Sue; Sackley, Catherine M.; Wing, Alan M.; Tyson, Sarah F.; Mathias, Jonathan; Hensman, Marianne; van Vliet, Paulette M.

2015-01-01

Objectives Given the importance of vision in the control of walking and evidence indicating varied practice of walking improves mobility outcomes, this study sought to examine the feasibility and preliminary efficacy of varied walking practice in response to visual cues, for the rehabilitation of walking following stroke. Design This 3 arm parallel, multi-centre, assessor blind, randomised control trial was conducted within outpatient neurorehabilitation services Participants Community dwelling stroke survivors with walking speed <0.8m/s, lower limb paresis and no severe visual impairments Intervention Over-ground visual cue training (O-VCT), Treadmill based visual cue training (T-VCT), and Usual care (UC) delivered by physiotherapists twice weekly for 8 weeks. Main outcome measures: Participants were randomised using computer generated random permutated balanced blocks of randomly varying size. Recruitment, retention, adherence, adverse events and mobility and balance were measured before randomisation, post-intervention and at four weeks follow-up. Results Fifty-six participants participated (18 T-VCT, 19 O-VCT, 19 UC). Thirty-four completed treatment and follow-up assessments. Of the participants that completed, adherence was good with 16 treatments provided over (median of) 8.4, 7.5 and 9 weeks for T-VCT, O-VCT and UC respectively. No adverse events were reported. Post-treatment improvements in walking speed, symmetry, balance and functional mobility were seen in all treatment arms. Conclusions Outpatient based treadmill and over-ground walking adaptability practice using visual cues are feasible and may improve mobility and balance. Future studies should continue a carefully phased approach using identified methods to improve retention. Trial Registration Clinicaltrials.gov NCT01600391 PMID:26445137

Preliminary assessment of the safety and immunogenicity of live oral cholera vaccine strain CVD 103-HgR in healthy Thai adults.

PubMed Central

Migasena, S; Pitisuttitham, P; Prayurahong, B; Suntharasamai, P; Supanaranond, W; Desakorn, V; Vongsthongsri, U; Tall, B; Ketley, J; Losonsky, G

1989-01-01

A single dose (5 x 10(8) organisms) of attenuated A- B+ Vibrio cholerae classical Inaba recombinant vaccine strain CVD 103-HgR or placebo was administered to 24 healthy young Thai adults in a randomized, placebo-controlled, double-blind trial of safety and immunogenicity. None of the volunteers experienced untoward reactions. The vaccine strain was recovered from 2 of 12 vaccines. The vibriocidal antibody response (the best immunological correlate of protection) was good: 11 of 12 vaccinees (92%) manifested significant serotype-homologous Inaba antibody rises with a peak reciprocal geometric mean titer (RGMT) postvaccination of 3,417; 9 of 12 exhibited significant serotype-heterologous Ogawa antibody rises (prevaccination RGMT, 180; peak RGMT, 2,874). Nine of 12 vaccinees had significant rises in serum antitoxin. None of the controls exhibited rises in vibriocidal or antitoxic antibody. This preliminary study further confirms the safety and immunogenicity of CVD 103-HgR live oral cholera vaccine and paves the way for larger community studies of this candidate cholera vaccine. PMID:2807523

An Integrated HIV Risk Reduction Intervention for Women with a History of Intimate Partner Violence: Pilot Test Results.

PubMed

Mittal, Mona; Thevenet-Morrison, Kelly; Landau, Judith; Cai, Xueya; Gibson, Lindsey; Schroeder, Allison; Chaize, Janet; Carey, Michael P

2017-08-01

There are few HIV risk reduction interventions to meet the unique needs of women who experience intimate partner violence (IPV). This pilot study tested the feasibility, safety, and preliminary effects of an integrated IPV-sexual risk reduction intervention for abused women. Fifty-five women were randomized to the supporting positive and healthy relationships (SUPPORT) intervention (n = 27) or to a control group (n = 28). Assessments were conducted pre- and post-intervention and at 3-month follow-up. Post-intervention, SUPPORT participants showed a significant decrease in frequency of unprotected sex and an increase in safer sex communications with steady and other sexual partners. Compared to the control group, SUPPORT participants reported a higher number of safer sex conversations with their steady partner at the 3-month follow-up, and fewer episodes of IPV at both assessments in comparison to baseline. They showed improvements in sexual relationship power at both follow-ups and in several hypothesized antecedents of HIV-risk behavior. These encouraging preliminary findings suggest the need for a larger clinical trial.

Phone-Delivered Mindfulness Training for Patients with Implantable Cardioverter Defibrillators: Results of a Pilot Randomized Controlled Trial

PubMed Central

Salmoirago-Blotcher, Elena; Crawford, Sybil L.; Carmody, James; Rosenthal, Lawrence; Yeh, Gloria; Stanley, Mary; Rose, Karen; Browning, Clifford; Ockene, Ira S.

2013-01-01

Background The reduction in adrenergic activity and anxiety associated with meditation may be beneficial for patients with implantable cardioverter defibrillators. Purpose To determine the feasibility of a phone-delivered mindfulness intervention in patients with defibrillators and to obtain preliminary indications of efficacy on mindfulness and anxiety. Methods Clinically stable outpatients were randomized to a mindfulness intervention (8 weekly individual phone sessions) or to a scripted follow-up phone call. We used the Hospital Anxiety and Depression Scale and the Five Facets of Mindfulness to measure anxiety and mindfulness; and multivariate linear regression to estimate the intervention effect on pre-post intervention changes in these variables. Results We enrolled 45 patients (23 mindfulness, 22 control; age 43–83; 30 % women). Retention was 93 %; attendance was 94 %. Mindfulness (beta = 3.31; p = .04) and anxiety (beta = − 1.15; p = .059) improved in the mindfulness group. Conclusions Mindfulness training can be effectively phone-delivered and may improve mindfulness and anxiety in cardiac defibrillator outpatients. PMID:23605175

A preliminary investigation on the efficacy of N-acetyl cysteine for mania or hypomania.

PubMed

Magalhães, Pedro Vieira da Silva; Dean, Olivia M; Bush, Ashley I; Copolov, David L; Malhi, Gin S; Kohlmann, Kristy; Jeavons, Susan; Schapkaitz, Ian; Anderson-Hunt, Murray; Berk, Michael

2013-06-01

Oxidative imbalance has emerged as a treatment target in bipolar disorder. As very limited data are available on the clinical use of antioxidants for mania, we report here results from a post hoc and exploratory subgroup analysis of a randomized, placebo-controlled trial of N-acetyl cysteine (NAC). This was a placebo-controlled, randomized, clinical trial assessing the effect of NAC over 24 weeks in mania or hypomania. Symptomatic and functional outcomes were collected over the study period. Fifteen participants were available for this report; two participants in each group failed to complete all assessments. Within-group analyses pointed to an improvement in the NAC group on manic symptoms and worsening in the placebo group on depressive symptoms at endpoint. Although the sample size was small, these results indicated within-group efficacy for this glutathione precursor as compared to placebo. Future trials specifically designed to demonstrate the efficacy of NAC in mania are needed.

Internet-Based Self-Help Intervention for ICD-11 Adjustment Disorder: Preliminary Findings.

PubMed

Eimontas, Jonas; Rimsaite, Zivile; Gegieckaite, Goda; Zelviene, Paulina; Kazlauskas, Evaldas

2018-06-01

Adjustment disorder is one of the most diagnosed mental disorders. However, there is a lack of studies of specialized internet-based psychosocial interventions for adjustment disorder. We aimed to analyze the outcomes of an internet-based unguided self-help psychosocial intervention BADI for adjustment disorder in a two armed randomized controlled trial with a waiting list control group. In total 284 adult participants were randomized in this study. We measured adjustment disorder as a primary outcome, and psychological well-being as a secondary outcome at pre-intervention (T1) and one month after the intervention (T2). We found medium effect size of the intervention for the completer sample on adjustment disorder symptoms. Intervention was effective for those participants who used it at least one time in 30-day period. Our results revealed the potential of unguided internet-based self-help intervention for adjustment disorder. However, high dropout rates in the study limits the generalization of the outcomes of the intervention only to completers.

Motivational and mindfulness intervention for young adult female marijuana users

PubMed Central

de Dios, Marcel A.; Herman, Debra S.; Britton, Willoughby B.; Hagerty, Claire E.; Anderson, Bradley J.; Stein, Michael D.

2011-01-01

This pilot study tested the efficacy of a brief intervention using motivational interviewing (MI) plus mindfulness meditation (MM) to reduce marijuana use among young adult female. Thirty-four female marijuana users between the ages of 18–29 were randomized to either the intervention group (n = 22), consisting of 2 sessions of MI-MM or an assessment-only control group (n = 12). Participants’ marijuana use was assessed at baseline, 1, 2, and 3 months post-treatment. Fixed-effects regression modeling was used to analyze treatment effects. Participants randomized to the intervention group were found to use marijuana on 6.15 (z = −2.42, p=.015), 7.81 (z = −2.78, p=.005), and 6.83 (z = −2.23, p=.026) fewer days at months 1, 2, and 3, respectively, than controls. Findings from this pilot study provide preliminary evidence for the feasibility and effectiveness of a brief MI-MM for young adult female marijuana users. PMID:21940136

Pilot Randomized Trial of Active Music Engagement Intervention Parent Delivery for Young Children With Cancer

PubMed Central

Haase, Joan E.; Perkins, Susan M.; Haut, Paul R.; Henley, Amanda K.; Knafl, Kathleen A.; Tong, Yan

2017-01-01

Objectives To examine the feasibility/acceptability of a parent-delivered Active Music Engagement (AME + P) intervention for young children with cancer and their parents. Secondary aim to explore changes in AME + P child emotional distress (facial affect) and parent emotional distress (mood; traumatic stress symptoms) relative to controls. Methods A pilot two-group randomized trial was conducted with parents/children (ages 3–8 years) receiving AME + P (n  =  9) or attention control (n  =  7). Feasibility of parent delivery was assessed using a delivery checklist and child engagement; acceptability through parent interviews; preliminary outcomes at baseline, postintervention, 30 days postintervention. Results Parent delivery was feasible, as they successfully delivered AME activities, but interviews indicated parent delivery was not acceptable to parents. Emotional distress was lower for AME + P children, but parents derived no benefit. Conclusion Despite child benefit, findings do not support parent delivery of AME + P. PMID:27289068

Better futures: a randomized field test of a model for supporting young people in foster care with mental health challenges to participate in higher education.

PubMed

Geenen, Sarah; Powers, Laurie E; Phillips, Lee Ann; Nelson, May; McKenna, Jessica; Winges-Yanez, Nichole; Blanchette, Linda; Croskey, Adrienne; Dalton, Lawrence D; Salazar, Amy; Swank, Paul

2015-04-01

The purpose of the study was to conduct a preliminary efficacy evaluation of the Better Futures model, which is focused on improving the postsecondary preparation and participation of youth in foster care with mental health challenges. Sixty-seven youth were randomized to either a control group that received typical services or an intervention group, which involved participation in a Summer Institute, individual peer coaching, and mentoring workshops. Findings indicate significant gains for the intervention group on measures of postsecondary participation, postsecondary and transition preparation, hope, self-determination, and mental health empowerment, as compared to the control group. Youth in the intervention group also showed positive trends in the areas of mental health recovery, quality of life, and high school completion. Implications for future research and practice are discussed, while emphasizing the capacities of youth in foster care with mental health conditions to successfully prepare for and participate fully in high education.

76 FR 2336 - Dynamic Random Access Memory Semiconductors From the Republic of Korea: Final Results of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-13

... DEPARTMENT OF COMMERCE International Trade Administration [C-580-851] Dynamic Random Access Memory... administrative review of the countervailing duty order on dynamic random access memory semiconductors from the... following events have occurred since the publication of the preliminary results of this review. See Dynamic...

Retention of Statistical Concepts in a Preliminary Randomization-Based Introductory Statistics Curriculum

ERIC Educational Resources Information Center

Tintle, Nathan; Topliff, Kylie; VanderStoep, Jill; Holmes, Vicki-Lynn; Swanson, Todd

2012-01-01

Previous research suggests that a randomization-based introductory statistics course may improve student learning compared to the consensus curriculum. However, it is unclear whether these gains are retained by students post-course. We compared the conceptual understanding of a cohort of students who took a randomization-based curriculum (n = 76)…

The Detroit Young Adult Asthma Project: Pilot of a Technology-Based Medication Adherence Intervention for African-American Emerging Adults.

PubMed

Kolmodin MacDonell, Karen; Naar, Sylvie; Gibson-Scipio, Wanda; Lam, Phebe; Secord, Elizabeth

2016-10-01

To conduct a randomized controlled pilot of a multicomponent, technology-based intervention promoting adherence to controller medication in African-American emerging adults with asthma. The intervention consisted of two computer-delivered sessions based on motivational interviewing combined with text messaged reminders between sessions. Participants (N = 49) were 18-29 years old, African-American, with persistent asthma requiring controller medication. Participants had to report poor medication adherence and asthma control. Youth were randomized to receive the intervention or an attention control. Data were collected through computer-delivered self-report questionnaires at baseline, 1, and 3 months. Ecological Momentary Assessment via two-way text messaging was also used to collect "real-time" data on medication use and asthma control. The intervention was feasible and acceptable to the target population, as evidenced by high retention rates and satisfaction scores. Changes in study outcomes from pre- to postintervention favored the intervention, particularly for decrease in asthma symptoms, t (42) = 2.22, p < .05 (Cohen's d = .071). Results suggest that the intervention is feasible and effective. However, findings are preliminary and should be replicated with a larger sample and more sophisticated data analyses. Copyright © 2016 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

A novel behavioral intervention in adolescents with type 1 diabetes mellitus improves glycemic control: preliminary results from a pilot randomized control trial.

PubMed

Maranda, Louise; Lau, May; Stewart, Sunita M; Gupta, Olga T

2015-04-01

The purpose of this study was to develop and pilot-test an innovative behavioral intervention in adolescents with type 1 diabetes mellitus (T1DM) incorporating structured care of a pet to improve glycemic control. Twenty-eight adolescents with A1C > 8.5% (69 mmol/mol) were randomly assigned to either the intervention group (care of a Betta splendens pet fish) or the control group (usual care). Adolescents in the intervention group were given instructions to associate daily and weekly fish care duties with diabetes self-management tasks, including blood glucose testing and parent-adolescent communication. After 3 months, the participants in the intervention group exhibited a statistically significant decrease in A1C level (-0.5%) compared with their peers in the control group, who had an increase in A1C level (0.8%) (P = .04). The younger adolescents (10-13 years of age) demonstrated a greater response to the intervention, which was statistically significant (-1.5% vs 0.6%, P = .04), compared with the older adolescents (14-17 years of age). Structured care of a pet fish can improve glycemic control in adolescents with T1DM, likely by providing cues to perform diabetes self-management behaviors. © 2015 The Author(s).

Neurofeedback Training as a New Method in Treatment of Crystal Methamphetamine Dependent Patients: A Preliminary Study.

PubMed

Rostami, R; Dehghani-Arani, F

2015-09-01

This study aimed to compare the effectiveness of neurofeedback (NFB) plus pharmacotherapy with pharmacotherapy alone, on addiction severity, mental health, and quality of life in crystal methamphetamine-dependent (CMD) patients. The study included 100 CMD patients undergoing a medical treatment who volunteered for this randomized controlled trial. After being evaluated by a battery of questionnaires that included addiction severity index questionnaire, Symptoms Check List 90 version, and World Health Organization Quality of Life, the participants were randomly assigned to an experimental or a control group. The experimental group received thirty 50-min sessions of NFB in addition to their usual medication over a 2-month period; meanwhile, the control group received only their usual medication. In accordance with this study's pre-test-post-test design, both study groups were evaluated again after completing their respective treatment regimens. Multivariate analysis of covariance showed the experimental group to have lower severity of addiction, better psychological health, and better quality of life in than the control group. The differences between the two groups were statistically significant. These finding suggest that NFB can be used to improve the effectiveness of treatment results in CMD patients.

Changing Community Health Behaviors with a Health Promotion Computer Network: Preliminary Findings from Stanford Health-Net

PubMed Central

Robinson, Thomas N.; Walters, Paul A.

1987-01-01

Computer-based health education has been employed in many settings. However, data on resultant behavior change are lacking. A randomized, controlled, prospective study was performed to test the efficacy of Stanford Health-Net in changing community health behaviors. Graduate and undergraduate students (N=1003) were randomly assigned to treatment and control conditions. The treatment group received access to Health-Net, a health promotion computer network emphasizing specific self-care and preventive strategies. Over a four month intervention period, 26% of the treatment group used Health-Net an average of 6.4 times each (range 1 to 97). Users rated Health-Net favorably. The mean number of ambulatory medical visits decreesed 22.5% more in the treatment group than in the control group (P<.05), while hospitalizations did not differ significantly between groups. In addition, perceived self-efficacy for preventing the acquisition of a STD and herpes increased 577% (P<.05) and 261% (P<.01) more, respectively, in the treatment group than in the control group. These findings suggest that access to Stanford Health-Net can result in significant health behavior change. The advantages of the network approach make it a potential model for other communities.

Analyzing social experiments as implemented: A reexamination of the evidence from the HighScope Perry Preschool Program

PubMed Central

Heckman, James; Moon, Seong Hyeok; Pinto, Rodrigo; Savelyev, Peter; Yavitz, Adam

2012-01-01

Social experiments are powerful sources of information about the effectiveness of interventions. In practice, initial randomization plans are almost always compromised. Multiple hypotheses are frequently tested. “Significant” effects are often reported with p-values that do not account for preliminary screening from a large candidate pool of possible effects. This paper develops tools for analyzing data from experiments as they are actually implemented. We apply these tools to analyze the influential HighScope Perry Preschool Program. The Perry program was a social experiment that provided preschool education and home visits to disadvantaged children during their preschool years. It was evaluated by the method of random assignment. Both treatments and controls have been followed from age 3 through age 40. Previous analyses of the Perry data assume that the planned randomization protocol was implemented. In fact, as in many social experiments, the intended randomization protocol was compromised. Accounting for compromised randomization, multiple-hypothesis testing, and small sample sizes, we find statistically significant and economically important program effects for both males and females. We also examine the representativeness of the Perry study. PMID:23255883

A Preliminary Report of Short-Term Cognitive-Behavioral Group Therapy for Inpatients With Personality Disorders

PubMed Central

SPRINGER, TAMAR; LOHR, NAOMI E.; BUCHTEL, HENRY A.; SILK, KENNETH R.

1996-01-01

A randomized, controlled study evaluated the effectiveness of a cognitive-behavioral therapy group, based on Linehan’s dialectical behavior therapy, for inpatients with personality disorders. The treatment, a problem-solving skills group focused on parasuicidality, was compared with a discussion control group. Change was assessed by self-report measures and behavioral observations on the unit. Subjects in both groups improved significantly on most change measures, although no significant between-group differences were found. However, the treatment group patients viewed the intervention as more beneficial to them in their lives outside the hospital. The usefulness of this type of group on a short-term unit is discussed. PMID:22700265

Design of the Resistance and Endurance exercise After ChemoTherapy (REACT) study: a randomized controlled trial to evaluate the effectiveness and cost-effectiveness of exercise interventions after chemotherapy on physical fitness and fatigue.

PubMed

Kampshoff, Caroline S; Buffart, Laurien M; Schep, Goof; van Mechelen, Willem; Brug, Johannes; Chinapaw, Mai J M

2010-11-30

Preliminary studies suggest that physical exercise interventions can improve physical fitness, fatigue and quality of life in cancer patients after completion of chemotherapy. Additional research is needed to rigorously test the effects of exercise programmes among cancer patients and to determine optimal training intensity accordingly. The present paper presents the design of a randomized controlled trial evaluating the effectiveness and cost-effectiveness of a high intensity exercise programme compared to a low-to-moderate intensity exercise programme and a waiting list control group on physical fitness and fatigue as primary outcomes. After baseline measurements, cancer patients who completed chemotherapy are randomly assigned to either a 12-week high intensity exercise programme or a low-to-moderate intensity exercise programme. Next, patients from both groups are randomly assigned to immediate training or a waiting list (i.e. waiting list control group). After 12 weeks, patients of the waiting list control group start with the exercise programme they have been allocated to.Both interventions consist of equal bouts of resistance and endurance interval exercises with the same frequency and duration, but differ in training intensity. Additionally, patients of both exercise programmes are counselled to improve compliance and achieve and maintain an active lifestyle, tailored to their individual preferences and capabilities.Measurements will be performed at baseline (t = 0), 12 weeks after randomization (t = 1), and 64 weeks after randomization (t = 2). The primary outcome measures are cardiorespiratory fitness and muscle strength assessed by means of objective performance indicators, and self-reported fatigue. Secondary outcome measures include health-related quality of life, self-reported physical activity, daily functioning, body composition, mood and sleep disturbances, and return to work. In addition, compliance and satisfaction with the interventions will be evaluated. Potential moderation by pre- and post-illness lifestyle, health and exercise-related attitudes, beliefs and motivation will also be assessed. Finally, the cost-effectiveness of both exercise interventions will be evaluated. This randomized controlled trial will be a rigorous test of effects of exercise programmes for cancer patients after chemotherapy, aiming to contribute to evidence-based practice in cancer rehabilitation programmes. This study is registered at the Netherlands Trial Register (NTR2153).

Effectiveness of maternal counseling in reducing caries in Cree children.

PubMed

Harrison, R L; Veronneau, J; Leroux, B

2012-11-01

This cluster-randomized pragmatic (effectiveness) trial tested maternal counseling based on Motivational Interviewing (MI) as an approach to control caries in indigenous children. Nine Cree communities in Quebec, Canada were randomly allocated to test or control. MI-style counseling was delivered in test communities to mothers during pregnancy and at well-baby visits. Data on outcomes were collected when children were 30 months old. Two hundred seventy-two mothers were recruited from the 5 test and 4 control communities. Baseline characteristics were comparable but not equivalent for both groups. At trial's end, 241 children had follow-up. The primary analysis outcome was enamel caries with substance loss (d2); no statistically significant treatment effect was detected. Prevalence of treated and untreated caries at the d2 level was 76% in controls vs. 65% in test (p = 0.17). Exploratory analyses suggested a substantial preventive effect for untreated decay at or beyond the level of the dentin, d3 (prevalences: 60% controls vs. 35% test), and a particularly large treatment effect when mothers had 4 or more MI-style sessions. Overall, these results provide preliminary evidence that, for these young, indigenous children, an MI-style intervention has an impact on severity of caries (clinical trial registration ISRCTN41467632).

Randomized Controlled Trial of Online Acceptance and Commitment Therapy for Fibromyalgia.

PubMed

Simister, Heather D; Tkachuk, Gregg A; Shay, Barbara L; Vincent, Norah; Pear, Joseph J; Skrabek, Ryan Q

2018-03-02

In this study, 67 participants (95% female) with fibromyalgia (FM) were randomly assigned to an online acceptance and commitment therapy (online ACT) and treatment as usual (TAU; ACT + TAU) protocol or a TAU control condition. Online ACT + TAU participants were asked to complete 7 modules over an 8-week period. Assessments were completed at pre-treatment, post-treatment, and 3-month follow-up periods and included measures of FM impact (primary outcome), depression, pain, sleep, 6-minute walk, sit to stand, pain acceptance (primary process variable), mindfulness, cognitive fusion, valued living, kinesiophobia, and pain catastrophizing. The results indicated that online ACT + TAU participants significantly improved in FM impact, relative to TAU (P <.001), with large between condition effect sizes at post-treatment (1.26) and follow-up (1.59). Increases in pain acceptance significantly mediated these improvements (P = .005). Significant improvements in favor of online ACT + TAU were also found on measures of depression (P = .02), pain (P = .01), and kinesiophobia (P = .001). Although preliminary, this study highlights the potential for online ACT to be an efficacious, accessible, and cost-effective treatment for people with FM and other chronic pain conditions. Online ACT reduced FM impact relative to a TAU control condition in this randomized controlled trial. Reductions in FM impact were mediated by improvements in pain acceptance. Online ACT appears to be a promising intervention for FM. Copyright © 2018 The American Pain Society. Published by Elsevier Inc. All rights reserved.

Contribution of Transcranial Direct Current Stimulation on Inhibitory Control to Assess the Neurobiological Aspects of Attention Deficit Hyperactivity Disorder: Randomized Controlled Trial

PubMed Central

Baptista, Abrahão Fontes; de Sena, Eduardo Pondé

2015-01-01

Background The applicability of transcranial direct current stimulation (tDCS) in individuals with attention deficit hyperactivity disorder (ADHD) has not yet been investigated. This low-cost, non-invasive, and safe technique optimized to modulate the inhibitory response might be a useful treatment option for those affected by this condition. Objective The aim of this single center, parallel, randomized, double-blinded, sham-controlled trial is to investigate the efficacy of transcranial direct current stimulation over the prefrontal cortex on the modulation of inhibitory control in adults with attention deficit hyperactivity disorder. Methods A total of 60 individuals will be divided into 2 groups by block randomization to receive active or sham stimulation. Anodal stimulation over the left dorsolateral prefrontal cortex will be applied at 1 mA during a single 20-minute session. Before and after interventions, subjects will perform 2 go/no go tasks and the brain electrical activity will be recorded by electroencephalogram (EEG) with 32 channels, according to the 10-20 international EEG system. Results The trial began in May 2013 and we are currently performing the statistical analysis for the secondary outcomes. Conclusions The findings from this study will provide preliminary results about the role of prefrontal cortex activation through tDCS on ADHD patients. Trial Registration Clinicaltrials.gov NCT01968512; http://clinicaltrials.gov/ct2/show/NCT01968512 (Archived by WebCite at www.webcitation.org/6YMSW2tkD). PMID:25986784

Contribution of transcranial direct current stimulation on inhibitory control to assess the neurobiological aspects of attention deficit hyperactivity disorder: randomized controlled trial.

PubMed

Cosmo, Camila; Baptista, Abrahão Fontes; de Sena, Eduardo Pondé

2015-05-18

The applicability of transcranial direct current stimulation (tDCS) in individuals with attention deficit hyperactivity disorder (ADHD) has not yet been investigated. This low-cost, non-invasive, and safe technique optimized to modulate the inhibitory response might be a useful treatment option for those affected by this condition. The aim of this single center, parallel, randomized, double-blinded, sham-controlled trial is to investigate the efficacy of transcranial direct current stimulation over the prefrontal cortex on the modulation of inhibitory control in adults with attention deficit hyperactivity disorder. A total of 60 individuals will be divided into 2 groups by block randomization to receive active or sham stimulation. Anodal stimulation over the left dorsolateral prefrontal cortex will be applied at 1 mA during a single 20-minute session. Before and after interventions, subjects will perform 2 go/no go tasks and the brain electrical activity will be recorded by electroencephalogram (EEG) with 32 channels, according to the 10-20 international EEG system. The trial began in May 2013 and we are currently performing the statistical analysis for the secondary outcomes. The findings from this study will provide preliminary results about the role of prefrontal cortex activation through tDCS on ADHD patients. Clinicaltrials.gov NCT01968512; http://clinicaltrials.gov/ct2/show/NCT01968512 (Archived by WebCite at www.webcitation.org/6YMSW2tkD).

Short-Term Impact of a Teen Pregnancy-Prevention Intervention Implemented in Group Homes.

PubMed

Oman, Roy F; Vesely, Sara K; Green, Jennifer; Fluhr, Janene; Williams, Jean

2016-11-01

Youth living in group home settings are at significantly greater risk for sexual risk behaviors; however, there are no sexual health programs designed specifically for these youth. The study's purpose was to assess the effectiveness of a teen pregnancy-prevention program for youth living in group home foster care settings and other out-of-home placements. The study design was a cluster randomized controlled trial involving youth (N = 1,037) recruited from 44 residential group homes located in California, Maryland, and Oklahoma. Within each state, youth (mean age = 16.2 years; 82% male; 37% Hispanic, 20% African-American, 20% white, and 17% multiracial) in half the group homes were randomly assigned to the intervention group (n = 40 clusters) and the other half were randomly assigned to a control group that offered "usual care" (n = 40 clusters). The intervention (i.e., Power Through Choices [PTC]) was a 10-session, age-appropriate, and medically accurate sexual health education program. Compared to the control group, youth in the PTC intervention showed significantly greater improvements (p < .05) from preintervention to postintervention in all three knowledge areas, one of two attitude areas, all three self-efficacy areas, and two of three behavioral intention areas. This is the first published randomized controlled trial of a teen pregnancy-prevention program designed for youth living in foster care settings and other out-of-home placements. The numerous significant improvements in short-term outcomes are encouraging and provide preliminary evidence that the PTC program is an effective pregnancy-prevention program. Copyright © 2016 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

A novel early intervention for preschool depression: findings from a pilot randomized controlled trial.

PubMed

Luby, Joan; Lenze, Shannon; Tillman, Rebecca

2012-03-01

Validation for depression in preschool children has been established; however, to date no empirical investigations of interventions for the early onset disorder have been conducted. Based on this and the modest efficacy of available treatments for childhood depression, the need for novel early interventions has been emphasized. Large effect sizes (ES) for preschool psychotherapies for several Axis I disorders suggest that earlier intervention in depression may also be promising. Therefore, a novel form of treatment for preschool depression, Parent-Child Interaction Therapy Emotion Development (PCIT-ED) was developed and tested. A preliminary randomized controlled trial (RCT) was conducted comparing PCIT-ED to psycho-education in depressed 3- to 7-year-olds and their caregivers. A total of 54 patients met symptom criteria for DSM-IV major depressive disorder and were randomized, 19 patients completed the active treatment (n = 8 dropouts) and 10 completed psycho-education (n = 17 dropouts). Both groups showed significant improvement in several domains, with PCIT-ED showing significance in a greater number of domains. An intent-to-treat analysis suggested that PCIT-ED was significantly more effective than psycho-education on executive functioning (p = .011, ES = 0.12) and emotion recognition skills (p = .002, ES = 0.83). The RCT proved feasible and suggests an individual control condition should be used in future trials to minimize differential dropout. These pilot data, although limited by power, suggest that PCIT-ED may be a promising early intervention for depression. Larger scale randomized controlled trials of PCIT-ED for depressed preschoolers are now warranted. © 2011 The Authors. Journal of Child Psychology and Psychiatry © 2011 Association for Child and Adolescent Mental Health.

Mindfulness-based stress reduction for overweight/obese women with and without polycystic ovary syndrome: design and methods of a pilot randomized controlled trial.

PubMed

Raja-Khan, Nazia; Agito, Katrina; Shah, Julie; Stetter, Christy M; Gustafson, Theresa S; Socolow, Holly; Kunselman, Allen R; Reibel, Diane K; Legro, Richard S

2015-03-01

Mindfulness-based stress reduction (MBSR) may be beneficial for overweight/obese women, including women with polycystic ovary syndrome (PCOS), as it has been shown to reduce psychological distress and improve quality of life in other patient populations. Preliminary studies suggest that MBSR may also have salutary effects on blood pressure and blood glucose. This paper describes the design and methods of an ongoing pilot randomized controlled trial evaluating the feasibility and effects of MBSR in PCOS and non-PCOS women who are overweight or obese (NCT01464398). Eighty six (86) women with body mass index ≥ 25 kg/m(2), including 31 women with PCOS, have been randomized to 8 weeks of MBSR or health education control, and followed for 16 weeks. The primary outcome is mindfulness assessed with the Toronto Mindfulness Scale. Secondary outcomes include measures of blood pressure, blood glucose, quality of life, anxiety and depression. Our overall hypothesis is that MBSR will increase mindfulness and ultimately lead to favorable changes in blood pressure, blood glucose, psychological distress and quality of life in PCOS and non-PCOS women. This would support the integration of MBSR with conventional medical treatments to reduce psychological distress, cardiovascular disease and diabetes in PCOS and non-PCOS women who are overweight or obese. Copyright © 2015 Elsevier Inc. All rights reserved.

Mindfulness-Based Stress Reduction for Overweight/Obese Women With and Without Polycystic Ovary Syndrome: Design and Methods of a Pilot Randomized Controlled Trial

PubMed Central

Raja-Khan, Nazia; Agito, Katrina; Shah, Julie; Stetter, Christy M.; Gustafson, Theresa S.; Socolow, Holly; Kunselman, Allen R.; Reibel, Diane K.; Legro, Richard S.

2015-01-01

Mindfulness-based stress reduction (MBSR) may be beneficial for overweight/obese women, including women with polycystic ovary syndrome (PCOS), as it has been shown to reduce psychological distress and improve quality of life in other patient populations. Preliminary studies suggest that MBSR may also have salutary effects on blood pressure and blood glucose. This paper describes the design and methods of an ongoing pilot randomized controlled trial evaluating the feasibility and effects of MBSR in PCOS and non-PCOS women who are overweight or obese. Eighty six (86) women with body mass index ≥25 kg/m2, including 31 women with PCOS, have been randomized to 8 weeks of MBSR or health education control, and followed for 16 weeks. The primary outcome is mindfulness assessed with the Toronto Mindfulness Scale. Secondary outcomes include measures of blood pressure, blood glucose, quality of life, anxiety and depression. Our overall hypothesis is that MBSR will increase mindfulness and ultimately lead to favorable changes in blood pressure, blood glucose, psychological distress and quality of life in PCOS and non-PCOS women. This would support the integration of MBSR with conventional medical treatments to reduce psychological distress, cardiovascular disease and diabetes in PCOS and non-PCOS women who are overweight or obese. PMID:25662105

A BRIEF ECOLOGICAL MOMENTARY INTERVENTION FOR GENERALIZED ANXIETY DISORDER: A RANDOMIZED CONTROLLED TRIAL OF THE WORRY OUTCOME JOURNAL.

PubMed

LaFreniere, Lucas S; Newman, Michelle G

2016-09-01

The efficacy of many cognitive behavioral component interventions has not been examined, with worry outcome monitoring among them. To address this issue, 51 participants with clinical levels of generalized anxiety disorder were randomly assigned to a treatment or control condition for 10 days. The treatment condition consisted of a brief ecological momentary intervention termed the Worry Outcome Journal (WOJ). WOJ participants recorded worries and tracked their outcomes, rating worry distress, interference, and expected outcome probabilities. Thought log (TL) control participants completed a record of their everyday thoughts and rated associated distress. All participants made four entries on paper each day when randomly prompted by text message. They then entered their paper contents online each night. After 30 days they reviewed their contents electronically and completed follow-up measures. Primary results revealed significant reductions in worry for WOJ users compared to TL users at postintervention. A marginally significant difference was found at 20-day follow-up and treatment gains were maintained. Secondary analyses showed no harmful increases in worry beliefs for WOJ users, as well as preliminary evidence for decreases in beliefs about the uncontrollability of thoughts in both groups. The WOJ may be a viable therapist-independent treatment for reducing worry, even after only 10 days of use. © 2016 Wiley Periodicals, Inc.

Early rehabilitation exercise program for inpatients during an acute exacerbation of chronic obstructive pulmonary disease: a randomized controlled trial.

PubMed

Tang, Clarice Y; Blackstock, Felicity C; Clarence, Michael; Taylor, Nicholas F

2012-01-01

To determine whether an early rehabilitation program was safe and feasible for patients during an acute exacerbation of chronic obstructive pulmonary disease (COPD). In this phase 1 randomized controlled trial, patients with an acute exacerbation of COPD admitted to the hospital were randomly allocated to a low-intensity exercise group, a moderate- to high-intensity exercise group, or a control group, who received routine physical therapy. In addition to routine physical therapy, patients in the exercise group had to participate in an exercise program. The program consisted of twice-daily aerobic and resistance exercise sessions. Primary outcomes were the number and classification of adverse events and program adherence. In 174 exercise sessions, there was 1 serious adverse event of arrhythmia in the low-intensity exercise group that resolved within 1 hour. There were 12 other minor adverse events involving 5 patients with no significant differences between groups. Patients completed an average of 80% of their scheduled sessions with no significant between-group differences. The exercise groups improved significantly in walking distance; however, no significant between-group differences were observed. There was preliminary evidence that it was safe and feasible to implement an exercise program for patients during an acute exacerbation of COPD. Additional studies with larger sample sizes are required to accurately evaluate program effectiveness.

Homeopathy for attention-deficit/hyperactivity disorder: a pilot randomized-controlled trial.

PubMed

Jacobs, Jennifer; Williams, Anna-Leila; Girard, Christine; Njike, Valentine Yanchou; Katz, David

2005-10-01

The aim of this study was to carry out a preliminary trial evaluating the effectiveness of homeopathy in the treatment of attention-deficit/hyperactivity disorder (ADHD). This work was a randomized, double-blind, placebo-controlled trial. This study was conducted in a private homeopathic clinic in the Seattle metropolitan area. Subjects included children 6-12 years of age meeting Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) criteria for ADHD. Forty-three subjects were randomized to receive a homeopathic consultation and either an individualized homeopathic remedy or placebo. Patients were seen by homeopathic physicians every 6 weeks for 18 weeks. Outcome measures included the Conner's Global Index-Parent, Conner's Global Index- Teacher, Conner's Parent Rating Scale-Brief, Continuous Performance Test, and the Clinical Global Impression Scale. There were no statistically significant differences between homeopathic remedy and placebo groups on the primary or secondary outcome variables. However, there were statistically and clinically significant improvements in both groups on many of the outcome measures. This pilot study provides no evidence to support a therapeutic effect of individually selected homeopathic remedies in children with ADHD. A therapeutic effect of the homeopathic encounter is suggested and warrants further evaluation. Future studies should be carried out over a longer period of time and should include a control group that does not receive the homeopathic consultation. Comparison to conventional stimulant medication for ADHD also should be considered.

Systematic review of herbs and dietary supplements for glycemic control in diabetes.

PubMed

Yeh, Gloria Y; Eisenberg, David M; Kaptchuk, Ted J; Phillips, Russell S

2003-04-01

To conduct a systematic review of the published literature on the efficacy and safety of herbal therapies and vitamin/mineral supplements for glucose control in patients with diabetes. We conducted an electronic literature search of MEDLINE, OLDMEDLINE, Cochrane Library Database, and HealthSTAR, from database inception to May 2002, in addition to performing hand searches and consulting with experts in the field. Available clinical studies published in the English language that used human participants and examined glycemic control were included. Data were extracted in a standardized manner, and two independent investigators assessed methodological quality of randomized controlled trials using the Jadad scale. A total of 108 trials examining 36 herbs (single or in combination) and 9 vitamin/mineral supplements, involving 4,565 patients with diabetes or impaired glucose tolerance, met the inclusion criteria and were analyzed. There were 58 controlled clinical trials involving individuals with diabetes or impaired glucose tolerance (42 randomized and 16 nonrandomized trials). Most studies involved patients with type 2 diabetes. Heterogeneity and the small number of studies per supplement precluded formal meta-analyses. Of these 58 trials, the direction of the evidence for improved glucose control was positive in 76% (44 of 58). Very few adverse effects were reported. There is still insufficient evidence to draw definitive conclusions about the efficacy of individual herbs and supplements for diabetes; however, they appear to be generally safe. The available data suggest that several supplements may warrant further study. The best evidence for efficacy from adequately designed randomized controlled trials (RCTs) is available for Coccinia indica and American ginseng. Chromium has been the most widely studied supplement. Other supplements with positive preliminary results include Gymnema sylvestre, Aloe vera, vanadium, Momordica charantia, and nopal.

A cross-validation trial of an Internet-based prevention program for alcohol and cannabis: Preliminary results from a cluster randomised controlled trial.

PubMed

Champion, Katrina E; Newton, Nicola C; Stapinski, Lexine; Slade, Tim; Barrett, Emma L; Teesson, Maree

2016-01-01

Replication is an important step in evaluating evidence-based preventive interventions and is crucial for establishing the generalizability and wider impact of a program. Despite this, few replications have occurred in the prevention science field. This study aims to fill this gap by conducting a cross-validation trial of the Climate Schools: Alcohol and Cannabis course, an Internet-based prevention program, among a new cohort of Australian students. A cluster randomized controlled trial was conducted among 1103 students (Mage: 13.25 years) from 13 schools in Australia in 2012. Six schools received the Climate Schools course and 7 schools were randomized to a control group (health education as usual). All students completed a self-report survey at baseline and immediately post-intervention. Mixed-effects regressions were conducted for all outcome variables. Outcomes assessed included alcohol and cannabis use, knowledge and intentions to use these substances. Compared to the control group, immediately post-intervention the intervention group reported significantly greater alcohol (d = 0.67) and cannabis knowledge (d = 0.72), were less likely to have consumed any alcohol (even a sip or taste) in the past 6 months (odds ratio = 0.69) and were less likely to intend on using alcohol in the future (odds ratio = 0.62). However, there were no effects for binge drinking, cannabis use or intentions to use cannabis. These preliminary results provide some support for the Internet-based Climate Schools: Alcohol and Cannabis course as a feasible way of delivering alcohol and cannabis prevention. Intervention effects for alcohol and cannabis knowledge were consistent with results from the original trial; however, analyses of longer-term follow-up data are needed to provide a clearer indication of the efficacy of the intervention, particularly in relation to behavioral changes. © The Royal Australian and New Zealand College of Psychiatrists 2015.

A pilot randomized controlled trial using EEG-based brain-computer interface training for a Chinese-speaking group of healthy elderly.

PubMed

Lee, Tih-Shih; Quek, Shin Yi; Goh, Siau Juinn Alexa; Phillips, Rachel; Guan, Cuntai; Cheung, Yin Bun; Feng, Lei; Wang, Chuan Chu; Chin, Zheng Yang; Zhang, Haihong; Lee, Jimmy; Ng, Tze Pin; Krishnan, K Ranga Rama

2015-01-01

There is growing evidence that cognitive training (CT) can improve the cognitive functioning of the elderly. CT may be influenced by cultural and linguistic factors, but research examining CT programs has mostly been conducted on Western populations. We have developed an innovative electroencephalography (EEG)-based brain-computer interface (BCI) CT program that has shown preliminary efficacy in improving cognition in 32 healthy English-speaking elderly adults in Singapore. In this second pilot trial, we examine the acceptability, safety, and preliminary efficacy of our BCI CT program in healthy Chinese-speaking Singaporean elderly. Thirty-nine elderly participants were randomized into intervention (n=21) and wait-list control (n=18) arms. Intervention consisted of 24 half-hour sessions with our BCI-based CT training system to be completed in 8 weeks; the control arm received the same intervention after an initial 8-week waiting period. At the end of the training, a usability and acceptability questionnaire was administered. Efficacy was measured using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), which was translated and culturally adapted for the Chinese-speaking local population. Users were asked about any adverse events experienced after each session as a safety measure. The training was deemed easily usable and acceptable by senior users. The median difference in the change scores pre- and post-training of the modified RBANS total score was 8.0 (95% confidence interval [CI]: 0.0-16.0, P=0.042) higher in the intervention arm than waitlist control, while the mean difference was 9.0 (95% CI: 1.7-16.2, P=0.017). Ten (30.3%) participants reported a total of 16 adverse events - all of which were graded "mild" except for one graded "moderate". Our BCI training system shows potential in improving cognition in both English- and Chinese-speaking elderly, and deserves further evaluation in a Phase III trial. Overall, participants responded positively on the usability and acceptability questionnaire.

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.

An Astrometric Facility For Planetary Detection On The Space Station

NASA Astrophysics Data System (ADS)

Nishioka, Kenji; Scargle, Jeffrey D.; Givens, John J.

1987-09-01

An Astrometric Telescope Facility (ATF) for planetary detection is being studied as a potential Space Station initial operating capability payload. The primary science objective of this mission is the detection and study of planetary systems around other stars. In addition, the facility will be capable of other astrometric measurements such as stellar motions of other galaxies and highly precise direct measurement of stellar distances within the Milky Way Galaxy. This paper summarizes the results of a recently completed ATF preliminary systems definition study. Results of this study indicate that the preliminary concept for the facility is fully capable of meeting the science objectives without the development of any new technologies. This preliminary systems study started with the following basic assumptions: 1) the facility will be placed in orbit by a single Shuttle launch, 2) the Space Station will provide a coarse pointing system , electrical power, communications, assembly and checkout, maintenance and refurbishment services, and 3) the facility will be operated from a ground facility. With these assumptions and the science performance requirements a preliminary "strawman" facility was designed. The strawman facility design with a prime-focus telescope of 1.25-m aperture, f-ratio of 13 and a single prime-focus instrument was chosen to minimize random and systemmatic errors. Total facility mass is 5100 kg and overall dimensions are 1.85-m diam by 21.5-m long. A simple straightforward operations approach has been developed for ATF. A real-time facility control is not normally required, but does maintain a near real-time ground monitoring capability for facility and science data stream on a full-time basis. Facility observational sequences are normally loaded once a week. In addition, the preliminary system is designed to be fail-safe and single-fault tolerant. Routine interactions by the Space Station crew with ATF will not be necessary, but onboard controls are provided for crew override as required for emergencies and maintenance.

77 FR 2287 - FFP Project 40, LLC and Northland Power Mississippi River LLC; Notice Announcing Preliminary...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-17

... Drawing The Commission has received two preliminary permit applications deemed filed on February 1, 2011..., or her designee, will conduct a random drawing to determine the filing priority of the applicants... section 4.37 of its regulations.\\2\\ The priority established by [[Page 2288

Description and Preliminary Training Evaluation of an Arc Welding Simulator. Research Report SRR 73-23.

ERIC Educational Resources Information Center

Abrams, Macy L.; And Others

A prototype arc welding training simulator was designed to provide immediate, discriminative feedback and the capacity for concentrated practice. Two randomly selected groups of welding trainees were compared to evaluate the simulator, one group being trained using the simulator and the other using conventional practice. Preliminary data indicated…

Preliminary Findings on Rural Homelessness in Ohio.

ERIC Educational Resources Information Center

First, Richard J.; And Others

This report is designed to present preliminary findings from the first comprehensive study of rural homelessness in the United States. The study was conducted during the first 6 months of 1990, and data were collected from interviews with 921 homeless adults in 21 randomly selected rural counties in Ohio. The sample counties represent 26% of the…

Effects of feedback-based balance and core resistance training vs. Pilates training on cognitive functions in older women with mild cognitive impairment: a pilot randomized controlled trial.

PubMed

Greblo Jurakic, Zrinka; Krizanic, Valerija; Sarabon, Nejc; Markovic, Goran

2017-12-01

There is limited research about beneficial effects of physical activity in older adults suffering from mild cognitive impairment (MCI). The aim of the study was to provide preliminary evidence on the effects of two types of non-aerobic training on cognitive functions in older women suffering from MCI. Twenty-eight participants aged 66-78 years with MCI were randomly assigned to a combined balance and core resistance training group (n = 14) or to a Pilates group (n = 14). Following completion of the 8-week exercise programme, both groups showed significant improvements in global and specific cognitive domains. Findings suggest that non-aerobic training should be further explored as a beneficial intervention for older adults suffering from MCI.

Gray Matter Differences between Pediatric Obsessive-Compulsive Disorder Patients and High-Risk Siblings: A Preliminary Voxel-Based Morphometry Study

PubMed Central

Gilbert, Andrew R.; Keshavan, Matcheri S.; Diwadkar, Vaibhav; Nutche, Jeffrey; MacMaster, Frank; Easter, Phillip C.; Buhagiar, Christian J.; Rosenberg, David R.

2008-01-01

Neuroimaging studies have identified alterations in frontostriatal circuitry in OCD. Voxel-based morphometry (VBM) allows for the assessment of differences in gray matter density across the whole brain. VBM has not previously been used to examine regional gray matter density in pediatric OCD patients and the siblings of pediatric OCD patients. Volumetric magnetic resonance imaging (MRI) studies were conducted in 10 psychotropic-naïve pediatric patients with OCD, 10 unaffected siblings of pediatric patients with OCD, and 10 healthy controls. VBM analysis was conducted using SPM2. Statistical comparisons were performed with the general linear model, implementing small volume random field corrections for a priori regions of interest (anterior cingulate cortex or ACC, striatum and thalamus). VBM analysis revealed significantly lower gray matter density in OCD patients compared to healthy in the left ACC and bilateral medial superior frontal gyrus (SFG). Furthermore, a small volume correction was used to identify a significantly greater gray matter density in the right putamen in OCD patients as compared to unaffected siblings of OCD patients. These findings in patients, siblings, and healthy controls, although preliminary, suggest the presence of gray matter structural differences between affected subjects and healthy controls as well as between affected subjects and individuals at risk for OCD. PMID:18314272

Mindful Yoga for women with metastatic breast cancer: design of a randomized controlled trial.

PubMed

Carson, James W; Carson, Kimberly M; Olsen, Maren K; Sanders, Linda; Porter, Laura S

2017-03-13

Women with metastatic breast cancer (MBC) have average life expectancies of about 2 years, and report high levels of disease-related symptoms including pain, fatigue, sleep disturbance, psychological distress, and functional impairment. There is growing recognition of the limitations of medical approaches to managing such symptoms. Yoga is a mind-body discipline that has demonstrated a positive impact on psychological and functional health in early stage breast cancer patients and survivors, but has not been rigorously studied in advanced cancer samples. This randomized controlled trial examines the feasibility and initial efficacy of a Mindful Yoga program, compared with a social support condition that controls for attention, on measures of disease-related symptoms such as pain and fatigue. The study will be completed by December 2017. Sixty-five women with MBC age ≥ 18 are being identified and randomized with a 2:1 allocation to Mindful Yoga or a support group control intervention. The 120-min intervention sessions take place weekly for 8 weeks. The study is conducted at an urban tertiary care academic medical center located in Durham, North Carolina. The primary feasibility outcome is attendance at intervention sessions. Efficacy outcomes include pain, fatigue, sleep quality, psychological distress, mindfulness and functional capacity at post-intervention, 3-month follow-up, and 6-month follow-up. In this article, we present the challenges of designing a randomized controlled trial with long-term follow-up among women with MBC. These challenges include ensuring adequate recruitment including of minorities, limiting and controlling for selection bias, tailoring of the yoga intervention to address special needs, and maximizing adherence and retention. This project will provide important information regarding yoga as an intervention for women with advanced cancer, including preliminary data on the psychological and functional effects of yoga for MBC patients. This investigation will also establish rigorous methods for future research into yoga as an intervention for this population. ClinicalTrials.gov identifer: NCT01927081 , registered August 16, 2013.

Statistical characterization of fluctuations of a laser beam transmitted through a random air-water interface: new results from a laboratory experiment

NASA Astrophysics Data System (ADS)

Majumdar, Arun K.; Land, Phillip; Siegenthaler, John

2014-10-01

New results for characterizing laser intensity fluctuation statistics of a laser beam transmitted through a random air-water interface relevant to underwater communications are presented. A laboratory watertank experiment is described to investigate the beam wandering effects of the transmitted beam. Preliminary results from the experiment provide information about histograms of the probability density functions of intensity fluctuations for different wind speeds measured by a CMOS camera for the transmitted beam. Angular displacements of the centroids of the fluctuating laser beam generates the beam wander effects. This research develops a probabilistic model for optical propagation at the random air-water interface for a transmission case under different wind speed conditions. Preliminary results for bit-error-rate (BER) estimates as a function of fade margin for an on-off keying (OOK) optical communication through the air-water interface are presented for a communication system where a random air-water interface is a part of the communication channel.

Positive Psychology Interventions for Patients With Heart Disease: A Preliminary Randomized Trial.

PubMed

Nikrahan, Gholam Reza; Suarez, Laura; Asgari, Karim; Beach, Scott R; Celano, Christopher M; Kalantari, Mehrdad; Abedi, Mohammad Reza; Etesampour, Ali; Abbas, Rezaei; Huffman, Jeff C

2016-01-01

Positive psychologic characteristics have been linked to superior cardiac outcomes. Accordingly, in this exploratory study, we assessed positive psychology interventions in patients who had recently undergone a procedure to treat cardiovascular disease. Participants were randomly assigned to receive 1 of 3 different 6-week face-to-face interventions or a wait-list control condition. We assessed intervention feasibility and compared changes in psychologic outcome measures postintervention (7wk) and at follow-up (15wk) between intervention and control participants. Across the interventions, 74% of assigned sessions were completed. When comparing outcomes between interventions and control participants (N = 55 total), there were no between-group differences post-intervention, but at follow-up intervention participants had greater improvements in happiness (β = 14.43, 95% CI: 8.66-20.2, p < 0.001), depression (β = -3.87, 95% CI: -7.72 to 0.02, p = 0.049), and hope (β = 7.12, 95% CI: 1.25-13.00, p =0.017), with moderate-large effect sizes. Efficacy of the 3 interventions was similar. Future studies are needed to identify an optimal positive psychology intervention for cardiac patients. Copyright © 2016 The Academy of Psychosomatic Medicine. Published by Elsevier Inc. All rights reserved.

Positive psychology interventions for patients with heart disease: a preliminary randomized trial

PubMed Central

Nikrahan, Gholam Reza; Suarez, Laura; Asgari, Karim; Beach, Scott R.; Celano, Christopher M.; Kalantari, Mehrdad; Abedi, Mohammad Reza; Etesampour, Ali; Abbas, Rezaei; Huffman, Jeff C.

2016-01-01

Objective Positive psychological characteristics have been linked to superior cardiac outcomes. Accordingly, in this exploratory study, we assessed positive psychology interventions in patients who had recently undergone a procedure to treat cardiovascular disease. Method Participants were randomly assigned to receive one of three different six-week face-to-face interventions or a wait-list control condition. We assessed intervention feasibility and compared changes in psychological outcome measures post-intervention (7 weeks) and at follow-up (15 weeks) between intervention and control participants. Across the interventions, 74% of assigned sessions were completed. Results When comparing outcomes between interventions and control participants (N=55 total), there were no between-group differences post-intervention, but at follow-up intervention participants had greater improvements in happiness (β=14.43, 95% confidence interval [CI]=8.66–20.2, p<.001), depression (β=−3.87, 95% CI=−7.72 to 0.02, p=.049), and hope (β=7.12, 95% CI=1.25–13.00, p=.017), with moderate-large effect sizes. Efficacy of the three interventions was similar. Conclusions Future studies are needed to identify an optimal positive psychology intervention for cardiac patients. PMID:27137709

A culturally tailored Internet cancer support group for Asian American breast cancer survivors: A randomized controlled pilot intervention study.

PubMed

Chee, Wonshik; Lee, Yaelim; Im, Eun-Ok; Chee, Eunice; Tsai, Hsiu-Min; Nishigaki, Masakazu; Yeo, Seon Ae; Schapira, Marilyn M; Mao, Jun James

2017-07-01

Introduction The necessity of culturally competent Internet Cancer Support Groups (ICSGs) for ethnic minorities has recently been highlighted in order to increase its attractiveness and usage. The purpose of this study was to determine the preliminary efficacy of a culturally tailored registered-nurse-moderated ICSG for Asian American breast cancer survivors in enhancing the women's breast cancer survivorship experience. Methods The study included two phases: (a) a usability test and an expert review; and (b) a randomized controlled pilot intervention study. The usability test was conducted among five Asian American breast cancer survivors using a one-month online forum, and the expert review was conducted among five experts using the Cognitive Walkthrough method. The randomized controlled pilot intervention study (a pre-test and post-test design) was conducted among 65 Asian American breast cancer survivors. The data were analysed using content analysis and descriptive and inferential statistics including the repeated ANOVA. Results All users and experts positively evaluated the program and provided their suggestions for the display, educational contents, and user-friendly structure. There were significant positive changes in the support care needs and physical and psychological symptoms ( p < 0.05) of the control group. There were significant negative changes in the uncertainty level of the intervention group ( p < 0.10). Controlling for background and disease factors, the intervention group showed significantly greater improvements than the control group in physical and psychological symptoms and quality of life ( p < 0.10). Discussion The findings supported the positive effects of ICSGs on support care needs, psychological and physical symptoms, and quality of life.

The effect of the homeopathic remedies Arnica montana and Bellis perennis on mild postpartum bleeding--a randomized, double-blind, placebo-controlled study--preliminary results.

PubMed

Oberbaum, Menachem; Galoyan, Narine; Lerner-Geva, Liat; Singer, Shepherd Roee; Grisaru, Sorina; Shashar, David; Samueloff, Arnon

2005-06-01

To evaluate the effect of Arnica Montana and Bellis perennis on postpartum blood loss. Double blind, placebo-controlled, randomized, clinical trial. Department of Gynecology, Shaare Zedek Medical Center, Jerusalem. Forty parturients were randomized to one of three groups: Arnica montana C6 and Bellis perennis C6 (n=14), Arnica montana C30 and Bellis perennis C30 (n=14), or double placebo (n=12). After 48 h the Arnica/placebo was halted, and patients continued the Bellis/placebo until cessation of lochia. Hemoglobin levels (Hb) at 48 and 72 h postpartum. At 72 h postpartum, mean Hb levels remained similar after treatment with homeopathic remedies (12.7 versus 12.4) as compared to a significant decrease in Hb levels in the placebo group (12.7 versus 11.6; p<0.05), in spite of less favorable initial characteristics of the treatment group. The mean difference in Hb levels at 72 h postpartum was -0.29 (95% CI -1.09; 0.52) in the treatment group and -1.18 (95% CI -1.82; -0.54) in the placebo group (p<0.05). Treatment with homeopathic Arnica montana and Bellis perennis may reduce postpartum blood loss, as compared with placebo.

Double-blind, randomized, controlled trial of rasagiline as monotherapy in early Parkinson's disease patients.

PubMed

Stern, Matthew B; Marek, Kenneth L; Friedman, Joseph; Hauser, Robert A; LeWitt, Peter A; Tarsy, Daniel; Olanow, C Warren

2004-08-01

Rasagiline (N-propargyl-1(R)-aminoindan) mesylate is a potent, selective, and irreversible monoamine oxidase-B inhibitor. This study was designed to evaluate the safety, tolerability, and preliminary efficacy of rasagiline monotherapy in early Parkinson's disease (PD) patients not receiving levodopa. The study was performed as a multicenter, parallel-group, double-blind, randomized, placebo-controlled, 10-week study. Fifty-six PD patients were randomly assigned to rasagiline mesylate 1, 2, or 4 mg once daily, or placebo. A 3-week dose-escalation period was followed by a 7-week maintenance phase. At week 10, the mean (+/-SE) changes from baseline in total Unified Parkinson's Disease Rating Scale (UPDRS) score were -1.8 (+/-1.3), -3.6 (+/-1.7), -3.6 (+/-1.2), and -0.5 (+/-0.8) in the rasagiline 1, 2, and 4 mg/day and placebo groups, respectively. Analysis of responders showed that 28% of patients (12 of 43) receiving rasagiline had an improvement in total UPDRS score of greater than 30%, compared with none of the patients receiving placebo (P < 0.05, Fisher's exact test). The frequency and types of adverse events reported by rasagiline-treated and placebo-treated patients were similar. These results suggest that rasagiline monotherapy is well tolerated and efficacious in early PD. Copyright 2004 Movement Disorder Society

Effects of exercise program on physiological functions in postmenopausal women with metabolic syndrome.

PubMed

Heli, Valkeinen; Ihab, Hajjar; Kun, Hu; Brad, Manor; Jessica, Wisocky; Vera, Novak

2013-12-01

The purpose of this study was to examine effects of mixed interval aerobic and strength training (MAST) program on physiological functions in older women with metabolic syndrome. 12 subjects were randomly assigned to the exercise group (16-week MAST program) or the control group. Outcomes included oxygen uptake (VO 2max ), cerebral blood flow velocity (BFV) and cognitive functions. The exercise group demonstrated increased VO 2max and certain improvements in cognitive functions. No changes were observed in BFV for both groups. These results can be used as a preliminary data for planning larger studies.

Biofeedback and dance performance: a preliminary investigation.

PubMed

Raymond, Joshua; Sajid, Imran; Parkinson, Lesley A; Gruzelier, John H

2005-03-01

Alpha-theta neurofeedback has been shown to produce professionally significant performance improvements in music students. The present study aimed to extend this work to a different performing art and compare alpha-theta neurofeedback with another form of biofeedback: heart rate variability (HRV) biofeedback. Twenty-four ballroom and Latin dancers were randomly allocated to three groups, one receiving neurofeedback, one HRV biofeedback and one no intervention. Dance was assessed before and after training. Performance improvements were found in the biofeedback groups but not in the control group. Neurofeedback and HRV biofeedback benefited performance in different ways. A replication with larger sample sizes is required.

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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.

Neurofeedback reduces overeating episodes in female restrained eaters: a randomized controlled pilot-study.

PubMed

Schmidt, Jennifer; Martin, Alexandra

2015-12-01

Overeating episodes, despite of intentions to control weight, are a common problem among women. Recurring episodes of overeating and dietary failure have been reported to result in higher Body Mass Indexes and to induce severe distress even in non-clinical groups. Based on findings from physiological research on eating behavior and craving, as well as previous biofeedback studies, we derived a cue exposure based EEG neurofeedback protocol to target overeating episodes. The treatment was evaluated in a randomized controlled trial, comparing a neurofeedback group (NFG; n = 14) with a waiting list control group (WLG; n = 13) in a sub-clinical sample of female restrained eaters. At post-treatment, the number of weekly overeating episodes and subsequent distress were significantly reduced in the NFG compared to the WLG (p < .01; r > .50). In a 3 month follow-up, effects in the NFG remained stable. As secondary outcomes, perceived dieting success was enhanced after the treatment. At follow-up, additional beneficial effects on trait food craving were observed. Altogether, we found preliminary evidence for the cue exposure neurofeedback against overeating episodes in female restrained eaters, although specific effects and underlying mechanisms still have to be explored in future research.

Moderate intensity exercise as an adjunct to standard smoking cessation treatment for women: a pilot study.

PubMed

Williams, David M; Whiteley, Jessica A; Dunsiger, Shira; Jennings, Ernestine G; Albrecht, Anna E; Ussher, Michael H; Ciccolo, Joseph T; Parisi, Alfred F; Marcus, Bess H

2010-06-01

Previous randomized controlled trials have not supported moderate intensity exercise as an efficacious adjunct to smoking cessation treatments for women; however, compliance with exercise programs in these studies has been poor. The purpose of this pilot study was to estimate the effects of moderate intensity exercise on smoking cessation outcomes under optimal conditions for exercise program compliance. Sixty previously sedentary, healthy, female smokers were randomized to an 8-week program consisting of brief baseline smoking cessation counseling and the nicotine patch plus either 150 min/week of moderate intensity exercise or contact control. Participants attended a median of 86.4% and 95.5% of prescribed exercise/control sessions, respectively. There was a moderate, though statistically nonsignificant, effect of exercise at post-treatment for objectively verified 7-day point prevalence abstinence (48.3% vs. 23.3%; OR = 3.07, 95% CI: 0.89-11.07) and prolonged abstinence (34.5% vs. 20.0%; OR = 2.11, 95% CI: 0.56-8.32). Effects were attenuated when controlling for potential confounders, and after a 1-month, no-treatment period. The findings provide a preliminary indication that, given adequate compliance, moderate intensity exercise may enhance short-term smoking cessation outcomes for women; however, a larger trial is warranted. (PsycINFO Database Record (c) 2010 APA, all rights reserved).

Evaluative Conditioning with Facial Stimuli in Dementia Patients.

PubMed

Blessing, Andreas; Zöllig, Jacqueline; Weierstall, Roland; Dammann, Gerhard; Martin, Mike

2013-01-01

We present results of a study investigating evaluative learning in dementia patients with a classic evaluative conditioning paradigm. Picture pairs of three unfamiliar faces with liked, disliked, or neutral faces, that were rated prior to the presentation, were presented 10 times each to a group of dementia patients (N = 15) and healthy controls (N = 14) in random order. Valence ratings of all faces were assessed before and after presentation. In contrast to controls, dementia patients changed their valence ratings of unfamiliar faces according to their pairing with either a liked or disliked face, although they were not able to explicitly assign the picture pairs after the presentation. Our finding suggests preserved evaluative conditioning in dementia patients. However, the result has to be considered preliminary, as it is unclear which factors prevented the predicted rating changes in the expected direction in the control group.

Causal role for inverse reasoning on obsessive-compulsive symptoms: Preliminary evidence from a cognitive bias modification for interpretation bias study.

PubMed

Wong, Shiu F; Grisham, Jessica R

2017-12-01

The inference-based approach (IBA) is a cognitive account of the genesis and maintenance of obsessive-compulsive disorder (OCD). According to the IBA, individuals with OCD are prone to using inverse reasoning, in which hypothetical causes form the basis of conclusions about reality. Several studies have provided preliminary support for an association between features of the IBA and OCD symptoms. However, there are currently no studies that have investigated the proposed causal relationship of inverse reasoning in OCD. In a non-clinical sample (N = 187), we used an interpretive cognitive bias procedure to train a bias towards using inverse reasoning (n = 64), healthy sensory-based reasoning (n = 65), or a control condition (n = 58). Participants were randomly allocated to these training conditions. This manipulation allowed us to assess whether, consistent with the IBA, inverse reasoning training increased compulsive-like behaviours and self-reported OCD symptoms. Results indicated that compared to a control condition, participants trained in inverse reasoning reported more OCD symptoms and were more avoidant of potentially contaminated objects. Moreover, change in inverse reasoning bias was a small but significant mediator of the relationship between training condition and behavioural avoidance. Conversely, training in a healthy (non-inverse) reasoning style did not have any effect on symptoms or behaviour relative to the control condition. As this study was conducted in a non-clinical sample, we were unable to generalise our findings to a clinical population. Findings generally support the IBA model by providing preliminary evidence of a causal role for inverse reasoning in OCD. Copyright © 2017 Elsevier Ltd. All rights reserved.

A preliminary placebo-controlled crossover trial of fludrocortisone for chronic fatigue syndrome.

PubMed

Peterson, P K; Pheley, A; Schroeppel, J; Schenck, C; Marshall, P; Kind, A; Haugland, J M; Lambrecht, L J; Swan, S; Goldsmith, S

1998-04-27

To provide a preliminary assessment of the efficacy and safety of fludrocortisone acetate treatment of chronic fatigue syndrome. A placebo-controlled, double-blind, random-allocation crossover trial of 6 weeks of fludrocortisone. An outpatient clinical trials unit. Twenty-five participants with chronic fatigue syndrome (mean age, 40 years; 19 [76%] women; mean duration of illness, 7.0 years) were recruited from a research and clinic registry. Five patients withdrew from the trial. All participants were scheduled to receive fludrocortisone acetate (0.1-0.2 mg) or a placebo for 6 weeks in each treatment. Self-administered questionnaires were completed at the beginning and end of each treatment arm that asked patients to rate the severity of their symptoms on a visual analogue scale. The Medical Outcomes Study 36-Item Short-Form Health Survey, a reaction time test, and a treadmill exercise test were used to assess functional status. Blood pressure, heart rate, and plasma norepinephrine levels were obtained at baseline. Blood pressure and heart rate were recorded at the end of the exercise test and monitored at all subsequent visits. At baseline, the study participants reported symptom severity greater than 5 for most symptoms, and all had evidence of marked functional impairments. No improvement was observed in the severity of any symptom or in any test of function for the 20 participants who completed both arms of the trial. Blood pressure and heart rate readings were unaffected by treatment, and plasma norepinephrine levels did not differ from those of a healthy control group. The incidence of adverse experiences was similar in the fludrocortisone and placebo arms of the trial. Low-dose fludrocortisone does not provide sufficient benefit to be evident in a preliminary blinded trial of unselected patients with chronic fatigue syndrome.

A Behavioral Lifestyle Intervention Enhanced With Multiple-Behavior Self-Monitoring Using Mobile and Connected Tools for Underserved Individuals With Type 2 Diabetes and Comorbid Overweight or Obesity: Pilot Comparative Effectiveness Trial.

PubMed

Wang, Jing; Cai, Chunyan; Padhye, Nikhil; Orlander, Philip; Zare, Mohammad

2018-04-10

Self-monitoring is a cornerstone of behavioral lifestyle interventions for obesity and type 2 diabetes mellitus. Mobile technology has the potential to improve adherence to self-monitoring and patient outcomes. However, no study has tested the use of a smartphone to facilitate self-monitoring in overweight or obese adults with type 2 diabetes mellitus living in the underserved community. The aim of this study was to examine the feasibility of and compare preliminary efficacy of a behavioral lifestyle intervention using smartphone- or paper-based self-monitoring of multiple behaviors on weight loss and glycemic control in a sample of overweight or obese adults with type 2 diabetes mellitus living in underserved communities. We conducted a randomized controlled trial to examine the feasibility and preliminary efficacy of a behavioral lifestyle intervention. Overweight or obese patients with type 2 diabetes mellitus were recruited from an underserved minority community health center in Houston, Texas. They were randomly assigned to one of the three groups: (1) behavior intervention with smartphone-based self-monitoring, (2) behavior intervention with paper diary-based self-monitoring, and (3) usual care group. Both the mobile and paper groups received a total of 11 face-to-face group sessions in a 6-month intervention. The mobile group received an Android-based smartphone with 2 apps loaded to help them record their diet, physical activity, weight, and blood glucose, along with a connected glucometer, whereas the paper group used paper diaries for these recordings. Primary outcomes of the study included percentage weight loss and glycated hemoglobin (HbA 1c ) changes over 6 months. A total of 26 patients were enrolled: 11 in the mobile group, 9 in the paper group, and 6 in the control group. We had 92% (24/26) retention rate at 6 months. The sample is predominantly African Americans with an average age of 56.4 years and body mass index of 38.1. Participants lost an average of 2.73% (mobile group) and 0.13% (paper group) weight at 6 months, whereas the control group had an average 0.49% weight gain. Their HbA 1c changed from 8% to 7 % in mobile group, 10% to 9% in paper group, and maintained at 9% for the control group. We found a significant difference on HbA 1c at 6 months among the 3 groups (P=.01). We did not find statistical group significance on percentage weight loss (P=.20) and HbA 1c changes (P=.44) overtime; however, we found a large effect size of 0.40 for weight loss and a medium effect size of 0.28 for glycemic control. Delivering a simplified behavioral lifestyle intervention using mobile health-based self-monitoring in an underserved community is feasible and acceptable and shows higher preliminary efficacy, as compared with paper-based self-monitoring. A full-scale randomized controlled trial is needed to confirm the findings in this pilot study. ClinicalTrials.gov NCT02858648; https://clinicaltrials.gov/ct2/show/NCT02858648 (Archived by WebCite at http://www.webcitation.org/6ySidjmT7). ©Jing Wang, Chunyan Cai, Nikhil Padhye, Philip Orlander, Mohammad Zare. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 10.04.2018.

A Behavioral Lifestyle Intervention Enhanced With Multiple-Behavior Self-Monitoring Using Mobile and Connected Tools for Underserved Individuals With Type 2 Diabetes and Comorbid Overweight or Obesity: Pilot Comparative Effectiveness Trial

PubMed Central

Cai, Chunyan; Padhye, Nikhil; Orlander, Philip; Zare, Mohammad

2018-01-01

Background Self-monitoring is a cornerstone of behavioral lifestyle interventions for obesity and type 2 diabetes mellitus. Mobile technology has the potential to improve adherence to self-monitoring and patient outcomes. However, no study has tested the use of a smartphone to facilitate self-monitoring in overweight or obese adults with type 2 diabetes mellitus living in the underserved community. Objective The aim of this study was to examine the feasibility of and compare preliminary efficacy of a behavioral lifestyle intervention using smartphone- or paper-based self-monitoring of multiple behaviors on weight loss and glycemic control in a sample of overweight or obese adults with type 2 diabetes mellitus living in underserved communities. Methods We conducted a randomized controlled trial to examine the feasibility and preliminary efficacy of a behavioral lifestyle intervention. Overweight or obese patients with type 2 diabetes mellitus were recruited from an underserved minority community health center in Houston, Texas. They were randomly assigned to one of the three groups: (1) behavior intervention with smartphone-based self-monitoring, (2) behavior intervention with paper diary-based self-monitoring, and (3) usual care group. Both the mobile and paper groups received a total of 11 face-to-face group sessions in a 6-month intervention. The mobile group received an Android-based smartphone with 2 apps loaded to help them record their diet, physical activity, weight, and blood glucose, along with a connected glucometer, whereas the paper group used paper diaries for these recordings. Primary outcomes of the study included percentage weight loss and glycated hemoglobin (HbA1c) changes over 6 months. Results A total of 26 patients were enrolled: 11 in the mobile group, 9 in the paper group, and 6 in the control group. We had 92% (24/26) retention rate at 6 months. The sample is predominantly African Americans with an average age of 56.4 years and body mass index of 38.1. Participants lost an average of 2.73% (mobile group) and 0.13% (paper group) weight at 6 months, whereas the control group had an average 0.49% weight gain. Their HbA1c changed from 8% to 7 % in mobile group, 10% to 9% in paper group, and maintained at 9% for the control group. We found a significant difference on HbA1c at 6 months among the 3 groups (P=.01). We did not find statistical group significance on percentage weight loss (P=.20) and HbA1c changes (P=.44) overtime; however, we found a large effect size of 0.40 for weight loss and a medium effect size of 0.28 for glycemic control. Conclusions Delivering a simplified behavioral lifestyle intervention using mobile health–based self-monitoring in an underserved community is feasible and acceptable and shows higher preliminary efficacy, as compared with paper-based self-monitoring. A full-scale randomized controlled trial is needed to confirm the findings in this pilot study. Trial Registration ClinicalTrials.gov NCT02858648; https://clinicaltrials.gov/ct2/show/NCT02858648 (Archived by WebCite at http://www.webcitation.org/6ySidjmT7) PMID:29636320

Pilot Randomized Trial of Active Music Engagement Intervention Parent Delivery for Young Children With Cancer.

PubMed

Robb, Sheri L; Haase, Joan E; Perkins, Susan M; Haut, Paul R; Henley, Amanda K; Knafl, Kathleen A; Tong, Yan

2017-03-01

To examine the feasibility/acceptability of a parent-delivered Active Music Engagement (AME + P) intervention for young children with cancer and their parents. Secondary aim to explore changes in AME + P child emotional distress (facial affect) and parent emotional distress (mood; traumatic stress symptoms) relative to controls. A pilot two-group randomized trial was conducted with parents/children (ages 3-8 years) receiving AME + P ( n  =  9) or attention control ( n  =  7). Feasibility of parent delivery was assessed using a delivery checklist and child engagement; acceptability through parent interviews; preliminary outcomes at baseline, postintervention, 30 days postintervention. Parent delivery was feasible, as they successfully delivered AME activities, but interviews indicated parent delivery was not acceptable to parents. Emotional distress was lower for AME + P children, but parents derived no benefit. Despite child benefit, findings do not support parent delivery of AME + P. © The Author 2016. Published by Oxford University Press on behalf of the Society of Pediatric Psychology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

Effects of fucoidan from Fucus vesiculosus in reducing symptoms of osteoarthritis: a randomized placebo-controlled trial

PubMed Central

Myers, Stephen P; Mulder, Ann M; Baker, Don G; Robinson, Shelley R; Rolfe, Margaret I; Brooks, Lyndon; Fitton, J Helen

2016-01-01

Purpose Preliminary investigation of a fucoidan with demonstrated reduction in the symptoms of osteoarthritis (OA) of the hip and knee. Patients and methods A double-blind randomized controlled trial was carried out to determine the safety and efficacy of a 300 mg dose of a Fucus vesiculosus extract (85% fucoidan) over a 12-week period in a population (n=122) with mild-to-moderate OA of the hip and knee as measured by the validated instrument “Comprehensive Osteoarthritis Test.” Safety was measured by assessing cholesterol, liver function, renal function, and hematopoietic function, and closely monitoring adverse events. Result Ninety-six participants completed the study. The reduction in symptoms of OA was not significantly different from the placebo response. There were no changes in the blood measurements that were of any clinical significance during the course of the study. Conclusion The F. vesiculosus fucoidan extract was safe and well tolerated. At a dose of 300 mg, the extract showed no difference in reduction of OA symptoms from the placebo. PMID:27307702

Using a web-based game to prevent posttraumatic stress in children following medical events: design of a randomized controlled trial.

PubMed

Marsac, Meghan L; Kohser, Kristen L; Winston, Flaura K; Kenardy, Justin; March, Sonja; Kassam-Adams, Nancy

2013-01-01

Medical events including acute illness and injury are among the most common potentially traumatic experiences for children. Despite the scope of the problem, only limited resources are available for prevention of posttraumatic stress symptoms (PTSS) after pediatric medical events. Web-based programs provide a low-cost, accessible means to reach a wide range of families and show promise in related areas of child mental health. To describe the design of a randomized controlled trial that will evaluate feasibility and estimate preliminary efficacy of Coping Coach, a web-based preventive intervention to prevent or reduce PTSS after acute pediatric medical events. Seventy children and their parents will be randomly assigned to either an intervention or a waitlist control condition. Inclusion criteria require that children are aged 8-12 years, have experienced a medical event, have access to Internet and telephone, and have sufficient competency in the English language to complete measures and understand the intervention. Participants will complete baseline measures and will then be randomized to the intervention or waitlist control condition. Children in the intervention condition will complete module 1 (Feelings Identification) in the hospital and will be instructed on how to complete modules 2 (Appraisals) and 3 (Avoidance) online. Follow-up assessments will be conducted via telephone at 6, 12, and 18 weeks after the baseline assessment. Following the 12-week assessment, children in the waitlist control condition will receive instructions for completing the intervention. Primary study outcomes include data on intervention feasibility and outcomes (child appraisals, coping, PTSS and health-related quality of life). Results will provide data on the feasibility of the implementation of the Coping Coach intervention and study procedures as well as estimations of efficacy to determine sample size for a larger study. Potential strengths and limitations of this design are discussed.

Effects of tai chi qigong on psychosocial well-being among hidden elderly, using elderly neighborhood volunteer approach: a pilot randomized controlled trial.

PubMed

Chan, Aileen Wk; Yu, Doris Sf; Choi, K C

2017-01-01

To test the feasibility and preliminary effectiveness of a tai chi qigong program with the assistance of elderly neighborhood volunteers in strengthening social networks and enhancing the psychosocial well-being of hidden elderly. "Hidden elderly" is a term used to describe older adults who are socially isolated and refuse social participation. This pilot randomized controlled trial recruited 48 older adults aged 60 or above who did not engage in any social activity. They were randomized into tai chi qigong (n=24) and standard care control (n=24) groups. The former group underwent a three-month program of two 60-minute sessions each week, with the socially active volunteers paired up with them during practice. Standard care included regular home visits by social workers. Primary outcomes were assessed by means of the Lubben social network and De Jong Gieveld loneliness scales, and by a revised social support questionnaire. Secondary outcomes were covered by a mental health inventory and the Rosenberg self-esteem scale, and quality of life by using the 12-Item Short Form Health Survey. Data was collected at baseline, and at three and six months thereafter. The generalized estimating equations model revealed general improvement in outcomes among participants on the tai chi qigong program. In particular, participants reported a significantly greater improvement on the loneliness scale ( B =-1.32, 95% confidence interval [CI] -2.54 to -0.11, P =0.033) and the satisfaction component of the social support questionnaire ( B =3.43, 95% CI 0.10-6.76, P =0.044) than the control group. The pilot study confirmed that tai chi qigong with elderly neighborhood volunteers is a safe and feasible social intervention for hidden elderly. Its potential benefits in improving social and psychological health suggest the need for a full-scale randomized controlled trial to reveal its empirical effects.

Using a web-based game to prevent posttraumatic stress in children following medical events: design of a randomized controlled trial

PubMed Central

Marsac, Meghan L.; Kohser, Kristen L.; Winston, Flaura K.; Kenardy, Justin; March, Sonja; Kassam-Adams, Nancy

2013-01-01

Background Medical events including acute illness and injury are among the most common potentially traumatic experiences for children. Despite the scope of the problem, only limited resources are available for prevention of posttraumatic stress symptoms (PTSS) after pediatric medical events. Web-based programs provide a low-cost, accessible means to reach a wide range of families and show promise in related areas of child mental health. Objectives To describe the design of a randomized controlled trial that will evaluate feasibility and estimate preliminary efficacy of Coping Coach, a web-based preventive intervention to prevent or reduce PTSS after acute pediatric medical events. Method Seventy children and their parents will be randomly assigned to either an intervention or a waitlist control condition. Inclusion criteria require that children are aged 8–12 years, have experienced a medical event, have access to Internet and telephone, and have sufficient competency in the English language to complete measures and understand the intervention. Participants will complete baseline measures and will then be randomized to the intervention or waitlist control condition. Children in the intervention condition will complete module 1 (Feelings Identification) in the hospital and will be instructed on how to complete modules 2 (Appraisals) and 3 (Avoidance) online. Follow-up assessments will be conducted via telephone at 6, 12, and 18 weeks after the baseline assessment. Following the 12-week assessment, children in the waitlist control condition will receive instructions for completing the intervention. Results Primary study outcomes include data on intervention feasibility and outcomes (child appraisals, coping, PTSS and health-related quality of life). Discussion Results will provide data on the feasibility of the implementation of the Coping Coach intervention and study procedures as well as estimations of efficacy to determine sample size for a larger study. Potential strengths and limitations of this design are discussed. PMID:23898396

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

Pilot Randomized Controlled Trial of Titrated Subcutaneous Ketamine in Older Patients with Treatment-Resistant Depression.

PubMed

George, Duncan; Gálvez, Verònica; Martin, Donel; Kumar, Divya; Leyden, John; Hadzi-Pavlovic, Dusan; Harper, Simon; Brodaty, Henry; Glue, Paul; Taylor, Rohan; Mitchell, Philip B; Loo, Colleen K

2017-11-01

To assess the efficacy and safety of subcutaneous ketamine for geriatric treatment-resistant depression. Secondary aims were to examine if repeated treatments were safe and more effective in inducing or prolonging remission than a single treatment. In this double-blind, controlled, multiple-crossover study with a 6-month follow-up (randomized controlled trial [RCT] phase), 16 participants (≥60 years) with treatment-resistant depression who relapsed after remission or did not remit in the RCT were administered an open-label phase. Up to five subcutaneous doses of ketamine (0.1, 0.2, 0.3, 0.4, and 0.5 mg/kg) were administered in separate sessions (≥1 week apart), with one active control (midazolam) randomly inserted (RCT phase). Twelve ketamine treatments were given in the open-label phase. Mood, hemodynamic, and psychotomimetic outcomes were assessed by blinded raters. Remitters in each phase were followed for 6 months. Seven of 14 RCT-phase completers remitted with ketamine treatment. Five remitted at doses below 0.5 mg/kg. Doses ≥ 0.2 mg/kg were significantly more effective than midazolam. Ketamine was well tolerated. Repeated treatments resulted in higher likelihood of remission or longer time to relapse. Results provide preliminary evidence for the efficacy and safety of ketamine in treating elderly depressed. Dose titration is recommended for optimizing antidepressant and safety outcomes on an individual basis. Subcutaneous injection is a practical method for giving ketamine. Repeated treatments may improve remission rates (clinicaltrials.gov; NCT01441505). Copyright © 2017 American Association for Geriatric Psychiatry. All rights reserved.

Memantine as an Adjuvant Treatment for Obsessive Compulsive Symptoms in Manic Phase of Bipolar Disorder: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

PubMed

Sahraian, Ali; Jahromi, Leila Razeghian; Ghanizadeh, Ahmad; Mowla, Arash

2017-04-01

The aim of this study is to examine the effects of memantine as an adjuvant treatment for obsessive compulsive (OC) symptoms in patients with bipolar disorder (BD) type I, manic phase. In this 16-week double-blind placebo-controlled randomized clinical trial, 58 patients in the manic phase of BD who had OC symptoms were randomly allocated to receive memantine or placebo plus their routine medications (lithium + olanzapine + clonazepam). The Yale Brown Obsessive Compulsive Behavior Scale was used to assess the outcomes. Adverse effects were also recorded. Thirty-eight patients (19 in the memantine group and 19 in the placebo group) completed the trial. Throughout the trial, the mean score decreased from 20.26 ± 5.91 to 9.73 ± 5.44 in the memantine group (P < 0.000) and from 22.89 ± 5.70 to 16.63 ± 4.00 in the placebo group (P < 0.000). At the end of the study, 15 (78.94%) patients in the memantine group and 7 (36.84%) patients in the placebo group demonstrated more than 34% decline in the Yale Brown Obsessive Compulsive Behavior Scale score (P < 0.01). No serious adverse effects were reported. Our double-blind controlled clinical trial showed that memantine is an effective adjuvant agent for reducing OC symptoms in patients with BD. However, it needs to be noted that our study is preliminary, and larger double-blind controlled studies are needed to confirm the results.

A Randomized Controlled Trial of a Group Motivational Interviewing Intervention for Adolescents with a First Time Alcohol or Drug Offense

PubMed Central

D’Amico, Elizabeth J.; Hunter, Sarah B.; Miles, Jeremy N.V.; Ewing, Brett A.; Osilla, Karen Chan

2013-01-01

Group Motivational Interviewing (MI) interventions that target youth at-risk for alcohol and other drug (AOD) use may prevent future negative consequences. Youth in a teen court setting (n=193; 67% male, 45% Hispanic; mean age 16.6 (SD = 1.05) were randomized to receive either a group MI intervention, Free Talk, or usual care (UC). We examined client acceptance, intervention feasibility and conducted a preliminary outcome evaluation. Free Talk teens reported higher quality and satisfaction ratings, and MI integrity scores were higher for Free Talk groups. AOD use and delinquency decreased for both groups at three months, and 12-month recidivism rates were lower but not significantly different for the Free Talk group compared to UC. Results contribute to emerging literature on MI in a group setting. A longer term follow-up is warranted. PMID:23891459

Virtual Reality Job Interview Training in Adults with Autism Spectrum Disorder

PubMed Central

Smith, Matthew J.; Ginger, Emily; Wright, Katherine; Wright, Michael; Taylor, Julie Lounds; Humm, Laura Boteler; Olsen, Dale; Bell, Morris D.; Fleming, Michael F.

2014-01-01

The feasibility and efficacy of Virtual Reality Job Interview Training (VR-JIT) was assessed in a single-blinded randomized controlled trial. Adults with autism spectrum disorder were randomized to VR-JIT (n=16) or treatment as usual (TAU) (n=10) groups. VR-JIT consisted of simulated job interviews with a virtual character and didactic training. Participants attended 90% of lab-based training sessions and found VR-JIT easy-to-use, enjoyable, and they felt prepared for future interviews. VR-JIT participants had greater improvement during live standardized job interview role-play performances than TAU participants (p=0.046). A similar pattern was observed for self-reported self-confidence at a trend level (p=0.060). VR-JIT simulation performance scores increased over time (R-Squared=0.83). Results indicate preliminary support for the feasibility and efficacy of VR-JIT, which can be administered using computer software or via the internet. PMID:24803366

Virtual reality job interview training in adults with autism spectrum disorder.

PubMed

Smith, Matthew J; Ginger, Emily J; Wright, Katherine; Wright, Michael A; Taylor, Julie Lounds; Humm, Laura Boteler; Olsen, Dale E; Bell, Morris D; Fleming, Michael F

2014-10-01

The feasibility and efficacy of virtual reality job interview training (VR-JIT) was assessed in a single-blinded randomized controlled trial. Adults with autism spectrum disorder were randomized to VR-JIT (n = 16) or treatment-as-usual (TAU) (n = 10) groups. VR-JIT consisted of simulated job interviews with a virtual character and didactic training. Participants attended 90 % of laboratory-based training sessions, found VR-JIT easy to use and enjoyable, and they felt prepared for future interviews. VR-JIT participants had greater improvement during live standardized job interview role-play performances than TAU participants (p = 0.046). A similar pattern was observed for self-reported self-confidence at a trend level (p = 0.060). VR-JIT simulation performance scores increased over time (R(2) = 0.83). Results indicate preliminary support for the feasibility and efficacy of VR-JIT, which can be administered using computer software or via the internet.

Comparison of a Web-Based Teaching Tool and Traditional Didactic Learning for In Vitro Fertilization Patients: A Preliminary Randomized Controlled Trial.

PubMed

Vause, Tannys Dawn Reiko; Allison, David J; Vause, Tricia; Tekok-Kilic, Ayda; Ditor, David S; Min, Jason K

2018-05-01

The objective of this prospective RCT was to compare the efficacy of a web-based teaching tool to traditional didactic teaching in IVF patients. Forty women undergoing their first IVF cycle were randomly allocated to an interactive web-based teaching session or a nurse-led didactic teaching session. The primary outcome measure was participant knowledge regarding the IVF process, risks, and logistics assessed before and after the respective teaching session. Secondary outcomes included patient stress, assessed before and after the respective teaching session, and patient satisfaction, assessed following the respective teaching session and on the day of embryo transfer (following implementation of the teaching protocol). Both groups demonstrated similar and significant improvements in knowledge and stress after exposure to their respective teaching sessions. The web-based group was significantly more satisfied than the didactic teaching group. Web-based teaching was also shown to be equally effective for participants of high versus low income and education status for knowledge, stress, and satisfaction. This study provides preliminary support for the use of web-based teaching as an equally effective tool for increasing knowledge and reducing stress compared to traditional didactic teaching in IVF patients, with the added benefit of increased patient satisfaction. Copyright © 2018 Society of Obstetricians and Gynaecologists of Canada. Published by Elsevier Inc. All rights reserved.

Pomegranate Juice Augments Memory and fMRI Activity in Middle-Aged and Older Adults with Mild Memory Complaints

PubMed Central

Bookheimer, Susan Y.; Renner, Brian A.; Ekstrom, Arne; Henning, Susanne M.; Brown, Jesse A.; Jones, Mike; Moody, Teena; Small, Gary W.

2013-01-01

Despite increasing emphasis on the potential of dietary antioxidants in preventing memory loss and on diet as a precursor of neurological health, rigorous studies investigating the cognitive effects of foods and their components are rare. Recent animal studies have reported memory and other cognitive benefits of polyphenols, found abundantly in pomegranate juice. We performed a preliminary, placebo-controlled randomized trial of pomegranate juice in older subjects with age-associated memory complaints using memory testing and functional brain activation (fMRI) as outcome measures. Thirty-two subjects (28 completers) were randomly assigned to drink 8 ounces of either pomegranate juice or a flavor-matched placebo drink for 4 weeks. Subjects received memory testing, fMRI scans during cognitive tasks, and blood draws for peripheral biomarkers before and after the intervention. Investigators and subjects were all blind to group membership. After 4 weeks, only the pomegranate group showed a significant improvement in the Buschke selective reminding test of verbal memory and a significant increase in plasma trolox-equivalent antioxidant capacity (TEAC) and urolithin A-glucuronide. Furthermore, compared to the placebo group, the pomegranate group had increased fMRI activity during verbal and visual memory tasks. While preliminary, these results suggest a role for pomegranate juice in augmenting memory function through task-related increases in functional brain activity. PMID:23970941

Oral curcumin for Alzheimer's disease: tolerability and efficacy in a 24-week randomized, double blind, placebo-controlled study.

PubMed

Ringman, John M; Frautschy, Sally A; Teng, Edmond; Begum, Aynun N; Bardens, Jenny; Beigi, Maryam; Gylys, Karen H; Badmaev, Vladimir; Heath, Dennis D; Apostolova, Liana G; Porter, Verna; Vanek, Zeba; Marshall, Gad A; Hellemann, Gerhard; Sugar, Catherine; Masterman, Donna L; Montine, Thomas J; Cummings, Jeffrey L; Cole, Greg M

2012-01-01

Curcumin is a polyphenolic compound derived from the plant Curcuma Long Lin that has been demonstrated to have antioxidant and anti-inflammatory effects as well as effects on reducing beta-amyloid aggregation. It reduces pathology in transgenic models of Alzheimer's disease (AD) and is a promising candidate for treating human AD. The purpose of the current study is to generate tolerability and preliminary clinical and biomarker efficacy data on curcumin in persons with AD. We performed a 24-week randomized, double blind, placebo-controlled study of Curcumin C3 Complex(®) with an open-label extension to 48 weeks. Thirty-six persons with mild-to-moderate AD were randomized to receive placebo, 2 grams/day, or 4 grams/day of oral curcumin for 24 weeks. For weeks 24 through 48, subjects that were receiving curcumin continued with the same dose, while subjects previously receiving placebo were randomized in a 1:1 ratio to 2 grams/day or 4 grams/day. The primary outcome measures were incidence of adverse events, changes in clinical laboratory tests and the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) at 24 weeks in those completing the study. Secondary outcome measures included the Neuropsychiatric Inventory (NPI), the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) scale, levels of Aβ1-40 and Aβ1-42 in plasma and levels of Aβ1-42, t-tau, p-tau181 and F2-isoprostanes in cerebrospinal fluid. Plasma levels of curcumin and its metabolites up to four hours after drug administration were also measured. Mean age of completers (n = 30) was 73.5 years and mean Mini-Mental Status Examination (MMSE) score was 22.5. One subject withdrew in the placebo (8%, worsened memory) and 5/24 subjects withdrew in the curcumin group (21%, 3 due to gastrointestinal symptoms). Curcumin C3 Complex(®) was associated with lowered hematocrit and increased glucose levels that were clinically insignificant. There were no differences between treatment groups in clinical or biomarker efficacy measures. The levels of native curcumin measured in plasma were low (7.32 ng/mL). Curcumin was generally well-tolerated although three subjects on curcumin withdrew due to gastrointestinal symptoms. We were unable to demonstrate clinical or biochemical evidence of efficacy of Curcumin C3 Complex(®) in AD in this 24-week placebo-controlled trial although preliminary data suggest limited bioavailability of this compound. ClinicalTrials.gov Identifier: NCT00099710.

Preliminary report on the ecology of Armillaria in the East Cascades of Oregon

Treesearch

Geral I. McDonald; John W. Hanna; Aaron L. Smith; Helen M. Maffei; Mee-Sook Kim; Amy L. Ross-Davis; Ned B. Klopfenstein

2011-01-01

As part of a larger effort to assess the distribution and ecology of Armillaria species throughout western North America, we present preliminary survey results for the East Cascades of Oregon. Surveys and sampling were conducted on 260 0.04-ha plots, which were randomly located across diverse environments and geographic locations. Using DNA-based techniques for the...

Preliminary antiplaque efficacy of aloe vera mouthwash on 4 day plaque re-growth model: randomized control trial.

PubMed

Gupta, Rajendra Kumar; Gupta, Devanand; Bhaskar, Dara John; Yadav, Ankit; Obaid, Khursheed; Mishra, Sumit

2014-04-01

Due to increasing resistance to antibiotics and rising incidence of oral diseases, there is a need for alternative treatment modalities to combat oral diseases. The aim of the present study was to access the effect of Aloe vera mouthwash on the dental plaque in the experimental period of 4 days and to compare it with the bench mark control chlorhexidine and placebo (saline water). A total of 300 systemically healthy subjects were randomly allocated into 3 groups: Aloe vera mouthwash group (n=100), control group (=100)-chlorhexidene group and saline water-Placebo (n=100). To begin with, Gingival index (GI) and plaque index (PI) were recorded. Then, baseline plaque scores were brought to zero by professionally cleaning the teeth with scaling and polishing. After randomization of the participants into three groups they were refrained from regular mechanical oral hygiene measures. Subjects were asked to swish with respective mouthwash (Aloe vera mouthwash, 0.2%chlorhexidine gluconate mouthwash, or normal saline) as per therapeutic dose for 4 days. The results showed that Aloe vera mouthrinse is equally effective in reducing plaque as Chlorhexidine compared to placebo over a period of 4 days. There was a significant reduction on plaque in Aloe vera and chlorhexidine groups and no statistically significant difference was observed among them (p>0.05). Aloe vera mouthwash showed no side effects. The results of the present study indicated that Aloe vera may prove an effective mouthwash due to its ability in reducing dental plaque.

A preliminary RCT of CBT-AD for adherence and depression among HIV-positive Latinos on the U.S.-Mexico border: the Nuevo Día study.

PubMed

Simoni, Jane M; Wiebe, John S; Sauceda, John A; Huh, David; Sanchez, Giselle; Longoria, Virginia; Andres Bedoya, C; Safren, Steven A

2013-10-01

We conducted a preliminary RCT among 40 HIV-positive Latinos of Mexican descent on the U.S.-Mexico border who indicated imperfect adherence and depressive symptomatology. Participants were randomly assigned to culturally adapted cognitive-behavioral therapy for adherence and depression with an alarmed pillbox or usual care. Outcomes were depressive symptoms (self-report and blind clinician ratings), adherence (self-report and electronic pillbox), and biological markers. The intervention, delivered in English and Spanish, proved feasible and acceptable. Generalized estimating equations in intent-to-treat analyses showed some effects of "moderate" to "large" size, with maintenance over time. For example, intervention (vs. control) participants demonstrated at post-intervention a greater drop in BDI scores (OR = -3.64, p = 0.05) and greater adherence according to the electronic pillbox (OR = 3.78, p = 0.03). Biological markers indicated some relative improvement for CD4 count but not VL. The promising results suggest a larger trial to determine efficacy is warranted.

Perioperative single high dose ATG-Fresenius S administration as induction immunosuppressive therapy in cadaveric renal transplantation--preliminary results.

PubMed

Samsel, R; Chmura, A; Włodarczyk, Z; Wyzgał, J; Cieciura, T; Lagiewska, B; Pliszczyński, J; Korczak, G; Lazowski, T; Paczek, L; Wałaszewski, J; Lao, M; Rowiński, W

1999-01-01

Monoclonal and polyclonal antilymphocyte antibodies have been used successfully in organ transplantation as induction therapy and in the treatment of acute graft rejection. Used for induction the medication is generally given for the first 7-10 days. The aim of this study was to assess the safety and efficacy of single high dose (9 mg/kg) ATG Fresenius S given perioperatively, before revascularization, to kidney allograft recipients. During last twelve months seventy six, first cadaveric kidney adult recipients were included into the study in two centers (center A-64, center B-12). All patients received triple drug immunosuppression (Neoral, steroids and Cellcept which was replaced by azathioprine after 4 months), and were randomized to receive ATG or not. The follow-up period ranged from 1 month up to 1 year. The preliminary results are very promising, the rejection rate in bolus group was significantly lower than in control. No significant side effects or serious adverse events in both groups were observed.

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

Control of oral human papillomavirus (HPV) by medicinal mushrooms, Trametes versicolor and Ganoderma lucidum: a preliminary clinical trial.

PubMed

Donatini, Bruno

2014-01-01

This preliminary randomized study investigated the efficacy of medicinal mushrooms, Trametes versicolor (TV), Ganoderma lucidum (GL), and Laetiporus sulphureus (LS), on the clearance of oral human papillomavirus (HPV, serotypes 16 and 18). Among 472 patients who underwent oral swabs for gingivitis, 61 patients were positive for HPV16 or HPV18. Twenty patients were included in group 1 (LS) and 41 patients were included in group 2 (TV+GL) for 2 months. Polymerase chain reaction (PCR) for HPV was performed at inclusion and after 2 months. In group 1, the clearance was equal to 5% after 2 months of treatment. In group 2, the clearance was equal to 88% (P<0.001). The detection of HPV16 or HPV18 could become relevant in routine since positivity is frequent and because a harmless and costless treatment may exist. The use of TV+GL for the clearance of oral HPV deserves further investigation.

Effect of a Counseling Session Bolstered by Text Messaging on Self-Selected Health Behaviors in College Students: A Preliminary Randomized Controlled Trial.

PubMed

Sandrick, Janice; Tracy, Doreen; Eliasson, Arn; Roth, Ashley; Bartel, Jeffrey; Simko, Melanie; Bowman, Tracy; Harouse-Bell, Karen; Kashani, Mariam; Vernalis, Marina

2017-05-17

The college experience is often the first time when young adults live independently and make their own lifestyle choices. These choices affect dietary behaviors, exercise habits, techniques to deal with stress, and decisions on sleep time, all of which direct the trajectory of future health. There is a need for effective strategies that will encourage healthy lifestyle choices in young adults attending college. This preliminary randomized controlled trial tested the effect of coaching and text messages (short message service, SMS) on self-selected health behaviors in the domains of diet, exercise, stress, and sleep. A second analysis measured the ripple effect of the intervention on health behaviors not specifically selected as a goal by participants. Full-time students aged 18-30 years were recruited by word of mouth and campuswide advertisements (flyers, posters, mailings, university website) at a small university in western Pennsylvania from January to May 2015. Exclusions included pregnancy, eating disorders, chronic medical diagnoses, and prescription medications other than birth control. Of 60 participants, 30 were randomized to receive a single face-to-face meeting with a health coach to review results of behavioral questionnaires and to set a health behavior goal for the 8-week study period. The face-to-face meeting was followed by SMS text messages designed to encourage achievement of the behavioral goal. A total of 30 control subjects underwent the same health and behavioral assessments at intake and program end but did not receive coaching or SMS text messages. The texting app showed that 87.31% (2187/2505) of messages were viewed by intervention participants. Furthermore, 28 of the 30 intervention participants and all 30 control participants provided outcome data. Among intervention participants, 22 of 30 (73%) showed improvement in health behavior goal attainment, with the whole group (n=30) showing a mean improvement of 88% (95% CI 39-136). Mean improvement in any behavioral domains was not seen in the control group. Intervention participants also increased their exercise significantly compared with controls, regardless of their self-selected goal category. The increased exercise was paralleled by significantly lower fasting glucose levels. The health coaching session plus tailored SMS text messages improved self-selected health behaviors with a modest ripple effect to include unselected health behaviors. Clinicaltrials.gov NCT02476604; https://clinicaltrials.gov/ct2/show/NCT02476604 (Archived by WebCite at http://www.webcitation.org/6qAAryS5t). ©Janice Sandrick, Doreen Tracy, Arn Eliasson, Ashley Roth, Jeffrey Bartel, Melanie Simko, Tracy Bowman, Karen Harouse-Bell, Mariam Kashani, Marina Vernalis. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 17.05.2017.

A randomized, double-blind, placebo-controlled, pilot study to assess the efficacy and safety of clindamycin 1.2% and tretinoin 0.025% combination gel for the treatment of acne rosacea over 12 weeks.

PubMed

Chang, Anne Lynn S; Alora-Palli, Maria; Lima, Xinaida T; Chang, Tiffany C; Cheng, Carol; Chung, Connie M; Amir, Omar; Kimball, Alexa B

2012-03-01

Papulopustular acne rosacea is a chronic inflammatory condition which can be difficult to treat. Many patients are unwilling to use systemic medications, and single topical agents alone may not address all the symptoms of rosacea. A combination topical clindamycin phosphate 1.2% and tretinoin 0.025% gel is efficacious for acne vulgaris, and may be helpful for rosacea, since acne vulgaris and rosacea shares many similar clinical and histologic features. To assess the preliminary efficacy and safety of a combination gel consisting of clindamycin phosphate 1.2% and tretinoin 0.025% on papulopustular rosacea after 12 weeks of usage. Randomized, double-blind, placebo controlled two site study of 79 participants with moderate to severe papulopustular acne rosacea using both physician and subjects' validated assessment tools. Primary endpoint consisted of statistically significant reduction in absolute papule or pustule count after 12 weeks of usage. There was no significant difference in papule/pustule count between placebo and treated groups after 12 weeks (P=0.10). However, there was nearly significant improvement in physicians' assessments of the telangiectasia component of rosacea (P=0.06) and erythematotelangiectatic rosacea subtype (P=0.05) in treated versus placebo group after 12 weeks. The only significant adverse event different was facial scaling, which was significantly increased in treated group (P=0.01), but this did not result in discontinuation of study drug. A combination gel of clindamycin phosphate 1.2% and tretinoin 0.025% may improve the telangiectatic component of rosacea and appears to better treat the erythemotelangiectatic subtype of rosacea rather than papulopustular subtype. Our preliminary study suggests that future studies with much larger sample size might confirm our findings.

Cognitive behavioral therapy for body image and self-care (CBT-BISC) in sexual minority men living with HIV: A randomized controlled trial.

PubMed

Blashill, Aaron J; Safren, Steven A; Wilhelm, Sabine; Jampel, Jonathan; Taylor, S Wade; O'Cleirigh, Conall; Mayer, Kenneth H

2017-10-01

Body image disturbance is a distressing and interfering problem among many sexual minority men living with HIV, and is associated with elevated depressive symptoms and poor HIV self-care (e.g., antiretroviral therapy [ART] nonadherence). The current study tested the preliminary efficacy of a newly created intervention: cognitive-behavioral therapy for body image and self-care (CBT-BISC) for this population. The current study entailed a 2-arm randomized controlled trial (N = 44) comparing CBT-BISC to an enhanced treatment as usual (ETAU) condition. Analyses were conducted at 3 and 6 months after baseline. The primary outcome was body image disturbance (BDD-YBOCS), and secondary outcomes were ART adherence (electronically monitored via Wisepill), depressive symptoms (MADRS), and global functioning (GAF). At 3 months, the CBT-BISC condition showed substantial improvement in BDD-YBOCS (b = -13.6, SE = 2.7, 95% CI [-19.0, -8.3], p < .001; dppc2 = 2.39); MADRS (b = -4.9, SE = 2.8, 95% CI [-10.6, .70], p = .086; dppc2 = .87); ART adherence (b = 8.8, SE = 3.3, 95% CI [2.0, 15.6], p = .01; dppc2 = .94); and GAF (b = 12.3, SE = 3.2, 95% CI [6.1, 18.6], p < .001; dppc2 = 2.91) compared with the ETAU condition. Results were generally maintained, or improved, at 6 months; although, adherence findings were mixed depending on the calculation method. CBT-BISC shows preliminary efficacy in the integrated treatment of body image disturbance and HIV self-care behaviors among sexual minority men living with HIV. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Design and methods for "Commit to Get Fit" - a pilot study of a school-based mindfulness intervention to promote healthy diet and physical activity among adolescents.

PubMed

Salmoirago-Blotcher, Elena; Druker, Sue; Meyer, Florence; Bock, Beth; Crawford, Sybil; Pbert, Lori

2015-03-01

Cardiovascular prevention is more effective if started early in life, but available interventions to promote healthy lifestyle habits among youth have been ineffective. Impulsivity in particular has proven to be an important barrier to the adoption of healthy behaviors in youth. Observational evidence suggests that mindfulness interventions may reduce impulsivity and improve diet and physical activity. We hypothesize that mindfulness training in adjunct to traditional health education will improve dietary habits and physical activity among teenagers by reducing impulsive behavior and improving planning skills. The Commit to Get Fit study is a pilot cluster randomized controlled trial examining the feasibility, acceptability and preliminary efficacy of school-based mindfulness training in adjunct to traditional health education for promotion of a healthy diet and physical activity among adolescents. Two schools in central Massachusetts (30 students per school) will be randomized to receive mindfulness training plus standard health education (HE-M) or an attention-control intervention plus standard health education (HE-AC). Assessments will be conducted at baseline, intervention completion (2 months), and 8 months. Primary outcomes are feasibility and acceptability. Secondary outcomes include physical activity, diet, impulsivity, mood, body mass index, and quality of life. This study will provide important information about feasibility and preliminary estimates of efficacy of a school-delivered mindfulness and health education intervention to promote healthy dietary and physical activity behaviors among adolescents. Our findings will provide important insights about the possible mechanisms by which mindfulness training may contribute to behavioral change and inform future research in this important area. Copyright © 2015 Elsevier Inc. All rights reserved.

Design and methods for “Commit to Get Fit” – A pilot study of a school-based mindfulness intervention to promote healthy diet and physical activity among adolescents

PubMed Central

Salmoirago-Blotcher, Elena; Druker, Sue; Meyer, Florence; Bock, Beth; Crawford, Sybil; Pbert, Lori

2015-01-01

Introduction Cardiovascular prevention is more effective if started early in life, but available interventions to promote healthy lifestyle habits among youth have been ineffective. Impulsivity in particular has proven to be an important barrier to the adoption of healthy behaviors in youth. Observational evidence suggests that mindfulness interventions may reduce impulsivity and improve diet and physical activity. We hypothesize that mindfulness training in adjunct to traditional health education will improve dietary habits and physical activity among teenagers by reducing impulsive behavior and improving planning skills. Methods/Design The Commit to Get Fit study is a pilot cluster randomized controlled trial examining the feasibility, acceptability and preliminary efficacy of school-based mindfulness training in adjunct to traditional health education for promotion of a healthy diet and physical activity among adolescents. Two schools in central Massachusetts (30 students per school) will be randomized to receive mindfulness training plus standard health education (HE-M) or an attention-control intervention plus standard health education (HE-AC). Assessments will be conducted at baseline, intervention completion (2 months), and 8 months. Primary outcomes are feasibility and acceptability. Secondary outcomes include physical activity, diet, impulsivity, mood, body mass index, and quality of life. Conclusions This study will provide important information about feasibility and preliminary estimates of efficacy of a school-delivered mindfulness and health education intervention to promote healthy dietary and physical activity behaviors among adolescents. Our findings will provide important insights about the possible mechanisms by which mindfulness training may contribute to behavioral change and inform future research in this important area. PMID:25687667

Internet-delivered lifestyle physical activity intervention improves body composition in multiple sclerosis: preliminary evidence from a randomized controlled trial.

PubMed

Pilutti, Lara A; Dlugonski, Deirdre; Sandroff, Brian M; Klaren, Rachel E; Motl, Robert W

2014-07-01

To examine the efficacy of a physical activity behavioral intervention for improving outcomes of body composition in persons with multiple sclerosis (MS). Secondary analysis of data from a randomized controlled trial. University research laboratory. Ambulatory persons with MS (N=82). A 6-month, internet-delivered physical activity behavioral intervention designed to increase lifestyle physical activity, primarily walking. The behavioral intervention was based on principles of social cognitive theory. Whole-body bone mineral content (BMC), bone mineral density (BMD), and soft tissue composition, using dual-energy x-ray absorptiometry. There were no significant differences between conditions posttrial on body composition outcomes using the adjusted critical value (P<.008). There was a significant effect of the intervention on whole-body BMC (P=.04, ω(2)<.001) and BMD (P=.01, ω(2)=.003) using the unadjusted critical value (P<.05). The effect of the intervention on percent body fat (P=.09, ω(2)=.001) and whole-body fat mass (P=.05, ω(2)=.003) approached significance using unadjusted criteria. There was not a significant effect on whole-body lean soft tissue (P=.28, ω(2)<.001) or body mass index (P=.86, ω(2)<.001). Our results provide preliminary evidence that an internet-delivered lifestyle physical activity intervention might improve bone health and body composition in MS. Such findings are important considering that physical activity is a modifiable behavior with the potential to confer long-term benefits for the prevention and management of fracture risk and comorbidities among those with MS. Copyright © 2014 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Complementary medicine for treatment of agitation and delirium in older persons: a systematic review and narrative synthesis.

PubMed

Levy, Ilana; Attias, Samuel; Ben-Arye, Eran; Bloch, Boaz; Schiff, Elad

2017-05-01

Agitation and delirium frequently occur in cognitively impaired older people. We conducted a systematic review with narrative synthesis of the literature aiming to assess effectiveness of complementary and alternative medicine (CAM) modalities to address these conditions. Following preliminary search, we included 40 original researches on CAM treatment of delirium and agitation in older persons. Then, the quality of these studies was assessed using the Downs and Black Checklist and Quality Assessment Tool for Studies with Diverse Designs, and the effect sizes were calculated. We subsequently conducted a narrative synthesis of the main findings, including theory development, preliminary synthesis, exploration of relationships within and between studies, and assessment of synthesis robustness. Forty articles that met the inclusion criteria were analyzed. Sixteen of these were randomized controlled trials. One article specifically addressed CAM treatment of delirium in patients without dementia, and the remaining 39 articles described treatments of agitated older persons with dementia. Thirty-five of the 40 included studies suggested that the investigated CAM therapies may ameliorate the severity of agitation and delirium. The physiological surrogates of agitation assessed in these studies included cortisol level, chromogranin A level, and heart rate variability. Very few of the studies systematically assessed safety issues, although no major adverse effects were reported. Overall, the systematic review of the literature suggests that several CAM modalities are potentially beneficial in the treatment of agitation and delirium among older persons. We suggest that promising CAM modalities should be further explored through large-scale randomized controlled trials in different clinical settings. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

Saw Palmetto for Symptom Management During Radiation Therapy for Prostate Cancer.

PubMed

Wyatt, Gwen K; Sikorskii, Alla; Safikhani, Abolfazl; McVary, Kevin T; Herman, James

2016-06-01

Lower urinary tract symptoms (LUTSs) affect 75%-80% of men undergoing radiation therapy (RT) for prostate cancer. To determine the safety, maximum tolerated dose (MTD), and preliminary efficacy of Serenoa repens commonly known as saw palmetto (SP) for management of LUTS during RT for prostate cancer. The dose finding phase used the time-to-event continual reassessment method to evaluate safety of three doses (320, 640, and 960 mg) of SP. Dose-limiting toxicities were assessed for 22 weeks using the Common Terminology Criteria for Adverse Events for nausea, gastritis, and anorexia. The exploratory randomized controlled trial phase assessed preliminary efficacy of the MTD against placebo. The primary outcome of LUTS was measured over 22 weeks using the International Prostate Symptom Score. Additional longitudinal assessments included quality of life measured with the Functional Assessment of Cancer Therapy-Prostate. The dose finding phase was completed by 27 men who reported no dose-limiting toxicities and with 20 participants at the MTD of 960 mg daily. The exploratory randomized controlled trial phase included 21 men, and no statistically significant differences in the International Prostate Symptom Score were observed. The prostate-specific concerns score of the Functional Assessment of Cancer Therapy-Prostate improved in the SP group (P = 0.03). Of 11 men in the placebo group, two received physician-prescribed medications to manage LUTS compared with none of the 10 men in the SP group. SP at 960 mg may be a safe herbal supplement, but its efficacy in managing LUTS during RT needs further investigation. Copyright © 2016 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

A mindfulness-based intervention to control weight after bariatric surgery: Preliminary results from a randomized controlled pilot trial.

PubMed

Chacko, Sara A; Yeh, Gloria Y; Davis, Roger B; Wee, Christina C

2016-10-01

This study aimed to develop and test a novel mindfulness-based intervention (MBI) designed to control weight after bariatric surgery. Randomized, controlled pilot trial. Beth Israel Deaconess Medical Center, Boston, MA, USA. Bariatric patients 1-5 years post-surgery (n=18) were randomized to receive a 10-week MBI or a standard intervention. Primary outcomes were feasibility and acceptability of the MBI. Secondary outcomes included changes in weight, eating behaviors, psychosocial outcomes, and metabolic and inflammatory biomarkers. Qualitative exit interviews were conducted post-intervention. Major themes were coded and extracted. Attendance was excellent (6 of 9 patients attended ≥7 of 10 classes). Patients reported high satisfaction and overall benefit of the MBI. The intervention was effective in reducing emotional eating at 6 months (-4.9±13.7 in mindfulness vs. 6.2±28.4 in standard, p for between-group difference=0.03) but not weight. We also observed a significant increase in HbA1C (0.34±0.38 vs. -0.06±0.31, p=0.03). Objective measures suggested trends of an increase in perceived stress and symptoms of depression, although patients reported reduced stress reactivity, improved eating behaviors, and a desire for continued mindfulness-based support in qualitative interviews. This novel mindfulness-based approach is highly acceptable to bariatric patients post-surgery and may be effective for reducing emotional eating, although it did not improve weight or glycemic control in the short term. Longer-term studies of mindfulness-based approaches may be warranted in this population. ClinicalTrials.gov identifier NCT02603601. Copyright © 2016 Elsevier Ltd. All rights reserved.

Multimodal exercise training in multiple sclerosis: A randomized controlled trial in persons with substantial mobility disability.

PubMed

Sandroff, Brian M; Bollaert, Rachel E; Pilutti, Lara A; Peterson, Melissa L; Baynard, Tracy; Fernhall, Bo; McAuley, Edward; Motl, Robert W

2017-10-01

Mobility disability is a common, debilitating feature of multiple sclerosis (MS). Exercise training has been identified as an approach to improve MS-related mobility disability. However, exercise randomized controlled trials (RCTs) on mobility in MS have generally not selectively targeted those with the onset of irreversible mobility disability. The current multi-site RCT compared the efficacy of 6-months of supervised, multimodal exercise training with an active control condition for improving mobility, gait, physical fitness, and cognitive outcomes in persons with substantial MS-related mobility disability. 83 participants with substantial MS-related mobility disability underwent initial mobility, gait, fitness, and cognitive processing speed assessments and were randomly assigned to 6-months of supervised multimodal (progressive aerobic, resistance, and balance) exercise training (intervention condition) or stretching-and-toning activities (control condition). Participants completed the same outcome assessments halfway through and immediately following the 6-month study period. There were statistically significant improvements in six-minute walk performance (F(2158)=3.12, p=0.05, η p 2 =0.04), peak power output (F(2150)=8.16, p<0.01, η p 2 =0.10), and Paced Auditory Serial Addition Test performance (F(2162)=4.67, p=0.01, η p 2 =0.05), but not gait outcomes, for those who underwent the intervention compared with those who underwent the control condition. This RCT provides novel, preliminary evidence that multimodal exercise training may improve endurance walking performance and cognitive processing speed, perhaps based on improvements in cardiorespiratory capacity, in persons with MS with substantial mobility disability. This is critical for informing the development of multi-site exercise rehabilitation programs in larger samples of persons with MS-related mobility disability. Copyright © 2017 Elsevier Inc. All rights reserved.

Clinical and cost-effectiveness of therapist-guided internet-delivered cognitive behavior therapy for older adults with symptoms of anxiety: a randomized controlled trial.

PubMed

Dear, Blake F; Zou, Judy B; Ali, Shehzad; Lorian, Carolyn N; Johnston, Luke; Sheehan, Joanne; Staples, Lauren G; Gandy, Milena; Fogliati, Vincent J; Klein, Britt; Titov, Nickolai

2015-03-01

There is preliminary support for internet-delivered cognitive behaviour therapy (iCBT) as a way of improving access to treatment among older adults with anxiety. The aim of this randomized controlled trial (RCT) was to examine the efficacy, long-term outcomes, and cost-effectiveness of an iCBT program for adults over 60 years of age with anxiety. Successful applicants were randomly allocated to either the treatment group (n=35) or the waitlist control group (n=37). The online treatment course was delivered over 8 weeks and provided with brief weekly contact with a clinical psychologist via telephone or secure email. Eighty-four percent of participants completed the iCBT course within the 8 weeks and 90% provided data at posttreatment. Significantly lower scores on measures of anxiety (Cohen's d=1.43; 95% CI: 0.89 - 1.93) and depression (Cohen's d=1.79; 95% CI: 1.21 - 2.32) were found among the treatment group compared to the control group at posttreatment. These lower scores were maintained at 3-month and 12-month follow-up and the treatment group rated the iCBT treatment as acceptable. The treatment group had slightly higher costs ($92.2; 95% CI: $38.7 to $149.2) and Quality-Adjusted Life-Years (QALYs=0.010; 95% CI: 0.003 to 0.018) than the control group at posttreatment and the intervention was found to have a greater than 95% probability of being cost-effective. The results support iCBT as an efficacious and cost-effective treatment option for older adults with symptoms of anxiety. Australian and New Zealand Clinical Trials Registry: ACTRN12611000929909; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12611000929909. Copyright © 2014. Published by Elsevier Ltd.

Feasibility and Efficacy of an mHealth Game for Managing Anxiety: "Flowy" Randomized Controlled Pilot Trial and Design Evaluation.

PubMed

Pham, Quynh; Khatib, Yasmin; Stansfeld, Stephen; Fox, Simon; Green, Tobias

2016-02-01

Meeting the complex needs of patients with chronic common mental health disorders (CMHDs) may be the greatest challenge facing organized medical practice. On the basis of a well-established and proven theoretical foundation for controlled respiration as a behavioral intervention for CMHDs, as well as preliminary evidence that gamification can improve health outcomes through increasing patient engagement, this randomized controlled pilot study evaluated the feasibility and clinical efficacy of a mobile health game called "Flowy" ( www.flowygame.com ) that digitally delivered breathing retraining exercises for anxiety, panic, and hyperventilation symptom management. We designed an unblinded, Web-based, parallel-group randomized controlled trial focusing on feasibility, clinical efficacy, and design proof of concept. In the intervention condition (n = 31), participants received free access to "Flowy" for 4 weeks. In the control condition (n = 32), participants were placed on a waitlist for 4 weeks before being offered free access to "Flowy." Online measurements using psychological self-report questionnaires were made at 2 and 4 weeks post-baseline. At trial conclusion, participants found "Flowy" acceptable as an anxiety management intervention. "Flowy" engaged participants sufficiently to endorse proactive gameplay. Intent-to-treat analysis revealed a reduction in anxiety, panic, and self-report hyperventilation scores in both trial arms, with the intervention arm experiencing greater quality of life. Participants perceived "Flowy" as a fun and useful intervention, proactively used "Flowy" as part of their care, and would recommend "Flowy" to family and friends. Our results suggest that a digital delivery of breathing retraining exercises through a mobile health game can manage anxiety, panic, and hyperventilation symptoms associated with CMHDs.

Effectiveness of Intraoral Chlorhexidine Protocols in the Prevention of Ventilator-Associated Pneumonia: Meta-Analysis and Systematic Review.

PubMed

Villar, Cristina C; Pannuti, Claudio M; Nery, Danielle M; Morillo, Carlos M R; Carmona, Maria José C; Romito, Giuseppe A

2016-09-01

Ventilator-associated pneumonia (VAP) is common in critical patients and related with increased morbidity and mortality. We conducted a systematic review and meta-analysis, with intention-to-treat analysis, of randomized controlled clinical trials that assessed the effectiveness of different intraoral chlorhexidine protocols for the prevention of VAP. Search strategies were developed for the MEDLINE, EMBASE, and LILACS databases. MeSH terms were combined with Boolean operators and used to search the databases. Eligible studies were randomized controlled trials of mechanically ventilated subjects receiving oral care with chlorhexidine or standard oral care protocols consisting of or associated with the use of a placebo or no chemicals. Pooled estimates of the relative risk and corresponding 95% CIs were calculated with random effects models, and heterogeneity was assessed with the Cochran Q statistic and I(2). The 13 included studies provided data on 1,640 subjects that were randomly allocated to chlorhexidine (n = 834) or control (n = 806) treatments. A preliminary analysis revealed that oral application of chlorhexidine fails to promote a significant reduction in VAP incidence (relative risk 0.80, 95% CI 0.59-1.07, I(2) = 45%). However, subgroup analyses showed that chlorhexidine prevents VAP development when used at 2% concentration (relative risk 0.53, 95% CI 0.31-0.91, I(2) = 0%) or 4 times/d (relative risk 0.56, 95% CI 0.38-0.81, I(2) = 0%). We found that oral care with chlorhexidine is effective in reducing VAP incidence in the adult population if administered at 2% concentration or 4 times/d. Copyright © 2016 by Daedalus Enterprises.

Intravenous immunoglobulin treatment of the complex regional pain syndrome: a randomized trial.

PubMed

Goebel, Andreas; Baranowski, Andrew; Maurer, Konrad; Ghiai, Artemis; McCabe, Candy; Ambler, Gareth

2010-02-02

Treatment of long-standing complex regional pain syndrome (CRPS) is empirical and often of limited efficacy. Preliminary data suggest that the immune system is involved in sustaining this condition and that treatment with low-dose intravenous immunoglobulin (IVIG) may substantially reduce pain in some patients. To evaluate the efficacy of IVIG in patients with longstanding CRPS under randomized, controlled conditions. A randomized, double-blind, placebo-controlled crossover trial. (National Research Registry number: N0263177713; International Standard Randomised Controlled Trial Number Registry: 63918259) University College London Hospitals Pain Management Centre. Persons who had pain intensity greater than 4 on an 11-point (0 to 10) numerical rating scale and had CRPS for 6 to 30 months that was refractory to standard treatment. IVIG, 0.5 g/kg, and normal saline in separate treatments, divided by a washout period of at least 28 days. The primary outcome was pain intensity 6 to 19 days after the initial treatment and the crossover treatment. 13 eligible participants were randomly assigned between November 2005 and May 2008; 12 completed the trial. The average pain intensity was 1.55 units lower after IVIG treatment than after saline (95% CI, 1.29 to 1.82; P < 0.001). In 3 patients, pain intensity after IVIG was less than after saline by 50% or more. No serious adverse reactions were reported. The trial was small, and recruitment bias and chance variation could have influenced results and their interpretation. IVIG, 0.5 g/kg, can reduce pain in refractory CRPS. Studies are required to determine the best immunoglobulin dose, the duration of effect, and when repeated treatments are needed. Association of Anaesthetists of Great Britain and Ireland, University College London Hospitals Charity, and CSL-Behring.

Surgical site infections following colorectal cancer surgery: a randomized prospective trial comparing common and advanced antimicrobial dressing containing ionic silver.

PubMed

Biffi, Roberto; Fattori, Luca; Bertani, Emilio; Radice, Davide; Rotmensz, Nicole; Misitano, Pasquale; Cenciarelli, Sabine; Chiappa, Antonio; Tadini, Liliana; Mancini, Marina; Pesenti, Giovanni; Andreoni, Bruno; Nespoli, Angelo

2012-05-23

An antimicrobial dressing containing ionic silver was found effective in reducing surgical-site infection in a preliminary study of colorectal cancer elective surgery. We decided to test this finding in a randomized, double-blind trial. Adults undergoing elective colorectal cancer surgery at two university-affiliated hospitals were randomly assigned to have the surgical incision dressed with Aquacel Ag Hydrofiber dressing or a common dressing. To blind the patient and the nursing and medical staff to the nature of the dressing used, scrub nurses covered Aquacel Ag Hydrofiber with a common wound dressing in the experimental arm, whereas a double common dressing was applied to patients of control group. The primary end-point of the study was the occurrence of any surgical-site infection within 30 days of surgery. A total of 112 patients (58 in the experimental arm and 54 in the control group) qualified for primary end-point analysis. The characteristics of the patient population and their surgical procedures were similar. The overall rate of surgical-site infection was lower in the experimental group (11.1% center 1, 17.5% center 2; overall 15.5%) than in controls (14.3% center 1, 24.2% center 2, overall 20.4%), but the observed difference was not statistically significant (P = 0.451), even with respect to surgical-site infection grade 1 (superficial) versus grades 2 and 3, or grade 1 and 2 versus grade 3. This randomized trial did not confirm a statistically significant superiority of Aquacel Ag Hydrofiber dressing in reducing surgical-site infection after elective colorectal cancer surgery. Clinicaltrials.gov: NCT00981110.

A randomized double-blind, placebo-controlled trial of minocycline in children and adolescents with fragile x syndrome.

PubMed

Leigh, Mary Jacena S; Nguyen, Danh V; Mu, Yi; Winarni, Tri I; Schneider, Andrea; Chechi, Tasleem; Polussa, Jonathan; Doucet, Paul; Tassone, Flora; Rivera, Susan M; Hessl, David; Hagerman, Randi J

2013-04-01

Minocycline rescued synaptic abnormalities and improved behavior in the fragile X mouse model. Previous open-label human studies demonstrated benefits in individuals with fragile X syndrome (FXS); however, its efficacy in patients with FXS has not been assessed in a controlled trial. Randomized, double-blind, placebo-controlled, crossover trial in individuals with FXS, aged 3.5 years to 16 years (n = 55, mean age 9.2 [SD, 3.6] years). Participants were randomized to minocycline or placebo for 3 months and then switched to the other treatment. Sixty-nine subjects were screened and 66 were randomized. Fifty-five subjects (83.3%) completed at least the first period and 48 (72.7%) completed the full trial. Intention-to-treat analysis demonstrated significantly greater improvements in one primary outcome, Clinical Global Impression Scale-Improvement after minocycline compared with placebo (2.49 ± 0.13 and 2.97 ± 0.13, respectively, p = .0173) and greater improvement in ad hoc analysis of anxiety and mood-related behaviors on the Visual Analog Scale (minocycline: 5.26 cm ± 0.46 cm, placebo: 4.05 cm ± 0.46 cm; p = .0488). Side effects were not significantly different during the minocycline and placebo treatments. No serious adverse events occurred on minocycline. Results may be potentially biased by study design weaknesses, including unblinding of subjects when they completed the study, drug-related side effects unblinding, and preliminary efficacy analysis results known to investigators. Minocycline treatment for 3 months in children with FXS resulted in greater global improvement than placebo. Treatment for 3 months appears safe; however, longer trials are indicated to further assess benefits, side effects, and factors associated with a clinical response to minocycline.

A Randomized Double-Blind, Placebo-Controlled Trial of Minocycline in Children and Adolescents with Fragile X Syndrome

PubMed Central

Leigh, Mary Jacena S.; Nguyen, Danh V.; Mu, Yi; Winarni, Tri I.; Schneider, Andrea; Chechi, Tasleem; Polussa, Jonathan; Doucet, Paul; Tassone, Flora; Rivera, Susan M.; Hessl, David; Hagerman, Randi J.

2013-01-01

Objective Minocycline rescued synaptic abnormalities and improved behavior in the fragile X mouse model. Prior open-label human studies demonstrated benefits in individuals with fragile X syndrome (FXS); however, its efficacy in patients with FXS has not been assessed in a controlled trial. Method Randomized, double-blind, placebo-controlled, crossover trial in individuals with FXS, ages 3.5-16 years (n=55, mean age 9.2 (SD 3.6 years)). Participants were randomized to minocycline or placebo for three months, then switched to the other treatment. Results Sixty-nine subjects were screened and 66 were randomized. Fifty-five subjects (83.3%) completed at least the first period and 48 (72.7%) completed the full trial. Intention-to-treat analysis demonstrated significantly greater improvements in one primary outcome, Clinical Global Impression Scale-Improvement after minocycline compared to placebo (2.49 ±0.13, 2.97 ±0.13, respectively, p 0.0173) and greater improvement in ad hoc analysis of anxiety and mood-related behaviors on the Visual Analoge Scale (minocycline 5.26 cm ±0.46 cm, placebo 4.05 cm±0.46cm; p 0.0488). Side effects were not significantly different during the minocycline and placebo treatments. No serious adverse events occurred on minocycline. Results may be potentially biased by study design weaknesses, including unblinding of subjects when they completed the study, drug-related side effects unblinding and preliminary efficacy analysis results known to investigators. Conclusion Minocycline treatment for three months in children with FXS resulted in greater global improvement than placebo. Treatment for three months appears safe; however, longer trials are indicated to further assess benefits, side effects, and factors associated with a clinical response to minocycline. PMID:23572165

Intratympanic dexamethasone versus high dosage of betahistine in the treatment of intractable unilateral Meniere disease.

PubMed

Albu, Silviu; Chirtes, Felician; Trombitas, Veronica; Nagy, Alina; Marceanu, Luigi; Babighian, Gregorio; Trabalzini, Franco

2015-01-01

The objective of our randomized, double-blind study was to compare the effectiveness of intratympanic (IT) dexamethasone versus high-dosage of betahistine in the treatment of patients with intractable unilateral Meniere disease (MD). Sixty six patients with definite unilateral MD were randomly divided in two groups: Group A received a combination of IT dexamethasone (DX) and identical-appearing placebo pills while Group B received a combination of high-dosage betahistine and IT saline. Intratympanic injections were repeated for three times with an interlude of 3days. High-dosage of betahistine entailed 144mg/day. Mean outcome measures consisted of vertigo control, pure tone average (PTA), speech discrimination score, Functional Level Score, Dizziness Handicap Inventory and Tinnitus Handicap Inventory. Fifty nine patients completed the study and were available at 12months for analysis. In Group A complete vertigo control (class A) was attained in 14 patients (46.6%) and substantial control (class B) in 7 patients (20%). In Group B, 12 patients (41%) achieved complete vertigo control (class A), 5 patients (17%) substantial control (class B). There is no statistical difference in vertigo control between the two treatment groups. In Group A hearing was unchanged in 14 patients and improved in 4 patients, while in Group B hearing was unchanged in 16 patients and improved in 2 patients. Our preliminary results demonstrate that high-dosage of betahistine achieved similar outcomes as IT dexamethasone in the control of vertigo and hearing preservation. Copyright © 2015 Elsevier Inc. All rights reserved.

Phase I/II randomized trial of aerobic exercise in Parkinson disease in a community setting.

PubMed

Uc, Ergun Y; Doerschug, Kevin C; Magnotta, Vincent; Dawson, Jeffrey D; Thomsen, Teri R; Kline, Joel N; Rizzo, Matthew; Newman, Sara R; Mehta, Sonya; Grabowski, Thomas J; Bruss, Joel; Blanchette, Derek R; Anderson, Steven W; Voss, Michelle W; Kramer, Arthur F; Darling, Warren G

2014-07-29

To (1) investigate effects of aerobic walking on motor function, cognition, and quality of life in Parkinson disease (PD), and (2) compare safety, tolerability, and fitness benefits of different forms of exercise intervention: continuous/moderate intensity vs interval/alternating between low and vigorous intensity, and individual/neighborhood vs group/facility setting. Initial design was a 6-month, 2 × 2 randomized trial of different exercise regimens in independently ambulatory patients with PD. All arms were required to exercise 3 times per week, 45 minutes per session. Randomization to group/facility setting was not feasible because of logistical factors. Over the first 2 years, we randomized 43 participants to continuous or interval training. Because preliminary analyses suggested higher musculoskeletal adverse events in the interval group and lack of difference between training methods in improving fitness, the next 17 participants were allocated only to continuous training. Eighty-one percent of 60 participants completed the study with a mean attendance of 83.3% (95% confidence interval: 77.5%-89.0%), exercising at 46.8% (44.0%-49.7%) of their heart rate reserve. There were no serious adverse events. Across all completers, we observed improvements in maximum oxygen consumption, gait speed, Unified Parkinson's Disease Rating Scale sections I and III scores (particularly axial functions and rigidity), fatigue, depression, quality of life (e.g., psychological outlook), and flanker task scores (p < 0.05 to p < 0.001). Increase in maximum oxygen consumption correlated with improvements on the flanker task and quality of life (p < 0.05). Our preliminary study suggests that aerobic walking in a community setting is safe, well tolerated, and improves aerobic fitness, motor function, fatigue, mood, executive control, and quality of life in mild to moderate PD. This study provides Class IV evidence that in patients with PD, an aerobic exercise program improves aerobic fitness, motor function, fatigue, mood, and cognition. © 2014 American Academy of Neurology.

Increasing Parent Involvement in Youth HIV Prevention: A Randomized Caribbean Study

ERIC Educational Resources Information Center

Baptiste, Donna R.; Kapungu, Chisina; Miller, Steve; Crown, Laurel; Henry, David; Da Costa Martinez, Dona; Jo-Bennett, Karen

2009-01-01

This article presents preliminary findings of a randomized HIV prevention study in Trinidad and Tobago in the Caribbean. The study centers on a family HIV workshop aimed at strengthening parenting skills that are empirically linked to reducing adolescent HIV exposure and other sexual risks. These skills include parental monitoring; educating youth…

Efficacy Trial of the Second Step Early Learning (SSEL) Curriculum: Preliminary Outcomes

ERIC Educational Resources Information Center

Upshur, Carole C.; Heyman, Miriam; Wenz-Gross, Melodie

2017-01-01

A classroom randomized trial (n = 31 classrooms) was conducted using the Second Step Early Learning (SSEL) curriculum compared to usual curricula. Head Start and community preschool classrooms enrolling low income children were randomly assigned to deliver SSEL (n = 16) or usual curricula (n = 15). Data are reported for four year olds…

75 FR 20564 - Dynamic Random Access Memory Semiconductors from the Republic of Korea: Extension of Time Limit...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-20

... DEPARTMENT OF COMMERCE International Trade Administration [C-580-851] Dynamic Random Access Memory Semiconductors from the Republic of Korea: Extension of Time Limit for Preliminary Results of Countervailing Duty... access memory semiconductors from the Republic of Korea, covering the period January 1, 2008 through...

Brief Report: Remotely Delivered Video Modeling for Improving Oral Hygiene in Children with ASD: A Pilot Study.

PubMed

Popple, Ben; Wall, Carla; Flink, Lilli; Powell, Kelly; Discepolo, Keri; Keck, Douglas; Mademtzi, Marilena; Volkmar, Fred; Shic, Frederick

2016-08-01

Children with autism have heightened risk of developing oral health problems. Interventions targeting at-home oral hygiene habits may be the most effective means of improving oral hygiene outcomes in this population. This randomized control trial examined the effectiveness of a 3-week video-modeling brushing intervention delivered to patients over the internet. Eighteen children with autism were assigned to an Intervention or Control video condition. Links to videos were delivered via email twice daily. Blind clinical examiners provided plaque index ratings at baseline, midpoint, and endpoint. Results show oral hygiene improvements in both groups, with larger effect sizes in the Intervention condition. The findings provide preliminary support for the use of internet-based interventions to improve oral hygiene for children with autism.

Online Communication about Depression and Anxiety among Twitter Users with Schizophrenia: Preliminary Findings to Inform a Digital Phenotype Using Social Media.

PubMed

Hswen, Yulin; Naslund, John A; Brownstein, John S; Hawkins, Jared B

2018-01-12

Digital technologies hold promise for supporting the detection and management of schizophrenia. This exploratory study aimed to generate an initial understanding of whether patterns of communication about depression and anxiety on popular social media among individuals with schizophrenia are consistent with offline representations of the illness. From January to July 2016, posts on Twitter were collected from a sample of Twitter users who self-identify as having a schizophrenia spectrum disorder (n = 203) and a randomly selected sample of control users (n = 173). Frequency and timing of communication about depression and anxiety were compared between groups. In total, the groups posted n = 1,544,122 tweets and users had similar characteristics. Twitter users with schizophrenia showed significantly greater odds of tweeting about depression compared with control users (OR = 2.69; 95% CI 1.76-4.10), and significantly greater odds of tweeting about anxiety compared with control users (OR = 1.81; 95% CI 1.20-2.73). This study offers preliminary insights that Twitter users with schizophrenia may express elevated symptoms of depression and anxiety in their online posts, which is consistent with clinical characteristics of schizophrenia observed in offline settings. Social media platforms could further our understanding of schizophrenia by informing a digital phenotype and may afford new opportunities to support early illness detection.

Prison Therapeutic Community Treatment for Female Offenders: Profiles and Preliminary Findings for Mental Health and Other Variables (Crime, Substance Use and HIV Risk)

ERIC Educational Resources Information Center

Sacks, Joann Y.; Sacks, Stanley; Mckendrick, Karen; Banks, Steven; Schoeneberger, Marlies; Hamilton, Zachary; Stommel, Joseph; Shoemaker, Joanie

2008-01-01

This random assignment study compared women in a prison Therapeutic Community (TC) program with those in a cognitive-behavioral intervention. Over two thirds of study subjects received a lifetime diagnosis of severe mental disorder, nearly one-half received a diagnosis of PTSD, and virtually all reported exposure to trauma. Preliminary analysis (n…

Preliminary Testing of a Program to Prevent Type 2 Diabetes among High-Risk Youth.(research Papers)

ERIC Educational Resources Information Center

Grey, Margaret; Berry, Diane; Davidson, Maryanne; Galasso, Pam; Gustafson, Elaine; Melkus, Gail

2004-01-01

Type 2 diabetes is increasing among youth, with minority youth at highest risk. This preliminary study tested the feasibility of a school-based program to prevent type 2 diabetes in youth at risk. Forty-one participants (age 12.6 [+ or -] 1.1 years; 63% female, 51% African American, 44% Hispanic, and 5% Caucasian) were randomly assigned to one of…

Virtual Sensorimotor Training for Balance: Pilot Study Results for Children With Fetal Alcohol Spectrum Disorders.

PubMed

Jirikowic, Tracy; Westcott McCoy, Sarah; Price, Robert; Ciol, Marcia A; Hsu, Lin-Ya; Kartin, Deborah

2016-01-01

To examine the effects of Sensorimotor Training to Affect Balance, Engagement, and Learning (STABEL), a virtual reality system to train sensory adaptation for balance control, for children with fetal alcohol spectrum disorders (FASDs). Twenty-three children with FASDs received STABEL training in a university laboratory, or home, or were controls. The Movement Assessment Battery for Children-2nd edition (MABC-2) and Pediatric Clinical Test of Sensory Interaction for Balance-2 (P-CTSIB-2) were analyzed by group (lab, home, and control), session (pre-STABEL, 1 week post-STABEL, and 1 month post-STABEL), and group-by-session interaction. Significant effects were group and session for MABC-2 Balance and interaction for MABC-2 Total Motor and P-CTSIB-2. Preliminary results support improved sensory adaptation, balance, and motor performance post-STABEL, which warrant further study with a larger, randomized sample.

Flight flutter testing technology at Grumman. [automated telemetry station for on line data reduction

NASA Technical Reports Server (NTRS)

Perangelo, H. J.; Milordi, F. W.

1976-01-01

Analysis techniques used in the automated telemetry station (ATS) for on line data reduction are encompassed in a broad range of software programs. Concepts that form the basis for the algorithms used are mathematically described. The control the user has in interfacing with various on line programs is discussed. The various programs are applied to an analysis of flight data which includes unimodal and bimodal response signals excited via a swept frequency shaker and/or random aerodynamic forces. A nonlinear response error modeling analysis approach is described. Preliminary results in the analysis of a hard spring nonlinear resonant system are also included.

Molindone and haloperidol in tardive dyskinesia.

PubMed

Glazer, W M; Hafez, H M; Benarroche, C L

1985-08-01

Preliminary results are described from a study of 11 outpatients manifesting exacerbated tardive dyskinesia after tapering and withdrawal of neuroleptic medications. Patients were randomly assigned to molindone or haloperidol under double-blind placebo-controlled conditions to compare the masking effects of the two drugs. Haloperidol treatment masked withdrawal-exacerbated tardive dyskinesia more than molindone did; this difference (measured by percent change in AIMS scores) was significant (p = .04) when the dose was 200% but not 100% of the prestudy neuroleptic dose. Despite several limitations to the study, the results suggest that molindone may have less dyskinetogenic potential than haloperidol. Further research in the area of site-specificity of molindone is indicated.

[Herbal medicine in womens' life cycle].

PubMed

Ben-Arye, Eran; Oren, Amnon; Ben-Arie, Alon

2006-10-01

Women use herbs and other traditional and complementary modalities to treat various ailments throughout their life circle. This article reviewed 19 randomized controlled trials, which studied efficacy and safety of various herbs in the treatment of premenstrual syndrome (PMS), nausea and vomiting in the first trimester of pregnancy and menopausal hot flushes. Preliminary data support the efficacy of Chaste tree fruit (Vitex agnus) in the treatment of PMS, Ginger (Zingiber officinale) in the treatment of hyperemesis gravidarum and (Cimicifuga racemosa) in the treatment of menopausal hot flushes. Additional and more rigorous studies are warranted in order to support the efficacy and safety of these herbal remedies.

Can Family-Based Treatment of Anorexia Nervosa Be Manualized?

PubMed Central

Lock, James; Le Grange, Daniel

2001-01-01

The authors report on the development of a manual for treating adolescents with anorexia nervosa modeled on a family-based intervention originating at the Maudsley Hospital in London. The manual provides the first detailed account of a clinical approach shown to be consistently efficacious in randomized clinical trials for this disorder. Manualized family therapy appears to be acceptable to therapists, patients, and families. Preliminary outcomes are comparable to what would be expected in clinically supervised sessions. These results suggest that through the use of this manual a valuable treatment approach can now be tested more broadly in controlled and uncontrolled settings. PMID:11696652

[Prevention and Treatment of Eating Disorders: The Health Care Network Anorexia and Bulimia nervosa].

PubMed

Weigel, Angelika; Gumz, Antje; Kästner, Denise; Romer, Georg; Wegscheider, Karl; Löwe, Bernd

2015-07-01

The "Health care network anorexia and bulimia nervosa", a subproject of psychenet - the Hamburg network for mental health - aims to decrease the incidence of eating disorders as well as the risk for chronic illness courses. One focal project, therefore, evaluates a school-based prevention manual in a randomized controlled trial. The other one examines the impact of a systemic public health intervention on early treatment initiation in anorexia nervosa. The present article provides an overview about study design and interventions in both focal projects as well as preliminary results. © Georg Thieme Verlag KG Stuttgart · New York.

Assessment of reporting quality of conference abstracts in sports injury prevention according to CONSORT and STROBE criteria and their subsequent publication rate as full papers.

PubMed

Yoon, Uzung; Knobloch, Karsten

2012-04-11

The preliminary results of a study are usually presented as an abstract in conference meetings. The reporting quality of those abstracts and the relationship between their study designs and full paper publication rate is unknown. We hypothesized that randomized controlled trials are more likely to be published as full papers than observational studies. 154 oral abstracts presented at the World Congress of Sports Injury Prevention 2005 Oslo and the corresponding full paper publication were identified and analysed. The main outcome measures were frequency of publication, time to publication, impact factor, CONSORT (for Consolidated Standards of Reporting Trials) score, STROBE (for Strengthening the Reporting of Observational Studies in Epidemiology) score, and minor and major inconsistencies between the abstract and the full paper publication. Overall, 76 of the 154 (49%) presented abstracts were published as full papers in a peer-reviewed journal with an impact factor of 1.946 ± 0.812. No significant difference existed between the impact factor for randomized controlled trials (2.122 ± 1.015) and observational studies (1.913 ± 0.765, p = 0.469). The full papers for the randomized controlled trials were published after an average (SD) of 17 months (± 13 months); for observational studies, the average (SD) was 12 months (± 14 months) (p = 0.323). A trend was observed in this study that a higher percentage of randomized controlled trial abstracts were published as full papers (71% vs. 47%, p = 0.078) than observational trials. The reporting quality of abstracts, published as full papers, significantly increased compared to conference abstracts both in randomized control studies ( 5.7 ± 0.7 to 7.2 ± 1.3; p = 0.018, CI -2.7 to -0.32) and in observational studies (STROBE: 8.2 ± 1.3 to 8.6 ± 1.4; p = 0.007, CI -0.63 to -0.10). All of the published abstracts had at least one minor inconsistency (title, authors, research center, outcome presentation, conclusion), while 65% had at least major inconsistencies (study objective, hypothesis, study design, primary outcome measures, sample size, statistical analysis, results, SD/CI). Comparing the results of conference and full paper; results changed in 90% vs. 68% (randomized, controlled studies versus observational studies); data were added (full paper reported more result data) in 60% vs. 30%, and deleted (full paper reported fewer result data) in 40% vs. 30%. No significant differences with respect to type of study (randomized controlled versus observational), impact factor, and time to publication existed for the likelihood that a World Congress of Sports Injury conference abstract could be published as a full paper.

Building capacity for rigorous controlled trials in autism: the importance of measuring treatment adherence.

PubMed

McConachie, H; Fletcher-Watson, S

2015-03-01

Research groups across Europe have been networking to share information and ideas about research on preschool children with autism. The paper describes preliminary work to develop capacity for future multi-site randomized controlled trials of early intervention, with a specific focus on the need to measure treatment adherence where parents deliver therapy. The paper includes a review of randomized and controlled studies of parent-mediated early intervention from two sources, a recent Cochrane Collaboration review and a mapping of European early intervention studies in autism published since 2002. The data extracted focused on methods for describing parent adherence, that is, how and to what extent parents carry out the strategies taught them by therapists. Less than half of the 32 studies reviewed included any measure of parent adherence. Only seven included a direct assessment method. The challenges of developing pan-European early intervention evaluation studies are discussed, including choice of intervention model and of important outcomes, the need for translation of measurement tools and achievement of joint training to reliability of assessors. Measurement of parent-child interaction style and of adherence to strategies taught need further study. © 2014 The Authors. Child: Care, Health and Development published by John Wiley & Sons Ltd.

Feedback of personal retinal images appears to have a motivational impact in people with non-proliferative diabetic retinopathy and suboptimal HbA1c: findings of a pilot study.

PubMed

Rees, G; Lamoureux, E L; Nicolaou, T E; Hodgson, L A B; Weinman, J; Speight, J

2013-09-01

To conduct a pilot study to explore the potential impact of visual feedback of personal retinal images on diabetes outcomes. Twenty-five participants with non-proliferative diabetic retinopathy and suboptimal HbA(1c) (> 53 mmol/mol; > 7%) were randomized to receive visual feedback of their own retinal images or to a control group. At baseline and 3-month follow-up, HbA(1c), standard measures of beliefs, diabetes-related distress and self-care activities were assessed. In unadjusted models, relative to controls, the intervention group showed significantly greater improvement in HbA(1c) at 3-month follow-up (-0.6% vs. +0.3%, P < 0.01), as well as enhanced motivation to improve blood glucose management (P < 0.05). This small pilot study provides preliminary evidence that visual feedback of personal retinal images may offer a practical educational strategy for clinicians in eye care services to improve diabetes outcomes in non-target compliant patients. A fully powered randomized controlled trial is required to confirm these findings and determine the optimal use of feedback to produce sustained effects. © 2013 The Authors. Diabetic Medicine © 2013 Diabetes UK.

Teaching Parents About Responsive Feeding Through a Vicarious Learning Video: A Pilot Randomized Controlled Trial.

PubMed

Ledoux, Tracey; Robinson, Jessica; Baranowski, Tom; O'Connor, Daniel P

2018-04-01

The American Academy of Pediatrics and World Health Organization recommend responsive feeding (RF) to promote healthy eating behaviors in early childhood. This project developed and tested a vicarious learning video to teach parents RF practices. A RF vicarious learning video was developed using community-based participatory research methods. Fifty parents of preschoolers were randomly assigned to watch Happier Meals or a control video about education. Knowledge and beliefs about RF practices were measured 1 week before and immediately after intervention. Experimental group participants also completed measures of narrative engagement and video acceptability. Seventy-four percent of the sample was White, 90% had at least a college degree, 96% were married, and 88% made >$50,000/year. RF knowledge increased ( p = .03) and positive beliefs about some unresponsive feeding practices decreased ( ps < .05) more among experimental than control parents. Knowledge and belief changes were associated with video engagement ( ps < .05). Parents perceived Happier Meals as highly relevant, applicable, and informative. Community-based participatory research methods were instrumental in developing this vicarious learning video, with preliminary evidence of effectiveness in teaching parents about RF. Happier Meals is freely available for parents or community health workers to use when working with families to promote healthy eating behaviors in early childhood.

Effectiveness of telerehabilitation programme following surgery in shoulder impingement syndrome (SIS): study protocol for a randomized controlled non-inferiority trial.

PubMed

Pastora-Bernal, Jose-Manuel; Martín-Valero, Rocío; Barón-López, Francisco Javier; García-Gómez, Oscar

2017-02-23

Shoulder pain is common in society, with high prevalence in the general population. Shoulder impingement syndrome (SIS) is the most frequent cause. Patients suffer pain, muscle weakness and loss of movement in the affected joint. Initial treatment is predominantly conservative. The surgical option has high success rates and is often used when conservative strategy fails. Traditional physiotherapy and post-operative exercises are needed for the recovery of joint range, muscle strength, stability and functionality. Telerehabilitation programmes have shown positive results in some orthopaedic conditions after surgery. Customized telerehabilitation intervention programmes should be developed to recover shoulder function after SIS surgery. The objective of this study is to evaluate the feasibility and effectiveness of a telerehabilitation intervention compared with usual care in patients after subacromial decompression surgery. We will compare an intervention group receiving videoconferences and a telerehabilitation programme to a control group receiving traditional physiotherapy intervention in a single-blind, randomized controlled non-inferiority trial study design. Through this study, we will further develop our preliminary data set and practical experience with the telerehabilitation programmes to evaluate their effectiveness and compare this with traditional intervention. We will also explore patient satisfaction and cost-effectiveness. Patient enrolment is ongoing. ClinicalTrials.gov, NCT02909920 . 14 September 2016.

Efficacy of water preloading before main meals as a strategy for weight loss in primary care patients with obesity: RCT.

PubMed

Parretti, Helen M; Aveyard, Paul; Blannin, Andrew; Clifford, Susan J; Coleman, Sarah J; Roalfe, Andrea; Daley, Amanda J

2015-09-01

To investigate the efficacy of water preloading before meals as a weight loss strategy for adults with obesity. A two-group randomized controlled trial was conducted in Birmingham, England. Eighty-four adults with obesity were recruited from general practices. All participants were given a face-to-face weight management consultation at baseline (30 min) and a follow-up telephone consultation at 2 weeks (10 min). At baseline, participants were randomized to either drinking 500 ml of water 30 min before their main meals or an attention control group where participants were asked to imagine their stomach was full before meals. The primary outcome was weight change at 12-week follow-up. Several measures of adherence were also used, including 24 h total urine collections. 41 participants were randomized to the intervention group and 43 to the comparator group. The water preloading group lost -1.3 kg (95% CI -2.4 to -0.1, P = 0.028) more than comparators at follow up. Adjusting for ethnicity, deprivation, age, and gender resulted in the intervention group losing -1.2 kg (95% CI -2.4 to 0.07, P = 0.063) more than the comparator. There is preliminary evidence that water preloading before main meals leads to a moderate weight loss at follow up. ISRCTN33238158. © 2015 The Obesity Society.

Association Splitting: A randomized controlled trial of a new method to reduce craving among inpatients with alcohol dependence.

PubMed

Schneider, Brooke C; Moritz, Steffen; Hottenrott, Birgit; Reimer, Jens; Andreou, Christina; Jelinek, Lena

2016-04-30

Association Splitting, a novel cognitive intervention, was tested in patients with alcohol dependence as an add-on intervention in an initial randomized controlled trial. Preliminary support for Association Splitting has been found in patients with obsessive-compulsive disorder, as well as in an online pilot study of patients with alcohol use disorders. The present variant sought to reduce craving by strengthening neutral associations with alcohol-related stimuli, thus, altering cognitive networks. Eighty-four inpatients with verified diagnoses of alcohol dependence, who were currently undergoing inpatient treatment, were randomly assigned to Association Splitting or Exercise Therapy. Craving was measured at baseline, 4-week follow-up, and six months later with the Obsessive-Compulsive Drinking Scale (primary outcome) and the Alcohol Craving Questionnaire. There was no advantage for Association Splitting after three treatment sessions relative to Exercise Therapy. Among Association Splitting participants, 51.9% endorsed a subjective decline in craving and 88.9% indicated that they would use Association Splitting in the future. Despite high acceptance, an additional benefit of Association Splitting beyond standard inpatient treatment was not found. Given that participants were concurrently undergoing inpatient treatment and Association Splitting has previously shown moderate effects, modification of the study design may improve the potential to detect significant effects in future trials. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

A first-in-human, randomized, controlled, subject- and reviewer-blinded multicenter study of Actamax™ Adhesion Barrier.

PubMed

Trew, Geoffrey H; Pistofidis, George A; Brucker, Sara Y; Krämer, Bernhard; Ziegler, Nicole M; Korell, Matthias; Ritter, Henning; McConnachie, Alex; Ford, Ian; Crowe, Alison M; Estridge, Trudy D; Diamond, Michael P; De Wilde, Rudy L

2017-02-01

Post-surgical adhesions remain a significant concern following abdominopelvic surgery. This study was to assess safety, manageability and explore preliminary efficacy of applying a degradable hydrogel adhesion barrier to areas of surgical trauma following gynecologic laparoscopic abdominopelvic surgery. This first-in-human, prospective, randomized, multicenter, subject- and reviewer-blinded clinical study was conducted in 78 premenopausal women (18-46 years) wishing to maintain fertility and undergoing gynecologic laparoscopic abdominopelvic surgery with planned clinically indicated second-look laparoscopy (SLL) at 4-12 weeks. The first two patients of each surgeon received hydrogel, up to 30 mL sprayed over all sites of surgical trauma, and were assessed for safety and application only (n = 12). Subsequent subjects (n = 66) were randomized 1:1 to receive either hydrogel (Treatment, n = 35) or not (Control, n = 31); 63 completed the SLL. No adverse event was assessed as serious, or possibly device related. None was severe or fatal. Adverse events were reported for 17 treated subjects (17/47, 36.2%) and 13 Controls (13/31, 41.9%). For 95.7% of treated subjects, surgeons found the device "easy" or "very easy" to use; in 54.5%, some residual material was evident at SLL. For 63 randomized subjects who completed the SLL, adjusted between-group difference in the change from baseline adhesion score demonstrated a 41.4% reduction for Treatment compared with Controls (p = 0.017), with a 49.5% reduction (p = 0.008) among myomectomy subjects (n = 34). Spray application of a degradable hydrogel adhesion barrier during gynecologic laparoscopic abdominopelvic surgery was performed easily and safely, without evidence of clinically significant adverse outcomes. Data suggest the hydrogel was effective in reducing postoperative adhesion development, particularly following myomectomy.

A yoga intervention for type 2 diabetes risk reduction: a pilot randomized controlled trial.

PubMed

McDermott, Kelly A; Rao, Mohan Raghavendra; Nagarathna, Raghuram; Murphy, Elizabeth J; Burke, Adam; Nagendra, Ramarao Hongasandra; Hecht, Frederick M

2014-07-01

Type 2 diabetes is a major health problem in many countries including India. Yoga may be an effective type 2 diabetes prevention strategy in India, particularly given its cultural familiarity. This was a parallel, randomized controlled pilot study to collect feasibility and preliminary efficacy data on yoga for diabetes risk factors among people at high risk of diabetes. Primary outcomes included: changes in BMI, waist circumference, fasting blood glucose, postprandial blood glucose, insulin, insulin resistance, blood pressure, and cholesterol. We also looked at measures of psychological well-being including changes in depression, anxiety, positive and negative affect and perceived stress. Forty-one participants with elevated fasting blood glucose in Bangalore, India were randomized to either yoga (n = 21) or a walking control (n = 20). Participants were asked to either attend yoga classes or complete monitored walking 3-6 days per week for eight weeks. Randomization and allocation was performed using computer-generated random numbers and group assignments delivered in sealed, opaque envelopes generated by off-site study staff. Data were analyzed based on intention to treat. This study was feasible in terms of recruitment, retention and adherence. In addition, yoga participants had significantly greater reductions in weight, waist circumference and BMI versus control (weight -0.8 ± 2.1 vs. 1.4 ± 3.6, p = 0.02; waist circumference -4.2 ± 4.8 vs. 0.7 ± 4.2, p < 0.01; BMI -0.2 ± 0.8 vs. 0.6 ± 1.6, p = 0.05). There were no between group differences in fasting blood glucose, postprandial blood glucose, insulin resistance or any other factors related to diabetes risk or psychological well-being. There were significant reductions in systolic and diastolic blood pressure, total cholesterol, anxiety, depression, negative affect and perceived stress in both the yoga intervention and walking control over the course of the study. Among Indians with elevated fasting blood glucose, we found that participation in an 8-week yoga intervention was feasible and resulted in greater weight loss and reduction in waist circumference when compared to a walking control. Yoga offers a promising lifestyle intervention for decreasing weight-related type 2 diabetes risk factors and potentially increasing psychological well-being. ClinicalTrials.gov Identified NCT00090506.

Biofeedback assisted control of respiratory sinus arrhythmia as a biobehavioral intervention for depressive symptoms in patients after cardiac surgery: a preliminary study.

PubMed

Patron, Elisabetta; Messerotti Benvenuti, Simone; Favretto, Giuseppe; Valfrè, Carlo; Bonfà, Carlotta; Gasparotto, Renata; Palomba, Daniela

2013-03-01

The current study investigated whether biofeedback training aimed at increasing respiratory sinus arrhythmia (RSA), a measure of cardiac vagal modulation, can reduce depressive symptoms in patients after cardiac surgery. This randomized controlled study enrolled 26 patients after first-time cardiac surgery. The patients were randomly assigned to an RSA-biofeedback group (N = 13) or to a treatment as usual group (N = 13). The biofeedback training consisted of five 45 min sessions designed to increase RSA. The outcome was assessed as changes in RSA and in the Centre for Epidemiologic Studies of Depression (CES-D) values from pre- to post-training. Both groups were comparable for demographic and biomedical characteristics. RSA increased significantly in patients who underwent RSA-biofeedback compared to controls. Moreover, the CES-D scores were reduced significantly from pre- to post-training in the RSA-biofeedback group compared to the controls. Changes in RSA were inversely related to changes in CES-D scores from pre- to post-training. These findings extend the effectiveness of RSA-biofeedback for increasing vagal modulation as well as for reducing depressive symptoms in post-surgical patients. Overall, the current study also suggests that this biobehavioral intervention may add to the efficacy of postoperative risk reduction programs and rehabilitation protocols in cardiac surgery patients.

A Pilot Randomized Controlled Trial of a New Supplementary Food Designed to Enhance Cognitive Performance during Prevention and Treatment of Malnutrition in Childhood.

PubMed

Roberts, Susan B; Franceschini, Maria Angela; Krauss, Amy; Lin, Pei-Yi; de Sa, Augusto Braima; Có, Raimundo; Taylor, Salima; Brown, Carrie; Chen, Oliver; Johnson, Elizabeth J; Pruzensky, William; Schlossman, Nina; Balé, Carlito; Wu, Kuan-Cheng Tony; Hagan, Katherine; Saltzman, Edward; Muentener, Paul

2017-11-01

Cognitive impairment associated with childhood malnutrition and stunting is generally considered irreversible. The aim was to test a new nutritional supplement for the prevention and treatment of moderate-acute malnutrition (MAM) focused on enhancing cognitive performance. An 11-wk, village-randomized, controlled pilot trial was conducted in 78 children aged 1-3 or 5-7 y living in villages in Guinea-Bissau. The supplement contained 291 kcal/d for young children and 350 kcal/d for older children and included 5 nutrients and 2 flavan-3-ol-rich ingredients not present in current food-based recommendations for MAM. Local bakers prepared the supplement from a combination of locally sourced items and an imported mix of ingredients, and it was administered by community health workers 5 d/wk. The primary outcome was executive function abilities at 11 wk. Secondary outcomes included additional cognitive measures and changes in z scores for weight (weight-for-age) and height (height-for-age) and hemoglobin concentrations at 11 wk. An index of cerebral blood flow (CBF) was also measured at 11 wk to explore the use of this measurement as a biological index of cognitive impairment. There were no significant differences in any outcome between groups at baseline. There was a beneficial effect of random assignment to the supplement group on working memory at 11 wk in children aged 1-3 y ( P < 0.05). This difference contrasted with no effect in older children and was not associated with faster growth rate. In addition, CBF correlated with task-switching performance ( P < 0.05). These preliminary data suggest that cognitive impairment can be monitored with measurement of CBF. In addition, the findings provide preliminary data that suggest that it may be possible to improve poor cognitive performance in young children through changes in the nutritional formulation of supplementary foods used to prevent and treat MAM. Powered studies of the new supplement formulation are needed. This trial was registered at clinicaltrials.gov as NCT03017209.

Six-month exercise training program to treat post-thrombotic syndrome: a randomized controlled two-centre trial

PubMed Central

Kahn, Susan R.; Shrier, Ian; Shapiro, Stan; Houweling, Adrielle H.; Hirsch, Andrew M.; Reid, Robert D.; Kearon, Clive; Rabhi, Khalil; Rodger, Marc A.; Kovacs, Michael J.; Anderson, David R.; Wells, Philip S.

2011-01-01

Background Exercise training may have the potential to improve post-thrombotic syndrome, a frequent, chronic complication of deep venous thrombosis. We conducted a randomized controlled two-centre pilot trial to assess the feasibility of a multicentre-based evaluation of a six-month exercise training program to treat post-thrombotic syndrome and to obtain preliminary data on the effectiveness of such a program. Methods Patients were randomized to receive exercise training (a six-month trainer-supervised program) or control treatment (an education session with monthly phone follow-ups). Levels of eligibility, consent, adherence and retention were used as indicators of study feasibility. Primary outcomes were change from baseline to six months in venous disease-specific quality of life (as measured using the Venous Insufficiency Epidemiological and Economic Study Quality of Life [VEINES-QOL] questionnaire) and severity of post-thrombotic syndrome (as measured by scores on the Villalta scale) in the exercise training group versus the control group, assessed by t tests. Secondary outcomes were change in generic quality of life (as measured using the Short-Form Health Survey-36 [SF-36] questionnaire), category of severity of post-thrombotic syndrome, leg strength, leg flexibility and time on treadmill. Results Of 95 patients with post-thrombotic syndrome, 69 were eligible, 43 consented and were randomized, and 39 completed the study. Exercise training was associated with improvement in VEINES-QOL scores (exercise training mean change 6.0, standard deviation [SD] 5.1 v. control mean change 1.4, SD 7.2; difference 4.6, 95% CI 0.54 to 8.7; p = 0.027) and improvement in scores on the Villalta scale (exercise training mean change −3.6, SD 3.7 v. control mean change −1.6, SD 4.3; difference −2.0, 95% CI −4.6 to 0.6; p = 0.14). Most secondary outcomes also showed greater improvement in the exercise training group. Interpretation Exercise training may improve post-thrombotic syndrome. It would be feasible to definitively evaluate exercise training as a treatment for post-thrombotic syndrome in a large multicentre trial. PMID:21098066

Combined effects of cerebellar transcranial direct current stimulation and transcutaneous spinal direct current stimulation on robot-assisted gait training in patients with chronic brain stroke: A pilot, single blind, randomized controlled trial.

PubMed

Picelli, Alessandro; Chemello, Elena; Castellazzi, Paola; Filippetti, Mirko; Brugnera, Annalisa; Gandolfi, Marialuisa; Waldner, Andreas; Saltuari, Leopold; Smania, Nicola

2018-01-01

Preliminary evidence showed additional effects of anodal transcranial direct current stimulation over the damaged cerebral hemisphere combined with cathodal transcutaneous spinal direct current stimulation during robot-assisted gait training in chronic stroke patients. This is consistent with the neural organization of locomotion involving cortical and spinal control. The cerebellum is crucial for locomotor control, in particular for avoidance of obstacles, and adaptation to novel conditions during walking. Despite its key role in gait control, to date the effects of transcranial direct current stimulation of the cerebellum have not been investigated on brain stroke patients treated with robot-assisted gait training. To evaluate the effects of cerebellar transcranial direct current stimulation combined with transcutaneous spinal direct current stimulation on robot-assisted gait training in patients with chronic brain stroke. After balanced randomization, 20 chronic stroke patients received ten, 20-minute robot-assisted gait training sessions (five days a week, for two consecutive weeks) combined with central nervous system stimulation. Group 1 underwent on-line cathodal transcranial direct current stimulation over the contralesional cerebellar hemisphere + cathodal transcutaneous spinal direct current stimulation. Group 2 received on-line anodal transcranial direct current stimulation over the damaged cerebral hemisphere + cathodal transcutaneous spinal direct current stimulation. The primary outcome was the 6-minute walk test performed before, after, and at follow-up at 2 and 4 weeks post-treatment. The significant differences in the 6-minute walk test noted between groups at the first post-treatment evaluation (p = 0.041) were not maintained at either the 2-week (P = 0.650) or the 4-week (P = 0.545) follow-up evaluations. Our preliminary findings support the hypothesis that cathodal transcranial direct current stimulation over the contralesional cerebellar hemisphere in combination with cathodal transcutaneous spinal direct current stimulation might be useful to boost the effects of robot-assisted gait training in chronic brain stroke patients with walking impairment.

Preliminary efficacy and feasibility of embedding high intensity interval training into the school day: A pilot randomized controlled trial.

PubMed

Costigan, S A; Eather, N; Plotnikoff, R C; Taaffe, D R; Pollock, E; Kennedy, S G; Lubans, D R

2015-01-01

Current physical activity and fitness levels among adolescents are low, increasing the risk of chronic disease. Although the efficacy of high intensity interval training (HIIT) for improving metabolic health is now well established, it is not known if this type of activity can be effective to improve adolescent health. The primary aim of this study is to assess the effectiveness and feasibility of embedding HIIT into the school day. A 3-arm pilot randomized controlled trial was conducted in one secondary school in Newcastle, Australia. Participants (n = 65; mean age = 15.8(0.6) years) were randomized into one of three conditions: aerobic exercise program (AEP) (n = 21), resistance and aerobic exercise program (RAP) (n = 22) and control (n = 22). The 8-week intervention consisted of three HIIT sessions per week (8-10 min/session), delivered during physical education (PE) lessons or at lunchtime. Assessments were conducted at baseline and post-intervention to detect changes in cardiorespiratory fitness (multi-stage shuttle-run), muscular fitness (push-up, standing long jump tests), body composition (Body Mass Index (BMI), BMI-z scores, waist circumference) and physical activity motivation (questionnaire), by researchers blinded to treatment allocation. Intervention effects for outcomes were examined using linear mixed models, and Cohen's d effect sizes were reported. Participants in the AEP and RAP groups had moderate intervention effects for waist circumference (p = 0.024), BMI-z (p = 0.037) and BMI (not significant) in comparison to the control group. A small intervention effect was also evident for cardiorespiratory fitness in the RAP group.

Self-efficacy program to prevent osteoporosis among Chinese immigrants: a randomized controlled trial.

PubMed

Qi, Bing-Bing; Resnick, Barbara; Smeltzer, Suzanne C; Bausell, Barker

2011-01-01

: Recent Chinese immigrants have a low bone mineral density and are at a great risk for developing osteoporosis. The majority of Chinese men and women of all ages have inadequate information about their risks for developing osteoporosis and are seldom involved in preventive activities. : The aim of this study was to evaluate the preliminary effectiveness of an educational intervention based on the self-efficacy theory aimed at increasing the knowledge of osteoporosis and adoption of preventive behaviors, including regular exercise and osteoporosis medication adherence, designed for Chinese immigrants, aged 45 years or above, living in the United States. : A randomized controlled trial was employed, using a repeated-measure design. Foreign-born Mandarin-speaking Asians (n = 110) were recruited to the study, and 83 of them (mean age = 64.08 years, SD = 9.48 years) were assigned randomly to either the intervention group (n = 42) or the attention control group (n = 41). There were 63 (75.9%) women and 20 (24.1%) men. Data were collected at baseline and 2 weeks after the intervention. : The participants who received the intervention had statistically significant improvements (p < .05) at 2 weeks postintervention with respect to osteoporosis-related knowledge, self-efficacy for exercise, and osteoporosis medication adherence. Moreover, the participants in the treatment group spent more time on moderate exercise, had higher energy expenditure on exercise, and had more osteoporosis medication use at 2 weeks postintervention when compared with controls. : The intervention targeting Mandarin-speaking immigrants was effective in increasing the knowledge of osteoporosis and improving the adoption of preventive behaviors. Future research is needed to explore the long-term effect of this intervention on bone health behavior.

The impact of metformin, oral contraceptives, and lifestyle modification on polycystic ovary syndrome in obese adolescent women in two randomized, placebo-controlled clinical trials.

PubMed

Hoeger, Kathleen; Davidson, Kristen; Kochman, Lynda; Cherry, Tracy; Kopin, Laurie; Guzick, David S

2008-11-01

Polycystic ovary syndrome (PCOS) presents in adolescence, and obesity is a common finding. The benefits and risks of alternate approaches to the management of PCOS in obese adolescent women are not clear. We investigated the effects of metformin, oral contraceptives (OCs), and/or lifestyle modification in obese adolescent women with PCOS. Two small, randomized, placebo-controlled clinical trials were performed. A total of 79 obese adolescent women with PCOS participated. In the single treatment trial, subjects were randomized to metformin, placebo, a lifestyle modification program, or OC. In the combined treatment trial, all subjects received lifestyle modification and OC and were randomized to metformin or placebo. Serum concentrations of androgens and lipids were measured. Lifestyle modification alone resulted in a 59% reduction in free androgen index with a 122% increase in SHBG. OC resulted in a significant decrease in total testosterone (44%) and free androgen index (86%) but also resulted in an increase in C-reactive protein (39.7%) and cholesterol (14%). The combination of lifestyle modification, OC, and metformin resulted in a 55% decrease in total testosterone, as compared to 33% with combined treatment and placebo, a 4% reduction in waist circumference, and a significant increase in HDL (46%). In these preliminary trials, both lifestyle modification and OCs significantly reduce androgens and increase SHBG in obese adolescents with PCOS. Metformin, in combination with lifestyle modification and OC, reduces central adiposity, reduces total testosterone, and increases HDL, but does not enhance overall weight reduction.

Review of Yoga Therapy During Cancer Treatment

PubMed Central

Danhauer, Suzanne C.; Addington, Elizabeth L.; Sohl, Stephanie J.; Chaoul, Alejandro; Cohen, Lorenzo

2017-01-01

Purpose Reviews of yoga research that distinguish results of trials conducted during (versus after) cancer treatment are needed to guide future research and clinical practice. We therefore conducted a review of non-randomized studies and randomized controlled trials of yoga interventions for children and adults undergoing treatment for any cancer type. Methods Studies were identified via research databases and reference lists. Inclusion criteria: (1) children or adults undergoing cancer treatment; (2) intervention stated as yoga or component of yoga; and (3) publication in English in peer-reviewed journals through October 2015. Exclusion criteria: (1) samples receiving hormone therapy only; (2) interventions involving only meditation; and (3) yoga delivered within broader cancer recovery or mindfulness-based stress reduction programs. Results Results of non-randomized (adult: n=8, pediatric: n=4) and randomized controlled trials (adult: n=13, pediatric: n=0) conducted during cancer treatment are summarized separately by age group. Findings most consistently support improvement in psychological outcomes (e.g., depression, distress, anxiety). Several studies also found that yoga enhanced quality of life, though further investigation is needed to clarify domain-specific efficacy (e.g., physical, social, cancer-specific). Regarding physical and biomedical outcomes, evidence increasingly suggests that yoga ameliorates sleep and fatigue; additional research is needed to advance preliminary findings for other treatment sequelae and stress/immunity biomarkers. Conclusions Among adults undergoing cancer treatment, evidence supports recommending yoga for improving psychological outcomes, with potential for also improving physical symptoms. Evidence is insufficient to evaluate the efficacy of yoga in pediatric oncology. We describe suggestions for strengthening yoga research methodology to inform clinical practice guidelines. PMID:28064385

Cognitive enhancement treatments for bipolar disorder: A systematic review and methodological recommendations.

PubMed

Miskowiak, Kamilla W; Carvalho, André F; Vieta, Eduard; Kessing, Lars V

2016-10-01

Cognitive dysfunction is an emerging treatment target in bipolar disorder (BD). Several trials have assessed the efficacy of novel pharmacological and psychological treatments on cognition in BD but the findings are contradictory and unclear. A systematic search following the PRISMA guidelines was conducted on PubMed and PsychInfo. Eligible articles reported randomized, controlled or open-label trials investigating pharmacological or psychological treatments targeting cognitive dysfunction in BD. The quality of the identified randomized controlled trials (RCTs) was evaluated with the Cochrane Collaboration's Risk of Bias tool. We identified 19 eligible studies of which 13 were RCTs and six were open-label or non-randomized studies. The findings regarding efficacy on cognition were overall disappointing or preliminary, possibly due to several methodological challenges. For the RCTs, the risk of bias was high in nine cases, unclear in one case and low in three cases. Key reasons for the high risk of bias were lack of details on the randomization process, suboptimal handling of missing data and lack of a priori priority between cognition outcomes. Other challenges were the lack of consensus on whether and how to screen for cognitive impairment and on how to assess efficacy on cognition. In conclusion, methodological problems are likely to impede the success rates of cognition trials in BD. We recommend adherence to the CONSORT guidelines for RCTs, screening for cognitive impairment before inclusion of trial participants and selection of one primary cognition outcome. Future implementation of a 'neurocircuitry-based' biomarker model to evaluate neural target engagement is warranted. Copyright © 2016 Elsevier B.V. and ECNP. All rights reserved.

A randomized pilot trial of a videoconference couples communication intervention for advanced GI cancer.

PubMed

Porter, Laura S; Keefe, Francis J; Baucom, Donald H; Olsen, Maren; Zafar, S Yousuf; Uronis, Hope

2017-07-01

This study aims to test the feasibility and preliminary efficacy of a couple-based communication intervention for advanced GI cancer delivered via videoconference. Thirty-two couples were randomly assigned to either couples communication skills training (CCST) or an education comparison intervention, both delivered via videoconference. Participation was limited to couples who reported communication difficulties at screening. Patients and partners completed measures of relationship functioning and individual functioning at baseline and post-intervention. Eighty-eight percent of randomized dyads completed all six sessions and reported high levels of satisfaction with the intervention. Between-group effect sizes suggested that the CCST intervention led to improvements in relationship satisfaction for patients and partners and to improvements in intimacy and communication for patients. A couples-based communication intervention delivered via videoconference is feasible and acceptable in the context of advanced cancer. Preliminary findings suggest that the intervention shows promise in contributing to enhanced relationship functioning. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Meta-analysis of technology-assisted interventions for social anxiety disorder.

PubMed

Kampmann, Isabel L; Emmelkamp, Paul M G; Morina, Nexhmedin

2016-08-01

This meta-analysis investigated the efficacy of technology-assisted interventions for individuals with social anxiety disorder (SAD). A systematic literature search in the databases Medline, PsychInfo, and Web of Science revealed 37 randomized controlled trials (2991 participants) that were grouped into internet delivered cognitive behavior therapy (ICBT; 21 trials), virtual reality exposure therapy (VRET; 3 trials), and cognitive bias modification (CBM; 13 trials). Patients undergoing ICBT and VRET showed significantly less SAD symptoms at postassessment than passive control conditions (g=0.84 and 0.82, respectively). Compared to active control conditions, ICBT had a small advantage (g=0.38) and VRET showed comparable effects (p>0.05). CBM was not more effective than passive control conditions, except when delivered in the laboratory (g=0.35). While the efficacy of CBM was limited, substantial evidence for ICBT and preliminary evidence for VRET suggests that both can effectively reduce SAD symptoms indicating the potential of technology-assisted interventions for SAD. Copyright © 2016 Elsevier Ltd. All rights reserved.

Social problem-solving plus psychoeducation for adults with personality disorder: pragmatic randomised controlled trial.

PubMed

Huband, Nick; McMurran, Mary; Evans, Chris; Duggan, Conor

2007-04-01

Social problem-solving therapy may be relevant in the treatment of personality disorder, although assessments of its effectiveness are uncommon. To determine the effectiveness of a problem-solving intervention for adults with personality disorder in the community under conditions resembling routine clinical practice. Participants were randomly allocated to brief psychoeducation plus 16 problem-solving group sessions (n=87) or to waiting-list control (n=89). Primary outcome was comparison of scores on the Social Problem Solving Inventory and the Social Functioning Questionnaire between intervention and control arms at the conclusion of treatment, on average at 24 weeks after randomisation. In intention-to-treat analysis, those allocated to intervention showed significantly better problem-solving skills (P<0.001), higher overall social functioning (P=0.031) and lower anger expression (P=0.039) compared with controls. No significant differences were found on use of services during the intervention period. Problem-solving plus psychoeducation has potential as a preliminary intervention for adults with personality disorder.

A randomized controlled trial of smartphone-based mindfulness training for smoking cessation: a study protocol.

PubMed

Garrison, Kathleen A; Pal, Prasanta; Rojiani, Rahil; Dallery, Jesse; O'Malley, Stephanie S; Brewer, Judson A

2015-04-14

Tobacco use is responsible for the death of about 1 in 10 individuals worldwide. Mindfulness training has shown preliminary efficacy as a behavioral treatment for smoking cessation. Recent advances in mobile health suggest advantages to smartphone-based smoking cessation treatment including smartphone-based mindfulness training. This study evaluates the efficacy of a smartphone app-based mindfulness training program for improving smoking cessation rates at 6-months follow-up. A two-group parallel-randomized clinical trial with allocation concealment will be conducted. Group assignment will be concealed from study researchers through to follow-up. The study will be conducted by smartphone and online. Daily smokers who are interested in quitting smoking and own a smartphone (n = 140) will be recruited through study advertisements posted online. After completion of a baseline survey, participants will be allocated randomly to the control or intervention group. Participants in both groups will receive a 22-day smartphone-based treatment program for smoking. Participants in the intervention group will receive mobile mindfulness training plus experience sampling. Participants in the control group will receive experience sampling-only. The primary outcome measure will be one-week point prevalence abstinence from smoking (at 6-months follow-up) assessed using carbon monoxide breath monitoring, which will be validated through smartphone-based video chat. This is the first intervention study to evaluate smartphone-based delivery of mindfulness training for smoking cessation. Such an intervention may provide treatment in-hand, in real-world contexts, to help individuals quit smoking. Clinicaltrials.gov NCT02134509 . Registered 7 May 2014.

Low-Dose Oral Sirolimus and the Risk of Menstrual-Cycle Disturbances and Ovarian Cysts: Analysis of the Randomized Controlled SUISSE ADPKD Trial

PubMed Central

Braun, Matthias; Young, James; Reiner, Cäcilia S.; Poster, Diane; Krauer, Fabienne; Kistler, Andreas D.; Kristanto, Paulus; Wang, Xueqi; Liu, Yang; Loffing, Johannes; Andreisek, Gustav; von Eckardstein, Arnold; Senn, Oliver; Wüthrich, Rudolf P.; Serra, Andreas L.

2012-01-01

Sirolimus has been approved for clinical use in non proliferative and proliferative disorders. It inhibits the mammalian target of rapamycin (mTOR) signaling pathway which is also known to regulate ovarian morphology and function. Preliminary observational data suggest the potential for ovarian toxicity but this issue has not been studied in randomized controlled trials. We reviewed the self-reported occurrence of menstrual cycle disturbances and the appearance of ovarian cysts post hoc in an open label randomized controlled phase II trial conducted at the University Hospital Zürich between March 2006 and March 2010. Adult females with autosomal dominant polycystic kidney disease, an inherited kidney disease not known to affect ovarian morphology and function, were treated with 1.3 to 1.5 mg sirolimus per day for a median of 19 months (N = 21) or standard care (N = 18). Sirolimus increased the risk of both oligoamenorrhea (hazard ratio [HR] 4.3, 95% confidence interval [CI] 1.1 to 29) and ovarian cysts (HR 4.4, CI 1.1 to 26); one patient was cystectomized five months after starting treatment with sirolimus. We also studied mechanisms of sirolimus-associated ovarian toxicity in rats. Sirolimus amplified signaling in rat ovarian follicles through the pro-proliferative phosphatidylinositol 3-kinase pathway. Low dose oral sirolimus increases the risk of menstrual cycle disturbances and ovarian cysts and monitoring of sirolimus-associated ovarian toxicity is warranted and might guide clinical practice with mammalian target of rapamycin inhibitors. Trial Registration ClinicalTrials.gov NCT00346918 PMID:23071528

Omega-3 (ω-3) and social skills interventions for reactive aggression and childhood externalizing behavior problems: a randomized, stratified, double-blind, placebo-controlled, factorial trial.

PubMed

Raine, Adrian; Ang, Rebecca P; Choy, Olivia; Hibbeln, Joseph R; Ho, Ringo M-H; Lim, Choon Guan; Lim-Ashworth, Nikki S J; Ling, Shichun; Liu, Jean C J; Ooi, Yoon Phaik; Tan, Yi Ren; Fung, Daniel S S

2018-05-10

While studies suggest that nutritional supplementation may reduce aggressive behavior in children, few have examined their effects on specific forms of aggression. This study tests the primary hypothesis that omega-3 (ω-3), both alone and in conjunction with social skills training, will have particular post-treatment efficacy for reducing childhood reactive aggression relative to baseline. In this randomized, double-blind, stratified, placebo-controlled, factorial trial, a clinical sample of 282 children with externalizing behavior aged 7-16 years was randomized into ω-3 only, social skills only, ω-3 + social skills, and placebo control groups. Treatment duration was 6 months. The primary outcome measure was reactive aggression collected at 0, 3, 6, 9, and 12 months, with antisocial behavior as a secondary outcome. Children in the ω-3-only group showed a short-term reduction (at 3 and 6 months) in self-report reactive aggression, and also a short-term reduction in overall antisocial behavior. Sensitivity analyses and a robustness check replicated significant interaction effects. Effect sizes (d) were small, ranging from 0.17 to 0.31. Findings provide some initial support for the efficacy of ω-3 in reducing reactive aggression over and above standard care (medication and parent training), but yield only preliminary and limited support for the efficacy of ω-3 in reducing overall externalizing behavior in children. Future studies could test further whether ω-3 shows promise in reducing more reactive, impulsive forms of aggression.

A pilot randomized controlled trial of the Occupational Goal Intervention method for the improvement of executive functioning in patients with treatment-resistant schizophrenia.

PubMed

Vizzotto, Adriana D B; Celestino, Diego L; Buchain, Patricia C; Oliveira, Alexandra M; Oliveira, Graça M R; Di Sarno, Elaine S; Napolitano, Isabel C; Elkis, Helio

2016-11-30

Schizophrenia is a chronic disabling mental disorder that involves impairments in several cognitive domains, especially in executive functions (EF), as well as impairments in functional performance. This is particularly true in patients with Treatment-Resistant Schizophrenia (TRS). The aim of this study was to test the efficacy of the Occupational Goal Intervention (OGI) method for the improvement of EF in patients with TRS. In this randomized, controlled, single-blind pilot study, 25 TRS patients were randomly assigned to attend 30 sessions of either OGI or craft activities (control) over a 15-week period and evaluated by the Behavioural Assessment of the Dysexecutive Syndrome (BADS) as the primary outcome and the Direct Assessment of Functional Status (DAFS-BR) as well as the Independent Living Skills Survey (ILSS-BR) as secondary outcomes, all adapted for the Brazilian population. The Positive and Negative Syndrome Scale (PANSS) was used for monitoring symptom severity. Results showed significant statistical differences, favoring the OGI group in terms of improvement on the BADS, both in subtests (Action Program and Key Search) and the total score. Improvements in EFs were observed by families in various dimensions as measured by different subtests of the ILSS-BR inventory. The OGI group showed no significant results in secondary outcomes (DAFS-BR) except in terms of improvement of communication skills. Although preliminary, our results indicate that the OGI method is efficacious and effective for patients with TRS. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Beneficial effects of an investigational wristband containing Synsepalum dulcificum (miracle fruit) seed oil on the performance of hand and finger motor skills in healthy subjects: A randomized controlled preliminary study.

PubMed

Gorin, Steven; Wakeford, Charles; Zhang, Guodong; Sukamtoh, Elvira; Matteliano, Charles Joseph; Finch, Alfred Earl

2018-02-01

Miracle fruit (Synsepalum dulcificum) seed oil (MFSO) contains phytochemicals and nutrients reported to affect musculoskeletal performance. The purpose of this study was to assess the safety and efficacy of a compression wristband containing MFSO on its ability to measurably improve the hand and finger motor skills of participants. Healthy right-handed participants (n = 38) were randomized in this double-blind, placebo-controlled study of MFSO and vehicle wristbands. Subjects wore the wristband on their left hand 4-6 weeks and then only on their right hand 2-4 weeks; the contralateral untreated hand served as an additional control. Twelve hand/finger motor skills were measured using quantitative bio-instrumentation tests, and subject self-assessment questionnaires were conducted. With each hand, in 9/12 tests, the MFSO group showed a clinically meaningful average improvement compared with an average worsening in the vehicle group. Statistical superiority to the control treatment group was exhibited in 9/12 tests for each hand (p < .01). After discontinuing the MFSO wristband on the left hand, test values regressed toward baseline levels. Subjects favored the MFSO wristband over the control, rating it as effective in improving their motor skills. Use of the MFSO wristband may improve an individual's manual dexterity skills and ability to maintain this performance. Copyright © 2017 The Authors Phytotherapy Research Published by John Wiley & Sons Ltd.

Integrating virtual reality with activity management for the treatment of fibromyalgia: acceptability and preliminary efficacy.

PubMed

Garcia-Palacios, Azucena; Herrero, Rocio; Vizcaíno, Yolanda; Belmonte, Miguel A; Castilla, Diana; Molinari, Guadalupe; Baños, Rosa Maria; Botella, Cristina

2015-06-01

Cognitive-behavioral therapies (CBT) for fibromyalgia syndrome (FMS) are important interventions in the management of this condition. Empirical evidence reports that although the results are promising, further research is needed to respond more appropriately to these patients. This study focuses on exploring the use of Virtual Reality (VR) as an adjunct to the activity management component. The aim of this study is to present the results of a small-sized randomized controlled trial to test the preliminary efficacy and acceptability of this component. The final sample was composed of 61 women diagnosed with FMS according to the American College of Rheumatology. The sample was randomly allocated to 2 conditions: VR treatment and treatment as usual. Participants in the VR condition achieved significant improvements in the primary outcome: disability measured with the FIQ. The improvement was also significant in secondary outcomes, such as perceived quality of life and some of the coping strategies included in the Chronic Pain Coping Inventory: task persistence and exercise. There were no differences in other secondary outcome measures like pain intensity and interference and depression. Participants reported high satisfaction with the VR component. The effects were related to the psychological aspects targeted in the treatment. The component was well accepted by FMS patients referred from a public hospital. These findings show that the VR component could be useful in the CBT treatment of FMS and encourage us to continue exploring the use of integrating VR with CBT interventions for the treatment of FMS.

Benefit-finding intervention for Alzheimer caregivers: conceptual framework, implementation issues, and preliminary efficacy.

PubMed

Cheng, Sheung-Tak; Lau, Rosanna W L; Mak, Emily P M; Ng, Natalie S S; Lam, Linda C W

2014-12-01

To describe an intervention promoting benefit-finding in Alzheimer caregivers, to discuss key issues in implementation and ways to resolve them, and to examine whether the intervention reduced burden and depression in a small randomized trial. Twenty-five caregivers were randomized into benefit-finding and psychoeducation groups. Both groups had eight weekly sessions. Outcome measures including role overload, Zarit Burden Interview, and Hamilton depression scale were collected at baseline and after treatment. Results were analyzed using analysis of covariance. Additionally, the challenges of implementing such interventions, some of which related to cultural issues, were analyzed qualitatively. Controlling for pretest, the benefit-finding group had lower depression than the psychoeducation group at post-test, despite the fact that some caregivers found benefit-finding challenging. The two groups did not differ on overload and burden. However, within-group analysis suggested that both groups showed significant reductions in overload from pretest to post-test. In addition, we discussed participants' difficulties in grasping the technique of thought modification for benefit-finding, recording such exercises at home, and sharing their thoughts and experiences in groups. We described measures undertaken in the main trial to overcome these issues. Cognitive approaches focusing on benefit-finding are feasible among Chinese caregivers, with preliminary evidence suggesting an effect on alleviating depression. © The Author 2014. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Monitoring stimulated cycles during in vitro fertilization treatment with ultrasound only--preliminary results.

PubMed

Wiser, Amir; Gonen, Ofer; Ghetler, Yehudit; Shavit, Tal; Berkovitz, Arie; Shulman, Adrian

2012-06-01

To evaluate if monitoring patients by ultrasound (US) only during in vitro fertilization (IVF) treatment is safe. Randomized prospective study. Patients undergoing their first IVF treatment were randomized into two groups. The ultrasound only group (study group) was monitored by US for follicle size and endometrial thickness without blood tests. In this group, only one blood test was taken before human chorionic gonadotropin (hCG) injection, to ensure a safe level of estradiol (E(2)) regarding ovarian hyperstimulation syndrome (OHSS) risk. The control group was monitored by ultrasound plus serum estradiol and progesterone concentration at each visit. Clinical pregnancy rate. No differences were found between the groups in the parameters of IVF treatment, induction days, number of ampoules, E(2) level of hCG, as well as embryo quality. The clinical pregnancy rate was not statistically different between the groups, 57.5% vs. 40.0%, respectively (p = 0.25). No OHSS cases were found among the study or control groups. Ultrasound as a single monitoring tool for IVF cycles is reliable, safe, patient friendly, and reduces treatment expenses. In an era of cost effectiveness awareness, this regimen should be considered for routine management in IVF programs.

Optimal therapy and prospects for new medicines in eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome).

PubMed

Pagnoux, Christian; Groh, Matthieu

2016-10-01

The prevalence of eosinophilic granulomatosis with polyangiitis (EGPA; previously known as Churg-Strauss syndrome) is lower than that of other antineutrophil cytoplasm antibody (ANCA)-associated vasculitides (AAV's), and only a few randomized controlled trials have been conducted for this rare disease. However, recent international efforts have helped delineate the best treatment approach. At present, EGPA conventional therapy is by default similar to that of other AAVs. Limited, non-severe EGPA can initially be treated with glucocorticoids (GCs) alone. Patients with life-threatening manifestations and/or major organ involvement must receive a combination of GCs and an immunosuppressant, mainly cyclophosphamide. Remission can be achieved in >85% of patients with these first-line treatments, but vasculitis relapses occur in more than one-third of patients, and about 85% cannot stop GC treatment because of GC-dependent asthma and/or ENT manifestations. A few biologic agents, including rituximab or mepolizumab, are now under investigation after interesting preliminary results. Expert commentary: Treatment for EGPA still has several unmet needs. Several biologic agents are now under investigation in randomized controlled trials, but a few others should be considered soon. Their benefit should be demonstrated for devising more EGPA-tailored therapeutic strategies (ideally GC-free).

Safety and preliminary immunogenicity of Cuban pneumococcal conjugate vaccine candidate in healthy children: a randomized phase I clinical trial.

PubMed

Dotres, Carlos P; Puga, Rinaldo; Ricardo, Yariset; Broño, Carmen R; Paredes, Beatriz; Echemendía, Vladimir; Rosell, Sandra; González, Nadezhda; García-Rivera, Dagmar; Valdés, Yury; Goldblatt, David; Vérez-Bencomo, Vicente

2014-09-15

A new heptavalent conjugate vaccine (PCV7-TT) is under development in Cuba. PCV7-TT contains 2 μg of serotypes 1, 5, 14, 18C, 19F, 23F and 4 μg of 6B, each one conjugated to tetanus toxoid (TT). This vaccine was designed with the serotypes that cause most invasive pneumococcal diseases (IPD) worldwide. In the present study, we investigated the safety and explored the immunogenicity of PCV7-TT during a controlled, randomized and double blind clinical trial phase I in 4-5-year-old children. PCV7-TT was well tolerated and as safe as Synflorix used as control vaccine. Following a single-dose vaccination, all individual serotypes included in PCV7-TT induced statistically significant increase of IgG GMC and OPA GMT. These are the first clinical results of PCV7-TT in children and they pave the way toward next clinical trials in children and infants. This clinical trial was published in the Cuban Public Register of Clinical Trials with code RPCEC00000173. Copyright © 2014 Elsevier Ltd. All rights reserved.

Effects of Omega-3 Fatty Acids on Resting Cerebral Perfusion in Patients with Mild Cognitive Impairment: A Randomized Controlled Trial.

PubMed

Schwarz, C; Wirth, M; Gerischer, L; Grittner, U; Witte, A V; Köbe, T; Flöel, A

2018-01-01

Alteration of cerebral perfusion can be considered as a possible therapeutic target in mild cognitive impairment. This randomized, placebo-controlled, double-blind proof-of-concept study assessed effects of omega-3 fatty acids on cerebral perfusion in patients with mild cognitive impairment. In thirteen patients (omega:n=5; placebo:n=8) cerebral perfusion was measured before and after 26-weeks intervention within posterior cortical regions using magnetic resonance imaging. There was a medium effect of intervention on cerebral blood flow (η2=0.122) and blood volume (η2=0.098). The omega group showed an increase in blood flow (mean difference: 0.02 [corresponds to 26.1%], 95% confidence interval:0.00-0.05) and blood volume (mean difference: 0.08 [corresponds to 18.5%], 95% confidence interval:0.01-0.15), which was not observed in the placebo group. These preliminary findings suggest that omega-3 fatty acids supplementation may improve perfusion in cerebral regions typically affected in mild cognitive impairment.Regulation of perfusion may help to maintain brain structure and function and potentially delay conversion to dementia.

Perceptive rehabilitation and trunk posture alignment in patients with Parkinson disease: a single blind randomized controlled trial.

PubMed

Morrone, Michelangelo; Miccinilli, Sandra; Bravi, Marco; Paolucci, Teresa; Melgari, Jean M; Salomone, Gaetano; Picelli, Alessandro; Spadini, Ennio; Ranavolo, Alberto; Saraceni, Vincenzo M; DI Lazzaro, Vincenzo; Sterzi, Silvia

2016-12-01

Recent studies aimed to evaluate the potential effects of perceptive rehabilitation in Parkinson Disease reporting promising preliminary results for postural balance and pain symptoms. To date, no randomized controlled trial was carried out to compare the effects of perceptive rehabilitation and conventional treatment in patients with Parkinson Disease. To evaluate whether a perceptive rehabilitation treatment could be more effective than a conventional physical therapy program in improving postural control and gait pattern in patients with Parkinson Disease. Single blind, randomized controlled trial. Department of Physical and Rehabilitation Medicine of a University Hospital. Twenty outpatients affected by idiopathic Parkinson Disease at Hoehn and Yahr stage ≤3. Recruited patients were divided into two groups: the first one underwent individual treatment with Surfaces for Perceptive Rehabilitation (Su-Per), consisting of rigid wood surfaces supporting deformable latex cones of various dimensions, and the second one received conventional group physical therapy treatment. Each patient underwent a training program consisting of ten, 45-minute sessions, three days a week for 4 consecutive weeks. Each subject was evaluated before treatment, immediately after treatment and at one month of follow-up, by an optoelectronic stereophotogrammetric system for gait and posture analysis, and by a computerized platform for stabilometric assessment. Kyphosis angle decreased after ten sessions of perceptive rehabilitation, thus showing a substantial difference with respect to the control group. No significant differences were found as for gait parameters (cadence, gait speed and stride length) within Su-Per group and between groups. Parameters of static and dynamic evaluation on stabilometric platform failed to demonstrate any statistically relevant difference both within-groups and between-groups. Perceptive training may help patients affected by Parkinson Disease into restoring a correct midline perception and, in turn, to improve postural control. Perceptive surfaces represent an alternative to conventional rehabilitation of postural disorders in Parkinson Disease. Further studies are needed to determine if the association of perceptive treatment and active motor training would be useful in improving also gait dexterity.

Children Learning About Second-Hand Smoking: A Feasibility Cluster Randomized Controlled Trial.

PubMed

Huque, Rumana; Dogar, Omara; Cameron, Ian; Thomson, Heather; Amos, Amanda; Siddiqi, Kamran

2015-12-01

Exposure to second-hand smoke is a threat to children's health. We developed a school-based smoke-free intervention (SFI) to support families in implementing smoke-free homes in Bangladesh, and gathered preliminary evidence of its effectiveness. A feasibility cluster randomized controlled trial of SFI was conducted in 24 schools in Mirpur, an urban area within Dhaka. Using simple stratified randomization, schools were allocated to: Arm A (SFI only), Arm B (SFI plus reminders), and Arm C (the control group). A total of 781 year-5 children (10-12 years old) in the consenting schools, participated in the study. Outcomes including "smoke-free homes" and "social visibility" that is, not smoking in front of children at home were assessed through questionnaire-based children's surveys, administered by researchers, at baseline and at weeks 1, 12, 27, and 52 in all arms. "Smoke-free homes" were significantly higher in Arm A (odds ratio [OR] = 4.8; 95% CI = 2.6-9.0) and in Arm B (OR = 3.9; 95% CI = 2.0-7.5) than in Arm C, when controlled for the baseline levels, at year 1. Similarly, "social visibility" was significantly reduced in Arm A (OR = 5.8; 95% CI = 2.8-11.7) and in Arm B (OR = 7.2; 95% CI = 3.3-15.9) than Arm C, when controlled for the baseline levels, at year 1. We observed an increasing trend (Cochrane Armitage test statistic [Z] = 3.8; p < .0001) in homes becoming smoke-free with increasing intensity of the intervention (control < Arm A < Arm B), and a decreasing trend (Z = -5.13; p < .0001) in social visibility at homes. SFI has the potential to encourage children to negotiate a smoke-free environment in their homes. © The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Pediatric endurance and limb strengthening (PEDALS) for children with cerebral palsy using stationary cycling: a randomized controlled trial.

PubMed

Fowler, Eileen G; Knutson, Loretta M; Demuth, Sharon K; Siebert, Kara L; Simms, Victoria D; Sugi, Mia H; Souza, Richard B; Karim, Roksana; Azen, Stanley P

2010-03-01

Effective interventions to improve and maintain strength (force-generating capacity) and endurance are needed for children with cerebral palsy (CP). This study was performed to examine the effects of a stationary cycling intervention on muscle strength, locomotor endurance, preferred walking speed, and gross motor function in children with spastic diplegic CP. This was a phase I randomized controlled trial with single blinding. The interventions were performed in community-based outpatient physical therapy clinics. Outcome assessments were performed in university laboratories. Sixty-two ambulatory children aged 7 to 18 years with spastic diplegic CP and Gross Motor Function Classification System levels I to III participated in this study. Participants were randomly assigned to cycling or control (no-intervention) groups. Thirty intervention sessions occurred over 12 weeks. Primary outcomes were peak knee extensor and flexor moments, the 600-Yard Walk-Run Test, the Thirty-Second Walk Test, and the Gross Motor Function Measure sections D and E (GMFM-66). Significant baseline-postintervention improvements were found for the 600-Yard Walk-Run Test, the GMFM-66, peak knee extensor moments at 120 degrees /s, and peak knee flexor moments at 30 degrees /s for the cycling group. Improved peak knee flexor moments at 120 degrees/s were found for the control group only, although not all participants could complete this speed of testing. Significant differences between the cycling and control groups based on change scores were not found for any outcomes. Limitations Heterogeneity of the patient population and intrasubject variability were limitations of the study. Significant improvements in locomotor endurance, gross motor function, and some measures of strength were found for the cycling group but not the control group, providing preliminary support for this intervention. As statistical differences were not found in baseline-postintervention change scores between the 2 groups; the results did not demonstrate that stationary cycling was more effective than no intervention. The results of this phase I study provide guidance for future research.

Competitive Employment for Youth with Autism Spectrum Disorders: Early Results from a Randomized Clinical Trial

ERIC Educational Resources Information Center

Wehman, Paul H.; Schall, Carol M.; McDonough, Jennifer; Kregel, John; Brooke, Valerie; Molinelli, Alissa; Ham, Whitney; Graham, Carolyn W.; Riehle, J. Erin; Collins, Holly T.; Thiss, Weston

2014-01-01

For most youth with autism spectrum disorders (ASD), employment upon graduation from high school or college is elusive. Employment rates are reported in many studies to be very low despite many years of intensive special education services. This paper presented the preliminary results of a randomized clinical trial of Project SEARCH plus ASD…

Feasibility and preliminary efficacy of high intensity interval training in type 2 diabetes.

PubMed

Terada, Tasuku; Friesen, Alanna; Chahal, Baljot S; Bell, Gordon J; McCargar, Linda J; Boulé, Normand G

2013-02-01

To compare the feasibility of high intensity interval exercise (HI-IE) versus moderate intensity continuous exercise (MI-CE) in patients with type 2 diabetes (T2D), and to investigate the preliminary efficacy of HI-IE and MI-CE for improving glycated hemoglobin A1c (HbA1c) and body composition. Individuals with T2D were recruited and randomly assigned to HI-IE and MI-CE. Exercise training was performed 5 days per week for 12 weeks. Recruitment, retention, adherence, feeling states and self-efficacy were analyzed for feasibility. Changes in HbA1c and percent body fat from baseline were investigated at 12 weeks to determine the preliminary efficacy. Of 126 participants showing interest to join the study, 15 individuals were randomized and completed the program. No participants dropped out from the study after enrollment. Adherence rates were high and did not differ between HI-IE and MI-CE (p>0.05; >97.2% of the eligible exercise sessions for both groups). Feeling states and self-efficacy did not differ between the groups. Percent trunk fat decreased in both HI-IE and MI-CE (p=0.007 and 0.085, respectively). Total percent body fat, percent leg fat, and subcutaneous fat width were significantly reduced in both groups (p<0.05), whereas HbA1c did not change from baseline (p>0.05). The degree of improvement was similar between the interventions (p>0.05). In individuals with T2D, implementing a 12-week structured HI-IE training can be as feasible as MI-CE training. Both interventions are equally effective in lowering total body fat but have little impact on HbA1c in relatively well controlled participants with T2D. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

American College of Rheumatology provisional criteria for defining clinical inactive disease in select categories of juvenile idiopathic arthritis.

PubMed

Wallace, Carol A; Giannini, Edward H; Huang, Bin; Itert, Lukasz; Ruperto, Nicolino

2011-07-01

To prospectively validate the preliminary criteria for clinical inactive disease (CID) in patients with select categories of juvenile idiopathic arthritis (JIA). We used the process for development of classification and response criteria recommended by the American College of Rheumatology Quality of Care Committee. Patient-visit profiles were extracted from the phase III randomized controlled trial of infliximab in polyarticular-course JIA (i.e., patients considered to resemble those with select categories of JIA) and sent to an international group of expert physician raters. Using the physician ratings as the gold standard, the sensitivity and specificity were calculated using the preliminary criteria. Modifications to the criteria were made, and these were sent to a larger group of pediatric rheumatologists to determine quantitative, face, and content validity. Variables weighted heaviest by physicians when making their judgment were the number of joints with active arthritis, erythrocyte sedimentation rate (ESR), physician's global assessment, and duration of morning stiffness. Three modifications were made: the definition of uveitis, the definition of abnormal ESR, and the addition of morning stiffness. These changes did not alter the accuracy of the preliminary set. The modified criteria, termed the "criteria for CID in select categories of JIA," have excellent feasibility and face, content, criterion, and discriminant validity to detect CID in select categories of JIA. The small changes made to the preliminary criteria set did not alter the area under the receiver operating characteristic curve (0.954) or accuracy (91%), but have increased face and content validity. Copyright © 2011 by the American College of Rheumatology.

Targeting functional fitness, hearing and health-related quality of life in older adults with hearing loss: Walk, Talk 'n' Listen, study protocol for a pilot randomized controlled trial.

PubMed

Lambert, Justin; Ghadry-Tavi, Rouzbeh; Knuff, Kate; Jutras, Marc; Siever, Jodi; Mick, Paul; Roque, Carolyn; Jones, Gareth; Little, Jonathan; Miller, Harry; Van Bergen, Colin; Kurtz, Donna; Murphy, Mary Ann; Jones, Charlotte Ann

2017-01-28

Hearing loss (HL) is a disability associated with poorer health-related quality of life including an increased risk for loneliness, isolation, functional fitness declines, falls, hospitalization and premature mortality. The purpose of this pilot trial is to determine the feasibility and acceptability of a novel intervention to reduce loneliness, improve functional fitness, social connectedness, hearing and health-related quality of life in older adults with HL. This 10-week, single-blind, pilot randomized control trial (RCT) will include a convenience sample of ambulatory adults aged 65 years or older with self-reported HL. Following baseline assessments, participants will be randomized to either intervention (exercise, health education, socialization and group auditory rehabilitation (GAR)) or control (GAR only) groups. The intervention group will attend a local YMCA twice a week and the control group once a week. Intervention sessions will include 45 min of strengthening, balance and resistance exercises, 30 min of group walking at a self-selected pace and 60 min of interactive health education or GAR. The control group will attend 60-min GAR sessions. GAR sessions will include education about hearing, hearing technologies, enhancing communication skills, and psychosocial support. Pre-post trial data collection and measures will include: functional fitness (gait speed, 30-s Sit to Stand Test), hearing and health-related quality of life, loneliness, depression, social participation and social support. At trial end, feasibility (recruitment, randomization, retention, acceptability) and GAR will be evaluated. Despite evidence suggesting that HL is associated with declines in functional fitness, there are no studies aimed at addressing functional fitness declines associated with the disability of HL. This pilot trial will provide knowledge about the physical, mental and social impacts on health related to HL as a disability. This will inform the feasibility of a larger RCT and preliminary evidence about the initial effects of a novel, community-based, holistic intervention addressing both the negative psychosocial and functional physical effects of HL among older adults. ClinicalTrials.gov, NCT02662192 . Registered on 14 January 2016.

Feasibility, Acceptability, and Preliminary Efficacy of an Online HIV Prevention Program for Diverse Young Men who have Sex with Men: The Keep It Up! Intervention

PubMed Central

Mustanski, Brian; Garofalo, Robert; Monahan, Colleen; Gratzer, Beau; Andrews, Rebecca

2013-01-01

Young men who have sex with men (YMSM) are disproportionately infected with HIV/AIDS and there are few prevention programs with published efficacy for this population. This study evaluated the feasibility, acceptability, and preliminary efficacy of an online, interactive, and highly engaging HIV prevention program called Keep It Up! The intervention was designed to be delivered to diverse YMSM upon receiving an HIV negative text result, with the goal for them to “Keep It Up” and stay negative. In a randomized clinical trial, the intervention was compared to an online didactic HIV knowledge condition. The study sample included 102 sexually active YMSM. Participants reported completing online modules in settings that were private and not distracting. Mixed methods data showed intervention participants felt the program was valuable and acceptable. Compared to the control condition, participants in the intervention arm had a 44 % lower rate of unprotected anal sex acts at the 12-week follow-up (p < 0.05). PMID:23673793

A Preliminary RCT of CBT-AD for Adherence and Depression among HIV-Positive Latinos on the U.S. –Mexico Border: The Nuevo Día Study

PubMed Central

Simoni, Jane M.; Wiebe, John S.; Sauceda, John A.; Huh, David; Sanchez, Giselle; Longoria, Virginia; Bedoya, C. Andres; Safren, Steven A.

2013-01-01

We conducted a preliminary RCT among 40 HIV-positive Latinos of Mexican descent on the U.S.-Mexico border who indicated imperfect adherence and depressive symptomatology. Participants were randomly assigned to culturally adapted cognitive-behavioral therapy for adherence and depression (CBT-AD) with an alarmed pillbox or usual care. Outcomes were depressive symptoms (self-report and blind clinician ratings), adherence (self-report and electronic pillbox), and biological markers. The intervention, delivered in English and Spanish, proved feasible and acceptable. Generalized estimating equations in intent-to-treat analyses showed some effects of “moderate” to “large” size, with maintenance over time. For example, intervention (vs. control) participants demonstrated at post-intervention a greater drop in BDI scores (OR = - 3.64, p = .05) and greater adherence according to the electronic pillbox (OR = 3.78, p = .03). Biological markers indicated some relative improvement for CD4 count but not VL. The promising results suggest a larger trial to determine efficacy is warranted. PMID:23812892

The effects of interactive music therapy on hospitalized children with cancer: a pilot study.

PubMed

Barrera, Maru E; Rykov, Mary H; Doyle, Sandra L

2002-01-01

The use of music therapy with children in health settings has been documented, but its effectiveness has not yet been well established. This pilot study is a preliminary exploration of the effectiveness of interactive music therapy in reducing anxiety and increasing the comfort of hospitalized children with cancer. Pre- and post-music therapy measures were obtained from children (N = 65) and parents. The measures consisted of children's ratings of mood using schematic faces, parental ratings of the child's play performance, and satisfaction questionnaires completed by parents, children and staff. There was a significant improvement in children's ratings of their feelings from pre- to post-music therapy. Parents perceived an improved play performance after music therapy in pre-schoolers and adolescents but not in school-aged children. Qualitative analyses of children's and parents' comments suggested a positive impact of music therapy on the child's well-being. These preliminary findings are encouraging and suggest beneficial effects of interactive music therapy with hospitalized pediatric hematology/oncology patients. In future studies replicating these findings should be conducted in a randomized control trial. Copyright 2002 John Wiley & Sons, Ltd.

Acamprosate and Baclofen were Not Effective in the Treatment of Pathological Gambling: Preliminary Blind Rater Comparison Study.

PubMed

Dannon, Pinhas N; Rosenberg, Oded; Schoenfeld, Netta; Kotler, Moshe

2011-01-01

Pathological gambling (PG) is a highly prevalent and disabling impulse control disorder. A range of psychopharmacological options are available for the treatment of PG, including selective serotonin reuptake inhibitors, opioid receptor antagonists, anti-addiction drugs, and mood stabilizers. In our preliminary study, we examined the efficacy of two anti-addiction drugs, baclofen and acamprosate, in the treatment of PG. Seventeen male gamblers were randomly divided into two groups. Each group received one of the two drugs without being blind to treatment. All patients underwent a comprehensive psychiatric diagnostic evaluation and completed a series of semi-structured interviews. During the 6-months of study, monthly evaluations were carried out to assess improvement and relapses. Relapse was defined as recurrent gambling behavior. None of the 17 patients reached the 6-months abstinence. One patient receiving baclofen sustained abstinence for 4 months. Fourteen patients succeeded in sustaining abstinence for 1-3 months. Two patients stopped attending monthly evaluations. Baclofen and acamprosate did not prove efficient in treating pathological gamblers.

A randomized controlled trial of yoga for pregnant women with symptoms of depression and anxiety.

PubMed

Davis, Kyle; Goodman, Sherryl H; Leiferman, Jenn; Taylor, Mary; Dimidjian, Sona

2015-08-01

Yoga may be well suited for depressed and anxious pregnant women, given reported benefits of meditation and physical activity and pregnant women's preference for nonpharmacological treatments. We randomly assigned 46 pregnant women with symptoms of depression and anxiety to an 8-week yoga intervention or treatment-as-usual (TAU) in order to examine feasibility and preliminary outcomes. Yoga was associated with high levels of credibility and satisfaction as an intervention for depression and anxiety during pregnancy. Participants in both conditions reported significant improvement in symptoms of depression and anxiety over time; and yoga was associated with significantly greater reduction in negative affect as compared to TAU (β = -0.53, SE = 0.20, p = .011). Prenatal yoga was found to be a feasible and acceptable intervention and was associated with reductions in symptoms of anxiety and depression; however, prenatal yoga only significantly outperformed TAU on reduction of negative affect. Published by Elsevier Ltd.

Preliminary data suggesting the efficacy of attention training for school-aged children with ADHD.

PubMed

Tamm, Leanne; Epstein, Jeffery N; Peugh, James L; Nakonezny, Paul A; Hughes, Carroll W

2013-04-01

A pilot randomized clinical trial was conducted to examine the initial efficacy of Pay Attention!, an intervention training sustained, selective, alternating, and divided attention, in children diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD). After a diagnostic and baseline evaluation, school-aged children with ADHD were randomized to receive 16 bi-weekly sessions of Pay Attention! (n=54) or to a waitlist control group (n=51). Participants completed an outcome evaluation approximately 12 weeks after their baseline evaluation. Results showed significant treatment effects for parent and clinician ratings of ADHD symptoms, child self-report of ability to focus, and parent ratings of executive functioning. Child performance on neuropsychological tests showed significant treatment-related improvement on strategic planning efficiency, but no treatment effects were observed on other neuropsychological outcomes. Treatment effects were also not observed for teacher ratings of ADHD. These data add to a growing body of literature supporting effects of cognitive training on attention and behavior, however, additional research is warranted. Copyright © 2012 Elsevier Ltd. All rights reserved.

Preliminary data suggesting the efficacy of attention training for school-aged children with ADHD

PubMed Central

Tamm, Leanne; Epstein, Jeffery N.; Peugh, James L.; Nakonezny, Paul A.; Hughes, Carroll W.

2013-01-01

A pilot randomized clinical trial was conducted to examine the initial efficacy of Pay Attention!, an intervention training sustained, selective, alternating, and divided attention, in children diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD). After a diagnostic and baseline evaluation, school-aged children with ADHD were randomized to receive 16 bi-weekly sessions of Pay Attention! (n = 54) or to a waitlist control group (n = 51). Participants completed an outcome evaluation approximately 12 weeks after their baseline evaluation. Results showed significant treatment effects for parent and clinician ratings of ADHD symptoms, child self-report of ability to focus, and parent ratings of executive functioning. Child performance on neuropsychological tests showed significant treatment-related improvement on strategic planning efficiency, but no treatment effects were observed on other neuropsychological outcomes. Treatment effects were also not observed for teacher ratings of ADHD. These data add to a growing body of literature supporting effects of cognitive training on attention and behavior, however, additional research is warranted. PMID:23219490

A preliminary report of percutaneous craniofacial osteoplasty in a rat calvarium.

PubMed

Parkes, William J; Greywoode, Jewel; O'Hara, Brian J; Heffelfinger, Ryan N; Krein, Howard

2014-07-01

To evaluate the potential for injectable, permanent bone augmentation by assessing the biocompatability and bioactivity of subperiosteal hydroxylapatite (Radiesse) deposition in a rat model. Randomized controlled animal model. Fourteen adult Sprague Dawley rats were injected in the parietal skull with 0.2 ml of hydroxylapatite (10 animals) or 0.2 ml of a carrier gel control (4 animals), using a subperiosteal injection technique on the right and a subcutaneous injection technique on the left. At 1, 3, and 6 months, three rats (1 negative control, 2 variables) were sacrificed and the calvaria were harvested. At 12 months, the remaining five rats were sacrificed. After each harvest, the specimens were processed and then examined under both light and polarized microscopy for new bone growth at the injection sites. The inflammatory response was limited with both hydroxylapatite and carrier injections. Injectables were still present 12 months after the injection. New bone formation was only observed when the injection was located deep to a disrupted periosteum The odds of new bone formation was 48.949 times higher (95% confidence intervals CI [2.637, 3759.961]; P=0.002) with subperiosteal hydroxylapatite injections compared to all other combinations of injection plane and injectable. This preliminary report of subperiosteal hydroxylapatite (Radiesse) injection in a rat model has verified the biocompatibility of injectable hydroxylapatite at the bony interface and suggests the potential for new bone formation. N/A. © 2013 The American Laryngological, Rhinological and Otological Society, Inc.

Dissonance-based eating disorder program reduces cardiac risk: A preliminary trial.

PubMed

Green, Melinda A; Willis, Mary; Fernandez-Kong, Kristen; Reyes, Shuhan; Linkhart, Ruby; Johnson, Molly; Thorne, Tyler; Kroska, Emily; Woodward, Halley; Lindberg, Jessica

2017-04-01

We conducted a randomized, controlled preliminary trial to examine the effect of a dissonance-based eating disorder program on eating disorder symptoms and cardiac risk indices in a community sample of women with subclinical and clinical symptoms (N = 47), examining the efficacy of the program in both the indicated prevention and treatment realms. Eating disorder symptoms, body mass index, and biomarkers of cardiac risk were examined in dissonance and assessment-only control conditions at baseline, postintervention, and 2-month follow-up. Specifically, we assessed mean R wave amplitude, QT interval length, vagal tone (high frequency spectral power of heart rate variability), and sympathetic tone (low/high frequency spectral power ratio) via electocardiography (ECG) at each assessment period. We predicted a statistically significant 2 (condition: control, dissonance) × 3 (time: baseline, postintervention, 2-month follow-up) interaction in the mixed factorial MANOVA results. Results confirmed this hypothesis. Eating disorder symptoms and cardiac risk indices decreased significantly among participants in the dissonance condition at postintervention and 2-month follow-up compared with baseline. Results provide support for the efficacy of a dissonance-based program in the reduction of eating disorder symptoms and cardiac risk indices among women with subclinical and clinical eating disorder symptoms. Findings establish the efficaciousness of this dissonance-based approach in the indicated prevention and treatment realms and establish its efficacy in reducing cardiac risk indicators. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Improving late life depression and cognitive control through the use of therapeutic video game technology: A proof-of-concept randomized trial.

PubMed

Anguera, Joaquin A; Gunning, Faith M; Areán, Patricia A

2017-06-01

Existing treatments for depression are known to have only modest effects, are insufficiently targeted, and are inconsistently utilized, particularly in older adults. Indeed, older adults with impaired cognitive control networks tend to demonstrate poor response to a majority of existing depression interventions. Cognitive control interventions delivered using entertainment software have the potential to not only target the underlying cerebral dysfunction associated with depression, but to do so in a manner that is engaging and engenders adherence to treatment protocol. In this proof-of-concept trial (Clinicaltrials.gov #: NCT02229188), individuals with late life depression (LLD) (22; 60+ years old) were randomized to either problem solving therapy (PST, n = 10) or a neurobiologically inspired digital platform designed to enhance cognitive control faculties (Project: EVO™, n = 12). Given the overlapping functional neuroanatomy of mood disturbances and executive dysfunction, we explored the impact of an intervention targeting cognitive control abilities, functional disability, and mood in older adults suffering from LLD, and how those outcomes compare to a therapeutic gold standard. EVO participants demonstrated similar improvements in mood and self-reported function after 4 weeks of treatment to PST participants. The EVO participants also showed generalization to untrained measures of working memory and attention, as well as negativity bias, a finding not evident in the PST condition. Individuals assigned to EVO demonstrated 100% adherence. This study provides preliminary findings that this therapeutic video game targeting cognitive control deficits may be an efficacious LLD intervention. Future research is needed to confirm these findings. © 2016 Wiley Periodicals, Inc.

Parental Outcomes Following Participation in Cognitive Behavior Therapy for Children with Autism Spectrum Disorder.

PubMed

Maughan, Andrea L; Weiss, Jonathan A

2017-10-01

Children with autism spectrum disorder (ASD) benefit from parent involvement in their therapy, and there is evidence that this involvement may improve parent functioning as well. We examined changes in parent mental health, parenting, and expressed emotion, following participation in a randomized controlled trial of cognitive behavior therapy for 57 children with ASD. Post-intervention, improvements occurred in the treatment group in parent depression and emotion regulation, compared to waitlisted parents. Treatment effects also occurred across all parents in depression, emotion regulation, perceptions of their children and mindful parenting. Though preliminary, these results have implications for intervention development and evaluation by focusing on parent outcomes in child treatment.

The meta-Gaussian Bayesian Processor of forecasts and associated preliminary experiments

NASA Astrophysics Data System (ADS)

Chen, Fajing; Jiao, Meiyan; Chen, Jing

2013-04-01

Public weather services are trending toward providing users with probabilistic weather forecasts, in place of traditional deterministic forecasts. Probabilistic forecasting techniques are continually being improved to optimize available forecasting information. The Bayesian Processor of Forecast (BPF), a new statistical method for probabilistic forecast, can transform a deterministic forecast into a probabilistic forecast according to the historical statistical relationship between observations and forecasts generated by that forecasting system. This technique accounts for the typical forecasting performance of a deterministic forecasting system in quantifying the forecast uncertainty. The meta-Gaussian likelihood model is suitable for a variety of stochastic dependence structures with monotone likelihood ratios. The meta-Gaussian BPF adopting this kind of likelihood model can therefore be applied across many fields, including meteorology and hydrology. The Bayes theorem with two continuous random variables and the normal-linear BPF are briefly introduced. The meta-Gaussian BPF for a continuous predictand using a single predictor is then presented and discussed. The performance of the meta-Gaussian BPF is tested in a preliminary experiment. Control forecasts of daily surface temperature at 0000 UTC at Changsha and Wuhan stations are used as the deterministic forecast data. These control forecasts are taken from ensemble predictions with a 96-h lead time generated by the National Meteorological Center of the China Meteorological Administration, the European Centre for Medium-Range Weather Forecasts, and the US National Centers for Environmental Prediction during January 2008. The results of the experiment show that the meta-Gaussian BPF can transform a deterministic control forecast of surface temperature from any one of the three ensemble predictions into a useful probabilistic forecast of surface temperature. These probabilistic forecasts quantify the uncertainty of the control forecast; accordingly, the performance of the probabilistic forecasts differs based on the source of the underlying deterministic control forecasts.

A new mini-invasive technique in treating pediatric diaphyseal forearm fractures by bioabsorbable elastic stable intramedullary nailing: a preliminary technical report.

PubMed

Sinikumpu, J-J; Keränen, J; Haltia, A-M; Serlo, W; Merikanto, J

2013-01-01

Operative treatment is often indicated in unstable pediatric diaphyseal forearm fractures. Recently minimally invasive reduction and elastic stable intramedullary nailing have been of increasing interest, instead of open reduction and internal fixation with plates. There are several disadvantages of metallic intramedullary implants, such as soft-tissue irritation and a risk of disturbing later imaging. Thus, they are generally removed in later operations. We aimed to develop a new technique to stabilize pediatric forearm fractures by the bioabsorbable intramedullary nailing. We developed a new, two-stage mini-invasive surgical technique to stabilize the unstable diaphyseal fractures in children. The procedure is bioabsorbable elastic stable intramedullary nailing. Ultra-high-strength bioabsorbable intramedullary nails of poly(lactide-co-glycolide) were manufactured for our purpose. The material has been widely proven to be biocompatible and stable enough for fracture treatment as screws and pins. We have used the new technique in the unstable both-bone diaphyseal forearm fractures in children between the ages of 5 and 15 years. We report the technique and our clinical experience in the series of those three cases that have been followed up for at least 12 months. The present series has been randomized for the procedure instead for titanium elastic stable intramedullary nailing, and the series represents a part of ongoing randomized trial. The reported cases operated by the new technique referred good union in the fractured bones and acceptable alignment in the follow-up. Removal of the implants was not required. No troubles with the procedure or implant per se were noticed, indicating good feasibility. One high-energy refracture occurred half year after the primary trauma. Traditional titanium implants were used to control the refracture. We report our preliminary experience of a new surgical mini-invasive procedure to stabilize the unstable pediatric forearm shaft fractures by bioabsorbable elastic stable intramedullary nailing. Our clinical experience suggests that the procedure combined with long-arm casting is feasible in treating the pediatric forearm fractures. The technique may bring benefits to handling these challenging fractures. The disadvantages of metallic implants may be avoided. In addition, removal of the implant will not be required. There was one refracture in the series, but it was due to new high-energy trauma. According to our understanding, it was not related to the type of former osteosynthesis. However, ignoring the good preliminary experience, still we do not have results of the superiority of the procedure over traditional elastic stable intramedullary nailing. Our ongoing randomized multicenter study is aimed to determine its long-term outcome against the present golden standard. Nevertheless, due to encouraging preliminary results, we see it necessary to report the technique.

Summary report: A preliminary investigation into the use of fuzzy logic for the control of redundant manipulators

NASA Technical Reports Server (NTRS)

Cheatham, John B., Jr.; Magee, Kevin N.

1991-01-01

The Rice University Department of Mechanical Engineering and Materials Sciences' Robotics Group designed and built an eight degree of freedom redundant manipulator. Fuzzy logic was proposed as a control scheme for tasks not directly controlled by a human operator. In preliminary work, fuzzy logic control was implemented for a camera tracking system and a six degree of freedom manipulator. Both preliminary systems use real time vision data as input to fuzzy controllers. Related projects include integration of tactile sensing and fuzzy control of a redundant snake-like arm that is under construction.

Examining mechanisms of change in a yoga intervention for women: the influence of mindfulness, psychological flexibility, and emotion regulation on PTSD symptoms.

PubMed

Dick, Alexandra M; Niles, Barbara L; Street, Amy E; DiMartino, Dawn M; Mitchell, Karen S

2014-12-01

This study explored possible mechanisms through which symptoms of posttraumatic stress disorder (PTSD) were reduced in a randomized controlled trial comparing the effect of a yoga intervention with an assessment control. We examined whether changes in psychological flexibility, mindfulness, and emotion regulation strategies (expressive suppression and reappraisal) were associated with posttreatment PTSD symptoms for 38 women with Diagnostic and Statistical Manual of Mental Disorders Fourth Edition full or subthreshold PTSD. Hierarchical linear regression models revealed that expressive suppression significantly decreased for the yoga group relative to the assessment control. Psychological flexibility increased significantly for the control but not yoga group. However, increases in psychological flexibility were associated with decreases in PTSD symptoms for the yoga but not control group. Preliminary findings suggest that yoga may reduce expressive suppression and may improve PTSD symptoms by increasing psychological flexibility. More research is needed to replicate and extend these findings. Published 2014. This article is a U.S. Government work and is in the public domain in the USA.

Randomized controlled trial of REbeL: A peer education program to promote positive body image, healthy eating behavior, and empowerment in teens.

PubMed

Eickman, Laura; Betts, Jessica; Pollack, Lauren; Bozsik, Frances; Beauchamp, Marshall; Lundgren, Jennifer

2018-01-01

Short-term outcomes associated with participation in REbeL, a peer-led dissonance-based eating disorder prevention program for high school students, were evaluated. Seventy-one students across the three high schools were enrolled in the study (REbeL N = 48; Control N = 23) and were assessed on measures of eating attitudes and behaviors, body image, weight bias, self-esteem, empowerment, and mood at the beginning of the school year; 37 REbeL students and 20 control students completed assessments at the end of the school year. Mixed effects GLM compared groups on outcomes at the end of the academic year. When controlling for baseline scores, students in both REbeL schools, compared to control school students, demonstrated statistically significantly lower scores at post-test on the EDE-Q Global score, the EDE-Q Restraint, Eating Concern, Shape Concern and Weight Concern subscales, and the Body Checking Questionnaire (all ps < .05). This study provides preliminary empirical support for the REbeL program.

12 CFR 238.21 - Control proceedings.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 12 Banks and Banking 4 2013-01-01 2013-01-01 false Control proceedings. 238.21 Section 238.21... (CONTINUED) SAVINGS AND LOAN HOLDING COMPANIES (REGULATION LL) Control Proceedings § 238.21 Control proceedings. (a) Preliminary determination of control. (1) The Board may issue a preliminary determination of...

12 CFR 238.21 - Control proceedings.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 12 Banks and Banking 4 2012-01-01 2012-01-01 false Control proceedings. 238.21 Section 238.21... (CONTINUED) SAVINGS AND LOAN HOLDING COMPANIES (REGULATION LL) Control Proceedings § 238.21 Control proceedings. (a) Preliminary determination of control. (1) The Board may issue a preliminary determination of...

Preliminary Marine Safety Risk Assessment, Brandon Road Lock and Dam Invasive Species Control Measures

DTIC Science & Technology

2016-12-01

i Classification | CG-926 RDC | author | audience | month year Preliminary Marine Safety Risk Assessment, Brandon Road Lock & Dam...No. 4. Title and Subtitle Preliminary Marine Safety Risk Assessment, Brandon Road Lock & Dam Invasive Species Control Measures 5. Report Date...safety due to proposed invasive species control measures located in the vicinity of the Brandon Road Lock and Dam (BRLD) Navigation Project on the

Direct-to-Consumer Marketing of Psychological Treatments: A Randomized Controlled Trial

PubMed Central

Gallo, Kaitlin P.; Comer, Jonathan S.; Barlow, David H.; Clarke, Roberta N.; Antony, Martin M.

2015-01-01

Objective Although direct-to-consumer (DTC) marketing of pharmacologic interventions is effective and common, similar approaches have yet to be evaluated in the promotion of psychological treatments (PTs). This is the first randomized controlled trial evaluating the potential of DTC marketing of PTs. Method Participants (N=344; 75.0% female, mean age=18.6, 48.5% non-Hispanic Caucasian) were randomly assigned to consume one of four extended commercial campaigns embedded within unrelated programming across 3 weeks. The four campaign conditions were: [1] PT campaign; [2] PT informing about Medication Side Effects campaign; [3] Medication campaign; and [4] Neutral campaign. Attitudes about and intention to seek psychological treatment were assessed prior to campaign exposure (T1), 1 week following the final week of campaign exposure (T2), and at a 3-month follow-up evaluation (T3). Results The percentage of participants who newly intended psychological treatment at T2 or T3 differed by condition, with those assigned to the PT campaign slightly more likely to have intended to receive psychological treatment at T2 or T3 than those in other conditions. Baseline reports of emotional symptoms moderated the effect of condition on attitudes toward PT and perceived likelihood of seeking treatment in the future. Conclusions Findings support the preliminary utility of DTC marketing of psychological treatments. Increasing consumer knowledge of PTs may be a worthwhile complement to current dissemination and implementation efforts aimed at promoting the uptake of PTs in mental health care. PMID:26098374

A Double-Blind, Randomized, Controlled Pilot Trial of N-Acetylcysteine in Veterans With Posttraumatic Stress Disorder and Substance Use Disorders.

PubMed

Back, Sudie E; McCauley, Jenna L; Korte, Kristina J; Gros, Daniel F; Leavitt, Virginia; Gray, Kevin M; Hamner, Mark B; DeSantis, Stacia M; Malcolm, Robert; Brady, Kathleen T; Kalivas, Peter W

2016-11-01

The antioxidant N-acetylcysteine is being increasingly investigated as a therapeutic agent in the treatment of substance use disorders (SUDs). This study explored the efficacy of N-acetylcysteine in the treatment of posttraumatic stress disorder (PTSD), which frequently co-occurs with SUD and shares impaired prefrontal cortex regulation of basal ganglia circuitry, in particular at glutamate synapses in the nucleus accumbens. Veterans with PTSD and SUD per DSM-IV criteria (N = 35) were randomly assigned to receive a double-blind, 8-week course of N-acetylcysteine (2,400 mg/d) or placebo plus cognitive-behavioral therapy for SUD (between March 2013 and April 2014). Primary outcome measures included PTSD symptoms (Clinician-Administered PTSD Scale, PTSD Checklist-Military) and craving (Visual Analog Scale). Substance use and depression were also assessed. Participants treated with N-acetylcysteine compared to placebo evidenced significant improvements in PTSD symptoms, craving, and depression (β values < -0.33; P values < .05). Substance use was low for both groups, and no significant between-group differences were observed. N-acetylcysteine was well tolerated, and retention was high. This is the first randomized controlled trial to investigate N-acetylcysteine as a pharmacologic treatment for PTSD and SUD. Although preliminary, the findings provide initial support for the use of N-acetylcysteine in combination with psychotherapy among individuals with co-occurring PTSD and SUD. ClinicalTrials.gov identifier: NCT02499029. © Copyright 2016 Physicians Postgraduate Press, Inc.

Performance of the Fecal Immunochemical Test for Colorectal Cancer Screening Using Different Stool-Collection Devices: Preliminary Results from a Randomized Controlled Trial.

PubMed

Shin, Hye Young; Suh, Mina; Baik, Hyung Won; Choi, Kui Son; Park, Boyoung; Jun, Jae Kwan; Hwang, Sang-Hyun; Kim, Byung Chang; Lee, Chan Wha; Oh, Jae Hwan; Lee, You Kyoung; Han, Dong Soo; Lee, Do-Hoon

2016-11-15

We are in the process of conducting a randomized trial to determine whether compliance with the fecal immunochemical test (FIT) for colorectal cancer screening differs according to the stool-collection method. This study was an interim analysis of the performance of two stool-collection devices (sampling bottle vs conventional container). In total, 1,701 individuals (age range, 50 to 74 years) were randomized into the sampling bottle group (intervention arm) or the conventional container group (control arm). In both groups, we evaluated the FIT positivity rate, the positive predictive value for advanced neoplasia, and the detection rate for advanced neoplasia. The FIT positivity rates were 4.1% for the sampling bottles and 2.0% for the conventional containers; these values were significantly different. The positive predictive values for advanced neoplasia in the sampling bottles and conventional containers were 11.1% (95% confidence interval [CI], -3.4 to 25.6) and 12.0% (95% CI, -0.7 to 24.7), respectively. The detection rates for advanced neoplasia in the sampling bottles and conventional containers were 4.5 per 1,000 persons (95% CI, 2.0 to 11.0) and 2.4 per 1,000 persons (95% CI, 0.0 to 5.0), respectively. The impact of these findings on FIT screening performance was unclear in this interim analysis. This impact should therefore be evaluated in the final analysis following the final enrollment period.

Direct-to-consumer marketing of psychological treatments: A randomized controlled trial.

PubMed

Gallo, Kaitlin P; Comer, Jonathan S; Barlow, David H; Clarke, Roberta N; Antony, Martin M

2015-10-01

Although direct-to-consumer (DTC) marketing of pharmacologic interventions is effective and common, similar approaches have yet to be evaluated in the promotion of psychological treatments (PTs). This is the first randomized controlled trial evaluating the potential of DTC marketing of PTs. Participants (N = 344; 75.0% female, mean age = 18.6 years, 48.5% non-Hispanic White) were randomly assigned to consume one of four extended commercial campaigns embedded within unrelated programming across 3 weeks. The four campaign conditions were a PT campaign, a PT informing about medication side effects campaign, a medication campaign, and a neutral campaign. Attitudes about and intention to seek psychological treatment were assessed prior to campaign exposure (T1), 1 week following the final week of campaign exposure (T2), and at a 3-month follow-up evaluation (T3). The percentage of participants who newly intended psychological treatment at T2 or T3 differed by condition, with those assigned to the PT campaign slightly more likely to have intended to receive psychological treatment at T2 or T3 than those in other conditions. Baseline reports of emotional symptoms moderated the effect of condition on attitudes toward PT and perceived likelihood of seeking treatment in the future. Findings support the preliminary utility of DTC marketing of psychological treatments. Increasing consumer knowledge of PTs may be a worthwhile complement to current dissemination and implementation efforts aimed at promoting the uptake of PTs in mental health care. (c) 2015 APA, all rights reserved).

Role of the α1 Blocker Doxazosin in Alcoholism: a Proof-of-Concept Randomized Controlled Trial

PubMed Central

Kenna, George A.; Haass-Koffler, Carolina L.; Zywiak, William H.; Edwards, Steven M.; Brickley, Michael B.; Swift, Robert M.; Leggio, Lorenzo

2015-01-01

Background Evidence suggests the norepinephrine system represents an important treatment target for alcohol dependence (AD) and the α1-blocker prazosin may reduce alcohol drinking in rodents and alcoholic patients. The α1-blocker doxazosin demonstrates a more favorable pharmacokinetic profile than prazosin but has never been studied for AD. Methods A double-blind placebo-controlled randomized clinical trial was conducted in AD individuals seeking outpatient treatment. Doxazosin or matched placebo was titrated to 16-mg/day (or maximum tolerable dose). Drinks per week (DPW) and heavy drinking days (HDD) per week were primary outcomes. Family history density of alcoholism (FHDA), severity of AD, and gender were a priori moderators. Results Forty-one AD individuals were randomized, 30 (doxazosin = 15) completed the treatment phase, and 28 (doxazosin = 14) also completed the follow-up. There were no significant differences between groups on DPW and HDD per week. With FHDA as a moderator, there were significant FHDA x medication interactions for both DPW [pcorrected = .001, d = 1.18] and HDD [pcorrected = .00009, d = 1.30]. Post-hoc analyses revealed that doxazosin significantly reduced alcohol drinking in AD patients with high FHDA and by contrast increased drinking in those with low FHDA. Conclusions Doxazosin may be effective selectively in AD patients with high FHDA. This study provides preliminary evidence for personalized medicine using α1-blockade to treat AD. However, confirmatory studies are required. PMID:26037245

Feasibility and preliminary efficacy of the effects of flavanoid-rich purple grape juice on the vascular health of childhood cancer survivors: a randomized, controlled crossover trial.

PubMed

Blair, Cindy K; Kelly, Aaron S; Steinberger, Julia; Eberly, Lynn E; Napurski, Char; Robien, Kim; Neglia, Joseph P; Mulrooney, Daniel A; Ross, Julie A

2014-12-01

Childhood cancer survivors have an increased risk of developing cardiovascular disease following treatment, yet few interventions have been evaluated to reduce this risk. Purple grape juice (pGJ), a rich source of flavonoids with antioxidant properties, has been shown in adults to reduce oxidative stress and improve endothelial function. We examined the effects of supplementing meals with pGJ on microvascular endothelial function and markers of oxidative stress and inflammation in 24 cancer survivors (ages 10-21 years). In a randomized controlled crossover trial consisting of two, 4 week intervention periods, each preceded by a 4 week washout period, subjects received in random order 6 ounces twice daily of pGJ and clear apple juice (cAJ; similar in calories but lower in flavonoids). Measurements were obtained before and after each supplementation period; change was evaluated using mixed effects ANOVA. pGJ did not improve endothelial function, measured using digital reactive hyperemia, compared with cAJ (mean change: pGJ 0.06, cAJ 0.22; difference of mean change [95% CI]: -0.16 [-0.42 - 0.11], P = 0.25). No significant changes in plasma concentrations of oxidized-LDL, myeloperoxidase, or high sensitivity C-reactive protein were observed. After 4 weeks of daily consumption of flavonoid-rich pGJ, no measurable change in vascular function was observed in these childhood cancer survivors. © 2014 Wiley Periodicals, Inc.

Energy Efficient Engine: Control system preliminary definition report

NASA Technical Reports Server (NTRS)

Howe, David C.

1986-01-01

The object of the Control Preliminary Definition Program was to define a preliminary control system concept as a part of the Energy Efficient Engine program. The program was limited to a conceptual definition of a full authority digital electronic control system. System requirements were determined and a control system was conceptually defined to these requirements. Areas requiring technological development were identified and a plan was established for implementing the identified technological features, including a control technology demonstration. A significant element of this program was a study of the potential benefits of closed-loop active clearance control, along with laboratory tests of candidate clearance sensor elements for a closed loop system.

Randomized Controlled Trial of Telephone-Delivered Cognitive Behavioral Therapy for Chronic Insomnia

PubMed Central

Arnedt, J. Todd; Cuddihy, Leisha; Swanson, Leslie M.; Pickett, Scott; Aikens, James; Chervin, Ronald D.

2013-01-01

Study Objectives: To compare the efficacy of telephone-delivered cognitive-behavioral therapy for insomnia to an information pamphlet control on sleep and daytime functioning at pretreatment, posttreatment, and 12-wk follow-up. Design: Randomized controlled parallel trial. Setting: N/A. Participants: Thirty individuals with chronic insomnia (27 women, age 39.1 ± 14.4 years, insomnia duration 8.7 ± 10.7 years). Interventions: Cognitive behavioral therapy for insomnia (CBTI) delivered in up to eight weekly telephone sessions (CBTI-Phone, n = 15) versus an information pamphlet control (IPC, n = 15). Measurements and Results: Sleep/wake diary, sleep-related questionnaires (Insomnia Severity Index, Pittsburgh Sleep Quality Index, 16-item Dysfunctional Beliefs and Attitudes about Sleep), and daytime symptom assessments (fatigue, depression, anxiety, and quality of life) were completed at pretreatment, posttreatment, and 12-wk follow-up. Linear mixed models indicated that sleep/wake diary sleep efficiency and total sleep time improved significantly at posttreatment in both groups and remained stable at 12-wk follow-up. More CBTI-Phone than IPC patients showed posttreatment improvements in unhelpful sleep-related cognitions (P < 0.001) and were classified as “in remission” from insomnia at follow-up (P < 0.05). Posttreatment effect sizes on most daytime symptoms were large (Cohen d = 0.8–2.5) for CBTI-Phone patients and small to moderate (Cohen d = -0.1–0.6) for IPC patients. All CBTI-Phone patients completed posttreatment and 12-wk follow-up assessments, but three IPC patients discontinued the study. Conclusions: The findings provide preliminary support for telephone-delivered CBTI in the treatment of chronic insomnia. Future larger-scale studies with more diverse samples are warranted. Some individuals with insomnia may also benefit from pamphlet-delivered CBTI with brief telephone support. Citation: Arnedt JT; Cuddihy L; Swanson LM; Pickett S; Aikens J; Chervin RD. Randomized controlled trial of telephone-delivered cognitive behavioral therapy for chronic insomnia. SLEEP 2013;36(3):353-362. PMID:23450712

A randomized controlled trial of Human Papillomavirus (HPV) testing for cervical cancer screening: trial design and preliminary results (HPV FOCAL Trial)

PubMed Central

2010-01-01

Background In the HPV FOCAL trial, we will establish the efficacy of hr-HPV DNA testing as a stand-alone screening test followed by liquid based cytology (LBC) triage of hr-HPV-positive women compared to LBC followed by hr-HPV triage with ≥ CIN3 as the outcome. Methods/Design HPV-FOCAL is a randomized, controlled, three-armed study over a four year period conducted in British Columbia. It will recruit 33,000 women aged 25-65 through the province's population based cervical cancer screening program. Control arm: LBC at entry and two years, and combined LBC and hr-HPV at four years among those with initial negative results and hr-HPV triage of ASCUS cases; Two Year Safety Check arm: hr-HPV at entry and LBC at two years in those with initial negative results with LBC triage of hr-HPV positives; Four Year Intervention Arm: hr-HPV at entry and combined hr-HPV and LBC at four years among those with initial negative results with LBC triage of hr-HPV positive cases Discussion To date, 6150 participants have a completed sample and epidemiologic questionnaire. Of the 2019 women enrolled in the control arm, 1908 (94.5%) were cytology negative. Women aged 25-29 had the highest rates of HSIL (1.4%). In the safety arm 92.2% of women were hr-HPV negative, with the highest rate of hr-HPV positivity found in 25-29 year old women (23.5%). Similar results were obtained in the intervention arm HPV FOCAL is the first randomized trial in North America to examine hr-HPV testing as the primary screen for cervical cancer within a population-based cervical cancer screening program. Trial Registration International Standard Randomised Controlled Trial Number Register, ISRCTN79347302 PMID:20334685

Safety and efficacy of a novel disposable circumcision device: A pilot randomized controlled clinical trial at 2 centers

PubMed Central

Wang, Jingen; Zhou, Yongfei; Xia, Shuxia; Zhu, Zunwei; Jia, Linghua; Liu, Yong; Jiang, Min

2014-01-01

Background We evaluated the safety and efficacy of a novel disposable male circumcision (MC) device developed by Jiangxi-Yuansheng-Langhe Medical Instrument Co., Ltd. Material/Methods Adult male patients (n=120; mean age, 26.6 years) with redundant foreskin and/or phimosis were included in a randomized, multicenter pilot clinical trial from October 2011 to February 2012. Patients were divided into 2 groups and subjected to MC with a novel disposable device (Device Group) (n=60) or to conventional dissection technique (CDT) (Control Group) (n=60). Intraoperative bleeding, surgery duration, pain, healing, and satisfaction with penis appearance were assessed. Adverse events (AEs) were noted. Results Intraoperative bleeding volume [3.5±2.7 (15–35) ml vs. 13.1±6.1 (4–25) ml] and mean surgical time [7.6±4.5 (2–23) min vs. 23.6±4.4 (15–35) min] in the Device Group were significantly less than in the Control Group (P<0.01). No AEs were observed in either group. There were no significant differences in postoperative pain, healing, or satisfaction with penis appearance between groups (P>0.05). Conclusions This novel disposable circumcision device produced satisfactory preliminary adult MC results compared with CDT treatments. This device may be broadly used in men, such as those with phimosis, who are ineligible for CDT. PMID:24647226

A low-fat yoghurt supplemented with a rooster comb extract on muscle joint function in adults with mild knee pain: a randomized, double blind, parallel, placebo-controlled, clinical trial of efficacy.

PubMed

Solà, Rosa; Valls, Rosa-Maria; Martorell, Isabel; Giralt, Montserrat; Pedret, Anna; Taltavull, Núria; Romeu, Marta; Rodríguez, Àurea; Moriña, David; Lopez de Frutos, Victor; Montero, Manuel; Casajuana, Maria-Carmen; Pérez, Laura; Faba, Jenny; Bernal, Gloria; Astilleros, Anna; González, Roser; Puiggrós, Francesc; Arola, Lluís; Chetrit, Carlos; Martinez-Puig, Daniel

2015-11-01

Preliminary results suggested that oral-administration of rooster comb extract (RCE) rich in hyaluronic acid (HA) was associated with improved muscle strength. Following these promising results, the objective of the present study was to evaluate the effect of low-fat yoghurt supplemented with RCE rich in HA on muscle function in adults with mild knee pain; a symptom of early osteoarthritis. Participants (n = 40) received low-fat yoghurt (125 mL d(-1)) supplemented with 80 mg d(-1) of RCE and the placebo group (n = 40) consumed the same yoghurt without the RCE, in a randomized, controlled, double-blind, parallel trial over 12 weeks. Using an isokinetic dynamometer (Biodex System 4), RCE consumption, compared to control, increased the affected knee peak torque, total work and mean power at 180° s(-1), at least 11% in men (p < 0.05) with no differences in women. No dietary differences were noted. These results suggest that long-term consumption of low-fat yoghurt supplemented with RCE could be a dietary tool to improve muscle strength in men, associated with possible clinical significance. However, further studies are needed to elucidate reasons for these sex difference responses observed, and may provide further insight into muscle function.

Preliminary investigation into application of problem-based learning in the practical teaching of diagnostics

PubMed Central

Rui, Zeng; Rong-Zheng, Yue; Hong-Yu, Qiu; Jing, Zeng; Xue-Hong, Wan; Chuan, Zuo

2015-01-01

Background Problem-based learning (PBL) is a pedagogical approach based on problems. Specifically, it is a student-centered, problem-oriented teaching method that is conducted through group discussions. The aim of our study is to explore the effects of PBL in diagnostic teaching for Chinese medical students. Methods A prospective, randomized controlled trial was conducted. Eighty junior clinical medical students were randomly divided into two groups. Forty students were allocated to a PBL group and another 40 students were allocated to a control group using the traditional teaching method. Their scores in the practice skills examination, ability to write and analyze medical records, and results on the stage test and behavior observation scale were compared. A questionnaire was administered in the PBL group after class. Results There were no significant differences in scores for writing medical records, content of interviewing, physical examination skills, and stage test between the two groups. However, compared with the control group, the PBL group had significantly higher scores on case analysis, interviewing skills, and behavioral observation scales. Conclusion The questionnaire survey revealed that PBL could improve interest in learning, cultivate an ability to study independently, improve communication and analytical skills, and good team cooperation spirit. However, there were some shortcomings in systematization of imparting knowledge. PBL has an obvious advantage in teaching with regard to diagnostic practice. PMID:25848334

Effect of Pregabalin on Cardiovascular Responses to Exercise and Postexercise Pain and Fatigue in Fibromyalgia: A Randomized, Double-Blind, Crossover Pilot Study

PubMed Central

White, Andrea T.; Light, Kathleen C.; Bateman, Lucinda; Hughen, Ronald W.; Vanhaitsma, Timothy A.; Light, Alan R.

2015-01-01

Pregabalin, an approved treatment for fibromyalgia (FM), has been shown to decrease sympathetic nervous system (SNS) activity and inhibit sympathetically maintained pain, but its effects on exercise responses have not been reported. Methods. Using a randomized double-blind crossover design, we assessed the effect of 5 weeks of pregabalin (versus placebo) on acute cardiovascular and subjective responses to moderate exercise in 19 FM patients. Blood pressure (BP), heart rate (HR), and ratings of perceived exertion (RPE) during exercise and ratings of pain, physical fatigue, and mental fatigue before, during, and for 48 hours after exercise were compared in patients on pregabalin versus placebo and also versus 18 healthy controls. Results. On placebo, exercise RPE and BP were significantly higher in FM patients than controls (p < 0.04). Pregabalin responders (n = 12, defined by patient satisfaction and symptom changes) had significantly lower exercise BP, HR, and RPE on pregabalin versus placebo (p < 0.03) and no longer differed from controls (p > 0.26). Cardiovascular responses of nonresponders (n = 7) were not altered by pregabalin. In responders, pregabalin improved ratings of fatigue and pain (p < 0.04), but negative effects on pain and fatigue were seen in nonresponders. Conclusions. These preliminary findings suggest that pregabalin may normalize cardiovascular and subjective responses to exercise in many FM patients. PMID:27026828

A randomized controlled trial of the impact of a teacher classroom management program on the classroom behavior of children with and without behavior problems.

PubMed

Hutchings, Judy; Martin-Forbes, Pam; Daley, David; Williams, Margiad Elen

2013-10-01

This randomized controlled trial (RCT) evaluated the efficacy of the Incredible Years (IY) Teacher Classroom Management (TCM; Webster-Stratton & Reid, 2002) program to assess whether training teachers in IY-TCM principles improve teacher behavior, whether any observed improvements impact pupil behavior classroom-wide, and whether these effects can be demonstrated with children at risk of developing conduct problems. Six intervention and six control classrooms comprising 12 teachers and 107 children (aged 3 to 7years) were recruited. Children were screened for high or low behavior problems using the cut-off points of the teacher-rated Strengths and Difficulties Questionnaire (Goodman, 1997). The primary outcome measure was independent classroom observations using the Teacher-Pupil Observation Tool (Martin et al., 2010). Multilevel modeling analyses were conducted to examine the effect of the intervention on teacher, classroom, and child behavior. Results showed a significant reduction in classroom off-task behavior (d=0.53), teacher negatives to target children (d=0.36), target child negatives towards the teacher (d=0.42), and target child off-task behavior (d=0.48). These preliminary results demonstrate the potential impact of IY-TCM on both teacher and child behavior. Copyright © 2013 Society for the Study of School Psychology. Published by Elsevier Ltd. All rights reserved.

Hypnosis Treatment of Gastrointestinal Disorders: A Comprehensive Review of the Empirical Evidence.

PubMed

Palsson, Olafur S

2015-10-01

Hypnotherapy has been investigated for 30 years as a treatment for gastrointestinal (GI) disorders. There are presently 35 studies in the published empirical literature, including 17 randomized controlled trials (RCTs) that have assessed clinical outcomes of such treatment. This body of research is reviewed comprehensively in this article. Twenty-four of the studies have tested hypnotherapy for adult irritable bowel syndrome (IBS) and 5 have focused on IBS or abdominal pain in children. All IBS hypnotherapy studies have reported significant improvement in gastrointestinal symptoms, and 7 out of 10 RCTs in adults and all 3 RCTs in pediatric patient samples found superior outcomes for hypnosis compared to control groups. Collectively this body of research shows unequivocally that for both adults and children with IBS, hypnosis treatment is highly efficacious in reducing bowel symptoms and can offer lasting and substantial symptom relief for a large proportion of patients who do not respond adequately to usual medical treatment approaches. For other GI disorders the evidence is more limited, but preliminary indications of therapeutic potential can be seen in the single randomized controlled trials published to date on hypnotherapy for functional dyspepsia, functional chest pain, and ulcerative colitis. Further controlled hypnotherapy trials in those three disorders should be a high priority. The mechanisms underlying the impact of hypnosis on GI problems are still unclear, but findings from a number of studies suggest that they involve both modulation of gut functioning and changes in the brain's handling of sensory signals from the GI tract.

A randomized controlled trial comparing Circle of Security Intervention and treatment as usual as interventions to increase attachment security in infants of mentally ill mothers: Study Protocol.

PubMed

Ramsauer, Brigitte; Lotzin, Annett; Mühlhan, Christine; Romer, Georg; Nolte, Tobias; Fonagy, Peter; Powell, Bert

2014-01-30

Psychopathology in women after childbirth represents a significant risk factor for parenting and infant mental health. Regarding child development, these infants are at increased risk for developing unfavorable attachment strategies to their mothers and for subsequent behavioral, emotional and cognitive impairments throughout childhood. To date, the specific efficacy of an early attachment-based parenting group intervention under standard clinical outpatient conditions, and the moderators and mediators that promote attachment security in infants of mentally ill mothers, have been poorly evaluated. This randomized controlled clinical trial tests whether promoting attachment security in infancy with the Circle of Security (COS) Intervention will result in a higher rate of securely attached children compared to treatment as usual (TAU). Furthermore, we will determine whether the distributions of securely attached children are moderated or mediated by variations in maternal sensitivity, mentalizing, attachment representations, and psychopathology obtained at baseline and at follow-up. We plan to recruit 80 mother-infant dyads when infants are aged 4-9 months with 40 dyads being randomized to each treatment arm. Infants and mothers will be reassessed when the children are 16-18 months of age. Methodological aspects of the study are systematic recruitment and randomization, explicit inclusion and exclusion criteria, research assessors and coders blinded to treatment allocation, advanced statistical analysis, manualized treatment protocols and assessments of treatment adherence and integrity. The aim of this clinical trial is to determine whether there are specific effects of an attachment-based intervention that promotes attachment security in infants. Additionally, we anticipate being able to utilize data on maternal and child outcome measures to obtain preliminary indications about potential moderators of the intervention and inform hypotheses about which intervention may be most suitable when offered in a clinical psychiatric outpatient context. Current Controlled Trials ISRCTN88988596.

A randomized controlled trial comparing Circle of Security Intervention and treatment as usual as interventions to increase attachment security in infants of mentally ill mothers: Study Protocol

PubMed Central

2014-01-01

Background Psychopathology in women after childbirth represents a significant risk factor for parenting and infant mental health. Regarding child development, these infants are at increased risk for developing unfavorable attachment strategies to their mothers and for subsequent behavioral, emotional and cognitive impairments throughout childhood. To date, the specific efficacy of an early attachment-based parenting group intervention under standard clinical outpatient conditions, and the moderators and mediators that promote attachment security in infants of mentally ill mothers, have been poorly evaluated. Methods/Design This randomized controlled clinical trial tests whether promoting attachment security in infancy with the Circle of Security (COS) Intervention will result in a higher rate of securely attached children compared to treatment as usual (TAU). Furthermore, we will determine whether the distributions of securely attached children are moderated or mediated by variations in maternal sensitivity, mentalizing, attachment representations, and psychopathology obtained at baseline and at follow-up. We plan to recruit 80 mother-infant dyads when infants are aged 4-9 months with 40 dyads being randomized to each treatment arm. Infants and mothers will be reassessed when the children are 16-18 months of age. Methodological aspects of the study are systematic recruitment and randomization, explicit inclusion and exclusion criteria, research assessors and coders blinded to treatment allocation, advanced statistical analysis, manualized treatment protocols and assessments of treatment adherence and integrity. Discussion The aim of this clinical trial is to determine whether there are specific effects of an attachment-based intervention that promotes attachment security in infants. Additionally, we anticipate being able to utilize data on maternal and child outcome measures to obtain preliminary indications about potential moderators of the intervention and inform hypotheses about which intervention may be most suitable when offered in a clinical psychiatric outpatient context. Trial registration Current Controlled Trials ISRCTN88988596 PMID:24476106

Review of yoga therapy during cancer treatment.

PubMed

Danhauer, Suzanne C; Addington, Elizabeth L; Sohl, Stephanie J; Chaoul, Alejandro; Cohen, Lorenzo

2017-04-01

Reviews of yoga research that distinguish results of trials conducted during (versus after) cancer treatment are needed to guide future research and clinical practice. We therefore conducted a review of non-randomized studies and randomized controlled trials of yoga interventions for children and adults undergoing treatment for any cancer type. Studies were identified via research databases and reference lists. Inclusion criteria were the following: (1) children or adults undergoing cancer treatment, (2) intervention stated as yoga or component of yoga, and (3) publication in English in peer-reviewed journals through October 2015. Exclusion criteria were the following: (1) samples receiving hormone therapy only, (2) interventions involving meditation only, and (3) yoga delivered within broader cancer recovery or mindfulness-based stress reduction programs. Results of non-randomized (adult n = 8, pediatric n = 4) and randomized controlled trials (adult n = 13, pediatric n = 0) conducted during cancer treatment are summarized separately by age group. Findings most consistently support improvement in psychological outcomes (e.g., depression, distress, anxiety). Several studies also found that yoga enhanced quality of life, though further investigation is needed to clarify domain-specific efficacy (e.g., physical, social, cancer-specific). Regarding physical and biomedical outcomes, evidence increasingly suggests that yoga ameliorates sleep and fatigue; additional research is needed to advance preliminary findings for other treatment sequelae and stress/immunity biomarkers. Among adults undergoing cancer treatment, evidence supports recommending yoga for improving psychological outcomes, with potential for also improving physical symptoms. Evidence is insufficient to evaluate the efficacy of yoga in pediatric oncology. We describe suggestions for strengthening yoga research methodology to inform clinical practice guidelines.

Using the MEDiPORT humanoid robot to reduce procedural pain and distress in children with cancer: A pilot randomized controlled trial.

PubMed

Jibb, Lindsay A; Birnie, Kathryn A; Nathan, Paul C; Beran, Tanya N; Hum, Vanessa; Victor, J Charles; Stinson, Jennifer N

2018-06-12

Subcutaneous port needle insertions are painful and distressing for children with cancer. The interactive MEDiPORT robot has been programmed to implement psychological strategies to decrease pain and distress during this procedure. This study assessed the feasibility of a future MEDiPORT trial. The secondary aim was to determine the preliminary effectiveness of MEDiPORT in reducing child pain and distress during subcutaneous port accesses. This 5-month pilot randomized controlled trial used a web-based service to randomize 4- to 9-year-olds with cancer to the MEDiPORT cognitive-behavioral arm (robot using evidence-based cognitive-behavioral interventions) or active distraction arm (robot dancing and singing) while a nurse conducted a needle insertion. We assessed accrual and retention; technical difficulties; outcome measure completion by children, parents, and nurses; time taken to complete the study and clinical procedure; and child-, parent-, and nurse-rated acceptability. Descriptive analyses, with exploratory inferential testing of child pain and distress data, were used to address study aims. Forty children were randomized across study arms. Most (85%) eligible children participated and no children withdrew. Technical difficulties were more common in the cognitive-behavioral arm. Completion times for the study and needle insertion were acceptable and >96% of outcome measure items were completed. Overall, MEDiPORT and the study were acceptable to participants. There was no difference in pain between arms, but distress during the procedure was less pronounced in the active distraction arm. The MEDiPORT study appears feasible to implement as an adequately-powered effectiveness-assessing trial following modifications to the intervention and study protocol. ClinicalTrials.gov NCT02611739. © 2018 Wiley Periodicals, Inc.

78 FR 42520 - Control Technology, Inc.; Notice of Preliminary Permit Application Accepted for Filing and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-16

... Technology, Inc.; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications On December 18, 2012, Control Technology, Inc. filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act, proposing to study...

A preliminary controlled evaluation of a school-based media literacy program and self-esteem program for reducing eating disorder risk factors.

PubMed

Wade, Tracey D; Davidson, Susan; O'Dea, Jennifer A

2003-05-01

This study compared the efficacy of a media literacy program and a self-esteem program designed to reduce general and specific risk factors for eating disorders. Four classes of 86 grade 8 students (53 boys and 33 girls), mean age of 13 years, were randomly assigned to either a control condition or one of the two intervention conditions. Assessment of general and specific risk factors was carried out at baseline, postintervention and 3-month follow-up. At postintervention the media literacy group had lower mean scores on weight concern than the control group (p =0.007) but the self-esteem group did not. There were some differences on self-esteem measures at the 3-month follow-up. Media literacy programs combined with an interactive, student-centered framework may potentially be a safe and effective way of reducing risk factors for eating disorders. The impact of teaching style needs to be further evaluated in prevention research. Copyright 2003 by Wiley Periodicals, Inc.

Randomness in Competitions

NASA Astrophysics Data System (ADS)

Ben-Naim, E.; Hengartner, N. W.; Redner, S.; Vazquez, F.

2013-05-01

We study the effects of randomness on competitions based on an elementary random process in which there is a finite probability that a weaker team upsets a stronger team. We apply this model to sports leagues and sports tournaments, and compare the theoretical results with empirical data. Our model shows that single-elimination tournaments are efficient but unfair: the number of games is proportional to the number of teams N, but the probability that the weakest team wins decays only algebraically with N. In contrast, leagues, where every team plays every other team, are fair but inefficient: the top √{N} of teams remain in contention for the championship, while the probability that the weakest team becomes champion is exponentially small. We also propose a gradual elimination schedule that consists of a preliminary round and a championship round. Initially, teams play a small number of preliminary games, and subsequently, a few teams qualify for the championship round. This algorithm is fair and efficient: the best team wins with a high probability and the number of games scales as N 9/5, whereas traditional leagues require N 3 games to fairly determine a champion.

Hypnosis, suggestions, and altered states of consciousness: experimental evaluation of the new cognitive-behavioral theory and the traditional trance-state theory of "hypnosis".

PubMed

Barber, T X; Wilson, S C

1977-10-07

Sixty-six subjects were tested on a new scale for evaluating "hypnotic-like" experiences (The Creative Imagination Scale), which includes ten standardized test-suggestions (e.g. suggestions for arm heaviness, finger anesthesia, time distortion, and age regression). The subjects were randomly assigned to one of three treatment groups (Think-With Instructions, trance induction, and Control), with 22 subjects to each group. The new Cognitive-Behavioral Theory predicted that subjects exposed to preliminary instructions designed to demonstrate how to think and imagine along with the suggested themes (Think-With Instructions) would be more responsive to test-suggestions for anesthesia, time distortion, age regression, and so on, than subjects exposed to a trance-induction procedure. On the other hand, the traditional Trance State Theory predicted that a trance induction would be more effective than Think-With Instructions in enhancing responses to such suggestions. Subjects exposed to the Think-With Instructions obtained significantly higher scores on the test-suggestions than those exposed either to the traditional trance-induction procedure or to the control treatment. Scores of subjects who received the trance-induction procedure were not significantly different from those of the subjects who received the control treatment. The results thus supported the new Cognitive-Behavioral Theory and contradicted the traditional Trance State Theory of hypnosis. Two recent experiments, by De Stefano and by Katz, confirmed the above experimental results and offered further support for the Cognitive-Behavioral Theory. In both recent experiments, subjects randomly assigned to a "Think-With Instructions" treatment were more responsive to test-suggestions than those randomly assigned to a traditional trance-induction treatment.

Low-dose naltrexone for the treatment of fibromyalgia: findings of a small, randomized, double-blind, placebo-controlled, counterbalanced, crossover trial assessing daily pain levels.

PubMed

Younger, Jarred; Noor, Noorulain; McCue, Rebecca; Mackey, Sean

2013-02-01

To determine whether low dosages (4.5 mg/day) of naltrexone reduce fibromyalgia severity as compared with the nonspecific effects of placebo. In this replication and extension study of a previous clinical trial, we tested the impact of low-dose naltrexone on daily self-reported pain. Secondary outcomes included general satisfaction with life, positive mood, sleep quality, and fatigue. Thirty-one women with fibromyalgia participated in the randomized, double-blind, placebo-controlled, counterbalanced, crossover study. During the active drug phase, participants received 4.5 mg of oral naltrexone daily. An intensive longitudinal design was used to measure daily levels of pain. When contrasting the condition end points, we observed a significantly greater reduction of baseline pain in those taking low-dose naltrexone than in those taking placebo (28.8% reduction versus 18.0% reduction; P = 0.016). Low-dose naltrexone was also associated with improved general satisfaction with life (P = 0.045) and with improved mood (P = 0.039), but not improved fatigue or sleep. Thirty-two percent of participants met the criteria for response (defined as a significant reduction in pain plus a significant reduction in either fatigue or sleep problems) during low-dose naltrexone therapy, as contrasted with an 11% response rate during placebo therapy (P = 0.05). Low-dose naltrexone was rated equally tolerable as placebo, and no serious side effects were reported. The preliminary evidence continues to show that low-dose naltrexone has a specific and clinically beneficial impact on fibromyalgia pain. The medication is widely available, inexpensive, safe, and well-tolerated. Parallel-group randomized controlled trials are needed to fully determine the efficacy of the medication. Copyright © 2013 by the American College of Rheumatology.

Happy Despite Pain: A Randomized Controlled Trial of an 8-Week Internet-delivered Positive Psychology Intervention for Enhancing Well-being in Patients With Chronic Pain.

PubMed

Peters, Madelon L; Smeets, Elke; Feijge, Marion; van Breukelen, Gerard; Andersson, Gerhard; Buhrman, Monica; Linton, Steven J

2017-11-01

There is preliminary evidence for the efficacy of positive psychology interventions for pain management. The current study examined the effects of an internet-based positive psychology self-help program for patients with chronic musculoskeletal pain and compared it with an internet-based cognitive-behavioral program. A randomized controlled trial was carried out with 3 conditions: an internet-delivered positive psychology program, an internet-delivered cognitive-behavioral program and waitlist control. A total of 276 patients were randomized to 1 of the 3 conditions and posttreatment data were obtained from 206 patients. Primary outcomes were happiness, depression, and physical impairments at posttreatment and at 6-month follow-up. Intention-to-treat analyses were carried out using mixed regression analyses. Both treatments led to significant increases in happiness and decreases in depression. Physical impairments did not significantly decrease compared with waitlist. Improvements in happiness and depression were maintained until 6-month follow-up. There were no overall differences in the efficacy of the 2 active interventions but effects seemed to be moderated by education. Patients with a higher level of education profited slightly more from the positive psychology intervention than from the cognitive-behavioral program. The results suggest that an internet-based positive psychology and cognitive-behavioral self-help interventions for the management of chronic pain are clinically useful. Because the self-help exercises as used in the current program do not require therapist involvement, dissemination potential is large. Further studies should examine whether it can best be used as stand-alone or add-on treatment combined with established pain treatment programs.

Weight gain in preterm infants following parent-administered Vimala massage: a randomized controlled trial.

PubMed

Gonzalez, Alma Patricia; Vasquez-Mendoza, Guadalupe; García-Vela, Alfonso; Guzmán-Ramirez, Andres; Salazar-Torres, Marcos; Romero-Gutierrez, Gustavo

2009-04-01

Massage has been proposed as a way of facilitating development and growth of newborns through its effects on increasing blood flow, heart rate, digestion, and immunity. Massage might increase basal metabolism and nutrient absorption through endocrine effects such as increase in insulin and adrenaline and decrease in cortisol. Preliminary studies have suggested significant impact on weight gain with shortening of in-hospital stays of up to 6 days. We compared weight gain among preterm infants receiving Vimala massage plus usual care versus usual care alone. A randomized controlled trial was conducted. Sixty clinically stable preterm newborns with a corrected gestational age of 30 to 35 weeks receiving enteral nutrition in the hospital nursery were included. Half of them were assigned at random to receive Vimala massage twice daily for 10 days plus usual nursery care; the others received usual nursery care. Weight, head circumference, caloric intake, and nutritional method were recorded daily. Group characteristics were compared with analysis of variance, T test, and chi (2) test as appropriate. There were no differences between groups in gender, gestational age, initial weight, head circumference, and caloric intake and type of nutrition at baseline. Infants receiving massage had a larger weight gain versus the control group since the third day (188.2 +/- 41.20 g/kg versus 146.7 +/- 56.43 g/kg, P < 0.001). Hospital stay was shorter in infants receiving massage and usual nursery care (15.63 +/- 5.41 days versus 19.33 +/- 7.92 days, P = 0.03). The addition of parent-administered Vimala massage to usual nursery care resulted in increased weight gain and shorter hospital stay among clinically stable preterm newborns.

Effectiveness of Disease-Specific Cognitive Behavioral Therapy on Anxiety, Depression, and Quality of Life in Youth With Inflammatory Bowel Disease: A Randomized Controlled Trial.

PubMed

Stapersma, Luuk; van den Brink, Gertrude; van der Ende, Jan; Szigethy, Eva M; Beukers, Ruud; Korpershoek, Thea A; Theuns-Valks, Sabine D M; Hillegers, Manon H J; Escher, Johanna C; Utens, Elisabeth M W J

2018-05-29

To evaluate the effectiveness of a disease-specific cognitive behavioral therapy (CBT) protocol on anxiety and depressive symptoms and health-related quality of life (HRQOL) in adolescents and young adults with inflammatory bowel disease (IBD). A parallel group randomized controlled trial was conducted in 6 centers of (pediatric) gastroenterology. Included were 70 patients and young adults (10-25 years) with IBD and subclinical anxiety and/or depressive symptoms. Patients were randomized into 2 groups, stratified by center: (a) standard medical care (care-as-usual [CAU]) plus disease-specific manualized CBT (Primary and Secondary Control Enhancement Training for Physical Illness; PASCET-PI), with 10 weekly sessions, 3 parent sessions, and 3 booster sessions (n = 37), or (b) CAU only (n = 33). Primary analysis concerned the reliable change in anxiety and depressive symptoms after 3 months (immediate posttreatment assessment). Exploratory analyses concerned (1) the course of anxiety and depressive symptoms and HRQOL in subgroups based on age, and (2) the influence of age, gender, and disease type on the effect of the PASCET-PI. Overall, all participants improved significantly in their anxiety and depressive symptoms and HRQOL, regardless of group, age, gender, and disease type. Primary chi-square tests and exploratory linear mixed models showed no difference in outcomes between the PASCET-PI (n = 35) and the CAU group (n = 33). In youth with IBD and subclinical anxiety and/or depressive symptoms, preliminary results of immediate post-treatment assessment indicated that a disease-specific CBT added to standard medical care did not perform better than standard medical care in improving psychological symptoms or HRQOL. ClinicalTrials.gov: NCT02265588.

Training the removal of negative information from working memory: A preliminary investigation of a working memory bias modification task.

PubMed

Robinaugh, Donald J; Crane, Margaret E; Enock, Philip M; McNally, Richard J

2016-01-01

Rumination in depressed adults is associated with a bias toward retaining negative information in working memory. We developed a task designed to modify this cognitive bias by having subjects repeatedly practice removing negative words from working memory, thereby enabling them to retain positive and neutral words. To assess the efficacy of this task, we recruited 60 adults who reported elevated repetitive negative thought (RNT) and randomly assigned them to receive a single administration of either the working memory bias modification (WMBM) task or a control task. Subjects in the WMBM condition exhibited greater reduction in proactive interference for negative information than did those in the control condition. These results suggest that the WMBM task reduces biased retention of negative information in working memory and, thus, may be useful in investigating the possible causal role of this cognitive bias in RNT or depression.

VIRTUAL REALITY HYPNOSIS FOR PAIN ASSOCIATED WITH RECOVERY FROM PHYSICAL TRAUMA1,2

PubMed Central

Patterson, David R.; Jensen, Mark P.; Wiechman, Shelley A.; Sharar, Sam R.

2010-01-01

Pain following traumatic injuries is common, can impair injury recovery and is often inadequately treated. In particular, the role of adjunctive nonpharmacologic analgesic techniques is unclear. The authors report a randomized, controlled study of 21 hospitalized trauma patients to assess the analgesic efficacy of virtual reality hypnosis (VRH)—hypnotic induction and analgesic suggestion delivered by customized virtual reality (VR) hardware/software. Subjective pain ratings were obtained immediately and 8 hours after VRH (used as an adjunct to standard analgesic care) and compared to both adjunctive VR without hypnosis and standard care alone. VRH patients reported less pain intensity and less pain unpleasantness compared to control groups. These preliminary findings suggest that VRH analgesia is a novel technology worthy of further study, both to improve pain management and to increase availability of hypnotic analgesia to populations without access to therapist-provided hypnosis and suggestion. PMID:20509069

Development and Evaluation of a Multimedia CD-ROM for Exercise During Pregnancy and Postpartum

PubMed Central

Hausenblas, Heather A.; Brewer, Britton W.; Van Raalte, Judy L.; Cook, Brian; Downs, Danielle Symons; Weis, Carol Ann; Nigg, Claudio; Cruz, Amelia

2008-01-01

Objective To meet the need for an interactive product on exercise during pregnancy and postpartum, we developed and evaluated a personally-tailored multimedia CD-ROM. Methods Pregnant and postpartum women, who were randomly assigned to either the experimental group (PregXercise™ CD-ROM) or the control group (CD-ROM with neutral content), navigated through the CD-ROM for 1 hour. Main outcomes were exercise self-efficacy and knowledge. Results In analyses of covariance, compared with the control group, the experimental group had significant increases in self-efficacy and knowledge. Conclusion The multimedia CD-ROM delivering information about exercise motivation, guidelines, and prescription was effective in improving exercise self-efficacy and knowledge. Practice Implications Our preliminary results illustrate that healthcare professionals and researchers may use interactive multimedia for improving exercise behavior and related outcomes with pregnant and postpartum women. PMID:18068940

Omega-3 Fatty Acid and Nutrient Deficits in Adverse Neurodevelopment and Childhood Behaviors

PubMed Central

Hibbeln, Joseph. R.; Gow, Rachel V.

2014-01-01

Synopsis Nutritional insufficiencies of omega-3 highly unsaturated fatty acids (HUFAs) may have adverse effects on brain development and neurodevelopmental outcomes. A recent meta-analysis of ten randomized controlled trials of omega-3 HUFAs reported a small to modest effect size for the efficacy of omega-3 for treating symptoms of ADHD in youth. Several controlled trials of omega-3 HUFAs combined with micronutrients (vitamins, minerals) show sizeable reductions in aggressive, antisocial, and violent behavior in youth and in young adult prisoners. Meta-analyses report efficacy for depressive symptoms in adults, and preliminary findings suggest anti-suicidal properties in adults, but studies in youth are insufficient to draw any conclusions regarding mood. Dietary adjustments to increase omega-3 and reduce omega-6 HUFA consumption are sensible recommendations for youth and adults based on general health considerations, while the evidence base for omega-3 HUFAs as potential psychiatric treatments develops. PMID:24975625

Mindfulness Meditation for Substance Use Disorders: A Systematic Review

PubMed Central

Zgierska, Aleksandra; Rabago, David; Chawla, Neharika; Kushner, Kenneth; Koehler, Robert; Marlatt, Allan

2009-01-01

Relapse is common in substance use disorders (SUDs), even among treated individuals. The goal of this article was to systematically review the existing evidence on mindfulness meditation-based interventions (MM) for SUDs. The comprehensive search for and review of literature found over 2,000 abstracts and resulted in 25 eligible manuscripts (22 published, 3 unpublished: 8 RCTs, 7 controlled non-randomized, 6 non-controlled prospective, 2 qualitative studies, 1 case report). When appropriate, methodological quality, absolute risk reduction, number needed to treat, and effect size (ES) were assessed. Overall, although preliminary evidence suggests MM efficacy and safety, conclusive data for MM as a treatment of SUDs are lacking. Significant methodological limitations exist in most studies. Further, it is unclear which persons with SUDs might benefit most from MM. Future trials must be of sufficient sample size to answer a specific clinical question and should target both assessment of effect size and mechanisms of action. PMID:19904664

A longitudinal examination of factors associated with social support satisfaction among HIV-positive young Black men who have sex with men.

PubMed

McCullagh, Charlotte; Quinn, Katherine; Voisin, Dexter R; Schneider, John

2017-12-01

This study examined the long-term predictors of social support satisfaction among HIV-positive young Black men who have sex with men (YBMSM). Data were collected across three waves between October 2012 and November 2014 as part of the baseline assessment from Project nGage, a preliminary efficacy randomized control study examining the role of social support in improving HIV care among YBMSM. The sample included 92 YBMSM aged 18-29. Major results controlling for age, education and intervention effects indicated that psychological health, social network size, and education at baseline predicted differences in social support satisfaction at Wave 3, with no significant effects based on length of HIV diagnosis. Therefore, interventions that are intended to promote the quality of life for YBMSM and their engagement and retention in HIV care must focus on their psychological health concerns and network size.

Evidence from the Cochrane Collaboration for Traditional Chinese Medicine Therapies

PubMed Central

Wieland, Susan; Kimbrough, Elizabeth; Cheng, Ker; Berman, Brian M.

2009-01-01

Abstract Background The Cochrane Collaboration, an international not-for-profit organization that prepares and maintains systematic reviews of randomized trials of health care therapies, has produced reviews summarizing much of the evidence on Traditional Chinese Medicine (TCM). Our objective was to review the evidence base according to Cochrane systematic reviews. Methods In order to detect reviews focusing on TCM, we searched the titles and abstracts of all reviews in Issue 4, 2008 of the Cochrane Database of Systematic Reviews. For each review, we extracted data on the number of trials included and the total number of participants. We provided an indication of the strength of the review findings by assessing the reviewers' abstract conclusions statement. We supplemented our assessment of the abstract conclusions statements with a listing of the comparisons and outcomes showing statistically significant meta-analyses results. Results We identified 70 Cochrane systematic reviews of TCM, primarily acupuncture (n = 26) and Chinese herbal medicine (n = 42), and 1 each of moxibustion and t'ai chi. Nineteen (19) of 26 acupuncture reviews and 22/42 herbal medicine reviews concluded that there was not enough good quality trial evidence to make any conclusion about the efficacy of the evaluated treatment, while the remaining 7 acupuncture and 20 herbal medicine reviews and each of the moxibustion and t'ai chi reviews indicated a suggestion of benefit, which was qualified by a caveat about the poor quality and quantity of studies. Most reviews included many distinct interventions, controls, outcomes, and populations, and a large number of different comparisons were made, each with a distinct forest plot. Conclusions Most Cochrane systematic reviews of TCM are inconclusive, due specifically to the poor methodology and heterogeneity of the studies reviewed. Some systematic reviews provide preliminary evidence of Chinese medicine's benefits to certain patient populations, underscoring the importance and appropriateness of further research. These preliminary findings should be considered tentative and need to be confirmed with rigorous randomized controlled trials. PMID:19757977

A yoga intervention for type 2 diabetes risk reduction: a pilot randomized controlled trial

PubMed Central

2014-01-01

Background Type 2 diabetes is a major health problem in many countries including India. Yoga may be an effective type 2 diabetes prevention strategy in India, particularly given its cultural familiarity. Methods This was a parallel, randomized controlled pilot study to collect feasibility and preliminary efficacy data on yoga for diabetes risk factors among people at high risk of diabetes. Primary outcomes included: changes in BMI, waist circumference, fasting blood glucose, postprandial blood glucose, insulin, insulin resistance, blood pressure, and cholesterol. We also looked at measures of psychological well-being including changes in depression, anxiety, positive and negative affect and perceived stress. Forty-one participants with elevated fasting blood glucose in Bangalore, India were randomized to either yoga (n = 21) or a walking control (n = 20). Participants were asked to either attend yoga classes or complete monitored walking 3–6 days per week for eight weeks. Randomization and allocation was performed using computer-generated random numbers and group assignments delivered in sealed, opaque envelopes generated by off-site study staff. Data were analyzed based on intention to treat. Results This study was feasible in terms of recruitment, retention and adherence. In addition, yoga participants had significantly greater reductions in weight, waist circumference and BMI versus control (weight −0.8 ± 2.1 vs. 1.4 ± 3.6, p = 0.02; waist circumference −4.2 ± 4.8 vs. 0.7 ± 4.2, p < 0.01; BMI −0.2 ± 0.8 vs. 0.6 ± 1.6, p = 0.05). There were no between group differences in fasting blood glucose, postprandial blood glucose, insulin resistance or any other factors related to diabetes risk or psychological well-being. There were significant reductions in systolic and diastolic blood pressure, total cholesterol, anxiety, depression, negative affect and perceived stress in both the yoga intervention and walking control over the course of the study. Conclusion Among Indians with elevated fasting blood glucose, we found that participation in an 8-week yoga intervention was feasible and resulted in greater weight loss and reduction in waist circumference when compared to a walking control. Yoga offers a promising lifestyle intervention for decreasing weight-related type 2 diabetes risk factors and potentially increasing psychological well-being. Trial registration ClinicalTrials.gov Identified NCT00090506. PMID:24980650

Studies in astronomical time series analysis: Modeling random processes in the time domain

NASA Technical Reports Server (NTRS)

Scargle, J. D.

1979-01-01

Random process models phased in the time domain are used to analyze astrophysical time series data produced by random processes. A moving average (MA) model represents the data as a sequence of pulses occurring randomly in time, with random amplitudes. An autoregressive (AR) model represents the correlations in the process in terms of a linear function of past values. The best AR model is determined from sampled data and transformed to an MA for interpretation. The randomness of the pulse amplitudes is maximized by a FORTRAN algorithm which is relatively stable numerically. Results of test cases are given to study the effects of adding noise and of different distributions for the pulse amplitudes. A preliminary analysis of the optical light curve of the quasar 3C 273 is given.

The effect of school meals with fatty fish on adolescents' self-reported symptoms for mental health: FINS-TEENS - a randomized controlled intervention trial.

PubMed

Skotheim, Siv; Handeland, Katina; Kjellevold, Marian; Øyen, Jannike; Frøyland, Livar; Lie, Øyvind; Eide Graff, Ingvild; Baste, Valborg; Stormark, Kjell Morten; Dahl, Lisbeth

2017-01-01

There is a growing body of evidence linking fish consumption and n-3 LCPUFAs to mental health. Still, the results from randomized trials with n-3 LCPUFAs show conflicting results, and it is possible that the combined effect of several nutrients in fish may explain the observed associations. To aim of the present study was to investigate if school meals with fatty fish three times per week for 12 weeks could alter mental health in a sample of typically developing adolescents. In the Fish Intervention Studies-TEENS (FINS-TEENS), adolescents from eight secondary schools (n=425) in Norway, were randomized to receive school meals with fatty fish, meat or n-3 LCPUFA supplements. Mental health was assessed with the Strengths and Difficulties Questionnaire (SDQ) and the differences between the groups were assessed with linear mixed effect models, unadjusted and adjusted for baseline and dietary compliance. The results showed no effects of school meals with fatty fish compared to similar meals with meat or n-3 LCPUFAs on the adolescents' self-reported symptom scores for mental health. Among adolescents scoring above the SDQ cut-offs (high-scorers), the fish- improved less than the meat group in the self-reported symptom scores for total difficulties- and emotional problems. However, the findings should be regarded as preliminary, as the analyses for the high-scorer group were underpowered. In conclusion, serving school meals with fatty fish did not alter mental health in a typically developing sample of adolescents. It is possible that serving healthy school meals with meat is more beneficial than similar meals with fatty fish in adolescents scoring high on mental health problems. However, the results should be seen as preliminary, as the dietary compliance in the fish group was low and the analyses in the high score group underpowered. Thus, further studies should investigate the associations between fish consumption and adolescents' mental health.

The Effects of Game-Based Breathing Exercise on Pulmonary Function in Stroke Patients: A Preliminary Study.

PubMed

Joo, Sunghee; Shin, Doochul; Song, Changho

2015-06-22

Reduction of respiratory function along with hemiparesis leads to decreased endurance, dyspnea, and increased sedentary behavior, as well as to an increased risk of stroke. The main purpose of this study was to investigate the preliminary effects of game-based breathing exercise (GBE) on pulmonary function in stroke patients. Thirty-eight in-patients with stroke (22 men, 16 women) were recruited for the study. Participants were randomly allocated into 2 groups: patients assigned to the GBE group (n=19), and the control group (n=19). The GBE group participated in a GBE program for 25 minutes a day, 3 days a week, during a 5 week period. For the same period, both groups participated in a conventional stroke rehabilitation program. Forced vital capacity (FVC), forced expiratory volume at 1 second (FEV1), FEV1/FVC, and maximum voluntary ventilation (MVV) were measured by a spirometer in pre- and post-testing. The GBE group had significantly improved FVC, FEV1, and MVV values compared with the control group (p<0.05), although there was no significant difference in FEV1/FVC value between groups. Significant short-term effects of the GBE program on pulmonary function in stroke patients were recorded in this study. These findings gave some indications that it may be feasible to include GBE in rehabilitation interventions with this population.

Surface EEG-Transcranial Direct Current Stimulation (tDCS) Closed-Loop System.

PubMed

Leite, Jorge; Morales-Quezada, Leon; Carvalho, Sandra; Thibaut, Aurore; Doruk, Deniz; Chen, Chiun-Fan; Schachter, Steven C; Rotenberg, Alexander; Fregni, Felipe

2017-09-01

Conventional transcranial direct current stimulation (tDCS) protocols rely on applying electrical current at a fixed intensity and duration without using surrogate markers to direct the interventions. This has led to some mixed results; especially because tDCS induced effects may vary depending on the ongoing level of brain activity. Therefore, the objective of this preliminary study was to assess the feasibility of an EEG-triggered tDCS system based on EEG online analysis of its frequency bands. Six healthy volunteers were randomized to participate in a double-blind sham-controlled crossover design to receive a single session of 10[Formula: see text]min 2[Formula: see text]mA cathodal and sham tDCS. tDCS trigger controller was based upon an algorithm designed to detect an increase in the relative beta power of more than 200%, accompanied by a decrease of 50% or more in the relative alpha power, based on baseline EEG recordings. EEG-tDCS closed-loop-system was able to detect the predefined EEG magnitude deviation and successfully triggered the stimulation in all participants. This preliminary study represents a proof-of-concept for the development of an EEG-tDCS closed-loop system in humans. We discuss and review here different methods of closed loop system that can be considered and potential clinical applications of such system.

Can mindfulness-based interventions influence cognitive functioning in older adults? A review and considerations for future research.

PubMed

Berk, Lotte; van Boxtel, Martin; van Os, Jim

2017-11-01

An increased need exists to examine factors that protect against age-related cognitive decline. There is preliminary evidence that meditation can improve cognitive function. However, most studies are cross-sectional and examine a wide variety of meditation techniques. This review focuses on the standard eight-week mindfulness-based interventions (MBIs) such as mindfulness-based stress reduction (MBSR) and mindfulness-based cognitive therapy (MBCT). We searched the PsychINFO, CINAHL, Web of Science, COCHRANE, and PubMed databases to identify original studies investigating the effects of MBI on cognition in older adults. Six reports were included in the review of which three were randomized controlled trials. Studies reported preliminary positive effects on memory, executive function and processing speed. However, most reports had a high risk of bias and sample sizes were small. The only study with low risk of bias, large sample size and active control group reported no significant findings. We conclude that eight-week MBI for older adults are feasible, but results on cognitive improvement are inconclusive due a limited number of studies, small sample sizes, and a high risk of bias. Rather than a narrow focus on cognitive training per se, future research may productively shift to investigate MBI as a tool to alleviate suffering in older adults, and to prevent cognitive problems in later life already in younger target populations.

Comparison of auto-fluorescence and tetracycline fluorescence for guided bone surgery of medication-related osteonecrosis of the jaw: a randomized controlled feasibility study.

PubMed

Ristow, O; Otto, S; Geiß, C; Kehl, V; Berger, M; Troeltzsch, M; Koerdt, S; Hohlweg-Majert, B; Freudlsperger, C; Pautke, C

2017-02-01

Recent studies have indicated that bone shows auto-fluorescence under an appropriate fluorescence lamp. The aim of this preliminary study was to compare the success rates of the established tetracycline fluorescence-guided bone surgery with auto-fluorescence-guided bone surgery in the treatment of medication-related osteonecrosis of the jaw (MRONJ). Forty patients suffering from MRONJ were referred for surgical treatment and were divided randomly into two groups: auto-fluorescence (n=20) or tetracycline fluorescence (n=20) guided bone surgery. The primary endpoint was treatment success, defined as the absence of exposed bone at 8 weeks after surgery. Secondary outcomes assessed were mucosal integrity, signs of infection, pain, and loss of sensitivity; these were evaluated descriptively at 10 days, 8 weeks, 6 months, and 1 year after surgery. At 8 weeks postoperative, 18/20 patients (90%) in the auto-fluorescence group and 17/20 patients (85%) in the tetracycline fluorescence group showed mucosal integrity (P>0.05). At the last follow-up, 94% in the auto-fluorescence group and 89% in the tetracycline fluorescence group presented complete mucosal coverage with no exposed bone, infection, or pain (P>0.05). There was no significant difference between the two techniques for any of the secondary outcomes (P>0.05). The results of this preliminary study show that auto-fluorescence-guided bone surgery has comparable success rates to the established tetracycline fluorescence-guided bone surgery. Copyright © 2016 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

A preliminary clinical evaluation of external snehan and asanas in the patients of sciatica

PubMed Central

Singh, Akhilesh K; Singh, Om P

2013-01-01

Lower back pain radiating to either on one leg or both legs along the course of sciatic nerve is a common ailment in the clinical practice, this type of peculiar symptomatology is termed as "Sciatica" in modern medicine. The medical treatment is unsatisfactory for both the patient and the neurosurgeons, as the surgical treatment has its own hazards and the cost of the surgical procedure and medical treatment is prohibitory to most of the Indian patients. Hence, most of the patients present themselves to the practitioners of Indian medicines like Ayurveda and yoga. This study was designed to evaluate the preliminary clinical effects of Bahya Snehan and Asanas in the patients of sciatica. This was a prospective randomized active control trial. A total of 60 participants showing classical symptoms of Sciatica between 18 and 65 years of age were randomly assigned to receive Ayurvedic or Yogic measure. One group received Snehan (external) with Bhujang and Shalabh Asana while another group received Bhujang and Salabh Asana only. Both groups practiced supervised intervention for 4 weeks. The signs and symptoms like Katishool (pain), tenderness, Stambha (rigidity), difficulty in walking, pain on bending forward were graded and interpreted at the end of the trail Significant improvement was observed in both groups before and after external Snehan with Bhujang and Shalabh Asana and in another group Bhujang and Salabh Asana only. Conclusions: Both groups, one with Snehan with asanas and the second with asanas only showed significant improvement in the patients of sciatica (Gridhrasi). PMID:23439799

Sharing Resources In Mobile/Satellite Communications

NASA Technical Reports Server (NTRS)

Yan, Tsun-Yee; Sue, Miles K.

1992-01-01

Report presents preliminary theoretical analysis of several alternative schemes for allocation of satellite resource among terrestrial subscribers of landmobile/satellite communication system. Demand-access and random-access approaches under code-division and frequency-division concepts compared.

Finite Element Analysis of the Random Response Suppression of Composite Panels at Elevated Temperatures using Shape Memory Alloy Fibers

NASA Technical Reports Server (NTRS)

Turner, Travis L.; Zhong, Z. W.; Mei, Chuh

1994-01-01

A feasibility study on the use of shape memory alloys (SMA) for suppression of the random response of composite panels due to acoustic loads at elevated temperatures is presented. The constitutive relations for a composite lamina with embedded SMA fibers are developed. The finite element governing equations and the solution procedures for a composite plate subjected to combined acoustic and thermal loads are presented. Solutions include: 1) Critical buckling temperature; 2) Flat panel random response; 3) Thermal postbuckling deflection; 4) Random response of a thermally buckled panel. The preliminary results demonstrate that the SMA fibers can completely eliminate the thermal postbuckling deflection and significantly reduce the random response at elevated temperatures.

Antibiotic treatment to prevent postextraction complications: a monocentric, randomized clinical trial. Preliminary outcomes.

PubMed

Barone, Antonio; Marchionni, Francesco S; Cinquini, Chiara; Cipolli Panattoni, Andrea; Toti, Paolo; Marconcini, Simone; Covani, Ugo; Gabriele, Mario

2017-08-01

Tooth extraction is a very common procedure in oral surgery. Despite this, very little information is available in the literature as to the antibiotic management of the patient. The aim of this study is to evaluate whether the antibiotic prophylaxis could be beneficial in preventing postextraction local complications and whether the use of a probiotic could help reduce the antibiotic gastro-intestinal side effects. One hundred eleven patients meeting the inclusion criteria were initially included in this randomized clinical trial and randomly allocated to one of the three experimental groups according to a computer-generated randomization list. Patients allocated to the group 1 were given amoxicillin+clavulanic acid (2 g/day for 6 days), patients allocated to the group 2 received antibiotic + probiotic (Bifidobacterium longum+lactoferrin) and patients allocated to the group 3 received no antibiotic therapy after the extraction. To evaluate post-extractive complications, controls were performed at days 7, 14 and 21 after the extraction. At T1 pain at the surgical site was present in the 48%, 30% and 71.4% of the patients belonging respectively to the antibiotic alone group, to the antibiotic+probiotic group and to the control group. The mean Numeric Rating Score (NRS) score was 1.56±1.91, 1.08±1.93, 2.02±2.27 respectively (P=0.0498). Two patients belonging to the control group experienced dry socket. In addition, 9 patients (33.3%) in the antibiotic-alone group and 1 patient (2.7%) in the antibiotic+probiotic group reported intestinal distension (P=0.0012), 7 days after surgery. Finally, diarrhea was recorded in 5 patients of the antibiotic alone group (18.5%), on the other hand, no patients of the antibiotic+probiotic group and the control group reported diarrhea. Postextractive complications observed in each group have been mild and fast to resolve. The antibiotic administration showed a decrease in pain suffered by patients but a higher incidence of gastrointestinal side effects, such as abdominal distension and diarrhea, which seemed to be relieved by the concomitant use of the probiotic.

PRELIMINARY COST ESTIMATES OF POLLUTION CONTROL TECHNOLOGIES FOR GEOTHERMAL DEVELOPMENTS

EPA Science Inventory

This report provides preliminary cost estimates of air and water pollution control technologies for geothermal energy conversion facilities. Costs for solid waste disposal are also estimated. The technologies examined include those for control of hydrogen sulfide emissions and fo...

Canoe game-based virtual reality training to improve trunk postural stability, balance, and upper limb motor function in subacute stroke patients: a randomized controlled pilot study.

PubMed

Lee, Myung-Mo; Shin, Doo-Chul; Song, Chang-Ho

2016-07-01

[Purpose] This study was aimed at investigating the preliminary therapeutic efficacy and usefulness of canoe game-based virtual reality training for stroke patients. [Subjects and Methods] Ten stroke patients were randomly assigned to an experimental group (EG; n=5) or a control group (CG; n=5). Patients in both groups participated in a conventional rehabilitation program, but those in the EG additionally participated in a 30-min canoe game-based virtual reality training program 3 days a week for 4 weeks. Therapeutic efficacy was assessed based on trunk postural stability, balance, and upper limb motor function. In addition, the usefulness of canoe game-based virtual reality training was assessed in the EG and therapist group (TG; n=20), which consisted of physical and occupational therapists, by using the System Usability Scale (SUS). [Results] Improvements in trunk postural stability, balance, and upper limb motor function were observed in the EG and CG, but were greater in the EG. The mean SUS scores in the EG and TG were 71 ± 5.2 and 74.2 ± 4.8, respectively. [Conclusion] Canoe game-based virtual reality training is an acceptable and effective intervention for improving trunk postural stability, balance, and upper limb motor function in stroke patients.

Integrated Behavior Therapy for Selective Mutism: a randomized controlled pilot study.

PubMed

Bergman, R Lindsey; Gonzalez, Araceli; Piacentini, John; Keller, Melody L

2013-10-01

To evaluate the feasibility, acceptability, and preliminary efficacy of a novel behavioral intervention for reducing symptoms of selective mutism and increasing functional speech. A total of 21 children ages 4 to 8 with primary selective mutism were randomized to 24 weeks of Integrated Behavior Therapy for Selective Mutism (IBTSM) or a 12-week Waitlist control. Clinical outcomes were assessed using blind independent evaluators, parent-, and teacher-report, and an objective behavioral measure. Treatment recipients completed a three-month follow-up to assess durability of treatment gains. Data indicated increased functional speaking behavior post-treatment as rated by parents and teachers, with a high rate of treatment responders as rated by blind independent evaluators (75%). Conversely, children in the Waitlist comparison group did not experience significant improvements in speaking behaviors. Children who received IBTSM also demonstrated significant improvements in number of words spoken at school compared to baseline, however, significant group differences did not emerge. Treatment recipients also experienced significant reductions in social anxiety per parent, but not teacher, report. Clinical gains were maintained over 3 month follow-up. IBTSM appears to be a promising new intervention that is efficacious in increasing functional speaking behaviors, feasible, and acceptable to parents and teachers. Copyright © 2013 Elsevier Ltd. All rights reserved.

A systematic review of SNAPO (Smoking, Nutrition, Alcohol, Physical activity and Obesity) randomized controlled trials in young adult men.

PubMed

Ashton, Lee M; Morgan, Philip J; Hutchesson, Melinda J; Rollo, Megan E; Young, Myles D; Collins, Clare E

2015-12-01

To investigate the effectiveness of Smoking, Nutrition, Alcohol, Physical activity and Obesity (SNAPO) interventions in young men exclusively. The secondary aim was to evaluate the recruitment, retention and engagement strategies. A search with no date restrictions was conducted across seven databases. Randomized controlled trials recruiting young men only (aged 18-35 years) into interventions targeting any SNAPO risk factors were included. Ten studies were included (two nutrition, six alcohol use, two targeting multiple SNAPO risk factors). Six studies (two nutrition, three alcohol use and one targeting multiple SNAPO risk factors) demonstrated significant positive short-term intervention effects, but impact was either not assessed beyond the intervention (n=3), had short-term follow-up (≤6 months) (n=2) or not sustained beyond six months (n=1). Overall, a high risk of bias was identified across studies. Only one study undertook a power calculation and recruited the required sample size. Adequate retention was achieved in three studies. Effectiveness of engagement strategies was not reported in any studies. Despite preliminary evidence of short-term effectiveness of SNAPO interventions in young men, few studies characterized by a high risk of bias were identified. High quality SNAPO interventions for young men are warranted. Copyright © 2015 Elsevier Inc. All rights reserved.

Depression Treatment by Non-Mental-Health Providers: Incremental Evidence for the Effectiveness of Listening Visits

PubMed Central

O’Hara, Michael W.; Segre, Lisa S.

2017-01-01

Maternal depression is a prevalent public health problem, particularly for low-income mothers of young children. Intervention development efforts, which often focus on surmounting instrumental barriers to care, have not successfully engaged and retained women in treatment. Task-sharing approaches like Listening Visits (LV) could overcome key instrumental and psychological barriers by leveraging the access of trusted, community caregivers to deliver treatment. A recent randomized controlled trial (RCT) demonstrated the efficacy of LV delivered by non-mental-health providers as compared to usual care. The present report presents results from a follow-up phase of that RCT during which participants who had completed LV were followed for an additional 8 weeks and completed measures of depression and quality of life. In addition, participants who were initially randomized to the wait-list control group received LV and were assessed. Treatment gains previously observed in participants completing LV were enhanced during the 8-week follow-up period. Participants receiving LV during the follow-up period experienced significant improvement in depressive symptoms. Results demonstrate the sustainability of LV delivered by non-mental-health providers, and provide preliminary evidence for the replicability of this approach in a sample of predominately low-income pregnant women and mothers of young children. PMID:28349604

Preliminary findings describing participant experience with iSTEP, an mHealth intervention to increase physical activity and improve neurocognitive function in people living with HIV

PubMed Central

Henry, Brook L.; Moore, David J.

2016-01-01

We assessed the feasibility and acceptability of using text messages to monitor and encourage physical activity in the first 21 participants enrolled in an ongoing randomized controlled trial evaluating a 16-week Short Message Service/Multimedia Message Service (SMS/MMS) intervention (iSTEP) designed to increase moderate physical activity and improve neurocognition in persons with HIV-associated neurocognitive disorders (HAND; iSTEP, n = 11; control group, n = 10). Data were collected during the intervention and from interviews conducted at the 16-week post-intervention visits. Text message response rates for both iSTEP and control participants were high (89% and 85%, respectively). Pedometer self-monitoring, step count goals, and milestone achievement texts were reported to facilitate physical activity. All iSTEP participants (100%) and 70% of control participants indicated that they would recommend the study to other people living with HIV. The results indicate that it is feasible to administer an SMS/MMS physical activity intervention to persons with HAND. PMID:26847379

Continuous infusion of low-dose unfractionated heparin after aneurysmal subarachnoid hemorrhage: a preliminary study of cognitive outcomes.

PubMed

James, Robert F; Khattar, Nicolas K; Aljuboori, Zaid S; Page, Paul S; Shao, Elaine Y; Carter, Lacey M; Meyer, Kimberly S; Daniels, Michael W; Craycroft, John; Gaughen, John R; Chaudry, M Imran; Rai, Shesh N; Everhart, D Erik; Simard, J Marc

2018-05-11

OBJECTIVE Cognitive dysfunction occurs in up to 70% of aneurysmal subarachnoid hemorrhage (aSAH) survivors. Low-dose intravenous heparin (LDIVH) infusion using the Maryland protocol was recently shown to reduce clinical vasospasm and vasospasm-related infarction. In this study, the Montreal Cognitive Assessment (MoCA) was used to evaluate cognitive changes in aSAH patients treated with the Maryland LDIVH protocol compared with controls. METHODS A retrospective analysis of all patients treated for aSAH between July 2009 and April 2014 was conducted. Beginning in 2012, aSAH patients were treated with LDIVH in the postprocedural period. The MoCA was administered to all aSAH survivors prospectively during routine follow-up visits, at least 3 months after aSAH, by trained staff blinded to treatment status. Mean MoCA scores were compared between groups, and regression analyses were performed for relevant factors. RESULTS No significant differences in baseline characteristics were observed between groups. The mean MoCA score for the LDIVH group (n = 25) was 26.4 compared with 22.7 in controls (n = 22) (p = 0.013). Serious cognitive impairment (MoCA ≤ 20) was observed in 32% of controls compared with 0% in the LDIVH group (p = 0.008). Linear regression analysis demonstrated that only LDIVH was associated with a positive influence on MoCA scores (β = 3.68, p =0.019), whereas anterior communicating artery aneurysms and fevers were negatively associated with MoCA scores. Multivariable linear regression analysis resulted in all 3 factors maintaining significance. There were no treatment complications. CONCLUSIONS This preliminary study suggests that the Maryland LDIVH protocol may improve cognitive outcomes in aSAH patients. A randomized controlled trial is needed to determine the safety and potential benefit of unfractionated heparin in aSAH patients.

A Controlled Pilot Trial of PainTracker Self-Manager, a Web-Based Platform Combined With Patient Coaching, to Support Patients' Self-Management of Chronic Pain.

PubMed

Sullivan, Mark; Langford, Dale J; Davies, Pamela Stitzlein; Tran, Christine; Vilardaga, Roger; Cheung, Gifford; Yoo, Daisy; McReynolds, Justin; Lober, William B; Tauben, David; Vowles, Kevin E

2018-03-29

The objective of this study was to develop and pilot test a chronic pain empowerment and self-management platform, derived from acceptance and commitment therapy, in a pain specialty setting. A controlled, sequential, nonrandomized study design was used to accommodate intervention development and to test the efficacy of the PainTracker Self-Manager (PTSM) intervention (Web-based educational modules and outcome tracking combined with tailored patient coaching sessions and provider guidance). Generalized estimating equations evaluated changes over time (baseline, 3 months, 6 months) in pain self-efficacy (primary outcome), chronic pain acceptance (activity engagement and pain willingness), perceived efficacy in patient-provider interactions, pain intensity and interference, and overall satisfaction with pain treatment (secondary outcomes) between intervention (n = 48) and usual care control groups (n = 51). The full study sample (N = 99) showed greater improvements over time (significant Group × Time interactions) in pain self-efficacy and satisfaction with pain treatment. Among study completers (n = 82), greater improvement in activity engagement as well as pain intensity and interference were also observed. These preliminary findings support the efficacy of the PTSM intervention in a pain specialty setting. Further research is needed to refine and expand the PTSM intervention and to test it in a randomized trial in primary care settings. We developed a Web-based patient empowerment platform that combined acceptance and commitment therapy-based educational modules and tailored coaching sessions with longitudinal tracking of treatments and patient-reported outcomes, named PTSM. Pilot controlled trial results provide preliminary support for its efficacy in improving pain self-efficacy, activity engagement, pain intensity and interference, and satisfaction with pain treatment. Copyright © 2018 The American Pain Society. Published by Elsevier Inc. All rights reserved.

Conditioned pharmacotherapeutic effects: a preliminary study.

PubMed

Ader, Robert; Mercurio, Mary Gail; Walton, James; James, Deborra; Davis, Michael; Ojha, Valerie; Kimball, Alexa Boer; Fiorentino, David

2010-02-01

To test the hypothesize that psoriasis patients treated under a partial schedule of pharmacologic (corticosteroid) reinforcement would show less severe symptoms and relapse than those given the same amount of drug under standard conditions. Behavioral conditioning as an inherent component of many pharmacotherapeutic protocols has never been examined. A double-blind, simple randomization intervention was conducted with 46 patients from California and New York. Initially, lesions were treated with 0.1% acetonide triamcinolone under standard treatment conditions. Thereafter, a Standard Therapy group continued on continuous reinforcement (active drug every treatment) with 100% of the initial dose; Partial Reinforcement patients received a full dose 25% to 50% of the time and placebo medication other times; Dose Control patients received continuous reinforcement with 25% to 50% of the initial dose. Severity of disease scores in California neither supported nor refuted the hypothesis. In New York, where there was no difference between Partial Reinforcement and Dose Control groups at baseline, partial reinforcement effected a greater reduction in lesion severity than Dose Control conditions and did not differ from Standard Therapy patients receiving two to four times more drug. For the entire population, the frequency of relapse under partial reinforcement (26.7%) was lower than in Dose Control patients (61.5%) and did not differ from full-dose treatment (22.2%). A partial schedule of pharmacotherapeutic reinforcement could maintain psoriasis patients with a cumulative amount of corticosteroid that was relatively ineffective when administered under standard treatment conditions. Conceivably, corticosteroid administration only one quarter or half as frequently as currently prescribed is sufficient to treat psoriasis. We posit, however, that these preliminary observations implicate conditioning processes in-and for the design of-regimens of pharmacotherapy.

Modular space station phase B extension, preliminary system design. Volume 4: Subsystems analyses

NASA Technical Reports Server (NTRS)

Antell, R. W.

1972-01-01

The subsystems tradeoffs, analyses, and preliminary design results are summarized. Analyses were made of the structural and mechanical, environmental control and life support, electrical power, guidance and control, reaction control, information, and crew habitability subsystems. For each subsystem a summary description is presented including subsystem requirements, subsystem description, and subsystem characteristics definition (physical, performance, and interface). The major preliminary design data and tradeoffs or analyses are described in detail at each of the assembly levels.

Effect of life-style modification on postmenopausal overweight and obese Indian women: A randomized controlled 24 weeks preliminary study.

PubMed

Tandon, Vishal R; Sharma, Sudhaa; Mahajan, Annil; Mahajan, Shagun

2014-01-01

The aim of the following study is to evaluate the effect of life-style modification on postmenopausal (PM) overweight and obese Indian women in a randomized controlled 24 week study. Two groups were formed Group I (n = 30) was designated as intervention (dietary and exercise group) and Group II (n = 24) served as control. Comparison of weight, waist circumference (WC) and body mass index (BMI) were made and compared among two groups at 4, 8, 16 and 24 weeks. Mean age at menopause was 48.35 years versus 49.65 years; mean number of menopausal symptoms were 5.70 ± 1.76 versus 5.10 ± 1.56 and mean duration since menopause was 2.70 versus 2.90 years in Groups I and II respectively. When the effect of Group I and control on weight was compared at 4, 8, 16 and 24 weeks, there was no significant difference between them up to 8 week. At 8 weeks Group I caused a significant decrease in weight (P ≤ 0.05) when compared with control arm and which continued throughout the study period (P < 0.05) at both 16 and 24 weeks. Group I produced a significant reduction in WC from 8 weeks onwards up to 24 weeks (P ≤ 0.05). BMI was statistically significant in Group I and the effect started at 4(th) week (P ≤ 0.05) and the differences in BMI reduction were highly significant at 16(th) and 24(th) weeks (P ≤ 0.001). The results of the present study strongly recommend the life-style management to be incorporated in daily style of postmenopausal women under controlled supervision.

Effects of Tailored and ACT-Influenced Internet-Based CBT for Eating Disorders and the Relation Between Knowledge Acquisition and Outcome: A Randomized Controlled Trial.

PubMed

Strandskov, Sandra Weineland; Ghaderi, Ata; Andersson, Hedvig; Parmskog, Nicole; Hjort, Emelie; Wärn, Anna Svanberg; Jannert, Maria; Andersson, Gerhard

2017-09-01

This is the first trial to investigate the outcome of tailored and ACT-influenced, cognitive behavioral Internet treatment for eating disorder psychopathology, and the relation between knowledge acquisition and outcome. This study utilized a randomized controlled design, with computer-based allocation to treatment or waiting list control group. Participants were recruited via advertisements in social media and newspapers in Sweden. Participants fulfilling the criteria for bulimia nervosa (BN), or Eating Disorder Not Otherwise Specified (EDNOS), with a BMI above 17.5, were enrolled in the study (N = 92). The treatment group received an Internet-based, ACT-influenced CBT intervention, developed by the authors, for eating disorders. The treatment lasted 8 weeks, and was adapted to the participant's individual needs. A clinician provided support. The main outcome measures were eating disorder symptoms and body shape dissatisfaction. Intent-to-treat analysis showed that the treatment group (n = 46) improved significantly on eating disorder symptoms and body dissatisfaction, compared with the waiting list control group (n = 46), with small to moderate effect sizes (between group effects, d = 0.35-0.64). More than a third of the participants in the treatment group (36.6%), compared to 7.1% in the waiting list control condition, made clinically significant improvements. Results showed a significant increase in knowledge in the treatment group compared to the waiting list control group (between group effect, d = 1.12), but we found no significant correlations between knowledge acquisition and outcome (r= -0.27 to -r = 0.23). The results provide preliminary support for Internet-based, tailored, and ACT-influenced treatment, based on CBT for participants with eating disorder psychopathology. Copyright © 2017. Published by Elsevier Ltd.

Family Maltreatment, Substance Problems, and Suicidality: Randomized Prevention Effectiveness Trial

DTIC Science & Technology

2008-02-01

IV. LAY SUMMARY & PROJECT DESCRIPTION (CONTINUING STUDY) ............................ 7 V. SUBJECT INFORMATION...assessment training evaluation at the 3 AF sites. At this time, we have no preliminary findings to report. IV. LAY SUMMARY & PROJECT DESCRIPTION

Comparing U.S. Army suicide cases to a control sample: initial data and methodological lessons.

PubMed

Alexander, Cynthia L; Reger, Mark A; Smolenski, Derek J; Fullerton, Nicole R

2014-10-01

Identification of risk and protective factors for suicide is a priority for the United States military, especially in light of the recent steady increase in military suicide rates. The Department of Defense Suicide Event Report contains comprehensive data on suicides for active duty military personnel, but no analogous control data is available to permit identification of factors that differentially determine suicide risk. This proof-of-concept study was conducted to determine the feasibility of collecting such control data. The study employed a prospective case-control design in which control cases were randomly selected from a large Army installation at a rate of four control participants for every qualifying Army suicide. Although 111 Army suicides were confirmed during the study period, just 27 control soldiers completed the study. Despite the small control sample, preliminary analyses comparing suicide cases to controls identified several factors more frequently reported for suicide cases, including recent failed intimate relationships, outpatient mental health history, mood disorder diagnosis, substance abuse history, and prior self-injury. No deployment-related risk factors were found. These data are consistent with existing literature and form a foundation for larger control studies. Methodological lessons learned regarding study design and recruitment are discussed to inform future studies. Reprint & Copyright © 2014 Association of Military Surgeons of the U.S.

Improving guideline concordance in multidisciplinary teams: preliminary results of a cluster-randomized trial evaluating the effect of a web-based audit and feedback intervention with outreach visits

PubMed Central

van Engen-Verheul, Mariëtte M.; Gude, Wouter T.; van der Veer, Sabine N.; Kemps, Hareld M.C.; Jaspers, Monique M.W.; de Keizer, Nicolette F.; Peek, Niels

2015-01-01

Despite their widespread use, audit and feedback (A&F) interventions show variable effectiveness on improving professional performance. Based on known facilitators of successful A&F interventions, we developed a web-based A&F intervention with indicator-based performance feedback, benchmark information, action planning and outreach visits. The goal of the intervention was to engage with multidisciplinary teams to overcome barriers to guideline concordance and to improve overall team performance in the field of cardiac rehabilitation (CR). To assess its effectiveness we conducted a cluster-randomized trial in 18 CR clinics (14,847 patients) already working with computerized decision support (CDS). Our preliminary results showed no increase in concordance with guideline recommendations regarding prescription of CR therapies. Future analyses will investigate whether our intervention did improve team performance on other quality indicators. PMID:26958310

Placebo-Controlled Trial of Familiar Auditory Sensory Training for Acute Severe Traumatic Brain Injury: A Preliminary Report.

PubMed

Pape, Theresa Louise-Bender; Rosenow, Joshua M; Steiner, Monica; Parrish, Todd; Guernon, Ann; Harton, Brett; Patil, Vijaya; Bhaumik, Dulal K; McNamee, Shane; Walker, Matthew; Froehlich, Kathleen; Burress, Catherine; Odle, Cheryl; Wang, Xue; Herrold, Amy A; Zhao, Weihan; Reda, Domenic; Mallinson, Trudy; Conneely, Mark; Nemeth, Alexander J

2015-07-01

Sensory stimulation is often provided to persons incurring severe traumatic brain injury (TBI), but therapeutic effects are unclear. This preliminary study investigated neurobehavioral and neurophysiological effects related to sensory stimulation on global neurobehavioral functioning, arousal, and awareness. A double-blind randomized placebo-controlled trial where 15 participants in states of disordered consciousness (DOC), an average of 70 days after TBI, were provided either the Familiar Auditory Sensory Training (FAST) or Placebo of silence. Global neurobehavioral functioning was measured with the Disorders of Consciousness Scale (DOCS). Arousal and awareness were measured with the Coma-Near-Coma (CNC) scale. Neurophysiological effect was measured using functional magnetic resonance imaging (fMRI). FAST (n = 8) and Placebo (n = 7) groups each showed neurobehavioral improvement. Mean DOCS change (FAST = 13.5, SD = 8.2; Placebo = 18.9, SD = 15.6) was not different, but FAST patients had significantly (P = .049; 95% confidence interval [CI] = -1.51, -.005) more CNC gains (FAST = 1.01, SD = 0.60; Placebo = 0.25, SD = 0.70). Mixed-effects models confirm CNC findings (P = .002). Treatment effect, based on CNC, is large (d = 1.88, 95% CI = 0.77, 3.00). Number needed to treat is 2. FAST patients had more fMRI activation in language regions and whole brain (P values <.05) resembling healthy controls' activation. For persons with DOC 29 to 170 days after TBI, FAST resulted in CNC gains and increased neural responsivity to vocal stimuli in language regions. Clinicians should consider providing the FAST to support patient engagement in neurorehabilitation. © The Author(s) 2015.

The Effects of a Single Electronic Music Improvisation Session on the Pain of Adults with Sickle Cell Disease: A Mixed Methods Pilot Study.

PubMed

Rodgers-Melnick, Samuel N; Matthie, Nadine; Jenerette, Coretta; Griest Pell, Tara J; Lane, Deforia; Fu, Pingfu; Margevicius, Seunghee; Little, Jane A

2018-06-07

Adults with sickle cell disease (SCD) experience acute pain that is multidimensional. Despite recent improvements in treatment, pain management remains a significant challenge for these individuals. Music therapy interventions have the potential to address several dimensions of SCD pain, but they require systematic investigation. This study investigated feasibility and preliminary efficacy of a single-session electronic music improvisation with a music therapist to diminish pain intensity and improve pain relief and mood in adults with SCD. Using a three-group mixed methods intervention design, we randomized 60 adults with SCD to standard care plus one of three 20-minute study conditions: 1) electronic music improvisation with a music therapist (MT); 2) recorded music listening (ML); or 3) no intervention (control). Measures of pain intensity (VASPI), pain relief (VASPR), and mood (VASMOOD) were assessed before and after the study conditions, with a subset of MT and ML participants interviewed after measure completion. Compared to control, MT produced significant improvements in VASPI (odds ratio (OR) = 5.12, P = 0.035) and VASMOOD (OR = 11.60, P = 0.005). ML produced significant improvements in VASMOOD compared to control (OR = 5.76, P = 0.040). Qualitatively, there were two prominent themes directly related to music: 1) ML and MT offered many positive and few negative effects; and 2) music therapists provided comfort beyond the music. Preliminary findings were promising and support the need for additional studies evaluating improvisational music therapy interventions for acute pain management in adults with SCD.

Concentrating solar collector subsystem: Preliminary design package

NASA Technical Reports Server (NTRS)

1977-01-01

Preliminary design data are presented for a concentrating solar collector including an attitude controller. Provided are schedules, technical status, all documents required for preliminary design, and other program activities.

THE EFFECTS OF INSTRUMENT ASSISTED SOFT TISSUE MOBILIZATION ON LOWER EXTREMITY MUSCLE PERFORMANCE: A RANDOMIZED CONTROLLED TRIAL.

PubMed

MacDonald, Nicole; Baker, Russell; Cheatham, Scott W

2016-12-01

Instrument-Assisted Soft Tissue Mobilization (IASTM) is a non-invasive therapeutic technique used to theoretically aid in scar tissue breakdown and absorption, fascial mobilization, and improved tissue healing. Researchers have hypothesized that utilizing IASTM will improve muscular efficiency and performance; yet previous Investigations has been focused on treating injury. The purpose of this investigation was to explore the effects of IASTM on muscle performance to assess if typical treatment application affected measures of muscular performance. A pretest-posttest randomized control design. A convenience sample of 48 physically active adults (mean age 24 ± 4 years), randomly assigned to one of three groups: quadriceps treatment group, triceps surae treatment group, or control group. Participants performed a five-minute warm-up on a Monark bicycle ergometer before performing three countermovement vertical jumps (CMJ). Immediately after, the IASTM treatment was applied by one researcher for three minutes on each leg at the specified site (e.g., quadriceps) for those assigned to the treatment groups, while the control group rested for six minutes. Immediately following treatment, participants performed three additional CMJs. Pre- and post-testing included measures of vertical jump height (JH), peak power (PP) and peak velocity (PV). There were no statistically significant differences found between treatment groups in JH, PP, or PV or across pre- and post-test trials. These preliminary findings suggest that standard treatment times of IASTM do not produce an immediate effect in muscular performance in healthy participants. This may help clinicians determine the optimal sequencing of IASTM when it is part of a pre-performance warm-up program. Future research should be conducted to determine the muscle performance effects of IASTM in individuals with known myofascial restriction and to determine optimal treatment parameters, such as instrument type, amount of pressure, and treatment time necessary to affect muscular performance. 1b.

Expert patient self-management program versus usual care in bronchiectasis: a randomized controlled trial.

PubMed

Lavery, Katherine A; O'Neill, Brenda; Parker, Michael; Elborn, J Stuart; Bradley, Judy M

2011-08-01

To investigate the efficacy of a disease-specific Expert Patient Programme (EPP) compared with usual care in patients with bronchiectasis. Proof-of-concept randomized controlled trial. Regional respiratory center. Adult patients (N=64; age, >18y) with a primary diagnosis of bronchiectasis based on a respiratory physician's assessment including a computed tomographic scan. Patients were randomly assigned to an intervention (usual care plus EPP; n=32) or control group (usual care only; n=32). The primary outcome measure was the Chronic Disease Self-efficacy Scale (CDSS). Other outcome measures included the Revised Illness Perception Questionnaire (IPQ-R), the St Georges Respiratory Questionnaire, and standard EPP questionnaires. Data were collected at baseline, postintervention, and 3 and 6 months postintervention. This disease-specific EPP for patients with bronchiectasis significantly improved self-efficacy in 6 of 10 subscales (CDSS subscales: exercise regularly [P=.02]; get information about disease [P=.03]; obtain help from community, family, and friends [P=.06]; communicate with physician [P=.85]; manage disease in general [P=.05]; do chores [P=.04]; social/recreational activities [P=.03]; manage symptoms [P<.01]; manage shortness of breath [P=.08]; control/manage depression [P=.01]) compared with usual care. There was no improvement on IPQ-R score. Patients who received the intervention reported more symptoms and decreased quality of life between 3 and 6 months postintervention and an increase in some components of self reported health care use. Patients receiving the disease-specific EPP indicated they were satisfied with the intervention and learned new self-management techniques. There were no significant differences in lung function over time. This original study indicates that a disease-specific EPP results in short-term improvements in self-efficacy. Based on these positive preliminary findings, a larger adequately powered study is justified to investigate the efficacy of a disease-specific EPP in patients with bronchiectasis. Copyright © 2011 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Preliminary Assessment of Optimal Longitudinal-Mode Control for Drag Reduction through Distributed Aeroelastic Shaping

NASA Technical Reports Server (NTRS)

Ippolito, Corey; Nguyen, Nhan; Lohn, Jason; Dolan, John

2014-01-01

The emergence of advanced lightweight materials is resulting in a new generation of lighter, flexible, more-efficient airframes that are enabling concepts for active aeroelastic wing-shape control to achieve greater flight efficiency and increased safety margins. These elastically shaped aircraft concepts require non-traditional methods for large-scale multi-objective flight control that simultaneously seek to gain aerodynamic efficiency in terms of drag reduction while performing traditional command-tracking tasks as part of a complete guidance and navigation solution. This paper presents results from a preliminary study of a notional multi-objective control law for an aeroelastic flexible-wing aircraft controlled through distributed continuous leading and trailing edge control surface actuators. This preliminary study develops and analyzes a multi-objective control law derived from optimal linear quadratic methods on a longitudinal vehicle dynamics model with coupled aeroelastic dynamics. The controller tracks commanded attack-angle while minimizing drag and controlling wing twist and bend. This paper presents an overview of the elastic aircraft concept, outlines the coupled vehicle model, presents the preliminary control law formulation and implementation, presents results from simulation, provides analysis, and concludes by identifying possible future areas for research

The development of insomnia or the plasticity of good sleep? A preliminary study of acute changes in sleep and insomnia resulting from an analogue trauma.

PubMed

Richardson, Cele; Gradisar, Michael; Pulford, Amanda

2015-01-01

The present preliminary study aimed to shed light on the mechanisms underlying the development of insomnia. An analogue stressor (i.e., trauma video) was used to prevent presleep cognitive de-arousal. Subsequent changes in nocturnal sleep and sleep-related attentional processing were examined. Thirty-four participants were randomly assigned to either a cognitive arousal (trauma video; age: M = 22.9, SD = 4.3, 6 male, 11 female) or control (pleasant video; age: M = 23.8, SD = 5.8, 7 male, 10 female) condition. Although no significant differences were found for presleep cognitive de-arousal (p = .39), the cognitive arousal group experienced a significant worsening in sleep latency (p = .048, partial η(2) = .12) and an increase in sleep-related attentional bias (p = .032, d = 0.51) following the manipulation. However, changes in sleep and attentional bias were not maintained. Vulnerability to stress did not significantly account for any change in attentional bias, arousal, or sleep. These findings challenge current conceptualizations of the development of insomnia, yet also supporting the notion that good sleep is a default state that protects individuals from sleep disturbance.

Which surgery should be offered for carpal tunnel syndrome in a patient who was previously treated for recurrence on the contralateral side? Preliminary study of 13 patients with the Canaletto® implant.

PubMed

Illuminati, I; Seigle-Murandi, F; Gouzou, S; Fabacher, T; Facca, S; Hidalgo Diaz, J J; Liverneaux, P

2017-12-01

There are no published studies on the management of carpal tunnel syndrome (CTS) patients who have already been operated for recurrent CTS on the contralateral side. The aim of this study was to evaluate 13 patients with CTS who underwent primary release using a Canaletto ® implant. The 13 patients had all been operated for recurrent CTS previously. On the contralateral side, they all had subjective signs, and two of them already had complications. All were operated with the Canaletto ® implant according to Duché's technique, in a mean of 20minutes. After a mean 19.3-month follow-up, paresthesia, pain, and QuickDASH scores were significantly improved, even in one patient who underwent revision at another facility. This preliminary study suggests that use of a Canaletto ® implant as first-line treatment for CTS in patients who already underwent revision surgery on the other side is a simple and safe technique, without worsening of symptoms. These findings should be assessed with a prospective randomized controlled trial. Copyright © 2017 SFCM. Published by Elsevier Masson SAS. All rights reserved.

Synbiotics could not reduce the scoring of childhood atopic dermatitis (SCORAD): a randomized double blind placebo-controlled trial.

PubMed

Shafiei, Alireza; Moin, Mostafa; Pourpak, Zahra; Gharagozlou, Mohammad; Aghamohammadi, Asghar; Aghamohamadi, Asghar; Sajedi, Vahid; soheili, Habib; Sotoodeh, Soheila; Movahedi, Masoud

2011-03-01

Despite preliminary evidence, the role of probiotic and synbiotic in treatment of the atopic dermatitis has shown varying results. We aimed to evaluate whether synbiotic supplementation decrease severity of atopic dermatitis (AD) in childhood. In a randomized double blind-placebo controlled trial, we evaluated the synbiotic supplementation efficiency on the treatment of atopic dermatitis. Infants aged 1-36 months with moderate to severe atopic dermatitis were randomized (n=41) and received either synbiotic (probiotic plus prebiotic) (n=20) or placebo (n=21) daily as a powder for two months. Emollient (Eucerin) and topical corticosteroid (Hydrocortisone) were permitted. Children were scored for severity of atopic dermatitis (SCORAD). Also allergen Skin Prick Tests (SPT), IgE blood level and eosinophil count were measured at first visit. Patients' SCORAD were reevaluated at the end of intervention. We followed 36 out of 41 subjects for two months (drop out rate = 9%). In the whole group, the mean Total SCORAD (at base line 40.93) decreased by 56% (p=0.00). The mean Objective SCORAD (at base line 31.29) decreased by 53% (p=0.00). There was no significant difference in the mean decrease of total SCORAD between placebo (22.3) and synbiotic groups (24.2). There was also no difference between two intervention groups in the mean decrease of total SCORAD regarding to different demographic, clinical and para clinical subgroups. This study could not confirm synbiotic as an effective treatment for childhood atopic dermatitis and further studies are needed. These findings challenge the role of synbiotics in the treatment of childhood atopic dermatitis.

MR elastographic methods for the evaluation of plantar fat pads: preliminary comparison of the shear modulus for shearing deformation and compressive deformation in normal subjects

NASA Astrophysics Data System (ADS)

Weaver, John B.; Miller, Timothy B.; Perrinez, Philip R.; Doyley, Marvin M.; Wang, Huifang; Cheung, Yvonne Y.; Wrobel, James S.; Comi, Richard J.; Kennedy, Francis E.; Paulsen, Keith D.

2006-03-01

MR elastography (MRE) images the intrinsic mechanical properties of soft tissues; e.g., the shear modulus, μ. The μ of the plantar soft tissues is important in understanding the mechanisms whereby the forces induced during normal motion produce ulcers that lead to amputation in diabetic feet. We compared the compliance of the heel fat pad to compressive forces and to shearing forces. The design of prosthetics to protect the foot depends on the proper understanding of the mechanisms inducing damage. In the heel fat pads of six normal subjects, between 25 and 65 years of age, the μ for deformation perpendicular to the direction of weight bearing is similar but not identical to that determined for deformation along the weight bearing axis. The average difference between μ along the weight bearing axis and μ perpendicular to the weight bearing axis, is well correlated with age (Correlation Coefficient = 0.789). The p-value for the data being random was 0.0347 indicating that the observed difference is not likely to be random. The p-value for control points is 0.8989, indicating a random process. The results are suggestive that the high compressive forces imposed during walking damage the heel fat pads over time resulting in softening to compression preferentially over shearing. It is important to validate the observed effect with larger numbers of subjects, and better controls including measures of activity, and to understand if diseases like diabetes increase the observed damage.

Nurse-delivered counselling intervention for parental HIV disclosure: results from a pilot randomized controlled trial in China.

PubMed

Simoni, Jane M; Yang, Joyce P; Shiu, Cheng-Shi; Chen, Wei-Ti; Udell, Wadiya; Bao, Meijuan; Zhang, Lin; Lu, Hongzhou

2015-06-01

The objective of this study was to design and conduct a preliminary evaluation of an intervention to assist parents in decision-making about disclosure of their HIV diagnosis to their children. This was a pilot randomized controlled trial (RCT) with blinded assessment. Participants were randomized to intervention or treatment-as-usual (TAU) arms. The study occurred at an outpatient HIV primary care centre in Shanghai, China. Participants were 20 HIV-positive outpatients with at least one child (13-25 years old) who was unaware of the parent's HIV diagnosis. The nurse-delivered intervention involved three, hour-long, individual sessions over 4 weeks. Intervention content comprised family assessment, discussion of advantages and disadvantages of disclosure, psycho-education about cognitive, social and emotional abilities of children at different developmental stages, and disclosure planning and practicing via role-plays. Primary study outcomes for intervention versus TAU arms were self-reported disclosure distress, self-efficacy, and behaviours along a continuum from no disclosure to full disclosure and open communication about HIV. In all cross-sectional (Wald tests) and longitudinal (general estimating equations) analyses, at both postintervention (4 weeks) and follow-up (13 weeks), effects were in the hypothesized directions. Despite the small sample size, most of these between-arm comparisons were statistically significant, with at least one result for each outcome indicating a 'large' effect size. Our results suggest that nurses are able to deliver a counselling intervention in a clinic setting with the potential to alleviate parental distress around HIV disclosure to their children. Findings warrant future trials powered for efficacy.

Role of the α1 blocker doxazosin in alcoholism: a proof-of-concept randomized controlled trial.

PubMed

Kenna, George A; Haass-Koffler, Carolina L; Zywiak, William H; Edwards, Steven M; Brickley, Michael B; Swift, Robert M; Leggio, Lorenzo

2016-07-01

Evidence suggests that the norepinephrine system represents an important treatment target for alcohol dependence (AD) and the α1 -blocker prazosin may reduce alcohol drinking in rodents and alcoholic patients. The α1 -blocker doxazosin demonstrates a more favorable pharmacokinetic profile than prazosin, but has never been studied for AD. A double-blind placebo-controlled randomized clinical trial was conducted in AD individuals seeking outpatient treatment. Doxazosin or matched placebo was titrated to 16 mg/day (or maximum tolerable dose). Drinks per week (DPW) and heavy drinking days (HDD) per week were the primary outcomes. Family history density of alcoholism (FHDA), severity of AD and gender were a priori moderators. Forty-one AD individuals were randomized, 30 (doxazosin = 15) completed the treatment phase and 28 (doxazosin = 14) also completed the follow-up. There were no significant differences between groups on DPW and HDD per week. With FHDA as a moderator, there were significant FHDA × medication interactions for both DPW (pcorrected  = 0.001, d = 1.18) and HDD (pcorrected  = 0.00009, d = 1.30). Post hoc analyses revealed that doxazosin significantly reduced alcohol drinking in AD patients with high FHDA and by contrast increased drinking in those with low FHDA. Doxazosin may be effective selectively in AD patients with high FHDA. This study provides preliminary evidence for personalized medicine using α1 -blockade to treat AD. However, confirmatory studies are required. © 2015 Society for the Study of Addiction.

A randomized controlled trial of the different impression methods for the complete denture fabrication: Patient reported outcomes.

PubMed

Jo, Ayami; Kanazawa, Manabu; Sato, Yusuke; Iwaki, Maiko; Akiba, Norihisa; Minakuchi, Shunsuke

2015-08-01

To compare the effect of conventional complete dentures (CD) fabricated using two different impression methods on patient-reported outcomes in a randomized controlled trial (RCT). A cross-over RCT was performed with edentulous patients, required maxillomandibular CDs. Mandibular CDs were fabricated using two different methods. The conventional method used a custom tray border moulded with impression compound and a silicone. The simplified used a stock tray and an alginate. Participants were randomly divided into two groups. The C-S group had the conventional method used first, followed by the simplified. The S-C group was in the reverse order. Adjustment was performed four times. A wash out period was set for 1 month. The primary outcome was general patient satisfaction, measured using visual analogue scales, and the secondary outcome was oral health-related quality of life, measured using the Japanese version of the Oral Health Impact Profile for edentulous (OHIP-EDENT-J) questionnaire scores. Twenty-four participants completed the trial. With regard to general patient satisfaction, the conventional method was significantly more acceptable than the simplified. No significant differences were observed between the two methods in the OHIP-EDENT-J scores. This study showed CDs fabricated with a conventional method were significantly more highly rated for general patient satisfaction than a simplified. CDs, fabricated with the conventional method that included a preliminary impression made using alginate in a stock tray and subsequently a final impression made using silicone in a border moulded custom tray resulted in higher general patient satisfaction. UMIN000009875. Copyright © 2015 Elsevier Ltd. All rights reserved.

Feasibility and Preliminary Efficacy of the Effects of Flavanoid-Rich Purple Grape Juice on the Vascular Health of Childhood Cancer Survivors: A Randomized, Controlled Crossover Trial

PubMed Central

Blair, Cindy K.; Kelly, Aaron S.; Steinberger, Julia; Eberly, Lynn E.; Napurski, Char; Robien, Kim; Neglia, Joseph P.; Mulrooney, Daniel A.; Ross, Julie A.

2016-01-01

Background Childhood cancer survivors have an increased risk of developing cardiovascular disease following treatment, yet few interventions have been evaluated to reduce this risk. Purple grape juice (pGJ), a rich source of flavonoids with antioxidant properties, has been shown in adults to reduce oxidative stress and improve endothelial function. We examined the effects of supplementing meals with pGJ on microvascular endothelial function and markers of oxidative stress and inflammation in 24 cancer survivors (ages 10–21 years). Procedure In a randomized controlled crossover trial consisting of two, 4 week intervention periods, each preceded by a 4 week washout period, subjects received in random order 6 ounces twice daily of pGJ and clear apple juice (cAJ; similar in calories but lower in flavonoids). Measurements were obtained before and after each supplementation period; change was evaluated using mixed effects ANOVA. Results pGJ did not improve endothelial function, measured using digital reactive hyperemia, compared with cAJ (mean change: pGJ 0.06, cAJ 0.22; difference of mean change [95% CI]: −0.16 [−0.42 – 0.11], P = 0.25). No significant changes in plasma concentrations of oxidized-LDL, myeloperoxidase, or high sensitivity C-reactive protein were observed. Conclusion After 4 weeks of daily consumption of flavonoid-rich pGJ, no measurable change in vascular function was observed in these childhood cancer survivors. Pediatr Blood Cancer 2014;61:2290–2296. PMID:25175762

Antimicrobial photodynamic therapy suppresses dental plaque formation in healthy adults: a randomized controlled clinical trial.

PubMed

Ichinose-Tsuno, Akiko; Aoki, Akira; Takeuchi, Yasuo; Kirikae, Teruo; Shimbo, Takuro; Lee, Masaichi-Chang-Il; Yoshino, Fumihiko; Maruoka, Yutaka; Itoh, Toshiyuki; Ishikawa, Isao; Izumi, Yuichi

2014-12-15

Oral care is important for oral and systemic health, especially for elderly institutionalized individuals and compromised patients. However, conventional mechanical plaque control is often difficult for these patients because of the pain or the risk of aspiration. Although antimicrobial photodynamic therapy (aPDT), which is considered an alternative or adjunct to mechanical approaches, has potential application as a less stressful method of daily plaque control, no clinical application of this technique has been reported. We investigated the inhibitory effect of a combination of toluidine blue O (TBO), and a red light-emitting diode (LED) on dental plaque formation in healthy volunteers. The optimal concentration of TBO was determined in preliminary in vitro experiments to evaluate the bactericidal effect of aPDT on Streptococcus oralis and to clarify its safety in fibroblast cells. To survey the mechanism of TBO-mediated aPDT, the quality and quantity of reactive oxygen species (ROS) generated during aPDT were also examined using electron spin resonance (ESR) spectroscopy. Subsequently, the inhibitory effect of aPDT on dental plaque formation was investigated in eleven subjects as a clinical pilot study. The right or left mandibular premolars were randomly assigned to the treatment (with aPDT) or control (without aPDT) groups. In total, aPDT was applied six times (twice per day) to the teeth in the test group over a period of four days. On the fourth day, the study concluded and the analyses were performed. A combination of 500 or 1000 μg/ml TBO and LED irradiation for 20 s significantly decreased the number of colony forming units of Streptococcus oralis. The cytotoxicity of aPDT was comparable to that of standard antiseptics used in the oral cavity. Hydroxyl radicals were detected by ESR analysis, but singlet oxygen was not. A randomized controlled trial demonstrated that aPDT with 1000 μg/ml TBO and red LED irradiation significantly suppressed dental plaque formation without harming teeth or the surrounding tissues. aPDT has the potential to be a promising novel technical modality for dental plaque control. This trial was registered with University Hospital Medical Information Network Clinical Trials Registry (number UMIN000012504).

Proof of Concept of a Mobile Health Short Message Service Text Message Intervention That Promotes Adherence to Oral Anticancer Agent Medications: A Randomized Controlled Trial.

PubMed

Spoelstra, Sandra L; Given, Charles W; Sikorskii, Alla; Coursaris, Constantinos K; Majumder, Atreyee; DeKoekkoek, Tracy; Schueller, Monica; Given, Barbara A

2016-06-01

This multisite, randomized controlled trial assigned 75 adult cancer patients prescribed an oral anticancer agent to either an experimental group that received daily text messages for adherence for 21 days plus usual care or a control group that received usual care. Measures were administered at baseline, weekly (Weeks 1-8), and at exit (Week 9). A satisfaction survey was conducted following the intervention. Acceptability, feasibility, and satisfaction were examined. Primary outcomes were adherence and symptoms. Secondary outcomes were depressive symptoms, self-efficacy, cognition, physical function, and social support. Mixed or general linear models were used for the analyses comparing trial groups. Effect sizes (ES) were estimated to gauge clinical significance. Regarding acceptability, 57.2% (83 of 145) of eligible patients consented, 88% (n = 37 of 42) receiving text messages read them most or all of the time, and 90% (n = 38) were satisfied. The differences between experimental and control groups' ES were 0.29 for adherence, 0.21 for symptom severity, and 0.21 for symptom interference, and differences were not statistically significant. Furthermore, perceived social support was higher (p = 0.04; ES = 0.54) in the experimental group. Proof of concept and preliminary efficacy of a mobile health intervention using text messages to promote adherence for patients prescribed oral anticancer agents were demonstrated. Patients accepted and had high satisfaction with the intervention, and adherence improved after the intervention. Text messages show promise. Additional research is needed prior to use in practice.

Effect of Retraining Approach-Avoidance Tendencies on an Exercise Task: A Randomized Controlled Trial.

PubMed

Cheval, Boris; Sarrazin, Philippe; Pelletier, Luc; Friese, Malte

2016-12-01

Promoting regular physical activity (PA) and lessening sedentary behaviors (SB) constitute a public health priority. Recent evidence suggests that PA and SB are not only related to reflective processes (eg, behavioral intentions), but also to impulsive approach-avoidance tendencies (IAAT). This study aims to test the effect of a computerized IAAT intervention on an exercise task. Participants (N = 115) were randomly assigned to 1 of 3 experimental conditions, in which they were either trained to approach PA and avoid SB (ApPA-AvSB condition), to approach SB and avoid PA (ApSB-AvPA condition), or to approach and avoid PA and SB equally often (active control condition). The main outcome variable was the time spent carrying out a moderate intensity exercise task. IAAT toward PA decreased in the ApSB-AvPA condition, tended to increase in the ApPA-AvSB condition, and remained stable in the control condition. Most importantly, the ApPA-AvSB manipulation led to more time spent exercising than the ApSB-AvPA condition. Sensitivity analyses excluding individuals who were highly physically active further revealed that participants in the ApPA-AvSB condition spent more time exercising than participants in the control condition. These findings provide preliminary evidence that a single intervention session can successfully change impulsive approach tendencies toward PA and can increase the time devoted to an exercise task, especially among individuals who need to be more physically active. Potential implications for health behavior theories and behavior change interventions are outlined.

Improving Sleep for Hospitalized Antepartum Patients: A Non-Randomized Controlled Pilot Study.

PubMed

Lee, Kathryn A; Gay, Caryl L

2017-12-15

To evaluate feasibility and efficacy of a hospital-based protocol for improving sleep in high- risk antepartum patients. Sleep measures were compared during 1 week of hospitalization before and after implementing a Sleep Improvement Protocol for Antepartum Patients (SIP-AP). A non-randomized convenience sample of usual care controls was compared to a subsequent intervention sample after the protocol was implemented. Women were eligible if they spoke English, were medically stable, pregnant for at least 20 weeks, and hospitalized at least 24 hours; 25 pregnant women had sufficient data for analyses (11 controls, 14 intervention). Sleep was assessed in 3 ways: the Pittsburgh Sleep Quality Index was completed after obtaining consent to estimate sleep quality prior to hospital admission; sleep diary completed each hospital day; and General Sleep Disturbance Scale completed at 7 days or prior to hospital discharge. Symptoms that could affect sleep were assessed with the Memorial Symptom Assessment Scale. Both groups recorded similar sleep duration (7 hours) but the intervention group had fewer symptoms and significantly ( P = .015) lower sleep disturbance scores (53.1 ± 14.5) than controls (71.9 ± 18.8). Participant feedback about the intervention was positive, although adherence to components of the intervention protocol was variable. This pilot study provides evidence of the feasibility and preliminary efficacy of the SIP-AP intervention for reducing symptoms and improving sleep of antepartum patients during hospitalization. Further detailed evaluation of specific components of this protocol is warranted, and other types of hospitalized patients may benefit from unit-based modifications to this SIP-AP protocol. © 2017 American Academy of Sleep Medicine

Efficacy of the Hydroalcoholic Extract of Tribulus terrestris on the Serum Glucose and Lipid Profile of Women With Diabetes Mellitus: A Double-Blind Randomized Placebo-Controlled Clinical Trial.

PubMed

Samani, Nasrin Babadaei; Jokar, Azam; Soveid, Mahmood; Heydari, Mojtaba; Mosavat, Seyed Hamdollah

2016-10-01

Considering traditional use of Tribulus terrestris in diabetes and proven antihyperglycemic and antihyperlipidemic effects of T terrestris in animal studies, we aimed to evaluate the efficacy of the hydroalcoholic extract of T terrestris on the serum glucose and lipid profile of women with non-insulin-dependent diabetes mellitus. Ninety-eight women with diabetes mellitus type 2 were randomly allocated to receive the T terrestris (1000 mg/d) or placebo for 3 months. The patients were evaluated in terms of the fasting blood glucose, 2-hour postprandial glucose, glycosylated hemoglobin, and lipid profile. Tribulus terrestris showed a significant blood glucose-lowering effect in diabetic women compared to placebo (P < .05). Also, the total cholesterol and low-density lipoprotein of T terrestris group was significantly reduced compared with placebo, while no significant effect was observed in the triglyceride and high-density lipoprotein levels. The study showed preliminary promising hypoglycemic effect of T terrestris in women with diabetes mellitus type 2. © The Author(s) 2016.

[Multicenter randomized trial of amnioinfusion].

PubMed

Fraser, W; Marcoux, S; Prendiville, W; Petrou, S; Hofmeyr, J; Reinharz, D; Goulet, C; Ohlsson, A

2000-05-01

Meconium staining of the amniotic fluid in labor is a frequent problem that is associated with an increase in the risk of neonatal and maternal morbidity. Amnioinfusion is a simple technique that is designed to prevent neonatal and maternal morbidity associated with meconium. Preliminary studies indicate that amnioinfusion is a promising approach to the prevention of such complications of labor. However, further research is required. The primary objective of this multi-centre randomized controlled study is to determine if amnioinfusion for thick meconium stained amniotic fluid results in a reduction in perinatal death or moderate to severe meconium aspiration syndrome. We will also assess the effects of amnioinfusion on other indicators of neonatal morbidity and on cesarean section. The study includes an evaluation of womens views on their childbirth experience and an economic evaluation of a policy of amnioinfusion The study will be achieved with the collaboration of approximately 50 obstetrical centres from across Canada, US, Europe, South America and South Africa. This multicentre trial will provide urgently needed information on the efficacy and effectiveness of amniofusion for the indication of meconium stained amniotic fluid.

The effect of deep brain stimulation on the non-motor symptoms of Parkinson’s disease: a critical review of the current evidence

PubMed Central

Kurtis, Mónica M; Rajah, Thadshani; Delgado, Luisa F; Dafsari, Haidar S

2017-01-01

The benefit of deep brain stimulation (DBS) in controlling the motor symptoms of Parkinson’s disease is well established, however, the impact on the non-motor symptoms (NMS) remains to be elucidated, although the growing investigative efforts are promising. This article reviews the reported data and considers the level of evidence available with regard to the effect of DBS on NMS total burden and on the cognitive, neuropsychiatric, sleep, pain, dysautonomic, and weight domains. Multiple case series suggest that DBS improves the burden of NMS by reducing prevalence, intensity, and non-motor fluctuations. There is level I evidence on the effect of DBS on cognition and mood. Slight cognitive decline has been reported in most class I studies, although the functional effect is probably minimal. Two randomized prospective studies reported no change in depression while improvement of anxiety has been reported by a class I trial. Prospective cohort studies point to improvement of hyperdopaminergic behaviors, such as impulse control disorders, while others report that hypodopaminergic states, like apathy, can appear after DBS. There is only class III evidence supporting the benefit of DBS on other NMS such as nocturnal sleep, pain, dysautonomia (urinary, gastrointestinal, cardiovascular, and sweating), and weight loss. Although preliminary results are promising, randomized prospectively controlled trials with NMS as primary end points are necessary to further explore the effect of DBS on these often invalidating symptoms and offer conclusions about efficacy. PMID:28725706

The effect of deep brain stimulation on the non-motor symptoms of Parkinson's disease: a critical review of the current evidence.

PubMed

Kurtis, Mónica M; Rajah, Thadshani; Delgado, Luisa F; Dafsari, Haidar S

2017-01-01

The benefit of deep brain stimulation (DBS) in controlling the motor symptoms of Parkinson's disease is well established, however, the impact on the non-motor symptoms (NMS) remains to be elucidated, although the growing investigative efforts are promising. This article reviews the reported data and considers the level of evidence available with regard to the effect of DBS on NMS total burden and on the cognitive, neuropsychiatric, sleep, pain, dysautonomic, and weight domains. Multiple case series suggest that DBS improves the burden of NMS by reducing prevalence, intensity, and non-motor fluctuations. There is level I evidence on the effect of DBS on cognition and mood. Slight cognitive decline has been reported in most class I studies, although the functional effect is probably minimal. Two randomized prospective studies reported no change in depression while improvement of anxiety has been reported by a class I trial. Prospective cohort studies point to improvement of hyperdopaminergic behaviors, such as impulse control disorders, while others report that hypodopaminergic states, like apathy, can appear after DBS. There is only class III evidence supporting the benefit of DBS on other NMS such as nocturnal sleep, pain, dysautonomia (urinary, gastrointestinal, cardiovascular, and sweating), and weight loss. Although preliminary results are promising, randomized prospectively controlled trials with NMS as primary end points are necessary to further explore the effect of DBS on these often invalidating symptoms and offer conclusions about efficacy.

Effects of transcranial direct current stimulation on esophageal motility in patients with gastroesophageal reflux disease.

PubMed

Vigneri, Simone; Bonventre, Sebastiano; Inviati, Angela; Schifano, Domenico; Cosentino, Giuseppe; Puma, Angela; Giglia, Giuseppe; Paladino, Piera; Brighina, Filippo; Fierro, Brigida

2014-09-01

To evaluate the effects of transcranial direct current stimulation (tDCS) on esophageal peristalsis in patients with gastroesophageal reflux disease (GERD). Patients with GERD preliminary diagnosis were included in a randomized double-blind sham-controlled study. Esophageal manometry was performed before and during transcranial direct current stimulation (tDCS) of the right precentral cortex. Half of patients were randomly assigned to anodal, half to sham stimulation. Distal waves amplitude and pathological waves percentage were measured, after swallowing water boli, for ten subsequent times. Last, a 24h pH-bilimetry was done to diagnose non-erosive reflux disease (NERD) or functional heartburn (FH). The values obtained before and during anodal or sham tDCS were compared. Sixty-eight patients were enrolled in the study. Distal waves mean amplitude increased significantly only during anodal tDCS in NERD (p=0.00002) and FH subgroups (p=0.008) while percentage of pathological waves strongly decreased only in NERDs (p=0.002). Transcranial stimulation can influence cortical control of esophageal motility and improve pathological motor pattern in NERD and FH but not in erosive reflux disease (ERD) patients. Pathophysiological processes in GERD are not only due to peripheral damage but to central neural control involvement as well. In ERD patients dysfunctions of the cortico-esophageal circuit seem to be more severe and may affect central nervous system physiology. Copyright © 2014 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

Randomized, Placebo-Controlled, Double-Blind Pilot Study of D-Cycloserine in Chronic Stroke

PubMed Central

Kallos, Justiss; Housley, Stephen N.; LaPlaca, Michelle C.; Traynelis, Stephen F.; Wolf, Steven L.

2015-01-01

Stroke is a leading cause of death and disability in the USA. Up to 60% of patients do not fully recover despite intensive physical therapy treatment. N-Methyl-D-aspartate receptors (NMDA-R) have been shown to play a role in synaptic plasticity when activated. D-Cycloserine promotes NMDA receptor function by binding to receptors with unoccupied glycine sites. These receptors are involved in learning and memory. We hypothesized that D-cycloserine, when combined with robotic-assisted physiotherapy (RAP), would result in greater gains compared with placebo + RAP in stroke survivors. Participants (n = 14) were randomized to D-cycloserine plus RAP or placebo plus RAP. Functional, cognitive, and quality-of-life measures were used to assess recovery. There was significant improvement in grip strength of the affected hand within both groups from baseline to 3 weeks (95% confidence interval for mean change, 3.95 ± 2.96 to 4.90 ± 3.56 N for D-cycloserine and 5.72 ± 3.98 to 8.44 ± 4.90 N for control). SIS mood domain showed improvement for both groups (95% confidence interval for mean change, 72.6 ± 16.3 to 82.9 ± 10.9 for D-cycloserine and 82.9 ± 13.5 to 90.3 ± 9.9 for control). This preliminary study does not provide evidence that D-cycloserine can provide greater gains in learning compared with placebo for stroke survivors. PMID:26587287

Randomized, Controlled Pilot Trial of a Smartphone App for Smoking Cessation Using Acceptance and Commitment Therapy

PubMed Central

Bricker, Jonathan B.; Mull, Kristin; Kientz, Julie A.; Vilardaga, Roger M.; Mercer, Laina D.; Akioka, Katrina; Heffner, Jaimee L.

2014-01-01

Background There is a dual need for (1) innovative theory-based smartphone applications for smoking cessation and (2) controlled trials to evaluate their efficacy. Accordingly, this study tested the feasibility, acceptability, preliminary efficacy, and mechanism of behavioral change of an innovative smartphone-delivered Acceptance and Commitment Therapy (ACT) application for smoking cessation versus an application following US Clinical Practice Guidelines. Method Adult participants were recruited nationally into the double-blind randomized controlled pilot trial (N = 196) that compared smartphone-delivered ACT for smoking cessation application (SmartQuit) with the National Cancer Institute's application for smoking cessation (QuitGuide). Results We recruited 196 participants in two months. SmartQuit participants opened their application an average of 37.2 times, as compared to 15.2 times for QuitGuide participants (p <.0001). The overall quit rates were 13% in SmartQuit vs. 8% in QuitGuide (OR=2.7; 95% CI=0.8-10.3). Consistent with ACT's theory of change, among those scoring low (below the median) on acceptance of cravings at baseline (n = 88), the quit rates were 15% in SmartQuit vs. 8% in QuitGuide (OR=2.9; 95% CI=0.6-20.7). Conclusions ACT is feasible to deliver by smartphone application and shows higher engagement and promising quit rates compared to an application that follows US Clinical Practice Guidelines. As results were limited by the pilot design (e.g., small sample), a full-scale efficacy trial is now needed. PMID:25085225

[Evaluation and symptomatic treatment of surinfectious exacerbations of COPD: preliminary study of antibiotic treatment combined with fenspiride (Pneumorel 80mg) versus placebo].

PubMed

Lirsac, B; Benezet, O; Dansin, E; Nouvet, G; Stach, B; Voisin, C

2000-02-01

Exacerbations of chronic obstructive pulmonary disease (COPD) have an inflammatory component in addition to the possible infectious component. The antiinflammatory properties of fenspiride (Pneumorel(R) 80 mg) should be evaluated in this frequent clinical situation. Assess the supplementary therapeutic benefit provided by fenspiride administered in combination with antibiotics in COPD patients presenting an episode of bronchial infection. A preliminary randomized placebo-controlled double-blind study was conduced in 7 centers. Patients under 80 years of age of both sexes were included. All patients had COPD and presented a bronchial infection defined as the presence of at least 2 of the 3 criteria defined by Anthonisen. Patients were randomly assigned to group F or group P. Group F received an antibiotic therapy from day 1 to day 11 plus fenspiride (3 x 80mg/d from day 0 to day 30). Group P received the same antibiotic therapy plus placebo. Amoxicillin 500mg plus clavulanic acid 125, 3 tablets/day, was administered in both groups. Thirty-nine patients were included (group F 19 patients, group P 20 patients; 6 women and 33 men; mean age 61.1 +/- 9.8 years). The 3 Anthonisen criteria were present in 79% and 75% of the patients in group F and P respectively (NS). On day 11, expectoration resolved in 39% and 32% (NS) and cough in 44% and 16% (NS) of the patients in groups F and P respectively. Lung auscultation returned to normal in 83% of the patients in group F compared with 47% in group P (p=0.05). A composite clinical score including expectoration cough and auscultation findings showed that 28% of the patients in group F were symptom-free on day 11 compared with 0% in group P (p=0.04). On day 30, the two groups were comparable. In this preliminary study of patients with COPD presenting a bronchial superinfection, there was a significant improvement in lung auscultation and in the composite clinical score in patients given fenspiride. Fenspiride was thus found to provide an early clinical benefit.

Effects of Virtual Reality Training using Xbox Kinect on Motor Function in Stroke Survivors: A Preliminary Study.

PubMed

Park, Dae-Sung; Lee, Do-Gyun; Lee, Kyeongbong; Lee, GyuChang

2017-10-01

Although the Kinect gaming system (Microsoft Corp, Redmond, WA) has been shown to be of therapeutic benefit in rehabilitation, the applicability of Kinect-based virtual reality (VR) training to improve motor function following a stroke has not been investigated. This study aimed to investigate the effects of VR training, using the Xbox Kinect-based game system, on the motor recovery of patients with chronic hemiplegic stroke. This was a randomized controlled trial. Twenty patients with hemiplegic stroke were randomly assigned to either the intervention group or the control group. Participants in the intervention group (n = 10) received 30 minutes of conventional physical therapy plus 30 minutes of VR training using Xbox Kinect-based games, and those in the control group (n = 10) received 30 minutes of conventional physical therapy only. All interventions consisted of daily sessions for a 6-week period. All measurements using Fugl-Meyer Assessment (FMA-LE), the Berg Balance Scale (BBS), the Timed Up and Go test (TUG), and the 10-meter Walk Test (10mWT) were performed at baseline and at the end of the 6 weeks. The scores on the FMA-LE, BBS, TUG, and 10mWT improved significantly from baseline to post intervention in both the intervention and the control groups after training. The pre-to-post difference scores on BBS, TUG, and 10mWT for the intervention group were significantly more improved than those for the control group (P <.05). Evidence from the present study supports the use of additional VR training with the Xbox Kinect gaming system as an effective therapeutic approach for improving motor function during stroke rehabilitation. Copyright © 2017 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Preliminary data from a randomized pilot study of web-based functional analytic psychotherapy therapist training.

PubMed

Kanter, Jonathan W; Tsai, Mavis; Holman, Gareth; Koerner, Kelly

2013-06-01

Therapists of many persuasions emphasize the therapy relationship in their work, a priority backed by strong empirical evidence. Training in how to maximize the power and potential of the therapy relationship, however, has lagged behind. A novel approach to using the therapy relationship and to training therapists in its use is provided by Functional Analytic Psychotherapy (FAP). FAP training involves eight 2-hr weekly training sessions conducted online using web-conferencing technology. The training integrates behavioral principles with a focus on trainee-trainer and trainee-trainee relationships in a highly structured course that evokes the desirable FAP therapist-trainee behaviors and collectively shapes the behaviors through reinforcement by the trainer and other trainees. In a preliminary study, 16 therapist-trainees were randomly assigned to receive either immediate FAP training or training after a waitlist period. Significant and large effects of training were found on both self-reported and observer-assessed measures for the first training group, and the waitlist training group replicated the first training group with significant within-subject change over the course of training. Finally, qualitative feedback from therapists indicated high satisfaction with the primary elements of the training protocol. Several important limitations to this preliminary study are discussed.

Cost analysis of PET and comprehensive lifestyle modification for the reversal of atherosclerosis.

PubMed

Delgado, Rigoberto I; Swint, J Michael; Lairson, David R; Johnson, Nils P; Gould, K Lance; Sdringola, Stefano

2014-01-01

We present a preliminary cost analysis of a combination intervention using PET and comprehensive lifestyle modification to reverse atherosclerosis. With a sensitivity of 92%-95% and specificity of 85%-95%, PET is an essential tool for high-precision diagnosis of coronary artery disease, accurately guiding optimal treatment for both symptomatic and asymptomatic patients. PET imaging provides a powerful visual and educational aid for helping patients identify and adopt appropriate treatments. However, little is known about the operational cost of using the technology for this purpose. The analysis was done in the context of the Century Health Study for Cardiovascular Medicine (Century Trial), a 1,300-patient, randomized study combining PET imaging with lifestyle changes. Our methodology included a microcosting and time study focusing on estimating average direct and indirect costs. The total cost of the Century Trial in present-value terms is $9.2 million, which is equal to $7,058 per patient. Sensitivity analysis indicates that the present value of total costs is likely to range between $8.8 and $9.7 million, which is equivalent to $6,655-$7,606 per patient. The clinical relevance of the Century Trial is significant since it is, to our knowledge, the first randomized controlled trial to combine high-precision imaging with lifestyle strategies. The Century Trial is in its second year of a 5-y protocol, and we present preliminary findings. The results of this cost study, however, provide policy makers with an early estimate of the costs of implementing, at large scale, a combined intervention such as the Century Trial. Further, we believe that imaging-guided lifestyle management may have considerable potential for improving outcomes and reducing health-care costs by eliminating unnecessary invasive procedures.

Management of complex regional pain syndrome type I in upper extremity-evaluation of continuous stellate ganglion block and continuous infraclavicular brachial plexus block: a pilot study.

PubMed

Toshniwal, Gokul; Sunder, Rani; Thomas, Ronald; Dureja, G P

2012-01-01

Interventional pain management techniques play an important role in the multidisciplinary approach to management of complex regional pain syndrome (CRPS). In this preliminary study we compared the efficacy of continuous stellate ganglion (CSG) block with that of continuous infraclavicular brachial plexus (CIBP) block in management of CRPS type I of upper extremity. Thirty-three patients with CRPS type I of upper extremity were randomly assigned to either CSG or CIBP group. Patients were treated for 1 week with continuous infusion of 0.125% bupivacaine at 2and 5mL/h, respectively. Catheter was removed at 1 week and patients were followed up for 4 weeks. The outcome was evaluated in terms of neuropathic pain scale score (NPSS), edema scores (Grades 0-2), and range of motion (ROM) of all upper extremity joints (Grades 0-2). CIBP group showed statistically significant improvement in NPSS compared with CSG group during the first 12 hours after the procedures (P value <0.05). After 12 hours, the NPSS was comparable between the groups. At 4 weeks, both groups showed clinically significant improvement in edema score and ROM of all upper extremity joints when compared with the baseline. This preliminary study suggests that CIBP block and CSG block may be feasible and effective interventional techniques for the management of CRPS type I of upper extremities. Hence, we recommend a larger well-randomized, well-controlled, clinical trial to confirm our findings and determine if any significant difference exists between the groups in terms of long-term pain relief and functional restoration. Wiley Periodicals, Inc.

Cytokine and clinical response to Saccharomyces boulardii therapy in diarrhea-dominant irritable bowel syndrome: a randomized trial.

PubMed

Abbas, Zaigham; Yakoob, Javed; Jafri, Wasim; Ahmad, Zubair; Azam, Zahid; Usman, Muhammad W; Shamim, Sara; Islam, Muhammad

2014-06-01

This preliminary study aimed to investigate the effects of the probiotic Saccharomyces boulardii on proinflammatory and anti-inflammatory cytokines in patients with diarrhea-dominant irritable bowel syndrome (IBS-D). The other objectives were to document any clinical improvement as judged by symptoms, quality of life, and histology. This was a randomized, double blind, placebo-controlled trial in which S. boulardii, 750 mg/day, or placebo was administered for 6 weeks in IBS-D patients, in addition to ispaghula husk standard treatment. Thirty-seven patients received S. boulardii and 35 patients received the placebo. As compared with placebo, the S. boulardii group showed a significant decrease in blood and tissue levels of proinflammatory cytokines interleukin-8 (IL-8) and tumor necrosis factor-α (P<0.001) and an increase in anti-inflammatory IL-10 levels, as well as an increase in the tissue IL-10/IL-12 ratio (P<0.001). No significant change in the blood and tissue levels of cytokines was found in the placebo group. Bowel-related IBS-D symptoms reported in the patients' daily diary improved in both groups. However, overall improvement in the quality of life was more marked in the S. boulardii group. Although baseline histological findings were mild, an improvement was observed in the probiotic group in the lymphocyte and neutrophil infiltrates (P=0.017 and 0.018), epithelial mitosis (P=0.003), and intraepithelial lymphocytes (P=0.024). No serious adverse events were found in either group. S. boulardii with ispaghula husk was superior to placebo with ispaghula husk in improving the cytokine profile, histology, and quality of life of patients with IBS-D. These preliminary results need to be confirmed in a well-powered trial.

Weekly Cisplatin and Volumetric-Modulated Arc Therapy With Simultaneous Integrated Boost for Radical Treatment of Advanced Cervical Cancer in Elderly Patients: Feasibility and Clinical Preliminary Results.

PubMed

Mazzola, Rosario; Ricchetti, Francesco; Fiorentino, Alba; Levra, Niccolò Giaj; Fersino, Sergio; Di Paola, Gioacchino; Ruggieri, Ruggero; Alongi, Filippo

2017-06-01

To evaluate the feasibility and clinical preliminary results of weekly cisplatin and volumetric-modulated arc therapy to the pelvis with simultaneous integrated boost to macroscopic disease in a cohort of elderly patients. Inclusion criteria of this prospective study were age ≥70 years, Karnofsky performance status 70 to 100, locally advanced histologically proven squamous cervical carcinoma, and patients unable to undergo brachytherapy. Radiation doses prescribed were 66 Gy to the macroscopic disease and 54 Gy to the pelvic nodes in 30 fractions. Weekly cisplatin dose was 40 mg/mq. A total of 30 patients were recruited. Median follow-up was 32 months (range: 8-48 months). Median age was 72 years (range: 70-84 years). The 3-year overall survival and local control were 93% and 80%, respectively. The median time to progression was 24 months (range: 6-30 months). Analyzing clinical outcome grouping based on the stage of disease, II versus III, the 3-year overall survival was 100% and 85%, respectively. The 3-year local control was 91% for stage II and 67% for stage III. Acute and late toxicities were acceptable without severe events. Weekly cisplatin and volumetric-modulated arc therapy-simultaneous integrated boost for radical treatment of advanced cervical cancer in the current cohort of elderly patients were feasible. Long-term results and prospective randomized trials are advocated.

Weekly Cisplatin and Volumetric-Modulated Arc Therapy With Simultaneous Integrated Boost for Radical Treatment of Advanced Cervical Cancer in Elderly Patients: Feasibility and Clinical Preliminary Results

PubMed Central

Mazzola, Rosario; Ricchetti, Francesco; Fiorentino, Alba; Levra, Niccolò Giaj; Fersino, Sergio; Di Paola, Gioacchino; Ruggieri, Ruggero

2016-01-01

Background: To evaluate the feasibility and clinical preliminary results of weekly cisplatin and volumetric-modulated arc therapy to the pelvis with simultaneous integrated boost to macroscopic disease in a cohort of elderly patients. Materials and Methods: Inclusion criteria of this prospective study were age ≥70 years, Karnofsky performance status 70 to 100, locally advanced histologically proven squamous cervical carcinoma, and patients unable to undergo brachytherapy. Radiation doses prescribed were 66 Gy to the macroscopic disease and 54 Gy to the pelvic nodes in 30 fractions. Weekly cisplatin dose was 40 mg/mq. Results: A total of 30 patients were recruited. Median follow-up was 32 months (range: 8-48 months). Median age was 72 years (range: 70-84 years). The 3-year overall survival and local control were 93% and 80%, respectively. The median time to progression was 24 months (range: 6-30 months). Analyzing clinical outcome grouping based on the stage of disease, II versus III, the 3-year overall survival was 100% and 85%, respectively. The 3-year local control was 91% for stage II and 67% for stage III. Acute and late toxicities were acceptable without severe events. Conclusion: Weekly cisplatin and volumetric-modulated arc therapy–simultaneous integrated boost for radical treatment of advanced cervical cancer in the current cohort of elderly patients were feasible. Long-term results and prospective randomized trials are advocated. PMID:27402633

Feasibility, Acceptability, and Preliminary Efficacy of a Live-Chat Social Media Intervention to Reduce HIV Risk Among Young Men Who Have Sex With Men

PubMed Central

Pachankis, John E.; Gamarel, Kristi E.; Surace, Anthony; Golub, Sarit A.; Parsons, Jeffrey T.

2014-01-01

Given the popularity of social media among young men who have sex with men (YMSM), and in light of YMSM’s elevated and increasing HIV rates, we tested the feasibility, acceptability and preliminary efficacy of a live chat intervention delivered on Facebook in reducing condomless anal sex and substance use within a group of high risk YMSM in a pre-post design with no control group. Participants (N = 41; 18–29 years old) completed up to eight one-hour motivational interviewing and cognitive behavioral skills-based online live chat intervention sessions, and reported on demographic, psychosocial, and behavioral characteristics at baseline and immediately post-intervention. Analyses indicated that participation in the intervention (n = 31) was associated with reductions of days of drug and alcohol use in the past month and instances of anal sex without a condom (including under the influence of substances), as well as increases in knowledge of HIV-related risks at 3-month follow-up. This pilot study argues for the potential of this social media-delivered intervention to reduce HIV risk among a most vulnerable group in the United States, in a manner that was highly acceptable to receive and feasible to execute. A future randomized controlled trial could generate an intervention blueprint for providers to support YMSM’s wellbeing by reaching them regardless of their geographical location, at a low cost. PMID:25256808

Effects of virtual reality-based training with BTs-Nirvana on functional recovery in stroke patients: preliminary considerations.

PubMed

De Luca, Rosaria; Russo, Margherita; Naro, Antonino; Tomasello, Provvidenza; Leonardi, Simona; Santamaria, Floriana; Desireè, Latella; Bramanti, Alessia; Silvestri, Giuseppe; Bramanti, Placido; Calabrò, Rocco Salvatore

2018-02-02

Cognitive impairment occurs frequently in post-stroke patients. This study aimed to determine the effects of a virtual reality training (VRT) with BTs-Nirvana (BTsN) on the recovery of cognitive functions in stroke patients, using the Interactive-Semi-Immersive Program (I-SIP). We enrolled 12 subjects (randomly divided into two groups: experimental group (EG); and control group (CG)), who attended the Laboratory of Robotic and Cognitive Rehabilitation of IRCCS Neurolesi of Messina from January to June 2016. The EG underwent a VRT with BTsN, whereas CG received a standard cognitive treatment. Both the groups underwent the same conventional physiotherapy program. Each treatment session lasted 45 minutes and was repeated three times a week for 8 weeks. All the patients were evaluated by a specific clinical-psychometric battery before (T0), immediately (T1), and one month (T2) after the end of the training. At T1, the EG presented a greater improvement in the trunk control test (p = 0.03), the Montreal Cognitive Assessment (p = 0.01), the selective attention assessment scores (p = 0.01), the verbal memory (p = 0.03), and the visuospatial and constructive abilities (p = 0.01), as compared to CG. Moreover, such amelioration persisted at T2 only in the EG. According to these preliminary data, VRT with I-SIP can be considered a useful complementary treatment to potentiate functional recovery, with regard to attention, visual-spatial deficits, and motor function in patients affected by stroke.

Using Wise Interventions to Motivate Deliberate Practice

PubMed Central

Eskreis-Winkler, Lauren; Shulman, Elizabeth P.; Young, Victoria; Tsukayama, Eli; Brunwasser, Steven M.; Duckworth, Angela L.

2015-01-01

Deliberate practice leads to world-class excellence across domains. In the current investigation, we examined whether psychologically “wise” interventions targeting expectancies and values—stock antecedents of ordinary effortful behaviors—could motivate non-experts to engage in deliberate practice and improve their achievement. As a preliminary, we developed and validated a novel task measure of deliberate practice and confirmed its association with (a) expectancy-value beliefs and (b) achievement in the non-expert setting (Study 1). Next, across four longitudinal, randomized-controlled, field experiments, we intervened. Among lower-achievers, wise deliberate practice interventions improved math performance for fifth and sixth graders (Study 2), end-of-semester grades for undergraduates (Study 3), and end-of-quarter grades for sixth graders (Study 4); the same pattern of results emerged in end-of-quarter grades for seventh graders (Study 5). Following the intervention, expectancy-value beliefs and deliberate practice improved for one month (Study 4), but not four (Study 5). Treatment proved beneficial over and above two control conditions, one that taught standard study skills (Studies 2 and 3), and one that discussed deep interests, generalized motivation, and high achievement (Studies 4 and 5). Collectively, these findings provide preliminary support for the heretofore untested hypothesis that deliberate practice submits to the same laws that govern typical forms of effortful behavior, and that wise interventions that tap into these laws can spur short-term gains in adaptive beliefs, deliberate practice, and objectively-measured achievement. PMID:27762575

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

PRELIMINARY REPORT ON NATIONWIDE STUDY OF DRINKING WATER AND CARDIOVASCULAR DISEASES

EPA Science Inventory

This study was designed to further investigate the association(s) of cardiovascular diseases and drinking water constituents. A sample of 4200 adults were randomly selected from 35 geographic areas to represent the civilian noninstitutionalized population of the contiguous United...

Improved estimation of random vibration loads in launch vehicles

NASA Technical Reports Server (NTRS)

Mehta, R.; Erwin, E.; Suryanarayan, S.; Krishna, Murali M. R.

1993-01-01

Random vibration induced load is an important component of the total design load environment for payload and launch vehicle components and their support structures. The current approach to random vibration load estimation is based, particularly at the preliminary design stage, on the use of Miles' equation which assumes a single degree-of-freedom (DOF) system and white noise excitation. This paper examines the implications of the use of multi-DOF system models and response calculation based on numerical integration using the actual excitation spectra for random vibration load estimation. The analytical study presented considers a two-DOF system and brings out the effects of modal mass, damping and frequency ratios on the random vibration load factor. The results indicate that load estimates based on the Miles' equation can be significantly different from the more accurate estimates based on multi-DOF models.

Culturally Based Intervention Development: The Case of Latino Families Dealing With Schizophrenia

PubMed Central

Barrio, Concepción; Yamada, Ann-Marie

2011-01-01

Objectives This article describes the process of developing a culturally based family intervention for Spanish-speaking Latino families with a relative diagnosed with schizophrenia. Method Our iterative intervention development process was guided by a cultural exchange framework and based on findings from an ethnographic study. We piloted this multifamily group 16-session intervention with 59 Latino families in a randomized control trial. Data were collected on family- and client-level outcomes, and poststudy focus groups were conducted with intervention participants. Results Preliminary evidence indicates that the intervention is effective by increasing illness knowledge and reducing family burden. Conclusions This work can provide a model for how to integrate cultural factors into psychosocial services and enhance interventions in real-world settings for culturally diverse populations. PMID:22121328

Phenelzine as a stimulant drug antagonist: a preliminary report.

PubMed

Maletzky, B M

1977-08-01

Phenelzine administration, monitored via a pharmacy-controlled program, was employed in 38 subjects over a 6-month period to prevent amphetamine-type drug abuse, in much the same manner as disulfiram programs are employed against alcohol abuse. Advantages of the program were apparent, with a majority of subjects abstaining during the enforced phenelzine trial. Subjects generally made use of this abstinent period to benefit from a variety of psychotherapeutic modes, and demonstrated enhanced job and school performance and improved marital relationships. Results based on subject and observer reports, reports from dispensing pharmacies, and random urinalyses for drugs were encouraging. However, the study was uncontrolled and observational, and thus results are merely suggestive at present. Potential dangers as well as benefits of administering phenelzine to such a population are discussed.

Single-blinded, randomised preliminary study evaluating the effects of 2 Hz electroacupuncture for postoperative pain in patients with total knee arthroplasty

PubMed Central

Tzeng, Chung-Yuh; Chang, Shih-Liang; Wu, Chih-Cheng; Chang, Chu-Ling; Chen, Wen-Gii; Tong, Kwok-Man; Huang, Kui-Chou; Hsieh, Ching-Liang

2015-01-01

Objective To explore the point-specific clinical effect of 2 Hz electroacupuncture (EA) in treating postoperative pain in patients undergoing total knee arthroplasty (TKA), Methods In a randomised, partially single-blinded preliminary study, 47patients with TKA were randomly divided into three groups: control group (CG, n=17) using only patient-controlled analgesia (PCA); EA group (EAG, n=16) with 2 Hz EA applied at ST36 (Zusanli) and GB34 (Yanglingquan) contralateral to the operated leg for 30 min on the first two postoperative days, also receiving PCA; and non-point group (NPG, n=14), with EA identical to the EAG except given 1 cm lateral to both ST36 and GB34. The Mann–Whitney test was used to show the difference between two groups and the Kruskal–Wallis test to show the difference between the three groups. Results The time until patients first required PCA in the CG was 34.1±22.0 min, which was significantly shorter than the 92.0±82.7 min in the EAG (p<0.001) and 90.7±94.8 min in the NPG (p<0.001); there was no difference between the EAG and NPG groups (p>0.05). The total dosage of PCA solution given was 4.6±0.9 mL/kg body weight in the CG, 4.2±1.0 mL/kg in the EAG and 4.5±1.0 mL/kg in the NPG; there were no significant differences (p>0.05) among the three groups. Conclusions In this small preliminary study, EA retarded the first demand for PCA in comparison with no EA. No effect was seen on the total dosage of PCA required and no point-specific effect was seen. PMID:25910930

Patient-Centered Personal Health Record and Portal Implementation Toolkit for Ambulatory Clinics: A Feasibility Study.

PubMed

Nahm, Eun-Shim; Diblasi, Catherine; Gonzales, Eva; Silver, Kristi; Zhu, Shijun; Sagherian, Knar; Kongs, Katherine

2017-04-01

Personal health records and patient portals have been shown to be effective in managing chronic illnesses. Despite recent nationwide implementation efforts, the personal health record and patient portal adoption rates among patients are low, and the lack of support for patients using the programs remains a critical gap in most implementation processes. In this study, we implemented the Patient-Centered Personal Health Record and Patient Portal Implementation Toolkit in a large diabetes/endocrinology center and assessed its preliminary impact on personal health record and patient portal knowledge, self-efficacy, patient-provider communication, and adherence to treatment plans. Patient-Centered Personal Health Record and Patient Portal Implementation Toolkit is composed of Patient-Centered Personal Health Record and Patient Portal Implementation Toolkit-General, clinic-level resources for clinicians, staff, and patients, and Patient-Centered Personal Health Record and Patient Portal Implementation Toolkit Plus, an optional 4-week online resource program for patients ("MyHealthPortal"). First, Patient-Centered Personal Health Record and Patient Portal Implementation Toolkit-General was implemented, and all clinicians and staff were educated about the center's personal health record and patient portal. Then general patient education was initiated, while a randomized controlled trial was conducted to test the preliminary effects of "MyHealthPortal" using a small sample (n = 74) with three observations (baseline and 4 and 12 weeks). The intervention group showed significantly greater improvement than the control group in patient-provider communication at 4 weeks (t56 = 3.00, P = .004). For other variables, the intervention group tended to show greater improvement; however, the differences were not significant. In this preliminary study, Patient-Centered Personal Health Record and Patient Portal Implementation Toolkit showed potential for filling the gap in the current personal health record and patient portal implementation process. Further studies are needed using larger samples in other settings to ascertain if these results are generalizable to other populations.

Assessment of two culturally competent diabetes education methods: individual versus individual plus group education in Canadian Portuguese adults with type 2 diabetes.

PubMed

Gucciardi, Enza; Demelo, Margaret; Lee, Ruth N; Grace, Sherry L

2007-04-01

To examine the impact of two culturally competent diabetes education methods, individual counselling and individual counselling in conjunction with group education, on nutrition adherence and glycemic control in Portuguese Canadian adults with type 2 diabetes over a three-month period. The Diabetes Education Centre is located in the urban multicultural city of Toronto, Ontario, Canada. We used a three-month randomized controlled trial design. Eligible Portuguese-speaking adults with type 2 diabetes were randomly assigned to receive either diabetes education counselling only (control group) or counselling in conjunction with group education (intervention group). Of the 61 patients who completed the study, 36 were in the counselling only and 25 in the counselling with group education intervention. We used a per-protocol analysis to examine the efficacy of the two educational approaches on nutrition adherence and glycemic control; paired t-tests to compare results within groups and analysis of covariance (ACOVA) to compare outcomes between groups adjusting for baseline measures. The Theory of Planned Behaviour was used to describe the behavioural mechanisms that influenced nutrition adherence. Attitudes, subjective norms, perceived behaviour control, and intentions towards nutrition adherence, self-reported nutrition adherence and glycemic control significantly improved in both groups, over the three-month study period. Yet, those receiving individual counselling with group education showed greater improvement in all measures with the exception of glycemic control, where no significant difference was found between the two groups at three months. Our study findings provide preliminary evidence that culturally competent group education in conjunction with individual counselling may be more efficacious in shaping eating behaviours than individual counselling alone for Canadian Portuguese adults with type 2 diabetes. However, larger longitudinal studies are needed to determine the most efficacious education method to sustain long-term nutrition adherence and glycemic control.

Regional Brain Activity in Abstinent Methamphetamine Dependent Males Following Cue Exposure.

PubMed

Malcolm, Robert; Myrick, Hugh; Li, Xingbao; Henderson, Scott; Brady, Kathleen T; George, Mark S; See, Ronald E

Neuroimaging of drug-associated cue presentations has aided in understanding the neurobiological substrates of craving and relapse for cocaine, alcohol, and nicotine. However, imaging of cue-reactivity in methamphetamine addiction has been much less studied. Nine caucasian male methamphetamine-dependent subjects and nine healthy controls were scanned in a Phillips 3.0T MRI scan when they viewed a randomized presentation of visual cues of methamphetamine, neutral objects, and rest conditions. Functional Imaging data were analyzed with Statistical Parametric Mapping software 5 (SPM 5). Methamphetamine subjects had significant brain activation in the ventral striatum and medial frontal cortex in comparison to meth pictures and neutral pictures in healthy controls (p<0.005, threshold 15 voxels). Interestingly the ventral striatum activation significantly correlated with the days since the last use of meth (r=-0.76, p=0.017). No significant activity was found in healthy control group. The preliminary data suggest that methamphetamine dependent subjects, when exposed to methamphetamine-associated visual cues, have increased brain activity in ventral striatum, caudate nucleus and medial frontal cortex which subserve craving, drug-seeking, and drug use.

Bee venom acupuncture point injection for central post stroke pain: a preliminary single-blind randomized controlled trial.

PubMed

Cho, Seung-Yeon; Park, Joo-Young; Jung, Woo-Sang; Moon, Sang-Kwan; Park, Jung-Mi; Ko, Chang-Nam; Park, Seong-Uk

2013-06-01

We investigated apipuncture, or acupuncture point injection with diluted bee venom, as a promising new treatment for central post stroke pain (CPSP). Bee venom, diluted to 0.005% in normal saline, was administered to the treatment group, and normal saline given to control group as twice-weekly injections for three weeks. The points were LI15, GB21, LI11, GB31, ST36 and GB39 of the affected side and the amount of injection was 0.05 ml at each point. Eight patients in each group were included in the analysis. After three weeks there were significant decreases in visual analogue pain scores compared with baseline in both groups and the treatment group improved more significantly than the control group (p = 0.009). Apipuncture significantly improved CPSP in this pilot trial. Further studies of its mechanisms and a larger and long-term follow-up trial will be needed to determine more definitely the efficacy of apipuncture and to elucidate duration of improvement. Copyright © 2013 Elsevier Ltd. All rights reserved.

The effect of need supportive text messages on motivation and physical activity behaviour.

PubMed

Kinnafick, Florence-Emilie; Thøgersen-Ntoumani, Cecilie; Duda, Joan

2016-08-01

Few short messaging service (SMS) studies to support behaviour change have used a theoretical underpinning. Using a self-determination theory perspective, we explored the effects of need supportive (NS) SMS on physical activity in 65 (BMI = 24.06 kg/m(2), SD = 5.49; M = 25.76 years, SD = 10.23) insufficiently active individuals embarking on an existing exercise programme. For 10 weeks participants were randomised to an intervention group (NS) or control group (neutral). SMS were sent twice weekly, randomly, via an online SMS service. Mixed design ANCOVA and MANCOVA analyses of measures taken at baseline, mid and post intervention revealed increased levels of perceived autonomy support and psychological need satisfaction in the intervention group post intervention. Both groups reported increases in intrinsic motivation from pre to post intervention. Moderate intensity physical activity was greater in the intervention than the control group at 4-month post intervention with control group returning to baseline levels. Findings provide preliminary causal evidence to support the use of NS SMS to optimise physical activity behaviour change in individuals who are insufficiently active.

A hotel-based outbreak of Salmonella enterica subsp. Enterica serovar Enteritidis (Salmonella Enteritidis) in the United Kingdom, 2006.

PubMed

Calvert, N; Murphy, L; Smith, A; Copeland, D

2007-03-01

An outbreak of food-borne Salmonella Enteritidis PT4 occurred in Cumbria, in north-west England, in the summer of 2006. Fifteen people, all with positive stool samples, met the case definition; three of these were admitted to hospital, including one patient who died. Preliminary investigations suggested a link to a meal served at a local hotel. A case control study was implemented, together with microbiological and environmental investigations. Fifteen microbiologically confirmed cases and 27 unmatched controls were included in the study, controls being randomly selected from people who had eaten at the hotel on the same day. The epidemiological evidence indicated a very strong association between infection and consumption of tiramisu made with raw shell eggs, although none were available for microbiological investigation. These results are in line with other salmonellosis outbreaks that have been associated with the use of raw shell eggs in food manufacturing and production. This paper highlights the continuing need for a greater awareness by those who work in the food industry of the health risks associated with the consumption of raw shell eggs.

The impact of a daily smartphone-based feedback system among women with gestational diabetes on compliance, glycemic control, satisfaction, and pregnancy outcome: a randomized controlled trial.

PubMed

Miremberg, Hadas; Ben-Ari, Tal; Betzer, Tal; Raphaeli, Hagit; Gasnier, Rose; Barda, Giulia; Bar, Jacob; Weiner, Eran

2018-04-01

Patient compliance and tight glycemic control have been demonstrated to improve outcome in pregnancies complicated by gestational diabetes mellitus. The use of advanced technological tools, including smartphone-based platforms, to improve medical care and outcomes has been demonstrated in various fields of medicine, but only a few small studies were performed with gestational diabetes mellitus patients. We aimed to study the impact of introducing a smartphone-based daily feedback and communication platform between gestational diabetes mellitus patients and their physicians, on patient compliance, glycemic control, pregnancy outcome, and patient satisfaction. This is a prospective, single-center, randomized controlled trial. Newly diagnosed gestational diabetes mellitus patients presenting to our multidisciplinary diabetes-in-pregnancy clinic were randomized to: (1) routine biweekly prenatal clinic care (control group); or (2) additional daily detailed feedback on their compliance and glycemic control from the clinic team via an application installed on their smartphone (smartphone group). The primary outcome was patient compliance defined as the actual blood glucose measurements/instructed measurements ×100. The secondary outcomes included diabetes-control parameters, pregnancy, and neonatal outcomes. The study was adequately powered to detect a 20% difference in patient compliance, based on a preliminary phase that demonstrated 70% baseline compliance to glucose measurements. A total of 120 newly diagnosed gestational diabetes mellitus patients were analyzed. The 2 groups did not differ in terms of age, parity, education, body mass index, family history, maternal comorbidities, oral glucose tolerance test values, and hemoglobin A1C at randomization. The smartphone group demonstrated higher level of compliance (84 ± 0.16% vs 66 ± 0.28%, P < .001); lower mean blood glucose (105.1 ± 8.6 mg/dL vs 112.6 ± 7.4 mg/dL, P < .001); lower rates of off-target measurements both fasting (4.7 ± 0.4% vs 8.4 ± 0.6%, P < .001) and 1-hour postprandial (7.7 ± 0.8% vs 14.3 ± 0.8%, P < .001); and a lower rate of pregnancies requiring insulin treatment (13.3% vs 30.0%, P = .044). The rates of macrosomia, neonatal hypoglycemia, shoulder dystocia, and other delivery and neonatal complications did not differ between the groups. Patients in the smartphone group reported excellent satisfaction from the use of the application and from their overall prenatal care. Introduction of a smartphone-based daily feedback and communication platform between gestational diabetes mellitus patients and the multidisciplinary diabetes-in-pregnancy clinic team improved patient compliance and glycemic control, and lowered the rate of insulin treatment. Copyright © 2018 Elsevier Inc. All rights reserved.

Enhanced invitation methods to increase uptake of NHS health checks: study protocol for a randomized controlled trial.

PubMed

Forster, Alice S; Burgess, Caroline; McDermott, Lisa; Wright, Alison J; Dodhia, Hiten; Conner, Mark; Miller, Jane; Rudisill, Caroline; Cornelius, Victoria; Gulliford, Martin C

2014-08-30

NHS Health Checks is a new program for primary prevention of heart disease, stroke, diabetes, chronic kidney disease, and vascular dementia in adults aged 40 to 74 years in England. Individuals without existing cardiovascular disease or diabetes are invited for a Health Check every 5 years. Uptake among those invited is lower than anticipated. The project is a three-arm randomized controlled trial to test the hypothesis that enhanced invitation methods, using the Question-Behaviour Effect (QBE), will increase uptake of NHS Health Checks compared with a standard invitation. Participants comprise individuals eligible for an NHS Health Check registered in two London boroughs. Participants are randomized into one of three arms. Group A receives the standard NHS Health Check invitation letter, information sheet, and reminder letter at 12 weeks for nonattenders. Group B receives a QBE questionnaire 1 week before receiving the standard invitation, information sheet, and reminder letter where appropriate. Group C is the same as Group B, but participants are offered a £5 retail voucher if they return the questionnaire. Participants are randomized in equal proportions, stratified by general practice. The primary outcome is uptake of NHS Health Checks 6 months after invitation from electronic health records. We will estimate the incremental health service cost per additional completed Health Check for trial groups B and C versus trial arm A, as well as evaluating the impact of the QBE questionnaire, and questionnaire plus voucher, on the socioeconomic inequality in uptake of Health Checks.The trial includes a nested comparison of two methods for implementing allocation, one implemented manually at general practices and the other implemented automatically through the information systems used to generate invitations for the Health Check. The research will provide evidence on whether asking individuals to complete a preliminary questionnaire, by using the QBE, is effective in increasing uptake of Health Checks and whether an incentive alters questionnaire return rates as well as uptake of Health Checks. The trial interventions can be readily translated into routine service delivery if they are shown to be cost-effective. Current Controlled Trials ISRCTN42856343. Date registered: 21.03.2013.

Multicolumn spinal cord stimulation for significant low back pain in failed back surgery syndrome: design of a national, multicentre, randomized, controlled health economics trial (ESTIMET Study).

PubMed

Roulaud, M; Durand-Zaleski, I; Ingrand, P; Serrie, A; Diallo, B; Peruzzi, P; Hieu, P D; Voirin, J; Raoul, S; Page, P; Fontaine, D; Lantéri-Minet, M; Blond, S; Buisset, N; Cuny, E; Cadenne, M; Caire, F; Ranoux, D; Mertens, P; Naous, H; Simon, E; Emery, E; Gadan, B; Regis, J; Sol, J-C; Béraud, G; Debiais, F; Durand, G; Guetarni Ging, F; Prévost, A; Brandet, C; Monlezun, O; Delmotte, A; d'Houtaud, S; Bataille, B; Rigoard, P

2015-03-01

Many studies have demonstrated the efficacy of spinal cord stimulation (SCS) for chronic neuropathic radicular pain over recent decades, but despite global favourable outcomes in failed back surgery syndrome (FBSS) with leg pain, the back pain component remains poorly controlled by neurostimulation. Technological and scientific progress has led to the development of new SCS leads, comprising a multicolumn design and a greater number of contacts. The efficacy of multicolumn SCS lead configurations for the treatment of the back pain component of FBSS has recently been suggested by pilot studies. However, a randomized controlled trial must be conducted to confirm the efficacy of new generation multicolumn SCS. Évaluation médico-économique de la STImulation MEdullaire mulTi-colonnes (ESTIMET) is a multicentre, randomized study designed to compare the clinical efficacy and health economics aspects of mono- vs. multicolumn SCS lead programming in FBSS patients with radicular pain and significant back pain. FBSS patients with a radicular pain VAS score≥50mm, associated with a significant back pain component were recruited in 14 centres in France and implanted with multicolumn SCS. Before the lead implantation procedure, they were 1:1 randomized to monocolumn SCS (group 1) or multicolumn SCS (group 2). Programming was performed using only one column for group 1 and full use of the 3 columns for group 2. Outcome assessment was performed at baseline (pre-implantation), and 1, 3, 6 and 12months post-implantation. The primary outcome measure was a reduction of the severity of low back pain (bVAS reduction≥50%) at the 6-month visit. Additional outcome measures were changes in global pain, leg pain, paraesthesia coverage mapping, functional capacities, quality of life, neuropsychological aspects, patient satisfaction and healthcare resource consumption. Trial recruitment started in May 2012. As of September 2013, all 14 study centres have been initiated and 112/115 patients have been enrolled. Preliminary results are expected to be published in 2015. Clinical trial registration information-URL: www.clinicaltrials.gov. Unique identifier NCT01628237. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

Collaborative care intervention targeting violence risk behaviors, substance use, and posttraumatic stress and depressive symptoms in injured adolescents: a randomized clinical trial.

PubMed

Zatzick, Douglas; Russo, Joan; Lord, Sarah Peregrine; Varley, Christopher; Wang, Jin; Berliner, Lucy; Jurkovich, Gregory; Whiteside, Lauren K; O'Connor, Stephen; Rivara, Frederick P

2014-06-01

Violence and injury risk behaviors, alcohol and drug use problems, and posttraumatic stress disorder (PTSD) and depressive symptoms occur frequently among adolescents presenting to acute care medical settings after traumatic physical injury. To test the effectiveness of a stepped collaborative care intervention targeting this constellation of risk behaviors and symptoms in randomly sampled hospitalized adolescents with and without traumatic brain injury. A pragmatic randomized clinical trial was conducted at a single US level I trauma center. Participants included 120 adolescents aged 12 to 18 years randomized to intervention (n = 59) and control (n = 61) conditions. Stepped collaborative care intervention included motivational interviewing elements targeting risk behaviors and substance use as well as medication and cognitive behavioral therapy elements targeting PTSD and depressive symptoms. Adolescents were assessed at baseline before randomization and 2, 5, and 12 months after injury hospitalization. Standardized instruments were used to assess violence risk behaviors, alcohol and drug use, and PTSD and depressive symptoms. The investigation attained more than 95% adolescent follow-up at each assessment point. At baseline, approximately one-third of the participants endorsed the violence risk behavior of carrying a weapon. Regression analyses demonstrated that intervention patients experienced significant reductions in weapon carrying compared with controls during the year after injury (group × time effect, F3,344 = 3.0; P = .03). At 12 months after the injury, 4 (7.3%) intervention patients vs 13 (21.3%) control patients reported currently carrying a weapon (relative risk, 0.31; 95% CI, 0.11-0.90). The intervention was equally effective in reducing the risk of weapon carrying among injured adolescents with and without traumatic brain injury. Other treatment targets, including alcohol and drug use problems and high levels of PTSD and depressive symptoms, occurred less frequently in the cohort relative to weapon carrying and were not significantly affected by the intervention. Collaborative care intervention reduced the risk of adolescent weapon carrying during the year after the injury hospitalization. Future investigation should replicate this preliminary observation. If the finding is replicated, orchestrated investigative and policy efforts could systematically implement and evaluate screening and intervention procedures targeting youth violence prevention at US trauma centers. clinicaltrials.gov identifier: NCT00619255.

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.

PRELIMINARY RESULTS: EVALUATIONS OF THE ALTERNATIVE ASBESTOS CONTROL METHOD FOR BUILDING DEMOLITION

EPA Science Inventory

This presentation describes the preliminary results of the evaluations of the alternative asbestos control method for demolishing buildings containing asbestos, and are covered under the regulatory requirements of the Asbestos NESHAP. This abstract and presentation are based, at ...

Comparison of a theory-based (AIDS Risk Reduction Model) cognitive behavioral intervention versus enhanced counseling for abused ethnic minority adolescent women on infection with sexually transmitted infection: results of a randomized controlled trial.

PubMed

Champion, Jane Dimmitt; Collins, Jennifer L

2012-02-01

Ethnic minority adolescent women with a history of sexual or physical abuse and sexually transmitted infections represent a vulnerable population at risk for HIV. Community-based interventions for behavior modification and subsequent risk reduction have not been effective among these women. To evaluate the effects of a theory-based (AIDS Risk Reduction Model) cognitive behavioral intervention model versus enhanced counseling for abused ethnic minority adolescent women on infection with sexually transmitted infection at 6 and 12 months follow-up. Controlled randomized trial with longitudinal follow-up. Southwestern United States, Metropolitan community-based clinic. Mexican-and-African American adolescent women aged 14-18 years with a history of abuse or sexually transmitted infection seeking sexual health care. Extensive preliminary study for intervention development was conducted including individual interviews, focus groups, secondary data analysis, pre-testing and feasibility testing for modification of an evidence-based intervention prior to testing in the randomized controlled trial. Following informed consents for participation in the trial, detailed interviews concerning demographics, abuse history, sexual risk behavior, sexual health and physical exams were obtained. Randomization into either control or intervention groups was conducted. Intervention participants received workshop, support group and individual counseling sessions. Control participants received abuse and enhanced clinical counseling. Follow-up including detailed interview and physical exam was conducted at 6 and 12 months following study entry to assess for infection. Intention to treat analysis was conducted to assess intervention effects using chi-square and multiple regression models. 409 Mexican-(n=342) and African-(n=67) American adolescent women with abuse and sexually transmitted infection histories were enrolled; 90% intervention group attendance; longitudinal follow-up at 6 (93%) and 12 (94%) months. Intervention (n=199) versus control (n=210) group participants experienced fewer infections at 0-6 (0% versus 6.6%, p=.001), 6-12 (3.6% versus 7.8%, p=.005, CI 95% lower-upper .001-.386) and 0-12 (4.8% versus 13.2%, p=.002, CI 95% lower-upper, .002-.531) month intervals. A cognitive behavioral intervention specifically designed for ethnic minority adolescent women with a history of abuse and sexually transmitted infection was effective for prevention of infection. These results provide evidence for development of evidence-based interventions for sexually transmitted infection/HIV. Implications include translation to community-clinic-based settings for prevention of adverse outcomes regarding sexual health of adolescent women. Copyright © 2011 Elsevier Ltd. All rights reserved.

An engineered human antibody to TNF (CDP571) for active Crohn's disease: a randomized double-blind placebo-controlled trial.

PubMed

Sandborn, W J; Feagan, B G; Hanauer, S B; Present, D H; Sutherland, L R; Kamm, M A; Wolf, D C; Baker, J P; Hawkey, C; Archambault, A; Bernstein, C N; Novak, C; Heath, P K; Targan, S R

2001-05-01

We evaluated CDP571, a humanized antibody to tumor necrosis factor, for the treatment of active Crohn's disease. One hundred sixty-nine patients with moderate-to-severe Crohn's disease were enrolled in a 24-week placebo-controlled trial. Patients were initially randomized to a single dose of 10 or 20 mg/kg CDP571 or placebo to assess dose response. Patients were then retreated with 10 mg/kg CDP571 or placebo every 8 or 12 weeks to assess subsequent dosing intervals. The primary endpoint was clinical response at week 2, defined as a decrease in the Crohn's Disease Activity Index score > or = 70 points. At week 2, clinical response occurred in 45% of CDP571-treated patients compared with 27% of patients in the placebo group (P = 0.023). Patients appeared to benefit from retreatment with CDP571 over 24 weeks, but not all of the results for secondary endpoints were statistically significant. The frequency of severe or serious adverse events was similar among all groups. CDP571 at an initial dose of 10 or 20 mg/kg is safe and effective for treatment of patients with moderate-to-severe Crohn's disease. Preliminary evidence suggests that retreatment with 10 mg/kg CDP571 at dose intervals of 8 or 12 weeks may also be beneficial, but additional studies are needed.

Development and Pilot Randomized Control Trial of a Drama Program to Enhance Well-being Among Older Adults

PubMed Central

Moore, Raeanne C.; Straus, Elizabeth; Dev, Sheena I.; Parish, Steven M.; Sueko, Seema; Eyler, Lisa T.

2016-01-01

Objective Develop a novel theatre-based program and test its feasibility, tolerability, and preliminary efficacy for improving empathy/compassion and well-being among older adults. Method Thirteen older adults were randomized to a 6-week Drama Workshop (DW) program or time-equivalent Backstage Pass (BP) control condition. Pre- and post-treatment measures included empathy, compassion, and mood scales. Additional post-treatment measures included self-rated change in empathy/compassion, confidence, and affect. Participants also rated their mood/affect after each session. Results The program was successfully completed and well-liked. No pre-to-post-treatment changes in empathy/compassion or mood symptoms were found in either group. Compared to BP, DW weekly ratings indicated higher levels of anxiety and lower happiness; however, the DW program had higher self-ratings of positive change in self-esteem, confidence, and happiness post-treatment. Discussion While the DW may not promote empathy/compassion and was personally challenging during the program, engagement in dramatic exercises and rehearsing and performing a dramatic piece was seen by participants as a positive growth experience, as indicated by the post-treatment ratings of enhanced self-esteem, confidence and happiness. Thus, such a program might be useful for counteracting some of the potential negative aspects of aging, including reduced self-efficacy due to physical limitations and negative affect due to losses. PMID:28503015

Autologous cord blood transfusion in preterm infants - could its humoral effect be the kez to control prematurity-related complications? A preliminary study.

PubMed

Kotowski, M; Litwinska, Z; Klos, P; Pius-Sadowska, E; Zagrodnik-Ulan, E; Ustianowski, P; Rudnicki, J; Machalinski, B

2017-12-01

Umbilical cord blood (UCB), rich in stem/progenitor cells, is partially eliminated from the bloodstream during childbirth because the cord is immediately clamped. We hypothesize that transfusion of autologous UCB to premature infants after delivery could serve as an adjuvant modality for preventing the development of prematurity-related complications. We randomly enrolled 20 preterm infants born before 32 weeks of gestational age (GA), all of whom developed anemia, necessitating transfusion of red blood cells (RBCs). Two groups, matched for GA, were selected: (1) infants (n = 5) who underwent UCB transfusion once within 5 days of birth (mean ± standard deviation, 3.2 ± 1.9 days) and (2) infants (n = 15) from whom UCB was not collected (e.g., lack of consent). The latter served as controls and received allogeneic RBC transfusions (7.8 ± 3.9 days after birth). Selected prematurity-related complications were monitored. Two weeks after UCB/RBC transfusion, peripheral blood samples were collected, and the concentrations of 41 selected growth factors and their receptors were analyzed using a multiplex protein array. UCB transfusions were found to be both feasible and tolerable. Intraventricular haemorrhage was diagnosed in two of five (40%) UCB recipients, but was found in thirteen of fifteen RBC recipients (86.7%). Twenty-two plasma proteins (e.g., insulin-like growth factors, stem cell factor, epidermal growth factors) were found with significantly different concentrations in UCB recipients compared to controls. Results demonstrate safety and feasibility of UCB transfusion in a small group of very premature neonates and should be interpreted as preliminary speculation. Transfusion of UCB could induce a specific humoral effects, and this could serve as an adjuvant modality for prevention of prematurity complications.

Navigation of autonomous vehicles for oil spill cleaning in dynamic and uncertain environments

NASA Astrophysics Data System (ADS)

Jin, Xin; Ray, Asok

2014-04-01

In the context of oil spill cleaning by autonomous vehicles in dynamic and uncertain environments, this paper presents a multi-resolution algorithm that seamlessly integrates the concepts of local navigation and global navigation based on the sensory information; the objective here is to enable adaptive decision making and online replanning of vehicle paths. The proposed algorithm provides a complete coverage of the search area for clean-up of the oil spills and does not suffer from the problem of having local minima, which is commonly encountered in potential-field-based methods. The efficacy of the algorithm is tested on a high-fidelity player/stage simulator for oil spill cleaning in a harbour, where the underlying oil weathering process is modelled as 2D random-walk particle tracking. A preliminary version of this paper was presented by X. Jin and A. Ray as 'Coverage Control of Autonomous Vehicles for Oil Spill Cleaning in Dynamic and Uncertain Environments', Proceedings of the American Control Conference, Washington, DC, June 2013, pp. 2600-2605.

An attitude of gratitude: The effects of body-focused gratitude on weight bias internalization and body image.

PubMed

Dunaev, Jamie; Markey, Charlotte H; Brochu, Paula M

2018-06-01

Internalized weight bias and body dissatisfaction are associated with a number of negative psychological and physical health outcomes. The current study examined the effectiveness of body-focused gratitude, through a short writing exercise, as a strategy to reduce internalized weight bias and improve body image. Young adults (M age  = 22.71, SD = 2.08, 51.2% female) were randomly assigned to either a body gratitude condition (n = 185) or a control condition (n = 184). Results indicated that participants in the gratitude condition reported significantly lower weight bias internalization and significantly more favorable appearance evaluation and greater body satisfaction when compared to the control condition. These effects were in the small range (ds = 0.27-0.33), and neither gender nor BMI moderated these effects. These findings provide preliminary support for body-focused gratitude writing exercises as an effective individual-level strategy for both reducing internalized weight bias and improving body image. Copyright © 2018 Elsevier Ltd. All rights reserved.

Cognitive Behavioral Treatment for Recurrent Binge Eating in Adolescent Girls: A Pilot Trial

PubMed Central

DeBar, Lynn L.; Wilson, G. Terence; Yarborough, Bobbi Jo; Burns, Beryl; Oyler, Barbara; Hildebrandt, Tom; Clarke, Gregory N.; Dickerson, John; Striegel, Ruth H.

2013-01-01

There is a need for treatment interventions to address the high prevalence of disordered eating throughout adolescence and early adulthood. We developed an adolescent-specific manualized CBT protocol to treat female adolescents with recurrent binge eating and tested its efficacy in a small, pilot randomized controlled trial. We present lessons learned in recruiting adolescents, a description of our treatment approach, acceptability of the treatment for teens and parents, as well as results from the pilot trial. Participants in the CBT group had significantly fewer posttreatment eating binges than those in a treatment as usual/delayed treatment (TAU-DT) control group; 100% of CBT participants were abstinent at follow-up. Our results provide preliminary support for the efficacy of this adolescent adaptation of evidence-based CBT for recurrent binge eating. The large, robust effect size estimate observed for the main outcome (NNT=2) places this among the larger effects observed for any mental health intervention. PMID:23645978

[Effects of a mindfulness intervention in Chilean high schoolers].

PubMed

Langer, Álvaro I; Schmidt, Carlos; Aguilar-Parra, José Manuel; Cid, Cristian; Magni, Antonella

2017-04-01

Mindfulness has been conceptualized as paying attention to present moment experience in a non-judgmental manner, and the practice of developing that skill. To determine the impact of a mindfulness-based intervention on negative emotional states of anxiety, stress, and depression in Chilean high schoolers. Eighty-eight teenagers aged 13 ± 0.6 years (46 females) were randomly assigned to a mindfulness group or a control (41 and 47, respectively). The mindfulness intervention consisted in eight weekly 45-minute sessions. A depression, anxiety, and stress scale (DASS-21) was applied at baseline, after the intervention, and at three and six-month follow-up. There was a significant reduction in anxiety, depression, and general symptomatology in the experimental group compared to the control group. However, these changes were not sustained at follow-up. These preliminary results suggest the feasibility and effectiveness of a mindfulness intervention in Chilean schools as a strategy to reduce negative emotional states and prevent risk factors in adolescent population groups.

Improvements in emotion regulation following repetitive transcranial magnetic stimulation for generalized anxiety disorder.

PubMed

Diefenbach, Gretchen J; Assaf, Michal; Goethe, John W; Gueorguieva, Ralitza; Tolin, David F

2016-10-01

Generalized anxiety disorder (GAD) is characterized by emotion regulation difficulties, which are associated with abnormalities in neural circuits encompassing fronto-limbic regions including the dorsolateral prefrontal cortex (DLPFC). The aim of this study was to determine whether DLPFC neuromodulation improves emotion regulation in patients with GAD. This is a secondary analysis from a randomized-controlled trial comparing 30 sessions of low-frequency right-sided active (n=13) versus sham (n=12, sham coil) repetitive transcranial magnetic stimulation (rTMS) at the right DLPFC in patients with GAD. Results indicated statistically significant improvements in self-reported emotion regulation difficulties at posttreatment and 3-month follow-up in the active group only. Improvements were found primarily in the domains of goal-directed behaviors and impulse control and were significantly associated with a global clinician rating of improvement. These preliminary results support rTMS as a treatment for GAD and suggest improved emotion regulation as a possible mechanism of change. Copyright © 2016 Elsevier Ltd. All rights reserved.

[The preliminary study on nursing the extraction of mandibular mesioangular impacted third molar using reversal high-speed air turbine].

PubMed

Song, Juan; Bi, Xiaoqin

2012-08-01

To study the nursing methods and its effect in mandibular mesioangular impacted third molar extraction with reversal high-speed air turbine. 60 patients with mandibular mesioangular impacted third molar were selected in this study, who were treated in Department of Senior Dentists, West China School of Stomatology, Sichuan University, between June to December 2010. They were randomly and equally divided into control group and experimental group (n=30). The former was treated with tradition chisel splint method while the latter was treated with reversal high-speed air turbine extraction and provided appropriate nursing interventions. Postoperative reactions and wound healing status were evaluated through consultation. There were significant differences between control group and experimental group in terms of postoperative bleeding wound, swelling, dry socket and so on (P<0.05). Mandibular mesioangular impacted third molar extraction with reversal high-speed air turbine is effective, and the corresponding nursing measure is worthy further promotion.

Role of rasagiline in treating Parkinson's disease: Effect on disease progression.

PubMed

Malaty, Irene A; Fernandez, Hubert H

2009-08-01

Rasagiline is a second generation, selective, irreversible monoamine oxidase type B (MAO-B) inhibitor. It has demonstrated efficacy in monotherapy for early Parkinson's disease (PD) patients in one large randomized, placebo-controlled trial (TVP-1012 in Early Monotherapy for Parkinson's Disease Outpatients), and has shown ability to reduce off time in more advanced PD patients with motor fluctuations in two large placebo-controlled trials (Parkinson's Rasagiline: Efficacy and Safety in the Treatment of "Off", and Lasting Effect in Adjunct Therapy With Rasagiline Given Once Daily). Preclinical data abound to suggest potential for neuroprotection by this compound against a variety of neurotoxic insults in cell cultures and in animals. The lack of amphetamine metabolites provides an advantage over the first generation MAO-B inhibitor selegiline. One large trial has investigated the potential for disease modification in PD patients (Attenuation of Disease progression with Azilect Given Once-daily) and preliminary results maintain some possible advantage to earlier initiation of the 1 mg/day dose. The clinical significance of the difference detected remains a consideration.

Effectiveness of a 10-week tier-1 response to intervention program in improving fine motor and visual-motor skills in general education kindergarten students.

PubMed

Ohl, Alisha M; Graze, Hollie; Weber, Karen; Kenny, Sabrina; Salvatore, Christie; Wagreich, Sarah

2013-01-01

This study examined the efficacy of a 10-wk Tier 1 Response to Intervention (RtI) program developed in collaboration with classroom teachers to improve the fine motor and visual-motor skills of general education kindergarten students. We recruited 113 students in six elementary schools. Two general education kindergarten classrooms at each school participated in the study. Classrooms were randomly assigned to the intervention and control groups. Fine motor skills, pencil grip, and visual-motor integration were measured at the beginning of the school year and after the 10-wk intervention. The intervention group demonstrated a statistically significant increase in fine motor and visual-motor skills, whereas the control group demonstrated a slight decline in both areas. Neither group demonstrated a change in pencil grip. This study provides preliminary evidence that a Tier 1 RtI program can improve fine motor and visual-motor skills in kindergarten students. Copyright © 2013 by the American Occupational Therapy Association, Inc.

A Preliminary Efficacy and Feasibility of an Obstructive Sleep Apnea Educational Intervention in Oman

NASA Astrophysics Data System (ADS)

Al Mezeini, Khamis Abdallah

Background: Obstructive sleep apnea (OSA) is chronic disorder that contributes to multiple physiological and psychological conditions. Obstructive sleep apnea contributes to high rates of morbidity and mortality and has substantial impacts on both health care costs and the quality of life for affected individuals and their families. Healthcare providers - particularly primary health care nurses - are ideally situated to interrupt the cascading consequences of OSA if they are equipped with evidence-based knowledge about the disease process and appropriate methods for screening, education, and preventive interventions. Purpose: The purpose of the study was to test the preliminary efficacy and feasibility of an online health educational intervention on the knowledge and attitudes of OSA among primary health care nurses in Oman. Methods: This study was designed to assess the preliminary efficacy and feasibility of an online educational program on OSA by randomly assigning subjects to either a treatment (OSA content) or attention control (diabetes content) group. At baseline, the OSA knowledge and attitudes of both groups were assessed by the Obstructive Sleep Apnea Knowledge and Attitudes (OSAKA) questionnaire; both groups also completed the Diabetes Basic Knowledge Test (DBKT) to use for control comparisons. Following randomization, the intervention group viewed a 15-minute narrated video on "Brief Introduction to OSA for Omani Nurses" and the control group viewed a similarly formatted 15-minute narrated video on diabetes. The intent was for the subjects in both groups to complete a posttest that included both the OSAKA and DBKT instruments; however, due to a programming error, the software did not present the DBKT to the intervention subjects and did not present the OSAKA instrument to the control subjects as intended. Therefore, the results describe the findings from a one-group, pretest-posttest intervention study to assess the preliminary efficacy and feasibility of the educational intervention. Feasibility data were also collected with face-to face interviews with a convenience sample of nurse administrators who oversee primary health care nurses in health centers in the Al-Batinah governorate in Oman. Results: Overall, the baseline OSA knowledge scores for the entire sample (N=156) were very low (M=8.87, SD=2.91; median=9, range 0-15 out of possible 18 points). There were no significant relationships between OSA knowledge and any of the demographic variables. There was no significant difference in the mean OSA knowledge scores (p=0.80, t =0.26) between the intervention group (M=8.90, SD=2.68, n=73) and the control group (M=8.84, SD=3.12, n=83) at baseline. Primary health care nurses in the intervention group (n = 73) had a significant improvement in posttest knowledge scores on the OSAKA as compared to pretest scores ( p = .037, t= -2.1). After the online OSA educational intervention, 91.8% (n=67) of participants (n=73) indicated they were "likely" or "very likely" to recommend the online video to other health professionals. Although posttest attitudes were higher than baseline for the intervention group, the difference did not reach statistical significance. Implications for Practice: The low levels of OSA knowledge in this sample of primary health care nurses may indicate that their ability to identify patients at risk for OSA, assess at-risk patients appropriately, or refer as needed to physicians is limited. Nursing educators may consider integrating content about sleep disorders - and OSA - into the baccalaureate nursing curricula. Continuing education programs might offer focused programs on sleep disorders and OSA to raise awareness among practicing nurses. Conclusion: Primary health care nurses in Oman are expected to assess patients, identify health risks, and refer as necessary to physicians or other practitioners. In this sample of primary health care nurses, knowledge about OSA was limited; low knowledge of risk factors, symptoms, and treatment options may undermine the nurses' ability to assure that patients who may have OSA are referred appropriately. Implications for basic nursing curricula and continuing education are offered.

Canine-assisted therapy for children with ADHD: preliminary findings from the positive assertive cooperative kids study.

PubMed

Schuck, Sabrina E B; Emmerson, Natasha A; Fine, Aubrey H; Lakes, Kimberley D

2015-02-01

The objective of this study was to provide preliminary findings from an ongoing randomized clinical trial using a canine-assisted intervention (CAI) for 24 children with ADHD. Project Positive Assertive Cooperative Kids (P.A.C.K.) was designed to study a 12-week cognitive-behavioral intervention delivered with or without CAI. Children were randomly assigned to group therapy with or without CAI. Parents of children in both groups simultaneously participated in weekly parent group therapy sessions. Across both treatment groups, parents reported improvements in children's social skills, prosocial behaviors, and problematic behaviors. In both groups, the severity of ADHD symptoms declined during the course of treatment; however, children who received the CAI model exhibited greater reductions in the severity of ADHD symptoms than did children who received cognitive-behavioral therapy without CAI. Results suggest that CAI offers a novel therapeutic strategy that may enhance cognitive-behavioral interventions for children with ADHD. © 2013 SAGE Publications.

Closed-Loop Aeromaneuvering for a Mars Precision Landing

NASA Technical Reports Server (NTRS)

Smith, Roy; Boussalis, Dhemetrios; Hadaegh, Fred Y.

1997-01-01

Controlled aeromaneuvering is considered as a means of achieving a precisely targeted landing on Mars. This paper presents a preliminary study of the control issues. The candidate vehicle is the existing Mars Pathfinder augmented with roll thrusters and a center of mass offset actuator. These allow control of both bank angle and lift force, giving the ability to control the range and cross-track during the aeromaneuvering entry. A preliminary control system structure is proposed and a design simulation illustrates significant targeting improvement under closed-loop control.

Cardiopoietic cell therapy for advanced ischaemic heart failure: results at 39 weeks of the prospective, randomized, double blind, sham-controlled CHART-1 clinical trial.

PubMed

Bartunek, Jozef; Terzic, Andre; Davison, Beth A; Filippatos, Gerasimos S; Radovanovic, Slavica; Beleslin, Branko; Merkely, Bela; Musialek, Piotr; Wojakowski, Wojciech; Andreka, Peter; Horvath, Ivan G; Katz, Amos; Dolatabadi, Dariouch; El Nakadi, Badih; Arandjelovic, Aleksandra; Edes, Istvan; Seferovic, Petar M; Obradovic, Slobodan; Vanderheyden, Marc; Jagic, Nikola; Petrov, Ivo; Atar, Shaul; Halabi, Majdi; Gelev, Valeri L; Shochat, Michael K; Kasprzak, Jaroslaw D; Sanz-Ruiz, Ricardo; Heyndrickx, Guy R; Nyolczas, Noémi; Legrand, Victor; Guédès, Antoine; Heyse, Alex; Moccetti, Tiziano; Fernandez-Aviles, Francisco; Jimenez-Quevedo, Pilar; Bayes-Genis, Antoni; Hernandez-Garcia, Jose Maria; Ribichini, Flavio; Gruchala, Marcin; Waldman, Scott A; Teerlink, John R; Gersh, Bernard J; Povsic, Thomas J; Henry, Timothy D; Metra, Marco; Hajjar, Roger J; Tendera, Michal; Behfar, Atta; Alexandre, Bertrand; Seron, Aymeric; Stough, Wendy Gattis; Sherman, Warren; Cotter, Gad; Wijns, William

2017-03-01

Cardiopoietic cells, produced through cardiogenic conditioning of patients' mesenchymal stem cells, have shown preliminary efficacy. The Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) trial aimed to validate cardiopoiesis-based biotherapy in a larger heart failure cohort. This multinational, randomized, double-blind, sham-controlled study was conducted in 39 hospitals. Patients with symptomatic ischaemic heart failure on guideline-directed therapy (n = 484) were screened; n = 348 underwent bone marrow harvest and mesenchymal stem cell expansion. Those achieving > 24 million mesenchymal stem cells (n = 315) were randomized to cardiopoietic cells delivered endomyocardially with a retention-enhanced catheter (n = 157) or sham procedure (n = 158). Procedures were performed as randomized in 271 patients (n = 120 cardiopoietic cells, n = 151 sham). The primary efficacy endpoint was a Finkelstein-Schoenfeld hierarchical composite (all-cause mortality, worsening heart failure, Minnesota Living with Heart Failure Questionnaire score, 6-min walk distance, left ventricular end-systolic volume, and ejection fraction) at 39 weeks. The primary outcome was neutral (Mann-Whitney estimator 0.54, 95% confidence interval [CI] 0.47-0.61 [value > 0.5 favours cell treatment], P = 0.27). Exploratory analyses suggested a benefit of cell treatment on the primary composite in patients with baseline left ventricular end-diastolic volume 200-370 mL (60% of patients) (Mann-Whitney estimator 0.61, 95% CI 0.52-0.70, P = 0.015). No difference was observed in serious adverse events. One (0.9%) cardiopoietic cell patient and 9 (5.4%) sham patients experienced aborted or sudden cardiac death. The primary endpoint was neutral, with safety demonstrated across the cohort. Further evaluation of cardiopoietic cell therapy in patients with elevated end-diastolic volume is warranted. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.

Comparative effectiveness and cost-effectiveness of Chuna manual therapy versus conventional usual care for nonacute low back pain: study protocol for a pilot multicenter, pragmatic randomized controlled trial (pCRN study).

PubMed

Shin, Byung-Cheul; Kim, Me-Riong; Cho, Jae-Heung; Jung, Jae-Young; Kim, Koh-Woon; Lee, Jun-Hwan; Nam, Kibong; Lee, Min Ho; Hwang, Eui-Hyoung; Heo, Kwang-Ho; Kim, Namkwen; Ha, In-Hyuk

2017-01-17

While Chuna manual therapy is a Korean manual therapy widely used primarily for low back pain (LBP)-related disorders in Korea, well-designed studies on the comparative effectiveness of Chuna manual therapy are scarce. This study is the protocol for a three-armed, multicenter, pragmatic randomized controlled pilot trial. Sixty severe nonacute LBP patients (pain duration of at least 3 weeks, Numeric Rating Scale (NRS) ≥5) will be recruited at four Korean medicine hospitals. Participants will be randomly allocated to the Chuna group (n = 20), usual care group (n = 20), or Chuna plus usual care group (n = 20) for 6 weeks of treatment. Usual care will consist of orally administered conventional medicine, physical therapy, and back pain care education. The trial will be conducted with outcome assessor and statistician blinding. The primary endpoint will be NRS of LBP at week 7 post randomization. Secondary outcomes include NRS of leg pain, the Oswestry Disability Index (ODI), the Patient Global Impression of Change (PGIC), the Credibility and Expectancy Questionnaire, lumbar range of motion (ROM), the EuroQol-5 Dimension (EQ-5D) health survey, the Health Utility Index III (HUI-III), and economic evaluation and safety data. Post-treatment follow-ups will be conducted at 1, 4, and 10 weeks after conclusion of treatment. This study will assess the comparative effectiveness of Chuna manual therapy compared to conventional usual care. Costs and effectiveness (utility) data will be analyzed for exploratory cost-effectiveness analysis. If this pilot study does not reach a definite conclusion due to its small sample size, these results will be used as preliminary results to calculate sample size for future large-scale clinical trials and contribute in the assessment of feasibility of a full-scale multicenter trial. Clinical Research Information Service (CRIS), KCT0001850 . Registered on 17 March 2016.

Preliminary Findings of a Randomized Trial of Non-Pharmaceutical Interventions to Prevent Influenza Transmission in Households

PubMed Central

Cowling, Benjamin J.; Fung, Rita O. P.; Cheng, Calvin K. Y.; Fang, Vicky J.; Chan, Kwok Hung; Seto, Wing Hong; Yung, Raymond; Chiu, Billy; Lee, Paco; Uyeki, Timothy M.; Houck, Peter M.; Peiris, J. S. Malik; Leung, Gabriel M.

2008-01-01

Background There are sparse data on whether non-pharmaceutical interventions can reduce the spread of influenza. We implemented a study of the feasibility and efficacy of face masks and hand hygiene to reduce influenza transmission among Hong Kong household members. Methodology/Principal Findings We conducted a cluster randomized controlled trial of households (composed of at least 3 members) where an index subject presented with influenza-like-illness of <48 hours duration. After influenza was confirmed in an index case by the QuickVue Influenza A+B rapid test, the household of the index subject was randomized to 1) control or 2) surgical face masks or 3) hand hygiene. Households were visited within 36 hours, and 3, 6 and 9 days later. Nose and throat swabs were collected from index subjects and all household contacts at each home visit and tested by viral culture. The primary outcome measure was laboratory culture confirmed influenza in a household contact; the secondary outcome was clinically diagnosed influenza (by self-reported symptoms). We randomized 198 households and completed follow up home visits in 128; the index cases in 122 of those households had laboratory-confirmed influenza. There were 21 household contacts with laboratory confirmed influenza corresponding to a secondary attack ratio of 6%. Clinical secondary attack ratios varied from 5% to 18% depending on case definitions. The laboratory-based or clinical secondary attack ratios did not significantly differ across the intervention arms. Adherence to interventions was variable. Conclusions/Significance The secondary attack ratios were lower than anticipated, and lower than reported in other countries, perhaps due to differing patterns of susceptibility, lack of significant antigenic drift in circulating influenza virus strains recently, and/or issues related to the symptomatic recruitment design. Lessons learnt from this pilot have informed changes for the main study in 2008. Trial Registration ClinicalTrials.gov NCT00425893 HKClinicalTrials.com HKCTR-365 PMID:18461182

Cardiopoietic cell therapy for advanced ischaemic heart failure: results at 39 weeks of the prospective, randomized, double blind, sham-controlled CHART-1 clinical trial

PubMed Central

Bartunek, Jozef; Terzic, Andre; Davison, Beth A.; Filippatos, Gerasimos S.; Radovanovic, Slavica; Beleslin, Branko; Merkely, Bela; Musialek, Piotr; Wojakowski, Wojciech; Andreka, Peter; Horvath, Ivan G.; Katz, Amos; Dolatabadi, Dariouch; El Nakadi, Badih; Arandjelovic, Aleksandra; Edes, Istvan; Seferovic, Petar M.; Obradovic, Slobodan; Vanderheyden, Marc; Jagic, Nikola; Petrov, Ivo; Atar, Shaul; Halabi, Majdi; Gelev, Valeri L.; Shochat, Michael K.; Kasprzak, Jaroslaw D.; Sanz-Ruiz, Ricardo; Heyndrickx, Guy R.; Nyolczas, Noémi; Legrand, Victor; Guédès, Antoine; Heyse, Alex; Moccetti, Tiziano; Fernandez-Aviles, Francisco; Jimenez-Quevedo, Pilar; Bayes-Genis, Antoni; Hernandez-Garcia, Jose Maria; Ribichini, Flavio; Gruchala, Marcin; Waldman, Scott A.; Teerlink, John R.; Gersh, Bernard J.; Povsic, Thomas J.; Henry, Timothy D.; Metra, Marco; Hajjar, Roger J.; Tendera, Michal; Behfar, Atta; Alexandre, Bertrand; Seron, Aymeric; Stough, Wendy Gattis; Sherman, Warren; Cotter, Gad; Wijns, William

2017-01-01

Aims Cardiopoietic cells, produced through cardiogenic conditioning of patients’ mesenchymal stem cells, have shown preliminary efficacy. The Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) trial aimed to validate cardiopoiesis-based biotherapy in a larger heart failure cohort. Methods and results This multinational, randomized, double-blind, sham-controlled study was conducted in 39 hospitals. Patients with symptomatic ischaemic heart failure on guideline-directed therapy (n = 484) were screened; n = 348 underwent bone marrow harvest and mesenchymal stem cell expansion. Those achieving > 24 million mesenchymal stem cells (n = 315) were randomized to cardiopoietic cells delivered endomyocardially with a retention-enhanced catheter (n = 157) or sham procedure (n = 158). Procedures were performed as randomized in 271 patients (n = 120 cardiopoietic cells, n = 151 sham). The primary efficacy endpoint was a Finkelstein–Schoenfeld hierarchical composite (all-cause mortality, worsening heart failure, Minnesota Living with Heart Failure Questionnaire score, 6-min walk distance, left ventricular end-systolic volume, and ejection fraction) at 39 weeks. The primary outcome was neutral (Mann–Whitney estimator 0.54, 95% confidence interval [CI] 0.47–0.61 [value > 0.5 favours cell treatment], P = 0.27). Exploratory analyses suggested a benefit of cell treatment on the primary composite in patients with baseline left ventricular end-diastolic volume 200–370 mL (60% of patients) (Mann–Whitney estimator 0.61, 95% CI 0.52–0.70, P = 0.015). No difference was observed in serious adverse events. One (0.9%) cardiopoietic cell patient and 9 (5.4%) sham patients experienced aborted or sudden cardiac death. Conclusion The primary endpoint was neutral, with safety demonstrated across the cohort. Further evaluation of cardiopoietic cell therapy in patients with elevated end-diastolic volume is warranted. PMID:28025189

“Smart” RCTs: Development of a Smartphone App for Fully Automated Nutrition-Labeling Intervention Trials

PubMed Central

Li, Nicole; Dunford, Elizabeth; Eyles, Helen; Crino, Michelle; Michie, Jo; Ni Mhurchu, Cliona

2016-01-01

Background There is substantial interest in the effects of nutrition labels on consumer food-purchasing behavior. However, conducting randomized controlled trials on the impact of nutrition labels in the real world presents a significant challenge. Objective The Food Label Trial (FLT) smartphone app was developed to enable conducting fully automated trials, delivering intervention remotely, and collecting individual-level data on food purchases for two nutrition-labeling randomized controlled trials (RCTs) in New Zealand and Australia. Methods Two versions of the smartphone app were developed: one for a 5-arm trial (Australian) and the other for a 3-arm trial (New Zealand). The RCT protocols guided requirements for app functionality, that is, obtaining informed consent, two-stage eligibility check, questionnaire administration, randomization, intervention delivery, and outcome assessment. Intervention delivery (nutrition labels) and outcome data collection (individual shopping data) used the smartphone camera technology, where a barcode scanner was used to identify a packaged food and link it with its corresponding match in a food composition database. Scanned products were either recorded in an electronic list (data collection mode) or allocated a nutrition label on screen if matched successfully with an existing product in the database (intervention delivery mode). All recorded data were transmitted to the RCT database hosted on a server. Results In total approximately 4000 users have downloaded the FLT app to date; 606 (Australia) and 1470 (New Zealand) users met the eligibility criteria and were randomized. Individual shopping data collected by participants currently comprise more than 96,000 (Australia) and 229,000 (New Zealand) packaged food and beverage products. Conclusions The FLT app is one of the first smartphone apps to enable conducting fully automated RCTs. Preliminary app usage statistics demonstrate large potential of such technology, both for intervention delivery and data collection. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12614000964617. New Zealand trial: Australian New Zealand Clinical Trials Registry ACTRN12614000644662. PMID:26988128

e-Learning versus lecture-based courses in ECG interpretation for undergraduate medical students: a randomized noninferiority study.

PubMed

Montassier, Emmanuel; Hardouin, Jean-Benoît; Segard, Julien; Batard, Eric; Potel, Gilles; Planchon, Bernard; Trochu, Jean-Noël; Pottier, Pierre

2016-04-01

An ECG is pivotal for the diagnosis of coronary heart disease. Previous studies have reported deficiencies in ECG interpretation skills that have been responsible for misdiagnosis. However, the optimal way to acquire ECG interpretation skills is still under discussion. Thus, our objective was to compare the effectiveness of e-learning and lecture-based courses for learning ECG interpretation skills in a large randomized study. We conducted a prospective, randomized, controlled, noninferiority study. Participants were recruited from among fifth-year medical students and were assigned to the e-learning group or the lecture-based group using a computer-generated random allocation sequence. The e-learning and lecture-based groups were compared on a score of effectiveness, comparing the 95% unilateral confidence interval (95% UCI) of the score of effectiveness with the mean effectiveness in the lecture-based group, adjusted for a noninferiority margin. Ninety-eight students were enrolled. As compared with the lecture-based course, e-learning was noninferior with regard to the postcourse test score (15.1; 95% UCI 14.2; +∞), which can be compared with 12.5 [the mean effectiveness in the lecture-based group (15.0) minus the noninferiority margin (2.5)]. Furthermore, there was a significant increase in the test score points in both the e-learning and lecture-based groups during the study period (both P<0.0001). Our randomized study showed that the e-learning course is an effective tool for the acquisition of ECG interpretation skills by medical students. These preliminary results should be confirmed with further multicenter studies before the implementation of e-learning courses for learning ECG interpretation skills during medical school.

Psilocybin for treating substance use disorders?

PubMed

de Veen, Bas T H; Schellekens, Arnt F A; Verheij, Michel M M; Homberg, Judith R

2017-02-01

Evidence based treatment for Substance use disorders (SUD) includes psychotherapy and pharmacotherapy. However, these are only partially effective. Hallucinogens, such as psilocybin, may represent potential new treatment options for SUD. This review provides a summary of (human) studies on the putative therapeutic effects of psilocybin, and discusses the receptor systems, brain regions and cognitive and emotional processes mediating psilocybin's effects. Psilocybin's chemical structure is similar to that of serotonin. Dysregulations in the serotonin system are associated with alterations in stress hormones, such as cortisol, and mood disorders. After psilocybin administration cortisol levels spike and activate the executive control network, with subsequent increased control over emotional processes, and relief of negative thinking and persistent negative emotions. Preliminary data of ongoing alcohol and smoking addiction studies in humans shows promising effects of psilocybin administration on substance use. Importantly, psilocybin has a low risk of toxicity and dependence and can be used safely under controlled clinical conditions. Areas covered: This paper is a narrative review based on the search terms: psilocybin, substance use disorder, addiction, depression, serotonin. Literature on potential efficacy and mechanisms of action of psilocybin in SUD is discussed. Expert commentary: Recent positive findings with psilocybin need confirmation in well-designed placebo controlled randomized trials employing a large sample size.

Landscape and Residential Variables Associated with Plague-Endemic Villages in the West Nile Region of Uganda

PubMed Central

MacMillan, Katherine; Enscore, Russell E.; Ogen-Odoi, Asaph; Borchert, Jeff N.; Babi, Nackson; Amatre, Gerald; Atiku, Linda A.; Mead, Paul S.; Gage, Kenneth L.; Eisen, Rebecca J.

2011-01-01

Plague, caused by the bacteria Yersinia pestis, is a severe, often fatal disease. This study focuses on the plague-endemic West Nile region of Uganda, where limited information is available regarding environmental and behavioral risk factors associated with plague infection. We conducted observational surveys of 10 randomly selected huts within historically classified case and control villages (four each) two times during the dry season of 2006 (N = 78 case huts and N = 80 control huts), which immediately preceded a large plague outbreak. By coupling a previously published landscape-level statistical model of plague risk with this observational survey, we were able to identify potential residence-based risk factors for plague associated with huts within historic case or control villages (e.g., distance to neighboring homestead and presence of pigs near the home) and huts within areas previously predicted as elevated risk or low risk (e.g., corn and other annual crops grown near the home, water storage in the home, and processed commercial foods stored in the home). The identified variables are consistent with current ecologic theories on plague transmission dynamics. This preliminary study serves as a foundation for future case control studies in the area. PMID:21363983

Protocol of an ongoing randomized controlled trial of care management for comorbid depression and hypertension: the Chinese Older Adult Collaborations in Health (COACH) study.

PubMed

Chen, Shulin; Conwell, Yeates; Xue, Jiang; Li, Lydia W; Tang, Wan; Bogner, Hillary R; Dong, Hengjin

2018-05-29

Depression and hypertension are common, costly, and destructive conditions among the rapidly aging population of China. The two disorders commonly coexist and are poorly recognized and inadequately treated, especially in rural areas. The Chinese Older Adult Collaborations in Health (COACH) Study is a cluster randomized controlled trial (RCT) designed to test the hypotheses that the COACH intervention, designed to manage comorbid depression and hypertension in older adult, rural Chinese primary care patients, will result in better treatment adherence and greater improvement in depressive symptoms and blood pressure control, and better quality of life, than enhanced Care-as-Usual (eCAU). Based on chronic disease management and collaborative care principles, the COACH model integrates the care provided by the older person's primary care provider (PCP) with that delivered by an Aging Worker (AW) from the village's Aging Association, supervised by a psychiatrist consultant. One hundred sixty villages, each of which is served by one PCP, will be randomly selected from two counties in Zhejiang Province and assigned to deliver eCAU or the COACH intervention. Approximately 2400 older adult residents from the selected villages who have both clinically significant depressive symptoms and a diagnosis of hypertension will be recruited into the study, randomized by the villages in which they live and receive primary care. After giving informed consent, they will undergo a baseline research evaluation; receive treatment for 12 months with the approach to which their village was assigned; and be re-evaluated at 3, 6, 9, and 12 months after entry. Depression and HTN control are the primary outcomes. Treatment received, health care utilization, and cost data will be obtained from the subjects' electronic medical records (EMR) and used to assess adherence to care recommendations and, in a preliminary manner, to establish cost and cost effectiveness of the intervention. The COACH intervention is designed to serve as a model for primary care-based management of common mental disorders that occur in tandem with common chronic conditions of later life. It leverages existing resources in rural settings, integrates social interventions with the medical model, and is consistent with the cultural context of rural life. ClinicalTrials.gov ID: NCT01938963 ; First posted: September 10, 2013.

Effects of intensive whole-body vibration training on muscle strength and balance in adults with chronic stroke: a randomized controlled pilot study.

PubMed

Tankisheva, Ekaterina; Bogaerts, An; Boonen, Steven; Feys, Hilde; Verschueren, Sabine

2014-03-01

To investigate the effects of a 6-week whole body vibration (WBV) training program in patients with chronic stroke. Randomized controlled pilot trial with 6 weeks' follow-up. University hospital. Adults with chronic stroke (N=15) were randomly assigned to an intervention (n=7) or a control group (n=8). Supervised, intensive WBV training. The vibration group performed a variety of static and dynamic squat exercises on a vibration platform with vibration amplitudes of 1.7 and 2.5mm and frequencies of 35 and 40Hz. The vibration lasted 30 to 60 seconds, with 5 to 17 repetitions per exercise 3 times weekly for 6 weeks. Participants in the control group continued their usual activities and were not involved in any additional training program. The primary outcome variable was the isometric and isokinetic muscle strength of the quadriceps (isokinetic dynamometer). Additionally, hamstrings muscle strength, static and dynamic postural control (dynamic posturography), and muscle spasticity (Ashworth Scale) were assessed. Compliance with the vibration intervention was excellent, and the participants completed all 18 training sessions. Vibration frequencies of both 35 and 40Hz were well tolerated by the patients, and no adverse effects resulting from the vibration were noted. Overall, the effect of intensive WBV intervention resulted in significant between-group differences in favor of the vibration group only in isometric knee extension strength (knee angle, 60°) (P=.022) after 6 weeks of intervention and in isokinetic knee extension strength (velocity, 240°/s) after a 6-week follow-up period (P=.005), both for the paretic leg. Postural control improved after 6 weeks of vibration in the intervention group when the patients had normal vision and a sway-referenced support surface (P<.05). Muscle spasticity was not affected by vibration (P>.05). These preliminary results suggest that intensive WBV might potentially be a safe and feasible way to increase some aspect of lower limb muscle strength and postural control in adults with chronic stroke. Further studies should focus on evaluating how the training protocol should be administered to achieve the best possible outcome, as well as comparing this training protocol to other interventions. Copyright © 2014 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Preliminary effects of progressive muscle relaxation on cigarette craving and withdrawal symptoms in experienced smokers in acute cigarette abstinence: a randomized controlled trial.

PubMed

Limsanon, Thatsanee; Kalayasiri, Rasmon

2015-03-01

Cigarette craving usually occurs in conjunction with unpleasant feelings, including stress, as part of a withdrawal syndrome. Progressive muscle relaxation (PMR), a behavioral technique used to reduce stress by concentrating on achieving muscle relaxation, may reduce levels of cigarette craving and other substance-related negative feelings and withdrawal symptoms. Demographic and cigarette use data were collected from 32 experienced smokers at the King Chulalongkorn Memorial Hospital, Bangkok, Thailand using the Semi-Structured Assessment for Drug Dependence and Alcoholism. Participants were asked to refrain from smoking for at least 3 hours before the visit (acute abstinence) and were randomly allocated to a 1-session PMR group (n =16) or a control activity group (e.g., reading newspaper, n =16). The intervention group was instructed to practice PMR individually in a quiet, private, air-conditioned room for about 20minutes. Craving, other substance-related feelings, and autonomic nervous responses (e.g., blood pressure and pulse rate) were assessed immediately before and after the 1-session intervention. There were no differences in demographics, cigarette use/dependence, and baseline craving characteristics between the PMR and control groups. However, the control group had higher levels of high and paranoia feeling, and pulse rate than the PMR group at baseline. After practicing PMR, but not after a control activity, smokers undergoing acute abstinence had significantly lower levels of cigarette craving, withdrawal symptoms, and systolic blood pressure than at baseline. After controlling for baseline differences, abstaining smokers using PMR had lower levels of cigarette craving, withdrawal symptoms, and systolic blood pressure than smokers who undertook a control activity. PMR significantly reduces cigarette craving, withdrawal symptoms, and blood pressure in smokers undergoing acute abstinence. PMR may be used as an adjunct to cigarette dependency treatments. Copyright © 2014. Published by Elsevier Ltd.

Effects of auriculotherapy on labour pain: a randomized clinical trial.

PubMed

Mafetoni, Reginaldo Roque; Shimo, Antonieta Keiko Kakuda

2016-01-01

Assessing the effects of auriculotherapy in pain control and its outcomes on the duration of labour. This is a randomized, controlled, double-blind trial with preliminary data. Thirty pregnant women with gestational age ≥ 37 weeks, cervical dilatation ≥ 4 cm and two or more contractions in 10 minutes were selected and randomly divided into three groups: auriculotherapy, placebo and control. Auriculotherapy was applied using crystal beads on four strategic points. No statistical significance was found between the groups with regard to pain; however, the women from the auriculotherapy group had lower intensity and less perception of pain at 30, 60 and 120 minutes of treatment. The average duration of labour was shorter in the auriculotherapy group (248.7 versus placebo 414.8 versus control 296.3 minutes); caesarean section rates were higher in the placebo group (50%) and the same in the other groups (10%). Mothers who received auriculotherapy presented a tendency for greater pain control and shorter labour duration; however, caesarean section rates in this group were similar to the control group. This trial precedes a larger study in progress. Registration of Brazilian Clinical Trials: RBR-47hhbj. Avaliar os efeitos da auriculoterapia no controle da dor e seus desfechos na duração do trabalho de parto. Trata-se de um ensaio controlado, randomizado e duplo-cego, com dados preliminares. Foram selecionadas 30 parturientes com idade gestacional ≥ 37 semanas, dilatação cervical ≥ 4 cm e duas ou mais contrações em 10 minutos, divididas aleatoriamente em três grupos: auriculoterapia, placebo ou controle. A auriculoterapia foi aplicada com microesferas de cristais em quatro pontos estratégicos. Não houve significância estatística entre os grupos com relação à dor; no entanto, as mulheres do grupo de auriculoterapia, apresentaram menor intensidade e menor percepção da dor aos 30, 60 e 120 minutos do tratamento. A média de duração do trabalho de parto foi menor no grupo de auriculoterapia (248,7 versus placebo 414,8 versus controle 296,3 minutos); a taxa de cesárea foi maior no grupo placebo (50%) e igual nos outros (10%). As parturientes que receberam auriculoterapia apresentaram tendência a um maior controle da dor e menor duração do trabalho de parto, porém a taxa de cesárea neste grupo foi semelhante à do grupo controle. Este ensaio precede um estudo maior, em andamento. Registro Brasileiro de Ensaio Clínico: RBR-47hhbj.

Randomized trial of a peer resistance skill-building game for Hispanic early adolescent girls.

PubMed

Norris, Anne E; Hughes, Charles; Hecht, Michael; Peragallo, Nilda; Nickerson, David

2013-01-01

Adolescents can use peer resistance skills to avoid being pressured into risky behavior, such as early sexual behavior. Avatar-based virtual reality technology offers a novel way to help build these skills. The aims of this study were to evaluate the feasibility of an avatar-based virtual reality peer resistance skill building game (DRAMA-RAMA), to explore the impact of game play on peer resistance self-efficacy, and to assess how positively the game was perceived. Forty-four low-income early adolescent Hispanic girls were assigned randomly to either the intervention (DRAMA-RAMA) or attention control game (Wii Dancing With the Stars) condition. All participants were offered a five-session curriculum that included peer resistance skill content before playing their respective game for 15 minutes, once a week, for 2 weeks. Participants completed electronic surveys at baseline, after game play, and at 2 months to assess demographics, peer resistance self-efficacy, and sexual behavior. They also completed a paper-pencil game experience questionnaire immediately after game play. Data were analyzed using descriptive statistics, t test, chi-square, and analyses of covariance. Separate analyses of covariance showed a significant game effect at posttest for the peer resistance self-efficacy measure (F = 4.21, p < .05), but not at follow-up (F = 0.01, p = .92). DRAMA-RAMA was rated as positively as the Wii Dancing With the Stars (p > .26). This randomized control trial provides preliminary support for the hypothesis that playing an avatar-based virtual reality technology game can strengthen peer resistance skills, and early adolescent Hispanic girls will have a positive response to this game.

Nurse-delivered counselling intervention for parental HIV disclosure: Results from a pilot randomized controlled trial in China

PubMed Central

Simoni, Jane M.; Yang, Joyce P.; Shiu, Cheng-Shi; Chen, Wei-ti; Udell, Wadiya; Bao, Meijuan; Zhang, Lin; Lu, Hongzhou

2016-01-01

Objective The objective of this study was to design and conduct a preliminary evaluation of an intervention to assist parents in decision-making about disclosure of their HIV diagnosis to their children. Design This was a pilot randomized controlled trial (RCT) with blinded assessment. Participants were randomized to intervention or treatment-as-usual (TAU) arms. Setting The study occurred at an outpatient HIV primary care centre in Shanghai, China. Participants Participants were 20 HIV-positive outpatients with at least one child (13–25 years old) who was unaware of the parent’s HIV diagnosis. Intervention The nurse-delivered intervention involved three, hour-long, individual sessions over 4 weeks. Intervention content comprised family assessment, discussion of advantages and disadvantages of disclosure, psycho-education about cognitive, social and emotional abilities of children at different developmental stages, and disclosure planning and practicing via role-plays. Main outcome measure(s) Primary study outcomes for intervention versus TAU arms were self-reported disclosure distress, self-efficacy and behaviours along a continuum from no disclosure to full disclosure and open communication about HIV. Results In all cross-sectional (Wald tests) and longitudinal (general estimating equations) analyses, at both postintervention (4 weeks) and follow-up (13 weeks), effects were in the hypothesized directions. Despite the small sample size, most of these between-arm comparisons were statistically significant, with at least one result for each outcome indicating a ‘large’ effect size. Conclusion Our results suggest that nurses are able to deliver a counselling intervention in a clinic setting with the potential to alleviate parental distress around HIV disclosure to their children. Findings warrant future trials powered for efficacy. PMID:26049544

Effects of vitamin D supplementation on alveolar macrophage gene expression: preliminary results of a randomized, controlled trial.

PubMed

Gerke, Alicia K; Pezzulo, Alejandro A; Tang, Fan; Cavanaugh, Joseph E; Bair, Thomas B; Phillips, Emily; Powers, Linda S; Monick, Martha M

2014-03-26

Vitamin D deficiency has been implicated as a factor in a number of infectious and inflammatory lung diseases. In the lung, alveolar macrophages play a key role in inflammation and defense of infection, but there are little data exploring the immunomodulatory effects of vitamin D on innate lung immunity in humans. The objective of this study was to determine the effects of vitamin D supplementation on gene expression of alveolar macrophages. We performed a parallel, double-blind, placebo-controlled, randomized trial to determine the effects of vitamin D on alveolar macrophage gene expression. Vitamin D3 (1000 international units/day) or placebo was administered to adults for three months. Bronchoscopy was performed pre- and post-intervention to obtain alveolar macrophages. Messenger RNA was isolated from the macrophages and subjected to whole genome exon array analysis. The primary outcome was differential gene expression of the alveolar macrophage in response to vitamin D supplementation. Specific genes underwent validation by polymerase chain reaction methods. Fifty-eight subjects were randomized to vitamin D (n = 28) or placebo (n = 30). There was a marginal overall difference between treatment group and placebo group in the change of 25-hydroxyvitaminD levels (4.43 ng/ml vs. 0.2 ng/ml, p = 0.10). Whole genome exon array analysis revealed differential gene expression associated with change in serum vitamin D levels in the treated group. CCL8/MCP-2 was the top-regulated cytokine gene and was further validated. Although only a non-significant increased trend was seen in serum vitamin D levels, subjects treated with vitamin D supplementation had immune-related differential gene expression in alveolar macrophages. ClinicalTrials.org: NCT01967628.

Clinicobiochemical evaluation of turmeric with black pepper and nigella sativa in management of oral submucous fibrosis-a double-blind, randomized preliminary study.

PubMed

Pipalia, Pratik R; Annigeri, Rajeshwari G; Mehta, Ranjeeta

2016-12-01

To investigate the effectiveness of turmeric with black pepper and nigella sativa in oral submucous fibrosis (OSMF). Forty OSMF patients were randomly divided into two groups. The study was performed under a double-blind, randomized design. Group A received turmeric with black pepper and group B received nigella sativa for 3 months. Clinical evaluation was done every 15 days. Patients' serum superoxide dismutase (SOD) levels were assessed before and after treatment and also compared with healthy controls. The response to treatment was analyzed using analysis of variance, paired t test, and unpaired t test. After the treatment, groups A and B showed 3.85 ± 0.22 mm and 3.6 ± 0.07 mm improvement in mouth opening, respectively (P < .01); 87.90% and 78.91% reduction in burning sensation, respectively (P < .01); and +0.62 U/mL and +0.74 U/mL improvement in serum SOD levels, respectively (P < .05). The maximum mouth opening achieved was 8 mm in group A and 7 mm in group B. The mean pretreatment SOD level for controls and patients was 3.61 ± 0.24 U/mL in group A and 2.63 ± 0.18 U/mL in group B. Turmeric with black pepper and nigella sativa improved mouth opening, burning sensation, and SOD levels in the present OSMF study patients; however, further investigations are needed. Copyright © 2016 Elsevier Inc. All rights reserved.

Problem Solving Skills Training for Parents of Children with Chronic Pain: A Pilot Randomized Controlled Trial

PubMed Central

Palermo, Tonya M.; Law, Emily F.; Bromberg, Maggie; Fales, Jessica; Eccleston, Christopher; Wilson, Anna C.

2016-01-01

This pilot randomized controlled trial aimed to determine the feasibility, acceptability, and preliminary efficacy of parental problem solving skills training (PSST) compared to treatment as usual (TAU) on improving parental mental health symptoms, physical health and well-being, and parenting behaviors. Effects of parent PSST on child outcomes (pain, emotional and physical functioning) were also examined. Participants included 61 parents of children aged 10–17 years with chronic pain randomized to PSST (n = 31) or TAU (n = 30). Parents receiving PSST participated in 4–6 individual sessions of training in problem solving skills. Outcomes were assessed at pre-treatment, immediately post-treatment, and at 3-month follow up. Feasibility was determined by therapy session attendance, therapist ratings, and parent treatment acceptability ratings. Feasibility of PSST delivery in this population was demonstrated by high compliance with therapy attendance, excellent retention, high therapist ratings of treatment engagement, and high parent ratings of treatment acceptability. PSST was associated with post-treatment improvements in parental depression (d = −0.68), general mental health (d = 0.64), and pain catastrophizing (d = −0.48), as well as in child depression (d = −0.49), child general anxiety (d = −0.56), and child pain-specific anxiety (d = −0.82). Several effects were maintained at 3-month follow-up. Findings demonstrate that PSST is feasible and acceptable to parents of youth with chronic pain. Treatment outcome analyses show promising but mixed patterns of effects of PSST on parent and child mental health outcomes. Further rigorous trials of PSST are needed to extend these pilot results. PMID:26845525

Internet-Based, Randomized Controlled Trial of Omega-3 Fatty Acids for Hyperactivity in Autism

PubMed Central

Bent, Stephen; Hendren, Robert L.; Zandi, Tara; Law, Kiely; Choi, Jae-Eun; Widjaja, Felicia; Kalb, Luther; Nestle, Jay; Law, Paul

2014-01-01

Objective Preliminary evidence suggests that omega-3 fatty acids may reduce hyperactivity in children with autism spectrum disorder (ASD). We sought to examine the feasibility of a novel, internet-based clinical trial design to evaluate the efficacy of this supplement. Method E-mail invitations were sent to parents of children aged 5-8 enrolled in the Interactive Autism Network. All study procedures, including screening, informed consent, and collection of outcome measures took place over the internet. The primary outcome measures were parent- and teacher-rated changes in hyperactivity on the Aberrant Behavior Checklist. Results During the 6-week recruitment period, 57 children from 28 states satisfied all eligibility criteria and were randomly assigned to 1.3 grams of omega-3 fatty acids or an identical placebo daily for 6 weeks. Outcome assessments were obtained from all 57 participants and 57 teachers, and the study was completed in 3 months. Children in the omega-3 fatty acid group had a greater reduction in hyperactivity (-5.3 points) compared to the placebo group (-2.6 points), but the difference was not statistically significant (1.9 point greater improvement in the omega-3 group, 95% CI -2.2 to 5.2). Side effects were rare and not associated with omega-3 fatty acids. Participant feedback was positive. Conclusion Internet-based randomized controlled trials of therapies in children with ASD are feasible and may lead to marked reductions in the time and cost of completing trials. A larger sample size is required to definitively determine the efficacy of omega-3 fatty acids. Clinical trial registration information—Omega-3 Fatty Acids for Hyperactivity Treatment in Autism Spectrum Disorder; http://clinicaltrials.gov; NCT01694667. PMID:24839884

Genetics moderate alcohol and intimate partner violence treatment outcomes in a randomized controlled trial of hazardous drinking men in batterer intervention programs: A preliminary investigation.

PubMed

Stuart, Gregory L; McGeary, John; Shorey, Ryan C; Knopik, Valerie S

2016-07-01

We examined whether a cumulative genetic score (CGS) containing MAOA and 5-HTTLPR polymorphisms moderated drinking and intimate partner violence (IPV) treatment outcomes in hazardous drinking men receiving batterer intervention or batterer intervention plus a brief alcohol intervention. We conducted a randomized controlled trial with 97 hazardous drinking men who had a relationship partner and were in batterer intervention programs. Participants were randomized to receive 40 hr of standard batterer program (SBP) or the SBP plus a 90-min alcohol intervention (SBP + BAI). Data were collected at baseline, 3-, 6-, and 12-month follow-up, with follow-up rates of 99.0%, 97.9%, and 93.8%, respectively. Genomic DNA was extracted from saliva. Substance use was measured with the timeline followback interview; IPV was assessed with the Revised Conflict Tactics scales. The primary outcomes were drinks per drinking day (DDD), percentage of days abstinent from alcohol (PDA), frequency of physical IPV, and injuries to partners. Consistent with hypotheses, analyses demonstrated significant treatment condition by CGS interactions for PDA, physical violence, and injuries, but not for DDD. At high levels of the CGS, men in SBP + BAI had greater PDA (B = .16, 95% CI [.04, .27], p = .01), less physical violence perpetration (B = -1.21, 95% CI [-2.21, -.21], p = .02), and fewer injuries to partners (B = -2.37, 95% CI [-3.19, -.82], p = .00) than men in SBP. No differences between the groups in PDA, physical violence, or injuries were observed at low levels of the CGS. Findings demonstrate the potential importance of MAOA and 5-HTTLPR polymorphisms in the treatment of IPV and drinking in men in batterer intervention programs. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Meditation and Music Improve Memory and Cognitive Function in Adults with Subjective Cognitive Decline: A Pilot Randomized Controlled Trial.

PubMed

Innes, Kim E; Selfe, Terry Kit; Khalsa, Dharma Singh; Kandati, Sahiti

2017-01-01

While effective therapies for preventing or slowing cognitive decline in at-risk populations remain elusive, evidence suggests mind-body interventions may hold promise. In this study, we assessed the effects of Kirtan Kriya meditation (KK) and music listening (ML) on cognitive outcomes in adults experiencing subjective cognitive decline (SCD), a strong predictor of Alzheimer's disease. Sixty participants with SCD were randomized to a KK or ML program and asked to practice 12 minutes/day for 3 months, then at their discretion for the ensuing 3 months. At baseline, 3 months, and 6 months we measured memory and cognitive functioning [Memory Functioning Questionnaire (MFQ), Trail-making Test (TMT-A/B), and Digit-Symbol Substitution Test (DSST)]. The 6-month study was completed by 53 participants (88%). Participants performed an average of 93% (91% KK, 94% ML) of sessions in the first 3 months, and 71% (68% KK, 74% ML) during the 3-month, practice-optional, follow-up period. Both groups showed marked and significant improvements at 3 months in memory and cognitive performance (MFQ, DSST, TMT-A/B; p's≤0.04). At 6 months, overall gains were maintained or improved (p's≤0.006), with effect sizes ranging from medium (DSST, ML group) to large (DSST, KK group; TMT-A/B, MFQ). Changes were unrelated to treatment expectancies and did not differ by age, gender, baseline cognition scores, or other factors. Findings of this preliminary randomized controlled trial suggest practice of meditation or ML can significantly enhance both subjective memory function and objective cognitive performance in adults with SCD, and may offer promise for improving outcomes in this population.

Pilot Randomized Trial of Integrated Cognitive-Behavioral Therapy and Neuromuscular Training for Juvenile Fibromyalgia: The FIT Teens Program.

PubMed

Kashikar-Zuck, Susmita; Black, William R; Pfeiffer, Megan; Peugh, James; Williams, Sara E; Ting, Tracy V; Thomas, Staci; Kitchen, Katie; Myer, Gregory D

2018-04-17

Cognitive-behavioral therapy (CBT) improves coping and daily functioning in adolescents with juvenile fibromyalgia (JFM), but is less effective in reducing pain. This pilot trial evaluated the efficacy of a novel intervention (Fibromyalgia Integrative Training for Teens; FIT Teens) which integrates CBT with specialized neuromuscular exercise training to enhance the effect of treatment on reducing pain and disability. Forty adolescents with JFM (12-18 years) were randomized to CBT-only or FIT Teens. Treatment was conducted in group-based sessions over 8 weeks with assessments at baseline, post-treatment, and 3-month follow-up (primary end point). Primary outcomes were pain intensity and functional disability. Secondary outcomes were depressive symptoms, fear of movement, and pain catastrophizing. Thirty-six participants (mean age=15.33 years; 90% female) completed the program. Intent to treat analysis was conducted to evaluate differences between the FIT Teens and CBT groups from baseline to 3-month follow-up, controlling for baseline group differences. Participants in the FIT Teens group showed significantly greater decreases in pain than the CBT group. FIT Teens participants also showed significant improvements in disability, but did not differ from CBT-only at the 3-month end point. Results provide preliminary evidence that the FIT Teens intervention provides added benefits beyond CBT in the treatment of JFM, particularly in pain reduction. Results from this pilot randomized controlled trial of a new combined CBT and specialized neuromuscular exercise intervention (FIT Teens), compared with CBT alone suggested that FIT Teens offers stronger treatment benefits than CBT alone at initial treatment follow-up, especially with respect to the outcome of pain reduction. Copyright © 2018 The American Pain Society. Published by Elsevier Inc. All rights reserved.

Effects of a guided web-based smoking cessation program with telephone counseling: a cluster randomized controlled trial.

PubMed

Mehring, Michael; Haag, Max; Linde, Klaus; Wagenpfeil, Stefan; Schneider, Antonius

2014-09-24

Preliminary findings suggest that Web-based interventions may be effective in achieving significant smoking cessation. To date, very few findings are available for primary care patients, and especially for the involvement of general practitioners. Our goal was to examine the short-term effectiveness of a fully automated Web-based coaching program in combination with accompanied telephone counseling in smoking cessation in a primary care setting. The study was an unblinded cluster-randomized trial with an observation period of 12 weeks. Individuals recruited by general practitioners randomized to the intervention group participated in a Web-based coaching program based on education, motivation, exercise guidance, daily short message service (SMS) reminding, weekly feedback through Internet, and active monitoring by general practitioners. All components of the program are fully automated. Participants in the control group received usual care and advice from their practitioner without the Web-based coaching program. The main outcome was the biochemically confirmed smoking status after 12 weeks. We recruited 168 participants (86 intervention group, 82 control group) into the study. For 51 participants from the intervention group and 70 participants from the control group, follow-up data were available both at baseline and 12 weeks. Very few patients (9.8%, 5/51) from the intervention group and from the control group (8.6%, 6/70) successfully managed smoking cessation (OR 0.86, 95% CI 0.25-3.0; P=.816). Similar results were found within the intent-to-treat analysis: 5.8% (5/86) of the intervention group and 7.3% (6/82) of the control group (OR 1.28, 95% CI 0.38-4.36; P=.694). The number of smoked cigarettes per day decreased on average by 9.3 in the intervention group and by 6.6 in the control group (2.7 mean difference; 95% CI -5.33 to -0.58; P=.045). After adjustment for the baseline value, age, gender, and height, this significance decreases (mean difference 2.2; 95% CI -4.7 to 0.3; P=.080). This trial did not show that the tested Web-based intervention was effective for achieving smoking cessation compared to usual care. The limited statistical power and the high drop-out rate may have reduced the study's ability to detect significant differences between the groups. Further randomized controlled trials are needed in larger populations and to investigate the long-term outcome. German Register for Clinical Trials, registration number DRKS00003067; http://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ ID=DRKS00003067 (Archived by WebCite at http://www.webcitation.org/6Sff1YZpx).

Preliminary Guidelines For Using Suppression Fires to Control Wildfires in the Southeast

Treesearch

Robert W. Cooper

1969-01-01

Suppression firing is defied as the application of fire to speed or strengthen control action on free-burning wildfires. The key to successful suppression firing is availability of personnel knowledgeable in specific application plus an adequate supply of manpower and equipment to contain the set fire. Preliminary guidelines for the use of this fire-control tool are...

Viking Orbiter 1975 articulation control subsystem design analysis

NASA Technical Reports Server (NTRS)

Horiuchi, H. H.; Vallas, L. J.

1973-01-01

The articulation control subsystem, developed for the Viking Orbiter 1975 spacecraft, is a digital, multiplexed, closed-loop servo system used to control the pointing and positioning of the science scan platform and the high-gain communication antenna, and to position the solar-energy controller louver blades for the thermal control of the propellant tanks. The development, design, and anlaysis of the subsystem is preliminary. The subsystem consists of a block-redundant control electronics multiplexed among eight control actuators. Each electronics block is capable of operating either individually or simultaneously with the second block. This provides the subsystem the capability of simultaneous two-actuator control or a single actuator control with the second block in a stand-by redundant mode. The result of the preliminary design and analysis indicates that the subsystem will perform satisfactorily in the Viking Orbiter 1975 mission. Some of the parameter values used, particularly those in the subsystem dynamics and the error estimates, are preliminary and the results will be updated as more accurate parameter values become available.

Safety and Preliminary Efficacy of the Acetylcholinesterase Inhibitor Huperzine A as a Treatment for Cocaine Use Disorder

PubMed Central

Verrico, Christopher D.; Newton, Thomas F.; Mahoney, James J.; Thompson-Lake, Daisy G. Y.

2016-01-01

Background: Cholinergic transmission is altered by drugs of abuse and contributes to psychostimulant reinforcement. In particular, acetylcholinesterase inhibitors, like huperzine A, may be effective as treatments for cocaine use disorder. Methods: The current report describes results from a double-blind, placebo-controlled study in which participants (n=14–17/group) were randomized to huperzine A (0.4 or 0.8mg) or placebo. Participants received randomized infusions of cocaine (0 and 40mg, IV) on days 1 and 9. On day 10, participants received noncontingent, randomized infusions of cocaine (0 and 20mg, IV) before making 5 choices to receive additional infusions. Results: Huperzine A was safe and well-tolerated and compared with placebo, treatment with huperzine A did not cause significant changes in any cocaine pharmacokinetic parameters (all P>.05). Time-course and peak effects analyses show that treatment with 0.4mg of huperzine A significantly attenuated cocaine-induced increases of “Any Drug Effect,” “High,” “Stimulated,” “Willing to Pay,” and “Bad Effects” (all P>.05). Conclusions: The current study represents a significant contribution to the addiction field since it serves as the first published report on the safety and potential efficacy of huperzine A as a treatment for cocaine use disorder. PMID:26364275

Clinical and psychological moderators of the effect of mindfulness-based cognitive therapy on persistent pain in women treated for primary breast cancer - explorative analyses from a randomized controlled trial.

PubMed

Johannsen, M; O'Toole, M S; O'Connor, M; Jensen, A B; Zachariae, R

2017-02-01

Mindfulness-based intervention has been found efficacious in reducing persistent pain in women treated for breast cancer. Little, however, is known about possible moderators of the effect. We explored clinical and psychological moderators of the effect on pain intensity previously found in a randomized controlled trial of mindfulness-based cognitive therapy (MBCT) with women treated for breast cancer with persistent pain. A total of 129 women treated for breast cancer reporting persistent pain were randomized to MBCT or a wait-list control. The primary outcome of pain intensity (11-point numeric rating scale) was measured at baseline, post-intervention, three, and six months follow-up. Proposed clinical moderators included age, axillary lymph node dissection (ALND), radiotherapy, and endocrine treatment. Psychological moderators included psychological distress [the Hospital Anxiety and Depression Scale (HADS)], the adult attachment dimensions anxiety and avoidance [the Experiences in Close Relationships Short Form (the ECR-SF)], and alexithymia [the Toronto Alexithymia Scale (TAS-20)]. Multi-level models were used to test moderation effects over time, i.e. time × group × moderator. Only attachment avoidance (p = 0.03, d = 0.36) emerged as a statistically significant moderator. Higher levels of attachment avoidance predicted a larger effect of MBCT in reducing pain intensity compared with lower levels attachment avoidance. None of the remaining psychological or clinical moderators reached statistical significance. However, based on the effect size, radiotherapy (p = 0.075, d = 0.49) was indicated as a possible clinical moderator of the effect, with radiotherapy being associated with a smaller effect of MBCT on pain intensity over time compared with no radiotherapy. Attachment avoidance, and potentially radiotherapy, may be clinically relevant factors for identifying the patients who may benefit most from MBCT as a pain intervention. Due to the exploratory nature of the analyses, the results should be considered preliminary.

Efficacy of Different Types of Mobilization Techniques in Patients With Primary Adhesive Capsulitis of the Shoulder: A Systematic Review.

PubMed

Noten, Suzie; Meeus, Mira; Stassijns, Gaetane; Van Glabbeek, Francis; Verborgt, Olivier; Struyf, Filip

2016-05-01

To systematically review the literature for efficacy of isolated articular mobilization techniques in patients with primary adhesive capsulitis (AC) of the shoulder. PubMed and Web of Science were searched for relevant studies published before November 2014. Additional references were identified by manual screening of the reference lists. All English language randomized controlled trials evaluating the efficacy of mobilization techniques on range of motion (ROM) and pain in adult patients with primary AC of the shoulder were included in this systematic review. Twelve randomized controlled trials involving 810 patients were included. Two reviewers independently screened the articles, scored methodologic quality, and extracted data for analysis. The review was conducted and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. All studies were assessed in duplicate for risk of bias using the Physiotherapy Evidence Database Scale for randomized controlled trials. The efficacy of 7 different types of mobilization techniques was evaluated. Angular mobilization (n=2), Cyriax approach (n=1), and Maitland technique (n=6) showed improvement in pain score and ROM. With respect to translational mobilizations (n=1), posterior glides are preferred to restore external rotation. Spine mobilizations combined with glenohumeral stretching and both angular and translational mobilization (n=1) had a superior effect on active ROM compared with sham ultrasound. High-intensity mobilization (n=1) showed less improvement in the Constant Murley Score than a neglect group. Finally, positive long-term effects of the Mulligan technique (n=1) were found on both pain and ROM. Overall, mobilization techniques have beneficial effects in patients with primary AC of the shoulder. Because of preliminary evidence for many mobilization techniques, the Maitland technique and combined mobilizations seem recommended at the moment. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Impact of Skill-Based Approaches in Reducing Stigma in Primary Care Physicians: Results from a Double-Blind, Parallel-Cluster, Randomized Controlled Trial

PubMed Central

Patten, Scott; Knaak, Stephanie; Weinerman, Rivian; Campbell, Helen; Lauria-Horner, Bianca

2017-01-01

Objective: Most interventions to reduce stigma in health professionals emphasize education and social contact–based strategies. We sought to evaluate a novel skill-based approach: the British Columbia Adult Mental Health Practice Support Program. We sought to determine the program’s impact on primary care providers’ stigma and their perceived confidence and comfort in providing care for mentally ill patients. We hypothesized that enhanced skills and increased comfort and confidence on the part of practitioners would lead to diminished social distance and stigmatization. Subsequently, we explored the program’s impact on clinical outcomes and health care costs. These outcomes are reported separately, with reference to this article. Methods: In a double-blind, cluster randomized controlled trial, 111 primary care physicians were assigned to intervention or control groups. A validated stigma assessment tool, the Opening Minds Scale for Health Care Providers (OMS-HC), was administered to both groups before and after training. Confidence and comfort were assessed using scales constructed from ad hoc items. Results: In the primary analysis, no significant differences in stigma were found. However, a subscale assessing social distance showed significant improvement in the intervention group after adjustment for a variable (practice size) that was unequally distributed in the randomization. Significant increases in confidence and comfort in managing mental illness were observed among intervention group physicians. A positive correlation was found between increased levels of confidence/comfort and improvements in overall stigma, especially in men. Conclusions: This study provides some preliminary evidence of a positive impact on health care professionals’ stigma through a skill-building approach to management of mild to moderate depression and anxiety in primary care. The intervention can be used as a primary vehicle for enhancing comfort and skills in health care providers and, ultimately, reducing an important dimension of stigma: preference for social distance. PMID:28095259

Impact of Skill-Based Approaches in Reducing Stigma in Primary Care Physicians: Results from a Double-Blind, Parallel-Cluster, Randomized Controlled Trial.

PubMed

Beaulieu, Tara; Patten, Scott; Knaak, Stephanie; Weinerman, Rivian; Campbell, Helen; Lauria-Horner, Bianca

2017-05-01

Most interventions to reduce stigma in health professionals emphasize education and social contact-based strategies. We sought to evaluate a novel skill-based approach: the British Columbia Adult Mental Health Practice Support Program. We sought to determine the program's impact on primary care providers' stigma and their perceived confidence and comfort in providing care for mentally ill patients. We hypothesized that enhanced skills and increased comfort and confidence on the part of practitioners would lead to diminished social distance and stigmatization. Subsequently, we explored the program's impact on clinical outcomes and health care costs. These outcomes are reported separately, with reference to this article. In a double-blind, cluster randomized controlled trial, 111 primary care physicians were assigned to intervention or control groups. A validated stigma assessment tool, the Opening Minds Scale for Health Care Providers (OMS-HC), was administered to both groups before and after training. Confidence and comfort were assessed using scales constructed from ad hoc items. In the primary analysis, no significant differences in stigma were found. However, a subscale assessing social distance showed significant improvement in the intervention group after adjustment for a variable (practice size) that was unequally distributed in the randomization. Significant increases in confidence and comfort in managing mental illness were observed among intervention group physicians. A positive correlation was found between increased levels of confidence/comfort and improvements in overall stigma, especially in men. This study provides some preliminary evidence of a positive impact on health care professionals' stigma through a skill-building approach to management of mild to moderate depression and anxiety in primary care. The intervention can be used as a primary vehicle for enhancing comfort and skills in health care providers and, ultimately, reducing an important dimension of stigma: preference for social distance.

Squill Oxymel, a traditional formulation from Drimia Maritima (L.) Stearn, as an add-on treatment in patients with moderate to severe persistent asthma: A pilot, triple-blind, randomized clinical trial.

PubMed

Nejatbakhsh, Fatemeh; Karegar-Borzi, Hossein; Amin, Gholamreza; Eslaminejad, Alireza; Hosseini, Mostafa; Bozorgi, Mahbubeh; Gharabaghi, Mehrnaz Asadi

2017-01-20

In Traditional Iranian Medicine (TIM), Squill (Drimia maritima (L.) Stearn) Oxymel was utilized in the treatment of asthma. Squill has been reported to exert anti-inflammatory, anti-oxidant, anti-cholinergic, and mucus secretion modulating effects. This study aimed to make a preliminary evaluation of the efficacy and safety of an add-on Squill Oxymel treatment in patients with moderate to severe persistent asthma. In a 6-week, triple-blind, randomized, placebo-controlled trial, 60 patients with stable moderate to severe persistent asthma were randomly allocated to receive either 10ml syrup of Squill Oxymel, simple oxymel, or a placebo 2 times a day, as an add-on to their routine treatment (inhaled corticosteroids and β2 agonists). Spirometry and plethysmography were performed on patients to evaluate the effect of the treatment at baseline and end of intervention. Forced Expiratory Volume in first second (FEV1) was considered the primary outcome. St. George's respiratory questionnaire (SGRQ) was also used for the subjective evaluation of patients' responses. Fifty-four patients completed the study. The results showed significant improvement in spirometry parameters, especially FEV1 (1.54±.38 vs. 2.11±.49l), in the Squill Oxymel group compared with the other groups. The increases in FEV1 liter, FEV1%, FEV1/FVC%, and MEF 25-75% during the intervention were significantly higher in the Squill Oxymel group than in the other groups (p<.001). However, the improvement of plethysmographic parameters showed no significant difference between the study groups (p>.05). The SGRQ scores (symptoms, activity, and total score) were significantly improved after intervention in both the Squill Oxymel and the simple honey oxymel groups (p<.001), but not in the placebo group. Nausea and vomiting was reported in 5 patients in Squill oxymel and simple oxymel groups. No other serious adverse event was observed. The results of the current study show preliminary evidence for the efficacy and safety of the add-on treatment of Squill Oxymel in patients with moderate to severe persistent asthma. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Outpatient safety assessment of an in-home predictive low-glucose suspend system with type 1 diabetes subjects at elevated risk of nocturnal hypoglycemia.

PubMed

Buckingham, Bruce A; Cameron, Fraser; Calhoun, Peter; Maahs, David M; Wilson, Darrell M; Chase, H Peter; Bequette, B Wayne; Lum, John; Sibayan, Judy; Beck, Roy W; Kollman, Craig

2013-08-01

Nocturnal hypoglycemia is a common problem with type 1 diabetes. In the home setting, we conducted a pilot study to evaluate the safety of a system consisting of an insulin pump and continuous glucose monitor communicating wirelessly with a bedside computer running an algorithm that temporarily suspends insulin delivery when hypoglycemia is predicted. After the run-in phase, a 21-night randomized trial was conducted in which each night was randomly assigned 2:1 to have either the predictive low-glucose suspend (PLGS) system active (intervention night) or inactive (control night). Three predictive algorithm versions were studied sequentially during the study for a total of 252 intervention and 123 control nights. The trial included 19 participants 18-56 years old with type 1 diabetes (hemoglobin A1c level of 6.0-7.7%) who were current users of the MiniMed Paradigm® REAL-Time Revel™ System and Sof-sensor® glucose sensor (Medtronic Diabetes, Northridge, CA). With the final algorithm, pump suspension occurred on 53% of 77 intervention nights. Mean morning glucose level was 144±48 mg/dL on the 77 intervention nights versus 133±57 mg/dL on the 37 control nights, with morning blood ketones >0.6 mmol/L following one intervention night. Overnight hypoglycemia was lower on intervention than control nights, with at least one value ≤70 mg/dL occurring on 16% versus 30% of nights, respectively, with the final algorithm. This study demonstrated that the PLGS system in the home setting is safe and feasible. The preliminary efficacy data appear promising with the final algorithm reducing nocturnal hypoglycemia by almost 50%.

A randomized controlled trial of a manual-based psychosocial group intervention for young people with epilepsy [PIE].

PubMed

Dorris, Liam; Broome, Helen; Wilson, Margaret; Grant, Cathy; Young, David; Baker, Gus; Balloo, Selina; Bruce, Susan; Campbell, Jo; Concannon, Bernie; Conway, Nadia; Cook, Lisa; Davis, Cheryl; Downey, Bruce; Evans, Jon; Flower, Diane; Garlovsky, Jack; Kearney, Shauna; Lewis, Susan; Stephens, Victoria; Turton, Stuart; Wright, Ingram

2017-07-01

We conducted an exploratory RCT to examine feasibility and preliminary efficacy for a manual-based psychosocial group intervention aimed at improving epilepsy knowledge, self-management skills, and quality of life in young people with epilepsy. Eighty-three participants (33:50m/f; age range 12-17years) were randomized to either the treatment or control group in seven tertiary paediatric neuroscience centres in the UK, using a wait-list control design. Participants were excluded if they reported suicidal ideation and/or scored above the cut off on mental health screening measures, or if they had a learning disability or other neurological disorder. The intervention consisted of six weekly 2-hour sessions using guided discussion, group exercises and role-plays facilitated by an epilepsy nurse and a clinical psychologist. At three month follow up the treatment group (n=40) was compared with a wait-list control group (n=43) on a range of standardized measures. There was a significant increase in epilepsy knowledge in the treatment group (p=0.02). Participants receiving the intervention were also significantly more confident in speaking to others about their epilepsy (p=0.04). Quality of life measures did not show significant change. Participants reported the greatest value of attending the group was: Learning about their epilepsy (46%); Learning to cope with difficult feelings (29%); and Meeting others with epilepsy (22%). Caregiver and facilitator feedback was positive, and 92% of participants would recommend the group to others. This brief psychosocial group intervention was effective in increasing participants' knowledge of epilepsy and improved confidence in discussing their epilepsy with others. We discuss the qualitative feedback, feasibility, strengths and limitations of the PIE trial. Copyright © 2017 Elsevier Inc. All rights reserved.

Motivational interviewing increases physical activity and self-efficacy in people living in the community after hip fracture: a randomized controlled trial.

PubMed

O'Halloran, Paul D; Shields, Nora; Blackstock, Felicity; Wintle, Elizabeth; Taylor, Nicholas F

2016-11-01

To investigate if motivational interviewing improved physical activity, self-efficacy, quality of life, mobility and mental health in people living in the community after hip fracture. Single-blind randomized controlled trial. Community. A total of 30 adults after hip fracture who had been discharged from rehabilitation to independent living in the community and allocated to a control group ( n = 14) or an intervention group ( n = 16). All participants received usual care. The intervention group also received eight weekly sessions of motivational interviewing as additional input, with the control group having no additional matching input. The primary outcome was physical activity levels as measured by an accelerometer (steps taken per day, time spent walking per day, and time spent sitting or lying each day). Secondary outcomes included self-efficacy (confidence about walking and not falling), health-related quality of life, mobility and mental health. Relative to usual care, the motivational interviewing group took significantly more steps per day (mean = 1237 steps, 95% confidence interval (CI) 12 to 2463), walked for longer per day (mean = 14.4 minutes, 95% CI 0.6 to 28.8), had improved self-efficacy evidenced by being more confident about walking (mean = 1.6 units out of 10, 95% CI 0.3 to 2.9) and not falling (mean = 1.1 units out of 10, 95% CI 0.3 to 1.9) and improved health-related quality of life and mental health. This study provides preliminary evidence that motivational interviewing can result in clinically meaningful improvements in physical activity and psychosocial outcomes for people recovering from hip fracture.

Effect of volunteering on risk factors for cardiovascular disease in adolescents: a randomized controlled trial.

PubMed

Schreier, Hannah M C; Schonert-Reichl, Kimberly A; Chen, Edith

2013-04-01

The idea that individuals who help others incur health benefits themselves suggests a novel approach to improving health while simultaneously promoting greater civic orientation in our society. The present study is the first experimental trial, to our knowledge, of whether regular volunteering can reduce cardiovascular risk factors in adolescents. To test a novel intervention that assigned adolescents to volunteer with elementary school-aged children as a means of improving adolescents' cardiovascular risk profiles. Randomized controlled trial, with measurements taken at baseline and 4 months later (postintervention). Urban public high school in western Canada. One hundred six 10th-grade high school students who were fluent in English and free of chronic illnesses. Weekly volunteering with elementary school-aged children for 2 months vs wait-list control group. Cardiovascular risk markers of C-reactive protein level, interleukin 6 level, total cholesterol level, and body mass index. No statistically significant group differences were found at baseline. Postintervention, adolescents in the intervention group showed significantly lower interleukin 6 levels (log10 mean difference, 0.13; 95% CI, 0.004 to 0.251), cholesterol levels (log10 mean difference, 0.03; 95% CI, 0.003 to 0.059), and body mass index (mean difference, 0.39; 95% CI, 0.07 to 0.71) compared with adolescents in the control group. Effects for C-reactive protein level were marginal (log10 mean difference, 0.13; 95% CI, -0.011 to 0.275). Preliminary analyses within the intervention group suggest that those who increased the most in empathy and altruistic behaviors, and who decreased the most in negative mood, also showed the greatest decreases in cardiovascular risk over time. Adolescents who volunteer to help others also benefit themselves, suggesting a novel way to improve health. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01698034.

Near-transfer effects following working memory intervention (Cogmed) in children with symptomatic epilepsy: An open randomized clinical trial.

PubMed

Kerr, Elizabeth N; Blackwell, Melissa C

2015-11-01

Limited research exists regarding the effectiveness of educational and psychological interventions for improving commonly presenting cognitive impairments experienced by children with epilepsy. We evaluated the efficacy of a commercially available, computerized, working memory (WM) program (Cogmed) using a well-defined population of children with epilepsy. In this controlled trial, 77 children with symptomatic epilepsy (ages 6.5-15.5 years; 100% taking medication) with estimated intellectual ability greater than the 2nd percentile were randomly assigned to an intervention (n = 42) or waitlist-control (n = 35) group. Standardized assessments of attention and WM were administered pre- and posttraining or waitlist interval, 7 weeks apart. Without intervention, participants displayed significant weaknesses in intelligence, attention, and WM compared to normative samples. After controlling for preintervention scores and intelligence, we found that significant treatment effects for the intervention group were evident for visual attention span, auditory WM, and visual-verbal WM. Intention-to-treat analyses (all participants) and sensitivity analyses (n = 37 and n = 21 for the intervention and waitlist-control groups, respectively) were highly similar, providing confidence to the results. Effect sizes for significant outcomes were large (greater than or equal to two thirds of the standard deviation of the normative-data). The clinical/demographic and functional factors studied did not elucidate who most benefits from training. This is the first study to evaluate the effectiveness of intervention to ameliorate WM deficits commonly experienced by children with symptomatic epilepsy. Results support group improvement on some untrained tasks immediately postintervention, demonstrating preliminary usefulness of Cogmed as a treatment option. Wiley Periodicals, Inc. © 2015 International League Against Epilepsy.

Clinical Evidence of Effects of Lactobacillus plantarum HY7714 on Skin Aging: A Randomized, Double Blind, Placebo-Controlled Study.

PubMed

Lee, Dong Eun; Huh, Chul-Sung; Ra, Jehyeon; Choi, Il-Dong; Jeong, Ji-Woong; Kim, Sung-Hwan; Ryu, Ja Hyun; Seo, Young Kyoung; Koh, Jae Sook; Lee, Jung-Hee; Sim, Jae-Hun; Ahn, Young-Tae

2015-12-28

The beneficial effects of probiotics are now widely reported, although there are only a few studies on their anti-aging effects. We have found that Lactobacillus plantarum HY7714 (HY7714) improves skin hydration and has anti-photoaging effects, and in the present study, we have further evaluated the anti-aging effect of HY7714 via a randomized, double blind, placebo-controlled clinical trial. The trial included 110 volunteers aged 41 and 59 years who have dry skin and wrinkles. Participants took 1 × 10(10) CFU/day of HY7714 (probiotic group) or a placebo (placebo group) for 12 weeks. Skin hydration, wrinkles, skin gloss, and skin elasticity were measured every 4 weeks during the study period. There were significant increases in the skin water content in the face (p < 0.01) and hands (p < 0.05) at week 12 in the probiotic group. Transepidermal water loss decreased significantly in both groups at weeks 4, 8, and 12 (p < 0.001 compared with baseline), and was suppressed to a greater extent in the face and forearm in the probiotic group at week 12. Volunteers in the probiotic group had a significant reduction in wrinkle depth at week 12, and skin gloss was also significantly improved by week 12. Finally, skin elasticity in the probiotic group improved by 13.17% (p < 0.05 vs. controls) after 4 weeks and by 21.73% (p < 0.01 vs. controls) after 12 weeks. These findings are preliminary confirmation of the anti-aging benefit to the skin of L. plantarum HY7714 as a nutricosmetic agent.

Using Mobile Health to Improve Social Support for Low-Income Latino Patients with Diabetes: A Mixed-Methods Analysis of the Feasibility Trial of TExT-MED + FANS.

PubMed

Burner, Elizabeth; Lam, Chun Nok; DeRoss, Rebecca; Kagawa-Singer, Marjorie; Menchine, Michael; Arora, Sanjay

2018-01-01

Social support interventions can improve diabetes self-care, particularly for Latinos, but are time and resource intensive. Mobile health may overcome these barriers by engaging and training supporters remotely. We conducted a randomized controlled feasibility trial of emergency department patients with diabetes to determine the feasibility of enrolling patients and supporters, acceptability of the intervention, and preliminary efficacy results to power a larger trial. All patients received an existing mHealth curriculum (TExT-MED). After identifying a supporter, patients were randomized to intervention: supporters receiving FANS (family and friends network support), a text message support curriculum synchronized to patient messages, or control: supporters receiving a mailed pamphlet of the same information. Participants followed up at 3 months. FANS intervention participants came to postintervention interviews as part of a qualitative analysis. We enrolled 44 patients (22 per arm) and followed up 36 at 3 months. Participants were positive about the program. FANS intervention improved HbA1c (intervention mean decreased from 10.4% to 9.0% vs. from 10.1% to 9.5%, delta -0.8%, confidence interval [CI] -0.4 to 2, P = 0.30), self-monitoring of glucose (intervention increased 1.6 days/week vs. control decreased 2 days/week, delta 2.3 days/week, CI 4-0.6, P = 0.02), and physical activity (mean Godin leisure time activity score improved 16.1 vs. decreased 9.6 for control, delta 25.7, CI 49.2-2.3, P = 0.10). In qualitative analysis, patients reported improved motivation, behaviors, and relationships. Supporters reported making healthier decisions for themselves. mHealth is a feasible, acceptable, and promising avenue to improve social support and diabetes outcomes.

A group-based counselling intervention for depression comorbid with HIV/AIDS using a task shifting approach in South Africa: a randomized controlled pilot study.

PubMed

Petersen, I; Hanass Hancock, J; Bhana, A; Govender, K

2014-04-01

Co-morbid depression in HIV-positive patients on anti-retroviral (ART) treatment poses a public health threat. It compromises treatment adherence and accelerates disease progression. This study aimed to assess the feasibility of a group-based counselling intervention for depressed HIV-positive patients in primary health care (PHC) in South Africa using a task shifting approach. Using a randomized control design, 76 HIV-positive patients with co-morbid depression were initially recruited. This reduced to 34 in the final cohort. Participants were assessed using the Patient Health Questionnaire (PHQ9), Hopkins Symptom Checklist (HSCL-25) and Multidimensional Scale of Perceived Social Support (MSPSS) at baseline and 3-month follow-up. The intervention was adapted from a local group-based Interpersonal Therapy (IPT) intervention. Process evaluation interviews were held with the HIV counsellors who delivered the intervention and a sub-sample of participants. Repeated measures ANOVA analysis showed significantly greater improvement on depression scores on the PHQ9 in the intervention group compared to the control group. A significant decline in the mean scores on the HSCL-25 was found for both groups although this was more pronounced for the intervention group. There was no significant improvement in the MSPSS scores. The small sample size of the final cohort affected the power of the study to detect significant differences between the intervention and control groups on the MSPSS. Longer term impact of the intervention is unknown. These preliminary findings suggest that group-based counselling for depression in HIV-positive patients can potentially be effectively delivered by appropriately trained and supported lay HIV counsellors. The need for a larger trial is indicated. Copyright © 2014 Elsevier B.V. All rights reserved.

Warm Ambient Temperature Decreases Food Intake in a Simulated Office Setting: A Pilot Randomized Controlled Trial.

PubMed

Bernhard, Molly C; Li, Peng; Allison, David B; Gohlke, Julia M

2015-01-01

We hypothesized that exposure to temperatures above the thermoneutral zone (TNZ) would decrease food intake in young adults in a sedentary office environment over a 2-h period. Participants wearing standardized clothing were randomized to perform routine office work in the TNZ, considered control (19-20°C), or above the TNZ considered warmer (26-27°C) using a parallel-group design (n = 11 and 9, respectively). Thermal images of the inner canthus of their eye and middle finger nail bed, representing proxies of core and peripheral temperatures, respectively, were taken at baseline, first, and second hour during this lunchtime study. Heat dissipation was estimated using peripheral temperature. General linear models were built to examine the effects of thermal treatment on caloric intake and potential mediation by heat dissipation. Researchers conducted the trial registered as NCT02386891 at Clinicaltrials.gov during April to May 2014. During the 2-h stay in different ambient temperatures, the participants in the control conditions ate 99.5 kcal more than those in the warmer conditions; however, the difference was not statistically significant. Female participants ate about 350 kcal less than the male participants (p = 0.024) in both groups and there was no significant association between caloric intake and participant's body mass index (BMI). After controlling for thermal treatment, gender and BMI, the participant's peripheral temperature was significantly associated with caloric intake (p = 0.002), suggesting a mediating effect. Specifically, for every 1°C increase in peripheral temperature suggesting increased heat dissipation, participants ate 85.9 kcal less food. This pilot study provided preliminary evidence of effects of thermal environment on food intake. It suggests that decreased food intake in the experimental (warmer) environment is potentially mediated through thermoregulatory mechanisms.

A randomized controlled trial of a new behavioral home-based nutrition education program, "Eat Well with CF," in adults with cystic fibrosis.

PubMed

Watson, Helen; Bilton, Diana; Truby, Helen

2008-05-01

Cystic fibrosis (CF) remains the most common genetically inherited disease in the white population and its prognosis is affected by nutritional status. Adults with the disease are now surviving longer and new strategies are required to ensure that they maintain optimal nutrition. This article reports preliminary data from a randomized controlled trial of a 10-week home-based behavioral nutrition intervention, "Eat Well with CF." Outcome measures of weight change over 6 and 12 months and changes in CF-specific nutrition knowledge score, self-efficacy score, reported dietary fat intake and health-related quality-of-life score were compared between the intervention group (n=34) and a standard care control group (n=34). The hypotheses to be tested were that adults with CF completing "Eat Well with CF" would have an improved nutritional status, improvement in specific nutrition knowledge, and an improvement in self-efficacy regarding their ability to cope with a special diet, compared to those receiving standard care. There were substantial improvements in the intervention group's specific CF nutrition knowledge score, self-efficacy score, and reported fat intake compared to control, but no substantial change in body mass index or health-related quality of life over time. Home-based nutrition education incorporating behavioral strategies can be an effective way to support adults with CF, enabling improvement in self-management skills in relation to diet and pancreatic enzyme replacement therapy. This study revealed gaps in basic nutrition knowledge and skills, inadequate knowledge of diet-disease links and pancreatic enzyme replacement therapy. These need to be identified when subjects progress from pediatric to adult care, and programs such as "Eat Well with CF" are a useful adjunct for registered dietitians trying to manage this diverse but growing population.

A Culturally Adapted Physical Activity intervention for Latinas A Randomized Controlled Trial

PubMed Central

Pekmezi, Dorothy W.; Neighbors, Charles J.; Lee, Christina S.; Gans, Kim M.; Bock, Beth C.; Morrow, Kathleen M.; Marquez, Becky; Dunsiger, Shira; Marcus, Bess H.

2010-01-01

Background In the U.S., Latinos report particularly high levels of inactivity and related chronic illnesses and are in need of intervention. Thus, the purpose of the current study was to culturally and linguistically adapt an empirically supported, individually tailored physical activity print intervention for Latinos and then conduct an RCT of the modified program. Design RCT Setting/Participants The sample included 93 overweight/obese (80%) Latinas with low income and acculturation. Intervention Data were collected in 2007–2008 and analyzed by intent-to-treat in 2009. Participants were randomly assigned to either: (1) a culturally and linguistically adapted physical activity intervention (Seamos Activas), or (2) a wellness contact control condition. Main outcome measures Self report physical activity, as measured pre- and post- intervention (6 months, 87% retention) by the 7-Day Physical Activity Recall. Results Moderate-intensity (or greater) physical activity increased from an average of 16.56 minutes/week (SD=25.76) at baseline to 147.27 (SD=241.55) at 6 months in the intervention arm (n=45) and from 11.88 minutes/week (SD=21.99) to 96.79 (SD=118.49) in the wellness contact control arm (n=48). No between-group differences were seen in overall physical activity. Intervention participants reported significantly greater increases in cognitive [F(1,91)= 9.53, p = .003] and behavioral processes of change [F(1,91)= 8.37, p = .005] and available physical activity supplies and equipment at home [F(1,91)=4.17, p=.04] than control participants. Conclusions Results supported the hypothesized feasibility, acceptability, and preliminary efficacy of individually tailored physical activity print interventions among Latinas. While more research is needed to corroborate these findings, such high-reach, low-cost approaches have great potential to positively affect public health. PMID:19944914

Efficacy of botulinum toxin in treating myofascial pain in bruxers: a controlled placebo pilot study.

PubMed

Guarda-Nardini, Luca; Manfredini, Daniele; Salamone, Milena; Salmaso, Luigi; Tonello, Stefano; Ferronato, Giuseppe

2008-04-01

The present investigation is a preliminary double-blind, controlled placebo, randomized clinical trial with a six month follow-up period. The study aimed to assess the efficacy of type A botulinum toxin (Botox, Allergan, Inc. Irvine, CA) to treat myofascial pain symptoms and to reduce muscle hyperactivity in bruxers. Twenty patients (ten males, ten females; age range 25-45) with a clinical diagnosis of bruxism and myofascial pain of the masticatory muscles were enrolled in a double-blind, controlled placebo, randomized clinical trial, with a treatment group (ten subjects treated with botulinum toxin injections- BTX-A) and a control group (ten subjects treated with saline placebo injections). A number of objective and subjective clinical parameters (pain at rest and during chewing; mastication efficiency; maximum nonassisted and assisted mouth opening, protrusive and laterotrusive movements; functional limitation during usual jaw movements; subjective efficacy of the treatment; tolerance of the treatment) were assessed at baseline time and at one week, one month, and six months follow-up appointments. Descriptive analysis showed that improvements in both objective (range of mandibular movements) and subjective (pain at rest; pain during chewing) clinical outcome variables were higher in the Botox treated group than in the placebo treated subjects. Patients treated with BTX-A had a higher subjective improvement in their perception of treatment efficacy than the placebo subjects. Differences were not significant in some cases due to the small sample size. Results from the present study supported the efficacy of BTX-A to reduce myofascial pain symptoms in bruxers, and provided pilot data which need to be confirmed by further research using larger samples.

The effects of exercise during pregnancy on the newborn’s brain: study protocol for a randomized controlled trial

PubMed Central

2012-01-01

Background It is generally accepted that an active lifestyle is beneficial for cognition in children, adults and the elderly. Recently, studies using the rat animal model found that the pups of mothers who exercised during pregnancy had increased hippocampal neurogenesis and better memory and learning abilities. The aim of this report is to present the experimental protocol of a study that is designed to verify if an active lifestyle during pregnancy in humans has an impact on the newborn's brain. Methods 60 pregnant women will be included in a randomized controlled study. The experimental group will be asked to exercise a minimum of 20 minutes three times per week, at a minimal intensity of 55% of their maximal aerobic capacity. The control group will not be exercising. The effect of exercise during pregnancy on the newborn's brain will be investigated 8 to 12 days postpartum by means of the mismatch negativity, a neurophysiological brain potential that is associated to auditory sensory memory. We hypothesize that children born to mothers who exercised during their pregnancy will present shorter latencies and larger mismatch negativity amplitudes, indicating more efficient auditory memory processes. Discussion As of September 2011, 17 women have joined the study. Preliminary results show that the experimental group are active 3.1 ± 0.9 days per week while the control group only exercise 0.8 ± 0.6 days per week. The results of this study will present insight on fetal neuroplasticity and will be a valuable tool for health professionals who wish to encourage pregnant women to exercise. Trial registration ClinicalTrials.gov registration: NTC01220778 PMID:22643160

A "novel" intervention: a pilot study of children's literature and healthy lifestyles.

PubMed

Bravender, Terrill; Russell, Alexandra; Chung, Richard J; Armstrong, Sarah C

2010-03-01

To determine if reading an age-appropriate novel has the potential to improve BMI percentile and exercise- and nutrition-related knowledge and behaviors in girls aged 9 to 13 years who were enrolled in a childhood obesity-treatment program. This preliminary, randomized, controlled trial followed 81 obese girls aged 9 to 13 years who were enrolled in the Duke University Healthy Lifestyles Program, a comprehensive clinical and behavioral lifestyle-modification program for overweight and obese children. Thirty-one girls were randomly assigned to read the intervention novel, which describes an overweight girl who discovers improved health and self-efficacy, and 33 participants were given a control novel to read. Participants were evaluated at the study intake and again at their scheduled follow-up appointments 1 to 2 months later. Intake and follow-up BMI percentiles were evaluated for 17 girls in the program who did not receive either book. Follow-up data were available for 11 of 31 girls in the intervention-book group, 14 of 33 girls in the control-book group, and 14 of 17 girls who did not receive a book. There was a significantly greater reduction in BMI percentile among those in the intervention-book group (-0.71) versus those in the control-book group (-0.33; P = .03). Girls who read either book had a significantly greater reduction in BMI percentile (-0.49) than girls who were followed in the program but who were not assigned a book (0.05; P = .02). Age-appropriate fiction, particularly if it addresses health-oriented behaviors, shows potential for augmenting weight loss in girls who participate in a weight-management program. Future research is needed to determine if the novel is effective for healthy lifestyle promotion among all overweight and obese adolescents.

A pelvic floor muscle training program in postmenopausal women: A randomized controlled trial.

PubMed

Alves, Fabíola K; Riccetto, Cássio; Adami, Délcia B V; Marques, Joseane; Pereira, Larissa C; Palma, Paulo; Botelho, Simone

2015-06-01

The purpose of this study was to investigate if a specific pelvic floor muscle training (PFMT) program effectively increases pelvic floor muscle (PFM) contractility and decreases anterior pelvic organ prolapse (POP) as well as urogynecological symptoms, in postmenopausal women. The mean outcome measure of this study was the pelvic floor surface electromyography (sEMG) activity. A clinical, randomized, blinded-assessor and controlled study was conducted with 46 postmenopausal women. Thirty women completed this study (mean age of 65.93 years), divided into two groups: Treatment Group - TG (n=18) and Control Group - CG (n=12). The evaluation was carried out using digital palpation, sEMG, pelvic organ prolapse quantification (POP-Q) as well as validated questionnaires by the International Consultation on Incontinence Questionnaires to investigate urogynecological symptoms. The treatment protocol consisted of 12 group sessions, twice a week, with 30 min of duration each. These data were then submitted to statistical analyses by the Statistical Analysis System for Windows software, with a significance level of 5%. The pelvic floor muscle contractility increased after PFMT, evaluated by sEMG (p=0.003) and digital palpation (p=0.001), accompanied by a decrease in urinary symptoms (p<0.001 for ICIQ-OAB scores e 0.036 for ICIQ UI-SF) as well as anterior pelvic organ prolapse (p=0.03). This preliminary study suggests that the applied PFMT program could be an effective way to increase PFM contractility, as well as to decrease both anterior pelvic organ prolapse and urinary symptoms, in postmenopausal women. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Effect of a nutritional reconditioning program for thin dairy cattle on body weight, carcass quality, and fecal pathogen shedding.

PubMed

Maier, Gabriele U; Hoar, Bruce R; Stull, Carolyn L; Kass, Philip H; Villanueva, Veronica; Maas, John

2011-12-15

To assess changes in body weight, carcass quality, and fecal pathogen shedding in cull dairy cows fed a high-energy ration for 28 or 56 days prior to slaughter. Randomized clinical trial. 31 adult Holstein dairy cows. Cows were randomly assigned to a control (immediate slaughter) group or a 28-day or 56-day feeding group. Cows in the feeding groups received a high-energy feed and were weighed every 7 days. Carcasses were evaluated by USDA employees. Fecal and blood samples were collected at the start and end of the feeding periods. Body condition score and adjusted preliminary yield grade were significantly increased in both feeding groups, compared with values for the control group; body weight, hot carcass weight, dressing percentage, and ribeye area were significantly increased after 56 days, but not after 28 days, compared with values for the control group. Average daily gain and marbling score were significantly lower after feeding for 28 days versus after 56 days. Prevalence of Escherichia coli O157:H7 shedding in feces decreased from 14% to 5.6%, but this difference was not significant. Cows seropositive for antibodies against bovine leukemia virus that had signs of lymphoma and lame cows had a low average daily gain. Net loss was $71.32/cow and $112.80/cow for the 28-day and 56-day feeding groups, respectively. Feeding market dairy cows improved body condition and carcass quality. Cows seropositive for antibodies against bovine leukemia virus that have signs of lymphoma and lame cows might be poor candidates for reconditioning.

Working memory training in survivors of pediatric cancer: a randomized pilot study.

PubMed

Hardy, Kristina K; Willard, Victoria W; Allen, Taryn M; Bonner, Melanie J

2013-08-01

Survivors of pediatric brain tumors and acute lymphoblastic leukemia (ALL) are at increased risk for neurocognitive deficits, but few empirically supported treatment options exist. We examined the feasibility and preliminary efficacy of a home-based, computerized working memory training program, CogmedRM, with survivors of childhood cancer. Survivors of brain tumors or ALL (n = 20) with identified deficits in attention and/or working memory were randomized to either the success-adapted computer intervention or a non-adaptive, active control condition. Specifically, children in the adaptive condition completed exercises that became more challenging with each correct trial, whereas those in the non-adaptive version trained with exercises that never increased in difficulty. All participants were asked to complete 25 training sessions at home, with weekly, phone-based coaching support. Brief assessments were completed pre-intervention and post-intervention; outcome measures included both performance-based and parent-report measures of working memory and attention. Eighty-five percent of survivors were compliant with the intervention, with no adverse events reported. After controlling for baseline intellectual functioning, survivors who completed the intervention program evidenced significant post-training improvements in their visual working memory and in parent-rated learning problems compared with those in the active control group. No differences in verbal working memory functioning were evident between groups, however. Home-based, computerized cognitive training demonstrates good feasibility and acceptability in our sample. Children with higher intellectual functioning at baseline appeared to benefit more from the training, although further study is needed to clarify the strength, scope, and particularly the generalizability of potential treatment effects. Copyright © 2012 John Wiley & Sons, Ltd.

Efficacy of exercise as an adjunct treatment for clinically depressed inpatients during the initial stages of antidepressant pharmacotherapy: An open randomized controlled trial.

PubMed

Legrand, Fabien D; Neff, Elise M

2016-02-01

Physical exercise as adjunctive treatment for hospitalized patients with major depressive disorder (MDD) has been of increasing interest in the past few years. While preliminary findings are promising, these prior studies have been plagued by inclusion of participants at different stages of medication use at study entry. The present study evaluates the effects of a short (10-days) add-on endurance-training intervention in hospitalized MDD patients on antidepressant medication for less than two weeks. Thirty-five participants were randomly assigned to one of three study groups: aerobic exercise (n=14), placebo (stretching) exercise (n=11), or no intervention (control; n=10). The study outcome was the change in the Beck Depression Inventory (BDI-II) total score from baseline to the end of the study period. The intent-to-treat analysis showed significant improvements in BDI-II scores for both the aerobic and the stretching groups. However, comparing pre- to post-study depression changes in these two groups, we found a large effect size in favor of aerobic exercise (Cohen's d=-1.06). No significant change in depressive symptoms was found in the control group. The nature of the intervention (i.e., exercise) meant blinding participants to treatments was not possible. Precise information on medication dosage was not available, and the short duration of interventions and lack of follow-up assessment were all limitations. Endurance-training can be a helpful adjunct treatment for hospitalized patients with severe affective disorders in the initial stages of pharmacotherapy. Copyright © 2015 Elsevier B.V. All rights reserved.

Randomized, controlled pilot trial of a smartphone app for smoking cessation using acceptance and commitment therapy.

PubMed

Bricker, Jonathan B; Mull, Kristin E; Kientz, Julie A; Vilardaga, Roger; Mercer, Laina D; Akioka, Katrina J; Heffner, Jaimee L

2014-10-01

There is a dual need for (1) innovative theory-based smartphone applications for smoking cessation and (2) controlled trials to evaluate their efficacy. Accordingly, this study tested the feasibility, acceptability, preliminary efficacy, and mechanism of behavioral change of an innovative smartphone-delivered acceptance and commitment therapy (ACT) application for smoking cessation vs. an application following US Clinical Practice Guidelines. Adult participants were recruited nationally into the double-blind randomized controlled pilot trial (n=196) that compared smartphone-delivered ACT for smoking cessation application (SmartQuit) with the National Cancer Institute's application for smoking cessation (QuitGuide). We recruited 196 participants in two months. SmartQuit participants opened their application an average of 37.2 times, as compared to 15.2 times for QuitGuide participants (p<0001). The overall quit rates were 13% in SmartQuit vs. 8% in QuitGuide (OR=2.7; 95% CI=0.8-10.3). Consistent with ACT's theory of change, among those scoring low (below the median) on acceptance of cravings at baseline (n=88), the quit rates were 15% in SmartQuit vs. 8% in QuitGuide (OR=2.9; 95% CI=0.6-20.7). ACT is feasible to deliver by smartphone application and shows higher engagement and promising quit rates compared to an application that follows US Clinical Practice Guidelines. As results were limited by the pilot design (e.g., small sample), a full-scale efficacy trial is now needed. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Monamine oxidase inhibitors: current and emerging agents for Parkinson disease.

PubMed

Fernandez, Hubert H; Chen, Jack J

2007-01-01

Monoamine oxidase type B (MAO-B) is the predominant isoform responsible for the metabolic breakdown of dopamine in the brain. Selective inhibition of brain MAO-B results in elevation of synaptosomal dopamine concentrations. Data have been reported regarding the selective MAO-B inhibitors, rasagiline and selegiline, for the symptomatic treatment of Parkinson disease (PD). Selegiline has demonstrated efficacy as monotherapy in patients with early PD (Deprenyl and Tocopherol Antioxidative Therapy of Parkinsonism study), but evidence of selegiline efficacy as adjunctive treatment in levodopa-treated PD patients with motor fluctuations is equivocal. A new formulation of selegiline (Zydis selegiline) has been evaluated in 2 small, placebo-controlled studies as adjunctive therapy to levodopa. The Zydis formulation allows pregastric absorption of selegiline, minimizing first-pass metabolism, and thereby increasing selegiline bioavailability and reducing the concentration of amphetamine metabolites. Rasagiline is a selective, second-generation, irreversible MAO-B inhibitor, with at least 5 times the potency of selegiline in vitro and in animal models. Rasagiline has demonstrated efficacy in 1 large, randomized, double-blind, placebo-controlled trial (TVP-1012 in Early Monotherapy for Parkinson's Disease Outpatients) as initial monotherapy in patients with early PD, and in 2 large, controlled trials (Parkinson's Rasagiline: Efficacy and Safety in the Treatment of "Off," Lasting Effect in Adjunct Therapy With Rasagiline Given Once Daily) as adjunctive treatment in levodopa-treated PD patients with motor fluctuations. Unlike selegiline, rasagiline is an aminoindan derivative with no amphetamine metabolites. A randomized clinical trial is underway to confirm preclinical and preliminary clinical data suggesting rasagiline has disease-modifying effects.

A Pilot Randomized Controlled Trial to Promote Immunosuppressant Adherence in Adult Kidney Transplant Recipients.

PubMed

Cukor, Daniel; Ver Halen, Nisha; Pencille, Melissa; Tedla, Fasika; Salifu, Moro

2017-01-01

Nonadherence to immunosuppressant medication is a prevalent practice among kidney transplant recipients and has been associated with increased risk for graft failure and economic burden. The aim of this pilot study was to test whether a culturally sensitive cognitive-behavioral adherence promotion program could significantly improve medication adherence to tacrolimus prescription as measured by telephone pill counts among kidney transplant recipients. Thirty-three adult transplant recipients were less than 98% adherent to tacrolimus prescription based on 3 telephone pill counts and were randomized either to the 2-session cognitive-behavioral adherence promotion program or to standard care. The curriculum was developed from an iterative process with transplant recipients into a 2-session group program that provided psychoeducation, addressed barriers to adherence, fostered motivation to improve adherence behavior, and discussed cultural messages on adherence behavior. The intervention group displayed significantly higher levels of adherence when compared to the control group (t = 2.2, p = 0.04) and. similarly, when the amount of change was compared between the groups, the intervention group showed more change than the control condition (F (22,1) = 12.005, p = 0.003). Tacrolimus trough concentration levels were used as a secondary measure of adherence and, while there were no significant between-group differences for mean trough concentration levels, the variability in the trough levels did significantly decrease over time indicating more consistent pill-taking behavior in the intervention group. There is preliminary support for the pilot program as a successful intervention in helping patients with their immunosuppressant medication. © 2016 S. Karger AG, Basel.

Effects of Various Cryotherapy Applications on Postoperative Pain in Molar Teeth with Symptomatic Apical Periodontitis: A Preliminary Randomized Prospective Clinical Trial.

PubMed

Gundogdu, Eyup Candas; Arslan, Hakan

2018-03-01

The purpose of the study was to evaluate the effects of intracanal, intraoral, and extraoral cryotherapy on postoperative pain in molar teeth with symptomatic apical periodontitis. A total of 100 patients were randomly distributed into 4 groups: control (without cryotherapy application), intracanal cryotherapy application, intraoral cryotherapy application, and extraoral cryotherapy application. The postoperative pain of the patients was recorded at the first, third, fifth, and seventh days. The data were statistically analyzed by using linear regression, χ 2 , one-way analysis of variance, Tukey post hoc, and Kruskal-Wallis H tests (P = .05). There were no statistically significant differences among the groups in terms of demographic data (P > .05). The preoperative pain levels and preoperative visual analogue scale (VAS) scores of pain on percussion were similar among the groups (P > .05). The linear regression analysis demonstrated that group variable had the most significant effect on postoperative pain at day 1 (P < .001) among the other variables (group, age, gender, tooth number, preoperative pain levels, and VAS scores of pain on percussion). When compared with the control group, all the cryotherapy groups exhibited less percussion pain and less postoperative pain at the first, third, fifth, and seventh days (P < .05). Within the study limitations, all the cryotherapy applications (intracanal, intraoral, and extraoral) resulted in lower postoperative pain levels and lower VAS scores of pain on percussion versus those of the control group. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

A preliminary study of silver sodium zirconium phosphate polyurethane foam wound dressing on wounds of the distal aspect of the forelimb in horses.

PubMed

Kelleher, Maureen E; Kilcoyne, Isabelle; Dechant, Julie E; Hummer, Emma; Kass, Philip H; Snyder, Jack R

2015-04-01

To determine if application of silver sodium zirconium phosphate polyurethane semi-occlusive foam (SPF) dressing would improve measures of wound healing and decrease bacterial contamination compared with a non-adherent, absorbent dressing applied to wounds created on the distal aspect of the equine limb. Controlled randomized experimental study. Adult Quarter Horse and Thoroughbred horses (n = 5). One 6.25 cm(2) wound was created on the dorsomedial aspect of the proximal metacarpus on each forelimb. A SPF dressing was applied to 1 randomly assigned limb as a treatment and a non-adherent, absorbent dressing was applied to the opposite limb as control. Bandages were changed every 3 days for 60 days. Granulation tissue was scored every 3 days, wound area measured every 6 days, and wound bed was cultured every 12 days. SPF-treatment wounds had significantly decreased wound area and decreased granulation tissue scores when evaluated <30 days and over the 60 day study, although complete wound healing times were not significantly different. Bacteria were cultured from all wounds at varying times throughout the study. The SPF wound dressing improved some measures of wound healing compared with the control dressing, most significantly during the first 30 days. This suggests that the SPF wound dressing may be useful in the early management of wounds on the equine lower limb. Further studies using the SPF dressing are needed to characterize the temporal and cellular effects on wound healing and evaluate this dressing in a clinical environment. © Copyright 2014 by The American College of Veterinary Surgeons.

Thrust vector control algorithm design for the Cassini spacecraft

NASA Technical Reports Server (NTRS)

Enright, Paul J.

1993-01-01

This paper describes a preliminary design of the thrust vector control algorithm for the interplanetary spacecraft, Cassini. Topics of discussion include flight software architecture, modeling of sensors, actuators, and vehicle dynamics, and controller design and analysis via classical methods. Special attention is paid to potential interactions with structural flexibilities and propellant dynamics. Controller performance is evaluated in a simulation environment built around a multi-body dynamics model, which contains nonlinear models of the relevant hardware and preliminary versions of supporting attitude determination and control functions.

40 CFR 1045.210 - May I get preliminary approval before I complete my application?

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 34 2012-07-01 2012-07-01 false May I get preliminary approval before I complete my application? 1045.210 Section 1045.210 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM SPARK-IGNITION PROPULSION...

40 CFR 1045.210 - May I get preliminary approval before I complete my application?

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 33 2011-07-01 2011-07-01 false May I get preliminary approval before I complete my application? 1045.210 Section 1045.210 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM SPARK-IGNITION PROPULSION...

40 CFR 1045.210 - May I get preliminary approval before I complete my application?

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 33 2014-07-01 2014-07-01 false May I get preliminary approval before I complete my application? 1045.210 Section 1045.210 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM SPARK-IGNITION PROPULSION...

40 CFR 1045.210 - May I get preliminary approval before I complete my application?

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 34 2013-07-01 2013-07-01 false May I get preliminary approval before I complete my application? 1045.210 Section 1045.210 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM SPARK-IGNITION PROPULSION...

40 CFR 1045.210 - May I get preliminary approval before I complete my application?

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 32 2010-07-01 2010-07-01 false May I get preliminary approval before I complete my application? 1045.210 Section 1045.210 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM SPARK-IGNITION PROPULSION...

PRELIMINARY PERFORMANCE AND COST ESTIMATES OF MERCURY EMISSION CONTROL OPTIONS FOR ELECTRIC UTILITY BOILERS

EPA Science Inventory

The paper discusses preliminary performance and cost estimates of mercury emission control options for electric utility boilers. Under the Clean Air Act Amendments of 1990, EPA had to determine whether mercury emissions from coal-fired power plants should be regulated. To a...