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Sample records for group randomized controlled

  1. Women's experiences as members of attention control and experimental intervention groups in a randomized controlled trial.

    PubMed

    Beal, Claudia C; Stuifbergen, Alexa; Volker, Deborah; Becker, Heather

    2009-12-01

    Attention control groups are often used in research testing the efficacy of psychosocial and behavioural interventions in order to control for placebo effects. The authors conducted a descriptive qualitative study to investigate how participants viewed their experiences in attention control and experimental intervention groups following a randomized controlled trial for women with fibromyalgia syndrome. Moderately structured interviews were conducted with 18 women (12 from the experimental intervention group and 6 from the attention control group). Members of the control group reported some benefits but few behavioural changes as a result of participating in the RCT, and some participants expressed disappointment at not receiving the intervention. Perceptions of changes in attitudes towards fibromyalgia syndrome and behaviours reported by the intervention group appear to be consistent with the theory underlying the intervention. Possible placebo effects identified in both groups include negative and positive social interactions with other participants.

  2. Usual and unusual care: existing practice control groups in randomized controlled trials of behavioral interventions.

    PubMed

    Freedland, Kenneth E; Mohr, David C; Davidson, Karina W; Schwartz, Joseph E

    2011-05-01

    To evaluate the use of existing practice control groups in randomized controlled trials of behavioral interventions and the role of extrinsic health care services in the design and conduct of behavioral trials. Selective qualitative review. Extrinsic health care services, also known as nonstudy care, have important but under-recognized effects on the design and conduct of behavioral trials. Usual care, treatment-as-usual, standard of care, and other existing practice control groups pose a variety of methodological and ethical challenges, but they play a vital role in behavioral intervention research. This review highlights the need for a scientific consensus statement on control groups in behavioral trials.

  3. Usual and Unusual Care: Existing Practice Control Groups In Randomized Controlled Trials of Behavioral Interventions

    PubMed Central

    Freedland, Kenneth E.; Mohr, David C.; Davidson, Karina W.; Schwartz, Joseph E.

    2011-01-01

    Objective To examine the use of existing practice control groups in randomized controlled trials of behavioral interventions, and the role of extrinsic healthcare services in the design and conduct of behavioral trials. Method Selective qualitative review. Results Extrinsic healthcare services, also known as nonstudy care, have important but under-recognized effects on the design and conduct of behavioral trials. Usual care, treatment as usual, standard of care, and other existing practice control groups pose a variety of methodological and ethical challenges, but they play a vital role in behavioral intervention research. Conclusion This review highlights the need for a scientific consensus statement on control groups in behavioral trials. PMID:21536837

  4. Improving the quality of randomized controlled trials in Chinese herbal medicine, part II: control group design.

    PubMed

    Bian, Zhao-Xiang; Moher, David; Dagenais, Simon; Li, You-Ping; Liu, Liang; Wu, Tai-Xiang; Miao, Jiang-Xia

    2006-03-01

    To discuss the types of control groups in randomized controlled trials (RCTs) of Chinese herbal medicine (CHM), and to provide suggestions for improving the design of control group in future clinical studies in this therapeutic area. A search of the Cochrane Library was conducted in July 2005 to identify RCTs of CHM, and 66 RCTs with CHM for type 2 diabetes mellitus were obtained as the basis for further analysis. Of 66 RCTs with CHM for type 2 diabetes mellitus, 61 (92.4%) trials had both a treatment group and a control group. Twenty-seven (40.9%) RCTs compared CHM plus conventional drug vs conventional drug, 24 (36.4%) compared CHM vs conventional drug, 5 (7.6%) compared CHM vs placebo, 3 (4.5%) compared CHM plus conventional drug vs conventional drug plus placebo, 3 (4.5%) compared CHM plus conventional drug vs other CHM, 1 (1.5%) compared CHM vs no treatment, 1 (1.5%) compared CHM plus placebo vs conventional drug plus placebo, 1 (1.5%) compared CHM vs CHM plus conventional drug vs conventional drug vs placebo, and 1 (1.5%) compared CHM vs conventional drug vs CHM plus conventional drug. A variety of control groups were used in RCTs of CHM for type 2 diabetes mellitus, including placebo, active, and no treatment control groups. Justification for selecting particular types of control groups were not provided in the trials reviewed in this study. Different control groups may be appropriate according to the study objectives, and several factors should be considered prior to selecting control groups in future RCTs of CHM. (1) Investigators of CHM who design clinical trials should understand the rationale for selecting different types of control groups; (2) Control groups for RCTs should be selected according to study objectives; (3) Active control groups should select interventions for comparisons that have the strongest evidence of efficacy and prescribe them as recommended; (4) Placebo control groups should select a placebo that mimics the physical

  5. Group Lidcombe Program Treatment for Early Stuttering: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Arnott, Simone; Onslow, Mark; O'Brian, Sue; Packman, Ann; Jones, Mark; Block, Susan

    2014-01-01

    Purpose: This study adds to the Lidcombe Program evidence base by comparing individual and group treatment of preschoolers who stutter. Method: A randomized controlled trial of 54 preschoolers was designed to establish whether group delivery outcomes were not inferior to the individual model. The group arm used a rolling group model, in which a…

  6. Group Lidcombe Program Treatment for Early Stuttering: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Arnott, Simone; Onslow, Mark; O'Brian, Sue; Packman, Ann; Jones, Mark; Block, Susan

    2014-01-01

    Purpose: This study adds to the Lidcombe Program evidence base by comparing individual and group treatment of preschoolers who stutter. Method: A randomized controlled trial of 54 preschoolers was designed to establish whether group delivery outcomes were not inferior to the individual model. The group arm used a rolling group model, in which a…

  7. What to Do when Data Are Missing in Group Randomized Controlled Trials. NCEE 2009-0049

    ERIC Educational Resources Information Center

    Puma, Michael J.; Olsen, Robert B.; Bell, Stephen H.; Price, Cristofer

    2009-01-01

    This NCEE Technical Methods report examines how to address the problem of missing data in the analysis of data in Randomized Controlled Trials (RCTs) of educational interventions, with a particular focus on the common educational situation in which groups of students such as entire classrooms or schools are randomized. Missing outcome data are a…

  8. Reconstructing Meaning with Others in Loss: A Feasibility Pilot Randomized Controlled Trial of a Bereavement Group.

    PubMed

    MacKinnon, Christopher J; Smith, Nathan Grant; Henry, Melissa; Milman, Evgenia; Chochinov, Harvey M; Körner, Annette; Berish, Mel; Farrace, Amanda Jessica; Liarikos, Nikoleta; Cohen, S Robin

    2015-01-01

    More effective psychosocial interventions that target uncomplicated bereavement are needed for those actively seeking support. The objective of this study was to assess the feasibility of evaluating a unique meaning-based group counseling (MBGC) intervention with a randomized controlled trial (RCT) design. Twenty-six bereft individuals were randomly assigned to either MBGC or a control bereavement support group. Twenty participants (11 experimental, nine control) completed all aspects of the study including self-report measures at baseline, postintervention, and 3-month follow-up of meaning in life, anxiety, depression, and grief. Results support the feasibility of an RCT with MBGC.

  9. Group Cognitive Behavioural Therapy and Group Recreational Activity for Adults with Autism Spectrum Disorders: A Preliminary Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Hesselmark, Eva; 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…

  10. Group Cognitive Behavioural Therapy and Group Recreational Activity for Adults with Autism Spectrum Disorders: A Preliminary Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Hesselmark, Eva; 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…

  11. A randomized, double-blind, placebo controlled, parallel group, efficacy study of alpha BRAIN® administered orally.

    PubMed

    Solomon, Todd M; Leech, Jarrett; deBros, Guy B; Murphy, Cynthia A; Budson, Andrew E; Vassey, Elizabeth A; Solomon, Paul R

    2016-03-01

    Alpha BRAIN® is a nootropic supplement that purports to enhance cognitive functioning in healthy adults. The goal of this study was to investigate the efficacy of this self-described cognitive enhancing nootropic on cognitive functioning in a group of healthy adults by utilizing a randomized, double blind, placebo-controlled design. A total of 63-treatment naïve individuals between 18 and 35 years of age completed the randomized, double-blind, placebo controlled trial. All participants completed a 2-week placebo run in before receiving active product, Alpha BRAIN® or new placebo, for 6 weeks. Participants undertook a battery of neuropsychological tests at randomization and at study completion. Primary outcome measures included a battery of neuropsychological tests and measures of sleep. Compared with placebo, Alpha BRAIN® significantly improved on tasks of delayed verbal recall and executive functioning. Results also indicated significant time-by-group interaction in delayed verbal recall for the Alpha BRAIN® group. The use of Alpha BRAIN® for 6 weeks significantly improved recent verbal memory when compared with controls, in a group of healthy adults. While the outcome of the study is encouraging, this is the first randomized controlled trial of Alpha BRAIN®, and the results merit further study. Copyright © 2016 John Wiley & Sons, Ltd.

  12. A single blind randomized control trial on support groups for Chinese persons with mild dementia.

    PubMed

    Young, Daniel K W; Kwok, Timothy C Y; Ng, Petrus Y N

    2014-01-01

    Persons with mild dementia experience multiple losses and manifest depressive symptoms. This research study aimed to evaluate the effectiveness of a support group led by a social worker for Chinese persons with mild dementia. Participants were randomly assigned to either a ten-session support group or a control group. Standardized assessment tools were used for data collection at pretreatment and post-treatment periods by a research assistant who was kept blind to the group assignment of the participants. Upon completion of the study, 20 treatment group participants and 16 control group participants completed all assessments. At baseline, the treatment and control groups did not show any significant difference on all demographic variables, as well as on all baseline measures; over one-half (59%) of all the participants reported having depression, as assessed by a Chinese Geriatric Depression Scale score ≥8. After completing the support group, the depressive mood of the treatment group participants reduced from 8.83 (standard deviation =2.48) to 7.35 (standard deviation =2.18), which was significant (Wilcoxon signed-rank test; P=0.017, P<0.05), while the control group's participants did not show any significant change. This present study supports the efficacy and effectiveness of the support group for persons with mild dementia in Chinese society. In particular, this present study shows that a support group can reduce depressive symptoms for participants.

  13. Individual- versus group-based financial incentives for weight loss: a randomized, controlled trial.

    PubMed

    Kullgren, Jeffrey T; Troxel, Andrea B; Loewenstein, George; Asch, David A; Norton, Laurie A; Wesby, Lisa; Tao, Yuanyuan; Zhu, Jingsan; Volpp, Kevin G

    2013-04-02

    Data on the effectiveness of employer-sponsored financial incentives for employee weight loss are limited. To test the effectiveness of 2 financial incentive designs for promoting weight loss among obese employees. Randomized, controlled trial. (ClinicalTrials.gov: NCT01208350) Children's Hospital of Philadelphia. 105 employees with a body mass index between 30 and 40 kg/m2. 24 weeks of monthly weigh-ins (control group; n = 35); individual incentive, designed as $100 per person per month for meeting or exceeding weight-loss goals (n = 35); and group incentive, designed as $500 per month split among participants within groups of 5 who met or exceeded weight-loss goals (n = 35). Weight loss after 24 weeks (primary outcome) and 36 weeks and changes in behavioral mediators of weight loss (secondary outcomes). Group-incentive participants lost more weight than control participants (mean between-group difference, 4.4 kg [95% CI, 2.0 to 6.7 kg]; P < 0.001) and individual-incentive participants (mean between-group difference, 3.2 kg [CI, 0.9 to 5.5 kg]; P = 0.008). Twelve weeks after incentives ended and after adjustment for 3-group comparisons, group-incentive participants maintained greater weight loss than control group participants (mean between-group difference, 2.9 kg [CI, 0.5 to 5.3 kg]; P = 0.016) but not greater than individual-incentive participants (mean between-group difference, 2.7 kg [CI, 0.4 to 5.0 kg]; P = 0.024). Single employer and short follow-up. A group-based financial incentive was more effective than an individual incentive and monthly weigh-ins at promoting weight loss among obese employees at 24 weeks. National Institute on Aging.

  14. An effective group psychoeducational intervention for improving compliance with vaginal dilation: A randomized controlled trial

    SciTech Connect

    Jeffries, Sherryl A.; Robinson, John W. . E-mail: johnrobi@cancerboard.ab.ca; Craighead, Peter S.; Keats, Melanie R.

    2006-06-01

    Purpose: Although vaginal dilation is often recommended to minimize or prevent vaginal scarring after pelvic radiotherapy, compliance with this recommendation has historically been very low. Therefore, effective intervention strategies are needed to enhance compliance with vaginal dilation after radiotherapy for gynecologic cancer. Methods and Materials: This study was a randomized controlled clinical trial of a psychoeducational intervention specifically designed to increase compliance with vaginal dilation. The information-motivation-behavioral skills model of enhancing compliance with behavioral change was the basis for the intervention design. Forty-two sexually active women, 21 to 65 years of age, diagnosed with Stages Ic-III cervical or endometrial cancer, who received pelvic radiotherapy, were randomized to either the experimental psychoeducational group or the information-only control group. Assessment via questionnaire occurred before treatment and at 6-week, 6-month, 12-month, 18-month, and 24-month follow-up. Assessment via interview also occurred at 6-month, 12-month, 18-month, and 24-month follow-up. Results: The psychoeducational intervention was successful in increasing compliance with vaginal dilation. Conclusions: This study is the first randomized controlled study to demonstrate the effectiveness of an intervention in increasing compliance with the use of vaginal dilators.

  15. Complicated grief in older adults: a randomized controlled trial of complicated grief group therapy.

    PubMed

    Supiano, Katherine P; Luptak, Marilyn

    2014-10-01

    This study compared the efficacy of complicated grief therapy (CGT; Shear, K. [2003]. Complicated grief: A guidebook for therapists [Liberty Version]. New York State Office of Mental Heath; Shear, K., Frank, E., Houck, P. R., & Reynolds, C. F. 3rd [2005]. Treatment of complicated grief: A randomized controlled trial. The Journal of the American Medical Association, 293, 2601-2608) administered as group therapy (CGGT) with standard group therapy (treatment as usual [TAU]) in older adults presenting with complicated grief (CG). The design was a 2×4, prospective, randomized controlled clinical trial. The independent variable was group type, with 1 group receiving experimental methods based on the work of Shear et al. (Shear, K., Frank, E., Houck, P. R., & Reynolds, C. F. 3rd. [2005]. Treatment of complicated grief: a randomized controlled trial. The Journal of the American Medical Association, 293, 2601-2608), CGGT versus. TAU. The dependent variable was treatment response. CGGT participants demonstrated higher treatment response than TAU participants. Although participants in both groups showed improvement in CG measures, CGGT participants realized significantly greater improvement. More importantly, when CG was measured on Prolonged Grief Disorder Scale, nearly half of CGGT participants realized clinically significant improvement. All CGGT completers had Brief Grief Questionnaire scores upon follow-up that, had they scored at that level at pretest, would have disqualified them for study enrollment. The high level of clinical significance suggests that CGGT participants were effectively treated for CG. This study offers evidence that CGGT holds promise for treatment of CG in older adults and merits inquiry in other populations. © The Author 2013. 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.

  16. Laughter yoga versus group exercise program in elderly depressed women: a randomized controlled trial.

    PubMed

    Shahidi, Mahvash; Mojtahed, Ali; Modabbernia, Amirhossein; Mojtahed, Mohammad; Shafiabady, Abdollah; Delavar, Ali; Honari, Habib

    2011-03-01

    Laughter Yoga founded by M. Kataria is a combination of unconditioned laughter and yogic breathing. Its effect on mental and physical aspects of healthy individuals was shown to be beneficial. The objective of this study was to compare the effectiveness of Kataria's Laughter Yoga and group exercise therapy in decreasing depression and increasing life satisfaction in older adult women of a cultural community of Tehran, Iran. Seventy depressed old women who were members of a cultural community of Tehran were chosen by Geriatric depression scale (score>10). After completion of Life Satisfaction Scale pre-test and demographic questionnaire, subjects were randomized into three groups of laughter therapy, exercise therapy, and control. Subsequently, depression post-test and life satisfaction post-test were done for all three groups. The data were analyzed using analysis of covariance and Bonferroni's correction. Sixty subjects completed the study. The analysis revealed a significant difference in decrease in depression scores of both Laughter Yoga and exercise therapy group in comparison to control group (p<0.001 and p<0.01, respectively). There was no significant difference between Laughter Yoga and exercise therapy groups. The increase in life satisfaction of Laughter Yoga group showed a significant difference in comparison with control group (p<0.001). No significant difference was found between exercise therapy and either control or Laughter Yoga group. Our findings showed that Laughter Yoga is at least as effective as group exercise program in improvement of depression and life satisfaction of elderly depressed women. Copyright © 2010 John Wiley & Sons, Ltd.

  17. Group Singing as a Therapy during Diabetes Training--A Randomized Controlled Pilot Study.

    PubMed

    Groener, J B; Neus, I; Kopf, S; Hartmann, M; Schanz, J; Kliemank, E; Wetekam, B; Kihm, L; Fleming, T; Herzog, W; Nawroth, P P

    2015-11-01

    Comprehensive diabetes treatment has been shown to reduce quality of life in diabetic patients. However, there is evidence to suggest that group singing can have positive effects on quality of life in various clinical settings. In this randomized controlled pilot study, the effect of singing as a therapy to reduce stress and improve quality of life was investigated in insulin-dependent diabetic patients, undergoing a lifestyle intervention program. Patients from the singing group felt less discontented following treatment. This effect, however, was lost after 3 months. No effect on serum cortisol and plasma adrenocorticotropic hormone (ACTH) levels could be seen when comparing the singing group with the control group, although reduced levels of ACTH and cortisol 3 days after treatment could be found and were still present after 3 months within the group of patients who undertook singing as a therapy. Singing led to an increase in bodyweight, which interestingly had no effect on glucose control or methylglyoxal levels. Therefore, singing during a lifestyle intervention program for insulin-dependent diabetic patients had a short lasting and weak effect on patients' mood without affecting glucose control, but no significant effect on stress related hormones. © Georg Thieme Verlag KG Stuttgart · New York.

  18. Effect of self-consistency group intervention for adolescents with schizophrenia: An inpatient randomized controlled trial.

    PubMed

    She, Pan; Zeng, Hongling; Yang, Bingxiang

    2016-02-01

    The aim of the study was to explore the efficacy of structural group therapy on the self-consistency and congruence of inpatient adolescents with a diagnosis of schizophrenia. Sixty inpatient adolescents with schizophrenia were randomly assigned to an intervention group (n = 30) and a control group (n = 30). The intervention group was provided with a 12-session structural group therapy program for six weeks (1 h, two times per week), while the control group participated in a handicraft group. All patients were assessed with the Self-Consistency and Congruence Scale (SCCS) and the Positive and Negative Syndrome Scale (PANSS) at pretest, posttest, three-month and one-year follow-up. The results were analyzed using t-test and repeated measures ANOVA. The two groups had no significant difference at the pre-test of outcome measures (p > 0.05). Significant differences existed between the two groups in ego-dystonic, self-flexibility, SCCS scores, positive syndrome, general psychopathology and PANSS scores after the intervention (p < 0.05). At the three-month follow-up, ego-dystonic, self-flexibility and PANSS scores were also found to be significantly different between the two groups (p < 0.05). But the outcome measures were not significantly different between the two groups at the one-year follow-up. Structural group therapy in a mental health setting had a positive effect on improving self-consistency and congruence, positive symptoms and general psychopathology of inpatient adolescents with a diagnosis of schizophrenia. Copyright © 2015 Elsevier Ltd. All rights reserved.

  19. Effectiveness of Group Wheelchair Skills Training for People With Spinal Cord Injury: A Randomized Controlled Trial.

    PubMed

    Worobey, Lynn A; Kirby, R Lee; Heinemann, Allen W; Krobot, Emily A; Dyson-Hudson, Trevor A; Cowan, Rachel E; Pedersen, Jessica Presperin; Shea, Mary; Boninger, Michael L

    2016-10-01

    To assess the effectiveness of group wheelchair skills training to elicit improvements in wheelchair skills. Randomized double-blinded controlled trial. Four Spinal Cord Injury Model Systems Centers. Manual wheelchair users with spinal cord injury (N=114). Six 90-minute group Wheelchair Skills Training Program (WSTP) classes or two 1-hour active control sessions with 6 to 10 people per group. Baseline (t1) and 1-month follow-up (t2) Wheelchair Skills Test Questionnaire (WST-Q) (Version 4.2) for capacity and performance and Goal Attainment Scale (GAS) score. Follow-up was completed by 79 participants (WSTP: n=36, active control: n=43). No differences were found between missing and complete cases. Many users were highly skilled at baseline with a WST-Q capacity interquartile range of 77% to 97%. There were no differences between groups at baseline in WST-Q measures or demographics. Compared with the active control group, the WSTP group improved in WST-Q capacity advanced score (P=.02) but not in WST-Q capacity or WST-Q performance total scores (P=.068 and P=.873, respectively). The average GAS score (0% at t1) for the WSTP group at t2 was 65.6%±34.8%. Higher GAS scores and WST-Q capacity scores were found for those who attended more classes and had lower baseline skills. Group training can improve advanced wheelchair skills capacity and facilitate achievement of individually set goals. Lower skill levels at baseline and increased attendance were correlated with greater improvement. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  20. Group critical incident stress debriefing with emergency services personnel: a randomized controlled trial.

    PubMed

    Tuckey, Michelle R; Scott, Jill E

    2014-01-01

    Although single-session individual debriefing is contraindicated, the efficacy of group psychological debriefing remains unresolved. We conducted the first randomized controlled trial of critical incident stress debriefing (CISD) with emergency workers (67 volunteer fire-fighters) following shared exposure to an occupational potentially traumatic event (PTE). The goals of group CISD are to prevent post-traumatic stress and promote return to normal functioning following a PTE. To assess both goals we measured four outcomes, before and after the intervention: post-traumatic stress, psychological distress, quality of life, and alcohol use. Fire brigades were randomly assigned to one of three treatment conditions: (1) CISD, (2) Screening (i.e., no-treatment), or (3) stress management Education. Controlling for pre-intervention scores, CISD was associated with significantly less alcohol use post-intervention relative to Screening, and significantly greater post-intervention quality of life relative to Education. There were no significant effects on post-traumatic stress or psychological distress. Overall, CISD may benefit broader functioning following exposure to work-related PTEs. Future research should focus on individual, group, and organizational factors and processes that can promote recovery from operational stressors. Ultimately, an occupational health (rather than victim-based) approach will provide the best framework for understanding and combating potential threats to the health and well-being of workers at high risk for PTE exposure.

  1. Supervising for Home Safety Program: A Randomized Controlled Trial (RCT) Testing Community-Based Group Delivery.

    PubMed

    Morrongiello, Barbara A; Hou, Sharon; Bell, Melissa; Walton, Kathryn; Filion, A Jordan; Haines, Jess

    2016-10-22

    OBJECTIVE : The individually delivered Supervising for Home Safety (SHS) program improves caregivers' injury-related beliefs and supervision practices. The current randomized controlled trial used a group delivery in a community setting and assessed program impact, feasibility, and acceptance. METHODS : Caregivers of 2-5-year-olds were randomized to receive either the SHS or an attention-matched control program. RESULTS : In the SHS group only, there were increases from baseline to postintervention in the following: beliefs about children's vulnerability to injury, caregiver preventability of injuries, and self-efficacy to do so; readiness for change in supervision; and watchful supervision Face-to-face recruitment by staff at community organizations proved most successful. Caregivers' satisfaction ratings were high, as was caregiver engagement (95% completed at least seven of the nine sessions). CONCLUSION : The SHS program can be delivered to groups of caregivers in community settings, is positively received by caregivers, and produces desirable changes that can be expected to improve caregivers' home safety practices. © 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.

  2. Exercise training improves walking function in an African group of stroke survivors: a randomized controlled trial.

    PubMed

    Olawale, O A; Jaja, S I; Anigbogu, C N; Appiah-Kubi, K O; Jones-Okai, D

    2011-05-01

    To evaluate the effects of treadmill walking and overground walking exercise training on recovery of walking function in an African group of stroke survivors. Prospective, randomized controlled study. Outpatient stroke rehabilitation unit in a tertiary hospital. Sixty patients with chronic stroke (≥3 months). All subjects received individual outpatient conventional physiotherapy rehabilitation for 12 weeks. In addition, subjects in Group A (n = 20) received treadmill walking exercise training (TWET) while those in Group B (n = 20) received overground walking exercise training (OWET). Those in Group C (control) (n = 20) received conventional physiotherapy rehabilitation only. Outcome measures were (i) 10-metre walk time (10MWT) test and (ii) six-minute walk distance (6MWD) test. These were evaluated at entry into the study and at the end of every four weeks. Paired t-tests were used to evaluate the significance of the difference between pre-training and post-training scores on the two measures (P < 0.05). Subjects in the TWET group recorded 22.6 ± 1.5% decrease in 10MWT and 31.0 ± 4.3% increase in 6MWD; those in the OWET group made 26.8 ± 1.3% and 45.2 ± 4.6% improvement in 10MWT and 6MWD respectively. Subjects in the control group made 2.2 ± 0.7% and 2.9 ± 0.8% improvement in the two functions. These changes were significant for the TWET and OWET groups (P < 0.05). This study indicated that treadmill and overground walking exercise training programmes, combined with conventional rehabilitation, improved walking function in an African group of adult stroke survivors. Therefore, professionals who conduct stroke rehabilitation programmes should utilize exercise training to optimize patient outcomes.

  3. A Randomized Controlled Trial of a Mindfulness and Acceptance Group Therapy for Residential Substance Use Patients.

    PubMed

    Shorey, Ryan C; Elmquist, Joanna; Gawrysiak, Michael J; Strauss, Catherine; Haynes, Ellen; Anderson, Scott; Stuart, Gregory L

    2017-09-19

    Substance use disorders are understood as a chronically relapsing condition that is difficult to treat. However, in recent years there have been promising developments in the treatment of substance use disorders, specifically with interventions based on mindfulness and acceptance and commitment therapy. Little research has examined whether these types of interventions may positively impact residential substance use treatment outcomes. Thus, in the current study we developed and examined, in a randomized controlled trial, a 4-week, eight-session, adjunctive mindfulness and acceptance group therapy for patients in residential substance use treatment. Our primary outcomes were substance use cravings, psychological flexibility, and dispositional mindfulness at treatment discharge. Patients (N = 117) from a private residential substance use facility were randomized to receive the adjunctive mindfulness and acceptance group or treatment-as-usual. Patients were assessed at treatment intake and at discharge from a 28-30-day residential program. Although treatment groups did not statistically differ at discharge on any primary outcome, small effect sizes favored the mindfulness and acceptance group on cravings and psychological flexibility. Conclusions/Importance: Continued research is needed to determine whether the addition of mindfulness and acceptance-based interventions improve outcomes long term following residential substance use treatment.

  4. Academic detailing and adherence to guidelines for Group B streptococci prenatal screening: a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Clinical practice guidelines (CPGs) recommend universal prenatal screening for Group B Streptococcus (GBS) to identify candidates for intrapartum antibiotic prophylaxis to prevent early onset neonatal GBS infection. Interventions to promote physician adherence to these guidelines are imperative. This study examined the effectiveness of academic detailing (AD) of obstetricians, compared with CPG mailshot and no intervention, on the screening of pregnant women for GBS. Methods A randomized controlled clinical trial was conducted in the medical cooperative of Porto Alegre, Brazil. All obstetricians who assisted in a delivery covered by private health insurance managed by the cooperative in the 3 months preceding the study (n = 241) were invited to participate. The obstetricians were randomized to three groups: direct mail (DM, n = 76), AD (n = 76) and control (C, n = 89, no intervention). Those in the DM group were sent guidelines on GBS. The AD group received the guidelines and an educational visit detailing the guidelines, which was conducted by a trained physician. Data on obstetrician age, gender, time since graduation, whether patients received GBS screening during pregnancy, and obstetricians who requested screening were collected for all participant obstetricians for 3 months before and after the intervention, using database from the private health insurance information system. Results Three months post-intervention, the data showed that the proportion of pregnant women screened for GBS was higher in the AD group (25.4%) than in the DM (15.9%) and C (17.7%) groups (P = 0.023). Similar results emerged when the three groups were taken as a cluster (pregnant women and their obstetricians), but the difference was not statistically significant (Poisson regression, P = 0.108). Additionally, when vaginal deliveries were analyzed separately, the proportion screened was higher in the AD group (75%) than in the DM group (41.9%) and the C group (30.4%) (chi

  5. Group behavioral activation for patients with severe obesity and binge eating disorder: a randomized controlled trial.

    PubMed

    Alfonsson, Sven; Parling, Thomas; Ghaderi, Ata

    2015-03-01

    The aim of the present study was to assess whether behavioral activation (BA) is an efficacious treatment for decreasing eating disorder symptoms in patients with obesity and binge eating disorder (BED). Ninety-six patients with severe obesity and BED were randomized to either 10 sessions of group BA or wait-list control. The study was conducted at an obesity clinic in a regular hospital setting. The treatment improved some aspects of disordered eating and had a positive effect on depressive symptoms but there was no significant difference between the groups regarding binge eating and most other symptoms. Improved mood but lack of effect on binge eating suggests that dysfunctional eating (including BED) is maintained by other mechanisms than low activation and negative mood. However, future studies need to investigate whether effects of BA on binge eating might emerge later than at post-assessment, as in interpersonal psychotherapy for bulimia nervosa. © The Author(s) 2014.

  6. Brief group psychoeducation for caregivers of individuals with bipolar disorder: A randomized controlled trial.

    PubMed

    Hubbard, Alison A; McEvoy, Peter M; Smith, Laura; Kane, Robert T

    2016-08-01

    Bipolar disorder is associated with significant impairment in personal and social functioning for the individual and their caregivers. Psychoeducation for caregivers is beneficial, but interventions have typically required a significant time commitment and have not assessed changes in self-efficacy. This study evaluated the effectiveness of a brief, two-session psychoeducational intervention for caregivers. It was hypothesized that the intervention would reduce caregiver burden and distress, and increase bipolar disorder knowledge and bipolar disorder self-efficacy. Participants (N=32) were randomized to immediate or waitlist control conditions. The intervention involved two, 150-minute group sessions spaced one-week apart. At pre-, post-, and one-month follow-up participants completed the Depression, Anxiety, Stress Scale (DASS-21), Burden Assessment Scale, Knowledge of Bipolar Disorder Scale, and a Bipolar Disorder Self-efficacy Scale. Compared to the waitlist control group, the immediate treatment group demonstrated large and significant reductions in caregiver burden, and increases in bipolar disorder knowledge and bipolar disorder self-efficacy. These improvements maintained or increased to follow-up. No significant change was observed on the DASS-21. Reliance on self-report and the sample comprised mostly of parents and partners, so it unclear if results generalize to other carer groups. Large and enduring improvements in carer burden, knowledge, and bipolar disorder self-efficacy can be achieved from a very brief, two-session intervention. Copyright © 2016 Elsevier B.V. All rights reserved.

  7. Individual vs. Group-Based Incentives for Weight Loss: A Randomized, Controlled Trial

    PubMed Central

    Kullgren, Jeffrey T.; Troxel, Andrea B.; Loewenstein, George; Asch, David A.; Norton, Laurie A.; Wesby, Lisa; Tao, Yuanyuan; Zhu, Jingsan; Volpp, Kevin G.

    2014-01-01

    Background There are limited data on the effectiveness of employer-sponsored financial incentives for employee weight loss. Objective To test the effectiveness of two financial incentive designs for promoting weight loss among obese employees. Design Randomized controlled trial. Allocation sequence was generated dynamically at the time of request of treatment assignment. Participants were unblinded to assignment; investigators were blinded to assignment until collection of primary outcome data. Setting Children’s Hospital of Philadelphia Participants 105 employees with a body mass index between 30 and 40 kg/m2 Interventions 24 weeks of monthly weigh-ins (control)(n=35); individual incentive, designed as $100 per person per month for meeting or exceeding target weight loss (individual arm)(n=35); group incentive, designed as $500 per month split between any participant within groups of 5 who met or exceeded their target weight loss (group arm)(n=35). Measurements Weight loss after 24 weeks (primary outcome); weight loss after 36 weeks, changes in behavioral mediators of weight loss (secondary outcomes). Results Group incentive participants lost more weight than individual arm participants (between-group difference in weight loss favoring group = mean 9.7 pounds, 95% CI 4.4 to 14.9; P < 0.001). Twelve weeks after incentives ended and adjusting for 3-group comparisons, group arm participants maintained greater weight loss than control arm participants (between-group difference in weight loss = mean 6.5 pounds, 95% CI 1.2 to 11.7; P = 0.016) but not more than individual arm participants (difference = 5.9 pounds, 95% CI, 0.8 to 11.0; P = 0.024). Limitations Single employer, short follow-up Conclusions A group-based financial incentive was more effective than an individual incentive and monthly weigh-ins at promoting weight loss among obese employees at 24 weeks. Primary Funding Source National Institute on Aging Trial Registration ClinicalTrials.gov Identifier: NCT

  8. Mindfulness training improves attentional task performance in incarcerated youth: a group randomized controlled intervention trial

    PubMed Central

    Leonard, Noelle R.; Jha, Amishi P.; Casarjian, Bethany; Goolsarran, Merissa; Garcia, Cristina; Cleland, Charles M.; Gwadz, Marya V.; Massey, Zohar

    2013-01-01

    We investigated the impact of cognitive behavioral therapy and mindfulness training (CBT/MT) on attentional task performance in incarcerated adolescents. Attention is a cognitive system necessary for managing cognitive demands and regulating emotions. Yet persistent and intensive demands, such as those experienced during high-stress intervals like incarceration and the events leading to incarceration, may deplete attention resulting in cognitive failures, emotional disturbances, and impulsive behavior. We hypothesized that CBT/MT may mitigate these deleterious effects of high stress and protect against degradation in attention over the high-stress interval of incarceration. Using a quasi-experimental, group randomized controlled trial design, we randomly assigned dormitories of incarcerated youth, ages 16–18, to a CBT/MT intervention (youth n = 147) or an active control intervention (youth n = 117). Both arms received approximately 750 min of intervention in a small-group setting over a 3–5 week period. Youth in the CBT/MT arm also logged the amount of out-of-session time spent practicing MT exercises. The Attention Network Test was used to index attentional task performance at baseline and 4 months post-baseline. Overall, task performance degraded over time in all participants. The magnitude of performance degradation was significantly less in the CBT/MT vs. control arm. Further, within the CBT/MT arm, performance degraded over time in those with no outside-of-class practice time, but remained stable over time in those who practiced mindfulness exercises outside of the session meetings. Thus, these findings suggest that sufficient CBT/MT practice may protect against functional attentional impairments associated with high-stress intervals. PMID:24265621

  9. 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

  10. 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.

  11. After-School Multifamily Groups: A Randomized Controlled Trial Involving Low-Income, Urban, Latino Children

    ERIC Educational Resources Information Center

    McDonald, Lynn; Moberg, D. Paul; Brown, Roger; Rodriguez-Espiricueta, Ismael; Flores, Nydia I.; Burke, Melissa P.; Coover, Gail

    2006-01-01

    This randomized controlled trial evaluated a culturally representative parent engagement strategy with Latino parents of elementary school children. Ten urban schools serving low-income children from mixed cultural backgrounds participated in a large study. Classrooms were randomly assigned either either to an after-school, multifamily support…

  12. Improving Parental Stress Levels Among Mothers Living with HIV: A Randomized Control Group Intervention Study

    PubMed Central

    Johnson, Erica R.; Davies, Susan L.; Aban, Inmaculada; Mugavero, Michael J.; Shrestha, Sadeep

    2015-01-01

    Abstract Limited knowledge exists regarding parenting efficacy interventions for mothers living with HIV (MLH). This study evaluated the impact of a supportive group intervention on lowering parenting stress among MLH. Eighty MLH were randomized to a parenting (N=34) or health focused (control) (N=46) group intervention. Pre- and post-intervention stress levels were assessed using the Parental Stress Index-Short Form (PSI/SF). Differences in PSI/SF scores were examined using ANOVA, and predictors of PSI/SF scores were evaluated using multivariable linear regression. Findings indicate that both groups experienced significant decreases in parenting stress from baseline to post-intervention (p=0.0001), with no significant differences between interventions. At baseline, 41% of participants were identified as highly stressed and 30% as clinically stressed, with PSI/SF scores above the 85th and 90th percentile, respectively. Amongst the highly stressed subpopulation, significant improvements in PSI/SF scores for Parental Distress PSI/SF (p=0.039), Difficult Child PSI/SF (p=0.048), and total PSI/SF (p=0.036) were seen, with greater improvements in the parenting intervention. Among the clinically stressed subpopulation, significant improvements in total post-intervention PSI/SF scores were seen (p=0.049), with greater improvements in the parenting intervention. Results indicate that screening for high levels of stress should be considered in clinical practice to effectively implement stress-reducing interventions among MLH. PMID:25734870

  13. Improving parental stress levels among mothers living with HIV: a randomized control group intervention study.

    PubMed

    Johnson, Erica R; Davies, Susan L; Aban, Inmaculada; Mugavero, Michael J; Shrestha, Sadeep; Kempf, Mirjam-Colette

    2015-04-01

    Limited knowledge exists regarding parenting efficacy interventions for mothers living with HIV (MLH). This study evaluated the impact of a supportive group intervention on lowering parenting stress among MLH. Eighty MLH were randomized to a parenting (N=34) or health focused (control) (N=46) group intervention. Pre- and post-intervention stress levels were assessed using the Parental Stress Index-Short Form (PSI/SF). Differences in PSI/SF scores were examined using ANOVA, and predictors of PSI/SF scores were evaluated using multivariable linear regression. Findings indicate that both groups experienced significant decreases in parenting stress from baseline to post-intervention (p=0.0001), with no significant differences between interventions. At baseline, 41% of participants were identified as highly stressed and 30% as clinically stressed, with PSI/SF scores above the 85(th) and 90(th) percentile, respectively. Amongst the highly stressed subpopulation, significant improvements in PSI/SF scores for Parental Distress PSI/SF (p=0.039), Difficult Child PSI/SF (p=0.048), and total PSI/SF (p=0.036) were seen, with greater improvements in the parenting intervention. Among the clinically stressed subpopulation, significant improvements in total post-intervention PSI/SF scores were seen (p=0.049), with greater improvements in the parenting intervention. Results indicate that screening for high levels of stress should be considered in clinical practice to effectively implement stress-reducing interventions among MLH.

  14. Weight change among people randomized to minimal intervention control groups in weight loss trials.

    PubMed

    Johns, David J; Hartmann-Boyce, Jamie; Jebb, Susan A; Aveyard, Paul

    2016-04-01

    Evidence on the effectiveness of behavioral weight management programs often comes from uncontrolled program evaluations. These frequently make the assumption that, without intervention, people will gain weight. The aim of this study was to use data from minimal intervention control groups in randomized controlled trials to examine the evidence for this assumption and the effect of frequency of weighing on weight change. Data were extracted from minimal intervention control arms in a systematic review of multicomponent behavioral weight management programs. Two reviewers classified control arms into three categories based on intensity of minimal intervention and calculated 12-month mean weight change using baseline observation carried forward. Meta-regression was conducted in STATA v12. Thirty studies met the inclusion criteria, twenty-nine of which had usable data, representing 5,963 participants allocated to control arms. Control arms were categorized according to intensity, as offering leaflets only, a single session of advice, or more than one session of advice from someone without specialist skills in supporting weight loss. Mean weight change at 12 months across all categories was -0.8 kg (95% CI -1.1 to -0.4). In an unadjusted model, increasing intensity by moving up a category was associated with an additional weight loss of -0.53 kg (95% CI -0.96 to -0.09). Also in an unadjusted model, each additional weigh-in was associated with a weight change of -0.42 kg (95% CI -0.81 to -0.03). However, when both variables were placed in the same model, neither intervention category nor number of weigh-ins was associated with weight change. Uncontrolled evaluations of weight loss programs should assume that, in the absence of intervention, their population would weigh up to a kilogram on average less than baseline at the end of the first year of follow-up. © 2016 The Authors Obesity published by Wiley Periodicals, Inc. on behalf of The Obesity Society (TOS).

  15. Weight change among people randomized to minimal intervention control groups in weight loss trials

    PubMed Central

    Johns, David J.; Hartmann‐Boyce, Jamie; Jebb, Susan A.; Aveyard, Paul

    2016-01-01

    Objective Evidence on the effectiveness of behavioral weight management programs often comes from uncontrolled program evaluations. These frequently make the assumption that, without intervention, people will gain weight. The aim of this study was to use data from minimal intervention control groups in randomized controlled trials to examine the evidence for this assumption and the effect of frequency of weighing on weight change. Methods Data were extracted from minimal intervention control arms in a systematic review of multicomponent behavioral weight management programs. Two reviewers classified control arms into three categories based on intensity of minimal intervention and calculated 12‐month mean weight change using baseline observation carried forward. Meta‐regression was conducted in STATA v12. Results Thirty studies met the inclusion criteria, twenty‐nine of which had usable data, representing 5,963 participants allocated to control arms. Control arms were categorized according to intensity, as offering leaflets only, a single session of advice, or more than one session of advice from someone without specialist skills in supporting weight loss. Mean weight change at 12 months across all categories was −0.8 kg (95% CI −1.1 to −0.4). In an unadjusted model, increasing intensity by moving up a category was associated with an additional weight loss of −0.53 kg (95% CI −0.96 to −0.09). Also in an unadjusted model, each additional weigh‐in was associated with a weight change of −0.42 kg (95% CI −0.81 to −0.03). However, when both variables were placed in the same model, neither intervention category nor number of weigh‐ins was associated with weight change. Conclusions Uncontrolled evaluations of weight loss programs should assume that, in the absence of intervention, their population would weigh up to a kilogram on average less than baseline at the end of the first year of follow‐up. PMID:27028279

  16. Rehabilitative online education versus internet discussion group for hearing aid users: a randomized controlled trial.

    PubMed

    Thorén, Elisabet; Svensson, Monica; Törnqvist, Anna; Andersson, Gerhard; Carlbring, Per; Lunner, Thomas

    2011-05-01

    By using the Internet in the audiological rehabilitation process, it might be possible in a cost-effective way to include additional rehabilitation components by informing and guiding hearing aid users about such topics as communication strategies, hearing tactics, and how to handle hearing aids. To evaluate the effectiveness of an online education program for adult experienced hearing aid users including professional guidance by an audiologist and compare it with the effects of participation in an online discussion forum without any professional contact. A randomized controlled study with two groups of participants. Repeated measures at prestudy, immediate follow-up, and a 6 mo follow-up. Fifty-nine experienced hearing aid users participated in the study, ranging in age from 24 to 84 yr (mean 63.5 yr). The intervention group (N = 29) underwent a five-week rehabilitative online education in which activities for each week included information, tasks, and assignments, and contact with a professional audiologist was included. The participants in the control group (N = 30) were referred to an online discussion forum without any audiologist contact. A set of questionnaires administered online were used as outcome measures: (1) Hearing Handicap Inventory for the Elderly, (2) International Outcome Inventory for Hearing Aids, (3) Satisfaction with Amplification in Daily Life, and (4) Hospital Anxiety and Depression Scale. Significant improvements measured by the Hearing Handicap Inventory for the Elderly were found in both groups of participants, and the effects were maintained at the 6 mo follow-up. The results on the Hospital Anxiety and Depression Scale showed that the participants in the intervention group showed reduced symptoms of depression immediately/6 mo after the intervention. At the 6 mo follow-up participants in the control group reported fewer symptoms of anxiety than they did before the intervention started. This study provides preliminary evidence that the

  17. Randomized controlled pilot trial of a novel dissonance-based group treatment for eating disorders.

    PubMed

    Stice, Eric; Rohde, Paul; Butryn, Meghan; Menke, Katharine S; Marti, C Nathan

    2015-02-01

    The authors conducted a pilot trial of a new dissonance-based group eating disorder treatment designed to be a cost-effective front-line transdiagnostic treatment that could be more widely disseminated than extant individual or family treatments that are more expensive and difficult to deliver. Young women with a DSM-5 eating disorder (N = 72) were randomized to an 8-week dissonance-based Counter Attitudinal Therapy group treatment or a usual care control condition, completing diagnostic interviews and questionnaires at pre, post, and 2-month follow-up. Intent-to-treat analyses revealed that intervention participants showed greater reductions in outcomes than usual care controls in a multivariate multilevel model (χ(2)[6] = 34.1, p < .001), producing large effects for thin-ideal internalization (d = .79), body dissatisfaction (d = 1.14), and blinded interview-assessed eating disorder symptoms (d = .95), and medium effects for dissonance regarding perpetuating the thin ideal (d = .65) and negative affect (d = .55). Midway through this pilot we refined engagement procedures, which was associated with increased effect sizes (e.g., the d for eating disorder symptoms increased from .51 to 2.30). This new group treatment produced large reductions in eating disorder symptoms, which is encouraging because it requires about 1/20th the therapist time necessary for extant individual and family treatments, and has the potential to provide a cost-effective and efficacious approach to reaching the majority of individuals with eating disorders who do not presently received treatment. Copyright © 2014 Elsevier Ltd. All rights reserved.

  18. Randomized Controlled Pilot Trial of a Novel Dissonance-Based Group Treatment for Eating Disorders

    PubMed Central

    Stice, Eric; Rohde, Paul; Butryn, Meghan; Menke, Katharine S.; Marti, C. Nathan

    2015-01-01

    Objective Conduct a pilot trial of a new dissonance-based group eating disorder treatment designed to be a cost-effective front-line transdiagnostic treatment that could be more widely disseminated than extant individual or family treatments that are more expensive and difficult to deliver. Method Young women with a DSM-5 eating disorder (N = 72) were randomized to an 8-week dissonance-based Body Acceptance Therapy group treatment or a usual care control condition, completing diagnostic interviews and questionnaires at pre, post, and 2-month follow-up. Results Intent-to-treat analyses revealed that intervention participants showed greater reductions in outcomes than usual care controls in a multivariate multilevel model (χ2[6] = 34.1, p < .001), producing large effects for thin-ideal internalization (d = 0.79), body dissatisfaction (d = 1.14), and blinded interview-assessed eating disorder symptoms (d = .95), and medium effects for dissonance regarding perpetuating the thin ideal (d = .65) and negative affect (d = .55). Midway through this pilot we refined engagement procedures, which was associated with increased effect sizes (e.g., the d for eating disorder symptoms increased from .51 to 2.30). Conclusions This new group treatment produced large reductions in eating disorder symptoms, which is encouraging because it requires about 1/20th the therapist time necessary for extant individual and family treatments, and has the potential to provide a cost-effective and efficacious approach to reaching the majority of individuals with eating disorders who do not presently received treatment. PMID:25577189

  19. A randomized controlled trial of a brief versus standard group parenting program for toddler aggression.

    PubMed

    Tully, Lucy A; Hunt, Caroline

    2017-05-01

    Physical aggression (PA) in the toddler years is common and developmentally normal, however, longitudinal research shows that frequent PA is highly stable and associated with long-term negative outcomes. Significant research has demonstrated the efficacy of parenting interventions for reducing externalizing behavior in children yet their typical length may overburden families, leading to low participation rates and high attrition rates. To increase the reach of parenting interventions and impact on the prevalence of externalizing behavior problems, brief interventions are needed. This RCT compared a standard (8 session) group Triple P to a brief (3 session) discussion group and a waitlist control for reducing toddler PA, dysfunctional parenting and related aspects of parent functioning. Sixty-nine self-referred families of toddlers with PA were randomized to the respective conditions. At post-assessment, families in the standard intervention had significantly lower levels of observed child aversive behavior, mother reports of PA and dysfunctional parenting, and higher levels of mother- and partner-rated behavioral self-efficacy than the waitlist control. Families in the standard intervention also had significantly lower levels mother-rated dysfunctional parenting than the brief intervention, and the brief intervention had significantly lower levels of mother-rated dysfunctional parenting than waitlist. There were no significant group differences at post-assessment for measures of parental negative affect or satisfaction with the partner relationship. By 6 month follow-up, families in the brief and standard intervention did not differ significantly on any measure. The implications of the findings to delivery of brief parenting interventions are discussed. Aggr. Behav. 43:291-303, 2017. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  20. Comparison of forgiveness and anger-reduction group treatments: a randomized controlled trial.

    PubMed

    Goldman, Daniel B; Wade, Nathaniel G

    2012-01-01

    Interventions to promote forgiveness are effective. However, in what ways and in comparison to what other treatments is still unresolved. College students (n=112) who had been hurt in the past and struggled to overcome their negative experiences of it participated in this study. They were randomly assigned to one of two treatments, one focused on promoting forgiveness and one focused on reducing anger for past hurts, or a waiting list control. Treatment consisted of six 90-minute sessions held in small groups led by one facilitator over the course of 3 weeks. Results of three-level (time within participants within groups) hierarchical linear modeling indicated that the forgiveness treatment (n=41) resulted in greater reductions in hostility and psychological symptoms and more empathy for the offender than the alternative treatment (n=39) and the waitlist (n=32). Participants in both treatment conditions reported greater reductions in desires for revenge than those in the waitlist condition. All participants reported a significant reduction in rumination about the offense. Clinical significance testing mirrored these results. These findings support forgiveness-promoting treatments as effective for reducing psychological symptoms and achieving forgiveness, and suggest that they may be more effective than other types of treatments.

  1. Comparison between the effects of muscle relaxation and support groups on the anxiety of nursing students: A randomized controlled trial.

    PubMed

    Torabizadeh, Camellia; Bostani, Sanaz; Yektatalab, Shahrzad

    2016-11-01

    To compare the effects of the two methods of muscle relaxation and support group on the anxiety levels of the nursing students. In this randomized controlled trial, 150 nursing students who met the inclusion criteria were divided into three equal groups-muscle relaxation, support group, and control-using the permuted-block randomization method. The experimental groups received 5 sessions of intervention, while the control group did not receive any intervention at all. Using Spielberger's inventory, the researchers measured the anxiety levels of all three groups before and after the intervention. The results showed that both methods had a significant impact on anxiety levels of the nursing students; however, a comparison between their effects revealed that muscle relaxation had been more effective than support group. Considering the seriousness of the issue of anxiety for nursing students, it is important that measures be taken to reduce anxiety in this group. Copyright © 2016 Elsevier Ltd. All rights reserved.

  2. Does Family Group Decision Making Affect Child Welfare Outcomes? Findings from a Randomized Control Study

    ERIC Educational Resources Information Center

    Berzin, Stephanie Cosner; Cohen, Ed; Thomas, Karen; Dawson, William C.

    2008-01-01

    This article describes the evaluation of two family group decision-making programs administered under the California Title IV-E Waiver Demonstration Project. This is the only evaluation using random assignment to examine FGDM. Overall, results did not indicate more positive outcomes for children receiving the intervention, but did indicate that…

  3. Restricted random labeling: testing for between-group interaction after controlling for joint population and within-group spatial structure

    NASA Astrophysics Data System (ADS)

    Kronenfeld, Barry J.; Leslie, Timothy F.

    2015-01-01

    Statistical measures of spatial interaction between multiple types of entities are commonly assessed against a null model of either toroidal shift (TS), which controls for spatial structure of individual subpopulations, or random labeling (RL), which controls for spatial structure of the joint population. Neither null model controls for both types of spatial structure simultaneously, although this may sometimes be desirable when more than two subpopulations are present. To address this, we propose a flexible framework for specifying null models that we refer to as restricted random labeling (rRL). Under rRL, a specified subset of individuals is restricted and other individuals are randomly relabeled. Within this framework, two specific null models are proposed for pairwise analysis within populations consisting of three or more subpopulations, to simultaneously control for spatial structure in the joint population and one or the other of the two subpopulations being analyzed. Formulas are presented for calculating expected nearest neighbor counts and co-location quotients within the proposed framework. Differences between TS, RL and rRL are illustrated by application to six types of generating processes in a simulation study, and to empirical datasets of tree species in a forest and crime locations in an urban setting. These examples show that rRL null models are typically stricter than either TS or RL, which often detect "interactions" that are an expected consequence either of the joint population pattern or of individual subpopulation patterns.

  4. Acceptance and Commitment Therapy and Cognitive-Behavioral Therapy as Treatments for Academic Procrastination: A Randomized Controlled Group Session

    ERIC Educational Resources Information Center

    Wang, Shuo; Zhou, Ya; Yu, Shi; Ran, Li-Wen; Liu, Xiang-Ping; Chen, Yu-Fei

    2017-01-01

    Objective: This study tested the efficacy of Acceptance and Commitment Therapy (ACT), compared with Cognitive-Behavioral Therapy (CBT), in alleviating academic procrastination. Method: A total of 60 (53.3% male) undergraduates suffering from academic procrastination were randomly assigned to two treatment groups (ACT and CBT) and a control group.…

  5. Acceptance and Commitment Therapy and Cognitive-Behavioral Therapy as Treatments for Academic Procrastination: A Randomized Controlled Group Session

    ERIC Educational Resources Information Center

    Wang, Shuo; Zhou, Ya; Yu, Shi; Ran, Li-Wen; Liu, Xiang-Ping; Chen, Yu-Fei

    2017-01-01

    Objective: This study tested the efficacy of Acceptance and Commitment Therapy (ACT), compared with Cognitive-Behavioral Therapy (CBT), in alleviating academic procrastination. Method: A total of 60 (53.3% male) undergraduates suffering from academic procrastination were randomly assigned to two treatment groups (ACT and CBT) and a control group.…

  6. Management of adolescents with very poorly controlled type 1 diabetes by nurses: a parallel group randomized controlled trial.

    PubMed

    Kassai, Behrouz; Rabilloud, Muriel; Bernoux, Delphine; Michal, Catherine; Riche, Benjamin; Ginhoux, Tiphanie; Laudy, Valérie; Terral, Daniel; Didier-Wright, Catherine; Maire, Veronique; Dumont, Catherine; Cottancin, Gilles; Plasse, Muriel; Jeannoel, Guy-Patrick; Khoury, Jamil; Bony, Claire; Lièvre, Michel; Drai, Jocelyne; Nicolino, Marc

    2015-09-08

    Fluctuation in glycemia due to hormonal changes, growth periods, physical activity, and emotions make diabetes management difficult during adolescence. Our objective was to show that a close control of patients' self-management of diabetes by nurse-counseling could probably improve metabolic control in adolescents with type 1 diabetes. We designed a multicenter, randomized controlled, parallel group, clinical trial. Seventy seven adolescents aged 12-17 years with A1C >8% were assigned to either an intervention group (pediatrician visit every 3 months + nurse visit and phone calls) or to the control group (pediatrician visit every 3 months). The primary outcome was the evolution of the rate of A1C during the 12 months of follow-up. Secondary outcomes include patient's acceptance of the disease (evaluated by visual analog scale), the number of hypoglycemic or ketoacidosis episodes requiring hospitalization, and evaluation of A1C rate over time in each group. Seventy-seven patients were enrolled by 10 clinical centers. Seventy (89.6%) completed the study, the evolution of A1C and participants satisfaction over the follow-up period was not significantly influenced by the nurse intervention. Nurse-led intervention to improve A1C did not show a significant benefit in adolescents with type 1 diabetes because of lack of power. Only psychological management and continuous glucose monitoring have shown, so far, a slight but significant benefit on A1C. We did not show improvements in A1C control in teenagers by nurse-led intervention. Clinical Trials.gov registration number: NCT00308256, 28 March 2006.

  7. Community-based group exercise for persons with Parkinson disease: a randomized controlled trial.

    PubMed

    Combs, Stephanie A; Diehl, M Dyer; Chrzastowski, Casey; Didrick, Nora; McCoin, Brittany; Mox, Nicholas; Staples, William H; Wayman, Jessica

    2013-01-01

    The purpose of this study was to compare group boxing training to traditional group exercise on function and quality of life in persons with Parkinson disease (PD). A convenience sample of adults with PD (n = 31) were randomly assigned to boxing training or traditional exercise for 24-36 sessions, each lasting 90 minutes, over 12 weeks. Boxing training included: stretching, boxing (e.g. lateral foot work, punching bags), resistance exercises, and aerobic training. Traditional exercise included: stretching, resistance exercises, aerobic training, and balance activities. Participants were tested before and after completion of training on balance, balance confidence, mobility, gait velocity, gait endurance, and quality of life. The traditional exercise group demonstrated significantly greater gains in balance confidence than the boxing group (p < 0.025). Only the boxing group demonstrated significant improvements in gait velocity and endurance over time with a medium between-group effect size for the gait endurance (d = 0.65). Both groups demonstrated significant improvements with the balance, mobility, and quality of life with large within-group effect sizes (d ≥ 0.80). While groups significantly differed in balance confidence after training, both groups demonstrated improvements in most outcome measures. Supporting options for long-term community-based group exercise for persons with PD will be an important future consideration for rehabilitation professionals.

  8. Group therapy for university students: A randomized control trial of dialectical behavior therapy and positive psychotherapy.

    PubMed

    Uliaszek, Amanda A; Rashid, Tayyab; Williams, Gregory E; Gulamani, Tahira

    2016-02-01

    The present study examined the efficacy of two evidence-based group treatments for significant psychopathology in university students. Fifty-four treatment-seeking participants were randomized to a semester-long dialectical behavior therapy (DBT) or positive psychotherapy (PPT) group treatment. Mixed modeling was used to assess improvement over time and group differences on variables related to symptomatology, adapative/maladaptive skill usage, and well-being/acceptability factors. All symptom and skill variables improved over the course of treatment. There were no statistically significant differences in rate of change between groups. The DBT group evidenced nearly all medium to large effect sizes for all measures from pre-to post-treatment, with mostly small to medium effect sizes for the PPT group. There was a significant difference in acceptability between treatments, with the DBT group demonstrating significantly lower attrition rates, higher attendance, and higher overall therapeutic alliance. While both groups demonstrated efficacy in this population, the DBT group appeared to be a more acceptable and efficacious treatment for implementation. Results may specifically apply to group therapy as an adjunctive treatment because a majority of participants had concurrent individual therapy. Copyright © 2015 Elsevier Ltd. All rights reserved.

  9. Group cognitive remediation therapy for chronic schizophrenia: A randomized controlled trial.

    PubMed

    Tan, Shuping; Zou, Yizhuang; Wykes, Til; Reeder, Clare; Zhu, Xiaolin; Yang, Fude; Zhao, Yanli; Tan, Yunlong; Fan, Fengmei; Zhou, Dongfeng

    2016-07-28

    Individual-level cognitive remediation therapy (CRT) has been shown to be effective for cognitive improvement and social function amelioration. Here, we aimed to test the efficacy of group-based CRT in Chinese subjects with schizophrenia. One-hundred and four inpatients were randomly assigned to either 40 sessions of small-group CRT therapy or therapeutic contact-matched Musical and Dancing Therapy (MDT). Cognitive and social functioning, as well as clinical symptoms, were evaluated over the course of treatment. Specifically, cognitive function was evaluated using a battery of cognitive measurements, clinical symptoms were evaluated using the Positive and Negative Syndrome Scale, and social function was evaluated using the Nurse's Observation Scale for Inpatient Evaluation-30. All patients were evaluated pre- and post-treatment. Forty-four individuals in the CRT group and 46 in the MDT group completed all of the planned treatments and analyses. Cognitive functions, especially cognitive flexibility and memory, showed significant improvement in the CRT group over the course of the study. The MDT group also showed improvement in several cognitive flexibility assessments, but the degree of improvement was significantly greater in the CRT group. Several social-function factors exhibited a significant improvement in the CRT group, but not in the MDT group. Cognitive function improvement correlated positively with social function without predicting social function change. We conclude that group-based CRT is an effective and promising therapy. Copyright © 2016. Published by Elsevier Ireland Ltd.

  10. Pediatric emergency medicine asynchronous e-learning: a multicenter randomized controlled Solomon four-group study.

    PubMed

    Chang, Todd P; Pham, Phung K; Sobolewski, Brad; Doughty, Cara B; Jamal, Nazreen; Kwan, Karen Y; Little, Kim; Brenkert, Timothy E; Mathison, David J

    2014-08-01

    Asynchronous e-learning allows for targeted teaching, particularly advantageous when bedside and didactic education is insufficient. An asynchronous e-learning curriculum has not been studied across multiple centers in the context of a clinical rotation. We hypothesize that an asynchronous e-learning curriculum during the pediatric emergency medicine (EM) rotation improves medical knowledge among residents and students across multiple participating centers. Trainees on pediatric EM rotations at four large pediatric centers from 2012 to 2013 were randomized in a Solomon four-group design. The experimental arms received an asynchronous e-learning curriculum consisting of nine Web-based, interactive, peer-reviewed Flash/HTML5 modules. Postrotation testing and in-training examination (ITE) scores quantified improvements in knowledge. A 2 × 2 analysis of covariance (ANCOVA) tested interaction and main effects, and Pearson's correlation tested associations between module usage, scores, and ITE scores. A total of 256 of 458 participants completed all study elements; 104 had access to asynchronous e-learning modules, and 152 were controls who used the current education standards. No pretest sensitization was found (p = 0.75). Use of asynchronous e-learning modules was associated with an improvement in posttest scores (p < 0.001), from a mean score of 18.45 (95% confidence interval [CI] = 17.92 to 18.98) to 21.30 (95% CI = 20.69 to 21.91), a large effect (partial η(2) = 0.19). Posttest scores correlated with ITE scores (r(2) = 0.14, p < 0.001) among pediatric residents. Asynchronous e-learning is an effective educational tool to improve knowledge in a clinical rotation. Web-based asynchronous e-learning is a promising modality to standardize education among multiple institutions with common curricula, particularly in clinical rotations where scheduling difficulties, seasonality, and variable experiences limit in-hospital learning. © 2014 by the Society for Academic

  11. A group randomized controlled trial integrating obesity prevention and control for postpartum adolescents in a home visiting program.

    PubMed

    Haire-Joshu, Debra L; Schwarz, Cynthia D; Peskoe, Sarah B; Budd, Elizabeth L; Brownson, Ross C; Joshu, Corinne E

    2015-06-26

    Adolescence represents a critical period for the development of overweight that tracks into adulthood. This risk is significantly heightened for adolescents that become pregnant, many of whom experience postpartum weight retention. The aim of this study was to evaluate Balance Adolescent Lifestyle Activities and Nutrition Choices for Energy (BALANCE), a multicomponent obesity prevention intervention targeting postpartum adolescents participating in a national home visiting child development-parent education program. A group randomized, nested cohort design was used with 1325 adolescents, 694 intervention and 490 control, (mean age = 17.8 years, 52 % underrepresented minorities) located across 30 states. Participatory methods were used to integrate lifestyle behavior change strategies within standard parent education practice. Content targeted replacement of high-risk obesogenic patterns (e.g. sweetened drink and high fat snack consumption, sedentary activity) with positive behaviors (e.g. water intake, fruit and vegetables, increased walking). Parent educators delivered BALANCE through home visits, school based classroom-group meetings, and website activities. Control adolescents received standard child development information. Phase I included baseline to posttest (12 months); Phase II included baseline to follow-up (24 months). When compared to the control group, BALANCE adolescents who were ≥12 weeks postpartum were 89 % more likely (p = 0.02) to maintain a normal BMI or improve an overweight/obese BMI by 12 months; this change was not sustained at 24 months. When compared to the control group, BALANCE adolescents significantly improved fruit and vegetable intake (p = .03). In stratified analyses, water intake improved among younger BALANCE teens (p = .001) and overweight/obese BALANCE teens (p = .05) when compared to control counterparts. There were no significant differences between groups in sweetened drink and snack consumption

  12. Improving Quality of Life in Men With Prostate Cancer: A Randomized Controlled Trial of Group Education Interventions

    PubMed Central

    Lepore, Stephen J.; Helgeson, Vicki S.; Eton, David T.; Schulz, Richard

    2008-01-01

    Men who were recently treated for prostate cancer (N = 250) were randomly assigned to a control group, a group education intervention (GE), or a group education-plus-discussion intervention (GED). Both GE and GED increased prostate cancer knowledge. In the year postintervention, men in the GED condition were less bothered by sexual problems than men in the control condition, and they were more likely to remain steadily employed (93.0%) than men in the GE (75.6%) or control (72.5%) conditions. Among noncollege graduates, GED and GE resulted in better physical functioning than the control condition, and GED resulted in more positive health behaviors than the control or GE condition. Among college graduates, controls were comparable with the GE and GED groups in physical functioning and positive health behaviors. PMID:14570527

  13. Group cognitive behavioural treatment for insomnia in primary care: a randomized controlled trial.

    PubMed

    Cape, J; Leibowitz, J; Whittington, C; Espie, C A; Pilling, S

    2016-04-01

    Insomnia disorder is common and often co-morbid with mental health conditions. Cognitive behavioural therapy (CBT) for insomnia is effective, but is rarely implemented as a discrete treatment. The aim of this study was to evaluate the effectiveness of brief CBT groups for insomnia compared to treatment as usual (TAU) for insomnia delivered by mental health practitioners in a primary-care mental health service. A total of 239 participants were randomized to either a five-session CBT group or to TAU. Assessments of sleep and of symptoms of depression and anxiety were carried out at baseline, post-treatment and at 20 weeks. Primary outcome was sleep efficiency post-treatment. Group CBT participants had better sleep outcomes post-treatment than those receiving TAU [sleep efficiency standardized mean difference 0.63, 95% confidence interval (CI) 0.34-0.92]. The effect at 20 weeks was smaller with a wide confidence interval (0.27, 95% CI -0.03 to 0.56). There were no important differences between groups at either follow-up period in symptoms of anxiety or depression. Dedicated CBT group treatment for insomnia improves sleep more than treating sleep as an adjunct to other mental health treatment.

  14. Disappointment and adherence among parents of newborns allocated to the control group: a qualitative study of a randomized clinical trial

    PubMed Central

    2014-01-01

    Background When a child participates in a clinical trial, informed consent has to be given by the parents. Parental motives for participation are complex, but the hope of getting a new and better treatment for the child is important. We wondered how parents react when their child is allocated to the control group of a randomized controlled trial, and how it will affect their future engagement in the trial. Methods We included parents of newborns randomized to the control arm in the Danish Calmette study at Rigshospitalet in Copenhagen. The Calmette study is a randomized clinical trial investigating the non-specific effects of early BCG-vaccine to healthy neonates. Randomization is performed immediately after birth and parents are not blinded to the allocation. We set up a semi-structured focus group with six parents from four families. Afterwards we telephone-interviewed another 19 mothers to achieve saturation. Thematic analysis was used to identify themes across the data sets. Results The parents reported good understanding of the randomization process. Their most common reaction to allocation was disappointment, though relief was also seen. A model of reactions to being allocated to the control group was developed based on the participants’ different positions along two continuities from ‘Our participation in trial is not important’ to ‘Our participation in trial is important’, and ‘Vaccine not important to us’ to ‘Vaccine important to us’. Four very disappointed families had thought of getting the vaccine elsewhere, and one had actually had their child vaccinated. All parents involved in the focus group and the telephone interviews wanted to participate in the follow-ups planned for the Calmette study. Conclusions This study identified an almost universal experience of disappointment among parents of newborns who were randomized to the control group, but also a broad expression of understanding and accepting the idea of randomization. The

  15. The impact of group music therapy on depression and cognition in elderly persons with dementia: a randomized controlled study.

    PubMed

    Chu, Hsin; Yang, Chyn-Yng; Lin, Yu; Ou, Keng-Liang; Lee, Tso-Ying; O'Brien, Anthony Paul; Chou, Kuei-Ru

    2014-04-01

    The aims of this study were to determine the effectiveness of group music therapy for improving depression and delaying the deterioration of cognitive functions in elderly persons with dementia. The study had a prospective, parallel-group design with permuted-block randomization. Older persons with dementia (N = 104) were randomly assigned to the experimental or control group. The experimental group received 12 sessions of group music therapy (two 30-min sessions per week for 6 weeks), and the control group received usual care. Data were collected 4 times: (1) 1 week before the intervention, (2) the 6th session of the intervention, (3) the 12th session of the intervention, and (4) 1 month after the final session. Group music therapy reduced depression in persons with dementia. Improvements in depression occurred immediately after music therapy and were apparent throughout the course of therapy. The cortisol level did not significantly decrease after the group music therapy. Cognitive function significantly improved slightly at the 6th session, the 12th session, and 1 month after the sessions ended; in particular, short-term recall function improved. The group music therapy intervention had the greatest impact in subjects with mild and moderate dementia. The group music intervention is a noninvasive and inexpensive therapy that appeared to reduce elders' depression. It also delayed the deterioration of cognitive functions, particularly short-term recall function. Group music therapy may be an appropriate intervention among elderly persons with mild and moderate dementia.

  16. A randomized clinical trial comparing general exercise, McKenzie treatment and a control group in patients with neck pain.

    PubMed

    Kjellman, Görel; Oberg, Birgitta

    2002-07-01

    Seventy-seven patients with neck pain in the primary health care were included in a prospective, randomized clinical trial and randomly assigned to general exercise, McKenzie treatment, or a control group. Seventy patients completed the treatment; response rate 93% at 12-month follow-up. All three groups showed significant improvement regarding the main outcomes, pain intensity and Neck Disability Index, even at 12-month follow-up, but there was no significant difference between the groups. In all, 79% reported that they were better or completely restored after treatment, although 51% reported constant/daily pain. In the McKenzie group compared with the control group, a tendency toward greater improvement was noted for pain intensity at 3 weeks and at 6-month follow-up, and for post-treatment Neck Disability Index. Significant improvement in Distress and Risk Assessment Method scores was shown in the McKenzie group only. The three groups had similar recurrence rates, although after 12 months the McKenzie group showed a tendency toward fewer visits for additional health care. The study did not provide a definite evidence of treatment efficacy in patients with neck pain, however, there was a tendency toward a better outcome with the two active alternatives compared with the control group.

  17. Effectiveness of a group diabetes education programme in underserved communities in South Africa: pragmatic cluster randomized control trial.

    PubMed

    Mash, Bob; Levitt, Naomi; Steyn, Krisela; Zwarenstein, Merrick; Rollnick, Stephen

    2012-12-24

    Diabetes is an important contributor to the burden of disease in South Africa and prevalence rates as high as 33% have been recorded in Cape Town. Previous studies show that quality of care and health outcomes are poor. The development of an effective education programme should impact on self-care, lifestyle change and adherence to medication; and lead to better control of diabetes, fewer complications and better quality of life. Pragmatic cluster randomized controlled trialParticipants: Type 2 diabetic patients attending 45 public sector community health centres in Cape TownInterventions: The intervention group will receive 4 sessions of group diabetes education delivered by a health promotion officer in a guiding style. The control group will receive usual care which consists of ad hoc advice during consultations and occasional educational talks in the waiting room. To evaluate the effectiveness of the group diabetes education programmeOutcomes: diabetes self-care activities, 5% weight loss, 1% reduction in HbA1c. self-efficacy, locus of control, mean blood pressure, mean weight loss, mean waist circumference, mean HbA1c, mean total cholesterol, quality of lifeRandomisation: Computer generated random numbersBlinding: Patients, health promoters and research assistants could not be blinded to the health centre's allocationNumbers randomized: Seventeen health centres (34 in total) will be randomly assigned to either control or intervention groups. A sample size of 1360 patients in 34 clusters of 40 patients will give a power of 80% to detect the primary outcomes with 5% precision. Altogether 720 patients were recruited in the intervention arm and 850 in the control arm giving a total of 1570. The study will inform policy makers and managers of the district health system, particularly in low to middle income countries, if this programme can be implemented more widely. Pan African Clinical Trial Registry PACTR201205000380384.

  18. Acceptance and commitment group therapy (ACT-G) for health anxiety: a randomized controlled trial.

    PubMed

    Eilenberg, T; Fink, P; Jensen, J S; Rief, W; Frostholm, L

    2016-01-01

    Severe health anxiety is frequent and costly, yet rarely diagnosed or treated. Earlier treatment studies show problems with recruitment, dropout and recovery. In the current study, the authors aimed to test the effect of acceptance and commitment group therapy (ACT-G) compared to waitlist in patients with severe health anxiety. During March 2010 to April 2012, 126 consecutively referred patients meeting research criteria for severe health anxiety were block-randomized (1:1) to ACT-G or a 10 months' waitlist (Clinicaltrials.gov, no. NCT01158430). Patients allocated to ACT-G were treated in seven groups of nine patients between December 2010 and October 2012 and received nine weekly 3-h group sessions and a booster session consisting of ACT techniques. The primary outcome was decided a priori as the mean change in self-reported illness worry on the Whiteley-7 Index (WI) from baseline to 10 months' follow-up. Secondary outcomes were improvement in emotional distress and health-related quality of life at 10 months' follow-up. Intention-to-treat analysis showed a statistically significant mean difference of 20.5 points [95% confidence interval (CI) 11.7-29.4, p < 0.001] on the WI between the groups at 10 months, and the between-group effect sizes were large (Cohen's d = 0.89, 95% CI 0.50-1.29). The number needed to treat was 2.4 (95% CI 1.4-3.4, p < 0.001). Diagnosis and treatment were well accepted by the patients. ACT-G seems feasible, acceptable and effective in treating severe health anxiety.

  19. Efficacy of Meaning-Centered Group Psychotherapy for Cancer Survivors: a Randomized Controlled Trial

    PubMed Central

    van der Spek, Nadia; Vos, Joël; van Uden-Kraan, Cornelia F.; Breitbart, William; Cuijpers, Pim; Holtmaat, Karen; Witte, Birgit I.; Tollenaar, Rob A. E. M.; Verdonck-de Leeuw, Irma M.

    2017-01-01

    Background The aim of this study was to assess the efficacy of meaning-centered group psychotherapy for cancer survivors (MCGP-CS) to improve personal meaning, compared to supportive group psychotherapy (SGP) and care as usual (CAU). Methods A total of 170 cancer survivors were randomly assigned to one of the three study arms: MCGP-CS (n = 57), SGP (n = 56), CAU (n = 57). Primary outcome measure was Personal Meaning Profile (total score PMP). Secondary outcome measures were subscales of the PMP, psychological well-being (SPWB), posttraumatic growth (PTGI), mental adjustment to cancer (MAC), optimism (LOT-R), hopelessness (BHS), psychological distress (anxiety and depression, HADS), and quality of life (EORTC QLQ-C30). Outcome measures were assessed before randomization, post-intervention, after three and six months follow-up (FU). Results Linear mixed model analyses (intention-to-treat) showed significant differences between MCGP-CS, SGP and CAU on the total PMP score, and on (sub)scales of the PMP, SPWB, MAC, and HADS. Post-hoc analyses showed significantly stronger treatment effects of MCGP-CS compared to CAU on personal meaning (d=0.81), goal-orientedness (d=1.07), positive relations (d=0.59), purpose in life (d=0.69); fighting spirit (d=0.61) (post-intervention), helpless/hopeless (d=−0.87) (3 months FU); distress (d=−0.6) and depression (d=−0.38) (6 months FU). Significantly stronger effects of MCGP-CS compared to SGP were found on personal growth (d=0.57) (3 months FU), and environmental mastery (d=0.66) (6 months FU). Conclusions MCGP-CS is an effective intervention for cancer survivors to improve personal meaning, psychological well-being and mental adjustment to cancer in the short term, and to reduce psychological distress in the long run. PMID:28374663

  20. Impact of a randomized control group on perceived effectiveness of a Disease Management Programme for diabetes type 2.

    PubMed

    Flamm, Maria; Panisch, Sigrid; Winkler, Henrike; Sönnichsen, Andreas C

    2012-10-01

    Disease Management Programmes (DMPs) are proposed to enhance the quality of care, to improve health outcomes and to reduce costs. Yet, the evidence regarding the effectiveness of such structured approaches remains uncertain. Randomized controlled trials (RCTs) represent the gold standard of evaluation for complex interventions. However, most of the evidence derives from non-randomized or even uncontrolled trials. We therefore tried to assess the impact of a randomized control group on the interpretation of DMP effectiveness. We analyzed the data of a RCT on a DMP for diabetes type 2 by creating two scenarios. The first solely includes data of the intervention group (n=649), representing an 'uncontrolled pre-test-post-test analysis'. The second comprehends all data (n=1489) of the 'randomized controlled analysis'. HbA1c was used as the primary outcome measure for metabolic control in diabetes. Depending on either scenario, we calculated relative and absolute risk reduction regarding clinically relevant endpoints and estimated costs by extrapolating our results according to the UK Prospective Diabetes Study (UKPDS) findings. The HbA1c reduction attributed to the DMP was 0.41% (uncontrolled analysis) vs. 0.13% (controlled comparison). Estimations of relative risk reduction for cardiovascular disease were 4.6% vs. 1.4%. The estimated numbers needed to treat (NNT) to avoid one myocardial infarction within 10 years differed from 125 (uncontrolled analysis) to 417 patients (controlled comparison), which led to a substantial scenario-dependent difference in cost estimations. Uncontrolled pre-test-post-test evaluation might lead to crucial overestimation of DMP effectiveness. We therefore recommend randomized controlled evaluations prior to long-term implementation.

  1. Meaning-centered group psychotherapy for patients with advanced cancer: a pilot randomized controlled trial

    PubMed Central

    Breitbart, William; Rosenfeld, Barry; Gibson, Christopher; Pessin, Hayley; Poppito, Shannon; Nelson, Christian; Tomarken, Alexis; Timm, Anne Kosinski; Berg, Amy; Jacobson, Colleen; Sorger, Brooke; Abbey, Jennifer; Olden, Megan

    2013-01-01

    Objectives An increasingly important concern for clinicians who care for patients at the end of life is their spiritual well-being and sense of meaning and purpose in life. In response to the need for short-term interventions to address spiritual well-being, we developed Meaning Centered Group Psychotherapy (MCGP) to help patients with advanced cancer sustain or enhance a sense of meaning, peace and purpose in their lives, even as they approach the end of life. Methods Patients with advanced (stage III or IV) solid tumor cancers (N = 90) were randomly assigned to either MCGP or a supportive group psychotherapy (SGP). Patients were assessed before and after completing the 8-week intervention, and again 2 months after completion. Outcome assessment included measures of spiritual well-being, meaning, hopelessness, desire for death, optimism/pessimism, anxiety, depression and overall quality of life. Results MCGP resulted in significantly greater improvements in spiritual well-being and a sense of meaning. Treatment gains were even more substantial (based on effect size estimates) at the second follow-up assessment. Improvements in anxiety and desire for death were also significant (and increased over time). There was no significant improvement on any of these variables for patients participating in SGP. Conclusions MCGP appears to be a potentially beneficial intervention for patients’ emotional and spiritual suffering at the end of life. Further research, with larger samples, is clearly needed to better understand the potential benefits of this novel intervention. PMID:19274623

  2. The Effect of Group Psychoeducation Program on Medication Adherence in Patients with Bipolar Mood Disorders: a Randomized Controlled Trial.

    PubMed

    Rahmani, Farnaz; Ebrahimi, Hossein; Ranjbar, Fatemeh; Razavi, Seyed Sajjad; Asghari, Elnaz

    2016-12-01

    Introduction: Medication nonadherence is highly prevalent in patients with bipolar disorders and often results in worsening disease prognosis. The purpose of this study was to investigate the effect of group psychoeducation on medication adherence in female patients with bipolar mood disorder type I. Methods: This randomized controlled trial was conducted on 76 patients with bipolar mood disorder admitted in female psychiatric wards of Razi teaching hospital, Tabriz, Iran. The participants were selected by convenience sampling method and were randomly assigned to experimental and control groups. Patients in experimental group received 10 continuous 90 minutes sessions of psychoeducation, two times a week. Medication adherence was measured using the medicine check list and medication adherence rating scale (MARS) before and after intervention. Data analysis was performed with SPSS ver.13. Results: There was no significant difference between two groups regarding medication adherence before the intervention. After the study intervention, the mean scores of medication adherence check list and medication adherence rating scale in the experimental group were significantly higher than the control group. Conclusion: Since group psychoeducation was effective in improving patients' medication adherence, it could be recommended for psychiatric nurses to apply this intervention in the clinical setting.

  3. The Effect of Group Psychoeducation Program on Medication Adherence in Patients with Bipolar Mood Disorders: a Randomized Controlled Trial

    PubMed Central

    Rahmani, Farnaz; Ebrahimi, Hossein; Ranjbar, Fatemeh; Razavi, Seyed Sajjad; Asghari, Elnaz

    2016-01-01

    Introduction: Medication nonadherence is highly prevalent in patients with bipolar disorders and often results in worsening disease prognosis. The purpose of this study was to investigate the effect of group psychoeducation on medication adherence in female patients with bipolar mood disorder type I. Methods: This randomized controlled trial was conducted on 76 patients with bipolar mood disorder admitted in female psychiatric wards of Razi teaching hospital, Tabriz, Iran. The participants were selected by convenience sampling method and were randomly assigned to experimental and control groups. Patients in experimental group received 10 continuous 90 minutes sessions of psychoeducation, two times a week. Medication adherence was measured using the medicine check list and medication adherence rating scale (MARS) before and after intervention. Data analysis was performed with SPSS ver.13. Results: There was no significant difference between two groups regarding medication adherence before the intervention. After the study intervention, the mean scores of medication adherence check list and medication adherence rating scale in the experimental group were significantly higher than the control group. Conclusion: Since group psychoeducation was effective in improving patients' medication adherence, it could be recommended for psychiatric nurses to apply this intervention in the clinical setting. PMID:28032073

  4. Comparison between group and personal rehabilitation for dementia in a geriatric health service facility: single-blinded randomized controlled study.

    PubMed

    Tanaka, Shigeya; Honda, Shin; Nakano, Hajime; Sato, Yuko; Araya, Kazufumi; Yamaguchi, Haruyasu

    2017-05-01

    The aim of this study was to compare the effects of rehabilitation involving group and personal sessions on demented participants. This single-blinded randomized controlled trial included 60 elderly participants with dementia in a geriatric health service facility, or R oken. Staff members, who did not participate in the intervention, examined cognitive function, mood, communication ability, severity of dementia, objective quality of life, vitality, and daily behaviour. After a baseline assessment, participants were randomly divided into three groups: (i) group intervention; (ii) personal intervention; and (iii) control. The 1-h group intervention (3-5 subjects) and 20-min personal intervention (one staff member per participant) were performed twice a week for 12 weeks (24 total sessions). The cognitive rehabilitation programme consisted of reminiscence, reality orientation, and physical exercise, and it was based on five principles of brain-activating rehabilitation; (i) pleasant atmosphere; (ii) communication; (iii) social roles; (iv) praising; and (v) errorless support. Data were analyzed after the second assessment. Outcome measures were analyzed in 43 participants-14 in the control group, 13 in group intervention, and 16 in personal intervention. Repeated measure ancova showed a significant interaction for cognitive function score (Mini-Mental State Examination) between group intervention and controls ( F  = 5.535, P = 0.029). In the post-hoc analysis, group intervention showed significant improvement (P = 0.016). Global severity of dementia tended to improve (P = 0.094) in group intervention compared to control (Mann-Whitney U -test). There were no significant interactions or improvements for other measurements. Group rehabilitation for dementia is more effective for improving cognitive function and global severity of dementia than personal rehabilitation in Roken. © 2016 Japanese Psychogeriatric Society.

  5. Effectiveness of interactive discussion group in suicide risk assessment among general nurses in Taiwan: a randomized controlled trial.

    PubMed

    Wu, Chia-Yi; Lin, Yi-Yin; Yeh, Mei Chang; Huang, Lian-Hua; Chen, Shaw-Ji; Liao, Shih-Cheng; Lee, Ming-Been

    2014-11-01

    The evidence of suicide prevention training for nurses is scarce. Strategies to enhance general nurses' ability in suicide risk assessment are critical to develop effective training programs in general medical settings. This study was aimed to examine the effectiveness of an interactive discussion group in a suicide prevention training program for general nurses. In this randomized study with two groups of pre-post study design, the sample was recruited from the Medical, Surgical, and Emergency/Intensive Care Sectors of a 2000-bed general hospital via stratified randomization. Among the 111 nurses, 57 participants randomly assigned to the control group received a two-hour baseline suicide gatekeeper lecture, and 54 participants assigning to the experimental group received an additional five-hour group discussion about suicide risk assessment skills. Using a case vignette, the nurses discussed and assessed suicide risk factors specified in a 10-item Chinese SAD PERSONS Scale during a group discussion intervention. The findings revealed that the nurses achieved significant and consistent improvements of risk identification and assessment after the intervention without influencing their mental health status for assessing suicide risks. The result suggested an effective approach of interactive group discussion for facilitating critical thinking and learning suicide risk assessment skills among general nurses. Copyright © 2014 Elsevier Ltd. All rights reserved.

  6. Effectiveness of a dissonance-based eating disorder prevention program for ethnic groups in two randomized controlled trials.

    PubMed

    Stice, Eric; Marti, C Nathan; Cheng, Zhen Hadassah

    2014-04-01

    As young women from certain ethnic minority groups have reported less pursuit of the thin ideal and body dissatisfaction than European American young women we tested whether a dissonance-based prevention program designed to reduce thin-ideal internalization among women with body dissatisfaction is less effective for the former relative to the later groups. We also tested whether intervention effects are larger when participants from minority groups worked with a facilitator matched versus not matched on ethnicity. In Study 1, 426 female undergraduates (M age=21.6, SD=5.6) were randomized to clinician-led Body Project groups or an educational control group. In Study 2, 189 female undergraduates were randomized to peer-led Body Project groups or a waitlist control condition. Although there was some variation in risk factor scores across ethnic groups, ethnic minority participants did not demonstrate consistently higher or lower risk relative to European American participants. Intervention effects did not significantly differ for participants from minority groups versus European American participants in either trial. There was no evidence that effects were significantly larger when minority participants and facilitators were matched on ethnicity. Results suggest that the Body Project is similarly effective for African American, Asian American, European American, and Hispanic female college students, and when participants and facilitators are matched or not on minority ethnicity status, implying that this prevention program can be broadly disseminated in this population. Copyright © 2014 Elsevier Ltd. All rights reserved.

  7. Effectiveness of a Dissonance-Based Eating Disorder Prevention Program for Ethnic Groups in Two Randomized Controlled Trials

    PubMed Central

    Stice, Eric; Marti, C. Nathan; Cheng, Zhen Hadassah

    2014-01-01

    Objective As young women from certain ethnic minority groups have reported less pursuit of the thin ideal and body dissatisfaction than European American young women we tested whether a dissonance-based prevention program designed to reduce thin-ideal internalization among women with body dissatisfaction is less effective for the former relative to the later groups. We also tested whether intervention effects are larger when participants from minority groups worked with a facilitator matched versus not matched on ethnicity. Method In Study 1, 426 female undergraduates (M age = 21.6, SD = 5.6) were randomized to clinician-led Body Project groups or an educational control group. In Study 2, 189 female undergraduates were randomized to peer-led Body Project groups or a waitlist control condition. Results Although there was some variation in risk factor scores across ethnic groups, ethnic minority participants did not demonstrate consistently higher or lower risk relative to European American participants. Intervention effects did not significantly differ for participants from minority groups versus European American participants in either trial. There was no evidence that effects were significantly larger when minority participants and facilitators were matched on ethnicity. Conclusions Results suggest that the Body Project is similarly effective for African American, Asian American, European American, and Hispanic female college students, and when participants and facilitators are matched or not on minority ethnicity status, implying that this prevention program can be broadly disseminated in this population. PMID:24655465

  8. Control of Blood Pressure and Risk Attenuation: Post Trial Follow-Up of Randomized Groups.

    PubMed

    Jafar, Tazeen H; Jehan, Imtiaz; Liang, Feng; Barbier, Sylvaine; Islam, Muhammad; Bux, Rasool; Khan, Aamir Hameed; Nadkarni, Nivedita; Poulter, Neil; Chaturvedi, Nish; Ebrahim, Shah

    2015-01-01

    Evidence on long term effectiveness of public health strategies for lowering blood pressure (BP) is scarce. In the Control of Blood Pressure and Risk Attenuation (COBRA) Trial, a 2 x 2 factorial, cluster randomized controlled trial, the combined home health education (HHE) and trained general practitioner (GP) intervention delivered over 2 years was more effective than no intervention (usual care) in lowering systolic BP among adults with hypertension in urban Pakistan. However, it was not clear whether the effect would be sustained after the cessation of intervention. We conducted 7 years follow-up inclusive of 5 years of post intervention period of COBRA trial participants to assess the effectiveness of the interventions on BP during extended follow-up. A total of 1341 individuals 40 years or older with hypertension (systolic BP 140 mm Hg or greater, diastolic BP 90 mm Hg or greater, or already receiving treatment) were followed by trained research staff masked to randomization status. BP was measured thrice with a calibrated automated device (Omron HEM-737 IntelliSense) in the sitting position after 5 minutes of rest. BP measurements were repeated after two weeks. Generalized estimating equations (GEE) were used to analyze the primary outcome of change in systolic BP from baseline to 7- year follow-up. The multivariable model was adjusted for clustering, age at baseline, sex, baseline systolic and diastolic BP, and presence of diabetes. After 7 years of follow-up, systolic BP levels among those randomised to combined HHE plus trained GP intervention were significantly lower (2.1 [4.1-0.1] mm Hg) compared to those randomised to usual care, (P = 0.04). Participants receiving the combined intervention compared to usual care had a greater reduction in LDL-cholesterol (2.7 [4.8 to 0.6] mg/dl. The benefit in systolic BP reduction observed in the original cohort assigned to the combined intervention was attenuated but still evident at 7- year follow-up. These findings

  9. Control of Blood Pressure and Risk Attenuation: Post Trial Follow-Up of Randomized Groups

    PubMed Central

    Jafar, Tazeen H.; Jehan, Imtiaz; Liang, Feng; Barbier, Sylvaine; Islam, Muhammad; Bux, Rasool; Khan, Aamir Hameed; Nadkarni, Nivedita; Poulter, Neil; Chaturvedi, Nish; Ebrahim, Shah

    2015-01-01

    Background Evidence on long term effectiveness of public health strategies for lowering blood pressure (BP) is scarce. In the Control of Blood Pressure and Risk Attenuation (COBRA) Trial, a 2 x 2 factorial, cluster randomized controlled trial, the combined home health education (HHE) and trained general practitioner (GP) intervention delivered over 2 years was more effective than no intervention (usual care) in lowering systolic BP among adults with hypertension in urban Pakistan. However, it was not clear whether the effect would be sustained after the cessation of intervention. We conducted 7 years follow-up inclusive of 5 years of post intervention period of COBRA trial participants to assess the effectiveness of the interventions on BP during extended follow-up. Methods A total of 1341 individuals 40 years or older with hypertension (systolic BP 140 mm Hg or greater, diastolic BP 90 mm Hg or greater, or already receiving treatment) were followed by trained research staff masked to randomization status. BP was measured thrice with a calibrated automated device (Omron HEM-737 IntelliSense) in the sitting position after 5 minutes of rest. BP measurements were repeated after two weeks. Generalized estimating equations (GEE) were used to analyze the primary outcome of change in systolic BP from baseline to 7- year follow-up. The multivariable model was adjusted for clustering, age at baseline, sex, baseline systolic and diastolic BP, and presence of diabetes. Findings After 7 years of follow-up, systolic BP levels among those randomised to combined HHE plus trained GP intervention were significantly lower (2.1 [4.1–0.1] mm Hg) compared to those randomised to usual care, (P = 0.04). Participants receiving the combined intervention compared to usual care had a greater reduction in LDL-cholesterol (2.7 [4.8 to 0.6] mg/dl. Conclusions The benefit in systolic BP reduction observed in the original cohort assigned to the combined intervention was attenuated but still

  10. Effectiveness of group reminiscence for improving wellbeing of institutionalized elderly adults: study protocol for a randomized controlled trial.

    PubMed

    Gaggioli, Andrea; Scaratti, Chiara; Morganti, Luca; Stramba-Badiale, Marco; Agostoni, Monica; Spatola, Chiara A M; Molinari, Enrico; Cipresso, Pietro; Riva, Giuseppe

    2014-10-25

    Group reminiscence therapy is a brief and structured intervention in which participants share personal past events with peers. This approach has been shown to be promising for improving wellbeing and reducing depressive symptoms among institutionalized older adults. However, despite the considerable interest in reminiscence group therapy, controlled studies to determine its specific benefits as compared to generic social interactions with peers (group conversations about everyday subjects) are still lacking. We have designed a randomized controlled trial aimed at comparing the effects of group reminiscence therapy with those of group recreational activity on the psychological wellbeing of an institutionalized sample of older adults. The study includes two groups of 20 hospitalized elderly participants: the experimental group and the control group. Participants included in the experimental group will receive six sessions of group reminiscence therapy, while the control group will participate in a recreational group discussion. A repeated-measures design will be used post-intervention and three months post-intervention to evaluate changes in self-reported outcome measures of depressive symptoms, self-esteem, life satisfaction, and quality of life from baseline. The protocol of a study aimed at examining the specific effects of group reminiscence therapy on psychological wellbeing, depression, and quality of life among institutionalized elderly people is described. It is expected that the outcomes of this trial will contribute to our knowledge about the process of group reminiscence, evaluate its effectiveness in improving psychological wellbeing of institutionalized individuals, and identify the best conditions for optimizing this approach. This trial was registered with ClinicalTrials.gov (registration number: NCT02077153) on 31 January 2014.

  11. Comparing Acceptance and Commitment Group Therapy and 12-Steps Narcotics Anonymous in Addict's Rehabilitation Process: A Randomized Controlled Trial.

    PubMed

    Azkhosh, Manoochehr; Farhoudianm, Ali; Saadati, Hemn; Shoaee, Fateme; Lashani, Leila

    2016-10-01

    Objective: Substance abuse is a socio-psychological disorder. The aim of this study was to compare the effectiveness of acceptance and commitment therapy with 12-steps Narcotics Anonymous on psychological well-being of opiate dependent individuals in addiction treatment centers in Shiraz, Iran. Method: This was a randomized controlled trial. Data were collected at entry into the study and at post-test and follow-up visits. The participants were selected from opiate addicted individuals who referred to addiction treatment centers in Shiraz. Sixty individuals were evaluated according to inclusion/ exclusion criteria and were divided into three equal groups randomly (20 participants per group). One group received acceptance and commitment group therapy (Twelve 90-minute sessions) and the other group was provided with the 12-steps Narcotics Anonymous program and the control group received the usual methadone maintenance treatment. During the treatment process, seven participants dropped out. Data were collected using the psychological well-being questionnaire and AAQ questionnaire in the three groups at pre-test, post-test and follow-up visits. Data were analyzed using repeated measure analysis of variance. Results: Repeated measure analysis of variance revealed that the mean difference between the three groups was significant (P<0.05) and that acceptance and commitment therapy group showed improvement relative to the NA and control groups on psychological well-being and psychological flexibility. Conclusion: The results of this study revealed that acceptance and commitment therapy can be helpful in enhancing positive emotions and increasing psychological well-being of addicts who seek treatment.

  12. Multifamily Group Psychoeducation and Cognitive Remediation for First-Episode Psychosis: A Randomized Controlled Trial

    PubMed Central

    2011-01-01

    Background Multifamily group psychoeducation (MFG) has been shown to reduce relapse rates among individuals with first-episode psychosis. However, given the cognitive demands associated with participating in this intervention (e.g., learning and applying a structured problem-solving activity), the cognitive deficits that accompany psychotic disorders may limit the ability of certain individuals to benefit from this intervention. Thus, the goal of this study is to examine whether individuals with first-episode psychosis who participate simultaneously in MFG and cognitive remediation--an intervention shown to improve cognitive functioning among individuals with psychotic disorders--will be less likely to experience a relapse than individuals who participate in MFG alone. Methods/Design Forty individuals with first-episode psychosis and their caregiving relative will be recruited to participate in this study. Individuals with first-episode psychosis will be randomized to one of two conditions: (i) MFG with concurrent participation in cognitive remediation or (ii) MFG alone. The primary outcome for this study is relapse of psychotic symptoms. We will also examine secondary outcomes among both individuals with first-episode psychosis (i.e., social and vocational functioning, health-related quality of life, service utilization, independent living status, and cognitive functioning) and their caregiving relatives (i.e., caregiver burden, anxiety, and depression) Discussion Cognitive remediation offers the possibility of ameliorating a specific deficit (i.e., deficits in cognitive functioning) that often accompanies psychotic symptoms and may restrict the magnitude of the clinical benefits derived from MFG. Trial Registration ClinicalTrials (NCT): NCT01196286 PMID:21226941

  13. Impact of caregiver group psychoeducation on the course and outcome of bipolar patients in remission: a randomized controlled trial.

    PubMed

    Reinares, María; Colom, Francesc; Sánchez-Moreno, José; Torrent, Carla; Martínez-Arán, Anabel; Comes, Mercè; Goikolea, José M; Benabarre, Antoni; Salamero, Manel; Vieta, Eduard

    2008-06-01

    Although there are some randomized controlled trials that highlight the positive role of family-focused treatment added to pharmacotherapy in bipolar disorder, no trials using contemporary methodologies have analyzed the specific effect of working with caregiver-only groups. The aim of this study was to assess the efficacy of a psychoeducational group intervention focused on caregivers of euthymic bipolar patients. A total of 113 medicated euthymic bipolar outpatients who lived with their caregivers were randomized into an experimental and a control group. Caregivers in the experimental group received twelve 90-min group psychoeducation sessions focused on knowledge of bipolar disorder and training in coping skills. The patients did not attend the groups. Caregivers assigned to the control group did not receive any specific intervention. Patients were assessed monthly during both the intervention and the 12 months of follow-up. The primary outcome was time to any mood recurrence. Psychoeducation group intervention focused on the caregivers of bipolar patients carried a reduction of the percentage of patients with any mood recurrence (chi2 = 6.53; p = 0.011) and longer relapse-free intervals (log-rank chi(2) = 4.04; p = 0.044). When different types of episodes were analyzed separately, the effect was significant for both the number of patients who experienced a hypomanic/manic recurrence (chi2 = 5.65; p = 0.017) and the time to such an episode (log-rank chi2 = 5.84; p = 0.015). The differences in preventing depressive and mixed episodes were not significant. A psychoeducation group intervention for the caregivers of bipolar patients is a useful adjunct to usual treatment for the patients in reducing the risk of recurrences, particularly mania and hypomania, in bipolar disorder.

  14. DVD training for depression identification and treatment in older adults: a two-group, randomized, wait-list control study.

    PubMed

    Lysack, Cathy; Leach, Carrie; Russo, Theresa; Paulson, Daniel; Lichtenberg, Peter A

    2013-01-01

    OBJECTIVE. To test the effectiveness of an educational intervention aimed at improving mental health knowledge and skills in occupational therapists working with older rehabilitation patients. METHOD. The DVD-format educational intervention was evaluated using a two-group randomized wait-list control design. Occupational therapists (n = 75) completed a 32-item knowledge questionnaire at three time points. Patient charts were reviewed (n = 960) at 3 months before and 3 and 6 months after DVD training to evaluate clinical practice change. RESULTS. A two-way analysis of variance showed knowledge scores increased significantly for both groups after DVD training. A significant Group × Time interaction and significant main effects for time and group were found. Chart review data also showed significant increases in desired clinical behaviors in both groups after training. The greatest single item of clinical practice change was use of a standardized depression screen. CONCLUSION. DVD-based training can significantly improve mental health practice.

  15. A Randomized Controlled Trial of Team-Based Learning Versus Lectures with Break-Out Groups on Knowledge Retention.

    PubMed

    Thrall, Grace C; Coverdale, John H; Benjamin, Sophiya; Wiggins, Anna; Lane, Christianne Joy; Pato, Michele T

    2016-10-01

    This goal of this study was to evaluate the efficacy of team-based learning (TBL) on knowledge retention compared to traditional lectures with small break-out group discussion (teaching as usual (TAU)) using a randomized controlled trial. This randomized controlled trial was conducted during a daylong conference for psychiatric educators on attention-deficit hyperactivity disorder and the research literacy topic of efficacy versus effectiveness trials. Learners (n = 115) were randomized with concealed allocation to either TBL or TAU. Knowledge was measured prior to the intervention, immediately afterward, and 2 months later via multiple-choice tests. Participants were necessarily unblinded. Data enterers, data analysts, and investigators were blinded to group assignment in data analysis. Per-protocol analyses of test scores were performed using change in knowledge from baseline. The primary endpoint was test scores at 2 months. At baseline, there were no statistically significant differences between groups in pre-test knowledge. At immediate post-test, both TBL and TAU groups showed improved knowledge scores compared with their baseline scores. The TBL group performed better statistically on the immediate post-test than the TAU group (Cohen's d = 0.73; p < 0.001), although the differences in knowledge scores were not educationally meaningful, averaging just one additional test question correct (out of 15). On the 2-month remote post-test, there were no group differences in knowledge retention among the 42 % of participants who returned the 2-month test. Both TBL and TAU learners acquired new knowledge at the end of the intervention and retained knowledge over 2 months. At the end of the intervention day and after 2 months, knowledge test scores were not meaningfully different between TBL and TAU completers. In conclusion, this study failed to demonstrate the superiority of TBL over TAU on the primary outcome of knowledge retention at 2 months post-intervention.

  16. Testing the Efficacy of OurSpace, a Brief, Group Dynamics-Based Physical Activity Intervention: A Randomized Controlled Trial.

    PubMed

    Irwin, Brandon; Kurz, Daniel; Chalin, Patrice; Thompson, Nicholas

    2016-05-06

    Emerging technologies (ie, mobile phones, Internet) may be effective tools for promoting physical activity (PA). However, few interventions have provided effective means to enhance social support through these platforms. Face-to-face programs that use group dynamics-based principles of behavior change have been shown to be highly effective in enhancing social support through promoting group cohesion and PA, but to date, no studies have examined their effects in Web-based programs. The aim was to explore proof of concept and test the efficacy of a brief, online group dynamics-based intervention on PA in a controlled experiment. We expected that the impact of the intervention on PA would be moderated by perceptions of cohesion and the partner's degree of presence in the online media. Participants (n=135) were randomized into same-sex dyads and randomly assigned to one of four experimental conditions: standard social support (standard), group dynamics-based-high presence, group dynamics-based-low presence, or individual control. Participants performed two sets of planking exercises (pre-post). Between sets, participants in partnered conditions interacted with a virtual partner using either a standard social support app or a group dynamics-based app (group dynamics-based-low presence and group dynamics-based-high presence), the latter of which they participated in a series of online team-building exercises. Individual participants were given an equivalent rest period between sets. To increase presence during the second set, participants in the group dynamics-based-high presence group saw a live video stream of their partner exercising. Perceptions of cohesion were measured using a modified PA Group Environment Questionnaire. Physical activity was calculated as the time persisted during set 2 after controlling for persistence in set 1. Perceptions of cohesion were higher in the group dynamics-based-low presence (overall mean 5.81, SD 1.04) condition compared to the

  17. Social support and education groups for single mothers: a randomized controlled trial of a community-based program.

    PubMed

    Lipman, Ellen L; Boyle, Michael H

    2005-12-06

    Members of families headed by single mothers are at increased risk of psychosocial disadvantage and mental health problems. We assessed the effect of a community-based program of social support and education groups for single mothers of young children on maternal well-being and parenting. We recruited 116 single mothers of children 3 to 9 years old through community advertisements. Eligible mothers were randomly assigned either to participate in a 10-week program of group sessions (1.5 hours per week) offering social support and education, with a parallel children's activity group, or to receive a standard list of community resources and the option to participate in group sessions at the end of the follow-up period. Interviewers blinded to the randomization collected assessment data from all mothers at baseline and at 3 follow-up visits (immediately after the intervention and at 3 and 6 months after the intervention). Outcome measures were self-reported mood, self-esteem, social support and parenting. Between February 2000 and April 2003, the program was offered to 9 groups of single mothers. Most of the mothers in the trial reported high levels of financial and mental health problems. In the short term (after the intervention), mothers in the intervention group had improved scores for mood (p < 0.01, standardized effect = 0.55) and self-esteem (p < 0.05, standardized effect = 0.29) compared with mothers in the control group; scores for the other 2 measures did not differ between the groups. Growth curve analysis of program effects over the follow-up period showed improvement in all 4 outcomes, with no significant difference between the intervention and control groups. This community-based program of group sessions offering social support and education to low-income single mothers had positive short-term effects on mood and self-esteem but not on social support and parenting. Longer follow-up showed attenuation of these effects.

  18. Randomized controlled trial of traditional Chinese medicine (acupuncture and tuina) in cerebral palsy: part 1--any increase in seizure in integrated acupuncture and rehabilitation group versus rehabilitation group?

    PubMed

    Wu, Yun; Zou, Li-Ping; Han, Tong-Li; Zheng, Hua; Caspi, Opher; Wong, Virginia; Su, Yani; Shen, Kun-Ling

    2008-10-01

    The objective of this study was to observe for any change in baseline seizure frequency with acupuncture in children with cerebral palsy. A randomized controlled study was conducted: Group I consisted of integrated acupuncture, tuina, and rehabilitation (physiotherapy, occupational therapy, and hydrotherapy) for 12 weeks; and Group II consisted of rehabilitation (physiotherapy, occupational therapy, and hydrotherapy) for 12 weeks. After a washout period of 4 weeks, Group II then received acupuncture and tuina for 12 weeks. Each subject received 5 daily acupuncture sessions per week for 12 weeks (total = 60 sessions). All children were assessed for any change in seizure frequency during treatment. One hundred and sixteen (116) children were recruited and randomized into Group I (N = 58) and Group II (N = 58). Thirty-three (33) children withdrew (9 from Group I and 24 from Group II). Of the remaining 83 children, Group I consisted of 49 and Group II of 34 children. For baseline, 5 children (6%; 5/83) had seizures. During phase 1 (12 weeks) of integrative treatment and subsequent 4-week follow-up, 3 children in Group I had seizures. Among those 3 children with seizures, 1 child with prior history of recurrent febrile seizure had 3 more recurrent febrile seizures during acupuncture treatment and 2 children without any prior history of seizures had new-onset seizures (1 with 3 recurrent febrile seizures and 1 with afebrile seizure). For Group I, 2 children with epilepsy had no increase in seizure frequency during acupuncture treatment. For Group II during the phase 2 acupuncture period, none had increase in seizure frequency. In both groups, 4 of 5 children (80%; 2 in Group I and 2 in Group II) with seizures had no increase in seizure frequency during acupuncture treatment and follow-up. The risk of increasing seizure is not increased with acupuncture treatment for cerebral palsy.

  19. Internal versus external motivation in referral of primary care patients with depression to an internet support group: randomized controlled trial.

    PubMed

    Van Voorhees, Benjamin W; Hsiung, Robert C; Marko-Holguin, Monika; Houston, Thomas K; Fogel, Joshua; Lee, Royce; Ford, Daniel E

    2013-03-12

    Depressive disorders and symptoms affect more than one-third of primary care patients, many of whom do not receive or do not complete treatment. Internet-based social support from peers could sustain depression treatment engagement and adherence. We do not know whether primary care patients will accept referral to such websites nor do we know which methods of referral would be most effective. We conducted a randomized clinical trial to determine whether (1) a simple generic referral card (control), (2) a patient-oriented brochure that provided examples of online postings and experience (internal motivation), or (3) a physician letter of recommendation (external motivation) would generate the greatest participation in a primary care Internet depression treatment support portal focused around an Internet support group (ISG). We used 3 offline methods to identify potential participants who had not used an ISG in the past 6 months. Eligibility was determined in part by a brief structured psychiatric interview based on the Patient Health Questionnaire-9 (PHQ-9). After consent and enrollment, participants were randomly assigned to 1 of 3 groups (control, internal motivation, or external motivation). We constructed a portal to connect primary care patients to both fact-based information and an established ISG (Psycho-Babble). The ISG allowed participants to view messages and then decide if they actually wished to register there. Participation in the portal and the ISG was assessed via automated activity tracking. Fifty participants were assigned to the 3 groups: a motivation-neutral control group (n=18), an internal motivation group (n=19), and an external motivation group (n=13). Of these participants, 31 (62%) visited the portal; 27 (54%) visited the ISG itself. The internal motivation group showed significantly greater participation than the control group on several measures. The external motivation group spent significantly less time logged onto the portal than the

  20. Multicomponent interdisciplinary group intervention for self-management of fibromyalgia: a mixed-methods randomized controlled trial.

    PubMed

    Bourgault, Patricia; Lacasse, Anaïs; Marchand, Serge; Courtemanche-Harel, Roxanne; Charest, Jacques; Gaumond, Isabelle; Barcellos de Souza, Juliana; Choinière, Manon

    2015-01-01

    This study evaluated the efficacy of the PASSAGE Program, a structured multicomponent interdisciplinary group intervention for the self-management of FMS. A mixed-methods randomized controlled trial (intervention (INT) vs. waitlist (WL)) was conducted with patients suffering from FMS. Data were collected at baseline (T0), at the end of the intervention (T1), and 3 months later (T2). The primary outcome was change in pain intensity (0-10). Secondary outcomes were fibromyalgia severity, pain interference, sleep quality, pain coping strategies, depression, health-related quality of life, patient global impression of change (PGIC), and perceived pain relief. Qualitative group interviews with a subset of patients were also conducted. Complete data from T0 to T2 were available for 43 patients. The intervention had a statistically significant impact on the three PGIC measures. At the end of the PASSAGE Program, the percentages of patients who perceived overall improvement in their pain levels, functioning and quality of life were significantly higher in the INT Group (73%, 55%, 77% respectively) than in the WL Group (8%, 12%, 20%). The same differences were observed 3 months post-intervention (Intervention group: 62%, 43%, 38% vs Waitlist Group: 13%, 13%, 9%). The proportion of patients who reported ≥ 50% pain relief was also significantly higher in the INT Group at the end of the intervention (36% vs 12%) and 3 months post-intervention (33% vs 4%). Results of the qualitative analysis were in line with the quantitative findings regarding the efficacy of the intervention. The improvement, however, was not reflected in the primary outcome and other secondary outcome measures. The PASSAGE Program was effective in helping FMS patients gain a sense of control over their symptoms. We suggest including PGIC in future clinical trials on FMS as they appear to capture important aspects of the patients' experience. International Standard Randomized Controlled Trial Number Register

  1. Multicomponent Interdisciplinary Group Intervention for Self-Management of Fibromyalgia: A Mixed-Methods Randomized Controlled Trial

    PubMed Central

    Bourgault, Patricia; Lacasse, Anaïs; Marchand, Serge; Courtemanche-Harel, Roxanne; Charest, Jacques; Gaumond, Isabelle; Barcellos de Souza, Juliana; Choinière, Manon

    2015-01-01

    Background This study evaluated the efficacy of the PASSAGE Program, a structured multicomponent interdisciplinary group intervention for the self-management of FMS. Methods A mixed-methods randomized controlled trial (intervention (INT) vs. waitlist (WL)) was conducted with patients suffering from FMS. Data were collected at baseline (T0), at the end of the intervention (T1), and 3 months later (T2). The primary outcome was change in pain intensity (0-10). Secondary outcomes were fibromyalgia severity, pain interference, sleep quality, pain coping strategies, depression, health-related quality of life, patient global impression of change (PGIC), and perceived pain relief. Qualitative group interviews with a subset of patients were also conducted. Complete data from T0 to T2 were available for 43 patients. Results The intervention had a statistically significant impact on the three PGIC measures. At the end of the PASSAGE Program, the percentages of patients who perceived overall improvement in their pain levels, functioning and quality of life were significantly higher in the INT Group (73%, 55%, 77% respectively) than in the WL Group (8%, 12%, 20%). The same differences were observed 3 months post-intervention (Intervention group: 62%, 43%, 38% vs Waitlist Group: 13%, 13%, 9%). The proportion of patients who reported ≥50% pain relief was also significantly higher in the INT Group at the end of the intervention (36% vs 12%) and 3 months post-intervention (33% vs 4%). Results of the qualitative analysis were in line with the quantitative findings regarding the efficacy of the intervention. The improvement, however, was not reflected in the primary outcome and other secondary outcome measures. Conclusion The PASSAGE Program was effective in helping FMS patients gain a sense of control over their symptoms. We suggest including PGIC in future clinical trials on FMS as they appear to capture important aspects of the patients’ experience. Trial registration

  2. Treatment of posttraumatic stress disorder in postwar Kosovar adolescents using mind-body skills groups: a randomized controlled trial.

    PubMed

    Gordon, James S; Staples, Julie K; Blyta, Afrim; Bytyqi, Murat; Wilson, Amy T

    2008-09-01

    To determine whether participation in a mind-body skills group program based on psychological self-care, mind-body techniques, and self-expression decreases symptoms of posttraumatic stress disorder (PTSD). Eighty-two adolescents meeting criteria for PTSD according to the Harvard Trauma Questionnaire (which corresponds with 16 of the 17 diagnostic criteria for PTSD in DSM-IV) were randomly assigned to a 12-session mind-body group program or a wait-list control group. The program was conducted by high school teachers in consultation with psychiatrists and psychologists and included meditation, guided imagery, and breathing techniques; self-expression through words, drawings, and movement; autogenic training and biofeedback; and genograms. Changes in PTSD symptoms were measured using the Harvard Trauma Questionnaire. The study was conducted from September 2004 to May 2005 by The Center for Mind-Body Medicine at a high school in the Suhareka region of Kosovo. Students in the immediate intervention group had significantly lower PTSD symptom scores following the intervention than those in the wait-list control group (F = 29.8, df = 1,76; p < .001). Preintervention and postintervention scores (mean [SD]) for the intervention group were 2.5 (0.3) and 2.0 (0.3), respectively, and for the control group, 2.5 (0.3) and 2.4 (0.4), respectively. The decreased PTSD symptom scores were maintained in the initial intervention group at 3-month follow-up. After the wait-list control group received the intervention, there was a significant decrease (p < .001) in PTSD symptom scores compared to the preintervention scores. Mind-body skills groups can reduce PTSD symptoms in war-traumatized high school students and can be effectively led by trained and supervised schoolteachers. Copyright 2008 Physicians Postgraduate Press, Inc.

  3. Efficacy of group psychotherapy for social anxiety disorder: A meta-analysis of randomized-controlled trials.

    PubMed

    Barkowski, Sarah; Schwartze, Dominique; Strauss, Bernhard; Burlingame, Gary M; Barth, Jürgen; Rosendahl, Jenny

    2016-04-01

    Group psychotherapy for social anxiety disorder (SAD) is an established treatment supported by findings from primary studies and earlier meta-analyses. However, a comprehensive summary of the recent evidence is still pending. This meta-analysis investigates the efficacy of group psychotherapy for adult patients with SAD. A literature search identified 36 randomized-controlled trials examining 2171 patients. Available studies used mainly cognitive-behavioral group therapies (CBGT); therefore, quantitative analyses were done for CBGT. Medium to large positive effects emerged for wait list-controlled trials for specific symptomatology: g=0.84, 95% CI [0.72; 0.97] and general psychopathology: g=0.62, 95% CI [0.36; 0.89]. Group psychotherapy was also superior to common factor control conditions in alleviating symptoms of SAD, but not in improving general psychopathology. No differences appeared for direct comparisons of group psychotherapy and individual psychotherapy or pharmacotherapy. Hence, group psychotherapy for SAD is an efficacious treatment, equivalent to other treatment formats. Copyright © 2016 Elsevier Ltd. All rights reserved.

  4. Effectiveness of a group-based self-management program for people with chronic fatigue syndrome: a randomized controlled trial.

    PubMed

    Pinxsterhuis, Irma; Sandvik, Leiv; Strand, Elin Bolle; Bautz-Holter, Erik; Sveen, Unni

    2017-01-01

    To evaluate the effectiveness of a group-based self-management program for people with chronic fatigue syndrome. A randomized controlled trial. Four mid-sized towns in southern Norway and two suburbs of Oslo. A total of 137 adults with chronic fatigue syndrome. A self-management program including eight biweekly meetings of 2.5 hours duration. The control group received usual care. Primary outcome measure: Medical Outcomes Study-Short Form-36 physical functioning subscale. Fatigue severity scale, self-efficacy scale, physical and mental component summary of the Short Form-36, and the illness cognition questionnaire (acceptance subscale). Assessments were performed at baseline, and at six-month and one-year follow-ups. At the six-month follow-up, a significant difference between the two groups was found concerning fatigue severity ( p = 0.039) in favor of the control group, and concerning self-efficacy in favor of the intervention group ( p = 0.039). These significant differences were not sustained at the one-year follow-up. No significant differences were found between the groups concerning physical functioning, acceptance, and health status at any of the measure points. The drop-out rate was 13.9% and the median number of sessions attended was seven (out of eight). The evaluated self-management program did not have any sustained effect, as compared with receiving usual care.

  5. Headache: the placebo effects in the control groups in randomized clinical trials; an analysis of systematic reviews.

    PubMed

    de Groot, Femke M; Voogt-Bode, Annieke; Passchier, Jan; Berger, Marjolein Y; Koes, Bart W; Verhagen, Arianne P

    2011-06-01

    The purpose of this study is to describe the effects in the placebo and "no treatment" arms in trials with headache patients. This is a secondary analysis of randomized controlled trials from 8 systematic reviews and selected trials with a "no treatment" or placebo control group. The different types of "no treatment" and placebo interventions were assessed and classified into 6 subgroups. The analyses were carried out according to type of outcome variable. In total, 119 studies were included (7119 participants). The mean recovery rate in all control groups was 35.7%. Significantly more participants recovered in control groups of pharmacological studies than in nonpharmacological studies: 38.5% vs 15.0%, respectively. Adults were more likely to recover in nonpharmacological studies and children in pharmacological studies. The mean recovery rate in the control groups was 36%. The recovery rate varied substantially between type of intervention and patients. Copyright © 2011 National University of Health Sciences. Published by Mosby, Inc. All rights reserved.

  6. Yearling trait comparisons among inbred lines and selected noninbred and randomly bred control groups of Rambouillet, Targhee and Columbia ewes.

    PubMed

    Ercanbrack, S K; Knight, A D

    1983-02-01

    Inbreeding with concurrent selection was used to develop 26 Rambouillet, 20 Targhee and 10 Columbia inbred lines of sheep. Inbreeding coefficients averaged 30, 29 and 30% for the three breeds, respectively, at the conclusion of the study. A selected noninbred control group and a randomly bred unselected control group were maintained for each breed. Yearling traits were evaluated for 545 Rambouillet, 572 Targhee and 411 Columbia yearling ewes, each belonging to one of the inbred lines or control groups. In each breed, the selected controls were generally of greatest overall merit, the unselected controls intermediate and the inbred lines of least merit. Only a few yearling traits of only a few inbred lines were superior (P less than .05) to those of their appropriate selected control groups. Selection within inbred lines was generally ineffective in offsetting inbreeding depression. However, single trait selection for traits of high heritability, notably yearling weight, clean fleece weight and staple length, appeared to compensate for inbreeding effects on those traits. Deleterious consequences of inbreeding were particularly apparent in yearling weight, average daily gain, type and condition scores, grease and clean fleece weights and index of overall merit. Inbreeding also resulted in fewer neck folds among inbreds of all three breeds. Correlations between the rankings of inbred lines at weaning and yearling ages were high for traits of higher heritability. Superiority of the selected controls in most traits was of about the same magnitude at weaning and yearling ages. In no case did the final overall merit (index value) of an inbred line of any of the three breeds significantly exceed the overall merit of its respective selected control group.

  7. Psychoeducational groups for adults with ADHD and their significant others (PEGASUS): A pragmatic multicenter and randomized controlled trial.

    PubMed

    Hirvikoski, T; Lindström, T; Carlsson, J; Waaler, E; Jokinen, J; Bölte, S

    2017-07-01

    To examine the feasibility, efficacy, and effectiveness of PEGASUS, a group-based structured psychoeducation for adults with ADHD and their significant others. A pragmatic parallel group add-on design multicenter randomized controlled trial was conducted, comparing an 8-session treatment with PEGASUS (allocated n=97; 48 with ADHD and 49 with significant others) to treatment as usual (TAU, allocated n=82; 39 with ADHD and 43 significant others). Participants (individuals with ADHD and significant others) were recruited from five psychiatric outpatient departments and block randomized to PEGASUS or TAU. Knowledge about ADHD was measured using the ADHD 20 scale pre- and post-intervention and served as primary outcome. Knowledge about ADHD (d=0.97 [95% CI: 0.61-1.31]) increased following PEGASUS participation compared to TAU. Improvements were also observed in secondary outcomes e.g. global life satisfaction (d=0.25 [95% CI: from -0.09 to 0.59]). Overall treatment satisfaction was good. Over 90% of the participants completed the program. Post-intervention data was obtained from n=89 in PEGASUS group and n=70 in TAU group and analyses were conducted per protocol. No important adverse effects or side effects were observed. Group-based structured psychoeducation PEGASUS for adults with ADHD and their significant others is a feasible, efficacious, and effective treatment option to increase ADHD knowledge and general life satisfaction in psychiatric outpatient care. Copyright © 2017 The Authors. Published by Elsevier Masson SAS.. All rights reserved.

  8. [Assessment of nociceptive suppression in laparoscopic postoperative status: prospective, randomized and comparative study with a control group].

    PubMed

    Jaime, A; Hernández-Favela, P; Zamora, R; Nava, E; Barroso, G; Kably, A

    2001-08-01

    In recent years endoscopic surgery has became a highly demanded procedure because it is an easy method for diagnosis and treatment in gynecological field. Post-operative pain is considered as a condition in the morbidity status. The objective of this study was to evaluate the nociceptive suppression in laparoscopic surgery. A prospective randomized trial was performed in order to evaluate this condition. A total of 45 patients were included. Three groups were randomized using two different anesthetics applied in the cult-de-sac and uterine-bladder union. Group A (n-15) received bupivacaine, group B (n = 15) ropivacaine and group C (control) saline solution was instilled. The pain was scored using the visual analog scale as same as blood pressure and heart rate in a 15 minute intervals in the recovery room. For study design there were no differences in age, weight, height and body mass index (EMI). The surgical and anesthetic times were similar among groups. However there were significant differences when pain was evaluated. For a less toxic effects and good preventive analgesia we recommend to use ropivacaine in the postoperative status.

  9. Random allocation software for parallel group randomized trials.

    PubMed

    Saghaei, Mahmood

    2004-11-09

    Typically, randomization software should allow users to exert control over the different aspects of randomization including block design, provision of unique identifiers and control over the format and type of program output. While some of these characteristics have been addressed by available software, none of them have all of these capabilities integrated into one package. The main objective of the Random Allocation Software project was to enhance the user's control over different aspects of randomization in parallel group trials, including output type and format, structure and ordering of generated unique identifiers and enabling users to specify group names for more than two groups. The program has different settings for: simple and blocked randomizations; length, format and ordering of generated unique identifiers; type and format of program output; and saving sessions for future use. A formatted random list generated by this program can be used directly (without further formatting) by the coordinator of the research team to prepare and encode different drugs or instruments necessary for the parallel group trial. Random Allocation Software enables users to control different attributes of the random allocation sequence and produce qualified lists for parallel group trials.

  10. Random allocation software for parallel group randomized trials

    PubMed Central

    Saghaei, Mahmood

    2004-01-01

    Background Typically, randomization software should allow users to exert control over the different aspects of randomization including block design, provision of unique identifiers and control over the format and type of program output. While some of these characteristics have been addressed by available software, none of them have all of these capabilities integrated into one package. The main objective of the Random Allocation Software project was to enhance the user's control over different aspects of randomization in parallel group trials, including output type and format, structure and ordering of generated unique identifiers and enabling users to specify group names for more than two groups. Results The program has different settings for: simple and blocked randomizations; length, format and ordering of generated unique identifiers; type and format of program output; and saving sessions for future use. A formatted random list generated by this program can be used directly (without further formatting) by the coordinator of the research team to prepare and encode different drugs or instruments necessary for the parallel group trial. Conclusions Random Allocation Software enables users to control different attributes of the random allocation sequence and produce qualified lists for parallel group trials. PMID:15535880

  11. Effectiveness of a mobile cooperation intervention during the clinical practicum of nursing students: a parallel group randomized controlled trial protocol.

    PubMed

    Strandell-Laine, Camilla; Saarikoski, Mikko; Löyttyniemi, Eliisa; Salminen, Leena; Suomi, Reima; Leino-Kilpi, Helena

    2017-06-01

    The aim of this study was to describe a study protocol for a study evaluating the effectiveness of a mobile cooperation intervention to improve students' competence level, self-efficacy in clinical performance and satisfaction with the clinical learning environment. Nursing student-nurse teacher cooperation during the clinical practicum has a vital role in promoting the learning of students. Despite an increasing interest in using mobile technologies to improve the clinical practicum of students, there is limited robust evidence regarding their effectiveness. A multicentre, parallel group, randomized, controlled, pragmatic, superiority trial. Second-year pre-registration nursing students who are beginning a clinical practicum will be recruited from one university of applied sciences. Eligible students will be randomly allocated to either a control group (engaging in standard cooperation) or an intervention group (engaging in mobile cooperation) for the 5-week the clinical practicum. The complex mobile cooperation intervention comprises of a mobile application-assisted, nursing student-nurse teacher cooperation and a training in the functions of the mobile application. The primary outcome is competence. The secondary outcomes include self-efficacy in clinical performance and satisfaction with the clinical learning environment. Moreover, a process evaluation will be undertaken. The ethical approval for this study was obtained in December 2014 and the study received funding in 2015. The results of this study will provide robust evidence on mobile cooperation during the clinical practicum, a research topic that has not been consistently studied to date. © 2016 John Wiley & Sons Ltd.

  12. 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.

  13. TEACCH-based group social skills training for children with high-functioning autism: a pilot randomized controlled trial.

    PubMed

    Ichikawa, Kayoko; Takahashi, Yoshimitsu; Ando, Masahiko; Anme, Tokie; Ishizaki, Tatsuro; Yamaguchi, Hinako; Nakayama, Takeo

    2013-10-01

    Although social skills training programs for people with high-functioning autism (HFA) are widely practiced, the standardization of curricula, the examination of clinical effectiveness, and the evaluation of the feasibility of future trials have yet to be done in Asian countries. To compensate for this problem, a Japanese pilot randomized controlled trial (RCT) of the Treatment and Education of Autistic and Related Communication Handicapped Children (TEACCH)-based group social skills training for children with HFA and their mothers was conducted. Eleven children with HFA, aged 5-6 years, and their mothers were randomly assigned to the TEACCH program (n=5) or a waiting-list control group (n=6). The program involved comprehensive group intervention and featured weekly 2-hour sessions, totaling 20 sessions over six months. The adaptive behaviors and social reciprocity of the children, parenting stress, and parent-child interactions were assessed using the Strengths and Difficulties Questionnaire (SDQ), Parenting Stress Index (PSI), Beck depression inventory-II (BDI-II), and Interaction Rating Scale (IRS). Through this pilot trial, the intervention and evaluation of the program has been shaped. There were no dropouts from the program and the mothers' satisfaction was high. The outcome measurements improved more in the program group than in the control group, with moderate effect sizes (SDQ, 0.71; PSI, 0.58; BDI-II, 0.40; and IRS, 0.69). This pilot trial also implied that this program is more beneficial for high IQ children and mothers with low stress than for those who are not. We have standardized the TEACCH program, confirmed the feasibility of a future trial, and successfully estimated the positive effect size. These findings will contribute to a larger trial in the future and to forthcoming systematic reviews with meta-analyses. UMIN000004560.

  14. A randomized controlled trial of group cognitive-behavioral therapy vs. enhanced supportive therapy for auditory hallucinations.

    PubMed

    Penn, David L; Meyer, Piper S; Evans, Elizabeth; Wirth, R J; Cai, Karen; Burchinal, Margaret

    2009-04-01

    There has been little research examining group cognitive-behavioral therapy (CBT) for schizophrenia, especially compared to an active control treatment. The purpose of this study was to investigate the effectiveness of group CBT for auditory hallucinations compared to an enhanced supportive therapy (ST). Sixty five participants with schizophrenia spectrum disorders and persistent hallucinations were randomly assigned to group CBT or enhanced group ST. Primary outcomes focused on beliefs about voices and global auditory hallucinations severity. Secondary outcomes included psychotic symptoms, self-esteem, social functioning, insight, depression, and hospitalization. Controlling for baseline levels, these outcomes were evaluated across post-treatment, 3 month and 12 month follow-ups. Participants who received enhanced ST were less likely to both resist voices and to rate them as less malevolent through 12-month follow-up relative to participants who received CBT. Group CBT was associated with lower general and total symptom scores on the PANSS through 12-month-followup relative to participants who received enhanced ST. Outcomes improved through 12-month follow-up in both therapy groups, with enhanced ST having more specific impact on auditory hallucinations, and CBT impacting general psychotic symptoms.

  15. Design of the integrative medical group visits randomized control trial for underserved patients with chronic pain and depression.

    PubMed

    Gardiner, Paula; Lestoquoy, Anna Sophia; Gergen-Barnett, Katherine; Penti, Brian; White, Laura F; Saper, Robert; Fredman, Lisa; Stillman, Sarah; Lily Negash, N; Adelstein, Pamela; Brackup, Ivy; Farrell-Riley, Christine; Kabbara, Karim; Laird, Lance; Mitchell, Suzanne; Bickmore, Timothy; Shamekhi, Ameneh; Liebschutz, Jane M

    2017-03-01

    Given the public health crisis of opioid overprescribing for pain, there is a need for evidence-based non pharmacological treatment options that effectively reduce pain and depression. We aim to examine the effectiveness of the Integrative Medical Group Visits (IMGV) model in reducing chronic pain and depressive symptoms, as well as increasing pain self-management. This paper details the study design and implementation of an ongoing randomized controlled trial of the IMGV model as compared to primary care visits. The research aims to determine if the IMGV model is effective in achieving: a) a reduction in self-reported pain and depressive symptoms and 2) an improvement in the self-management of pain, through increasing pain self-efficacy and reducing use of self-reported pain medication. We intend to recruit 154 participants to be randomized in our intervention, the IMGV model (n=77) and to usual care (n=77). Usual care of chronic pain through pharmacological treatment has mixed evidence of efficacy and may not improve quality of life or functional status. We aim to conduct a randomized controlled trial to evaluate the effectiveness of the IMGV model as compared to usual care in reducing self-reported pain and depressive symptoms as well as increasing pain management skills. Copyright © 2016 Elsevier Inc. All rights reserved.

  16. Mindfulness-and body-psychotherapy-based group treatment of chronic tinnitus: a randomized controlled pilot study

    PubMed Central

    2012-01-01

    Background Tinnitus, the perception of sound in absence of an external acoustic source, impairs the quality of life in 2% of the population. Since in most cases causal treatment is not possible, the majority of therapeutic attempts aim at developing and strengthening individual coping and habituation strategies. Therapeutic interventions that incorporate training in mindfulness meditation have become increasingly popular in the treatment of stress-related disorders. Here we conducted a randomized, controlled clinical study to investigate the efficacy of a specific mindfulness- and body-psychotherapy based program in patients suffering from chronic tinnitus. Methods Thirty-six patients were enrolled in this pilot study. The treatment was specifically developed for tinnitus patients and is based on mindfulness and body psychotherapy. Treatment was performed as group therapy at two training weekends that were separated by an interval of 7 weeks (eleven hours/weekend) and in four further two-hour sessions (week 2, 9, 18 and 22). Patients were randomized to receive treatment either immediately or after waiting time, which served as a control condition. The primary study outcome was the change in tinnitus complaints as measured by the German Version of the Tinnitus Questionnaire (TQ). Results ANOVA testing for the primary outcome showed a significant interaction effect time by group (F = 7.4; df = 1,33; p = 0.010). Post hoc t-tests indicated an amelioration of TQ scores from baseline to week 9 in both groups (intervention group: t = 6.2; df = 17; p < 0.001; control group: t = 2.5; df = 16; p = 0.023), but the intervention group improved more than the control group. Groups differed at week 7 and 9, but not at week 24 as far as the TQ score was concerned. Conclusions Our results suggest that this mindfulness- and body-psychotherapy-based approach is feasible in the treatment of tinnitus and merits further evaluation in clinical studies

  17. Cost-Effectiveness of Group and Internet Cognitive Behavioral Therapy for Insomnia in Adolescents: Results from a Randomized Controlled Trial

    PubMed Central

    De Bruin, Eduard J.; van Steensel, Francisca J.A.; Meijer, Anne Marie

    2016-01-01

    Study Objectives: To investigate cost-effectiveness of adolescent cognitive behavioral therapy for insomnia (CBTI) in group- and Internet-delivered formats, from a societal perspective with a time horizon of 1 y Methods: Costs and effects data up to 1-y follow-up were obtained from a randomized controlled trial (RCT) comparing Internet CBTI to face-to-face group CBTI. The study was conducted at the laboratory of the Research Institute of Child Development and Education at the University of Amsterdam, and the academic youth mental health care center UvAMinds in Amsterdam. Sixty-two participants meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision criteria for insomnia were randomized to face-to-face group CBTI (GT; n = 31, age = 15.6 y ± 1.8, 71.0% girls) or individual Internet CBTI (IT; n = 31, age = 15.4 y ± 1.5, 83.9% girls). The intervention consisted of six weekly sessions and a 2-mo follow up booster-session of CBTI, consisting of psychoeducation, sleep hygiene, restriction of time in bed, stimulus control, cognitive therapy, and relaxation techniques. GT sessions were held in groups of six to eight adolescents guided by two trained sleep therapists. IT consisted of individual Internet therapy with preprogrammed content similar to GT, and guided by trained sleep therapists. Results: Outcome measures were subjective sleep efficiency (SE) ≥ 85%, and quality-adjusted life-years (QALY). Analyses were conducted from a societal perspective. Incremental cost-effectiveness ratios (ICERs) were calculated using bootstrap sampling, and presented in cost-effectiveness planes. Primary analysis showed costs over 1 y were higher for GT but effects were similar for IT and GT. Bootstrapped ICERs demonstrated there is a high probability of IT being cost-effective compared to GT. Secondary analyses confirmed robustness of results. Conclusions: Internet CBTI is a cost-effective treatment compared to group CBTI for adolescents, although

  18. Recovery of positive future thinking within a high-risk parasuicide group: results from a pilot randomized controlled trial.

    PubMed

    MacLeod, A K; Tata, P; Evans, K; Tyrer, P; Schmidt, U; Davidson, K; Thornton, S; Catalan, J

    1998-11-01

    The research examined: (i) whether high risk parasuicide patients showed a deficit in positive future thinking but no increase in negative future thinking; and (ii) whether such a deficit could be remedied by a brief, manual-assisted psychological intervention (manual assisted cognitive-behaviour therapy; MACT). A cross-sectional, mixed model design was used to assess differences between a sample of high risk parasuicide patients and matched controls on future thinking. A longitudinal mixed model design was used to assess changes in future thinking in the different groups over time. Parasuicide patients with a history of previous suicidal behaviour and personality disturbance were compared with a matched group of community controls on an adapted fluency measure of future thinking, which measured both quantitative and qualitative aspects of anticipated experiences. Patients were then randomly allocated to either the specific intervention (MACT) or treatment as usual (TAU) and assessed again at 6 month follow-up. Parasuicide patients showed reduced positive future thinking but no increased negative future thinking. Patients who received MACT showed a significant improvement in positive future thinking over the follow-up period whereas the TAU group showed no such improvement. However, interpretation of this finding was made more difficult by the control group also showing a significant improvement in positive future thinking. The results confirm that parasuicide patients exhibit a relative deficit in positive future thinking and suggest that this lack of positive future thinking may be remedied, at least partly, by a brief intervention.

  19. Effectiveness of a psycho-educational group program for major depression in primary care: a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Studies show the effectiveness of group psychoeducation in reducing symptoms in people with depression. However, few controlled studies that have included aspects of personal care and healthy lifestyle (diet, physical exercise, sleep) together with cognitive-behavioral techniques in psychoeducation are proven to be effective. The objective of this study is to assess the effectiveness of a psychoeducational program, which includes aspects of personal care and healthy lifestyle, in patients with mild/moderate depression symptoms in Primary Care (PC). Methods In a randomized, controlled trial, 246 participants over 20 years old with ICD-10 major depression were recruited through nurses/general practitioners at 12 urban Primary Care Centers (PCCs) in Barcelona. The intervention group (IG) (n=119) received a group psychoeducational program (12 weekly, 1.5 h sessions led by two nurses) and the control group (CG) (n=112) received usual care. Patients were assessed at baseline and at, 3, 6 and 9 months. The main outcome measures were the BDI, EQ-5D and remission based upon the BDI. Results 231 randomized patients were included, of whom 85 had mild depression and 146 moderate depression. The analyses showed significant differences between groups in relation to remission of symptoms, especially in the mild depression group with a high rate of 57% (p=0.009) at post-treatment and 65% (p=0.006) at 9 month follow up, and only showed significant differences on the BDI at post-treatment (p=0.016; effect size Cohen’s d’=.51) and at 6 and 9 month follow-up (p= 0.048; d’=.44). In the overall and moderate sample, the analyses only showed significant differences between groups on the BDI at post-treatment, p=0.02 (d’=.29) and p=0.010 (d’=.47), respectively. The psychoeducation group improved significantly on the EQ-5D at short and long-term. Conclusions This psychoeducational intervention is a short and long-term effective treatment for patients with mild

  20. A randomized controlled trial of group cognitive behavioral therapy for Chinese breast cancer patients with major depression.

    PubMed

    Qiu, Jianyin; Chen, Weijun; Gao, Xiufei; Xu, Yong; Tong, Huiqi; Yang, Min; Xiao, Zeping; Yang, Min

    2013-06-01

    This study aims to evaluate the effects of Group Cognitive Behavioral Therapy (GCBT) in treating major depression in Chinese women with breast cancer. Sixty-two breast cancer patients diagnosed with major depression were randomly assigned to GCBT group (N = 31) or a waiting list control group provided with an educational booklet (N = 31). The primary outcome measure was the 17-Item Hamilton Depression Rating Scale (17-HAMD). The second outcome measures were Self-Rating Anxiety Scale, Functional Assessment of Cancer Therapy - Breast and Self-Esteem Scale (SES). Assessments were carried out at completion of the study and six-month afterwards. Patients in the GCBT group had a significant reduction in the 17-HAMD mean score by 9 points (p < 0.001), more than any reduction among patients in the control group from baseline to the end of therapy and a significant 7 points (p < 0.001) more reduction from baseline to six-month follow-up. GCBT also yielded significantly greater improvement than the control group with regard to quality of life (QoL; p < 0.01) and self-esteem (p < 0.05). No significant differences were found between groups on improving anxiety (p > 0.05). The results of this trial suggest that GCBT is effective for treating major depression, as well as for improving QoL and self-esteem in breast cancer patients. Chictr.org ChiCTR-TRC-11001689.

  1. Social support and education groups for single mothers: a randomized controlled trial of a community-based program

    PubMed Central

    Lipman, Ellen L.; Boyle, Michael H.

    2005-01-01

    Background Members of families headed by single mothers are at increased risk of psychosocial disadvantage and mental health problems. We assessed the effect of a community-based program of social support and education groups for single mothers of young children on maternal well-being and parenting. Methods We recruited 116 single mothers of children 3 to 9 years old through community advertisements. Eligible mothers were randomly assigned either to participate in a 10-week program of group sessions (1.5 hours per week) offering social support and education, with a parallel children's activity group, or to receive a standard list of community resources and the option to participate in group sessions at the end of the follow-up period. Interviewers blinded to the randomization collected assessment data from all mothers at baseline and at 3 follow-up visits (immediately after the intervention and at 3 and 6 months after the intervention). Outcome measures were self-reported mood, self-esteem, social support and parenting. Results Between February 2000 and April 2003, the program was offered to 9 groups of single mothers. Most of the mothers in the trial reported high levels of financial and mental health problems. In the short term (after the intervention), mothers in the intervention group had improved scores for mood (p < 0.01, standardized effect = 0.55) and self-esteem (p < 0.05, standardized effect = 0.29) compared with mothers in the control group; scores for the other 2 measures did not differ between the groups. Growth curve analysis of program effects over the follow-up period showed improvement in all 4 outcomes, with no significant difference between the intervention and control groups. Interpretation This community-based program of group sessions offering social support and education to low-income single mothers had positive short-term effects on mood and self-esteem but not on social support and parenting. Longer follow-up showed attenuation of these

  2. Effect of Facilitation of Local Maternal-and-Newborn Stakeholder Groups on Neonatal Mortality: Cluster-Randomized Controlled Trial.

    PubMed

    Persson, Lars Åke; Nga, Nguyen T; Målqvist, Mats; Thi Phuong Hoa, Dinh; Eriksson, Leif; Wallin, Lars; Selling, Katarina; Huy, Tran Q; Duc, Duong M; Tiep, Tran V; Thi Thu Thuy, Vu; Ewald, Uwe

    2013-01-01

    Facilitation of local women's groups may reportedly reduce neonatal mortality. It is not known whether facilitation of groups composed of local health care staff and politicians can improve perinatal outcomes. We hypothesised that facilitation of local stakeholder groups would reduce neonatal mortality (primary outcome) and improve maternal, delivery, and newborn care indicators (secondary outcomes) in Quang Ninh province, Vietnam. In a cluster-randomized design 44 communes were allocated to intervention and 46 to control. Laywomen facilitated monthly meetings during 3 years in groups composed of health care staff and key persons in the communes. A problem-solving approach was employed. Births and neonatal deaths were monitored, and interviews were performed in households of neonatal deaths and of randomly selected surviving infants. A latent period before effect is expected in this type of intervention, but this timeframe was not pre-specified. Neonatal mortality rate (NMR) from July 2008 to June 2011 was 16.5/1,000 (195 deaths per 11,818 live births) in the intervention communes and 18.4/1,000 (194 per 10,559 live births) in control communes (adjusted odds ratio [OR] 0.96 [95% CI 0.73-1.25]). There was a significant downward time trend of NMR in intervention communes (p = 0.003) but not in control communes (p = 0.184). No significant difference in NMR was observed during the first two years (July 2008 to June 2010) while the third year (July 2010 to June 2011) had significantly lower NMR in intervention arm: adjusted OR 0.51 (95% CI 0.30-0.89). Women in intervention communes more frequently attended antenatal care (adjusted OR 2.27 [95% CI 1.07-4.8]). A randomized facilitation intervention with local stakeholder groups composed of primary care staff and local politicians working for three years with a perinatal problem-solving approach resulted in increased attendance to antenatal care and reduced neonatal mortality after a latent period.

  3. The efficacy of lymphatic drainage and traditional massage in the prophylaxis of migraine: a randomized, controlled parallel group study.

    PubMed

    Happe, Svenja; Peikert, Andreas; Siegert, Rudolf; Evers, Stefan

    2016-10-01

    This study aimed at examining the efficacy of lymphatic drainage (LD) and traditional massage (TM) in the prophylactic treatment of migraine using controlled prospective randomized clinical trial of 64 patients (57 women, 45 ± 10 years) with migraine with and without aura. Patients were randomized into three groups: LD (n = 21); TM (n = 21); waiting group (WG, n = 22). After a 4-week-baseline, a treatment period of 8 weeks was applied followed by a 4-week observation period. The patients filled in a headache diary continuously; every 4 weeks they filled in the German version of the CES-D and the German version of the Headache Disability Inventory. The main outcome measure was migraine frequency per month. At the end of the observation period, the number of migraine attacks and days decreased in the LD group by 1.8 and 3.1, respectively, in the TM group by 1.3 and 2.4, and in the WG by 0.4 and 0.2, respectively. The differences between LD and WG were significant (p = 0.006 and p = 0.015, respectively) as well as the differences between TM und WG (p = 0.042 and p = 0.016, respectively). There was a significant decrease in the amount of analgesic intake in the LD group compared to the two other groups (p = 0.004). TM and LD resulted in a reduction of migraine attack frequency. The analgesic intake only decreased significantly during LD intervention. Useful effects were identified for LD and TM as compared to WG for the prophylaxis of migraine. LD was more efficacious in some parameters than TM.

  4. A randomized controlled trial of a brief psychoeducational support group for partners of early stage breast cancer patients.

    PubMed

    Bultz, B D; Speca, M; Brasher, P M; Geggie, P H; Page, S A

    2000-01-01

    Partners of breast cancer patients are relied upon for support at a time when their own coping abilities are taxed by the challenge of cancer, yet few studies have investigated psychosocial interventions that include or target the patient's 'significant other'. Of the 118 consecutive patients approached, 36 patients and their partners participated in a randomized controlled trial of a brief psychoeducational group program for partners only. Psychometric instruments (including the Profile of Mood States (POMS), the Index of Marital Satisfaction (IMS) and DUKE-UNC Functional Social Support Scale (FSSS)) were administered pre-test, post-test and at 3 months follow-up. The Mental Adjustment to Cancer Scale (MAC) was also completed by patients. Three months after the intervention, partners had less mood disturbance than did controls. Patients whose partners received the intervention reported less mood disturbance, greater confidant support (CS) and greater marital satisfaction.

  5. Effectiveness of a cognitive-behavioral group intervention for knee osteoarthritis pain: protocol of a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Knee osteoarthritis is the most common type of arthritis, with pain being its most common symptom. Little is known about the psychological aspects of knee osteoarthritis pain. There is an emerging consensus among osteoarthritis specialists about the importance of addressing not only biological but also psychosocial factors in the assessment and treatment of osteoarthritis. As few studies have evaluated the effect of psychological interventions on knee osteoarthritis pain, good quality randomized controlled trials are needed to determine their effectiveness. Methods/Design We intend to conduct a 6-week single-blinded randomized controlled trial with a 12-month follow-up. Altogether, 108 patients aged from 35 to 75 years with clinical symptoms and radiographic grading (KL 2–4) of knee osteoarthritis will be included. The clinical inclusion criteria are pain within the last year in or around the knee occurring on most days for at least one month, and knee pain of ≥40 mm on a 100-mm visual analogue scale in the WOMAC pain subscale for one week prior to study entry. Patients with any severe psychiatric disorder, other back or lower limb pain symptoms more aggravating than knee pain, or previous or planned lower extremity joint surgery will be excluded. The patients will be randomly assigned to a combined GP care and cognitive-behavioral intervention group (n = 54) or to a GP care control group (n = 54). The cognitive-behavioral intervention will consist of 6 weekly group sessions supervised by a psychologist and a physiotherapist experienced in the treatment of pain. The main goals of the intervention are to reduce maladaptive pain coping and to increase the self-management of pain and disability. The follow-up-points will be arranged at 3 and 12 months. The primary outcome measure will be the WOMAC pain subscale. Secondary outcome measures will include self-reports of pain and physical function, a health related quality of life questionnaire, and various

  6. The Effectiveness of a Group Triple P with Chinese Parents Who Have a Child with Developmental Disabilities: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Leung, Cynthia; Fan, Angel; Sanders, Matthew R.

    2013-01-01

    The study examined the effectiveness of Group Triple P, a Level 4 variant of the Triple P multilevel system of parenting support, with Chinese parents who had a preschool aged child with a developmental disability, using randomized controlled trial design. Participants (Intervention group: 42; Waitlist Control group: 39) completed measures on…

  7. The Effectiveness of a Group Triple P with Chinese Parents Who Have a Child with Developmental Disabilities: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Leung, Cynthia; Fan, Angel; Sanders, Matthew R.

    2013-01-01

    The study examined the effectiveness of Group Triple P, a Level 4 variant of the Triple P multilevel system of parenting support, with Chinese parents who had a preschool aged child with a developmental disability, using randomized controlled trial design. Participants (Intervention group: 42; Waitlist Control group: 39) completed measures on…

  8. Group Parent-Child Interaction Therapy: A Randomized Control Trial for the Treatment of Conduct Problems in Young Children

    PubMed Central

    Niec, Larissa N.; Barnett, Miya L.; Prewett, Matthew S.; Shanley, Jenelle

    2016-01-01

    Objective Although efficacious interventions exist for childhood conduct problems, a majority of families in need of services do not receive them. To address problems of treatment access and adherence, innovative adaptations of current interventions are needed. This randomized control trial investigated the relative efficacy of a novel format of parent-child interaction therapy (PCIT), a treatment for young children with conduct problems. Methods Eighty-one families with three- to six-year-old children (71.6% male; 85.2% Caucasian) with diagnoses of oppositional defiant or conduct disorder were randomized to individual PCIT (n = 42) or the novel format, group PCIT. Parents completed standardized measures of children’s conduct problems, parenting stress, and social support at intake, posttreatment, and six-month follow-up. Therapist ratings, parent attendance, and homework completion provided measures of treatment adherence. Throughout treatment, parenting skills were assessed using the Dyadic Parent-Child Interaction Coding System. Results Parents in both group and individual PCIT reported significant improvements from intake to posttreatment and follow-up in their children’s conduct problems and adaptive functioning, as well as significant decreases in parenting stress. Parents in both treatment conditions also showed significant improvements in their parenting skills. There were no interactions between time and treatment format. Contrary to expectation, parents in group PCIT did not experience greater social support or treatment adherence. Conclusions Group PCIT was not inferior to individual PCIT and may be a valuable format to reach more families in need of services. Future work should explore the efficiency and sustainability of group PCIT in community settings. PMID:27018531

  9. A randomized, controlled, pilot study of dialectical behavior therapy skills in a psychoeducational group for individuals with bipolar disorder.

    PubMed

    Van Dijk, Sheri; Jeffrey, Janet; Katz, Mark R

    2013-03-05

    Bipolar disorder (BD) is a chronic and disabling psychiatric disorder characterized by recurrent episodes of mania/hypomania and depression. Dialectical behavior therapy (DBT) techniques have been shown to effectively treat borderline personality disorder, a condition also marked by prominent affective disturbances. The utility of DBT techniques in treating BD has been largely unexplored. The purpose of this research was to conduct a pilot study of a DBT-based psychoeducational group (BDG) in treating euthymic, depressed, or hypomanic Bipolar I or II patients. In this experiment, 26 adults with bipolar I or II were randomized to intervention or wait-list control groups and completed the Beck depression inventory II, mindfulness-based self-efficacy scale, and affective control scale at baseline and 12 weeks. The BDG intervention consisted of 12 weekly 90-min sessions which taught DBT skills, mindfulness techniques, and general BD psychoeducation. Using RM-ANOVA, subjects in BDG demonstrated a trend toward reduced depressive symptoms, and significant improvement in several MSES subscales indicating greater mindful awareness, and less fear toward and more control of emotional states (ACS). These findings were supported with a larger sample of patients who completed the BDG. Furthermore, group attendees had reduced emergency room visits and mental health related admissions in the six months following BDG. The small sample size in RCT affects power to detect between group differences. How well improvements after the12-week BDG were maintained is unknown. There is preliminary evidence that DBT skills reduce depressive symptoms, improve affective control, and improve mindfulness self-efficacy in BD. Its application warrants further evaluation in larger studies. Copyright © 2012 Elsevier B.V. All rights reserved.

  10. Factors associated with attrition from a randomized controlled trial of meaning-centered group psychotherapy for patients with advanced cancer

    PubMed Central

    Applebaum, Allison J.; Lichtenthal, Wendy G.; Pessin, Hayley A.; Radomski, Julia N.; Gökbayrak, N. Simay; Katz, Aviva M.; Rosenfeld, Barry; Breitbart, William

    2013-01-01

    Objective The generalizability of palliative care intervention research is often limited by high rates of study attrition. This study examined factors associated with attrition from a randomized controlled trial comparing meaning-centered group psychotherapy (MCGP), an intervention designed to help advanced cancer patients sustain or enhance their sense of meaning to the supportive group psychotherapy (SGP), a standardized support group. Methods Patients with advanced solid tumor cancers (n = 153) were randomized to eight sessions of either the MCGP or SGP. They completed assessments of psychosocial, spiritual, and physical well-being pretreatment, midtreatment, and 2 months post-treatment. Attrition was assessed in terms of the percent of participants who failed to complete these assessments, and demographic, psychiatric, medical, and study-related correlates of attrition were examined for the participants in each of these categories. Results The rates of attrition at these time points were 28.1%, 17.7%, and 11.1%, respectively; 43.1% of the participants (66 of 153) completed the entire study. The most common reason for dropout was patients feeling too ill. Attrition rates did not vary significantly between study arms. The participants who dropped out pretreatment reported less financial concerns than post-treatment dropouts, and the participants who dropped out of the study midtreatment had poorer physical health than treatment completers. There were no other significant associations between attrition and any demographic, medical, psychiatric, or study-related variables. Conclusions These findings highlight the challenge of maintaining advanced cancer patients in longitudinal research and suggest the need to consider alternative approaches (e.g., telemedicine) for patients who might benefit from group interventions but are too ill to travel. PMID:21751295

  11. A Comprehensive Lifestyle Peer Group-Based Intervention on Cardiovascular Risk Factors: The Randomized Controlled Fifty-Fifty Program.

    PubMed

    Gómez-Pardo, Emilia; Fernández-Alvira, Juan Miguel; Vilanova, Marta; Haro, Domingo; Martínez, Ramona; Carvajal, Isabel; Carral, Vanesa; Rodríguez, Carla; de Miguel, Mercedes; Bodega, Patricia; Santos-Beneit, Gloria; Peñalvo, Jose Luis; Marina, Iñaki; Pérez-Farinós, Napoleón; Dal Re, Marian; Villar, Carmen; Robledo, Teresa; Vedanthan, Rajesh; Bansilal, Sameer; Fuster, Valentin

    2016-02-09

    Cardiovascular diseases stem from modifiable risk factors. Peer support is a proven strategy for many chronic illnesses. Randomized trials assessing the efficacy of this strategy for global cardiovascular risk factor modification are lacking. This study assessed the hypothesis that a peer group strategy would help improve healthy behaviors in individuals with cardiovascular risk factors. A total of 543 adults 25 to 50 years of age with at least 1 risk factor were recruited; risk factors included hypertension (20%), overweight (82%), smoking (31%), and physical inactivity (81%). Subjects were randomized 1:1 to a peer group-based intervention group (IG) or a self-management control group (CG) for 12 months. Peer-elected leaders moderated monthly meetings involving role-play, brainstorming, and activities to address emotions, diet, and exercise. The primary outcome was mean change in a composite score related to blood pressure, exercise, weight, alimentation, and tobacco (Fuster-BEWAT score, 0 to 15). Multilevel models with municipality as a cluster variable were applied to assess differences between groups. Participants' mean age was 42 ± 6 years, 71% were female, and they had a mean baseline Fuster-BEWAT score of 8.42 ± 2.35. After 1 year, the mean scores were significantly higher in the IG (n = 277) than in the CG (n = 266) (IG mean score: 8.84; 95% confidence interval (CI): 8.37 to 9.32; CG mean score: 8.17; 95% CI: 7.55 to 8.79; p = 0.02). The increase in the overall score was significantly larger in the IG compared with the CG (difference: 0.75; 95% CI: 0.32 to 1.18; p = 0.02). The mean improvement in the individual components was uniformly greater in the IG, with a significant difference for the tobacco component. The peer group intervention had beneficial effects on cardiovascular risk factors, with significant improvements in the overall score and specifically on tobacco cessation. A follow-up assessment will be performed 1 year after the final assessment

  12. Effectiveness of group versus individual cognitive-behavioral therapy in patients with abridged somatization disorder: a randomized controlled trial.

    PubMed

    Moreno, Sergio; Gili, Margalida; Magallón, Rosa; Bauzá, Natalia; Roca, Miquel; Del Hoyo, Yolanda Lopez; Garcia-Campayo, Javier

    2013-01-01

    To evaluate the effectiveness and feasibility of a cognitive-behavioral program for patients in primary care units who were diagnosed as having abridged somatization disorder. A multicenter, randomized controlled trial was designed. One hundred sixty-eight patients were recruited from 29 primary care units and randomly assigned to one of three arms: treatment as usual (TAU), individual cognitive-behavioral therapy (CBT), and group CBT. Somatic symptoms were measured using the Screening for Somatoform Disorders and the Severity of Somatic Symptoms scale. The Hamilton Anxiety Rating Scale and the Hamilton Depression Rating Scale were used to assess the severity of anxiety and depression. Individual CBT achieves greater changes in the Screening for Somatoform Disorders posttreatment compared with group CBT (mean [95% confidence interval], 14.17 [11.9-16.3] versus 11.63 [9.4-13.7], p < .001). These improvements were observed at 6 and 12 months (p < .001 and p < .001, respectively). For individual CBT versus TAU, the number-needed-to-treat was 8, whereas for group CBT versus TAU, the number-needed-to-treat was 9. Individual CBT treatment resulted in lower anxiety scores compared with group CBT and TAU (7.33 [5.4-9.2] versus 11.47 [9.4-13.9] versus 13.07 [10.9-15.2], p < .001) posttreatment. Individual CBT and group CBT were associated with sustained benefits at 12-month follow-up compared with TAU (8.6 [6.6-10.6] versus 9.28 [7.2-11.2] versus 16.2 [13.9-18.5], p < .001). Depressive symptoms were lower for individual CBT posttreatment than for TAU (6.96 [5.3-8.6] versus 10.87-12.7], p < .01). CBT in individual and group settings results in significant improvements in somatic symptoms among patients with somatoform abridged disorder compared with TAU. Individual CBT results in greater posttreatment improvements at 6-month and 12-month follow-ups. current controlled trials identifier ISRCTN69944771.

  13. Efficacy of simple integrated group rehabilitation program for patients with knee osteoarthritis: Single-blind randomized controlled trial.

    PubMed

    da Silva, Flávio S; de Melo, Flávio E S; do Amaral, Marcelo M G; Caldas, Vinícius V A; Pinheiro, Íria Lúcia D; Abreu, Bento J; Vieira, Wouber H

    2015-01-01

    We investigated the role of an evidence-based integrated group rehabilitation program on the treatment of patients with knee osteoarthritis (KOA). This was a two-group, randomized controlled, 8 wk trial with 41 patients with moderate to very severe KOA. Patients were assigned to an intervention group (IG) or control group (CG). After both groups had received a self-management education program, IG participants underwent a rehabilitation program, including educational aspects about KOA followed by exercises. CG participants received only general health orientation about KOA during this period. The outcome measures were the Lequesne algofunctional index; 36-Item Short Form Health Survey (SF-36); and chair-stand, sit-and-reach, timed up-and-go, and 6-minute walk tests. Analysis of covariance revealed significant postintervention improvements of IG participants compared with CG participants (p < 0.05) on Lequesne total score and pain and function subdomains; SF-36 physical function, role physical, bodily pain, general health, vitality, and role emotional subdomains; and performance assessed by chair-stand, timed up-and-go, and 6-minute walk tests. Focusing on the primary outcome (Lequesne total score), the mean +/- standard deviation after 8 wk was 5.50 +/- 2.98 for the IG and 7.87 +/- 3.48 for the CG (p = 0.009). The corresponding effect size (partial eta squared with 90% confidence interval) was 0.23 (0.04-0.42), indicating a large effect. The presented rehabilitation program reduced pain and improved quality of life and function in patients with KOA. ClinicalTrials.gov; Progressive Collective-exercise Program on the Knee Osteoarthritis; NCT01850862; https://clinicaltrials.gov/ct2/show/NCT01850862?term=NCT01850862&rank=1.

  14. Culturally appropriate health education for Type 2 diabetes in ethnic minority groups: an updated Cochrane Review of randomized controlled trials.

    PubMed

    Creamer, J; Attridge, M; Ramsden, M; Cannings-John, R; Hawthorne, K

    2016-02-01

    To give an updated perspective of interventions from additional data collected since our first review, conducted in 2008. This updated Cochrane Review incorporates new information from recent randomized controlled trials on culturally appropriate diabetes health education interventions. An electronic literature search of six databases was repeated, with databases of ongoing trials checked and three journals hand-searched. Meta-analysis was carried out for sufficiently homogeneous outcomes, and common themes among trials were highlighted. A total of 22 new trials were added to the original 11. Meta-analysis of 28 trials containing suitable data showed significant improvements in glycaemic control (HbA1c ) and diabetes knowledge over a period of 24 months, after the delivery of culturally appropriate education to participants, compared with those receiving 'conventional' care. There were no consistent benefits over the control group in other selected outcome measures, and lack of data continued to make analysis of several outcome measures difficult. Research activity in this field has increased considerably over the past 6 years, with culturally appropriate diabetes education showing consistent benefits over conventional care in terms of glycaemic control and diabetes knowledge, sustained in the short- to mid-term. Further research is needed to determine the clinical significance of these improvements and their cost-effectiveness. © 2015 The Authors. Diabetic Medicine © 2015 Diabetes UK.

  15. A Randomized Controlled Study of Mind-Body Skills Groups for Treatment of War-Zone Stress in Military and Veteran Populations

    DTIC Science & Technology

    2010-10-01

    Award Number: W81XWH-08-1-0739 TITLE: A Randomized Controlled Study of Mind -Body Skills Groups for Treatment of War-Zone Stress in Military...CONTRACTING ORGANIZATION: The Center for Mind -Body Medicine Washington, DC 20015-1813...SUBTITLE A Randomized Controlled Study of Mind -Body Skills Groups for 5a. CONTRACT NUMBER Treatment of War-Zone Stress in Military and

  16. Can group-based reassuring information alter low back pain behavior? A cluster-randomized controlled trial

    PubMed Central

    Indahl, Aage; Andersen, Lars L.; Burton, Kim; Hertzum-Larsen, Rasmus

    2017-01-01

    Background Low back pain (LBP) is common in the population and multifactorial in nature, often involving negative consequences. Reassuring information to improve coping is recommended for reducing the negative consequences of LBP. Adding a simple non-threatening explanation for the pain (temporary muscular dysfunction) has been successful at altering beliefs and behavior when delivered with other intervention elements. This study investigates the isolated effect of this specific information on future occupational behavior outcomes when delivered to the workforce. Design A cluster-randomized controlled trial. Methods Publically employed workers (n = 505) from 11 Danish municipality centers were randomized at center-level (cluster) to either intervention (two 1-hour group-based talks at the workplace) or control. The talks provided reassuring information together with a simple non-threatening explanation for LBP—the ‘functional-disturbance’-model. Data collections took place monthly over a 1-year period using text message tracking (SMS). Primary outcomes were self-reported days of cutting down usual activities and work participation. Secondary outcomes were self-reported back beliefs, work ability, number of healthcare visits, bothersomeness, restricted activity, use of pain medication, and sadness/depression. Results There was no between-group difference in the development of LBP during follow-up. Cumulative logistic regression analyses showed no between-group difference on days of cutting down activities, but increased odds for more days of work participation in the intervention group (OR = 1.83 95% CI: 1.08–3.12). Furthermore, the intervention group was more likely to report: higher work ability, reduced visits to healthcare professionals, lower bothersomeness, lower levels of sadness/depression, and positive back beliefs. Conclusion Reassuring information involving a simple non-threatening explanation for LBP significantly increased the odds for days of

  17. Cost-Effectiveness of Group and Internet Cognitive Behavioral Therapy for Insomnia in Adolescents: Results from a Randomized Controlled Trial.

    PubMed

    De Bruin, Eduard J; van Steensel, Francisca J A; Meijer, Anne Marie

    2016-08-01

    To investigate cost-effectiveness of adolescent cognitive behavioral therapy for insomnia (CBTI) in group- and Internet-delivered formats, from a societal perspective with a time horizon of 1 y. Costs and effects data up to 1-y follow-up were obtained from a randomized controlled trial (RCT) comparing Internet CBTI to face-to-face group CBTI. The study was conducted at the laboratory of the Research Institute of Child Development and Education at the University of Amsterdam, and the academic youth mental health care center UvAMinds in Amsterdam. Sixty-two participants meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision criteria for insomnia were randomized to face-to-face group CBTI (GT; n = 31, age = 15.6 y ± 1.8, 71.0% girls) or individual Internet CBTI (IT; n = 31, age = 15.4 y ± 1.5, 83.9% girls). The intervention consisted of six weekly sessions and a 2-mo follow up booster-session of CBTI, consisting of psychoeducation, sleep hygiene, restriction of time in bed, stimulus control, cognitive therapy, and relaxation techniques. GT sessions were held in groups of six to eight adolescents guided by two trained sleep therapists. IT consisted of individual Internet therapy with preprogrammed content similar to GT, and guided by trained sleep therapists. Outcome measures were subjective sleep efficiency (SE) ≥ 85%, and quality-adjusted life-years (QALY). Analyses were conducted from a societal perspective. Incremental cost-effectiveness ratios (ICERs) were calculated using bootstrap sampling, and presented in cost-effectiveness planes. Primary analysis showed costs over 1 y were higher for GT but effects were similar for IT and GT. Bootstrapped ICERs demonstrated there is a high probability of IT being cost-effective compared to GT. Secondary analyses confirmed robustness of results. Internet CBTI is a cost-effective treatment compared to group CBTI for adolescents, although effects were largely similar for both formats

  18. Renoprotective effects of febuxostat in hyperuricemic patients with chronic kidney disease: a parallel-group, randomized, controlled trial.

    PubMed

    Tanaka, Kenichi; Nakayama, Masaaki; Kanno, Makoto; Kimura, Hiroshi; Watanabe, Kimio; Tani, Yoshihiro; Hayashi, Yoshimitsu; Asahi, Koichi; Terawaki, Hiroyuki; Watanabe, Tsuyoshi

    2015-12-01

    Hyperuricemia is associated with the onset of chronic kidney disease (CKD) and renal disease progression. Febuxostat, a novel, non-purine, selective xanthine oxidase inhibitor, has been reported to have a stronger effect on hyperuricemia than conventional therapy with allopurinol. However, few data are available regarding the clinical effect of febuxostat in patients with CKD. A prospective, randomized, open-label, parallel-group trial was conducted in hyperuricemic patients with stage 3 CKD. Patients were randomly assigned to treatment with febuxostat (n = 21) or to continue conventional therapy (n = 19). Treatment was continued for 12 weeks. The efficacy of febuxostat was determined by monitoring serum uric acid (UA) levels, blood pressures, renal function, and urinary protein levels. In addition, urinary liver-type fatty acid-binding protein (L-FABP), urinary albumin, urinary beta 2 microglobulin (β2MG), and serum high sensitivity C-reactive protein were measured before and 12 weeks after febuxostat was added to the treatment. Febuxostat resulted in a significantly greater reduction in serum UA (-2.2 mg/dL) than conventional therapy (-0.3 mg/dL, P < 0.001). Serum creatinine and estimated glomerular filtration rate changed little during the study period in each group. However, treatment with febuxostat for 12 weeks reduced the urinary levels of L-FABP, albumin, and β2MG, whereas the levels of these markers did not change in the control group. Febuxostat reduced serum UA levels more effectively than conventional therapy and might have a renoprotective effect in hyperuricemic patients with CKD. Further studies should clarify whether febuxostat prevents the progression of renal disease and improves the prognosis of CKD.

  19. Cluster Randomized Controlled Trial of Group Prenatal Care: Perinatal Outcomes Among Adolescents in New York City Health Centers

    PubMed Central

    Earnshaw, Valerie; Lewis, Jessica B.; Kershaw, Trace S.; Magriples, Urania; Stasko, Emily; Rising, Sharon Schindler; Cassells, Andrea; Cunningham, Shayna; Bernstein, Peter; Tobin, Jonathan N.

    2016-01-01

    Objectives. We compared an evidence-based model of group prenatal care to traditional individual prenatal care on birth, neonatal, and reproductive health outcomes. Methods. We performed a multisite cluster randomized controlled trial in 14 health centers in New York City (2008–2012). We analyzed 1148 pregnant women aged 14 to 21 years, at less than 24 weeks of gestation, and not at high obstetrical risk. We assessed outcomes via medical records and surveys. Results. In intention-to-treat analyses, women at intervention sites were significantly less likely to have infants small for gestational age (< 10th percentile; 11.0% vs 15.8%; odds ratio = 0.66; 95% confidence interval = 0.44, 0.99). In as-treated analyses, women with more group visits had better outcomes, including small for gestational age, gestational age, birth weight, days in neonatal intensive care unit, rapid repeat pregnancy, condom use, and unprotected sex (P = .030 to < .001). There were no associated risks. Conclusions. CenteringPregnancy Plus group prenatal care resulted in more favorable birth, neonatal, and reproductive outcomes. Successful translation of clinical innovations to enhance care, improve outcomes, and reduce cost requires strategies that facilitate patient adherence and support organizational change. PMID:26691105

  20. Methods and analysis of realizing randomized grouping.

    PubMed

    Hu, Liang-Ping; Bao, Xiao-Lei; Wang, Qi

    2011-07-01

    Randomization is one of the four basic principles of research design. The meaning of randomization includes two aspects: one is to randomly select samples from the population, which is known as random sampling; the other is to randomly group all the samples, which is called randomized grouping. Randomized grouping can be subdivided into three categories: completely, stratified and dynamically randomized grouping. This article mainly introduces the steps of complete randomization, the definition of dynamic randomization and the realization of random sampling and grouping by SAS software.

  1. Variations of high frequency parameter of heart rate variability following osteopathic manipulative treatment in healthy subjects compared to control group and sham therapy: randomized controlled trial.

    PubMed

    Ruffini, Nuria; D'Alessandro, Giandomenico; Mariani, Nicolò; Pollastrelli, Alberto; Cardinali, Lucia; Cerritelli, Francesco

    2015-01-01

    Heart Rate Variability (HRV) indicates how heart rate changes in response to inner and external stimuli. HRV is linked to health status and it is an indirect marker of the autonomic nervous system (ANS) function. To investigate the influence of osteopathic manipulative treatment (OMT) on cardiac autonomic modulation in healthy subjects, compared with sham therapy and control group. Sixty-six healthy subjects, both male and female, were included in the present 3-armed randomized placebo controlled within subject cross-over single blinded study. Participants were asymptomatic adults (26.7 ± 8.4 y, 51% male, BMI 18.5 ± 4.8), both smokers and non-smokers and not on medications. At enrollment subjects were randomized in three groups: A, B, C. Standardized structural evaluation followed by a patient need-based osteopathic treatment was performed in the first session of group A and in the second session of group B. Standardized evaluation followed by a protocoled sham treatment was provided in the second session of group A and in the first session of group B. No intervention was performed in the two sessions of group C, acting as a time-control. The trial was registered on clinicaltrials.gov identifier: NCT01908920. HRV was calculated from electrocardiography before, during and after the intervention, for a total amount time of 25 min and considering frequency domain as well as linear and non-linear methods as outcome measures. OMT engendered a statistically significant increase of parasympathetic activity, as shown by High Frequency power (p < 0.001), expressed in normalized and absolute unit, and possibly decrease of sympathetic activity, as revealed by Low Frequency power (p < 0.01); results also showed a reduction of Low Frequency/High Frequency ratio (p < 0.001) and Detrended fluctuation scaling exponent (p < 0.05). Findings suggested that OMT can influence ANS activity increasing parasympathetic function and decreasing sympathetic activity, compared to sham

  2. Intervention leads to improvements in the nutrient profile of snacks served in afterschool programs: a group randomized controlled trial.

    PubMed

    Beets, Michael W; Turner-McGrievy, Brie; Weaver, R Glenn; Huberty, Jennifer; Moore, Justin B; Ward, Dianne S; Freedman, Darcy A

    2016-09-01

    Widely adopted nutrition policies for afterschool programs (ASPs) focus on serving a fruit/vegetable daily and eliminating sugar-sweetened foods/beverages. The impact of these policies on the nutrient profile of snacks served is unclear. Evaluate changes in macro/micronutrient content of snacks served in ASPs. A 1-year group randomized controlled trial was conducted in 20 ASPs serving over 1700 elementary-age children. Intervention ASPs received a multistep adaptive framework intervention. Direct observation of snack served was collected and nutrient information determined using the USDA Nutrient Database, standardized to nutrients/100 kcal. By post-assessment, intervention ASPs reduced total kcal/snack served by 66 kcal (95CI -114 to -19 kcal) compared to control ASPs. Total fiber (+1.7 g/100 kcal), protein (+1.4 g/100 kcal), polyunsaturated fat (+1.2 g/100 kcal), phosphorous (+49.0 mg/100 kcal), potassium (+201.8 mg/100 kcal), and vitamin K (+21.5 μg/100 kcal) increased in intervention ASPs, while added sugars decreased (-5.0 g/100 kcal). Nutrition policies can lead to modest daily caloric reductions and improve select macro/micronutrients in snacks served. Long-term, these nutritional changes may contribute to healthy dietary habits.

  3. Randomized controlled trial of group cognitive behavioral therapy compared to a discussion group for co-morbid anxiety and depression in older adults.

    PubMed

    Wuthrich, V M; Rapee, R M; Kangas, M; Perini, S

    2016-03-01

    Co-morbid anxiety and depression in older adults is associated with worse physical and mental health outcomes and poorer response to psychological and pharmacological treatments in older adults. However, there is a paucity of research focused on testing the efficacy of the co-morbid treatment of anxiety and depression in older adults using psychological interventions. Accordingly, the primary objective of the current study was to test the effects of a group cognitive behavior therapy (CBT) program in treating co-morbid anxiety and depression in a sample of older age adults. A total of 133 community-dwelling participants aged ⩾60 years (mean age = 67.35, s.d. = 5.44, male = 59) with both an anxiety disorder and unipolar mood disorder, as assessed on the Anxiety Disorder Interview Schedule (ADIS), were randomly allocated to an 11-week CBT group or discussion group. Participants with Mini-Mental State Examination scores <26 were excluded. Participants were assessed pre-treatment, post-treatment and at 6 months follow-up on the ADIS, a brief measure of well-being, Geriatric Anxiety Inventory and Geriatric Depression Scale. Both conditions resulted in significant improvements over time on all diagnostic, symptom and wellbeing measures. Significant group × time interaction effects emerged at post-treatment only for diagnostic severity of the primary disorder, mean severity of all anxiety disorders, mood disorders, and all disorders, and recovery rates on primary disorder. Group CBT produced faster and sustained improvements in anxiety and depression on diagnostic severity and recovery rates compared to an active control in older adults.

  4. Economic evaluation of a group randomized controlled trial on healthy eating and physical activity in afterschool programs.

    PubMed

    Beets, Michael W; Brazendale, Keith; Glenn Weaver, R; Turner-McGrievy, Gabrielle M; Huberty, Jennifer; Moore, Justin B; Mahmud Khan, M; Ward, Dianne S

    2017-10-04

    Limited information is available on the cost-effectiveness of interventions to achieve healthy eating and physical activity policies in afterschool programs (ASPs). The objective of this study is to present the costs associated with a comprehensive intervention in ASPs. Intervention delivery inputs (IDIs) associated with a group randomized delayed treatment controlled trial involving 20 ASPs serving >1700 children (5-12yrs) were catalogued prospectively across 2-years (2014-2015). IDIs, analyzed 2015, were expressed as increases in per-child per-week enrollment fees based on a 34-week school year in US$. Total IDIs for year-1 were $15,058 (+$0.58/child/week enrollment fee). In year-2, total costs were $13,828 (+$0.52/child/week) for the delayed group and $7916 (+$0.30/child/week) for the immediate group, respectively. Site leader and staff hourly wages represented 11-17% and 45-46% of initial training costs; travel and trainer wages represented 31-42% and 50-58% of booster costs. Overall, a 1% increase in boys and girls, separately, accumulating 30 mins/d of moderate-to-vigorous physical activity ranged from $0.05 to $0.26/child/week, while a one-day increase in serving a fruit/vegetable or water, or not serving sugar-added foods/beverages ranged from $0.16 to $0.87/child/week. Costs associated with implementing the intervention were minimal. Additional efforts to reduce costs and improve intervention effectiveness are necessary. Copyright © 2017. Published by Elsevier Inc.

  5. A randomized, controlled, pilot trial of methylphenidate and cognitive-behavioral group therapy for cocaine dependence in heroin prescription.

    PubMed

    Dürsteler-MacFarland, Kenneth M; Farronato, Nadine S; Strasser, Johannes; Boss, Jakob; Kuntze, Marcus F; Petitjean, Sylvie A; Bürki, Christoph; Wiesbeck, Gerhard A

    2013-02-01

    Cocaine dependence has proved difficult to treat, whether it occurs alone or in combination with opiate dependence. No intervention has been demonstrated to be uniquely effective. Patients might benefit most from combined pharmacotherapeutic and psychotherapeutic interventions. The present study sought to evaluate the feasibility, tolerability, and efficacy of methylphenidate (MP) and cognitive-behavioral group therapy (CBGT) for cocaine dependence in diacetylmorphine-maintained patients. Sixty-two cocaine-dependent diacetylmorphine-maintained patients participated in a dual-site, double-blind, placebo-controlled pilot trial with 4 treatment conditions. The participants were randomly assigned to receive MP or a placebo each combined with either CBGT or treatment as usual for 12 weeks. Methylphenidate 30 mg and a placebo in identical capsules were administered onsite twice daily under supervision in a fixed-dose regimen without titration. Manual-guided CBGT consisted of 12 weekly sessions. Participation in the CBGT sessions was voluntary. Primary outcome measures were retention in pharmacologic treatment, cocaine-free urine samples, self-reported cocaine use, and adverse effects. Urine screens were performed thrice weekly. Seventy-one percent of the participants completed the study protocol. Methylphenidate was well tolerated with similar retention rates compared with the placebo. No serious adverse effects occurred. No difference in cocaine-free urine screens was found across the 4 treatment groups. Self-reported cocaine use was reduced in all 4 study groups. Methylphenidate and CBGT did not provide an advantage over a placebo or treatment as usual in reducing cocaine use. There were no signs of additive benefits of MP and CBGT. Because of the small sample size, the results are preliminary.

  6. Improving Nutrition and Physical Activity Policies in Afterschool Programs: Results from a Group-Randomized Controlled Trial

    PubMed Central

    Kenney, Erica L.; Giles, Catherine M.; deBlois, Madeleine E.; Gortmaker, Steven L.; Chinfatt, Sherene; Cradock, Angie L.

    2017-01-01

    OBJECTIVE Afterschool programs can be health-promoting environments for children. Written policies positively influence nutrition and physical activity (PA) environments, but effective strategies for building staff capacity to write such policies have not been evaluated. This study measures the comprehensiveness of written nutrition, PA, and screen time policies in afterschool programs and assesses impact of the Out of School Nutrition and Physical Activity (OSNAP) intervention on key policies. METHODS Twenty afterschool programs in Boston, MA participated in a group-randomized, controlled trial from September 2010 to June 2011. Intervention program staff attended learning collaboratives focused on practice and policy change. The Out-of-School Time (OST) Policy Assessment Index evaluated written policies. Inter-rater reliability and construct validity of the measure and impact of the intervention on written policies were assessed. RESULTS The measure demonstrated moderate to excellent inter-rater reliability (Spearman’s r=0.53 to 0.97) and construct validity. OSNAP was associated with significant increases in standards-based policy statements surrounding snacks (+2.6, p=0.003), beverages (+2.3, p=0.008), screen time (+0.8, p=0.046), family communication (+2.2, p=0.002), and a summary index of OSNAP goals (+3.3, p=0.02). CONCLUSIONS OSNAP demonstrated success in building staff capacity to write health-promoting policy statements. Future research should focus on determining policy change impact on practices. PMID:24941286

  7. Addressing behavioral impacts of childhood leukemia: A feasibility pilot randomized controlled trial of a group videoconferencing parenting intervention.

    PubMed

    Williams, Lauren K; McCarthy, Maria C; Burke, Kylie; Anderson, Vicki; Rinehart, Nicole

    2016-10-01

    Child emotional and behavioral problems constitute significant sequelae of acute lymphoblastic leukemia (ALL) treatment. The aims of this study were to a) examine the feasibility, acceptability and satisfaction of a parenting intervention amongst parents of children with ALL and b) explore whether participation in a parenting intervention shows promise for improvements in child behavior. 12 parents with a child aged between 2 and 8 years receiving maintenance phase treatment for ALL participated in a phase 2 randomized controlled trial comparing eight weeks of group online participation in Triple P: Positive Parenting Program with no intervention. The number of eligible parents who completed the intervention was low (31.6%). Main reasons for non-consent or dropout were program time commitment too high or content not relevant. For parents who completed the intervention, satisfaction and acceptability was high. Parents reported the intervention as highly relevant and topical, feasible, helpful and a positive experience. Results indicated a non-significant trend towards improved total child behavioral and emotional difficulties following the intervention. Qualitative results indicated that intervention group parents reported improvements in parenting skills and competence, and decreased child behavioral problems. These pilot data highlight the difficulties of engaging and retaining parents in an 8-week parenting intervention in this context. For parents who completed the intervention, results indicated high feasibility, acceptability and satisfaction. Suggestions for further research and intervention modifications are provided to enhance uptake and strengthen efforts to assist parents in addressing child behavioral and emotional challenges during ALL treatment. Copyright © 2016 Elsevier Ltd. All rights reserved.

  8. 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

  9. Results From the Scandinavian Prostate Cancer Group Trial Number 4: A Randomized Controlled Trial of Radical Prostatectomy Versus Watchful Waiting

    PubMed Central

    2012-01-01

    In the Scandinavian Prostate Cancer Group Trial Number 4 (SPCG-4), 347 men were randomly assigned to radical prostatectomy and 348 to watchful waiting. In the most recent analysis (median follow-up time = 12.8 years), the cumulative mortality curves had been stable over the follow-up. At 15 years, the absolute risk reduction of dying from prostate cancer was 6.1% following randomization to radical prostatectomy, compared with watchful waiting. Hence, 17 need to be randomized to operation to avert one death. Data on self-reported symptoms, stress from symptoms, and quality of life were collected at 4 and 12.2 years of median follow-up. These questionnaire studies show an intricate pattern of symptoms evolving after surgery, hormonal treatments, signs of tumor progression, and also from natural aging. This article discusses some of the main findings of the SPCG-4 study. PMID:23271778

  10. Randomized controlled trial of a cognitive-behavioral motivational intervention in a group versus individual format for substance use disorders.

    PubMed

    Sobell, Linda Carter; Sobell, Mark B; Agrawal, Sangeeta

    2009-12-01

    Although group therapy is widely used for individuals with substance use disorders (SUDs), randomized clinical trials (RCTs) comparing the same treatment in a group versus individual format are rare. This paper presents the results of a RCT comparing guided self-change (GSC) treatment, a cognitive-behavioral motivational intervention, conducted in a group versus individual format with 212 alcohol abusers and 52 drug abusers who voluntarily sought outpatient treatment. Treatment outcomes demonstrated significant and large reductions in clients' alcohol and drug use during treatment and at the 12-month follow-up, with no significant differences between the group and individual therapy conditions. A therapist time ratio analysis found that it took 41.4% less therapist time to treat clients using the group versus the individual format. Participants' end-of-treatment group cohesion scores characterized the groups as having high engagement, low levels of interpersonal conflict, and low avoidance of group work, all desirable group characteristics. These findings suggest that the GSC treatment model was effectively integrated into a brief group treatment format. Health care cost containment compels further evaluations of the efficacy of group treatments for SUDs. Copyright 2009 APA

  11. Variations of high frequency parameter of heart rate variability following osteopathic manipulative treatment in healthy subjects compared to control group and sham therapy: randomized controlled trial

    PubMed Central

    Ruffini, Nuria; D'Alessandro, Giandomenico; Mariani, Nicolò; Pollastrelli, Alberto; Cardinali, Lucia; Cerritelli, Francesco

    2015-01-01

    Context: Heart Rate Variability (HRV) indicates how heart rate changes in response to inner and external stimuli. HRV is linked to health status and it is an indirect marker of the autonomic nervous system (ANS) function. Objective: To investigate the influence of osteopathic manipulative treatment (OMT) on cardiac autonomic modulation in healthy subjects, compared with sham therapy and control group. Methods: Sixty-six healthy subjects, both male and female, were included in the present 3-armed randomized placebo controlled within subject cross-over single blinded study. Participants were asymptomatic adults (26.7 ± 8.4 y, 51% male, BMI 18.5 ± 4.8), both smokers and non-smokers and not on medications. At enrollment subjects were randomized in three groups: A, B, C. Standardized structural evaluation followed by a patient need-based osteopathic treatment was performed in the first session of group A and in the second session of group B. Standardized evaluation followed by a protocoled sham treatment was provided in the second session of group A and in the first session of group B. No intervention was performed in the two sessions of group C, acting as a time-control. The trial was registered on clinicaltrials.gov identifier: NCT01908920. Main Outcomes Measures: HRV was calculated from electrocardiography before, during and after the intervention, for a total amount time of 25 min and considering frequency domain as well as linear and non-linear methods as outcome measures. Results: OMT engendered a statistically significant increase of parasympathetic activity, as shown by High Frequency power (p < 0.001), expressed in normalized and absolute unit, and possibly decrease of sympathetic activity, as revealed by Low Frequency power (p < 0.01); results also showed a reduction of Low Frequency/High Frequency ratio (p < 0.001) and Detrended fluctuation scaling exponent (p < 0.05). Conclusions: Findings suggested that OMT can influence ANS activity increasing

  12. Group schema therapy versus group cognitive behavioral therapy for social anxiety disorder with comorbid avoidant personality disorder: study protocol for a randomized controlled trial.

    PubMed

    Baljé, Astrid; Greeven, Anja; van Giezen, Anne; Korrelboom, Kees; Arntz, Arnoud; Spinhoven, Philip

    2016-10-08

    Social anxiety disorder (SAD) with comorbid avoidant personality disorder (APD) has a high prevalence and is associated with serious psychosocial problems and high societal costs. When patients suffer from both SAD and APD, the Dutch multidisciplinary guidelines for personality disorders advise offering prolonged cognitive behavioral therapy (CBT). Recently there is increasing evidence for the effectiveness of schema therapy (ST) for personality disorders such as borderline personality disorder and cluster C personality disorders. Since ST addresses underlying personality characteristics and maladaptive coping strategies developed in childhood, this treatment might be particularly effective for patients with SAD and comorbid APD. To our knowledge, there are no studies comparing CBT with ST in this particular group of patients. This superiority trial aims at comparing the effectiveness of these treatments. As an additional goal, predictors and underlying mechanisms of change will be explored. The design of the study is a multicentre two-group randomized controlled trial (RCT) in which the treatment effect of group cognitive behavioral therapy (GCBT) will be compared to that of group schema therapy (GST) in a semi-open group format. A total of 128 patients aged 18-65 years old will be enrolled. Patients will receive 30 sessions of GCBT or GST during a period of approximately 9 months. Primary outcome measures are the Liebowitz Social Anxiety Scale Self-Report (LSAS-SR) for social anxiety disorder and the newly developed Avoidant Personality Disorder Severity Index (AVPDSI) for avoidant personality disorder. Secondary outcome measures are the MINI section SAD, the SCID-II section APD, the Schema Mode Inventory (SMI-2), the Inventory of Depressive Symptomatology Self-Report (IDS-SR), the World Health Organization Quality of Life-BREF (WHOQOL-BREF), the Difficulties in Emotion Regulation Scale (DERS), the Rosenberg Self-Esteem Scale (RSES) and the Acceptance and Action

  13. Participants' experiences of care during a randomized controlled trial comparing a lay-facilitated angina management programme with usual care: a qualitative study using focus groups

    PubMed Central

    Nelson, Pauline; Cox, Helen; Furze, Gill; Lewin, Robert JP; Morton, Veronica; Norris, Heather; Patel, Nicky; Elton, Peter; Carty, Richard

    2013-01-01

    Aim This paper is a report of a qualitative study conducted as part of a randomized controlled trial comparing a lay-facilitated angina management programme with usual care. Its aim was to explore participants' beliefs, experiences, and attitudes to the care they had received during the trial, particularly those who had received the angina management intervention. Background Angina affects over 50 million people worldwide. Over half of these people have symptoms that restrict their daily life and would benefit from knowing how to manage their condition. Design A nested qualitative study within a randomized controlled trial of lay-facilitated angina management. Method We conducted four participant focus groups during 2008; three were with people randomized to the intervention and one with those randomized to control. We recruited a total of 14 participants to the focus groups, 10 intervention, and 4 control. Findings Although recruitment to the focus groups was relatively low by comparison to conventional standards, each generated lively discussions and a rich data set. Data analysis demonstrated both similarities and differences between control and intervention groups. Similarities included low levels of prior knowledge about angina, whereas differences included a perception among intervention participants that lifestyle changes were more easily facilitated with the help and support of a lay-worker. Conclusion Lay facilitation with the Angina Plan is perceived by the participants to be beneficial in supporting self-management. However, clinical expertise is still required to meet the more complex information and care needs of people with stable angina. PMID:22738415

  14. Effects of resource-building group intervention on career management and mental health in work organizations: randomized controlled field trial.

    PubMed

    Vuori, Jukka; Toppinen-Tanner, Salla; Mutanen, Pertti

    2012-03-01

    A resource-building group intervention was developed to enhance career management, mental health, and job retention in work organizations. The in-company training program provided employees with better preparedness to manage their own careers. The program activities were universally implemented using an organization-level, 2-trainer model with trainers from the human resources management and occupational health services. The study was a within-organizations, randomly assigned field experimental study; it investigated the impacts of the intervention on immediate career management preparedness and later mental health and intentions to retire early. A total of 718 eligible individuals returned a questionnaire in 17 organizations and became voluntary participants. The respondents were randomly assigned to either an intervention (N = 369) or a comparison group (N = 349). Those in the intervention group were invited to group intervention workshops, whereas those in the comparison group received printed information about career and health-related issues. The 7-month follow-up results showed that the program significantly decreased depressive symptoms and intentions to retire early and increased mental resources among the group participants compared to the others. The mediation analyses demonstrated that the increase in career management preparedness as a proximal impact of the intervention mediated the longer term mental health effects. Those who benefited most from the intervention as regards their mental health were employees with elevated levels of depression or exhaustion and younger employees, implying additional benefits of a more targeted use of the intervention. The results demonstrated the benefits of the enhancement of individual-level career management and resilience resources as career and health promotion practice in work organizations.

  15. Longitudinal Effects of Coping on Outcome in a Randomized Controlled Trial of a Group Intervention for HIV-Positive Adults with AIDS-Related Bereavement

    ERIC Educational Resources Information Center

    Hansen, Nathan B.; Tarakeshwar, Nalini; Ghebremichael, Musie; Zhang, Heping; Kochman, Arlene; Sikkema, Kathleen J.

    2006-01-01

    This study examined the longitudinal effects of coping on outcome one year following completion of a randomized, controlled trial of a group coping intervention for AIDS-related bereavement. Bereaved HIV-positive participants (N = 267) were administered measures of grief, psychiatric distress, quality of life, and coping at baseline,…

  16. Competency-Based Training and Worker Turnover in Community Supports for People with IDD: Results from a Group Randomized Controlled Study

    ERIC Educational Resources Information Center

    Bogenschutz, Matthew; Nord, Derek; Hewitt, Amy

    2015-01-01

    Turnover among direct support professionals (DSPs) in community support settings for individuals with intellectual and developmental disabilities (IDD) has been regarded as a challenge since tracking of this workforce began in the 1980s. This study utilized a group randomized controlled design to test the effects of a competency-based training…

  17. Social Stories: Mechanisms of Effectiveness in Increasing Game Play Skills in Children Diagnosed with Autism Spectrum Disorder Using a Pretest Posttest Repeated Measures Randomized Control Group Design

    ERIC Educational Resources Information Center

    Quirmbach, Linda M.; Lincoln, Alan J.; Feinberg-Gizzo, Monica J.; Ingersoll, Brooke R.; Andrews, Siri M.

    2009-01-01

    An increasing body of literature has indicated that social stories are an effective way to teach individuals diagnosed with autism appropriate social behavior. This study compared two formats of a social story targeting the improvement of social skills during game play using a pretest posttest repeated measures randomized control group design. A…

  18. Social Stories: Mechanisms of Effectiveness in Increasing Game Play Skills in Children Diagnosed with Autism Spectrum Disorder Using a Pretest Posttest Repeated Measures Randomized Control Group Design

    ERIC Educational Resources Information Center

    Quirmbach, Linda M.; Lincoln, Alan J.; Feinberg-Gizzo, Monica J.; Ingersoll, Brooke R.; Andrews, Siri M.

    2009-01-01

    An increasing body of literature has indicated that social stories are an effective way to teach individuals diagnosed with autism appropriate social behavior. This study compared two formats of a social story targeting the improvement of social skills during game play using a pretest posttest repeated measures randomized control group design. A…

  19. Competency-Based Training and Worker Turnover in Community Supports for People with IDD: Results from a Group Randomized Controlled Study

    ERIC Educational Resources Information Center

    Bogenschutz, Matthew; Nord, Derek; Hewitt, Amy

    2015-01-01

    Turnover among direct support professionals (DSPs) in community support settings for individuals with intellectual and developmental disabilities (IDD) has been regarded as a challenge since tracking of this workforce began in the 1980s. This study utilized a group randomized controlled design to test the effects of a competency-based training…

  20. The Effects of Waiting for Treatment: A Meta-Analysis of Waitlist Control Groups in Randomized Controlled Trials for Social Anxiety Disorder.

    PubMed

    Steinert, Christiane; Stadter, Katja; Stark, Rudolf; Leichsenring, Falk

    2016-07-22

    Social anxiety disorder (SAD) is a highly prevalent mental disorder. However, little is known about how SAD changes in subjects who do not receive treatment. Waitlist control groups (WLCGs) are frequently included in randomized controlled trials (RCTs) on the treatment of mental disorders. Data from WLCGs are of value as they provide information on the untreated short-term course of a disorder and may serve as disorder-specific norms of change (benchmarks) against which treatment outcomes of SAD can be compared. Thus, we performed a meta-analysis focusing on the effects occurring in WLCGs of RCTs for SAD. Our study was conducted along the PRISMA guidelines. Thirty RCTs (total n = 2460) comprising 30 WLCGs and 47 treatment groups were included. Mean waiting time was 10.6 weeks. The pooled effect of waiting on SAD measures was g = 0.128 (95% CI: 0.057-0.199). Effects regarding other forms of anxiety, depression and functioning were of similarly small size. In contrast, change in the treatment groups was large, both within (g = 0.887) and between groups (g = 0.860). Our results show that for SAD, changes occurring in WLCGs of RCTs are small. The findings may serve as benchmarks in pilot studies of a new treatment or as an additional comparison in studies comparing two active treatments. For psychotherapy research in general, the small effect sizes found in WLCGs confirm that testing a treatment against a waiting list is not a very strict test. Further research on WLCGs in specific mental disorders is required, for example examining the expectancies of patients randomized to waiting. Copyright © 2016 John Wiley & Sons, Ltd. Key Practitioner Message In clinical practice, patients suffering from a mental disorder often have to wait for treatment. By analyzing data from waitlist control groups we can gain estimates of symptom change that occur during waiting. It could be seen that waiting for treatment only results in a negligible effect. Thus, in the

  1. Effect of aerobic exercise on peripheral nerve functions of population with diabetic peripheral neuropathy in type 2 diabetes: a single blind, parallel group randomized controlled trial.

    PubMed

    Dixit, Snehil; Maiya, Arun G; Shastry, B A

    2014-01-01

    To evaluate the effect of moderate intensity aerobic exercise (40%-60% of Heart Rate Reserve (HRR)) on diabetic peripheral neuropathy. A parallel-group, randomized controlled trial was carried out in a tertiary health care setting, India. The study comprised of experimental (moderate intensity aerobic exercise and standard care) and control groups (standard care). Population with type 2 diabetes with clinical neuropathy, defined as a minimum score of seven on the Michigan Diabetic Neuropathy Score (MDNS), was randomly assigned to experimental and control groups by computer generated random number tables. RANOVA was used for data analysis (p<0.05 was significant). A total of 87 patients with DPN were evaluated in the study. After randomization there were 47 patients in the control group and 40 patients in the experimental group. A comparison of two groups using RANOVA for anthropometric measures showed an insignificant change at eight weeks. For distal peroneal nerve's conduction velocity there was a significant difference in two groups at eight weeks (p<0.05), Degrees of freedom (Df)=1, 62, F=5.14, and p=0.03. Sural sensory nerve at eight weeks showed a significant difference in two groups for conduction velocity, Df =1, 60, F=10.16, and p=0.00. Significant differences in mean scores of MDNS were also observed in the two groups at eight weeks (p value significant<0.05). Moderate intensity aerobic exercises can play a valuable role to disrupt the normal progression of DPN in type 2 diabetes. Copyright © 2014 Elsevier Inc. All rights reserved.

  2. Group cognitive behavior therapy or social skills training for individuals with a recent onset of psychosis? Results of a randomized controlled trial.

    PubMed

    Lecomte, Tania; Leclerc, Claude; Corbière, Marc; Wykes, Til; Wallace, Charles J; Spidel, Alicia

    2008-12-01

    This study aimed at determining the effectiveness of group cognitive behavior therapy (CBT) for recent onset psychosis in comparison with a recognized intervention for individuals with severe mental illness-social skills training. One hundred twenty-nine participants took part in a single-blind randomized controlled trial with repeated measures (baseline, 3 months, and 9 months). Participants were randomized to 1 of 3 conditions: group CBT, group social skills training for symptom management, or a wait-list control group. Both interventions were delivered by mental health staff with minimal training. Both treatments resulted in improvements on positive and negative symptoms compared with the wait-list control group, with the CBT group having significant effects over time on overall symptoms, and post-treatment effects on self-esteem, and active coping skills compared with the wait-list control group and lower drop-out rates than the skills training group. Therapist fidelity was adequate for both treatment conditions. Group CBT for psychosis is a promising intervention for individuals with recent onset of psychosis and their mental health professionals.

  3. Efficacy of a single-session HIV prevention intervention for black women: a group randomized controlled trial.

    PubMed

    Diallo, Dázon Dixon; Moore, Trent Wade; Ngalame, Paulyne M; White, Lisa Diane; Herbst, Jeffrey H; Painter, Thomas M

    2010-06-01

    SisterLove Inc., a community-based organization (CBO) in Atlanta, Georgia, evaluated the efficacy of its highly interactive, single-session HIV prevention intervention for black women, the Healthy Love Workshop (HLW). HLW is delivered to pre-existing groups of women (e.g., friends, sororities) in settings of their choosing. Eligible groups of women were randomly assigned to receive the intervention (15 groups; 161 women) or a comparison workshop (15 groups; 152 women). Behavioral assessments were conducted at baseline and at 3- and 6-month follow-ups. Among sexually active women at the 3-month follow-up, HLW participants were more likely than comparison participants to report having used condoms during vaginal sex with any male partner or with a primary male partner, and to have used condoms at last vaginal, anal or oral sex with any male partner. At the 6-month follow-up, HLW participants were more likely to report condom use at last vaginal, anal or oral sex with any male partner, and having an HIV test and receiving their test results. The study findings suggest that a single-session intervention delivered to pre-existing groups of black women is an efficacious approach to HIV prevention. This study also demonstrates that a CBO can develop and deliver a culturally appropriate, effective HIV prevention intervention for the population it serves and, with adequate resources and technical assistance, rigorously evaluate its intervention.

  4. The effect of cognitive-behavioral group therapy on depressive symptoms in people with type 2 diabetes: A randomized controlled clinical trial

    PubMed Central

    Sharif, Farkhondeh; Masoudi, Maria; Ghanizadeh, Ahmad; Dabbaghmanesh, Mohammad Hossein; Ghaem, Haleh; Masoumi, Samira

    2014-01-01

    Background: Diabetes mellitus is considered as the most common metabolic disorder. The patients with diabetes are likely to be affected by mental distress, especially depression. Nurses should pay attention to the psychological needs of depressive patients by participating in an application of non-pharmacological treatment such as cognitive-behavioral therapy. This study aimed to assess the effect of cognitive-behavioral group therapy on depression in patients with diabetes. Materials and Methods: This randomized controlled trial was performed in 2010 in the diabetes clinics affiliated to Shiraz University of Medical Sciences, Shiraz, southern Iran. In this study, 60 eligible patients suffering from depression were randomly divided into two groups by convenience sampling method, using random block allocation. The experimental group was randomly subdivided into three groups of 10 each and received eight sessions of cognitive-behavioral group therapy. The level of depression was checked before as well as 2 weeks, 4 weeks, and 2 months after the intervention in both groups. Glycosylated hemoglobin (HbA1c) level was also checked before and 2 months after the intervention. Results: Both groups were demographically homogeneous with no statistically significant difference. The trend in depression scores before as well as 2 weeks, 4 weeks, and 2 months after the intervention was statistically significant in the experimental group (P ≤ 0.001), but not in the control group (P = 0.087). The results showed that HbA1c variation was statistically significant before and after the intervention in both groups (P ≤ 0.001). However, the mean variation of HbA1c was not statistically significant between the groups (P = 0.473). Conclusions: Cognitive-behavioral group therapy was effective in reducing depression in patients with diabetes. Therefore, this method can be recommended for such patients. PMID:25400683

  5. A randomized, controlled clinical trial of standard, group and brief cognitive-behavioral therapy for panic disorder with agoraphobia: a two-year follow-up.

    PubMed

    Marchand, André; Roberge, Pasquale; Primiano, Sandra; Germain, Vanessa

    2009-12-01

    A randomized controlled clinical trial with a wait-list control group was conducted to examine the effectiveness of three modalities (brief, group, and standard) of cognitive-behavioral treatment (CBT) for panic disorder with agoraphobia. A total of 100 participants meeting DSM-IV criteria were randomly assigned to each treatment condition: a 14-session standard CBT (n=33), a 14-session group CBT (n=35) and a 7-session brief CBT (n=32). Participants received a self-study manual and were assigned weekly readings and exercises. The results indicate that regardless of the treatment condition, CBT for moderate to severe PDA is beneficial in medium and long term. To this effect, all three-treatment conditions significantly reduced the intensity of symptoms, increased participants' quality of life, offered high effect sizes, superior maintenance of gains over time, and lower rates of relapse, compared to the wait-list control.

  6. Effects of a Topical Saffron (Crocus sativus L) Gel on Erectile Dysfunction in Diabetics: A Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Trial.

    PubMed

    Mohammadzadeh-Moghadam, Hossein; Nazari, Seyed Mohammad; Shamsa, Ali; Kamalinejad, Mohammad; Esmaeeli, Habibollah; Asadpour, Amir Abbas; Khajavi, Abdoljavad

    2015-10-01

    Erectile dysfunction is a man's persistent or recurrent inability to achieve and maintain erection for a satisfactory sexual relationship. As diabetes is a major risk factor for erectile dysfunction, the prevalence of erectile dysfunction among diabetic men has been reported as 35% to 90%. This randomized, parallel-group, double-blind, placebo-controlled trial investigated the effects of a topical saffron (Crocus sativus L) gel on erectile dysfunction in diabetic men. Patients were randomly allocated to 2 equal groups (with 25 patients each). The intervention group was treated with topical saffron, and the control received a similar treatment with placebo. The 2 groups were assessed using the International Index of Erectile Function Questionnaire before the intervention and 1 month after the intervention. Compared to placebo, the prepared saffron gel could significantly improve erectile dysfunction in diabetic patients (P < .001). This preliminary evidence suggests that saffron can be considered as a treatment option for diabetic men with erectile dysfunction.

  7. A randomized, controlled trial of the effectiveness of cognitive-behavioral therapy and sertraline versus a waitlist control group for anxiety disorders in older adults.

    PubMed

    Schuurmans, Josien; Comijs, Hannie; Emmelkamp, Paul M G; Gundy, Chad M M; Weijnen, Ingrid; van den Hout, Marcel; van Dyck, Richard

    2006-03-01

    This study is the first to investigate the relative effectiveness of cognitive-behavioral therapy (CBT) compared with a selective serotonin reuptake inhibitor (SSRI; sertraline) in a randomized, controlled trial on the treatment of anxiety disorders in older adults. Eighty-four patients 60 years of age and over with a principal diagnosis of generalized anxiety disorder, panic disorder, agoraphobia, or social phobia were randomly assigned to one of three conditions: 15 sessions of CBT, pharmacologic treatment with an SSRI (sertraline; maximum dosage 150 mg), or a waitlist control group. Participants completed measures of primary outcome (anxiety) and coexistent worry and depressive symptoms at baseline, posttreatment, and at three-month follow up. Attrition rates were high in both treatment groups. Consequently, findings are based on a relatively small sample of completers (N = 52). Although both CBT and sertraline led to significant improvement in anxiety, worry, and depressive symptoms both at posttreatment and at three-month follow up, sertraline showed superior results on worry symptoms. Effect size estimates for CBT were in the small to medium range both at posttreatment (mean d = 0.42) and at three-month follow up (mean d = 0.35), whereas effect sizes for sertraline fell into the large range (posttreatment mean d = 0.94 and three-month follow up mean d = 1.02). The waitlist condition showed virtually no effects (posttreatment mean d = .03). Our findings strongly suggest that the pharmacologic treatment of late-life anxiety with SSRIs has not been given the proper attention in research to date.

  8. The effects and costs of the universal parent group program - all children in focus: a study protocol for a randomized wait-list controlled trial.

    PubMed

    Lindberg, Lene; Ulfsdotter, Malin; Jalling, Camilla; Skärstrand, Eva; Lalouni, Maria; Lönn Rhodin, Kajsa; Månsdotter, Anna; Enebrink, Pia

    2013-07-29

    In recent decades, parents have been involved in programs that aim to improve parenting style and reduce child behavior problems. Research of preventive parenting programs has shown that these interventions generally have a positive influence on both parents and children. However, to our knowledge there is a gap in the scientific literature when it comes to randomized controlled trials of brief, manual-based structured programs which address general parenting among the population, and focus on promoting health. A four-session universal health promotion parent group program named All Children in Focus was developed. It aims at promoting parental competence and children's positive development with the parent-child relationship as the target. There is currently no randomized controlled trial existing of the program. A prospective multicenter randomized wait-list controlled trial is being conducted. Approximately 600 parents with children ranging in age from 3-12 years have been recruited in eleven municipalities and city districts in the County of Stockholm, Sweden. Parents are randomized at baseline to an intervention group, which receives the program directly, or to a waiting-list control group, which participates in the program six months later. Changes in parenting and child health and development are assessed with measures immediately post-intervention and six months after the baseline. Observations of a minor group of parents and children are conducted to explore possible relations between parental reports and observed behaviors, as well as changes in the interaction between parent and child. Further, data collected within the evaluation will also be applied to evaluate the possible cost-effectiveness of the program. This paper describes a study protocol of a randomized controlled trial. Except for the quantitative outcome measures to evaluate the effectiveness of All Children in Focus, this protocol also describes health economic and qualitative analyses to

  9. The Effectiveness of Group Cognitive Behavioral Therapy in Treating Obsessive-Compulsive Disorder in Women with Multiple Sclerosis (MS): A randomized double-blind controlled trial.

    PubMed

    Sayyah, Mehdi; Bagheri, Parisa; Karimi, Negar; Ghasemzadeh, Azizreza

    2016-04-01

    Obsessive-compulsive disorder (OCD) is one of the most prevalent psychiatric disorders and can cause problems for individuals in all aspects of life, including social and personal dimensions. To study the effect of group cognitive-behavioral therapy on the reduction of OCD symptoms in female participants with multiple sclerosis (MS). This double-blind randomized control trial was conducted from May 2012 to December 2014. The participants included 75 patients with MS who suffered from OCD and were referred to the Loghman Hakim and Imam Khomeini hospitals in Tehran, Iran. Thirty participants had been diagnosed through Yale-Brown Obsessive-Compulsive Symptoms (Y-BOCS). The participants were randomly divided into an experimental group (n=15) and a control group (n=15). Eleven sessions of cognitive-behavioral therapy were provided for the experimental group. Patients in the control group continued with their normal living. Hypotheses were tested using an analysis of covariance (ANCOVA). A significant reduction was found in the experimental group's obsessive-compulsive symptoms after cognitive-behavioral therapy (p<0.001). In addition, mean scores for participants in the experimental group were significantly lower than for those in the control group (p=0.000). It can be inferred that cognitive-behavioral therapy could considerably reduce OCD symptoms in women with MS. The application of this method by therapists, especially Iranian clinicians, is recommended.

  10. The Effectiveness of Group Cognitive Behavioral Therapy in Treating Obsessive-Compulsive Disorder in Women with Multiple Sclerosis (MS): A randomized double-blind controlled trial

    PubMed Central

    Sayyah, Mehdi; Bagheri, Parisa; Karimi, Negar; Ghasemzadeh, Azizreza

    2016-01-01

    Background Obsessive-compulsive disorder (OCD) is one of the most prevalent psychiatric disorders and can cause problems for individuals in all aspects of life, including social and personal dimensions. Objective To study the effect of group cognitive-behavioral therapy on the reduction of OCD symptoms in female participants with multiple sclerosis (MS). Methods This double-blind randomized control trial was conducted from May 2012 to December 2014. The participants included 75 patients with MS who suffered from OCD and were referred to the Loghman Hakim and Imam Khomeini hospitals in Tehran, Iran. Thirty participants had been diagnosed through Yale-Brown Obsessive-Compulsive Symptoms (Y-BOCS). The participants were randomly divided into an experimental group (n=15) and a control group (n=15). Eleven sessions of cognitive-behavioral therapy were provided for the experimental group. Patients in the control group continued with their normal living. Hypotheses were tested using an analysis of covariance (ANCOVA). Results A significant reduction was found in the experimental group’s obsessive-compulsive symptoms after cognitive-behavioral therapy (p<0.001). In addition, mean scores for participants in the experimental group were significantly lower than for those in the control group (p=0.000). Conclusion It can be inferred that cognitive-behavioral therapy could considerably reduce OCD symptoms in women with MS. The application of this method by therapists, especially Iranian clinicians, is recommended. PMID:27279999

  11. Individual versus group family-focused cognitive-behaviour therapy for childhood anxiety: pilot randomized controlled trial.

    PubMed

    de Groot, Jules; Cobham, Vanessa; Leong, Joyce; McDermott, Brett

    2007-12-01

    The aim of the present study was to compare the relative effectiveness of group and individual formats of a family-focused cognitive-behavioural intervention, for the treatment of childhood anxiety disorders. Twenty-nine clinically anxious children aged between 7 and 12 years were randomly allocated to either individual cognitive-behaviour therapy (ICBT) or group cognitive-behaviour therapy (GCBT). At post-treatment assessment 57% of children in the ICBT condition no longer met criteria for any anxiety disorder, compared to 47% of children in the GCBT condition. At 3 month follow up these improvements were retained with some weakening. By the 6 month follow up 50% of children in the ICBT compared to 53% of children in the GCBT condition were anxiety diagnosis free. In terms of questionnaire data, no significant differences were detected between the ICBT and GCBT conditions at any of the follow-up points. However, a significant treatment effect for time was found, with both self-reports and parent reports indicating a significant reduction over time in anxiety symptoms. Overall, results suggest that children with anxiety disorders appear to improve following a family-focused cognitive behavioural intervention, regardless of individual or group administration. The interpretation and potential clinical implications of these findings are discussed, together with the limitations of this study and suggestions for future research.

  12. Evaluating a community-based early childhood education and development program in Indonesia: study protocol for a pragmatic cluster randomized controlled trial with supplementary matched control group.

    PubMed

    Pradhan, Menno; Brinkman, Sally A; Beatty, Amanda; Maika, Amelia; Satriawan, Elan; de Ree, Joppe; Hasan, Amer

    2013-08-16

    This paper presents the study protocol for a pragmatic cluster randomized controlled trial (RCT) with a supplementary matched control group. The aim of the trial is to evaluate a community-based early education and development program launched by the Government of Indonesia. The program was developed in collaboration with the World Bank with a total budget of US$127.7 million, and targets an estimated 738,000 children aged 0 to 6 years living in approximately 6,000 poor communities. The aim of the program is to increase access to early childhood services with the secondary aim of improving school readiness. The study is being conducted across nine districts. The baseline survey contained 310 villages, of which 100 were originally allocated to the intervention arm, 20 originally allocated to a 9-month delay staggered start, 100 originally allocated to an 18-month delay staggered start and 90 allocated to a matched control group (no intervention). The study consists of two cohorts, one comprising children aged 12 to 23 months and the other comprising children aged 48 to 59 months at baseline. The data collection instruments include child observations and task/game-based assessments as well as a questionnaire suite, village head questionnaire, service level questionnaires, household questionnaire, and child caretaker questionnaire. The baseline survey was conducted from March to April 2009, midline was conducted from April to August 2010 and endline conducted early 2013. The resultant participation rates at both the district and village levels were 90%. At the child level, the participation rate was 99.92%. The retention rate at the child level at midline was 99.67%. This protocol paper provides a detailed record of the trial design including a discussion regarding difficulties faced with compliance to the randomization, compliance to the dispersion schedule of community block grants, and procurement delays for baseline and midline data collections. Considering the

  13. Evaluating a community-based early childhood education and development program in Indonesia: study protocol for a pragmatic cluster randomized controlled trial with supplementary matched control group

    PubMed Central

    2013-01-01

    Background This paper presents the study protocol for a pragmatic cluster randomized controlled trial (RCT) with a supplementary matched control group. The aim of the trial is to evaluate a community-based early education and development program launched by the Government of Indonesia. The program was developed in collaboration with the World Bank with a total budget of US$127.7 million, and targets an estimated 738,000 children aged 0 to 6 years living in approximately 6,000 poor communities. The aim of the program is to increase access to early childhood services with the secondary aim of improving school readiness. Methods/Design The study is being conducted across nine districts. The baseline survey contained 310 villages, of which 100 were originally allocated to the intervention arm, 20 originally allocated to a 9-month delay staggered start, 100 originally allocated to an 18-month delay staggered start and 90 allocated to a matched control group (no intervention). The study consists of two cohorts, one comprising children aged 12 to 23 months and the other comprising children aged 48 to 59 months at baseline. The data collection instruments include child observations and task/game-based assessments as well as a questionnaire suite, village head questionnaire, service level questionnaires, household questionnaire, and child caretaker questionnaire. The baseline survey was conducted from March to April 2009, midline was conducted from April to August 2010 and endline conducted early 2013. The resultant participation rates at both the district and village levels were 90%. At the child level, the participation rate was 99.92%. The retention rate at the child level at midline was 99.67%. Discussion This protocol paper provides a detailed record of the trial design including a discussion regarding difficulties faced with compliance to the randomization, compliance to the dispersion schedule of community block grants, and procurement delays for baseline and midline

  14. Quality assurance of HIV prevention counseling in a multi-center randomized controlled trial. Project RESPECT Study Group.

    PubMed Central

    Kamb, M L; Dillon, B A; Fishbein, M; Willis, K L

    1996-01-01

    Current HIV prevention counseling strategies rely largely on interventions aimed at changing behaviors. Among these is HIV prevention counseling and testing, which has been a prominent component in the federally supported strategies for HIV/AIDS prevention in the United States. To assess the efficacy of HIV counseling in reducing risk behaviors and preventing HIV infection and other sexually transmitted diseases, a multicenter, randomized controlled trial is being conducted among sexually transmitted disease clinic patients (Project RESPECT). The trial compares three separate HIV prevention strategies on increasing condom use and decreasing new cases of sexually transmitted diseases. The strategies are (a) Enhanced HIV Prevention Counseling, a 4-session individual counseling intervention based on behavioral and social science theory; (b) HIV Prevention Counseling, a 2-session individual pre- and post test counseling strategy that attempts to increase perception of risk and reduce risk behaviors using small, achievable steps; and (c) HIV Education, a brief 2-session pre- and post-test strategy that is purely informational. One difficulty in conducting randomized trials of behavioral interventions is assuring that the interventions are being conducted both as conceptualized and in a consistent manner by different counselors and, for multicenter studies, at different study sites. This article describes the quality assurance measures that have been used for Project RESPECT. These have included development of standard tools, standard training, frequent observation and feedback to study personnel, and process evaluation. PMID:8862164

  15. Effectiveness and cost-effectiveness of meaning-centered group psychotherapy in cancer survivors: protocol of a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Meaning-focused coping may be at the core of adequate adjustment to life after cancer. Cancer survivors who experience their life as meaningful are better adjusted, have better quality of life and psychological functioning. Meaning-Centered Group Psychotherapy for Cancer Survivors (MCGP-CS) was designed to help patients to sustain or enhance a sense of meaning and purpose in their lives. The aim of the proposed study is to evaluate the effectiveness and cost-effectiveness of MCGP-CS. Methods/Design Survivors diagnosed with cancer in the last 5 years and treated with curative intent, are recruited via several hospitals in the Netherlands. After screening, 168 survivors are randomly assigned to one of the three study arms: 1. Meaning-Centered Group Psychotherapy (MCGP-CS) 2. Supportive group psychotherapy (SGP) 3. Care as usual (CAU). Baseline assessment takes place before randomisation, with follow up assessments post-intervention and at 3, 6 and 12 months follow-up. Primary outcome is meaning making (PMP, PTGI, SPWB). Secondary outcome measures address quality of life (EORTC-30), anxiety and depression (HADS), hopelessness (BHS), optimism (LOT-R), adjustment to cancer (MAC), and costs (TIC-P, EQ-5D, PRODISQ). Discussion Meaning-focused coping is key to adjustment to life after cancer, however, there is a lack of evidence based psychological interventions in this area. Many cancer survivors experience feelings of loneliness and alienation, and have a need for peer support, therefore a group method in particular, can be beneficial for sustaining or enhancing a sense of meaning. If this MCGP-CS is effective for cancer survivors, it can be implemented in the practice of psycho-oncology care. Trial registration Netherlands Trial Register, NTR3571 PMID:24467861

  16. Effectiveness and cost-effectiveness of meaning-centered group psychotherapy in cancer survivors: protocol of a randomized controlled trial.

    PubMed

    van der Spek, Nadia; Vos, Joël; van Uden-Kraan, Cornelia F; Breitbart, William; Cuijpers, Pim; Knipscheer-Kuipers, Kitty; Willemsen, Vincent; Tollenaar, Rob A E M; van Asperen, Christi J; Verdonck-de Leeuw, Irma M

    2014-01-28

    Meaning-focused coping may be at the core of adequate adjustment to life after cancer. Cancer survivors who experience their life as meaningful are better adjusted, have better quality of life and psychological functioning. Meaning-Centered Group Psychotherapy for Cancer Survivors (MCGP-CS) was designed to help patients to sustain or enhance a sense of meaning and purpose in their lives. The aim of the proposed study is to evaluate the effectiveness and cost-effectiveness of MCGP-CS. Survivors diagnosed with cancer in the last 5 years and treated with curative intent, are recruited via several hospitals in the Netherlands. After screening, 168 survivors are randomly assigned to one of the three study arms: 1. Meaning-Centered Group Psychotherapy (MCGP-CS) 2. Supportive group psychotherapy (SGP) 3. Care as usual (CAU). Baseline assessment takes place before randomisation, with follow up assessments post-intervention and at 3, 6 and 12 months follow-up. Primary outcome is meaning making (PMP, PTGI, SPWB). Secondary outcome measures address quality of life (EORTC-30), anxiety and depression (HADS), hopelessness (BHS), optimism (LOT-R), adjustment to cancer (MAC), and costs (TIC-P, EQ-5D, PRODISQ). Meaning-focused coping is key to adjustment to life after cancer, however, there is a lack of evidence based psychological interventions in this area. Many cancer survivors experience feelings of loneliness and alienation, and have a need for peer support, therefore a group method in particular, can be beneficial for sustaining or enhancing a sense of meaning. If this MCGP-CS is effective for cancer survivors, it can be implemented in the practice of psycho-oncology care. Netherlands Trial Register, NTR3571.

  17. A randomized controlled trial of a group-based gaze training intervention for children with Developmental Coordination Disorder

    PubMed Central

    Miles, Charlotte A. L.; Coyles, Ginny; Alizadehkhaiyat, Omid; Vine, Samuel J.; Vickers, Joan N.; Wilson, Mark R.

    2017-01-01

    The aim of this study was to integrate a gaze training intervention (i.e., quiet eye training; QET) that has been shown to improve the throwing and catching skill of children with Developmental Coordination Disorder (DCD), within an approach (i.e., group therapy) that might alleviate the negative psychosocial impact of these motor skill deficits. Twenty-one children with DCD were split into either QET (8 male 3 female, mean age of 8.6 years (SD = 1.04) or technical training (TT) groups (7 male 3 female, mean age of 8.6 years (SD = 1.84). The TT group were given movement-related instructions via video, relating to the throw and catch phases, while the QET group were also taught to fixate a target location on the wall prior to the throw (QE1) and to track the ball prior to the catch (QE2). Each group partook in a 4-week, group therapy intervention and measurements of QE duration and catching performance were taken before and after training, and at a 6-week delayed retention test. Parental feedback on psychosocial and motor skill outcomes was provided at delayed retention. Children improved their gaze control and catching coordination following QET, compared to TT. Mediation analysis showed that a longer QE aiming duration (QE1) predicted an earlier onset of tracking the ball prior to catching (QE2) which predicted catching success. Parents reported enhanced perceptions of their child’s catching ability and general coordination in the QET group compared to the TT group. All parents reported improvements in their child’s confidence, social skills and predilection for physical activity following the trial. The findings offer initial support for an intervention that practitioners could apply to address deficits in the motor and psychosocial skills of children with DCD. Trial registration: ClinicalTrials.gov NCT02904980 PMID:28187138

  18. Eyelash growth in subjects treated with bimatoprost: a multicenter, randomized, double-masked, vehicle-controlled, parallel-group study.

    PubMed

    Smith, Stacy; Fagien, Steven; Whitcup, Scott M; Ledon, Fred; Somogyi, Christine; Weng, Emily; Beddingfield, Frederick C

    2012-05-01

    Bimatoprost 0.03% is associated with increased growth and prominence of eyelashes. We sought to compare the safety and efficacy of once-daily bimatoprost 0.03% versus vehicle in increasing eyelash length, thickness, and darkness after topical administration to upper eyelid margins. In this 5-month study, subjects were randomized to receive once-daily bimatoprost 0.03% (n = 137) or vehicle (n = 141). The primary end point was eyelash prominence assessed by the investigator global eyelash assessment scale. Secondary efficacy measures included eyelash length, thickness, and darkness measured by digital image analysis and patient-reported outcomes. Safety data included adverse event monitoring and ophthalmic examinations. A higher percentage of subjects treated with bimatoprost 0.03% (78.1%) versus vehicle (18.4%) demonstrated at least a 1-grade increase in global eyelash assessment score at week 16 (P < .0001). Subjects in the bimatoprost 0.03% group also had statistically significantly greater increases in eyelash length, thickness, and darkness (P < .0001) than those in the vehicle group. For adverse events, only conjunctival hyperemia occurred at a statistically significant higher incidence rate in the bimatoprost 0.03% versus the vehicle group (P = .03). Short-term duration of the trial was a limitation; black subjects were not enrolled secondary to technical requirements of digital image analysis. Bimatoprost 0.03% was found to be effective at enhancing eyelashes in adults with a very good safety profile. Copyright © 2011 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

  19. Exploring the efficacy of an acceptance, mindfulness & compassionate-based group intervention for women struggling with their weight (Kg-Free): A randomized controlled trial.

    PubMed

    Palmeira, Lara; Pinto-Gouveia, José; Cunha, Marina

    2017-05-01

    This randomized-controlled trial aims to test the efficacy of a group intervention (Kg-Free) for women with overweight or obesity based on mindfulness, ACT and compassion approaches. The intervention aimed to reduce weight self-stigma and unhealthy eating patterns and increase quality-of-life (QoL). Seventy-three women, aged between 18 and 55 years old, with BMI ≥25 without binge-eating seeking weight loss treatment were randomly assigned to intervention or control groups. Kg-Free comprises 10 weekly group sessions plus 2 booster fortnightly sessions, of 2h30 h each. The control group maintained Treatment as Usual (TAU). Data was collected at baseline and at the end of the Kg-Free intervention. Overall, participants enrolled in Kg-Free found the intervention to be very important and helpful when dealing with their weight-related unwanted internal experiences. Moreover, when compared with TAU, the Kg-Free group revealed a significant increased health-related QoL and physical exercise and a reduction of weight self-stigma, unhealthy eating behaviors, BMI, self-criticism, weight-related experiential avoidance and psychopathological symptoms at post-treatment. Results for self-compassion showed a trend towards significance, whereas no significant between-groups differences were found for mindfulness. Taken together, evidence was found for Kg-Free efficacy in reducing weight-related negative experiences and promoting healthy behaviors, psychological functioning, and QoL.

  20. Effectiveness of group acceptance and commitment therapy for fibromyalgia: a 6-month randomized controlled trial (EFFIGACT study).

    PubMed

    Luciano, Juan V; Guallar, José A; Aguado, Jaume; López-Del-Hoyo, Yolanda; Olivan, Bárbara; Magallón, Rosa; Alda, Marta; Serrano-Blanco, Antoni; Gili, Margalida; Garcia-Campayo, Javier

    2014-04-01

    In the last decade, there has been burgeoning interest in the effectiveness of third-generation psychological therapies for managing fibromyalgia (FM) symptoms. The present study examined the effectiveness of acceptance and commitment therapy (ACT) on functional status as well as the role of pain acceptance as a mediator of treatment outcomes in FM patients. A total of 156 patients with FM were enrolled at primary health care centers in Zaragoza, Spain. The patients were randomly assigned to a group-based form of ACT (GACT), recommended pharmacological treatment (RPT; pregabalin + duloxetine), or wait list (WL). The primary end point was functional status (measured with the Fibromyalgia Impact Questionnaire, FIQ). Secondary end points included pain catastrophizing, pain acceptance, pain, anxiety, depression, and health-related quality of life. The differences between groups were calculated by linear mixed-effects (intention-to-treat approach) and mediational models through path analyses. Overall, GACT was statistically superior to both RPT and WL immediately after treatment, and improvements were maintained at 6months with medium effect sizes in most cases. Immediately after treatment, the number needed to treat for 20% improvement compared to RPT was 2 (95% confidence interval 1.2-2.0), for 50% improvement 46, and for achieving a status of no worse than mild impaired function (FIQ total score <39) also 46. Unexpectedly, 4 of the 5 tested path analyses did not show a mediation effect. Changes in pain acceptance only mediated the relationship between study condition and health-related quality of life. These findings are discussed in relation to previous psychological research on FM treatment.

  1. The effect of adding group-based counselling to individual lifestyle counselling on changes in dietary intake. The Inter99 study – a randomized controlled trial

    PubMed Central

    Toft, Ulla; Kristoffersen, Lis; Ladelund, Steen; Ovesen, Lars; Lau, Cathrine; Pisinger, Charlotta; Smith, Lisa von Huth; Borch-Johnsen, Knut; Jørgensen, Torben

    2008-01-01

    Background Few studies have investigated the specific effect of single intervention components in randomized controlled trials. The purpose was to investigate the effect of adding group-based diet and exercise counselling to individual life-style counselling on long-term changes in dietary habits. Methods The study was a randomized controlled intervention study. From a general Danish population, aged 30 to 60 years (n = 61,301), two random sample were drawn (group A, n = 11,708; group B, n = 1,308). Subjects were invited for a health screening program. Participation rate was 52.5%. All participants received individual life-style counselling. Individuals at high risk of ischemic heart disease in group A were furthermore offered group-based life-style counselling. The intervention was repeated for high-risk individuals after one and three years. At five-year follow-up all participants were invited for a health examination. High risk individuals were included in this study (n = 2 356) and changes in dietary intake were analyzed using multilevel linear regression analyses. Results At one-year follow-up group A had significantly increased the unsaturated/saturated fat ratio compared to group B and in men a significantly greater decrease in saturated fat intake was found in group A compared to group B (net change: -1.13 E%; P = 0.003). No differences were found between group A and B at three-year follow-up. At five-year follow-up group A had significantly increased the unsaturated/saturated fat ratio (net change: 0.09; P = 0.01) and the fish intake compared to group B (net change: 5.4 g/day; P = 0.05). Further, in men a non-significant tendency of a greater decrease was found at five year follow-up in group A compared to group B (net change: -0.68 E%; P = 0.10). The intake of fibre and vegetables increased in both groups, however, no significant difference was found between the groups. No differences between groups were found for saturated fat intake in women. Conclusion

  2. One-Year Follow-Up of the Effectiveness of Cognitive Behavioral Group Therapy for Patients' Depression: A Randomized, Single-Blinded, Controlled Study.

    PubMed

    Chiang, Kai-Jo; Chen, Tsai-Hui; Hsieh, Hsiu-Tsu; Tsai, Jui-Chen; Ou, Keng-Liang; Chou, Kuei-Ru

    2015-01-01

    The aim of the study was to investigate the long-term (one year) effectiveness of a 12-session weekly cognitive behavior group therapy (CBGT) on patients with depression. This was a single-blind randomized controlled study with a 2-arm parallel group design. Eighty-one subjects were randomly assigned to 12 sessions intervention group (CBGT) or control group (usual outpatient psychiatric care group) and 62 completed the study. The primary outcome was depression measured with Beck Depression Inventory (BDI-II) and Hamilton Rating Scale for Depression (HRSD). The secondary outcomes were automatic thoughts measured by automatic thoughts questionnaire (ATQ). Both groups were evaluated at the pretest (before 2 weeks), posttest (after 12 therapy sessions), and short- (3 months), medium- (6 months), and long-term (12 months) follow-up. After receiving CBGT, the experimental group had a statistically significant reduction in the BDI-II from 40.30 at baseline to 17.82 points at session eight and to 10.17 points at postintervention (P < 0.001). Similar effects were seen on the HRSD. ATQ significantly decreased at the 12th session, 6 months after sessions, and 1 year after the sessions ended (P < 0.001). We concluded that CBGT is effective for reducing depression and continued to be effective at 1 year of follow-up.

  3. One-Year Follow-Up of the Effectiveness of Cognitive Behavioral Group Therapy for Patients' Depression: A Randomized, Single-Blinded, Controlled Study

    PubMed Central

    Chiang, Kai-Jo; Chen, Tsai-Hui; Hsieh, Hsiu-Tsu; Tsai, Jui-Chen; Ou, Keng-Liang; Chou, Kuei-Ru

    2015-01-01

    The aim of the study was to investigate the long-term (one year) effectiveness of a 12-session weekly cognitive behavior group therapy (CBGT) on patients with depression. This was a single-blind randomized controlled study with a 2-arm parallel group design. Eighty-one subjects were randomly assigned to 12 sessions intervention group (CBGT) or control group (usual outpatient psychiatric care group) and 62 completed the study. The primary outcome was depression measured with Beck Depression Inventory (BDI-II) and Hamilton Rating Scale for Depression (HRSD). The secondary outcomes were automatic thoughts measured by automatic thoughts questionnaire (ATQ). Both groups were evaluated at the pretest (before 2 weeks), posttest (after 12 therapy sessions), and short- (3 months), medium- (6 months), and long-term (12 months) follow-up. After receiving CBGT, the experimental group had a statistically significant reduction in the BDI-II from 40.30 at baseline to 17.82 points at session eight and to 10.17 points at postintervention (P < 0.001). Similar effects were seen on the HRSD. ATQ significantly decreased at the 12th session, 6 months after sessions, and 1 year after the sessions ended (P < 0.001). We concluded that CBGT is effective for reducing depression and continued to be effective at 1 year of follow-up. PMID:26380359

  4. Reducing menopausal symptoms for women during the menopause transition using group education in a primary health care setting-a randomized controlled trial.

    PubMed

    Rindner, Lena; Strömme, Gunilla; Nordeman, Lena; Hange, Dominique; Gunnarsson, Ronny; Rembeck, Gun

    2017-04-01

    Women's physical and mental ill-health shows a marked increase during menopause, which usually occurs between 45 and 55 years of age. Mental illness and somatic symptoms are common causes of long-term sick leave. Women suffer from a lack of knowledge about the menopause transition and its associated symptoms. The aim of the study was to investigate whether group education for women in primary health care (PHC) about the menopause transition can improve their physical and mental ill-health. This randomized controlled study was conducted in PHC and aimed to evaluate a group education programme for women aged 45-55 years, around the menopause transition. A total of 131 women were randomized to group education or no intervention. The group intervention included two education sessions with topics related to menopause. They answered two questionnaires at baseline and at four-month follow-up: the Menopause Rating Scale (MRS) and the Montgomery-Asberg Depression Rating Scale (MADRS). Change in MRS and MADRS scores over the four months. The intervention group experienced a slight reduction in symptoms while the control group mostly experienced the opposite. This study showed that it was feasible to implement group education on menopause for women aged 45-55 years. NTC02852811. Copyright © 2017 Elsevier B.V. All rights reserved.

  5. Whole body and local cryotherapy in restless legs syndrome: A randomized, single-blind, controlled parallel group pilot study.

    PubMed

    Happe, Svenja; Evers, Stefan; Thiedemann, Christian; Bunten, Sabine; Siegert, Rudolf

    2016-11-15

    Treatment of restless legs syndrome (RLS) is primarily based on drugs. Since many patients report improvement of symptoms due to cooling their legs, we examined the efficacy of cryotherapy in RLS. 35 patients (28 women, 60.9±12.5years) with idiopathic RLS and symptoms starting not later than 6pm were randomized into three groups: cold air chamber at -60°C (n=12); cold air chamber at -10°C (n=12); local cryotherapy at -17°C (n=11). After a two week baseline, the different therapies were applied three minutes daily at 6pm over two weeks, followed by a four week observation period. The patients completed several questionnaires regarding RLS symptoms, sleep, and quality of life on a weekly basis (IRLS, ESS), VAS and sleep/morning protocol were completed daily, MOSS/RLS-QLI were completed once in each period. Additionally, the PLM index was measured by a mobile device at the end of baseline, intervention, and follow-up. The IRLS score was chosen as primary efficacy parameter. At the end of follow-up, significant improvement of RLS symptoms and quality of life could be observed only in the -60°C group as compared to baseline (IRLS: p=0.009; RLS-QLI: p=0.006; ESS: p=0.020). Local cryotherapy led to improvement in quality of life (VAS4: p=0.028; RLS-QLI: p=0.014) and sleep quality (MOSS: p=0.020; MOSS2: p=0.022) but not in IRLS and ESS. In the -10°C group, the only significant effect was shortening of number of wake phases per night. Serious side-effects were not reported. Whole body cryotherapy at -60°C and, to a less extent, local cryotherapy seem to be a treatment option for RLS in addition to conventional pharmacological treatment. However, the exact mode of cryotherapy needs to be established. Copyright © 2016. Published by Elsevier B.V.

  6. Comparing Acceptance and Commitment Group Therapy and 12-Steps Narcotics Anonymous in Addict’s Rehabilitation Process: A Randomized Controlled Trial

    PubMed Central

    Azkhosh, Manoochehr; Farhoudianm, Ali; Saadati, Hemn; Shoaee, Fateme; Lashani, Leila

    2016-01-01

    Objective: Substance abuse is a socio-psychological disorder. The aim of this study was to compare the effectiveness of acceptance and commitment therapy with 12-steps Narcotics Anonymous on psychological well-being of opiate dependent individuals in addiction treatment centers in Shiraz, Iran. Method: This was a randomized controlled trial. Data were collected at entry into the study and at post-test and follow-up visits. The participants were selected from opiate addicted individuals who referred to addiction treatment centers in Shiraz. Sixty individuals were evaluated according to inclusion/ exclusion criteria and were divided into three equal groups randomly (20 participants per group). One group received acceptance and commitment group therapy (Twelve 90-minute sessions) and the other group was provided with the 12-steps Narcotics Anonymous program and the control group received the usual methadone maintenance treatment. During the treatment process, seven participants dropped out. Data were collected using the psychological well-being questionnaire and AAQ questionnaire in the three groups at pre-test, post-test and follow-up visits. Data were analyzed using repeated measure analysis of variance. Results: Repeated measure analysis of variance revealed that the mean difference between the three groups was significant (P<0.05) and that acceptance and commitment therapy group showed improvement relative to the NA and control groups on psychological well-being and psychological flexibility. Conclusion: The results of this study revealed that acceptance and commitment therapy can be helpful in enhancing positive emotions and increasing psychological well-being of addicts who seek treatment. PMID:28050185

  7. The effects and costs of the universal parent group program – all children in focus: a study protocol for a randomized wait-list controlled trial

    PubMed Central

    2013-01-01

    Background In recent decades, parents have been involved in programs that aim to improve parenting style and reduce child behavior problems. Research of preventive parenting programs has shown that these interventions generally have a positive influence on both parents and children. However, to our knowledge there is a gap in the scientific literature when it comes to randomized controlled trials of brief, manual-based structured programs which address general parenting among the population, and focus on promoting health. A four-session universal health promotion parent group program named All Children in Focus was developed. It aims at promoting parental competence and children’s positive development with the parent–child relationship as the target. There is currently no randomized controlled trial existing of the program. Methods/Design A prospective multicenter randomized wait-list controlled trial is being conducted. Approximately 600 parents with children ranging in age from 3–12 years have been recruited in eleven municipalities and city districts in the County of Stockholm, Sweden. Parents are randomized at baseline to an intervention group, which receives the program directly, or to a waiting-list control group, which participates in the program six months later. Changes in parenting and child health and development are assessed with measures immediately post-intervention and six months after the baseline. Observations of a minor group of parents and children are conducted to explore possible relations between parental reports and observed behaviors, as well as changes in the interaction between parent and child. Further, data collected within the evaluation will also be applied to evaluate the possible cost-effectiveness of the program. Discussion This paper describes a study protocol of a randomized controlled trial. Except for the quantitative outcome measures to evaluate the effectiveness of All Children in Focus, this protocol also describes

  8. A group-based exercise program did not improve physical activity in patients with chronic heart failure and comorbidity: a randomized controlled trial.

    PubMed

    Borland, Maria; Rosenkvist, Agneta; Cider, Asa

    2014-05-01

    To investigate how group-based exercise affects the levels of physical activity, physical fitness and health- related quality of life (HRQoL) in patients with chronic heart failure and comorbidities. Randomized controlled trial. A total of 48 patients (10 women, 38 men), mean age 71 years (standard deviation 8 years), ejection fraction 27% (standard deviation 10%), and New York Heart Association functional class II-III. A bicycle test, 6-min walk test (6MWT) and muscle endurance tests were performed. Physical activity was assessed with a pedometer and the International Physical Activity Questionnaire (IPAQ), HRQoL was evaluated with the Short Form-36 (SF-36). Patients were randomized to control or intervention groups. Intervention consisted of an individually designed group-based exercise programme twice a week, for a period of 3 months. Subjects in the control group were asked to continue with their usual lives. A total of 42 patients completed the study, and 6 dropped-out. Steps/day did not increase significantly after intervention (p = 0.351), but IPAQ score did (p = 0.008). Exercise tolerance (p = 0.001), 6MWT (p = 0.014), shoulder abduction (p = 0.028), heel lift (p < 0.0001) and HRQoL (p = 0.018) improved significantly in the intervention group compared with the control group. Group-based exercise did not improve the level of physical activity in patients with chronic heart failure and comorbidity; however, physical fitness and HRQoL were significantly improved.

  9. A randomized controlled trial of a support group intervention on the quality of life and fatigue in women after primary treatment for early breast cancer.

    PubMed

    Björneklett, Helena Granstam; Lindemalm, Christina; Ojutkangas, Marja-Leena; Berglund, Anders; Letocha, Henry; Strang, Peter; Bergkvist, Leif

    2012-12-01

    When diagnosed with breast cancer, most women's lives change as well as their perspectives on and appreciation of life. The aim of the present study was to evaluate whether psychosocial support intervention could influence health-related quality of life (HRQOL) and fatigue during the first year after diagnosis. Of 382 patients with newly diagnosed breast cancer, 191 patients were randomized to an intervention group and 191 patients were randomized to a routine control group. The intervention group received support intervention that lasted 1 week on a residential basis, followed by 4 days of follow-up 2 months later. The support intervention included informative educational parts, relaxation training, mental visualization, and nonverbal communication. HRQOL was measured using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-BR23 questionnaires and fatigue with the Norwegian version of the fatigue scale at baseline and at 2, 6, and 12 months after intervention. There was a time-dependent improvement in both functional and symptom scales between baseline and 12 months as measured by the EORTC QLQ-C30 and BR23 questionnaires and there was a decrease in fatigue between baseline and after 2 months with further improvement up to 12 months in both groups, but there were no differences between the intervention and control groups at any point in time. HRQOL improves and symptoms of fatigue decrease over time, but we could not see any additional effect from the rehabilitation program in this setting.

  10. Social stories: mechanisms of effectiveness in increasing game play skills in children diagnosed with autism spectrum disorder using a pretest posttest repeated measures randomized control group design.

    PubMed

    Quirmbach, Linda M; Lincoln, Alan J; Feinberg-Gizzo, Monica J; Ingersoll, Brooke R; Andrews, Siri M

    2009-02-01

    An increasing body of literature has indicated that social stories are an effective way to teach individuals diagnosed with autism appropriate social behavior. This study compared two formats of a social story targeting the improvement of social skills during game play using a pretest posttest repeated measures randomized control group design. A total of 45 children diagnosed with Autism Spectrum Disorder (ASD) ages 7-14 were randomly assigned to standard, directive, or control story conditions. Results demonstrated that the standard and directive story formats were equally as effective in eliciting, generalizing and maintaining the targeted social skills in participants who had prior game play experience and Verbal Comprehension Index (VCI) scores from the WISC-IV intelligence test in the borderline range or above.

  11. 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

  12. Impact of the Self-Determined Learning Model of Instruction on Self-Determination: A Randomized-Trial Control Group Study

    PubMed Central

    Wehmeyer, Michael L.; Shogren, Karrie A.; Palmer, Susan B.; Williams-Diehm, Kendra L.; Little, Todd; Boulton, Aaron

    2014-01-01

    Promoting self-determination has become best practice in special education. There remains, however, a paucity of causal evidence for interventions to promote self-determination. We conducted a group-randomized, modified equivalent control group design study of the efficacy of the Self-Determined Learning Model of Instruction to promote self-determination. Data on self-determination using multiple measures was collected with 312 high school students with cognitive disabilities in both a control and treatment group. We examined the relationship between the SDLMI and self-determination using structural equation modeling. After determining strong measurement invariance for each latent construct, we found significant differences in latent means across measurement occasions and differential effects attributable to the SDLMI. This was true across disability category, though there was variance across disability populations. PMID:25253899

  13. The effect of peer-group size on the delivery of feedback in basic life support refresher training: a cluster randomized controlled trial.

    PubMed

    Cho, Youngsuk; Je, Sangmo; Yoon, Yoo Sang; Roh, Hye Rin; Chang, Chulho; Kang, Hyunggoo; Lim, Taeho

    2016-07-04

    Students are largely providing feedback to one another when instructor facilitates peer feedback rather than teaching in group training. The number of students in a group affect the learning of students in the group training. We aimed to investigate whether a larger group size increases students' test scores on a post-training test with peer feedback facilitated by instructor after video-guided basic life support (BLS) refresher training. Students' one-rescuer adult BLS skills were assessed by a 2-min checklist-based test 1 year after the initial training. A cluster randomized controlled trial was conducted to evaluate the effect of student number in a group on BLS refresher training. Participants included 115 final-year medical students undergoing their emergency medicine clerkship. The median number of students was 8 in the large groups and 4 in the standard group. The primary outcome was to examine group differences in post-training test scores after video-guided BLS training. Secondary outcomes included the feedback time, number of feedback topics, and results of end-of-training evaluation questionnaires. Scores on the post-training test increased over three consecutive tests with instructor-led peer feedback, but not differ between large and standard groups. The feedback time was longer and number of feedback topics generated by students were higher in standard groups compared to large groups on the first and second tests. The end-of-training questionnaire revealed that the students in large groups preferred the smaller group size compared to their actual group size. In this BLS refresher training, the instructor-led group feedback increased the test score after tutorial video-guided BLS learning, irrespective of the group size. A smaller group size allowed more participations in peer feedback.

  14. Pre-consultation educational group intervention to improve shared decision-making in postmastectomy breast reconstruction: study protocol for a pilot randomized controlled trial

    PubMed Central

    2013-01-01

    Background The Pre-Consultation Educational Group Intervention pilot study seeks to assess the feasibility and inform the optimal design for a definitive randomized controlled trial that aims to improve the quality of decision-making in postmastectomy breast reconstruction patients. Methods/design This is a mixed-methods pilot feasibility randomized controlled trial that will follow a single-center, 1:1 allocation, two-arm parallel group superiority design. Setting: The University Health Network, a tertiary care cancer center in Toronto, Canada. Participants: Adult women referred to one of three plastic and reconstructive surgeons for delayed breast reconstruction or prophylactic mastectomy with immediate breast reconstruction. Intervention: We designed a multi-disciplinary educational group workshop that incorporates the key components of shared decision-making, decision-support, and psychosocial support for cancer survivors prior to the initial surgical consult. The intervention consists of didactic lectures by a plastic surgeon and nurse specialist on breast reconstruction choices, pre- and postoperative care; a value-clarification exercise led by a social worker; and discussions with a breast reconstruction patient. Control: Usual care includes access to an informational booklet, website, and patient volunteer if desired. Outcomes: Expected pilot outcomes include feasibility, recruitment, and retention targets. Acceptability of intervention and full trial outcomes will be established through qualitative interviews. Trial outcomes will include decision-quality measures, patient-reported outcomes, and service outcomes, and the treatment effect estimate and variability will be used to inform the sample size calculation for a full trial. Discussion Our pilot study seeks to identify the (1) feasibility, acceptability, and design of a definitive RCT and (2) the optimal content and delivery of our proposed educational group intervention. Thirty patients have been

  15. Decision aid on breast cancer screening reduces attendance rate: results of a large-scale, randomized, controlled study by the DECIDEO group.

    PubMed

    Bourmaud, Aurelie; Soler-Michel, Patricia; Oriol, Mathieu; Regnier, Véronique; Tinquaut, Fabien; Nourissat, Alice; Bremond, Alain; Moumjid, Nora; Chauvin, Franck

    2016-03-15

    Controversies regarding the benefits of breast cancer screening programs have led to the promotion of new strategies taking into account individual preferences, such as decision aid. The aim of this study was to assess the impact of a decision aid leaflet on the participation of women invited to participate in a national breast cancer screening program. This Randomized, multicentre, controlled trial. Women aged 50 to 74 years, were randomly assigned to receive either a decision aid or the usual invitation letter. Primary outcome was the participation rate 12 months after the invitation. 16 000 women were randomized and 15 844 included in the modified intention-to-treat analysis. The participation rate in the intervention group was 40.25% (3174/7885 women) compared with 42.13% (3353/7959) in the control group (p = 0.02). Previous attendance for screening (RR = 6.24; [95%IC: 5.75-6.77]; p < 0.0001) and medium household income (RR = 1.05; [95%IC: 1.01-1.09]; p = 0.0074) were independently associated with attendance for screening. This large-scale study demonstrates that the decision aid reduced the participation rate. The decision aid activate the decision making process of women toward non-attendance to screening. These results show the importance of promoting informed patient choices, especially when those choices cannot be anticipated.

  16. Challenges and recommendations for placebo controls in randomized trials in physical and rehabilitation medicine: a report of the international placebo symposium working group.

    PubMed

    Fregni, Felipe; Imamura, Marta; Chien, Hsin Fen; Lew, Henry L; Boggio, Paulo; Kaptchuk, Ted J; Riberto, Marcelo; Hsing, Wu Tu; Battistella, Linamara Rizzo; Furlan, Andrea

    2010-02-01

    Compared with other specialties, the field of physical and rehabilitation medicine has not received the deserved recognition from clinicians and researchers in the scientific community. One of the reasons is the lack of sound evidence to support the traditional physical and rehabilitation medicine treatments. The best way to change this disadvantage is through a well conducted clinical research, such as standard placebo- or sham-controlled randomized clinical trials. Therefore, having placebo groups in clinical trials is essential to improve the level of evidence-based practice in physical and rehabilitation medicine that ultimately translates to better clinical care. To address the challenges for the use of placebo in physical and rehabilitation medicine and randomized clinical trials and to create useful recommendations, we convened a working group during the inaugural International Symposium in Placebo (February 2009, in Sao Paulo, Brazil) in which the following topics were discussed: (1) current status of randomized clinical trials in physical and rehabilitation medicine, (2) challenges for the use of placebo in physical and rehabilitation medicine, (3) bioethics, (4) use of placebo in acupuncture trials and for the treatment of low-back pain, (5) mechanisms of placebo, and (6) insights from other specialties. The current article represents the consensus report from the working group.

  17. Daily electronic self-monitoring in bipolar disorder using smartphones - the MONARCA I trial: a randomized, placebo-controlled, single-blind, parallel group trial.

    PubMed

    Faurholt-Jepsen, M; Frost, M; Ritz, C; Christensen, E M; Jacoby, A S; Mikkelsen, R L; Knorr, U; Bardram, J E; Vinberg, M; Kessing, L V

    2015-10-01

    The number of studies on electronic self-monitoring in affective disorder and other psychiatric disorders is increasing and indicates high patient acceptance and adherence. Nevertheless, the effect of electronic self-monitoring in patients with bipolar disorder has never been investigated in a randomized controlled trial (RCT). The objective of this trial was to investigate in a RCT whether the use of daily electronic self-monitoring using smartphones reduces depressive and manic symptoms in patients with bipolar disorder. A total of 78 patients with bipolar disorder according to ICD-10 criteria, aged 18-60 years, and with 17-item Hamilton Depression Rating Scale (HAMD-17) and Young Mania Rating Scale (YMRS) scores ≤17 were randomized to the use of a smartphone for daily self-monitoring including a clinical feedback loop (the intervention group) or to the use of a smartphone for normal communicative purposes (the control group) for 6 months. The primary outcomes were differences in depressive and manic symptoms measured using HAMD-17 and YMRS, respectively, between the intervention and control groups. Intention-to-treat analyses using linear mixed models showed no significant effects of daily self-monitoring using smartphones on depressive as well as manic symptoms. There was a tendency towards more sustained depressive symptoms in the intervention group (B = 2.02, 95% confidence interval -0.13 to 4.17, p = 0.066). Sub-group analysis among patients without mixed symptoms and patients with presence of depressive and manic symptoms showed significantly more depressive symptoms and fewer manic symptoms during the trial period in the intervention group. These results highlight that electronic self-monitoring, although intuitive and appealing, needs critical consideration and further clarification before it is implemented as a clinical tool.

  18. Long-term effects of new progressive group balance training for elderly people with increased risk of falling - a randomized controlled trial.

    PubMed

    Halvarsson, Alexandra; Franzén, Erika; Farén, Elin; Olsson, Elisabeth; Oddsson, Lars; Ståhle, Agneta

    2013-05-01

    To evaluate the long-term effects of a progressive and specific balance group-based program in healthy elderly individuals with increased risk of falling. Follow-up of a randomized controlled trial at nine and 15 months on a population that has previously been described at three months. The study was conducted in Stockholm, Sweden. 59 community-dwelling elderly (age 67-93 years), recruited by advertisement, were randomly allocated to training or to serve as controls. Group balance training three times per week during 12 weeks with a 15 month follow-up time. Participants were assessed at baseline, three, nine, and 15 months thereafter for gait function (preferred and fast walking), rapid step execution (single and dual task), fear of falling, and likelihood of depression. Fast gait speed (p = 0.004), dual task step execution (p = 0.006) and fear of falling (p = 0.001) were still improved in the training group at nine months follow-up. Only self-perceived fear of falling remained significantly improved (p = 0.012) at 15 months follow-up. Although fast gait speed had decreased to baseline level in the training group (1.49 m/s) it remained significantly higher than in the control group (1.37 m/s) at the end of the study, a difference between the groups that was not seen at baseline. This training program provided important positive short and long-term benefits to gait, balance function, and fear of falling.

  19. Depressive symptoms and gestational length among pregnant adolescents: Cluster randomized control trial of CenteringPregnancy® plus group prenatal care.

    PubMed

    Felder, Jennifer N; Epel, Elissa; Lewis, Jessica B; Cunningham, Shayna D; Tobin, Jonathan N; Rising, Sharon Schindler; Thomas, Melanie; Ickovics, Jeannette R

    2017-06-01

    Depressive symptoms are associated with preterm birth among adults. Pregnant adolescents have high rates of depressive symptoms and low rates of treatment; however, few interventions have targeted this vulnerable group. Objectives are to: (a) examine impact of CenteringPregnancy® Plus group prenatal care on perinatal depressive symptoms compared to individual prenatal care; and (b) determine effects of depressive symptoms on gestational age and preterm birth among pregnant adolescents. This cluster-randomized controlled trial was conducted in 14 community health centers and hospitals in New York City. Clinical sites were randomized to receive standard individual prenatal care (n = 7) or CenteringPregnancy® Plus group prenatal care (n = 7). Pregnant adolescents (ages 14-21, N = 1,135) completed the Center for Epidemiologic Studies Depression Scale during pregnancy (second and third trimesters) and postpartum (6 and 12 months). Gestational age was obtained from medical records, based on ultrasound dating. Intention to treat analyses were used to examine objectives. Adolescents at clinical sites randomized to CenteringPregnancy® Plus experienced greater reductions in perinatal depressive symptoms compared to those at clinical sites randomized to individual care (p = .003). Increased depressive symptoms from second to third pregnancy trimester were associated with shorter gestational age at delivery and preterm birth (<37 weeks gestation). Third trimester depressive symptoms were also associated with shorter gestational age and preterm birth. All p < .05. Pregnant adolescents should be screened for depressive symptoms prior to third trimester. Group prenatal care may be an effective nonpharmacological option for reducing depressive symptoms among perinatal adolescents. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  20. Three nested randomized controlled trials of peer-only or multiple stakeholder group feedback within Delphi surveys during core outcome and information set development.

    PubMed

    Brookes, Sara T; Macefield, Rhiannon C; Williamson, Paula R; McNair, Angus G; Potter, Shelley; Blencowe, Natalie S; Strong, Sean; Blazeby, Jane M

    2016-08-17

    Methods for developing a core outcome or information set require involvement of key stakeholders to prioritise many items and achieve agreement as to the core set. The Delphi technique requires participants to rate the importance of items in sequential questionnaires (or rounds) with feedback provided in each subsequent round such that participants are able to consider the views of others. This study examines the impact of receiving feedback from different stakeholder groups, on the subsequent rating of items and the level of agreement between stakeholders. Randomized controlled trials were nested within the development of three core sets each including a Delphi process with two rounds of questionnaires, completed by patients and health professionals. Participants rated items from 1 (not essential) to 9 (absolutely essential). For round 2, participants were randomized to receive feedback from their peer stakeholder group only (peer) or both stakeholder groups separately (multiple). Decisions as to which items to retain following each round were determined by pre-specified criteria. Whilst type of feedback did not impact on the percentage of items for which a participant subsequently changed their rating, or the magnitude of change, it did impact on items retained at the end of round 2. Each core set contained discordant items retained by one feedback group but not the other (3-22 % discordant items). Consensus between patients and professionals in items to retain was greater amongst those receiving multiple group feedback in each core set (65-82 % agreement for peer-only feedback versus 74-94 % for multiple feedback). In addition, differences in round 2 scores were smaller between stakeholder groups receiving multiple feedback than between those receiving peer group feedback only. Variability in item scores across stakeholders was reduced following any feedback but this reduction was consistently greater amongst the multiple feedback group. In the development of

  1. Manage at work: a randomized, controlled trial of a self-management group intervention to overcome workplace challenges associated with chronic physical health conditions.

    PubMed

    Shaw, William S; Besen, Elyssa; Pransky, Glenn; Boot, Cécile R L; Nicholas, Michael K; McLellan, Robert K; Tveito, Torill H

    2014-05-28

    The percentage of older and chronically ill workers is increasing rapidly in the US and in many other countries, but few interventions are available to help employees overcome the workplace challenges of chronic pain and other physical health conditions. While most workers are eligible for job accommodation and disability compensation benefits, other workplace strategies might improve individual-level coping and problem solving to prevent work disability. In this study, we hypothesize that an employer-sponsored group intervention program employing self-management principles may improve worker engagement and reduce functional limitation associated with chronic disorders. In a randomized controlled trial (RCT), workers participating in an employer-sponsored self-management group intervention will be compared with a no-treatment (wait list) control condition. Volunteer employees (n = 300) will be recruited from five participating employers and randomly assigned to intervention or control. Participants in the intervention arm will attend facilitated group workshop sessions at work (10 hours total) to explore methods for improving comfort, adjusting work habits, communicating needs effectively, applying systematic problem solving, and dealing with negative thoughts and emotions about work. Work engagement and work limitation are the principal outcomes. Secondary outcomes include fatigue, job satisfaction, self-efficacy, turnover intention, sickness absence, and health care utilization. Measurements will be taken at baseline, 6-, and 12-month follow-up. A process evaluation will be performed alongside the randomized trial. This study will be most relevant for organizations and occupational settings where some degree of job flexibility, leeway, and decision-making autonomy can be afforded to affected workers. The study design will provide initial assessment of a novel workplace approach and to understand factors affecting its feasibility and effectiveness

  2. Manage at work: a randomized, controlled trial of a self-management group intervention to overcome workplace challenges associated with chronic physical health conditions

    PubMed Central

    2014-01-01

    Background The percentage of older and chronically ill workers is increasing rapidly in the US and in many other countries, but few interventions are available to help employees overcome the workplace challenges of chronic pain and other physical health conditions. While most workers are eligible for job accommodation and disability compensation benefits, other workplace strategies might improve individual-level coping and problem solving to prevent work disability. In this study, we hypothesize that an employer-sponsored group intervention program employing self-management principles may improve worker engagement and reduce functional limitation associated with chronic disorders. Methods In a randomized controlled trial (RCT), workers participating in an employer-sponsored self-management group intervention will be compared with a no-treatment (wait list) control condition. Volunteer employees (n = 300) will be recruited from five participating employers and randomly assigned to intervention or control. Participants in the intervention arm will attend facilitated group workshop sessions at work (10 hours total) to explore methods for improving comfort, adjusting work habits, communicating needs effectively, applying systematic problem solving, and dealing with negative thoughts and emotions about work. Work engagement and work limitation are the principal outcomes. Secondary outcomes include fatigue, job satisfaction, self-efficacy, turnover intention, sickness absence, and health care utilization. Measurements will be taken at baseline, 6-, and 12-month follow-up. A process evaluation will be performed alongside the randomized trial. Discussion This study will be most relevant for organizations and occupational settings where some degree of job flexibility, leeway, and decision-making autonomy can be afforded to affected workers. The study design will provide initial assessment of a novel workplace approach and to understand factors affecting its feasibility

  3. Pre-consultation educational group intervention to improve shared decision-making in postmastectomy breast reconstruction: study protocol for a pilot randomized controlled trial.

    PubMed

    Platt, Jennica; Baxter, Nancy; Jones, Jennifer; Metcalfe, Kelly; Causarano, Natalie; Hofer, Stefan O P; O'Neill, Anne; Cheng, Terry; Starenkyj, Elizabeth; Zhong, Toni

    2013-07-06

    The Pre-Consultation Educational Group INTERVENTION pilot study seeks to assess the feasibility and inform the optimal design for a definitive randomized controlled trial that aims to improve the quality of decision-making in postmastectomy breast reconstruction patients. This is a mixed-methods pilot feasibility randomized controlled trial that will follow a single-center, 1:1 allocation, two-arm parallel group superiority design. The University Health Network, a tertiary care cancer center in Toronto, Canada. Adult women referred to one of three plastic and reconstructive surgeons for delayed breast reconstruction or prophylactic mastectomy with immediate breast reconstruction. We designed a multi-disciplinary educational group workshop that incorporates the key components of shared decision-making, decision-support, and psychosocial support for cancer survivors prior to the initial surgical consult. The intervention consists of didactic lectures by a plastic surgeon and nurse specialist on breast reconstruction choices, pre- and postoperative care; a value-clarification exercise led by a social worker; and discussions with a breast reconstruction patient. Usual care includes access to an informational booklet, website, and patient volunteer if desired. Expected pilot outcomes include feasibility, recruitment, and retention targets. Acceptability of intervention and full trial outcomes will be established through qualitative interviews. Trial outcomes will include decision-quality measures, patient-reported outcomes, and service outcomes, and the treatment effect estimate and variability will be used to inform the sample size calculation for a full trial. Our pilot study seeks to identify the (1) feasibility, acceptability, and design of a definitive RCT and (2) the optimal content and delivery of our proposed educational group intervention. Thirty patients have been recruited to date (8 April 2013), of whom 15 have been randomized to one of three decision

  4. Effects of intake of Lactobacillus casei subsp. casei 327 on skin conditions: a randomized, double-blind, placebo-controlled, parallel-group study in women

    PubMed Central

    SAITO, Yuhi; MIHARA, Toshihiro; MARUYAMA, Kentaro; SAITO, Jiro; IKEDA, Masumi; TOMONAGA, Akihito; KUMAGAI, Takehisa

    2017-01-01

    Lactic acid bacteria are gut flora that play key roles in intestinal homeostasis, which may affect a variety of physiological functions. Our preliminary double-blind, placebo-controlled, parallel-group trials have suggested that intake of heat-killed Lactobacillus casei subsp. casei 327 (designated L. K-1) is effective for improving skin conditions. The aim of this study was to confirm the effect of L. K-1 intake in a randomized, double-blind, placebo-controlled, parallel-group study in healthy female volunteers. Sixty-four subjects were allocated to either the placebo food group (group P, n=32) or active food group (group A, n=32), in which subjects consumed lactobacillus K-1 50 mg (approximately 1 × 1011 bacteria) daily for 8 weeks. After excluding subjects who declined to participate (n=1), violated restrictions (n=4), or were judged ineligible by the principal investigators (n=1), data obtained with 58 subjects (30 in group A and 28 in group P) were analyzed for efficacy by comparing differences from pretrial levels between the two groups. When the level of transepidermal water loss (TEWL) was measured at the arm, the level of TEWL at week 4 of the intake period was significantly lower in group A than group P (p=0.021), suggesting an improvement of skin barrier function. Analysis of skin condition questionnaire data revealed a significant reduction in skin flakiness on the face (week 4). No adverse events were associated with intake of the test foods. The safety of L. K-1 was also confirmed in an independent open-label trial in 11 healthy subjects who consumed excessive amounts of L. K-1 250 mg (approximately 5 × 1011 bacteria). Intake of L. K-1 may therefore be beneficial to skin condition improvement. PMID:28748132

  5. A randomized controlled trial of a senior centre group programme for increasing social support and preventing depression in elderly people living at home in Norway.

    PubMed

    Bøen, Hege; Dalgard, Odd Steffen; Johansen, Rune; Nord, Erik

    2012-05-20

    Late-life depression is a common condition and a challenging public health problem. A lack of social support is strongly associated with psychological distress. Senior centres seem to be suitable arenas for community-based health promotion interventions, although few studies have addressed this subject. The objectives were to examine the effect of a preventive senior centre group programme consisting of weekly meetings, on social support, depression and quality of life. A questionnaire was sent to a random sample of 4,000 persons over 65 in Oslo, and a total of 2,387 completed questionnaires were obtained. These subjects served as a basis for recruitment of participants for a trial, with scores on HSCL-10 being used as a main inclusion criterion. A total of 138 persons were randomized into an intervention group (N = 77) and control group (N = 61). Final analyses included 92 persons. Social support (OSS-3), depression (BDI), life satisfaction and health were measured in interviews at baseline and after 12 months (at the end of the intervention programme). Perceptions of benefits from the intervention were also measured. Mean scores, SD, SE and CI were used to describe the changes in outcomes. Effect sizes were calculated based on the original scales and as Cohen's d. Paired sample tests and ANOVA were used to test group differences. There was an increase in social support in both groups, but greatest in the intervention group. The level of depression increased for both groups, but more so in the control than the intervention group. There was a decrease in life satisfaction, although the decrease was largest among controls. There were almost no differences in reported health between groups. However, effect sizes were small and differences were not statistically significant. In contrast, most of the participants said the intervention meant much to them and led to increased use of the centre. In all probability, the intervention failed to meet optimistic

  6. Efficacy of Cognitive Behavioral Therapy for Insomnia in Adolescents: A Randomized Controlled Trial with Internet Therapy, Group Therapy and A Waiting List Condition

    PubMed Central

    de Bruin, Eduard J.; Bögels, Susan M.; Oort, Frans J.; Meijer, Anne Marie

    2015-01-01

    Study Objectives: To investigate the efficacy of cognitive behavioral therapy for insomnia (CBTI) in adolescents. Design: A randomized controlled trial of CBTI in group therapy (GT), guided internet therapy (IT), and a waiting list (WL), with assessments at baseline, directly after treatment (post-test), and at 2 months follow-up. Setting: Diagnostic interviews were held at the laboratory of the Research Institute of Child Development and Education at the University of Amsterdam. Treatment for GT occurred at the mental health care center UvAMinds in Amsterdam, the Netherlands. Participants: One hundred sixteen adolescents (mean age = 15.6 y, SD = 1.6 y, 25% males) meeting DSM-IV criteria for insomnia, were randomized to IT, GT, or WL. Interventions: CBTI of 6 weekly sessions, consisted of psychoeducation, sleep hygiene, restriction of time in bed, stimulus control, cognitive therapy, and relaxation techniques. GT was conducted in groups of 6 to 8 adolescents, guided by 2 trained sleep therapists. IT was applied through an online guided self-help website with programmed instructions and written feedback from a trained sleep therapist. Measurements and Results: Sleep was measured with actigraphy and sleep logs for 7 consecutive days. Symptoms of insomnia and chronic sleep reduction were measured with questionnaires. Results showed that adolescents in both IT and GT, compared to WL, improved significantly on sleep efficiency, sleep onset latency, wake after sleep onset, and total sleep time at post-test, and improvements were maintained at follow-up. Most of these improvements were found in both objective and subjective measures. Furthermore, insomnia complaints and symptoms of chronic sleep reduction also decreased significantly in both treatment conditions compared to WL. Effect sizes for improvements ranged from medium to large. A greater proportion of participants from the treatment conditions showed high end-state functioning and clinically significant

  7. Longitudinal effects of coping on outcome in a randomized controlled trial of a group intervention for HIV-positive adults with AIDS-related bereavement.

    PubMed

    Hansen, Nathan B; Tarakeshwar, Nalini; Ghebremichael, Musie; Zhang, Heping; Kochman, Arlene; Sikkema, Kathleen J

    2006-09-01

    This study examined the longitudinal effects of coping on outcome one year following completion of a randomized, controlled trial of a group coping intervention for AIDS-related bereavement. Bereaved HIV-positive participants (N = 267) were administered measures of grief, psychiatric distress, quality of life, and coping at baseline, post-intervention, and at 4-, 8-, and 12-month follow-ups. Coping strategies directly impacted all outcome variables for both study conditions. Additionally, the coping intervention moderated the relationship between avoidant coping and the longitudinal course of grief and psychiatric distress, resulting in greater reductions in grief and distress for intervention participants after accounting for avoidant coping strategies.

  8. A randomized controlled trial of chronic vagus nerve stimulation for treatment of medically intractable seizures. The Vagus Nerve Stimulation Study Group.

    PubMed

    1995-02-01

    Preliminary reports have suggested that chronic, intermittent stimulation of the vagus nerve (VNS) is an alternative treatment for patients with medically refractory seizures. We performed a multicenter, randomized, controlled trial to evaluate the efficacy and safety of adjunctive VNS in patients with poorly controlled partial seizures. An implanted, programmable pacemaker-like device was connected to two stimulating electrodes wrapped around the left vagus nerve. One hundred fourteen patients were randomized to receive 14 weeks of high-level stimulation (presumed therapeutic dose) or low-level stimulation (presumed subtherapeutic dose) using a blinded, parallel study design. Seizure frequency was compared with a 12-week baseline. Mean reduction in seizure frequency was 24.5% for the "high" stimulation group versus 6.1% for the "low" stimulation group (p = 0.01). Thirty-one percent of patients receiving high stimulation had a seizure frequency reduction of > or = 50%, versus 13% of patients in the low group (p = 0.02). Treatment emergent side effects were largely limited to a transient hoarseness occurring during the stimulation train. One patient with no previous history of cardiac disease experienced a myocardial infarction during the third month of vagal stimulation. VNS may be an effective alternative treatment for patients who have failed antiepileptic drug therapy and are not optimal candidates for epilepsy surgery.

  9. Effect of cognitive behavioral group therapy for recovery of self-esteem on community-living individuals with mental illness: Non-randomized controlled trial.

    PubMed

    Kunikata, Hiroko; Yoshinaga, Naoki; Nakajima, Kazuo

    2016-10-01

    The aim of this study was to examine over a 12-month post-intervention period whether the participation of community-living individuals with mental illness in cognitive behavioral group therapy for recovery of self-esteem (CBGTRS) resulted in improved outcomes. This was a non-randomized controlled trial. The participants were persons with mental illness who resided in communities in the Chugoku region of Japan. In total, 41 were assigned to an experimental group (CBGTRS intervention, 12 group sessions), and 21 to a control group. Outcome indices (self-esteem, moods, cognition, subjective well-being, psychiatric symptoms) were measured for the experimental group prior to intervention (T0), immediately post-intervention (T1), and at 3 (T2) and 12 (T3) months post-intervention. The control group was measured at the same intervals. For the experimental group, self-esteem scores at T1, T2, and T3 were significantly higher than at T0. Moods and cognition scores remained significantly low until T2. Scores for Inadequate Mental Mastery in the subjective well-being index had not decreased by T3. Confidence in Coping remained significantly high until T2. Psychiatric symptoms scores at T0, T1, T2, and T3 were significantly lower than at T0. The means and standard errors for self-esteem and Inadequate Mental Mastery increased until T3, and those for Tension-Anxiety, Depression-Dejection, and Confusion decreased until T2. From within-group trends and between-group differences in self-esteem, we conclude that CBGTRS may have a relatively long-term effect on self-esteem recovery. T2 is the turning point for moods and cognition; thus, follow-up is needed 3 months following the initial program. © 2016 The Authors. Psychiatry and Clinical Neurosciences © 2016 Japanese Society of Psychiatry and Neurology.

  10. Using WhatsApp and Facebook Online Social Groups for Smoking Relapse Prevention for Recent Quitters: A Pilot Pragmatic Cluster Randomized Controlled Trial

    PubMed Central

    Chan, Ching Han Helen; Lai, Chi-Keung Jonah; Chan, Wai Fung Vivian; Wang, Man Ping; Li, Ho Cheung William; Chan, Sophia Siu Chee; Lam, Tai-Hing

    2015-01-01

    Background Quit attempters often have episodes of smoking relapse before they eventually quit. Interactive text messaging through mobile phones has been shown to increase abstinence. This service can be potentially applied on the platform of a social networking service to help quitters maintain abstinence. Objective Our aim was to determine if the group discussion and reminders via the WhatsApp or Facebook social group were effective to prevent smoking relapse in quitters who had stopped smoking recently. Methods This was a single-blinded, parallel, 3-arm pilot cluster randomized controlled trial allocating recent quitters, who had completed an 8-week treatment and reported abstinence for at least 7 days, to WhatsApp (n=42), Facebook (n=40), and a control group (n=54). The 2 intervention groups participated in a 2-month online group discussion with either WhatsApp or Facebook moderated by a trained smoking cessation counselor and received a self-help booklet on smoking cessation. The control group only received the booklet. The primary outcome was the 2- and 6-month relapse rates, defined as the proportion of participants who smoked at least 5 cigarettes in 3 consecutive days. Results Fewer participants in the WhatsApp group (17%, 7/42) reported relapse than the control group (42.6%, 23/54) at 2-month (OR 0.27, 95% CI 0.10-0.71) and 6-month (40.5%, 17/42 vs 61.1%, 33/54; OR 0.43, 95% CI 0.19-0.99) follow-ups. The Facebook group (30.0%, 12/40) had an insignificantly lower relapse rate than the control group (42.6%, 23/54) at 2-month (OR 0.58, 95% CI 0.24-1.37) and 6-month (52.5%, 13/40 vs 61.1%, 33/54; OR 0.70, 95% CI 0.31-1.61) follow-ups. The WhatsApp social groups had more moderators’ posts (median 60, IQR 25 vs median 32, IQR 7; P=.05) and participants’ posts (median 35, IQR 50 vs median 6, IQR 9; P=.07) than their Facebook counterparts, but the difference was insignificant. Conclusions The intervention via the WhatsApp social group was effective in reducing

  11. Using WhatsApp and Facebook Online Social Groups for Smoking Relapse Prevention for Recent Quitters: A Pilot Pragmatic Cluster Randomized Controlled Trial.

    PubMed

    Cheung, Yee Tak Derek; Chan, Ching Han Helen; Lai, Chi-Keung Jonah; Chan, Wai Fung Vivian; Wang, Man Ping; Li, Ho Cheung William; Chan, Sophia Siu Chee; Lam, Tai-Hing

    2015-10-22

    Quit attempters often have episodes of smoking relapse before they eventually quit. Interactive text messaging through mobile phones has been shown to increase abstinence. This service can be potentially applied on the platform of a social networking service to help quitters maintain abstinence. Our aim was to determine if the group discussion and reminders via the WhatsApp or Facebook social group were effective to prevent smoking relapse in quitters who had stopped smoking recently. This was a single-blinded, parallel, 3-arm pilot cluster randomized controlled trial allocating recent quitters, who had completed an 8-week treatment and reported abstinence for at least 7 days, to WhatsApp (n=42), Facebook (n=40), and a control group (n=54). The 2 intervention groups participated in a 2-month online group discussion with either WhatsApp or Facebook moderated by a trained smoking cessation counselor and received a self-help booklet on smoking cessation. The control group only received the booklet. The primary outcome was the 2- and 6-month relapse rates, defined as the proportion of participants who smoked at least 5 cigarettes in 3 consecutive days. Fewer participants in the WhatsApp group (17%, 7/42) reported relapse than the control group (42.6%, 23/54) at 2-month (OR 0.27, 95% CI 0.10-0.71) and 6-month (40.5%, 17/42 vs 61.1%, 33/54; OR 0.43, 95% CI 0.19-0.99) follow-ups. The Facebook group (30.0%, 12/40) had an insignificantly lower relapse rate than the control group (42.6%, 23/54) at 2-month (OR 0.58, 95% CI 0.24-1.37) and 6-month (52.5%, 13/40 vs 61.1%, 33/54; OR 0.70, 95% CI 0.31-1.61) follow-ups. The WhatsApp social groups had more moderators' posts (median 60, IQR 25 vs median 32, IQR 7; P=.05) and participants' posts (median 35, IQR 50 vs median 6, IQR 9; P=.07) than their Facebook counterparts, but the difference was insignificant. The intervention via the WhatsApp social group was effective in reducing relapse probably because of enhanced discussion and

  12. Tier 2 Language Intervention for Diverse Preschoolers: An Early-Stage Randomized Control Group Study Following an Analysis of Response to Intervention.

    PubMed

    Spencer, Trina D; Petersen, Douglas B; Adams, John L

    2015-11-01

    The first purpose of this study was to explore the use of a whole class, test-teach-test, dynamic assessment of narratives for identifying participants. The second purpose was to examine the efficacy of a Tier 2 narrative language intervention for culturally and linguistically diverse preschoolers. A dynamic assessment was conducted with students from 3 Head Start classrooms. On the basis of the results of the dynamic assessment, 22 children were randomly assigned to treatment (n = 12) and control (n = 10) groups for intervention. Participants received a small-group (4:1), differentiated, narrative intervention for 15-20 min, twice a week, for 9 weeks. Interventionists used weekly progress monitoring data to explicitly focus on individualized narrative and linguistic targets. The treatment group showed significant improvement over the control group on proximal and distal measures of narrative retells, with large effect sizes. Group differences on a measure of children's language in the context of personal stories were not statistically significant. This early-stage study provides evidence that narrative language intervention is an effective approach to improving the language skills of preschoolers with diverse language needs. Furthermore, the evidence supports the use of dynamic assessment for reducing overidentification and identifying candidates for small-group language intervention.

  13. The effectiveness of standardized skin care regimens on skin dryness in nursing home residents: A randomized controlled parallel-group pragmatic trial.

    PubMed

    Hahnel, Elisabeth; Blume-Peytavi, Ulrike; Trojahn, Carina; Dobos, Gabor; Stroux, Andrea; Garcia Bartels, Natalie; Jahnke, Irina; Lichterfeld-Kottner, Andrea; Neels-Herzmann, Heike; Klasen, Anja; Kottner, Jan

    2017-05-01

    Aged residents of institutional long-term care facilities are at high risk for developing skin and tissue diseases. Besides various common skin problems, dry skin (xerosis cutis) is one of the most frequent skin conditions in this setting. To investigate the effectiveness of two structured skin care regimens in comparison to routine skin care on xerosis cutis in nursing home residents. A multi-center, pragmatic, randomized, controlled, investigator blinded study with three parallel groups. The study was conducted in a random sample of ten out of 291 institutional long-term care facilities of the federal state of Berlin, Germany. Long-term care residents being 65+ years affected by dry skin were included. The residents were allocated into one of three study groups. Two interventional groups used standardized skin care regimens, consisting of a body wash and twice daily applications of leave-on products for eight weeks. The third control group performed skin care as usual. All participating residents were examined at baseline and after 4 and 8 weeks. Xerosis cutis was measured with the Overall Dry Skin score. Instrumental skin barrier measurements were performed at baseline and after 8 weeks. Diaries were used to document washing and skin care frequencies. In total, 133 residents were included and allocated to one of the three groups. Mean age was 83.8 (SD 8.3) years, 65.4% were female and most residents had care levels I (42.9%) or II (42.9%) according to the German Social Code Book XI. Mean Barthel score was 46.8 (SD 24.2) and mean Braden score was 17.6 (SD 3.7). Leg skin areas were drier compared to arms and trunk areas. At the end of the study the Overall Dry Skin scores in the intervention groups were lower compared to the control group. There were statistically significant improvements of skin dryness in both intervention groups compared to the control group over time. The results of this pragmatic trial indicate that structured skin care regimens are effective

  14. Video-games used in a group setting is feasible and effective to improve indicators of physical activity in individuals with chronic stroke: a randomized controlled trial.

    PubMed

    Givon, Noa; Zeilig, Gabi; Weingarden, Harold; Rand, Debbie

    2016-04-01

    To investigate the feasibility of using video-games in a group setting and to compare the effectiveness of video-games as a group intervention to a traditional group intervention for improving physical activity in individuals with chronic stroke. A single-blind randomized controlled trial with evaluations pre and post a 3-month intervention, and at 3-month follow-up. Compliance (session attendance), satisfaction and adverse effects were feasibility measures. Grip strength and gait speed were measures of physical activity. Hip accelerometers quantified steps/day and the Action Research Arm Test assessed the functional ability of the upper extremity. Forty-seven community-dwelling individuals with chronic stroke (29-78 years) were randomly allocated to receive video-game (N=24) or traditional therapy (N=23) in a group setting. There was high treatment compliance for both interventions (video-games-78%, traditional therapy-66%), but satisfaction was rated higher for the video-game (93%) than the traditional therapy (71%) (χ(2)=4.98, P=0.026). Adverse effects were not reported in either group. Significant improvements were demonstrated in both groups for gait speed (F=3.9, P=0.02), grip strength of the weaker (F=6.67, P=0.002) and stronger hands (F=7.5, P=0.001). Daily steps and functional ability of the weaker hand did not increase in either group. Using video-games in a small group setting is feasible, safe and satisfying. Video-games improve indicators of physical activity of individuals with chronic stroke. © The Author(s) 2015.

  15. Effectiveness of using group visit model to support diabetes patient self-management in rural communities of Shanghai: a randomized controlled trial.

    PubMed

    Liu, Shengsheng; Bi, Anhua; Fu, Dongbo; Fu, Hua; Luo, Wei; Ma, Xiaoying; Zhuang, Liyan

    2012-12-03

    Diabetes has become a major public health problem in China. Support of patient self-management is a key component of effective diabetes care and improved patient outcomes. A series of peer-led community-based disease-specific self-management programs including diabetes have been widely disseminated in urban communities of Shanghai since 1999. However, the strategy of using trained lay leaders to support patient self-management faces challenges in rural communities in Shanghai. This study developed a Chinese diabetes group visit program as an alternative approach to support patient self-management and examined its effectiveness on self-management behaviors, self-efficacy and health status for patients with type 2 diabetes in rural communities of Shanghai. 208 patients with type 2 diabetes aged 35-80 years were randomly assigned to the intervention group (n=119) of 12 monthly group visit sessions or to a control group (n=89) of usual care. The trial was undertaken in two rural communities in Shanghai, China. Randomization and allocation to study group were carried out by using a random number table. Analysis of covariance was used to compare changes in the 17 self-management behavior, self-efficacy and health status related variables in two groups at 12 months' follow-up based on 176 patients (n=98; n=78). Compared with controls, the intervention patients, on average, increased their duration of aerobic exercise by more than 40 minutes per week (p=0.001); had significant increase of 0.71 in mean score on self-efficacy to manage diabetes (p=0.02); and had significant improvements in measures of illness intrusiveness and systolic blood pressure. The intervention patients attended an average of 10.1 of the 12 program sessions with 75.6% of them attended 10 and more sessions. The Chinese diabetes group visit model is a feasible, acceptable and effective alternative for supporting diabetes patient self-management in Chinese rural communities. The model requires larger

  16. Randomized controlled trial evaluating the effect of an interactive group counseling intervention for HIV-positive women on prenatal depression and disclosure of HIV status.

    PubMed

    Kaaya, Sylvia F; Blander, Jeffrey; Antelman, Gretchen; Cyprian, Fileuka; Emmons, Karen M; Matsumoto, Kenji; Chopyak, Elena; Levine, Michelle; Smith Fawzi, Mary C

    2013-01-01

    The objective of the study was to assess the effectiveness of group counseling, using a problem-solving therapy approach, on reducing depressive symptoms and increasing prenatal disclosure rates of HIV status among HIV-positive pregnant women living in Dar es Salaam, Tanzania. A randomized controlled trial was performed comparing a six-week structured nurse-midwife facilitated psychosocial support group with the standard of care. Sixty percent of women in the intervention group were depressed post-intervention, versus 73% in the control group [Relative Risk (RR) = 0.82, 95% confidence interval (CI): 0.67-1.01, p=0.066]. HIV disclosure rates did not differ across the two study arms. However, among those women who disclosed, there was a significantly higher level of overall personal satisfaction with the response to disclosure from family and friends among women in the treatment (88%) compared to the control group (62%; p=0.004). The results indicate reductions in the level of depressive symptoms comparable with major depressive disorder (MDD) for HIV-positive pregnant women participating in a group counseling intervention. Although the psychosocial group counseling did not significantly increase disclosure rates, an improvement in the level of personal satisfaction resulting from disclosure was associated with the intervention. This suggests that the counseling sessions have likely reduced the burden of depression and helped clients better manage partner reactions to disclosure. Public agencies and non-governmental organizations working in Tanzania and similar settings should consider offering structured psychosocial support groups to HIV-positive pregnant women to prevent poor mental health outcomes, promote early childhood development, and potentially impact HIV-related disease outcomes in the long term.

  17. Effectiveness and cost-effectiveness of a group-based pain self-management intervention for patients undergoing total hip replacement: feasibility study for a randomized controlled trial.

    PubMed

    Wylde, Vikki; Marques, Elsa; Artz, Neil; Blom, Ashley; Gooberman-Hill, Rachael

    2014-05-20

    Total hip replacement (THR) is a common elective surgical procedure and can be effective for reducing chronic pain. However, waiting times can be considerable. A pain self-management intervention may provide patients with skills to more effectively manage their pain and its impact during their wait for surgery. This study aimed to evaluate the feasibility of conducting a randomized controlled trial to assess the effectiveness and cost-effectiveness of a group-based pain self-management course for patients undergoing THR. Patients listed for a THR at one orthopedic center were posted a study invitation pack. Participants were randomized to attend a pain self-management course plus standard care or standard care only. The lay-led course was delivered by Arthritis Care and consisted of two half-day sessions prior to surgery and one full-day session after surgery. Participants provided outcome and resource-use data using a diary and postal questionnaires prior to surgery and one month, three months and six months after surgery. Brief telephone interviews were conducted with non-participants to explore barriers to participation. Invitations were sent to 385 eligible patients and 88 patients (23%) consented to participate. Interviews with 57 non-participants revealed the most common reasons for non-participation were views about the course and transport difficulties. Of the 43 patients randomized to the intervention group, 28 attended the pre-operative pain self-management sessions and 11 attended the post-operative sessions. Participant satisfaction with the course was high, and feedback highlighted that patients enjoyed the group format. Retention of participants was acceptable (83% of recruited patients completed follow-up) and questionnaire return rates were high (72% to 93%), with the exception of the pre-operative resource-use diary (35% return rate). Resource-use completion rates allowed for an economic evaluation from the health and social care payer perspective

  18. Randomized, parallel-group, double-blind, controlled study to evaluate the efficacy and safety of carbohydrate-derived fulvic acid in topical treatment of eczema

    PubMed Central

    Gandy, Justin J; Snyman, Jacques R; van Rensburg, Constance EJ

    2011-01-01

    Background The purpose of this study was to evaluate the efficacy and safety of carbohydratederived fulvic acid (CHD-FA) in the treatment of eczema in patients two years and older. Methods In this single-center, double-blind, placebo-controlled, parallel-group comparative study, 36 volunteers with predetermined eczema were randomly assigned to receive either the study drug or placebo twice daily for four weeks. Results All safety parameters remained within normal limits, with no significant differences in either group. Significant differences were observed for both severity and erythema in the placebo and CHD-FA treated groups, and a significant difference was observed for scaling in the placebo-treated group. With regard to the investigator assessment of global response to treatment, a significant improvement was observed in the CHD-FA group when compared with the placebo group. A statistically significant decrease in visual analog scale score was observed in both groups, when comparing the baseline with the final results. Conclusion CHD-FA was well tolerated, with no difference in reported side effects other than a short-lived burning sensation on application. CHD-FA significantly improved some aspects of eczema. Investigator assessment of global response to treatment with CHD-FA was significantly better than that with emollient therapy alone. The results of this small exploratory study suggest that CHD-FA warrants further investigation in the treatment of eczema. PMID:21931500

  19. Motivating first-time, group O blood donors to return: Rationale and design of a randomized controlled trial of a post-donation telephone interview.

    PubMed

    France, Janis L; France, Christopher R; Carlson, Bruce W; Kessler, Debra A; Rebosa, Mark; Shaz, Beth H; Madden, Katrala; Carey, Patricia M

    2015-08-03

    First-time blood donors are essential to the US donor pool, providing nearly a third of all donations. Unfortunately, there are a wide variety of obstacles to repeat donation and new donors are extremely difficult to retain. Because each donor experiences a unique set of deterrents, we developed a post-donation interview based on motivational interview principles in order to flexibly address individual barriers. The primary aim of this randomized clinical trial is to examine retention of first-time, group O blood donors who are randomly assigned to receive either a telephone-delivered interview with motivational and action planning components or a standard-of-care control call approximately six weeks after their donation. Measures of donation attitude, perceived behavioral control, intention, and motivational autonomy will be measured before and after the telephone contact using online surveys, and donation attempts will be tracked for one year using blood center donor databases. We hypothesize that, compared to controls, donors who receive the telephone interview will be more likely to make a donation attempt over the following year. In addition, we will examine possible mechanisms of action of the interview using key predictors of donation behavior as described by Self Determination Theory (i.e., motivational autonomy) and the Theory of Planned Behavior (i.e., attitude, perceived behavioral control, and intention). Results of this intervention may help to support a novel strategy to enhance retention of selected blood donors in an effort to better meet the nation's blood supply needs.

  20. Examination of early group dynamics and treatment outcome in a randomized controlled trial of group cognitive behavior therapy for binge eating disorder.

    PubMed

    Pisetsky, Emily M; Durkin, Nora E; Crosby, Ross D; Berg, Kelly C; Mitchell, James E; Crow, Scott J; Wonderlich, Stephen A; Peterson, Carol B

    2015-10-01

    This study examined whether perceptions of group dynamics early in treatment predicted eating disorder outcomes in a sample of adults (N = 190) with binge eating disorder (BED) who participated in a 15-session group cognitive behavior therapy (gCBT) treatment with differing levels of therapist involvement (therapist led, therapist assisted, and self-help). The group dynamic variables included the Engaged subscale of the Group Climate Questionnaire--Short Form and the Group Attitude Scale, measured at session 2 and session 6. Treatment outcome was assessed in terms of global eating disorder severity and frequency of binge eating at end of treatment, 6-month, and 12-month follow-up. Session 2 engagement and group attitudes were associated with improved outcome at 12-month follow-up. No other group dynamic variables were significantly associated with treatment outcome. Group dynamic variables did not differ by levels of therapist involvement. Results indicate that early engagement and attitudes may be predictive of improved eating disorder psychopathology at 12 month follow-up. However, the pattern of mostly insignificant findings indicates that in gCBT, group process variables may be less influential on outcomes relative to other treatment components. Additionally, participants were able to engage in group treatment regardless of level of therapist involvement.

  1. Examination of Early Group Dynamics and Treatment Outcome in a Randomized Controlled Trial of Group Cognitive Behavior Therapy for Binge Eating Disorder

    PubMed Central

    Pisetsky, Emily M.; Durkin, Nora E.; Crosby, Ross D.; Berg, Kelly C.; Mitchell, James E.; Crow, Scott J.; Wonderlich, Stephen A.; Peterson, Carol B.

    2015-01-01

    This study examined whether perceptions of group dynamics early in treatment predicted eating disorder outcomes in a sample of adults (N = 190) with binge eating disorder (BED) who participated in a 15-session group cognitive behavior therapy (gCBT) treatment with differing levels of therapist involvement (therapist led, therapist assisted, and self-help). The group dynamic variables included the Engaged subscale of the Group Climate Questionnaire – Short Form and the Group Attitude Scale, measured at session 2 and session 6. Treatment outcome was assessed in terms of global eating disorder severity and frequency of binge eating at end of treatment, 6-month, and 12-month follow-up. Session 2 engagement and group attitudes were associated with improved outcome at 12-month follow-up. No other group dynamic variables were significantly associated with treatment outcome. Group dynamic variables did not differ by levels of therapist involvement. Results indicate that early engagement and attitudes may be predictive of improved eating disorder psychopathology at 12 month follow-up. However, the pattern of mostly insignificant findings indicates that in gCBT, group process variables may be less influential on outcomes relative to other treatment components. Additionally, participants were able to engage in group treatment regardless of level of therapist involvement. PMID:26264648

  2. Results of a Randomized Controlled Trial to Examine the Efficacy of a Chronic Pain Self-Management Group for Older Adults [ISRCTN11899548

    PubMed Central

    Ersek, Mary; Turner, Judith A.; Cain, Kevin C.; Kemp, Carol A.

    2008-01-01

    Chronic pain is a common, disabling problem in older adults. Pain self-management training is a multimodal therapy that has been found to be effective in young to middle-aged adult samples; however, few studies have examined the effectiveness of this therapy in older adults. In this randomized, controlled trial, we evaluated a pain self-management training group (SMG) intervention as compared with an education-only (BOOK) control condition. Participants, 65 years of age or older who experienced persistent, noncancer pain that limited their activities, were recruited from 43 retirement communities in the Pacific Northwest of the United States. The primary outcome was physical disability, as measured by the Roland-Morris Disability Questionnaire. Secondary outcomes were depression (Geriatric Depression Scale), pain intensity (Brief Pain Inventory), and pain-related interference with activities (Brief Pain Inventory). Randomization occurred by facility to minimize cross-contamination between groups. Two-hundred and fifty-six individuals, mean age=81.8 (SD: 6.5), enrolled and 218 completed the study. No significant differences in outcomes were found between groups at post-intervention, 6-month follow-up, or 12-month follow-up. The SMG group showed a significantly greater increase over time, relative to the BOOK group, in two process measures, as measured by the Chronic Pain Coping Inventory: use of relaxation and use of exercise/stretching. In both cases, the increase was greatest from baseline to the post-intervention assessment. Study findings indicate that additional research is needed to determine the most effective content and delivery methods for self-management therapies targeted at older adults with chronic pain. PMID:18086516

  3. Effects of new, individually adjusted, progressive balance group training for elderly people with fear of falling and tend to fall: a randomized controlled trial.

    PubMed

    Halvarsson, Alexandra; Oddsson, Lars; Olsson, Elisabeth; Farén, Elin; Pettersson, Anna; Ståhle, Agneta

    2011-11-01

    To evaluate the effects of a new, individually adjusted, progressive and specific balance group training programme on fear of falling, step execution, and gait in healthy elderly people with fear of falling and tend to fall. Randomized controlled trial. The study was conducted in Stockholm County, Sweden. Fifty-nine community dwelling elderly people were recruited by advertisement, and allocated at random to an intervention group (n = 38) or a control group (n = 21). Individually adjusted, progressive and specific balance group training was given three times a week for three months. The training incorporated elements included in, and required for, independent activities of daily living, and for reactions to loss of balance during dual or multiple tasks. Fear of falling was assessed with Falls Efficacy Scale International (FES-I). The reaction time of step execution was measured with the step-execution test, and gait was measured with GAITRite®. After three months the intervention group showed significant positive changes in the FES-I (P = 0.008), in the step-execution phase of dual-task performance (P = 0.012), and in gait at preferred speed during single-task performance; in cadence (P = 0.030) and, at fast speed, in velocity (P = 0.004) and cadence (P = 0.001). Significant decreases were also found for the likelihood of depression after participating in the training programme. This new balance training programme is feasible and leads to decreased fear of falling, decreased time for step execution during dual-task performance and increased velocity during fast walking.

  4. Effectiveness of a School-Based Group Psychotherapy Program for War-Exposed Adolescents: A Randomized Control Trial

    ERIC Educational Resources Information Center

    Layne, Christopher M.; Saltzman, William R.; Poppleton, Landon; Burlingame, Gary M.; Pasalic, Alma; Durakovic, Elvira; Music, Mirjana; Campara, Nihada; Dapo, Nermin; Arslanagic, Berina; Steinberg, Alan M.; Pynoos, Robert S.

    2008-01-01

    The study assesses the comparative efficacy of a classroom-based psycho-education and skills intervention and a school-based trauma- and grief-focused group treatment of a three-tiered mental health program for adolescents exposed to severe war-trauma, traumatic bereavement, and postwar adversity. The two-tier approach, combined with…

  5. Internet-Delivered Targeted Group Intervention for Body Dissatisfaction and Disordered Eating in Adolescent Girls: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Heinicke, Brooke E.; Paxton, Susan J.; McLean, Sian A.; Wertheim, Eleanor H.

    2007-01-01

    This study evaluated a targeted intervention designed to alleviate body image and eating problems in adolescent girls that was delivered over the internet so as to increase access to the program. The program consisted of six, 90-minute weekly small group, synchronous on-line sessions and was facilitated by a therapist and manual. Participants were…

  6. Effectiveness of a School-Based Group Psychotherapy Program for War-Exposed Adolescents: A Randomized Control Trial

    ERIC Educational Resources Information Center

    Layne, Christopher M.; Saltzman, William R.; Poppleton, Landon; Burlingame, Gary M.; Pasalic, Alma; Durakovic, Elvira; Music, Mirjana; Campara, Nihada; Dapo, Nermin; Arslanagic, Berina; Steinberg, Alan M.; Pynoos, Robert S.

    2008-01-01

    The study assesses the comparative efficacy of a classroom-based psycho-education and skills intervention and a school-based trauma- and grief-focused group treatment of a three-tiered mental health program for adolescents exposed to severe war-trauma, traumatic bereavement, and postwar adversity. The two-tier approach, combined with…

  7. Internet-Delivered Targeted Group Intervention for Body Dissatisfaction and Disordered Eating in Adolescent Girls: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Heinicke, Brooke E.; Paxton, Susan J.; McLean, Sian A.; Wertheim, Eleanor H.

    2007-01-01

    This study evaluated a targeted intervention designed to alleviate body image and eating problems in adolescent girls that was delivered over the internet so as to increase access to the program. The program consisted of six, 90-minute weekly small group, synchronous on-line sessions and was facilitated by a therapist and manual. Participants were…

  8. Randomized control trial to assess the efficacy of metacognitive training compared with a psycho-educational group in people with a recent-onset psychosis.

    PubMed

    Ochoa, S; López-Carrilero, R; Barrigón, M L; Pousa, E; Barajas, A; Lorente-Rovira, E; González-Higueras, F; Grasa, E; Ruiz-Delgado, I; Cid, J; Birulés, I; Esteban-Pinos, I; Casañas, R; Luengo, A; Torres-Hernández, P; Corripio, I; Montes-Gámez, M; Beltran, M; De Apraiz, A; Domínguez-Sánchez, L; Sánchez, E; Llacer, B; Pélaez, T; Bogas, J L; Moritz, S

    2017-07-01

    Aims were to assess the efficacy of metacognitive training (MCT) in people with a recent onset of psychosis in terms of symptoms as a primary outcome and metacognitive variables as a secondary outcome. A multicenter, randomized, controlled clinical trial was performed. A total of 126 patients were randomized to an MCT or a psycho-educational intervention with cognitive-behavioral elements. The sample was composed of people with a recent onset of psychosis, recruited from nine public centers in Spain. The treatment consisted of eight weekly sessions for both groups. Patients were assessed at three time-points: baseline, post-treatment, and at 6 months follow-up. The evaluator was blinded to the condition of the patient. Symptoms were assessed with the PANSS and metacognition was assessed with a battery of questionnaires of cognitive biases and social cognition. Both MCT and psycho-educational groups had improved symptoms post-treatment and at follow-up, with greater improvements in the MCT group. The MCT group was superior to the psycho-educational group on the Beck Cognitive Insight Scale (BCIS) total (p = 0.026) and self-certainty (p = 0.035) and dependence self-subscale of irrational beliefs, comparing baseline and post-treatment. Moreover, comparing baseline and follow-up, the MCT group was better than the psycho-educational group in self-reflectiveness on the BCIS (p = 0.047), total BCIS (p = 0.045), and intolerance to frustration (p = 0.014). Jumping to Conclusions (JTC) improved more in the MCT group than the psycho-educational group (p = 0.021). Regarding the comparison within each group, Theory of Mind (ToM), Personalizing Bias, and other subscales of irrational beliefs improved in the MCT group but not the psycho-educational group (p < 0.001-0.032). MCT could be an effective psychological intervention for people with recent onset of psychosis in order to improve cognitive insight, JTC, and tolerance to frustration. It seems that MCT could be useful to

  9. Making healthy eating and physical activity policy practice: process evaluation of a group randomized controlled intervention in afterschool programs

    PubMed Central

    Weaver, R. Glenn; Beets, Michael W.; Hutto, Brent; Saunders, Ruth P.; Moore, Justin B.; Turner-McGrievy, Gabrielle; Huberty, Jennifer L.; Ward, Dianne S.; Pate, Russell R.; Beighle, Aaron; Freedman, Darcy

    2015-01-01

    This study describes the link between level of implementation and outcomes from an intervention to increase afterschool programs’ (ASPs) achievement of healthy eating and physical activity (HE-PA) Standards. Ten intervention ASPs implemented the Strategies-To-Enhance-Practice (STEPs), a multi-component, adaptive intervention framework identifying factors essential to meeting HE-PA Standards, while 10 control ASPs continued routine practice. All programs, intervention and control, were assigned a STEPs for HE-PA index score based on implementation. Mixed-effects linear regressions showed high implementation ASPs had the greatest percentage of boys and girls achieving 30 min of moderate-to-vigorous physical activity (47.3 and 29.3%), followed by low implementation ASPs (41.3 and 25.0%), and control ASPs (34.8 and 18.5%). For healthy eating, high/low implementation programs served fruits and vegetables an equivalent number of days, but more days than control programs (74.0 and 79.1% of days versus 14.2%). A similar pattern emerged for the percent of days sugar-sweetened foods and beverages were served, with high and low implementation programs serving sugar-sweetened foods (8.0 and 8.4% of days versus 52.2%), and beverages (8.7 and 2.9% of days versus 34.7%) equivalently, but less often than control programs. Differences in characteristics and implementation of STEPs for HE-PA between high/low implementers were also identified. PMID:26590240

  10. Making healthy eating and physical activity policy practice: process evaluation of a group randomized controlled intervention in afterschool programs.

    PubMed

    Weaver, R Glenn; Beets, Michael W; Hutto, Brent; Saunders, Ruth P; Moore, Justin B; Turner-McGrievy, Gabrielle; Huberty, Jennifer L; Ward, Dianne S; Pate, Russell R; Beighle, Aaron; Freedman, Darcy

    2015-12-01

    This study describes the link between level of implementation and outcomes from an intervention to increase afterschool programs' (ASPs) achievement of healthy eating and physical activity (HE-PA) Standards. Ten intervention ASPs implemented the Strategies-To-Enhance-Practice (STEPs), a multi-component, adaptive intervention framework identifying factors essential to meeting HE-PA Standards, while 10 control ASPs continued routine practice. All programs, intervention and control, were assigned a STEPs for HE-PA index score based on implementation. Mixed-effects linear regressions showed high implementation ASPs had the greatest percentage of boys and girls achieving 30 min of moderate-to-vigorous physical activity (47.3 and 29.3%), followed by low implementation ASPs (41.3 and 25.0%), and control ASPs (34.8 and 18.5%). For healthy eating, high/low implementation programs served fruits and vegetables an equivalent number of days, but more days than control programs (74.0 and 79.1% of days versus 14.2%). A similar pattern emerged for the percent of days sugar-sweetened foods and beverages were served, with high and low implementation programs serving sugar-sweetened foods (8.0 and 8.4% of days versus 52.2%), and beverages (8.7 and 2.9% of days versus 34.7%) equivalently, but less often than control programs. Differences in characteristics and implementation of STEPs for HE-PA between high/low implementers were also identified. © The Author 2015. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  11. Imiquimod 5% cream for the treatment of actinic keratosis: results from two phase III, randomized, double-blind, parallel group, vehicle-controlled trials.

    PubMed

    Lebwohl, Mark; Dinehart, Scott; Whiting, David; Lee, Peter K; Tawfik, Naji; Jorizzo, Joseph; Lee, James H; Fox, Terry L

    2004-05-01

    The immune system plays a critical role in the development and pathogenesis of actinic keratosis (AK). Imiquimod has been shown to stimulate the cutaneous immune response and be effective for the treatment of nonmelanoma skin cancers. Two phase III, randomized, double-blind, vehicle-controlled studies evaluated the efficacy of imiquimod 5% cream compared with vehicle in the treatment of AK lesions on the face and balding scalp. A total of 436 participants at 24 centers in the United States and Canada were randomized to either imiquimod 5% or vehicle cream. Study cream was applied one time per day, 2 days per week for 16 weeks. Clearance of AK lesions was clinically assessed at an 8-week posttreatment visit. The complete clearance rate was 45.1% for the imiquimod group and 3.2% for the vehicle group. The difference in complete clearance rates (imiquimod minus vehicle) was 41.9% with a 95% confidence interval of 34.9% to 49%. The partial (> or =75%) clearance rate was 59.1% for the imiquimod group and 11.8% for the vehicle group. The difference in partial clearance rates (imiquimod minus vehicle) was 47.3% with a 95% confidence interval of 39.5% to 55.1%. The median percent reduction in AK lesions was 83.3% for the imiquimod group and 0% for the vehicle group. Local skin reactions were common. Severe erythema was reported by 17.7% of participants who received imiquimod and 2.3% of participants who received vehicle. Overall, imiquimod was very well tolerated. Imiquimod 5% cream used 2 times per week for 16 weeks is an effective and well-tolerated treatment for AK.

  12. A Comparison of Web-based and Small-Group Palliative and End-of-Life Care Curricula: A Quasi-Randomized Controlled Study at One Institution

    PubMed Central

    Day, Frank C.; Srinivasan, Malathi; Der-Martirosian, Claudia; Griffin, Erin; Hoffman, Jerome R.; Wilkes, Michael S.

    2014-01-01

    Purpose Few studies have compared the effect of web-based eLearning versus small-group learning on medical student outcomes. Palliative and end-of-life (PEOL) education is ideal for this comparison, given uneven access to PEOL experts and content nationally. Method In 2010, the authors enrolled all third-year medical students at the University of California, Davis School of Medicine into a quasi-randomized controlled trial of web-based interactive education (eDoctoring) compared to small-group education (Doctoring) on PEOL clinical content over two months. All students participated in three 3-hour PEOL sessions with similar content. Outcomes included a 24-item PEOL-specific self-efficacy scale with three domains (diagnosis/treatment [Cronbach’s alpha = 0.92, CI: 0.91–0.93], communication/prognosis [alpha = 0.95; CI: 0.93–0.96], and social impact/self-care [alpha = 0.91; CI: 0.88–0.92]); eight knowledge items; ten curricular advantage/disadvantages, and curricular satisfaction (both students and faculty). Results Students were randomly assigned to web-based eDoctoring (n = 48) or small-group Doctoring (n = 71) curricula. Self-efficacy and knowledge improved equivalently between groups: e.g., prognosis self-efficacy, 19%; knowledge, 10–42%. Student and faculty ratings of the web-based eDoctoring curriculum and the small group Doctoring curriculum were equivalent for most goals, and overall satisfaction was equivalent for each, with a trend towards decreased eDoctoring student satisfaction. Conclusions Findings showed equivalent gains in self-efficacy and knowledge between students participating in a web-based PEOL curriculum, in comparison to students learning similar content in a small-group format. Web-based curricula can standardize content presentation when local teaching expertise is limited, but may lead to decreased user satisfaction. PMID:25539518

  13. Outcomes from a randomized controlled trial of a group intervention for HIV positive men and women coping with AIDS-related loss and bereavement.

    PubMed

    Sikkema, Kathleen J; Hansen, Nathan B; Kochman, Arlene; Tate, David C; Difranceisco, Wayne

    2004-01-01

    The purpose of this study was to examine the impact of a group coping intervention for HIV-positive men and women who have lost a loved one(s) to AIDS in the past 2 years. Two hundred thirty-five participants, diverse with respect to race/ethnicity and sexual orientation, were randomly assigned to a 12-week cognitive-behavioral group intervention or to an individual therapy on request comparison condition. Measures assessing grief and psychiatric distress were administered at baseline and 2 weeks post-intervention period. Although a strong gender effect was observed in outcome, both men and women participating in the group intervention demonstrated significantly more reduction in psychiatric distress than controls. Further, women in the group intervention demonstrated significant reductions in grief and depressive symptoms over men in both conditions and women in the comparison condition. Brief cognitive-behavioral group interventions for coping with grief have a positive impact on the psychiatric functioning of HIV-positive participants. This appears to be especially true for HIV-positive women; a group not previously focused on in clinical research related to AIDS bereavement.

  14. Metformin Treatment in Type 2 Diabetes in Pregnancy: An Active Controlled, Parallel-Group, Randomized, Open Label Study in Patients with Type 2 Diabetes in Pregnancy

    PubMed Central

    Ainuddin, Jahan Ara; Karim, Nasim; Zaheer, Sidra; Ali, Syed Sanwer; Hasan, Anjum Ara

    2015-01-01

    Aims. To assess the effect of metformin and to compare it with insulin treatment in patients with type 2 diabetes in pregnancy in terms of perinatal outcome, maternal complications, additional insulin requirement, and treatment acceptability. Methods. In this randomized, open label study, 206 patients with type 2 diabetes in pregnancy who met the eligibility criteria were selected from the antenatal clinics. Insulin was added to metformin treatment when required, to maintain the target glycemic control. The patients were followed up till delivery. Maternal, and perinatal outcomes and pharmacotherapeutic characteristics were recorded on a proforma. Results. Maternal characteristics were comparable in metformin and insulin treated group. 84.9% patients in metformin group required add-on insulin therapy at mean gestational age of 26.58 ± 3.85 weeks. Less maternal weight gain (P < 0.001) and pregnancy induced hypertension (P = 0.029) were observed in metformin treated group. Small for date babies were more in metformin group (P < 0.01). Neonatal hypoglycemia was significantly less and so was NICU stay of >24 hours in metformin group (P < 0.01). Significant reduction in cost of treatment was found in metformin group. Conclusion. Metformin alone or with add-on insulin is an effective and cheap treatment option for patients with type 2 diabetes in pregnancy. This trial is registered with clinical trial registration number: Clinical trials.gov NCT01855763. PMID:25874236

  15. Efficacy of a computerized cognitive training application on cognition and depressive symptomatology in a group of healthy older adults: A randomized controlled trial.

    PubMed

    Millán-Calenti, José C; Lorenzo, Trinidad; Núñez-Naveira, Laura; Buján, Ana; Rodríguez-Villamil, José L; Maseda, Ana

    2015-01-01

    The purpose of this study was to evaluate the efficacy of a multimedia and interactive cognitive program on cognition and depressive symptomatology in healthy older adults. Adults aged ≥65 years were randomly assigned to two groups: the experimental group in which the participants received a computerized cognitive training application; and the control group in which the participants received no intervention during the protocol. Performance on the mini-mental state examination (MMSE) and the short-form of the geriatric depression scale (GDS-SF) were analysed using a three-way repeated-measure analysis of variance. To determine cognition after the training, the cognitive program was used and the results were assessed using the MMSE, indicating that the significant time effects within the groups reflected the score for cognitive assessment that was significantly better after the intervention in the experimental group. No significant differences were observed with regard to the depressive symptomatology or between the groups according to sex or educational level on the two dimensions previously established (cognition and depressive symptomatology). The development of technological applications for intervention in older adults is increasing. Based on the established objective, we can conclude that the computerized intervention may constitute a good alternative to enhance the cognitive status in older people. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  16. Stabilizing group treatment for complex posttraumatic stress disorder related to child abuse based on psychoeducation and cognitive behavioural therapy: a multisite randomized controlled trial.

    PubMed

    Dorrepaal, Ethy; Thomaes, Kathleen; Smit, Johannes H; van Balkom, Anton J L M; Veltman, Dick J; Hoogendoorn, Adriaan W; Draijer, Nel

    2012-01-01

    Evidence-based treatments for complex posttraumatic stress disorder (PTSD) related to childhood abuse are scarce. This is the first randomized controlled trial to test the efficacy of psycho-educational and cognitive behavioural stabilizing group treatment in terms of both PTSD and complex PTSD symptom severity. Seventy-one patients with complex PTSD and severe comorbidity (e.g., 74% axis II comorbidity) were randomly assigned to either a 20-week group treatment in addition to treatment as usual or to treatment as usual only. Primary outcome measures were the Davidson trauma scale (DTS) for PTSD and the structured interview for disorders of extreme stress (SIDES) for complex PTSD symptoms. Statistical analysis was conducted in the intention-to-treat (ITT) and in the completer sample. Subjects were considered responders when scoring at 20 weeks at least 1 standard deviation below pretest findings. The 16% attrition was relatively low. After 20 weeks, the experimental condition (large effect sizes) and control condition (medium effect sizes) both showed significant decreases on the DTS and SIDES, but differences between the conditions were not significant. The secondary responder analysis (ITT) revealed significantly more responders on the DTS (45 vs. 21%), but not on the SIDES (61 vs. 42%). Adding psycho-educational and cognitive behavioural stabilizing group treatment for complex PTSD related to child abuse to treatment as usual showed an equivocal outcome. Patients in both conditions improved substantially during stabilizing treatment, and while significant superiority on change scores was absent, responder analysis suggested clinical meaningfulness of adding group treatment. Copyright © 2012 S. Karger AG, Basel.

  17. Randomized controlled trial of supportive-expressive group therapy and body-mind-spirit intervention for Chinese non-metastatic breast cancer patients.

    PubMed

    Ho, Rainbow T H; Fong, Ted C T; Lo, Phyllis H Y; Ho, Samuel M Y; Lee, Peter W H; Leung, Pamela P Y; Spiegel, David; Chan, Cecilia L W

    2016-12-01

    This study aimed to evaluate the efficacy of supportive-expressive group (SEG) therapy and body-mind-spirit (BMS) intervention on emotional suppression and psychological distress in Chinese breast cancer patients. This three-arm randomized controlled trial assigned 157 non-metastatic breast cancer patients to BMS, SEG, or social support control group. SEG focused on emotional expression and group support, whereas BMS emphasized relaxation and self-care. All groups received 2-h weekly sessions for 8 weeks. The participants completed measurements on emotional suppression, perceived stress, anxiety, and depression at baseline and three follow-up assessments in 1 year. Using latent growth modeling, overall group difference was found for emotional suppression (χ (2)(2) = 8.88, p = 0.012), marginally for perceived stress (χ (2)(2) = 5.70, p = 0.058), but not for anxiety and depression (χ (2)(2) = 0.19-0.94, p > 0.05). Post-hoc analyses revealed a significant and moderate reduction (Cohen d = 0.55, p = 0.007) in emotional suppression in SEG compared to control group, whereas BMS resulted in a marginally significant and moderate fall (d = 0.46, p = 0.024) in perceived stress. Neither SEG nor BMS significantly improved anxiety and depression (d < 0.20, p > 0.05). The present results did not demonstrate overall effectiveness for either BMS or SEG therapy in the present sample of Chinese non-metastatic breast cancer patients. The participants appear to derive only modest benefits in terms of their psychological well-being from either intervention.

  18. The Efficacy of a Group Cognitive Behavioral Therapy for War-Affected Young Migrants Living in Australia: A Cluster Randomized Controlled Trial

    PubMed Central

    Ooi, Chew S.; Rooney, Rosanna M.; Roberts, Clare; Kane, Robert T.; Wright, Bernadette; Chatzisarantis, Nikos

    2016-01-01

    Background: Preventative and treatment programs for people at risk of developing psychological problems after exposure to war trauma have mushroomed in the last decade. However, there is still much contention about evidence-based and culturally sensitive interventions for children. The aim of this study was to examine the efficacy of the Teaching Recovery Techniques in improving the emotional and behavioral outcomes of war-affected children resettled in Australia. Methods and Findings: A cluster randomized controlled trial with pre-test, post-test, and 3-month follow-up design was employed. A total of 82 participants (aged 10–17 years) were randomized by school into the 8-week intervention (n = 45) or the waiting list (WL) control condition (n = 37). Study outcomes included symptoms of post-traumatic stress disorder, depression, internalizing and externalizing problems, as well as psychosocial functioning. A medium intervention effect was found for depression symptoms. Participants in the intervention condition experienced a greater symptom reduction than participants in the WL control condition, F(1, 155) = 5.20, p = 0.024, partial η2 = 0.07. This improvement was maintained at the 3-month follow-up, F(2, 122) = 7.24, p = 0.001, partial η2 = 0.20. Conclusions: These findings suggest the potential benefit of the school and group-based intervention on depression symptoms but not on other outcomes, when compared to a waiting list control group. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12611000 948998. PMID:27843435

  19. Sample size determinations for group-based randomized clinical trials with different levels of data hierarchy between experimental and control arms.

    PubMed

    Heo, Moonseong; Litwin, Alain H; Blackstock, Oni; Kim, Namhee; Arnsten, Julia H

    2017-02-01

    We derived sample size formulae for detecting main effects in group-based randomized clinical trials with different levels of data hierarchy between experimental and control arms. Such designs are necessary when experimental interventions need to be administered to groups of subjects whereas control conditions need to be administered to individual subjects. This type of trial, often referred to as a partially nested or partially clustered design, has been implemented for management of chronic diseases such as diabetes and is beginning to emerge more commonly in wider clinical settings. Depending on the research setting, the level of hierarchy of data structure for the experimental arm can be three or two, whereas that for the control arm is two or one. Such different levels of data hierarchy assume correlation structures of outcomes that are different between arms, regardless of whether research settings require two or three level data structure for the experimental arm. Therefore, the different correlations should be taken into account for statistical modeling and for sample size determinations. To this end, we considered mixed-effects linear models with different correlation structures between experimental and control arms to theoretically derive and empirically validate the sample size formulae with simulation studies.

  20. PSYCHOMETRIC EVALUATION OF PATIENT REPORTED OUTCOMES IN IBS RANDOMIZED CONTROLLED TRIALS: A Rome Foundation Working Group Report

    PubMed Central

    Spiegel, Brennan; Camilleri, Michael; Bolus, Roger; Andresen, Viola; Chey, William D.; Fehnel, Sheri; Mangel, Allen; Talley, Nicholas J.; Whitehead, William E.

    2009-01-01

    Background There is debate about how best to measure patient reported outcomes (PROs) in irritable bowel syndrome (IBS). We pooled data from clinical trials to measure the psychometric properties of IBS endpoints, including binary responses (e.g. “adequate relief”) and 50% improvement in symptom severity. Methods We pooled patient-level data from 12 IBS drug trials involving 10,066 participants. We tested the properties of binary response and 50% improvement endpoints, including the impact of baseline severity on performance, and measured construct validity using clinical anchors. We calculated confidence intervals for the psychometric parameters of each endpoint, and compared estimates side-by-side between PROs. Results There were 9044 evaluable subjects (age=44; 85% F; 58% IBS-C; 31% IBS-D). Using the binary endpoint, the proportion responding in the mild, moderate, and severe groups was 42%, 40%, and 38%, respectively (p=0.0008). There was no effect of baseline severity on binary response (OR=0.99; CI=0.99–1.0; p=0.07). The proportions reaching 50% improvement in pain were 45%, 41%, and 41% respectively; there was a small, yet significant, impact of baseline severity (OR=1.04; CI=1.03–1.05; p<0.0001) that did not meet criteria for clinical relevance. Both endpoints revealed strong construct validity, and detected “minimally clinically important differences” (0.5 SD) in bowel symptoms. Both endpoints provided better discriminant spread in IBS-D than IBS-C subgroups. Conclusions Both the traditional binary and 50% improvement endpoints are equivalent in their psychometric properties. Neither is impacted by baseline severity, and both demonstrate excellent construct validity. They are optimized for the IBS-D population, but also appear valid in IBS-C. PMID:19706292

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

    PubMed

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

    2015-09-01

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

  2. Efficacy of movement control exercises versus general exercises on recurrent sub-acute nonspecific low back pain in a sub-group of patients with movement control dysfunction. protocol of a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Practice guidelines recommend various types of exercise for chronic back pain but there have been few head-to-head comparisons of these interventions. General exercise seems to be an effective option for management of chronic low back pain (LBP) but very little is known about the management of a sub-acute LBP within sub-groups. Recent research has developed clinical tests to identify a subgroup of patients with chronic non-specific LBP who have movement control dysfunction (MD). Method/Design We are conducting a randomized controlled trial (RCT) to compare the effects of general exercise and specific movement control exercise (SMCE) on disability and function in patients with MD within recurrent sub-acute LBP. The main outcome measure is the Roland Morris Disability Questionnaire. Discussion European clinical guideline for management of chronic LBP recommends that more research is required to develop tools to improve the classification and identification of specific clinical sub-groups of chronic LBP patients. Good quality RCTs are then needed to determine the effectiveness of specific interventions aimed at these specific target groups. This RCT aims to test the hypothesis whether patients within a sub-group of MD benefit more through a specific individually tailored movement control exercise program than through general exercises. PMID:22494776

  3. The Efficacy and Safety of Wenxin Keli in Patients with Frequent Premature Ventricular Contractions: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Trial.

    PubMed

    Hua, Wei; Gao, Run-Lin; Zhao, Bu-Chang; Wang, Jing; Chen, Xu-Hua; Cai, Chi; Zhang, Shu

    2015-10-05

    Premature ventricular contractions (PVCs) are common in the general population, and frequent PVCs may result in the poor quality of life or even the damage of cardiac function. We examined the efficacy and safety of a traditional Chinese medicine Wenxin Keli for the treatment of frequent PVCs among a relatively large Chinese cohort. We performed a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial. A total of 1200 eligible participants were randomly assigned in a ratio of 1:1 to receive Wenxin Keli or the placebo for 4 weeks. The primary and secondary endpoint was the change of PVC numbers and PVC-related symptoms after a 4-week treatment compared with baseline, respectively. In addition, vital signs, laboratory values, and electrocardiographic parameters were assessed in a safety analysis. At the initial evaluation, no significant differences in the baseline characteristics were observed between the Wenxin Keli group and the placebo group. A smaller number of PVCs was observed after the 4-week treatment than at baseline, in both the Wenxin Keli group (5686 ± 5940 vs. 15,138 ± 7597 beats/d, P < 0.001) and the placebo group (10,592 ± 8009 vs. 14,529 ± 5929 beats/d, P < 0.001); moreover, the Wenxin Keli group demonstrated a significantli greater reduction in the frequency of PVCs than the placebo group (P < 0.001). In a full analysis set, patients in the Wenxin Keli group exhibited significantly higher total effective responses in the reduction of PVCs compared to those in the placebo group (83.8% vs. 43.5%,P < 0.001). The per-protocol analysis yielded similar results (83.0% vs. 39.3%,P < 0.001). Treatment with Wenxin Keli also demonstrated superior performance compared to the placebo with respect to PVC-related symptoms. No severe adverse effects attributable to Wenxin Keli were reported. Wenxin Keli treatment effectively reduced the overall number of PVCs and alleviated PVC-related symptoms in patients without structural heart

  4. The effect of participatory women's groups on birth outcomes in Bangladesh: does coverage matter? Study protocol for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Progress on neonatal survival has been slow in most countries. While there is evidence on what works to reduce newborn mortality, there is limited knowledge on how to deliver interventions effectively when health systems are weak. Cluster randomized trials have shown strong reductions in neonatal mortality using community mobilisation with women's groups in rural Nepal and India. A similar trial in Bangladesh showed no impact. A main hypothesis is that this negative finding is due to the much lower coverage of women's groups in the intervention population in Bangladesh compared to India and Nepal. For evidence-based policy making it is important to examine if women's group coverage is a main determinant of their impact. The study aims to test the effect on newborn and maternal health outcomes of a participatory women's group intervention with a high population coverage of women's groups. Methods A cluster randomised trial of a participatory women's group intervention will be conducted in 3 districts of rural Bangladesh. As we aim to study a women's group intervention with high population coverage, the same 9 intervention and 9 control unions will be used as in the 2005-2007 trial. These had been randomly allocated using the districts as strata. To increase coverage, 648 new groups were formed in addition to the 162 existing groups that were part of the previous trial. An open cohort of women who are permanent residents in the union in which their delivery or death was identified, is enrolled. Women and their newborns are included after birth, or, if a woman dies during pregnancy, after her death. Excluded are women who are temporary residents in the union in which their birth or death was identified. The primary outcome is neonatal mortality in the last 24 months of the study. A low cost surveillance system will be used to record all birth outcomes and deaths to women of reproductive age in the study population. Data on home care practices and health

  5. The effect of participatory women's groups on birth outcomes in Bangladesh: does coverage matter? Study protocol for a randomized controlled trial.

    PubMed

    Houweling, Tanja Aj; Azad, Kishwar; Younes, Layla; Kuddus, Abdul; Shaha, Sanjit; Haq, Bedowra; Nahar, Tasmin; Beard, James; Fottrell, Edward F; Prost, Audrey; Costello, Anthony

    2011-09-26

    Progress on neonatal survival has been slow in most countries. While there is evidence on what works to reduce newborn mortality, there is limited knowledge on how to deliver interventions effectively when health systems are weak. Cluster randomized trials have shown strong reductions in neonatal mortality using community mobilisation with women's groups in rural Nepal and India. A similar trial in Bangladesh showed no impact. A main hypothesis is that this negative finding is due to the much lower coverage of women's groups in the intervention population in Bangladesh compared to India and Nepal. For evidence-based policy making it is important to examine if women's group coverage is a main determinant of their impact. The study aims to test the effect on newborn and maternal health outcomes of a participatory women's group intervention with a high population coverage of women's groups. A cluster randomised trial of a participatory women's group intervention will be conducted in 3 districts of rural Bangladesh. As we aim to study a women's group intervention with high population coverage, the same 9 intervention and 9 control unions will be used as in the 2005-2007 trial. These had been randomly allocated using the districts as strata. To increase coverage, 648 new groups were formed in addition to the 162 existing groups that were part of the previous trial. An open cohort of women who are permanent residents in the union in which their delivery or death was identified, is enrolled. Women and their newborns are included after birth, or, if a woman dies during pregnancy, after her death. Excluded are women who are temporary residents in the union in which their birth or death was identified. The primary outcome is neonatal mortality in the last 24 months of the study. A low cost surveillance system will be used to record all birth outcomes and deaths to women of reproductive age in the study population. Data on home care practices and health care use are collected

  6. The Efficacy and Safety of Wenxin Keli in Patients with Frequent Premature Ventricular Contractions: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Trial

    PubMed Central

    Hua, Wei; Gao, Run-Lin; Zhao, Bu-Chang; Wang, Jing; Chen, Xu-Hua; Cai, Chi; Zhang, Shu

    2015-01-01

    Background: Premature ventricular contractions (PVCs) are common in the general population, and frequent PVCs may result in the poor quality of life or even the damage of cardiac function. We examined the efficacy and safety of a traditional Chinese medicine Wenxin Keli for the treatment of frequent PVCs among a relatively large Chinese cohort. Methods: We performed a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial. A total of 1200 eligible participants were randomly assigned in a ratio of 1:1 to receive Wenxin Keli or the placebo for 4 weeks. The primary and secondary endpoint was the change of PVC numbers and PVC-related symptoms after a 4-week treatment compared with baseline, respectively. In addition, vital signs, laboratory values, and electrocardiographic parameters were assessed in a safety analysis. Results: At the initial evaluation, no significant differences in the baseline characteristics were observed between the Wenxin Keli group and the placebo group. A smaller number of PVCs was observed after the 4-week treatment than at baseline, in both the Wenxin Keli group (5686 ± 5940 vs. 15,138 ± 7597 beats/d, P < 0.001) and the placebo group (10,592 ± 8009 vs. 14,529 ± 5929 beats/d, P < 0.001); moreover, the Wenxin Keli group demonstrated a significantli greater reduction in the frequency of PVCs than the placebo group (P < 0.001). In a full analysis set, patients in the Wenxin Keli group exhibited significantly higher total effective responses in the reduction of PVCs compared to those in the placebo group (83.8% vs. 43.5%, P < 0.001). The per-protocol analysis yielded similar results (83.0% vs. 39.3%, P < 0.001). Treatment with Wenxin Keli also demonstrated superior performance compared to the placebo with respect to PVC-related symptoms. No severe adverse effects attributable to Wenxin Keli were reported. Conclusions: Wenxin Keli treatment effectively reduced the overall number of PVCs and alleviated PVC

  7. Access to a simulator is not enough: the benefits of virtual reality training based on peer-group-derived benchmarks--a randomized controlled trial.

    PubMed

    von Websky, Martin W; Raptis, Dimitri A; Vitz, Martina; Rosenthal, Rachel; Clavien, P A; Hahnloser, Dieter

    2013-11-01

    Virtual reality (VR) simulators are widely used to familiarize surgical novices with laparoscopy, but VR training methods differ in efficacy. In the present trial, self-controlled basic VR training (SC-training) was tested against training based on peer-group-derived benchmarks (PGD-training). First, novice laparoscopic residents were randomized into a SC group (n = 34), and a group using PGD-benchmarks (n = 34) for basic laparoscopic training. After completing basic training, both groups performed 60 VR laparoscopic cholecystectomies for performance analysis. Primary endpoints were simulator metrics; secondary endpoints were program adherence, trainee motivation, and training efficacy. Altogether, 66 residents completed basic training, and 3,837 of 3,960 (96.8 %) cholecystectomies were available for analysis. Course adherence was good, with only two dropouts, both in the SC-group. The PGD-group spent more time and repetitions in basic training until the benchmarks were reached and subsequently showed better performance in the readout cholecystectomies: Median time (gallbladder extraction) showed significant differences of 520 s (IQR 354-738 s) in SC-training versus 390 s (IQR 278-536 s) in the PGD-group (p < 0.001) and 215 s (IQR 175-276 s) in experts, respectively. Path length of the right instrument also showed significant differences, again with the PGD-training group being more efficient. Basic VR laparoscopic training based on PGD benchmarks with external assessment is superior to SC training, resulting in higher trainee motivation and better performance in simulated laparoscopic cholecystectomies. We recommend such a basic course based on PGD benchmarks before advancing to more elaborate VR training.

  8. A randomized, controlled trial of group cognitive-behavioral therapy for compulsive buying disorder: posttreatment and 6-month follow-up results.

    PubMed

    Mueller, Astrid; Mueller, Ulrike; Silbermann, Andrea; Reinecker, Hans; Bleich, Stefan; Mitchell, James E; de Zwaan, Martina

    2008-07-01

    The purpose of this study was to conduct a randomized trial comparing the efficacy of a group cognitive-behavioral therapy (CBT) intervention designed for the treatment of compulsive buying disorder to a waiting list control (WLC) group. Thirty-one patients with compulsive buying problems according to the criteria developed by McElroy et al. were assigned to receive active treatment (12 weekly sessions and 6-month follow-up) and 29 to the WLC group. The treatment was specifically aimed at interrupting and controlling the problematic buying behavior, establishing healthy purchasing patterns, restructuring maladaptive thoughts and negative feelings associated with shopping and buying, and developing healthy coping skills. Primary outcome measures were the Compulsive Buying Scale (CBS), the Yale-Brown Obsessive Compulsive Scale-Shopping Version (YBOCS-SV), and the German Compulsive Buying Scale (G-CBS). Secondary outcome measures were the Symptom Checklist-90-Revised (SCL-90-R), the Barratt Impulsiveness Scale (BIS-11), and the Saving Inventory-Revised (SI-R). The study was completed between November 2003 and May 2007 at the University Hospital of Erlangen, Bavaria, Germany. Multivariate analysis revealed significant differences between the CBT and the WLC groups on the primary outcome variables (outcome-by-time-by-group effect, Pillai's trace, F = 6.960, df = 1, p = .002). The improvement was maintained during the 6-month follow-up. The treatment did not affect other psychopathology, e.g., compulsive hoarding, impulsivity, or SCL-90-R scores. We found that lower numbers of visited group therapy sessions and higher pretreatment hoarding traits as measured with the SI-R total score were significant predictors for nonresponse. The results suggest that a disorder-specific cognitive-behavioral intervention can significantly impact compulsive buying behavior.

  9. Efficacy of Cognitive Behavioral Therapy for Insomnia in Adolescents: A Randomized Controlled Trial with Internet Therapy, Group Therapy and A Waiting List Condition.

    PubMed

    de Bruin, Eduard J; Bögels, Susan M; Oort, Frans J; Meijer, Anne Marie

    2015-12-01

    To investigate the efficacy of cognitive behavioral therapy for insomnia (CBTI) in adolescents. A randomized controlled trial of CBTI in group therapy (GT), guided internet therapy (IT), and a waiting list (WL), with assessments at baseline, directly after treatment (post-test), and at 2 months follow-up. Diagnostic interviews were held at the laboratory of the Research Institute of Child Development and Education at the University of Amsterdam. Treatment for GT occurred at the mental health care center UvAMinds in Amsterdam, the Netherlands. One hundred sixteen adolescents (mean age = 15.6 y, SD = 1.6 y, 25% males) meeting DSM-IV criteria for insomnia, were randomized to IT, GT, or WL. CBTI of 6 weekly sessions, consisted of psychoeducation, sleep hygiene, restriction of time in bed, stimulus control, cognitive therapy, and relaxation techniques. GT was conducted in groups of 6 to 8 adolescents, guided by 2 trained sleep therapists. IT was applied through an online guided self-help website with programmed instructions and written feedback from a trained sleep therapist. Sleep was measured with actigraphy and sleep logs for 7 consecutive days. Symptoms of insomnia and chronic sleep reduction were measured with questionnaires. Results showed that adolescents in both IT and GT, compared to WL, improved significantly on sleep efficiency, sleep onset latency, wake after sleep onset, and total sleep time at post-test, and improvements were maintained at follow-up. Most of these improvements were found in both objective and subjective measures. Furthermore, insomnia complaints and symptoms of chronic sleep reduction also decreased significantly in both treatment conditions compared to WL. Effect sizes for improvements ranged from medium to large. A greater proportion of participants from the treatment conditions showed high end-state functioning and clinically significant improvement after treatment and at follow-up compared to WL. This study is the first randomized

  10. A 24-week multicenter, randomized, double-blind, parallel-group, dose-ranging study of rufinamide in adults and adolescents with inadequately controlled partial seizures.

    PubMed

    Elger, Christian E; Stefan, Hermann; Mann, Allison; Narurkar, Milind; Sun, Yijun; Perdomo, Carlos

    2010-02-01

    To assess the efficacy, safety, tolerability, and pharmacokinetics of adjunctive rufinamide in adults and adolescents with inadequately controlled partial seizures receiving treatment with one to three concomitant antiepileptic drugs (AEDs). A 24-week multicenter Phase II clinical study was conducted (n=647), comprising a 12-week prospective baseline phase and a 12-week randomized double-blind, parallel-group, five-arm (placebo and rufinamide 200, 400, 800, and 1600mg/day) treatment phase. The linear trend of dose response for seizure frequency per 28 days in the double-blind treatment phase - the primary efficacy outcome measure - was statistically significant in favor of rufinamide (estimated slope=-0.049, P=0.003; minimally efficacious dose, 400mg/day). Response rates, defined as a >or=50% reduction in seizure frequency per 28 days, also revealed a significant linear trend of dose response (P=0.0019, logistic regression analysis). Adverse events were comparable between placebo and all rufinamide groups except the 1600mg/day group; no safety signals were observed. These results suggest that in the dose range of 400-1600mg/day, add-on rufinamide therapy may benefit patients with inadequately controlled partial seizures and is generally well tolerated. These data also suggest that higher doses may confer additional efficacy without adversely affecting safety and tolerability.

  11. Pilot randomized controlled trial of a mindfulness-based group intervention in adolescent girls at risk for type 2 diabetes with depressive symptoms.

    PubMed

    Shomaker, Lauren B; Bruggink, Stephanie; Pivarunas, Bernadette; Skoranski, Amanda; Foss, Jillian; Chaffin, Ella; Dalager, Stephanie; Annameier, Shelly; Quaglia, Jordan; Brown, Kirk Warren; Broderick, Patricia; Bell, Christopher

    2017-06-01

    (1) Evaluate feasibility and acceptability of a mindfulness-based group in adolescent girls at-risk for type 2 diabetes (T2D) with depressive symptoms, and (2) compare efficacy of a mindfulness-based versus cognitive-behavioral group for decreasing depressive symptoms and improving insulin resistance. Parallel-group, randomized controlled pilot trial conducted at a university. Thirty-three girls 12-17y with overweight/obesity, family history of diabetes, and elevated depressive symptoms were randomized to a six-week mindfulness-based (n=17) or cognitive-behavioral program (n=16). Both interventions included six, one-hour weekly group sessions. The mindfulness-based program included guided mindfulness awareness practices. The cognitive-behavioral program involved cognitive restructuring and behavioral activation. Adolescents were evaluated at baseline, post-intervention, and six-months. Feasibility/acceptability were measured by attendance and program ratings. Depressive symptoms were assessed by validated survey. Insulin resistance was determined from fasting insulin and glucose, and dual energy x-ray absorptiometry was used to assess body composition. Most adolescents attended ≥80% sessions (mindfulness: 92% versus cognitive-behavioral: 87%, p=1.00). Acceptability ratings were strong. At post-treatment and six-months, adolescents in the mindfulness condition had greater decreases in depressive symptoms than adolescents in the cognitive-behavioral condition (ps<.05). Compared to the cognitive-behavioral condition, adolescents in the mindfulness-based intervention also had greater decreases in insulin resistance and fasting insulin at post-treatment, adjusting for fat mass and other covariates (ps<.05). A mindfulness-based intervention shows feasibility and acceptability in girls at-risk for T2D with depressive symptoms. Compared to a cognitive-behavioral program, after the intervention, adolescents who received mindfulness showed greater reductions in depressive

  12. Pre-consultation educational group intervention to improve shared decision-making for postmastectomy breast reconstruction: a pilot randomized controlled trial.

    PubMed

    Causarano, Natalie; Platt, Jennica; Baxter, Nancy N; Bagher, Shaghayegh; Jones, Jennifer M; Metcalfe, Kelly A; Hofer, Stefan O P; O'Neill, Anne C; Cheng, Terry; Starenkyj, Elizabeth; Zhong, Toni

    2015-05-01

    Breast cancer survivors who make preference-sensitive decisions about postmastectomy breast reconstruction often have large gaps in knowledge and undergo procedures that are misaligned with their treatment goals. We evaluated the feasibility and effect of a pre-consultation educational group intervention on the decision-making process for breast reconstruction. We conducted a pilot randomized controlled trial (RCT) where participants were randomly assigned to the intervention with routine education or routine education alone. The outcomes evaluated were decisional conflict, decision self-efficacy, satisfaction with information, perceived involvement in care, and uptake of reconstruction following surgical consultation. Trial feasibility and acceptability were evaluated, and effect sizes were calculated to determine the primary outcome for the full-scale RCT. Of the 41 patients enrolled, recruitment rate was 72 %, treatment fidelity was 98 %, and retention rate was 95 %. The Cohen's d effect size in reduction of decisional conflict was moderate to high for the intervention group compared to routine education (0.69, 95 % CI = 0.02-1.42), while the effect sizes of increase in decision self-efficacy (0.05, 95 % CI = -0.60-0.71) and satisfaction with information (0.11, 95 % CI = -0.53-0.76) were small. A higher proportion of patients receiving routine education signed informed consent to undergo breast reconstruction (14/20 or 70 %) compared to the intervention group (8/21 or 38 %) P = 0.06. A pre-consultation educational group intervention improves patients' shared decision-making quality compared to routine preoperative patient education. A full-scale definitive RCT is warranted based on high feasibility outcomes, and the primary outcome for the main trial will be decisional conflict.

  13. Protocol and Recruitment Results from a Randomized Controlled Trial Comparing Group Phone-Based versus Newsletter Interventions for Weight Loss Maintenance among Rural Breast Cancer Survivors

    PubMed Central

    Befort, Christie A.; Klemp, Jennifer R.; Fabian, Carol; Perri, Michael G.; Sullivan, Debra K.; Schmitz, Kathryn H.; Diaz, Francisco J.; Shireman, Theresa

    2014-01-01

    Obesity is a risk factor for breast cancer recurrence and death. Women who reside in rural areas have higher obesity prevalence and suffer from breast cancer treatment-related disparities compared to urban women. The objective of this 5-year randomized controlled trial is to compare methods for delivering extended care for weight loss maintenance among rural breast cancer survivors. Group phone-based counseling via conference calls addresses access barriers, is more cost-effective than individual phone counseling, and provides group support which may be ideal for rural breast cancer survivors who are more likely to have unmet support needs. Women (n = 210) diagnosed with Stage 0 to III breast cancer in the past 10 years who are ≥ 3 months out from initial cancer treatments, have a BMI 27–45 kg/m2, and have physician clearance were enrolled from multiple cancer centers. During Phase I (months 0 to 6), all women receive a behavioral weight loss intervention delivered through group phone sessions. Women who successfully lose 5% of weight enter Phase II (months 6 to 18) and are randomized to one of two extended care arms: continued group phone-based treatment or a mail-based newsletter. During Phase III, no contact is made (months 18 to 24). The primary outcome is weight loss maintenance from 6 to 18 months. Secondary outcomes include quality of life, serum biomarkers, and cost-effectiveness. This study will provide essential information in how to reach rural survivors in future efforts to establish weight loss support for breast cancer survivors as a standard of care. PMID:24486636

  14. Internet-based individually versus group guided self-help treatment for social anxiety disorder: protocol of a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Social anxiety disorder (SAD) is one of the most common mental disorders and causes subjective suffering and economic burden worldwide. Although effective treatments are available, a lot of cases go untreated. Internet-based self-help is a low-threshold and flexible treatment alternative for SAD. Various studies have already shown that internet-based self-help can be effective to reduce social phobic symptoms significantly. Most of the interventions tested include therapist support, whereas the role of peer support within internet-based self-help has not yet been fully understood. There is evidence suggesting that patients’ mutual exchange via integrated discussion forums can increase the efficacy of internet-based treatments. This study aims at investigating the added value of therapist-guided group support on the treatment outcome of internet-based self-help for SAD. Methods/design The study is conducted as a randomized controlled trial. A total of 150 adults with a diagnosis of SAD are randomly assigned to either a waiting-list control group or one of the active conditions. The participants in the two active conditions use the same internet-based self-help program, either with individual support by a psychologist or therapist-guided group support. In the group guided condition, participants can communicate with each other via an integrated, protected discussion forum. Subjects are recruited via topic related websites and links; diagnostic status will be assessed with a telephone interview. The primary outcome variables are symptoms of SAD and diagnostic status after the intervention. Secondary endpoints are general symptomology, depression, quality of life, as well as the primary outcome variables 6 months later. Furthermore, process variables such as group processes, the change in symptoms and working alliance will be studied. Discussion The results of this study should indicate whether group-guided support could enhance the efficacy of an

  15. Internet-based individually versus group guided self-help treatment for social anxiety disorder: protocol of a randomized controlled trial.

    PubMed

    Schulz, Ava; Stolz, Timo; Berger, Thomas

    2014-04-15

    Social anxiety disorder (SAD) is one of the most common mental disorders and causes subjective suffering and economic burden worldwide. Although effective treatments are available, a lot of cases go untreated. Internet-based self-help is a low-threshold and flexible treatment alternative for SAD. Various studies have already shown that internet-based self-help can be effective to reduce social phobic symptoms significantly. Most of the interventions tested include therapist support, whereas the role of peer support within internet-based self-help has not yet been fully understood. There is evidence suggesting that patients' mutual exchange via integrated discussion forums can increase the efficacy of internet-based treatments. This study aims at investigating the added value of therapist-guided group support on the treatment outcome of internet-based self-help for SAD. The study is conducted as a randomized controlled trial. A total of 150 adults with a diagnosis of SAD are randomly assigned to either a waiting-list control group or one of the active conditions. The participants in the two active conditions use the same internet-based self-help program, either with individual support by a psychologist or therapist-guided group support. In the group guided condition, participants can communicate with each other via an integrated, protected discussion forum. Subjects are recruited via topic related websites and links; diagnostic status will be assessed with a telephone interview. The primary outcome variables are symptoms of SAD and diagnostic status after the intervention. Secondary endpoints are general symptomology, depression, quality of life, as well as the primary outcome variables 6 months later. Furthermore, process variables such as group processes, the change in symptoms and working alliance will be studied. The results of this study should indicate whether group-guided support could enhance the efficacy of an internet-based self-help treatment for SAD

  16. CHILE: Outcomes of a group randomized controlled trial of an intervention to prevent obesity in preschool Hispanic and American Indian children

    PubMed Central

    Davis, Sally M.; Myers, Orrin B.; Cruz, Theresa H.; Morshed, Alexandra B.; Canaca, Glenda F.; Keane, Patricia C.; O'Donald, Elena R.

    2016-01-01

    Objective We examined the outcomes of the Child Health Initiative for Lifelong Eating and Exercise (CHILE) study, a group randomized controlled trial to design, implement, and test the efficacy of a trans-community intervention to prevent obesity in children enrolled in Head Start centers in rural American Indian and Hispanic communities in New Mexico. Methods CHILE was a 5-year evidence-based intervention that used a socioecological approach to improving dietary intake and increasing physical activity of 1898 children. The intervention included a classroom curriculum, teacher and food service training, family engagement, grocery store participation, and healthcare provider support. Height and weight measurements were obtained four times (fall of 2008, spring and fall of 2009, and spring of 2010), and body mass index (BMI) z-scores in the intervention and comparison groups were compared. Results At baseline, demographic characteristics in the comparison and intervention groups were similar, and 33% of all the children assessed were obese or overweight. At the end of the intervention, there was no significant difference between the two groups in BMI z-scores. Conclusions Obesity prevention research among Hispanic and AI preschool children in rural communities is challenging and complex. Although the CHILE intervention was implemented successfully, changes in overweight and obesity may take longer than 2 years to achieve. PMID:27222162

  17. The effect of group training on pregnancy-induced lumbopelvic pain: systematic review and meta-analysis of randomized control trials.

    PubMed

    Fisseha, Berihu; Mishra, Prakash Kumar

    2016-02-01

    Since there is lack of up to date consensus exists as to whether group training is effective in improving lumbopelvic pain (LPP) after pregnancy, a review of the recent evidences is needed. To determine the effect of group exercise training for the management of LPP among pregnant women compared with usual antenatal care. An electronic database search for relevant randomized control trials published in English from 2006 to 2015 was conducted. Articles with outcome measures of self-reported LPP, visual analogue scale and sick leave due to LPP after pregnancy were included. Quality of the included articles was rated using Physiotherapy Evidence Database (PEDro) scale and the pooled effect of self-reported LPP was obtained by Review Manager (RevMan 5) software. Significant effect of group training was detected over usual antenatal care or no treatment with P=0.0035 (95% confidence interval, -0.2348 to -0.0044). The results of this systematic review proposed that group training reduces LPP significantly better than routine antenatal care for pregnant women suffered from LPP.

  18. A topical microemulsion for the prevention of allergic rhinitis symptoms: results of a randomized, controlled, double-blind, parallel group, multicentre, multinational clinical trial (Nares study)

    PubMed Central

    2013-01-01

    Background Since barrier protection measures to avoid contact with allergens are being increasingly developed, we assessed the clinical efficacy and tolerability of a topical nasal microemulsion made of glycerol esters in patients with allergic rhinitis. Methods Randomized, controlled, double-blind, parallel group, multicentre, multinational clinical trial in which adult patients with allergic rhinitis or rhinoconjunctivitis due to sensitization to birch, grass or olive tree pollens received treatment with topical microemulsion or placebo during the pollen seasons. Efficacy variables included scores in the mini-RQLQ questionnaire, number and severity of nasal, ocular and lung signs and symptoms, need for symptomatic medications and patients’ satisfaction with treatment. Adverse events were also recorded. Results Demographic characteristics were homogeneous between groups and mini-RQLQ scores did not differ significantly at baseline (visit 1). From symptoms recorded in the diary cards, the ME group showed statistically significant better scores for nasal congestion (0.72 vs. 1.01; p = 0.017) and mean total nasal symptoms (0.7 vs. 0.9; p = 0.045). At visit 2 (pollen season), lower values were observed in the mini-RQLQ in the ME group, although there were no statistically significant differences between groups in both full analysis set (FAS) and patients completing treatment (PPS) populations. The results obtained in the nasal symptoms domain of the mini-RQLQ at visit 2 showed the highest difference (−0.43; 95% CI: -0.88 to 0.02) for the ME group in the FAS population. The topical microemulsion was safe and well tolerated and no major discomforts were observed. Satisfaction rating with the treatment was similar between the groups. Conclusions The topical application of the microemulsion is a feasible and safe therapy in the prevention of allergic symptoms, particularly nasal congestion. Trial registration ClinicalTrials.gov Identifier: NCT01478425 PMID

  19. Use of participant focus groups to identify barriers and facilitators to worksite exercise therapy adherence in randomized controlled trials involving firefighters

    PubMed Central

    Mayer, John M; Nuzzo, James L; Dagenais, Simon

    2013-01-01

    Background Firefighters are at increased risk for back injuries, which may be mitigated through exercise therapy to increase trunk muscle endurance. However, long-term adherence to exercise therapy is generally poor, limiting its potential benefits. Focus groups can be used to identify key barriers and facilitators to exercise adherence among study participants. Objective To explore barriers and facilitators to worksite exercise therapy adherence among firefighters to inform future randomized controlled trials (RCTs). Methods Participants enrolled in a previous RCT requiring twice-weekly worksite exercise therapy for 24 weeks were asked to take part in moderated focus group discussions centered on eight open-ended questions related to exercise adherence. Responses were analyzed qualitatively using a social ecological framework to identify key intrapersonal, interpersonal, and institutional barriers and potential facilitators to exercise adherence. Results A total of 27 participants were included in the four focus group discussions, representing 50% of those assigned to a worksite exercise therapy group in the previous RCT, in which only 67% of scheduled exercise therapy sessions were completed. Lack of self-motivation was cited as the key intrapersonal barrier to adherence, while lack of peer support was the key interpersonal barrier reported, and lack of time to exercise during work shifts was the key institutional barrier identified. Conclusion Focus group discussions identified both key barriers and potential facilitators to increase worksite exercise therapy adherence among firefighters. Future studies should consider educating and reminding participants about the benefits of exercise, providing individual and group incentives based on exercise adherence and performance, providing outside monitoring of exercise adherence, varying the exercise routine, encouraging group exercise and competition, and scheduling exercise during each work shift. PMID:23515182

  20. Motivating first-time, group O blood donors to return: Rationale and design of a randomized controlled trial of a post-donation telephone interview

    PubMed Central

    France, Janis L.; France, Christopher R.; Carlson, Bruce W.; Kessler, Debra A.; Rebosa, Mark; Shaz, Beth H.; Madden, Katrala; Carey, Patricia M.

    2015-01-01

    First-time blood donors are essential to the US donor pool, providing nearly a third of all donations. Unfortunately, there are a wide variety of obstacles to repeat donation and new donors are extremely difficult to retain. Because each donor experiences a unique set of deterrents, we developed a post-donation interview based on motivational interview principles in order to flexibly address individual barriers. The primary aim of this randomized clinical trial is to examine retention of first-time, group O blood donors who are randomly assigned to receive either a telephone-delivered interview with motivational and action planning components or a standard-of-care control call approximately six weeks after their donation. Measures of donation attitude, perceived behavioral control, intention, and motivational autonomy will be measured before and after the telephone contact using online surveys, and donation attempts will be tracked for one year using blood center donor databases. We hypothesize that, compared to controls, donors who receive the telephone interview will be more likely to make a donation attempt over the following year. In addition, we will examine possible mechanisms of action of the interview using key predictors of donation behavior as described by Self Determination Theory (i.e., motivational autonomy) and the Theory of Planned Behavior (i.e., attitude, perceived behavioral control, and intention). Results of this intervention may help to support a novel strategy to enhance retention of selected blood donors in an effort to better meet the nation’s blood supply needs. PMID:26247570

  1. A Randomized Controlled Trial to Decrease Job Burnout in First-Year Internal Medicine Residents Using a Facilitated Discussion Group Intervention.

    PubMed

    Ripp, Jonathan A; Fallar, Robert; Korenstein, Deborah

    2016-05-01

    Background Burnout is common in internal medicine (IM) trainees and is associated with depression and suboptimal patient care. Facilitated group discussion reduces burnout among practicing clinicians. Objective We hypothesized that this type of intervention would reduce incident burnout among first-year IM residents. Methods Between June 2013 and May 2014, participants from a convenience sample of 51 incoming IM residents were randomly assigned (in groups of 3) to the intervention or a control. Twice-monthly theme-based discussion sessions (18 total) led by expert facilitators were held for intervention groups. Surveys were administered at study onset and completion. Demographic and personal characteristics were collected. Burnout and burnout domains were the primary outcomes. Following convention, we defined burnout as a high emotional exhaustion or depersonalization score on the Maslach Burnout Inventory. Results All 51 eligible residents participated; 39 (76%) completed both surveys. Initial burnout prevalence (10 of 21 [48%] versus 7 of 17 [41%], P = .69), incidence of burnout at year end (9 of 11 [82%] versus 5 of 10 [50%], P = .18), and secondary outcomes were similar in intervention and control arms. More residents in the intervention group had high year-end depersonalization scores (18 of 21 [86%] versus 9 of 17 [53%], P = .04). Many intervention residents revealed that sessions did not truly free them from clinical or educational responsibilities. Conclusions A facilitated group discussion intervention did not decrease burnout in resident physicians. Future discussion-based interventions for reducing resident burnout should be voluntary and effectively free participants from clinical duties.

  2. Safety evaluation of the consumption of high dose milk fat globule membrane in healthy adults: a double-blind, randomized controlled trial with parallel group design.

    PubMed

    Hari, Sayaka; Ochiai, Ryuji; Shioya, Yasushi; Katsuragi, Yoshihisa

    2015-01-01

    Consumption of milk fat globule membrane (MFGM) in combination with habitual exercise suppresses age-associated muscle loss. The effects of high dose MFGM, however, are not known. A double-blind, randomized controlled trial with parallel group design was conducted to evaluate the safety of consuming high dose MFGM tablets. The subjects were 32 healthy adult men and women. Subjects were given 5 times the recommended daily intake of the tablets containing 6.5 g of MFGM or whole milk powder for 4 weeks. Stomach discomfort and diarrhea were observed; however, these symptoms were transitory and slight and were not related to consumption of the test tablets. In addition, there were no clinically significant changes in anthropometric measurements or blood tests. Total degree of safety assessed by the physicians of all subjects was "safe." These findings suggest that consumption of the tablets containing 6.5 g MFGM for 4 weeks is safe for healthy adults.

  3. Matching with Multiple Control Groups with Adjustment for Group Differences

    ERIC Educational Resources Information Center

    Stuart, Elizabeth A.; Rubin, Donald B.

    2008-01-01

    When estimating causal effects from observational data, it is desirable to approximate a randomized experiment as closely as possible. This goal can often be achieved by choosing a subsample from the original control group that matches the treatment group on the distribution of the observed covariates. However, sometimes the original control group…

  4. A randomized, double-blind, placebo-controlled, parallel-group study of rufinamide as adjunctive therapy for refractory partial-onset seizures.

    PubMed

    Biton, Victor; Krauss, Gregory; Vasquez-Santana, Blanca; Bibbiani, Francesco; Mann, Allison; Perdomo, Carlos; Narurkar, Milind

    2011-02-01

    Efficacy and safety of adjunctive rufinamide (3,200 mg/day) was assessed in adolescents and adults with inadequately controlled partial-onset seizures receiving maintenance therapy with up to three antiepileptic drugs (AEDs). This randomized, double-blind, placebo-controlled, parallel-group, multicenter study comprised a 56-day baseline phase (BP), 12-day titration phase, and 84-day maintenance phase (MP). The primary efficacy variable was percentage change in total partial seizure frequency per 28 days (MP vs. BP). Secondary efficacy outcome measures included ≥50% responder rate and reduction in mean total partial seizure frequency during the MP. Safety and tolerability evaluation included adverse events (AEs), physical and neurologic examinations, and laboratory values. Pharmacokinetic and pharmacodynamic assessments were conducted. Three hundred fifty-seven patients were randomized: 176 to rufinamide and 181 to placebo. Patients had a median of 13.3 seizures per 28 days during BP; 86% were receiving ≥2 AEDs. For the intent-to-treat population, the median percentage reduction in total partial seizure frequency per 28 days was 23.25 for rufinamide versus 9.80 for placebo (p = 0.007). Rufinamide-treated patients were more than twice as likely to have had a ≥50% reduction in partial seizure frequency (32.5% vs. 14.3%; p < 0.001) and had a greater reduction in median total partial seizure rate per 28 days during the MP (13.2 vs. 5.2; p < 0.001). Treatment-emergent AEs occurring at ≥5% higher incidence in the rufinamide group compared with placebo were dizziness, fatigue, nausea, somnolence, and diplopia. Adjunctive treatment with rufinamide reduced total partial seizures in refractory patients. AEs reported were consistent with the known tolerability profile of rufinamide. Wiley Periodicals, Inc. © 2010 International League Against Epilepsy.

  5. A double-blind, randomized, placebo-controlled, parallel group study of THC/CBD spray in peripheral neuropathic pain treatment.

    PubMed

    Serpell, M; Ratcliffe, S; Hovorka, J; Schofield, M; Taylor, L; Lauder, H; Ehler, E

    2014-08-01

    Peripheral neuropathic pain (PNP) associated with allodynia poses a significant clinical challenge. The efficacy of Δ(9) -tetrahydrocannabinol/cannabidiol (THC/CBD) oromucosal spray, a novel cannabinoid formulation, was investigated in this 15-week randomized, double-blind, placebo-controlled parallel group study. In total, 303 patients with PNP associated with allodynia were screened; 128 were randomized to THC/CBD spray and 118 to placebo, in addition to their current analgesic therapy. The co-primary efficacy endpoints were the 30% responder rate in PNP 0-10 numerical rating scale (NRS) score and the mean change from baseline to the end of treatment in this score. Various key secondary measures of pain and functioning were also investigated. At the 30% responder level, there were statistically significant treatment differences in favour of THC/CBD spray in the full analysis (intention-to-treat) dataset [p = 0.034; 95% confidence interval (CI): 1.05-3.70]. There was also a reduction in mean PNP 0-10 NRS scores in both treatment groups that was numerically higher in the THC/CBD spray group, but which failed to reach statistical significance. Secondary measures of sleep quality 0-10 NRS score (p = 0.0072) and Subject Global Impression of Change (SGIC) (p = 0.023) also demonstrated statistically significant treatment differences in favour of THC/CBD spray treatment. These findings demonstrate that, in a meaningful proportion of otherwise treatment-resistant patients, clinically important improvements in pain, sleep quality and SGIC of the severity of their condition are obtained with THC/CBD spray. THC/CBD spray was well tolerated and no new safety concerns were identified. © 2014 European Pain Federation - EFIC®

  6. Tretinoin Nanogel 0.025% Versus Conventional Gel 0.025% in Patients with Acne Vulgaris: A Randomized, Active Controlled, Multicentre, Parallel Group, Phase IV Clinical Trial

    PubMed Central

    Chandrashekhar, B S; Anitha, M.; Ruparelia, Mukesh; Vaidya, Pradyumna; Aamir, Riyaz; Shah, Sunil; Thilak, S; Aurangabadkar, Sanjeev; Pal, Sandeep; Saraswat, Abir

    2015-01-01

    Background: Conventional topical tretinoin formulation is often associated with local adverse events. Nanogel formulation of tretinoin has good physical stability and enables good penetration of tretinoin into the pilo-sebaceous glands. Aim: The present study was conducted to assess the efficacy and safety of a nanogel formulation of tretinoin as compared to its conventional gel formulation in the treatment of acne vulgaris of the face. Materials and Methods: This randomized, active controlled, multicentric, phase IV clinical trial evaluated the treatment of patients with acne vulgaris of the face by the two gel formulations locally applied once daily at night for 12 wk. Acne lesion counts (inflammatory, non-inflammatory & total) and severity grading were carried out on the monthly scheduled visits along with the tolerability assessments. Results: A total of 207 patients were randomized in the study. Reductions in the total (72.9% vs. 65.0%; p = 0.03) and inflammatory (78.1% vs. 66.9%; p = 0.02) acne lesions were reported to be significantly greater with the nanogel formulation as compared to the conventional gel formulation. Local adverse events were significantly less (p = 0.04) in the nanogel group (13.3%) as compared to the conventional gel group (24.7%). Dryness was the most common adverse event reported in both the treatment groups while peeling of skin, burning sensation and photosensitivity were reported in patients using the conventional gel only. Conclusion: In the treatment of acne vulgaris of the face, tretinoin nanogel formulation appears to be more effective and better tolerated than the conventional gel formulation. PMID:25738069

  7. Post-discharge management following hip fracture - get you back to B4: A parallel group, randomized controlled trial study protocol

    PubMed Central

    2011-01-01

    Background Fall-related hip fractures result in significant personal and societal consequences; importantly, up to half of older adults with hip fracture never regain their previous level of mobility. Strategies of follow-up care for older adults after fracture have improved investigation for osteoporosis; but managing bone health alone is not enough. Prevention of fractures requires management of both bone health and falls risk factors (including the contributing role of cognition, balance and continence) to improve outcomes. Methods/Design This is a parallel group, pragmatic randomized controlled trial to test the effectiveness of a post-fracture clinic compared with usual care on mobility for older adults following their hospitalization for hip fracture. Participants randomized to the intervention will attend a fracture follow-up clinic where a geriatrician and physiotherapist will assess and manage their mobility and other health issues. Depending on needs identified at the clinical assessment, participants may receive individualized and group-based outpatient physiotherapy, and a home exercise program. Our primary objective is to assess the effectiveness of a novel post-discharge fracture management strategy on the mobility of older adults after hip fracture. We will enrol 130 older adults (65 years+) who have sustained a hip fracture in the previous three months, and were admitted to hospital from home and are expected to be discharged home. We will exclude older adults who prior to the fracture were: unable to walk 10 meters; diagnosed with dementia and/or significant comorbidities that would preclude their participation in the clinical service. Eligible participants will be randomly assigned to the Intervention or Usual Care groups by remote allocation. Treatment allocation will be concealed; investigators, measurement team and primary data analysts will be blinded to group allocation. Our primary outcome is mobility, operationalized as the Short Physical

  8. A 9-year follow-up of a self-management group intervention for persistent neck pain in primary health care: a randomized controlled trial

    PubMed Central

    Gustavsson, Catharina; von Koch, Lena

    2017-01-01

    Background and objective In previous short-term and 2-year follow-ups, a pain and stress self-management group intervention (PASS) had better effect on pain-related disability, self-efficacy, catastrophizing, and perceived pain control than individually administered physiotherapy (IAPT) for patients with persistent tension-type neck pain. Studies that have evaluated long-term effects of self-management approaches toward persistent neck pain are sparse. The objective of this study was to compare pain-related disability, self-efficacy for activities of daily living (ADL), catastrophizing, pain, pain control, use of analgesics, and health care utilization in people with persistent tension-type neck pain 9 years after they received the PASS or IAPT. Materials and methods Of 156 people (PASS, n = 77; IAPT, n = 79) originally included in a randomized controlled trial, 129 people (PASS, n = 63; IAPT, n = 66) were eligible and were approached for the 9-year follow-up. They were sent a self-assessment questionnaire, comprising the Neck Disability Index, the Self-Efficacy Scale, the Coping Strategies Questionnaire, and questions regarding pain, analgesics, and health care utilization. Mixed linear models for repeated measures analysis or generalized estimating equations were used to evaluate the differences between groups and within groups over time (baseline, previous follow-ups, and 9-year follow-up) and the interaction effect of “time by group”. Results Ninety-four participants (73%) responded (PASS, n = 48; IAPT, n = 46). At 9 years, PASS participants reported less pain-related disability, pain at worst, and analgesics usage, and a trend toward better self-efficacy compared to IAPT participants. There was a difference between groups in terms of change over time for disability, self-efficacy for ADL, catastrophizing, perceived pain control, and health care visits in favor of PASS. Analyses of simple main effects at 9 years showed that the PASS group had less

  9. The ACTIVATE study: results from a group-randomized controlled trial comparing a traditional worksite health promotion program with an activated consumer program.

    PubMed

    Terry, Paul E; Fowles, Jinnet Briggs; Xi, Min; Harvey, Lisa

    2011-01-01

    PURPOSE. This study compares a traditional worksite-based health promotion program with an activated consumer program and a control program DESIGN. Group randomized controlled trial with 18-month intervention. SETTING. Two large Midwestern companies. SUBJECTS. Three hundred and twenty employees (51% response). INTERVENTION. The traditional health promotion intervention offered population-level campaigns on physical activity, nutrition, and stress management. The activated consumer intervention included population-level campaigns for evaluating health information, choosing a health benefits plan, and understanding the risks of not taking medications as prescribed. The personal development intervention (control group) offered information on hobbies. The interventions also offered individual-level coaching for high risk individuals in both active intervention groups. MEASURES. Health risk status, general health status, consumer activation, productivity, and the ability to evaluate health information. ANALYSIS. Multivariate analyses controlled for baseline differences among the study groups. RESULTS. At the population level, compared with baseline performance, the traditional health promotion intervention improved health risk status, consumer activation, and the ability to recognize reliable health websites. Compared with baseline performance, the activated consumer intervention improved consumer activation, productivity, and the ability to recognize reliable health websites. At the population level, however, only the activated consumer intervention improved any outcome more than the control group did; that outcome was consumer activation. At the individual level for high risk individuals, both traditional health coaching and activated consumer coaching positively affected health risk status and consumer activation. In addition, both coaching interventions improved participant ability to recognize a reliable health website. Consumer activation coaching also

  10. A community-based group upper extremity exercise program improves motor function and performance of functional activities in chronic stroke: a randomized controlled trial

    PubMed Central

    Pang, Marco Y C; Harris, Jocelyn E; Eng, Janice J

    2011-01-01

    Objective To assess the effects of a community-based exercise program on motor recovery and functional abilities of the paretic upper extremity in persons with chronic stroke. Design Randomized controlled trial. Setting Rehabilitation research laboratory and a community hall. Participants A sample of 63 people (≥ 50 years) with chronic deficits resulting from stroke (onset ≥ 1 year). Interventions The arm group underwent an exercise program designed to improve upper extremity function (1 hour per session, 3 sessions per week for 19 weeks). The leg group underwent a lower extremity exercise program. Main outcome measures (1) Wolf Motor Function Test (WMFT), (2) Fugl-Meyer Motor Assessment (FMA), (3) hand-held dynamometry (grip strength), and (4) Motor Activity Log. Results Multivariate analysis showed a significant group × time interaction (Wilk’s Lambda=0.726, P=0.017), indicating that overall, the arm group had significantly more improvement than the leg group. Post-hoc analysis demonstrated that gains in WMFT (functional ability) (P=0.001) and FMA (P=0.001) were significantly higher in the arm group. The amount of improvement was comparable to other novel treatment approaches such as constraint-induced movement therapy or robot-aided exercise training previously reported in chronic stroke. Participants with moderate arm impairment benefited more from the program. Conclusions The pilot study showed that a community-based exercise program can improve upper extremity function in persons with chronic stroke. This outcome justifies a larger clinical trial to further assess efficacy and cost-effectiveness. PMID:16401430

  11. Effect on arm function and cost of robot-assisted group therapy in subacute patients with stroke and a moderately to severely affected arm: a randomized controlled trial.

    PubMed

    Hesse, Stefan; Heß, Anke; Werner C, Cordula; Kabbert, Nadine; Buschfort, Rüdiger

    2014-07-01

    To evaluate the effectiveness and efficiency of robot-assisted arm group therapy (RAGT) versus individual arm therapy (IAT) to restore motor function in the moderately to severely affected patient after stroke. Single blind randomized controlled trial. Two in-patient neurological rehabilitation centers. Fifty first time subacute patients with stroke and a non-functional hand. The patients practiced either 30 minutes of RAGT + 30 minutes of IAT (group A) or 2x30 minutes of IAT (group B), per workday for four weeks. The RAGT consisted of six workstations enabling repetitive practice of finger, wrist, forearm and shoulder movements. Patients practiced according to their impairment level on at least two workstations per session. The IAT followed the Motor Relearning Programme, enriched by elements of the impairment-oriented training. Changes of the Fugl Meyer Score (FM, 0-66) between baseline and after 4 weeks, incremental cost effectiveness. Patients were homogeneous at study onset. All patients improved their upper limb motor function over time, but there were no between group differences. The initial (terminal) FM scores were 14.6±9.4 (25.7±16.5) in group A and 16.5±9.8 (31.1±19.1) in group B. The treatment of a single patient with RAGT cost 4.15 €, compared to 10.00 € for a patient to receive IAT. RAGT in combination with IAT was equally effective as a double session of IAT regarding the restoration of upper limb motor functions in moderate to severely affected subacute patients with stroke. The treatment costs for RAGT were less. © The Author(s) 2014.

  12. Cost-effectiveness of Internet-based cognitive behavior therapy vs. cognitive behavioral group therapy for social anxiety disorder: results from a randomized controlled trial.

    PubMed

    Hedman, Erik; Andersson, Erik; Ljótsson, Brjánn; Andersson, Gerhard; Rück, Christian; Lindefors, Nils

    2011-11-01

    Social anxiety disorder (SAD) is highly prevalent and associated with a substantial societal economic burden, primarily due to high costs of productivity loss. Cognitive behavior group therapy (CBGT) is an effective treatment for SAD and the most established in clinical practice. Internet-based cognitive behavior therapy (ICBT) has demonstrated efficacy in several trials in recent years. No study has however investigated the cost-effectiveness of ICBT compared to CBGT from a societal perspective, i.e. an analysis where both direct and indirect costs are included. The aim of the present study was to investigate the cost-effectiveness of ICBT compared to CBGT from a societal perspective using a prospective design. We conducted a randomized controlled trial where participants with SAD were randomized to ICBT (n=64) or CBGT (n=62). Economic data were assessed at pre-treatment, immediately following treatment and six months after treatment. Results showed that the gross total costs were significantly reduced at six-month follow-up, compared to pre-treatment in both treatment conditions. As both treatments were equivalent in reducing social anxiety and gross total costs, ICBT was more cost-effective due to lower intervention costs. We conclude that ICBT can be more cost-effective than CBGT in the treatment of SAD and that both treatments reduce societal costs for SAD. Copyright © 2011 Elsevier Ltd. All rights reserved.

  13. The effectiveness of "Exercise on Prescription" in stimulating physical activity among women in ethnic minority groups in the Netherlands: protocol for a randomized controlled trial.

    PubMed

    Hosper, Karen; Deutekom, Marije; Stronks, Karien

    2008-12-10

    Lack of physical activity is an important risk factor for overweight, diabetes, cardiovascular disease and other chronic conditions. In the Netherlands, ethnic minority groups are generally less physically active and rate their own health poorer compared to ethnic Dutch. This applies in particular to women. For this reason women from ethnic minority groups are an important target group for interventions to promote physical activity.In the Netherlands, an exercise referral program ("Exercise on Prescription") seems successful in reaching women from ethnic minority groups, in particular because of referral by the general practitioner and because the program fits well with the needs of these women. However, the effect of the intervention on the level of physical activity and related health outcomes has not been formally evaluated within this population. This paper describes the study design for the evaluation of the effect of "Exercise on Prescription" on level of physical activity and related health outcomes. The randomized controlled trial will include 360 inactive women from ethnic minority groups, with the majority having a non-Western background, aged between 18 and 65 years old, with regular visits to their general practitioner. Participants will be recruited at healthcare centres within a deprived neighbourhood in the city of The Hague, the Netherlands. An intervention group of 180 women will participate in an exercise program with weekly exercise sessions during 20 weeks. The control group (n = 180) will be offered care as usual. Measurements will take place at baseline, and after 6 and 12 months. Main outcome measure is minutes of self reported physical activity per week. Secondary outcomes are the mediating motivational factors regarding physical activity, subjective and objective health outcomes (including wellbeing, perceived health, fitness and body size) and use of (primary) health care. Attendance and attrition during the program will be determined

  14. Teaching tobacco dependence treatment and counseling skills during medical school: rationale and design of the Medical Students helping patients Quit tobacco (MSQuit) group randomized controlled trial.

    PubMed

    Hayes, Rashelle B; Geller, Alan; Churchill, Linda; Jolicoeur, Denise; Murray, David M; Shoben, Abigail; David, Sean P; Adams, Michael; Okuyemi, Kola; Fauver, Randy; Gross, Robin; Leone, Frank; Xiao, Rui; Waugh, Jonathan; Crawford, Sybil; Ockene, Judith K

    2014-03-01

    Physician-delivered tobacco treatment using the 5As is clinically recommended, yet its use has been limited. Lack of adequate training and confidence to provide tobacco treatment is cited as leading reasons for limited 5A use. Tobacco dependence treatment training while in medical school is recommended, but is minimally provided. The MSQuit trial (Medical Students helping patients Quit tobacco) aims to determine if a multi-modal and theoretically-guided tobacco educational intervention will improve tobacco dependence treatment skills (i.e. 5As) among medical students. 10 U.S. medical schools were pair-matched and randomized in a group-randomized controlled trial to evaluate whether a multi-modal educational (MME) intervention compared to traditional education (TE) will improve observed tobacco treatment skills. MME is primarily composed of TE approaches (i.e. didactics) plus a 1st year web-based course and preceptor-facilitated training during a 3rd year clerkship rotation. The primary outcome measure is an objective score on an Objective Structured Clinical Examination (OSCE) tobacco-counseling smoking case among 3rd year medical students from schools who implemented the MME or TE. MSQuit is the first randomized to evaluate whether a tobacco treatment educational intervention implemented during medical school will improve medical students' tobacco treatment skills. We hypothesize that the MME intervention will better prepare students in tobacco dependence treatment as measured by the OSCE. If a comprehensive tobacco treatment educational learning approach is effective, while also feasible and acceptable to implement, then medical schools may substantially influence skill development and use of the 5As among future physicians. Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.

  15. Teaching tobacco dependence treatment and counseling skills during medical school: rationale and design of the Medical Students helping patients Quit tobacco (MSQuit) group randomized controlled trial

    PubMed Central

    Hayes, Rashelle B.; Geller, Alan; Churchill, Linda; Jolicoeur, Denise; Murray, David M.; Shoben, Abigail; David, Sean P.; Adams, Michael; Okuyemi, Kola; Fauver, Randy; Gross, Robin; Leone, Frank; Xiao, Rui; Waugh, Jonathan; Crawford, Sybil; Ockene, Judith K.

    2014-01-01

    INTRODUCTION Physician-delivered tobacco treatment using the 5As is clinically recommended, yet its use has been limited. Lack of adequate training and confidence to provide tobacco treatment are cited as leading reasons for limited 5A use. Tobacco dependence treatment training while in medical school is recommended, but is minimally provided. The MSQuit trial (Medical Students helping patients Quit tobacco) aims to determine if a multi-modal and theoretically-guided tobacco educational intervention will improve tobacco dependence treatment skills (i.e. 5As) among medical students. METHODS/DESIGN 10 U.S. medical schools were pair-matched and randomized in a group-randomized controlled trial to evaluate whether a multi-modal educational (MME) intervention compared to traditional education (TE) will improve observed tobacco treatment skills. MME is primarily composed of TE approaches (i.e. didactics) plus a 1st year web-based course and preceptor-facilitated training during a 3rd year clerkship rotation. The primary outcome measure is an objective score on an Objective Structured Clinical Examination (OSCE) tobacco-counseling smoking case among 3rd year medical students from schools who implemented the MME or TE. DISCUSSION MSQuit is the first randomized to evaluate whether a tobacco treatment educational intervention implemented during medical school will improve medical students’ tobacco treatment skills. We hypothesize that the MME intervention will better prepare students in tobacco dependence treatment as measured by the OSCE. If a comprehensive tobacco treatment educational learning approach is effective, while also feasible and acceptable to implement, then medical schools may substantially influence skill development and use of the 5As among future physicians. PMID:24486635

  16. Psychosocial group intervention to enhance self-management skills of people with dementia and their caregivers: study protocol for a randomized controlled trial.

    PubMed

    Laakkonen, Marja-Liisa; Hölttä, Eeva H; Savikko, Niina; Strandberg, Timo E; Suominen, Merja; Pitkälä, Kaisu H

    2012-08-07

    After diagnosis of a dementing illness, patients and their spouses have many concerns related to the disease and their future. This often leads to poor psychological well-being and reduced health-related quality of life (HRQoL) of the family. Support for self-management skills has been proven to be an effective method to improve prognosis of asthma, heart failure and osteoarthritis. However, self-management interventions have not been studied in dementia. Therefore, our aim was to examine, in an objective-oriented group intervention, the efficacy of self-management support program (SMP) on the HRQoL of dementia patients and their spousal caregivers as well as on the sense of competence and psychological well-being of caregivers. During the years 2011 to 12, 160 dementia patients and their spouses will be recruited from memory clinics and randomized into two arms: 80 patients for group-based SMP sessions including topics selected by the participants, 80 patients will serve as controls in usual community care. Sessions may include topics on dementia, community services, active lifestyle and prevention for cognitive decline, spousal relationship, future planning and emotional well-being. The patients and spouses will have their separate group sessions (ten participants per group) once a week for eight weeks. Main outcome measures will be patients' HRQoL (15D) and spousal caregivers' HRQoL (RAND-36), and sense of competence (SCQ). Secondary measures will be caregivers' psychological well-being (GHQ-12) and coping resources, patients' depression, cognition and signs of frailty. Data concerning admissions to institutional care and the use and costs of health and social services will be collected during a two-year follow-up. This is a 'proof-of-concept' study to explore the efficacy of group support for self-management skills among dementia families. It will also provide data on cost-effectiveness of the intervention. ACTRN12611001173987.

  17. Patient-reported outcomes of bimatoprost for eyelash growth: results from a randomized, double-masked, vehicle-controlled, parallel-group study.

    PubMed

    Fagien, Steven; Walt, John G; Carruthers, Jean; Cox, Sue Ellen; Wirta, David; Weng, Emily; Beddingfield, Frederick C

    2013-08-01

    Hypotrichosis of the eyelashes may negatively influence an individual's self-perception and appearance. Assessing the impact of treatment from a patient's perspective may be particularly relevant in trials of aesthetic agents. Once-daily dermal (topically applied) administration of bimatoprost ophthalmic solution 0.03% has been associated with increased eyelash prominence (ie, length, thickness, darkness). The authors assess patient-reported outcomes (PRO) after treatment with bimatoprost for hypotrichosis of the eyelashes. In this multicenter, double-masked, randomized, vehicle-controlled, parallel clinical trial, 4 PRO questionnaires were distributed to 278 patients (bimatoprost [n = 137] and vehicle [n = 141]). The primary PRO questionnaire was the 23-item Eyelash Satisfaction Questionnaire (ESQ), which measured satisfaction in 3 domains: length, fullness, and overall satisfaction (LFOS); confidence, attractiveness, and professionalism (CAP); and impact on daily routine (DR). By week 16, the bimatoprost group reported significantly greater improvements from baseline on all ESQ items (P ≤ .0433). These improvements were sustained through the 4-week posttreatment study visit. Patient satisfaction was significantly greater in the bimatoprost group than in the vehicle group for all 3 domains: LFOS (weeks 8-20; P ≤ .0052), CAP (weeks 12-20; P < .0001), and DR (weeks 16 and 20; P ≤ .01). The bimatoprost group reported significantly greater levels of positive patient outcomes and satisfaction than the vehicle group across all 23 questions and all 3 domains of the primary PRO questionnaire. These results support the effectiveness, as measured by objective measures and PRO, of once-daily bimatoprost ophthalmic solution 0.03% at producing more prominent eyelashes in adults.

  18. Random vibrational networks and the renormalization group.

    PubMed

    Hastings, M B

    2003-04-11

    We consider the properties of vibrational dynamics on random networks, with random masses and spring constants. The localization properties of the eigenstates contrast greatly with the Laplacian case on these networks. We introduce several real-space renormalization techniques which can be used to describe this dynamics on general networks, drawing on strong disorder techniques developed for regular lattices. The renormalization group is capable of elucidating the localization properties, and provides, even for specific network instances, a fast approximation technique for determining the spectra which compares well with exact results.

  19. A randomized controlled trial on the efficacy of mindfulness-based cognitive therapy and a group version of cognitive behavioral analysis system of psychotherapy for chronically depressed patients.

    PubMed

    Michalak, Johannes; Schultze, Martin; Heidenreich, Thomas; Schramm, Elisabeth

    2015-10-01

    Mindfulness-based cognitive therapy (MBCT) has recently been proposed as a treatment option for chronic depression. The cognitive behavioral analysis system of psychotherapy (CBASP) is the only approach specifically developed to date for the treatment of chronically depressed patients. The efficacy of MBCT plus treatment-as-usual (TAU), and CBASP (group version) plus TAU, was compared to TAU alone in a prospective, bicenter, randomized controlled trial. One hundred and six patients with a current DSM-IV defined major depressive episode and persistent depressive symptoms for more than 2 years were randomized to TAU only (N = 35), or to TAU with additional 8-week group therapy of either 8 sessions of MBCT (n = 36) or CBASP (n = 35). The primary outcome measure was the Hamilton Depression Rating Scale (24-item HAM-D, Hamilton, 1967) at the end of treatment. Secondary outcome measures were the Beck Depression Inventory (BDI; Beck, Steer, & Brown, 1996) and measures of social functioning and quality of life. In the overall sample as well as at 1 treatment site, MBCT was no more effective than TAU in reducing depressive symptoms, although it was significantly superior to TAU at the other treatment site. CBASP was significantly more effective than TAU in reducing depressive symptoms in the overall sample and at both treatment sites. Both treatments had only small to medium effects on social functioning and quality of life. Further studies should inquire whether the superiority of CBASP in this trial might be explained by the more active, problem-solving, and interpersonal focus of CBASP. (c) 2015 APA, all rights reserved).

  20. Making healthy eating and physical activity policy practice: the design and overview of a group randomized controlled trial in afterschool programs.

    PubMed

    Beets, Michael W; Glenn Weaver, R; Turner-McGrievy, Gabrielle; Huberty, Jennifer; Ward, Dianne S; Freedman, Darcy A; Saunders, Ruth; Pate, Russell R; Beighle, Aaron; Hutto, Brent; Moore, Justin B

    2014-07-01

    National and state organizations have developed policies calling upon afterschool programs (ASPs, 3-6 pm) to serve a fruit or vegetable (FV) each day for snack, while eliminating foods and beverages high in added-sugars, and to ensure children accumulate a minimum of 30 min/d of moderate-to-vigorous physical activity (MVPA). Few efficacious and cost-effective strategies exist to assist ASP providers in achieving these important public health goals. This paper reports on the design and conceptual framework of Making Healthy Eating and Physical Activity (HEPA) Policy Practice in ASPs, a 3-year group randomized controlled trial testing the effectiveness of strategies designed to improve snacks served and increase MVPA in children attending community-based ASPs. Twenty ASPs, serving over 1800 children (6-12 years) will be enrolled and match-paired based on enrollment size, average daily min/d MVPA, and days/week FV served, with ASPs randomized after baseline data collection to immediate intervention or a 1-year delayed group. The framework employed, STEPs (Strategies To Enhance Practice), focuses on intentional programming of HEPA in each ASPs' daily schedule, and includes a grocery store partnership to reduce price barriers to purchasing FV, professional development training to promote physical activity to develop core physical activity competencies, as well as ongoing technical support/assistance. Primary outcome measures include children's accelerometry-derived MVPA and time spend sedentary while attending an ASP, direct observation of staff HEPA promoting and inhibiting behaviors, types of snacks served, and child consumption of snacks, as well as, cost of snacks via receipts and detailed accounting of intervention delivery costs to estimate cost-effectiveness. Copyright © 2014 Elsevier Inc. All rights reserved.

  1. An Exploratory Analysis of the Smoking and Physical Activity Outcomes From a Pilot Randomized Controlled Trial of an Exercise Assisted Reduction to Stop Smoking Intervention in Disadvantaged Groups.

    PubMed

    Thompson, Tom Paul; Greaves, Colin J; Ayres, Richard; Aveyard, Paul; Warren, Fiona C; Byng, Richard; Taylor, Rod S; Campbell, John L; Ussher, Michael; Green, Colin; Michie, Susan; West, Robert; Taylor, Adrian

    2016-03-01

    Economically disadvantaged smokers not intending to stop may benefit from interventions aimed at reducing their smoking. This study assessed the effects of a behavioral intervention promoting an increase in physical activity versus usual care in a pilot randomized controlled trial. Disadvantaged smokers who wanted to reduce but not quit were randomized to either a counseling intervention of up to 12 weeks to support smoking reduction and increased physical activity (n = 49) or usual care (n = 50). Data at 16 weeks were collected for various smoking and physical activity outcomes. Primary analyses consisted of an intention to treat analysis based on complete case data. Secondary analyses explored the impact of handling missing data. Compared with controls, intervention smokers were more likely to initiate a quit attempt (36 vs. 10%; odds ratio 5.05, [95% CI: 1.10; 23.15]), and a greater proportion achieved at least 50% reduction in cigarettes smoked (63 vs. 32%; 4.21 [1.32; 13.39]). Postquit abstinence measured by exhaled carbon monoxide at 4-week follow-up showed promising differences between groups (23% vs. 6%; 4.91 [0.80; 30.24]). No benefit of intervention on physical activity was found. Secondary analyses suggested that the standard missing data assumption of "missing" being equivalent to "smoking" may be conservative resulting in a reduced intervention effect. A smoking reduction intervention for economically disadvantaged smokers which involved personal support to increase physical activity appears to be more effective than usual care in achieving reduction and may promote cessation. The effect does not appear to be influenced by an increase in physical activity. © 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.

  2. A placebo-controlled, double-blind, randomized trial of an extract of Ginkgo biloba for dementia. North American EGb Study Group.

    PubMed

    Le Bars, P L; Katz, M M; Berman, N; Itil, T M; Freedman, A M; Schatzberg, A F

    EGb 761 is a particular extract of Ginkgo biloba used in Europe to alleviate symptoms associated with numerous cognitive disorders. Its use in dementias is based on positive results from only a few controlled clinical trials, most of which did not include standard assessments of cognition and behavior. To assess the efficacy and safety of EGb in Alzheimer disease and multi-infarct dementia. A 52-week, randomized double-blind, placebo-controlled, parallel-group, multicenter study. Mildly to severely demented outpatients with Alzheimer disease or multi-infarct dementia, without other significant medical conditions. Patients assigned randomly to treatment with EGb (120 mg/d) or placebo. Safety, compliance, and drug dispensation were monitored every 3 months with complete outcome evaluation at 12, 26, and 52 weeks. Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog), Geriatric Evaluation by Relative's Rating Instrument (GERRI), and Clinical Global Impression of Change (CGIC). From 309 patients included in an intent-to-treat analysis, 202 provided evaluable data for the 52-week end point analysis. In the intent-to-treat analysis, the EGbgroup had an ADAS-Cog score 1.4 points better than the placebo group (P=.04) and a GERRI score 0.14 points better than the placebo group (P=.004). The same patterns were observed with the evaluable data set in which 27% of patients treated with EGb achieved at least a 4-point improvement on the ADAS-Cog, compared with 14% taking placebo (P=.005); on the GERRI, 37% were considered improved with EGb, compared with 23% taking placebo (P=.003). No difference was seen in the CGIC. Regarding the safety profile of EGb, no significant differences compared with placebo were observed in the number of patients reporting adverse events or in the incidence and severity of these events. EGb was safe and appears capable of stabilizing and, in a substantial number of cases, improving the cognitive performance and the social functioning of

  3. A randomized controlled study of 5 and 10 days treatment with phenoxymethylpenicillin for pharyngotonsillitis caused by streptococcus group A - a protocol study.

    PubMed

    Skoog, Gunilla; Edlund, Charlotta; Giske, Christian G; Mölstad, Sigvard; Norman, Christer; Sundvall, Pär-Daniel; Hedin, Katarina

    2016-09-13

    In 2014 the Swedish government assigned to The Public Health Agency of Sweden to conduct studies to evaluate optimal use of existing antibiotic agents. The aim is to optimize drug use and dosing regimens to improve the clinical efficacy. The present study was selected following a structured prioritizing process by independent experts. This phase IV study is a randomized, open-label, multicenter study with non-inferiority design regarding the therapeutic use of penicillin V with two parallel groups. The overall aim is to study if the total exposure with penicillin V can be reduced from 1000 mg three times daily for 10 days to 800 mg four times daily for 5 days when treating Streptococcus pyogenes (Lancefield group A) pharyngotonsillitis. Patients will be recruited from 17 primary health care centers in Sweden. Adult men and women, youth and children ≥6 years of age who consult for sore throat and is judged to have a pharyngotonsillitis, with 3-4 Centor criteria and a positive rapid test for group A streptococci, will be included in the study. The primary outcome is clinical cure 5-7 days after discontinuation of antibiotic treatment. Follow-up controls will be done by telephone after 1 and 3 months. Throat symptoms, potential relapses and complications will be monitored, as well as adverse events. Patients (n = 432) will be included during 2 years. In the era of increasing antimicrobial resistance and the shortage of new antimicrobial agents it is necessary to revisit optimal usage of old antibiotics. Old antimicrobial drugs are often associated with inadequate knowledge on pharmacokinetics and pharmacodynamics and lack of optimized dosing regimens based on randomized controlled clinical trials. If a shorter and more potent treatment regimen is shown to be equivalent with the normal 10 day regimen this can imply great advantages for both patients (adherence, adverse events, resistance) and the community (resistance, drug costs). EudraCT number 2015

  4. Outcomes with individual versus group physical therapy for treating urinary incontinence and low back pain: a systematic review and meta-analysis of randomized controlled trials.

    PubMed

    Robertson, Belinda; Harding, Katherine E

    2014-11-01

    To evaluate the existing evidence comparing the outcomes of rehabilitation conducted in a group setting and individual therapy for patients receiving rehabilitation. Electronic databases MEDLINE, CINAHL, EMBASE, PEDro, and OT Seeker were searched from the earliest date possible to July 2013. Additional references were identified by manual scanning of reference lists. Randomized controlled trials investigating the effect of group therapy compared with individual therapy for patients receiving rehabilitation were included for review. Two reviewers independently applied the inclusion and exclusion criteria to identify included articles. Initial search identified 1527 potential articles, of which 16 trials with 2337 participants were included in the final review. Data extraction was completed for all included trials by one reviewer, using a customized data extraction form. Data were checked for accuracy by a second reviewer. Trials were independently assessed by 2 reviewers for methodological quality using the PEDro scale. Trials meeting inclusion criteria had been conducted in back pain (n=6 studies), urinary incontinence (n=5), learning disability (n=2), hearing loss (n=1), joint replacement (n=1), and aphasia (n=1). Meta-analysis of physical therapy trials in back pain and urinary incontinence reporting sufficient homogeneous data showed no significant difference in outcomes for group versus individual therapy. These results were also supported by qualitative analysis of the remaining studies in these populations, but there is insufficient evidence to draw conclusions regarding other clinical areas. Evidence shows that providing rehabilitation in a group format results in equivalent clinical outcomes to provision of similar therapy in an individual format in the treatment of back pain and urinary incontinence. There is currently insufficient evidence to draw similar conclusions in other populations or fields of rehabilitation. Copyright © 2014 American Congress of

  5. Culturally appropriate health education for Type 2 diabetes in ethnic minority groups: a systematic and narrative review of randomized controlled trials.

    PubMed

    Hawthorne, K; Robles, Y; Cannings-John, R; Edwards, A G K

    2010-06-01

    To determine if culturally appropriate health education is more effective than 'usual' health education for people with diabetes from ethnic minority groups living in high- and upper-middle-income countries. A systematic review with meta-analysis, following the methodology of the Cochrane Collaboration. Electronic literature searches of nine databases were made, with hand searching of three journals and 16 author contacts. The criteria for inclusion into the analysis were randomized controlled trials of a specified diabetes health education intervention, and a named ethnic minority group with Type 2 diabetes. Data were collected on HbA(1c), blood pressure, and quality-of-life measures. A narrative review was also performed. Few studies fitted the selection criteria, and were heterogeneous in methodologies and outcome measures, making meta-analysis difficult. HbA(1c) showed an improvement at 3 months [weighted mean difference (WMD) -0.32%, 95% confidence interval (CI) -0.63, -0.01] and 6 months post intervention (WMD -0.60%, 95% CI -0.85, -0.35). Knowledge scores also improved in the intervention groups at 6 months (standardized mean difference 0.46, 95% CI 0.27, 0.65). There was only one longer-term follow-up study, and one formal cost-effectiveness analysis. Culturally appropriate health education was more effective than 'usual' health education in improving HbA(1c) and knowledge in the short to medium term. Due to poor standardization between studies, the data did not allow determination of the key elements of interventions across countries, ethnic groups and health systems, or a broad view of their cost-effectiveness. The narrative review identifies learning points to direct future research.

  6. Assessing the efficacy of imagery-enhanced cognitive behavioral group therapy for social anxiety disorder: Study protocol for a randomized controlled trial.

    PubMed

    McEvoy, Peter M; Moulds, Michelle L; Grisham, Jessica R; Holmes, Emily A; Moscovitch, David A; Hendrie, Delia; Saulsman, Lisa M; Lipp, Ottmar V; Kane, Robert T; Rapee, Ronald M; Hyett, Matthew P; Erceg-Hurn, David M

    2017-09-01

    Cognitive behavior group therapy (CBGT) is effective for social anxiety disorder (SAD), but a substantial proportion of patients do not typically achieve normative functioning. Cognitive behavioral models of SAD emphasize negative self-imagery as an important maintaining factor, and evidence suggests that imagery is a powerful cognitive mode for facilitating affective change. This study will compare two group CBGT interventions, one that predominantly uses verbally-based strategies (VB-CBGT) and another that predominantly uses imagery-enhanced strategies (IE-CBGT), in terms of (a) efficacy, (b) mechanisms of change, and (c) cost-effectiveness. This study is a parallel groups (two-arm) single-blind randomized controlled trial. A minimum of 96 patients with SAD will be recruited within a public outpatient community mental health clinic in Perth, Australia. The primary outcomes will be self-reported symptom severity, caseness (SAD present: yes/no) based on a structured diagnostic interview, and clinician-rated severity and life impact. Secondary outcomes and mechanism measures include blind observer-rated use of safety behaviors, physiological activity (heart rate variability and skin conductance level) during a standardized speech task, negative self-beliefs, imagery suppression, fear of negative and positive evaluation, repetitive negative thinking, anxiety, depression, self-consciousness, use of safety behaviors, and the EQ-5D-5L and TiC-P for the health economic analysis. Homework completion, group cohesion, and working alliance will also be monitored. The outcomes of this trial will inform clinicians as to whether integrating imagery-based strategies in cognitive behavior therapy for SAD is likely to improve outcomes. Common and distinct mechanisms of change might be identified, along with relative cost-effectiveness of each intervention. Copyright © 2017 Elsevier Inc. All rights reserved.

  7. Effects of the Quest to Lava Mountain Computer Game on Dietary and Physical Activity Behaviors of Elementary School Children: A Pilot Group-Randomized Controlled Trial.

    PubMed

    Sharma, Shreela V; Shegog, Ross; Chow, Joanne; Finley, Carrie; Pomeroy, Mike; Smith, Carolyn; Hoelscher, Deanna M

    2015-08-01

    Computer-based educational games present an opportunity for health education in school; however, their feasibility in school settings and effectiveness in changing behavior are poorly understood. To evaluate the feasibility, acceptability, and effects of the Quest to Lava Mountain (QTLM) computer game on dietary behaviors, physical activity behaviors, and psychosocial factors among ethnically diverse children in Texas. Quasi-experimental group-randomized controlled trial conducted during the 2012-2013 school year. A total of 107 children in fourth and fifth grade consented. There was an attrition rate of 8.8% with a final sample size of 44 children in three intervention schools, and a sample of 50 children in three comparison schools. Dietary intake was measured using two random 24-hour recalls, whereas child self-report surveys measured diet, physical activity, and psychosocial factors before and after the intervention. Process data on QTLM usability and back-end server data on QTLM exposure and progress achieved were collected. QTLM was implemented as part of the in-school or afterschool program. Recommended game exposure duration was 90 min/wk for 6 weeks. Analysis of covariance or logistic regression models evaluated effects of QTLM on diet, physical activity, and psychosocial factors. Post hoc exploratory analysis examined the changes before and after the intervention in outcome variables among children in the intervention group. Significance was set at P<0.05. Children played an average of 274±110 minutes (approximately 4.6 hours) of QTLM during the 6 weeks (51% of recommended dosage). Compared with the comparison group, children in the intervention group reported decreased sugar consumption (P=0.021) and higher nutrition/physical activity attitudes (P=0.041) pre- to postintervention. There were no significant effects of QTLM on physical activity. However, post hoc analysis showed that higher QTLM exposure and gaming progress was associated with increased

  8. Working memory training in healthy young adults: Support for the null from a randomized comparison to active and passive control groups

    PubMed Central

    Lawlor-Savage, Linette; Goghari, Vina M.

    2017-01-01

    Training of working memory as a method of increasing working memory capacity and fluid intelligence has received much attention in recent years. This burgeoning field remains highly controversial with empirically-backed disagreements at all levels of evidence, including individual studies, systematic reviews, and even meta-analyses. The current study investigated the effect of a randomized six week online working memory intervention on untrained cognitive abilities in a community-recruited sample of healthy young adults, in relation to both a processing speed training active control condition, as well as a no-contact control condition. Results of traditional null hypothesis significance testing, as well as Bayesian factor analyses, revealed support for the null hypothesis across all cognitive tests administered before and after training. Importantly, all three groups were similar at pre-training for a variety of individual variables purported to moderate transfer of training to fluid intelligence, including personality traits, motivation to train, and expectations of cognitive improvement from training. Because these results are consistent with experimental trials of equal or greater methodological rigor, we suggest that future research re-focus on: 1) other promising interventions known to increase memory performance in healthy young adults, and; 2) examining sub-populations or alternative populations in which working memory training may be efficacious. PMID:28558000

  9. Using Social and Mobile Tools for Weight Loss in Overweight and Obese Young Adults (Project SMART): A 2-Year Parallel Group Randomized Controlled Trial

    PubMed Central

    Godino, Job G.; Merchant, Gina; Norman, Gregory J.; Donohue, Michael C.; Marshall, Simon J.; Fowler, James H.; Calfas, Karen J.; Huang, Jeannie S.; Rock, Cheryl L.; Griswold, William G.; Gupta, Anjali; Raab, Fredric; Fogg, B.J.; Robinson, Thomas N.; Patrick, Kevin

    2016-01-01

    Background Few weight-loss interventions are evaluated for longer than a year, and even fewer employ social and mobile technologies commonly used among young adults. We assessed the efficacy of a two-year, theory-based weight-loss intervention that was remotely and adaptively delivered via integrated user-experiences with 1) Facebook, 2) mobile apps, 3) text messaging, 4) emails, 5) a website, and 6) technology-mediated communication with a health coach. Methods From May 2011 to May 2012, 404 overweight or obese college students (aged 18 to 35 years) from three universities in San Diego, CA were randomized using a computer-based procedure to receive either the intervention (n=202) or general information about health and wellness (control group, n=202). The primary outcome was objectively measured weight in kg at 24 months, and differences between groups were evaluated using linear mixed-effects regression and an intention-to-treat framework. The trial was registered with ClinicalTrials.gov NCT01200459. Findings Participants’ mean (standard deviation (SD)) age was 22·7 (3.8) years. They were 70% female and 31% Hispanic. Mean (SD) body mass index was 29·0 (2.8) kg/m2. At 24 months, weight was assessed in 341 (84%) participants, but all 404 were included in analyses. Weight, adjusted for sex, ethnicity, and college, was significantly less in the intervention group compared to the control group at 6 months (−1·33 kg, 95% confidence interval (CI) = −2·36 to −0·30, p = 0·011) and 12 months (−1·33 kg, 95% CI =−2·30 to −0·35, p = 0·008). However, differences between groups at 18 months (−0·67 kg, 95% CI = −1·69 to 0·35, p = 0·200) and 24 months (−0·79 kg, 95% CI = −2·02 to 0·43, p = 0·204) were not significant. Interpretation Social and mobile technologies may facilitate limited short-term weight loss among young adults, but as utilized in this intervention, these approaches did not produce sustained reductions in weight. PMID

  10. A community-based group-guided self-help intervention for low mood and stress: study protocol for a randomized controlled trial.

    PubMed

    McClay, Carrie-Anne; Morrison, Jill; McConnachie, Alex; Williams, Christopher

    2013-11-19

    Depression is a mental health condition which affects millions of people each year, with worldwide rates increasing. Cognitive behavioral therapy (CBT) is recommended in the National Institute for Health and Clinical Excellence (NICE) guidelines for the treatment of depression. However, waiting lists can cause delays for face-to-face therapy. Also a proportion of people decline to present for help through the health service - the so-called treatment gap. Self-referral to CBT using community-based group interventions delivered by a voluntary sector organization may serve to resolve this problem. The aim of this randomized controlled trial (RCT) is to determine the efficacy of such a guided CBT self-help course, the 'Living Life to the Full' (LLTTF) classes delivered by the charity Action on Depression (AOD). The primary outcome is level of depression at 6 months assessed using the patient health questionnaire-9 (PHQ9) depression scale. Secondary measures include levels of anxiety and social functioning. Participants with symptoms of low mood will be recruited from the community through newspaper adverts and also via the AOD website. Participants will receive either immediate or delayed access to guided CBT self-help classes - the eight session LLTTF course. The primary endpoint will be at 6 months at which point the delayed group will be offered the intervention. Levels of depression, anxiety and social functioning will be assessed and an economic analysis will be carried out. This RCT will test whether the LLTTF intervention is effective and/or cost-effective. If the LLTTF community-based classes are found to be cost effective, they may be helpful as both an intervention for those already seeking care in the health service, as well as those seeking help outside that setting, widening access to psychological therapy. Current Controlled Trials ISRCTN86292664.

  11. Analytic Methods for Individually Randomized Group Treatment Trials and Group-Randomized Trials When Subjects Belong to Multiple Groups

    PubMed Central

    Andridge, Rebecca. R.; Shoben, Abigail B.; Muller, Keith E.; Murray, David M.

    2014-01-01

    Participants in trials may be randomized either individually or in groups, and may receive their treatment either entirely individually, entirely in groups, or partially individually and partially in groups. This paper concerns cases in which participants receive their treatment either entirely or partially in groups, regardless of how they were randomized. Participants in Group-Randomized Trials (GRTs) are randomized in groups and participants in Individually Randomized Group Treatment (IRGT) trials are individually randomized, but participants in both types of trials receive part or all of their treatment in groups or through common change agents. Participants who receive part or all of their treatment in a group are expected to have positively correlated outcome measurements. This paper addresses a situation that occurs in GRTs and IRGT trials – participants receive treatment through more than one group. As motivation, we consider trials in The Childhood Obesity Prevention and Treatment Research Consortium (COPTR), in which each child participant receives treatment in at least two groups. In simulation studies we considered several possible analytic approaches over a variety of possible group structures. A mixed model with random effects for both groups provided the only consistent protection against inflated type I error rates and did so at the cost of only moderate loss of power when intraclass correlations were not large. We recommend constraining variance estimates to be positive and using the Kenward-Roger adjustment for degrees of freedom; this combination provided additional power but maintained type I error rates at the nominal level. PMID:24399701

  12. Efficacy and safety of bilastine in Japanese patients with perennial allergic rhinitis: A multicenter, randomized, double-blind, placebo-controlled, parallel-group phase III study.

    PubMed

    Okubo, Kimihiro; Gotoh, Minoru; Asako, Mikiya; Nomura, Yasuyuki; Togawa, Michinori; Saito, Akihiro; Honda, Takayuki; Ohashi, Yoshihiro

    2017-01-01

    Bilastine, a novel non-sedating second-generation H1 antihistamine, has been approved in most European countries since 2010. This study aimed to evaluate the superiority of bilastine over placebo in Japanese patients with perennial allergic rhinitis (PAR). This randomized, double-blind, placebo-controlled, parallel-group, phase III study (trial registration number JapicCTI-142600) evaluated the effect of a 2-week treatment period with bilastine (20 mg once daily), fexofenadine (60 mg twice daily), or a matched placebo (double dummy) in patients with PAR. All patients were instructed to record individual nasal and ocular symptoms in diaries daily. The primary endpoint was the mean change in total nasal symptom scores (TNSS) from baseline to Week 2 (Days 10-13). A total of 765 patients were randomly allocated to receive bilastine, fexofenadine, or placebo (256, 254, and 255 patients, respectively). The mean change in TNSS from baseline at Week 2 was significantly decreased by bilastine (-0.98) compared to placebo (-0.63, P = 0.023). Bilastine and fexofenadine showed no significant difference in the primary endpoint. However, the mean change in TNSS from baseline on Day 1 was more significantly decreased by bilastine (-0.99) than by placebo (-0.28, P < 0.001) or fexofenadine (-0.62, P = 0.032). The active drugs also improved instantaneous TNSS 1 h after the first and before the second drug administration on Day 1 (P < 0.05). The study drugs were well tolerated. After 2-week treatment period, bilastine 20 mg once daily was effective and tolerable in Japanese patients with PAR, and exhibited a rapid onset of action. Copyright © 2016 Japanese Society of Allergology. Production and hosting by Elsevier B.V. All rights reserved.

  13. An intervention for reducing secondary traumatization and improving professional self-efficacy in well baby clinic nurses following war and terror: a random control group trial.

    PubMed

    Berger, Rony; Gelkopf, Marc

    2011-05-01

    Due to the terror and war-related situation in Israel, well baby clinic nurses dealing with a large number of traumatized and highly distressed infants, toddlers and their parents have become overwhelmed. (1) Assess the level of secondary traumatization, including lack of compassion satisfaction, burnout and compassion fatigue of well baby clinic nurses living under chronic threat of war and terror. (2) Assess the efficacy of an intervention aimed at providing well baby clinic nurses with psycho-educational knowledge pertaining to stress and trauma in infants, young children and parents. This intervention provides the nurses with screening tools for identifying children and parents at risk of developing stress-related problems and equips them with stress management techniques. Quasi-random control trial. The intervention took place in Israel, in war (North) and terror (South) affected areas. Ninety well baby clinic nurses from the most war and terror affected areas in Israel were approached, 42 were randomly assigned the experimental intervention and 38 served as a waiting list group. The intervention was comprised of 12 weekly 6-h sessions. Each session included theoretical knowledge, experiential exercises based on the nurses' work or personal life experience, and the learning of skills accompanied by homework assignments. Participants were assessed on self-report measures of secondary traumatization, professional self-efficacy, hope, sense of mastery and self-esteem before and after the intervention. (1) Well baby clinic nurses were found to have elevated secondary traumatization levels. (2) Compared to the waiting list group, the intervention group improved significantly on the professional self-efficacy measure as well as reducing the level of secondary traumatization. Furthermore, improvement on all secondary traumatization measures covaried with the improvement on the professional self-efficacy assessments. Based on additional informal reports, the

  14. Intake of black-vinegar-mash-garlic enhances salivary release of secretory IgA: A randomized, double-blind, placebo-controlled, parallel-group study

    PubMed Central

    NAKASONE, YASUSHI; SATO, NORIMASA; AZUMA, TAKAYUKI; HASUMI, KEIJI

    2016-01-01

    Several previous studies have provided evidence that suggests the beneficial effects of garlic and black vinegar on human health, including benefits to immune function. The preliminary study indicated that the intake of black-vinegar-mash-garlic-containing food, created from aged garlic pickled in the mash of black vinegar, enhanced the release of secretory immunoglobulin A (sIgA) in the saliva. The aim of the present study was to evaluate the effect of the food in a randomized, double-blind, placebo-controlled, parallel-group trial. The trial was conducted in subjects aged between 30 and 60 years whose rate of salivary sIgA release was moderately low. Subjects consumed 2.49 g of placebo or black-vinegar-mash-garlic-containing food (active food) daily for 8 weeks. The data obtained with 54 eligible subjects (n=28 and 26 for placebo and active, respectively) were analyzed for efficacy. The rates of salivary sIgA release in the active food group (35.9±84.6 and 47.9±123.4 µg/min at weeks 4 and 8 of intake; changes from pretrial value) were higher compared to the respective rates in the placebo food group (−12.3±72.1 and −3.2±85.9 µg/min, P=0.028 and 0.082, respectively). These findings indicate that intake of black-vinegar-mash-garlic-containing food enhanced the intraoral immune response. There was no adverse event associated with the intake of active food. PMID:27347407

  15. Intake of black-vinegar-mash-garlic enhances salivary release of secretory IgA: A randomized, double-blind, placebo-controlled, parallel-group study.

    PubMed

    Nakasone, Yasushi; Sato, Norimasa; Azuma, Takayuki; Hasumi, Keiji

    2016-07-01

    Several previous studies have provided evidence that suggests the beneficial effects of garlic and black vinegar on human health, including benefits to immune function. The preliminary study indicated that the intake of black-vinegar-mash-garlic-containing food, created from aged garlic pickled in the mash of black vinegar, enhanced the release of secretory immunoglobulin A (sIgA) in the saliva. The aim of the present study was to evaluate the effect of the food in a randomized, double-blind, placebo-controlled, parallel-group trial. The trial was conducted in subjects aged between 30 and 60 years whose rate of salivary sIgA release was moderately low. Subjects consumed 2.49 g of placebo or black-vinegar-mash-garlic-containing food (active food) daily for 8 weeks. The data obtained with 54 eligible subjects (n=28 and 26 for placebo and active, respectively) were analyzed for efficacy. The rates of salivary sIgA release in the active food group (35.9±84.6 and 47.9±123.4 µg/min at weeks 4 and 8 of intake; changes from pretrial value) were higher compared to the respective rates in the placebo food group (-12.3±72.1 and -3.2±85.9 µg/min, P=0.028 and 0.082, respectively). These findings indicate that intake of black-vinegar-mash-garlic-containing food enhanced the intraoral immune response. There was no adverse event associated with the intake of active food.

  16. Cardiac safety of indacaterol in healthy subjects: a randomized, multidose, placebo- and positive-controlled, parallel-group thorough QT study.

    PubMed

    Khindri, Sanjeev; Sabo, Ronald; Harris, Stuart; Woessner, Ralph; Jennings, Simon; Drollmann, Anton F

    2011-05-26

    Indacaterol is a novel once-daily ultra long-acting β2-agonist for the treatment of chronic obstructive pulmonary disease. It is known that β2-agonists, like other adrenergic compounds, can prolong the QT-interval. This thorough QT/QTc study (as per ICH E14 guideline) evaluated the effect of indacaterol on the QT interval in healthy subjects. In this randomized, double-blind, parallel-group, placebo- and positive-controlled (open-label moxifloxacin) study, non-smoking healthy subjects (18-55 years, body mass index: 18.5-32.0 kg/m2) were randomized (4:4:2:4:1) to 14-day treatment with once-daily indacaterol (150 μg, 300 μg, or 600 μg), placebo, or placebo/moxifloxacin (double-blind 14-day treatment with placebo and a single open-label dose of 400 mg moxifloxacin on Day 14). The primary endpoint was the change from baseline on Day 14 in QTcF (QT interval corrected for heart rate using Fridericia's formula). In total, 404 subjects were randomized to receive indacaterol (150 [n = 108], 300 [n = 108], 600 μg [n = 54]), placebo (n = 107), or placebo/moxifloxacin (n = 27); 388 subjects completed the study. Maximal time-matched mean (90% confidence intervals) treatment differences from placebo in QTcF change from baseline on Day 14 were 2.66 (0.55, 4.77), 2.98 (1.02, 4.93) and 3.34 (0.86, 5.82) ms for indacaterol 150 μg, 300 μg and 600 μg, respectively. Study sensitivity was confirmed with moxifloxacin demonstrating a significant maximal time-matched QTcF prolongation of 13.90 (10.58, 17.22) ms compared to placebo. All indacaterol doses were well tolerated. Indacaterol, at doses up to 600 μg once daily (2-4 times the therapeutic dose) does not have any clinically relevant effect on the QT interval.

  17. Cardiac safety of indacaterol in healthy subjects: a randomized, multidose, placebo- and positive-controlled, parallel-group thorough QT study

    PubMed Central

    2011-01-01

    Background Indacaterol is a novel once-daily ultra long-acting β2-agonist for the treatment of chronic obstructive pulmonary disease. It is known that β2-agonists, like other adrenergic compounds, can prolong the QT-interval. This thorough QT/QTc study (as per ICH E14 guideline) evaluated the effect of indacaterol on the QT interval in healthy subjects. Methods In this randomized, double-blind, parallel-group, placebo- and positive-controlled (open-label moxifloxacin) study, non-smoking healthy subjects (18-55 years, body mass index: 18.5-32.0 kg/m2) were randomized (4:4:2:4:1) to 14-day treatment with once-daily indacaterol (150 μg, 300 μg, or 600 μg), placebo, or placebo/moxifloxacin (double-blind 14-day treatment with placebo and a single open-label dose of 400 mg moxifloxacin on Day 14). The primary endpoint was the change from baseline on Day 14 in QTcF (QT interval corrected for heart rate using Fridericia's formula). Results In total, 404 subjects were randomized to receive indacaterol (150 [n = 108], 300 [n = 108], 600 μg [n = 54]), placebo (n = 107), or placebo/moxifloxacin (n = 27); 388 subjects completed the study. Maximal time-matched mean (90% confidence intervals) treatment differences from placebo in QTcF change from baseline on Day 14 were 2.66 (0.55, 4.77), 2.98 (1.02, 4.93) and 3.34 (0.86, 5.82) ms for indacaterol 150 μg, 300 μg and 600 μg, respectively. Study sensitivity was confirmed with moxifloxacin demonstrating a significant maximal time-matched QTcF prolongation of 13.90 (10.58, 17.22) ms compared to placebo. All indacaterol doses were well tolerated. Conclusion Indacaterol, at doses up to 600 μg once daily (2-4 times the therapeutic dose) does not have any clinically relevant effect on the QT interval. Trial Registration ClinicalTrials.gov: NCT01263808 PMID:21615886

  18. Effective components of feedback from Routine Outcome Monitoring (ROM) in youth mental health care: study protocol of a three-arm parallel-group randomized controlled trial

    PubMed Central

    2014-01-01

    Background Routine Outcome Monitoring refers to regular measurements of clients’ progress in clinical practice, aiming to evaluate and, if necessary, adapt treatment. Clients fill out questionnaires and clinicians receive feedback about the results. Studies concerning feedback in youth mental health care are rare. The effects of feedback, the importance of specific aspects of feedback, and the mechanisms underlying the effects of feedback are unknown. In the present study, several potentially effective components of feedback from Routine Outcome Monitoring in youth mental health care in the Netherlands are investigated. Methods/Design We will examine three different forms of feedback through a three-arm parallel-group randomized controlled trial. 432 children and adolescents (aged 4 to 17 years) and their parents, who have been referred to mental health care institution Pro Persona, will be randomly assigned to one of three feedback conditions (144 participants per condition). Randomization will be stratified by age of the child or adolescent and by department. All participants fill out questionnaires at the start of treatment, one and a half months after the start of treatment, every three months during treatment, and at the end of treatment. Participants in the second and third feedback conditions fill out an additional questionnaire. In condition 1, clinicians receive basic feedback regarding clients’ symptoms and quality of life. In condition 2, the feedback of condition 1 is extended with feedback regarding possible obstacles to a good outcome and with practical suggestions. In condition 3, the feedback of condition 2 is discussed with a colleague while following a standardized format for case consultation. The primary outcome measure is symptom severity and secondary outcome measures are quality of life, satisfaction with treatment, number of sessions, length of treatment, and rates of dropout. We will also examine the role of being not on track (not

  19. Outcomes from a Randomized Controlled Trial of a Group Intervention for HIV Positive Men and Women Coping with AIDS-Related Loss and Bereavement

    ERIC Educational Resources Information Center

    Sikkema, Kathleen J.; Hansen, Nathan B.; Kochman, Arlene; Tate, David C.; DiFranceisco, Wayne

    2004-01-01

    The purpose of this study was to examine the impact of a group coping intervention for HIV-positive men and women who have lost a loved one(s) to AIDS in the past 2 years. Two hundred thirty-five participants, diverse with respect to race/ethnicity and sexual orientation, were randomly assigned to a 12-week cognitive-behavioral group intervention…

  20. Outcomes from a Randomized Controlled Trial of a Group Intervention for HIV Positive Men and Women Coping with AIDS-Related Loss and Bereavement

    ERIC Educational Resources Information Center

    Sikkema, Kathleen J.; Hansen, Nathan B.; Kochman, Arlene; Tate, David C.; DiFranceisco, Wayne

    2004-01-01

    The purpose of this study was to examine the impact of a group coping intervention for HIV-positive men and women who have lost a loved one(s) to AIDS in the past 2 years. Two hundred thirty-five participants, diverse with respect to race/ethnicity and sexual orientation, were randomly assigned to a 12-week cognitive-behavioral group intervention…

  1. Effects of antihypertensive treatment in Asian populations: a meta-analysis of prospective randomized controlled studies (CARdiovascular protectioN group in Asia: CARNA).

    PubMed

    Yano, Yuichiro; Briasoulis, Alexandros; Bakris, George L; Hoshide, Satoshi; Wang, Ji-Guang; Shimada, Kazuyuki; Kario, Kazuomi

    2014-02-01

    To examine the effects of antihypertensive treatment on cardiovascular disease (CVD) in Asian populations, we systematically evaluated prospective randomized studies carried out in Asia (1991-2013). We identified 18 trials with 23,215 and 21,986 hypertensive patients in the intervention (ie, strict blood pressure [BP] lowering or add-on treatment) and reference groups, respectively (mean age, 65 years; follow-up duration, 3.2 years). Analysis was performed through 1) first subgroup: eight trials that compared active antihypertensive treatment with placebo or intensive with less intensive BP control and 2) second subgroup: 10 trials that compared different antihypertensive treatments. In the first subgroup analysis, BP was reduced from 160.3/87.3 mm Hg to 140.2/78.4 mm Hg in the intervention group with a -6.7/-2.2 mm Hg (P < .001) greater BP reduction than the reference group. Compared with the reference group, the intervention group had a lower risk of composite CVD events (odd ratio [OR], 0.73; 95% confidence interval [CI], 0.66-0.81), myocardial infarction (OR, 0.79; 95% CI, 0.63-1.0), stroke (OR, 0.71; 95% CI, 0.63-0.80), and CVD mortality (OR, 0.81; 95% CI, 0.68-0.97; all P ≤ .05). In the second subgroup analysis, no difference was found for any outcome between renin-angiotensin blockers and calcium-channel blockers or diuretics. The meta-regression line among the 18 trials indicated that a 10 mm Hg reduction in systolic BP was associated with a reduced risk for composite CVD events (-39.5%) and stroke (-30.0%). Our meta-analysis shows a benefit when a BP target of less than 140/80 mm Hg is achieved in Asian hypertensives. BP reduction itself, regardless of BP lowering agents, is important for achieving CVD risk reduction. Copyright © 2014 American Society of Hypertension. Published by Elsevier Inc. All rights reserved.

  2. Prevention of diarrhea and pneumonia by zinc supplementation in children in developing countries: pooled analysis of randomized controlled trials. Zinc Investigators' Collaborative Group.

    PubMed

    Bhutta, Z A; Black, R E; Brown, K H; Gardner, J M; Gore, S; Hidayat, A; Khatun, F; Martorell, R; Ninh, N X; Penny, M E; Rosado, J L; Roy, S K; Ruel, M; Sazawal, S; Shankar, A

    1999-12-01

    This study assessed the effects of zinc supplementation in the prevention of diarrhea and pneumonia with the use of a pooled analysis of randomized controlled trials in children in developing countries. Trials included were those that provided oral supplements containing at least one half of the United States Recommended Daily Allowance (RDA) of zinc in children <5 years old and evaluated the prevention of serious infectious morbidity through household visits. Analysis included 7 "continuous" trials providing 1 to 2 RDA of elemental zinc 5 to 7 times per week throughout the period of morbidity surveillance and 3 "short-course" trials providing 2 to 4 RDA daily for 2 weeks followed by 2 to 3 months of morbidity surveillance. The effects on diarrhea and pneumonia were analyzed overall and in subgroups defined by age, baseline plasma zinc concentration, nutritional status, and sex. The analysis used random effects hierarchical models to calculate odds ratios (OR) and 95% CIs. For the zinc-supplemented children compared with the control group in the continuous trials, the pooled ORs for diarrheal incidence and prevalence were 0.82 (95% CI 0.72 to 0.93) and 0.75 (95% CI 0.63 to 0.88), respectively. Zinc-supplemented children had an OR of 0.59 (95% CI 0.41 to 0.83) for pneumonia. No significant differences were seen in the effects of the zinc supplement between the subgroups examined for either diarrhea or pneumonia. In the short-course trials the OR for the effects of zinc on diarrheal incidence (OR 0.89, 95% CI 0.62 to 1.28) and prevalence (OR 0.66, 95% CI 0.52 to 0.83) and pneumonia incidence (OR 0.74, 95% CI 0.40 to 1.37) were similar to those in the continuous trials. Zinc supplementation in children in developing countries is associated with substantial reductions in the rates of diarrhea and pneumonia, the 2 leading causes of death in these settings.

  3. Tailored exercise program reduces symptoms of upper limb work-related musculoskeletal disorders in a group of metalworkers: A randomized controlled trial.

    PubMed

    Rasotto, Chiara; Bergamin, Marco; Simonetti, Alberto; Maso, Stefano; Bartolucci, Giovanni B; Ermolao, Andrea; Zaccaria, Marco

    2015-02-01

    Work-related musculoskeletal disorders (WRMDs) are a leading cause of work-related disability and loss of productivity in the developed countries; these disorders may concur with the indirect costs of an illness or injury included losses of potential output. Literature on workplace physical activity program provided a mixed but positive impact on health and important worksite outcomes. Therefore, programs of physical activity organized and performed in the workplace could reveal as essential tool to reduce musculoskeletal symptoms. This investigation aimed to assess the effectiveness of a tailored physical activity program, performed in a work-environment, to reduce the symptoms in upper extremities and neck with the novelty in personalizing the approach applied to the exercise protocol, basing on pain and disability levels, to reduce the onset and symptoms in upper extremity and neck WRMDs increasing upper-limb strength and flexibility. 68 metalworkers were recruited, 34 were randomly allocated to an intervention group (IG), while the other 34 to a control group. Primary outcomes concerned pain symptoms measured with visual analog scales while disability was measured by DASH (Disability of the Arm, Shoulder and Hand), and NPDS-I (Neck Pain and Disability Scale) questionnaires. Grip strength, upper-limb mobility, neck and shoulder range of motion were also assessed. After the 9-month intervention, IG reduced pain symptoms on neck, shoulders, elbows and on wrists. Grip strength and upper-limb mobility improved as well as scores on questionnaires. This protocol suggests that performing a tailored physical activity program is beneficial to reduce pain and disability on upper-limb WRMDs. Copyright © 2014 Elsevier Ltd. All rights reserved.

  4. Treatment of Bipolar Depression with Deep TMS: Results from a Double-Blind, Randomized, Parallel Group, Sham-Controlled Clinical Trial.

    PubMed

    Tavares, Diego F; Myczkowski, Martin L; Alberto, Rodrigo L; Valiengo, Leandro; Rios, Rosa M; Gordon, Pedro; de Sampaio-Junior, Bernardo; Klein, Izio; Mansur, Carlos G; Marcolin, Marco Antonio; Lafer, Beny; Moreno, Ricardo A; Gattaz, Wagner; Daskalakis, Zafiris J; Brunoni, André R

    2017-02-01

    Bipolar depression (BD) is a highly prevalent condition with limited therapeutic options. Deep (H1-coil) transcranial magnetic stimulation (dTMS) is a novel TMS modality with established efficacy for unipolar depression. We conducted a randomized sham-controlled trial to evaluate the efficacy and safety of dTMS in treatment-resistant BD patients. Patients received 20 sessions of active or sham dTMS over the left dorsolateral prefrontal cortex (H1-coil, 55 18 Hz 2 s 120% MT trains). The primary outcome was changes in the 17-item Hamilton Depression Rating Scale (HDRS-17) from baseline to endpoint (week 4). Secondary outcomes were changes from baseline to the end of the follow-up phase (week 8), and response and remission rates. Safety was assessed using a dTMS adverse effects questionnaire and the Young Mania Rating Scale to assess treatment-emergent mania switch (TEMS). Out of 50 patients, 43 finished the trial. There were 2 and 5 dropouts in the sham and active groups, respectively. Active dTMS was superior to sham at end point (difference favoring dTMS=4.88; 95% CI 0.43 to 9.32, p=0.03) but not at follow-up. There was also a trend for greater response rates in the active (48%) vs sham (24%) groups (OR=2.92; 95% CI=0.87 to 9.78, p=0.08). Remission rates were not statistically different. No TEMS episodes were observed. Deep TMS is a potentially effective and well-tolerated add-on therapy in resistant bipolar depressed patients receiving adequate pharmacotherapy.Neuropsychopharmacology advance online publication, 31 May 2017; doi:10.1038/npp.2017.26.

  5. Human computation as a new method for evidence-based knowledge transfer in Web-based guideline development groups: proof of concept randomized controlled trial.

    PubMed

    Heselmans, Annemie; Aertgeerts, Bert; Donceel, Peter; Van de Velde, Stijn; Vanbrabant, Peter; Ramaekers, Dirk

    2013-01-17

    Guideline developers use different consensus methods to develop evidence-based clinical practice guidelines. Previous research suggests that existing guideline development techniques are subject to methodological problems and are logistically demanding. Guideline developers welcome new methods that facilitate a methodologically sound decision-making process. Systems that aggregate knowledge while participants play a game are one class of human computation applications. Researchers have already proven that these games with a purpose are effective in building common sense knowledge databases. We aimed to evaluate the feasibility of a new consensus method based on human computation techniques compared to an informal face-to-face consensus method. We set up a randomized design to study 2 different methods for guideline development within a group of advanced students completing a master of nursing and obstetrics. Students who participated in the trial were enrolled in an evidence-based health care course. We compared the Web-based method of human-based computation (HC) with an informal face-to-face consensus method (IC). We used 4 clinical scenarios of lower back pain as the subject of the consensus process. These scenarios concerned the following topics: (1) medical imaging, (2) therapeutic options, (3) drugs use, and (4) sick leave. Outcomes were expressed as the amount of group (dis)agreement and the concordance of answers with clinical evidence. We estimated within-group and between-group effect sizes by calculating Cohen's d. We calculated within-group effect sizes as the absolute difference between the outcome value at round 3 and the baseline outcome value, divided by the pooled standard deviation. We calculated between-group effect sizes as the absolute difference between the mean change in outcome value across rounds in HC and the mean change in outcome value across rounds in IC, divided by the pooled standard deviation. We analyzed statistical significance of

  6. Transdiagnostic group CBT vs. standard group CBT for depression, social anxiety disorder and agoraphobia/panic disorder: Study protocol for a pragmatic, multicenter non-inferiority randomized controlled trial.

    PubMed

    Arnfred, Sidse M; Aharoni, Ruth; Hvenegaard, Morten; Poulsen, Stig; Bach, Bo; Arendt, Mikkel; Rosenberg, Nicole K; Reinholt, Nina

    2017-01-23

    Transdiagnostic Cognitive Behavior Therapy (TCBT) manuals delivered in individual format have been reported to be just as effective as traditional diagnosis specific CBT manuals. We have translated and modified the "The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders" (UP-CBT) for group delivery in Mental Health Service (MHS), and shown effects comparable to traditional CBT in a naturalistic study. As the use of one manual instead of several diagnosis-specific manuals could simplify logistics, reduce waiting time, and increase therapist expertise compared to diagnosis specific CBT, we aim to test the relative efficacy of group UP-CBT and diagnosis specific group CBT. The study is a partially blinded, pragmatic, non-inferiority, parallel, multi-center randomized controlled trial (RCT) of UP-CBT vs diagnosis specific CBT for Unipolar Depression, Social Anxiety Disorder and Agoraphobia/Panic Disorder. In total, 248 patients are recruited from three regional MHS centers across Denmark and included in two intervention arms. The primary outcome is patient-ratings of well-being (WHO Well-being Index, WHO-5), secondary outcomes include level of depressive and anxious symptoms, personality variables, emotion regulation, reflective functioning, and social adjustment. Assessments are conducted before and after therapy and at 6 months follow-up. Weekly patient-rated outcomes and group evaluations are collected for every session. Outcome assessors, blind to treatment allocation, will perform the observer-based symptom ratings, and fidelity assessors will monitor manual adherence. The current study will be the first RCT investigating the dissemination of the UP in a MHS setting, the UP delivered in groups, and with depressive patients included. Hence the results are expected to add substantially to the evidence base for rational group psychotherapy in MHS. The planned moderator and mediator analyses could spur new hypotheses about mechanisms of change in

  7. Short-term intensive psychodynamic group therapy versus cognitive-behavioral group therapy in day treatment of anxiety disorders and comorbid depressive or personality disorders: study protocol for a randomized controlled trial.

    PubMed

    Suszek, Hubert; Holas, Paweł; Wyrzykowski, Tomasz; Lorentzen, Steinar; Kokoszka, Andrzej

    2015-07-29

    Psychodynamic and cognitive-behavioral group therapies are frequently applied in day hospitals for the treatment of anxiety disorders and comorbid depressive or personality disorders in Poland and other Eastern European countries. Yet there is not enough evidence as to their effectiveness in this environment; this study addresses this gap. The aim of the study is to determine the effectiveness of these two kinds of day treatment care consisting of intensive, short-term group psychodynamic and cognitive-behavioral therapy, for patients with anxiety disorders and/or comorbid depressive or personality disorders. Our objectives are to: 1) show the effectiveness of each treatment in a day-care setting relative to the wait-list control group; 2) demonstrate the relative short- and long-term effectiveness of the two active treatments; 3) carry out a preliminary examination of the predictors and moderators of treatment response; 4) carry out a preliminary examination of the mediators of therapeutic change; and 5) compare the impact of both methods of treatment on the outcome of the measures used in this study. In this randomized controlled trial, a total of 199 patients with anxiety disorders and comorbid depressive and/or personality disorders will be assigned to one of three conditions: 1) psychodynamic group therapy; 2) cognitive-behavioral group therapy; or 3) wait-list control group. The therapy will last 12 weeks. Both treatments will be manualized (the manuals will address comorbidity). Primary outcome measures will include self-reported symptoms of anxiety, observer-rated symptoms of anxiety, global improvement, and recovery rate. Secondary outcome measures will include the number of pathological personality traits, depression, self-esteem, defense mechanisms, beliefs about self and others, interpersonal problems, object relations, parental bonding, meta-cognition, and quality of life. Measures will be taken at baseline, post-treatment, and at six months following

  8. A failure to confirm the effectiveness of a brief group psychoeducational program for mothers of children with high-functioning pervasive developmental disorders: a randomized controlled pilot trial

    PubMed Central

    Suzuki, Masako; Yamada, Atsurou; Watanabe, Norio; Akechi, Tatsuo; Katsuki, Fujika; Nishiyama, Takeshi; Imaeda, Masayuki; Miyachi, Taishi; Otaki, Kazuo; Mitsuda, Yumiko; Ota, Akino; Furukawa, Toshi A

    2014-01-01

    Objective The purpose of this study was to examine the effectiveness of group psychoeducation to relieve the psychological distress of mothers of children with high-functioning pervasive developmental disorders (HFPDD) and to improve the behaviors of the children. Methods Seventy-two mothers of preschool outpatients with HFPDD were randomly assigned to a four-session brief group psychoeducational program (GP). The sessions were held every second week in addition to the usual treatment (GP + treatment as usual [TAU] group), or to a TAU-alone group. The primary outcome was self-reported symptoms of maternal mental health as assessed using the 28-item General Health Questionnaire (GHQ-28) at 21 weeks post-randomization (week 21). The GHQ-28 at the end of the intervention (week 7), Aberrant Behavior Checklist (ABC) for the behavior of the children, the Zarit Burden Interview (ZBI), and the Medical Outcomes Study 36-item Short Form Health Survey (SF-36) were carried out at weeks 7 and 21. We tested the group effects with the interaction between the intervention and the evaluation points. Results The GHQ-28 score at week 21 was significantly higher in the GP + TAU group as compared to that in the TAU-alone group, indicating a greater improvement in the TAU-alone group. There was no evidence that GP + TAU led to a greater improvement of maternal mental health than TAU-alone at week 7. Similarly, no evidence was obtained to indicate that GP + TAU led to a reduction in the ABC or ZBI scores by week 7 or 21. The adjusted scores for the RF (role emotional) and MH (mental health) subscales of the SF-36 at week 21 were also significantly lower in the GP + TAU group, indicating a similar tendency to that of the change of the GHQ-28 score at week 21. Conclusion The psychoeducational program did not alleviate maternal distress, aberrant behaviors of the children, or caregiver burden. PMID:25061301

  9. Botulinum toxin type-A in the prophylactic treatment of medication-overuse headache: a multicenter, double-blind, randomized, placebo-controlled, parallel group study.

    PubMed

    Sandrini, Giorgio; Perrotta, Armando; Tassorelli, Cristina; Torelli, Paola; Brighina, Filippo; Sances, Grazia; Nappi, Giuseppe

    2011-08-01

    Medication-overuse headache (MOH) represents a severely disabling condition, with a low response to prophylactic treatments. Recently, consistent evidences have emerged in favor of botulinum toxin type-A (onabotulinum toxin A) as prophylactic treatment in chronic migraine. In a 12-week double-blind, parallel group, placebo-controlled study, we tested the efficacy and safety of onabotulinum toxin A as prophylactic treatment for MOH. A total of 68 patients were randomized (1:1) to onabotulinum toxin A (n = 33) or placebo (n = 35) treatment and received 16 intramuscular injections. The primary efficacy end point was mean change from baseline in the frequency of headache days for the 28-day period ending with week 12. No significant differences between onabotulinum toxin A and placebo treatment were detected in the primary (headache days) end point (12.0 vs. 15.9; p = 0.81). A significant reduction was recorded in the secondary end point, mean acute pain drug consumption at 12 weeks in onabotulinum toxin A-treated patients when compared with those with placebo (12.1 vs. 18.0; p = 0.03). When we considered the subgroup of patients with pericranial muscle tenderness, we recorded a significant improvement in those treated with onabotulinum toxin A compared to placebo treated in both primary (headache days) and secondary end points (acute pain drug consumption, days with drug consumption), as well as in pain intensity and disability measures (HIT-6 and MIDAS) at 12 weeks. Onabotulinum toxin A was safe and well tolerated, with few treatment-related adverse events. Few subjects discontinued due to adverse events. Our data identified the presence of pericranial muscle tenderness as predictor of response to onabotulinum toxin A in patients with complicated form of migraine such as MOH, the presence of pericranial muscle tenderness and support it as prophylactic treatment in these patients.

  10. Internet-Based Self-Help with Therapist Feedback and in Vivo Group Exposure for Social Phobia: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Andersson, Gerhard; Carlbring, Per; Holmstrom, Annelie; Sparthan, Elisabeth; Furmark, Tomas; Nilsson-Ihrfelt, Elisabeth; Buhrman, Monica; Ekselius, Lisa

    2006-01-01

    Sixty-four individuals with social phobia (social anxiety disorder) were assigned to a multimodal cognitive-behavioral treatment package or to a waiting list control group. Treatment consisted of a 9-week, Internet-delivered, self-help program that was combined with 2 group exposure sessions in real life and minimal therapist contact via e-mail.…

  11. Internet-Based Self-Help with Therapist Feedback and in Vivo Group Exposure for Social Phobia: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Andersson, Gerhard; Carlbring, Per; Holmstrom, Annelie; Sparthan, Elisabeth; Furmark, Tomas; Nilsson-Ihrfelt, Elisabeth; Buhrman, Monica; Ekselius, Lisa

    2006-01-01

    Sixty-four individuals with social phobia (social anxiety disorder) were assigned to a multimodal cognitive-behavioral treatment package or to a waiting list control group. Treatment consisted of a 9-week, Internet-delivered, self-help program that was combined with 2 group exposure sessions in real life and minimal therapist contact via e-mail.…

  12. Cognitive Behavioral Principles Within Group Mentoring: A Randomized Pilot Study

    PubMed Central

    JENT, JASON F.; NIEC, LARISSA N.

    2010-01-01

    This study evaluated the effectiveness of a group mentoring program that included components of empirically supported mentoring and cognitive behavioral techniques for children served at a community mental health center. Eighty-six 8- to 12-year-old children were randomly assigned to either group mentoring or a wait-list control group. Group mentoring significantly increased children’s reported social problem-solving skills and decreased parent-reported child externalizing and internalizing behavior problems after controlling for other concurrent mental health services. Attrition from the group mentoring program was notably low (7%) for children. The integration of a cognitive behavioral group mentoring program into children’s existing community mental health services may result in additional reductions in externalizing and internalizing behavior problems. PMID:20582243

  13. Cognitive Behavioral Principles Within Group Mentoring: A Randomized Pilot Study.

    PubMed

    Jent, Jason F; Niec, Larissa N

    2009-07-01

    This study evaluated the effectiveness of a group mentoring program that included components of empirically supported mentoring and cognitive behavioral techniques for children served at a community mental health center. Eighty-six 8- to 12-year-old children were randomly assigned to either group mentoring or a wait-list control group. Group mentoring significantly increased children's reported social problem-solving skills and decreased parent-reported child externalizing and internalizing behavior problems after controlling for other concurrent mental health services. Attrition from the group mentoring program was notably low (7%) for children. The integration of a cognitive behavioral group mentoring program into children's existing community mental health services may result in additional reductions in externalizing and internalizing behavior problems.

  14. Group-Based Compassion-Focused Therapy as an Adjunct to Outpatient Treatment for Eating Disorders: A Pilot Randomized Controlled Trial.

    PubMed

    Kelly, Allison Catherine; Wisniewski, Lucene; Martin-Wagar, Caitlin; Hoffman, Ellen

    2016-05-30

    The current study sought to assess the acceptability and feasibility of a compassion-focused therapy (CFT) group as an adjunct to evidence-based outpatient treatment for eating disorders, and to examine its preliminary efficacy relative to treatment as usual (TAU). Twenty-two outpatients with various types of eating disorders were randomly assigned to 12 weeks of TAU (n = 11) or TAU plus weekly CFT groups adapted for an eating disorder population (CFT + TAU; n = 11). Participants in both conditions completed measures of self-compassion, fears of compassion, shame and eating disorder pathology at baseline, week 4, week 8 and week 12. Additionally, participants receiving the CFT group completed measures assessing acceptability and feasibility of the group. Results indicated that the CFT group demonstrated strong acceptability; attendance was high and the group retained over 80% of participants. Participants rated the group positively and indicated they would be very likely to recommend it to peers with similar symptoms. Intention-to-treat analyses revealed that compared to the TAU condition, the CFT + TAU condition yielded greater improvements in self-compassion, fears of self-compassion, fears of receiving compassion, shame and eating disorder pathology over the 12 weeks. Results suggest that group-based CFT, offered in conjunction with evidence-based outpatient TAU for eating disorders, may be an acceptable, feasible and efficacious intervention. Furthermore, eating disorder patients appear to see benefit in, and observe gains from, working on the CFT goals of overcoming fears of compassion, developing more self-compassion and accessing more compassion from others. Copyright © 2016 John Wiley & Sons, Ltd.

  15. Oral Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 to reduce Group B Streptococcus colonization in pregnant women: A randomized controlled trial.

    PubMed

    Ho, Ming; Chang, Yin-Yi; Chang, Wei-Chun; Lin, Hung-Chih; Wang, Mei-Hung; Lin, Wu-Chou; Chiu, Tsan-Hung

    2016-08-01

    This study is to examine the effect of Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 taken orally before bedtime on Group B Streptococcus (GBS)-positive pregnant women with respect to becoming GBS negative. In total, 110 pregnant women at 35-37 weeks of gestation who were diagnosed by GBS culture as being GBS positive for both vaginal and rectal GBS colonization were randomly assigned to be orally treated with two placebo capsules or two probiotic capsules (containing L. rhamnosus GR-1 and L. reuteri RC-14) before bedtime until delivery. All women were tested for vaginal and rectal GBS colonization again by GBS culture on admission for delivery. Of the 110 participants, 99 completed the study (49 in the probiotic group and 50 in the placebo group). The GBS colonization results changed from positive to negative in 21 women in the probiotic group (42.9%) and in nine women in the placebo group (18.0%) during this period (Chi-square p=0.007). Oral probiotic containing L. rhamnosus GR-1 and L. reuteri RC-14 could reduce the vaginal and rectal GBS colonization rate in pregnant women. Copyright © 2016. Published by Elsevier B.V.

  16. Do Reported Effects of Acute Aerobic Exercise on Subsequent Higher Cognitive Performances Remain if Tested against an Instructed Self-Myofascial Release Training Control Group? A Randomized Controlled Trial

    PubMed Central

    Oberste, Max; Bloch, Wilhelm; Hübner, Sven T.; Zimmer, Philipp

    2016-01-01

    A substantial body of evidence suggests positive effects of acute aerobic exercise (AAE) on subsequent higher cognitive functions in healthy young adults. These effects are widely understood as a result of the ongoing physiological adaptation processes induced by the preceding AAE. However, designs of published studies do not control for placebo, Hawthorne and subject expectancy effects. Therefore, these studies do not, at a high degree of validity, allow attributing effects of AEE on subsequent cognitive performance to exercise induced physical arousal. In the present study, we applied a randomized controlled blinded experiment to provide robust evidence for a physiological basis of exercise induced cognitive facilitation. Beyond that, the dose response relationship between AAE`s intensity and subsequent cognitive performances as well as a potentially mediating role of peripheral lactate in AAE induced cognitive facilitation was investigated. The 121 healthy young subjects who participated in this study were assigned randomly into 3 exercise groups and a self-myofascial release training control group. Exercise groups comprised a low, moderate and high intensity condition in which participants cycled on an ergometer at a heart rate corresponding to 45–50%, 65–70% and 85–90% of their individual maximum heart rate, respectively, for 35 minutes. Participants assigned to the control group completed a 35 minute instructed self-massage intervention using a foam roll. Before and after treatment, participants completed computer based versions of the Stroop task and the Trail Making Test as well as a free recall task. None of the applied exercise regimes exerted a significant effect on participants`performance at any of the applied cognitive testing procedure if compared to self-myofascial release training control group. Post hoc power analyses revealed no effect in the population of f = .2 or larger at a risk of type II error (β) ≤.183 for all measured variables

  17. Analytic versus systemic group therapy for women with a history of child sexual abuse: 1-year follow-up of a randomized controlled trial.

    PubMed

    Elkjaer, Henriette; Kristensen, Ellids; Mortensen, Erik L; Poulsen, Stig; Lau, Marianne

    2014-06-01

    This randomized prospective study examines durability of improvement in general symptomatology, psychosocial functioning and interpersonal problems, and compares the long-term efficacy of analytic and systemic group psychotherapy in women 1 year after completion of treatment for childhood sexual abuse. Women (n = 106) randomly assigned to analytic or systemic psychotherapy completed the Symptom Checklist-90-R, Global Assessment of Functioning, Global Life Quality, Registration Chart Questionnaire, and Flashback Registration at pre-treatment, post-treatment, and at a 1-year follow-up. Post-treatment gains were significant for both treatment modalities on all measures, but significantly larger after systemic therapy. Significant treatment response was maintained 1-year post-treatment, but different trajectories were observed: 1 year after treatment completion, improvements for analytic therapy were maintained, whereas they decreased after systemic therapy, resulting in no statistically significant difference in gains between the groups at the 1-year follow-up. Despite maintaining significant gains, more than half of the patients remained above cut-off for caseness concerning general symptomatology at post-treatment and at 1-year follow-up. The findings stress the importance of long-term follow-up data in effect studies. Different trajectories were associated with the two treatments, but improvement in the two treatment groups did not differ significantly at the 1-year follow-up. Implications of the difference in trajectories for treatment planning are discussed. Both analytic and systemic group therapy proved efficient in improving general symptomatology, psychosocial functioning, and interpersonal problems in women with a history of CSA and gains were maintained at a 1-year follow-up. Despite maintaining statistically significant gains at the 1-year follow-up, 54% of the patients remained above the cut-off for caseness with respect to general symptomatology, which

  18. Effectiveness of Peer Group and Conventional Method (Dentist) of Oral Health Education Programme Among 12-15 year Old School Children - A Randomized Controlled Trial

    PubMed Central

    Jha, Abhishek; Raju, Rekha; Bashyam, Mamtha

    2016-01-01

    Introduction Oral Health Education (OHE) in schools is routinely delivered by the dentist. Another approach which can be cost-effective, easily accessible and equally effective is the trained group of peer students. Aim The objective of the present study was to assess and compare the effectiveness of peer–led and conventional method (dentist-led), OHE on oral health status, oral health knowledge, attitude and practices among 12-15 year old government school children in Bengaluru South Zone-I at baseline, 3 months and 6 months. Materials and Methods The study population comprised of 450 subjects, 150 each in peer, dentist and control group. At baseline, a pre-tested 14 item questionnaire was used to assess the existing oral health knowledge, attitude and oral hygiene practices of the subjects. Clinical examination included recording of plaque index and gingival index, by a pre-calibrated examiner. OHE was provided by the peer group and dentist (using power-point presentation, chalk and talk presentation, using charts, posters, booklets and tooth brushing demonstration models). Data was analyzed using Kruskal Wallis and Chi-square test. Results Both the peer-led and dentist-led OHE intervention were effective in improving oral health knowledge, attitude, oral hygiene practices and oral health status at three and six months when compared to control group. The adolescents in the peer-led group, however, exhibited statistically better oral health behavior than their counterparts in the dentist-led group and control group. Conclusion The two educator-led strategies (peer group and dentist) had a modest effect on the outcome variables included in the study, the results provide some evidence to show that the peer-led strategy may provide a feasible and almost equally effective alternative to the traditional dentist led strategy of oral health education. PMID:27437345

  19. A randomized controlled trial of an enhanced interdisciplinary community based group program for people with Parkinson's disease: study rationale and protocol.

    PubMed

    Peters, Catherine; Currin, Michelle; Tyson, Sara; Rogers, Anthea; Healy, Susan; McPhail, Steven; Brauer, Sandra G; Heathcote, Katharine; Comans, Tracy

    2012-01-09

    Parkinson's disease (PD) is a progressive, chronic neurodegenerative disorder for which there is no known cure. Physical exercise programs may be used to assist with the physical management of PD. Several studies have demonstrated that community based physical therapy programs are effective in reducing physical aspects of disability among people with PD. While multidisciplinary therapy interventions may have the potential to reduce disability and improve the quality of life of people with PD, there is very limited clinical trial evidence to support or refute the use of a community based multidisciplinary or interdisciplinary programs for people with PD. A two group randomized trial is being undertaken within a community rehabilitation service in Brisbane, Australia. Community dwelling adults with a diagnosis of Idiopathic Parkinson's disease are being recruited. Eligible participants are randomly allocated to a standard exercise rehabilitation group program or an intervention group which incorporates physical, cognitive and speech activities in a multi-tasking framework. Outcomes will be measured at 6-week intervals for a period of six months. Primary outcome measures are the Montreal Cognitive Assessment (MoCA) and the Timed Up and Go (TUG) cognitive test. Secondary outcomes include changes in health related quality of life, communication, social participation, mobility, strength and balance, and carer burden measures. This study will determine the immediate and long-term effectiveness of a unique multifocal, interdisciplinary, dual-tasking approach to the management of PD as compared to an exercise only program. We anticipate that the results of this study will have implications for the development of cost effective evidence based best practice for the treatment of people with PD living in the community.

  20. Polyphenon E, non-futile at neuroprotection in multiple sclerosis but unpredictably hepatotoxic: Phase I single group and phase II randomized placebo-controlled studies.

    PubMed

    Lovera, Jesus; Ramos, Alexander; Devier, Deidre; Garrison, Virginia; Kovner, Blake; Reza, Tara; Koop, Dennis; Rooney, William; Foundas, Anne; Bourdette, Dennis

    2015-11-15

    Phase I (PhI): assess the safety of Polyphenon E in people with multiple sclerosis (MS) and determine the futility of Polyphenon E as a neuroprotective agent. Correlate plasma levels of EGCG with neuroprotective effects. Phase II (PhII): Further assess safety and confirm the neuroprotective effects of Polyphenon E. PhI: single group futility study. PhII: parallel group randomized double-blind placebo-controlled study. Recruitment area (both studies): LSU MS Center, New Orleans, LA and general public from surrounding areas. Inclusion criteria (both studies): 1) MS per 2005 McDonald criteria; 2) relapsing remitting or secondary progressive MS; 3) stable for six months prior to enrollment on either no therapy or glatiramer acetate (GA) for the PhI study and on either on GA or Interferon β for the PhII study. Exclusion criteria (both studies): 1) complete bone marrow ablation or alentuzumab use at any time; 2) mitoxantrone, cyclophosphamide, natalizumab or fingolimod use in the prior nine months; 3) liver problems or significant medical problems. PhI: Polyphenon E, a green tea extract containing 50% of the antioxidant Epigallocatechin-gallate (EGCG), two capsules twice daily (200mg of EGCG per capsule; total daily dose 800mg) for six months. PhII: Polyphenon E or matching placebo capsules, same dose for one year. Only the research pharmacist knew treatment assignment and she randomized participants (one-to-one, stratified by GA or Interferon β, blocks of 4 or 6). Outcome evaluators did not discuss side effects with participants. PhI: 1) adverse events (AE); 2) futility: decrease in N-acetyl aspartate (NAA) from baseline to six months of 10% or more; 3) association between EGCG plasma levels and change in NAA. PhII: 1) AEs; 2) difference in the rate of change of NAA-levels over twelve months.We measured NAA using a point resolved magnetic resonance spectroscopic imaging sequence (TE30/TR2000) on a 10cm×10cm×1cm volume of interest (VOI) located just superior to the

  1. Polyphenon E, Non-futile at Neuroprotection in Multiple Sclerosis but Unpredictably Hepatotoxic: Phase I Single Group and Phase II Randomized Placebo-Controlled Studies

    PubMed Central

    Lovera, Jesus; Ramos, Alexander; Devier, Deidre; Garrison, Virginia; Kovner, Blake; Reza, Tara; Koop, Dennis; Rooney, William; Foundas, Anne; Bourdette, Dennis

    2015-01-01

    Objectives Phase I (PhI): assess the safety of Polyphenon E in people with multiple sclerosis (MS) and determine the futility of Polyphenon E as a neuroprotective agent. Correlate plasma levels of EGCG with neuroprotective effects. Phase II (PhII): Further assess safety and confirm the neuroprotective effects of Polyphenon E. Design PhI: single group futility study. PhII: parallel group randomized double-blind placebo-controlled study. Participants Recruitment area (both studies) LSU MS Center, New Orleans, LA and general public from surrounding areas. Inclusion criteria (both studies) 1) MS per 2005 McDonald criteria; 2) relapsing remitting or secondary progressive MS; 3) stable for six months prior to enrollment on either no therapy or glatiramer acetate (GA) for the PhI study and on either on GA or Interferon β for the PhII study. Exclusion criteria (both studies) 1) complete bone marrow ablation or alentuzumab use at any time; 2) mitoxantrone, cyclophosphamide, natalizumab or fingolimod use in the prior nine months; 3) liver problems or significant medical problems. Interventions PhI: Polyphenon E, a green tea extract containing 50% of the antioxidant Epigallocatechin-gallate (EGCG), two capsules twice daily (200 mg of EGCG per capsule; total daily dose 800mg) for six months. PhII: Polyphenon E or matching placebo capsules, same dose for one year. Only the research pharmacist knew treatment assignment and she randomized participants (one-to-one, stratified by GA or Interferon β, blocks of 4 or 6). Outcome evaluators did not discuss side effects with participants. Outcome measures PhI: 1) adverse events (AE); 2) futility: decrease in N-acetyl aspartate (NAA) from baseline to six months of 10% or more; 3) association between EGCG plasma levels and change in NAA. PhII: 1) AEs; 2) difference in the rate of change of NAA-levels over twelve months. We measured NAA using a point resolved magnetic resonance spectroscopic imaging sequence (TE30/TR2000) on a 10cm × 10

  2. A randomized controlled trial of a cognitive-behavioural group intervention versus waiting-list control for women with uterovaginal agenesis (Mayer-Rokitansky-Küster-Hauser syndrome: MRKH).

    PubMed

    Heller-Boersma, J G; Schmidt, U H; Edmonds, D K

    2007-08-01

    Uterovaginal agenesis (Mayer-Rokitansky-Küster-Hauser syndrome: MRKH) is a congenital abnormality of the female genital tract, characterized by the non-formation of the vagina and uterus. There is a widespread agreement that MRKH has a lasting negative psychological impact on women with this condition, but as yet little is known about how to conceptualize and manage this. We developed a cognitive-behavioural group treatment (CBT) of MRKH. The aim of the present study was to determine whether this intervention, compared to waiting-list control, improves psychosocial outcomes in women with MRKH. After stratifying for age and type of MRKH (simple or complex), 39 women with MRKH were randomized to group CBT (n = 19) or waiting list (n = 20). Outcomes were assessed at pre-treatment, post-treatment (7 weeks) and at 3 months follow-up. The main outcome measure was the Symptom Check-List (SCL-90-R). Other outcomes included impact of event, self-esteem and interpersonal functioning. Participants allocated to group CBT showed significantly reduced psychological symptoms on the SCL-90-R and non-significant improvements on all secondary outcomes at the end of treatment and follow-up, whereas those on the waiting list remained unchanged. A group CBT intervention improves psychological outcomes in MRKH. This treatment may also be applicable to other gynaecological conditions.

  3. Placebo-controlled, double-blind, prospective, randomized study on the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: a report from the PROMID Study Group.

    PubMed

    Rinke, Anja; Müller, Hans-Helge; Schade-Brittinger, Carmen; Klose, Klaus-Jochen; Barth, Peter; Wied, Matthias; Mayer, Christina; Aminossadati, Behnaz; Pape, Ulrich-Frank; Bläker, Michael; Harder, Jan; Arnold, Christian; Gress, Thomas; Arnold, Rudolf

    2009-10-01

    Somatostatin analogs are indicated for symptom control in patients with gastroenteropancreatic neuroendocrine tumors (NETs). The ability of somatostatin analogs to control the growth of well-differentiated metastatic NETs is a matter of debate. We performed a placebo-controlled, double-blind, phase IIIB study in patients with well-differentiated metastatic midgut NETs. The hypothesis was that octreotide LAR prolongs time to tumor progression and survival. Treatment-naive patients were randomly assigned to either placebo or octreotide LAR 30 mg intramuscularly in monthly intervals until tumor progression or death. The primary efficacy end point was time to tumor progression. Secondary end points were survival time and tumor response. This report is based on 67 tumor progressions and 16 observed deaths in 85 patients at the time of the planned interim analysis. Median time to tumor progression in the octreotide LAR and placebo groups was 14.3 and 6 months, respectively (hazard ratio [HR] = 0.34; 95% CI, 0.20 to 0.59; P = .000072). After 6 months of treatment, stable disease was observed in 66.7% of patients in the octreotide LAR group and 37.2% of patients in the placebo group. Functionally active and inactive tumors responded similarly. The most favorable effect was observed in patients with low hepatic tumor load and resected primary tumor. Seven and nine deaths were observed in the octreotide LAR and placebo groups, respectively. The HR for overall survival was 0.81 (95% CI, 0.30 to 2.18). Octreotide LAR significantly lengthens time to tumor progression compared with placebo in patients with functionally active and inactive metastatic midgut NETs. Because of the low number of observed deaths, survival analysis was not confirmatory.

  4. An allopurinol-controlled, multicenter, randomized, double-blind, parallel between-group, comparative study of febuxostat in Chinese patients with gout and hyperuricemia.

    PubMed

    Huang, Xinfang; Du, Hui; Gu, Jieruo; Zhao, Dongbao; Jiang, Lindi; Li, Xinfu; Zuo, Xiaoxia; Liu, Yi; Li, Zhanguo; Li, Xiangpei; Zhu, Ping; Li, Juan; Zhang, Zhiyi; Huang, Anbin; Zhang, Yuanchao; Bao, Chunde

    2014-07-01

    Febuxostat, a novel non-purine selective inhibitor of xanthine oxidase, has been identified as a potential alternative to allopurinol in patients with hyperuricemia. The purpose of this study was to compare the urate-lowering (UL) efficacy and safety of daily febuxostat and allopurinol in Chinese gout patients with hyperuricemia. Gout patients (n = 512) with serum uric acid (sUA) concentrations of at least 8.0 mg/dL were randomized to receive daily febuxostat 40 mg or 80 mg or allopurinol 300 mg for 28 weeks. Prophylaxis against gout flares with meloxicam or colchicine was provided during weeks 1 through 8. The primary endpoint was the percentage of subjects achieving a sUA concentration of <6.0 mg/dL at the last three monthly measurements. The primary endpoint was reached in 44.77% of patients receiving 80 mg of febuxostat, 27.33% of those receiving 40 mg of febuxostat, and 23.84% of those receiving allopurinol. The UL efficacy in the febuxostat 80 mg group was higher than in the allopurinol (P < 0.0001) and febuxostat 40 mg (P = 0.0008) groups. The UL efficacy of the febuxostat 40 mg group was statistically non-inferior to that of the allopurinol group. No significant change in the number of tophi was observed during the final visit relative to baseline in each treatment group. The rate of gout flares requiring treatment from weeks 9 through 28 and the incidence of adverse events was similar among treatment groups. The UL efficacy of daily febuxostat 80 mg was greater than that of febuxostat 40 mg and allopurinol 300 mg, which exhibited comparable UL efficacy. Safety of febuxostat and allopurinol was comparable at the doses tested. © 2014 Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd.

  5. Multilevel analysis of group-randomized trials with binary outcomes.

    PubMed

    Kim, Hae-Young; Preisser, John S; Rozier, R Gary; Valiyaparambil, Jayasanker V

    2006-08-01

    Many dental studies have assessed the effectiveness of community- or group-based interventions such as community water fluoridation. These cluster trials, of which group-randomized trials (GRTs) are one type, have design and analysis considerations not found in studies with randomization of treatments to individuals (randomized controlled trials, RCTs). The purpose of this paper is to review analytic methods used for the analysis of binary outcomes from cluster trials and to illustrate these concepts and analytical methods using a school-based GRT. We examine characteristics of GRTs including intra-class correlation (ICC), their most distinctive feature, and review analytical methods for GRTs including group-level analysis, adjusted chi-square test and multivariable analysis (mixed effect models and generalized estimating equations) for correlated binary data. We consider two- and three-level modeling of data from a cross-sectional cluster design. We apply the concepts reviewed using a GRT designed to determine the effect of incentives on response rates in a school-based dental study. We compare the results of analyses using methods for correlated binary data with those from traditional methods that do not account for ICC. Application of traditional analytic methods to the dental GRT used as an example for this paper led to a substantial overstatement of the effectiveness of the intervention. Ignoring the ICC among members of the same group in the analysis of public health intervention studies can lead to erroneous conclusions where groups are the unit of assignment. Special consideration is needed in the analysis of data from these cluster trials. Randomization of treatments to groups also should receive more consideration in the design of cluster trials in dental public health.

  6. ADULTS: A RANDOMIZED CONTROLLED CLINICAL TRIAL

    PubMed Central

    Shah, Krupa N.; Majeed, Zahraa; Yoruk, Yilmaz B.; Yang, Hongmei; Hilton, Tiffany N.; McMahon, James M.; Hall, William J.; Walck, Donna; Luque, Amneris E.; Ryan, Richard M.

    2016-01-01

    Objective HIV-infected older adults (HOA) are at risk of functional decline. Interventions promoting physical activity that can attenuate functional decline and are easily translated into the HOA community are of high priority. We conducted a randomized, controlled clinical trial to evaluate whether a physical activity counseling intervention based on self-determination theory (SDT) improves physical function, autonomous motivation, depression and the quality of life (QOL) in HOA. Methods A total of 67 community-dwelling HOA with mild-to-moderate functional limitations were randomized to one of two groups: a physical activity counseling group or the usual care control group. We used SDT to guide the development of the experimental intervention. Outcome measures that were collected at baseline and final study visits included a battery of physical function tests, levels of physical activity, autonomous motivation, depression, and QOL. Results The study participants were similar in their demographic and clinical characteristics in both the treatment and control groups. Overall physical performance, gait speed, measures of endurance and strength, and levels of physical activity improved in the treatment group compared to the control group (p<0.05). Measures of autonomous regulation such as identified regulation, and measures of depression and QOL improved significantly in the treatment group compared to the control group (p<0.05). Across the groups, improvement in intrinsic regulation and QOL correlated with an improvement in physical function (p<0.05). Conclusion Our findings suggest that a physical activity counseling program grounded in SDT can improve physical function, autonomous motivation, depression, and QOL in HOA with functional limitations. PMID:26867045

  7. Metal-carbon fiber composite femoral stems in hip replacements: a randomized controlled parallel-group study with mean ten-year follow-up.

    PubMed

    Bennett, D B; Hill, J C; Dennison, J; O'Brien, S; Mantel, J L; Isaac, G H; Beverland, D E

    2014-12-17

    Attempts to improve proximal load transfer and minimize stress shielding have included reducing the stiffness of femoral stems and using alternative stem materials, including carbon fiber composites. An uncemented implant (SR71) composed of a carbon-fiber-composite distal section and a porous-coated titanium-alloy proximal section, designed to improve proximal load transfer and provide good fixation, was clinically evaluated in a prospective randomized study. Sixty patients were enrolled and randomized to receive either the SR71 stem or an all-metal stem (Stability). All patients received a cemented all-polyethylene acetabular component and a 28-mm metal femoral head. All uncemented stems were implanted by the same surgeon. Patients were followed for up to ten years with repeated assessments of bone mineral density, radiographs, Harris hip scores (HHS), and visual analog scale (VAS) pain scores. Ten years postoperatively, nineteen patients who had been treated with the SR71 stem and not lost to follow-up showed a significantly greater increase in proximal bone mineral density (Gruen zones 1 [p = 0.003] and 7 [p = 0.0007]) from baseline than did the twenty-two who had been treated with the Stability stem and not lost to follow-up. In contrast, the Stability group showed a significantly greater increase in distal bone mineral density (Gruen zones 2 [p = 0.0004], 3 [p = 0.0001], and 5 [p = 0.0035]) compared with the SR71 group. Radiographs demonstrated one case of progressive migration of an acetabular component used with an SR71 stem and one case of bone resorption in Gruen zones 7 and 14 in a patient treated with a Stability stem. There was no significant difference between the SR71 and Stability stems in terms of changes in the total HHS, HHS for pain, HHS for range of motion, or VAS pain scores ten years postoperatively relative to preoperative levels. There was one reported revision of an SR71 femoral stem at the ten-year review. The investigational SR71 implant

  8. Quality Control in Small Groups

    NASA Astrophysics Data System (ADS)

    Lemmens, L. F.

    2008-11-01

    The smallness of some groups in a set up to control the quality of a service using questionnaires limits the size of the samples, this limitation has several consequences. Indeed the common approach used for relatively large groups, based on the central limit theorem and the law of large numbers, cannot be used anymore to construct estimators for the parameters of the model. Using an inverse probability will lift these restrictions. A questionnaire is a collection of items. In an item the respondent indicates on a Likert scale his or her agreement with a statement. Dimensions are a set of items dealing with one aspect of the service. In a questionnaire several dimensions are addressed but usually the items are presented in a random sequence. The model for an item is hierarchical with following components: a multivariate hypergeometric model takes the sampling in a finite population into account, the multinomial serves as a prior for the sampling and the Dirichlet-distribution serves as a prior for the multinomials. The composition of dimensions allows to use the posterior for one of the items as a prior for another item of that dimension and so on. After analysis of several questionnaires using this model, the reliability of the responses from some respondents turned out to be a key-problem, in the sense the responses can be classified into at least two classes and a decision rule had to be developed to neglect some of them. The influence of rejecting some answers, on the confidence for the most plausible statement can be estimated. This leads often to the result that there is only minimal evidence for the most probable statement.

  9. Enhancing adoptive parenting: a randomized controlled trial.

    PubMed

    Rushton, Alan; Monck, Elizabeth; Leese, Morven; McCrone, Paul; Sharac, Jessica

    2010-10-01

    The aim was to conduct a pragmatic randomized controlled trial (RCT) to evaluate two parenting programmes designed for adopters of children late placed from care. Adoptive parents, with children between 3 and 8 years who were screened to have serious behavioural problems early in the placement, participated in home-based, manualized, parenting programmes delivered by trained and supervised family social workers. The adopters who agreed to join the study were randomly allocated to one of two parenting interventions or to a "services as usual" group. Baseline, immediate post-intervention and six-month follow-ups were assessed using questionnaires and adopter interviews. No cases were lost to follow-up at any point and satisfaction was high with both parenting interventions. At the six-month follow-up, a significant difference (p < 0.007) was found for "satisfaction with parenting" in favour of the intervention group (Effect Size d = 0.7). Negative parenting approaches were reduced in the intervention group. However, no significant differences in child problems were found between the intervention groups and control group, adjusting for baseline scores. Costs analysis showed that a relatively modest investment in post-adoption support would be well spent in improving adopters' satisfaction with parenting in the intervention group compared to the routine service group.

  10. A group-randomized controlled trial for health promotion in Girl Scouts: healthier troops in a SNAP (Scouting Nutrition & Activity Program).

    PubMed

    Rosenkranz, Richard R; Behrens, Timothy K; Dzewaltowski, David A

    2010-02-19

    Girl Scouting may offer a viable channel for health promotion and obesity prevention programs. This study evaluated the effectiveness of an intervention program delivered through Girl Scout Junior troops that was designed to foster healthful troop meeting environments and increase obesity prevention behaviors at home. Seven Girl Scout troops were randomized to intervention (n = 3, with 34 girls) or standard-care control (n = 4, with 42 girls) conditions. Girls ranged in age from 9 to 13 years (mean 10.5 years). Intervention troop leaders were trained to implement policies promoting physical activity (PA) and healthful eating opportunities at troop meetings, and to implement a curriculum promoting obesity-prevention behaviors at home. The primary outcome variable was child body mass index (BMI) z-score. Secondary outcomes included accelerometer-assessed PA levels in troop meetings, direct observations of snack offerings, time spent in physically active meeting content, and leader encouragement of PA and healthful eating. The intervention was delivered with good fidelity, and intervention troops provided greater opportunities for healthful eating and PA (x2 = 210.8, p < .001), relative to control troops. In troop meetings, intervention troop leaders promoted PA (x2 = 23.46, p < .001) and healthful eating (x2 = 18.14, p < .001) more frequently, and discouraged healthful eating and PA less frequently (x2 = 9.63, p = .002) compared to control troop leaders. Most effects of the intervention on individual-level variables of girls and parents were not significantly different from the control condition, including the primary outcome of child BMI z-score (F1, 5 = 0.42, p = .544), parent BMI (F1, 5 = 1.58, p = .264), and related behavioral variables. The notable exception was for objectively assessed troop PA, wherein girls in intervention troops accumulated significantly less sedentary (x2 = 6.3, p = .011), significantly more moderate (x2 = 8.2, p = .004), and more moderate

  11. A group-randomized controlled trial for health promotion in Girl Scouts: Healthier Troops in a SNAP (Scouting Nutrition & Activity Program)

    PubMed Central

    2010-01-01

    Background Girl Scouting may offer a viable channel for health promotion and obesity prevention programs. This study evaluated the effectiveness of an intervention program delivered through Girl Scout Junior troops that was designed to foster healthful troop meeting environments and increase obesity prevention behaviors at home. Methods Seven Girl Scout troops were randomized to intervention (n = 3, with 34 girls) or standard-care control (n = 4, with 42 girls) conditions. Girls ranged in age from 9 to 13 years (mean 10.5 years). Intervention troop leaders were trained to implement policies promoting physical activity (PA) and healthful eating opportunities at troop meetings, and to implement a curriculum promoting obesity-prevention behaviors at home. The primary outcome variable was child body mass index (BMI) z-score. Secondary outcomes included accelerometer-assessed PA levels in troop meetings, direct observations of snack offerings, time spent in physically active meeting content, and leader encouragement of PA and healthful eating. Results The intervention was delivered with good fidelity, and intervention troops provided greater opportunities for healthful eating and PA (x2 = 210.8, p < .001), relative to control troops. In troop meetings, intervention troop leaders promoted PA (x2 = 23.46, p < .001) and healthful eating (x2 = 18.14, p < .001) more frequently, and discouraged healthful eating and PA less frequently (x2 = 9.63, p = .002) compared to control troop leaders. Most effects of the intervention on individual-level variables of girls and parents were not significantly different from the control condition, including the primary outcome of child BMI z-score (F1, 5 = 0.42, p = .544), parent BMI (F1, 5 = 1.58, p = .264), and related behavioral variables. The notable exception was for objectively assessed troop PA, wherein girls in intervention troops accumulated significantly less sedentary (x2 = 6.3, p = .011), significantly more moderate (x2 = 8.2, p

  12. Efficacy and safety of oral betaine glucuronate in non-alcoholic steatohepatitis. A double-blind, randomized, parallel-group, placebo-controlled prospective clinical study.

    PubMed

    Miglio, F; Rovati, L C; Santoro, A; Setnikar, I

    2000-08-01

    In a prospective, randomized, double-blind therapeutic trial, 191 patients with non-alcoholic steatohepatitis were treated for 8 weeks daily b.i.d. orally either with betaine glucuronate combined with diethanolamine glucuronate and nicotinamide ascorbate (Ietepar) (96 patients) or with undistinguishable placebo capsules (95 patients). The verum treatment effectively reduced by 25% hepatic steatosis (p < 0.01) and by 6% hepatomegaly (p < 0.05), while placebo did not significantly reduce the disorders. Verum was also more effective than placebo on discomfort in abdominal upper right quadrant. The global efficacy of treatment was rated by the doctor "very good" or "good" in 48% of verum treated patients and only in 17% after placcbo (P of difference = 9 x 10(-6)). 52% of patients self-rated efficacy as "very good" or "good" after verum and only 34% after placebo (P of difference = 0.017). The verum treatment provoked a significant reduction of the increased liver transaminases (ALT, AST and gamma-GT) while placebo was ineffective. Adverse events were recorded in 10% of verum-treated patients and in 7% under placebo (no significant difference). In both groups the adverse events were mild and transient, did not require treatment discontinuation and were undistinguishable from common symptoms of liver disorders. In conclusion, the 8-week treatment with betaine glucuronate combined with diethanolamine glucuronate and nicotinamide ascorbate was found effective in non-alcoholic steatohepatitis, a disorder for which the hitherto pharmacological interventions were poorly and inconsistently effective.

  13. Protocol: the effect of 12 weeks of Tai Chi practice on anxiety in healthy but stressed people compared to exercise and wait-list comparison groups: a randomized controlled trial.

    PubMed

    Zheng, Shuai; Lal, Sara; Meier, Peter; Sibbritt, David; Zaslawski, Chris

    2014-06-01

    Stress is a major problem in today's fast-paced society and can lead to serious psychosomatic complications. The ancient Chinese mind-body exercise of Tai Chi may provide an alternative and self-sustaining option to pharmaceutical medication for stressed individuals to improve their coping mechanisms. The protocol of this study is designed to evaluate whether Tai Chi practice is equivalent to standard exercise and whether the Tai Chi group is superior to a wait-list control group in improving stress coping levels. This study is a 6-week, three-arm, parallel, randomized, clinical trial designed to evaluate Tai Chi practice against standard exercise and a Tai Chi group against a nonactive control group over a period of 6 weeks with a 6-week follow-up. A total of 72 healthy adult participants (aged 18-60 years) who are either Tai Chi naïve or have not practiced Tai Chi in the past 12 months will be randomized into a Tai Chi group (n = 24), an exercise group (n = 24) or a wait-list group (n = 24). The primary outcome measure will be the State Trait Anxiety Inventory with secondary outcome measures being the Perceived Stress Scale 14, heart rate variability, blood pressure, Short Form 36 and a visual analog scale. The protocol is reported using the appropriate Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) items. Copyright © 2014. Published by Elsevier B.V.

  14. Stress management and mind-body medicine: a randomized controlled longitudinal evaluation of students' health and effects of a behavioral group intervention at a middle-size German university (SM-MESH).

    PubMed

    Esch, Tobias; Sonntag, Ulrike; Esch, Sonja Maren; Thees, Stefanie

    2013-01-01

    Student life can be stressful. Hence, we started a regular mind-body medical stress management program in 2006. By today, more than 500 students took part and evaluations showed significant results, especially with regard to a reduction of stress warning signals. For further analysis, we now decided to run a randomized controlled longitudinal trial. Participating students at Coburg University were randomized into an intervention (n = 24) or a waitlist control group (n = 19). The intervention group completed 3 sets (pre/post/follow-up) and the control group 2 sets (pre/post) of self-administered questionnaires. The questionnaires included: SF-12 Health Survey, Perceived Stress Scale (PSS), Sense of Coherence (SOC-L9), Visual Analogue Scale (VAS) concerning stress, and the Stress Warning Signs (SWS) scale. Randomly selected participants of the intervention group were also queried in qualitative interviews. The intervention consisted of an 8 week stress management group program (mind-body medical stress reduction - MBMSR). Follow-up measures were taken after 6 months. Virtually, no drop-out occurred. Our study showed significant effects in the intervention group concerning SF-12 Mental Component Scale (p = 0.05), SF-12 Physical Component Scale (p = 0.001), VAS (in general, p = 0.001) and SWS (emotional reactions, p <0.001), underlined by qualitative results, which showed a higher quality of life. The effectiveness of an MBMSR program in a group of supposedly healthy students could be demonstrated. Findings suggest that stress management might be given importance at universities that care for the performance, the quality of life, and stress-health status of their students, acknowledging and accounting for the challenging circumstances of university life, as well as the specific needs of the modern student population. Copyright © 2013 S. Karger AG, Basel.

  15. Evaluation of Yoga for Preventing Adolescent Substance Use Risk Factors in a Middle School Setting: A Preliminary Group-Randomized Controlled Trial.

    PubMed

    Butzer, Bethany; LoRusso, Amanda; Shin, Sunny H; Khalsa, Sat Bir S

    2017-03-01

    Adolescence is a key developmental period for preventing substance use initiation, however prevention programs solely providing educational information about the dangers of substance use rarely change adolescent substance use behaviors. Recent research suggests that mind-body practices such as yoga may have beneficial effects on several substance use risk factors, and that these practices may serve as promising interventions for preventing adolescent substance use. The primary aim of the present study was to test the efficacy of yoga for reducing substance use risk factors during early adolescence. Seventh-grade students in a public school were randomly assigned by classroom to receive either a 32-session yoga intervention (n = 117) in place of their regular physical education classes or to continue with physical-education-as-usual (n = 94). Participants (63.2 % female; 53.6 % White) completed pre- and post-intervention questionnaires assessing emotional self-regulation, perceived stress, mood impairment, impulsivity, substance use willingness, and actual substance use. Participants also completed questionnaires at 6-months and 1-year post-intervention. Results revealed that participants in the control condition were significantly more willing to try smoking cigarettes immediately post-intervention than participants in the yoga condition. Immediate pre- to post-intervention differences did not emerge for the remaining outcomes. However, long-term follow-up analyses revealed a pattern of delayed effects in which females in the yoga condition, and males in the control condition, demonstrated improvements in emotional self-control. The findings suggest that school-based yoga may have beneficial effects with regard to preventing males' and females' willingness to smoke cigarettes, as well as improving emotional self-control in females. However additional research is required, particularly with regard to the potential long-term effects of mind-body interventions

  16. Pregnenolone and dehydroepiandrosterone as an adjunctive treatment in schizophrenia and schizoaffective disorder: an 8-week, double-blind, randomized, controlled, 2-center, parallel-group trial.

    PubMed

    Ritsner, Michael S; Gibel, Anatoly; Shleifer, Tatyana; Boguslavsky, Igor; Zayed, Ahmad; Maayan, Rachel; Weizman, Abraham; Lerner, Vladimir

    2010-10-01

    Pregnenolone (PREG) and dehydroepiandrosterone (DHEA) are reported to have a modulatory effect on neuronal excitability, synaptic plasticity, and response to stress; they are associated with mood regulation and cognitive performance. We investigated the influence of PREG and DHEA on psychotic symptoms and cognitive functioning as an add-on to ongoing antipsychotic treatment of patients with chronic schizophrenia or schizoaffective disorder. This 8-week, double-blind, randomized, placebo-controlled, 2-center study compared 30 mg/d of PREG (PREG-30), 200 mg/d of PREG (PREG-200), 400 mg/d of DHEA, and placebo as an adjunctive treatment of 58 chronic schizophrenia or schizoaffective disorder patients (DSM-IV). The data were collected from February 2005 until June 2007. The outcome measures were symptomatic and neurocognitive changes, functioning, and tolerability as assessed primarily by the Clinical Global Impressions-Severity of Illness scale and the Positive and Negative Syndrome Scale. Analyses are presented for 44 patients who completed 8 weeks of treatment and for 14 noncompleters. Compared with subjects who received placebo, those administered PREG-30 had significant reductions in positive symptom scores and extrapyramidal side effects (EPS) and improvement in attention and working memory performance, whereas subjects treated with PREG-200 did not differ on outcome variable scores for the study period. The general psychopathology severity and general functioning of patients receiving placebo and PREG-30 improved more than that of those subjects treated with DHEA, while EPS improved more in subjects treated with DHEA than in patients receiving placebo. Negative symptoms and akathisia were not significantly benefited by any treatment. The administration of PREG and DHEA was well tolerated. Low-dose PREG augmentation demonstrated significant amelioration of positive symptoms and EPS and improvement in attention and working memory performance of schizophrenia and

  17. A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of osmotic-controlled release oral delivery system methylphenidate HCl in adults with attention-deficit/hyperactivity disorder in Japan.

    PubMed

    Takahashi, Nagahide; Koh, Tadaishi; Tominaga, Yushin; Saito, Yuki; Kashimoto, Yuji; Matsumura, Taka

    2014-08-01

    To evaluate the safety and efficacy of osmotic-controlled release oral delivery system (OROS) methylphenidate (MPH) HCl in adults with attention-deficit/hyperactivity disorder (ADHD). In this study, 284 adults with ADHD were randomized to OROS MPH or placebo. During the 4-week titration period, patients were titrated from a starting dose of 18 mg once daily to an individually-optimized dose of up to 72 mg once daily in weekly 18-mg increments. Patients continued on their individualized dose during the 4-week efficacy assessment period. The primary efficacy endpoint was change in DSM-IV Total ADHD Symptoms subscale score of Conners' Adult ADHD Rating Scale-Observer: Screening Version (CAARS-O:SV) from baseline to endpoint. The mean change in DSM-IV Total ADHD Symptoms subscale score of CAARS-O:SV was significantly larger with OROS MPH compared with placebo (P < 0.0001, ANCOVA). Similar results were observed for the majority of secondary endpoints, including CAARS-O:SV total score and other subscale scores. Although treatment-emergent adverse events were reported more frequently in the OROS MPH group (81.8%) versus the placebo group (53.9%), OROS-MPH showed a well-tolerated safety profile overall. OROS MPH in a dose range of 18-72 mg once daily was effective and well-tolerated in adult patients with ADHD.

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

    PubMed Central

    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

    Background 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. Methods 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. Results 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”. Conclusion Our BCI training system shows potential in improving cognition in both English- and Chinese-speaking elderly, and deserves further

  19. Desvenlafaxine compared with placebo for treatment of menopausal vasomotor symptoms: a 12-week, multicenter, parallel-group, randomized, double-blind, placebo-controlled efficacy trial.

    PubMed

    Pinkerton, JoAnn V; Constantine, Ginger; Hwang, Eunhee; Cheng, Ru-Fong J

    2013-01-01

    The aim of this study was to assess the 12-week efficacy of desvenlafaxine in treating moderate to severe vasomotor symptoms and the clinical relevance of improvements in postmenopausal women experiencing 50 or more moderate to severe hot flashes per week. Participants were randomized to placebo or desvenlafaxine 100 mg/day in the 12-week efficacy substudy of a year-long, multicenter, parallel-group, double-blind study. Coprimary outcomes were changes from baseline in the daily number and severity of hot flashes on weeks 4 and 12. The percentage of women achieving the minimal clinically important difference (MCID) in the number of hot flashes on week 12 was determined. The efficacy substudy modified intent-to-treat population included 365 women (desvenlafaxine, n = 184; placebo, n = 181). Desvenlafaxine 100 mg/day significantly reduced the number and severity of hot flashes versus placebo on week 4 (P < 0.001) and week 12 (P < 0.001). On week 12, desvenlafaxine reduced the number of moderate and severe hot flashes by 7.3 (62%) per day (placebo, -4.5 [38%] per day) and the severity score by 0.59 (25%) per day (placebo, -0.28 [12%] per day). MCID-a reduction of 5.35 moderate and severe hot flashes per day-was achieved by 64% of desvenlafaxine-treated women (placebo, 41%; P < 0.001). In all, 17.2% (67/390) of participants discontinued, 10.0% (20/200) of participants taking desvenlafaxine and 3.7% (7/190) of participants taking placebo discontinued because of adverse events (P = 0.016), and 2.5% (5/200) of participants taking desvenlafaxine and 8.4% (16/190) of participants taking placebo discontinued because of lack of efficacy (P = 0.012). Postmenopausal women with moderate to severe hot flashes who are treated with desvenlafaxine achieve rapid symptom reduction that is clinically relevant based on MCID.

  20. Small-Group Randomized Controlled Trial to Increase Condom Use and HIV Testing Among Hispanic/Latino Gay, Bisexual, and Other Men Who Have Sex With Men.

    PubMed

    Rhodes, Scott D; Alonzo, Jorge; Mann, Lilli; Song, Eunyoung Y; Tanner, Amanda E; Arellano, Jorge Elias; Rodriguez-Celedon, Rodrigo; Garcia, Manuel; Freeman, Arin; Reboussin, Beth A; Painter, Thomas M

    2017-06-01

    To evaluate the HOLA en Grupos intervention, a Spanish-language small-group behavioral HIV prevention intervention designed to increase condom use and HIV testing among Hispanic/Latino gay, bisexual, and other men who have sex with men. In 2012 to 2015, we recruited and randomized 304 Hispanic/Latino men who have sex with men, aged 18 to 55 years in North Carolina, to the 4-session HOLA en Grupos intervention or an attention-equivalent general health education comparison intervention. Participants completed structured assessments at baseline and 6-month follow-up. Follow-up retention was 100%. At follow-up, relative to comparison participants, HOLA en Grupos participants reported increased consistent condom use during the past 3 months (adjusted odds ratio [AOR] = 4.1; 95% confidence interval [CI] = 2.2, 7.9; P < .001) and HIV testing during the past 6 months (AOR = 13.8; 95% CI = 7.6, 25.3; P < .001). HOLA en Grupos participants also reported increased knowledge of HIV (P < .001) and sexually transmitted infections (P < .001); condom use skills (P < .001), self-efficacy (P < .001), expectancies (P < .001), and intentions (P < .001); sexual communication skills (P < .01); and decreased fatalism (P < .001). The HOLA en Grupos intervention is efficacious for reducing HIV risk behaviors among Hispanic/Latino men who have sex with men.

  1. Small-Group Randomized Controlled Trial to Increase Condom Use and HIV Testing Among Hispanic/Latino Gay, Bisexual, and Other Men Who Have Sex With Men

    PubMed Central

    Alonzo, Jorge; Mann, Lilli; Song, Eunyoung Y.; Tanner, Amanda E.; Arellano, Jorge Elias; Rodriguez-Celedon, Rodrigo; Garcia, Manuel; Freeman, Arin; Reboussin, Beth A.; Painter, Thomas M.

    2017-01-01

    Objectives. To evaluate the HOLA en Grupos intervention, a Spanish-language small-group behavioral HIV prevention intervention designed to increase condom use and HIV testing among Hispanic/Latino gay, bisexual, and other men who have sex with men. Methods. In 2012 to 2015, we recruited and randomized 304 Hispanic/Latino men who have sex with men, aged 18 to 55 years in North Carolina, to the 4-session HOLA en Grupos intervention or an attention-equivalent general health education comparison intervention. Participants completed structured assessments at baseline and 6-month follow-up. Follow-up retention was 100%. Results. At follow-up, relative to comparison participants, HOLA en Grupos participants reported increased consistent condom use during the past 3 months (adjusted odds ratio [AOR] = 4.1; 95% confidence interval [CI] = 2.2, 7.9; P < .001) and HIV testing during the past 6 months (AOR = 13.8; 95% CI = 7.6, 25.3; P < .001). HOLA en Grupos participants also reported increased knowledge of HIV (P < .001) and sexually transmitted infections (P < .001); condom use skills (P < .001), self-efficacy (P < .001), expectancies (P < .001), and intentions (P < .001); sexual communication skills (P < .01); and decreased fatalism (P < .001). Conclusions. The HOLA en Grupos intervention is efficacious for reducing HIV risk behaviors among Hispanic/Latino men who have sex with men. PMID:28426301

  2. Can the Onset of Type 2 Diabetes Be Delayed by a Group-Based Lifestyle Intervention in Women with Prediabetes following Gestational Diabetes Mellitus (GDM)? Findings from a Randomized Control Mixed Methods Trial.

    PubMed

    O'Dea, Angela; Tierney, Marie; McGuire, Brian E; Newell, John; Glynn, Liam G; Gibson, Irene; Noctor, Eoin; Danyliv, Andrii; Connolly, Susan B; Dunne, Fidelma P

    2015-01-01

    To evaluate a 12-week group-based lifestyle intervention programme for women with prediabetes following gestational diabetes (GDM). A two-group, mixed methods randomized controlled trial in which 50 women with a history of GDM and abnormal glucose tolerance postpartum were randomly assigned to intervention (n = 24) or wait control (n = 26) and postintervention qualitative interviews with participants. Modifiable biochemical, anthropometric, behavioural, and psychosocial risk factors associated with the development of type 2 diabetes. The primary outcome variable was the change in fasting plasma glucose (FPG) from study entry to one-year follow-up. At one-year follow-up, the intervention group showed significant improvements over the wait control group on stress, diet self-efficacy, and quality of life. There was no evidence of an effect of the intervention on measures of biochemistry or anthropometry; the effect on one health behaviour, diet adherence, was close to significance. Prevention programmes must tackle the barriers to participation faced by this population; home-based interventions should be investigated. Strategies for promoting long-term health self-management need to be developed and tested.

  3. Can the Onset of Type 2 Diabetes Be Delayed by a Group-Based Lifestyle Intervention in Women with Prediabetes following Gestational Diabetes Mellitus (GDM)? Findings from a Randomized Control Mixed Methods Trial

    PubMed Central

    O'Dea, Angela; Tierney, Marie; McGuire, Brian E.; Newell, John; Glynn, Liam G.; Gibson, Irene; Noctor, Eoin; Danyliv, Andrii; Connolly, Susan B.; Dunne, Fidelma P.

    2015-01-01

    Objective. To evaluate a 12-week group-based lifestyle intervention programme for women with prediabetes following gestational diabetes (GDM). Design. A two-group, mixed methods randomized controlled trial in which 50 women with a history of GDM and abnormal glucose tolerance postpartum were randomly assigned to intervention (n = 24) or wait control (n = 26) and postintervention qualitative interviews with participants. Main Outcome Measures. Modifiable biochemical, anthropometric, behavioural, and psychosocial risk factors associated with the development of type 2 diabetes. The primary outcome variable was the change in fasting plasma glucose (FPG) from study entry to one-year follow-up. Results. At one-year follow-up, the intervention group showed significant improvements over the wait control group on stress, diet self-efficacy, and quality of life. There was no evidence of an effect of the intervention on measures of biochemistry or anthropometry; the effect on one health behaviour, diet adherence, was close to significance. Conclusions. Prevention programmes must tackle the barriers to participation faced by this population; home-based interventions should be investigated. Strategies for promoting long-term health self-management need to be developed and tested. PMID:26347894

  4. Control systems on Lie groups.

    NASA Technical Reports Server (NTRS)

    Jurdjevic, V.; Sussmann, H. J.

    1972-01-01

    The controllability properties of systems which are described by an evolution equation in a Lie group are studied. The revelant Lie algebras induced by a right invariant system are singled out, and the basic properties of attainable sets are derived. The homogeneous case and the general case are studied, and results are interpreted in terms of controllability. Five examples are given.

  5. Control systems on Lie groups.

    NASA Technical Reports Server (NTRS)

    Jurdjevic, V.; Sussmann, H. J.

    1972-01-01

    The controllability properties of systems which are described by an evolution equation in a Lie group are studied. The revelant Lie algebras induced by a right invariant system are singled out, and the basic properties of attainable sets are derived. The homogeneous case and the general case are studied, and results are interpreted in terms of controllability. Five examples are given.

  6. Group theory for embedded random matrix ensembles

    NASA Astrophysics Data System (ADS)

    Kota, V. K. B.

    2015-04-01

    Embedded random matrix ensembles are generic models for describing statistical properties of finite isolated quantum many-particle systems. For the simplest spinless fermion (or boson) systems with say m fermions (or bosons) in N single particle states and interacting with say k-body interactions, we have EGUE(k) [embedded GUE of k-body interactions) with GUE embedding and the embedding algebra is U(N). In this paper, using EGUE(k) representation for a Hamiltonian that is fc-body and an independent EGUE(t) representation for a transition operator that is t-body and employing the embedding U(N) algebra, finite-N formulas for moments up to order four are derived, for the first time, for the transition strength densities (transition strengths multiplied by the density of states at the initial and final energies). In the asymptotic limit, these formulas reduce to those derived for the EGOE version and establish that in general bivariate transition strength densities take bivariate Gaussian form for isolated finite quantum systems. Extension of these results for other types of transition operators and EGUE ensembles with further symmetries are discussed.

  7. Twelve-week, multicenter, placebo-controlled, randomized, double-blind, parallel-group, comparative phase II/III study of benzoyl peroxide gel in patients with acne vulgaris: A secondary publication.

    PubMed

    Kawashima, Makoto; Sato, Shinichi; Furukawa, Fukumi; Matsunaga, Kayoko; Akamatsu, Hirohiko; Igarashi, Atsuyuki; Tsunemi, Yuichiro; Hayashi, Nobukazu; Yamamoto, Yuki; Nagare, Toshitaka; Katsuramaki, Tsuneo

    2017-03-11

    A placebo-controlled, randomized, double-blind, parallel-group, comparative, multicenter study was conducted to investigate the efficacy and safety of benzoyl peroxide (BPO) gel, administrated once daily for 12 weeks to Japanese patients with acne vulgaris. Efficacy was evaluated by counting all inflammatory and non-inflammatory lesions. Safety was evaluated based on adverse events, local skin tolerability scores and laboratory test values. All 609 subjects were randomly assigned to receive the study products (2.5% and 5% BPO and placebo), and 607 subjects were included in the full analysis set, 544 in the per protocol set and 609 in the safety analyses. The median rates of reduction from baseline to the last evaluation of the inflammatory lesion counts, the primary end-point, in the 2.5% and 5% BPO groups were 72.7% and 75.0%, respectively, and were significantly higher than that in the placebo group (41.7%). No deaths or other serious adverse events were observed. The incidences of adverse events in the 2.5% and 5% BPO groups were 56.4% and 58.8%, respectively; a higher incidence than in the placebo group, but there was no obvious difference between the 2.5% and 5% BPO groups. All adverse events were mild or moderate in severity. Most adverse events did not lead to study product discontinuation. The results suggested that both 2.5% and 5% BPO are useful for the treatment of acne vulgaris.

  8. Group-based multimodal exercises integrated with cognitive-behavioural therapy improve disability, pain and quality of life of subjects with chronic neck pain: a randomized controlled trial with one-year follow-up.

    PubMed

    Monticone, Marco; Ambrosini, Emilia; Rocca, Barbara; Cazzaniga, Daniele; Liquori, Valentina; Pedrocchi, Alessandra; Vernon, Howard

    2017-06-01

    To evaluate the effect of a group-based multidisciplinary rehabilitation programme on disability, pain and quality of life in subjects with chronic neck pain. Randomized controlled trial. Specialized rehabilitation centre. A total of 170 patients (mean age of 53 years (13); 121 females). The multidisciplinary group underwent a multidisciplinary rehabilitation programme combining multimodal exercises with psychologist-lead cognitive-behavioural therapy sessions. The general exercise group underwent general physiotherapy. Both groups followed group-based programmes once a week for ten weeks. Additionally, the multidisciplinary group met with the psychologist once a week for a 60-minute session. The Neck Disability Index (primary outcome), the Tampa Scale for Kinesiophobia, the Pain Catastrophizing Scale, a pain numerical rating scale and the Short-Form Health Survey. The participants were evaluated before, after training and after 12 months. A linear mixed model for repeated measures was used for each outcome measure. Significant effects ( p-value <0.001) were found over time and between groups for all outcome measures. After training, significant improvements were found for both groups for all outcome measures except kinesiophobia and catastrophizing, which did not change in the control group; however, the improvements were significantly greater for the multidisciplinary group. At 12-month follow-up a clinically meaningful between-group difference of 12.4 Neck Disability Index points was found for disability. A group-based multidisciplinary rehabilitation programme including cognitive-behavioural therapy was superior to group-based general physiotherapy in improving disability, pain and quality of life of subjects with chronic neck pain. The effects lasted for at least one year.

  9. Phase III double-blind, placebo-controlled, prospective randomized trial of adjuvant tamoxifen vs. tamoxifen and fenretinide in postmenopausal women with positive receptors (EB193): an intergroup trial coordinated by the Eastern Cooperative Oncology Group.

    PubMed

    Rao, Ruta D; Cobleigh, Melody A; Gray, Robert; Graham, Mark L; Norton, Larry; Martino, Silvana; Budd, George Thomas; Ingle, James N; Wood, William C

    2011-12-01

    Fenretinide and tamoxifen have additive antitumor effects preclinically. We performed a randomized, placebo-controlled, double-blind adjuvant trial in breast cancer patients treated for 5 years with tamoxifen, with or without fenretinide. Between October 1995 and October 1999, 426 postmenopausal women with hormone receptor-positive breast cancer were randomized. Patients were monitored for efficacy and toxicity. Four hundred and nineteen patients were evaluable. The study was terminated early due to slow accrual. There were no significant differences between treatment groups in DFS, TTR or survival. More patients stopped treatment early on the fenretinide arm than on placebo (P = 0.02). Grade 3/4 toxicities, including visual problems and musculoskeletal complaints were more common in patients receiving fenretinide (P = 0.007). A Night Blindness Questionnaire was used to monitor nyctalopia, which was slightly, but not significantly, more common on fenretinide. In this underpowered study, no significant difference was observed in efficacy between treatment groups. This trial provides important toxicity information about fenretinide, a retinoid that has been used in the prevention setting, because it is the only placebo-controlled, double-blind randomized study ever performed.

  10. Phase III Double-Blind, Placebo-Controlled, Prospective Randomized Trial of Adjuvant Tamoxifen vs. Tamoxifen and Fenretinide in Postmenopausal Women with Positive Receptors (EB193): An Intergroup Trial Coordinated by the Eastern Cooperative Oncology Group

    PubMed Central

    Rao, Ruta D.; Cobleigh, Melody A.; Gray, Robert; Graham, Mark L.; Norton, Larry; Martino, Silvana; Budd, George Thomas; Ingle, James N.; Wood, William C.

    2016-01-01

    Purpose Fenretinide and tamoxifen have additive antitumor effects preclinically. We performed a randomized, placebo-controlled, double-blind adjuvant trial in breast cancer patients treated for five years with tamoxifen, with or without fenretinide. Patients and methods Between October 1995 and October 1999, 426 postmenopausal women with hormone receptor-positive breast cancer were randomized. Patients were monitored for efficacy and toxicity. Results Four hundred nineteen patients were evaluable. The study was terminated early due to slow accrual. There were no significant differences between treatment groups in DFS, TTR or survival. More patients stopped treatment early on the fenretinide arm than on placebo (p=.02). Grade 3/4 toxicities, including visual problems and musculoskeletal complaints were more common in patients receiving fenretinide (p=.007). A Night Blindness Questionnaire was used to monitor nyctalopia, which was slightly, but not significantly, more common on fenretinide. Conclusions In this underpowered study, no significant difference was observed in efficacy between treatment groups. This trial provides important toxicity information about fenretinide, a retinoid which has been used in the prevention setting, because it is the only placebo-controlled, double-blind randomized study ever performed. PMID:20878269

  11. Affectionate Writing Reduces Total Cholesterol: Two Randomized, Controlled Trials

    ERIC Educational Resources Information Center

    Floyd, Kory; Mikkelson, Alan C.; Hesse, Colin; Pauley, Perry M.

    2007-01-01

    In two 5-week trials, healthy college students were randomly assigned either to experimental or control groups. Participants in the experimental groups wrote about their affection for significant friends, relatives, and/or romantic partners for 20 minutes on three separate occasions; on the same schedule, those in the control groups wrote about…

  12. Affectionate Writing Reduces Total Cholesterol: Two Randomized, Controlled Trials

    ERIC Educational Resources Information Center

    Floyd, Kory; Mikkelson, Alan C.; Hesse, Colin; Pauley, Perry M.

    2007-01-01

    In two 5-week trials, healthy college students were randomly assigned either to experimental or control groups. Participants in the experimental groups wrote about their affection for significant friends, relatives, and/or romantic partners for 20 minutes on three separate occasions; on the same schedule, those in the control groups wrote about…

  13. A pilot randomized controlled trial of deprescribing.

    PubMed

    Beer, Christopher; Loh, Poh-Kooi; Peng, Yan Gee; Potter, Kathleen; Millar, Alasdair

    2011-04-01

    Polypharmacy and adverse drug reactions are frequent and important among older people. Few clinical trials have evaluated systematic withdrawal of medications among older people. This small, open, study was conducted to determine the feasibility of a randomized controlled deprescribing trial. Ten volunteers living in the community (recruited by media advertising) and 25 volunteers living in residential aged-care facilities (RCFs) were randomized to intervention or control groups. The intervention was gradual withdrawal of one target medication. The primary outcome was the number of intervention participants in whom medication withdrawal could be achieved. Other outcomes measures were quality of life, medication adherence, sleep quality, and cognitive impairment. Participants were aged 80 ± 11 years and were taking 9 ± 2 medications. Fifteen participants commenced medication withdrawal and all ceased or reduced the dose of their target medication. Two subjects withdrew; one was referred for clinical review, and one participant declined further dose reductions. A randomized controlled trial of deprescribing was acceptable to participants. Recruitment in RCFs is feasible. Definitive trials of deprescribing are required.

  14. Efficacy of an internet-based learning module and small-group debriefing on trainees' attitudes and communication skills toward patients with substance use disorders: results of a cluster randomized controlled trial.

    PubMed

    Lanken, Paul N; Novack, Dennis H; Daetwyler, Christof; Gallop, Robert; Landis, J Richard; Lapin, Jennifer; Subramaniam, Geetha A; Schindler, Barbara A

    2015-03-01

    To examine whether an Internet-based learning module and small-group debriefing can improve medical trainees' attitudes and communication skills toward patients with substance use disorders (SUDs). In 2011-2012, 129 internal and family medicine residents and 370 medical students at two medical schools participated in a cluster randomized controlled trial, which assessed the effect of adding a two-part intervention to the SUDs curricula. The intervention included a self-directed, media-rich Internet-based learning module and a small-group, faculty-led debriefing. Primary study outcomes were changes in self-assessed attitudes in the intervention group (I-group) compared with those in the control group (C-group) (i.e., a difference of differences). For residents, the authors used real-time, Web-based interviews of standardized patients to assess changes in communication skills. Statistical analyses, conducted separately for residents and students, included hierarchical linear modeling, adjusted for site, participant type, cluster, and individual scores at baseline. The authors found no significant differences between the I- and C-groups in attitudes for residents or students at baseline. Compared with those in the C-group, residents, but not students, in the I-group had more positive attitudes toward treatment efficacy and self-efficacy at follow-up (P<.006). Likewise, compared with residents in the C-group, residents in the I-group received higher scores on screening and counseling skills during the standardized patient interview at follow-up (P=.0009). This intervention produced improved attitudes and communication skills toward patients with SUDs among residents. Enhanced attitudes and skills may result in improved care for these patients.

  15. Radiotherapy with or without hyperthermia in the treatment of superficial localized breast cancer: results from five randomized controlled trials. International Collaborative Hyperthermia Group.

    PubMed

    Vernon, C C; Hand, J W; Field, S B; Machin, D; Whaley, J B; van der Zee, J; van Putten, W L; van Rhoon, G C; van Dijk, J D; González González, D; Liu, F F; Goodman, P; Sherar, M

    1996-07-01

    Claims for the value of hyperthermia as an adjunct to radiotherapy in the treatment of cancer have mostly been based on small Phase I or II trials. To test the benefit of this form of treatment, randomized Phase III trials were needed. Five randomized trials addressing this question were started between 1988 and 1991. In these trials, patients were eligible if they had advanced primary or recurrent breast cancer, and local radiotherapy was indicated in preference to surgery. In addition, heating of the lesions and treatment with a prescribed (re)irradiation schedule had to be feasible and informed consent was obtained. The primary endpoint of all trials was local complete response. Slow recruitment led to a decision to collaborate and combine the trial results in one analysis, and report them simultaneously in one publication. Interim analyses were carried out and the trials were closed to recruitment when a previously agreed statistically significant difference in complete response rate was observed in the two larger trials. We report on pretreatment characteristics, the treatments received, the local response observed, duration of response, time to local failure, distant progression and survival, and treatment toxicity of the 306 patients randomized. The overall CR rate for RT alone was 41% and for the combined treatment arm was 59%, giving, after stratification by trial, an odds ratio of 2.3. Not all trials demonstrated an advantage for the combined treatment, although the 95% confidence intervals of the different trials all contain the pooled odds ratio. The greatest effect was observed in patients with recurrent lesions in previously irradiated areas, where further irradiation was limited to low doses. The combined result of the five trials has demonstrated the efficacy of hyperthermia as an adjunct to radiotherapy for treatment of recurrent breast cancer. The implication of these encouraging results is that hyperthermia appears to have an important role in

  16. Study protocol for a group randomized controlled trial of a classroom-based intervention aimed at preventing early risk factors for drug abuse: integrating effectiveness and implementation research

    PubMed Central

    Poduska, Jeanne; Kellam, Sheppard; Brown, C Hendricks; Ford, Carla; Windham, Amy; Keegan, Natalie; Wang, Wei

    2009-01-01

    Background While a number of preventive interventions delivered within schools have shown both short-term and long-term impact in epidemiologically based randomized field trials, programs are not often sustained with high-quality implementation over time. This study was designed to support two purposes. The first purpose was to test the effectiveness of a universal classroom-based intervention, the Whole Day First Grade Program (WD), aimed at two early antecedents to drug abuse and other problem behaviors, namely, aggressive, disruptive behavior and poor academic achievement. The second purpose--the focus of this paper--was to examine the utility of a multilevel structure to support high levels of implementation during the effectiveness trial, to sustain WD practices across additional years, and to train additional teachers in WD practices. Methods The WD intervention integrated three components, each previously tested separately: classroom behavior management; instruction, specifically reading; and family-classroom partnerships around behavior and learning. Teachers and students in 12 schools were randomly assigned to receive either the WD intervention or the standard first-grade program of the school system (SC). Three consecutive cohorts of first graders were randomized within schools to WD or SC classrooms and followed through the end of third grade to test the effectiveness of the WD intervention. Teacher practices were assessed over three years to examine the utility of the multilevel structure to support sustainability and scaling-up. Discussion The design employed in this trial appears to have considerable utility to provide data on WD effectiveness and to inform the field with regard to structures required to move evidence-based programs into practice. Trial Registration Clinical Trials Registration Number: NCT00257088 PMID:19725979

  17. Oral rehydration solution containing a mixture of non-digestible carbohydrates in the treatment of acute diarrhea: a multicenter randomized placebo controlled study on behalf of the ESPGHAN working group on intestinal infections.

    PubMed

    Hoekstra, J H; Szajewska, H; Zikri, M Abu; Micetic-Turk, D; Weizman, Z; Papadopoulou, A; Guarino, A; Dias, J A; Oostvogels, B

    2004-09-01

    A randomized, double-blind, placebo-controlled multicenter study to evaluate efficacy and safety of a mixture of non-digestible carbohydrates (NDC) as an adjunct to oral rehydration therapy in treatment of acute infectious diarrhea in children with mild to moderate dehydration. 144 boys aged 1 to 36 months with diarrhea defined as three or more watery stools per day for >1 day but <5 days with mild or moderate dehydration (World Health Organization criteria) were randomly assigned to receive hypotonic oral rehydration solution (ORS) (Na 60 mmol/L, glucose 111 mmol/L) with or without a mixture of NDC (soy polysaccharide 25%, alpha-cellulose 9%, gum arabic 19%, fructooligosaccharides 18.5%, inulin 21.5%, resistant starch 7%). Intention-to-treat analysis did not show significant differences in mean 48 hour stool volume (ESPGHAN-ORS with NDC versus ESPGHAN-ORS, 140 +/- 124 g/kg versus 143 +/- 114 g/kg; P = 0.41). Duration of diarrhea after randomization was similar in both groups (82 +/- 39 hours versus 97 +/- 76 hours, P = 0.24). There were no significant differences in the duration of hospital stay (111 +/- 44 hours versus 126 +/- 78 hours; P = 0.3). Unscheduled intravenous rehydration was similar in both groups (21.4% versus 16.2%, P = 0.42). In boys with acute non-cholera diarrhea with mild to moderate dehydration a mixture of non-digestible carbohydrates was ineffective as an adjunct to oral rehydration therapy.

  18. Daily electronic monitoring of subjective and objective measures of illness activity in bipolar disorder using smartphones--the MONARCA II trial protocol: a randomized controlled single-blind parallel-group trial.

    PubMed

    Faurholt-Jepsen, Maria; Vinberg, Maj; Frost, Mads; Christensen, Ellen Margrethe; Bardram, Jakob; Kessing, Lars Vedel

    2014-11-25

    Patients with bipolar disorder often show decreased adherence with mood stabilizers and frequently interventions on prodromal depressive and manic symptoms are delayed. Recently, the MONARCA I randomized controlled trial investigated the effect of electronic self-monitoring using smartphones on depressive and manic symptoms. The findings suggested that patients using the MONARCA system had more sustained depressive symptoms than patients using a smartphone for normal communicative purposes, but had fewer manic symptoms during the trial. It is likely that the ability of these self-monitored measures to detect prodromal symptoms of depression and mania may be insufficient compared to automatically generated objective data on measures of illness activity such as phone usage, social activity, physical activity, and mobility. The Monsenso system, for smartphones integrating subjective and objective measures of illness activity was developed and will be tested in the present trial. The MONARCA II trial uses a randomized controlled single-blind parallel-group design. Patients with bipolar disorder according to ICD-10 who previously have been treated at the Copenhagen Clinic for Affective Disorder, Denmark are included and randomized to either daily use of the Monsenso system including an feedback loop between patients and clinicians (the intervention group) or to the use of a smartphone for normal communicative purposes (the control group) for a 9-month trial period. The trial was started in September 2014 and recruitment is ongoing. The outcomes are: differences in depressive and manic symptoms; rate of depressive and manic episodes (primary); automatically generated objective data on measures of illness activity; number of days hospitalized; psychosocial functioning (secondary); perceived stress; quality of life; self-rated depressive symptoms; self-rated manic symptoms; recovery; empowerment and adherence to medication (tertiary) between the intervention group and the

  19. Impact of the total pericardial closure using bilateral trap door incision and pericardial cavity intervention on outcomes following coronary artery bypass grafting: a randomized, controlled, parallel-group prospective study.

    PubMed

    Kaya, Mehmet; Satılmışoğlu, Muhammet Hulusi; Buğra, Abdül Kerim; Kyaruzi, Mugisha; Kafa, Ülkü; Utkusavaş, Ayfer; Bakır, İhsan

    2015-12-01

    In this randomized, controlled and parallel-group prospective study, the feasibility of total pericardial closure with an intrapericardial drain and a pericardio-pleural window (pericardial cavity intervention) was investigated by examining postoperative outcomes, including atrial fibrillation and pericardial effusion, following coronary artery surgery. Cases were classified into two groups using a random procedure: the closure group and the open group. Insertion of an intrapericardial drain along the right atrium, pericardio-pleural window and total closure of the pericardium were performed in patients in the closure group. Partial closure of the pericardium was performed in patients in the open group. A straight semi-rigid drain was inserted into the extrapericardial anterior mediastinum and a right angle drain was inserted into the left chest in all patients. The primary endpoint was to evaluate the impact of surgical technique on the rate of postoperative in-hospital atrial fibrillation in the closure group. The secondary endpoint was to evaluate the relationship between the surgical technique and postoperative amount of pericardial effusion. A total of 142 isolated, on-pump cases were examined: 72 in the open group and 70 in the closure group. Postoperative atrial fibrillation occurred in 27.78% of the cases in the open group and 8.57% of the patients in the closure group (P = 0.003). Another statistically significant outcome was the lower incidence of small pericardial effusion in the patient group with a closed pericardium during the second day of postoperative care (P = 0.039). The length of both critical care unit (P = 0.008) and hospital stay (P = 0.047) were also significantly shorter in the patient group with a closed pericardium. Total pericardiorrhaphy with pericardial cavity intervention can be acceptable and favourable in terms of its outcomes, including reducing incidence of postoperative atrial fibrillation, pericardial effusion and length of

  20. Mentalization-based treatment in groups for adolescents with borderline personality disorder (BPD) or subthreshold BPD versus treatment as usual (M-GAB): study protocol for a randomized controlled trial.

    PubMed

    Beck, Emma; Bo, Sune; Gondan, Matthias; Poulsen, Stig; Pedersen, Liselotte; Pedersen, Jesper; Simonsen, Erik

    2016-07-12

    Evidence-based outpatient psychotherapeutic programs are first-line treatment of borderline personality disorder (BPD). Early and effective treatment of BPD is crucial to the prevention of its individual, psychosocial, and economic consequences. However, in spite of recent advantages in diagnosing adolescent BPD, there is a lack of cost-effective evidence-based treatment programs for adolescents. Mentalization-based treatment is an evidence-based program for BPD, originally developed for adults. We will investigate whether a specifically designed mentalization-based treatment in groups is an efficacious treatment for adolescents with BPD or subthreshold BPD compared to treatment as usual. The trial is a four-center, two-armed, parallel-group, assessor-blinded randomized clinical superiority trial. One hundred twelve patients aged 14 to 17 referred to Child and Adolescent Psychiatric Clinics in Region Zealand are randomized to 1 year of either mentalization-based treatment in groups or treatment as usual. Patients will be included if they meet at least four DSM-5 criteria for BPD. The primary outcome is self-reported borderline features at discharge. Secondary outcomes will include self-harm, depression, BPD criteria, externalizing and internalizing symptoms, and social functioning, together with parental reports on borderline features, externalizing and internalizing symptoms. Measures of attachment and mentalization will be included as mediational variables. Follow-up assessment will take place at 3 and 12 months after end of treatment. This is the first randomized controlled trial to test the efficacy of a group-based mentalization-based treatment for adolescents with BPD or subthreshold BPD. If the results confirm our hypothesis, this trial will add to the treatment options of cost-effective treatment of adolescent BPD. Clinicaltrials.gov NCT02068326 , February 19, 2014.

  1. Use of a Motivational Interviewing-Informed Strategy in Group Orientations to Improve Retention and Intervention Attendance in a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Xiao, Lan; Lv, Nan; Rosas, Lisa G.; Karve, Shweta; Luna, Veronica; Jameiro, Elizabeth; Wittels, Nancy; Ma, Jun

    2016-01-01

    High retention and treatment adherence are essential to ensure the quality of evidence from clinical trials. Strategies for improving these have been explored but actual rates in lifestyle intervention trials indicate challenges. This study examined the use of a motivational interviewing-informed strategy during interactive group orientations…

  2. Study protocol of a multicenter randomized controlled trial comparing the effectiveness of group and individual internet-based Mindfulness-Based Cognitive Therapy with treatment as usual in reducing psychological distress in cancer patients: the BeMind study.

    PubMed

    Compen, F R; Bisseling, E M; Van der Lee, M L; Adang, E M M; Donders, A R T; Speckens, A E M

    2015-01-01

    Mindfulness-based interventions have shown to reduce psychological distress in cancer patients. The accessibility of mindfulness-based interventions for cancer patients could be further improved by providing mindfulness using an individual internet-based format. The aim of this study is to test the effectiveness of a Mindfulness-Based Cognitive Therapy (MBCT) group intervention for cancer patients in comparison with individual internet-based MBCT and treatment as usual (TAU). A three-armed multicenter randomized controlled trial comparing group-based MBCT to individual internet-based MBCT and TAU in cancer patients who suffer from at least mild psychological distress (Hospital Anxiety and Depression Scale (HADS) ≥ 11). Measurements will be conducted prior to randomization (baseline), post-treatment and at 3 months and 9 months post-treatment. Participants initially allocated to TAU are subsequently randomized to either group- or individual internet-based MBCT and will receive a second baseline measurement after 3 months. Thus, the three-armed comparison will have a time span of approximately 3 months. The two-armed intervention comparison includes a 9-month follow-up and will also consist of participants randomized to the intervention after TAU. Primary outcome will be post-treatment psychological distress (HADS). Secondary outcomes are fear of cancer recurrence (Fear of Cancer Recurrence Inventory), rumination (Rumination and Reflection Questionnaire), positive mental health (Mental Health Continuum - Short Form), and cost-effectiveness (health-related quality of life (EuroQol -5D and Short Form-12) and health care usage (Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness). Potential predictors: DSM-IV-TR mood/anxiety disorders (SCID-I) and neuroticism (NEO-Five Factor Inventory) will be measured. Mediators of treatment effect: mindfulness skills, (Five-Facets of Mindfulness Questionnaire- Short Form), working alliance (Working Alliance

  3. Comparison of the effectiveness and tolerability of lidocaine patch 5% versus celecoxib for osteoarthritis-related knee pain: post hoc analysis of a 12 week, prospective, randomized, active-controlled, open-label, parallel-group trial in adults.

    PubMed

    Kivitz, Alan; Fairfax, Michael; Sheldon, Eric A; Xiang, Qinfang; Jones, Beverly A; Gammaitoni, Arnold R; Gould, Errol M

    2008-12-01

    Cyclooxygenase-2 (COX-2) selective inhibitors and nonselective NSAIDs are commonly used to treat osteoarthritis (OA) of the knee. The aim of this study was to compare the effectiveness of the lidocaine patch 5% with that of celecoxib 200 mg/d in the treatment of OA-related knee pain; however, the study was terminated prematurely by the sponsor because of tolerability concerns regarding the class of COX-2 selective inhibitors. A post hoc analysis of the available data is presented here. This multicenter, randomized, open-label, active-controlled, parallel-group study included patients >or=18 years of age with unilateral or bilateral moderate to severe OA of the knee. Patients were randomized to receive treatment with either the lidocaine patch 5% or celecoxib 200 mg/d. The primary efficacy end point was change from baseline to 12 weeks in the Western Ontario and McMaster Universities (WOMAC) OA Index pain subscale. Secondary end points included additional WOMAC subscales and Brief Pain Inventory (BPI) measures. Because this trial was prematurely terminated, a post hoc analysis was performed using a random pattern-mixture model of all observed cases of the intent-to-treat population. A total of 143 patients were randomized to treatment (lidocaine patch 5%, 69 patients; mean [SD] age, 60.2 [11.4] years; 65.2% female; 66.7% white; weight, 94.1 [23.3] kg) or celecoxib 200 mg/d (74 patients; age, 58.2 [12.1] years; 63.5% female; 68.9% white; weight, 94.3 [22.5] kg). Baseline pain WOMAC OA subscale scores (lidocaine patch 5%, 12.087; celecoxib 200 mg/d, 12.514) and mean rates of change over time (baseline to week 2, -1.5916 vs -1.6513 per week; weeks 2-6, -0.0168 vs -0.119 per week; weeks 6-12, -0.1818 vs -0.1579 per week) were not significantly different between the 2 groups. Improvement in additional WOMAC subscales and in several BPI measures were not significantly different between the 2 groups. Treatment-related adverse events were reported in 8 patients in each

  4. Efficacy of Diosmectite (Smecta)® in the Treatment of Acute Watery Diarrhoea in Adults: A Multicentre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study

    PubMed Central

    Khediri, Faouzi; Mrad, Abdennebi Ilhem; Azzouz, Moussadek; Doughi, Hedi; Najjar, Taoufik; Mathiex-Fortunet, Hélène; Garnier, Philippe; Cortot, Antoine

    2011-01-01

    Background. Although diosmectite has demonstrated efficacy in the treatment of acute watery diarrhoea in children, its efficacy in adults still needs to be assessed. The objective of this study was therefore to assess the efficacy of diosmectite on the time to recovery in adults with acute diarrhoea. Methods. A total of 346 adults with at least three watery stools per day over a period of less than 48 hours were prospectively randomized to diosmectite (6 g tid) or placebo during four days. The primary endpoint was time to diarrhoea recovery. Results. In the intention-to-treat population, median time to recovery was 53.8 hours (range [3.7–167.3]) with diosmectite (n = 166) versus 69.0 hours [2.2–165.2] with placebo, (n = 163; P = .029), which corresponds to a difference of 15.2 hours. Diosmectite was well tolerated. Conclusion. Diosmectite at 6 g tid was well tolerated and reduced the time to recovery of acute watery diarrhoea episode in a clinically relevant manner. PMID:21760777

  5. Effects of quality improvement in health facilities and community mobilization through women’s groups on maternal, neonatal and perinatal mortality in three districts of Malawi: MaiKhanda, a cluster randomized controlled effectiveness trial

    PubMed Central

    Colbourn, Tim; Nambiar, Bejoy; Bondo, Austin; Makwenda, Charles; Tsetekani, Eric; Makonda-Ridley, Agnes; Msukwa, Martin; Barker, Pierre; Kotagal, Uma; Williams, Cassie; Davies, Ros; Webb, Dale; Flatman, Dorothy; Lewycka, Sonia; Rosato, Mikey; Kachale, Fannie; Mwansambo, Charles; Costello, Anthony

    2016-01-01

    Background Maternal, perinatal and neonatal mortality remains high in low-income countries. We evaluated community and facility-based interventions to reduce deaths in three districts of Malawi. Methods We evaluated a rural participatory women’s group community intervention (CI) and a quality improvement intervention at health centres (FI) via a two-by-two factorial cluster randomized controlled trial. Consenting pregnant women were followed-up to 2 months after birth using key informants. Primary outcomes were maternal, perinatal and neonatal mortality. Clusters were health centre catchment areas assigned using stratified computer-generated randomization. Following exclusions, including non-birthing facilities, 61 clusters were analysed: control (17 clusters, 4912 births), FI (15, 5335), CI (15, 5080) and FI + CI (14, 5249). This trial was registered as International Standard Randomised Controlled Trial [ISRCTN18073903]. Outcomes for 14 576 and 20 576 births were recorded during baseline (June 2007–September 2008) and intervention (October 2008–December 2010) periods. Results For control, FI, CI and FI + CI clusters neonatal mortality rates were 34.0, 28.3, 29.9 and 27.0 neonatal deaths per 1000 live births and perinatal mortality rates were 56.2, 55.1, 48.0 and 48.4 per 1000 births, during the intervention period. Adjusting for clustering and stratification, the neonatal mortality rate was 22% lower in FI + CI than control clusters (OR = 0.78, 95% CI 0.60–1.01), and the perinatal mortality rate was 16% lower in CI clusters (OR = 0.84, 95% CI 0.72–0.97). We did not observe any intervention effects on maternal mortality. Conclusions Despite implementation problems, a combined community and facility approach using participatory women’s groups and quality improvement at health centres reduced newborn mortality in rural Malawi. PMID:24030269

  6. Direct versus Indirect and Individual versus Group Modes of Language Therapy for Children with Primary Language Impairment: Principal Outcomes from a Randomized Controlled Trial and Economic Evaluation

    ERIC Educational Resources Information Center

    Boyle, James M.; McCartney, Elspeth; O'Hare, Anne; Forbes, John

    2009-01-01

    Background: Many school-age children with language impairments are enrolled in mainstream schools and receive indirect language therapy, but there have been, to the authors' knowledge, no previous controlled studies comparing the outcomes and costs of direct and indirect intervention delivered by qualified therapists and therapy assistants, and…

  7. Intralesional immunotherapy with tuberculin purified protein derivative (PPD) in recalcitrant wart: A randomized, placebo-controlled, double-blind clinical trial including an extra group of candidates for cryotherapy.

    PubMed

    Amirnia, Mehdi; Khodaeiani, Effat; Fouladi, Daniel F; Masoudnia, Sima

    2016-01-01

    Due to paucity of randomized clinical trials, intralesional immunotherapy has not been yet accepted as a standard therapeutic method. To examine the efficacy and safety of intralesional immunotherapy with tuberculin purified protein derivative (PPD) for treating recalcitrant wart. In this randomized, placebo-controlled, double-blind clinical trial, a total of 69 patients with recalcitrant warts received either intralesional PPD antigen (n = 35) or intralesional saline (n = 34) for six times at 2-week intervals. A third group of candidates for cryotherapy (n = 33) was also included. The decrease in lesion size (good: complete response, intermediate: 50-99% improvement, poor: <50% improvement), adverse effects and recurrence within 6-month follow-up were documented. At the final session, good, intermediate and poor responses were observed in 77.1%, 22.9% and 0% of the PPD patients; 0%, 14.7% and 85.3% of the placebo patients and 18.2%, 33.3% and 48.5% of the cryotherapy patients, respectively (PPD versus placebo: p < 0.001; PPD versus cryotherapy: p < 0.001). No significant complication was seen in the PPD group. The recurrence rate was 8.6%, 5.9% and 24.2% in the PPD, placebo and cryotherapy groups, respectively (p > 0.05). Intralesional immunotherapy with PPD antigen is highly effective and safe for treating recalcitrant warts. IRCT201407089844N3 in the Iranian Registry of Clinical Trials (IRCT).

  8. Multicenter, randomized, double-blind, active-controlled, parallel-group trial of the long-term (6-12 months) safety of acetaminophen in adult patients with osteoarthritis.

    PubMed

    Temple, Anthony R; Benson, Gordon D; Zinsenheim, Joyce R; Schweinle, Jo Ellen

    2006-02-01

    This study evaluated the safety of acetaminophen 4 g/d administered for up to 12 months to adult patients with osteoarthritis pain, using naproxen 750 mg/d as an active comparator. This multicenter, multidose, single-dummy, randomized, double-blind, active-controlled, parallel-group study enrolled patients with mild to moderate osteoarthritis pain of the hip or knee. Patients received acetaminophen 4 g/d or naproxen 750 mg/d for 12 months (group 1) or 6 months (group 2). Patients in both groups had follow-up visits at months 1, 3, and 6 of treatment (or at the time of study withdrawal). Patients in group 1 also had follow-up visits at months 9 and 12 (or at the time of study withdrawal). Tolerability evaluations consisted of determinations of hepatic (aminotransferase activities) and renal (serum creatinine) function, adverse events, and physical examinations. Adverse events reported by the patient or observed by the investigator during clinical evaluation were recorded. In addition, patients were questioned at each visit regarding the occurrence of adverse events using a nonspecific question. Investigators rated the intensity of adverse events and their subjective assessment of the relationship to study medication while blinded to the treatment group. At all visits, patients completed the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), in visual analog scale format, to assess pain, stiffness, and physical function over the previous 2 weeks. The primary efficacy end point was the mean change from baseline in the WOMAC pain subscale score at 6 months. Data from the 6- and 12-month groups were combined for analysis. Of 581 randomized patients, the safety population included 571 patients who received > or = 1 dose of study medication. The 571 patients had a mean (SD) age of 59.3 (8.6) years, 395 (69.2%) were female, and 480 (84.1%) were white. Of 290 patients randomized to receive acetaminophen, 134 completed 3 months of treatment, 96 completed

  9. A Promotora-administered group education intervention to promote breast and cervical cancer screening in a rural community along the U.S.-Mexico border: a randomized controlled trial.

    PubMed

    Nuño, Tomas; Martinez, Maria Elena; Harris, Robin; García, Francisco

    2011-03-01

    Breast cancer is the most common neoplasm among Hispanic women. Cervical cancer has a higher incidence and mortality among Hispanic women compared with non-Hispanic White women. To assess the effectiveness of a promotora-administered educational intervention to promote breast and cervical cancer screening among post-reproductive age, medically underserved Hispanic women residing along the U.S.-Mexico border. Women age 50 or older were eligible to participate in this intervention study. A total of 381 subjects agreed to participate. Women were randomly assigned into one of two groups, educational intervention or usual care. The primary outcomes were self-reported mammogram and Pap smear screening. Logistic regression analysis was used to compute odds ratios for comparisons between intervention and control groups. Women in the intervention group were 2.0 times more likely to report having had a mammogram within the last year when compared with the usual care group (95% CI = 1.3-3.1). Likewise, women in the intervention group were 1.5 times more likely to report having a Pap smear within the last year when compared with the usual care group, although this was not statistically significant (95% CI = 0.9-2.6). In a secondary analysis, the intervention suggests a stronger effect on those that had not had a mammogram or Pap smear within the past year at baseline. A promotora-based educational intervention can be used to increase breast and cervical cancer screening utilization among Hispanic women.

  10. Analyzing Randomized Controlled Interventions: Three Notes for Applied Linguists

    ERIC Educational Resources Information Center

    Vanhove, Jan

    2015-01-01

    I discuss three common practices that obfuscate or invalidate the statistical analysis of randomized controlled interventions in applied linguistics. These are (a) checking whether randomization produced groups that are balanced on a number of possibly relevant covariates, (b) using repeated measures ANOVA to analyze pretest-posttest designs, and…

  11. A Multiple-Dose, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group QT/QTc Study to Evaluate the Electrophysiologic Effects of THC/CBD Spray.

    PubMed

    Sellers, Edward M; Schoedel, Kerri; Bartlett, Cindy; Romach, Myroslava; Russo, Ethan B; Stott, Colin G; Wright, Stephen; White, Linda; Duncombe, Paul; Chen, Chien-Feng

    2013-07-01

    Delta-9-tetrahydrocannabinol (THC)/cannabidiol (CBD) oromucosal spray has proved efficacious in the treatment of spasticity in multiple sclerosis and chronic pain. A thorough QT/QTc study was performed to investigate the effects of THC/CBD spray on electrocardiogram (ECG) parameters in compliance with regulatory requirements, evaluating the effect of a recommended daily dose (8 sprays/day) and supratherapeutic doses (24 or 36 sprays/day) of THC/CBD spray on the QT/QTc interval in 258 healthy volunteers. The safety, tolerability, and pharmacokinetic profile of THC/CBD spray were also evaluated. Therapeutic and supratherapeutic doses of THC/CBD spray had no effect on cardiac repolarization with primary and secondary endpoints of QTcI and QTcF/QTcB, respectively, showing similar results. There was no indication of any effect on heart rate, atrioventricular conduction, or cardiac depolarization and no new clinically relevant morphological changes were observed. Overall, 19 subjects (25.0%) in the supratherapeutic (24/36 daily sprays of THC/CBD spray) dose group and one (1.6%) in the moxifloxacin group withdrew early due to intolerable AEs. Four psychiatric serious adverse events (AEs) in the highest dose group resulted in a reduction in the surpatherapeutic dose to 24 sprays/day. In conclusion, THC/CBD spray does not significantly affect ECG parameters. Additionally, THC/CBD spray is well tolerated at therapeutic doses with an AE profile similar to previous clinical studies. © The Author(s) 2013.

  12. Cognitively Engaging Chronic Physical Activity, But Not Aerobic Exercise, Affects Executive Functions in Primary School Children: A Group-Randomized Controlled Trial.

    PubMed

    Schmidt, Mirko; Jäger, Katja; Egger, Fabienne; Roebers, Claudia M; Conzelmann, Achim

    2015-12-01

    Although the positive effects of different kinds of physical activity (PA) on cognitive functioning have already been demonstrated in a variety of studies, the role of cognitive engagement in promoting children's executive functions is still unclear. The aim of the current study was therefore to investigate the effects of two qualitatively different chronic PA interventions on executive functions in primary school children. Children (N = 181) aged between 10 and 12 years were assigned to either a 6-week physical education program with a high level of physical exertion and high cognitive engagement (team games), a physical education program with high physical exertion but low cognitive engagement (aerobic exercise), or to a physical education program with both low physical exertion and low cognitive engagement (control condition). Executive functions (updating, inhibition, shifting) and aerobic fitness (multistage 20-m shuttle run test) were measured before and after the respective condition. Results revealed that both interventions (team games and aerobic exercise) have a positive impact on children's aerobic fitness (4-5% increase in estimated VO2max). Importantly, an improvement in shifting performance was found only in the team games and not in the aerobic exercise or control condition. Thus, the inclusion of cognitive engagement in PA seems to be the most promising type of chronic intervention to enhance executive functions in children, providing further evidence for the importance of the qualitative aspects of PA.

  13. Targeting young drinkers online: the effectiveness of a web-based brief alcohol intervention in reducing heavy drinking among college students: study protocol of a two-arm parallel group randomized controlled trial.

    PubMed

    Voogt, Carmen V; Poelen, Evelien A P; Kleinjan, Marloes; Lemmers, Lex A C J; Engels, Rutger C M E

    2011-04-14

    The prevalence of heavy drinking among college students and its associated health related consequences highlights an urgent need for alcohol prevention programs targeting 18 to 24 year olds. Nevertheless, current alcohol prevention programs in the Netherlands pay surprisingly little attention to the drinking patterns of this specific age group. The study described in this protocol will test the effectiveness of a web-based brief alcohol intervention that is aimed at reducing alcohol use among heavy drinking college students aged 18 to 24 years old. The effectiveness of the What Do You Drink web-based brief alcohol intervention will be tested among 908 heavy drinking college students in a two-arm parallel group randomized controlled trial. Participants will be allocated at random to either the experimental (N=454: web-based brief alcohol intervention) or control condition (N=454: no intervention). The primary outcome measure will be the percentage of participants who drink within the normative limits of the Dutch National Health Council for low-risk drinking. These limits specify that, for heavy alcohol use, the mean consumption cannot exceed 14 or 21 glasses of standard alcohol units per week for females and males, respectively, while for binge drinking, the consumption cannot exceed five or more glasses of standard alcohol units on one drinking occasion at least once per week within one month and six months after the intervention. Reductions in mean weekly alcohol consumption and frequency of binge drinking are also primary outcome measures. Weekly Ecological Momentary Assessment will measure alcohol-related cognitions, that is, attitudes, self-efficacy, subjective norms and alcohol expectancies, which will be included as the secondary outcome measures. This study protocol describes the two-arm parallel group randomized controlled trial developed to evaluate the effectiveness of a web-based brief alcohol intervention. We expect a reduction of mean weekly alcohol

  14. The Effects of Twelve Weeks of Tai Chi Practice on Anxiety in Stressed But Healthy People Compared to Exercise and Wait-List Groups-A Randomized Controlled Trial.

    PubMed

    Zheng, Shuai; Kim, Christine; Lal, Sara; Meier, Peter; Sibbritt, David; Zaslawski, Chris

    2017-06-13

    This randomized controlled trial was undertaken to determine whether 12 weeks of Tai Chi (TC) practice can reduce anxiety in healthy but stressed people. Fifty participants were randomized into TC (n=17), exercise (n=17), and wait-list (WL) groups (n=16). Outcome measures used were State Trait Anxiety Inventory, Perceived Stress Scale 14 (PSS14), blood pressure and heart rate variability, visual analogue scale (VAS), and Short Form 36. Significant improvements were observed from baseline for both TC and exercise groups for both state (p <0.01) and trait (p <0.01) anxiety, PSS14 (p <0.01), VAS (p <0.01), mental health domain (p <0.01), and vitality domain (p <0.01). Superior outcomes were also observed for TC when compared with WL for state and trait anxiety (p <0.01) and mental health domain (p <0.05). TC reduces stress levels in healthy individuals and provides a safer, cost effective, and less physically vigorous alternative to exercise. © 2017 Wiley Periodicals, Inc.

  15. Thermal Control Working Group report

    NASA Technical Reports Server (NTRS)

    Haslett, Robert; Mahefkey, E. Thomas

    1986-01-01

    The Thermal Control Working Group limited its evaluation to issues associated with Earth orbiting and planetary spacecraft with power levels up to 50 kW. It was concluded that the space station technology is a necessary precursor but does not meet S/C 2000 needs (life, high heat flux, long term cryogenics, and survivability). Additional basic and applied research are required (fluid/materials compatibility and two phase system modeling). Scaling, the key issue, must define accelerated life test criteria. The two phase systems require 0g to 1 g correlation. Additional ground test beds are required and combined space environment tests of materials.

  16. Dietary supplementation with rice bran fermented with Lentinus edodes increases interferon-γ activity without causing adverse effects: a randomized, double-blind, placebo-controlled, parallel-group study

    PubMed Central

    2014-01-01

    Background The purpose of this study was to investigate the hypothesis that dietary supplementation with rice bran fermented with Lentinus edodes (rice bran exo-biopolymer, RBEP), a substance known to contain arabinoxylan, enhances natural killer (NK) cell activity and modulates cytokine production in healthy adults. Methods This study was designed in a randomized, double-blind, placebo-controlled, and parallel-group format. Eighty healthy participants with white blood cell counts of 4,000-8,000 cells/μL were randomly assigned to take six capsules per day of either 3 g RBEP or 3 g placebo for 8 weeks. Three participants in the placebo group were excluded after initiation of the protocol; no severe adverse effects from RBEP supplementation were reported. NK cell activity of peripheral blood mononuclear cells was measured using nonradioactive cytotoxicity assay kits and serum cytokine concentrations included interferon (IFN)-γ, tumor necrosis factor (TNF)-α, interleukin (IL)-2, IL-4, IL-10, and IL-12 were measured by Bio-Plex cytokine assay kit. This study was registered with the Clinical Research Information Service (KCT0000536). Results Supplementation of RBEP significantly increased IFN-γ production compared with the placebo group (P = 0.012). However, RBEP supplementation did not affect either NK cell activity or cytokine levels, including IL-2, IL-4, IL-10, IL-12, and TNF-α, compared with the placebo group. Conclusions The data obtained in this study indicate that RBEP supplementation increases IFN-γ secretion without causing significant adverse effects, and thus may be beneficial to healthy individuals. This new rice bran-derived product may therefore be potentially useful to include in the formulation of solid and liquid foods designed for treatment and prevention of pathological states associated with defective immune responses. PMID:24755139

  17. Dietary supplementation with rice bran fermented with Lentinus edodes increases interferon-γ activity without causing adverse effects: a randomized, double-blind, placebo-controlled, parallel-group study.

    PubMed

    Choi, Ji-Young; Paik, Doo-Jin; Kwon, Dae Young; Park, Yongsoon

    2014-04-22

    The purpose of this study was to investigate the hypothesis that dietary supplementation with rice bran fermented with Lentinus edodes (rice bran exo-biopolymer, RBEP), a substance known to contain arabinoxylan, enhances natural killer (NK) cell activity and modulates cytokine production in healthy adults. This study was designed in a randomized, double-blind, placebo-controlled, and parallel-group format. Eighty healthy participants with white blood cell counts of 4,000-8,000 cells/μL were randomly assigned to take six capsules per day of either 3 g RBEP or 3 g placebo for 8 weeks. Three participants in the placebo group were excluded after initiation of the protocol; no severe adverse effects from RBEP supplementation were reported. NK cell activity of peripheral blood mononuclear cells was measured using nonradioactive cytotoxicity assay kits and serum cytokine concentrations included interferon (IFN)-γ, tumor necrosis factor (TNF)-α, interleukin (IL)-2, IL-4, IL-10, and IL-12 were measured by Bio-Plex cytokine assay kit. This study was registered with the Clinical Research Information Service (KCT0000536). Supplementation of RBEP significantly increased IFN-γ production compared with the placebo group (P = 0.012). However, RBEP supplementation did not affect either NK cell activity or cytokine levels, including IL-2, IL-4, IL-10, IL-12, and TNF-α, compared with the placebo group. The data obtained in this study indicate that RBEP supplementation increases IFN-γ secretion without causing significant adverse effects, and thus may be beneficial to healthy individuals. This new rice bran-derived product may therefore be potentially useful to include in the formulation of solid and liquid foods designed for treatment and prevention of pathological states associated with defective immune responses.

  18. Top-down control in contour grouping.

    PubMed

    Volberg, Gregor; Wutz, Andreas; Greenlee, Mark W

    2013-01-01

    Human observers tend to group oriented line segments into full contours if they follow the Gestalt rule of 'good continuation'. It is commonly assumed that contour grouping emerges automatically in early visual cortex. In contrast, recent work in animal models suggests that contour grouping requires learning and thus involves top-down control from higher brain structures. Here we explore mechanisms of top-down control in perceptual grouping by investigating synchronicity within EEG oscillations. Human participants saw two micro-Gabor arrays in a random order, with the task to indicate whether the first (S1) or the second stimulus (S2) contained a contour of collinearly aligned elements. Contour compared to non-contour S1 produced a larger posterior post-stimulus beta power (15-21 Hz). Contour S2 was associated with a pre-stimulus decrease in posterior alpha power (11-12 Hz) and in fronto-posterior theta (4-5 Hz) phase couplings, but not with a post-stimulus increase in beta power. The results indicate that subjects used prior knowledge from S1 processing for S2 contour grouping. Expanding previous work on theta oscillations, we propose that long-range theta synchrony shapes neural responses to perceptual groupings regulating lateral inhibition in early visual cortex.

  19. Comparison of topiroxostat and allopurinol in Japanese hyperuricemic patients with or without gout: a phase 3, multicentre, randomized, double-blind, double-dummy, active-controlled, parallel-group study.

    PubMed

    Hosoya, T; Ogawa, Y; Hashimoto, H; Ohashi, T; Sakamoto, R

    2016-06-01

    There are no clinical reports that have compared topiroxostat, a selective xanthine oxidase inhibitor, with allopurinol in serum urate-lowering efficacy. The aim of this study was to compare the efficacy and safety of topiroxostat and allopurinol in Japanese hyperuricemic patients with or without gout. A phase 3, multicentre, randomized, double-blind, double-dummy, active-controlled, parallel-group study conducted in Japan. Patients who had inadequate serum urate levels (a gout patient: serum urate level ≥416·4 μmol/L; an asymptomatic hyperuricemic patient with specific complications (urinary lithiasis, hypertension, hyperlipidemia and/or diabetes): serum urate level ≥475·8 μmol/L; and an asymptomatic hyperuricemic patient with no specific complications: serum urate level ≥535·3 μmol/L) were randomized to topiroxostat 120 mg/day or allopurinol 200 mg/day, with an equal allocation ratio, for 16 weeks. To prevent the onset of gouty arthritis by rapid serum urate reduction, these doses were increased in a stepwise manner. The primary efficacy endpoint was the per cent change in serum urate level from baseline to the final visit. Overall, 206 patients were randomly assigned to topiroxostat and allopurinol. Two hundred and three patients (allopurinol: n = 105, topiroxostat: n = 98) received at least one dose of the study drug and had their serum urate level assessed at least once. The baseline characteristics were comparable between groups. The mean age of patients was 53·0 ± 11·4 years and 99% of patients were male. The primary efficacy endpoint was -34·3 ± 11·1% in the allopurinol group (n = 105) and -36·3 ± 12·7% in the topiroxostat group (n = 98). Non-inferiority of the serum urate-lowering efficacy of topiroxostat to allopurinol was proved by the predefined non-inferiority margin (95% confidence interval, -5·3 to 1·3%). The overall incidences of adverse events and adverse drug reactions were similar between both groups. Topiroxostat 120 mg

  20. Effects of single-dose injectable paracetamolversus propacetamol in pain management after minor gynecologic surgery: A multicenter, randomized, double-blind, active-controlled, two-parallel-group study.

    PubMed

    Marty, Jean; Benhamou, Dan; Chassard, Dominique; Emperaire, Nicole; Roche, Alain; Mayaud, Annick; Haro, Dominique; Baron, Xavier; Hiesse-Provost, Odile

    2005-07-01

    Intravenous administration is the route of choice for drug therapy in the immediate postoperative period. Propacetamol (ProAPAP), an injectable prodrug of paracetamol requiring reconstitution, has demonstrated efficacy in managing acute pain and fever. However, it has been associated with pain at the injection site. A stable, ready-to-use formulation of paracetamol solution infused intravenously (IV-APAP) has been developed and might be associated with less pain at the injection site compared with ProAPAR. The objective of this study was to assess the tolerability and efficacy of a single dose of IV APAP 1 g compared with those of a single dose of ProAPAP 2 g in patients with moderate to severe pain after minor gynecologic surgery. This single-dose, randomized, double-blind, active-controlled,2-parallel-group study was conducted at 23 hospitals and outpatient clinics in France. After minor gynecologic surgery, patients reporting moderate to severe pain were randomized to receive a single 15-minute infusion of IV-APAP 1 g or ProAPAP 2 g (bioeyuivalent doses). Tolerability was monitored using local and systemic adverse event (AE) reporting, clinical examination including vital sign measurement, and patients' ratings of acceptability of the infusion. Efficacy end points included pain intensity at 0, 1, 2, 4, and 6 hours; median time to rescue medication (defined as the time at which 50% of patients requested rescue medication); and percentage of patients requesting rescue medication. Patients' satisfaction with the study drugs was assessed using patient's global evaluation (PGE) and the percentage of patients willing to receive the treatment again. Of the 163 women who were randomized, 161 received the studymedication. The IV-APAP group comprised 80 patients (mean [SD] age, 38.3 [12.8] years [range, 18.0-69.0 years]; mean [SD] weight, 61.1 [11.0] kg [range, 49.0-90.0 kg]), and the ProAPAP group comprised 81 patients (mean [SD] age, 33.9 [12.0] years [range, 18

  1. "A randomized controlled trial on the efficacy of mindfulness-based cognitive therapy and a group version of cognitive behavioral analysis system of psychotherapy for chronically depressed patients": Correction to Michalak et al. (2015).

    PubMed

    2016-06-01

    Reports an error in "A randomized controlled trial on the efficacy of mindfulness-based cognitive therapy and a group version of cognitive behavioral analysis system of psychotherapy for chronically depressed patients" by Johannes Michalak, Martin Schultze, Thomas Heidenreich and Elisabeth Schramm (Journal of Consulting and Clinical Psychology, 2015[Oct], Vol 83[5], 951-963). In the article there was an error in the Method section in the Statistical Analysis subsection. The last sentence in the seventh paragraph should read "A remitter was defined as a participant with a HAM-D score of 8 or less at posttreatment." (The following abstract of the original article appeared in record 2015-36864-001.) Mindfulness-based cognitive therapy (MBCT) has recently been proposed as a treatment option for chronic depression. The cognitive behavioral analysis system of psychotherapy (CBASP) is the only approach specifically developed to date for the treatment of chronically depressed patients. The efficacy of MBCT plus treatment-as-usual (TAU), and CBASP (group version) plus TAU, was compared to TAU alone in a prospective, bicenter, randomized controlled trial. One hundred and six patients with a current DSM-IV defined major depressive episode and persistent depressive symptoms for more than 2 years were randomized to TAU only (N = 35), or to TAU with additional 8-week group therapy of either 8 sessions of MBCT (n = 36) or CBASP (n = 35). The primary outcome measure was the Hamilton Depression Rating Scale (24-item HAM-D, Hamilton, 1967) at the end of treatment. Secondary outcome measures were the Beck Depression Inventory (BDI; Beck, Steer, & Brown, 1996) and measures of social functioning and quality of life. In the overall sample as well as at 1 treatment site, MBCT was no more effective than TAU in reducing depressive symptoms, although it was significantly superior to TAU at the other treatment site. CBASP was significantly more effective than TAU in reducing depressive

  2. Comparison of the effects of ossein-hydroxyapatite complex and calcium carbonate on bone metabolism in women with senile osteoporosis: a randomized, open-label, parallel-group, controlled, prospective study.

    PubMed

    Ciria-Recasens, Manel; Blanch-Rubió, Josep; Coll-Batet, Mónica; Del Pilar Lisbona-Pérez, María; Díez-Perez, Adolfo; Carbonell-Abelló, Jordi; Manasanch, José; Pérez-Edo, Lluís

    2011-12-01

    Calcium and vitamin D supplementation is recommended in patients with osteopenia and osteoporosis. One group that could benefit from this treatment is women with senile osteoporosis. Two sources of supplementary calcium are ossein-hydroxyapatite complex (OHC) and calcium carbonate, but, to date, their comparative effects on bone metabolism have not been studied in women with senile osteoporosis. The objective of this study was to compare the effects of OHC and calcium carbonate on bone metabolism in women with senile osteoporosis. This was a randomized, open-label, parallel-group, controlled, prospective study to compare the effects of OHC (treatment group) and calcium carbonate (control group) on bone metabolism. Patients were included between 2000 and 2004 and followed up for a maximum of 3 years. The study was carried out at the bone metabolism unit of two university hospitals in Barcelona, Spain. Subjects were women aged >65 years with densitometric osteoporosis of the lumbar spine or femoral neck. The treatment group received open-label OHC (Osteopor®) at a dose of two 830 mg tablets every 12 hours (712 mg elemental calcium per day). The control group received open-label calcium carbonate at a dose of 500 mg of elemental calcium every 12 hours (1000 mg elemental calcium per day). Both groups also received a vitamin D supplement (calcifediol 266 μg) at a dose of one vial orally every 15 days. Biochemical markers of bone remodelling (osteocalcin by electrochemiluminescence, tartrate-resistant acid phosphatase using colorimetry) were measured at baseline and annually for 3 years. Bone mineral density (BMD) at the lumbar spine and femoral neck was also measured. One hundred and twenty women were included (55 in the OHC group and 65 in the calcium carbonate group), of whom 54 completed 3 years of follow-up. Levels of serum osteocalcin increased to a greater extent in the OHC group compared with the calcium carbonate group (by a mean ± SD of 0.84

  3. Cost-Utility of Group Acceptance and Commitment Therapy for Fibromyalgia Versus Recommended Drugs: An Economic Analysis Alongside a 6-Month Randomized Controlled Trial Conducted in Spain (EFFIGACT Study).

    PubMed

    Luciano, Juan V; D'Amico, Francesco; Feliu-Soler, Albert; McCracken, Lance M; Aguado, Jaume; Peñarrubia-María, María T; Knapp, Martin; Serrano-Blanco, Antoni; García-Campayo, Javier

    2017-07-01

    The aim of this study was to analyze the cost utility of a group-based form of acceptance and commitment therapy (GACT) in patients with fibromyalgia (FM) compared with patients receiving recommended pharmacological treatment (RPT) or on a waiting list (WL). The data were derived from a previously published study, a randomized controlled trial that focused on clinical outcomes. Health economic outcomes included health-related quality of life and health care use at baseline and at 6-month follow-up using the EuroQoL and the Client Service Receipt Inventory, respectively. Analyses included quality-adjusted life years, direct and indirect cost differences, and incremental cost effectiveness ratios. A total of 156 FM patients were randomized (51 GACT, 52 RPT, 53 WL). GACT was related to significantly less direct costs over the 6-month study period compared with both control arms (GACT €824.2 ± 1,062.7 vs RPT €1,730.7 ± 1,656.8 vs WL €2,462.7 ± 2,822.0). Lower direct costs for GACT compared with RPT were due to lower costs from primary care visits and FM-related medications. The incremental cost effectiveness ratios were dominant in the completers' analysis and remained robust in the sensitivity analyses. In conclusion, acceptance and commitment therapy appears to be a cost-effective treatment compared with RPT in patients with FM. Decision-makers have to prioritize their budget on the treatment option that is the most cost effective for the management of a specific patient group. From government as well as health care perspectives, this study shows that a GACT is more cost effective than pharmacological treatment in management of FM. Copyright © 2017 American Pain Society. Published by Elsevier Inc. All rights reserved.

  4. Efficacy and safety of rebamipide liquid for chemoradiotherapy-induced oral mucositis in patients with head and neck cancer: a multicenter, randomized, double-blind, placebo-controlled, parallel-group phase II study.

    PubMed

    Yokota, T; Ogawa, T; Takahashi, S; Okami, K; Fujii, T; Tanaka, K; Iwae, S; Ota, I; Ueda, T; Monden, N; Matsuura, K; Kojima, H; Ueda, S; Sasaki, K; Fujimoto, Y; Hasegawa, Y; Beppu, T; Nishimori, H; Hirano, S; Naka, Y; Matsushima, Y; Fujii, M; Tahara, M

    2017-05-05

    Recent preclinical and phase I studies have reported that rebamipide decreased the severity of chemoradiotherapy-induced oral mucositis in patients with oral cancer. This placebo-controlled randomized phase II study assessed the clinical benefit of rebamipide in reducing the incidence of severe chemoradiotherapy-induced oral mucositis in patients with head and neck cancer (HNC). Patients aged 20-75 years with HNC who were scheduled to receive chemoradiotherapy were enrolled. Patients were randomized to receive rebamipide 2% liquid, rebamipide 4% liquid, or placebo. The primary endpoint was the incidence of grade ≥ 3 oral mucositis determined by clinical examination and assessed by central review according to the Common Terminology Criteria of Adverse Events version 3.0. Secondary endpoints were the time to onset of grade ≥ 3 oral mucositis and the incidence of functional impairment (grade ≥ 3) based on the evaluation by the Oral Mucositis Evaluation Committee. From April 2014 to August 2015, 97 patients with HNC were enrolled, of whom 94 received treatment. The incidence of grade ≥ 3 oral mucositis was 29% and 25% in the rebamipide 2% and 4% groups, respectively, compared with 39% in the placebo group. The proportion of patients who did not develop grade ≥ 3 oral mucositis by day 50 of treatment was 57.9% in the placebo group, whereas the proportion was 68.0% in the rebamipide 2% group and 71.3% in the rebamipide 4% group. The incidences of adverse events potentially related to the study drug were 16%, 26%, and 13% in the placebo, rebamipide 2%, and rebamipide 4% groups, respectively. There was no significant difference in treatment compliance among the groups. The present phase II study suggests that mouth washing with rebamipide may be effective and safe for patients with HNC receiving chemoradiotherapy, and 4% liquid is the optimal dose of rebamipide. ClinicalTrials.gov under the identifier NCT02085460 (the date of trial registration: March

  5. The effect of addition of low dose fentanyl to epidural bupivacaine (0.5%) in patients undergoing elective caesarean section: A randomized, parallel group, double blind, placebo controlled study

    PubMed Central

    Parate, LH; Manjrekar, SP; Anandaswamy, TC; Manjunath, B

    2015-01-01

    Background: Opioids have synergistic action with local anesthetics which may alter characteristics of epidural block. Giving opioids to mother before delivery of baby is still fully not accepted with some fearing risk of neonatal depression. Aims: Our primary aim was to evaluate the analgesic effect of addition of 50 μg fentanyl to epidural 0.5% bupivacaine in patients undergoing elective caesarean section using visual analog scale. The secondary aim was to assess onset of analgesia, volume of drug required to achieve T6 level, grade and duration of motor block and Apgar score. Materials and Methods: In this prospective, randomized, double blind, placebo controlled study 64 patients scheduled for elective caesarean section under epidural anesthesia were randomly divided into two groups of 32 each. The fentanyl group received 1ml of 50 μg fentanyl and the saline group received 1ml of normal saline mixed with 10ml of 0.5% bupivacaine for epidural anesthesia. VAS score, time to achieve T6 level, dose of bupivacaine, intraoperative analgesic consumption and duration of analgesia, grade and duration of motor block and any adverse maternal and neonatal effects were noted. Statistical Analysis: Data was analyzed using Students t test, chi-square test and Mann-Whitney U-test. The values of P < 0.05 were considered statistically significant. Results: Fentanyl improved the VAS score significantly (1.6 ± 1.32) compared to the saline group (3.77 ± 1.0, P < 0.0001). It also reduced the intraoperaitve analgesic supplementation compared to the saline group. (P = 0.031). The postoperative duration of analgesia was prolonged in the fentanyl group (275.80 ± 13.61 min) compared to the saline group (191.47 ± 12.16 min, P < 0.0001). The other characteristics of epidural block were unaltered. Conclusion: Addition of 50 μg fentanyl to epidural 0.5% bupivacaine significantly reduces the VAS score. It also reduces intra-operative analgesia supplementation and prolongs the duration

  6. Positive benefits of theophylline in a randomized, double-blind, parallel-group, placebo-controlled study of low-dose, slow-release theophylline in the treatment of COPD for 1 year.

    PubMed

    Zhou, Yumin; Wang, Xiaoping; Zeng, Xiangyi; Qiu, Rong; Xie, Junfeng; Liu, Shengming; Zheng, Jingping; Zhong, Nanshan; Ran, Pixin

    2006-09-01

    Increasing evidence suggests that low-dose theophylline has anti-inflammatory benefits and is safe in the treatment of COPD. This study aims to evaluate the efficacy and safety of low-dose, slow-release oral theophylline administered over a 1-year period in patients with COPD. A randomized, double-blind, parallel-group, placebo-controlled trial was carried out. In total, 110 participants with COPD were randomly assigned to receive slow-release theophylline (100 mg b.i.d.) or placebo for 1 year. Use of medicine and symptoms recorded by diary cards; pulmonary function, exacerbations of COPD, quality of life and the use of rescue medicine were evaluated. Superiority test was used to estimate the efficacy. Of 110 participants, 85 (77.3%) complied with the protocol, with 42 subjects in theophylline and 43 subjects on placebo. In both intention-to-treat and per-protocol population analysis, greater improvement in pre-bronchodilator FEV(1) (P = 0.038 and P = 0.070, respectively), lower frequency of COPD exacerbations (P = 0.047 and P = 0.035, respectively), fewer days of COPD exacerbations (P = 0.045 and P = 0.046, respectively), lower frequency of clinical visits (P = 0.017 and P = 0.039, respectively), greater improvement in satisfaction with treatment (P = 0.014 and P = 0.004, respectively) were found in the theophylline group than in the placebo group. In per-protocol population, greater improvements in quality of life (P = 0.047) were also observed in the theophylline group and the mean time to the first exacerbation was delayed in theophylline group in comparison with placebo group (P = 0.047). Drug-related adverse events such as stomach discomfort (3.51%), headache (3.51%), insomnia (1.75%) and palpitation (1.75%) were found in the theophylline group. Low-dose, slow-release oral theophylline is effective and well-tolerated in the long term treatment of stable COPD, although it does not improve post-bronchodilator lung function.

  7. Results of a randomized, double-blind, parallel-group, placebo- and active-controlled, multicenter study of mirabegron, a β3-adrenoceptor agonist, in patients with overactive bladder in Asia.

    PubMed

    Kuo, Hann-Chorng; Lee, Kyu-Sung; Na, Yanqun; Sood, Rajeev; Nakaji, Shigeru; Kubota, Yosuke; Kuroishi, Kentarou

    2015-09-01

    To assess the efficacy and safety of mirabegron 50 mg once daily compared with placebo and the active control, tolterodine extended-release (ER) 4 mg once daily, in patients with symptoms of overactive bladder (OAB) in Taiwan, Korea, China, and India. A 12-week multinational, randomized, double-blind, parallel-group placebo- and active-controlled trial. The primary efficacy endpoint was change from baseline to final visit in mean number of micturitions/24 hr. Secondary endpoints were: mean number of urgency episodes, incontinence episodes and urge incontinence episodes/24 hr, mean number of nocturia episodes per night, mean volume voided per micturition, and quality-of-life (QoL) scores as assessed by the King's Health Questionnaire (KHQ). Of 1,126 patients who were randomized to receive double-blind study drug, 921 patients (300, 311, and 310 in the placebo, mirabegron 50 mg, and tolterodine ER 4 mg groups, respectively) completed the treatment period. Demographic characteristics were similar across treatment groups. A statistically significant improvement versus placebo in mean number of micturitions/24 hr was seen with mirabegron 50 mg at all timepoints (P < 0.05) as well as final visit (-0.57 with 95% confidence intervals [CIs] of [-1.04, -0.09], P = 0.019). There was no significant difference between treatment groups in improvement from baseline to final visit in any of the secondary outcome measures except volume voided per micturition. The overall incidence of drug-related adverse events was 17.2%, 15.8%, and 21.3%, in the placebo, mirabegron 50 mg, and tolterodine ER 4 mg groups, respectively. Mirabegron 50 mg once daily for 12 weeks was superior to placebo in reducing the frequency of micturitions in patients with symptoms of OAB in Taiwan, Korea, China, and India. © 2014 Wiley Periodicals, Inc.

  8. Multicenter, double-blind, randomized, placebo-controlled, parallel-group study of the efficacy, safety, and tolerability of THC:CBD extract and THC extract in patients with intractable cancer-related pain.

    PubMed

    Johnson, Jeremy R; Burnell-Nugent, Mary; Lossignol, Dominique; Ganae-Motan, Elena Doina; Potts, Richard; Fallon, Marie T

    2010-02-01

    This study compared the efficacy of a tetrahydrocannabinol:cannabidiol (THC:CBD) extract, a nonopioid analgesic endocannabinoid system modulator, and a THC extract, with placebo, in relieving pain in patients with advanced cancer. In total, 177 patients with cancer pain, who experienced inadequate analgesia despite chronic opioid dosing, entered a two-week, multicenter, double-blind, randomized, placebo-controlled, parallel-group trial. Patients were randomized to THC:CBD extract (n = 60), THC extract (n = 58), or placebo (n = 59). The primary analysis of change from baseline in mean pain Numerical Rating Scale (NRS) score was statistically significantly in favor of THC:CBD compared with placebo (improvement of -1.37 vs. -0.69), whereas the THC group showed a nonsignificant change (-1.01 vs. -0.69). Twice as many patients taking THC:CBD showed a reduction of more than 30% from baseline pain NRS score when compared with placebo (23 [43%] vs. 12 [21%]). The associated odds ratio was statistically significant, whereas the number of THC group responders was similar to placebo (12 [23%] vs. 12 [21%]) and did not reach statistical significance. There was no change from baseline in median dose of opioid background medication or mean number of doses of breakthrough medication across treatment groups. No significant group differences were found in the NRS sleep quality or nausea scores or the pain control assessment. However, the results from the European Organisation for Research and Treatment of Cancer Quality of Life Cancer Questionnaire showed a worsening in nausea and vomiting with THC:CBD compared with placebo (P = 0.02), whereas THC had no difference (P = 1.0). Most drug-related adverse events were mild/moderate in severity. This study shows that THC:CBD extract is efficacious for relief of pain in patients with advanced cancer pain not fully relieved by strong opioids. Copyright 2010 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.

  9. A randomized, double-blind, active-controlled, double-dummy, parallel-group study to determine the safety and efficacy of oxycodone/naloxone prolonged-release tablets in patients with moderate/severe, chronic cancer pain

    PubMed Central

    Ahmedzai, Sam H; Nauck, Friedemann; Bar-Sela, Gil; Bosse, Björn; Leyendecker, Petra

    2012-01-01

    Objective: An examination of whether oxycodone/naloxone prolonged-release tablets (OXN PR) can improve constipation and maintain analgesia, compared with oxycodone prolonged-release tablets (OxyPR) in patients with moderate/severe cancer pain. Methods: Randomized, double-blind, active-controlled, double-dummy, parallel-group study in which 185 patients were randomized to receive up to 120 mg/day of OXN PR or OxyPR over 4 weeks. Efficacy assessments included Bowel Function Index (BFI), Brief Pain Inventory Short-Form (BPI-SF), laxative and rescue medication use. Quality of life (QoL) and safety assessments were conducted. Results: After 4 weeks, mean BFI score was significantly lower with OXN PR; mean total laxative intake was 20% lower with OXN PR. Mean BPI-SF scores were similar for both treatments and the average rate of analgesic rescue medication use was low and comparable. QoL assessments were stable and comparable with greater improvements in constipation-specific QoL assessments with OXN PR. Overall, rates of adverse drug reactions were similar. Conclusions: OXN PR provides superior bowel function in cancer pain patients, compared with OxyPR, without compromising analgesic efficacy or safety. This study confirms that OXN PR is well tolerated and efficacious in cancer pain patients and results are in line with those seen in non-malignant pain patients. PMID:21937568

  10. A community-based, culturally relevant intervention to promote healthy eating and physical activity among middle-aged African American women in rural Alabama: Findings from a group randomized controlled trial

    PubMed Central

    Scarinci, Isabel C.; Moore, Artisha; Wynn, Theresa; Cherrington, Andrea; Fouad, Mona; Li, Yufeng

    2015-01-01

    Objective We examined the efficacy of a community-based, culturally relevant intervention to promote healthy eating and physical activity among African American (AA) women between the ages of 45–65 years, residing in rural Alabama. Methods We conducted a group randomized controlled trial with counties as the unit of randomization that evaluated two interventions based on health priorities identified by the community: (1) promotion of healthy eating and physical activity; and (2) promotion of breast and cervical cancer screening. A total of 6 counties with 565 participants were enrolled in the study between November 2009 and October 2011. Results The overall retention rate at 24-month follow-up was 54.7%. Higher retention rate was observed in the “healthy lifestyle” arm (63.1%) as compared to the “screening” arm (45.3%). Participants in the “healthy lifestyle” arm showed significant positive changes compared to the “screening” arm at 12-month follow-up with regard to decrease in fried food consumption and an increase in both fruit/vegetable intake and physical activity. At 24-month follow-up, these positive changes were maintained with healthy eating behaviors, but not engagement in physical activity. Conclusions A culturally relevant intervention, developed in collaboration with the target audience, can improve (and maintain) healthy eating among AA women living in rural areas. PMID:25152504

  11. A review of the 2001 Volvo Award winner in clinical studies: lumbar fusion versus nonsurgical treatment for chronic low back pain: a multicenter randomized controlled trial from the Swedish lumbar spine study group.

    PubMed

    Kwon, Brian; Katz, Jeffrey N; Kim, David H; Jenis, Louis G

    2006-01-15

    The current debate over the efficacy of lumbar fusion for low back pain has not been settled. Fritzell et al published a landmark paper entitled "Lumbar fusion versus nonsurgical treatment for chronic low back pain: a multicenter randomized controlled trial from the Swedish lumbar spine study group." Their goal was to provide objective evidence supporting lumbar fusion. While it was well designed and important to our knowledge base, it has limitations. We set out to review their work in an unbiased yet critical manner. Our goals are to summarize the strengths and weaknesses of the paper, place it in the context of current knowledge, and highlight its significance for present-day practice and research. From technical and study design perspectives, Fritzell et al were able to validate the use of lumbar fusion for the treatment of low back pain. However, their use of "usual nonoperative" care and nonspecific definition of low back pain precluded a truly genuine comparison of operative and nonoperative groups. We commend the Swedish lumbar spine study group and their remarkable efforts; they elevated the sophistication of spine research and spawned many more excellent works to help settle the ongoing controversy on the ideal treatment of low back pain.

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

    PubMed

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

    2016-07-26

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

  13. Take A Breath: study protocol for a randomized controlled trial of an online group intervention to reduce traumatic stress in parents of children with a life threatening illness or injury.

    PubMed

    Rayner, Meredith; Muscara, Frank; Dimovski, Anica; McCarthy, Maria C; Yamada, Jackie; Anderson, Vicki A; Burke, Kylie; Walser, Robyn; Nicholson, Jan M

    2016-05-27

    A substantial proportion of parents whose child is diagnosed with a life-threatening illness, experience high levels of distress that can lead to long-term difficulties in mental health, family functioning and child adjustment. This study evaluates the efficacy of an Acceptance Commitment Therapy-based group intervention designed to reduce distress symptoms in these parents. The program is delivered using videoconferencing to overcome factors that prevent participation in traditional face-to-face therapy. The study is a randomized control trial of the Take A Breath group intervention for parents demonstrating elevated symptoms of acute stress, delivered via videoconferencing in six 90 min group sessions. Participants are the primary caregivers of children aged 0 to 18 years admitted for a life threatening illness or injury to the Oncology, Cardiology, Neurology or Intensive Care Departments of a tertiary pediatric hospital. Parents will be randomized to intervention or waitlist control 4-10 months after their child's diagnosis. Measures will be collected prior to and immediately post intervention for intervention and waitlist parents to assess program efficacy. Intervention parents will be followed up at 6 months to assess the maintenance of program effects. We predict that intervention parents will show fewer symptoms post intervention than waitlist parents (primary outcomes: traumatic stress, depression, anxiety, stress symptoms), reflecting improvements in the psychological skills addressed in the intervention (mediating factors). It is anticipated that reductions in mental health difficulties for intervention parents will be maintained up to 6 months post-intervention and will be associated with broader improvements in parents' adjustment, child adjustment and child wellbeing (secondary outcomes). This study is unique in evaluating a group intervention delivered to parents of children affected by of a diverse range life-threatening illness or injury

  14. Potential explanations for control group benefit.

    PubMed

    Nichols, Linda O; Martindale-Adams, Jennifer L; Burns, Robert; Graney, Marshall J; Zuber, Jeffrey K; Kennedy, Sarah E

    2012-10-01

    Estimating effectiveness of clinical interventions depends on detecting differences between the responses of intervention and control groups. The outcome, intervention, and moderating factors all may influence the between group change. The absence of a clinically or statistically meaningful difference may also result from control group improvement due to nonspecific factors such as participants' perception of attention, positive regard, expectations, desire to please, and therapeutic alliance with the care provider. We examined perceived benefit and sources of benefit for control caregivers who participated in the CONNECT randomized controlled trial of a dementia caregiving intervention. After the final scheduled data collection in CONNECT, control group participants were asked whether they believed they benefited from study participation. Those who reported benefit were asked to describe the benefit received. Data were analyzed qualitatively. Of 60 available control caregivers, 82% reported a perceived benefit from study participation in five areas: getting information about dementia and caregiving; having someone to talk to and feeling supported; receiving understanding and validation of feelings; knowledge that others were in similar situations; and perceived appreciation of own abilities. Control caregivers who reported benefit were less burdened and depressed and spent less time on duty at baseline than those who did not report benefit. From caregivers' responses, we have identified the assessment battery, both content and time spent in data collection, as a possible mechanism of action for benefit. Study limitations include the better baseline characteristics of the control caregivers who reported benefit, the sample size of benefit control caregivers, the possibility of perceptions of benefit being a function of social desirability, and the lack of a similar question about benefit being asked of intervention caregivers. These findings suggest that the

  15. A primer on randomized controlled trials.

    PubMed

    Likosky, Donald S

    2006-03-01

    Randomized Clinical Trials are held as the gold standard for quantifying the effect of an intervention across two or more groups. In such a trial an intervention is randomly allocated to one of two groups. The benefit of such a trial lies in its ability to establish nearly comparable groups of subjects in all manner except for the effect of the intervention. As such, the effect of a given intervention may be attributed solely to the intervention and not to any other extraneous factor. In the following editorial, we will discuss several issues that are important for understanding how to conduct and interpret randomized trials: choosing the study population, choosing the comparison group, choosing your outcome, study design, data analysis, and issues of inference. This editorial is intended to make the reader an educated consumer of such trial designs.

  16. IRINI: random group allocation of multiple prognostic factors.

    PubMed

    Kasturi, Jyotsna; Geisler, John G; Liu, Jianying; Kirchner, Thomas; Amaratunga, Dhammika; Lubomirski, Mariusz

    2011-05-01

    Statistically sound experimental design in pharmacology studies ensures that the known prognostic factors, if any, are equally represented across investigational groups to avoid bias and imbalance which could render the experiment invalid or lead to false conclusions. Complete randomization can be effective to reduce bias in the created groups especially in large sample size situations. However, in small studies which involve only few treatment subjects, as in preclinical trials, there is a high chance of imbalance. The effects of this imbalance may be removed through covariate analysis or prevented with stratified randomization, however small studies limit the number of covariates to be analyzed this way. The problem is accentuated when there are multiple baseline covariates with varying scales and magnitudes to be considered in the randomization, and creating a balanced solution becomes a combinatorial challenge. Our method, IRINI, uses an optimization technique to achieve treatment to subject group allocation across multiple prognostic factors concurrently. It ensures that the created groups are equal in size and statistically comparable in terms of mean and variance. This method is a novel application of genetic algorithms to solve the allocation problem and simultaneously ensure quality, speed of the results and randomness of the process. Results from preclinical trials demonstrate the effectiveness of the method. Copyright © 2010 Elsevier Inc. All rights reserved.

  17. Effectiveness of the Lunch is in the Bag program on communication between the parent, child and child-care provider around fruits, vegetables and whole grain foods: A group-randomized controlled trial.

    PubMed

    Sharma, Shreela V; Rashid, Tasnuva; Ranjit, Nalini; Byrd-Williams, Courtney; Chuang, Ru-Jye; Roberts-Gray, Cynthia; Briley, Margaret; Sweitzer, Sara; Hoelscher, Deanna M

    2015-12-01

    To evaluate the effectiveness of the parent- and early care education (ECE) center-based Lunch is in the Bag program on communication between parent, child, and their ECE center providers around fruits, vegetables and whole grain foods (FVWG). A total of n=30 ECE center; 577 parent-child dyads participated in this group-randomized controlled trial conducted from 2011 to 2013 in Texas (n=15 ECE center, 327 dyads intervention group; n=15 ECE center, 250 dyads comparison group). Parent-child and parent-ECE center provider communication was measured using a parent-reported survey administered at baseline and end of the five-week intervention period. Multilevel linear regression analysis was used to compare the pre-to-post intervention changes in the parent-child and parent-ECE center provider communication scales. Significance was set at p<0.05. At baseline, parent-child and parent-ECE center provider communication scores were low. There was a significant increase post-intervention in the parent-ECE center provider communication around vegetables (Adjusted β=0.78, 95%CI: 0.13, 1.43, p=0.002), and around fruit (Adjusted β=0.62, 95%CI: 0.04, 0.20, p=0.04) among the parents in the intervention group as compared to those in the comparison group. There were no significant intervention effects on parent-child communication. Lunch is in the Bag had significant positive effects on improving communication between the parents and ECE center providers around FVWG. Copyright © 2015 Elsevier Inc. All rights reserved.

  18. Effectiveness of the Lunch is in the Bag program on communication between the parent, child and child-care provider around fruits, vegetables and whole grain foods: a group-randomized controlled trial

    PubMed Central

    Rashid, Tasnuva; Ranjit, Nalini; Byrd-Williams, Courtney; Chuang, Ru-Jye; Roberts-Gray, Cindy; Briley, Margaret; Sweitzer, Sara; Hoelscher, Deanna M.

    2015-01-01

    Objective To evaluate the effectiveness of the parent- and early care education (ECE) center-based Lunch is in the Bag program on communication between parent, child, and their ECE center providers around fruits, vegetables and whole grain foods (FVWG). Method A total of n=30 ECE center; 577 parent-child dyads participated in this group-randomized controlled trial conducted from 2011–2013 in Texas (n=15 ECE center, 327 dyads intervention group; n=15 ECE center, 250 dyads comparison group). Parent-child and parent-ECE center provider communication was measured using a parent-reported survey administered at baseline and end of the five-week intervention period. Multilevel linear regression analysis was used to compare the pre-to-post intervention changes in the parent-child and parent-ECE center provider communication scales. Significance was set at p<0.05. Results At baseline, parent-child and parent-ECE center provider communication scores were low. There was a significant increase post-intervention in the parent-ECE center provider communication around vegetables (Adjusted β = 0.78, 95%CI: 0.13, 1.43, p=0.002), and around fruit (Adjusted β = 0.62, 95%CI: 0.04, 0.20, p=0.04) among the parents in the intervention group as compared to those in the comparison group. There were no significant intervention effects on parent-child communication. Conclusion Lunch is in the Bag had significant positive effects on improving communication between the parents and ECE center providers around FVWG. PMID:26190371

  19. Random allocation in controlled clinical trials: a review.

    PubMed

    Egbewale, Bolaji Emmanuel

    2014-01-01

    An allocation strategy that allows for chance placement of participants to study groups is crucial to the experimental nature of randomised controlled trials. Following decades of the discovery of randomisation considerable erroneous opinion and misrepresentations of its concept both in principle and practice still exists. In some circles, opinions are also divided on the strength and weaknesses of each of the random allocation strategies. This review provides an update on various random allocation techniques so as to correct existing misconceptions on this all important procedure. This is a review of literatures published in the Pubmed database on concepts of common allocation techniques used in controlled clinical trials. Allocation methods that use; case record number, date of birth, date of presentation, haphazard or alternating assignment are non-random allocation techniques and should not be confused as random methods. Four main random allocation techniques were identified. Minimisation procedure though not fully a random technique, however, proffers solution to the limitations of stratification at balancing for multiple prognostic factors, as the procedure makes treatment groups similar in several important features even in small sample trials. Even though generation of allocation sequence by simple randomisation procedure is easily facilitated, a major drawback of the technique is that treatment groups can by chance end up being dissimilar both in size and composition of prognostic factors. More complex allocation techniques that yield more comparable treatment groups also have certain drawbacks. However, it is important that whichever allocation technique is employed, unpredictability of random assignment should not be compromised.

  20. Agrobacterium sp.-derived β-1,3-glucan enhances natural killer cell activity in healthy adults: a randomized, double-blind, placebo-controlled, parallel-group study

    PubMed Central

    Lee, Yeon Joo; Paik, Doo-Jin; Kwon, Dae Young; Yang, Hye Jeong

    2017-01-01

    BACKGROUND/OBJECTIVES The present study investigated the hypothesis that a highly pure linear β-1,3-glucan produced by Agrobacterium sp. R259 enhances human natural killer (NK) cell activity and suppresses pro-inflammatory cytokines. SUBJECTS/METHODS In an eight-week, double-blind, randomized, placebo-controlled clinical trial, 83 healthy adults with white blood cell counts of 4,000-8,000 cells/µL were participated and randomly assigned to take two capsules per day containing either 350 mg β-1,3-glucan or placebo. Six participants withdrew their study consent or were excluded due to NK cell activity levels outside the normal range. NK cell activity and serum levels of immunoglobulin G (IgG) and cytokines, such as interferon (IFN)-γ, interleukin (IL)-2, IL-4, IL-6, IL-10, IL-12 and tumor necrosis factor (TNF)-α were measured. RESULTS NK cell activity and the serum levels of IL-10 were significantly higher from baseline to week 8 in the β-glucan group compared with the placebo group (P = 0.048, P = 0.029). Consumption of β-1,3-glucan also significantly increased NK cell activity compared with placebo after adjusting for smoking and stress status (P = 0.009). In particular, the effect of β-1,3-glucan on NK cell activity was greater in participants with severe stress than in those experiencing mild stress. However, the administration β-1,3-glucan did not significantly modulate the levels of IFN-γ, IL-2, IL-4, IL-6, IL-12, TNF-α and IgG compared with the placebo. CONCLUSION The results showed that supplementation with bacterial β-1,3-glucan significantly increased NK cell activity without causing any adverse effects. Additionally, the beneficial effect of β-1,3-glucan on NK cell activity was greater in participants experiencing severe stress. PMID:28194264

  1. A fixed-dose combination of naproxen and esomeprazole magnesium has comparable upper gastrointestinal tolerability to celecoxib in patients with osteoarthritis of the knee: results from two randomized, parallel-group, placebo-controlled trials.

    PubMed

    Cryer, Byron L; Sostek, Mark B; Fort, John G; Svensson, Ola; Hwang, Clara; Hochberg, Marc C

    2011-12-01

    BACKGROUND. Non-steroidal anti-inflammatory drugs are associated with poor upper gastrointestinal (UGI) tolerability and increased ulcer risk, but patient adherence to gastroprotective co-therapy is frequently inadequate. A fixed-dose combination of enteric-coated naproxen 500 mg and immediate-release esomeprazole magnesium 20 mg was evaluated: efficacy is reported by Hochberg et al. (Curr Med Res Opin 2011;27:1243-53); tolerability findings are reported here. PATIENTS AND METHODS. In two 12-week double-blind, placebo-controlled, multicenter, phase III studies (PN400-307 and PN400-309), patients aged ≥ 50 years with symptomatic knee osteoarthritis randomly (2:2:1) received naproxen/esomeprazole magnesium BID, celecoxib 200 mg QD, or placebo. Tolerability end-points included: modified Severity of Dyspepsia Assessment (mSODA); heartburn severity; and UGI adverse events (AEs). RESULTS. Overall, 619 (PN400-307) and 615 (PN400-309) patients were randomized; mSODA scores improved (baseline to week 12) in each group, with no significant treatment differences between naproxen/esomeprazole magnesium and celecoxib (95% CIs: PN400-307: -0.4, 1.9; PN400-309: -1.8, 0.6). Naproxen/esomeprazole magnesium-treated patients reported significantly more heartburn-free days versus celecoxib (95% CIs: PN400-307: 2.1, 12.7; PN400-309: 2.5, 13.4). UGI AE incidence (PN400-307: 17.3%; PN400-309: 20.3%) was similar between treatment groups. UGI AEs resulted in few discontinuations (< 4%, either study). CONCLUSIONS. Naproxen/esomeprazole magnesium has comparable UGI tolerability to celecoxib in patients with osteoarthritis.

  2. A prospective, randomized, double-blind, placebo-controlled parallel-group dual site trial to evaluate the effects of a Bacillus coagulans-based product on functional intestinal gas symptoms

    PubMed Central

    2009-01-01

    Background This randomized double blind placebo controlled dual site clinical trial compared a probiotic dietary supplement to placebo regarding effects on gastrointestinal symptoms in adults with post-prandial intestinal gas-related symptoms (abdominal pain, distention, flatulence) but no gastrointestinal (GI) diagnoses to explain the symptoms. Methods Sixty-one adults were enrolled (age 36.5 ± 12.6 years; height 165.1 ± 9.2 cm; weight 75.4 ± 17.3 kg) and randomized to either Digestive Advantage™ Gas Defense Formula - (GanedenBC30 Bacillus coagulans GBI-30, 6086): n = 30; or Placebo: n = 31. Study subjects were evaluated every two weeks over a four-week period using validated questionnaires and standard biochemical safety testing. Outcome criteria of interest included change from baseline in Gastrointestinal Symptom Rating Scale (GSRS) abdominal pain, abdominal distention, flatus, and the Severity of Dyspepsia Assessment (SODA) bloating and gas subscores over four weeks of product use. Results Measured against the placebo, subjects in the probiotic group achieved significant improvements in GSRS abdominal pain subscore (p = 0.046) and the GSRS total score (p = 0.048), with a strong trend for improvement on the GSRS abdominal distension subscore (p = 0.061). A strong placebo effect was evident which could explain the lack of statistical significant differences between the groups for many of the efficacy variables. Conclusion In conclusion, the Bacillus coagulans-based product was effective in improving the quality of life and reducing gastrointestinal symptoms in adults with post prandial intestinal gas-related symptoms and no GI diagnoses. Trial Registration ClinicalTrials.gov Identifier: NCT00881322 PMID:19922649

  3. The effectiveness of the 'what do you drink' web-based brief alcohol intervention in reducing heavy drinking among students: a two-arm parallel group randomized controlled trial.

    PubMed

    Voogt, Carmen V; Poelen, Evelien A P; Kleinjan, Marloes; Lemmers, Lex A C J; Engels, Rutger C M E

    2013-01-01

    To evaluate the effectiveness of a web-based brief alcohol intervention 'What Do You Drink' (WDYD) among heavy drinking students at 1- and 6-month post-intervention. Additionally, it was investigated whether certain subgroups would benefit more than others from the WDYD intervention. A two-arm parallel group randomized controlled trial was conducted online in the Netherlands in 2010-2011. Inclusion criteria were: (1) being between 18- and 24-year old, (2) reporting heavy drinking in the past 6 months, (3) being motivated to change alcohol consumption, (4) having access to the Internet and (5) giving informed consent. Participants (n = 913) were randomized to the experimental (WDYD intervention) or control condition (no intervention). Measures were heavy drinking, frequency of binge drinking and weekly alcohol consumption. Analyses according to the intention-to-treat principle revealed no significant main intervention effects in reducing the alcohol measures at the follow-up assessments. Secondary analyses revealed that gender, freshmen and fraternity or sorority membership did not moderate the effect of the WDYD intervention at both follow-ups. Readiness to change, problem drinking and carnival participation moderated intervention effects such that contemplators, those with severe symptoms of alcohol abuse or dependence, and those who participated in carnival benefited more than others from the WDYD intervention regarding weekly alcohol consumption at 1-month follow-up. The WDYD intervention was not effective in reducing the alcohol measures among heavy drinking students at 1- and 6-month post-intervention. However, there is preliminary evidence that the WDYD intervention is effective in lowering drinking levels for subgroups of heavy drinking students in the short term.

  4. A randomized controlled trial of an electronic informed consent process.

    PubMed

    Rothwell, Erin; Wong, Bob; Rose, Nancy C; Anderson, Rebecca; Fedor, Beth; Stark, Louisa A; Botkin, Jeffrey R

    2014-12-01

    A pilot study assessed an electronic informed consent model within a randomized controlled trial (RCT). Participants who were recruited for the parent RCT project were randomly selected and randomized to either an electronic consent group (n = 32) or a simplified paper-based consent group (n = 30). Results from the electronic consent group reported significantly higher understanding of the purpose of the study, alternatives to participation, and who to contact if they had questions or concerns about the study. However, participants in the paper-based control group reported higher mean scores on some survey items. This research suggests that an electronic informed consent presentation may improve participant understanding for some aspects of a research study. © The Author(s) 2014.

  5. A double-blind, randomized, placebo-controlled, parallel-group study of THC/CBD oromucosal spray in combination with the existing treatment regimen, in the relief of central neuropathic pain in patients with multiple sclerosis.

    PubMed

    Langford, R M; Mares, J; Novotna, A; Vachova, M; Novakova, I; Notcutt, W; Ratcliffe, S

    2013-04-01

    Central neuropathic pain (CNP) occurs in many multiple sclerosis (MS) patients. The provision of adequate pain relief to these patients can very difficult. Here we report the first phase III placebo-controlled study of the efficacy of the endocannabinoid system modulator delta-9-tetrahydrocannabinol (THC)/cannabidiol (CBD) oromucosal spray (USAN name, nabiximols; Sativex, GW Pharmaceuticals, Salisbury, Wiltshire, UK), to alleviate CNP. Patients who had failed to gain adequate analgesia from existing medication were treated with THC/CBD spray or placebo as an add-on treatment, in a double-blind manner, for 14 weeks to investigate the efficacy of the medication in MS-induced neuropathic pain. This parallel-group phase of the study was then followed by an 18-week randomized-withdrawal study (14-week open-label treatment period plus a double-blind 4-week randomized-withdrawal phase) to investigate time to treatment failure and show maintenance of efficacy. A total of 339 patients were randomized to phase A (167 received THC/CBD spray and 172 received placebo). Of those who completed phase A, 58 entered the randomized-withdrawal phase. The primary endpoint of responder analysis at the 30 % level at week 14 of phase A of the study was not met, with 50 % of patients on THC/CBD spray classed as responders at the 30 % level compared to 45 % of patients on placebo (p = 0.234). However, an interim analysis at week 10 showed a statistically significant treatment difference in favor of THC/CBD spray at this time point (p = 0.046). During the randomized-withdrawal phase, the primary endpoint of time to treatment failure was statistically significant in favor of THC/CBD spray, with 57 % of patients receiving placebo failing treatment versus 24 % of patients from the THC/CBD spray group (p = 0.04). The mean change from baseline in Pain Numerical Rating Scale (NRS) (p = 0.028) and sleep quality NRS (p = 0.015) scores, both secondary endpoints in phase B, were also statistically

  6. A two-site, two-arm, 34-week, double-blind, parallel-group, randomized controlled trial of reduced nicotine cigarettes in smokers with mood and/or anxiety disorders: trial design and protocol.

    PubMed

    Allen, Sophia I; Foulds, Jonathan; Pachas, Gladys N; Veldheer, Susan; Cather, Corinne; Azzouz, Nour; Hrabovsky, Shari; Hameed, Ahmad; Yingst, Jessica; Hammett, Erin; Modesto, Jennifer; Krebs, Nicolle M; Zhu, Junjia; Liao, Jason; Muscat, Joshua E; Richie, John; Evins, A Eden

    2017-01-19

    The U.S. Food and Drug Administration can set standards for cigarettes that could include reducing their nicotine content. Such a standard should improve public health without causing unintended serious consequences for sub-populations. This study evaluates the effect of progressive nicotine reduction in cigarettes on smoking behavior, toxicant exposure, and psychiatric symptoms in smokers with comorbid mood and/or anxiety disorders using a two-site, two-arm, double-blind, parallel group, randomized controlled trial (RCT) in four phases over 34 weeks. Adult smokers (N = 200) of 5 or more cigarettes per day will be randomized across two sites (Penn State and Massachusetts General). Participants must have not had a quit attempt in the prior month, nor be planning to quit in the next 6 months, meet criteria for a current or lifetime unipolar mood and/or anxiety disorder based on the structured Mini-International Neuropsychiatric Interview, and must not have an unstable medical or psychiatric condition. After a week of smoking their own cigarettes, participants receive two weeks of Spectrum research cigarettes with usual nicotine content (11.6 mg). After this baseline period, participants will be randomly assigned to continue smoking Spectrum research cigarettes that contain either (a) Usual Nicotine Content (11.6 mg); or (b) Reduced Nicotine Content: the nicotine content per cigarette is progressively reduced from approximately 11.6 mg to 0.2 mg in five steps over 18 weeks. At the end of the randomization phase, participants will be offered the choice to either (a) quit smoking with assistance, (b) continue smoking free research cigarettes, or (c) return to purchasing their own cigarettes, for the final 12 weeks of the study. The primary outcome measure is blood cotinine; key secondary outcomes are: exhaled carbon monoxide, urinary total NNAL- 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and 1-hydroxypyrene, oxidative stress biomarkers including 8

  7. Lobeglitazone and pioglitazone as add-ons to metformin for patients with type 2 diabetes: a 24-week, multicentre, randomized, double-blind, parallel-group, active-controlled, phase III clinical trial with a 28-week extension.

    PubMed

    Jin, S-M; Park, C-Y; Cho, Y M; Ku, B J; Ahn, C W; Cha, B-S; Min, K W; Sung, Y A; Baik, S H; Lee, K W; Yoon, K-H; Lee, M-K; Park, S W

    2015-06-01

    We aimed to compare the efficacy and safety of lobeglitazone and pioglitazone as add-ons to metformin in patients with type 2 diabetes. Patients who were inadequately controlled by metformin were randomized and treated once daily with either lobeglitazone (0.5 mg, n = 128) or pioglitazone (15 mg, n = 125) for 24 weeks, with a 28-week extension trial of lobeglitazone treatment in patients who consented. The primary endpoint was the change in glycated haemoglobin (HbA1c) concentration from baseline to week 24. At week 24, the mean change from baseline in HbA1c was -0.74% for the lobeglitazone group and -0.74% for the pioglitazone group, with a mean difference of 0.01% [95% confidence interval (CI) of difference, -0.16 to 0.18]. The effects of lobeglitazone on lipid variables and the adverse events associated with lobeglitazone were similar to those observed with pioglitazone. Lobeglitazone was not inferior to pioglitazone as an add-on to metformin in terms of their efficacy and safety.

  8. Rationale and design of the HepZero study: a prospective, multicenter, international, open, randomized, controlled clinical study with parallel groups comparing heparin-free dialysis with heparin-coated dialysis membrane (Evodial) versus standard care: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Anticoagulation for chronic dialysis patients with contraindications to heparin administration is challenging. Current guidelines state that in patients with increased bleeding risks, strategies that can induce systemic anticoagulation should be avoided. Heparin-free dialysis using intermittent saline flushes is widely adopted as the method of choice for patients at risk of bleeding, although on-line blood predilution may also be used. A new dialyzer, Evodial (Gambro, Lund, Sweden), is grafted with unfractionated heparin during the manufacturing process and may allow safe and efficient heparin-free hemodialysis sessions. In the present trial, Evodial was compared to standard care with either saline flushes or blood predilution. Metho