A randomized controlled trial of Pivotal Response Treatment Group for parents of children with autism.

PubMed

Hardan, Antonio Y; Gengoux, Grace W; Berquist, Kari L; Libove, Robin A; Ardel, Christina M; Phillips, Jennifer; Frazier, Thomas W; Minjarez, Mendy B

2015-08-01

With rates of autism diagnosis continuing to rise, there is an urgent need for effective and efficient service delivery models. Pivotal Response Treatment (PRT) is considered an established treatment for autism spectrum disorder (ASD); however, there have been few well-controlled studies with adequate sample size. The aim of this study was to conduct a randomized controlled trial to evaluate PRT parent training group (PRTG) for targeting language deficits in young children with ASD. Fifty-three children with autism and significant language delay between 2 and 6 years old were randomized to PRTG (N = 27) or psychoeducation group (PEG; N = 26) for 12 weeks. The PRTG taught parents behavioral techniques to facilitate language development. The PEG taught general information about ASD (clinical trial NCT01881750; http://www.clinicaltrials.gov). Analysis of child utterances during the structured laboratory observation (primary outcome) indicated that, compared with children in the PEG, children in the PRTG demonstrated greater improvement in frequency of utterances (F(2, 43) = 3.53, p = .038, d = 0.42). Results indicated that parents were able to learn PRT in a group format, as the majority of parents in the PRTG (84%) met fidelity of implementation criteria after 12 weeks. Children also demonstrated greater improvement in adaptive communication skills (Vineland-II) following PRTG and baseline Mullen visual reception scores predicted treatment response to PRTG. This is the first randomized controlled trial of group-delivered PRT and one of the largest experimental investigations of the PRT model to date. The findings suggest that specific instruction in PRT results in greater skill acquisition for both parents and children, especially in functional and adaptive communication skills. Further research in PRT is warranted to replicate the observed results and address other core ASD symptoms. © 2014 Association for Child and Adolescent Mental Health.

Effect of an orientation group for patients with chronic heart failure: randomized controlled trial.

PubMed

Arruda, Cristina Silva; Pereira, Juliana de Melo Vellozo; Figueiredo, Lyvia da Silva; Scofano, Bruna Dos Santos; Flores, Paula Vanessa Peclat; Cavalcanti, Ana Carla Dantas

2018-01-08

To evaluate the effect of the orientation group on therapeutic adherence and self-care among patients with chronic heart failure. Randomized controlled trial with 27 patients with chronic heart failure. The intervention group received nursing consultations and participated in group meetings with the multi-professional team. The control group only received nursing consultations in a period of four months. Questionnaires validated for use in Brazil were applied in the beginning and in the end of the study to assess self-care outcomes and adherence to treatment. Categorical variables were expressed through frequency and percentage distributions and the continuous variables through mean and standard deviation. The comparison between the initial and final scores of the intervention and control groups was done through the Student's t-test. The mean adherence in the intervention group was 13.9 ± 3.6 before the study and 4.8 ± 2.3 after the study. In the control group it was 14.2 ± 3.4 before the study and 14.7 ± 3.5 after the study. The self-care confidence score was lower after the intervention (p=0.01). The orientation group does not improve adherence to treatment and self-care management and maintenance and it may reduce confidence in self-care. Registry REBEC RBR-7r9f2m.

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

PubMed

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

2017-12-20

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

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

2017-08-01

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. Caregivers of 2-5-year-olds were randomized to receive either the SHS or an attention-matched control program. 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). 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

Brief Group Intervention Using Emotional Freedom Techniques for Depression in College Students: A Randomized Controlled Trial

PubMed Central

Church, Dawson; De Asis, Midanelle A.; Brooks, Audrey J.

2012-01-01

Two hundred thirty-eight first-year college students were assessed using the Beck Depression Inventory (BDI). Thirty students meeting the BDI criteria for moderate to severe depression were randomly assigned to either a treatment or control group. The treatment group received four 90-minute group sessions of EFT (Emotional Freedom Techniques), a novel treatment that combines exposure, cognitive reprocessing, and somatic stimulation. The control group received no treatment. Posttests were conducted 3 weeks later on those that completed all requirements (N = 18). The EFT group (n = 9) had significantly more depression at baseline than the control group (n = 9) (EFT BDI mean = 23.44, SD = 2.1 versus control BDI mean = 20.33, SD = 2.1). After controlling for baseline BDI score, the EFT group had significantly less depression than the control group at posttest, with a mean score in the “nondepressed” range (P = .001; EFT BDI mean = 6.08, SE = 1.8 versus control BDI mean = 18.04, SE = 1.8). Cohen's d was 2.28, indicating a very strong effect size. These results are consistent with those noted in other studies of EFT that included an assessment for depression and indicate the clinical usefulness of EFT as a brief, cost-effective, and efficacious treatment. PMID:22848802

Brief group intervention using emotional freedom techniques for depression in college students: a randomized controlled trial.

PubMed

Church, Dawson; De Asis, Midanelle A; Brooks, Audrey J

2012-01-01

Two hundred thirty-eight first-year college students were assessed using the Beck Depression Inventory (BDI). Thirty students meeting the BDI criteria for moderate to severe depression were randomly assigned to either a treatment or control group. The treatment group received four 90-minute group sessions of EFT (Emotional Freedom Techniques), a novel treatment that combines exposure, cognitive reprocessing, and somatic stimulation. The control group received no treatment. Posttests were conducted 3 weeks later on those that completed all requirements (N = 18). The EFT group (n = 9) had significantly more depression at baseline than the control group (n = 9) (EFT BDI mean = 23.44, SD = 2.1 versus control BDI mean = 20.33, SD = 2.1). After controlling for baseline BDI score, the EFT group had significantly less depression than the control group at posttest, with a mean score in the "nondepressed" range (P = .001; EFT BDI mean = 6.08, SE = 1.8 versus control BDI mean = 18.04, SE = 1.8). Cohen's d was 2.28, indicating a very strong effect size. These results are consistent with those noted in other studies of EFT that included an assessment for depression and indicate the clinical usefulness of EFT as a brief, cost-effective, and efficacious treatment.

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.

Prevalence and factors associated with use of placebo control groups in randomized controlled trials in psoriasis: a cross-sectional study.

PubMed

Katz, Kenneth A; Karlawish, Jason H; Chiang, David S; Bognet, Rachel A; Propert, Katherine J; Margolis, David J

2006-11-01

The ethics and science of using placebo control groups in clinical trials have been widely debated. Few studies, however, have examined factors associated with choice of control group. Our aim was to assess the prevalence of use of placebo controls in randomized controlled trials in psoriasis and to identify factors associated with use of placebo controls in these trials. This is a cross-sectional study of randomized controlled trials in psoriasis published from January 1, 2001 to December 20, 2005 and indexed in the Cochrane Central Register of Controlled Trials. We extracted data on types of control groups used, design issues (number of patients enrolled, primary end point), disease characteristics (psoriasis type and severity), and extrascientific issues (trial location, funding source, and year of publication). We used bivariable and multivariable logistic regression to determine factors associated with use of a placebo control group. Of 194 citations, 187 were available for review. One hundred thirty-five trials from 134 articles in 38 journals met inclusion criteria. Eighty-three trials (61.5%) enrolling 8171 subjects (41.7%) used active controls only, and 52 trials (38.5%) enrolling 11,406 subjects (58.3%) used placebo controls. Adjusted for trial location and funding source, trials significantly more likely to have used placebo controls included those conducted in the United States (odds ratio [OR], 5.79; 95% confidence interval [CI], 2.45-13.68; P < .001) and those funded by pharmaceutical companies (OR, 2.61; 95% CI, 1.19-5.73; P = .02). Predicted frequencies of placebo use ranged from 77.6% (industry-funded, conducted trials in the United States) to 18.6% (non-industry-funded trials not conducted in the United States). Our searches may not have identified all published trials, and we did not have access to data from unpublished trials. Use of placebo controls has been more common in psoriasis trials conducted in the United States and funded by

Group antenatal intervention to reduce perinatal stress and depressive symptoms related to intergenerational conflicts: a randomized controlled trial.

PubMed

Leung, Sharron S K; Lam, T H

2012-11-01

Intergenerational conflicts are a major source of stress, which might lead to depression in new mothers. The conflict is heightened when grandparents are involved in childcare. To examine the effectiveness of an interpersonal psychotherapy oriented group intervention to reduce stress and depressive symptoms in new mothers and enhance happiness and self-efficacy in managing intergenerational conflict in childcare. This study is one of the intervention projects of FAMILY: A Jockey Club Initiative for a Harmonious Society, funded by The Hong Kong Jockey Club Charities Trust. Multisite randomized controlled trial with two arms: an intervention group attended an additional 4-week program and a control group who received usual care only. Six Maternal and Child Health Centres in Hong Kong From September 2009 to January 2010, 156 pregnant women who would have grandparents involved in childcare were recruited at their 14-32 weeks' gestation. Participants were randomized to groups using computer generated random sequences by blinded recruitment staff. Primary outcomes were stress and depressive symptoms immediately after the intervention and 6-8 weeks after delivery. Secondary outcomes were happiness and self-efficacy in managing conflict. After screening 2870 pregnant women, 156 eligible participants were randomized. Intention-to-treat analysis showed that the intervention group (n=78) had significantly lower perceived stress (p=0.017; Cohen d=0.38) and greater happiness (p=0.004; Cohen d=0.41) than the control group (n=78) immediately after the intervention. However, the effects were not sustained at postnatal follow-up. Subgroup analysis showed that participants with depressive symptoms (EPDS>12) at baseline reported significantly lower stress, greater happiness (p=0.035 and 0.037, respectively; both Cohen d=0.61), greater self-efficacy in managing conflict (p=0.012; Cohen d=0.76) than the control group after the intervention. Also, after delivery, they had significantly

Controlling Chronic Diseases Through Evidence-Based Decision Making: A Group-Randomized Trial.

PubMed

Brownson, Ross C; Allen, Peg; Jacob, Rebekah R; deRuyter, Anna; Lakshman, Meenakshi; Reis, Rodrigo S; Yan, Yan

2017-11-30

Although practitioners in state health departments are ideally positioned to implement evidence-based interventions, few studies have examined how to build their capacity to do so. The objective of this study was to explore how to increase the use of evidence-based decision-making processes at both the individual and organization levels. We conducted a 2-arm, group-randomized trial with baseline data collection and follow-up at 18 to 24 months. Twelve state health departments were paired and randomly assigned to intervention or control condition. In the 6 intervention states, a multiday training on evidence-based decision making was conducted from March 2014 through March 2015 along with a set of supplemental capacity-building activities. Individual-level outcomes were evidence-based decision making skills of public health practitioners; organization-level outcomes were access to research evidence and participatory decision making. Mixed analysis of covariance models was used to evaluate the intervention effect by accounting for the cluster randomized trial design. Analysis was performed from March through May 2017. Participation 18 to 24 months after initial training was 73.5%. In mixed models adjusted for participant and state characteristics, the intervention group improved significantly in the overall skill gap (P = .01) and in 6 skill areas. Among the 4 organizational variables, only access to evidence and skilled staff showed an intervention effect (P = .04). Tailored and active strategies are needed to build capacity at the individual and organization levels for evidence-based decision making. Our study suggests several dissemination interventions for consideration by leaders seeking to improve public health practice.

Integrating CHWs as Part of the Team Leading Diabetes Group Visits: A Randomized Controlled Feasibility Study.

PubMed

Vaughan, Elizabeth M; Johnston, Craig A; Cardenas, Victor J; Moreno, Jennette P; Foreyt, John P

2017-12-01

Purpose The purpose of the study was to evaluate the feasibility of integrating Community Health Workers (CHWs) as part of the team leading diabetes group visits. Methods This was a randomized controlled study that integrated CHWs as part of the team leading diabetes group visits for low-income Hispanic adults (n = 50). Group visits met for 3 hours each month for a 6-month duration. Main measures included baseline and 6-month clinical outcomes (ie, A1C, lipids), concordance with 8 standard of care guidelines (ie, screens for cervical, breast, and colon cancer) from the US Preventive Task Force and American Diabetes Association, and participant acceptability. Results Compared to control participants, the intervention group resulted in significantly better clinical outcomes or guideline concordance for the following areas: target A1C levels, retinal eye exams, diabetes foot exams, mammograms, and urine microalbumin. Significantly more individuals in the control group gained weight, whereas a greater number of participants in the intervention group lost weight. Intervention participants found the group visits highly acceptable. Conclusions Integrating CHWs as part a comprehensive diabetes group visit program is a feasible and effective system-level intervention to improve glycemic control and achieve guideline concordance.

Effect of an orientation group for patients with chronic heart failure: randomized controlled trial 1

PubMed Central

Arruda, Cristina Silva; Pereira, Juliana de Melo Vellozo; Figueiredo, Lyvia da Silva; Scofano, Bruna dos Santos; Flores, Paula Vanessa Peclat; Cavalcanti, Ana Carla Dantas

2018-01-01

ABSTRACT Objective: To evaluate the effect of the orientation group on therapeutic adherence and self-care among patients with chronic heart failure. Method: Randomized controlled trial with 27 patients with chronic heart failure. The intervention group received nursing consultations and participated in group meetings with the multi-professional team. The control group only received nursing consultations in a period of four months. Questionnaires validated for use in Brazil were applied in the beginning and in the end of the study to assess self-care outcomes and adherence to treatment. Categorical variables were expressed through frequency and percentage distributions and the continuous variables through mean and standard deviation. The comparison between the initial and final scores of the intervention and control groups was done through the Student’s t-test. Results: The mean adherence in the intervention group was 13.9 ± 3.6 before the study and 4.8 ± 2.3 after the study. In the control group it was 14.2 ± 3.4 before the study and 14.7 ± 3.5 after the study. The self-care confidence score was lower after the intervention (p=0.01). Conclusion: The orientation group does not improve adherence to treatment and self-care management and maintenance and it may reduce confidence in self-care. Registry REBEC RBR-7r9f2m. PMID:29319747

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…

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.

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.…

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

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.

A randomized controlled trial of group Stepping Stones Triple P: a mixed-disability trial.

PubMed

Roux, Gemma; Sofronoff, Kate; Sanders, Matthew

2013-09-01

Stepping Stones Triple P (SSTP) is a parenting program designed for families of a child with a disability. The current study involved a randomized controlled trial of Group Stepping Stones Triple P (GSSTP) for a mixed-disability group. Participants were 52 families of children diagnosed with an Autism Spectrum Disorder, Down syndrome, Cerebral Palsy, or an intellectual disability. The results demonstrated significant improvements in parent-reported child behavior, parenting styles, parental satisfaction, and conflict about parenting. Results among participants were similar despite children's differing impairments. The intervention effect was maintained at 6-month follow-up. The results indicate that GSSTP is a promising intervention for a mixed-disability group. Limitations of the study, along with areas for future research, are also discussed. © FPI, Inc.

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…

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

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.

Standard versus prosocial online support groups for distressed breast cancer survivors: a randomized controlled trial.

PubMed

Lepore, Stephen J; Buzaglo, Joanne S; Lieberman, Morton A; Golant, Mitch; Davey, Adam

2011-08-25

The Internet can increase access to psychosocial care for breast cancer survivors through online support groups. This study will test a novel prosocial online group that emphasizes both opportunities for getting and giving help. Based on the helper therapy principle, it is hypothesized that the addition of structured helping opportunities and coaching on how to help others online will increase the psychological benefits of a standard online group. A two-armed randomized controlled trial with pretest and posttest. Non-metastatic breast cancer survivors with elevated psychological distress will be randomized to either a standard facilitated online group or to a prosocial facilitated online group, which combines online exchanges of support with structured helping opportunities (blogging, breast cancer outreach) and coaching on how best to give support to others. Validated and reliable measures will be administered to women approximately one month before and after the interventions. Self-esteem, positive affect, and sense of belonging will be tested as potential mediators of the primary outcomes of depressive/anxious symptoms and sense of purpose in life. This study will test an innovative approach to maximizing the psychological benefits of cancer online support groups. The theory-based prosocial online support group intervention model is sustainable, because it can be implemented by private non-profit or other organizations, such as cancer centers, which mostly offer face-to-face support groups with limited patient reach. ClinicalTrials.gov: NCT01396174.

Worksite Environmental Interventions for Obesity Prevention and Control: Evidence from Group Randomized Trials.

PubMed

Fernandez, Isabel Diana; Becerra, Adan; Chin, Nancy P

2014-06-01

Worksites provide multiple advantages to prevent and treat obesity and to test environmental interventions to tackle its multiple causal factors. We present a literature review of group-randomized and non-randomized trials that tested worksite environmental, multiple component interventions for obesity prevention and control paying particular attention to the conduct of formative research prior to intervention development. The evidence on environmental interventions on measures of obesity appears to be strong since most of the studies have a low (4/8) and unclear (2/8) risk of bias. Among the studies reviewed whose potential risk of bias was low, the magnitude of the effect was modest and sometimes in the unexpected direction. None of the four studies describing an explicit formative research stage with clear integration of findings into the intervention was able to demonstrate an effect on the main outcome of interest. We present alternative explanation for the findings and recommendations for future research.

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.

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

PubMed Central

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

Background 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. Methods and Findings 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]). Conclusions 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

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.

Comparison of group-based outpatient physiotherapy with usual care after total knee replacement: a feasibility study for a randomized controlled trial.

PubMed

Artz, Neil; Dixon, Samantha; Wylde, Vikki; Marques, Elsa; Beswick, Andrew D; Lenguerrand, Erik; Blom, Ashley W; Gooberman-Hill, Rachael

2017-04-01

To evaluate the feasibility of conducting a randomized controlled trial comparing group-based outpatient physiotherapy with usual care in patients following total knee replacement. A feasibility study for a randomized controlled trial. One secondary-care hospital orthopaedic centre, Bristol, UK. A total of 46 participants undergoing primary total knee replacement. The intervention group were offered six group-based exercise sessions after surgery. The usual care group received standard postoperative care. Participants were not blinded to group allocation. Feasibility was assessed by recruitment, reasons for non-participation, attendance, and completion rates of study questionnaires that included the Lower Extremity Functional Scale and Knee Injury and Osteoarthritis Outcome Score. Recruitment rate was 37%. Five patients withdrew or were no longer eligible to participate. Intervention attendance was high (73%) and 84% of group participants reported they were 'very satisfied' with the exercises. Return of study questionnaires at six months was lower in the usual care (75%) than in the intervention group (100%). Mean (standard deviation) Lower Extremity Functional Scale scores at six months were 45.0 (20.8) in the usual care and 57.8 (15.2) in the intervention groups. Recruitment and retention of participants in this feasibility study was good. Group-based physiotherapy was acceptable to participants. Questionnaire return rates were lower in the usual care group, but might be enhanced by telephone follow-up. The Lower Extremity Functional Scale had high responsiveness and completion rates. Using this outcome measure, 256 participants would be required in a full-scale randomized controlled trial.

Randomized controlled GH trial: effects on anthropometry, body composition and body proportions in a large group of children with Prader-Willi syndrome.

PubMed

Festen, Dederieke A M; de Lind van Wijngaarden, Roderick; van Eekelen, Marielle; Otten, Barto J; Wit, Jan M; Duivenvoorden, Hugo J; Hokken-Koelega, Anita C S

2008-09-01

Prader-Willi syndrome (PWS) children have impaired growth, and abnormal body composition. Previous 1-year controlled studies showed improvement of height and body composition during GH-treatment. To evaluate growth, body composition and body proportions during GH-treatment in a large group of PWS children. We performed a randomized controlled GH trial in 91 prepubertal PWS children (42 infants, 49 children, aged 3-14 years). After stratification for age, infants were randomized to GH-treatment (GH-group; 1 mg/m(2)/day; n = 20), or no treatment (control group; n = 22) for 1 year. In the second year all infants were treated with GH. After stratification for BMI, children > 3 years of age were randomized to GH-treatment (GH-group; 1 mg/m(2)/day; n = 27) or no treatment (control group; n = 22) for 2 years. Anthropometric parameters were assessed once in every 3 months. Body composition was measured by Dual Energy X-ray Absorptiometry. Median (interquartile range, iqr) height SDS increased during 2 years of GH in infants from -2.3 (-2.8 to -0.7) to -0.4 (-1.1-0.0) and in prepubertal children from -2.0 (-3.1 to -1.7) to -0.6 (-1.1 to -0.1). In non-GH-treated children height SDS did not increase. Head circumference completely normalized during 1 and 2 years of GH in infants and children, respectively. Body fat percentage and body proportions improved in GH-treated children, but did not completely normalize. Lean body mass SDS improved compared to the control group. Serum IGF-I increased to levels above the normal range in most GH-treated children. Our randomized study shows that GH-treatment in PWS children significantly improves height, BMI, head circumference, body composition and body proportions. PWS children are highly sensitive to GH, suggesting that monitoring of serum IGF-I is indicated.

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.

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.

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.

Specific collaborative group intervention for patients with medically unexplained symptoms in general practice: a cluster randomized controlled trial.

PubMed

Schaefert, R; Kaufmann, C; Wild, B; Schellberg, D; Boelter, R; Faber, R; Szecsenyi, J; Sauer, N; Guthrie, E; Herzog, W

2013-01-01

Patients with medically unexplained symptoms (MUS) are frequent in primary care and substantially impaired in their quality of life (QoL). Specific training of general practitioners (GPs) alone did not demonstrate sustained improvement at later follow-up in current reviews. We evaluated a collaborative group intervention. We conducted a cluster randomized controlled trial. Thirty-five GPs recruited 304 MUS patients (intervention group: 170; control group: 134). All GPs were trained in diagnosis and management of MUS (control condition). Eighteen randomly selected intervention GPs participated in training for a specific collaborative group intervention. They conducted 10 weekly group sessions and 2 booster meetings in their practices, together with a psychosomatic specialist. Six and 12 months after baseline, QoL was assessed with the Short-Form 36. The primary outcome was the physical composite score (PCS), and the secondary outcome was the mental composite score (MCS). At 12 months, intention-to-treat analyses showed a significant between-group effect for the MCS (p = 0.023) but not for the PCS (p = 0.674). This effect was preceded by a significant reduction of somatic symptom severity (15-item somatic symptom severity scale of the Patient Health Questionnaire, PHQ-15) at 6 months (p = 0.008) that lacked significance at 12 months (p = 0.078). As additional between-group effects at 12 months, per-protocol analyses showed less health anxiety (Whiteley-7; p = 0.038) and less psychosocial distress (PHQ; p = 0.024); GP visits were significantly (p = 0.042) reduced in the intervention group. Compared to pure GP training, collaborative group intervention achieved a progressive, clinically meaningful improvement in mental but not physical QoL. It could bridge gaps between general practice and mental health care. Copyright © 2012 S. Karger AG, Basel.

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.

Adolescent Pregnancy Prevention Among Youths Living in Group Care Homes: A Cluster Randomized Controlled Trial

PubMed Central

Vesely, Sara K.; Green, Jennifer; Clements-Nolle, Kristen; Lu, Minggen

2018-01-01

Objectives. To determine if the Power Through Choices (PTC) intervention can increase the use of birth control and reduce pregnancy among system-involved youths living in group care homes. Methods. We performed a 2-arm cluster randomized controlled trial involving group care homes operated by child welfare or juvenile justice systems in California, Maryland, and Oklahoma with assessments immediately before and after the intervention, and at 6- and 12-month follow-up. We collected data from 2012 to 2014 via self-administered questionnaires. Participants (n = 1036) were young (mean age = 16.1 years), predominantly male (79%), racially/ethnically diverse (37% Hispanic, 20% Black, 21% White, 17% multiracial), and sexually experienced (88%). Results. At 6-month follow-up, participants in the intervention group had significantly lower odds of having recent sexual intercourse without using birth control (adjusted odds ratio [AOR] = 0.72; 95% confidence interval [CI] = 0.52, 0.98). At 12-month follow-up assessment, participants in the intervention group had significantly lower odds of ever being pregnant or getting someone pregnant (AOR = 0.67; 95% CI = 0.46, 0.99). Conclusions. The results suggest that PTC is an effective sexual health education intervention that can be implemented with system-involved youths who represent a sexually experienced multiracial youth population. PMID:29443557

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

PubMed

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

2017-07-01

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

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

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.

Cognitive Behavioral Principles within Group Mentoring: A Randomized Pilot Study

ERIC Educational Resources Information Center

Jent, Jason F.; Niec, Larissa N.

2009-01-01

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…

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

Motivational Interviewing Versus Cognitive Behavioral Group Therapy in the Treatment of Problem and Pathological Gambling: A Randomized Controlled Trial

PubMed Central

Carlbring, Per; Jonsson, Jakob; Josephson, Henrik; Forsberg, Lars

2009-01-01

Pathological gambling is a widespread problem with major implications for society and the individual. There are effective treatments, but little is known about the relative effectiveness of different treatments. The aim of this study was to test the effectiveness of motivational interviewing, cognitive behavioral group therapy, and a no-treatment control (wait-list) in the treatment of pathological gambling. This was done in a randomized controlled trial at an outpatient dependency clinic at Karolinska Institute (Stockholm, Sweden). A total of 150 primarily self-recruited patients with current gambling problems or pathological gambling according to an NORC DSM-IV screen for gambling problems were randomized to four individual sessions of motivational interviewing (MI), eight sessions of cognitive behavioral group therapy (CBGT), or a no-treatment wait-list control. Gambling-related measures derived from timeline follow-back as well as general levels of anxiety and depression were administered at baseline, termination, and 6 and 12 months posttermination. Treatment showed superiority in some areas over the no-treatment control in the short term, including the primary outcome measure. No differences were found between MI and CBGT at any point in time. Instead, both MI and CBGT produced significant within-group decreases on most outcome measures up to the 12-month follow-up. Both forms of intervention are promising treatments, but there is room for improvement in terms of both outcome and compliance. PMID:19967577

A 1-year videoconferencing-based psychoeducational group intervention following bariatric surgery: results of a randomized controlled study.

PubMed

Wild, Beate; Hünnemeyer, Katharina; Sauer, Helene; Hain, Bernhard; Mack, Isabelle; Schellberg, Dieter; Müller-Stich, Beat Peter; Weiner, Rudolf; Meile, Tobias; Rudofsky, Gottfried; Königsrainer, Alfred; Zipfel, Stephan; Herzog, Wolfgang; Teufel, Martin

2015-01-01

For severely obese patients, bariatric surgery has been recommended as an effective therapy. The Bariataric Surgery and Education (BaSE) study aimed to assess the efficacy of a videoconferencing-based psychoeducational group intervention in patients after bariatric surgery. The BaSE study is a randomized, controlled multicenter clinical trial involving 117 patients undergoing bariatric surgery (mean preoperative body mass index [BMI] 49.9 kg/m(2), SD 6.4). Patients were enrolled between May 2009 and November 2012 and were randomly assigned to receive either conventional postsurgical visits or, in addition, a videoconferencing-based 1-year group program. Primary outcome measures were weight in kilograms, health-related quality of life (HRQOL), and general self-efficacy (GSE). Secondary outcome measures were depression symptoms and eating behavior. 94% of the patients completed the study. Mean weight loss for all patients was 45.9 kg (SD 16.4) 1 year after surgery (mean excess weight loss [EWL] 63%). Intention-to-treat analyses revealed no differences in weight loss, EWL, HRQOL, or self-efficacy between study groups at 1 year after surgery. However, patients with clinically significant depression symptoms (CSD) at baseline assigned to the intervention group (n = 29) had a significantly better HRQOL (P = .03), lower depression scores (P = .02), and a trend for a better EWL (.06) 1 year after surgery compared with the control group (n = 20). We could not prove the efficacy of the group program for the whole study sample. However, results indicate that the intervention is effective for the important subgroup of patients with CSD. Copyright © 2015 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

Group music therapy for patients with persistent post-traumatic stress disorder--an exploratory randomized controlled trial with mixed methods evaluation.

PubMed

Carr, Catherine; d'Ardenne, Patricia; Sloboda, Ann; Scott, Carleen; Wang, Duolao; Priebe, Stefan

2012-06-01

Not all patients with post-traumatic stress disorder (PTSD) respond to cognitive behavioural therapy (CBT). Literature suggests group music therapy might be beneficial in treating PTSD. However, feasibility and effectiveness have not been assessed. The study objectives were to assess whether group music therapy was feasible for patients who did not respond to CBT, and whether it has an effect on PTSD symptoms and depression. The study employed mixed methods comprising of an exploratory randomized controlled trial, qualitative content analysis of therapy, and patient interviews. Patients with significant PTSD symptoms (n = 17) following completion of CBT were randomly assigned to treatment (n = 9) or control groups (n = 8). The treatment group received 10 weeks of group music therapy after which exit interviews were conducted. Control group patients were offered the intervention at the end of the study. Symptoms were assessed on the Impact of Events Scale-Revised and Beck Depression Inventory II at the beginning and end of treatment. Treatment-group patients experienced a significant reduction in severity of PTSD symptoms (-20.18; 95% confidence interval [CI]: [-31.23, -9.12]) and a marginally significant reduction in depression (-11.92; 95%CI: [-24.05, 0.21]) at 10 weeks from baseline compared to the control. Patients viewed music therapy as helpful and reported experiences concur with current literature. Group music therapy appears feasible and effective for PTSD patients who have not sufficiently responded to CBT. Limitations include the small sample size and lack of blinding. Further research should address these limitations, test sustainability, and identify specific factors that address symptoms in treatment. ©2011 The British Psychological Society.

Acupuncture for migraine prophylaxis: a randomized controlled trial

PubMed Central

Li, Ying; Zheng, Hui; Witt, Claudia M.; Roll, Stephanie; Yu, Shu-guang; Yan, Jie; Sun, Guo-jie; Zhao, Ling; Huang, Wen-jing; Chang, Xiao-rong; Zhang, Hong-xing; Wang, De-jun; Lan, Lei; Zou, Ran; Liang, Fan-rong

2012-01-01

Background: Acupuncture is commonly used to treat migraine. We assessed the efficacy of acupuncture at migraine-specific acupuncture points compared with other acupuncture points and sham acupuncture. Methods: We performed a multicentre, single-blind randomized controlled trial. In total, 480 patients with migraine were randomly assigned to one of four groups (Shaoyang-specific acupuncture, Shaoyang-nonspecific acupuncture, Yangming-specific acupuncture or sham acupuncture [control]). All groups received 20 treatments, which included electrical stimulation, over a period of four weeks. The primary outcome was the number of days with a migraine experienced during weeks 5–8 after randomization. Our secondary outcomes included the frequency of migraine attack, migraine intensity and migraine-specific quality of life. Results: Compared with patients in the control group, patients in the acupuncture groups reported fewer days with a migraine during weeks 5–8, however the differences between treatments were not significant (p > 0.05). There was a significant reduction in the number of days with a migraine during weeks 13–16 in all acupuncture groups compared with control (Shaoyang-specific acupuncture v. control: difference –1.06 [95% confidence interval (CI) –1.77 to –0.5], p = 0.003; Shaoyang-nonspecific acupuncture v. control: difference –1.22 [95% CI –1.92 to –0.52], p < 0.001; Yangming-specific acupuncture v. control: difference –0.91 [95% CI –1.61 to –0.21], p = 0.011). We found that there was a significant, but not clinically relevant, benefit for almost all secondary outcomes in the three acupuncture groups compared with the control group. We found no relevant differences between the three acupuncture groups. Interpretation: Acupuncture tested appeared to have a clinically minor effect on migraine prophylaxis compared with sham acupuncture. Trial Registration: Clinicaltrials.gov NCT00599586 PMID:22231691

Cluster Randomized Controlled Trial

PubMed Central

Young, John; Chapman, Katie; Nixon, Jane; Patel, Anita; Holloway, Ivana; Mellish, Kirste; Anwar, Shamaila; Breen, Rachel; Knapp, Martin; Murray, Jenni; Farrin, Amanda

2015-01-01

Background and Purpose— We developed a new postdischarge system of care comprising a structured assessment covering longer-term problems experienced by patients with stroke and their carers, linked to evidence-based treatment algorithms and reference guides (the longer-term stroke care system of care) to address the poor longer-term recovery experienced by many patients with stroke. Methods— A pragmatic, multicentre, cluster randomized controlled trial of this system of care. Eligible patients referred to community-based Stroke Care Coordinators were randomized to receive the new system of care or usual practice. The primary outcome was improved patient psychological well-being (General Health Questionnaire-12) at 6 months; secondary outcomes included functional outcomes for patients, carer outcomes, and cost-effectiveness. Follow-up was through self-completed postal questionnaires at 6 and 12 months. Results— Thirty-two stroke services were randomized (29 participated); 800 patients (399 control; 401 intervention) and 208 carers (100 control; 108 intervention) were recruited. In intention to treat analysis, the adjusted difference in patient General Health Questionnaire-12 mean scores at 6 months was −0.6 points (95% confidence interval, −1.8 to 0.7; P=0.394) indicating no evidence of statistically significant difference between the groups. Costs of Stroke Care Coordinator inputs, total health and social care costs, and quality-adjusted life year gains at 6 months, 12 months, and over the year were similar between the groups. Conclusions— This robust trial demonstrated no benefit in clinical or cost-effectiveness outcomes associated with the new system of care compared with usual Stroke Care Coordinator practice. Clinical Trial Registration— URL: http://www.controlled-trials.com. Unique identifier: ISRCTN 67932305. PMID:26152298

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

Incorporating spirituality in psychosocial group intervention for women undergoing in vitro fertilization: a prospective randomized controlled study.

PubMed

Chan, Celia H Y; Chan, Cecilia L W; Ng, Ernest H Y; Ho, P C; Chan, Timothy H Y; Lee, G L; Hui, W H C

2012-12-01

This study examined the efficacy of a group intervention, the Integrative Body-Mind-Spirit (I-BMS) intervention, which aims at improving the psychosocial and spiritual well-being of Chinese women undergoing their first IVF treatment cycle. The I-BMS intervention facilitates the search of meaning of life in the context of family and childbearing, as well as the letting go of high IVF expectations. A randomized controlled study of 339 women undergoing first IVF treatment cycle in a local Hong Kong hospital was conducted (intervention: n= 172; no-intervention control: n= 167). Assessments of anxiety, perceived importance of childbearing, and spiritual well-being were made at randomization (T(0) ), on the day starting ovarian stimulations (T(1)), and on the day undertaking embryo transfer (T(2)). Comparing T(0) and T(2), interaction analyses showed women who had received the intervention reported lower levels of physical distress, anxiety, and disorientation. They reported being more tranquil and satisfied with their marriage, and saw childbearing as less important compared to women in the control group. These findings suggest that I-BMS intervention was successful at improving the psychosocial and spiritual well-being of women undergoing their first IVF treatment cycle. This study highlights the importance of providing integrative fertility treatment that incorporates psychosocial and spiritual dimensions. ©2011 The British Psychological Society.

Effectiveness of preventive support groups for children of mentally ill or addicted parents: a randomized controlled trial.

PubMed

van Santvoort, Floor; Hosman, Clemens M H; van Doesum, Karin T M; Janssens, Jan M A M

2014-06-01

In various countries preventive support groups are offered to children of mentally ill and/or addicted parents to reduce the risk that they will develop problems themselves. This study assessed the effectiveness of Dutch support groups for children aged 8-12 years old in terms of reducing negative cognitions; improving social support, competence, and parent-child interaction (direct intervention goals); and reducing emotional and behavioural problems (ultimate intervention aim). Children from 254 families were randomly assigned to the intervention or a control condition. Parents and children completed questionnaires at baseline and 3 and 6 months later. Emotional and behavioural problems of intervention group children were also assessed 1 year after the start. Univariate analyses of variance showed that children in the intervention group experienced a greater decrease in negative cognitions and sought more social support, immediately after participation and 3 months later, as compared to control group children. They also remained stable in their feelings of social acceptance (competence aspect) immediately after the intervention, whereas these feelings declined in control group children. The intervention and control groups both improved over time in terms of cognitions, competence, parent-child interaction and emotional and behavioural problem scores. Additional improvement in terms of problem scores was found in the intervention group 1 year after baseline. Further enhancement of effectiveness requires re-consideration of the support group goals; it should be studied whether the goals reflect the most important and influential risk and protective factors for this specific population. Besides, effects should be studied over a longer period.

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.

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.

The Effect of Group Discussion-based Education on Self-management of Adults with Type 2 Diabetes Mellitus Compared with Usual Care: A Randomized Control Trial.

PubMed

Habibzadeh, Hosein; Sofiani, Akbar; Alilu, Leyla; Gillespie, Mark

2017-11-01

We sought to determine the effect of group discussion-based education on the self-management capability of patients with type 2 diabetes in Iran. This randomized control trial was conducted on 90 patients with type 2 diabetes. Participants were allocated randomly into one of two groups; intervention and control. The intervention group received the group discussion-based education while the control group received routine care only. The Lin's self-management questionnaire was completed at baseline and three months post-intervention. Statistical analysis, including the use of independent t -test, identified that in comparison to the control group, significant increases were observed in the scores of self-organization ( t =11.24, p < 0.001), self-adjustment ( t = 7.53, p < 0.001), interaction with health experts ( t = 7.31, p < 0.001), blood sugar self-monitoring ( t = 6.42, p < 0.001), adherence to the proposed diet ( t = 5.22, p < 0.001), and total self-management ( t = 10.82, p < 0.001) in the intervention group. Sharing experiences through group discussions and receiving instructive feedback can improve the ability to self-manage diabetes.

Autoshaping, random control, and omission training in the rat.

PubMed

Locurto, C; Terrace, H S; Gibbon, J

1976-11-01

The role of the stimulus-reinforcer contingency in the development and maintenance of lever contact responding was studied in hooded rats. In Experiment I, three groups of experimentally naive rats were trained either on autoshaping, omission training, or a random-control procedure. Subjects trained by the autoshaping procedure responded more consistently than did either random-control or omission-trained subjects. The probability of at least one lever contact per trial was slightly higher in subjects trained by the omission procedure than by the random-control procedure. However, these differences were not maintained during extended training, nor were they evident in total lever-contact frequencies. When omission and random-control subjects were switched to the autoshaping condition, lever contacts increased in all animals, but a pronounced retardation was observed in omission subjects relative to the random-control subjects. In addition, subjects originally exposed to the random-control procedure, and later switched to autoshaping, acquired more rapidly than naive subjects that were exposed only on the autoshaping procedure. In Experiment II, subjects originally trained by an autoshaping procedure were exposed either to an omission, a random-control, or an extinction procedure. No differences were observed among the groups either in the rate at which lever contacts decreased or in the frequency of lever contacts at the end of training. These data implicate prior experience in the interpretation of omission-training effects and suggest limitations in the influence of stimulus-reinforcer relations in autoshaping.

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

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

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.

A Randomized Controlled Trial of an Electronic Informed Consent Process

PubMed Central

Rothwell, Erin; Wong, Bob; Rose, Nancy C.; Anderson, Rebecca; Fedor, Beth; Stark, Louisa A.; Botkin, Jeffrey R.

2018-01-01

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. PMID:25747685

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.

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

A Randomized Control Study on Psycho-Education Group on Improving Health-Related Quality of Life of Chinese Persons with Major Neurocognitive Disorder.

PubMed

Young, Kim-Wan

2016-01-01

People with a major neurocognitive disorder (PwND) are found to have a lower health related quality of life (HRQoL) than those without neurocognitive disorder. This research study aims to evaluate the effectiveness of a psycho-education group in improving the HRQoL of Chinese PwND. By adopting randomized control trial (RCT), Chinese PwND were randomly assigned to either a 10-session psycho-education group or the control group. Family caregivers of treatment group were encouraged to take part in two sessions focusing on the caring and communication skills. Control group and their family caregivers received standardized educational materials on basic information on neurocognitive disorder for them to read at home. Standardized assessment was conducted both with PwND and their caregivers independently to give the self-rated and caregiver-rated HRQoL of PwND in the pre- and post- treatment periods by a research assistant who was blind to the group assignment of the participants. Moreover, qualitative interviews were also conducted for ten participants and five family caregivers of the treatment group to identify those group elements relating to its effectiveness. 2 × 2 repeated measures ANCOVA demonstrated that the treatment group (n = 32) was significantly more effective than the control group (n = 32) in improving the caregiver-rated HRQoL (F[1, 61] = 4.35, p = .04 < .05) with a moderate effect size, but not self-rated HRQoL, Qualitative analysis suggested several group elements relating to its effectiveness. This present RCT shows that the psycho-education group significantly improves caregiver-rated HRQoL of PwND, supporting the feasibility and effectiveness of the psycho-education group.

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

PubMed

Bogenschutz, Matthew; Nord, Derek; Hewitt, Amy

2015-06-01

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 intervention for DSPs on site-level turnover rates over a one year period. Results suggested that, compared with the control group, sites receiving the training intervention experienced a significant decrease in annual turnover, when multiple factors were controlled. Implications, including the importance of considering quality training as a long term organizational investment and intervention to reduce turnover, are discussed.

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

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.

A focus group study to understand biases and confounders in a cluster randomized controlled trial on low back pain in primary care in Norway.

PubMed

Werner, Erik L; Løchting, Ida; Storheim, Kjersti; Grotle, Margreth

2018-05-22

Cluster randomized controlled trials are often used in research in primary care but creates challenges regarding biases and confounders. We recently presented a study on low back pain from primary care in Norway with equal effects in the intervention and the control group. In order to understand the specific mechanisms that may produce biases in a cluster randomized trial we conducted a focus group study among the participating health care providers. The aim of this study was to understand how the participating providers themselves influenced on the study and thereby possibly on the results of the cluster randomized controlled trial. The providers were invited to share their experiences from their participation in the COPE study, from recruitment of patients to accomplishment of either the intervention or control consultations. Six clinicians from the intervention group and four from the control group took part in the focus group interviews. The group discussions focused on feasibility of the study in primary care and particularly on identifying potential biases and confounders in the study. The audio-recorded interviews were transcribed verbatim and analyzed according to a systematic text condensation. The themes for the analysis emerged from the group discussions. A personal interest for back pain, logistic factors at the clinics and an assessment of the patients' capacity to accomplish the study prior to their recruitment was reported. The providers were allowed to provide additional therapy to the intervention and it turned out that some of these could be regarded as opposed to the messages of the intervention. The providers seemed to select different items from the educational package according to personal beliefs and their perception of the patients' acceptance. The study disclosed several potential biases to the COPE study which may have impacted on the study results. Awareness of these is highly important when planning and conducting a cluster randomized

Oral sumatriptan for migraine in children and adolescents: a randomized, multicenter, placebo-controlled, parallel group study.

PubMed

Fujita, Mitsue; Sato, Katsuaki; Nishioka, Hiroshi; Sakai, Fumihiko

2014-04-01

The objective of this article is to evaluate the efficacy and tolerability of two doses of oral sumatriptan vs placebo in the acute treatment of migraine in children and adolescents. Currently, there is no approved prescription medication in Japan for the treatment of migraine in children and adolescents. This was a multicenter, outpatient, single-attack, double-blind, randomized, placebo-controlled, parallel-group study. Eligible patients were children and adolescents aged 10 to 17 years diagnosed with migraine with or without aura (ICHD-II criteria 1.1 or 1.2) from 17 centers. They were randomized to receive sumatriptan 25 mg, 50 mg or placebo (1:1:2). The primary efficacy endpoint was headache relief by two grades on a five-grade scale at two hours post-dose. A total of 178 patients from 17 centers in Japan were enrolled and randomized to an investigational product in double-blind fashion. Of these, 144 patients self-treated a single migraine attack, and all provided a post-dose efficacy assessment and completed the study. The percentage of patients in the full analysis set (FAS) population who report pain relief at two hours post-treatment for the primary endpoint was higher in the placebo group than in the pooled sumatriptan group (38.6% vs 31.1%, 95% CI: -23.02 to 8.04, P  = 0.345). The percentage of patients in the FAS population who reported pain relief at four hours post-dose was higher in the pooled sumatriptan group (63.5%) than in the placebo group (51.4%) but failed to achieve statistical significance ( P  = 0.142). At four hours post-dose, percentages of patients who were pain free or had complete relief of photophobia or phonophobia were numerically higher in the sumatriptan pooled group compared to placebo. Both doses of oral sumatriptan were well tolerated. No adverse events (AEs) were serious or led to study withdrawal. The most common AEs were somnolence in 6% (two patients) in the sumatriptan 25 mg treatment group and chest

The effectiveness of a Group Triple P with Chinese parents who have a child with developmental disabilities: a randomized controlled trial.

PubMed

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

2013-03-01

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 child behaviour, parental stress, dysfunctional discipline styles and parental conflict before and after program completion by the Intervention group. Intervention group participants also completed these same measures six months after program completion. Compared to the Waitlist Control group, parents receiving Group Triple P reported significantly lower levels of child behaviour problems, parental stress, dysfunctional discipline style and parental conflict scores. The Intervention group participants maintained their gains six months after program completion. The results provided promising evidence for the Level 4 Group Triple P as an effective intervention program for Chinese parents who have preschool aged children with developmental disabilities. Copyright © 2012 Elsevier Ltd. All rights reserved.

Efficacy of individualized social competence training for children with oppositional defiant disorders/conduct disorders: a randomized controlled trial with an active control group.

PubMed

Goertz-Dorten, Anja; Benesch, Christina; Berk-Pawlitzek, Emel; Faber, Martin; Hautmann, Christopher; Hellmich, Martin; Lindenschmidt, Timo; Schuh, Lioba; Stadermann, Rahel; Doepfner, Manfred

2018-03-28

Patient-focused cognitive-behavioral therapy in children with aggressive behavior, which uses group-based social skills training, has resulted in significant reductions in behavioral problems, with effect sizes in the small-to-medium range. However, effects of individually delivered treatments and effects on aggressive behavior and comorbid conditions rated from different perspectives, child functional impairment, child quality of life, parent-child relationship, and parental psychopathology have rarely been assessed. In a randomized controlled trial, 91 boys aged 6-12 years with a diagnosis of oppositional defiant disorder/conduct disorder and peer-related aggression were randomized to receive individually delivered social competence training (Treatment Program for Children with Aggressive Behavior, THAV) or to an active control involving group play that included techniques to activate resources and the opportunity to train prosocial interactions in groups (PLAY). Outcome measures were rated by parents, teachers, or clinicians. Mostly moderate treatment effects for THAV compared to PLAY were found in parent ratings and/or clinician ratings on aggressive behavior, comorbid symptoms, psychosocial impairment, quality of life, parental stress, and negative expressed emotions. In teacher ratings, significant effects were found for ADHD symptoms and prosocial behavior only. THAV is a specifically effective intervention for boys aged 6-12 years with oppositional defiant disorder/conduct disorder and peer-related aggressive behavior as rated by parents and clinicians.

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

2017-05-01

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. 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 short-term (i.e., 10.6�

The effects of holistic health group interventions on improving the cognitive ability of persons with mild cognitive impairment: a randomized controlled trial.

PubMed

Young, Kim-Wan; Ng, Petrus; Kwok, Timothy; Cheng, Daphne

2017-01-01

Persons with mild cognitive impairment (PwMCI) are at a higher risk of developing dementia than those without cognitive impairment. This research study aims to evaluate the effectiveness of a holistic health group intervention, which is based on the holistic brain health approach as well as an Eastern approach to health care, on improving the cognitive ability of Chinese PwMCI. In a randomized controlled trial (RCT), 38 Chinese PwMCI were randomly assigned to either a 10-session holistic health intervention group or the control group. The holistic health treatment group attempted to promote the acceptance of their illness, enhance memory and coping skills, develop a positive lifestyle, maintain positive emotions, and facilitate emotional support among participants. The 10-session holistic health group intervention was structured, with each session conducted once per week and ~90 minutes in length. Control group patients and their family caregivers received standardized basic educational materials that provided basic information on cognitive decline for them to read at home. The Montreal Cognitive Assessment (MoCA) test was used to assess the cognitive ability of PwMCI in the pre- and posttreatment periods by a research assistant who was blind to the group assignment of the participants. The paired-samples t -test indicated that the treatment group (n=18) showed significant improvement in the MoCA score, whereas the control group (n=20) did not. Moreover, 2×2 (group × time) repeated-measures analysis of covariance (ANCOVA) demonstrated that the holistic health group treatment was significantly more effective than the control intervention in improving the MoCA score, with a moderate effect size, and improving the delayed recall (ie, short-term memory), with a strong effect size, after controlling for age, sex, education, and marital status. This present RCT provides evidence to support the feasibility and effectiveness of the holistic health group intervention in

The effects of holistic health group interventions on improving the cognitive ability of persons with mild cognitive impairment: a randomized controlled trial

PubMed Central

Young, Kim-wan; Ng, Petrus; Kwok, Timothy; Cheng, Daphne

2017-01-01

Purpose Persons with mild cognitive impairment (PwMCI) are at a higher risk of developing dementia than those without cognitive impairment. This research study aims to evaluate the effectiveness of a holistic health group intervention, which is based on the holistic brain health approach as well as an Eastern approach to health care, on improving the cognitive ability of Chinese PwMCI. Research methods In a randomized controlled trial (RCT), 38 Chinese PwMCI were randomly assigned to either a 10-session holistic health intervention group or the control group. The holistic health treatment group attempted to promote the acceptance of their illness, enhance memory and coping skills, develop a positive lifestyle, maintain positive emotions, and facilitate emotional support among participants. The 10-session holistic health group intervention was structured, with each session conducted once per week and ~90 minutes in length. Control group patients and their family caregivers received standardized basic educational materials that provided basic information on cognitive decline for them to read at home. The Montreal Cognitive Assessment (MoCA) test was used to assess the cognitive ability of PwMCI in the pre- and posttreatment periods by a research assistant who was blind to the group assignment of the participants. Results The paired-samples t-test indicated that the treatment group (n=18) showed significant improvement in the MoCA score, whereas the control group (n=20) did not. Moreover, 2×2 (group × time) repeated-measures analysis of covariance (ANCOVA) demonstrated that the holistic health group treatment was significantly more effective than the control intervention in improving the MoCA score, with a moderate effect size, and improving the delayed recall (ie, short-term memory), with a strong effect size, after controlling for age, sex, education, and marital status. Conclusion This present RCT provides evidence to support the feasibility and effectiveness of

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

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…

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…

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

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

PubMed

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

2016-05-01

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

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…

Autoshaping, random control, and omission training in the rat1

PubMed Central

Locurto, Charles; Terrace, H. S.; Gibbon, John

1976-01-01

The role of the stimulus-reinforcer contingency in the development and maintenance of lever contact responding was studied in hooded rats. In Experiment I, three groups of experimentally naive rats were trained either on autoshaping, omission training, or a random-control procedure. Subjects trained by the autoshaping procedure responded more consistently than did either random-control or omission-trained subjects. The probability of at least one lever contact per trial was slightly higher in subjects trained by the omission procedure than by the random-control procedure. However, these differences were not maintained during extended training, nor were they evident in total lever-contact frequencies. When omission and random-control subjects were switched to the autoshaping condition, lever contacts increased in all animals, but a pronounced retardation was observed in omission subjects relative to the random-control subjects. In addition, subjects originally exposed to the random-control procedure, and later switched to autoshaping, acquired more rapidly than naive subjects that were exposed only on the autoshaping procedure. In Experiment II, subjects originally trained by an autoshaping procedure were exposed either to an omission, a random-control, or an extinction procedure. No differences were observed among the groups either in the rate at which lever contacts decreased or in the frequency of lever contacts at the end of training. These data implicate prior experience in the interpretation of omission-training effects and suggest limitations in the influence of stimulus-reinforcer relations in autoshaping. PMID:16811960

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

Effects of supportive-expressive discussion groups on loneliness, hope and quality of life in breast cancer survivors: a randomized control trial.

PubMed

Tabrizi, Fatemeh Moghaddam; Radfar, Moloud; Taei, Zeynab

2016-09-01

Evaluation of the effect of supportive expressive discussion groups on loneliness, hope and quality of life in breast cancer survivors. A randomized control trial including breast cancer patients who had completed chemotherapy and randomly allocated into two groups: intervention (n = 41) and control (n = 40). The intervention consisted of twelve weekly 90-min sessions for groups of six to eight breast cancer survivors. Data were obtained pre-to -post the intervention and at 8-week follow-up. The data were analyzed using a repeated-measures analysis of variance (ANOVA). The findings revealed a significant reduction in loneliness scores (F = 69.85, p < 0.001), promotion in total hope (F = 20.8, p < 0.05) and enhancement in quality of life from pre- to post-intervention, and then over the 8-week follow-up period in the intervention group, while scores of control participants did not show this pattern during the study. The strongest effects were found for global quality of life (effect size) = 0.59), for future perspectives (effect size = 0.51), emotional functioning (effect size = 0.35) and social functioning (effect size = 0.31). The intervention was effective on loneliness, hope and quality of life in the intervention group. The intervention needs further evaluation in a larger study and with other cancer types. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

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.

A cognitive behavioral group approach to enhance adherence to hemodialysis fluid restrictions: a randomized controlled trial.

PubMed

Sharp, John; Wild, Matt R; Gumley, Andrew I; Deighan, Christopher J

2005-06-01

Adhering to fluid restrictions represents one of the most difficult aspects of the hemodialysis treatment regimen. This report describes a randomized controlled trial of a group-based cognitive behavioral intervention aimed at improving fluid-restriction adherence in patients receiving hemodialysis. It was hypothesized that the intervention would improve adherence, measured by means of interdialytic weight gain (IWG), without impacting negatively on psychosocial functioning. Fifty-six participants receiving hemodialysis from 4 renal outpatient settings were randomly assigned to an immediate-treatment group (ITG; n = 29) or deferred-treatment group (DTG; n = 27). Participants were assessed at baseline, posttreatment, and follow-up stages. Treatment consisted of a 4-week intervention using educational, cognitive, and behavioral strategies to enhance effective self-management of fluid consumption. No significant difference in mean IWGs was found between the ITG and DTG during the acute-phase analysis (F(1,54) = 0.03; P > 0.05). However, in longitudinal analysis, there was a significant main effect for mean IWG (F(1.76,96.80) = 9.10; P < 0.001) and a significant difference between baseline and follow-up IWG values (t55 = 3.85; P < 0.001), reflecting improved adherence over time. No adverse effects of treatment were indicated through measures of psychosocial functioning. Some significant changes were evidenced in cognitions thought to be important in mediating behavioral change. The current study provides evidence for the feasibility and effectiveness of applying group-based cognitive behavior therapy to enhance adherence to hemodialysis fluid restrictions. Results are discussed in the context of the study's methodological limitations.

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.

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

Cognitive behavioral treatment groups for people with chronic depression in Hong Kong: a randomized wait-list control design.

PubMed

Wong, Daniel Fu Keung

2008-01-01

This study examined the effectiveness of a cognitive-behavioral treatment (CBT) group for Chinese people with depression in Hong Kong. Ninety-six subjects with depression were randomly assigned to CBT and control groups. After 10 weeks of treatment, participants in the CBT group had significantly fewer symptoms of depression, dysfunctional rules, and negative emotions, and significantly more adaptive coping skills when compared to the participants in the control group. Effect size statistics showed medium to large differences in symptoms of depression, coping skills, dysfunctional rules, and assumptions and negative emotions between the participants of the two groups (Cohen's d, between 0.50 and 0.88, except for positive emotions). Forty percent of the participants in the experimental group achieved a clinically significant level [reliable change index (RC)>1.96] of improvement. Lastly, the results of a multiple regression analysis provided some evidence of a linkage between cognition and depression among the participants in the experimental group. The design and content of the CBT groups, which aimed at facilitating the understanding and modification of automatic thoughts and dysfunctional rules, and of negative and positive coping skills among the participants, might have contributed to the initial positive results. (c) 2007 Wiley-Liss, Inc.

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

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.

Group Interventions were not Effective for Female Turkish Migrants with Recurrent Depression – Recommendations from a Randomized Controlled Study

PubMed Central

Renner, Walter; Berry, John W.

2010-01-01

We tested group interventions for women with a Turkish migration background living in Austria and suffering from recurrent depression. N = 66 participants were randomized to: (1) Self-Help Groups (SHG), (2) Cognitive Behavior Therapy (CBT) Groups, and (3) a Wait-List (WL) Control condition. Neither SHG nor CBT were superior to WL. On an individual basis, about one third of the participants showed significant improvements with respect to symptoms of depression. Younger women, women with a longer duration of stay in Austria and those who had encountered a higher number of traumatic experiences, showed increased improvement of depressive symptoms. The results suggest that individual treatment by ethnic, female psychotherapists should be preferred to group interventions. PMID:21976784

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

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

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.

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.

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.

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

PubMed

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

2011-11-01

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

A randomized controlled trial of qigong for fibromyalgia

PubMed Central

2012-01-01

Introduction Fibromyalgia is difficult to treat and requires the use of multiple approaches. This study is a randomized controlled trial of qigong compared with a wait-list control group in fibromyalgia. Methods One hundred participants were randomly assigned to immediate or delayed practice groups, with the delayed group receiving training at the end of the control period. Qigong training (level 1 Chaoyi Fanhuan Qigong, CFQ), given over three half-days, was followed by weekly review/practice sessions for eight weeks; participants were also asked to practice at home for 45 to 60 minutes per day for this interval. Outcomes were pain, impact, sleep, physical function and mental function, and these were recorded at baseline, eight weeks, four months and six months. Immediate and delayed practice groups were analyzed individually compared to the control group, and as a combination group. Results In both the immediate and delayed treatment groups, CFQ demonstrated significant improvements in pain, impact, sleep, physical function and mental function when compared to the wait-list/usual care control group at eight weeks, with benefits extending beyond this time. Analysis of combined data indicated significant changes for all measures at all times for six months, with only one exception. Post-hoc analysis based on self-reported practice times indicated greater benefit with the per protocol group compared to minimal practice. Conclusions This study demonstrates that CFQ, a particular form of qigong, provides long-term benefits in several core domains in fibromyalgia. CFQ may be a useful adjuvant self-care treatment for fibromyalgia. Trial registration clinicaltrials.gov NCT00938834. PMID:22863206

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.

Increasing Physical Activity in Mothers Using Video Exercise Groups and Exercise Mobile Apps: Randomized Controlled Trial

PubMed Central

Chan, June Maylin; Vittinghoff, Eric; Van Blarigan, Erin Lynn; Hecht, Frederick

2018-01-01

Background Women significantly decrease their activity levels in the transition to motherhood. Digital health technologies are low cost, scalable, and can provide an effective delivery mechanism for behavior change. This is the first study that examines the use of videoconferencing and mobile apps to create exercise groups for mothers. Objective The aim of the study was to test the feasibility, acceptability, and effectiveness of an individually adaptive and socially supportive physical activity intervention incorporating videoconferencing and mobile apps for mothers. Methods The Moms Online Video Exercise Study was an 8-week, 2-armed, Web-based randomized trial comparing the effectiveness of a group exercise intervention with a waitlist control. Healthy mothers with at least 1 child under the age of 12 years were recruited through Facebook and email listservs. Intervention participants joined exercise groups using videoconferencing (Google Hangouts) every morning on weekdays and exercised together in real time, guided by exercise mobile apps (eg, Nike+, Sworkit) of their choice. Waitlist control participants had access to recommended mobile apps and an invitation to join an exercise group after the 8-week study period. Main outcomes assessed included changes in self-reported moderate, vigorous, and moderate to vigorous physical activity (MVPA) minutes per week in aggregate and stratified by whether women met Centers for Disease Control and Prevention guidelines for sufficient aerobic activity at baseline. Outcomes were measured through self-assessed Web-based questionnaires at baseline and 8 weeks. Results The intervention was effective at increasing exercise for inactive women and proved to be feasible and acceptable to all participants. A total of 64 women were randomized, 30 to intervention and 34 to control. Women attended 2.8 sessions per week. There was a strong, but not statistically significant, trend toward increasing moderate, vigorous, and MVPA minutes

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.

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

The effectiveness of a Housing First adaptation for ethnic minority groups: findings of a pragmatic randomized controlled trial.

PubMed

Stergiopoulos, Vicky; Gozdzik, Agnes; Misir, Vachan; Skosireva, Anna; Sarang, Aseefa; Connelly, Jo; Whisler, Adam; McKenzie, Kwame

2016-10-21

Little is known about the effectiveness of Housing First (HF) among ethnic minority groups, despite its growing popularity for homeless adults experiencing mental illness. This randomized controlled trial tests the effectiveness of a HF program using rent supplements and intensive case management, enhanced by anti-racism and anti-oppression practices for homeless adults with mental illness from diverse ethnic minority backgrounds. This unblinded pragmatic field trial was carried out in community settings in Toronto, Canada. Participants were 237 adults from ethnic minority groups experiencing mental illness and homelessness, who met study criteria for moderate needs for mental health services. Participants were randomized to either adapted HF (n = 135) or usual care (n = 102) and followed every 3 months for 24 months. The primary study outcome was housing stability; secondary outcomes included physical and mental health, social functioning, quality of life, arrests and health service use. Intention to treat statistical analyses examined the effectiveness of the intervention compared to usual care. During the 24-month study period, HF participants were stably housed a significantly greater proportion of time compared to usual care participants, 75 % (95 % CI 70 to 81) vs. 41 % (95 % CI 35 to 48), respectively, for a difference of 34 %, 95 % CI 25 to 43. HF also led to improvements in community integration over the course of the study: the change in the mean difference between treatment groups from baseline to 24-months was significantly greater among HF participants compared to those in usual care (change in mean difference = 2.2, 95 % CI 0.06 to 4.3). Baseline diagnosis of psychosis was associated with reduced likelihood of being housed ≥ 50 % of the study period (OR = 0.37, 95 % CI 0.18 to 0.72). Housing First enhanced with anti-racism and anti-oppression practices can improve housing stability and community functioning among

AIDE-Acute Illness and Depression in Elderly Patients. Cognitive Behavioral Group Psychotherapy in Geriatric Patients With Comorbid Depression: A Randomized, Controlled Trial.

PubMed

Hummel, Jana; Weisbrod, Cecilia; Boesch, Leila; Himpler, Katharina; Hauer, Klaus; Hautzinger, Martin; Gaebel, Andrea; Zieschang, Tania; Fickelscherer, Andrea; Diener, Slawomira; Dutzi, Ilona; Krumm, Bertram; Oster, Peter; Kopf, Daniel

2017-04-01

Comorbid depression is highly prevalent in geriatric patients and associated with functional loss, frequent hospital re-admissions, and a higher mortality rate. Cognitive behavioral psychotherapy (CBT) has shown to be effective in older depressive patients living in the community. To date, CBT has not been applied to older patients with acute physical illness and comorbid depression. To evaluate the effectiveness of CBT in depressed geriatric patients, hospitalized for acute somatic illness. Randomized controlled trial with waiting list control group. Postdischarge intervention in a geriatric day clinic; follow-up evaluations at the patients' homes. A total of 155 randomized patients, hospitalized for acute somatic illness, aged 82 ± 6 years and suffering from depression [Hospital Anxiety and Depression Scale (HADS) scores >7]. Exclusion criteria were dementia, delirium, and terminal state of medical illness. Fifteen, weekly group sessions based on a CBT manual. Commencement of psychotherapy immediately after discharge in the intervention group and a 4-month waiting list interval with usual care in the control group. HADS depression total score after 4 months. Secondary endpoints were functional, cognitive, psychosocial and physical status, resource utilization, caregiver burden, and amount of contact with physician. The intervention group improved significantly in depression scores (HADS baseline 18.8; after 4 months 11.4), whereas the control group deteriorated (HADS baseline 18.1; after 4 months 21.6). Significant improvement in the intervention group, but not in the control group, was observed for most secondary outcome parameters such as the Barthel and Karnofsky indexes. Intervention effects were less pronounced in patients with cognitive impairment or acute fractures. CBT is feasible and highly effective in geriatric patients. The benefits extend beyond effective recovery and include improvement in physical and functional parameters. Early diagnosis

A cognitive behavioral based group intervention for children with a chronic illness and their parents: a multicentre randomized controlled trial.

PubMed

Scholten, Linde; Willemen, Agnes M; Grootenhuis, Martha A; Maurice-Stam, Heleen; Schuengel, Carlo; Last, Bob F

2011-07-14

Coping with a chronic illness (CI) challenges children's psychosocial functioning and wellbeing. Cognitive-behavioral intervention programs that focus on teaching the active use of coping strategies may prevent children with CI from developing psychosocial problems. Involvement of parents in the intervention program may enhance the use of learned coping strategies in daily life, especially on the long-term. The primary aim of the present study is to examine the effectiveness of a cognitive behavioral based group intervention (called 'Op Koers') 1 for children with CI and of a parallel intervention for their parents. A secondary objective is to investigate why and for whom this intervention works, in order to understand the underlying mechanisms of the intervention effect. This study is a multicentre randomized controlled trial. Participants are children (8 to 18 years of age) with a chronic illness, and their parents, recruited from seven participating hospitals in the Netherlands. Participants are randomly allocated to two intervention groups (the child intervention group and the child intervention combined with a parent program) and a wait-list control group. Primary outcomes are child psychosocial functioning, wellbeing and child disease related coping skills. Secondary outcomes are child quality of life, child general coping skills, child self-perception, parental stress, quality of parent-child interaction, and parental perceived vulnerability. Outcomes are evaluated at baseline, after 6 weeks of treatment, and at a 6 and 12-month follow-up period. The analyses will be performed on the basis of an intention-to-treat population. This study evaluates the effectiveness of a group intervention improving psychosocial functioning in children with CI and their parents. If proven effective, the intervention will be implemented in clinical practice. Strengths and limitations of the study design are discussed. Current Controlled Trials ISRCTN60919570.

The effects of Internet-based exercise compared with supervised group exercise in people with type 2 diabetes: a randomized controlled study.

PubMed

Akinci, Buket; Yeldan, Ipek; Satman, Ilhan; Dirican, Ahmet; Ozdincler, Arzu Razak

2018-06-01

To compare the effects of Internet-based exercise on glycaemic control, blood lipids, body composition, physical activity level, functional capacity, and quality of life with supervised group exercise in patients with type 2 diabetes. Single-blind, randomized controlled study. A Faculty of Health Sciences. A total of 65 patients with type 2 diabetes (47 women, 18 men). Group A ( n = 22), control group - physical activity counselling once with a brochure. Group B ( n = 22), supervised group-based exercise, three days per week for eight weeks. Group C ( n = 21), Internet-based exercise following the same programme via a website. Primary outcomes - glycosylated haemoglobin, fasting blood glucose, high-density and low-density lipoprotein, triglyceride, and cholesterol. Secondary outcomes - waist and hip circumferences, body mass index, number of steps, six-minute walking test, and Euro-Quality of Life-5 Dimension. After treatment, glycaemic control (mean change for Group B; Group C; -0.80%, -0.91%, P = 0.003), waist circumference (-4.23 cm, 5.64 cm, P = 0.006), and quality of life (0.26, 0.15, P = 0.013) significantly improved in both training groups compared with the control group. Fasting blood glucose (-46.86 mg/dL, P = 0.009) and hip circumference (-2.7 cm, P = 0.011) were significantly decreased in Group B and total cholesterol (-16.4 mg/dL, P = 0.028), six-minute walking distance (30.5 m, P = 0.01), and number of steps (1258.05, P = 0.023) significantly improved in Group C compared with control group. Group B and Group C changed with equal magnitude. In type 2 diabetes, supervised group-based and Internet-based exercise can improve equally glycaemic control, waist circumference, and quality of life, and both are better than simply counselling.

Comparison of natural drainage group and negative drainage groups after total thyroidectomy: prospective randomized controlled study.

PubMed

Woo, Seung Hoon; Kim, Jin Pyeong; Park, Jung Je; Shim, Hyun Seok; Lee, Sang Ha; Lee, Ho Joong; Won, Seong Jun; Son, Hee Young; Kim, Rock Bum; Son, Young-Ik

2013-01-01

The aim of this study was to compare a negative pressure drain with a natural drain in order to determine whether a negative pressure drainage tube causes an increase in the drainage volume. Sixty-two patients who underwent total thyroidectomy for papillary thyroid carcinoma (PTC) were enrolled in the study between March 2010 and August 2010 at Gyeongsang National University Hospital. The patients were prospectively and randomly assigned to two groups, a negative pressure drainage group (n=32) and natural drainage group (n=30). Every 3 hours, the volume of drainage was checked in the two groups until the tube was removed. The amount of drainage during the first 24 hours postoperatively was 41.68 ± 3.93 mL in the negative drain group and 25.3 ± 2.68 mL in the natural drain group (p<0.001). After 24 additional hours, the negative drain group was 35.19 ± 4.26 mL and natural drain groups 21.53 ± 2.90 mL (p<0.001). However, the drainage at postoperative day 3 was not statistically different between the two groups. In addition, the vocal cord palsy and temporary and permanent hypocalcemia were not different between the two groups. These results indicate that a negative pressure drain may increase the amount of drainage during the first 24-48 hours postoperatively. Therefore, it is not necessary to place a closed suction drain when only a total thyroidectomy is done.

The use of control groups in artificial grammar learning.

PubMed

Reber, Rolf; Perruchet, Pierre

2003-01-01

Experimenters assume that participants of an experimental group have learned an artificial grammar if they classify test items with significantly higher accuracy than does a control group without training. The validity of such a comparison, however, depends on an additivity assumption: Learning is superimposed on the action of non-specific variables-for example, repetitions of letters, which modulate the performance of the experimental group and the control group to the same extent. In two experiments we were able to show that this additivity assumption does not hold. Grammaticality classifications in control groups without training (Experiments 1 and 2) depended on non-specific features. There were no such biases in the experimental groups. Control groups with training on randomized strings (Experiment 2) showed fewer biases than did control groups without training. Furthermore, we reanalysed published research and demonstrated that earlier experiments using control groups without training had produced similar biases in control group performances, bolstering the finding that using control groups without training is methodologically unsound.

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…

Tapentadol immediate-release for acute postbunionectomy pain: a phase 3, randomized, double-blind, placebo-controlled, parallel-group study in Taiwan.

PubMed

Chen, Yeung-Jen; Chiang, Chao-Ching; Huang, Peng-Ju; Huang, Jason; Karcher, Keith; Li, Honglan

2015-11-01

To evaluate the efficacy and safety of tapentadol immediate-release (IR) for treating acute pain following orthopedic bunionectomy surgery in a Taiwanese population. This was a phase 3, randomized, double-blind, placebo-controlled, parallel-group bridging study in which Taiwanese patients (N = 60) with moderate-to-severe pain following bunionectomy were randomized (1:1:1) to receive tapentadol IR 50 or 75 mg or placebo orally every 4-6 hours over a 72 hour period. The primary endpoint was the sum of pain intensity difference over 48 hours (SPID48), analyzed using analysis of variance. Out of 60 patients randomized (mainly women [96.7%]; median age 44 years), 41 (68.3%) completed the treatment. Mean SPID48 values were significantly higher for tapentadol IR (p ≤ 0.006: 50 mg, p ≤ 0.004: 75 mg) compared with placebo. Between-group differences in LS means of SPID48 (vs. placebo) were tapentadol IR 50 mg: 105.6 (95% CI: 32.0; 179.2); tapentadol IR 75 mg: 126.6 (95% CI: 49.5; 203.7). Secondary endpoints including SPID at 12, 24, and 72 hours, time to first use of rescue medication, cumulative distribution of responder rates, total pain relief and sum of total pain relief and sum of pain intensity difference at 12, 24, 48, and 72 hours, and patient global impression of change showed numerically better results supporting that tapentadol IR (50 and 75 mg) was more efficacious than placebo in relieving acute pain. The most frequent treatment emergent adverse events reported in ≥ 10% patients in either group were dizziness, nausea, and vomiting. A limitation of this study may possibly include more controlled patient monitoring through 4-6 hour dosing intervals, which reflects optimal conditions and thus may not approximate real-world clinical practice. However, all treatment groups would be equally affected by such bias of frequent monitoring, if any, since it was a randomized and double-blind study. Tapentadol IR treatment significantly relieved acute postoperative

Increasing Physical Activity in Mothers Using Video Exercise Groups and Exercise Mobile Apps: Randomized Controlled Trial.

PubMed

Mascarenhas, Maya Nina; Chan, June Maylin; Vittinghoff, Eric; Van Blarigan, Erin Lynn; Hecht, Frederick

2018-05-18

Women significantly decrease their activity levels in the transition to motherhood. Digital health technologies are low cost, scalable, and can provide an effective delivery mechanism for behavior change. This is the first study that examines the use of videoconferencing and mobile apps to create exercise groups for mothers. The aim of the study was to test the feasibility, acceptability, and effectiveness of an individually adaptive and socially supportive physical activity intervention incorporating videoconferencing and mobile apps for mothers. The Moms Online Video Exercise Study was an 8-week, 2-armed, Web-based randomized trial comparing the effectiveness of a group exercise intervention with a waitlist control. Healthy mothers with at least 1 child under the age of 12 years were recruited through Facebook and email listservs. Intervention participants joined exercise groups using videoconferencing (Google Hangouts) every morning on weekdays and exercised together in real time, guided by exercise mobile apps (eg, Nike+, Sworkit) of their choice. Waitlist control participants had access to recommended mobile apps and an invitation to join an exercise group after the 8-week study period. Main outcomes assessed included changes in self-reported moderate, vigorous, and moderate to vigorous physical activity (MVPA) minutes per week in aggregate and stratified by whether women met Centers for Disease Control and Prevention guidelines for sufficient aerobic activity at baseline. Outcomes were measured through self-assessed Web-based questionnaires at baseline and 8 weeks. The intervention was effective at increasing exercise for inactive women and proved to be feasible and acceptable to all participants. A total of 64 women were randomized, 30 to intervention and 34 to control. Women attended 2.8 sessions per week. There was a strong, but not statistically significant, trend toward increasing moderate, vigorous, and MVPA minutes for all women. As hypothesized, in

Comparison of Natural Drainage Group and Negative Drainage Groups after Total Thyroidectomy: Prospective Randomized Controlled Study

PubMed Central

Woo, Seung Hoon; Kim, Jin Pyeong; Park, Jung Je; Shim, Hyun Seok; Lee, Sang Ha; Lee, Ho Joong; Won, Seong Jun; Son, Hee Young; Kim, Rock Bum

2013-01-01

Purpose The aim of this study was to compare a negative pressure drain with a natural drain in order to determine whether a negative pressure drainage tube causes an increase in the drainage volume. Materials and Methods Sixty-two patients who underwent total thyroidectomy for papillary thyroid carcinoma (PTC) were enrolled in the study between March 2010 and August 2010 at Gyeongsang National University Hospital. The patients were prospectively and randomly assigned to two groups, a negative pressure drainage group (n=32) and natural drainage group (n=30). Every 3 hours, the volume of drainage was checked in the two groups until the tube was removed. Results The amount of drainage during the first 24 hours postoperatively was 41.68±3.93 mL in the negative drain group and 25.3±2.68 mL in the natural drain group (p<0.001). After 24 additional hours, the negative drain group was 35.19±4.26 mL and natural drain groups 21.53±2.90 mL (p<0.001). However, the drainage at postoperative day 3 was not statistically different between the two groups. In addition, the vocal cord palsy and temporary and permanent hypocalcemia were not different between the two groups. Conclusion These results indicate that a negative pressure drain may increase the amount of drainage during the first 24-48 hours postoperatively. Therefore, it is not necessary to place a closed suction drain when only a total thyroidectomy is done. PMID:23225820

The Efficacy of Parent-Child Interaction Therapy with Chinese Families: Randomized Controlled Trial

ERIC Educational Resources Information Center

Leung, Cynthia; Tsang, Sandra; Sin, Tammy C. S.; Choi, Siu-yan

2015-01-01

Objective: This study aimed to examine the efficacy of the Parent-Child Interaction Therapy (PCIT) in Hong Kong Chinese families, using randomized controlled trial design. Methods: The participants included 111 Hong Kong Chinese parents with children aged 2--7 years old, who were randomized into the intervention group (n = 54) and control group (n…

Effectiveness of Mindfulness Intervention on Psychological Behaviors Among Adolescents With Parental HIV Infection: A Group-Randomized Controlled Trial.

PubMed

Mon, Myo-Myo; Liabsuetrakul, Tippawan; Htut, Kyaw-Min

2016-11-01

This study aims to identify the effectiveness of mindfulness intervention on the psychological behaviors of adolescents with parental HIV infection and its associated factors in Myanmar. A total of 80 adolescents from 2 intervention townships and 80 adolescents from 2 control townships were enrolled in a group randomized controlled trial with assessments at baseline and 6 months follow-up. The mindfulness intervention involved monthly group sessions for 3 consecutive months led by an experienced mindfulness trainer. Three domains of psychological behaviors-namely, emotional, conduct, and social behaviors-were assessed at baseline and compared after 6 months. Multilevel regression analysis was used to determine the effectiveness of the intervention and associated factors for psychological behaviors. The intervention significantly improved emotional and conduct behaviors at 6 months (P < .001) but had no effect on social behavior. The significant effect of the intervention existed after adjusting for gender, family type, child age, and orphan status. © 2016 APJPH.

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

PubMed Central

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

2016-01-01

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. PMID:26883201

Men with chronic occupational stress benefit from behavioural/psycho-educational group training: a randomized, prospective, controlled trial.

PubMed

Nickel, C; Tanca, S; Kolowos, S; Pedrosa-Gil, F; Bachler, E; Loew, T H; Gross, M; Rother, W K; Nickel, M K

2007-08-01

Overworking is one of the most frequent stressors. The purpose of this study was to determine the effectiveness of behavioural/psycho-educational group training in men who are chronically stressed from overworking. Of 72 male subjects, 36 were randomly assigned to training for 8 weeks and another 36 formed the control group, which received a placebo intervention. Primary outcome measures were systolic blood pressure, salivary cortisol concentration upon awakening, and self-reported changes on the scales of the Trier Inventory for the Assessment of Chronic Stress (TICS), the State-Trait Anger Expression Inventory (STAXI) and the 36-item Short Form Health Survey (SF-36). A significant reduction in mean values was observed in daily systolic blood pressure and salivary cortisol concentration on all the TICS and most of the STAXI and SF-36 scales. Behavioural/psycho-educational group training appears to be effective in the treatment of men suffering from chronic stress due to overworking.

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

PubMed

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

2015-01-01

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

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

PubMed Central

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

2015-01-01

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

CoDuSe group exercise programme improves balance and reduces falls in people with multiple sclerosis: A multi-centre, randomized, controlled pilot study.

PubMed

Carling, Anna; Forsberg, Anette; Gunnarsson, Martin; Nilsagård, Ylva

2017-09-01

Imbalance leading to falls is common in people with multiple sclerosis (PwMS). To evaluate the effects of a balance group exercise programme (CoDuSe) on balance and walking in PwMS (Expanded Disability Status Scale, 4.0-7.5). A multi-centre, randomized, controlled single-blinded pilot study with random allocation to early or late start of exercise, with the latter group serving as control group for the physical function measures. In total, 14 supervised 60-minute exercise sessions were delivered over 7 weeks. Pretest-posttest analyses were conducted for self-reported near falls and falls in the group starting late. Primary outcome was Berg Balance Scale (BBS). A total of 51 participants were initially enrolled; three were lost to follow-up. Post-intervention, the exercise group showed statistically significant improvement ( p = 0.015) in BBS and borderline significant improvement in MS Walking Scale ( p = 0.051), both with large effect sizes (3.66; -2.89). No other significant differences were found between groups. In the group starting late, numbers of falls and near falls were statistically significantly reduced after exercise compared to before ( p < 0.001; p < 0.004). This pilot study suggests that the CoDuSe exercise improved balance and reduced perceived walking limitations, compared to no exercise. The intervention reduced falls and near falls frequency.

Group parent-child interaction therapy: A randomized control trial for the treatment of conduct problems in young children.

PubMed

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

2016-08-01

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. Eighty-one families with 3- to 6-year-old children (71.6% boys, 85.2% White) 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 6-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. 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. 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. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

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

Motivational intervention to enhance post-detoxification 12-Step group affiliation: a randomized controlled trial.

PubMed

Vederhus, John-Kåre; Timko, Christine; Kristensen, Oistein; Hjemdahl, Bente; Clausen, Thomas

2014-05-01

To compare a motivational intervention (MI) focused on increasing involvement in 12-Step groups (TSGs; e.g. Alcoholics Anonymous) versus brief advice (BA) to attend TSGs. Patients were assigned randomly to either the MI or BA condition, and followed-up at 6 months after discharge. One hundred and forty substance use disorder (SUD) patients undergoing in-patient detoxification (detox) in Norway. The primary outcome was TSG affiliation measured with the Alcoholics Anonymous Affiliation Scale (AAAS), which combines meeting attendance and TSG involvement. Substance use and problem severity were also measured. At 6 months after treatment, compared with the BA group, the MI group had higher TSG affiliation [0.91 point higher AAAS score; 95% confidence interval (CI) = 0.04 to 1.78; P = 0.041]. The MI group reported 3.5 fewer days of alcohol use (2.1 versus 5.6 days; 95% CI = -6.5 to -0.6; P = 0.020) and 4.0 fewer days of drug use (3.8 versus 7.8 days; 95% CI = -7.5 to -0.4; P = 0.028); however, abstinence rates and severity scores did not differ between conditions. Analyses controlling for duration of in-patient treatment did not alter the results. A motivational intervention in an in-patient detox ward was more successful than brief advice in terms of patient engagement in 12-Step groups and reduced substance use at 6 months after discharge. There is a potential benefit of adding a maintenance-focused element to standard detox. © 2014 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.

Motivational intervention to enhance post-detoxification 12-Step group affiliation: a randomized controlled trial

PubMed Central

Vederhus, John-Kåre; Timko, Christine; Kristensen, Øistein; Hjemdahl, Bente; Clausen, Thomas

2014-01-01

Aims To compare a motivational intervention (MI) focused on increasing involvement in 12-Step groups (TSGs; e.g. Alcoholics Anonymous) versus brief advice (BA) to attend TSGs. Design Patients were assigned randomly to either the MI or BA condition, and followed-up at 6 months after discharge. Setting and participants One hundred and forty substance use disorder (SUD) patients undergoing in-patient detoxification (detox) in Norway. Measurements The primary outcome was TSG affiliation measured with the Alcoholics Anonymous Affiliation Scale (AAAS), which combines meeting attendance and TSG involvement. Substance use and problem severity were also measured. Findings At 6 months after treatment, compared with the BA group, the MI group had higher TSG affiliation [0.91 point higher AAAS score; 95% confidence interval (CI) = 0.04 to 1.78; P = 0.041]. The MI group reported 3.5 fewer days of alcohol use (2.1 versus 5.6 days; 95% CI = −6.5 to −0.6; P = 0.020) and 4.0 fewer days of drug use (3.8 versus 7.8 days; 95% CI = −7.5 to −0.4; P = 0.028); however, abstinence rates and severity scores did not differ between conditions. Analyses controlling for duration of in-patient treatment did not alter the results. Conclusions A motivational intervention in an in-patient detox ward was more successful than brief advice in terms of patient engagement in 12-Step groups and reduced substance use at 6 months after discharge. There is a potential benefit of adding a maintenance-focused element to standard detox. PMID:24400937

Building Kindergartners' Number Sense: A Randomized Controlled Study.

PubMed

Jordan, Nancy C; Glutting, Joseph; Dyson, Nancy; Hassinger-Das, Brenna; Irwin, Casey

2012-08-01

Math achievement in elementary school is mediated by performance and growth in number sense during kindergarten. The aim of the present study was to test the effectiveness of a targeted small group number sense intervention for high-risk kindergartners from low-income communities. Children were randomly assigned to one of three groups ( n = 44 in each group): a number sense intervention group, a language intervention group, or a business as usual control group. Accounting for initial skill level in mathematical knowledge, children who received the number sense intervention performed better than controls at immediate post test, with meaningful effects on measures of number competencies and general math achievement. Many of the effects held eight weeks after the intervention was completed, suggesting that children internalized what they had learned. There were no differences between the language and control groups on any math-related measures.

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.

Electroacupuncture treatment for pancreatic cancer pain: a randomized controlled trial.

PubMed

Chen, Hao; Liu, Tang-Yi; Kuai, Le; Zhu, Ji; Wu, Cai-Jun; Liu, Lu-Ming

2013-01-01

Pancreatic cancer is often accompanied by severe abdominal or back pain. It's the first study to evaluate the analgesic effect of electroacupuncture on pancreatic cancer pain. A randomized controlled trial compared electroacupuncture with control acupuncture using the placebo needle. Sixty patients with pancreatic cancer pain were randomly assigned to the electroacupuncture group (n = 30) and the placebo control group (n = 30). Patients were treated on Jiaji (Ex-B2) points T8-T12 bilaterally for 30 min once a day for 3 days. Pain intensity was assessed with numerical rated scales (NRS) before the treatment (Baseline), after 3 treatments, and 2 days follow-up. Baseline characteristics were similar in the two groups. After 3 treatment, pain intensity on NRS decreased compared with Baseline (-1.67, 95% confidence interval [CI] -1.46 to -1.87) in the electroacupuncture group; there was little change (-0.13, 95% CI 0.08 to -0.35) in control group; the difference between two groups was statistically significant (P < 0.001). Follow-up also found a significant reduction in pain intensity in the electroacupuncture group compared with the control group (P < 0.001). Electroacupuncture was an effective treatment for relieving pancreatic cancer pain. Copyright © 2013 IAP and EPC. Published by Elsevier B.V. All rights reserved.

Moxibustion for breech version: a randomized controlled trial.

PubMed

Guittier, Marie-Julia; Pichon, Michelle; Dong, Hongguang; Irion, Olivier; Boulvain, Michel

2009-11-01

To estimate the efficacy of moxibustion between 34 and 38 weeks of gestation to facilitate the cephalic version of fetuses in breech presentation and the acceptability of this method by women. We conducted a randomized controlled trial in a Swiss university hospital maternity unit. We proposed to stimulate the acupoint BL 67 by moxibustion daily for 2 weeks for 212 consenting women between 34 and 36 weeks of gestation with a single fetus in breech presentation. We did the intervention three times weekly in the hospital and a teaching session and information leaflet on the technique for additional daily therapy at home. The control group received expectant management care. The availability of external cephalic version was maintained for both groups. The main outcome measure was the comparison of the proportion of women with cephalic presentation at delivery. Baseline characteristics were similar between groups, except more nulliparous women were randomized to moxibustion. The percentage of versions was similar between groups: 18% in the moxibustion group compared with 16% in the control group (relative risk 1.12, 95% confidence interval 0.62 to 2.03). Adjustment for the imbalance in parity did not change these results. The frequency of cesarean delivery was similar (64% compared with 58% in the moxibustion group and the control group, respectively). Acceptability of the intervention and women's perceptions of moxibustion were favorable. We observed no beneficial effect of moxibustion to facilitate the cephalic version of fetuses in breech presentation. Despite this lack of proven effectiveness, women had positive opinions on the intervention. ClinicalTrials.gov, www.clinicaltrials.gov,NCT00890474. I.

Rigorous control conditions diminish treatment effects in weight loss randomized controlled trials

PubMed Central

Dawson, John A.; Kaiser, Kathryn A.; Affuso, Olivia; Cutter, Gary R.; Allison, David B.

2015-01-01

Background It has not been established whether control conditions with large weight losses (WLs) diminish expected treatment effects in WL or prevention of weight gain (PWG) randomized controlled trials (RCTs). Subjects/Methods We performed a meta-analysis of 239 WL/PWG RCTs that include a control group and at least one treatment group. A maximum likelihood meta-analysis framework is used in order to model and understand the relationship between treatment effects and control group outcomes. Results Under the informed model, an increase in control group WL of one kilogram corresponds with an expected shrinkage of the treatment effect by 0.309 kg [95% CI (−0.480, −0.138), p = 0.00081]; this result is robust against violations of the model assumptions. Conclusions We find that control conditions with large weight losses diminish expected treatment effects. Our investigation may be helpful to clinicians as they design future WL/PWG studies. PMID:26449419

Effectiveness of a group-based intervention to change medication beliefs and improve medication adherence in patients with rheumatoid arthritis: a randomized controlled trial.

PubMed

Zwikker, Hanneke E; van den Ende, Cornelia H; van Lankveld, Wim G; den Broeder, Alfons A; van den Hoogen, Frank H; van de Mosselaar, Birgit; van Dulmen, Sandra; van den Bemt, Bart J

2014-03-01

To assess the effect of a group-based intervention on the balance between necessity beliefs and concern beliefs about medication and on medication non-adherence in patients with rheumatoid arthritis (RA). Non-adherent RA patients using disease-modifying anti-rheumatic drugs (DMARDs) were randomized to an intervention or control arm. The intervention consisted, amongst others, of two motivational interviewing-guided group sessions led by the same pharmacist. Control patients received brochures about their DMARDs. Questionnaires were completed up to 12 months follow-up. 123 patients (mean age: 60 years, female: 69%) were randomized. No differences in necessity beliefs and concern beliefs about medication and in medication non-adherence were detected between the intervention and control arm, except at 12 months' follow-up: participants in the intervention arm had less strong necessity beliefs about medication than participants in the control arm (b: -1.0 (95% CI: -2.0, -0.1)). This trial did not demonstrate superiority of our intervention over the control arm in changing beliefs about medication or in improving medication adherence over time. Absent intervention effects might have been due to, amongst others, selection bias and a suboptimal treatment integrity level. Hence, targeting beliefs about medication in clinical practice should not yet be ruled out. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

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

Fundamental movement skills in preschoolers: a randomized controlled trial targeting object control proficiency.

PubMed

Donath, L; Faude, O; Hagmann, S; Roth, R; Zahner, L

2015-11-01

Adequately developed fundamental movement skills, particularly object control dimensions, are considered essential to learn more complex movement patterns and to increase the likelihood to successfully participate in organized and non-organized sports during later years. Thus, the present randomized controlled trial aimed at improving object control dimensions at an early state in a kindergarten setting. Catching, throwing, kicking, rolling and stationary dribbling were assessed via gross motor development 2 (TGMD-2) testing in 41 normally developed preschoolers. On a cluster-randomized basis [strata: age, sex and body mass index (BMI)], three kindergartens were randomly assigned to an intervention group (n = 22, INT, age: 4.6 ± 1.0 years; BMI: 16.2 ± 1.1 kg/m(2) ) and three to a control group (n = 19, CON: age: 4.5 ± 1.2 years; BMI: 16.8 ± 1.2 kg/m(2) ). Twelve structured training sessions were given within 6 weeks (12 sessions). The total training volume was 330 min. Moderate time × group interaction were observed for the total sum score (Δ+22%, P = 0.05) and dribbling (Δ+41%, P = 0.002). Adjusting for baseline differences analyses of covariance did not affect these results. Interestingly, likely to most likely practically worthwhile effects were detected for the total sum score, catching and dribbling. Object control dimensions such as dribbling and catching that apparently rely on rhythmical movement patterns and anticipatory eye-hand coordination seem to benefit from short-term object control training. These skills are considered important for successful team-sport participation and appropriate sportive motor development. © 2015 John Wiley & Sons Ltd.

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.

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.

Building Kindergartners’ Number Sense: A Randomized Controlled Study

PubMed Central

Jordan, Nancy C.; Glutting, Joseph; Dyson, Nancy; Hassinger-Das, Brenna; Irwin, Casey

2015-01-01

Math achievement in elementary school is mediated by performance and growth in number sense during kindergarten. The aim of the present study was to test the effectiveness of a targeted small group number sense intervention for high-risk kindergartners from low-income communities. Children were randomly assigned to one of three groups (n = 44 in each group): a number sense intervention group, a language intervention group, or a business as usual control group. Accounting for initial skill level in mathematical knowledge, children who received the number sense intervention performed better than controls at immediate post test, with meaningful effects on measures of number competencies and general math achievement. Many of the effects held eight weeks after the intervention was completed, suggesting that children internalized what they had learned. There were no differences between the language and control groups on any math-related measures. PMID:25866417

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.

Effects of whole body vibration training on postural control in older individuals: a 1 year randomized controlled trial.

PubMed

Bogaerts, An; Verschueren, Sabine; Delecluse, Christophe; Claessens, Albrecht L; Boonen, Steven

2007-07-01

This randomized controlled trial investigated the effects of a 12 month whole body vibration training program on postural control in healthy older adults. Two hundred and twenty people were randomly assigned to a whole body vibration group (n=94), a fitness group (n=60) or a control group (n=66). The whole body vibration and fitness groups trained three times a week for 1 year. The vibration group performed exercises on a vibration platform and the fitness group performed cardiovascular, strength, balance and stretching exercises. Balance was measured using dynamic computerized posturography at baseline and after 6 and 12 months. Whole body vibration training was associated with reduced falls frequency on a moving platform when vision was disturbed and improvements in the response to toes down rotations at the ankle induced by the moving platform. The fitness group showed reduced falls frequency on the moving surface when vision was disturbed. Thus, whole body vibration training may improve some aspects of postural control in community dwelling older individuals.

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.

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

Design and rationale of the medical students learning weight management counseling skills (MSWeight) group randomized controlled trial.

PubMed

Ockene, Judith K; Ashe, Karen M; Hayes, Rashelle B; Churchill, Linda C; Crawford, Sybil L; Geller, Alan C; Jolicoeur, Denise; Olendzki, Barbara C; Basco, Maria Theresa; Pendharkar, Jyothi A; Ferguson, Kristi J; Guck, Thomas P; Margo, Katherine L; Okuliar, Catherine A; Shaw, Monica A; Soleymani, Taraneh; Stadler, Diane D; Warrier, Sarita S; Pbert, Lori

2018-01-01

Physicians have an important role addressing the obesity epidemic. Lack of adequate teaching to provide weight management counseling (WMC) is cited as a reason for limited treatment. National guidelines have not been translated into an evidence-supported, competency-based curriculum in medical schools. Weight Management Counseling in Medical Schools: A Randomized Controlled Trial (MSWeight) is designed to determine if a multi-modal theoretically-guided WMC educational intervention improves observed counseling skills and secondarily improve perceived skills and self-efficacy among medical students compared to traditional education (TE). Eight U.S. medical schools were pair-matched and randomized in a group randomized controlled trial to evaluate whether a multi-modal education (MME) intervention compared to traditional education (TE) improves observed WMC skills. The MME intervention includes innovative components in years 1-3: a structured web-course; a role play exercise, WebPatientEncounter, and an enhanced outpatient internal medicine or family medicine clerkship. This evidence-supported curriculum uses the 5As framework to guide treatment and incorporates patient-centered counseling to engage the patient. The primary outcome is a comparison of scores on an Objective Structured Clinical Examination (OSCE) WMC case among third year medical students. The secondary outcome compares changes in scores of medical students from their first to third year on an assessment of perceived WMC skills and self-efficacy. MSWeight is the first RCT in medical schools to evaluate whether interventions integrated into the curriculum improve medical students' WMC skills. If this educational approach for teaching WMC is effective, feasible and acceptable it can affect how medical schools integrate WMC teaching into their curriculum. Copyright © 2017 Elsevier Inc. All rights reserved.

Mirror therapy for distal radial fractures: A pilot randomized controlled study.

PubMed

Bayon-Calatayud, Manuel; Benavente-Valdepeñas, Ana Maria; Del Prado Vazquez-Muñoz, Maria

2016-10-12

To investigate the efficacy of mirror therapy in reducing pain and disability in patients with distal radial fractures. Pilot randomized controlled study. Twenty-two patients with closed distal radial fracture. Patients were randomly assigned to experimental (= 11) or control (= 11) groups. Researchers were blinded to group allocation. Both groups received conventional physiotherapy. In addition, the experimental group had 15 sessions of mirror therapy (a daily session, 30 min). The control group received the same amount of conventional occupational therapy. Assessment was made from baseline to post-treatment. Pain was measured on a visual analogue scale (VAS). Active wrist extension and Quick-DASH (Disabilities of Arm, Shoulder and Hand) were used to assess functional recovery. Pain, disability, and range of motion improved for both groups after intervention. No significant post-treatment differences were found between groups in Quick-DASH (= 0.409), active wrist extension (= 0.191) and VAS scores (= 0.807). There was no significant difference in active wrist extension between groups. Mirror therapy was not superior to conventional occupational therapy in reducing pain and disability.

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.

Does Oral Implant Design Affect Marginal Bone Loss? Results of a Parallel-Group Randomized Controlled Equivalence Trial

PubMed Central

Bateli, Maria; Ben Rahal, Ghada; Christmann, Marin; Vach, Kirstin; Kohal, Ralf-Joachim

2018-01-01

Objective To test whether or not the modified design of the test implant (intended to increase primary stability) has an equivalent effect on MBL compared to the control. Methods Forty patients were randomly assigned to receive test or control implants to be installed in identically dimensioned bony beds. Implants were radiographically monitored at installation, at prosthetic delivery, and after one year. Treatments were considered equivalent if the 90% confidence interval (CI) for the mean difference (MD) in MBL was in between −0.25 and 0.25 mm. Additionally, several soft tissue parameters and patient-reported outcome measures (PROMs) were evaluated. Linear mixed models were fitted for each patient to assess time effects on response variables. Results Thirty-three patients (21 males, 12 females; 58.2 ± 15.2 years old) with 81 implants (47 test, 34 control) were available for analysis after a mean observation period of 13.9 ± 4.5 months (3 dropouts, 3 missed appointments, and 1 missing file). The adjusted MD in MBL after one year was −0.13 mm (90% CI: −0.46–0.19; test group: −0.49; control group: −0.36; p = 0.507). Conclusion Both implant systems can be considered successful after one year of observation. Concerning MBL in the presented setup, equivalence of the treatments cannot be concluded. Registration This trial is registered with the German Clinical Trials Register (ID: DRKS00007877). PMID:29610765

Physical activity measurements affected participants' behavior in a randomized controlled trial.

PubMed

van Sluijs, Esther M F; van Poppel, Mireille N M; Twisk, Jos W R; van Mechelen, Willem

2006-04-01

Assessing levels and determinants of physical activity as outcome measurements might have an independent effect on participant's physical activity behavior. The objective is to study this effect in a randomized controlled trial (RCT) promoting regular physical activity in Dutch general practice. Using a Solomon four-group design, participants were randomized twice. After randomization to a control or intervention-condition at general practice level (N = 29), participants were randomized to a group participating in measurements at baseline, 2 and 6 months (3M-group, N = 361), or a group only participating in measurements at 6 months (1M-group, N = 356). Outcome measures assessed at 6 months included: level of physical activity (self-reported and objectively measured with accelerometry), meeting ACSM/CDC guideline for regular physical activity, stage of change, and determinants of physical activity. Follow-up data on 635 participants (89%) was collected. Statistically significant measurement effects were found for meeting the ACSM/CDC guideline (self-reported), self-efficacy for resisting relapse, knowledge, and on awareness. Other outcome measures showed positive trends, except stages of change. Measurements of physical activity affect participant's physical activity behavior, possibly triggered by a raised awareness about their own physical activity level. Implications for future research are discussed, as well as methodologic limitations of the study design.

Epidemiological evaluation quality of life in patients suffering from early rheumatoid arthritis: a pragmatic, prospective, randomized, blind allocation controlled of a modular program group intervention.

PubMed

Yousefi, Hadi; Chopra, Arvind; Farrokhseresht, Reza; Sarmukaddam, Sanjeev; Noghabi, Fariba Asadi; Bedekar, Nilima; Madani, Abdolhosain

2015-01-01

Epidemiology has taken on new roles in the management of health care services. In this study, we developed a non-pharmacological self-management modular program group intervention and evaluated its efficacy as an adjunct therapy in patients suffering from early rheumatoid arthritis (RA). Patients were randomized to either participate in a non-equivalent intervention group along with the standard of care or only receive standard-of-care treatment at a community rheumatology center. The outcomes measured were a pain visual analog scale (VAS), patient general health (GH) on a VAS, and the Short Form 36 Health Survey version 2 scale measuring quality of life. These parameters were evaluated in the first week to obtain baseline values, and at 20, 32, 48, and 60 weeks to evaluate the efficacy of the intervention group. The patients were randomized, with 100 patients in the intervention group and 106 in the control group. The intervention and control groups were similar with regard to the percentage of women (86% vs. 89.6%), tobacco usage (25% vs. 19.8%), mean age (42.6±13.2 years vs. 46.6±10.9 years), and disease duration (15.3±6.7 months vs. 14.5±6.6 months). The mean outcomes were significantly different between the two groups, and post-hoc pairwise analysis demonstrated significant deterioration in the control group in contrast to improvement in the intervention group at the second, third, fourth, and fifth evaluations. Improvements were often seen as early as the 12-week and 24-week follow-up visits. Epidemiology contributes to the evaluation of how well specific therapies or other health interventions prevent or control health problems. The modular program group intervention implemented in this study appears to be a suitable and feasible method to facilitate much more comprehensive management of early RA in socioeconomically challenged communities.

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

Making Healthy Eating Policy Practice: A Group Randomized Controlled Trial on Changes in Snack Quality, Costs, and Consumption in After-School Programs.

PubMed

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

2016-09-01

The aim of this study was to evaluate an intervention designed to assist after-school programs (ASPs) in meeting snack nutrition policies that specify that a fruit or vegetable be served daily and sugar-sweetened beverages/foods and artificially flavored foods eliminated. The study used a 1-year group-randomized controlled trial. The study took place in ASPs operating in South Carolina, United States. Twenty ASPs serving over 1700 children were recruited, match-paired postbaseline on enrollment size and days fruits/vegetables were served per week, and randomized to either intervention (n = 10) or control (n = 10) groups. The study used Strategies To Enhance Practice for Healthy Eating (STEPs-HE), a multistep adaptive intervention framework that assists ASP leaders and staff to serve snacks that meet nutrition policies while maintaining cost. Direct observation of snacks served and consumed and monthly snack expenditures as determined by receipts were used. The study used nonparametric and mixed-model repeated measures. By postassessment, intervention ASPs increased serving of fruits/vegetables to 3.9 ± 2.1 vs. 0.7 ± 1.7 d/wk and decreased serving sugar-sweetened beverages to 0.1 ± 0.7 vs. 1.8 ± 2.4 d/wk and sugar-sweetened foods to 0.3 ± 1.1 vs. 2.7 ± 2.5 d/wk compared to controls, respectively. Cost of snacks increased by $0.02/snack in the intervention ASPs ($0.36 to $0.38) compared to a $0.01 per snack decrease in the control group ($0.39 to $0.38). Across both assessments and groups, 80% to 100% of children consumed FVs. The STEPs-HE intervention can assist ASPs in meeting nationally endorsed nutrition policies with marginal increases in cost. © 2016 by American Journal of Health Promotion, Inc.

NSAID Use after Bariatric Surgery: a Randomized Controlled Intervention Study.

PubMed

Yska, Jan Peter; Gertsen, Sanneke; Flapper, Gerbrich; Emous, Marloes; Wilffert, Bob; van Roon, Eric N

2016-12-01

Use of nonsteroidal anti-inflammatory drugs (NSAIDs) should be avoided in bariatric surgery patients. If use of an NSAID is inevitable, a proton pump inhibitor (PPI) should also be used. To determine the effect of an, compared to care-as-usual, additional intervention to reduce NSAID use in patients who underwent bariatric surgery, and to determine the use of PPIs in patients who use NSAIDs after bariatric surgery. A randomized controlled intervention study in patients after bariatric surgery. Patients were randomized to an intervention or a control group. The intervention consisted of sending a letter to patients and their general practitioners on the risks of use of NSAIDs after bariatric surgery and the importance of avoiding NSAID use. The control group received care-as-usual. Dispensing data of NSAIDs and PPIs were collected from patients' pharmacies: from a period of 6 months before and from 3 until 9 months after the intervention. Two hundred forty-eight patients were included (intervention group: 124; control group: 124). The number of users of NSAIDs decreased from 22 to 18 % in the intervention group and increased from 20 to 21 % in the control group (NS). The use of a PPI with an NSAID rose from 52 to 55 % in the intervention group, and from 52 to 69 % in the control group (NS). Informing patients and their general practitioners by letter, in addition to care-as-usual, is not an effective intervention to reduce the use of NSAIDs after bariatric surgery (trial number NTR3665).

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

Effect of Oral Carbohydrate Intake on Labor Progress: Randomized Controlled Trial

PubMed Central

Rahmani, R; Khakbazan, Z; Yavari, P; Granmayeh, M; Yavari, L

2012-01-01

Background Lack of information regarding biochemical changes in women during labor and its outcomes on maternal and neonatal health still is an unanswered question. This study aims to explore the effectiveness of oral carbohydrate intake during labor on the duration of the active phase and other maternal and neonatal outcomes. Methods: A parallel prospective randomized controlled trial, conducted at the University Affiliated Teaching Hospital in Gonabad. Totally, 190 women were randomly assigned to an intervention (N=87) or control (N=90) group. Inclusion criteria were low-risk women with singleton cephalic presentation; and cervical dilatation 3–4 cm. Randomization was used by random number generator on every day. Odd numbers was used for intervention and even numbers for control group. Intervention was based on the preferences between: 3 medium dates plus 110 ml water; 3 dates plus 110 ml light tea without sugar; or 110 ml orange juice. The protocol is only run once but women ate and drank gradually before second stage of labor. Control group were fasted as routine practice. Neither participants nor care givers or staff could be blinded to group allocation. Differences between duration of the active phase of labor were assessed as primary outcome measure. Results: There was significant difference in the length of second stage of labor (P <.05). The effect size for this variable was 0.48. There were no significant differences in other maternal and neonatal outcomes. Conclusions: Oral intake of carbohydrate was an effective method for shortening the duration of second stage of labor in low-risk women. PMID:23304677

Impact of Playing Exergames on Mood States: A Randomized Controlled Trial.

PubMed

Huang, Han-Chung; Wong, May-Kuen; Yang, Ya-Hui; Chiu, Hsin-Ying; Teng, Ching-I

2017-04-01

To examine how playing exergames impacts the mood states of university students and staff, and whether such an impact depends on gender and players' previous exercise time. This study was designed as a randomized controlled trial. It enrolled 337 participants and randomly assigned them to an intervention group (n = 168) or a control group (n = 167). A 2-week exergame program was designed for the participants in the intervention group. They were required to play exergames for 30 consecutive minutes each week for 2 weeks and respond to the items measuring vigor, happiness, and perceived stress. All measures were administered before and after the study. Repeated measures analysis of variances were conducted. Playing exergames enhanced vigor and happiness for participants in the intervention group. This group exhibited more positive change in vigor and happiness than the control group. This effect of playing exergames was not moderated by gender, age, occupation (student or staff), or previous exercise time. Playing exergames may induce positive mood states among university students and staff.

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.

Making healthy eating policy practice: A group randomized controlled trial on changes in snack quality, costs, and consumption in after school programs

PubMed Central

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

2017-01-01

Purpose The aim of this study was to evaluate an intervention designed to assist after school programs (ASPs) in meeting snack nutrition policies that specify that a fruit or vegetable (FV) be served daily, and sugar-sweetened beverages/foods and artificially flavored foods eliminated. Design One-year group randomized controlled trial Setting Afterschool programs operating in South Carolina, US. Subjects Twenty ASPs serving over 1,700 children were recruited, match-paired post-baseline on enrollment size and days FV were served/week (days/wk), and randomized to either an intervention (n=10) or control (n=10) groups. Intervention Strategies To Enhance Practice for Healthy Eating (STEPs-HE), a multi-step adaptive intervention framework, which assists ASP leaders and staff to serve snacks that meet nutrition policies while maintaining cost. Measures Direct observation of snacks served and consumed, and monthly snack expenditures via receipts. Analysis Nonparametric and mixed-model repeated-measures Results By post-assessment, intervention ASPs increased serving FV to 3.9±2.1 vs. 0.7±1.7days/wk and decreased serving sugar-sweetened beverages to 0.1±0.7 vs. 1.8±2.4days/wk and foods to 0.3±1.1 vs. 2.7±2.5days/wk compared to controls, respectively. Cost of snacks increased by $0.02/snack in the intervention ASPs ($0.36 to $0.38) compared to a $0.01/snack decrease in the control ($0.39 to $0.38). Across both assessments and groups 80–100% of children consumed FV. Conclusions The STEPs-HE intervention can assist ASPs in meeting nationally endorsed nutrition policies with marginal increases in cost. PMID:26158679

The use of video in standardized patient training to improve portrayal accuracy: A randomized post-test control group study.

PubMed

Schlegel, Claudia; Bonvin, Raphael; Rethans, Jan Joost; van der Vleuten, Cees

2014-10-14

Abstract Introduction: High-stake objective structured clinical examinations (OSCEs) with standardized patients (SPs) should offer the same conditions to all candidates throughout the exam. SP performance should therefore be as close to the original role script as possible during all encounters. In this study, we examined the impact of video in SP training on SPs' role accuracy, investigating how the use of different types of video during SP training improves the accuracy of SP portrayal. Methods: In a randomized post-test, control group design three groups of 12 SPs each with different types of video training and one control group of 12 SPs without video use in SP training were compared. The three intervention groups used role-modeling video, performance-feedback video, or a combination of both. Each SP from each group had four students encounter. Two blinded faculty members rated the 192 video-recorded encounters, using a case-specific rating instrument to assess SPs' role accuracy. Results: SPs trained by video showed significantly (p < 0.001) better role accuracy than SPs trained without video over the four sequential portrayals. There was no difference between the three types of video training. Discussion: Use of video during SP training enhances the accuracy of SP portrayal compared with no video, regardless of the type of video intervention used.

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

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

MiDAS ENCORE: Randomized Controlled Study Design and Protocol.

PubMed

Benyamin, Ramsin M; Staats, Peter S

2015-01-01

Epidural steroid injections (ESIs) are commonly used for treatment of symptomatic lumbar spinal stenosis (LSS). ESIs are generally administered after failure of conservative therapy. For LSS patients suffering from neurogenic claudication, the mild® procedure provides an alternative to ESIs via minimally invasive lumbar decompression. Both ESIs and mild offer interventional pain treatment options for LSS patients experiencing neurogenic claudication refractory to more conservative therapies. Prospective, multi-center, randomized controlled, clinical study. Twenty-six interventional pain management centers throughout the United States. To compare patient outcomes following treatment with either mild or ESIs in LSS patients with neurogenic claudication and having verified ligamentum flavum hypertrophy. Study participants include Medicare beneficiaries who meet study inclusion/exclusion criteria. Eligible patients will be randomized in a 1:1 ratio to one of 2 treatment arms, mild (treatment group) or ESI (control group). Each study group will include approximately 150 patients who have experienced neurogenic claudication symptoms for ≥ 3 months duration who have failed to respond to physical therapy, home exercise programs, and oral analgesics. Those randomized to mild are prohibited from receiving lumbar ESIs during the study period, while those randomized to ESI may receive ESIs up to 4 times per year. Patient assessments will occur at baseline, 6 months, and one year. An additional assessment will be conducted for the mild patient group at 2 years. The primary efficacy outcome measure is the proportion of Oswestry Disability Index (ODI) responders from baseline to one year follow-up in the treatment group (mild) versus the control group (ESI). ODI responders are defined as those patients achieving the validated Minimal Important Change (MIC) of ≥ 10 point improvement in ODI from baseline to follow-up as a clinically significant efficacy threshold. Secondary

Web-based proactive system to improve breast cancer screening: a randomized controlled trial.

PubMed

Chaudhry, Rajeev; Scheitel, Sidna M; McMurtry, Erin K; Leutink, Dorinda J; Cabanela, Rosa L; Naessens, James M; Rahman, Ahmed S; Davis, Lynn A; Stroebel, Robert J

2007-03-26

Screening mammography is recommended for early detection of breast cancer but screening rates remain suboptimal. A primary care portal for a large academic primary practice was developed for all preventive services. Another Web-based system (PRECARES [PREventive CAre REminder System]) was developed for appointment secretaries to manage proactive breast cancer screening. Female patients aged 40 to 75 years were randomly assigned to a control group (usual care) and an intervention group. For the intervention group, 2 monthly letters inviting patients to undergo mammography were sent starting 3 months before they were due for annual screening, followed by a telephone call to nonresponding patients. A subgroup of women employees was further randomized to receive a reminder by either US mail or e-mail. Of the total eligible population of 6665 women identified as having consented to participate in research, 3339 were randomly assigned to the control group and 3326 to the intervention group. The screening rate for annual mammography was 64.3% for the intervention group and 55.3% for the control group (P <.001). There were no significant differences between the 2 groups for any of the other adult preventive services. For the employee subgroup, the screening rate was 57.5% for the control group, 68.1% for the US mail group, and 72.2% for the e-mail group (intervention vs control, P <.001; e-mail vs US mail; P = .24). The breast cancer screening rate improved significantly with the practice redesign of having appointment secretaries proactively manage breast cancer screening needs.

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

PubMed

Hazlett-Stevens, Holly; Oren, Yelena

2017-06-01

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

Three controlled trials of interventions to increase recruitment to a randomized controlled trial of mobile phone based smoking cessation support.

PubMed

Free, Caroline; Hoile, Elizabeth; Robertson, Steven; Knight, Rosemary

2010-06-01

Recruitment is a major challenge for trials but there is little evidence regarding interventions to increase trial recruitment. We report three controlled trials of interventions to increase recruitment to the Txt2stop trial. To evaluate: Trial 1. The impact on registrations of a text message regarding an online registration facility; Trial 2. The impact on randomizations of sending pound5 with a covering letter to those eligible to join the trial; Trial 3. The impact on randomizations of text messages containing quotes from existing participants. Single blind controlled trials with allocation concealment. Trial 1: A text message regarding our new online registration facility; Trial 2: A letter with pound5 enclosed; Trial 3: A series of four text messages containing quotes from participants. The control group in each trial received standard Txt2stop procedures. Trial 1: 3.6% (17/470) of the intervention group and 1.1% (5/467) of the control group registered for the trial, risk difference 2.5% (95% CI 0.6-4.5). 0% (0/ 470) of the intervention group and 0.2% (1/467) of the control group registered successfully online, risk difference -0.2 (95% CI -0.6-0.2); Trial 2: 4.5% (11/246) of the intervention group and 0.4% (1/245) of the control group were randomized into the Txt2stop trial, risk difference 4.0% (95% CI 1.4-6.7); Trial 3: 3.5% (14/405) of the intervention group and 0% (0/406) of the control group were randomized into the Txt2stop trial, risk difference 3.5 (95% CI 1.7-5.2). There were no baseline data available for trial 1. Allocation of participant IDs in trials 2 and 3 were systematic. Sending a text message about an online registration facility increased registrations to Txt2stop, but did not increase online registrations. Sending a pound5 reimbursement for participants' time and sending text messages containing quotes from existing participants increased randomizations into the Txt2stop trial. Clinical Trials 2010; 7: 265-273. http://ctj.sagepub.com.

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

PubMed

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

2013-05-01

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

Mindfulness meditation in older adults with postherpetic neuralgia: a randomized controlled pilot study.

PubMed

Meize-Grochowski, Robin; Shuster, George; Boursaw, Blake; DuVal, Michelle; Murray-Krezan, Cristina; Schrader, Ron; Smith, Bruce W; Herman, Carla J; Prasad, Arti

2015-01-01

This parallel-group, randomized controlled pilot study examined daily meditation in a diverse sample of older adults with postherpetic neuralgia. Block randomization was used to allocate participants to a treatment group (n = 13) or control group (n = 14). In addition to usual care, the treatment group practiced daily meditation for six weeks. All participants completed questionnaires at enrollment in the study, two weeks later, and six weeks after that, at the study's end. Participants recorded daily pain and fatigue levels in a diary, and treatment participants also noted meditation practice. Results at the 0.10 level indicated improvement in neuropathic, affective, and total pain scores for the treatment group, whereas affective pain worsened for the control group. Participants were able to adhere to the daily diary and meditation requirements in this feasibility pilot study. Copyright © 2015 Elsevier Inc. All rights reserved.

Cost-effectiveness of an adjustment group for people with multiple sclerosis and low mood: a randomized trial.

PubMed

Humphreys, Ioan; Drummond, Avril E R; Phillips, Ceri; Lincoln, Nadina B

2013-11-01

To evaluate the cost effectiveness of a psychological adjustment group shown to be clinically effective in comparison with usual care for people with multiple sclerosis. Randomized controlled trial with comparison of costs and calculation of incremental cost effectiveness ratio. Community. People with multiple sclerosis were screened on the General Health Questionnaire 12 and Hospital Anxiety and Depression Scale, and those with low mood were recruited. Participants randomly allocated to the adjustment group received six group treatment sessions. The control group received usual care, which did not include psychological interventions. Outcomes were assessed four and eight months after randomization, blind to group allocation. The costs were assessed from a service use questionnaire and information provided on medication. Quality of life was assessed using the EQ-5D. Of the 311 patients identified, 221 (71%) met the criteria for having low mood. Of these, 72 were randomly allocated to receive treatment and 79 to usual care. Over eight months follow-up there was a decrease in the combined average costs of £378 per intervention respondent and an increase in the costs of £297 per patient in the control group, which was a significant difference (p=0.03). The incremental cost-effectiveness ratio indicated that the cost per point reduction on the Beck depression inventory-II was £118. In the short term, the adjustment group programme was cost effective when compared with usual care, for people with multiple sclerosis presenting with low mood. The longer-term costs need to be assessed.

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.

Control groups in recent septic shock trials: a systematic review.

PubMed

Pettilä, Ville; Hjortrup, Peter Buhl; Jakob, Stephan M; Wilkman, Erika; Perner, Anders; Takala, Jukka

2016-12-01

The interpretation of septic shock trial data is profoundly affected by patients, control intervention, co-interventions and selected outcome measures. We evaluated the reporting of control groups in recent septic shock trials. We searched for original articles presenting randomized clinical trials (RCTs) in adult septic shock patients from 2006 to 2016. We included RCTs focusing on septic shock patients with at least two parallel groups and at least 50 patients in the control group. We selected and evaluated data items regarding patients, control group characteristics, and mortality outcomes, and calculated a data completeness score to provide an overall view of quality of reporting. A total of 24 RCTs were included (mean n = 287 patients and 71 % of eligible patients were randomized). Of the 24 studies, 14 (58 %) presented baseline data on vasopressors and 58 % the proportion of patients with elevated lactate values. Five studies (21 %) provided data to estimate the proportion of septic shock patients fulfilling the Sepsis-3 definition. The mean data completeness score was 19 out of 36 (range 8-32). Of 18 predefined control group characteristics, a mean of 8 (range 2-17) were reported. Only 2 (8 %) trials provided adequate data to confirm that their control group treatment represented usual care. Recent trials in septic shock provide inadequate data on the control group treatment and hemodynamic values. We propose a standardized trial dataset to be created and validated, comprising characteristics of patient population, interventions administered, hemodynamic values achieved, surrogate organ dysfunction, and mortality outcomes, to allow better analysis and interpretation of future trial results.

A randomized trial of a lay person-led self-management group intervention for back pain patients in primary care.

PubMed

Von Korff, M; Moore, J E; Lorig, K; Cherkin, D C; Saunders, K; González, V M; Laurent, D; Rutter, C; Comite, F

1998-12-01

Randomized, controlled trial. To evaluate a four-session self-management group intervention for patients with pain in primary care, led by trained lay persons with back pain. The intervention was designed to reduce patient worries, encourage self-care, and reduce activity limitations. Randomized trials of educational interventions suggest that activating interventions may improve back pain outcomes. Expert opinion increasingly regards effective self-management of back pain as important in achieving good outcomes. In this study, an educational intervention designed to activate patients and support effective self-management was evaluated. Six to 8 weeks after a primary care visit for back pain, patients were invited to participate in an educational program to improve back pain self-management. Those showing interest by returning a brief questionnaire became eligible for the study. Participants (n = 255) randomly were assigned to either a self-management group intervention or to a usual care control group. The effect of the intervention, relative to usual care, was assessed 3, 6, and 12 months after randomization, controlling for baseline values. The intervention consisted of a four-session group applying problem-solving techniques to back pain self-management, supplemented by educational materials (book and videos) supporting active management of back pain. The groups were led by lay persons trained to implement a fully structured group protocol. The control group received usual care, supplemented by a book on back pain care. Participants randomly assigned to the self-management groups reported significantly less worry about back pain and expressed more confidence in self-care. Roland Disability Questionnaire Scores were significantly lower among participants in the self-management groups relative to the usual care controls at 6 months (P = 0.007), and this difference was sustained at 12 months at borderline significance levels (P = 0.09). Among self-management group

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).

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.

Pharmaceutical care of elderly patients with poorly controlled type 2 diabetes mellitus: a randomized controlled trial.

PubMed

Chen, Jyun-Hong; Ou, Huang-Tz; Lin, Tzu-Chieh; Lai, Edward Chia-Cheng; Kao, Yea-Huei Yang

2016-02-01

Care of the elderly with diabetes is more complicated than that for other age groups. The elderly and/or those with multiple comorbidities are often excluded from randomized controlled trials of treatments for diabetes. The heterogeneity of health status of the elderly also increases the difficulty in diabetes care; therefore, diabetes care for the elderly should be individualized. Motivated patients educated about diabetes benefit the most from collaborating with a multidisciplinary patient-care team. A pharmacist is an important team member by serving as an educator, coach, healthcare manager, and pharmaceutical care provider. To evaluate the effects of pharmaceutical care on glycemic control of ambulatory elderly patients with type 2 diabetes. A 421-bed district hospital in Nantou City, Taiwan. We conducted a randomized controlled clinical trial involving 100 patients with type 2 diabetes with poor glycemic control (HbA1c levels of ≥9.0 %) aged ≥65 years over 6 months. Participants were randomly assigned to a standard-care (control, n = 50) or pharmaceutical-care (intervention, n = 50) group. Pharmaceutical care was provided by a certified diabetes-educator pharmacist who identified and resolved drug-related problems and established a procedure for consultations pertaining to medication. The Mann–Whitney test was used to evaluate nonparametric quantitative data. Statistical significance was defined as P < 0.05. The change in the mean HbA1c level from the baseline to the next level within 6 months after recruiting. Nonparametric data (Mann–Whitney test) showed that the mean HbA1c level significantly decreased (0.83 %) after 6 months for the intervention group compared with an increase of 0.43 % for the control group (P ≤ 0.001). Medical expenses between groups did not significantly differ (−624.06 vs. −418.7, P = 0.767). There was no significant difference in hospitalization rates between groups. The pharmacist intervention program provided

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

Randomized controlled trial of a comprehensive stroke education program for patients and caregivers.

PubMed

Rodgers, H; Atkinson, C; Bond, S; Suddes, M; Dobson, R; Curless, R

1999-12-01

We report the findings of a randomized controlled trial to determine the effectiveness of a multidisciplinary Stroke Education Program (SEP) for patients and their informal carers. Two hundred four patients admitted with acute stroke and their 176 informal carers were randomized to receive an invitation to the SEP or to receive conventional stroke unit care. The SEP consisted of one 1-hour small group educational session for inpatients followed by six 1-hour sessions after discharge. The primary outcome measure was patient- and carer-perceived health status (SF-36) at 6 months after stroke. Knowledge of stroke, satisfaction with services, emotional outcome, disability, and handicap and were secondary outcome measures. Only 51 of 108 (47%) surviving patients randomized to the SEP completed the program, as did 20 of 93 (22%) informal carers of surviving patients. Perceived health status (Short Form 36 [SF-36] health survey) scores were similar for SEP patients and controls. Informal carers in the control group scored better on the social functioning component of the SF-36 than the SEP group (P=0.04). Patients and informal carers in the SEP group scored higher on the stroke knowledge scale than controls (patients, P=0.02; carers, P=0. 01). Patients in the SEP group were more satisfied with the information that they had received about stroke (P=0.004). There were no differences in emotional or functional outcomes between groups. Although the SEP improved patient and informal carer knowledge about stroke and patient satisfaction with some components of stroke services, this was not associated with an improvement in their perceived health status. Indeed, the social functioning of informal carers randomized to the SEP was less than in the control group.

Lower reinjury rate with a coach-controlled rehabilitation program in amateur male soccer: a randomized controlled trial.

PubMed

Hägglund, Martin; Waldén, Markus; Ekstrand, Jan

2007-09-01

Soccer injuries are common, and athletes returning to play after injury are especially at risk. Few studies have investigated how to prevent reinjury. The rate of reinjury is reduced using a coach-controlled rehabilitation program. Randomized controlled trial; Level of evidence, 1. Twenty-four male amateur soccer teams were randomized into an intervention (n = 282) and control group (n = 300). The intervention was implemented by team coaches and consisted of information about risk factors for reinjury, rehabilitation principles, and a 10-step progressive rehabilitation program including return to play criteria. During the 2003 season, coaches reported individual exposure and all time loss injuries were evaluated by a doctor and a physiotherapist. Four teams (n = 100) withdrew from the study after randomization, leaving 10 teams with 241 players for analysis in both groups. There were 90 injured players (132 injuries) in the intervention group, and 10 of these (11%) suffered 14 reinjuries during the season. In the control group, 23 of 79 injured players (29%) had 40 recurrences (134 injuries). A Cox regression analysis showed a 66% reinjury risk reduction in the intervention group for all injury locations (hazard ratio [HR] 0.34, 95% confidence interval [CI] 0.16-0.72, P = .0047) and 75% for lower limb injuries (HR 0.25, 95% CI 0.11-0.57, P < .001). The preventive effect was greatest within the first week of return to play. Injured players in the intervention group complied with the intervention for 90 of 132 injuries (68%). The reinjury rate in amateur male soccer players was reduced after a controlled rehabilitation program implemented by coaches.

Working Memory Training for Adolescents with Cannabis Use Disorders: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Sweeney, Mary M.; Rass, Olga; DiClemente, Cara; Schacht, Rebecca L.; Vo, Hoa T.; Fishman, Marc J.; Leoutsakos, Jeannie-Marie S.; Mintzer, Miriam Z.; Johnson, Matthew W.

2018-01-01

Adolescent cannabis use is associated with working memory impairment. The present randomized controlled trial assigned adolescents ages 14 to 21 enrolled in cannabis use treatment to receive either working memory training (experimental group) or a control training (control group) as an adjunctive treatment. Cognitive function, drug use, and other…

A long-term self-managed handwriting intervention for people with Parkinson's disease: results from the control group of a phase II randomized controlled trial.

PubMed

Collett, Johnny; Franssen, Marloes; Winward, Charlotte; Izadi, Hooshang; Meaney, Andy; Mahmoud, Wala; Bogdanovic, Marko; Tims, Martin; Wade, Derick; Dawes, Helen

2017-12-01

To report on the control group of a trial primarily designed to investigate exercise for improving mobility in people with Parkinson's disease (pwP). The control group undertook a handwriting intervention to control for attention and time spent practising a specific activity. Secondary analysis of a two-arm parallel phase II randomized controlled trial with blind assessment. Community. PwP able to walk ⩾100 m and with no contraindication to exercise were recruited from the Thames Valley, UK, and randomized (1:1) to exercise or handwriting, via a concealed computer-generated list. Handwriting was undertaken at home and exercise in community facilities; both were delivered through workbooks with monthly support visits and involved practice for 1 hour, twice weekly, over a period of six months. Handwriting was assessed, at baseline, 3, 6 and 12 months, using a pangram giving writing speed, amplitude (area) and progressive reduction in amplitude (ratio). The Movement Disorder Society (MDS)-Unified Parkinson's Disease Rating Scale (UPDRS) item 2.7 measured self-reported handwriting deficits. In all, 105 pwP were recruited (analysed: n  = 51 handwriting, n  = 54 exercise). A total of 40 pwP adhered to the handwriting programme, most completing ⩾1 session/week. Moderate effects were found for amplitude (total area: d = 0.32; 95% confidence interval (CI): -0.11 to 0.7; P = 0.13) in favour of handwriting over a period of12 months; effects for writing speed and ratio parameters were small ≤0.11. Self-reported handwriting difficulties also favoured handwriting (UPDRS 2.7: odds ratio (OR) = 0.55; 95% CI: 0.34 to 0.91; P = 0.02). No adverse effects were reported. PwP generally adhere to self-directed home handwriting which may provide benefit with minimal risk. Encouraging effects were found in writing amplitude and, moreover, perceived ability.

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.

Epidemiological evaluation quality of life in patients suffering from early rheumatoid arthritis: a pragmatic, prospective, randomized, blind allocation controlled of a modular program group intervention

PubMed Central

2015-01-01

OBJECTIVES: Epidemiology has taken on new roles in the management of health care services. In this study, we developed a non-pharmacological self-management modular program group intervention and evaluated its efficacy as an adjunct therapy in patients suffering from early rheumatoid arthritis (RA). METHODS: Patients were randomized to either participate in a non-equivalent intervention group along with the standard of care or only receive standard-of-care treatment at a community rheumatology center. The outcomes measured were a pain visual analog scale (VAS), patient general health (GH) on a VAS, and the Short Form 36 Health Survey version 2 scale measuring quality of life. These parameters were evaluated in the first week to obtain baseline values, and at 20, 32, 48, and 60 weeks to evaluate the efficacy of the intervention group. RESULTS: The patients were randomized, with 100 patients in the intervention group and 106 in the control group. The intervention and control groups were similar with regard to the percentage of women (86% vs. 89.6%), tobacco usage (25% vs. 19.8%), mean age (42.6±13.2 years vs. 46.6±10.9 years), and disease duration (15.3±6.7 months vs. 14.5±6.6 months). The mean outcomes were significantly different between the two groups, and post-hoc pairwise analysis demonstrated significant deterioration in the control group in contrast to improvement in the intervention group at the second, third, fourth, and fifth evaluations. Improvements were often seen as early as the 12-week and 24-week follow-up visits. CONCLUSIONS: Epidemiology contributes to the evaluation of how well specific therapies or other health interventions prevent or control health problems. The modular program group intervention implemented in this study appears to be a suitable and feasible method to facilitate much more comprehensive management of early RA in socioeconomically challenged communities. PMID:26552423

Strength and Agility Training in Adolescents with Down Syndrome: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Lin, Hsiu-Ching; Wuang, Yee-Pay

2012-01-01

The purpose of this study was to investigate the effects of a proposed strength and agility training program of adolescents with Down syndrome. Ninety-two adolescents were recruited and evenly randomized to two intervention groups (exercise group vs. control group). The mean age for the exercise and the control group was 10.6 plus or minus 3.2 and…

Balneotherapy in fibromyalgia: a single blind randomized controlled clinical study.

PubMed

Ozkurt, Seçil; Dönmez, Arif; Zeki Karagülle, M; Uzunoğlu, Emel; Turan, Mustafa; Erdoğan, Nergis

2012-07-01

We aimed to evaluate the effectiveness of balneotherapy in fibromyalgia management. Fifty women with fibromyalgia under pharmacological treatment were randomly assigned to either the balneotherapy (25) or the control (25) group. Four patients from the balneotherapy group and one patient from the control group left the study after randomization. The patients in the balneotherapy group (21) had 2 thermomineral water baths daily for 2 weeks in Tuzla Spa Center. The patients in the control group (24) continued to have their medical treatment and routine daily life. An investigator who was blinded to the study arms assessed the patients. All patients were assessed four times; at the beginning of the study, at the end of the 2nd week, the 1st month, and the 3rd month after balneotherapy. Outcome measures of the study were pain intensity, Fibromyalgia Impact Questionnaire (FIQ), Beck Depression Inventory (BDI), patient's global assessment, investigator's global assessment, SF-36 scores, and tender point count. Balneotherapy was found to be superior at the end of the cure period in terms of pain intensity, FIQ, Beck Depression Inventory, patient's global assessment, investigator's global assessment scores, and tender point count as compared to the control group. The superiority of balneotherapy lasted up to the end of the 3rd month, except for the Beck Depression Inventory score and the investigator's global assessment score. Significant improvements were observed in PF, GH, and MH subscales of SF-36 during the study period in the balneotherapy group; however, no such improvement was observed in the control group. Balneotherapy was superior only in VT subscale at the end of therapy and at the end of the third month after the therapy as compared to the controls. It was concluded that balneotherapy provides beneficial effects in patients with fibromyalgia.

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

Safety of Spectacles for Children's Vision: A Cluster-Randomized Controlled Trial.

PubMed

Ma, Xiaochen; Congdon, Nathan; Yi, Hongmei; Zhou, Zhongqiang; Pang, Xiaopeng; Meltzer, Mirjam E; Shi, Yaojiang; He, Mingguang; Liu, Yizhi; Rozelle, Scott

2015-11-01

To study safety of children's glasses in rural China, where fear that glasses harm vision is an important barrier for families and policy makers. Exploratory analysis from a cluster-randomized, investigator-masked, controlled trial. Among primary schools (n = 252) in western China, children were randomized by school to 1 of 3 interventions: free glasses provided in class, vouchers for free glasses at a local facility, or glasses prescriptions only (Control group). The main outcome of this analysis is uncorrected visual acuity after 8 months, adjusted for baseline acuity. Among 19 934 children randomly selected for screening, 5852 myopic (spherical equivalent refractive error ≤-0.5 diopters) eyes of 3001 children (14.7%, mean age 10.5 years) had VA ≤6/12 without glasses correctable to >6/12 with glasses, and were eligible. Among these, 1903 (32.5%), 1798 (30.7%), and 2151 (36.8%) were randomized to Control, Voucher, and Free Glasses, respectively. Intention-to-treat analyses were performed on all 1831 (96.2%), 1699 (94.5%), and 2007 (93.3%) eyes of children with follow-up in Control, Voucher, and Free Glasses groups. Final visual acuity for eyes of children in the treatment groups (Free Glasses and Voucher) was significantly better than for Control children, adjusting only for baseline visual acuity (difference of 0.023 logMAR units [0.23 vision chart lines, 95% CI: 0.03, 0.43]) or for other baseline factors as well (0.025 logMAR units [0.25 lines, 95% CI 0.04, 0.45]). We found no evidence that spectacles promote decline in uncorrected vision with aging among children. Copyright © 2015 Elsevier Inc. All rights reserved.

Essential considerations in developing attention control groups in behavioral research.

PubMed

Aycock, Dawn M; Hayat, Matthew J; Helvig, Ashley; Dunbar, Sandra B; Clark, Patricia C

2018-06-01

Attention control groups strengthen randomized controlled trials of behavioral interventions, but researchers need to give careful consideration to the attention control activities. A comparative effectiveness research framework provides an ideal opportunity for an attention control group as a supplement to standard care, so participants potentially receive benefit regardless of group assignment. The anticipated benefit of the control condition must be independent of the study outcome. Resources needed for attention control activities need to be carefully considered and ethical considerations carefully weighed. In this paper we address nine considerations for the design and implementation of attention control groups: (1) ensure attention control activities are not associated with the outcome; (2) avoid contamination of the intervention or control group; (3) design comparable control and intervention activities; (4) ensure researcher training to adequately administer both treatment arms; (5) design control activities to be interesting and acceptable to participants; (6) evaluate attention control activities; (7) consider additional resources needed to implement attention control activities; (8) quantifying the effects of attention control and intervention groups; and (9) ethical considerations with attention control groups. Examples from the literature and ongoing research are presented. Careful planning for the attention control group is as important as for the intervention group. Researchers can use the considerations presented here to assist in planning for the best attention control group for their study. © 2018 Wiley Periodicals, Inc.

Active Video Game Exercise Training Improves the Clinical Control of Asthma in Children: Randomized Controlled Trial.

PubMed

Gomes, Evelim L F D; Carvalho, Celso R F; Peixoto-Souza, Fabiana Sobral; Teixeira-Carvalho, Etiene Farah; Mendonça, Juliana Fernandes Barreto; Stirbulov, Roberto; Sampaio, Luciana Maria Malosá; Costa, Dirceu

2015-01-01

The aim of the present study was to determine whether aerobic exercise involving an active video game system improved asthma control, airway inflammation and exercise capacity in children with moderate to severe asthma. A randomized, controlled, single-blinded clinical trial was carried out. Thirty-six children with moderate to severe asthma were randomly allocated to either a video game group (VGG; N = 20) or a treadmill group (TG; n = 16). Both groups completed an eight-week supervised program with two weekly 40-minute sessions. Pre-training and post-training evaluations involved the Asthma Control Questionnaire, exhaled nitric oxide levels (FeNO), maximum exercise testing (Bruce protocol) and lung function. No differences between the VGG and TG were found at the baseline. Improvements occurred in both groups with regard to asthma control and exercise capacity. Moreover, a significant reduction in FeNO was found in the VGG (p < 0.05). Although the mean energy expenditure at rest and during exercise training was similar for both groups, the maximum energy expenditure was higher in the VGG. The present findings strongly suggest that aerobic training promoted by an active video game had a positive impact on children with asthma in terms of clinical control, improvement in their exercise capacity and a reduction in pulmonary inflammation. Clinicaltrials.gov NCT01438294.

Active Video Game Exercise Training Improves the Clinical Control of Asthma in Children: Randomized Controlled Trial

PubMed Central

Gomes, Evelim L. F. D.; Carvalho, Celso R. F.; Peixoto-Souza, Fabiana Sobral; Teixeira-Carvalho, Etiene Farah; Mendonça, Juliana Fernandes Barreto; Stirbulov, Roberto; Sampaio, Luciana Maria Malosá; Costa, Dirceu

2015-01-01

Objective The aim of the present study was to determine whether aerobic exercise involving an active video game system improved asthma control, airway inflammation and exercise capacity in children with moderate to severe asthma. Design A randomized, controlled, single-blinded clinical trial was carried out. Thirty-six children with moderate to severe asthma were randomly allocated to either a video game group (VGG; N = 20) or a treadmill group (TG; n = 16). Both groups completed an eight-week supervised program with two weekly 40-minute sessions. Pre-training and post-training evaluations involved the Asthma Control Questionnaire, exhaled nitric oxide levels (FeNO), maximum exercise testing (Bruce protocol) and lung function. Results No differences between the VGG and TG were found at the baseline. Improvements occurred in both groups with regard to asthma control and exercise capacity. Moreover, a significant reduction in FeNO was found in the VGG (p < 0.05). Although the mean energy expenditure at rest and during exercise training was similar for both groups, the maximum energy expenditure was higher in the VGG. Conclusion The present findings strongly suggest that aerobic training promoted by an active video game had a positive impact on children with asthma in terms of clinical control, improvementin their exercise capacity and a reductionin pulmonary inflammation. Trial Registration Clinicaltrials.gov NCT01438294 PMID:26301706

The Effects of Pilates Training on Balance Control and Self-Reported Health Status in Community-Dwelling Older Adults: A Randomized Controlled Trial.

PubMed

Gabizon, Hadas; Press, Yan; Volkov, Ilia; Melzer, Itshak

2016-07-01

To evaluate the effect of a group-based Pilates training program on balance control and health status in healthy older adults. A single-blind, randomized, controlled trial. General community. A total of 88 community-dwelling older adults (age 71.15 ± 4.30 years), without evidence of functional balance impairment, were recruited and allocated at random to a Pilates intervention group (n = 44) or a control group (n = 44). The Pilates intervention group received 36 training sessions over three months (3 sessions a week), while the control group did not receive any intervention. Standing upright postural stability, performance-based measures of balance, and self-reported health status was assessed in both groups at baseline and at the end of the intervention period. Compared with the control group, the Pilates intervention did not improve postural stability, baseline functional measures of balance, or health status. The results suggest that because Pilates training is not task specific, it does not improve balance control or balance function in independent older adults.

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

Motivational interviewing and screening colonoscopy in high-risk individuals. A randomized controlled trial.

PubMed

Salimzadeh, Hamideh; Khabiri, Roghaye; Khazaee-Pool, Maryam; Salimzadeh, Somayeh; Delavari, Alireza

2018-06-01

To measure the impact of motivational interviewing (MI) on cancer knowledge and screening practice among first degree relatives (FDRs) of patients with colon cancer. This randomized controlled trial targeted patients with colon cancer first to recruit their possible FDRs. Digit randomization of the eligible index patients into intervention or control groups resulted in allocating their belonging FDRs to the same study arm. FDRs (n = 120) in intervention arm received MI counseling on phone by a trained oncology nurse and FDRs (n = 120) in control group received standard generic information by a physician on phone. Primary outcome was the rate of documented colonoscopy in FDRs within six months after the baseline. A total of 227 FDRs were followed up, 115 in the intervention and 112 in the control group. At follow-up, the uptake of screening colonoscopy in the intervention group was 83.5% versus 48.2% in controls (crude odds ratio, 5.4; 95% confidence interval, 2.9-10.0, P < .001). This was the first randomized controlled trial in Iran that confirmed the efficaciousness of a phone-based MI counseling in improving colonoscopy uptake among family members of patients with colon cancer. Phone-based motivational counseling that involves trained nurses or health providers seems to be feasible approach in Iran health system and enhances screening for colon cancer. Copyright © 2018 Elsevier B.V. All rights reserved.

Measurement Error Correction Formula for Cluster-Level Group Differences in Cluster Randomized and Observational Studies

ERIC Educational Resources Information Center

Cho, Sun-Joo; Preacher, Kristopher J.

2016-01-01

Multilevel modeling (MLM) is frequently used to detect cluster-level group differences in cluster randomized trial and observational studies. Group differences on the outcomes (posttest scores) are detected by controlling for the covariate (pretest scores) as a proxy variable for unobserved factors that predict future attributes. The pretest and…

Evaluation of a workplace treadmill desk intervention: a randomized controlled trial.

PubMed

Schuna, John M; Swift, Damon L; Hendrick, Chelsea A; Duet, Megan T; Johnson, William D; Martin, Corby K; Church, Timothy S; Tudor-Locke, Catrine

2014-12-01

To evaluate the effectiveness of a 3-month treadmill desk intervention in eliciting changes in physical activity and sedentary behavior among overweight/obese office workers. A randomized controlled trial was conducted among overweight/obese office workers (n = 41; mean age = 40.1 ± 10.1 years) at a private workplace. Participants were randomly assigned to a shared-treadmill desk intervention (n = 21) or a usual working condition control group (n = 20). Accelerometer-determined physical activity and sedentary behavior were measured before and after the intervention. Compared with the control group, the intervention group increased daily steps (1622 steps/day; P = 0.013) and light physical activity (1.6 minutes/hour; P = 0.008), and decreased sedentary time (-3.6 minutes/hour; P = 0.047) during working hours. Shared-treadmill desks in the workplace can be effective at promoting favorable changes in light physical activity (specifically 40 to 99 steps/minute) and sedentary behavior among overweight/obese office workers.

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.

PubMed

Boyle, James M; McCartney, Elspeth; O'Hare, Anne; Forbes, John

2009-01-01

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 each delivery mode offered to children individually or in groups. To investigate the relative effectiveness of indirect and direct intervention therapy modes delivered individually or in groups for children with primary language impairment. A multi-centre randomized controlled trial investigated 161 children with primary language impairment aged 6-11 years randomized to a usual-therapy control group or to direct individual, indirect individual, direct group or indirect group therapy modes. Intervention was delivered three times a week for 30-40-min sessions in mainstream schools over 15 weeks. Language performance was assessed at baseline, post-therapy and at 12 months. Cost analysis was based on salary and travel costs for intervention modes and usual therapy. Compared with controls, children receiving project therapy made short-term improvements in expressive (p = 0.031), but not receptive, language immediately following intervention. Children with specific expressive language delay were more likely to show improvement than those with mixed receptive-expressive difficulties. The four project therapy modes did not differ on primary language outcomes (all p-values>0.392) and there were no further improvements evident at follow-up. Indirect group therapy was the least costly mode, with direct individual therapy the most costly. Intervention in this age group can be effective for expressive language and can be delivered equally effectively though speech and language therapy assistants and to children in groups.

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®

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.

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.

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

Mini-intervention for subacute low back pain: a randomized controlled trial.

PubMed

Karjalainen, Kaija; Malmivaara, Antti; Pohjolainen, Timo; Hurri, Heikki; Mutanen, Pertti; Rissanen, Pekka; Pahkajärvi, Helena; Levon, Heikki; Karpoff, Hanna; Roine, Risto

2003-03-15

Randomized controlled trial. To investigate the effectiveness and costs of a mini-intervention, provided in addition to the usual care, and the incremental effect of a work site visit for patients with subacute disabling low back pain. There is lack of data on cost-effectiveness of brief interventions for patients with prolonged low back pain. A total of 164 patients with subacute low back pain were randomized to a mini-intervention group (A), a work site visit group (B), or a usual care group (C). Groups A (n = 56) and B (n = 51) underwent one assessment by a physician plus a physiotherapist. Group B received a work site visit in addition. Group C served as controls (n = 57) and was treated in municipal primary health care. All patients received a leaflet on back pain. Pain, disability, specific and generic health-related quality of life, satisfaction with care, days on sick leave, and use and costs of health care consumption were measured at 3-, 6-, and 12-month follow-ups. During follow-up, fewer subjects had daily pain in Groups A and B than in Group C (Group A Group C, = 0.002; Group B Group C, = 0.030). In Group A, pain was less bothersome (Group A Group C, = 0.032) and interfered less with daily life (Group A Group C, = 0.040) than among controls. Average days on sick leave were 19 in Group A, 28 in Group B, and 41 in Group C (Group A Group C, = 0.019). Treatment satisfaction was better in the intervention groups than among the controls, and costs were lowest in the mini-intervention group. Mini-intervention reduced daily back pain symptoms and sickness absence, improved adaptation to pain and patient satisfaction among patients with subacute low back pain, without increasing health care costs. A work site visit did not increase effectiveness.

Stochastic resonance whole-body vibration improves postural control in health care professionals: a worksite randomized controlled trial.

PubMed

Elfering, Achim; Schade, Volker; Stoecklin, Lukas; Baur, Simone; Burger, Christian; Radlinger, Lorenz

2014-05-01

Slip, trip, and fall injuries are frequent among health care workers. Stochastic resonance whole-body vibration training was tested to improve postural control. Participants included 124 employees of a Swiss university hospital. The randomized controlled trial included an experimental group given 8 weeks of training and a control group with no intervention. In both groups, postural control was assessed as mediolateral sway on a force plate before and after the 8-week trial. Mediolateral sway was significantly decreased by stochastic resonance whole-body vibration training in the experimental group but not in the control group that received no training (p < .05). Stochastic resonance whole-body vibration training is an option in the primary prevention of balance-related injury at work. Copyright 2014, SLACK Incorporated.

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

Early control treatment with montelukast in preschool children with asthma: A randomized controlled trial.

PubMed

Nagao, Mizuho; Ikeda, Masanori; Fukuda, Norimasa; Habukawa, Chizu; Kitamura, Tetsuro; Katsunuma, Toshio; Fujisawa, Takao

2018-01-01

While Japanese guideline recommends initial control treatment for preschool children with asthma symptoms more than once a month, Western guidelines do not. To determine whether control treatment with montelukast was more effective than as-needed β 2 -agonists in this population, we conducted a randomized controlled trial. Eligible patients were children aged 1-5 years who had asthma symptoms more than once a month but less than once a week. Patients were randomly assigned in a 1:1 ratio to receive montelukast 4 mg daily for 48 weeks or as-needed β 2 -agonists. The primary endpoint was the number of acute asthma exacerbations before starting step-up treatment with inhaled corticosteroids. This study is registered with the University Hospital Medical Information Network clinical trials registry, number UMIN000002219. From September 2009 to November 2012, 93 patients (47 in the montelukast group and 46 in the no-controller group) were enrolled into the study. All patients were included in the analysis. During the study, 13 patients (28%) in the montelukast group and 23 patients (50%) in the no-controller group had acute exacerbations with the mean numbers of 0.9 and 1.9/year, respectively (P = 0.027). In addition, 10 (21%) and 19 (41%) patients received step-up treatment, respectively. Cumulative incidence of step-up treatment was significantly lower in the montelukast group (hazard ratio 0.45, 95% confidence interval 0.21 to 0.92; P = 0.033). Montelukast is an effective control treatment for preschool children who had asthma symptoms more than once a month but less than once a week. Copyright © 2017 Japanese Society of Allergology. Production and hosting by Elsevier B.V. All rights reserved.

A randomized trial of integrated group therapy versus group drug counseling for patients with bipolar disorder and substance dependence.

PubMed

Weiss, Roger D; Griffin, Margaret L; Kolodziej, Monika E; Greenfield, Shelly F; Najavits, Lisa M; Daley, Dennis C; Doreau, Heidi Ray; Hennen, John A

2007-01-01

Although bipolar disorder and substance use disorder frequently co-occur, there is little information on the effectiveness of behavioral treatment for this population. Integrated group therapy, which addresses the two disorders simultaneously, was compared with group drug counseling, which focuses on substance use. The authors hypothesized that patients receiving integrated group therapy would have fewer days of substance use and fewer weeks ill with bipolar disorder. A randomized controlled trial compared 20 weeks of integrated group therapy or group drug counseling with 3 months of posttreatment follow-up. Sixty-two patients with bipolar disorder and current substance dependence, treated with mood stabilizers for >or=2 weeks, were randomly assigned to integrated group therapy (N=31) or group drug counseling (N=31). The primary outcome measure was the number of days of substance use. The primary mood outcome was the number of weeks ill with a mood episode. Intention-to-treat analysis revealed significantly fewer days of substance use for integrated group therapy patients during treatment and follow-up. Groups were similar in the number of weeks ill with bipolar disorder during treatment and follow-up, although integrated group therapy patients had more depressive and manic symptoms. Integrated group therapy, a new treatment developed specifically for patients with bipolar disorder and substance dependence, appears to be a promising approach to reduce substance use in this population.

A compound herbal preparation (CHP) in the treatment of children with ADHD: a randomized controlled trial.

PubMed

Katz, M; Levine, A Adar; Kol-Degani, H; Kav-Venaki, L

2010-11-01

Evaluation of the efficacy of a patented, compound herbal preparation (CHP) in improving attention, cognition, and impulse control in children with ADHD. A randomized, double-blind, placebo-controlled trial. University-affiliated tertiary medical center. 120 children newly diagnosed with ADHD, meeting DSM-IV criteria. Random assignment to the herbal treatment group (n = 80) or control group (placebo; n = 40); 73 patients in the treatment group (91%) and 19 in the control group (48%) completed the 4-month trial. Test of Variables of Attention (TOVA) administered before and after the treatment period; overall score and 4 subscales. The treatment group showed substantial, statistically significant improvement in the 4 subscales and overall TOVA scores, compared with no improvement in the control group, which persisted in an intention-to-treat analysis. The well-tolerated CHP demonstrated improved attention, cognition, and impulse control in the intervention group, indicating promise for ADHD treatment in children.

The effect of asthma education program on knowledge of school teachers: a randomized controlled trial.

PubMed

Kawafha, Mariam M; Tawalbeh, Loai Issa

2015-04-01

The purpose of this study was to examine the effect of an asthma education program on schoolteachers' knowledge. Pre-test-post-test experimental randomized controlled design was used. A multistage-cluster sampling technique was used to randomly select governorate, primary schools, and schoolteachers. Schoolteachers were randomly assigned either to the experimental group (n = 36) and attended three educational sessions or to the control group (n = 38) who did not receive any intervention. Knowledge about asthma was measured using the Asthma General Knowledge Questionnaire for Adults (AGKQA). The results indicated that teachers in the experimental group showed significantly (p < .001) higher knowledge of asthma in the first post-test and the second post-test compared with those in the control group. Implementing asthma education enhanced schoolteachers' knowledge of asthma. The asthma education program should target schoolteachers to improve knowledge about asthma. © The Author(s) 2014.

Efficacy of the epilepsy nurse: Results of a randomized controlled study.

PubMed

Pfäfflin, Margarete; Schmitz, Bettina; May, Theodor W

2016-07-01

We investigated the efficacy of epilepsy nurses on satisfaction with counseling about epilepsy in a randomized, controlled, prospective trial. Patients with epilepsy treated by neurologists in outpatient clinics were consecutively enrolled and randomly allocated to either the epilepsy nurse (EN) group (n = 92) or the control group (n = 95). Patients in the EN group were advised according to their needs by epilepsy nurses. The control group received routine care without additional counseling. The EN group completed the questionnaires before the first consultation (T1) and 6 months later (T2); the control group completed the questionnaires twice with an interval of 6 months. Primary outcome measure was satisfaction of patients with information and support. Secondary outcome measures were satisfaction with patient-doctor relationship, organization of treatment, epilepsy knowledge, coping, and restrictions in daily life. Anxiety and depression (Hospital Anxiety and Depression Scale) and global Quality of Life (item from QOLIE-31) were also assessed. Statistical analysis included generalized estimating equation (GEE) and nonparametric tests. Satisfaction with information and support improved significantly in the EN group compared to the control group (GEE, interaction group × time, p = 0.001). In addition, Epilepsy Knowledge (p = 0.014) and Coping (subscale Information Seeking) (p = 0.023) improved. Increase in satisfaction with counseling was dependent on patients' needs for information and on the amount of received information (Jonckheere-Terpstra test, p < 0.001). No differences between the groups were observed on other epilepsy-specific scales. A reliable questionnaire for satisfaction with epilepsy care has been developed. Epilepsy nurses improve the satisfaction of patients with counseling and information about epilepsy and concomitant problems. Wiley Periodicals, Inc. © 2016 International League Against Epilepsy.

Educational interventions to improve screening mammography interpretation: a randomized controlled trial.

PubMed

Geller, Berta M; Bogart, Andy; Carney, Patricia A; Sickles, Edward A; Smith, Robert; Monsees, Barbara; Bassett, Lawrence W; Buist, Diana M; Kerlikowske, Karla; Onega, Tracy; Yankaskas, Bonnie C; Haneuse, Sebastien; Hill, Deirdre; Wallis, Matthew G; Miglioretti, Diana

2014-06-01

The objective of our study was to conduct a randomized controlled trial of educational interventions that were created to improve performance of screening mammography interpretation. We randomly assigned physicians who interpret mammography to one of three groups: self-paced DVD, live expert-led educational seminar, or control. The DVD and seminar interventions used mammography cases of varying difficulty and provided associated teaching points. Interpretive performance was compared using a pretest-posttest design. Sensitivity, specificity, and positive predictive value (PPV) were calculated relative to two outcomes: cancer status and consensus of three experts about recall. The performance measures for each group were compared using logistic regression adjusting for pretest performance. One hundred two radiologists completed all aspects of the trial. After adjustment for preintervention performance, the odds of improved sensitivity for correctly identifying a lesion relative to expert recall were 1.34 times higher for DVD participants than for control subjects (95% CI, 1.00-1.81; p = 0.050). The odds of an improved PPV for correctly identifying a lesion relative to both expert recall (odds ratio [OR] = 1.94; 95% CI, 1.24-3.05; p = 0.004) and cancer status (OR = 1.81; 95% CI, 1.01-3.23; p = 0.045) were significantly improved for DVD participants compared with control subjects, with no significant change in specificity. For the seminar group, specificity was significantly lower than the control group (OR relative to expert recall = 0.80; 95% CI, 0.64-1.00; p = 0.048; OR relative to cancer status = 0.79; 95% CI, 0.65-0.95; p = 0.015). In this randomized controlled trial, the DVD educational intervention resulted in a significant improvement in screening mammography interpretive performance on a test set, which could translate into improved interpretative performance in clinical practice.

Antenatal hypnosis training and childbirth experience: a randomized controlled trial.

PubMed

Werner, Anette; Uldbjerg, Niels; Zachariae, Robert; Wu, Chun Sen; Nohr, Ellen A

2013-12-01

Childbirth is a demanding event in a woman's life. The aim of this study was to explore whether a brief intervention in the form of an antenatal course in self-hypnosis to ease childbirth could improve the childbirth experience. In a randomized, controlled, single-blinded trial, 1,222 healthy nulliparous women were allocated to one of three groups during pregnancy: A hypnosis group participating in three 1-hour sessions teaching self-hypnosis to ease childbirth, a relaxation group receiving three 1-hour lessons in various relaxation methods and Mindfulness, and a usual care group receiving ordinary antenatal care only. Wijmas Delivery Expectancy/Experience Questionnaire (W-DEQ) was used to measure the childbirth experience 6 weeks postpartum. The intention-to-treat analysis indicated that women in the hypnosis group experienced their childbirth as better compared with the other two groups (mean W-DEQ score of 42.9 in the Hypnosis group, 47.2 in the Relaxation group, and 47.5 in the Care as usual group (p = 0.01)). The tendency toward a better childbirth experience in the hypnosis group was also seen in subgroup analyses for mode of delivery and for levels of fear. In this large randomized controlled trial, a brief course in self-hypnosis improved the women's childbirth experience. © 2013, Copyright the Authors Journal compilation © 2013, Wiley Periodicals, Inc.

MiDAS ENCORE: Randomized Controlled Clinical Trial Report of 6-Month Results.

PubMed

Staats, Peter S; Benyamin, Ramsin M

2016-02-01

Patients suffering from neurogenic claudication due to lumbar spinal stenosis (LSS) often experience moderate to severe pain and significant functional disability. Neurogenic claudication results from progressive degenerative changes in the spine, and most often affects the elderly. Both the MILD® procedure and epidural steroid injections (ESIs) offer interventional pain treatment options for LSS patients experiencing neurogenic claudication refractory to more conservative therapies. MILD provides an alternative to ESIs via minimally invasive lumbar decompression. Prospective, multi-center, randomized controlled clinical trial. Twenty-six US interventional pain management centers. To compare patient outcomes following treatment with either MILD (treatment group) or ESIs (active control group) in LSS patients with neurogenic claudication and verified ligamentum flavum hypertrophy. This prospective, multi-center, randomized controlled clinical trial includes 2 study arms with a 1-to-1 randomization ratio. A total of 302 patients were enrolled, with 149 randomized to MILD and 153 to the active control. Six-month follow-up has been completed and is presented in this report. In addition, one year follow-up will be conducted for patients in both study arms, and supplementary 2 year outcome data will be collected for patients in the MILD group only. Outcomes are assessed using the Oswestry Disability Index (ODI), numeric pain rating scale (NPRS) and Zurich Claudication Questionnaire (ZCQ). Primary efficacy is the proportion of ODI responders, tested for statistical superiority of the MILD group versus the active control group. ODI responders are defined as patients achieving the validated Minimal Important Change (MIC) of =10 point improvement in ODI from baseline to follow-up. Similarly, secondary efficacy includes proportion of NPRS and ZCQ responders using validated MIC thresholds. Primary safety is the incidence of device or procedure-related adverse events in each

Xyloglucan for the treatment of acute diarrhea: results of a randomized, controlled, open-label, parallel group, multicentre, national clinical trial.

PubMed

Gnessi, Lucio; Bacarea, Vladimir; Marusteri, Marius; Piqué, Núria

2015-10-30

There is a strong rationale for the use of agents with film-forming protective properties, like xyloglucan, for the treatment of acute diarrhea. However, few data from clinical trials are available. A randomized, controlled, open-label, parallel group, multicentre, clinical trial was performed to evaluate the efficacy and safety of xyloglucan, in comparison with diosmectite and Saccharomyces in adult patients with acute diarrhea due to different causes. Patients were randomized to receive a 3-day treatment. Symptoms (stools type, nausea, vomiting, abdominal pain and flatulence) were assessed by a self-administered ad-hoc questionnaire 1, 3, 6, 12, 24, 48 and 72 h following the first dose administration. Adverse events were also recorded. A total of 150 patients (69.3 % women and 30.7 % men, mean age 47.3 ± 14.7 years) were included (n = 50 in each group). A faster onset of action was observed in the xyloglucan group compared with the diosmectite and S. bouliardii groups. At 6 h xyloglucan produced a statistically significant higher decrease in the mean number of type 6 and 7 stools compared with diosmectite (p = 0.031). Xyloglucan was the most efficient treatment in reducing the percentage of patients with nausea throughout the study period, particularly during the first hours (from 26 % at baseline to 4 % after 6 and 12 h). An important improvement of vomiting was observed in all three treatment groups. Xyloglucan was more effective than diosmectite and S. bouliardii in reducing abdominal pain, with a constant improvement observed throughout the study. The clinical evolution of flatulence followed similar patterns in the three groups, with continuous improvement of the symptom. All treatments were well tolerated, without reported adverse events. Xyloglucan is a fast, efficacious and safe option for the treatment of acute diarrhea. EudraCT number 2014-001814-24 (date: 2014-04-28) ISRCTN number: 90311828.

Group medical consultations (GMCs) and tablet-based online support group sessions in the follow-up of breast cancer: A multicenter randomized controlled trial.

PubMed

Visser, Annemiek; Prins, Judith B; Jansen, Lisette; Radema, Sandra A; Schlooz, Margrethe S; van Dalen, Thijs; van Laarhoven, Hanneke W M

2018-06-12

Group medical consultations (GMCs) provide individual medical visits in the presence of ≤7 peer-patients. In the follow-up of breast cancer, we evaluated the efficacy of a new type of blended care My-GMC, a GMC combined with a tablet-based online app, consisting of three online support group sessions (SGS) and additional information. This randomized controlled trial compared the effect of My-GMC (n = 59) with one individual medical visit (n = 50) (care as usual). Between-group differences on the outcomes distress and empowerment were analyzed 1 week, 3 and 6 months after the visit. No between-group differences were found for the primary outcomes distress and empowerment. More themes were discussed in GMCs compared to individual visits. Significantly more patients experienced peer-support in GMCs (78%) than via the online app (29%). Satisfaction with the online app was low. My-GMC did not result in improvements in distress or empowerment, which might partly be explained by low baseline distress levels. This paper provides valuable information concerning factors on organizational level as well as individual level influencing the evaluation of a blended care intervention. My-GMC provided an innovative alternative, combining professional and peer-support in face-to-face and online SGS, resulting in additional information provision and peer-support. Further improvement of the apps is needed to improve user satisfaction. NTR3771. Copyright © 2018 Elsevier Ltd. All rights reserved.

Household Obesity Prevention: Take Action—a Group-Randomized Trial

PubMed Central

French, Simone A.; Gerlach, Anne F.; Mitchell, Nathan R.; Hannan, Peter J.; Welsh, Ericka M.

2018-01-01

The purpose of the present study was to evaluate an intervention to prevent weight gain among households (HHs) in the community. Ninety HHs were randomized to intervention or control group for 1 year. Intervention consisted of six face-to-face group sessions, placement of a television (TV) locking device on all home TVs, and home-based intervention activities. Measures were collected in person at baseline and 1 year. Weight, height, eating behaviors, physical activity (PA), and TV viewing were measured among HH members ages ≥12 years. Follow-up rate at 1 year was 96%. No significant intervention effects were observed for change in HH BMI-z score. Intervention HHs significantly reduced TV viewing, snacks/sweets intake, and dollars per person spent eating out, and increased (adults only) PA and self-weighing frequency compared with control HHs. A 1 year obesity prevention intervention targeting entire HHs was effective in reducing TV viewing, snack/sweets intake and eating out purchases. Innovative methods are needed to strengthen the home food environment intervention component. Longer intervention durations also need to be evaluated. PMID:21212771

Household obesity prevention: Take Action--a group-randomized trial.

PubMed

French, Simone A; Gerlach, Anne F; Mitchell, Nathan R; Hannan, Peter J; Welsh, Ericka M

2011-10-01

The purpose of the present study was to evaluate an intervention to prevent weight gain among households (HHs) in the community. Ninety HHs were randomized to intervention or control group for 1 year. Intervention consisted of six face-to-face group sessions, placement of a television (TV) locking device on all home TVs, and home-based intervention activities. Measures were collected in person at baseline and 1 year. Weight, height, eating behaviors, physical activity (PA), and TV viewing were measured among HH members ages ≥ 12 years. Follow-up rate at 1 year was 96%. No significant intervention effects were observed for change in HH BMI-z score. Intervention HHs significantly reduced TV viewing, snacks/sweets intake, and dollars per person spent eating out, and increased (adults only) PA and self-weighing frequency compared with control HHs. A 1 year obesity prevention intervention targeting entire HHs was effective in reducing TV viewing, snack/sweets intake and eating out purchases. Innovative methods are needed to strengthen the home food environment intervention component. Longer intervention durations also need to be evaluated.

Validation of Placebo in a Manual Therapy Randomized Controlled Trial

PubMed Central

Chaibi, Aleksander; Šaltytė Benth, Jūratė; Bjørn Russell, Michael

2015-01-01

At present, no consensus exists among clinical and academic experts regarding an appropriate placebo for randomized controlled trials (RCTs) of spinal manipulative therapy (SMT). Therefore, we investigated whether it was possible to conduct a chiropractic manual-therapy RCT with placebo. Seventy migraineurs were randomized to a single-blinded placebo-controlled clinical trial that consisted of 12 treatment sessions over 3 months. The participants were randomized to chiropractic SMT or placebo (sham manipulation). After each session, the participants were surveyed on whether they thought they had undergone active treatment (“yes” or “no”) and how strongly they believed that active treatment was received (numeric rating scale 0–10). The outcome measures included the rate of successful blinding and the certitude of the participants’ beliefs in both treatment groups. At each treatment session, more than 80% of the participants believed that they had undergone active treatment, regardless of group allocation. The odds ratio for believing that active treatment was received was >10 for all treatment sessions in both groups (all p < 0.001). The blinding was maintained throughout the RCT. Our results strongly demonstrate that it is possible to conduct a single-blinded manual-therapy RCT with placebo and to maintain the blinding throughout 12 treatment sessions given over 3 months. PMID:26145718

Empathy training in medical students - a randomized controlled trial.

PubMed

Wündrich, M; Schwartz, C; Feige, B; Lemper, D; Nissen, C; Voderholzer, U

2017-10-01

Empathy is a core element in the doctor-patient relationship. This study examined whether empathy in medical students can be improved by specific training. 158 medical students were randomized into two groups. The intervention group participated in an empathy skills training with simulated patients (SPs). The control group participated in a history course. After the intervention, empathy was assessed by blinded SPs and experts in an Objective Structured Clinical Examination (OSCE). Students also filled out a self-assessment concerning their attitude on empathy (Jefferson Scale of Physician Empathy Student Version, JSPE-S-S). Participants of the intervention group showed significantly higher levels of empathy when rated by SPs and experts than the control group. In contrast to that, no significant group differences were observed in self-rated empathy. The results underpin the value of empathy skills trainings in medical school study programs.

School-based mindfulness intervention for stress reduction in adolescents: Design and methodology of an open-label, parallel group, randomized controlled trial.

PubMed

Johnstone, Jeanette M; Roake, Chelsea; Sheikh, Ifrah; Mole, Ashlie; Nigg, Joel T; Oken, Barry

2016-12-15

Adolescents are in a high-risk period developmentally, in terms of susceptibility to stress. A mindfulness intervention represents a potentially useful strategy for developing cognitive and emotion regulation skills associated with successful stress coping. Mindfulness strategies have been used successfully for emotional coping in adults, but are not as well studied in youth. This article details a novel proposal for the design of an 8-week randomized study to evaluate a high school-based mindfulness curriculum delivered as part of a two semester health class. A wellness education intervention is proposed as an active control, along with a waitlist control condition. All students enrolled in a sophomore (10 th grade) health class at a private suburban high school will be invited to participate ( n = 300). Pre-test assessments will be obtained by youth report, parent ratings, and on-site behavioral testing. The assessments will evaluate baseline stress, mood, emotional coping, controlled attention, and working memory. Participants, divided into 13 classrooms, will be randomized into one of three conditions, by classroom: A mindfulness intervention, an active control (wellness education), and a passive control (waitlist). Waitlisted participants will receive one of the interventions in the following term. Intervention groups will meet weekly for 8 weeks during regularly scheduled health classes. Immediate post-tests will be conducted, followed by a 60-day post-test. It is hypothesized that the mindfulness intervention will outperform the other conditions with regard to the adolescents' mood, attention and response to stress.

Heparin for prolonging peripheral intravenous catheter use in neonates: a randomized controlled trial.

PubMed

Upadhyay, A; Verma, K K; Lal, P; Chawla, D; Sreenivas, V

2015-04-01

To determine the efficacy of heparinized saline administered as intermittent flush on functional duration of the peripheral intravenous catheter (PIVC) in neonates. Randomized, double-blind and placebo-controlled trial. Neonatal intensive care unit of a teaching hospital. Term and preterm neonates born at >32 weeks of gestation who required PIVC only for intermittent administration of antibiotics. Eligible neonates were randomized to receive 1 ml of either heparinized saline (10 U ml(-1)) (n=60) or normal saline (n=60) every 12 h before and after intravenous antibiotics. Functional duration of first peripheral intravenous catheter. A total of 120 neonates were randomized to two groups of 60 neonates each. The mean (s.d.) of age of babies in case and control group was 5.7 (2.5) days and 4.6 (3.1) days, respectively. The average weight of babies in both the groups was 2.1 kg. Mean functional duration of first catheter was more in heparinized saline group, mean (s.d.) of 71.68 h  (27.3) as compared with 57.7 h (23.6) in normal saline group (P<0.005). The mean (95% confidence interval) difference in functional duration in the two groups was 13.9 h (4.7-23.15). Mean duration of patency for any catheter was also significantly more in heparinized saline group than control group. Heparinized saline flush increases the functional duration of peripheral intravenous catheter.

Contribution of family social support to the metabolic control of people with diabetes mellitus: A randomized controlled clinical trial.

PubMed

Gomes, Lilian Cristiane; Coelho, Anna Claudia Martins; Gomides, Danielle Dos Santos; Foss-Freitas, Maria Cristina; Foss, Milton César; Pace, Ana Emilia

2017-08-01

This randomized controlled clinical trial aimed to evaluate the contribution of family social support to the clinical/metabolic control of people with type 2 diabetes mellitus. Diabetes mellitus is a chronic disease that requires continuous care in order for individuals to reach glycemic control, the primordial goal of treatment. Family social support is essential to the development of care skills and their maintenance. However, there are few studies that investigate the contribution of family social support to diabetes control. The study was developed between June 2011 and May 2013, and included 164 people who were randomized using simple randomization. The intervention group differed from the control group in that it included a family caregiver, who was recognized by the patient as a source of social support. The educational interventions received by people with diabetes mellitus were used as the basis of the education provided through telephone calls to patients' family members and caregivers, and their purpose was to encourage dialogue between the patients and their relatives about the topics related to diabetes. Regarding the clinical impact, the results showed that there was a greater reduction in blood pressure and glycated hemoglobin in the intervention group than in the control group, showing a positive effect on the control of the disease. Families should be incorporated into the care of people with diabetes mellitus and especially in health care programs, in particular those that can promote different forms of social support to strengthen the bond between family members. Copyright © 2017 Elsevier Inc. All rights reserved.

Reducing antibiotic prescriptions for respiratory tract infections in family practice: results of a cluster randomized controlled trial evaluating a multifaceted peer-group-based intervention.

PubMed

Vervloet, Marcia; Meulepas, Marianne A; Cals, Jochen W L; Eimers, Mariëtta; van der Hoek, Lucas S; van Dijk, Liset

2016-02-04

Irrational antibiotic use for respiratory tract infections (RTI) is a major driver of bacterial resistance. The aim of this study was to evaluate the effect of a multifaceted peer-group based intervention aiming to reduce RTI-related antibiotic prescriptions in family practice. This was a cluster randomized controlled trial with pre- and follow-up measurement. The intervention was implemented through PharmacoTherapy Audit Meetings (PTAM) in which family physicians (FPs) and pharmacists collaborate. Four PTAM groups received the intervention consisting of: (1) FP communication skills training, including communication about delayed prescribing; (2) implementation of antibiotic prescribing agreements in FPs' Electronic Prescribing Systems; (3) quarterly feedback figures for FPs. Four other PTAM groups were matched controls. Primary outcome measure was the number of RTI-related antibiotic prescriptions after the intervention, assessed with multilevel linear regression analyses. Total number and number of prescriptions stratified by age (under/over 12 years) were analysed. At baseline, the average total number of RTI-related antibiotic prescriptions per 1,000 patients was 207.9 and 176.7 in the intervention and control PTAM groups, respectively. At follow-up, FPs in both the intervention and control groups prescribed significantly less antibiotics. For adolescents and adults, the drop in number of antibiotic prescription was significantly larger in the intervention groups (-27.8 per 1,000 patients) than the control groups (-7.2 per 1,000 patients; P<0.05). This multifaceted peer-group-based intervention was effective in reducing the number of RTI-related antibiotic prescriptions for adolescents and adults. To affect antibiotic prescribing in children other methods are needed.

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.

Project LifeSkills - a randomized controlled efficacy trial of a culturally tailored, empowerment-based, and group-delivered HIV prevention intervention for young transgender women: study protocol.

PubMed

Kuhns, Lisa M; Mimiaga, Matthew J; Reisner, Sari L; Biello, Katie; Garofalo, Robert

2017-09-16

Transgender women in the U.S. have an alarmingly high incidence rate of HIV infection; condomless anal and vaginal sex is the primary risk behavior driving transmission. Young transgender women are the subpopulation at the highest risk for HIV. Despite this, there are no published randomized controlled efficacy trials testing interventions to reduce sexual risk for HIV among this group. This paper describes the design of a group-based intervention trial to reduce sexual risk for HIV acquisition and transmission in young transgender women. This study, funded by the National Institutes of Health, is a randomized controlled trial of a culturally-specific, empowerment-based, and group-delivered six-session HIV prevention intervention, Project LifeSkills, among sexually active young transgender women, ages 16-29 years in Boston and Chicago. Participants are randomized (2:2:1) to either the LifeSkills intervention, standard of care only, or a diet and nutrition time- and attention-matched control. At enrollment, all participants receive standardized HIV pre- and post-test counseling and screening for HIV and urogenital gonorrhea and chlamydia infections. The primary outcome is difference in the rate of change in the number of self-reported condomless anal or vaginal sex acts during the prior 4-months, assessed at baseline, 4-, 8-, and 12-month follow-up visits. Behavioral interventions to reduce sexual risk for HIV acquisition and transmission are sorely needed for young transgender women. This study will provide evidence to determine feasibility and efficacy in one of the first rigorously designed trials for this population. ClinicalTrials.gov number, NCT01575938 , registered March 29, 2012.

Impact of Computerized Decision Support on Blood Pressure Management and Control: A Randomized Controlled Trial

PubMed Central

Sequist, Thomas D.; Ayanian, John Z.; Shaykevich, Shimon; Fairchild, David G.; Orav, E. John; Bates, David W.

2008-01-01

BACKGROUND We conducted a cluster randomized controlled trial to examine the effectiveness of computerized decision support (CDS) designed to improve hypertension care and outcomes in a racially diverse sample of primary care patients. METHODS We randomized 2,027 adult patients receiving hypertension care in 14 primary care practices to either 18 months of their physicians receiving CDS for each hypertensive patient or to usual care without computerized support for the control group. We assessed prescribing of guideline-recommended drug therapy and levels of blood pressure control for patients in each group and examined if the effects of the intervention differed by patients’ race/ethnicity using interaction terms. MEASUREMENTS AND MAIN RESULTS Rates of blood pressure control were 42% at baseline and 46% at the outcome visit with no significant differences between groups. After adjustment for patients’ demographic and clinical characteristics, number of prior visits, and levels of baseline blood pressure control, there were no differences between intervention groups in the odds of outcome blood pressure control. The use of CDS to providers significantly improved Joint National Committee (JNC) guideline adherent medication prescribing compared to usual care (7% versus 5%, P < 0.001); the effects of the intervention remained after multivariable adjustment (odds ratio [OR] 1.39 [CI, 1.13–1.72]) and the effects of the intervention did not differ by patients’ race and ethnicity. CONCLUSIONS CDS improved appropriate medication prescribing with no improvement in disparities in care and overall blood pressure control. Future work focusing on improvement of these interventions and the study of other practical interventions to reduce disparities in hypertension-related outcomes is needed. PMID:18373141

Effectiveness of cognitive-behavioral stress management on psychological stress and glycemic control in gestational diabetes: a randomized controlled trial.

PubMed

Zaheri, Hamideh; Najar, Shahnaz; Abbaspoor, Zahra

2017-06-01

This study was conducted to determine the effect of cognitive-behavioral stress management (CBT) on reducing psychological stress in diabetic pregnant women. This randomized controlled trial applied through pretest and post-test with control group was conducted on 88 eligible women with gestational diabetes. Women who had a stress score more than 15, randomly assigned to intervention or control groups. Intervention group received stress management training within six two-hour sessions for three weeks. Stress and FBS were measured before intervention and two weeks after the last session. Data were analyzed using the SPSS version 19.0. Results were analyzed using chi-square, paired t test and independent sample t test. In CBT training group, stress significantly decreased two weeks after the training (p < 0.001). In the control group, the stress scores were significantly different before and after the intervention and women had a significant increase in the stress scores (p = 0.028). There was a significant difference between two groups in stress scores, two weeks after intervention (p = 0.001). Cognitive-behavioral stress management reduces stress in women with gestational diabetes and reducing stress may also improve the pregnancy outcomes, especially whose glycemic along with stress is not adequately controlled by medication.

A randomized controlled comparison of stretching procedures for posterior shoulder tightness.

PubMed

McClure, Philip; Balaicuis, Jenna; Heiland, David; Broersma, Mary Ellen; Thorndike, Cheryl K; Wood, April

2007-03-01

Randomized controlled trial, To compare changes in shoulder internal rotation range of motion (ROM), for 2 stretching exercises, the "cross-body stretch" and the "sleeper stretch," in individuals with posterior shoulder tightness. Recently, some authors have expressed the belief that the sleeper stretch is better than the cross-body stretch to address glenohumeral posterior tightness because the scapula is stabilized. Fifty-four asymptomatic subjects (20 males, 34 females) participated in the study. The control group (n=24) consisted of subjects with a between-shoulder difference in internal rotation ROM of less than 10 degrees, whereas those subjects with more than a 10 degrees difference were randomly assigned to 1 of 2 intervention groups, the sleeper stretch group (n=15) or the cross-body stretch group (n=15). Shoulder internal rotation ROM, with the arm abducted to 90 degrees and scapula motion prevented, was measured before and after a 4-week intervention period. Subjects in the control group were asked not to engage in any new stretching activities, while subjects in the 2 stretching groups were asked to perform stretching exercises on the more limited side only, once daily for 5 repetitions, holding each stretch for 30 seconds. The improvements in internal rotation ROM for the subjects in the cross-body stretch group (mean +/- SD, 20.0 degrees +/- 12.9 degrees) were significantly greater than for the subjects in the control group (5.9 degrees +/- 9.4 degrees, P = .009). The gains in the sleeper stretch group (12.4 degrees +/- 10.4 degrees) were not significant compared to those of the control group (P = .586) and those of the cross-body stretch group (P = .148). The cross-body stretch in individuals with limited shoulder internal rotation ROM appears to be more effective than no stretching in controls without internal rotation asymmetry to improve shoulder internal rotation ROM. While the improvement in internal rotation from the cross-body stretch was

Aromatherapy for reducing colonoscopy related procedural anxiety and physiological parameters: a randomized controlled study.

PubMed

Hu, Pei-Hsin; Peng, Yen-Chun; Lin, Yu-Ting; Chang, Chi-Sen; Ou, Ming-Chiu

2010-01-01

Colonoscopy is generally tolerated, some patients regarding the procedure as unpleasant and painful and generally performed with the patient sedated and receiving analgesics. The effect of sedation and analgesia for colonoscopy is limited. Aromatherapy is also applied to gastrointestinal endoscopy to reduce procedural anxiety. There is lack of information about aromatherapy specific for colonoscopy. In this study, we aimed to performed a randomized controlled study to investigate the effect of aromatherapy on relieve anxiety, stress and physiological parameters of colonoscopy. A randomized controlled trail was carried out and collected in 2009 and 2010. The participants were randomized in two groups. Aromatherapy was then carried out by inhalation of Sunflower oil (control group) and Neroli oil (Experimental group). The anxiety index was evaluated by State Trait Anxiety Inventory-state (STAI-S) score before aromatherapy and after colonoscopy as well as the pain index for post-procedural by visual analogue scale (VAS). Physiological indicators, such as blood pressure (systolic and diastolic blood pressure), heart rate and respiratory rate were evaluated before and after aromatherapy. Participates in this study were 27 subjects, 13 in control group and 14 in Neroli group with average age 52.26 +/- 17.79 years. There was no significance of procedural anxiety by STAI-S score and procedural pain by VAS. The physiological parameters showed a significant lower pre- and post-procedural systolic blood pressure in Neroli group than control group. Aromatic care for colonoscopy, although with no significant effect on procedural anxiety, is an inexpensive, effective and safe pre-procedural technique that could decrease systolic blood pressure.

Ketorolac does not increase perioperative bleeding: a meta-analysis of randomized controlled trials.

PubMed

Gobble, Ryan M; Hoang, Han L T; Kachniarz, Bart; Orgill, Dennis P

2014-03-01

Postoperative pain control is essential for optimal patient outcomes. Ketorolac is an attractive alternative for achieving pain control postoperatively, but concerns over postoperative bleeding have limited its use. Computer searches of the MEDLINE, EMBASE, and Cochrane Library databases were performed. Twenty-seven double-blind, randomized, controlled studies were reviewed by two independent investigators for the incidence of adverse events, including postoperative bleeding. Comprehensive meta-analysis software was used to evaluate the differences between ketorolac and control groups. Twenty-seven studies with 2314 patients were analyzed. Postoperative bleeding occurred in 33 of 1304 patients (2.5 percent) in the ketorolac group compared with 21 of 1010 (2.1 percent) in the control group (OR, 1.1; 95 percent CI, 0.61 to 2.06; p = 0.72). Adverse events were similar in the groups, 31.7 percent in the control group and 27.9 percent in the ketorolac group (OR, 0.64; 95 percent CI, 0.41 to 1.01; p = 0.06). There was a lower incidence of adverse effects with low-dose ketorolac (OR, 0.49; 95 percent CI, 0.27 to 0.91; p = 0.02). Pain control with ketorolac was superior to controls and equivalent to opioids. This is the first meta-analysis of randomized controlled trials examining whether there is increased postoperative bleeding with ketorolac. Postoperative bleeding was not significantly increased with ketorolac compared with controls, and adverse effects were not statistically different between the groups. Pain control was found to be superior with ketorolac compared with controls. Ketorolac should be considered for postoperative pain control, especially to limit the use of opioid pain medications. Therapeutic, II.

Bias from historical control groups used in orthodontic research: a meta-epidemiological study.

PubMed

Papageorgiou, Spyridon N; Koretsi, Vasiliki; Jäger, Andreas

2017-02-01

The validity of meta-analysis is dependent upon the quality of included studies. Here, we investigated whether the design of untreated control groups (i.e. source and timing of data collection) influences the results of clinical trials in orthodontic research. This meta-epidemiological study used unrestricted literature searching for meta-analyses in orthodontics including clinical trials with untreated control groups. Differences in standardized mean differences (ΔSMD) and their 95% confidence intervals (CIs) were calculated according to the untreated control group through multivariable random-effects meta-regression controlling for nature of the interventional group and study sample size. Effects were pooled with random-effects synthesis, followed by mixed-effect subgroup and sensitivity analyses. Studies with historical control groups reported deflated treatment effects compared to studies with concurrent control groups (13 meta-analyses; ΔSMD = -0.31; 95% CI = -0.53, -0.10; P = 0.004). Significant differences were found according to the type of historical control group (based either on growth study or clinical archive; 11 meta-analyses; ΔSMD = 0.40; 95% CI = 0.21, 0.59; P < 0.001). The use of historical control groups in orthodontic clinical research was associated with deflation of treatment effects, which was independent from whether the interventional group was prospective or retrospective and from the study's sample size. Caution is warranted when interpreting clinical studies with historical untreated control groups or when interpreting systematic reviews that include such studies. PROSPERO (CRD42015024179). None. © The Author 2016. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Experience with multiple control groups in a large population-based case-control study on genetic and environmental risk factors.

PubMed

Pomp, E R; Van Stralen, K J; Le Cessie, S; Vandenbroucke, J P; Rosendaal, F R; Doggen, C J M

2010-07-01

We discuss the analytic and practical considerations in a large case-control study that had two control groups; the first control group consisting of partners of patients and the second obtained by random digit dialling (RDD). As an example of the evaluation of a general lifestyle factor, we present body mass index (BMI). Both control groups had lower BMIs than the patients. The distribution in the partner controls was closer to that of the patients, likely due to similar lifestyles. A statistical approach was used to pool the results of both analyses, wherein partners were analyzed with a matched analysis, while RDDs were analyzed without matching. Even with a matched analysis, the odds ratio with partner controls remained closer to unity than with RDD controls, which is probably due to unmeasured confounders in the comparison with the random controls as well as intermediary factors. However, when studying injuries as a risk factor, the odds ratio remained higher with partner control subjects than with RRD control subjects, even after taking the matching into account. Finally we used factor V Leiden as an example of a genetic risk factor. The frequencies of factor V Leiden were identical in both control groups, indicating that for the analyses of this genetic risk factor the two control groups could be combined in a single unmatched analysis. In conclusion, the effect measures with the two control groups were in the same direction, and of the same order of magnitude. Moreover, it was not always the same control group that produced the higher or lower estimates, and a matched analysis did not remedy the differences. Our experience with the intricacies of dealing with two control groups may be useful to others when thinking about an optimal research design or the best statistical approach.

Effect of Rosa damascene aromatherapy on sleep quality in cardiac patients: a randomized controlled trial.

PubMed

Hajibagheri, Ali; Babaii, Atye; Adib-Hajbaghery, Mohsen

2014-08-01

Sleep disorders are common among patients hospitalized in coronary care unit (CCU). This study aimed to investigate the effect of Rosa damascene aromatherapy on sleep quality of patients hospitalized in CCU. In this randomized controlled trial, 60 patients who met the inclusion criteria were conveniently sampled and randomly allocated to the experimental and control groups. Patients in the control group received routine care. In the experimental group, patients received routine care and Rosa damascene aromatherapy for three subsequent nights. In the both groups the sleep quality was assessed using the Pittsburgh Sleep Quality Index. After the study, the mean scores of five domains of Pittsburg Sleep Quality Index as well as the mean of total score of the index in the experimental group were significantly lower than the control group. Rosa damascene aromatherapy can significantly improve the sleep quality of patients hospitalized in CCUs. Copyright © 2014 Elsevier Ltd. All rights reserved.

A Randomized Controlled Trial to Improve the Success of Women Assistant Professors.

PubMed

Grisso, Jeane Ann; Sammel, Mary Dupuis; Rubenstein, Arthur H; Speck, Rebecca M; Conant, Emily F; Scott, Patricia; Tuton, Lucy Wolf; Westring, Alyssa Friede; Friedman, Stewart; Abbuhl, Stephanie B

2017-05-01

Given the persistent disparity in the advancement of women compared with men faculty in academic medicine, it is critical to develop effective interventions to enhance women's careers. We carried out a cluster-randomized, multifaceted intervention to improve the success of women assistant professors at a research-intensive medical school. Twenty-seven departments/divisions were randomly assigned to intervention or control groups. The three-tiered intervention included components that were aimed at (1) the professional development of women assistant professors, (2) changes at the department/division level through faculty-led task forces, and (3) engagement of institutional leaders. Generalized linear models were used to test associations between assignment and outcomes, adjusting for correlations induced by the clustered design. Academic productivity and work self-efficacy improved significantly over the 3-year trial in both intervention and control groups, but the improvements did not differ between the groups. Average hours worked per week declined significantly more for faculty in the intervention group as compared with the control group (-3.82 vs. -1.39 hours, respectively, p = 0.006). The PhD faculty in the intervention group published significantly more than PhD controls; however, no differences were observed between MDs in the intervention group and MDs in the control group. Significant improvements in academic productivity and work self-efficacy occurred in both intervention and control groups, potentially due to school-wide intervention effects. A greater decline in work hours in the intervention group despite similar increases in academic productivity may reflect learning to "work smarter" or reveal efficiencies brought about as a result of the multifaceted intervention. The intervention appeared to benefit the academic productivity of faculty with PhDs, but not MDs, suggesting that interventions should be more intense or tailored to specific faculty

A Randomized Controlled Trial to Improve the Success of Women Assistant Professors

PubMed Central

Grisso, Jeane Ann; Sammel, Mary Dupuis; Rubenstein, Arthur H.; Speck, Rebecca M.; Conant, Emily F.; Scott, Patricia; Tuton, Lucy Wolf; Westring, Alyssa Friede; Friedman, Stewart

2017-01-01

Abstract Background: Given the persistent disparity in the advancement of women compared with men faculty in academic medicine, it is critical to develop effective interventions to enhance women's careers. We carried out a cluster-randomized, multifaceted intervention to improve the success of women assistant professors at a research-intensive medical school. Materials and Methods: Twenty-seven departments/divisions were randomly assigned to intervention or control groups. The three-tiered intervention included components that were aimed at (1) the professional development of women assistant professors, (2) changes at the department/division level through faculty-led task forces, and (3) engagement of institutional leaders. Generalized linear models were used to test associations between assignment and outcomes, adjusting for correlations induced by the clustered design. Results: Academic productivity and work self-efficacy improved significantly over the 3-year trial in both intervention and control groups, but the improvements did not differ between the groups. Average hours worked per week declined significantly more for faculty in the intervention group as compared with the control group (−3.82 vs. −1.39 hours, respectively, p = 0.006). The PhD faculty in the intervention group published significantly more than PhD controls; however, no differences were observed between MDs in the intervention group and MDs in the control group. Conclusions: Significant improvements in academic productivity and work self-efficacy occurred in both intervention and control groups, potentially due to school-wide intervention effects. A greater decline in work hours in the intervention group despite similar increases in academic productivity may reflect learning to “work smarter” or reveal efficiencies brought about as a result of the multifaceted intervention. The intervention appeared to benefit the academic productivity of faculty with PhDs, but not MDs, suggesting

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

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

A randomized controlled trial of a group intervention for siblings of children with cancer: Changes in symptoms of anxiety in siblings and caregivers.

PubMed

Barrera, Maru; Atenafu, Eshetu G; Schulte, Fiona; Nathan, Paul C; Hancock, Kelly; Saleh, Amani

2018-06-01

This study assessed the effects of a group intervention-Siblings Coping Together (SibCT)-on siblings' and caregivers' anxiety symptoms compared to controls, and potential moderators. Seventy healthy siblings of children on or off treatment (7-16 y old, 41 males) participated in a randomized controlled trial (RCT) with 2 arms/groups: SibCT (n = 41) and an attention control (CG) (n = 34). Both groups had eight 2-hour weekly sessions. EG followed SibCT's educational, social, and problem-solving activities. CG had planned games and crafts. Siblings and caregivers self-reported on anxiety symptoms at baseline, intervention end, and 3 months later. Multivariable mixed model analyses examined the intervention effect over time, and potential moderators (gender, on/off ill child's treatment). No main effects of group or time were found in sibling scores. A group × gender interaction (P < .05) indicated that in the intervention group female siblings reported less total anxiety symptoms than male siblings, with no significant gender differences in the control group. Caregivers' total anxiety symptoms declined over time (P < .02). A group × on/off treatment interaction in physiological/panic subscale (P < .03) indicated that when ill child was on treatment, caregivers of siblings in SibCT reported less anxiety compared with caregivers of CG. There was no clear SibCT intervention effect. SibCT may benefit female siblings, and caregivers whose ill child is on active treatment. Contextual factors (gender) seem to influence psychosocial intervention in this population. Copyright © 2018 John Wiley & Sons, Ltd.

Group physiotherapy compared to individual physiotherapy to treat urinary incontinence in aging women: study protocol for a randomized controlled trial.

PubMed

Dumoulin, Chantale; Morin, Mélanie; Mayrand, Marie-Hélène; Tousignant, Michel; Abrahamowicz, Michal

2017-11-16

Urinary incontinence (UI), one of the most prevalent health concerns confronting women aged over 60 years, affects up to 55% of older community-dwelling women-20-25% with severe symptoms. Clinical practice guidelines recommend individualized pelvic floor muscle training (PFMT) as a first-line treatment for stress or mixed UI in women, although lack of human and financial resources limits delivery of this first-line treatment. Preliminary data suggest that group-based treatments may provide the answer. To date, no adequately powered trials have evaluated the effectiveness or cost-effectiveness of group compared to individual PFMT for UI in older women. Given demographic projections, high prevalence of UI in older women, costly barriers, and group PFMT promising results, there is a clear need to rigorously compare the short- and long-term effectiveness and cost-effectiveness of group vs individual PFMT. The study is designed as a non-inferiority randomized controlled trial, conducted in two facilities (Montreal and Sherbrooke) in the Canadian province of Quebec. Participants include 364 ambulatory, community-dwelling women, aged 60 years and older, with stress or mixed UI. Randomly assigned participants will follow a 12-week PFMT, either in one-on-one sessions or as part of a group, under the supervision of a physiotherapist. Blinded assessments at baseline, immediately post intervention, and at one year will include the seven-day bladder diary, the 24-h pad test, symptoms and quality of life questionnaires, adherence and self-efficacy questionnaire, pelvic floor muscle function, and cost assessments. Primary analysis will test our main hypothesis that group-based treatment is not inferior to individualized treatment with respect to the primary outcome: relative (%) reduction in the number of leakages. Should this study find that a group-based approach is not less effective than individual PFMT, and more cost-effective, this trial will impact positively continence

Effect of physical training on urinary incontinence: a randomized parallel group trial in nursing homes.

PubMed

Vinsnes, Anne G; Helbostad, Jorunn L; Nyrønning, Signe; Harkless, Gene E; Granbo, Randi; Seim, Arnfinn

2012-01-01

Residents in nursing homes (NHs) are often frail older persons who have impaired physical activity. Urinary incontinence (UI) is a common complaint for residents in NHs. Reduced functional ability and residence in NHs are documented to be risk factors for UI. To investigate if an individualized training program designed to improve activity of daily living (ADL) and physical capacity among residents in nursing homes has any impact on UI. This randomized controlled trial was a substudy of a Nordic multicenter study. Participants had to be >65 years, have stayed in the NH for more than 3 months and in need of assistance in at least one ADL. A total of 98 residents were randomly allocated to either a training group (n = 48) or a control group (n = 50) after baseline registrations. The training program lasted for 3 months and included accommodated physical activity and ADL training. Personal treatment goals were elicited for each subject. The control group received their usual care. The main outcome measure was UI as measured by a 24-hour pad-weighing test. There was no statistically significant difference between the groups on this measure at baseline (P = 0.15). Changes were calculated from baseline to 3 months after the end of the intervention. Altogether, 68 participants were included in the analysis, 35 in the intervention group and 33 in the control group. The average age was 84.3 years. The 3 months' postintervention adjusted mean difference between groups according to amount of leakage was 191 g (P = 0.03). This result was statistically significant after adjusting for baseline level, age, sex, and functional status. The leakage increased in residents not receiving the experimental intervention, while UI in the training group showed improvement. The intervention group had significant better results compared with the control group after an individualized training program designed to improve ADL and physical capacity. Further studies are needed to evaluate the

Cockroach allergen reduction by cockroach control alone in low-income urban homes: a randomized control trial.

PubMed

Sever, Michelle L; Arbes, Samuel J; Gore, J Chad; Santangelo, Richard G; Vaughn, Ben; Mitchell, Herman; Schal, Coby; Zeldin, Darryl C

2007-10-01

We previously reported significant reductions in cockroach allergen concentrations in urban homes by reducing cockroach infestations. To determine the effectiveness of pest control performed by professional entomologists, compared with commercial companies, in reducing cockroach allergen. This 3-arm randomized controlled trial enrolled 60 cockroach-infested homes in North Carolina. Homes were randomly assigned to a control group or 1 of 2 treatment groups. Treatment 1 had insecticide baits placed by entomologists from North Carolina State University. Treatment 2 received pest control from a randomly assigned commercial company. Vacuumed dust sampling and cockroach trapping were conducted at 0, 6, and 12 months. Dust samples were analyzed by ELISA. In treatment 1 homes, there were significant reductions in geometric mean trap counts compared with control and treatment 2 homes at 12 months. Relative to control, significant 12-month reductions in Bla g 1 were evident in treatment 1 homes at all sampled sites, except bedroom floor. From baseline to month 12, geometric mean Bla g 1 concentrations (U/g) decreased from 64.2 to 5.6 in kitchen, 10.6 to 1.1 in living room, 10.7 to 1.9 on bedroom floor, and 3.6 to 2.3 in bed. Treatment 2 homes showed no significant 12-month allergen reductions versus control. Reductions in Bla g 1 in cockroach-infested homes can be achieved by reducing infestations; however, the magnitude of allergen reduction is dependent on the thoroughness and effectiveness of cockroach eradication efforts. Elimination of cockroaches is an effective method for reducing exposure to cockroach allergen.

The effect of foot massage on long-term care staff working with older people with dementia: a pilot, parallel group, randomized controlled trial.

PubMed

Moyle, Wendy; Cooke, Marie; O'Dwyer, Siobhan T; Murfield, Jenny; Johnston, Amy; Sung, Billy

2013-02-18

Caring for a person with dementia can be physically and emotionally demanding, with many long-term care facility staff experiencing increased levels of stress and burnout. Massage has been shown to be one way in which nurses' stress can be reduced. However, no research has been conducted to explore its effectiveness for care staff working with older people with dementia in long-term care facilities. This was a pilot, parallel group, randomized controlled trial aimed at exploring feasibility for a larger randomized controlled trial. Nineteen staff, providing direct care to residents with dementia and regularly working ≥ two day-shifts a week, from one long-term care facility in Queensland (Australia), were randomized into either a foot massage intervention (n=9) or a silent resting control (n=10). Each respective session lasted for 10-min, and participants could receive up to three sessions a week, during their allocated shift, over four-weeks. At pre- and post-intervention, participants were assessed on self-report outcome measures that rated mood state and experiences of working with people with dementia. Immediately before and after each intervention/control session, participants had their blood pressure and anxiety measured. An Intention To Treat framework was applied to the analyses. Individual qualitative interviews were also undertaken to explore participants' perceptions of the intervention. The results indicate the feasibility of undertaking such a study in terms of: recruitment; the intervention; timing of intervention; and completion rates. A change in the intervention indicated the importance of a quiet, restful environment when undertaking a relaxation intervention. For the psychological measures, although there were trends indicating improvement in mood there was no significant difference between groups when comparing their pre- and post- scores. There were significant differences between groups for diastolic blood pressure (p= 0.04, partial η2

Is Reducing Uncertain Control the Key to Successful Test Anxiety Intervention for Secondary School Students? Findings from a Randomized Control Trial

ERIC Educational Resources Information Center

Putwain, David W.; Pescod, Marc

2018-01-01

The aim of the study was to conduct a randomized control trial of a targeted, facilitated, test anxiety intervention for a group of adolescent students, and to examine the mediating role of uncertain control. Fifty-six participants (male = 19, white = 21, mean age = 14.7 years) were randomly allocated to an early intervention or wait-list control…

Universal screening and decolonization for control of MRSA in nursing homes: a cluster randomized controlled study.

PubMed

Bellini, Cristina; Petignat, Christiane; Masserey, Eric; Büla, Christophe; Burnand, Bernard; Rousson, Valentin; Blanc, Dominique S; Zanetti, Giorgio

2015-04-01

The risk of carrying methicillin-resistant Staphylococcus aureus (MRSA) is higher among nursing home (NH) residents than in the general population. However, control strategies are not clearly defined in this setting. In this study, we compared the impact of standard precautions either alone (control) or combined with screening of residents and decolonization of carriers (intervention) to control MRSA in NHs. Cluster randomized controlled trial. NHs of the state of Vaud, Switzerland. Of 157 total NHs in Vaud, 104 (67%) participated in the study. Standard precautions were enforced in all participating NHs, and residents underwent MRSA screening at baseline and 12 months thereafter. All carriers identified in intervention NHs, either at study entry or among newly admitted residents, underwent topical decolonization combined with environmental disinfection, except in cases of MRSA infection, MRSA bacteriuria, or deep skin ulcers. NHs were randomly allocated to a control group (51 NHs, 2,412 residents) or an intervention group (53 NHs, 2,338 residents). Characteristics of NHs and residents were similar in both groups. The mean screening rates were 86% (range, 27%-100%) in control NHs and 87% (20%-100%) in intervention NHs. Prevalence of MRSA carriage averaged 8.9% in both control NHs (range, 0%-43%) and intervention NHs (range, 0%-38%) at baseline, and this rate significantly declined to 6.6% in control NHs and to 5.8% in intervention NHs after 12 months. However, the decline did not differ between groups (P=.66). Universal screening followed by decolonization of carriers did not significantly reduce the prevalence of the MRSA carriage rate at 1 year compared with standard precautions.

Effectiveness of preventive home visits in reducing the risk of falls in old age: a randomized controlled trial

PubMed Central

Luck, Tobias; Motzek, Tom; Luppa, Melanie; Matschinger, Herbert; Fleischer, Steffen; Sesselmann, Yves; Roling, Gudrun; Beutner, Katrin; König, Hans-Helmut; Behrens, Johann; Riedel-Heller, Steffi G

2013-01-01

Background Falls in older people are a major public health issue, but the underlying causes are complex. We sought to evaluate the effectiveness of preventive home visits as a multifactorial, individualized strategy to reduce falls in community-dwelling older people. Methods Data were derived from a prospective randomized controlled trial with follow-up examination after 18 months. Two hundred and thirty participants (≥80 years of age) with functional impairment were randomized to intervention and control groups. The intervention group received up to three preventive home visits including risk assessment, home counseling intervention, and a booster session. The control group received no preventive home visits. Structured interviews at baseline and follow-up provided information concerning falls in both study groups. Random-effects Poisson regression evaluated the effect of preventive home visits on the number of falls controlling for covariates. Results Random-effects Poisson regression showed a significant increase in the number of falls between baseline and follow-up in the control group (incidence rate ratio 1.96) and a significant decrease in the intervention group (incidence rate ratio 0.63) controlling for age, sex, family status, level of care, and impairment in activities of daily living. Conclusion Our results indicate that a preventive home visiting program can be effective in reducing falls in community-dwelling older people. PMID:23788832

Long-term follow-up of a randomized study of support group intervention in women with primary breast cancer.

PubMed

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

2013-04-01

Despite a fairly good prognosis, many breast-cancer patients suffer from symptoms such as anxiety, depression and fatigue, which may affect health-related quality of life and may persist for several years. The aim of the present study was to perform a long-term follow-up of a randomized study of support group intervention in women after primary breast cancer treatment. Three hundred and eighty two women with primary breast cancer were randomized to support group intervention or control group, 181 in each group. Women in the intervention group participated in 1 week of intervention followed by 4 days of follow-up 2 months later. This is a long-term follow-up undertaken, in average, 6.5 years after randomization. Patients answered the questionnaires the European Organisation for Research and Treatment of Cancer, quality of life questionnaire (EORTC QLQ-C30) and the breast cancer module questionnaire (BR 23), the hospital anxiety and depression scale (HAD) and the Norwegian version of the fatigue scale (FQ). After adjusting for treatment with chemotherapy, age, marriage, education and children at home, there was a significant improvement in physical, mental and total fatigue (FQ), cognitive function, body image and future perspective (EORTC QLQ C30 and BR23) in the intervention group compared with controls. The proportion of women affected by high anxiety and depression scores were not significantly different between the groups. Support intervention significantly improved cognitive function, body image, future perspective and fatigue, compared with to the findings in the control group. Copyright © 2012 Elsevier Inc. All rights reserved.

Randomized controlled trial of video self-modeling following speech restructuring treatment for stuttering.

PubMed

Cream, Angela; O'Brian, Sue; Jones, Mark; Block, Susan; Harrison, Elisabeth; Lincoln, Michelle; Hewat, Sally; Packman, Ann; Menzies, Ross; Onslow, Mark

2010-08-01

In this study, the authors investigated the efficacy of video self-modeling (VSM) following speech restructuring treatment to improve the maintenance of treatment effects. The design was an open-plan, parallel-group, randomized controlled trial. Participants were 89 adults and adolescents who undertook intensive speech restructuring treatment. Post treatment, participants were randomly assigned to 2 trial arms: standard maintenance and standard maintenance plus VSM. Participants in the latter arm viewed stutter-free videos of themselves each day for 1 month. The addition of VSM did not improve speech outcomes, as measured by percent syllables stuttered, at either 1 or 6 months postrandomization. However, at the latter assessment, self-rating of worst stuttering severity by the VSM group was 10% better than that of the control group, and satisfaction with speech fluency was 20% better. Quality of life was also better for the VSM group, which was mildly to moderately impaired compared with moderate impairment in the control group. VSM intervention after treatment was associated with improvements in self-reported outcomes. The clinical implications of this finding are discussed.

The Effects of School Gardens on Children's Science Knowledge: A Randomized Controlled Trial of Low-Income Elementary Schools

ERIC Educational Resources Information Center

Wells, Nancy M.; Myers, Beth M.; Todd, Lauren E.; Barale, Karen; Gaolach, Brad; Ferenz, Gretchen; Aitken, Martha; Henderson, Charles R.; Tse, Caroline; Pattison, Karen Ostlie; Taylor, Cayla; Connerly, Laura; Carson, Janet B.; Gensemer, Alexandra Z.; Franz, Nancy K.; Falk, Elizabeth

2015-01-01

This randomized controlled trial or "true experiment" examines the effects of a school garden intervention on the science knowledge of elementary school children. Schools were randomly assigned to a group that received the garden intervention (n?=?25) or to a waitlist control group that received the garden intervention at the end of the…

Resistance training for hot flushes in postmenopausal women: Randomized controlled trial protocol.

PubMed

Berin, Emilia; Hammar, Mats L; Lindblom, Hanna; Lindh-Åstrand, Lotta; Spetz Holm, Anna-Clara E

2016-03-01

Hot flushes and night sweats affect 75% of all women after menopause and is a common reason for decreased quality of life in mid-aged women. Hormone therapy is effective in ameliorating symptoms but cannot be used by all women due to contraindications and side effects. Engagement in regular exercise is associated with fewer hot flushes in observational studies, but aerobic exercise has not proven effective in randomized controlled trials. It remains to be determined whether resistance training is effective in reducing hot flushes and improves quality of life in symptomatic postmenopausal women. The aim of this study is to investigate the effect of standardized resistance training on hot flushes and other health parameters in postmenopausal women. This is an open, parallel-group, randomized controlled intervention study conducted in Linköping, Sweden. Sixty symptomatic and sedentary postmenopausal women with a mean of at least four moderate to severe hot flushes per day or 28 per week will be randomized to an exercise intervention or unchanged physical activity (control group). The intervention consists of 15 weeks of standardized resistance training performed three times a week under supervision of a physiotherapist. The primary outcome is hot flush frequency assessed by self-reported hot flush diaries, and the difference in change from baseline to week 15 will be compared between the intervention group and the control group. The intention is that this trial will contribute to the evidence base regarding effective treatment for hot flushes. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

YAG laser peripheral iridotomy for the prevention of pigment dispersion glaucoma a prospective, randomized, controlled trial.

PubMed

Scott, Andrew; Kotecha, Aachal; Bunce, Catey; Balidis, Miltos; Garway-Heath, David F; Miller, Michael H; Wormald, Richard

2011-03-01

To test the hypothesis that neodymium:yttrium-aluminum-garnet (Nd:YAG) laser peripheral iridotomy (LPI) significantly reduces the incidence of conversion from pigment dispersion syndrome (PDS) with ocular hypertension (OHT) to pigmentary glaucoma (PG). Prospective, randomized, controlled 3-year trial. One hundred sixteen eyes of 116 patients with PDS and OHT. Patients were assigned randomly either to Nd:YAG LPI or to a control group (no laser). The primary outcome measure was conversion to PG within 3 years, based on full-threshold visual field (VF) analysis using the Ocular Hypertension Treatment Study criteria. Secondary outcome measures were whether eyes required topical antiglaucoma medications during the study period and the time to conversion or medication. Fifty-seven patients were randomized to undergo laser treatment and 59 were randomized to no laser (controls). Age, gender, spherical equivalent refraction, and intraocular pressure at baseline were similar between groups. Outcome data were available for 105 (90%) of recruited subjects, 52 in the laser treatment group and 53 in the no laser treatment group. Patients were followed up for a median of 35.9 months (range, 10-36 months) in the laser arm and 35.9 months (range, 1-36 months) in the control arm. Eight eyes (15%) in the laser group and 3 eyes (6%) in the control group converted to glaucoma in the study period. The proportion of eyes started on medical treatment was similar in the 2 groups: 8 eyes (15%) in the laser group and 9 eyes (17%) in the control group. Survival analyses showed no evidence of any difference in time to VF progression or commencement of topical therapy between the 2 groups. Cataract extraction was performed on 1 patient in the laser group and in 1 patient in the control group during the study period (laser eye at 18 months; control eye at 34 months). This study suggests that there was no benefit of Nd:YAG LPI in preventing progression from PDS with OHT to PG within 3 years of

Efficacy of Parent-Child Interaction Therapy with Chinese ADHD Children: Randomized Controlled Trial

ERIC Educational Resources Information Center

Leung, Cynthia; Tsang, Sandra; Ng, Gene S. H.; Choi, S. Y.

2017-01-01

Purpose: This study aimed to evaluate the efficacy of Parent-Child Interaction Therapy (PCIT) in Chinese children with attention-deficit/hyperactivity disorder (ADHD) or ADHD features. Methods: This study adopted a randomized controlled trial design without blinding. Participants were randomized into either the intervention group (n = 32) and…

Acupuncture for sequelae of Bell's palsy: a randomized controlled trial protocol

PubMed Central

2011-01-01

Objective Incomplete recovery from facial palsy has a long-term impact on the quality of life, and medical options for the sequelae of Bell's palsy are limited. Invasive treatments and physiotherapy have been employed to relieve symptoms, but there is limited clinical evidence for their effectiveness. Acupuncture is widely used on Bell's palsy patients in East Asia, but there is insufficient evidence for its effectiveness on Bell's palsy sequelae. The objective is to evaluate the efficacy and safety of acupuncture in patients with sequelae of Bell's palsy. Method/Design This study consists of a randomized controlled trial with two parallel arms: an acupuncture group and a waitlist group. The acupuncture group will receive acupuncture treatment three times per week for a total of 24 sessions over 8 weeks. Participants in the waitlist group will not receive any acupuncture treatments during this 8 week period, but they will participate in the evaluations of symptoms at the start of the study, at 5 weeks and at 8 weeks after randomization, at which point the same treatment as the acupuncture group will be provided. The primary outcome will be analyzed by the change in the Facial Disability Index (FDI) from baseline to week eight. The secondary outcome measures will include FDI from baseline to week five, House-Brackmann Grade, lip mobility, and stiffness scales. Trial registration Current Controlled-Trials ISRCTN43104115; registration date: 06 July 2010; the date of the first patient's randomization: 04 August 2010 PMID:21388554

Acupuncture for the sequelae of Bell's palsy: a randomized controlled trial.

PubMed

Kwon, Hyo-Jung; Choi, Jun-Yong; Lee, Myeong Soo; Kim, Yong-Suk; Shin, Byung-Cheul; Kim, Jong-In

2015-06-03

Incomplete recovery from facial palsy results in social and physical disabilities, and the medical options for the sequelae of Bell's palsy are limited. Acupuncture is widely used for Bell's palsy patients in East Asia, but its efficacy is unclear. We performed a randomized controlled trial including participants with the sequelae of Bell's palsy with the following two parallel arms: an acupuncture group (n = 26) and a waiting list group (n = 13). The acupuncture group received acupuncture treatments for 8 weeks, whereas the waiting list group did not receive acupuncture treatments during the 8-week period after randomization. The primary outcome measure was change in the Facial Disability Index (FDI) social and well-being subscale at week 8. We also analyzed changes in the FDI physical function subscale, the House-Brackmann score, the Sunnybrook Facial Nerve Grading system, lip mobility and stiffness at 5 and 8 weeks after randomization. An intention-to-treat analysis was applied. The acupuncture group exhibited greater improvements in the FDI social score (mean difference, 23.54; 95% confidence interval, 12.99 to 34.08) and better results on the FDI physical function subscale (mean difference, 21.54; 95% confidence interval, 7.62 to 35.46), Sunnybrook Facial Nerve Grading score (mean difference, 14.77; 95% confidence interval, 5.05 to 24.49), and stiffness scale (mean difference, -1.58; 95% confidence interval,-2.26 to -0.89) compared with the waiting list group after 8 weeks. No severe adverse event occurred in either group. Compared with the waiting list group, acupuncture had better therapeutic effects on the social and physical aspects of sequelae of Bell's palsy. Current Controlled Trials ISRCTN43104115.

Empowerment Program for People With Prediabetes: A Randomized Controlled Trial.

PubMed

Chen, Mei-Fang; Hung, Shu-Ling; Chen, Shu-Lin

2017-04-01

Practicing a health-promoting lifestyle is believed to be effective for delaying or preventing the onset of diabetes. However, although empowerment interventions have proven effective for encouraging the adoption of a health-promoting lifestyle in people with diabetes, these interventions are rarely promoted to people with prediabetes. The aims of this study were to develop an empowerment program for people with prediabetes and to examine its efficacy in terms of the adoption of a health-promoting lifestyle and improvements in blood sugar, body mass index, and self-efficacy. A randomized controlled trial was conducted between May and December 2013. A convenience sample of people with a fasting blood sugar level of 100-125 mg/dl during the previous 3 months was recruited from the health examination center of a hospital in Kaohsiung, Taiwan. Participants were assigned to either the experimental group or the control group using block randomization with a block size of 8. The experimental group (n = 38) participated in a 4-month empowerment program (the ABC empowerment program), which encouraged participants to practice a health-promoting lifestyle in three phases: awareness raising, behavior building, and results checking. The control group (n = 40) received routine clinical care. Statistical analyses included descriptive statistics, independent t test, paired t test, and generalized estimated equations. After controlling for the differences at baseline and considering the interaction between group and time from baseline to 1 week and 3 months after completing the intervention, the generalized estimating equation showed significantly larger improvements in a health-promoting lifestyle, blood sugar, and self-efficacy in the experimental group than in the control group (p < .01). Furthermore, the experimental group achieved a larger reduction in body mass index than the control group at 3 months after completing the intervention (p = .001). The empowerment program was

A Pilot Randomized Controlled Trial of the ACCESS Program: A Group Intervention to Improve Social, Adaptive Functioning, Stress Coping, and Self-Determination Outcomes in Young Adults with Autism Spectrum Disorder

ERIC Educational Resources Information Center

Oswald, Tasha M.; Winder-Patel, Breanna; Ruder, Steven; Xing, Guibo; Stahmer, Aubyn; Solomon, Marjorie

2018-01-01

The purpose of this pilot randomized controlled trial was to investigate the acceptability and efficacy of the Acquiring Career, Coping, Executive control, Social Skills (ACCESS) Program, a group intervention tailored for young adults with autism spectrum disorder (ASD) to enhance critical skills and beliefs that promote adult functioning,…

Educational interventions to improve screening mammography interpretation: a randomized, controlled trial

PubMed Central

BM, Geller; A, Bogart; PA, Carney; EA, Sickles; RA, Smith; B, Monsees; LW, Bassett; DM, Buist; K, Kerlikowske; T, Onega; B, Yankaskas; S, Haneuse; DA, Hill; M, Wallis; DL, Miglioretti

2014-01-01

Purpose Conduct a randomized controlled trial of educational interventions to improve performance of screening mammography interpretation. Materials and Methods We randomly assigned physicians who interpret mammography to one of three groups: (1) self-paced DVD; (2) live, expert-led educational session; or (3) control. The DVD and live interventions used mammography cases of varying difficulty and associated teaching points. Interpretive performance was compared using a pre-/post-test design. Sensitivity, specificity, and positive predictive value (PPV) were calculated relative to two outcomes: cancer status and consensus of three experts about recall, and each were compared using logistic regression adjusting for pre-test performance. Results 102 radiologists completed all aspects of the trial. After adjustment for pre-intervention performance, the odds of improved sensitivity for correctly identifying a lesion relative to expert recall were 1.34 times higher for DVD participants than controls (95% confidence interval [CI]: 1.00, 1.81; P=0.050). The odds of improved PPV for correctly identifying a lesion relative to both expert recall (odds ratio [OR]=1.94, 95% CI: 1.24, 3.05; P=0.004) and cancer status (OR=1.81, 95% CI: 1.01, 3.23; P=0.045) were significantly improved for DVD participants compared to controls with no significant change in specificity. For the live-intervention group, specificity was significantly lower than the control group (OR relative to expert recall=0.80; 95% CI: 0.64, 1.00; P=0.048; OR relative to cancer=0.79; 95% CI: 0.65, 0.95; P=0.015). Conclusion In this randomized controlled trial, the DVD educational intervention resulted in a significant improvement in mammography interpretive screening performance on a test-set, which could translate into improved clinical interpretative performance. PMID:24848854

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.

Evaluation of a cognitive behavioural self-help manual for reducing depression: a randomized controlled trial.

PubMed

Songprakun, W; McCann, T V

2012-09-01

The prevalence of depression is increasing in Thailand. We used a randomized controlled trial to examine the effectiveness of a self-help programme in reducing depression in people with depression in Chiang Mai Province in Thailand. Fifty-six individuals diagnosed with moderate depression participated. They were assigned randomly to an intervention (n= 27) or control (n= 29) group. The intervention group were given a self-help manual along with standard care and treatment, while the control group continued to receive standard care and treatment. Both groups were also given a short weekly telephone call. The findings showed statistically significant differences between the groups, and within the intervention group, in their depression levels. Between baseline and post-test, a sharp decrease in depression was evident in the intervention group, whereas the level of depression increased in the control group. Between post-test and follow-up, a decrease was apparent in depression in both groups. However, the intervention group showed a much lower level of depression than the control group. The results support the use of bibliotherapy as an adjunct to mental health nurses' and other professionals' work in caring for people with moderate depression in the community. http://www.ANZCTR.org.au/ACTRN12611000905965.aspx. © 2012 Blackwell Publishing.

Randomized controlled trial of a patient decision-making aid for orthodontics.

PubMed

Parker, Kate; Cunningham, Susan J; Petrie, Aviva; Ryan, Fiona S

2017-08-01

Patient decision-making aids (PDAs) are instruments that facilitate shared decision making and enable patients to reach informed, individual decisions regarding health care. The objective of this study was to assess the efficacy of a PDA compared with traditional information provision for adolescent patients considering fixed appliance orthodontic treatment. Before treatment, orthodontic patients were randomly allocated into 2 groups: the intervention group received the PDA and standard information regarding fixed appliances, and the control group received the standard information only. Decisional conflict was measured using the Decisional Conflict Scale, and the levels of decisional conflict were compared between the 2 groups. Seventy-two patients were recruited and randomized in a ratio of 1:1 to the PDA and control groups. Seventy-one patients completed the trial (control group, 36; PDA group, 35); this satisfied the sample size calculation. The median total Decisional Conflict Scale score in the PDA group was lower than in the control group (15.63 and 19.53, respectively). However, this difference was not statistically significant (difference between groups, 3.90; 95% confidence interval of the difference, -4.30 to 12.11). Sex, ethnicity, age, and the time point at which patients were recruited did not have significant effects on Decisional Conflict Scale scores. No harm was observed or reported for any participant in the study. The results of this study showed that the provision of a PDA to adolescents before they consented for fixed appliances did not significantly reduce decisional conflict. There may be a benefit in providing a PDA for some patients, but it is not yet possible to say how these patients could be identified. This trial was registered with the Harrow National Research Ethics Committee (reference 12/LO/0279). The protocol was not published before trial commencement. Copyright © 2017. Published by Elsevier Inc.

A randomized controlled trial to promote volunteering in older adults.

PubMed

Warner, Lisa M; Wolff, Julia K; Ziegelmann, Jochen P; Wurm, Susanne

2014-12-01

Volunteering is presumed to confer health benefits, but interventions to encourage older adults to volunteer are sparse. Therefore, a randomized controlled trial with 280 community-dwelling older German adults was conducted to test the effects of a theory-based social-cognitive intervention against a passive waiting-list control group and an active control intervention designed to motivate physical activity. Self-reports of weekly volunteering minutes were assessed at baseline (5 weeks before the intervention) as well as 2 and 6 weeks after the intervention. Participants in the treatment group increased their weekly volunteering minutes to a greater extent than participants in the control groups 6 weeks after the intervention. We conclude that a single, face-to-face group session can increase volunteering among older community-dwelling adults. However, the effects need some time to unfold because changes in volunteering were not apparent 2 weeks after the intervention. (PsycINFO Database Record (c) 2014 APA, all rights reserved).

Weight Control Intervention for Truck Drivers: The SHIFT Randomized Controlled Trial, United States

PubMed Central

Wipfli, Brad; Thompson, Sharon V.; Elliot, Diane L.; Anger, W. Kent; Bodner, Todd; Hammer, Leslie B.; Perrin, Nancy A.

2016-01-01

Objectives. To evaluate the effectiveness of the Safety and Health Involvement For Truckers (SHIFT) intervention with a randomized controlled design. Methods. The multicomponent intervention was a weight-loss competition supported with body weight and behavioral self-monitoring, computer-based training, and motivational interviewing. We evaluated intervention effectiveness with a cluster-randomized design involving 22 terminals from 5 companies in the United States in 2012 to 2014. Companies were required to provide interstate transportation services and operate at least 2 larger terminals. We randomly assigned terminals to intervention or usual practice control conditions. We assessed participating drivers (n = 452) at baseline and 6 months. Results. In an intent-to-treat analysis, the postintervention difference between groups in mean body mass index change was 1.00 kilograms per meters squared (P < .001; intervention = −0.73; control = +0.27). Behavioral changes included statistically significant improvements in fruit and vegetable consumption and physical activity. Conclusions. Results establish the effectiveness of a multicomponent and remotely administered intervention for producing significant weight loss among commercial truck drivers. PMID:27463067

Weight Control Intervention for Truck Drivers: The SHIFT Randomized Controlled Trial, United States.

PubMed

Olson, Ryan; Wipfli, Brad; Thompson, Sharon V; Elliot, Diane L; Anger, W Kent; Bodner, Todd; Hammer, Leslie B; Perrin, Nancy A

2016-09-01

To evaluate the effectiveness of the Safety and Health Involvement For Truckers (SHIFT) intervention with a randomized controlled design. The multicomponent intervention was a weight-loss competition supported with body weight and behavioral self-monitoring, computer-based training, and motivational interviewing. We evaluated intervention effectiveness with a cluster-randomized design involving 22 terminals from 5 companies in the United States in 2012 to 2014. Companies were required to provide interstate transportation services and operate at least 2 larger terminals. We randomly assigned terminals to intervention or usual practice control conditions. We assessed participating drivers (n = 452) at baseline and 6 months. In an intent-to-treat analysis, the postintervention difference between groups in mean body mass index change was 1.00 kilograms per meters squared (P < .001; intervention = -0.73; control = +0.27). Behavioral changes included statistically significant improvements in fruit and vegetable consumption and physical activity. Results establish the effectiveness of a multicomponent and remotely administered intervention for producing significant weight loss among commercial truck drivers.

Social marketing and student documentation of asthma care: a quasi-randomized controlled trial.

PubMed

Gimbel, Ronald W; Olsen, Cara H; Williams, Pamela M; Stephens, Mark B

2012-02-01

The study's objective was to determine the effectiveness of a social marketing intervention in influencing use of a targeted electronic medical record (EMR) template to document a standard asthma encounter. This quasi-randomized controlled trial used intervention groups exposed to an educational workshop on EMR documentation with embedded social marketing messages aimed at persuading behavior. Conducted in July 2009 to June 2010, participants in the study included third-year medical students. The primary outcome was the number of participants using a target EMR template. (Clinicaltrials.gov identifier: NCT01043113). A total of 155 participants randomized across eight clusters. Following the workshop, intervention groups were more likely to use the target asthma template than the control group (PR 3.97, 95% CI=1.34--11.79). At slightly over 30 days following the workshop, the intervention group continued to use the asthma template more often than the control group (PR 2.40, 95% CI=1.10--5.21). Stratifying by gender, intervention group females used the asthma template more after the interventions than control group females (PR 10.79, 95% CI=1.18--64.27). In follow-up at slightly over 30 days after the intervention, intervention group female participant asthma template use continued to be used more than control group females (PR 2.82, 95% CI=1.58--5.02). There were no significant differences in group use of asthma template use by intervention group males immediately after the intervention compared to control group males (PR 2.55, 95% CI=0.80--8.14) or similarly at slightly over 30 day follow-up (PR 2.18, 95% CI=0.74-6.42). Social marketing can effectively influence medical student use of EMR templates for clinical documentation in a controlled setting.

Effects of prenatal yoga on women's stress and immune function across pregnancy: A randomized controlled trial.

PubMed

Chen, Pao-Ju; Yang, Luke; Chou, Cheng-Chen; Li, Chia-Chi; Chang, Yu-Cune; Liaw, Jen-Jiuan

2017-04-01

The effects of prenatal yoga on biological indicators have not been widely studied. Thus, we compared changes in stress and immunity salivary biomarkers from 16 to 36 weeks' gestation between women receiving prenatal yoga and those receiving routine prenatal care. For this longitudinal, prospective, randomized controlled trial, we recruited 94 healthy pregnant women at 16 weeks' gestation through convenience sampling from a prenatal clinic in Taipei. Participants were randomly assigned to intervention (n=48) or control (n=46) groups using Clinstat block randomization. The 20-week intervention comprised two weekly 70-min yoga sessions led by a midwife certified as a yoga instructor; the control group received only routine prenatal care. In both groups, participants' salivary cortisol and immunoglobulin A levels were collected before and after yoga every 4 weeks from 16 to 36 weeks' gestation. The intervention group had lower salivary cortisol (p<0.001) and higher immunoglobulin A (p<0.001) levels immediately after yoga than the control group. Specifically, the intervention group had significantly higher long-term salivary immunoglobulin A levels than the control group (p=0.018), and infants born to women in the intervention group weighed more than those born to the control group (p<0.001). Prenatal yoga significantly reduced pregnant women's stress and enhanced their immune function. Clinicians should learn the mechanisms of yoga and its effects on pregnant women. Our findings can guide clinicians to help pregnant women alleviate their stress and enhance their immune function. Copyright © 2017. Published by Elsevier Ltd.

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.

Autogenic training to reduce anxiety in nursing students: randomized controlled trial.

PubMed

Kanji, Nasim; White, Adrian; Ernst, Edzard

2006-03-01

This paper reports a study to determine the effectiveness of autogenic training in reducing anxiety in nursing students. Nursing is stressful, and nursing students also have the additional pressures and uncertainties shared with all academic students. Autogenic training is a relaxation technique consisting of six mental exercises and is aimed at relieving tension, anger and stress. Meta-analysis has found large effect sizes for autogenic trainings intervention comparisons, medium effect sizes against control groups, and no effects when compared with other psychological therapies. A controlled trial with 50 nursing students found that the number of certified days off sick was reduced by autogenic training compared with no treatment, and a second trial with only 18 students reported greater improvement in Trait Anxiety, but not State Anxiety, compared with untreated controls. A randomized controlled trial with three parallel arms was completed in 1998 with 93 nursing students aged 19-49 years. The setting was a university college in the United Kingdom. The treatment group received eight weekly sessions of autogenic training, the attention control group received eight weekly sessions of laughter therapy, and the time control group received no intervention. The outcome measures were the State-Trait Anxiety Inventory, the Maslach Burnout Inventory, blood pressure and pulse rate completed at baseline, 2 months (end of treatment), and 5, 8, and 11 months from randomization. There was a statistically significantly greater reduction of State (P<0.001) and Trait (P<0.001) Anxiety in the autogenic training group than in both other groups immediately after treatment. There were no differences between the groups for the Maslach Burnout Inventory. The autogenic training group also showed statistically significantly greater reduction immediately after treatment in systolic (P<0.01) and diastolic (P<0.05) blood pressure, and pulse rate (P<0.002), than the other two groups

A Web-Based, Social Networking Beginners’ Running Intervention for Adults Aged 18 to 50 Years Delivered via a Facebook Group: Randomized Controlled Trial

PubMed Central

Boshoff, Kobie; Maher, Carol

2018-01-01

Background Online social networks continue to grow in popularity, with 1.7 billion users worldwide accessing Facebook each month. The use of social networking sites such as Facebook for the delivery of health behavior programs is relatively new. Objective The primary aim of this study was to determine the effectiveness of a Web-based beginners’ running program for adults aged 18 to 50 years, delivered via a Facebook group, in increasing physical activity (PA) and cardiorespiratory fitness. Methods A total of 89 adults with a mean age of 35.2 years (SD 10.9) were recruited online and via print media. Participants were randomly allocated to receive the UniSA Run Free program, an 8-week Web-based beginners’ running intervention, delivered via a closed Facebook group (n=41) that included daily interactive posts (information with links, motivational quotes, opinion polls, or questions) and details of the running sessions; or to the control group who received a hard copy of the running program (n=48). Assessments were completed online at baseline, 2 months, and 5 months. The primary outcome measures were self-reported weekly moderate to vigorous physical activity (MVPA) and objectively measured cardiorespiratory fitness. Secondary outcomes were social support, exercise attitudes, and self-efficacy. Analyses were undertaken using random effects mixed modeling. Compliance with the running program and engagement with the Facebook group were analyzed descriptively. Results Both groups significantly increased MVPA across the study period (P=.004); however, this was significantly higher in the Facebook group (P=.04). The Facebook group increased their MVPA from baseline by 140 min/week versus 91 min for the control at 2 months. MVPA remained elevated for the Facebook group (from baseline) by 129 min/week versus a 50 min/week decrease for the control at 5 months. Both groups had significant increases in social support scores at 2 months (P=.02); however, there were no group

Improving early relationships: a randomized, controlled trial of an age-paced parenting newsletter.

PubMed

Waterston, Tony; Welsh, Brenda; Keane, Brigid; Cook, Margaret; Hammal, Donna; Parker, Louise; McConachie, Helen

2009-01-01

Parenting is recognized as a key mediator in both health and educational outcomes. Much is known on the value of support and group work in benefiting parenting, but little is known on the effect of written information. A randomized, controlled trial was conducted to evaluate the effect of a parenting newsletter, sent monthly to the parents' home from birth to 1 year, on maternal well-being and parenting style. We tested the hypothesis that mothers receiving the newsletter would show less stress and better parenting characteristics than controls. Parents of first infants born in a North East England District General Hospital between February and October 2003 who consented to take part in the study were randomly allocated to either the intervention or control arm. Those in the intervention arm were sent 12 monthly issues of an age-paced parenting newsletter containing information on emotional development, parent-child interaction, and play. Both the intervention and control group received normal parenting support. Mothers in both groups completed the Well-being Index, Parenting Daily Hassles Scale, and the Adult-Adolescent Parenting Inventory at birth and at 1 year. One hundred eighty-five mothers were recruited, with 94 randomly assigned to the intervention group, and 91 controls. Allowing for differences at recruitment, there were significant differences between the groups at 1 year: the intervention mothers had lower frequency and intensity of perceived hassles and fewer inappropriate expectations of the infant on the Adult-Adolescent Parenting Inventory than the control mothers. A monthly parenting newsletter sent directly to the home in the first year of life seems to help parents to understand their infant better and feel less hassled. This intervention is low cost and can be applied to all parents, so it is nonstigmatizing.

Preventing Urinary Incontinence With Supervised Prenatal Pelvic Floor Exercises: A Randomized Controlled Trial.

PubMed

Fritel, Xavier; de Tayrac, Renaud; Bader, Georges; Savary, Denis; Gueye, Ameth; Deffieux, Xavier; Fernandez, Hervé; Richet, Claude; Guilhot, Joëlle; Fauconnier, Arnaud

2015-08-01

To compare, in an unselected population of nulliparous pregnant women, the postnatal effect of prenatal supervised pelvic floor muscle training with written instructions on postpartum urinary incontinence (UI). In a randomized controlled trial in two parallel groups, 282 women were recruited from five university teaching hospitals in France and randomized during the second trimester of pregnancy. The physiotherapy group received prenatal individually supervised exercises. Both groups received written instructions about how to perform exercises at home. Women were blindly assessed at baseline, end of pregnancy, and 2 and 12 months postpartum. The primary outcome measured was UI severity, assessed with an International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form score (range 0-21; 1-5 is slight UI) at 12 months postpartum; other outcomes were UI prevalence and pelvic floor troubles assessed using self-administered questionnaires. To give a 1-point difference in UI severity score, we needed 91 women in each group (standard deviation 2.4, α=0.05, β=0.20, and bilateral analysis). Between February 2008 and June 2010, 140 women were randomized in the physiotherapy group and 142 in the control group. No difference was observed between the two groups in UI severity, prevalence, or pelvic floor troubles at baseline, end of pregnancy, and at 2 and 12 months postpartum. At 12 months postpartum, the primary outcome was available for 190 women (67.4%); mean UI severity was 1.9 in the physiotherapy group compared with 2.1 in the control group (P=.38). Prenatal supervised pelvic floor training was not superior to written instructions in reducing postnatal UI. ClinicalTrials.gov; www.clinicaltrials.gov, NCT00551551. I.

High-fluoride toothpaste: a multicenter randomized controlled trial in adults

PubMed Central

Srinivasan, Murali; Schimmel, Martin; Riesen, Martine; Ilgner, Alexander; Wicht, Michael J; Warncke, Michael; Ellwood, Roger P; Nitschke, Ina; Müller, Frauke; Noack, Michael J

2014-01-01

Objective The aim of this single – blind, multicenter, parallel, randomized controlled trial was to evaluate the effectiveness of the application of a high-fluoride toothpaste on root caries in adults. Methods Adult patients (n = 130, ♂ = 74, ♀ = 56; mean age ± SD: 56.9 ± 12.9) from three participating centers, diagnosed with root caries, were randomly allocated into two groups: Test (n = 64, ♂ = 37, ♀ = 27; lesions = 144; mean age: 59.0 ± 12.1; intervention: high-fluoride toothpaste with 5000 ppm F), and Control (n = 66, ♂ = 37, ♀ = 29; lesions = 160; mean age: 54.8 ± 13.5; intervention: regular-fluoride toothpaste with 1350 ppm F) groups. Clinical examinations and surface hardness scoring of the carious lesions were performed for each subject at specified time intervals (T0 – at baseline before intervention, T1 – at 3 months and T2 – at 6 months after intervention). Mean surface hardness scores (HS) were calculated for each patient. Statistical analyses comprised of two-way analysis of variance and post hoc comparisons using the Bonferroni–Dunn correction. Results At T0, there was no statistical difference between the two groups with regard to gender (P = 0.0682, unpaired t-test), or age (P = 0.9786, chi-squared test), and for the overall HS (Test group: HS = 3.4 ± 0.61; Control group: HS = 3.4 ± 0.66; P = 0.8757, unpaired t-test). The anova revealed significantly better HS for the test group than for the control groups (T1: Test group: HS = 2.9 ± 0.67; Control group: HS = 3.1 ± 0.75; T2: Test group: HS = 2.4 ± 0.81; Control group: HS = 2.8 ± 0.79; P < 0.0001). However, the interaction term time-point*group was not significant. Conclusions The application of a high-fluoride containing dentifrice (5000 ppm F) in adults, twice daily, significantly improves the surface hardness of otherwise untreated root caries lesions when compared with the use of regular fluoride

Effects of zinc supplementation on subscales of anorexia in children: A randomized controlled trial.

PubMed

Khademian, Majid; Farhangpajouh, Neda; Shahsanaee, Armindokht; Bahreynian, Maryam; Mirshamsi, Mehran; Kelishadi, Roya

2014-01-01

This study aims to assess the effects of zinc supplementation on improving the appetite and its subscales in children. This study was conducted in 2013 in Isfahan, Iran. It had two phases. At the first step, after validation of the Child Eating Behaviour Questionaire (CEBQ), it was completed for 300 preschool children, who were randomly selected. The second phase was conducted as a randomized controlled trial. Eighty of these children were randomly selected, and were randomly assigned to two groups of equal number receiving zinc (10 mg/day) or placebo for 12 weeks. Overall 77 children completed the trial (39 in the case and 3 in the control group).The results showed that zinc supplement can improve calorie intake in children by affecting some CEBQ subscales like Emotional over Eating and Food Responsible. Zinc supplementation had positive impact in promoting the calorie intake and some subscales of anorexia.

Sustained effects of a psychoeducational group intervention following bariatric surgery: follow-up of the randomized controlled BaSE study.

PubMed

Wild, Beate; Hünnemeyer, Katharina; Sauer, Helene; Schellberg, Dieter; Müller-Stich, Beat Peter; Königsrainer, Alfred; Weiner, Rudolf; Zipfel, Stephan; Herzog, Wolfgang; Teufel, Martin

2017-09-01

Evidence regarding the efficacy of psychosocial interventions after bariatric surgery is rare and shows conflicting results. The Bariatric Surgery and Education (BaSE) study aimed to assess the efficacy of a psychoeducational group intervention in patients after bariatric surgery. The BaSE study was a randomized, controlled, multicenter clinical trial involving 117 patients who underwent bariatric surgery. Patients received either conventional postsurgical visits or, in addition, a 1-year psychoeducational group program. The present study evaluated the sustained effects of the intervention program. Mean follow-up duration was 37.9 months (standard deviation [SD] 8.2 months) after surgery. Outcome measures were as follows: body mass index (BMI), weight loss, self-efficacy, depression severity, and health-related quality of life (HRQOL). Groups were compared using an intention-to-treat approach with a mixed model for repeated measurements. A total of 74 patients (63.2%) completed the follow-up (T5) assessment. Mean weight loss for all patients was 43 kg (SD 15.5 kg) at T5 (mean BMI 35.1 kg/m 2 ). Mean excess weight loss was 60.4%. The effects of the surgery during the first postsurgical year were reflected, on average, by both decreasing weight and psychosocial burden. At the T5 time point, patients had slowly started to regain weight and to deteriorate regarding psychosocial aspects. However, at T5, patients who had participated in the intervention program (n = 39) showed significantly lower depression severity scores (p = .03) and significantly higher self-efficacy (p = .03) compared to the control group (n = 35). The 2 groups did not differ regarding weight loss and quality of life. Psychoeducational intervention shows sustained effects on both depression severity scores and self-efficacy. Copyright © 2017 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

Yoga for generalized anxiety disorder: design of a randomized controlled clinical trial.

PubMed

Hofmann, Stefan G; Curtiss, Joshua; Khalsa, Sat Bir S; Hoge, Elizabeth; Rosenfield, David; Bui, Eric; Keshaviah, Aparna; Simon, Naomi

2015-09-01

Generalized anxiety disorder (GAD) is a common disorder associated with significant distress and interference. Although cognitive behavioral therapy (CBT) has been shown to be the most effective form of psychotherapy, few patients receive or have access to this intervention. Yoga therapy offers another promising, yet under-researched, intervention that is gaining increasing popularity in the general public, as an anxiety reduction intervention. The purpose of this innovative clinical trial protocol is to investigate the efficacy of a Kundalini Yoga intervention, relative to CBT and a control condition. Kundalini yoga and CBT are compared with each other in a noninferiority test and both treatments are compared to stress education training, an attention control intervention, in superiority tests. The sample will consist of 230 individuals with a primary DSM-5 diagnosis of GAD. This randomized controlled trial will compare yoga (N=95) to both CBT for GAD (N=95) and stress education (N=40), a commonly used control condition. All three treatments will be administered by two instructors in a group format over 12 weekly sessions with four to six patients per group. Groups will be randomized using permuted block randomization, which will be stratified by site. Treatment outcome will be evaluated bi-weekly and at 6month follow-up. Furthermore, potential mediators of treatment outcome will be investigated. Given the individual and economic burden associated with GAD, identifying accessible alternative behavioral treatments will have substantive public health implications. Copyright © 2015 Elsevier Inc. All rights reserved.

Yoga for Generalized Anxiety Disorder: Design of a Randomized Controlled Clinical Trial

PubMed Central

Hofmann, Stefan G.; Curtiss, Joshua; Khalsa, Sat Bir S.; Hoge, Elizabeth; Rosenfield, David; Bui, Eric; Keshaviah, Aparna; Simon, Naomi

2015-01-01

Generalized anxiety disorder (GAD) is a common disorder associated with significant distress and interference. Although cognitive behavioral therapy (CBT) has been shown to the most effective form of psychotherapy, few patients receive or have access to this intervention. Yoga therapy offers another promising, yet under-researched, intervention that is gaining increasing popularity in the general public, as an anxiety reduction intervention. The purpose of this innovative clinical trial protocol is to investigate the efficacy of a Kundalini Yoga intervention, relative to CBT and a control condition. Kundalini yoga and CBT are compared with each other in a noninferiority test and both treatments are compared to stress education training, an attention control intervention, in superiority tests. The sample will consist of 230 individuals with a primary DSM-5 diagnosis of GAD. This randomized controlled trial will compare yoga (N = 95) to both CBT for GAD (N=95) and stress education (N = 40), a commonly used control condition. All three treatments will be administered by two instructors in a group format over 12 weekly sessions with four to six patients per group. Groups will be randomized using permuted block randomization, which will be stratified by site. Treatment outcome will be evaluated bi-weekly and at 6 month follow-up. Furthermore, potential mediators of treatment outcome will be investigated. Given the individual and economic burden associated with GAD, identifying accessible alternative behavioral treatments will have substantive public health implications. PMID:26255236

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.

Controlling surface-segregation of a polymer to display carboxy groups on an outermost surface using perfluoroacyl groups.

PubMed

Nishimori, Keisuke; Kitahata, Shigeru; Nishino, Takashi; Maruyama, Tatsuo

2018-05-10

Controlling the surface properties of solid polymers is important for practical applications. We here succeeded in controlling the surface segregation of polymers to display carboxy groups on an outermost surface, which allowed the covalent immobilization of functional molecules via the carboxy groups on a substrate surface. Random methacrylate-based copolymers containing carboxy groups, in which carboxy groups were protected with perfluoroacyl (Rf) groups, were dip-coated on acrylic substrate surfaces. X-ray photoelectron spectroscopy and contact-angle measurements revealed that the Rf groups were segregated to the outermost surface of the dip-coated substrates. The Rf groups were removed by hydrolysis of the Rf esters in the copolymers, resulting in the display of carboxy groups on the surface. The quantification of carboxy groups on a surface revealed that the carboxy groups were reactive to a water-soluble solute in aqueous solution. The surface segregation was affected by the molecular structure of the copolymer used for dip-coating.

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.

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

A Randomized Controlled Study of the Virginia Student Threat Assessment Guidelines in Kindergarten through Grade 12

ERIC Educational Resources Information Center

Cornell, Dewey G.; Allen, Korrie; Fan, Xitao

2012-01-01

This randomized controlled study examined disciplinary outcomes for 201 students who made threats of violence at school. The students attended 40 schools randomly assigned to use the Virginia Student Threat Assessment Guidelines or follow a business-as-usual disciplinary approach in a control group. Logistic regression analyses found, after…

United States Military Cancer Institute Clinical Trials Group (USMCI GI-01) randomized controlled trial comparing targeted nodal assessment and ultrastaging with standard pathological evaluation for colon cancer.

PubMed

Nissan, Aviram; Protic, Mladjan; Bilchik, Anton J; Howard, Robin S; Peoples, George E; Stojadinovic, Alexander

2012-09-01

Our randomized controlled trial previously demonstrated improved staging accuracy with targeted nodal assessment and ultrastaging (TNA-us) in colon cancer (CC). Our objective was to test the hypothesis that TNA-us improves disease-free survival (DFS) in CC. In this randomized trial, targeted nodal assessment and ultrastaging resulted in enhanced lymph node diagnostic yield associated with improved staging accuracy, which was further associated with improved disease-free survival in early colon cancer. Clinical parameters of the control (n = 94) and TNA-us (n = 98) groups were comparable. Median (interquartile range) lymph node yield was higher in the TNA-us arm: 16 (12-22) versus 13 (10-18); P = 0.002. Median follow-up was 46 (29-70) months. Overall 5-year DFS was 61% in the control arm and 71% in the TNA-us arm (P = 0.11). Clinical parameters of node-negative patients in the control (n = 51) and TNA-us (n = 55) groups were comparable. Lymph node yield was higher in the TNA-us arm: 15 (12-21) versus 13 (8-18); P = 0.03. Five-year DFS differed significantly between groups with node-negative CC (control 71% vs TNA-us 86%; P = 0.04). Survival among stage II CC alone was higher in the TNA-us group, 83% versus 65%; P = 0.03. Adjuvant chemotherapy use was nearly identical between groups. TNA-us stratified CC prognosis; DFS differed significantly between ultrastaged and conventionally staged node-negative patients [control pN0 72% vs TNA-us pN0(i-) 87%; P = 0.03]. Survival varied according to lymph node yield in patients with node-negative CC [5-year DFS: <12 lymph nodes = 57% vs 12+ lymph nodes = 85%; P = 0.011] but not in stage III CC. TNA-us is associated with improved nodal diagnostic yield and enhanced staging accuracy (stage migration), which is further associated with improved DFS in early CC. This study is registered at clinicaltrials.gov under the registration number: NCT01623258.

Involving fathers in teaching youth about farm tractor seatbelt safety--a randomized control study.

PubMed

Jinnah, Hamida Amirali; Stoneman, Zolinda; Rains, Glen

2014-03-01

Farm youth continue to experience high rates of injury and deaths as a result of agricultural activities. Farm machinery, especially tractors, is the most common cause of casualties to youth. A Roll-Over Protection Structure (ROPS) along with a fastened seatbelt can prevent almost all injuries and fatalities from tractor overturns. Despite this knowledge, the use of seatbelts by farmers on ROPS tractors remains low. This study treats farm safety as a family issue and builds on the central role of parents as teachers and role models of farm safety for youth. This research study used a longitudinal, repeated-measures, randomized-control design in which youth 10-19 years of age were randomly assigned to either of two intervention groups (parent-led group and staff-led group) or the control group. Fathers in the parent-led group were less likely to operate ROPS tractors without a seatbelt compared with other groups. They were more likely to have communicated with youth about the importance of wearing seatbelts on ROPS tractors. Consequently, youth in the parent-led group were less likely to operate a ROPS tractor without a seatbelt than the control group at post-test. This randomized control trial supports the effectiveness of a home-based, father-led farm safety intervention as a promising strategy for reducing youth as well as father-unsafe behaviors (related to tractor seatbelts) on the farm. This intervention appealed to fathers' strong motivation to practice tractor safety for the sake of their youth. Involving fathers helped change both father as well as youth unsafe tractor-seatbelt behaviors. Copyright © 2014 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

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.

Kinesio Taping for pain control during labor: Protocol of a randomized, controlled trial.

PubMed

Miquelutti, Maria Amelia; Cecatti, José Guilherme

2017-03-01

This study protocol will evaluate the effectiveness and safety during labor and delivery of the Kinesio Taping bandage for pain sensation, satisfaction of patients, and obstetric and neonatal outcomes. A randomized controlled trial with 60 participants divided into two groups will be conducted. The intervention group will receive bandage application on the vertebral regions corresponding to uterine dermatomes - from T10 to L1 and from S2 to S4. The control group will receive bandage application away from uterine dermatomes, from T1 to T4. The primary endpoint is pain during labor. Secondary endpoints are perinatal outcomes and patient satisfaction with the bandage and with her labor. Pain levels will be evaluated on an hourly basis during labor, and intention-to-treat analysis will be performed. Risk ratios and 95% confidence intervals will be calculated. Findings on effectiveness of pain control with no adverse effects to both the mother and neonate are the first step in evaluating the systematic use of Kinesio Taping during labor. Since self-control may affect birthing experience satisfaction, discovering new alternatives for pain control may allow for a better experience. © 2017 John Wiley & Sons Australia, Ltd.

Effect of management training in organizational justice: a randomized controlled trial

PubMed Central

NAKAMURA, Saki; SOMEMURA, Hironori; SASAKI, Norio; YAMAMOTO, Megumi; TANAKA, Mika; TANAKA, Katsutoshi

2016-01-01

Organizational justice (OJ) influences the well-being of employees of organizations. We conducted a randomized controlled trial to examine whether or not brief management training increases OJ for subordinates. Study participants were managers and subordinates working in the private manufacturing sector. Randomization at the departmental level generated an intervention group of 23 departments (93 managers and 248 subordinates) and a control group of 23 departments (91 managers and 314 subordinates). Managers in the intervention group received a 90-min training session to investigate the attitudes and behavior of managers and help increase OJ. Subordinates completed self-administered OJ questionnaire surveys on procedural, interpersonal, and informational justice before and 3 months after intervention. For all subordinates, the interaction between group and time in OJ scores obtained before and 3 months after intervention were not significant. However, in subgroup analyses of the lowest tertile group in relation to the baseline of each of the three OJ subscales and total scores, the lowest tertile group of the interpersonal justice subscale showed significant improvement. The results of this study suggest that brief management training in OJ for managers significantly improves a low rating from subordinates in interpersonal justice. Further studies are required to develop a specific intervention method to increase OJ. PMID:26860786

Effect of management training in organizational justice: a randomized controlled trial.

PubMed

Nakamura, Saki; Somemura, Hironori; Sasaki, Norio; Yamamoto, Megumi; Tanaka, Mika; Tanaka, Katsutoshi

2016-06-10

Organizational justice (OJ) influences the well-being of employees of organizations. We conducted a randomized controlled trial to examine whether or not brief management training increases OJ for subordinates. Study participants were managers and subordinates working in the private manufacturing sector. Randomization at the departmental level generated an intervention group of 23 departments (93 managers and 248 subordinates) and a control group of 23 departments (91 managers and 314 subordinates). Managers in the intervention group received a 90-min training session to investigate the attitudes and behavior of managers and help increase OJ. Subordinates completed self-administered OJ questionnaire surveys on procedural, interpersonal, and informational justice before and 3 months after intervention. For all subordinates, the interaction between group and time in OJ scores obtained before and 3 months after intervention were not significant. However, in subgroup analyses of the lowest tertile group in relation to the baseline of each of the three OJ subscales and total scores, the lowest tertile group of the interpersonal justice subscale showed significant improvement. The results of this study suggest that brief management training in OJ for managers significantly improves a low rating from subordinates in interpersonal justice. Further studies are required to develop a specific intervention method to increase OJ.

Randomized Controlled Pilot Trial of Mindfulness Training for Stress Reduction during Pregnancy

PubMed Central

Guardino, Christine M.; Dunkel Schetter, Christine; Bower, Julienne E.; Lu, Michael C.; Smalley, Susan L.

2014-01-01

This randomized controlled pilot trial tested a 6-week mindfulness-based intervention in a sample of pregnant women experiencing high levels of perceived stress and pregnancy anxiety. Forty-seven women enrolled between 10 and 25 weeks gestation were randomly assigned to either a series of weekly Mindful Awareness Practices (MAPS) classes (n = 24) with home practice or to a reading control condition (n = 23). Hierarchical linear models of between-group differences in change over time demonstrated that participants in the mindfulness intervention experienced larger decreases from pre-to post-intervention in pregnancy-specific anxiety and pregnancy-related anxiety than participants in the reading control condition. However, these effects were not sustained through follow-up at six weeks post-intervention. Participants in both groups experienced increased mindfulness, as well as decreased perceived stress and state anxiety over the course of the intervention and follow-up periods. This study is one of the first randomized controlled pilot trials of a mindfulness meditation intervention during pregnancy and provides some evidence that mindfulness training during pregnancy may effectively reduce pregnancy-related anxiety and worry. We discuss some of the dilemmas in pursuing this translational strategy and offer suggestions for researchers interested in conducting mind-body interventions during pregnancy. PMID:24180264

Wheel of Wellness Counseling in Community Dwelling, Korean Elders: A Randomized, Controlled Trial.

PubMed

Kwon, So Hi

2015-06-01

The purpose of this study was to investigate the effects of Wheel of Wellness counseling on wellness lifestyle, depression, and health-related quality of life in community dwelling elderly people. A parallel, randomized controlled, open label, trial was conducted. Ninety-three elderly people in a senior welfare center were randomly assigned to two groups: 1) A Wheel of Wellness counseling intervention group (n=49) and 2) a no-treatment control group (n=44). Wheel of Wellness counseling consisted of structured, individual counseling based on the Wheel of Wellness model and provided once a week for four weeks. Wellness lifestyle, depression, and health-related quality of life were assessed pre-and post-test in both groups. Data from 89 participants were analyzed. For participants in the experimental group, there was a significant improvement on all of the wellness-lifestyle subtasks except realistic beliefs. Perceived wellness and depression significantly improved after the in the experimental group (n=43) compared to the control group (n=46) from pre- to post-test in the areas of sense of control (p=.033), nutrition (p=.017), exercise (p=.039), self-care (p<.001), stress management (p=.017), work (p=.011), perceived wellness (p=.019), and depression (p=.031). One participant in the intervention group discontinued the intervention due to hospitalization and three in the control group discontinued the sessions. Wheel of Wellness counseling was beneficial in enhancing wellness for the community-dwelling elderly people. Research into long-term effects of the intervention and health outcomes is recommended.

Enhancing physical function in HIV-infected older adults: A randomized controlled clinical trial.

PubMed

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

2016-06-01

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. In total, 67 community-dwelling HOA with mild-to-moderate functional limitations were randomized to 1 of 2 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. 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 < .05). Measures of autonomous regulation such as identified regulation, and measures of depression and QOL improved significantly in the treatment group compared with the control group (p < .05). Across the groups, improvement in intrinsic regulation and QOL correlated with an improvement in physical function (p < .05). 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. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Effects of electro-acupuncture on personality traits in depression: a randomized controlled study.

PubMed

Wang, Wei-dong; Lu, Xue-yu; Ng, Siu-man; Hong, Lan; Zhao, Yang; Lin, Ying-na; Wang, Fang

2013-10-01

To explore the personality-adjusting effect of electro-acupuncture treatment for depression and compared this treatment with paroxetine treatment. A non-blinded, randomized controlled trial was adopted. Sixty depressed patients, who met trial criteria, were randomly assigned to the treatment and the control groups. In the treatment group, electro-acupuncture treatment was used, and paroxetine treatment was used in the control group. During the 24-week study period, 12 patients dropped out and 48 patients completed the study. The Minnesota Multiple Personality Inventory (MMPI) was adopted as the evaluation tool. At the same time, the Self-rating Depression Scale (SDS), Self-rating Anxiety Scale (SAS) and Montgomery-Asberg Depression Rating Scale (MADRS) were used to evaluate the psychological state. Evaluations were done before and after treatment. After treatment, patients' psychological state improved significantly in both groups (P<0.01). For the treatment group, within-group comparison between baseline and after 24 weeks of treatment showed that severity of depression had significantly decreased (P<0.01). MADRS and SDS scores decreased significantly (P<0.05) and MMPI subscale scores for hypochondriasis, depression, psychopathic deviate, psychasthenia, social introversion and fake decreased significantly (P<0.05). For the control group, severity of depression also decreased significantly. MADRS and SDS scores decreased significantly (P<0.05); and MMPI subscale scores for hypochondriasis, depression, hysteria, paranoia, and psychasthenia decreased significantly (P<0.05). Between-group comparison demonstrated that for the MMPI subscales paranoia and social introversion, the decrease of score was greater in the treatment group than in the control group (P<0.05). However, there were no other significant differences between the control group and the treatment group. Electro-acupuncture is effective for treating depression and affects personality traits.

Sleep Promotion Program for Improving Sleep Behaviors in Adolescents: A Randomized Controlled Pilot Study

PubMed Central

John, Bindu; Bellipady, Sumanth Shetty; Bhat, Shrinivasa Undaru

2016-01-01

Aims. The purpose of this pilot trial was to determine the efficacy of sleep promotion program to adapt it for the use of adolescents studying in various schools of Mangalore, India, and evaluate the feasibility issues before conducting a randomized controlled trial in a larger sample of adolescents. Methods. A randomized controlled trial design with stratified random sampling method was used. Fifty-eight adolescents were selected (mean age: 14.02 ± 2.15 years; intervention group, n = 34; control group, n = 24). Self-report questionnaires, including sociodemographic questionnaire with some additional questions on sleep and activities, Sleep Hygiene Index, Pittsburgh Sleep Quality Index, The Cleveland Adolescent Sleepiness Questionnaire, and PedsQL™ Present Functioning Visual Analogue Scale, were used. Results. Insufficient weekday-weekend sleep duration with increasing age of adolescents was observed. The program revealed a significant effect in the experimental group over the control group in overall sleep quality, sleep onset latency, sleep duration, daytime sleepiness, and emotional and overall distress. No significant effect was observed in sleep hygiene and other sleep parameters. All target variables showed significant correlations with each other. Conclusion. The intervention holds a promise for improving the sleep behaviors in healthy adolescents. However, the effect of the sleep promotion program treatment has yet to be proven through a future research. This trial is registered with ISRCTN13083118. PMID:27088040

Parent involvement in pain management for NICU infants: a randomized controlled trial.

PubMed

Franck, Linda S; Oulton, Kate; Nderitu, Sue; Lim, Magdalene; Fang, Swee; Kaiser, Anthony

2011-09-01

To demonstrate feasibility and estimate the effect of an intervention to increase parental involvement in infant pain management in the NICU on parents' stress and postdischarge parenting competence and confidence. The study involved a randomized controlled trial. Parents recruited from 4 NICUs were randomly assigned by site to receive (1) a pain information booklet and instruction on infant comforting techniques (n = 84 intervention) in addition to a generic NICU care booklet or (2) the generic NICU care booklet alone (n = 85 control). The primary outcome was postintervention Parent Stressor Scale: NICU (PSS:NICU) scores. Secondary outcomes included parent attitudes about infant pain, nursing pain assessment, and parenting competence and role attainment after discharge. No differences were found between groups in PSS:NICU scores. Significant differences favoring the intervention group were found for satisfaction with pain information, parents shown infant pain cues and comforting techniques, nursing pain assessment, and parent preference for involvement during painful procedures. Role attainment after discharge was higher for the intervention group than for the control group. Both the intervention and control groups highly valued attention to infant pain and wanted information and involvement. These results provide no evidence of a reduction in NICU-related stress for parents who receive an intervention to increase their understanding and involvement in infant pain management. However, parents in the intervention group were better prepared to take an active role in infant pain care and had more positive views about their role attainment in the postdischarge period.

Cognitive rehabilitation in patients with gliomas: a randomized, controlled trial.

PubMed

Gehring, Karin; Sitskoorn, Margriet M; Gundy, Chad M; Sikkes, Sietske A M; Klein, Martin; Postma, Tjeerd J; van den Bent, Martin J; Beute, Guus N; Enting, Roelien H; Kappelle, Arnoud C; Boogerd, Willem; Veninga, Theo; Twijnstra, Albert; Boerman, Dolf H; Taphoorn, Martin J B; Aaronson, Neil K

2009-08-01

Patients with gliomas often experience cognitive deficits, including problems with attention and memory. This randomized, controlled trial evaluated the effects of a multifaceted cognitive rehabilitation program (CRP) on cognitive functioning and selected quality-of-life domains in patients with gliomas. One hundred forty adult patients with low-grade and anaplastic gliomas, favorable prognostic factors, and both subjective cognitive symptoms and objective cognitive deficits were recruited from 11 hospitals in the Netherlands. Patients were randomly assigned to an intervention group or to a waiting-list control group. The intervention incorporated both computer-based attention retraining and compensatory skills training of attention, memory, and executive functioning. Participants completed a battery of neuropsychological (NP) tests and self-report questionnaires on cognitive functioning, fatigue, mental health-related quality of life, and community integration at baseline, after completion of the CRP, and at 6-month follow-up. At the immediate post-treatment evaluation, statistically significant intervention effects were observed for measures of subjective cognitive functioning and its perceived burden but not for the objective NP outcomes or for any of the other self-report measures. At the 6-month follow-up, the CRP group performed significantly better than the control group on NP tests of attention and verbal memory and reported less mental fatigue. Group differences in other subjective outcomes were not significant at 6 months. The CRP has a salutary effect on short-term cognitive complaints and on longer-term cognitive performance and mental fatigue. Additional research is needed to identify which elements of the intervention are most effective.

Effects of online cognitive treatment for problematic anger: a randomized controlled trial.

PubMed

Howie, Amanda J; Malouff, John M

2014-01-01

Problematic anger, which is common, has been associated with a wide range of negative interpersonal and intrapersonal consequences, including violent behaviour, relationship damage, health problems and low self-esteem. This article reports the results of the first randomized controlled trial of brief online cognitive treatment for anger. The sample included 75 adults who were randomly assigned to cognitive treatment or a waiting list control. The analyses with the 59 participants who completed the post-intervention assessment at four weeks after the beginning of the intervention showed that individuals who received the intervention reported significantly lower anger levels than the control group at post-assessment. The treatment group showed a substantial decrease in anger from pre to post. The results suggest that brief online cognitive treatment can be effective for reducing problematic anger in adults. These findings provide an initial support for the development of internet-based cognitive treatment for problematic anger.

Information without Implementation: A Practical Example for Developing a Best Practice Education Control Group.

PubMed

Balderson, Benjamin H; McCurry, Susan M; Vitiello, Michael V; Shortreed, Susan M; Rybarczyk, Bruce D; Keefe, Francis J; Korff, Michael Von

2016-01-01

This article considers methodology for developing an education-only control group and proposes a simple approach to designing rigorous and well-accepted control groups. This approach is demonstrated in a large randomized trial. The Lifestyles trial (n = 367) compared three group interventions: (a) cognitive-behavioral treatment (CBT) for osteoarthritis pain, (b) CBT for osteoarthritis pain and insomnia, and (c) education-only control (EOC). EOC emulated the interventions excluding hypothesized treatment components and controlling for nonspecific treatment effects. Results showed this approach resulted in a control group that was highly credible and acceptable to patients. This approach can be an effective and practical guide for developing high-quality control groups in trials of behavioral interventions.

A randomized, controlled clinical trial of a geriatric consultation team. Compliance with recommendations.

PubMed

Allen, C M; Becker, P M; McVey, L J; Saltz, C; Feussner, J R; Cohen, H J

1986-05-16

As part of a prospective, randomized, controlled study of the effectiveness of a geriatric consultation team, we examined compliance by the house staff with recommendations made by the team. Recommendations were formulated for 185 patients, aged 75 years or older, who were randomized into intervention (n = 92) and control (n = 93) groups. In the control group, only 27.1% of the actions that would have been recommended by the team were implemented independently by the house staff. Problems commonly neglected included polypharmacy, sensory impairment, confusion, and depression. In the intervention group, overall compliance was 71.7%. Highest compliance occurred for recommendations addressing instability and falls (95.0%) and discharge planning (94.3%). We conclude that a geriatric consultation team contributes substantial additional input into the care of older patients. Furthermore, relatively high compliance can be achieved with recommendations made by a geriatric consultation team, thereby overcoming the first barrier to the establishment of such a service.

Virtual reality-based training improves community ambulation in individuals with stroke: a randomized controlled trial.

PubMed

Yang, Yea-Ru; Tsai, Meng-Pin; Chuang, Tien-Yow; Sung, Wen-Hsu; Wang, Ray-Yau

2008-08-01

This is a single blind randomized controlled trial to examine the effect of virtual reality-based training on the community ambulation in individuals with stroke. Twenty subjects with stroke were assigned randomly to either the control group (n=9) or the experimental group (n=11). Subjects in the control group received the treadmill training. Subjects in the experimental group underwent the virtual reality-based treadmill training. Walking speed, community walking time, walking ability questionnaire (WAQ), and activities-specific balance confidence (ABC) scale were evaluated. Subjects in the experimental group improved significantly in walking speed, community walking time, and WAQ score at posttraining and 1-month follow-up periods. Their ABC score also significantly increased at posttraining but did not maintain at follow-up period. Regarding the between-group comparisons, the experimental group improved significantly more than control group in walking speed (P=0.03) and community walking time (P=0.04) at posttraining period and in WAQ score (P=0.03) at follow-up period. Our results support the perceived benefits of gait training programs that incorporate virtual reality to augment the community ambulation of individuals with stroke.

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.

Effect of Vitamin E on Oxaliplatin-induced Peripheral Neuropathy Prevention: A Randomized Controlled Trial.

PubMed

Salehi, Zeinab; Roayaei, Mahnaz

2015-01-01

Peripheral neuropathy is one of the most important limitations of oxaliplatin base regimen, which is the standard for the treatment of colorectal cancer. Evidence has shown that Vitamin E may be protective in chemotherapy-induced peripheral neuropathy. The aim of this study is to evaluate the effect of Vitamin E administration on prevention of oxaliplatin-induced peripheral neuropathy in patients with colorectal cancer. This was a prospective randomized, controlled clinical trial. Patients with colorectal cancer and scheduled to receive oxaliplatin-based regimens were enrolled in this study. Enrolled patients were randomized into two groups. The first group received Vitamin E at a dose of 400 mg daily and the second group observed, until after the sixth course of the oxaliplatin regimen. For oxaliplatin-induced peripheral neuropathy assessment, we used the symptom experience diary questionnaire that completed at baseline and after the sixth course of chemotherapy. Only patients with a score of zero at baseline were eligible for this study. Thirty-two patients were randomized to the Vitamin E group and 33 to the control group. There was no difference in the mean peripheral neuropathy score changes (after - before) between two groups, after sixth course of the oxaliplatin base regimen (mean difference [after - before] of Vitamin E group = 6.37 ± 2.85, control group = 6.57 ± 2.94; P = 0.78). Peripheral neuropathy scores were significantly increased after intervention compared with a base line in each group (P < 0.001). The results from this current trial demonstrate a lack of benefit for Vitamin E in preventing oxaliplatin-induced peripheral neuropathy.

Open-Label, Randomized, Parallel-Group Controlled Clinical Trial of Massage for Treatment of Depression in HIV-Infected Subjects

PubMed Central

Gertsik, Lev; Favreau, Joya T.; Smith, Shawnee I.; Mirocha, James M.; Rao, Uma; Daar, Eric S.

2013-01-01

Abstract Objectives The study objectives were to determine whether massage therapy reduces symptoms of depression in subjects with human immunodeficiency virus (HIV) disease. Design Subjects were randomized non-blinded into one of three parallel groups to receive Swedish massage or to one of two control groups, touch or no intervention for eight weeks. Settings/location The study was conducted at the Department of Psychiatry and Behavioral Neurosciences at Cedars-Sinai Medical Center in Los Angeles, California, which provided primary clinical care in an institutional setting. Subjects Study inclusion required being at least 16 years of age, HIV-seropositive, with a diagnosis of major depressive disorder. Subjects had to be on a stable neuropsychiatric, analgesic, and antiretroviral regimen for >30 days with no plans to modify therapy for the duration of the study. Approximately 40% of the subjects were currently taking antidepressants. All subjects were medically stable. Fifty-four (54) subjects were randomized, 50 completed at least 1 week (intent-to-treat; ITT), and 37 completed the study (completers). Interventions Swedish massage and touch subjects visited the massage therapist for 1 hour twice per week. The touch group had a massage therapist place both hands on the subject with slight pressure, but no massage, in a uniform distribution in the same pattern used for the massage subjects. Outcome measures The primary outcome measure was the Hamilton Rating Scale for Depression score, with the secondary outcome measure being the Beck Depression Inventory. Results For both the ITT and completers analyses, massage significantly reduced the severity of depression beginning at week 4 (p≤0.04) and continuing at weeks 6 (p≤0.03) and 8 (p≤0.005) compared to no intervention and/or touch. Conclusions The results indicate that massage therapy can reduce symptoms of depression in subjects with HIV disease. The durability of the response, optimal “dose” of massage

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…

Upper limb robot-assisted therapy in cerebral palsy: a single-blind randomized controlled trial.

PubMed

Gilliaux, Maxime; Renders, Anne; Dispa, Delphine; Holvoet, Dominique; Sapin, Julien; Dehez, Bruno; Detrembleur, Christine; Lejeune, Thierry M; Stoquart, Gaëtan

2015-02-01

Several pilot studies have evoked interest in robot-assisted therapy (RAT) in children with cerebral palsy (CP). To assess the effectiveness of RAT in children with CP through a single-blind randomized controlled trial. Sixteen children with CP were randomized into 2 groups. Eight children performed 5 conventional therapy sessions per week over 8 weeks (control group). Eight children completed 3 conventional therapy sessions and 2 robot-assisted sessions per week over 8 weeks (robotic group). For both groups, each therapy session lasted 45 minutes. Throughout each RAT session, the patient attempted to reach several targets consecutively with the REAPlan. The REAPlan is a distal effector robot that allows for displacements of the upper limb in the horizontal plane. A blinded assessment was performed before and after the intervention with respect to the International Classification of Functioning framework: body structure and function (upper limb kinematics, Box and Block test, Quality of Upper Extremity Skills Test, strength, and spasticity), activities (Abilhand-Kids, Pediatric Evaluation of Disability Inventory), and participation (Life Habits). During each RAT session, patients performed 744 movements on average with the REAPlan. Among the variables assessed, the smoothness of movement (P < .01) and manual dexterity assessed by the Box and Block test (P = .04) improved significantly more in the robotic group than in the control group. This single-blind randomized controlled trial provides the first evidence that RAT is effective in children with CP. Future studies should investigate the long-term effects of this therapy. © The Author(s) 2014.

Enhancing the parent-child relationship: a Hong Kong community-based randomized controlled trial.

PubMed

Fabrizio, Cecilia S; Stewart, Sunita M; Ip, Alison K Y; Lam, Tai Hing

2014-02-01

Adolescence is a critical risk period for negative academic and behavioral outcomes, but a strong parent-child relationship can be a powerful protective factor. Our previous pilot of an academic-community agency collaborative randomized controlled trial (RCT) demonstrated initial evidence of benefit for a parenting intervention with preadolescents in Hong Kong. The present RCT assessed the effect of brief training in positive discipline parenting skills on parental satisfaction with the parent-child relationship. A community sample of 461 Hong Kong Chinese parents of children aged 10-13 years were randomized to (a) the Harmony@Home intervention, (b) an attention control, or (c) a third active intervention that shared the control group. Participants were followed for 12 months and multiple methods of assessment were used. Compared with the control group, the Harmony@Home group reported an increase in the primary outcome of satisfaction with the parent-child relationship at 3 months' postintervention. Although results are mixed, this study demonstrates how a culturally adaptive community intervention can improve the parental behaviors that serve as protective factors against negative academic and behavioral outcomes for Chinese adolescents.

Mirror therapy in unilateral neglect after stroke (MUST trial): a randomized controlled trial.

PubMed

Pandian, Jeyaraj D; Arora, Rajni; Kaur, Paramdeep; Sharma, Deepika; Vishwambaran, Dheeraj K; Arima, Hisatomi

2014-09-09

We explored the effectiveness of mirror therapy (MT) in the treatment of unilateral neglect in stroke patients. This is an open, blinded endpoint, randomized controlled trial carried out from January 2011 to August 2013. We included stroke patients with thalamic and parietal lobe lesions with unilateral neglect 48 hours after stroke. Patients were randomized to the MT group or the control group (sham MT), and both the groups received limb activation. Patients received treatment for 1-2 hours a day 5 days a week for 4 weeks. The primary outcome was unilateral neglect assessed by a blinded assessor using the star cancellation test, the line bisection test, and a picture identification task at 1, 3, and 6 months. This study was registered at http://clinicaltrials.gov (NCT 01735877). Forty-eight patients were randomized to MT (n = 27) or the control group (n = 21). Improvement in scores on the star cancellation test over 6 months was greater in the MT group (mean difference 23, 95% confidence interval [CI] 19-28; p < 0.0001). Similarly, improvement in the MT group was observed in the scores on the picture identification task (mean difference 3.2, 95% CI 2.4-4.0; p < 0.0001) and line bisection test (mean difference 8.6, 95% CI 2.7-14.6; p = 0.006). In patients with stroke, MT is a simple treatment that improves unilateral neglect. This study provides Class I evidence that for patients with neglect from thalamic and parietal lobe strokes, MT improves neglect. © 2014 American Academy of Neurology.

Two controlled trials to increase participant retention in a randomized controlled trial of mobile phone-based smoking cessation support in the United Kingdom.

PubMed

Severi, Ettore; Free, Caroline; Knight, Rosemary; Robertson, Steven; Edwards, Philip; Hoile, Elizabeth

2011-10-01

Loss to follow-up of trial participants represents a threat to research validity. To date, interventions designed to increase participants' awareness of benefits to society of completing follow-up, and the impact of a telephone call from a senior female clinician and researcher requesting follow-up have not been evaluated robustly. Trial 1 aimed to evaluate the effect on trial follow-up of written information regarding the benefits of participation to society. Trial 2 aimed to evaluate the effect on trial follow-up of a telephone call from a senior female clinician and researcher. Two single-blind randomized controlled trials were nested within a larger trial, Txt2stop. In Trial 1, participants were allocated using minimization to receive a refrigerator magnet and a text message emphasizing the benefits to society of completing follow-up, or to a control group receiving a simple reminder regarding follow-up. In Trial 2, participants were randomly allocated to receive a telephone call from a senior female clinician and researcher, or to a control group receiving standard Txt2stop follow-up procedures. Trial 1: 33.5% (327 of 976) of the intervention group and 33.8% (329 of 974) of the control group returned the questionnaire within 26 weeks of randomization, risk ratio (RR) 0.99; 95% confidence interval (CI) 0.88-1.12. In all, 83.3% (813 of 976) of the intervention group and 82.2% (801 of/974) of the control group sent back the questionnaire within 30 weeks of randomization, RR 1.01; 95% CI 0.97, 1.05. Trial 2: 31% (20 of 65) of the intervention group and 32% (20 of 62) of the control group completed trial follow-up, RR 0.93; 95%CI 0.44, 1.98. In presence of other methods to increase follow-up neither experimental method (refrigerator magnet and text message emphasizing participation's benefits to society nor a telephone call from study's principal investigator) increased participant follow-up in the Txt2stop trial.

Change in Pulmonary Function after Incentive Spirometer Exercise in Children with Spastic Cerebral Palsy: A Randomized Controlled Study.

PubMed

Choi, Ja Young; Rha, Dong-wook; Park, Eun Sook

2016-05-01

The aim of this study was to investigate the effect of incentive spirometer exercise (ISE) on pulmonary function and maximal phonation time (MPT) in children with spastic cerebral palsy (CP). Fifty children with CP were randomly assigned to two groups: the experimental group and the control group. Both groups underwent comprehensive rehabilitation therapy. The experimental group underwent additional ISE. The forced vital capacity (FVC), forced expiratory volume at one second (FEV₁), FEV₁/FVC ratio, peak expiratory flow (PEF), and MPT were assessed as outcome measures before and after 4 weeks of training. There were significant improvements in FVC, FEV₁, PEF, and MPT in the experimental group, but not in the control group. In addition, the improvements in FVC, FEV₁, and MPT were significantly greater in the experimental group than in the control group. The results of this randomized controlled study support the use of ISE for enhancing pulmonary function and breath control for speech production in children with CP.

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

PubMed Central

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

2016-01-01

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

A Pilot Randomized Controlled Trial of the ACCESS Program: A Group Intervention to Improve Social, Adaptive Functioning, Stress Coping, and Self-Determination Outcomes in Young Adults with Autism Spectrum Disorder.

PubMed

Oswald, Tasha M; Winder-Patel, Breanna; Ruder, Steven; Xing, Guibo; Stahmer, Aubyn; Solomon, Marjorie

2018-05-01

The purpose of this pilot randomized controlled trial was to investigate the acceptability and efficacy of the Acquiring Career, Coping, Executive control, Social Skills (ACCESS) Program, a group intervention tailored for young adults with autism spectrum disorder (ASD) to enhance critical skills and beliefs that promote adult functioning, including social and adaptive skills, self-determination skills, and coping self-efficacy. Forty-four adults with ASD (ages 18-38; 13 females) and their caregivers were randomly assigned to treatment or waitlist control. Compared to controls, adults in treatment significantly improved in adaptive and self-determination skills, per caregiver report, and self-reported greater belief in their ability to access social support to cope with stressors. Results provide evidence for the acceptability and efficacy of the ACCESS Program.

Effects of zinc supplementation on subscales of anorexia in children: A randomized controlled trial

PubMed Central

Khademian, Majid; Farhangpajouh, Neda; Shahsanaee, Armindokht; Bahreynian, Maryam; Mirshamsi, Mehran; Kelishadi, Roya

2014-01-01

Objectives: This study aims to assess the effects of zinc supplementation on improving the appetite and its subscales in children. Methods: This study was conducted in 2013 in Isfahan, Iran. It had two phases. At the first step, after validation of the Child Eating Behaviour Questionaire (CEBQ), it was completed for 300 preschool children, who were randomly selected. The second phase was conducted as a randomized controlled trial. Eighty of these children were randomly selected, and were randomly assigned to two groups of equal number receiving zinc (10 mg/day) or placebo for 12 weeks. Results: Overall 77 children completed the trial (39 in the case and 3 in the control group).The results showed that zinc supplement can improve calorie intake in children by affecting some CEBQ subscales like Emotional over Eating and Food Responsible. Conclusion: Zinc supplementation had positive impact in promoting the calorie intake and some subscales of anorexia. PMID:25674110

Meditation or Exercise for Preventing Acute Respiratory Infection: A Randomized Controlled Trial

PubMed Central

Barrett, Bruce; Hayney, Mary S.; Muller, Daniel; Rakel, David; Ward, Ann; Obasi, Chidi N.; Brown, Roger; Zhang, Zhengjun; Zgierska, Aleksandra; Gern, James; West, Rebecca; Ewers, Tola; Barlow, Shari; Gassman, Michele; Coe, Christopher L.

2012-01-01

PURPOSE This study was designed to evaluate potential preventive effects of meditation or exercise on incidence, duration, and severity of acute respiratory infection (ARI) illness. METHODS Community-recruited adults aged 50 years and older were randomized to 1 of 3 study groups: 8-week training in mindfulness meditation, matched 8-week training in moderate-intensity sustained exercise, or observational control. The primary outcome was area-under-the-curve global illness severity during a single cold and influenza season, using the Wisconsin Upper Respiratory Symptom Survey (WURSS-24) to assess severity. Health care visits and days of missed work were counted. Nasal wash collected during ARI illness was assayed for neutrophils, interleukin-8, and viral nucleic acid. RESULTS Of 154 adults randomized into the study, 149 completed the trial (82% female, 94% white, mean age 59.3 ± 6.6 years). There were 27 ARI episodes and 257 days of ARI illness in the meditation group (n = 51), 26 episodes and 241 illness days in the exercise group (n = 47), and 40 episodes and 453 days in the control group (n = 51). Mean global severity was 144 for meditation, 248 for exercise, and 358 for control. Compared with control, global severity was significantly lower for meditation (P = .004). Both global severity and total days of illness (duration) trended toward being lower for the exercise group (P=.16 and P=.032, respectively), as did illness duration for the meditation group (P=.034). Adjusting for covariates using zero-inflated multivariate regression models gave similar results. There were 67 ARI-related days of-work missed in the control group, 32 in the exercise group (P = .041), and 16 in the meditation group (P <.001). Health care visits did not differ significantly. Viruses were identified in 54% of samples from meditation, 42% from exercise, and 54% from control groups. Neutrophil count and interleukin-8 levels were similar among intervention groups. CONCLUSIONS Training in

Telehealth to improve asthma control in pregnancy: A randomized controlled trial.

PubMed

Zairina, Elida; Abramson, Michael J; McDonald, Christine F; Li, Jonathan; Dharmasiri, Thanuja; Stewart, Kay; Walker, Susan P; Paul, Eldho; George, Johnson

2016-07-01

Poorly controlled asthma during pregnancy is hazardous for both mother and foetus. Better asthma control may be achieved if patients are involved in regular self-monitoring of symptoms and self-management according to a written asthma action plan. Telehealth applications to optimize asthma management and outcomes in pregnant women have not yet been evaluated. This study evaluated the efficacy of a telehealth programme supported by a handheld respiratory device in improving asthma control during pregnancy. Pregnant women with asthma (n = 72) from two antenatal clinics in Melbourne, Australia, were randomized to one of two groups: (i) intervention-involving a telehealth programme (management of asthma with supportive telehealth of respiratory function in pregnancy (MASTERY(©) )) supported by a handheld respiratory device and an Android smart phone application (Breathe-easy(©) ) and written asthma action plan or (ii) control-usual care. The primary outcome was change in asthma control at 3 and 6 months (prenatal). Secondary outcomes included changes in quality of life and lung function, and perinatal/neonatal outcomes. At baseline, participants' mean (± standard deviation) age was 31.4 ± 4.5 years and gestational age 16.7 ± 3.1 weeks. At 6 months, the MASTERY group had better asthma control (P = 0.02) and asthma-related quality of life (P = 0.002) compared with usual care. There were no significant differences between groups in lung function, unscheduled health-care visits, days off work/study, oral corticosteroid use, or perinatal outcomes. Differences between groups were not significant at 3 months. Telehealth interventions supporting self-management are feasible and could potentially improve asthma control and asthma-related quality of life during pregnancy. © 2016 Asian Pacific Society of Respirology.

Mobile Health (mHealth) Versus Clinic-Based Group Intervention for People With Serious Mental Illness: A Randomized Controlled Trial.

PubMed

Ben-Zeev, Dror; Brian, Rachel M; Jonathan, Geneva; Razzano, Lisa; Pashka, Nicole; Carpenter-Song, Elizabeth; Drake, Robert E; Scherer, Emily A

2018-05-25

mHealth approaches that use mobile phones to deliver interventions can help improve access to care for people with serious mental illness. The goal was to evaluate how mHealth performs against more traditional treatment. A three-month randomized controlled trial was conducted of a smartphone-delivered intervention (FOCUS) versus a clinic-based group intervention (Wellness Recovery Action Plan [WRAP]). Participants were 163 clients, mostly from racial minority groups and with long-term, serious mental illness (schizophrenia or schizoaffective disorder, 49%; bipolar disorder, 28%; and major depressive disorder, 23%). Outcomes were engagement throughout the intervention; satisfaction posttreatment (three months); and improvement in clinical symptoms, recovery, and quality of life (assessed at baseline, posttreatment, and six months). Participants assigned to FOCUS were more likely than those assigned to WRAP to commence treatment (90% versus 58%) and remain fully engaged in eight weeks of care (56% versus 40%). Satisfaction ratings were comparably high for both interventions. Participants in both groups improved significantly and did not differ in clinical outcomes, including general psychopathology and depression. Significant improvements in recovery were seen for the WRAP group posttreatment, and significant improvements in recovery and quality of life were seen for the FOCUS group at six months. Both interventions produced significant gains among clients with serious and persistent mental illnesses who were mostly from racial minority groups. The mHealth intervention showed superior patient engagement and produced patient satisfaction and clinical and recovery outcomes that were comparable to those from a widely used clinic-based group intervention for illness management.

Effects of an Antioxidant-enriched Multivitamin in Cystic Fibrosis: Randomized, Controlled, Multicenter Trial.

PubMed

Sagel, Scott D; Khan, Umer; Jain, Raksha; Graff, Gavin; Daines, Cori L; Dunitz, Jordan M; Borowitz, Drucy; Orenstein, David M; Abdulhamid, Ibrahim; Noe, Julie; Clancy, John P; Slovis, Bonnie; Rock, Michael J; McCoy, Karen S; Strausbaugh, Steven; Livingston, Floyd R; Papas, Konstantinos A; Shaffer, Michele L

2018-04-24

Cystic fibrosis (CF) is characterized by dietary antioxidant deficiencies, which may contribute to an oxidant-antioxidant imbalance and oxidative stress. Evaluate the effects of an oral antioxidant-enriched multivitamin supplement on antioxidant concentrations, markers of inflammation and oxidative stress, and clinical outcomes. In this investigator-initiated, multicenter, randomized, double-blind, controlled trial, 73 pancreatic insufficient CF subjects 10 years of age and older with an FEV1 between 40-100% predicted were randomized to 16 weeks of an antioxidant-enriched multivitamin or control multivitamin without antioxidant enrichment. Endpoints included systemic antioxidant concentrations, markers of inflammation and oxidative stress, clinical outcomes (pulmonary exacerbations, anthropometric measures, pulmonary function), safety and tolerability. Change in sputum myeloperoxidase concentration over 16 weeks, the primary efficacy endpoint, was not significantly different between the treated and control groups. Systemic antioxidant concentrations (β-carotene, CoQ10, γ-tocopherol, lutein) significantly increased in the antioxidant treated group (p<0.001 for each), while circulating calprotectin and myeloperoxidase decreased in the treated group compared to the control group at week 4. The treated group had a lower risk of first pulmonary exacerbation requiring antibiotics than the control group (adjusted hazard ratio=0.50, p=0.04). Lung function and growth endpoints did not differ between groups. Adverse events and tolerability were similar between groups. Antioxidant supplementation was safe and well tolerated, resulting in increased systemic antioxidant concentrations and modest reductions in systemic inflammation after 4 weeks. Antioxidant treatment was also associated with a lower risk of first pulmonary exacerbation. Clinical trial registration available at www.clinicaltrials.gov, ID NCT01859390.

Gastrografin in Prolonged Postoperative Ileus: A Double-blinded Randomized Controlled Trial.

PubMed

Vather, Ryash; Josephson, Rachel; Jaung, Rebekah; Kahokehr, Arman; Sammour, Tarik; Bissett, Ian

2015-07-01

To investigate the therapeutic value of Gastrografin in shortening duration of prolonged postoperative ileus (PPOI) after elective colorectal surgery. Gut wall edema is central to the pathogenesis of PPOI. Hyperosmotic, orally administered, water-soluble contrast media such as Gastrografin are theoretically capable of mitigating this edema. A double-blinded, placebo-controlled, randomized trial was conducted. Participants were allocated to receive 100 mL of Gastrografin (Exposure Group) or flavored distilled water (Control Group) administered enterally. Other aspects of management were standardized. Resolution of PPOI was assessed 12-hourly. Eighty patients were randomized equally, with 5 in the Exposure Group and 4 in the Control Group excluded from analysis. Participants were evenly matched at baseline. Mean duration of PPOI did not differ between Exposure and Control Groups (83.7 vs 101.3 hours; P = 0.191). When considering individual markers of PPOI resolution, Gastrografin did not affect time to resolution of nausea and vomiting (64.5 vs 74.3 hours; P = 0.404) or consumption of oral diet (75.8 vs 90.0 hours; P = 0.297). However, it accelerated time to flatus or stool (18.9 vs 32.7 hours; P = 0.047) and time to resolution of abdominal distension (52.8 vs 77.7 hours; P = 0.013). There were no significant differences between groups in nasogastric output; analgesia, antiemetic, or fluid requirement; complications; or length of stay. Gastrografin is not clinically useful in shortening an episode of PPOI characterized by upper and lower gastrointestinal symptoms. It may however be of therapeutic benefit in the subset of PPOI patients who display lower gastrointestinal symptoms exclusively after surgery.

Electro-acupuncture for pain relief after nasal septoplasty: a randomized controlled study.

PubMed

Sahmeddini, Mohammad A; Farbood, Arash; Ghafaripuor, Sina

2010-01-01

Electro-acupuncture (EA) can be effective in some pain conditions, but still there have been no randomized controlled studies of EA for treatment of acute postoperative pain in nasal septoplasty. Therefore, we did a study to test whether EA of specific points is superior to sham acupuncture for complementary analgesia after nasal septoplasty. Ninety (90) patients with an American Society of Anesthesiology (ASA) physical status of I-II scheduled for elective septoplasty were randomly allocated to acupuncture group or control group. Postoperative pain was treated with intravenous meperidine. The time to the first analgesic request, and pain intensity on a 100-mm visual analogue scale (VAS-100) were used to evaluate postoperative pain, and the amount of postoperative meperidine and incidence of analgesia related to side-effects were recorded. Postoperative pain intensity on VAS-100 and respiratory depression were similar in both groups (p > 0.05), but nausea and vomiting were less in the acupuncture group than in the control group (p < 0.05). Findings from our study demonstrate that both uses of EA and 0.1 mg/kg IV morphine given intraoperatively resulted in a similar postoperative pain score, and meperidine was not given in any patient in the two groups during postoperative period because the VAS scores of all patients were less than 40 mm.

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.

Two-year impact of community-based health screening and parenting groups on child development in Zambia: Follow-up to a cluster-randomized controlled trial.