When Wait Lists Are Not Feasible, Nothing Is a Thing That Does Not Need to Be Done

ERIC Educational Resources Information Center

Devilly, Grant J.; McFarlane, Alexander C.

2009-01-01

Clinical psychology practices initially grew through the use of case studies, uncontrolled trials, and eventually through randomized controlled trials (RCTs). The use of a wait-list control group is standard practice in such trials of treatment regimens for psychopathological conditions. However, as knowledge advances regarding the successful…

A Randomized Controlled Trial of Koru: A Mindfulness Program for College Students and Other Emerging Adults

PubMed Central

Greeson, Jeffrey M.; Juberg, Michael K.; Maytan, Margaret; James, Kiera; Rogers, Holly

2014-01-01

Objective To evaluate the effectiveness of Koru, a mindfulness training program for college students and other emerging adults. Participants Ninety students (66% female, 62% white, 71% graduate students) participated between Fall 2012 and Spring 2013. Methods Randomized controlled trial. We hypothesized that Koru, compared to a wait-list control group, would reduce perceived stress and sleep problems, and increase mindfulness, self-compassion, and gratitude. Results As hypothesized, results showed significant Group (Koru, wait-list) X Time (pre, post) interactions for improvements in perceived stress (F=4.50, df [1, 76.40], p=.037, d=.45), sleep problems (F= 4.71, df [1,79.49], p=.033, d=.52), mindfulness (F=26.80, df [1, 79.09], p<.001, d=.95), and self-compassion (F=18.08, df [1, 74.77], p<.001, d=.75). All significant effects were replicated in the wait-list group. Significant correlations were observed among changes in perceived stress, sleep problems, mindfulness, and self-compassion. Conclusions Results support the effectiveness of the Koru program for emerging adults in the university setting. PMID:24499130

Habit Reversal versus Object Manipulation Training for Treating Nail Biting: A Randomized Controlled Clinical Trial

PubMed Central

Ghanizadeh, Ahmad; Bazrafshan, Amir; Dehbozorgi, Gholamreza

2013-01-01

Objective This is a parallel, three group, randomized, controlled clinical trial, with outcomes evaluated up to three months after randomization for children and adolescents with chronic nail biting. The current study investigates the efficacy of habit reversal training (HRT) and compares its effect with object manipulation training (OMT) considering the limitations of the current literature. Method Ninety one children and adolescents with nail biting were randomly allocated to one of the three groups. The three groups were HRT (n = 30), OMT (n = 30), and wait-list or control group (n = 31). The mean length of nail was considered as the main outcome. Results The mean length of the nails after one month in HRT and OMT groups increased compared to the waiting list group (P < 0.001, P < 0.001, respectively). In long term, both OMT and HRT increased the mean length of nails (P < 0.01), but HRT was more effective than OMT (P < 0.021). The parent-reported frequency of nail biting did show similar results as to the mean length of nails assessment in long term. The number of children who completely stopped nail biting in HRT and OMT groups during three months was 8 and 7, respectively. This number was zero during one month for the wait-list group. Conclusion This trial showed that HRT is more effective than wait-list and OMT in increasing the mean length of nails of children and adolescents in long terms. PMID:24130603

Randomized Trial of Internet-Delivered Self-Help with Telephone Support for Pathological Gamblers

ERIC Educational Resources Information Center

Carlbring, Per; Smit, Filip

2008-01-01

Although effective therapies for pathological gambling exist, their uptake is limited to 10% of the target population. To lower the barriers for help seeking, the authors tested an online alternative in a randomized trial (N = 66). The participants were pathological gamblers not presenting with severe comorbid depression. A wait-list control was…

Cognitive-Behavioral Therapy for Intermittent Explosive Disorder: A Pilot Randomized Clinical Trial

ERIC Educational Resources Information Center

McCloskey, Michael S.; Noblett, Kurtis L.; Deffenbacher, Jerry L.; Gollan, Jackie K.; Coccaro, Emil F.

2008-01-01

No randomized clinical trials have evaluated the efficacy of psychotherapy for intermittent explosive disorder (IED). In the present study, the authors tested the efficacy of 12-week group and individual cognitive-behavioral therapies (adapted from J. L. Deffenbacher & M. McKay, 2000) by comparing them with a wait-list control in a randomized…

Cognitive Behavioral Therapy for 4- to 7-Year-Old Children with Anxiety Disorders: A Randomized Clinical Trial

ERIC Educational Resources Information Center

Hirshfeld-Becker, Dina R.; Masek, Bruce; Henin, Aude; Blakely, Lauren Raezer; Pollock-Wurman, Rachel A.; McQuade, Julia; DePetrillo, Lillian; Briesch, Jacquelyn; Ollendick, Thomas H.; Rosenbaum, Jerrold F.; Biederman, Joseph

2010-01-01

Objective: To examine the efficacy of a developmentally appropriate parent-child cognitive behavioral therapy (CBT) protocol for anxiety disorders in children ages 4-7 years. Method: Design: Randomized wait-list controlled trial. Conduct: Sixty-four children (53% female, mean age 5.4 years, 80% European American) with anxiety disorders were…

An Evaluation of a Behaviorally Based Social Skills Group for Individuals Diagnosed with Autism Spectrum Disorder

ERIC Educational Resources Information Center

Leaf, Justin B.; Leaf, Jeremy A.; Milne, Christine; Taubman, Mitchell; Oppenheim-Leaf, Misty; Torres, Norma; Townley-Cochran, Donna; Leaf, Ronald; McEachin, John; Yoder, Paul

2017-01-01

In this study we evaluated a social skills group which employed a progressive applied behavior analysis model for individuals diagnosed with autism spectrum disorder. A randomized control trial was utilized; eight participants were randomly assigned to a treatment group and seven participants were randomly assigned to a waitlist control group. The…

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.

A randomized wait-list controlled analysis of the implementation integrity of team-initiated problem solving processes.

PubMed

Newton, J Stephen; Horner, Robert H; Algozzine, Bob; Todd, Anne W; Algozzine, Kate

2012-08-01

Members of Positive Behavior Interventions and Supports (PBIS) teams from 34 elementary schools participated in a Team-Initiated Problem Solving (TIPS) Workshop and follow-up technical assistance. Within the context of a randomized wait-list controlled trial, team members who were the first recipients of the TIPS intervention demonstrated greater implementation integrity in using the problem-solving processes during their team meetings than did members of PBIS Teams in the Wait-List Control group. The success of TIPS at improving implementation integrity of the problem-solving processes is encouraging and suggests the value of conducting additional research focused on determining whether there is a functional relation between use of these problem-solving processes and actual resolution of targeted student academic and social problems. Copyright © 2012 Society for the Study of School Psychology. Published by Elsevier Ltd. All rights reserved.

Parent Training with High-Risk Immigrant Chinese Families: A Pilot Group Randomized Trial Yielding Practice-Based Evidence

ERIC Educational Resources Information Center

Lau, Anna S.; Fung, Joey J.; Ho, Lorinda Y.; Liu, Lisa L.; Gudino, Omar G.

2011-01-01

We studied the efficacy and implementation outcomes of a culturally responsive parent training (PT) program. Fifty-four Chinese American parents participated in a wait-list controlled group randomized trial (32 immediate treatment, 22 delayed treatment) of a 14-week intervention designed to address the needs of high-risk immigrant families.…

Hypertension analysis of stress reduction using mindfulness meditation and yoga: results from the HARMONY randomized controlled trial.

PubMed

Blom, Kimberly; Baker, Brian; How, Maxine; Dai, Monica; Irvine, Jane; Abbey, Susan; Abramson, Beth L; Myers, Martin G; Kiss, Alex; Perkins, Nancy J; Tobe, Sheldon W

2014-01-01

The HARMONY study was a randomized, controlled trial examining the efficacy of an 8-week mindfulness-based stress reduction (MBSR) program for blood pressure (BP) lowering among unmedicated stage 1 hypertensive participants. Participants diagnosed with stage 1 hypertension based on ambulatory BP were randomized to either immediate treatment of MBSR for 8 weeks or wait-list control. Primary outcome analysis evaluated whether change in awake and 24-hour ambulatory BP from baseline to week 12 was significantly different between the 2 groups. A within-group before and after MBSR analysis was also performed. The study enrolled 101 adults (38% male) with baseline average 24-hour ambulatory BP of 135±7.9/82±5.8mm Hg and daytime ambulatory BP of 140±7.7/87±6.3 mmHg. At week 12, the change from baseline in 24-hour ambulatory BP was 0.4±6.7/0.0±4.9mm Hg for the immediate intervention and 0.4±7.8/-0.4±4.6mm Hg for the wait-list control. There were no significant differences between intervention and wait-list control for all ambulatory BP parameters. The secondary within-group analysis found a small reduction in BP after MBSR compared with baseline, a finding limited to female subjects in a sex analysis. MBSR did not lower ambulatory BP by a statistically or clinically significant amount in untreated, stage 1 hypertensive patients when compared with a wait-list control group. It leaves untested whether MBSR might be useful for lowering BP by improving adherence in treated hypertensive participants. NCT00825526.

Movement-Pattern Training to Improve Function in People With Chronic Hip Joint Pain: A Feasibility Randomized Clinical Trial.

PubMed

Harris-Hayes, Marcie; Czuppon, Sylvia; Van Dillen, Linda R; Steger-May, Karen; Sahrmann, Shirley; Schootman, Mario; Salsich, Gretchen B; Clohisy, John C; Mueller, Michael J

2016-06-01

Study Design Feasibility randomized clinical trial. Background Rehabilitation may be an appropriate treatment strategy for patients with chronic hip joint pain; however, the evidence related to the effectiveness of rehabilitation is limited. Objectives To assess feasibility of performing a randomized clinical trial to investigate the effectiveness of movement-pattern training (MPT) to improve function in people with chronic hip joint pain. Methods Thirty-five patients with chronic hip joint pain were randomized into a treatment (MPT) group or a control (wait-list) group. The MPT program included 6 one-hour supervised sessions and incorporated (1) task-specific training for basic functional tasks and symptom-provoking tasks, and (2) strengthening of hip musculature. The wait-list group received no treatment. Primary outcomes for feasibility were patient retention and adherence. Secondary outcomes to assess treatment effects were patient-reported function (Hip disability and Osteoarthritis Outcome Score), lower extremity kinematics, and hip muscle strength. Results Retention rates did not differ between the MPT (89%) and wait-list groups (94%, P = 1.0). Sixteen of the 18 patients (89%) in the MPT group attended at least 80% of the treatment sessions. For the home exercise program, 89% of patients reported performing their home program at least once per day. Secondary outcomes support the rationale for conduct of a superiority randomized clinical trial. Conclusion Based on retention and adherence rates, a larger randomized clinical trial appears feasible and warranted to assess treatment effects more precisely. Data from this feasibility study will inform our future clinical trial. Level of Evidence Therapy, level 2b-. J Orthop Sports Phys Ther 2016;46(6):452-461. Epub 26 Apr 2016. doi:10.2519/jospt.2016.6279.

Parenting Intervention Combined With Acceptance and Commitment Therapy: A Trial With Families of Children With Cerebral Palsy

PubMed Central

Sanders, Matthew R.; McKinlay, Lynne; Boyd, Roslyn N.

2016-01-01

Objective To examine the effects of Stepping Stones Triple P (SSTP) and Acceptance and Commitment Therapy (ACT) on child functioning, quality of life, and parental adjustment. Method 67 parents (97.0% mothers) of children (64.2% male; mean age 5.3 ± 3.0 years) with cerebral palsy participated in a randomized controlled trial with three groups: wait-list control, SSTP, and SSTP + ACT. This article details the secondary outcomes. Results In comparison with wait-list, the SSTP + ACT group showed increased functional performance and quality of life as well as decreased parental psychological symptoms. No differences were found for parental confidence. No differences were found between SSTP and wait-list or between SSTP and SSTP + ACT. Conclusions ACT-integrated parenting intervention may be an effective way to target child functioning, quality of life, and parental adjustment. PMID:26702629

Mobile Phone-Delivered Cognitive Behavioral Therapy for Insomnia: A Randomized Waitlist Controlled Trial

PubMed Central

Lancee, Jaap; Griffioen-Both, Fiemke; Spruit, Sandor; Fitrianie, Siska; Neerincx, Mark A; Beun, Robbert Jan; Brinkman, Willem-Paul

2017-01-01

Background This study is one of the first randomized controlled trials investigating cognitive behavioral therapy for insomnia (CBT-I) delivered by a fully automated mobile phone app. Such an app can potentially increase the accessibility of insomnia treatment for the 10% of people who have insomnia. Objective The objective of our study was to investigate the efficacy of CBT-I delivered via the Sleepcare mobile phone app, compared with a waitlist control group, in a randomized controlled trial. Methods We recruited participants in the Netherlands with relatively mild insomnia disorder. After answering an online pretest questionnaire, they were randomly assigned to the app (n=74) or the waitlist condition (n=77). The app packaged a sleep diary, a relaxation exercise, sleep restriction exercise, and sleep hygiene and education. The app was fully automated and adjusted itself to a participant’s progress. Program duration was 6 to 7 weeks, after which participants received posttest measurements and a 3-month follow-up. The participants in the waitlist condition received the app after they completed the posttest questionnaire. The measurements consisted of questionnaires and 7-day online diaries. The questionnaires measured insomnia severity, dysfunctional beliefs about sleep, and anxiety and depression symptoms. The diary measured sleep variables such as sleep efficiency. We performed multilevel analyses to study the interaction effects between time and condition. Results The results showed significant interaction effects (P<.01) favoring the app condition on the primary outcome measures of insomnia severity (d=–0.66) and sleep efficiency (d=0.71). Overall, these improvements were also retained in a 3-month follow-up. Conclusions This study demonstrated the efficacy of a fully automated mobile phone app in the treatment of relatively mild insomnia. The effects were in the range of what is found for Web-based treatment in general. This supports the applicability of such technical tools in the treatment of insomnia. Future work should examine the generalizability to a more diverse population. Furthermore, the separate components of such an app should be investigated. It remains to be seen how this app can best be integrated into the current health regimens. Trial Registration Netherlands Trial Register: NTR5560; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5560 (Archived by WebCite at http://www.webcitation.org/6noLaUdJ4) PMID:28400355

Evaluation of a spirituality informed e-mental health tool as an intervention for major depressive disorder in adolescents and young adults - a randomized controlled pilot trial.

PubMed

Rickhi, Badri; Kania-Richmond, Ania; Moritz, Sabine; Cohen, Jordan; Paccagnan, Patricia; Dennis, Charlotte; Liu, Mingfu; Malhotra, Sonya; Steele, Patricia; Toews, John

2015-12-24

Depression in adolescents and young adults is a major mental health condition that requires attention. Research suggests that approaches that include spiritual concepts and are delivered through an online platform are a potentially beneficial approach to treating/managing depression in this population. The purpose of this study was to evaluate the effectiveness of an 8-week online spirituality informed e-mental health intervention (the LEAP Project) on depression severity, and secondary outcomes of spiritual well-being and self-concept, in adolescents and young adults with major depressive disorder of mild to moderate severity. A parallel group, randomized, waitlist controlled, assessor-blinded clinical pilot trial was conducted in Calgary, Alberta, Canada. The sample of 62 participants with major depressive disorder (DSM-IV-TR) was defined by two age subgroups: adolescents (ages 13 to 18 years; n = 31) and young adults (ages 19 to 24 years; n = 31). Participants in each age subgroup were randomized into the study arm (intervention initiated upon enrolment) or the waitlist control arm (intervention initiated after an 8-week wait period). Comparisons were made between the study and waitlist control arms at week 8 (the point where study arm had completed the intervention and the waitlist control arm had not) and within each arm at four time points over 24-week follow-up period. At baseline, there was no statistical difference between study and waitlist participants for both age subgroups for all three outcomes of interest. After the intervention, depression severity was significantly reduced; comparison across arms at week 8 and over time within each arm and both age subgroups. Spiritual well-being changes were not significant, with the exception of an improvement over time for the younger participants in the study arm (p = 0.01 at week 16 and p = 0.0305 at week 24). Self-concept improved significantly for younger participants immediately after the intervention (p = 0.045 comparison across arms at week 8; p = 0.0175 in the waitlist control arm) and over time in the study arm (p = 0.0025 at week 16). In the older participants, change was minimal, with the exception of a significant improvement in one of six factors (vulnerability) in study arm over time (p = 0.025 at week 24). The results of the LEAP Project pilot trial suggest that it is an effective, online intervention for youth ages 13 to 24 with mild to moderate major depressive disorder with various life situations and in a limited way on spiritual well-being and self-concept. ClinicalTrials.gov NCT00985686. Registered 24 September 2009.

Effect of an Ecological Executive Skill Training Program for School-aged Children with Attention Deficit Hyperactivity Disorder: A Randomized Controlled Clinical Trial

PubMed Central

Qian, Ying; Chen, Min; Shuai, Lan; Cao, Qing-Jiu; Yang, Li; Wang, Yu-Feng

2017-01-01

Background: As medication does not normalize outcomes of children with attention deficit hyperactivity disorder (ADHD), especially in real-life functioning, nonpharmacological methods are important to target this field. This randomized controlled clinical trial was designed to evaluate the effects of a comprehensive executive skill training program for school-aged children with ADHD in a relatively large sample. Methods: The children (aged 6–12 years) with ADHD were randomized to the intervention or waitlist groups. A healthy control group was composed of gender- and age-matched healthy children. The intervention group received a 12-session training program for multiple executive skills. Executive function (EF), ADHD symptoms, and social functioning in the intervention and waitlist groups were evaluated at baseline and the end of the final training session. The healthy controls (HCs) were only assessed once at baseline. Repeated measures analyses of variance were used to compare EF, ADHD symptoms, and social function between intervention and waitlist groups. Results: Thirty-eight children with ADHD in intervention group, 30 in waitlist group, and 23 healthy children in healthy control group were included in final analysis. At posttreatment, intervention group showed significantly lower Behavior Rating Inventory of Executive Function (BRIEF) total score (135.89 ± 16.80 vs. 146.09 ± 23.92, P = 0.04) and monitoring score (18.05 ± 2.67 vs. 19.77 ± 3.10, P = 0.02), ADHD-IV overall score (41.11 ± 7.48 vs. 47.20 ± 8.47, P < 0.01), hyperactivity-impulsivity (HI) subscale score (18.92 ± 5.09 vs. 21.93 ± 4.93, P = 0.02), and inattentive subscale score (22.18 ± 3.56 vs. 25.27 ± 5.06, P < 0.01), compared with the waitlist group. Repeated measures analyses of variance revealed significant interactions between time and group on the BRIEF inhibition subscale (F = 5.06, P = 0.03), working memory (F = 4.48, P = 0.04), ADHD-IV overall score (F = 21.72, P < 0.01), HI subscale score (F = 19.08, P < 0.01), and inattentive subscale score (F = 12.40, P < 0.01). Multiple-way analysis of variance showed significant differences on all variables of BRIEF, ADHD-rating scale-IV, and WEISS Functional Impairment Scale-Parent form (WFIRS-P) among the intervention and waitlist groups at posttreatment and HCs at baseline. Conclusions: This randomized controlled study on executive skill training in a relatively large sample provided some evidences that the training could improve EF deficits, reduce problematic symptoms, and potentially enhance the social functioning in school-aged children with ADHD. Clinical Trial Registration: http://www.clinicaltrials.gov; NCT02327585. PMID:28639564

A randomized controlled trial examining Iyengar yoga for young adults with rheumatoid arthritis: a study protocol

PubMed Central

2011-01-01

Background Rheumatoid arthritis is a chronic, disabling disease that can compromise mobility, daily functioning, and health-related quality of life, especially in older adolescents and young adults. In this project, we will compare a standardized Iyengar yoga program for young people with rheumatoid arthritis to a standard care wait-list control condition. Methods/Design Seventy rheumatoid arthritis patients aged 16-35 years will be randomized into either the 6-week Iyengar yoga program (12 - 1.5 hour sessions twice weekly) or the 6-week wait-list control condition. A 20% attrition rate is anticipated. The wait-list group will receive the yoga program following completion of the first arm of the study. We will collect data quantitatively, using questionnaires and markers of disease activity, and qualitatively using semi-structured interviews. Assessments include standardized measures of general and arthritis-specific function, pain, mood, and health-related quality of life, as well as qualitative interviews, blood pressure/resting heart rate measurements, a medical exam and the assessment of pro-inflammatory cytokines. Data will be collected three times: before treatment, post-treatment, and two months following the treatment. Discussion Results from this study will provide critical data on non-pharmacologic methods for enhancing function in rheumatoid arthritis patients. In particular, results will shed light on the feasibility and potential efficacy of a novel intervention for rheumatoid arthritis symptoms, paving the way for a larger clinical trial. Trial Registration ClinicalTrials.gov NCT01096823 PMID:21255431

Self-administered acupressure for symptom management among Chinese family caregivers with caregiver stress: a randomized, wait-list controlled trial.

PubMed

Tiwari, Agnes; Lao, Lixing; Wang, Amy Xiao-Min; Cheung, Denise Shuk Ting; So, Mike Ka Pui; Yu, Doris Sau Fung; Lum, Terry Yat Sang; Yuk Fung, Helina Yin King; Yeung, Jerry Wing Fai; Zhang, Zhang-Jin

2016-10-28

Caregiving can be stressful, potentially creating physical and psychological strain. Substantial evidence has shown that family caregivers suffer from significant health problems arising from the demands of caregiving. Although there are programs supporting caregivers, there is little evidence regarding their effectiveness. Acupressure is an ancient Chinese healing method designed to restore the flow of Qi (vital energy) by applying external pressure to acupoints. A randomized, wait-list controlled trial was developed to evaluate the effectiveness of a self-administered acupressure intervention on caregiver stress (primary objective) and stress-related symptoms of fatigue, insomnia, depression, and health-related quality of life (secondary objectives) in Chinese caregivers of older family members. Two hundred Chinese participants, aged ≥ 21 years, who are the primary caregivers of an older family member and screen positive for caregiver stress and symptoms of fatigue/insomnia/depression will be recruited from a community setting in Hong Kong. Subjects will be randomized to receive either an immediate treatment condition (self-administered acupressure intervention) or a wait-list control condition. The self-administered acupressure intervention will include (i) an individual learning and practice session twice a week for 2 weeks, (ii) a home follow-up visit once a week for 2 weeks, and (iii) 15-min self-practice twice a day for 6 weeks. The wait-list control group will receive the same acupressure training after the intervention group has completed the intervention. We hypothesize that Chinese family caregivers in the intervention group will have lower levels of caregiver stress, fatigue, insomnia, depression, and higher health-related quality of life after completion of the intervention than participants in the wait-list control group. This study will provide evidence for the effectiveness of self-administered acupressure in reducing stress and improving symptoms of fatigue, insomnia, depression, and health-related quality of life in Chinese family caregivers. The findings will inform the design of interventions to relieve negative health effects of caregiving. Furthermore, the results can raise community awareness and serve as a basis for policymaking, planning, and allocation of resources regarding empowerment of family caregivers for self-care. Current Controlled Trials NCT02526446 . Registered August 10, 2015.

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.

Involving Parents in Paired Reading with Preschoolers: Results from a Randomized Controlled Trial

ERIC Educational Resources Information Center

Lam, Shui-fong; Chow-Yeung, Kamfung; Wong, Bernard P. H.; Lau, Kwok Kiu; Tse, Shuk In

2013-01-01

A paired reading program was implemented for 195 Hong Kong preschoolers (mean age = 4.7 years) and their parents from families with a wide range of family income. The preschoolers were randomly assigned to experimental or waitlist control groups. The parents in the experimental group received 12 sessions of school-based training on paired reading…

A Randomized Controlled Trial of a Parent Training and Emotion Socialization Program for Families of Hyperactive Preschool-Aged Children

ERIC Educational Resources Information Center

Herbert, Sharonne D.; Harvey, Elizabeth A.; Roberts, Jasmin L.; Wichowski, Kayla; Lugo-Candelas, Claudia I.

2013-01-01

The present study evaluated the effectiveness of a parent training and emotion socialization program designed specifically for hyperactive preschoolers. Participants were 31 preschool-aged children whose parents were randomly assigned to a parent training (PT) or waitlist (WL) control group. PT parents took part in a 14-week parenting program that…

Protocol: the effect of 12 weeks of Tai Chi practice on anxiety in healthy but stressed people compared to exercise and wait-list comparison groups: a randomized controlled trial.

PubMed

Zheng, Shuai; Lal, Sara; Meier, Peter; Sibbritt, David; Zaslawski, Chris

2014-06-01

Stress is a major problem in today's fast-paced society and can lead to serious psychosomatic complications. The ancient Chinese mind-body exercise of Tai Chi may provide an alternative and self-sustaining option to pharmaceutical medication for stressed individuals to improve their coping mechanisms. The protocol of this study is designed to evaluate whether Tai Chi practice is equivalent to standard exercise and whether the Tai Chi group is superior to a wait-list control group in improving stress coping levels. This study is a 6-week, three-arm, parallel, randomized, clinical trial designed to evaluate Tai Chi practice against standard exercise and a Tai Chi group against a nonactive control group over a period of 6 weeks with a 6-week follow-up. A total of 72 healthy adult participants (aged 18-60 years) who are either Tai Chi naïve or have not practiced Tai Chi in the past 12 months will be randomized into a Tai Chi group (n = 24), an exercise group (n = 24) or a wait-list group (n = 24). The primary outcome measure will be the State Trait Anxiety Inventory with secondary outcome measures being the Perceived Stress Scale 14, heart rate variability, blood pressure, Short Form 36 and a visual analog scale. The protocol is reported using the appropriate Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) items. Copyright © 2014. Published by Elsevier B.V.

Behavioral Family Intervention for Children with Developmental Disabilities and Behavioral Problems

ERIC Educational Resources Information Center

Roberts, Clare; Mazzucchelli, Trevor; Studman, Lisa; Sanders, Matthew R.

2006-01-01

The outcomes of a randomized clinical trial of a new behavioral family intervention, Stepping Stones Triple P, for preschoolers with developmental and behavior problems are presented. Forty-eight children with developmental disabilities participated, 27 randomly allocated to an intervention group and 20 to a wait-list control group. Parents…

Promoting Protective Factors for Young Adolescents: ABCD Parenting Young Adolescents Program Randomized Controlled Trial

ERIC Educational Resources Information Center

Burke, Kylie; Brennan, Leah; Cann, Warren

2012-01-01

This study examined the efficacy of a program for parents of young adolescents combining behavioral family intervention with acceptance-based strategies. 180 parents were randomly allocated to a 6-session group ABCD Parenting Young Adolescent Program or wait-list condition. Completer analysis indicated parents in the intervention reported…

Structuring Process Evaluation to Forecast Use and Sustainability of an Intervention: Theory and Data from the Efficacy Trial for "Lunch Is in the Bag"

ERIC Educational Resources Information Center

Roberts-Gray, Cindy; Sweitzer, Sara J.; Ranjit, Nalini; Potratz, Christa; Rood, Magdalena; Romo-Palafox, Maria Jose; Byrd-Williams, Courtney E.; Briley, Margaret E.; Hoelscher, Deanna M.

2017-01-01

Background: A cluster-randomized trial at 30 early care and education centers (Intervention = 15, waitlist Control = 15) showed the "Lunch Is in the Bag" intervention increased parents' packing of fruits, vegetables, and whole grains in their preschool children's bag lunches (parent-child dyads = 351 Intervention, 282 Control). Purpose:…

Effectiveness of an Internet- and App-Based Intervention for College Students With Elevated Stress: Randomized Controlled Trial

PubMed Central

Adam, Sophia Helen; Fleischmann, Rebecca Jessica; Baumeister, Harald; Auerbach, Randy; Bruffaerts, Ronny; Cuijpers, Pim; Kessler, Ronald C; Berking, Matthias; Lehr, Dirk; Ebert, David Daniel

2018-01-01

Background Mental health problems are highly prevalent among college students. Most students with poor mental health, however, do not receive professional help. Internet-based self-help formats may increase the utilization of treatment. Objective The aim of this randomized controlled trial was to evaluate the efficacy of an internet-based, app-supported stress management intervention for college students. Methods College students (n=150) with elevated levels of stress (Perceived Stress Scale 4-item version, PSS-4 ≥8) were randomly assigned to either an internet- and mobile-based stress intervention group with feedback on demand or a waitlist control group. Self-report data were assessed at baseline, posttreatment (7 weeks), and 3-month follow-up. The primary outcome was perceived stress posttreatment (PSS-4). Secondary outcomes included mental health outcomes, modifiable risk and protective factors, and college-related outcomes. Subgroup analyses were conducted in students with clinically relevant symptoms of depression (Center for Epidemiological Studies’ Depression Scale >17). Results A total of 106 participants (76.8%) indicated that they were first-time help-seekers, and 77.3% (intervention group: 58/75; waitlist control group: 58/75) showed clinically relevant depressive symptoms at baseline. Findings indicated significant effects of the intervention compared with the waitlist control group for stress (d=0.69; 95% CI 0.36-1.02), anxiety (d=0.76; 95% CI 0.43-1.09), depression (d=0.63; 95% CI 0.30-0.96), college-related productivity (d=0.33; 95% CI 0.01-0.65), academic work impairment (d=0.34; 95% CI 0.01-0.66), and other outcomes after 7 weeks (posttreatment). Response rates for stress symptoms were significantly higher for the intervention group (69%, 52/75) compared with the waitlist control group (35%, 26/75, P<.001; number needed to treat=2.89, 95% CI 2.01-5.08) at posttest (7 weeks). Effects were sustained at 3-month follow-up, and similar findings emerged in students with symptoms of depression. Conclusions Internet- and mobile-based interventions could be an effective and cost-effective approach to reduce consequences of college-related stress and might potentially attract students with clinically relevant depression who would not otherwise seek help. Trial Registration German Clinical Trial Register DRKS00010212; http://www.drks.de/drks_web/navigate.do? navigationId=trial.HTML&TRIAL_ID=DRKS00010212 (Archived by WebCite at http://www.webcitation.org/6w55Ewhjd) PMID:29685870

Psychotherapy With Somatosensory Stimulation for Endometriosis-Associated Pain: A Randomized Controlled Trial.

PubMed

Meissner, Karin; Schweizer-Arau, Annemarie; Limmer, Anna; Preibisch, Christine; Popovici, Roxana M; Lange, Isabel; de Oriol, Barbara; Beissner, Florian

2016-11-01

To evaluate whether psychotherapy with somatosensory stimulation is effective for the treatment of pain and quality of life in patients with endometriosis-related pain. Patients with a history of endometriosis and chronic pelvic pain were randomized to either psychotherapy with somatosensory stimulation (ie, different techniques of acupuncture point stimulation) or wait-list control for 3 months, after which all patients were treated. The primary outcome was brain connectivity assessed by functional magnetic resonance imaging. Prespecified secondary outcomes included pain on 11-point numeric rating scales (maximal and average global pain, pelvic pain, dyschezia, and dyspareunia) and physical and mental quality of life. A sample size of 30 per group was planned to compare outcomes in the treatment group and the wait-list control group. From March 2010 through March 2012, 67 women (mean age 35.6 years) were randomly allocated to intervention (n=35) or wait-list control (n=32). In comparison with wait-list controls, treated patients showed improvements after 3 months in maximal global pain (mean group difference -2.1, 95% confidence interval [CI] -3.4 to -0.8; P=.002), average global pain (-2.5, 95% CI -3.5 to -1.4; P<.001), pelvic pain (-1.4, 95% CI -2.7 to -0.1; P=.036), dyschezia (-3.5, 95% CI -5.8 to -1.3; P=.003), physical quality of life (3.8, 95% CI 0.5-7.1, P=.026), and mental quality of life (5.9, 95% CI 0.6-11.3; P=.031); dyspareunia improved nonsignificantly (-1.8, 95% CI -4.4 to 0.7; P=.150). Improvements in the intervention group remained stable at 6 and 24 months, and control patients showed comparable symptom relief after delayed intervention. Psychotherapy with somatosensory stimulation reduced global pain, pelvic pain, and dyschezia and improved quality of life in patients with endometriosis. After 6 and 24 months, when all patients were treated, both groups showed stable improvements. ClinicalTrials.gov, https://clinicaltrials.gov, NCT01321840.

A randomized controlled trial of internet-based therapy in depression.

PubMed

Moritz, Steffen; Schilling, Lisa; Hauschildt, Marit; Schröder, Johanna; Treszl, András

2012-08-01

Depression is among the most prevalent disorders worldwide. In view of numerous treatment barriers, internet-based interventions are increasingly adopted to "treat the untreated". The present trial (registered as NCT01401296) was conducted over the internet and aimed to assess the efficacy of an online self-help program for depression (Deprexis). In random order, participants with elevated depression symptoms received program access or were allocated to a wait-list control condition. After eight weeks, participants were invited to take part in an online re-assessment. To compensate for common problems of online studies, such as low completion rates and unclear diagnostic status, reminders and incentives were used, and clinical diagnoses were externally confirmed in a subgroup of 29% of participants. Relative to the wait-list group, program users experienced significant symptom decline on the Beck Depression Inventory (BDI; primary outcome), the Dysfunctional Attitudes Scale (DAS), the Quality of Life scale (WHOQOL-BREF) and the Rosenberg Self-Esteem Scale (RSE). Compared to wait-list participants, symptom decline was especially pronounced among those with moderate symptoms at baseline as well as those not currently consulting a therapist. Completion (82%) and re-test reliability of the instruments (r = .72-.87) were good. The results of this trial suggest that online treatment can be beneficial for people with depression, particularly for those with moderate symptoms. Copyright © 2012 Elsevier Ltd. All rights reserved.

Cognitive Therapy Versus Exposure and Applied Relaxation in Social Phobia: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Clark, David M.; Ehlers, Anke; Hackmann, Ann; McManus, Freda; Fennell, Melanie; Grey, Nick; Waddington, Louise; Wild, Jennifer

2006-01-01

A new cognitive therapy (CT) program was compared with an established behavioral treatment. Sixty-two patients meeting Diagnostic and Statistical Manual of Mental Disorders (4th ed.; American Psychiatric Association, 1994) criteria for social phobia were randomly assigned to CT, exposure plus applied relaxation (EXP = AR), or wait-list (WAIT). CT…

A Randomized, Controlled Trial of Meditation for Work Stress, Anxiety and Depressed Mood in Full-Time Workers

PubMed Central

Manocha, R.; Black, D.; Sarris, J.; Stough, C.

2011-01-01

Objective. To assess the effect of meditation on work stress, anxiety and mood in full-time workers. Methods. 178 adult workers participated in an 8-week, 3-arm randomized controlled trial comparing a “mental silence” approach to meditation (n = 59) to a “relaxation” active control (n = 56) and a wait-list control (n = 63). Participants were assessed before and after using Psychological Strain Questionnaire (PSQ), a subscale of the larger Occupational Stress Inventory (OSI), the State component of the State/Trait Anxiety Inventory for Adults (STAI), and the depression-dejection (DD) subscale of the Profile of Mood States (POMS). Results. There was a significant improvement for the meditation group compared to both the relaxation control and the wait-list groups the PSQ (P = .026), and DD (P = .019). Conclusions. Mental silence-orientated meditation, in this case Sahaja Yoga meditation, is a safe and effective strategy for dealing with work stress and depressive feelings. The findings suggest that “thought reduction” or “mental silence” may have specific effects relevant to work stress and hence occupational health. PMID:21716708

Glutamate in Pediatric Obsessive-Compulsive Disorder and Response to Cognitive-Behavioral Therapy: Randomized Clinical Trial.

PubMed

O'Neill, Joseph; Piacentini, John; Chang, Susanna; Ly, Ronald; Lai, Tsz M; Armstrong, Casey C; Bergman, Lindsey; Rozenman, Michelle; Peris, Tara; Vreeland, Allison; Mudgway, Ross; Levitt, Jennifer G; Salamon, Noriko; Posse, Stefan; Hellemann, Gerhard S; Alger, Jeffry R; McCracken, James T; Nurmi, Erika L

2017-11-01

Cognitive-behavioral therapy (CBT) is effective for pediatric obsessive-compulsive disorder (OCD), but non-response is common. Brain glutamate (Glu) signaling may contribute to OCD pathophysiology and moderate CBT outcomes. We assessed whether Glu measured with magnetic resonance spectroscopy (MRS) was associated with OCD and/or CBT response. Youths aged 7-17 years with DSM-IV OCD and typically developing controls underwent 3 T proton echo-planar spectroscopic imaging (PEPSI) MRS scans of pregenual anterior cingulate cortex (pACC) and ventral posterior cingulate cortex (vPCC)-regions possibly affected by OCD-at baseline. Controls returned for re-scan after 8 weeks. OCD youth-in a randomized rater-blinded trial-were re-scanned after 12-14 weeks of CBT or after 8 weeks of minimal-contact waitlist; waitlist participants underwent a third scan after crossover to 12-14 weeks of CBT. Forty-nine children with OCD (mean age 12.2±2.9 years) and 29 controls (13.2±2.2 years) provided at least one MRS scan. At baseline, Glu did not differ significantly between OCD and controls in pACC or vPCC. Within controls, Glu was stable from scan-to-scan. Within OCD subjects, a treatment-by-scan interaction (p=0.034) was observed, driven by pACC Glu dropping 19.5% from scan-to-scan for patients randomized to CBT, with minor increases (3.8%) for waitlist participants. The combined OCD participants (CBT-only plus waitlist-CBT) also showed a 16.2% (p=0.004) post-CBT decrease in pACC Glu. In the combined OCD group, within vPCC, lower pre-CBT Glu predicted greater post-CBT improvement in symptoms (CY-BOCS; r=0.81, p=0.00025). Glu may be involved in the pathophysiology of OCD and may moderate response to CBT.

A Breathing-Based Meditation Intervention for Patients With Major Depressive Disorder Following Inadequate Response to Antidepressants: A Randomized Pilot Study.

PubMed

Sharma, Anup; Barrett, Marna S; Cucchiara, Andrew J; Gooneratne, Nalaka S; Thase, Michael E

2017-01-01

To evaluate feasibility, efficacy, and tolerability of Sudarshan Kriya yoga (SKY) as an adjunctive intervention in patients with major depressive disorder (MDD) with inadequate response to antidepressant treatment. Patients with MDD (defined by DSM-IV-TR) who were depressed despite ≥ 8 weeks of antidepressant treatment were randomized to SKY or a waitlist control (delayed yoga) arm for 8 weeks. The primary efficacy end point was change in 17-item Hamilton Depression Rating Scale (HDRS-17) total score from baseline to 2 months. The key secondary efficacy end points were change in Beck Depression Inventory (BDI) and Beck Anxiety Inventory (BAI) total scores. Analyses of the intent-to-treat (ITT) and completer sample were performed. The study was conducted at the University of Pennsylvania between October 2014 and December 2015. In the ITT sample (n = 25), the SKY arm (n = 13) showed a greater improvement in HDRS-17 total score compared to waitlist control (n = 12) (-9.77 vs 0.50, P = .0032). SKY also showed greater reduction in BDI total score versus waitlist control (-17.23 vs -1.75, P = .0101). Mean changes in BAI total score from baseline were significantly greater for SKY than waitlist (ITT mean difference: -5.19; 95% CI, -0.93 to -9.34; P = .0097; completer mean difference: -6.23; 95% CI, -1.39 to -11.07; P = .0005). No adverse events were reported. Results of this randomized, waitlist-controlled pilot study suggest the feasibility and promise of an adjunctive SKY-based intervention for patients with MDD who have not responded to antidepressants. ClinicalTrials.gov identifier: NCT02616549. © Copyright 2016 Physicians Postgraduate Press, Inc.

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

Moderating Effects of Parental Characteristics on the Effectiveness of a Theory of Mind Training for Children with Autism: A Randomized Controlled Trial

ERIC Educational Resources Information Center

de Veld, Danielle M. J.; Howlin, Patricia; Hoddenbach, Elske; Mulder, Fleur; Wolf, Imke; Koot, Hans M.; Lindauer, Ramón; Begeer, Sander

2017-01-01

This RCT investigated whether the effect of a Theory of Mind (ToM) intervention for children with ASD was moderated by parental education level and employment, family structure, and parental ASD. Children with autism aged 8-13 years (n = 136) were randomized over a waitlist control or treatment condition. At posttest, children in the treatment…

The Effects of Twelve Weeks of Tai Chi Practice on Anxiety in Stressed But Healthy People Compared to Exercise and Wait-List Groups-A Randomized Controlled Trial.

PubMed

Zheng, Shuai; Kim, Christine; Lal, Sara; Meier, Peter; Sibbritt, David; Zaslawski, Chris

2018-01-01

This randomized controlled trial was undertaken to determine whether 12 weeks of Tai Chi (TC) practice can reduce anxiety in healthy but stressed people. Fifty participants were randomized into TC (n=17), exercise (n=17), and wait-list (WL) groups (n=16). Outcome measures used were State Trait Anxiety Inventory, Perceived Stress Scale 14 (PSS14), blood pressure and heart rate variability, visual analogue scale (VAS), and Short Form 36. Significant improvements were observed from baseline for both TC and exercise groups for both state (p <0.01) and trait (p <0.01) anxiety, PSS14 (p <0.01), VAS (p <0.01), mental health domain (p <0.01), and vitality domain (p <0.01). Superior outcomes were also observed for TC when compared with WL for state and trait anxiety (p <0.01) and mental health domain (p <0.05). TC reduces stress levels in healthy individuals and provides a safer, cost effective, and less physically vigorous alternative to exercise. © 2017 Wiley Periodicals, Inc.

Relationship of cravings with weight loss and hunger: results from a 6 month worksite weight loss intervention

USDA-ARS?s Scientific Manuscript database

We examined the association of food cravings with weight loss and eating behaviors in a 6 month worksite lifestyle weight loss program. This randomized controlled trial of the intervention versus a wait-listed control was conducted at 4 worksites, and 95 participants completed outcome assessments ...

Social Mishap Exposures for Social Anxiety Disorder: An Important Treatment Ingredient

ERIC Educational Resources Information Center

Fang, Angela; Sawyer, Alice T.; Asnaani, Anu; Hofmann, Stefan G.

2013-01-01

Conventional cognitive-behavioral therapy for social anxiety disorder, which is closely based on the treatment for depression, has been shown to be effective in numerous randomized placebo-controlled trials. Although this intervention is more effective than waitlist control group and placebo conditions, a considerable number of clients do not…

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 health economic and qualitative analyses to deepen the knowledge of the program. We further discuss some issues regarding the implementation of the program in municipalities and city districts. Trial registration Current Controlled Trials ISRCTN70202532 PMID:23890316

Cognitive-behavioral conjoint therapy for PTSD improves various PTSD symptoms and trauma-related cognitions: Results from a randomized controlled trial.

PubMed

Macdonald, Alexandra; Pukay-Martin, Nicole D; Wagner, Anne C; Fredman, Steffany J; Monson, Candice M

2016-02-01

Numerous studies document an association between posttraumatic stress disorder (PTSD) and impairments in intimate relationship functioning, and there is evidence that PTSD symptoms and associated impairments are improved by cognitive-behavioral conjoint therapy for PTSD (CBCT for PTSD; Monson & Fredman, 2012). The present study investigated changes across treatment in clinician-rated PTSD symptom clusters and patient-rated trauma-related cognitions in a randomized controlled trial comparing CBCT for PTSD with waitlist in a sample of 40 individuals with PTSD and their partners (N = 40; Monson et al., 2012). Compared with waitlist, patients who received CBCT for PTSD immediately demonstrated greater improvements in all PTSD symptom clusters, trauma-related beliefs, and guilt cognitions (Hedge's gs -.33 to -1.51). Results suggest that CBCT for PTSD improves all PTSD symptom clusters and trauma-related cognitions among individuals with PTSD and further supports the value of utilizing a couple-based approach to the treatment of PTSD. (c) 2016 APA, all rights reserved).

Study protocol of a multicenter randomized controlled trial of mindfulness training to reduce burnout and promote quality of life in police officers: the POLICE study.

PubMed

Trombka, Marcelo; Demarzo, Marcelo; Bacas, Daniel Campos; Antonio, Sonia Beira; Cicuto, Karen; Salvo, Vera; Claudino, Felipe Cesar Almeida; Ribeiro, Letícia; Christopher, Michael; Garcia-Campayo, Javier; Rocha, Neusa Sica

2018-05-25

Police officers experience a high degree of chronic stress. Policing ranks among the highest professions in terms of disease and accident rates. Mental health is particularly impacted, evidenced by elevated rates of burnout, anxiety and depression, and poorer quality of life than the general public. Mindfulness training has been shown to reduce stress, anxiety, burnout and promote quality of life in a variety of settings, although its efficacy in this context has yet to be systematically evaluated. Therefore, this trial will investigate the efficacy of a mindfulness-based intervention versus a waitlist control in improving quality of life and reducing negative mental health symptoms in police officers. This multicenter randomized controlled trial has three assessment points: baseline, post-intervention, and six-month follow-up. Active police officers (n = 160) will be randomized to Mindfulness-Based Health Promotion (MBHP) or waitlist control group at two Brazilian major cities: Porto Alegre and São Paulo. The primary outcomes are burnout symptoms and quality of life. Consistent with the MBHP conceptual model, assessed secondary outcomes include perceived stress, anxiety and depression symptoms, and the potential mechanisms of resilience, mindfulness, decentering, self-compassion, spirituality, and religiosity. Findings from this study will inform and guide future research, practice, and policy regarding police offer health and quality of life in Brazil and globally. ClinicalTrials.gov NCT03114605 . Retrospectively registered on March 21, 2017.

Mindfulness-Based Cognitive Therapy for Individuals Whose Lives Have Been Affected by Cancer: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Foley, Elizabeth; Baillie, Andrew; Huxter, Malcolm; Price, Melanie; Sinclair, Emma

2010-01-01

Objective: This study evaluated the effectiveness of mindfulness-based cognitive therapy (MBCT) for individuals with a diagnosis of cancer. Method: Participants (N = 115) diagnosed with cancer, across site and stage, were randomly allocated to either the treatment or the wait-list condition. Treatment was conducted at 1 site, by a single…

A Randomized Trial of a Computer-Assisted Tutoring Program Targeting Letter-Sound Expression

ERIC Educational Resources Information Center

DuBois, Matthew R.; Volpe, Robert J.; Hemphill, Elizabeth M.

2014-01-01

Given that many schools have limited resources and a high proportion of students who present with deficits in early literacy skills, supports aimed at preventing reading failure must be simple and efficient and generate meaningful changes in student learning. We used a randomized group design with a wait-list control to extend the work of Volpe,…

A randomized waitlist-controlled trial of culturally sensitive relationship education for male same-sex couples.

PubMed

Whitton, Sarah W; Weitbrecht, Eliza M; Kuryluk, Amanda D; Hutsell, David W

2016-09-01

Relationship education, effective in improving relationship quality among different-sex couples, represents a promising and nonstigmatizing approach to promoting the health and stability of same-sex couples. A new culturally sensitive relationship education program was developed specifically for male same-sex couples, which includes adaptations of evidence-based strategies to build core relationship skills (e.g., communication skills training) and newly developed content to address unique challenges faced by this group (e.g., discrimination; low social support). A small randomized waitlist-control trial (N = 20 couples) was conducted to evaluate the program. To assess program efficacy, dyadic longitudinal data (collected at pre- and postprogram and 3-month follow-up) were analyzed using multilevel models that accounted for nonindependence in data from indistinguishable dyads. Results indicated significant program effects in comparison to waitlist controls on couple constructive and destructive communication, perceived stress, and relationship satisfaction. Gains in each of these areas were maintained at 3-month follow-up. Although there was no evidence of within-person program effects on social support, satisfaction, or relationship instability immediately postprogram, all 3 showed within-person improvements by follow-up. Ratings of program satisfaction were high. In summary, study findings support the feasibility, acceptability, and initial efficacy of the program and highlight the potential value of culturally sensitive adaptations of relationship education for same-sex couples. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

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

PubMed

Hillier, Susan; McIntyre, Auburn; Plummer, Leanne

2010-05-01

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

The effect of waiting: A meta-analysis of wait-list control groups in trials for tinnitus distress.

PubMed

Hesser, Hugo; Weise, Cornelia; Rief, Winfried; Andersson, Gerhard

2011-04-01

The response rates and effects of being placed on a wait-list control condition are well documented in psychiatric populations. Despite the usefulness of such estimates and the frequent use of no-treatment controls in clinical trials for tinnitus, the effect of waiting in a tinnitus trial has not been investigated systematically. The aim of the present study was to quantify the overall effect of wait-list control groups on tinnitus distress. Studies were retrieved via a systematic review of randomised controlled trials of cognitive behaviour therapy for tinnitus distress. Outcomes of psychometrically robust tinnitus-specific measures (Tinnitus Handicap Inventory, Tinnitus Questionnaire, Tinnitus Reaction Questionnaire) from wait-list control groups were quantified using meta-analytic techniques. Percentage of change and standard mean difference effect sizes were calculated using the pre and post wait period. Eleven studies involving 314 wait-list subjects with tinnitus were located. The analysis for a waiting period of 6 to 12 weeks revealed a mean decrease in scores on tinnitus-specific measures of 3% to 8%. Across studies, a statically significant small mean within-group effect size was obtained (Hedges' g=.17). The effects were moderated by methodological quality of the trial, sample characteristics (i.e., age, tinnitus duration), time of the wait-list and how diagnosis was established. Subjects in a tinnitus trial improve in tinnitus distress over a short waiting phase. The effects of waiting are highly variable and depend on the characteristics of the sample and of the trial. Copyright © 2011 Elsevier Inc. All rights reserved.

Mobile Phone-Delivered Cognitive Behavioral Therapy for Insomnia: A Randomized Waitlist Controlled Trial.

PubMed

Horsch, Corine Hg; Lancee, Jaap; Griffioen-Both, Fiemke; Spruit, Sandor; Fitrianie, Siska; Neerincx, Mark A; Beun, Robbert Jan; Brinkman, Willem-Paul

2017-04-11

This study is one of the first randomized controlled trials investigating cognitive behavioral therapy for insomnia (CBT-I) delivered by a fully automated mobile phone app. Such an app can potentially increase the accessibility of insomnia treatment for the 10% of people who have insomnia. The objective of our study was to investigate the efficacy of CBT-I delivered via the Sleepcare mobile phone app, compared with a waitlist control group, in a randomized controlled trial. We recruited participants in the Netherlands with relatively mild insomnia disorder. After answering an online pretest questionnaire, they were randomly assigned to the app (n=74) or the waitlist condition (n=77). The app packaged a sleep diary, a relaxation exercise, sleep restriction exercise, and sleep hygiene and education. The app was fully automated and adjusted itself to a participant's progress. Program duration was 6 to 7 weeks, after which participants received posttest measurements and a 3-month follow-up. The participants in the waitlist condition received the app after they completed the posttest questionnaire. The measurements consisted of questionnaires and 7-day online diaries. The questionnaires measured insomnia severity, dysfunctional beliefs about sleep, and anxiety and depression symptoms. The diary measured sleep variables such as sleep efficiency. We performed multilevel analyses to study the interaction effects between time and condition. The results showed significant interaction effects (P<.01) favoring the app condition on the primary outcome measures of insomnia severity (d=-0.66) and sleep efficiency (d=0.71). Overall, these improvements were also retained in a 3-month follow-up. This study demonstrated the efficacy of a fully automated mobile phone app in the treatment of relatively mild insomnia. The effects were in the range of what is found for Web-based treatment in general. This supports the applicability of such technical tools in the treatment of insomnia. Future work should examine the generalizability to a more diverse population. Furthermore, the separate components of such an app should be investigated. It remains to be seen how this app can best be integrated into the current health regimens. Netherlands Trial Register: NTR5560; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5560 (Archived by WebCite at http://www.webcitation.org/6noLaUdJ4). ©Corine HG Horsch, Jaap Lancee, Fiemke Griffioen-Both, Sandor Spruit, Siska Fitrianie, Mark A Neerincx, Robbert Jan Beun, Willem-Paul Brinkman. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 11.04.2017.

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 deepen the knowledge of the program. We further discuss some issues regarding the implementation of the program in municipalities and city districts. Current Controlled Trials ISRCTN70202532.

Telephone-Based Physical Activity Counseling for Major Depression in People with Multiple Sclerosis

ERIC Educational Resources Information Center

Bombardier, Charles H.; Ehde, Dawn M.; Gibbons, Laura E.; Wadhwani, Roini; Sullivan, Mark D.; Rosenberg, Dori E.; Kraft, George H.

2013-01-01

Objective: Physical activity represents a promising treatment for major depressive disorder (MDD) in people with multiple sclerosis (MS). We conducted a single-blind, two-arm randomized controlled trial comparing a 12-week physical activity counseling intervention delivered primarily by telephone (n = 44) to a wait-list control group (N = 48).…

Parenting Intervention Combined With Acceptance and Commitment Therapy: A Trial With Families of Children With Cerebral Palsy.

PubMed

Whittingham, Koa; Sanders, Matthew R; McKinlay, Lynne; Boyd, Roslyn N

2016-06-01

To examine the effects of Stepping Stones Triple P (SSTP) and Acceptance and Commitment Therapy (ACT) on child functioning, quality of life, and parental adjustment. 67 parents (97.0% mothers) of children (64.2% male; mean age 5.3 ± 3.0 years) with cerebral palsy participated in a randomized controlled trial with three groups: wait-list control, SSTP, and SSTP + ACT. This article details the secondary outcomes. In comparison with wait-list, the SSTP + ACT group showed increased functional performance and quality of life as well as decreased parental psychological symptoms. No differences were found for parental confidence. No differences were found between SSTP and wait-list or between SSTP and SSTP + ACT. ACT-integrated parenting intervention may be an effective way to target child functioning, quality of life, and parental adjustment. © The Author 2015. 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.

Treatment of intra-oral injection phobia: a randomized delayed intervention controlled trial among Norwegian 10- to 16-year-olds.

PubMed

Berge, Karin G; Agdal, Maren Lillehaug; Vika, Margrethe; Skeie, Marit Slåttelid

2017-05-01

To evaluate the effect of five sessions of cognitive behavioural therapy (CBT) for 10- to 16-year-olds with intra-oral injection phobia. This was a randomized delayed intervention controlled trial in 67 patients, fulfilling the DSM-5 criteria for specific phobia. All patients received the same CBT performed by dentists specially trained in CBT. The patients were randomly assigned to either an immediate treatment group (ITG) (34 patients) or a waitlist-control group (WCG) (33 patients). The WCG was put on a waitlist for 5 weeks. After treatment, all patients were combined for post-treatment analyses. Assessments including the psychometric self-report scales Intra-oral injection fear scale (IOIF-s), Children's Fear Survey Schedule-Dental Subscale (CFSS-DS), Injection Phobia Scale for children (IS-c) and Mutilation Questionnaire for children (MQ-c) and a behavioural avoidance test (BAT) followed by a questionnaire on cognitions during the BAT, occurred pre-, post-treatment/waitlist and at a 1-year follow-up. CBT had a significant effect compared to no treatment (WCG). After treatment, the scores on the psychometric self-report scales were significantly reduced and higher levels in the BAT were achieved. The results were maintained at 1-year follow-up. Of the 67 patients, 70.1% received intra-oral injections during CBT treatment, whereas 69.4% of those completing the CBT, in need for further dental treatment, managed to receive the necessary intra-oral injections at their regular dentist. The 10- to 16-year-olds diagnosed with intra-oral injection phobia benefitted positively on CBT performed by specially trained dentists.

Efficacy of an internet-based intervention for burnout: a randomized controlled trial in the German working population.

PubMed

Jonas, Benjamin; Leuschner, Fabian; Tossmann, Peter

2017-03-01

Internet-based interventions are a viable treatment option for various mental problems. However, their effects on the burnout syndrome yielded mixed results. In this paper, we examine the efficacy of a structured and therapist-guided internet intervention, based on solution-focused and cognitive-behavioral therapy, for individuals with symptoms of burnout. Two-arm, Internet-based, randomized, wait-list controlled trial (RCT). Participants were recruited through in-house events and online advertising. They were randomly assigned to the intervention or a wait-list. Group comparison was conducted three months after randomization. Outcomes were the burnout level according to the Maslach Burnout Inventory (MBI-GS) and the levels of depression, anxiety and stress according to the DASS-21. Thirty-nine participants were included in the trial; 36 (92.3%) took part at the 3-months-follow-up. Intention-to-treat analyses revealed significant group differences in favor of the intervention group in depression (d = 0.66), cynicism (d = 0.87) and personal accomplishment (d = 0.75). The intervention helped ameliorate symptoms of work-related stress and burnout. Although limited by a small sample size, the study suggests that the program provides effective support for affected individuals. However, further studies with bigger sample sizes should be conducted to examine the effects of such programs more precisely.

The Effects of Mindfulness-Based Intervention on Children's Attention Regulation.

PubMed

Felver, Joshua C; Tipsord, Jessica M; Morris, Maxwell J; Racer, Kristina Hiatt; Dishion, Thomas J

2017-08-01

This article describes results from a randomized clinical trial of a mindfulness-based intervention for parents and children, Mindful Family Stress Reduction, on a behavioral measure of attention in youths, the Attention Network Task (ANT). Forty-one parent-child dyads were randomly assigned to either the mindfulness-based intervention condition or a wait-list control. School-age youths completed the ANT before and after the intervention. Results demonstrate significant, medium-size ( f 2 = -.16) intervention effects to the conflict monitoring subsystem of the ANT such that those in the intervention condition decreased in conflict monitoring more than those in the wait-list control. Youths in the intervention condition also showed improvements in their orienting subsystem scores, compared with controls. Mindfulness-based interventions for youths have potential utility to improve attentional self-regulation, and future research should consider incorporating measures of attention into interventions that use mindfulness training.

Quasi-experimental designs in practice-based research settings: design and implementation considerations.

PubMed

Handley, Margaret A; Schillinger, Dean; Shiboski, Stephen

2011-01-01

Although randomized controlled trials are often a gold standard for determining intervention effects, in the area of practice-based research (PBR), there are many situations in which individual randomization is not possible. Alternative approaches to evaluating interventions have received increased attention, particularly those that can retain elements of randomization such that they can be considered "controlled" trials. Methodological design elements and practical implementation considerations for two quasi-experimental design approaches that have considerable promise in PBR settings--the stepped-wedge design, and a variant of this design, a wait-list cross-over design, are presented along with a case study from a recent PBR intervention for patients with diabetes. PBR-relevant design features include: creation of a cohort over time that collects control data but allows all participants (clusters or patients) to receive the intervention; staggered introduction of clusters; multiple data collection points; and one-way cross-over into the intervention arm. Practical considerations include: randomization versus stratification, training run in phases; and extended time period for overall study completion. Several design features of practice based research studies can be adapted to local circumstances yet retain elements to improve methodological rigor. Studies that utilize these methods, such as the stepped-wedge design and the wait-list cross-over design, can increase the evidence base for controlled studies conducted within the complex environment of PBR.

Effectiveness of an Internet- and App-Based Intervention for College Students With Elevated Stress: Randomized Controlled Trial.

PubMed

Harrer, Mathias; Adam, Sophia Helen; Fleischmann, Rebecca Jessica; Baumeister, Harald; Auerbach, Randy; Bruffaerts, Ronny; Cuijpers, Pim; Kessler, Ronald C; Berking, Matthias; Lehr, Dirk; Ebert, David Daniel

2018-04-23

Mental health problems are highly prevalent among college students. Most students with poor mental health, however, do not receive professional help. Internet-based self-help formats may increase the utilization of treatment. The aim of this randomized controlled trial was to evaluate the efficacy of an internet-based, app-supported stress management intervention for college students. College students (n=150) with elevated levels of stress (Perceived Stress Scale 4-item version, PSS-4 ≥8) were randomly assigned to either an internet- and mobile-based stress intervention group with feedback on demand or a waitlist control group. Self-report data were assessed at baseline, posttreatment (7 weeks), and 3-month follow-up. The primary outcome was perceived stress posttreatment (PSS-4). Secondary outcomes included mental health outcomes, modifiable risk and protective factors, and college-related outcomes. Subgroup analyses were conducted in students with clinically relevant symptoms of depression (Center for Epidemiological Studies' Depression Scale >17). A total of 106 participants (76.8%) indicated that they were first-time help-seekers, and 77.3% (intervention group: 58/75; waitlist control group: 58/75) showed clinically relevant depressive symptoms at baseline. Findings indicated significant effects of the intervention compared with the waitlist control group for stress (d=0.69; 95% CI 0.36-1.02), anxiety (d=0.76; 95% CI 0.43-1.09), depression (d=0.63; 95% CI 0.30-0.96), college-related productivity (d=0.33; 95% CI 0.01-0.65), academic work impairment (d=0.34; 95% CI 0.01-0.66), and other outcomes after 7 weeks (posttreatment). Response rates for stress symptoms were significantly higher for the intervention group (69%, 52/75) compared with the waitlist control group (35%, 26/75, P<.001; number needed to treat=2.89, 95% CI 2.01-5.08) at posttest (7 weeks). Effects were sustained at 3-month follow-up, and similar findings emerged in students with symptoms of depression. Internet- and mobile-based interventions could be an effective and cost-effective approach to reduce consequences of college-related stress and might potentially attract students with clinically relevant depression who would not otherwise seek help. German Clinical Trial Register DRKS00010212; http://www.drks.de/drks_web/navigate.do? navigationId=trial.HTML&TRIAL_ID=DRKS00010212 (Archived by WebCite at http://www.webcitation.org/6w55Ewhjd). ©Mathias Harrer, Sophia Helen Adam, Rebecca Jessica Fleischmann, Harald Baumeister, Randy Auerbach, Ronny Bruffaerts, Pim Cuijpers, Ronald C Kessler, Matthias Berking, Dirk Lehr, David Daniel Ebert. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 23.04.2018.

Randomized controlled trial of a cognitive-behavioral intervention for HIV-positive persons: an investigation of treatment effects on psychosocial adjustment.

PubMed

Carrico, Adam W; Chesney, Margaret A; Johnson, Mallory O; Morin, Stephen F; Neilands, Torsten B; Remien, Robert H; Rotheram-Borus, Mary Jane; Lennie Wong, F

2009-06-01

Questions remain regarding the clinical utility of psychological interventions for HIV-positive persons because randomized controlled trials have utilized stringent inclusion criteria and focused extensively on gay men. The present randomized controlled trial examined the efficacy of a 15-session, individually delivered cognitive-behavioral intervention (n = 467) compared to a wait-list control (n = 469) in a diverse sample of HIV-positive persons who reported HIV transmission risk behavior. Five intervention sessions that dealt with executing effective coping responses were delivered between baseline and the 5 months post-randomization. Additional assessments were completed through 25 months post-randomization. Despite previously documented reductions in HIV transmission risk, no intervention-related changes in psychosocial adjustment were observed across the 25-month investigation period. In addition, there were no intervention effects on psychosocial adjustment among individuals who presented with mild to moderate depressive symptoms. More intensive mental health interventions may be necessary to improve psychosocial adjustment among HIV-positive individuals.

Randomized, Controlled Trial of CBT Training for PTSD Providers

DTIC Science & Technology

2013-10-01

Statistician and Co- Investigator), Michelle Pucillo, MPH (Project Manager ), Gayatri Ranganathan , MS (Statistician), Julia Coleman (Research Associate...Journal of Consulting and Clinical Psychology, 74, 898-907. Ruzek, J. I., Friedman, M. J., & Murray, S. (2005). Toward a knowledge management system...result in superior CBT skills than wait-list control. Secondary Aim #1: To compare improvements in knowledge and attitudes following internet- based

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

PubMed

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

2013-01-01

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

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

PubMed Central

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

2013-01-01

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

Improvement in Social Competence Using a Randomized Trial of a Theatre Intervention for Children with Autism Spectrum Disorder

ERIC Educational Resources Information Center

Corbett, Blythe A.; Key, Alexandra P.; Qualls, Lydia; Fecteau, Stephanie; Newsom, Cassandra; Coke, Catherine; Yoder, Paul

2016-01-01

The efficacy of a peer-mediated, theatre-based intervention on social competence in participants with autism spectrum disorder (ASD) was tested. Thirty 8-to-14 year-olds with ASD were randomly assigned to the treatment (n = 17) or a wait-list control (n = 13) group. Immediately after treatment, group effects were seen on social ability,…

Cognitive Processing Therapy for Veterans with Military-Related Posttraumatic Stress Disorder

ERIC Educational Resources Information Center

Monson, Candice M.; Schnurr, Paula P.; Resick, Patricia A.; Friedman, Matthew J.; Young-Xu, Yinong; Stevens, Susan P.

2006-01-01

Sixty veterans (54 men, 6 women) with chronic military-related posttraumatic stress disorder (PTSD) participated in a wait-list controlled trial of cognitive processing therapy (CPT). The overall dropout rate was 16.6% (20% from CPT, 13% from waiting list). Random regression analyses of the intention-to-treat sample revealed significant…

A Waitlist-Controlled Trial of Behavioral Parent Training for Fathers of Children with ADHD

ERIC Educational Resources Information Center

Fabiano, Gregory A.; Pelham, William E.; Cunningham, Charles E.; Yu, Jihnhee; Gangloff, Brian; Buck, Melina; Linke, Stuart; Gormley, Matthew; Gera, Shradha

2012-01-01

Fathers, in general, have been underrepresented in studies of parent training outcome for children with attention deficit hyperactivity disorder (ADHD), and the present study aimed to investigate the efficacy of a behavioral parent training program developed expressly for fathers. The present investigation randomly assigned 55 fathers of children…

Child Directed Interaction Training for Young Children in Kinship Care: A Pilot Study

PubMed Central

N’zi, Amanda M.; Stevens, Monica L.; Eyberg, Sheila M.

2016-01-01

This pilot study used a randomized controlled trial design to examine the feasibility and explore initial outcomes of a twice weekly, 8-session Child Directed Interaction Training (CDIT) program for children living in kinship care. Participants included 14 grandmothers and great-grandmothers with their 2- to 7-year-old children randomized either to CDIT or a waitlist control condition. Training was delivered at a local, community library with high fidelity to the training protocol. There was no attrition in either condition. After training, kinship caregivers in the CDIT condition demonstrated more positive relationships with their children during behavioral observation. The caregivers in the CDIT condition also reported clinically and statistically significant decreases in parenting stress and caregiver depression, as well as fewer externalizing child behavior problems than waitlist controls. Parent daily report measures indicated significant changes in disciplining that included greater use of limit-setting and less use of critical verbal force. Results appeared stable at 3-month follow-up. Changes in child internalizing behaviors and caregiver use of non-critical verbal force were not seen until 3-month follow-up. Results of this pilot study suggest both the feasibility of conducting full scale randomized clinical trials of CDIT in the community and the promise of this approach for providing effective parent training for kinship caregivers. PMID:27012997

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.

A home-based intervention to reduce depressive symptoms and improve quality of life in older African Americans: a randomized trial.

PubMed

Gitlin, Laura N; Harris, Lynn Fields; McCoy, Megan C; Chernett, Nancy L; Pizzi, Laura T; Jutkowitz, Eric; Hess, Edward; Hauck, Walter W

2013-08-20

Effective care models for treating older African Americans with depressive symptoms are needed. To determine whether a home-based intervention alleviates depressive symptoms and improves quality of life in older African Americans. Parallel, randomized trial stratified by recruitment site. Interviewers assessing outcomes were blinded to treatment assignment. (ClinicalTrials.gov: NCT00511680). A senior center and participants' homes from 2008 to 2010. African Americans aged 55 years or older with depressive symptoms. A multicomponent, home-based intervention delivered by social workers or a wait-list control group that received the intervention at 4 months. Self-reported depression severity at 4 months (primary outcome) and depression knowledge, quality of life, behavioral activation, anxiety, function, and remission at 4 and 8 months. Of 208 participants (106 and 102 in the intervention and wait-list groups, respectively), 182 (89 and 93, respectively) completed 4 months and 160 (79 and 81, respectively) completed 8 months. At 4 months, participants in the intervention group showed reduced depression severity (difference in mean change in Patient Health Questionnaire-9 score from baseline, -2.9 [95% CI, -4.6 to -1.2]; difference in mean change in Center for Epidemiologic Studies Depression Scale score from baseline, -3.7 [CI, -5.4 to -2.1]); improved depression knowledge, quality of life, behavioral activation, and anxiety (P < 0.001); and improved function (P = 0.014) compared with wait-list participants. More intervention than wait-list participants entered remission at 4 months (43.8% vs. 26.9%). After treatment, control participants showed benefits similar in magnitude to those of participants in the initial intervention group. Those in the initial intervention group maintained benefits at 8 months. The study had a small sample, short duration, and differential withdrawal rate. A home-based intervention delivered by social workers could reduce depressive symptoms and enhance quality of life in most older African Americans. National Institute of Mental Health.

Study protocol on comparative effectiveness of mindfulness meditation and qigong on psychophysiological outcomes for patients with colorectal cancer: a randomized controlled trial.

PubMed

Ho, Rainbow T H; Wan, Adrian H Y; Chan, Jessie S M; Ng, S M; Chung, K F; Chan, Cecilia L W

2017-08-08

Colorectal cancer imposes threats to patients' well-being. Although most physical symptoms can be managed by medication, psychosocial stressors may complicate survival and hamper quality of life. Mindfulness and Qigong, two kinds of mind-body exercise rooted in Eastern health philosophy, has been found effective in symptoms management, improving mental health, and reducing stress. With these potential benefits, a randomized controlled trial (RCT) is planned to investigate the comparative effectiveness of mindfulness and Baduanjin intervention on the bio-psychosocial wellbeing of people with colorectal cancer. A 3-arm RCT with waitlist control design will be used in this study. One hundred eighty-nine participants will be randomized into (i) Mindfulness, (ii) Baduanjin, or (iii) waitlist control groups. Participants in both the Baduanjin and mindfulness groups will receive 8-weeks of specific intervention. All three groups will undergo four assessment phases: (i) at baseline, (ii) at 4-week, (iii) at 8-week (post-intervention), and 6-month post-intervention (maintenance). All participants will be assessed in terms of cancer-related symptoms and symptom distress, mental health status, quality of life, stress level based on physiological marker. Based on prior research studies, participants in both the mindfulness and Baduanjn intervention group are expected to have better symptoms management, lower stress level, better mental health, and higher level of quality of life than the control group. This study contributes to better understanding on the common and unique effectiveness of mindfulness and Baduanjin qigong, as such patients and qualified healthcare professionals can select or provide practices which will produce maximum benefits, satisfaction, adherence, and sustainability. The trial has been registered in the Clinical Trials Centre of the University of Hong Kong ( HKCTR-2198 ) on 08 March 2017.

Randomized Clinical Trial Replication of a Psychosocial Treatment for Children with High-Functioning Autism Spectrum Disorders

ERIC Educational Resources Information Center

Thomeer, Marcus L.; Lopata, Christopher; Volker, Martin A.; Toomey, Jennifer A.; Lee, Gloria K.; Smerbeck, Audrey M.; Rodgers, Jonathan D.; McDonald, Christin A.; Smith, Rachael A.

2012-01-01

This replication randomized clinical trial examined the efficacy of a comprehensive psychosocial intervention for children aged 7 to 12 years with high-functioning autism spectrum disorders (HFASDs). Participants were randomly assigned to treatment or wait-list conditions. Treatment included instruction and therapeutic activities targeting social…

Psychological Intervention for Improving Cognitive Function in Cancer Survivors: A Literature Review and Randomized Controlled Trial

PubMed Central

King, Summer; Green, Heather Joy

2015-01-01

Although the impact of cancer and associated treatments on cognitive functioning is becoming an increasingly recognized problem, there are few published studies that have investigated psychological interventions to address this issue. A waitlist randomized controlled trial methodology was used to assess the efficacy of a group cognitive rehabilitation intervention (“ReCog”) that successfully targeted cancer-related cognitive decline in previously published pilot research. Participants were 29 cancer survivors who were randomly allocated to either the intervention group or a waitlist group who received the intervention at a later date, and 16 demographically matched community volunteers with no history of cancer (trial registration ACTRN12615000009516, available at http://www.ANZCTR.org.au/ACTRN12615000009516.aspx). The study was the first to include an adapted version of the Traumatic Brain Injury Self-Efficacy Scale to assess cognitive self-efficacy (CSE) in people who have experienced cancer. Results revealed participating in the intervention was associated with significantly faster performance on one objective cognitive task that measures processing speed and visual scanning. Significantly larger improvements for the intervention group were also found on measures of perceived cognitive impairments and CSE. There was some evidence to support the roles of CSE and illness perceptions as potential mechanisms of change for the intervention. Overall, the study provided additional evidence of feasibility and efficacy of group psychological intervention for targeting cancer-related cognitive decline. PMID:25859431

Can Physical Education and Physical Activity Outcomes Be Developed Simultaneously Using a Game-Centered Approach?

ERIC Educational Resources Information Center

Miller, Andrew; Christensen, Erin; Eather, Narelle; Gray, Shirley; Sproule, John; Keay, Jeanne; Lubans, David

2016-01-01

The primary objective of this study was to evaluate the efficacy of a pilot intervention using a game-centered approach for improvement of physical activity (PA) and physical education (PE) outcomes simultaneously, and if this had an impact on enjoyment of PE. A group-randomized controlled trial with a 7-week wait-list control group was conducted…

Long-Term Effectiveness of a Stress Management Intervention at Work: A 9-Year Follow-Up Study Based on a Randomized Wait-List Controlled Trial in Male Managers.

PubMed

Li, Jian; Riedel, Natalie; Barrech, Amira; Herr, Raphael M; Aust, Birgit; Mörtl, Kathrin; Siegrist, Johannes; Gündel, Harald; Angerer, Peter

2017-01-01

Short- and medium-term effectiveness (up to 3 years) of individual level stress management interventions (SMI) at work were demonstrated, yet long-term effectiveness remains unexplored. We therefore aimed to address this research gap. 94 male middle managers participated in a randomized wait-list controlled trial between 2006 and 2008 and in a post-trial-follow-up survey in 2015. During the first two years, all received an 18-hour psychotherapeutic SMI intervention which was based on the Effort-Reward Imbalance (ERI) model: tackling stressor on mismatch between effort and reward and promoting recovery on overcommitment. Work stress (i.e., ERI indicators) was the primary outcome, and the secondary outcome was depressive symptoms. The long-term effectiveness of the SMI was examined by mixed modeling, using an external control group ( n = 94). Effort and reward were substantially improved with significant intervention ⁎ time interaction effects ( p < 0.001) compared to the external control group; effects on overcommitment and depressive symptoms were also significant ( p < 0.05 and p < 0.01, resp.), though their trajectories in the intervention group were less sustainable. The effectiveness of this psychotherapeutic SMI at work based on the ERI model was observed over a 9-year period, particularly on the effort-reward ratio.

Educational program for middle-level public health nurses to develop new health services regarding community health needs: protocol for a randomized controlled trial.

PubMed

Yoshioka-Maeda, Kyoko; Katayama, Takafumi; Shiomi, Misa; Hosoya, Noriko

2018-01-01

Developing health services is a key strategy for improving the community health provided by public health nurses. However, an effective educational program for improving their skills in planning such services has not been developed. To describe our program and its evaluation protocol for the education of middle-level public health nurses to improve their skills in developing new health services to fulfil community health needs in Japan. In this randomized control trial, eligible participants in Japan will be randomly allocated to an intervention group and a control wait-list group. We will provide 8 modules of web-based learning for public health nurses from July to October 2018. To ensure fairness of educational opportunity, the wait-list group will participate in the same program as the intervention group after collection of follow-up data of the intervention group. The primary outcomes will be evaluated using the scale of competency measurement of creativity for public health nurses at baseline, immediately after the intervention. Secondary outcomes will be knowledge and performance regarding program development of public health nurses. This study will enable the analysis of the effects of the educational program on public health nurses for improving their competency to develop new health services for fulfilling community health needs and enriching health care systems. We registered our study protocol to the University hospital Medical Information Network- Clinical Trials Registry approved by International Committee of Medical Journal Editors (No. UMIN000032176, April, 2018).

Effectiveness and cost-effectiveness of unsupervised buprenorphine-naloxone for the treatment of heroin dependence in a randomized waitlist controlled trial.

PubMed

Dunlop, Adrian J; Brown, Amanda L; Oldmeadow, Christopher; Harris, Anthony; Gill, Anthony; Sadler, Craig; Ribbons, Karen; Attia, John; Barker, Daniel; Ghijben, Peter; Hinman, Jennifer; Jackson, Melissa; Bell, James; Lintzeris, Nicholas

2017-05-01

Access to opioid agonist treatment can be associated with extensive waiting periods with significant health and financial burdens. This study aimed to determine whether patients with heroin dependence dispensed buprenorphine-naloxone weekly have greater reductions in heroin use and related adverse health effects 12-weeks after commencing treatment, compared to waitlist controls and to examine the cost-effectiveness of this strategy. An open-label waitlist RCT was conducted in an opioid treatment clinic in Newcastle, Australia. Fifty patients with DSM-IV-TR heroin dependence (and no other substance dependence) were recruited. The intervention group (n=25) received take-home self-administered sublingual buprenorphine-naloxone weekly (mean dose, 22.7±5.7mg) and weekly clinical review. Waitlist controls (n=25) received no clinical intervention. The primary outcome was heroin use (self-report, urine toxicology verified) at weeks four, eight and 12. The primary cost-effectiveness outcome was incremental cost per additional heroin-free-day. Outcome data were available for 80% of all randomized participants. Across the 12-weeks, treatment group heroin use was on average 19.02days less/month (95% CI -22.98, -15.06, p<0.0001). A total 12-week reduction in adjusted costs including crime of $A5,722 (95% CI 3299, 8154) in favor of treatment was observed. Excluding crime, incremental cost per heroin-free-day gained from treatment was $A18.24 (95% CI 4.50, 28.49). When compared to remaining on a waitlist, take-home self-administered buprenorphine-naloxone treatment is associated with significant reductions in heroin use for people with DSM-IV-TR heroin dependence. This cost-effective approach may be an efficient strategy to enhance treatment capacity. Crown Copyright © 2017. Published by Elsevier B.V. All rights reserved.

Breathe Easier Online: Evaluation of a Randomized Controlled Pilot Trial of an Internet-Based Intervention to Improve Well-being in Children and Adolescents With a Chronic Respiratory Condition

PubMed Central

Dunn, Tamara L; Casey, Leanne M; Sheffield, Jeanie K; Petsky, Helen; Anderson-James, Sophie; Chang, Anne B

2012-01-01

Background Chronic respiratory illnesses are the most common group of childhood chronic health conditions and are overrepresented in socially isolated groups. Objective To conduct a randomized controlled pilot trial to evaluate the efficacy of Breathe Easier Online (BEO), an Internet-based problem-solving program with minimal facilitator involvement to improve psychosocial well-being in children and adolescents with a chronic respiratory condition. Methods We randomly assigned 42 socially isolated children and adolescents (18 males), aged between 10 and 17 years to either a BEO (final n = 19) or a wait-list control (final n = 20) condition. In total, 3 participants (2 from BEO and 1 from control) did not complete the intervention. Psychosocial well-being was operationalized through self-reported scores on depression symptoms and social problem solving. Secondary outcome measures included self-reported attitudes toward their illness and spirometry results. Paper-and-pencil questionnaires were completed at the hospital when participants attended a briefing session at baseline (time 1) and in their homes after the intervention for the BEO group or a matched 9-week time period for the wait-list group (time 2). Results The two groups were comparable at baseline across all demographic measures (all F < 1). For the primary outcome measures, there were no significant group differences on depression (P = .17) or social problem solving (P = .61). However, following the online intervention, those in the BEO group reported significantly lower depression (P = .04), less impulsive/careless problem solving (P = .01), and an improvement in positive attitude toward their illness (P = .04) compared with baseline. The wait-list group did not show these differences. Children in the BEO group and their parents rated the online modules very favorably. Conclusions Although there were no significant group differences on primary outcome measures, our pilot data provide tentative support for the feasibility (acceptability and user satisfaction) and initial efficacy of an Internet-based intervention for improving well-being in children and adolescents with a chronic respiratory condition. Trial registration Australian New Zealand Clinical Trials Registry number: ACTRN12610000214033; http://www.anzctr.org.au/trial_view.aspx?ID=308074 (Archived by WebCite at http://www.webcitation.org/63BL55mXH) PMID:22356732

An adapted mindfulness-based stress reduction program for elders in a continuing care retirement community: quantitative and qualitative results from a pilot randomized controlled trial.

PubMed

Moss, Aleezé S; Reibel, Diane K; Greeson, Jeffrey M; Thapar, Anjali; Bubb, Rebecca; Salmon, Jacqueline; Newberg, Andrew B

2015-06-01

The purpose of this study was to test the feasibility and effectiveness of an adapted 8-week Mindfulness-Based Stress Reduction (MBSR) program for elders in a continuing care community. This mixed-methods study used both quantitative and qualitative measures. A randomized waitlist control design was used for the quantitative aspect of the study. Thirty-nine elderly were randomized to MBSR (n = 20) or a waitlist control group (n = 19), mean age was 82 years. Both groups completed pre-post measures of health-related quality of life, acceptance and psychological flexibility, facets of mindfulness, self-compassion, and psychological distress. A subset of MBSR participants completed qualitative interviews. MBSR participants showed significantly greater improvement in acceptance and psychological flexibility and in role limitations due to physical health. In the qualitative interviews, MBSR participants reported increased awareness, less judgment, and greater self-compassion. Study results demonstrate the feasibility and potential effectiveness of an adapted MBSR program in promoting mind-body health for elders. © The Author(s) 2014.

Training Parents of Youth with Autism Spectrum Disorder to Advocate for Adult Disability Services: Results from a Pilot Randomized Controlled Trial

PubMed Central

Taylor, Julie Lounds; Hodapp, Robert M.; Burke, Meghan M.; Waitz-Kudla, Sydney N.; Rabideau, Carol

2017-01-01

This study presents findings from a pilot randomized controlled trial, testing a 12-week intervention to train parents of youth with autism spectrum disorder (ASD) to advocate for adult disability services—the Volunteer Advocacy Project-Transition (VAP-T). Participants included 41 parents of youth with ASD within two years of high school exit, randomly assigned to a treatment (N = 20) or wait-list control (N = 21) group. Outcomes, collected before and after the intervention, included parental knowledge about adult services, advocacy skills-comfort, and empowerment. The VAP-T had acceptable feasibility, treatment fidelity, and acceptability. After participating in the VAP-T, intervention parents (compared to controls) knew more about the adult service system, were more skilled/comfortable advocating, and felt more empowered. PMID:28070786

Parent Education for Migrant Mothers of Left-Behind Children in China: A Pilot Randomized Controlled Trial.

PubMed

To, Siu-Ming; Kwok, Ching-Man; So, Yuk-Yan; Yan, Ming-Wai

2018-06-13

Although numerous studies have indicated the significance of parental support and parent-child communication in alleviating the adverse effects of parental departure on left-behind children, researchers have rarely addressed the impact of parent education on migrant parents. On the basis of the results of a pilot randomized controlled trial, the study reported here involved examining the possible outcomes and feasibility of a parent education program for rural-to-urban migrant mothers of left-behind children in China. Informed by an existential-narrative approach to parent education, the program was composed of six 2.5-hour sessions. The sample included 56 migrant mothers recruited from a social service center in Shenzhen, China, who were randomly assigned to either the immediate group (n = 28, M = 34.82 years, SD = 4.12, aged 23-43) or the waitlist control group (n = 28, M = 34.68 years, SD = 4.53, aged 28-43). The hypotheses of the trial were twofold: that the program would positively affect participants' parental identity and that it would improve mother-child relationships and parenting practices. The results revealed no significant difference in parental identity between the intervention group and the waitlist control group at the post-test assessment after ruling out the effects of pretest survey scores. However, significant differences did emerge in parent-child relationships and parenting practices. Overall, the results corroborate the feasibility of examining the current program for migrant mothers in China in a full trial. The findings also offer insights into developing empirically supported parent education programs for migrant parents. © 2018 Family Process Institute.

Effects of Positive Psychology Interventions on Risk Biomarkers in Coronary Patients: A Randomized, Wait-List Controlled Pilot Trial.

PubMed

Nikrahan, Gholam Reza; Laferton, Johannes A C; Asgari, Karim; Kalantari, Mehrdad; Abedi, Mohammad Reza; Etesampour, Ali; Rezaei, Abbas; Suarez, Laura; Huffman, Jeff C

2016-01-01

Among cardiac patients, positive psychologic factors are consistently linked with superior clinical outcomes and improvement in key markers of inflammation and hypothalamic-pituitary-adrenal axis functioning. Further, positive psychology interventions (PPI) have effectively increased psychologic well-being in a wide variety of populations. However, there has been minimal study of PPIs in cardiac patients, and no prior study has evaluated their effect on key prognostic biomarkers of cardiac outcome. Accordingly, we investigated the effect of 3 distinct PPIs on risk biomarkers in cardiac patients. In an exploratory trial, 69 patients with recent coronary artery bypass graft surgery or percutaneous intervention were randomized to (1) one of three 6-week in-person PPIs (based on the work of Seligman, Lyubomirsky, or Fordyce) or (2) a wait-list control group. Risk biomarkers were assessed at baseline, postintervention (7 weeks), and at 15-week follow-up. Between-group differences in change from baseline biomarker levels were examined via random effects models. Compared with the control group, participants randomized to the Seligman (B = -2.06; p = 0.02) and Fordyce PPI (B = -1.54; p = 0.04) had significantly lower high-sensitivity C-reactive protein levels at 7 weeks. Further, the Lyubomirsky PPI (B = -245.86; p = 0.04) was associated with a significantly lower cortisol awakening response at 7 weeks when compared with control participants. There were no other significant between-group differences. Despite being an exploratory pilot study with multiple between-group comparisons, this initial trial offers the first suggestion that PPIs might be effective in reducing risk biomarkers in high-risk cardiac patients. Copyright © 2016 The Academy of Psychosomatic Medicine. All rights reserved.

Effects of positive psychology interventions on risk biomarkers in coronary patients: A randomized, wait-list controlled pilot trial

PubMed Central

Nikrahan, Gholam Reza; Laferton, Johannes A. C.; Asgari, Karim; Kalantari, Mehrdad; Abedi, Mohammad Reza; Etesampour, Ali; Rezaei, Abbas; Suarez, Laura; Huffman, Jeff C.

2016-01-01

Background Among cardiac patients, positive psychological factors are consistently linked with superior clinical outcomes and improvement in key markers of inflammation and hypothalamic-pituitary-adrenal axis functioning. Further, positive psychology interventions (PPI) have effectively increased psychological well-being in a wide variety of populations. However, there has been minimal study of PPIs in cardiac patients, and no prior study has evaluated their effect on key prognostic biomarkers of cardiac outcome. Accordingly, we investigated the effect of three distinct PPIs on risk biomarkers in cardiac patients. Methods In an exploratory trial, 69 patients with recent coronary artery bypass graft surgery or percutaneous intervention were randomized to a) one of three 6-week in-person PPIs (based on the work of Seligman, Lyubomirsky, or Fordyce) or b) a wait-list control group. Risk biomarkers were assessed at baseline, post-intervention (7 weeks), and at 15 week follow-up. Between-group differences in change from baseline biomarker levels were examined via random effects models. Results Compared to the control group, participants randomized to the Seligman (B= −2.06; p= .02) and Fordyce PPI (B= −1.54; p= .04) had significantly lower high-sensitivity C-reactive protein (hs-CRP) levels at 7 weeks. Further, the Lyubomirsky PPI (B= −245.86; p= .04) was associated with a significantly lower cortisol awakening response (CARg) at 7 weeks compared to control participants. There were no other significant between-group differences. Conclusion Despite being an exploratory pilot study with multiple between-group comparisons, this initial trial offers the first suggestion that PPIs might be effective in reducing risk biomarkers in high-risk cardiac patients. PMID:27129358

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

PubMed

Kwon, Hyo-Jung; Kim, Jong-In; Lee, Myeong Soo; Choi, Jun-Yong; Kang, Sungkeel; Chung, Jie-Yoon; Kim, Young-Jin; Lee, Seung-Hoon; Lee, Sanghoon; Nam, Dongwoo; Kim, Yong-Suk; Lee, Jae-Dong; Choi, Do-Young

2011-03-09

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. 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.

Feasibility and Preliminary Efficacy of the Fit4Fun Intervention for Improving Physical Fitness in a Sample of Primary School Children: A Pilot Study

ERIC Educational Resources Information Center

Eather, Narelle; Morgan, Philip J.; Lubans, David R.

2013-01-01

Objective: The primary objective of this study was to evaluate the feasibility and preliminary efficacy of a school-based physical fitness intervention (Fit4Fun) on the physical fitness and physical activity (PA) levels of primary school children. Methods: A group-randomized controlled trial with a 3-month wait-list control group was conducted in…

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.

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.

Child Directed Interaction Training for young children in kinship care: A pilot study.

PubMed

N'zi, Amanda M; Stevens, Monica L; Eyberg, Sheila M

2016-05-01

This pilot study used a randomized controlled trial design to examine the feasibility and explore initial outcomes of a twice weekly, 8-session Child Directed Interaction Training (CDIT) program for children living in kinship care. Participants included 14 grandmothers and great-grandmothers with their 2- to 7-year-old children randomized either to CDIT or a waitlist control condition. Training was delivered at a local, community library with high fidelity to the training protocol. There was no attrition in either condition. After training, kinship caregivers in the CDIT condition demonstrated more positive relationships with their children during behavioral observation. The caregivers in the CDIT condition also reported clinically and statistically significant decreases in parenting stress and caregiver depression, as well as fewer externalizing child behavior problems than waitlist controls. Parent daily report measures indicated significant changes in disciplining that included greater use of limit-setting and less use of critical verbal force. Results appeared stable at 3-month follow-up. Changes in child internalizing behaviors and caregiver use of non-critical verbal force were not seen until 3-month follow-up. Results of this pilot study suggest both the feasibility of conducting full scale randomized clinical trials of CDIT in the community and the promise of this approach for providing effective parent training for kinship caregivers. Copyright © 2016 Elsevier Ltd. All rights reserved.

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

Shoe Orthotics for the Treatment of Chronic Low Back Pain: A Randomized Controlled Trial.

PubMed

Cambron, Jerrilyn A; Dexheimer, Jennifer M; Duarte, Manuel; Freels, Sally

2017-09-01

To investigate the efficacy of shoe orthotics with and without chiropractic treatment for chronic low back pain compared with no treatment. Randomized controlled trial. Integrative medicine teaching clinic at a university. Adult subjects (N=225) with symptomatic low back pain of ≥3 months were recruited from a volunteer sample. Subjects were randomized into 1 of 3 treatment groups (shoe orthotic, plus, and waitlist groups). The shoe orthotic group received custom-made shoe orthotics. The plus group received custom-made orthotics plus chiropractic manipulation, hot or cold packs, and manual soft tissue massage. The waitlist group received no care. The primary outcome measures were change in perceived back pain (numerical pain rating scale) and functional health status (Oswestry Disability Index) after 6 weeks of study participation. Outcomes were also assessed after 12 weeks and then after an additional 3, 6, and 12 months. After 6 weeks, all 3 groups demonstrated significant within-group improvement in average back pain, but only the shoe orthotic and plus groups had significant within-group improvement in function. When compared with the waitlist group, the shoe orthotic group demonstrated significantly greater improvements in pain (P<.0001) and function (P=.0068). The addition of chiropractic to orthotics treatment demonstrated significantly greater improvements in function (P=.0278) when compared with orthotics alone, but no significant difference in pain (P=.3431). Group differences at 12 weeks and later were not significant. Six weeks of prescription shoe orthotics significantly improved back pain and dysfunction compared with no treatment. The addition of chiropractic care led to higher improvements in function. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Near-transfer effects following working memory intervention (Cogmed) in children with symptomatic epilepsy: An open randomized clinical trial.

PubMed

Kerr, Elizabeth N; Blackwell, Melissa C

2015-11-01

Limited research exists regarding the effectiveness of educational and psychological interventions for improving commonly presenting cognitive impairments experienced by children with epilepsy. We evaluated the efficacy of a commercially available, computerized, working memory (WM) program (Cogmed) using a well-defined population of children with epilepsy. In this controlled trial, 77 children with symptomatic epilepsy (ages 6.5-15.5 years; 100% taking medication) with estimated intellectual ability greater than the 2nd percentile were randomly assigned to an intervention (n = 42) or waitlist-control (n = 35) group. Standardized assessments of attention and WM were administered pre- and posttraining or waitlist interval, 7 weeks apart. Without intervention, participants displayed significant weaknesses in intelligence, attention, and WM compared to normative samples. After controlling for preintervention scores and intelligence, we found that significant treatment effects for the intervention group were evident for visual attention span, auditory WM, and visual-verbal WM. Intention-to-treat analyses (all participants) and sensitivity analyses (n = 37 and n = 21 for the intervention and waitlist-control groups, respectively) were highly similar, providing confidence to the results. Effect sizes for significant outcomes were large (greater than or equal to two thirds of the standard deviation of the normative-data). The clinical/demographic and functional factors studied did not elucidate who most benefits from training. This is the first study to evaluate the effectiveness of intervention to ameliorate WM deficits commonly experienced by children with symptomatic epilepsy. Results support group improvement on some untrained tasks immediately postintervention, demonstrating preliminary usefulness of Cogmed as a treatment option. Wiley Periodicals, Inc. © 2015 International League Against Epilepsy.

Effects of the FITKids physical activity randomized controlled trial on conflict monitoring in youth.

PubMed

Drollette, Eric S; Pontifex, Matthew B; Raine, Lauren B; Scudder, Mark R; Moore, R Davis; Kao, Shih-Chun; Westfall, Daniel R; Wu, Chien-Ting; Kamijo, Keita; Castelli, Darla M; Khan, Naiman A; Kramer, Arthur F; Hillman, Charles H

2018-03-01

The present study investigated the effect of a 9-month physical activity (PA) intervention on children's cardiorespiratory fitness levels and neuroelectric indices of conflict monitoring (i.e., error-related negativity, ERN). Four hundred twenty-eight preadolescent children (8-9 years old) were randomized into a PA intervention or wait-list control group, and completed a fitness and cognitive control assessment (i.e., modified flanker task) at pre- and posttest. Following exclusion criterion, 308 children were included in the analyses (PA intervention: n = 139; wait-list control: n = 169). Children in the intervention displayed greater improvements in fitness and response accuracy, which were accompanied by stability of ERN amplitude from pre- to posttest. In contrast, the control group revealed increased ERN amplitude at posttest compared to pretest, despite no change in fitness or task performance. These findings demonstrate the efficacy of daily PA for promoting children's fitness and underlying neural processes associated with effective conflict monitoring. Such findings have significant implications for promoting organized PA programs intended to foster overall physical and brain health in school age children. © 2017 Society for Psychophysiological Research.

The Feasibility, Acceptability, and Efficacy of Delivering Internet-Based Self-Help and Guided Self-Help Interventions for Generalized Anxiety Disorder to Indian University Students: Design of a Randomized Controlled Trial.

PubMed

Kanuri, Nitya; Newman, Michelle G; Ruzek, Josef I; Kuhn, Eric; Manjula, M; Jones, Megan; Thomas, Neil; Abbott, Jo-Anne M; Sharma, Smita; Taylor, C Barr

2015-12-11

Generalized anxiety disorder (GAD) is one of the most common mental disorders among university students; however, many students go untreated due to treatment costs, stigma concerns, and limited access to trained mental health professionals. These barriers are heightened in universities in India, where there are scant mental health care services and severe stigma surrounding help seeking. To evaluate the feasibility, acceptability, and efficacy of Internet-based, or "online," cognitive behavioral therapy (CBT)-based unguided and guided self-help interventions (using the programs GAD Online and Lantern, respectively) to reduce GAD symptoms in students with clinical and subthreshold GAD and, ultimately, reduce the prevalence and incidence of GAD among the student population. Students will be recruited via 3 colleges in Hyderabad, India, and referred for a campus-wide online screening. Self-report data will be collected entirely online. A total of 300 qualifying students will be randomized in a 1:1:1 ratio to receive GAD Online, Lantern, or to be in a wait-list control condition, stratified by clinical and subthreshold GAD symptomatology. Students will complete a postintervention assessment after 3 months and a follow-up assessment 6 months later, at which point students in the wait-list control condition will receive one of the programs. The primary outcome is GAD symptom severity at 3 months postintervention. Secondary outcomes include GAD caseness at 9 months, other anxiety and depression symptoms, self-efficacy, and functional measures (eg, sleep, social functioning) at 3 and 9 months, respectively. Primary analyses will be differences between each of the intervention groups and the wait-list control group, analyzed on an intention-to-treat (ITT) basis using mixed-design ANOVA. The study commenced in February 2015. The sample was recruited over a 3-week period at each college. The trial is expected to end in December 2015. This trial will be the first to evaluate the use of Internet-based CBT programs compared with a wait-list control group for the treatment of GAD among students in Indian universities. If effective, these programs have the potential to reduce the mental health care treatment gap by providing readily accessible, private, and cost-effective evidence-based care to students with GAD who do not currently receive the treatment they need. ClinicalTrials.gov NCT02410265 http://clinicaltrials.gov/ct2/show/NCT02410265 (Archived by WebCite at http://www.webcitation.org/6ddqH6Rbt).

Implementation of Treat-to-Target in Rheumatoid Arthritis Through a Learning Collaborative: Results of a Randomized Controlled Trial.

PubMed

Solomon, Daniel H; Losina, Elena; Lu, Bing; Zak, Agnes; Corrigan, Cassandra; Lee, Sara B; Agosti, Jenifer; Bitton, Asaf; Harrold, Leslie R; Pincus, Theodore; Radner, Helga; Yu, Zhi; Smolen, Josef S; Fraenkel, Liana; Katz, Jeffrey N

2017-07-01

Treat-to-target (TTT) is an accepted paradigm for the management of rheumatoid arthritis (RA), but some evidence suggests poor adherence. The purpose of this study was to test the effects of a group-based multisite improvement learning collaborative on adherence to TTT. We conducted a cluster-randomized quality-improvement trial with waitlist control across 11 rheumatology sites in the US. The intervention entailed a 9-month group-based learning collaborative that incorporated rapid-cycle improvement methods. A composite TTT implementation score was calculated as the percentage of 4 required items documented in the visit notes for each patient at 2 time points, as evaluated by trained staff. The mean change in the implementation score for TTT across all patients for the intervention sites was compared with that for the control sites after accounting for intracluster correlation using linear mixed models. Five sites with a total of 23 participating rheumatology providers were randomized to intervention and 6 sites with 23 participating rheumatology providers were randomized to the waitlist control. The intervention included 320 patients, and the control included 321 patients. At baseline, the mean TTT implementation score was 11% in both arms; after the 9-month intervention, the mean TTT implementation score was 57% in the intervention group and 25% in the control group (change in score of 46% for intervention and 14% for control; P = 0.004). We did not observe excessive use of resources or excessive occurrence of adverse events in the intervention arm. A learning collaborative resulted in substantial improvements in adherence to TTT for the management of RA. This study supports the use of an educational collaborative to improve quality. © 2017, American College of Rheumatology.

Acceptability of an open-label wait-listed trial design: Experiences from the PROUD PrEP study.

PubMed

Gafos, Mitzy; Brodnicki, Elizabeth; Desai, Monica; McCormack, Sheena; Nutland, Will; Wayal, Sonali; White, Ellen; Wood, Gemma; Barber, Tristan; Bell, Gill; Clarke, Amanda; Dolling, David; Dunn, David; Fox, Julie; Haddow, Lewis; Lacey, Charles; Nardone, Anthony; Quinn, Killian; Rae, Caroline; Reeves, Iain; Rayment, Michael; White, David; Apea, Vanessa; Ayap, Wilbert; Dewsnap, Claire; Collaco-Moraes, Yolanda; Schembri, Gabriel; Sowunmi, Yinka; Horne, Rob

2017-01-01

PROUD participants were randomly assigned to receive pre-exposure prophylaxis (PrEP) immediately or after a deferred period of one-year. We report on the acceptability of this open-label wait-listed trial design. Participants completed an acceptability questionnaire, which included categorical study acceptability data and free-text data on most and least liked aspects of the study. We also conducted in-depth interviews (IDI) with a purposely selected sub-sample of participants. Acceptability questionnaires were completed by 76% (415/544) of participants. After controlling for age, immediate-group participants were almost twice as likely as deferred-group participants to complete the questionnaire (AOR:1.86;95%CI:1.24,2.81). In quantitative data, the majority of participants in both groups found the wait-listed design acceptable when measured by satisfaction of joining the study, intention to remain in the study, and interest in joining a subsequent study. However, three-quarters thought that the chance of being in the deferred-group might put other volunteers off joining the study. In free-text responses, data collection tools were the most frequently reported least liked aspect of the study. A fifth of deferred participants reported 'being deferred' as the thing they least liked about the study. However, more deferred participants disliked the data collection tools than the fact that they had to wait a year to access PrEP. Participants in the IDIs had a good understanding of the rationale for the open-label wait-listed study design. Most accepted the design but acknowledged they were, or would have been, disappointed to be randomised to the deferred group. Five of the 25 participants interviewed reported some objection to the wait-listed design. The quantitative and qualitative findings suggest that in an environment where PrEP was not available, the rationale for the wait-listed trial design was well understood and generally acceptable to most participants in this study.

A randomised controlled trial of acceptance-based cognitive behavioural therapy for command hallucinations in psychotic disorders.

PubMed

Shawyer, Frances; Farhall, John; Mackinnon, Andrew; Trauer, Tom; Sims, Eliza; Ratcliff, Kirk; Larner, Chris; Thomas, Neil; Castle, David; Mullen, Paul; Copolov, David

2012-02-01

Command hallucinations represent a special problem for the clinical management of psychosis. While compliance with both non-harmful and harmful commands can be problematic, sometimes in the extreme, active efforts to resist commands may also contribute to their malignancy. Previous research suggests Cognitive Behaviour Therapy (CBT) to be a useful treatment for reducing compliance with harmful command hallucinations. The purpose of this trial was to evaluate whether CBT augmented with acceptance-based strategies from Acceptance and Commitment Therapy could more broadly reduce the negative impact of command hallucinations. Forty-three participants with problematic command hallucinations were randomized to receive 15 sessions of the intervention "TORCH" (Treatment of Resistant Command Hallucinations) or the control, Befriending, then followed up for 6 months. A sub-sample of 17 participants was randomized to a waitlist control before being allocated to TORCH or Befriending. Participants engaged equally well with both treatments. Despite TORCH participants subjectively reporting greater improvement in command hallucinations compared to Befriending participants, the study found no significant group differences in primary and secondary outcome measures based on blinded assessment data. Within-group analyses and comparisons between the combined treatments and waitlist suggested, however, that both treatments were beneficial with a differential pattern of outcomes observed across the two conditions. Copyright © 2011 Elsevier Ltd. All rights reserved.

Efficacy of the resilience and adjustment intervention after traumatic brain injury: a randomized controlled trial.

PubMed

Kreutzer, Jeffrey S; Marwitz, Jennifer H; Sima, Adam P; Mills, Ana; Hsu, Nancy H; Lukow, Herman R

2018-05-24

Examine a psychoeducational and skill-building intervention's effectiveness for individuals after traumatic brain injury (TBI), using a two-arm, parallel, randomized, controlled trial with wait-listed control. The Resilience and Adjustment Intervention (RAI) targets adjustment challenges and emphasizes education, skill-building and psychological support. Overall, 160 outpatients were randomly assigned to a treatment or wait-list control (WLC) group. The manualized treatment was delivered in seven 1-h sessions. The Connor-Davidson Resilience Scale (CD-RISC) was the primary outcome measure. Secondary measures included the Mayo Portland Adaptability Inventory-4 (MPAI-4), Brief Symptom Inventory-18 (BSI-18) and 13-Item Stress Test. After adjusting for injury severity, education and time postinjury, the RAI group (N = 75) demonstrated a significantly greater increase in resilience (effect size = 1.03) compared to the WLC group (N = 73). Participants in the RAI group demonstrated more favourable scores on the MPAI-4 Adjustment and Ability Indices, BSI-18 and the 13-item Stress Test. However, only the CD-RISC and BSI-18 demonstrated a clinically significant difference. In addition, RAI participants demonstrated maintenance of gains from pre-treatment to 3-month follow-up; however, only the BSI-18 maintained a clinically significant difference. Investigation provided evidence that a resilience-focused intervention can improve psychological health and adjustment after TBI. Additional research is needed to ascertain the longer term benefits of intervention and the efficacy of alternative delivery methods (e.g., via telephone, Internet).

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

PubMed

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

2016-04-01

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

The Feasibility, Acceptability, and Efficacy of Delivering Internet-Based Self-Help and Guided Self-Help Interventions for Generalized Anxiety Disorder to Indian University Students: Design of a Randomized Controlled Trial

PubMed Central

Newman, Michelle G; Ruzek, Josef I; Kuhn, Eric; Manjula, M; Jones, Megan; Thomas, Neil; Abbott, Jo-Anne M; Sharma, Smita; Taylor, C. Barr

2015-01-01

Background Generalized anxiety disorder (GAD) is one of the most common mental disorders among university students; however, many students go untreated due to treatment costs, stigma concerns, and limited access to trained mental health professionals. These barriers are heightened in universities in India, where there are scant mental health care services and severe stigma surrounding help seeking. Objective To evaluate the feasibility, acceptability, and efficacy of Internet-based, or “online,” cognitive behavioral therapy (CBT)-based unguided and guided self-help interventions (using the programs GAD Online and Lantern, respectively) to reduce GAD symptoms in students with clinical and subthreshold GAD and, ultimately, reduce the prevalence and incidence of GAD among the student population. Methods Students will be recruited via 3 colleges in Hyderabad, India, and referred for a campus-wide online screening. Self-report data will be collected entirely online. A total of 300 qualifying students will be randomized in a 1:1:1 ratio to receive GAD Online, Lantern, or to be in a wait-list control condition, stratified by clinical and subthreshold GAD symptomatology. Students will complete a postintervention assessment after 3 months and a follow-up assessment 6 months later, at which point students in the wait-list control condition will receive one of the programs. The primary outcome is GAD symptom severity at 3 months postintervention. Secondary outcomes include GAD caseness at 9 months, other anxiety and depression symptoms, self-efficacy, and functional measures (eg, sleep, social functioning) at 3 and 9 months, respectively. Primary analyses will be differences between each of the intervention groups and the wait-list control group, analyzed on an intention-to-treat (ITT) basis using mixed-design ANOVA. Results The study commenced in February 2015. The sample was recruited over a 3-week period at each college. The trial is expected to end in December 2015. Conclusions This trial will be the first to evaluate the use of Internet-based CBT programs compared with a wait-list control group for the treatment of GAD among students in Indian universities. If effective, these programs have the potential to reduce the mental health care treatment gap by providing readily accessible, private, and cost-effective evidence-based care to students with GAD who do not currently receive the treatment they need. Trial Registration ClinicalTrials.gov NCT02410265 http://clinicaltrials.gov/ct2/show/NCT02410265 (Archived by WebCite at http://www.webcitation.org/6ddqH6Rbt). PMID:26679295

Rationale and design for cognitive behavioral therapy for anxiety disorders in children with autism spectrum disorder: a study protocol of a randomized controlled trial.

PubMed

Kilburn, Tina R; Sørensen, Merete Juul; Thastum, Mikael; Rapee, Ronald M; Rask, Charlotte Ulrikka; Arendt, Kristian Bech; Thomsen, Per Hove

2018-04-02

Autism spectrum disorder (ASD) is found in approximately 1% of the population and includes core symptoms that affect general and social development. Beside these core symptoms, it is suggested that up to 60% of children with ASD suffer from comorbid anxiety disorders which may further affect educational, social and general development as well as quality of life. The main goal of this study is to examine the effectiveness of a manualized cognitive behavioral therapy (CBT) anxiety program adapted for children with ASD. This study is a randomized controlled trial (RCT). Fifty children with ASD and anxiety, aged 7 to 13 years, will be randomly assigned to group CBT or a wait-list control (WL) condition. The design will follow a two (CBT and WL) by two (pre-post assessment) mixed between-within design. The control group will receive intervention after the waitlist period of 13 weeks. Primary outcomes are diagnostic status and severity of the anxiety disorders, measured with The Anxiety Disorder Interview Schedule for DSM-IV, Parent and Child Versions. Secondary outcomes are parent and child ratings on questionnaires on the child's level of anxiety and impact on everyday life. Additional outcomes entail information gathered from parents, child and teachers on the child's behavior and negative self-statements, together with social and adaptive skills. Follow-up data will be collected 3 months after intervention. This study aims to evaluate the effectiveness of a manualized CBT program in Danish children with ASD and anxiety within a mental health clinic setting. The hypothesis is that training anxiety reduction skills will decrease anxiety in children, as well as ensure better psychosocial development for the child in general. https://ClinicalTrials.gov ( NCT02908321 ). Registered 19th of September 2016.

A randomized waitlist-controlled trial of cognitive behavior therapy to improve emotion regulation in children with autism.

PubMed

Weiss, Jonathan A; Thomson, Kendra; Burnham Riosa, Priscilla; Albaum, Carly; Chan, Victoria; Maughan, Andrea; Tablon, Paula; Black, Karen

2018-04-23

Mental health problems are common among individuals with autism spectrum disorder (ASD), and difficulties with emotion regulation processes may underlie these issues. Cognitive behavior therapy (CBT) is considered an efficacious treatment for anxiety in children with ASD. Additional research is needed to examine the efficacy of a transdiagnostic treatment approach, whereby the same treatment can be applied to multiple emotional problems, beyond solely anxiety. The purpose of the present study was to examine the efficacy of a manualized and individually delivered 10-session, transdiagnostic CBT intervention, aimed at improving emotion regulation and mental health difficulties in children with ASD. Sixty-eight children (M age = 9.75, SD = 1.27) and their parents participated in the study, randomly allocated to either a treatment immediate (n = 35) or waitlist control condition (n = 33) (ISRCTN #67079741). Parent-, child-, and clinician-reported measures of emotion regulation and mental health were administered at baseline, postintervention/postwaitlist, and at 10-week follow-up. Children in the treatment immediate condition demonstrated significant improvements on measures of emotion regulation (i.e., emotionality, emotion regulation abilities with social skills) and aspects of psychopathology (i.e., a composite measure of internalizing and externalizing symptoms, adaptive behaviors) compared to those in the waitlist control condition. Treatment gains were maintained at follow-up. This study is the first transdiagnostic CBT efficacy trial for children with ASD. Additional investigations are needed to further establish its relative efficacy compared to more traditional models of CBT for children with ASD and other neurodevelopmental conditions. © 2018 The Authors. Journal of Child Psychology and Psychiatry published by John Wiley & Sons Ltd on behalf of Association for Child and Adolescent Mental Health.

Effectiveness of Parent-Child Mediation in Improving Family Functioning and Reducing Adolescent Problem Behavior: Results from a Pilot Randomized Controlled Trial.

PubMed

Tucker, Joan S; Edelen, Maria Orlando; Huang, Wenjing

2017-03-01

Parent-child mediation programs are intended to resolve or manage disputes and improve family functioning, but rigorous evaluations of their effectiveness are lacking. Families referred to a community-based mediation program (N = 111) were randomized to an intervention or wait-list control group, and completed three surveys over a 12-week period. With the exception of parent-reported child delinquency (which decreased more in the intervention group), this evaluation provides little support for the short-term effectiveness of parent-child mediation for improving family functioning and reducing child problem behaviors in general. Given that this is the first randomized controlled trial of a parent-child mediation program, additional evaluations involving larger samples and longer follow-ups are needed before firm conclusions can be drawn about the effectiveness of this intervention.

Effectiveness of Parent-Child Mediation in Improving Family Functioning and Reducing Adolescent Problem Behavior: Results from a Pilot Randomized Controlled Trial

PubMed Central

Tucker, Joan S.; Edelen, Maria Orlando; Huang, Wenjing

2016-01-01

Parent-child mediation programs are intended to resolve or manage disputes and improve family functioning, but rigorous evaluations of their effectiveness are lacking. Families referred to a community-based mediation program (N=111) were randomized to an intervention or wait-list control group, and completed three surveys over a 12-week period. With the exception of parent-reported child delinquency (which decreased more in the intervention group), this evaluation provides little support for the short-term effectiveness of parent-child mediation for improving family functioning and reducing child problem behaviors in general. Given that this is the first randomized controlled trial of a parent-child mediation program, additional evaluations involving larger samples and longer follow-ups are needed before firm conclusions can be drawn about the effectiveness of this intervention. PMID:26762375

Internet-based instructor-led mindfulness for work-related rumination, fatigue, and sleep: Assessing facets of mindfulness as mechanisms of change. A randomized waitlist control trial.

PubMed

Querstret, Dawn; Cropley, Mark; Fife-Schaw, Chris

2017-04-01

This study aimed to extend our theoretical understanding of how mindfulness-based interventions exert their positive influence on measures of occupational health. Employing a randomized waitlist control study design, we sought to (a) assess an Internet-based instructor-led mindfulness intervention for its effect on key factors associated with "recovery from work," specifically, work-related rumination, fatigue, and sleep quality; (b) assess different facets of mindfulness (acting with awareness, describing, nonjudging, and nonreacting) as mechanisms of change; and (c) assess whether the effect of the intervention was maintained over time by following up our participants after 3 and 6 months. Participants who completed the mindfulness intervention (n = 60) reported significantly lower levels of work-related rumination and fatigue, and significantly higher levels of sleep quality, when compared with waitlist control participants (n = 58). Effects of the intervention were maintained at 3- and 6-month follow-up with medium to large effect sizes. The effect of the intervention was primarily explained by increased levels of only 1 facet of mindfulness (acting with awareness). This study provides support for online mindfulness interventions to aid recovery from work and furthers our understanding with regard to how mindfulness interventions exert their positive effects. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Psychosocial intervention improves depression, quality of life, and fluid adherence in hemodialysis.

PubMed

Cukor, Daniel; Ver Halen, Nisha; Asher, Deborah Rosenthal; Coplan, Jeremy D; Weedon, Jeremy; Wyka, Katarzyna E; Saggi, Subodh J; Kimmel, Paul L

2014-01-01

Patients with ESRD have high rates of depression, which is associated with diminished quality of life and survival. We determined whether individual cognitive behavioral therapy (CBT) reduces depression in hemodialysis patients with elevated depressive affect in a randomized crossover trial. Of 65 participants enrolled from two dialysis centers in New York, 59 completed the study and were assigned to the treatment-first group (n=33) or the wait-list control group (n=26). In the intervention phase, CBT was administered chairside during dialysis treatments for 3 months; participants were assessed 3 and 6 months after randomization. Compared with the wait-list group, the treatment-first group achieved significantly larger reductions in Beck Depression Inventory II (self-reported, P=0.03) and Hamilton Depression Rating Scale (clinician-reported, P<0.001) scores after intervention. Mean scores for the treatment-first group did not change significantly at the 3-month follow-up. Among participants with depression diagnosed at baseline, 89% in the treatment-first group were not depressed at the end of treatment compared with 38% in the wait-list group (Fisher's exact test, P=0.01). Furthermore, the treatment-first group experienced greater improvements in quality of life, assessed with the Kidney Disease Quality of Life Short Form (P=0.04), and interdialytic weight gain (P=0.002) than the wait-list group, although no effect on compliance was evident at follow-up. In summary, CBT led to significant improvements in depression, quality of life, and prescription compliance in this trial, and studies should be undertaken to assess the long-term effects of CBT on morbidity and mortality in patients with ESRD.

STRENGTHENING THE REFLECTIVE FUNCTIONING CAPACITIES OF PARENTS WHO HAVE A CHILD WITH A NEURODEVELOPMENTAL DISABILITY THROUGH A BRIEF, RELATIONSHIP-FOCUSED INTERVENTION.

PubMed

Sealy, Julie; Glovinsky, Ira P

2016-01-01

This randomized controlled trial examined the reflective functioning capacities of caregivers who have a child with a neurodevelopmental disorder between the ages of 2 years 0 months and 6 years 11 months. Children with a neurodevelopmental disorder receive a range of diagnoses, including sutism; however, they all exhibit social communication challenges that can derail social relationships. Forty parent-child dyads in Barbados were randomly assigned to either a developmental individual-difference, relationship-based/floortime(DIR/FT) group (n = 20), or a psychoeducational (wait-list) group (n = 20) with parental reflective functioning measured before and after a 12-week DIR/FT treatment intervention. Results revealed significant gains in parental reflective functioning in the treatment group, as compared to the psychoeducational (wait-list) group, after the 12-week relationship-focused intervention. © 2016 Michigan Association for Infant Mental Health.

A Randomized Controlled Trial of 7-Day Intensive and Standard Weekly Cognitive Therapy for PTSD and Emotion-Focused Supportive Therapy

PubMed Central

Ehlers, Anke; Hackmann, Ann; Grey, Nick; Wild, Jennifer; Liness, Sheena; Albert, Idit; Deale, Alicia; Stott, Richard; Clark, David M.

2014-01-01

Objective Psychological treatments for posttraumatic stress disorder (PTSD) are usually delivered once or twice weekly over several months. It is unclear whether they can be successfully delivered over a shorter period of time. This clinical trial had two goals, (1) to investigate the acceptability and efficacy of a 7-day intensive version of cognitive therapy for PTSD, and (2) to investigate whether cognitive therapy has specific treatment effects by comparing intensive and standard weekly cognitive therapy with an equally credible alternative treatment. Method Patients with chronic PTSD (N=121) were randomly allocated to 7-day intensive or standard 3-month weekly cognitive therapy for PTSD, 3-month weekly emotion-focused supportive therapy, or a 14-week waitlist condition. Primary outcomes were PTSD symptoms and diagnosis as assessed by independent assessors and self-report. Secondary outcomes were disability, anxiety, depression, and quality of life. Measures were taken at initial assessment, 6 weeks and 14 weeks (post-treatment/wait). For groups receiving treatment, measures were also taken at 3 weeks, and follow-ups at 27 and 40 weeks after randomization. All analyses were intent-to-treat. Results At post-treatment/wait assessment, 73%, 77%, 43%, 7% of the intensive cognitive therapy, standard cognitive therapy, supportive therapy, and waitlist groups, respectively, had recovered from PTSD. All treatments were well tolerated and were superior to waitlist on all outcome measures, with the exception of no difference between supportive therapy and waitlist on quality of life. For primary outcomes, disability and general anxiety, intensive and standard cognitive therapy were superior to supportive therapy. Intensive cognitive therapy achieved faster symptom reduction and comparable overall outcomes to standard cognitive therapy. Conclusions Cognitive therapy for PTSD delivered intensively over little more than a week is as effective as cognitive therapy delivered over 3 months. Both had specific effects and were superior to supportive therapy. Intensive cognitive therapy for PTSD is a feasible and promising alternative to traditional weekly treatment. PMID:24480899

Workstyle Intervention for the Prevention of Work-Related Upper Extremity Problems: A Randomized Controlled Trial

DTIC Science & Technology

2005-01-01

questions are about how you feel and how things have been with you during the past 4 weeks. For each question, please give the one answer that...better overall treatment gains because a focus on workstyle may simultaneously address multiple risk factors for WRUEDs. This study compared treatment...alone. Symptomatic workers were recruited to participate in one of the three intervention conditions or in a wait-list control condition, where

A cognitive-behavioral intervention for emotion regulation in adults with high-functioning autism spectrum disorders: study protocol for a randomized controlled trial.

PubMed

Kuroda, Miho; Kawakubo, Yuki; Kuwabara, Hitoshi; Yokoyama, Kazuhito; Kano, Yukiko; Kamio, Yoko

2013-07-23

Adults with high-functioning autism spectrum disorders (ASD) have difficulties in social communication; thus, these individuals have trouble understanding the mental states of others. Recent research also suggests that adults with ASD are unable to understand their own mental states, which could lead to difficulties in emotion-regulation. Some studies have reported the efficacy of cognitive-behavioral therapy (CBT) in improving emotion-regulation among children with ASD. The current study will investigate the efficacy of group-based CBT for adults with ASD. The study is a randomized, waitlist controlled, single-blinded trial. The participants will be 60 adults with ASD; 30 will be assigned to a CBT group and 30 to a waitlist control group. Primary outcome measures are the 20-item Toronto Alexithymia Scale, the Coping Inventory for Stressful Situations, the Motion Picture Mind-Reading task, and an ASD questionnaire. The secondary outcome measures are the Center for Epidemiological Studies Depression Scale, the World Health Organization Quality of Life Scale 26-item version, the Global Assessment of Functioning, State-trait Anxiety Inventory, Social Phobia and Anxiety Inventory, and Liebowitz Social Anxiety Scale. All will be administered during the pre- and post-intervention, and 12 week follow-up periods. The CBT group will receive group therapy over an 8 week period (one session per week) with each session lasting approximately 100 minutes. Group therapy will consist of four or five adults with ASD and two psychologists. We will be using visual materials for this program, mainly the Cognitive Affective Training kit. This trial will hopefully indicate the efficacy of group-based CBT for adults with high- functioning ASD. This trial was registered in The University Hospital Medical Information Network Clinical Trials Registry No. UMIN000006236.

Training Older Siblings to be Better Supervisors: An RCT Evaluating the "Safe Sibs" Program.

PubMed

Schell, Stacey L; Morrongiello, Barbara A; Pogrebtsova, Ekaterina

2015-09-01

This study evaluated a new online training program, Safe Sibs, aimed at improving supervision knowledge and behaviors of sibling supervisors. Participants included older children (7-11 years) and their younger siblings (2-5 years). A randomized controlled trial design was used, with older siblings randomly assigned to either an intervention or wait-list control group. Before and after either the intervention or wait-list period, older siblings completed measures of supervision knowledge and their supervision behaviors were unobtrusively observed when with their younger sibling. Compared with the control group, the intervention group showed significant improvements in supervision knowledge (child development, knowledge of effective supervision practices, injury beliefs, intervention-specific knowledge) and in some aspects of supervision behavior (frequency of proactive safety behaviors to prevent supervisee access to injury hazards). Although adult supervision is ideal, this new program can support older children to become more knowledgeable and improved supervisors of younger ones. © The Author 2015. 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.

A Randomized, Controlled Trial of Wholistic Hybrid Derived From Eye Movement Desensitization and Reprocessing and Emotional Freedom Technique (WHEE) for Self-Treatment of Pain, Depression, and Anxiety in Chronic Pain Patients

PubMed Central

Benor, Daniel; Rossiter-Thornton, John; Toussaint, Loren

2016-01-01

In this pilot study, a convenience sample of 24 chronic pain patients (17 with chronic fatigue syndrome/fibromyalgia) were randomized into WHEE treatment and wait-list control groups for 6 weeks. Assessments of depression, anxiety, and pain were completed before, during, and at 1 and 3 months after treatment. Wait-listed patients then received an identical course of WHEE and assessments. WHEE decreased anxiety (P < .5) and depression (P < .05) compared with the control group. The wait-list-turned-WHEE assessments demonstrated decreased pain severity (P < .05) and depression (P < .04) but not pain interference or anxiety. WHEE appears a promising method for pain, anxiety, and depression in patients with chronic pain, compared to standard medical care alone. Though a small pilot study, the present results suggest that further research appears warranted. An incidental finding was that a majority of patients with chronic pain had suffered psychological trauma in childhood and/or adulthood. PMID:27432773

Implementation of treat-to-target in rheumatoid arthritis through a Learning Collaborative: Rationale and design of the TRACTION trial.

PubMed

Solomon, Daniel H; Lee, Sara B; Zak, Agnes; Corrigan, Cassandra; Agosti, Jenifer; Bitton, Asaf; Harrold, Leslie; Losina, Elena; Lu, Bing; Pincus, Ted; Radner, Helga; Smolen, Josef; Katz, Jeffrey N; Fraenkel, Liana

2016-08-01

Treat-to-target (TTT) is a recommended strategy in the management of rheumatoid arthritis (RA), but various data sources suggest that its uptake in routine care in the US is suboptimal. Herein, we describe the design of a randomized controlled trial of a Learning Collaborative to facilitate implementation of TTT. We recruited 11 rheumatology sites from across the US and randomized them into the following two groups: one received the Learning Collaborative intervention in Phase 1 (month 1-9) and the second formed a wait-list control group to receive the intervention in Phase 2 (months 10-18). The Learning Collaborative intervention was designed using the Model for Improvement, consisting of a Change Package with corresponding principles and action phases. Phase 1 intervention practices had nine learning sessions, collaborated using a web-based tool, and shared results of plan-do-study-act cycles and monthly improvement metrics collected at each practice. The wait-list control group sites had no intervention during Phase 1. The primary trial outcome is the implementation of TTT as measured by chart review, comparing the differences from baseline to end of Phase 1, between intervention and control sites. All intervention sites remained engaged in the Learning Collaborative throughout Phase 1, with a total of 38 providers participating. The primary trial outcome measures are currently being collected by the study team through medical record review. If the Learning Collaborative is an effective means for improving implementation of TTT, this strategy could serve as a way of implementing disseminating TTT more widely. Copyright © 2016 Elsevier Inc. All rights reserved.

Meta-analysis: aerobic exercise for the treatment of anxiety disorders.

PubMed

Bartley, Christine A; Hay, Madeleine; Bloch, Michael H

2013-08-01

This meta-analysis investigates the efficacy of exercise as a treatment for DSM-IV diagnosed anxiety disorders. We searched PubMED and PsycINFO for randomized, controlled trials comparing the anxiolytic effects of aerobic exercise to other treatment conditions for DSM-IV defined anxiety disorders. Seven trials were included in the final analysis, totaling 407 subjects. The control conditions included non-aerobic exercise, waitlist/placebo, cognitive-behavioral therapy, psychoeducation and meditation. A fixed-effects model was used to calculate the standardized mean difference of change in anxiety rating scale scores of aerobic exercise compared to control conditions. Subgroup analyses were performed to examine the effects of (1) comparison condition; (2) whether comparison condition controlled for time spent exercising and (3) diagnostic indication. Aerobic exercise demonstrated no significant effect for the treatment of anxiety disorders (SMD=0.02 (95%CI: -0.20-0.24), z = 0.2, p = 0.85). There was significant heterogeneity between trials (χ(2) test for heterogeneity = 22.7, df = 6, p = 0.001). The reported effect size of aerobic exercise was highly influenced by the type of control condition. Trials utilizing waitlist/placebo controls and trials that did not control for exercise time reported large effects of aerobic exercise while other trials report no effect of aerobic exercise. Current evidence does not support the use of aerobic exercise as an effective treatment for anxiety disorders as compared to the control conditions. This remains true when controlling for length of exercise sessions and type of anxiety disorder. Future studies evaluating the efficacy of aerobic exercise should employ larger sample sizes and utilize comparison interventions that control for exercise time. Copyright © 2013. Published by Elsevier Inc.

Randomized Trial of Cognitive-Behavioral Therapy for Chronic Posttraumatic Stress Disorder in Adult Female Survivors of Childhood Sexual Abuse

ERIC Educational Resources Information Center

McDonagh, Annmarie; Friedman, Matthew; McHugo, Gregory; Ford, Julian; Sengupta, Anjana; Mueser, Kim; Demment, Christine Carney; Fournier, Debra; Schnurr, Paula P.

2005-01-01

The authors conducted a randomized clinical trial of individual psychotherapy for women with posttraumatic stress disorder (PTSD) related to childhood sexual abuse (n = 74), comparing cognitive-behavioral therapy (CBT) with a problem-solving therapy (present-centered therapy; PCT) and to a wait-list (WL). The authors hypothesized that CBT would be…

Improving Nurses' Peripheral Intravenous Catheter Insertion Knowledge, Confidence, and Skills Using a Simulation-Based Blended Learning Program: A Randomized Trial.

PubMed

Keleekai, Nowai L; Schuster, Catherine A; Murray, Connie L; King, Mary Anne; Stahl, Brian R; Labrozzi, Laura J; Gallucci, Susan; LeClair, Matthew W; Glover, Kevin R

2016-12-01

Peripheral intravenous catheter (PIVC) insertion is one of the most common invasive procedures performed in a hospital, but most nurses receive little formal training in this area. Blended PIVC insertion training programs that incorporate deliberate simulated practice have the potential to improve clinical practice and patient care. The study was a randomized, wait-list control group with crossover using nurses on three medical/surgical units. Baseline PIVC knowledge, confidence, and skills assessments were completed for both groups. The intervention group then received a 2-hour PIVC online course, followed by an 8-hour live training course using a synergistic mix of three simulation tools. Both groups were then reassessed. After crossover, the wait-list group received the same intervention and both groups were reassessed. At baseline, both groups were similar for knowledge, confidence, and skills. Compared with the wait-list group, the intervention group had significantly higher scores for knowledge, confidence, and skills upon completing the training program. After crossover, the wait-list group had similarly higher scores for knowledge, confidence, and skills than the intervention group. Between the immediate preintervention and postintervention periods, the intervention group improved scores for knowledge by 31%, skills by 24%, and decreased confidence by 0.5%, whereas the wait-list group improved scores for knowledge by 28%, confidence by 16%, and skills by 15%. Results demonstrate significant improvements in nurses' knowledge, confidence, and skills with the use of a simulation-based blended learning program for PIVC insertion. Transferability of these findings from a simulated environment into clinical practice should be further explored.

Interreality for the management and training of psychological stress: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Psychological stress occurs when an individual perceives that environmental demands tax or exceed his or her adaptive capacity. Its association with severe health and emotional diseases, points out the necessity to find new efficient strategies to treat it. Moreover, psychological stress is a very personal problem and requires training focused on the specific needs of individuals. To overcome the above limitations, the INTERSTRESS project suggests the adoption of a new paradigm for e-health - Interreality - that integrates contextualized assessment and treatment within a hybrid environment, bridging the physical and the virtual worlds. According to this premise, the aim of this study is to investigate the advantages of using advanced technologies, in combination with cognitive behavioral therapy (CBT), based on a protocol for reducing psychological stress. Methods/Design The study is designed as a randomized controlled trial. It includes three groups of approximately 50 subjects each who suffer from psychological stress: (1) the experimental group, (2) the control group, (3) the waiting list group. Participants included in the experimental group will receive a treatment based on cognitive behavioral techniques combined with virtual reality, biofeedback and mobile phone, while the control group will receive traditional stress management CBT-based training, without the use of new technologies. The wait-list group will be reassessed and compared with the two other groups five weeks after the initial evaluation. After the reassessment, the wait-list patients will randomly receive one of the two other treatments. Psychometric and physiological outcomes will serve as quantitative dependent variables, while subjective reports of participants will be used as the qualitative dependent variable. Discussion What we would like to show with the present trial is that bridging virtual experiences, used to learn coping skills and emotional regulation, with real experiences using advanced technologies (virtual reality, advanced sensors and smartphones) is a feasible way to address actual limitations of existing protocols for psychological stress. Trial registration http://clinicaltrials.gov/ct2/show/NCT01683617 PMID:23806013

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

PubMed

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

2015-01-01

This study evaluated the efficacy of the PASSAGE Program, a structured multicomponent interdisciplinary group intervention for the self-management of FMS. A mixed-methods randomized controlled trial (intervention (INT) vs. waitlist (WL)) was conducted with patients suffering from FMS. Data were collected at baseline (T0), at the end of the intervention (T1), and 3 months later (T2). The primary outcome was change in pain intensity (0-10). Secondary outcomes were fibromyalgia severity, pain interference, sleep quality, pain coping strategies, depression, health-related quality of life, patient global impression of change (PGIC), and perceived pain relief. Qualitative group interviews with a subset of patients were also conducted. Complete data from T0 to T2 were available for 43 patients. The intervention had a statistically significant impact on the three PGIC measures. At the end of the PASSAGE Program, the percentages of patients who perceived overall improvement in their pain levels, functioning and quality of life were significantly higher in the INT Group (73%, 55%, 77% respectively) than in the WL Group (8%, 12%, 20%). The same differences were observed 3 months post-intervention (Intervention group: 62%, 43%, 38% vs Waitlist Group: 13%, 13%, 9%). The proportion of patients who reported ≥ 50% pain relief was also significantly higher in the INT Group at the end of the intervention (36% vs 12%) and 3 months post-intervention (33% vs 4%). Results of the qualitative analysis were in line with the quantitative findings regarding the efficacy of the intervention. The improvement, however, was not reflected in the primary outcome and other secondary outcome measures. The PASSAGE Program was effective in helping FMS patients gain a sense of control over their symptoms. We suggest including PGIC in future clinical trials on FMS as they appear to capture important aspects of the patients' experience. International Standard Randomized Controlled Trial Number Register ISRCTN14526380.

A pilot study: mindfulness meditation intervention in COPD.

PubMed

Chan, Roxane Raffin; Giardino, Nicholas; Larson, Janet L

2015-01-01

Living well with chronic obstructive pulmonary disease (COPD) requires people to manage disease-related symptoms in order to participate in activities of daily living. Mindfulness practice is an intervention that has been shown to reduce symptoms of chronic disease and improve accurate symptom assessment, both of which could result in improved disease management and increased wellness for people with COPD. A randomized controlled trial was conducted to investigate an 8-week mindful meditation intervention program tailored for the COPD population and explore the use of breathing timing parameters as a possible physiological measure of meditation uptake. Results demonstrated that those randomized to the mindful meditation intervention group (N=19) had a significant increase in respiratory rate over time as compared to those randomized to the wait-list group (N=22) (P=0.045). It was also found that the mindful meditation intervention group demonstrated a significant decrease in level of mindfulness over time as compared to the wait-list group (P=0.023). When examining participants from the mindful meditation intervention who had completed six or more classes, it was found that respiratory rate did not significantly increase in comparison to the wait-list group. Furthermore, those who completed six or more classes (N=12) demonstrated significant improvement in emotional function in comparison to the wait-list group (P=0.032) even though their level of mindfulness did not improve. This study identifies that there may be a complex relationship between breathing parameters, emotion, and mindfulness in the COPD population. The results describe good feasibility and acceptability for meditation interventions in the COPD population.

A pilot study: mindfulness meditation intervention in COPD

PubMed Central

Chan, Roxane Raffin; Giardino, Nicholas; Larson, Janet L

2015-01-01

Living well with chronic obstructive pulmonary disease (COPD) requires people to manage disease-related symptoms in order to participate in activities of daily living. Mindfulness practice is an intervention that has been shown to reduce symptoms of chronic disease and improve accurate symptom assessment, both of which could result in improved disease management and increased wellness for people with COPD. A randomized controlled trial was conducted to investigate an 8-week mindful meditation intervention program tailored for the COPD population and explore the use of breathing timing parameters as a possible physiological measure of meditation uptake. Results demonstrated that those randomized to the mindful meditation intervention group (N=19) had a significant increase in respiratory rate over time as compared to those randomized to the wait-list group (N=22) (P=0.045). It was also found that the mindful meditation intervention group demonstrated a significant decrease in level of mindfulness over time as compared to the wait-list group (P=0.023). When examining participants from the mindful meditation intervention who had completed six or more classes, it was found that respiratory rate did not significantly increase in comparison to the wait-list group. Furthermore, those who completed six or more classes (N=12) demonstrated significant improvement in emotional function in comparison to the wait-list group (P=0.032) even though their level of mindfulness did not improve. This study identifies that there may be a complex relationship between breathing parameters, emotion, and mindfulness in the COPD population. The results describe good feasibility and acceptability for meditation interventions in the COPD population. PMID:25767382

Stress Management and Resiliency Training (SMART) program among Department of Radiology faculty: a pilot randomized clinical trial.

PubMed

Sood, Amit; Sharma, Varun; Schroeder, Darrell R; Gorman, Brian

2014-01-01

To test the efficacy of a Stress Management and Resiliency Training (SMART) program for decreasing stress and anxiety and improving resilience and quality of life among Department of Radiology physicians. The study was approved by the institutional review board. A total of 26 Department of Radiology physicians were randomized in a single-blind trial to either the SMART program or a wait-list control arm for 12 weeks. The program involved a single 90-min group session in the SMART training with two follow-up phone calls. Primary outcomes measured at baseline and week 12 included the Perceived Stress Scale, Linear Analog Self-Assessment Scale, Mindful Attention Awareness Scale, and Connor-Davidson Resilience Scale. A total of 22 physicians completed the study. A statistically significant improvement in perceived stress, anxiety, quality of life, and mindfulness at 12 weeks was observed in the study arm compared to the wait-list control arm; resilience also improved in the active arm, but the changes were not statistically significant when compared to the control arm. A single session to decrease stress among radiologists using the SMART program is feasible. Furthermore, the intervention afforded statistically significant and clinically meaningful improvement in anxiety, stress, quality of life, and mindful attention. Further studies including larger sample size and longer follow-up are warranted. Copyright © 2014. Published by Elsevier Inc.

Effects of a multidisciplinary stress treatment programme on patient return to work rate and symptom reduction: results from a randomised, wait-list controlled trial.

PubMed

Netterstrøm, Bo; Friebel, Lene; Ladegaard, Yun

2013-01-01

To evaluate the efficacy of a multidisciplinary stress treatment programme. General practitioners referred 198 employed patients on sick leave with symptoms of persistent work-related stress. Using a waitlisted randomised controlled trial design, the participants were randomly divided into the following three groups: the intervention group (IG, 69 participants); treatment-as-usual control group (TAUCG, 71 participants), which received 12 consultations with a psychologist, and the waitlisted control group (WLCG, 58 participants). The stress treatment intervention consisted of nine 1-hour sessions conducted over 3 months. The goals of the sessions were the following: (1) identifying relevant stressors; (2) changing the participant's coping strategies; (3) adjusting the participant's workload and tasks, and (4) improving workplace dialogue. Each participant also attended a mindfulness-based stress reduction (MBSR) course for 2 h a week over 8 weeks. The IG and TAUCG showed significantly greater symptom level (Symptom Check List 92) reductions compared to the WLCG. Regarding the return to work (RTW) rate, 67% of participants in the IG returned to full-time work after treatment, which was a significantly higher rate than in the TAUCG (36%) and WLCG (24%). Significantly more participants in the IG (97%) increased their working hours during treatment compared with the participants in the control groups, TAUCG (71%) and WLCG (64%). The stress treatment programme--a combination of work place-focused psychotherapy and MBSR--significantly reduced stress symptom levels and increased RTW rates compared with the WLCG and TAUCG. Copyright © 2013 S. Karger AG, Basel.

Effects of music therapy on self- and experienced stigma in patients on an acute care psychiatric unit: a randomized three group effectiveness study.

PubMed

Silverman, Michael J

2013-10-01

Stigma is a major social barrier that can restrict access to and willingness to seek psychiatric care. Psychiatric consumers may use secrecy and withdrawal in an attempt to cope with stigma. The purpose of this study was to determine the effects of music therapy on self- and experienced stigma in acute care psychiatric inpatients using a randomized design with wait-list control. Participants (N=83) were randomly assigned by cluster to one of three single-session group-based conditions: music therapy, education, or wait-list control. Participants in the music therapy and education conditions completed only posttests while participants in the wait-list control condition completed only pretests. The music therapy condition was a group songwriting intervention wherein participants composed lyrics for "the stigma blues." Results indicated significant differences in measures of discrimination (experienced stigma), disclosure (self-stigma), and total stigma between participants in the music therapy condition and participants in the wait-list control condition. From the results of this randomized controlled investigation, music therapy may be an engaging and effective psychosocial technique to treat stigma. Limitations, suggestions for future research, and implications for clinical practice and psychiatric music therapy research are provided. © 2013.

Who Benefits and How Does It Work? Moderators and Mediators of Outcome in an Effectiveness Trial of a Parenting Intervention

ERIC Educational Resources Information Center

Gardner, Frances; Hutchings, Judy; Bywater, Tracey; Whitaker, Chris

2010-01-01

We examined mediators and moderators of change in conduct problems, in a multiagency randomized trial of the Incredible Years parenting program. Preschoolers (n = 153) at risk for conduct problems were randomly assigned to intervention (n = 104) and wait-list (n = 49) groups. Boys and younger children, and those with more depressed mothers, tended…

Effectiveness of an Educational Intervention on Reducing Misconceptions Among Ethnic Minorities With Complicated Mild to Severe Traumatic Brain Injury

PubMed Central

Pappadis, Monique R.; Sander, Angelle M.; Łukaszewska, Beata; Struchen, Margaret A.; Leung, Patrick; Smith, Dennis W.

2018-01-01

Objective To evaluate the effectiveness of an educational intervention designed to reduce traumatic brain injury (TBI)–related misconceptions among blacks and Latinos with complicated mild to severe TBI. Design Randomized controlled trial with masked 1-month follow-up. Setting Community. Participants Persons (N = 52) with complicated mild to severe TBI (mean best day 1 Glasgow Coma Scale score, 11.27±3.89) were randomly recruited from 141 eligible participants (mean age, 37.71±13.88y; age range, 19–66y; mean months postinjury, 24.69±11.50); 25 participants (48.1%) of participants were black and 27 (51.9%) were Hispanic/Latino. Of the Hispanic/Latino participants, 18 (66.7%) were non-U.S. born and 12 (44.4%) spoke Spanish as their primary language. Twenty-seven individuals were randomized to the educational intervention group and 25 were randomized to the wait-list control group. Interventions Single-session educational intervention with written materials provided in English or Spanish. Main Outcome Measures Forty-item Common Misconceptions about Traumatic Brain Injury Questionnaire administered at baseline and 1-month follow-up. Results After controlling for ethnic and language differences, a significant between-group main effect (P = .010) and a significant time-group interaction for the Common Misconceptions about Traumatic Brain Injury Questionnaire were noted (Wilks Λ = .89; F1,46 = 6.00; P = .02). The intervention group showed a decrease in TBI misconception percentages, whereas the wait-list control group maintained similar percentages. At 1-month follow-up, the wait-list control group reported more misconceptions than did the intervention group (P = .019). Conclusions An educational intervention developed to address the recovery process, common symptoms, and ways to handle the symptoms provides promise as a tool to decrease TBI misconceptions among persons from ethnically and educationally diverse backgrounds. The effects of therapist characteristics and the client-therapist relation on outcomes should be further explored. PMID:28007444

Effect of the WeCareAdvisor™ on family caregiver outcomes in dementia: a pilot randomized controlled trial.

PubMed

Kales, Helen C; Gitlin, Laura N; Stanislawski, Barbara; Myra Kim, H; Marx, Katherine; Turnwald, Molly; Chiang, Claire; Lyketsos, Constantine G

2018-05-10

Behavioral and psychological symptoms of dementia (BPSD) are universal and associated with multiple negative outcomes. This pilot randomized controlled trial (RCT) evaluated the effect of using the WeCareAdvisor, an innovative web-based tool developed to enable family caregivers to assess, manage, and track BPSD. This RCT enrolled 57 dementia family caregivers from community and clinical settings in Ann Arbor, Michigan and Baltimore, Maryland. Participants were randomly assigned to immediate use of the WeCareAdvisor tool (WCA, n = 27) or a Waitlist control group (n = 30) that received the tool after a one-month waiting period. Outcomes for the caregiver and the person they were caring for were assessed at baseline (T0) and one-month followup for both the WCA (T1) and Waitlist control (T2) groups. Caregiver mean age was 65.9 ± 14.0 years old. About half (49%) were spouses. Baseline characteristics were comparable between groups except for mean caregiver confidence which was higher in the control group (WCA 35.0 ± 10.0 vs. Waitlist control 39.7 ± 6.9, p = 0.04). There were no significant differences between the WCA and control groups in characteristics of the person with dementia. After their one-month of tool use (T1), WCA caregivers showed significant within group improvement in caregiver distress (- 6.08 ± 6.31 points, t = - 4.82, p < 0.0001) and behavioral frequency (- 3.60 ± 5.05, t = - 3.56, p = 0.002), severity (- 3.24 ± 3.87, t = - 4.19, p = 0.0003) and total behavioral score (- 6.80 ± 10.73, t = - 3.17, p = 004). In the same timeframe, Waitlist control caregivers showed a significant decrease in confidence (- 6.40 ± 10.30, t = - 3.40, p = 0.002). The WCA group showed greater improvement in distress compared to the Waitlist group (T0-T1; t = - 2.49, p = 0.02), which remained significant after adjusting for site and baseline distress. There were no significant between-group differences in caregiver confidence or other secondary outcomes. After their one month of tool use (T2), the Waitlist group also showed significant improvement in caregiver distress (- 3.72 ± 7.53, t = - 2.66, p = 0.013), stress (- 0.41 ± 1.02, t = - 2.19, p = 0.037), confidence (4.38 ± 5.17, t = 4.56, p < 0.0001), burden (- 2.76 ± 7.26, t = - 2.05, p = 0.05), negative communication (- 1.48 ± 2.96, t = - 2.70, p = 0.012) and behavioral frequency (- 1.86 ± 4.58, t = - 2.19, p = 0.037); distress remained significant after adjustment. In this pilot RCT, WCA use resulted in a significant decrease in caregiver distress. Future research will identify whether longer use of WCA can impact other caregiver and behavioral outcomes. Clinicaltrials.gov identifier NCT02420535 (Date of registry: 4/20/2015, prior to the start of the clinical trial).

A 3-arm randomized controlled trial on the effects of dance movement intervention and exercises on elderly with early dementia.

PubMed

Ho, Rainbow Tin Hung; Cheung, Jacob Kai Ki; Chan, Wai Chi; Cheung, Irene Kit Man; Lam, Linda Chiu Wah

2015-10-19

Dementia is characterized by a progressive decline and deterioration of brain regions such as memory, spatial navigation and language, along with disturbances in daily functioning. Non-pharmacological interventions that offer a holistic approach by targeting cognitive functioning, prognosis and the psychological and social effects of dementia require rigorous investigation. The well-established benefits of physical activity for cognitive functioning and psychological support in dementia have been observed with dance-movement intervention. There is substantial evidence that dance-movement interventions provide emotional and social advantages. Thus, a randomized controlled trial (RCT) is planned to investigate the positive effects of a dance movement intervention, compared with mild physical exercise, on the physical and psychological well-being of elderly Chinese individuals with early dementia. A 3-arm RCT with waitlist control design will be used in this study. Two hundred and one elderly participants with very mild to mild dementia will be screened and randomized into the following groups: (i) dance movement based intervention, (ii) stretching and exercise intervention and (iii) no intervention waitlist-control group. The two intervention groups will receive a 1-h intervention, twice a week, for 12 weeks. The participants will be assessed four times over the course of 12 months: baseline before randomization, post-intervention (3 months), 6 months from baseline and 12 months from baseline. The primary outcomes will be compared between assessment points and between groups on neuropsychiatric symptoms, psychosocial well-being and cognitive and daily functioning. Secondary outcomes will assess the changes in salivary cortisol levels and their relationships with the primary outcome measures. This study will provide substantial evidence of the efficacy of a dance-movement-based intervention in slowing down dementia progression, due to its ability to act as a buffer against decline and improve areas affected by dementia. We also anticipate an association between cortisol levels and the outcome measures. The further development of this intervention into a structural program may be warranted for early psychosocial support among elderly populations. The trial has been registered in the Chinese Clinical Trial Registry ( ChiCTR-IOR-15006541 ).

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

PubMed

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

2018-01-01

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

Changes in negative implicit evaluations in patients of hypochondriasis after treatment with cognitive therapy or exposure therapy.

PubMed

Schreiber, Franziska; Witthöft, Michael; Neng, Julia M B; Weck, Florian

2016-03-01

Previous studies using modified versions of the Affect Misattribution Procedure (AMP; Payne, Cheng, Govorun, & Stewart, 2005) have revealed that there is an implicit negative evaluation bias of illness-related information in patients with hypochondriasis (HYP), which might be a maintaining feature of HYP. However, there is no evidence on whether this bias might be targeted successfully by effective treatments, such as exposure therapy (ET) or cognitive therapy (CT). This is the first study to examine the change in negative implicit evaluations in a randomized controlled trial, including individual CT and ET, compared to a wait-list control group for HYP. An AMP with illness, symptom and neutral primes was used in 70 patients with HYP before and after treatment (wait-list respectively). There was no significant change in negative implicit affective evaluations in both CT and ET, compared to wait-list. However, comparisons between the two active treatments revealed an interaction effect, that only for CT were the affective reactions on illness-as well as symptom-related prime trials (but not neutral primes) significantly more positive at post-compared to pre-treatment. In CT but not in ET, the reduction of implicit negative evaluation bias regarding symptom-related primes was significantly related to the reduction of self-reported health anxiety. The small subsample sizes for CT and ET, in comparison to wait-list, prohibit the detection of smaller effects. Formal cognitive restructuring is necessary for reducing implicit negative evaluation bias in HYP, but the latter is not a prerequisite for reducing health anxiety. Thus, the importance of the negative implicit evaluation bias for the maintenance of HYP remains questionable. Copyright © 2015 Elsevier Ltd. All rights reserved.

Using Acceptance and Commitment Therapy to Increase Self-Compassion: A Randomized Controlled Trial

PubMed Central

Yadavaia, James E.; Hayes, Steven C.; Vilardaga, Roger

2014-01-01

Self-compassion has been shown to be related to several types of psychopathology, including traumatic stress, and has been shown to improve in response to various kinds of interventions. Current conceptualizations of self-compassion fit well with the psychological flexibility model, which underlies acceptance and commitment therapy (ACT). However, there has been no research on ACT interventions specifically aimed at self-compassion. This randomized trial therefore compared a 6-hour ACT-based workshop targeting self-compassion to a wait-list control. From pretreatment to 2-month follow-up, ACT was significantly superior to the control condition in self-compassion, general psychological distress, and anxiety. Process analyses revealed psychological flexibility to be a significant mediator of changes in self-compassion, general psychological distress, depression, anxiety, and stress. Exploratory moderation analyses revealed the intervention to be of more benefit in terms of depression, anxiety, and stress to those with greater trauma history. PMID:25506545

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

PubMed

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

2015-01-01

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

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

PubMed Central

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

2015-01-01

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

Using Acceptance and Commitment Therapy to Increase Self-Compassion: A Randomized Controlled Trial.

PubMed

Yadavaia, James E; Hayes, Steven C; Vilardaga, Roger

2014-10-01

Self-compassion has been shown to be related to several types of psychopathology, including traumatic stress, and has been shown to improve in response to various kinds of interventions. Current conceptualizations of self-compassion fit well with the psychological flexibility model, which underlies acceptance and commitment therapy (ACT). However, there has been no research on ACT interventions specifically aimed at self-compassion. This randomized trial therefore compared a 6-hour ACT-based workshop targeting self-compassion to a wait-list control. From pretreatment to 2-month follow-up, ACT was significantly superior to the control condition in self-compassion, general psychological distress, and anxiety. Process analyses revealed psychological flexibility to be a significant mediator of changes in self-compassion, general psychological distress, depression, anxiety, and stress. Exploratory moderation analyses revealed the intervention to be of more benefit in terms of depression, anxiety, and stress to those with greater trauma history.

Web-based cognitive rehabilitation for survivors of adult cancer: A randomised controlled trial.

PubMed

Mihuta, Mary E; Green, Heather J; Shum, David H K

2018-04-01

Cognitive dysfunction associated with cancer is frequently reported and can reduce quality of life. This study evaluated a Web-based cognitive rehabilitation therapy program (eReCog) in cancer survivors compared with a waitlist control group. Adult cancer survivors with self-reported cognitive symptoms who had completed primary treatment at least 6 months prior were recruited. Participants completed telephone screening and were randomly allocated to the 4-week online intervention or waitlist. Primary outcome was perceived cognitive impairment assessed with the Functional Assessment of Cancer Therapy-Cognitive Function version 3. Secondary outcomes were additional measures of subjective cognitive functioning, objective cognitive functioning, and psychosocial variables. Seventy-six women were allocated to the intervention (n = 40) or waitlist (n = 36). A significant interaction was found on the instrumental activities of daily living measure of self-reported prospective memory whereby the intervention group reported a greater reduction in prospective memory failures than the waitlist group. Interaction trends were noted on perceived cognitive impairments (P = .089) and executive functioning (P = .074). No significant interactions were observed on other measures of objective cognitive functioning or psychosocial variables. The Web-based intervention shows promise for improving self-reported cognitive functioning in adult cancer survivors. Further research is warranted to better understand the mechanisms by which the intervention might contribute to improved self-reported cognition. Copyright © 2017 John Wiley & Sons, Ltd.

Quasi-experimental trial of diabetes Self-Management Automated and Real-Time Telephonic Support (SMARTSteps) in a Medicaid managed care plan: study protocol

PubMed Central

2012-01-01

Background Health information technology can enhance self-management and quality of life for patients with chronic disease and overcome healthcare barriers for patients with limited English proficiency. After a randomized controlled trial of a multilingual automated telephone self-management support program (ATSM) improved patient-centered dimensions of diabetes care in safety net clinics, we collaborated with a nonprofit Medicaid managed care plan to translate research into practice, offering ATSM as a covered benefit and augmenting ATSM to promote medication activation. This paper describes the protocol of the Self-Management Automated and Real-Time Telephonic Support Project (SMARTSteps). Methods/Design This controlled quasi-experimental trial used a wait-list variant of a stepped wedge design to enroll 362 adult health plan members with diabetes who speak English, Cantonese, or Spanish and receive care at 4 publicly-funded clinics. Through language-stratified randomization, participants were assigned to four intervention statuses: SMARTSteps-ONLY, SMARTSteps-PLUS, or wait-list for either intervention. In addition to usual primary care, intervention participants received 27 weekly calls in their preferred language with rotating queries and response-triggered education about self-care, medication adherence, safety concerns, psychological issues, and preventive services. Health coaches from the health plan called patients with out-of-range responses for collaborative goal setting and action planning. SMARTSteps-PLUS also included health coach calls to promote medication activation, adherence and intensification, if triggered by ATSM-reported non-adherence, refill non-adherence from pharmacy claims, or suboptimal cardiometabolic indicators. Wait-list patients crossed-over to SMARTSteps-ONLY or -PLUS at 6 months. For participants who agreed to structured telephone interviews at baseline and 6 months (n = 252), primary outcomes will be changes in quality of life and functional status with secondary outcomes of 6-month changes in self-management behaviors/efficacy and patient-centered processes of care. We will also evaluate 6-month changes in cardiometabolic (HbA1c, blood pressure, and LDL) and utilization indicators for all participants. Discussion Outcomes will provide evidence regarding real-world implementation of ATSM within a Medicaid managed care plan serving safety net settings. The evaluation trial will provide insight into translating and scaling up health information technology interventions for linguistically and culturally diverse vulnerable populations with chronic disease. Trial Registration ClinicalTrials.gov: NCT00683020 PMID:22280514

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

PubMed Central

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

2017-01-01

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

Internet-based cognitive-behavior therapy for procrastination: A randomized controlled trial.

PubMed

Rozental, Alexander; Forsell, Erik; Svensson, Andreas; Andersson, Gerhard; Carlbring, Per

2015-08-01

Procrastination can be a persistent behavior pattern associated with personal distress. However, research investigating different treatment interventions is scarce, and no randomized controlled trial has examined the efficacy of cognitive-behavior therapy (CBT). Meanwhile, Internet-based CBT has been found promising for several conditions, but has not yet been used for procrastination. Participants (N = 150) were randomized to guided self-help, unguided self-help, and wait-list control. Outcome measures were administered before and after treatment, or weekly throughout the treatment period. They included the Pure Procrastination Scale, the Irrational Procrastination Scale, the Susceptibility to Temptation Scale, the Montgomery Åsberg Depression Rating Scale-Self-report version, the Generalized Anxiety Disorder Assessment, and the Quality of Life Inventory. The intention-to-treat principle was used for all statistical analyses. Mixed-effects models revealed moderate between-groups effect sizes comparing guided and unguided self-help with wait-list control; the Pure Procrastination Scale, Cohen's d = 0.70, 95% confidence interval (CI) [0.29, 1.10], and d = 0.50, 95% CI [0.10, 0.90], and the Irrational Procrastination Scale, d = 0.81 95% CI [0.40, 1.22], and d = 0.69 95% CI [0.29, 1.09]. Clinically significant change was achieved among 31.3-40.0% for guided self-help, compared with 24.0-36.0% for unguided self-help. Neither of the treatment conditions was found to be superior on any of the outcome measures, Fs(98, 65.17-72.55) < 1.70, p > .19. Internet-based CBT could be useful for managing self-reported difficulties due to procrastination, both with and without the guidance of a therapist. (c) 2015 APA, all rights reserved).

Behavioral family intervention for children with developmental disabilities and behavioral problems.

PubMed

Roberts, Clare; Mazzucchelli, Trevor; Studman, Lisa; Sanders, Matthew R

2006-06-01

The outcomes of a randomized clinical trial of a new behavioral family intervention, Stepping Stones Triple P, for preschoolers with developmental and behavior problems are presented. Forty-eight children with developmental disabilities participated, 27 randomly allocated to an intervention group and 20 to a wait-list control group. Parents completed measures of parenting style and stress, and independent observers assessed parent-child interactions. The intervention was associated with fewer child behavior problems reported by mothers and independent observers, improved maternal and paternal parenting style, and decreased maternal stress. All effects were maintained at 6-month follow-up.

Effectiveness of adolescent suicide prevention e-learning modules that aim to improve knowledge and self-confidence of gatekeepers: study protocol for a randomized controlled trial.

PubMed

Ghoncheh, Rezvan; Kerkhof, Ad J F M; Koot, Hans M

2014-02-08

Providing e-learning modules can be an effective strategy for enhancing gatekeepers' knowledge, self-confidence and skills in adolescent suicide prevention. The aim of this study was to test the effectiveness of an online training program called Mental Health Online which consists of eight short e-learning modules, each capturing an important aspect of the process of recognition, guidance and referral of suicidal adolescents (12-20 years). The primary outcomes of this study are participant's ratings on perceived knowledge, perceived self-confidence, and actual knowledge regarding adolescent suicidality. A randomized controlled trial will be carried out among 154 gatekeepers. After completing the first assessment (pre-test), participants will be randomly assigned to either the experimental group or the waitlist control group. One week after completing the first assessment the experimental group will have access to the website Mental Health Online containing the eight e-learning modules and additional information on adolescent suicide prevention. Participants in both conditions will be assessed 4 weeks after completing the first assessment (post-test), and 12 weeks after completing the post-test (follow-up). At post-test, participants from the experimental group are asked to complete an evaluation questionnaire on the modules. The waitlist control group will have access to the modules and additional information on the website after completing the follow-up assessment. Gatekeepers can benefit from e-learning modules on adolescent suicide prevention. This approach allows them to learn about this sensitive subject at their own pace and from any given location, as long as they have access to the Internet. Given the flexible nature of the program, each participant can compose his/her own training creating an instant customized course with the required steps in adolescent suicide prevention. Netherlands Trial Register NTR3625.

Randomized controlled trial of web-based multimodal therapy for children with acquired brain injury to improve gross motor capacity and performance.

PubMed

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

2017-06-01

To compare efficacy of a web-based multimodal training programme, 'Move it to improve it' (Mitii TM ), to usual care on gross motor capacity and performance for children with an acquired brain injury. Randomized waitlist controlled trial. Home environment. A total of 60 independently ambulant children (30 in each group), minimum 12 months post-acquired brain injury were recruited and randomly allocated to receive either 20 weeks of Mitii TM training (30 minutes/day, six days/week, total 60 hours) immediately, or waitlisted (usual care control group) for 20 weeks. A total of 58 children completed baseline assessments (32 males; age 11 years 11 months ± 2 years 6 months; Gross Motor Function Classification System equivalent I = 29, II = 29). The Mitii TM program comprised of gross motor, upper limb and visual perception/cognitive activities. The primary outcome was 30-second, repetition maximum functional strength tests for the lower limb (sit-to-stand, step-ups, half-kneel to stand). Secondary outcomes were the 6-minute walk test, High-level Mobility Assessment Tool, Timed Up and Go Test and habitual physical activity as captured by four-day accelerometry. Groups were equivalent at baseline on demographic and clinical measures. The Mitii TM group demonstrated significantly greater improvements on combined score of functional strength tests (mean difference 10.19 repetitions; 95% confidence interval, 3.26-17.11; p = 0.006) compared with the control group. There were no other between-group differences on secondary outcomes. Although the Mitii TM programme demonstrated statistically significant improvements in the functional strength tests of the lower limb, results did not exceed the minimum detectable change and cannot be considered clinically relevant for children with an acquired brain injury. Australian New Zealand Clinical Trials Registration Number, ANZCTR12613000403730.

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.

Cognitive behavioral therapy for early adolescents with autism spectrum disorders and clinical anxiety: a randomized, controlled trial.

PubMed

Wood, Jeffrey J; Ehrenreich-May, Jill; Alessandri, Michael; Fujii, Cori; Renno, Patricia; Laugeson, Elizabeth; Piacentini, John C; De Nadai, Alessandro S; Arnold, Elysse; Lewin, Adam B; Murphy, Tanya K; Storch, Eric A

2015-01-01

Clinically elevated anxiety is a common, impairing feature of autism spectrum disorders (ASD). A modular CBT program designed for preteens with ASD, Behavioral Interventions for Anxiety in Children with Autism (BIACA; Wood et al., 2009) was enhanced and modified to address the developmental needs of early adolescents with ASD and clinical anxiety. Thirty-three adolescents (11-15 years old) were randomly assigned to 16 sessions of CBT or an equivalent waitlist period. The CBT model emphasized exposure, challenging irrational beliefs, and behavioral supports provided by caregivers, as well as numerous ASD-specific treatment elements. Independent evaluators, parents, and adolescents rated symptom severity at baseline and posttreatment/postwaitlist. In intent-to-treat analyses, the CBT group outperformed the waitlist group on independent evaluators' ratings of anxiety severity on the Pediatric Anxiety Rating Scale (PARS) and 79% of the CBT group met Clinical Global Impressions-Improvement scale criteria for positive treatment response at posttreatment, as compared to only 28.6% of the waitlist group. Group differences were not found for diagnostic remission or questionnaire measures of anxiety. However, parent-report data indicated that there was a positive treatment effect of CBT on autism symptom severity. The CBT manual under investigation, enhanced for early adolescents with ASD, yielded meaningful treatment effects on the primary outcome measure (PARS), although additional developmental modifications to the manual are likely warranted. Future studies examining this protocol relative to an active control are needed. Copyright © 2014. Published by Elsevier Ltd.

Detailed methods of two home-based vegetable gardening intervention trials to improve diet, physical activity, and quality of life in two different populations of cancer survivors

PubMed Central

Cases, Mallory G.; Frugé, Andrew D.; De Los Santos, Jennifer F.; Locher, Julie L.; Cantor, Alan B.; Smith, Kerry P.; Glover, Tony A.; Cohen, Harvey J.; Daniel, Michael; Morrow, Casey D.; Moellering, Douglas R.; Demark-Wahnefried, Wendy

2016-01-01

Background Cancer survivors suffer from long-term adverse effects that reduce health-related quality of life (QOL) and physical functioning, creating an urgent need to develop effective, durable, and disseminable interventions. Harvest for Health, a home-based vegetable gardening intervention, holds promise for these domains. Methods This report describes the methods and recruitment experiences from two randomized controlled feasibility trials that employ a waitlist-controlled design. Delivered in partnership with Cooperative Extension Master Gardeners, this intervention provides one-on-one mentorship of cancer survivors in planning and maintaining three seasonal vegetable gardens over 12 months. The primary aim is to determine intervention feasibility and acceptability; secondary aims are to explore effects on objective and subjective measures of diet, physical activity and function, and QOL and examine participant factors associated with potential effects. One trial is conducted exclusively among 82 female breast cancer survivors residing in the Birmingham, AL metropolitan area (BBCS); another broadly throughout Alabama among 46 older cancer survivors aged ≥60 (ASCS). Results Response rates were 32.6% (BBCS) and 52.3% (ASCS). Both trials exceeded 80% of their accrual target. Leading reasons for ineligibility were removal of >10 lymph nodes (lymphedema risk factor), lack of physician approval, and unwillingness to be randomized to the waitlist. Conclusion To date, recruitment and implementation of Harvest for Health appears feasible. Discussion Although both studies encountered recruitment challenges, lessons learned can inform future larger-scale studies. Vegetable gardening interventions are of interest to cancer survivors and may provide opportunities to gain life skills leading to improvements in overall health and QOL. PMID:27565830

Detailed methods of two home-based vegetable gardening intervention trials to improve diet, physical activity, and quality of life in two different populations of cancer survivors.

PubMed

Cases, Mallory G; Frugé, Andrew D; De Los Santos, Jennifer F; Locher, Julie L; Cantor, Alan B; Smith, Kerry P; Glover, Tony A; Cohen, Harvey J; Daniel, Michael; Morrow, Casey D; Moellering, Douglas R; Demark-Wahnefried, Wendy

2016-09-01

Cancer survivors suffer from long-term adverse effects that reduce health-related quality of life (QOL) and physical functioning, creating an urgent need to develop effective, durable, and disseminable interventions. Harvest for Health, a home-based vegetable gardening intervention, holds promise for these domains. This report describes the methods and recruitment experiences from two randomized controlled feasibility trials that employ a waitlist-controlled design. Delivered in partnership with Cooperative Extension Master Gardeners, this intervention provides one-on-one mentorship of cancer survivors in planning and maintaining three seasonal vegetable gardens over 12months. The primary aim is to determine intervention feasibility and acceptability; secondary aims are to explore effects on objective and subjective measures of diet, physical activity and function, and QOL and examine participant factors associated with potential effects. One trial is conducted exclusively among 82 female breast cancer survivors residing in the Birmingham, AL metropolitan area (BBCS); another broadly throughout Alabama among 46 older cancer survivors aged >60 (ASCS). Response rates were 32.6% (BBCS) and 52.3% (ASCS). Both trials exceeded 80% of their accrual target. Leading reasons for ineligibility were removal of >10 lymph nodes (lymphedema risk factor), lack of physician approval, and unwillingness to be randomized to the waitlist. To date, recruitment and implementation of Harvest for Health appears feasible. Although both studies encountered recruitment challenges, lessons learned can inform future larger-scale studies. Vegetable gardening interventions are of interest to cancer survivors and may provide opportunities to gain life skills leading to improvements in overall health and QOL. Copyright © 2016 Elsevier Inc. All rights reserved.

Effectiveness of a Self Help Cognitive Behavioural Treatment Program for Problem Gamblers: A Randomised Controlled Trial.

PubMed

Oei, T P S; Raylu, N; Lai, W W

2018-06-01

The study aimed to strengthen the scarce literature on self-help treatments for Problem Gambling (PG) by comparing the effectiveness of a Self-Help Cognitive Behavioral Treatment (SHCBT) program (n = 23) with a 6-week Waitlist condition (n = 32) in problem gamblers. Participants were community volunteers with gambling problems and were randomly allocated to the Waitlist and treatment conditions. Results showed significant improvements at post-treatment in gambling behaviors including frequency of gambling, average amount gambled per day and PG symptoms as well as a number of gambling correlates including psychological states (e.g., depression, anxiety and stress), gambling cognitions, gambling urges, gambling related self-efficacy, satisfaction with life, and quality of life among those who completed the SHCBT program, when compared with the waitlist condition. The effect size (partial η 2 ) ranged from .25 to .57 for all assessed outcomes that showed significant improvement from pre- to post-treatment. It was concluded that a self-help CBT program can be beneficial for treating community problem gamblers.

Feasibility and Efficacy of a Parent-Focused, Text Message–Delivered Intervention to Reduce Sedentary Behavior in 2- to 4-Year-Old Children (Mini Movers): Pilot Randomized Controlled Trial

PubMed Central

Salmon, Jo; Hinkley, Trina; Hnatiuk, Jill A; Hesketh, Kylie D

2018-01-01

Background Despite public health guidelines to limit sedentary behavior, many young children spend large amounts of time sedentary (eg, screen and sitting time) during waking hours. Objective The objective of this study was to test the feasibility and efficacy of a parent-focused, predominantly text message–delivered intervention to support parents to reduce the amount of time their children spend in sedentary behavior. Methods Mini Movers was a pilot randomized controlled trial delivered to parents of 2- to 4-year-old children in Melbourne, Australia. Participants were recruited through playgroups, social media, and snowball sampling. Eligibility criteria were having an ambulatory child (2-4 years), English literacy, and smartphone ownership. Participants were randomized to intervention or wait-list control on a 1:1 ratio after baseline data collection. The 6-week intervention was predominantly delivered via text messages, using a Web-based bulk text message platform managed by the interventionist. Intervention strategies focused on increasing parental knowledge, building self-efficacy, setting goals, and providing reinforcement, and were underpinned by the Coventry, Aberdeen & London-Refined taxonomy of behavior change techniques and social cognitive theory. The primary outcome was intervention feasibility, measured by recruitment, retention, intervention delivery, and fidelity; process evaluation questionnaires; and qualitative interviews with a subsample of participants. Secondary outcomes were children’s screen and restraint time (parent report), sitting time (parent report, activPAL), and potential mediators (parent report). Linear regression models were used to determine intervention effects on secondary outcomes, controlling for the child’s sex and age and clustering by playgroup; effect sizes (Cohen's d) were calculated. Results A total of 57 participants (30 intervention; 27 wait-list control) were recruited, and retention was high (93%). Process evaluation results showed that the intervention was highly acceptable to parents. The majority of intervention components were reported to be useful and relevant. Compared with children in the control group, children in the intervention group had significantly less screen time postintervention (adjusted difference [95% CI]=−35.0 [−64.1 to −5.9] min/day; Cohen's d=0.82). All other measures of sedentary behavior were in the expected direction, with small to moderate effect sizes. Conclusions Mini Movers was shown to be a feasible, acceptable, and efficacious pilot intervention for parents of young children, warranting a larger-scale randomized control trial. Trial Registration Australian New Zealand Clinical Trials registry: ACTRN12616000628448; https://www.anzctr.org.au/ Trial/Registration/TrialReview.aspx?ACTRN=12616000628448p (Archived by WebCite at http://www.webcitation.org/ 6wZcA3cYM) PMID:29426816

Quasi-experimental trial of diabetes Self-Management Automated and Real-Time Telephonic Support (SMARTSteps) in a Medicaid managed care plan: study protocol.

PubMed

Ratanawongsa, Neda; Handley, Margaret A; Quan, Judy; Sarkar, Urmimala; Pfeifer, Kelly; Soria, Catalina; Schillinger, Dean

2012-01-26

Health information technology can enhance self-management and quality of life for patients with chronic disease and overcome healthcare barriers for patients with limited English proficiency. After a randomized controlled trial of a multilingual automated telephone self-management support program (ATSM) improved patient-centered dimensions of diabetes care in safety net clinics, we collaborated with a nonprofit Medicaid managed care plan to translate research into practice, offering ATSM as a covered benefit and augmenting ATSM to promote medication activation. This paper describes the protocol of the Self-Management Automated and Real-Time Telephonic Support Project (SMARTSteps). This controlled quasi-experimental trial used a wait-list variant of a stepped wedge design to enroll 362 adult health plan members with diabetes who speak English, Cantonese, or Spanish and receive care at 4 publicly-funded clinics. Through language-stratified randomization, participants were assigned to four intervention statuses: SMARTSteps-ONLY, SMARTSteps-PLUS, or wait-list for either intervention. In addition to usual primary care, intervention participants received 27 weekly calls in their preferred language with rotating queries and response-triggered education about self-care, medication adherence, safety concerns, psychological issues, and preventive services. Health coaches from the health plan called patients with out-of-range responses for collaborative goal setting and action planning. SMARTSteps-PLUS also included health coach calls to promote medication activation, adherence and intensification, if triggered by ATSM-reported non-adherence, refill non-adherence from pharmacy claims, or suboptimal cardiometabolic indicators. Wait-list patients crossed-over to SMARTSteps-ONLY or -PLUS at 6 months. For participants who agreed to structured telephone interviews at baseline and 6 months (n = 252), primary outcomes will be changes in quality of life and functional status with secondary outcomes of 6-month changes in self-management behaviors/efficacy and patient-centered processes of care. We will also evaluate 6-month changes in cardiometabolic (HbA1c, blood pressure, and LDL) and utilization indicators for all participants. Outcomes will provide evidence regarding real-world implementation of ATSM within a Medicaid managed care plan serving safety net settings. The evaluation trial will provide insight into translating and scaling up health information technology interventions for linguistically and culturally diverse vulnerable populations with chronic disease. ClinicalTrials.gov: NCT00683020.

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 weeks) time is no healer in social anxiety disorder. Our results are similar to previous meta-analyses on the effects of waiting in other disorders, e.g., depression and posttraumatic stress disorder. Copyright © 2016 John Wiley & Sons, Ltd.

Internet-Delivered Cognitive-Behavioral Therapy for Social Anxiety Disorder in Romania: A Randomized Controlled Trial

PubMed Central

Tulbure, Bogdan Tudor; Szentagotai, Aurora; David, Oana; Ștefan, Simona; Månsson, Kristoffer N. T.; David, Daniel; Andersson, Gerhard

2015-01-01

Background and Aims Internet-based cognitive-behavioral therapy (iCBT) for social anxiety disorder has been found effective, as attested by independently conducted randomized controlled trials in four languages. The study aim is to test the efficacy of an iCBT program in a culture where it was not tested before (i.e. Romania). Methods Participants (n = 76) were recruited, screened and randomized to either a nine-week guided iCBT or a wait-list control group in April and May 2012. Self-report measures were collected before (April 2012) and after the intervention (July 2012), as well as six months later (January 2013). Although social anxiety was assessed with multiple measures, the Liebowitz Social Anxiety Scale - Self Report version (LSAS-SR) and Social Phobia Inventory (SPIN) were used as the primary outcome measures. Results A significant difference with a large between-group effect size in favor of iCBT was found (Cohen´s d = 1.19 for LSAS-SR and d = 1.27 for SPIN). Recovery rates show that 36.8% (n = 14) in the treatment group score below the SPIN clinical cut-off compared to only 2.6% (n = 1) in the wait-list control group. Post-intervention clinical interviews also revealed that 34.2% (n = 13) of the treatment group was completely recovered (full remission) while additionally 36.8% (n = 14) retained some social anxiety symptoms (partial remission). However, an important study limitation is that post-intervention interviewers were not blinded to the study conditions. The program also effectively reduced depression and dysfunctional thinking (between-group Cohen´s d = 0.84 for depression and d = 0.63 for dysfunctional thinking). Moreover, the iCBT intervention appears to have a long-term impact for participants’ functioning, as the treatment gains were maintained six months later. Conclusions Internet-delivered interventions display a high potential to quickly and widely disseminate effective evidence-based programs around the world. This study provides support for guided iCBT as a promising treatment approach in Romania. Trial Registration ClinicalTrials.gov NCT01557894 PMID:25938241

A Randomized Trial Comparing Live and Telemedicine Delivery of an Imagery-based Behavioral Intervention for Breast Cancer Survivors: Reducing Symptoms and Barriers to Care

PubMed Central

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

2015-01-01

Objective This multi-site randomized trial evaluates the quality of life (QOL) benefits of an imagery-based group intervention titled “Envision the Rhythms of Life” (ERL). Methods Breast cancer survivors >6 weeks post-treatment were randomized to attend five weekly 4-hour group sessions at a community center with therapist present (live-delivery; LD, n=48); therapist streamed via telemedicine (telemedicine-delivery; TD, n=23); or to a waitlist control group (WL, n=47). Weekly individual phone calls to encourage at-home practice began at session one and continued until the 3-month follow-up. Seven self-report measures of QOL were examined at baseline, 1 and 3 months post-treatment including health-related and breast cancer-specific QOL, fatigue, cognitive function, spirituality, distress, and sleep. Results The Bonferroni method was used to correct for multiple comparisons, and alpha was adjusted to 0.01. LMM analyses revealed less fatigue, cognitive dysfunction, and sleep disturbance for LD and TD compared to WL across the follow-up (p’s <0.01). Changes in fatigue, cognitive dysfunction, sleep disturbance, and health-related and breast cancer-related QOL were clinically significant. There were no differences between LD and TD. Conclusions Both the live and telemedicine delivered ERL intervention resulted in improvements in multiple QOL domains for breast cancer survivors compared to a waitlist control. Further, there were no significant differences between live- and telemedicine-delivery, suggesting telemedicine delivered ERL intervention may represent an effective and viable option for cancer survivors in remote areas. PMID:25146413

A pilot randomized controlled trial of the Yoga of Awareness program in the management of fibromyalgia

PubMed Central

Carson, James W.; Carson, Kimberly M.; Jones, Kim D.; Bennett, Robert M.; Wright, Cheryl L.; Mist, Scott D.

2017-01-01

A mounting body of literature recommends that treatment for fibromyalgia (FM) encompass medications, exercise and improvement of coping skills. However, there is a significant gap in determining an effective counterpart to pharmacotherapy that incorporates both exercise and coping. The aim of this randomized controlled trial was to evaluate the effects of a comprehensive yoga intervention on FM symptoms and coping. A sample of 53 female FM patients were randomized to the 8-week Yoga of Awareness program (gentle poses, meditation, breathing exercises, yoga-based coping instructions, group discussions) or to wait-listed standard care. Data were analyzed by intention to treat. At post-treatment, women assigned to the yoga program showed significantly greater improvements on standardized measures of FM symptoms and functioning, including pain, fatigue, and mood, and in pain catastrophizing, acceptance, and other coping strategies. This pilot study provides promising support for the potential benefits of a yoga program for women with FM. PMID:20946990

Improving adolescent social competence and behavior: a randomized trial of an 11-week equine facilitated learning prevention program.

PubMed

Pendry, Patricia; Carr, Alexa M; Smith, Annelise N; Roeter, Stephanie M

2014-08-01

There is growing evidence that promoting social competence in youth is an effective strategy to prevent mental, emotional, and behavioral disorders in adulthood. Research suggests that programs delivered in collaboration with schools are particularly effective when they target social and emotional skill building, utilize an interactive instructional style, provide opportunities for youth participation and self-direction, and include explicit attempts to enhance youth social competence. A relatively new but popular approach that incorporates these characteristics is human animal interaction, which can be implemented in educational settings. We report the results from a randomized clinical trial examining the effects of an 11-week equine facilitated learning (EFL) program on the social competence and behavior of 5th-8th grade children. Children (N = 131) were recruited through referral by school counselors and school-based recruitment and then screened for low social competence. Researchers randomly assigned children to an experimental (n = 53) or waitlisted control group (n = 60). Children in the experimental group participated in an 11-week EFL program consisting of once-weekly, 90-min sessions of individual and team-focused activities, whereas children in the control group served as a wait-listed control and participated 16 weeks later. Parents of children in both groups rated child social competence at pretest and posttest. Three independent raters observed and reported children's positive and negative behavior using a validated checklist during each weekly session. Results indicated that program participation had a moderate treatment effect (d = .55) on social competence (p = .02) that was independent of pretest levels, age, gender, and referral status. Results showed that higher levels of program attendance predicted children's trajectories of observed positive (β = .500; p = .003) and negative behavior (β = -.062; p < .001) over the 11-week program.

Happy Despite Pain: A Randomized Controlled Trial of an 8-Week Internet-delivered Positive Psychology Intervention for Enhancing Well-being in Patients With Chronic Pain.

PubMed

Peters, Madelon L; Smeets, Elke; Feijge, Marion; van Breukelen, Gerard; Andersson, Gerhard; Buhrman, Monica; Linton, Steven J

2017-11-01

There is preliminary evidence for the efficacy of positive psychology interventions for pain management. The current study examined the effects of an internet-based positive psychology self-help program for patients with chronic musculoskeletal pain and compared it with an internet-based cognitive-behavioral program. A randomized controlled trial was carried out with 3 conditions: an internet-delivered positive psychology program, an internet-delivered cognitive-behavioral program and waitlist control. A total of 276 patients were randomized to 1 of the 3 conditions and posttreatment data were obtained from 206 patients. Primary outcomes were happiness, depression, and physical impairments at posttreatment and at 6-month follow-up. Intention-to-treat analyses were carried out using mixed regression analyses. Both treatments led to significant increases in happiness and decreases in depression. Physical impairments did not significantly decrease compared with waitlist. Improvements in happiness and depression were maintained until 6-month follow-up. There were no overall differences in the efficacy of the 2 active interventions but effects seemed to be moderated by education. Patients with a higher level of education profited slightly more from the positive psychology intervention than from the cognitive-behavioral program. The results suggest that an internet-based positive psychology and cognitive-behavioral self-help interventions for the management of chronic pain are clinically useful. Because the self-help exercises as used in the current program do not require therapist involvement, dissemination potential is large. Further studies should examine whether it can best be used as stand-alone or add-on treatment combined with established pain treatment programs.

Internet-based affect-focused psychodynamic therapy for social anxiety disorder: A randomized controlled trial with 2-year follow-up.

PubMed

Johansson, Robert; Hesslow, Thomas; Ljótsson, Brjánn; Jansson, Angelica; Jonsson, Lina; Färdig, Smilla; Karlsson, Josefine; Hesser, Hugo; Frederick, Ronald J; Lilliengren, Peter; Carlbring, Per; Andersson, Gerhard

2017-12-01

Social anxiety disorder (SAD) is associated with considerable individual suffering and societal costs. Although there is ample evidence for the efficacy of cognitive behavior therapy, recent studies suggest psychodynamic therapy may also be effective in treating SAD. Furthermore, Internet-based psychodynamic therapy (IPDT) has shown promising results for addressing mixed depression and anxiety disorders. However, no study has yet investigated the effects of IPDT specifically for SAD. This paper describes a randomized controlled trial testing the efficacy of a 10-week, affect-focused IPDT protocol for SAD, compared with a wait-list control group. Long-term effects were also estimated by collecting follow-up data, 6, 12, and 24 months after the end of therapy. A total of 72 individuals meeting diagnostic criteria for DSM-IV social anxiety disorder were included. The primary outcome was the self-report version of Liebowitz Social Anxiety Scale. Mixed model analyses using the full intention-to-treat sample revealed a significant interaction effect of group and time, suggesting a larger effect in the treatment group than in the wait-list control. A between-group effect size Cohen's d = 1.05 (95% [CI]: [0.62, 1.53]) was observed at termination. Treatment gains were maintained at the 2-year follow-up, as symptom levels in the treated group continued to decrease significantly. The findings suggest that Internet-based affect-focused psychodynamic therapy is a promising treatment for social anxiety disorder. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

An Evaluation of a Behaviorally Based Social Skills Group for Individuals Diagnosed with Autism Spectrum Disorder.

PubMed

Leaf, Justin B; Leaf, Jeremy A; Milne, Christine; Taubman, Mitchell; Oppenheim-Leaf, Misty; Torres, Norma; Townley-Cochran, Donna; Leaf, Ronald; McEachin, John; Yoder, Paul

2017-02-01

In this study we evaluated a social skills group which employed a progressive applied behavior analysis model for individuals diagnosed with autism spectrum disorder. A randomized control trial was utilized; eight participants were randomly assigned to a treatment group and seven participants were randomly assigned to a waitlist control group. The social skills group consisted of 32, 2 h sessions. Teachers implemented a variety of behaviorally based procedures. A blind evaluator measured participants' behavior immediately prior to intervention, immediately following intervention, and during 16 and 32-week maintenance probes. Results of the study demonstrated that participants made significant improvements with their social behavior (p < .001) following intervention, and the results were maintained up to 32 weeks after intervention had concluded.

A Randomized Controlled Trial of an Internet Intervention for Adults with Insomnia: Effects on Comorbid Psychological and Fatigue Symptoms

PubMed Central

Thorndike, Frances P.; Ritterband, Lee M.; Gonder-Frederick, Linda A.; Lord, Holly R.; Ingersoll, Karen S.; Morin, Charles M.

2014-01-01

Objective Insomnia is frequently comorbid with other medical and psychological disorders. This secondary data analysis investigated whether an Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) intervention could also reduce comorbid psychological and fatigue symptoms. Method Data from a pilot randomized controlled trial (RCT) testing the efficacy of Internet-delivered CBT-I relative to a waitlist control was used to examine changes in symptoms of depression, anxiety, mental health quality of life (QOL), and fatigue. Results Group by time interactions from repeated measures analyses revealed significant post intervention improvements in Internet participants (n = 22) relative to control participants (n = 22) on all psychological symptoms, mental health QOL, and fatigue. A small post hoc subsample of Internet participants with mild or moderate depression also showed large effect size changes in these constructs (depression, anxiety, mental health QOL, and fatigue). Conclusion Internet-delivered CBT-I appears to not only improve sleep but also reduce comorbid psychological and fatigue symptoms. PMID:24014057

A randomized controlled trial of an internet intervention for adults with insomnia: effects on comorbid psychological and fatigue symptoms.

PubMed

Thorndike, Frances P; Ritterband, Lee M; Gonder-Frederick, Linda A; Lord, Holly R; Ingersoll, Karen S; Morin, Charles M

2013-10-01

Insomnia is frequently comorbid with other medical and psychological disorders. This secondary data analysis investigated whether an Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) intervention could also reduce comorbid psychological and fatigue symptoms. Data from a pilot randomized controlled trial (RCT) testing the efficacy of Internet-delivered CBT-I relative to a waitlist control was used to examine changes in symptoms of depression, anxiety, mental health quality of life (QOL), and fatigue. Group by time interactions from repeated measures analyses revealed significant post intervention improvements in Internet participants (n = 22) relative to control participants (n = 22) on all psychological symptoms, mental health QOL, and fatigue. A small post hoc subsample of Internet participants with mild or moderate depression also showed large effect size changes in these constructs (depression, anxiety, mental health QOL, and fatigue). Internet-delivered CBT-I appears to not only improve sleep but also reduce comorbid psychological and fatigue symptoms. © 2013 Wiley Periodicals, Inc.

Efficacy and Safety of the Traditional Herbal Medicine, Gamiguibi-tang, in Patients With Cancer-Related Sleep Disturbance: A Prospective, Randomized, Wait-List-Controlled, Pilot Study.

PubMed

Lee, Jee Young; Oh, Hye Kyung; Ryu, Han Sung; Yoon, Sung Soo; Eo, Wankyu; Yoon, Seong Woo

2018-06-01

Sleep disturbance is the second most bothersome symptom in patients with cancer, and it can significantly impair their quality of life. The aim of this study was to investigate the efficacy and safety of the traditional herbal medicine Gamiguibi-tang (GGBT) in patients with cancer-related sleep disturbance. We conducted a prospective, randomized, wait-list-controlled, open-label pilot clinical trial on cancer-related sleep disturbance. Patients with cancer experiencing poor sleep quality with a Pittsburgh Sleep Quality Index of at least 6 were randomly assigned to the GGBT and wait-list groups to receive GGBT and conventional care, respectively, for 2 weeks. The primary endpoint was the Insomnia Severity Index (ISI) score. Fatigue, depression, and cognitive impairment were assessed as the secondary endpoints by using the Brief Fatigue Inventory (BFI), Beck Depression Inventory (BDI), and Montreal Cognitive Assessment (MoCA). Thirty participants who met the eligibility criteria were enrolled. Sleep disturbance assessed using the ISI improved significantly more in the GGBT group than in the wait-list group (-5.5 ± 4.4 vs 0.1 ± 1.1, P < .001). Fatigue level determined using the BFI also improved significantly more in the GGBT group than in the wait-list group (-0.8 ± 0.8 vs 0.0 ± 0.3, P = .002). The BDI and MoCA scores showed no significant changes. Adverse events were reported in two patients in the GGBT group and consisted of mild dyspepsia and mild edema. GGBT may be a potential treatment option for cancer-related sleep disturbance. Further research is needed to investigate the efficacy and safety of GGBT.

Effects of exercise on fitness and cognition in progressive MS: a randomized, controlled pilot trial.

PubMed

Briken, S; Gold, S M; Patra, S; Vettorazzi, E; Harbs, D; Tallner, A; Ketels, G; Schulz, K H; Heesen, C

2014-03-01

Exercise may have beneficial effects on both well-being and walking ability in multiple sclerosis (MS). Exercise is shown to be neuroprotective in rodents and may also enhance cognitive function in humans. It may, therefore, be particularly useful for MS patients with pronounced neurodegeneration. To investigate the potential of standardized exercise as a therapeutic intervention for progressive MS, in a randomized-controlled pilot trial. Patients with progressive MS and moderate disability (Expanded Disability Status Scale (EDSS) of 4-6) were randomized to one of three exercise interventions (arm ergometry, rowing, bicycle ergometry) for 8-10 weeks or a waitlist control group. We analyzed the drop-out rate as a measure of feasibility. The primary endpoint of the study was aerobic fitness. Secondary endpoints were walking ability, cognitive function as measured by a neuropsychological test battery, depression and fatigue. A total of 42 patients completed the trial (10.6% drop-out rate). Significant improvements were seen in aerobic fitness. In addition, exercise improved walking ability, depressive symptoms, fatigue and several domains of cognitive function. This study indicated that aerobic training is feasible and could be beneficial for patients with progressive MS. Larger exercise studies are needed to confirm the effect on cognition. ISRCTN (trial number 76467492) http://isrctn.org.

Complaint-Directed Mini-Interventions for Depressive Complaints: A Randomized Controlled Trial of Unguided Web-Based Self-Help Interventions.

PubMed

Lokman, Suzanne; Leone, Stephanie S; Sommers-Spijkerman, Marion; van der Poel, Agnes; Smit, Filip; Boon, Brigitte

2017-01-04

Prevention of depression is important due to the substantial burden of disease associated with it. To this end, we developed a novel, brief, and low-threshold Web-based self-help approach for depressive complaints called complaint-directed mini-interventions (CDMIs). These CDMIs focus on highly prevalent complaints that are demonstrably associated with depression and have a substantial economic impact: stress, sleep problems, and worry. The aim was to evaluate the effectiveness of the Web-based self-help CDMIs in a sample of adults with mild-to-moderate depressive symptoms compared to a wait-list control group. A two-armed randomized controlled trial was conducted. An open recruitment strategy was used. Participants were randomized to either the Web-based CDMIs or the no-intervention wait-list control group. The CDMIs are online, unguided, self-help interventions, largely based on cognitive behavioral techniques, which consist of 3 to 4 modules with up to 6 exercises per module. Participants are free to choose between the modules and exercises. Assessments, using self-report questionnaires, took place at baseline and at 3 and 6 months after baseline. The control group was given access to the intervention following the 3-month assessment. The primary goal of the CDMIs is to reduce depressive complaints. The primary outcome of the study was a reduction in depressive complaints as measured by the Inventory of Depressive Symptomatology Self-Report (IDS-SR). Secondary outcomes included reductions in stress, worry, sleep problems, and anxiety complaints, and improvements in well-being. Data were analyzed using linear mixed models. In total, 329 participants enrolled in the trial, of which 165 were randomized to the intervention group and 164 to the control group. Approximately three-quarters of the intervention group actually created an account. Of these participants, 91.3% (116/127) logged into their chosen CDMI at least once during the 3-month intervention period (median 3, range 0-166). After 3 months, there was a significant reduction in depressive symptomatology for participants in the intervention group compared to participants in the wait-list control group (reduction in depression: mean -4.47, 95% CI -6.54 to -2.40; Cohen d=-0.70). Furthermore, significant effects were observed for sleep problems, worry, anxiety, and well-being, with effect sizes ranging from -0.29 to -0.40. The intervention did not significantly reduce stress. At 6-month follow-up, the improvements in the intervention group were generally sustained. This study shows that the online self-help CDMIs have a positive impact on various mental health outcomes. Future research should focus on which specific strategies may boost adherence, and increase the reach of the CDMIs among people with low socioeconomic status. Netherlands Trial Register (NTR): NTR4612; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4612 (Archived by WebCite at http://www.webcitation.org/6n4PVYddM). ©Suzanne Lokman, Stephanie S Leone, Marion Sommers-Spijkerman, Agnes van der Poel, Filip Smit, Brigitte Boon. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 04.01.2017.

Training communication partners of people with severe traumatic brain injury improves everyday conversations: a multicenter single blind clinical trial.

PubMed

Togher, Leanne; McDonald, Skye; Tate, Robyn; Power, Emma; Rietdijk, Rachael

2013-07-01

To determine effectiveness of communication training for partners of people with severe traumatic brain injury. Three arm non-randomized controlled trial comparing communication partner training (JOINT) with individual treatment (TBI SOLO) and a waitlist control group with 6 month follow-up. Forty-four outpatients with severe chronic traumatic brain injuries were recruited. Ten-week conversational skills treatment program encompassing weekly group and individual sessions for both treatment groups. The JOINT condition focused on both the partner and the person with traumatic brain injury while the TBI SOLO condition focused on the individual with TBI only. Primary outcomes were blind ratings of the person with traumatic brain injury's level of participation during conversation on the Measure of Participation in Communication Adapted Kagan scales. Communication partner training improved conversational performance relative to training the person with traumatic brain injury alone and a waitlist control group on the primary outcome measures. Results were maintained at six months post-training. Training communication partners of people with chronic severe traumatic brain injury was more efficacious than training the person with traumatic brain injury alone. The Adapted Kagan scales proved to be a robust and sensitive outcome measure for a conversational skills training program.

Web-based stress management for newly diagnosed cancer patients (STREAM-1): a randomized, wait-list controlled intervention study.

PubMed

Grossert, Astrid; Urech, Corinne; Alder, Judith; Gaab, Jens; Berger, Thomas; Hess, Viviane

2016-11-03

Being diagnosed with cancer causes major psychological distress, yet the majority of newly diagnosed cancer patients lack psychological support. Internet interventions overcome many barriers for seeking face-to-face support and allow for independence in time and place. We assess efficacy and feasibility of the first web-based stress management intervention (STREAM: STREss-Aktiv-Mindern) for newly diagnosed, German-speaking cancer patients. In a prospective, wait-list controlled trial 120 newly diagnosed cancer patients will be included within 12 weeks of starting anti-cancer treatment and randomized between an immediate (intervention group) or delayed (control group) 8-week, web-based intervention. The intervention consists of eight modules with weekly written feedback by a psychologist ("minimal-contact") based on well-established stress management manuals including downloadable audio-files and exercises. The aim of this study is to evaluate efficacy in terms of improvement in quality of life (FACT-F), as well as decrease in anxiety and depression (HADS), as compared to patients in the wait-list control group. A sample size of 120 patients allows demonstrating a clinically relevant difference of nine points in the FACT score after the intervention (T2) with a two-sided alpha of 0.05 and 80 % power. As this is the first online stress management intervention for German-speaking cancer patients, more descriptive outcomes are equally important to further refine the group of patients with the largest potential for benefit who then will be targeted more specifically in future trials. These descriptive endpoints include: patients' characteristics (type of cancer, type of treatment, socio-demographic factors), dropout rate and dropout reasons, adherence and satisfaction with the program. New technologies open new opportunities: minimal-contact psychological interventions are becoming standard of care in several psychological disorders, where their efficacy is often comparable to face-to-face interventions. With our study we open this field to the population of newly diagnosed cancer patients. We will not only assess clinical efficacy but also further refine the target population who has the most potential to benefit. An internet-based minimal-contact stress management program might be an attractive, time- and cost-effective way to effectively deliver psychological support to newly diagnosed cancer patients and an opportunity to include those who currently are not reached by conventional support. ClinicalTrials.gov NCT02289014 .

Thought Field Therapy (TFT) as a treatment for anxiety symptoms: a randomized controlled trial.

PubMed

Irgens, Audun; Dammen, Toril; Nysæter, Tor Erik; Hoffart, Asle

2012-01-01

To investigate whether thought field therapy (TFT) has an impact on anxiety symptoms in patients with a variety of anxiety disorders. Forty-five patients were randomized to either TFT (n = 23) or a waiting list (n = 22) condition. The wait-list group was reassessed and compared with the TFT group two and a half months after the initial evaluation. After the reassessment, the wait-list patients received treatment with TFT. All 45 patients were followed up one to two weeks after TFT treatment, as well as at three and 12 months after treatment. Patients with an anxiety disorder, mostly outpatients. TFT aims to influence the body's bioenergy field by tapping on specific points along energy meridians, thereby relieving anxiety and other symptoms. Symptom Checklist 90-Revised, Hospital Anxiety and Depression Scale, the Sheehan Disability Scale. Repeated-measures analysis of variance was used to compare the TFT and the wait-list group. The TFT group had a significantly better outcome on two measures of anxiety and one measure of function. Follow-up data for all patients taken together showed a significant decrease in all symptoms during the one to two weeks between the pretreatment and the post-treatment assessments. The significant improvement seen after treatment was maintained at the three- and 12-month assessments. The results suggest that TFT may have an enduring anxiety-reducing effect. Copyright © 2012 Elsevier Inc. All rights reserved.

A randomized waitlist-controlled pilot trial of voice over Internet protocol-delivered behavior therapy for youth with chronic tic disorders.

PubMed

Ricketts, Emily J; Goetz, Amy R; Capriotti, Matthew R; Bauer, Christopher C; Brei, Natalie G; Himle, Michael B; Espil, Flint M; Snorrason, Ívar; Ran, Dagong; Woods, Douglas W

2016-04-01

Comprehensive Behavioral Intervention for Tics (CBIT) has been shown to be efficacious for chronic tic disorders (CTDs), but utilization is limited by a lack of treatment providers and perceived financial and time burden of commuting to treatment. A promising alternative to in-person delivery is voice over Internet protocol (VoIP), allowing for remote, real-time treatment delivery to patients' homes. However, little is known about the effectiveness of VoIP for CTDs. Therefore, the present study examined the preliminary efficacy, feasibility, and acceptability of VoIP-delivered CBIT (CBIT-VoIP). Twenty youth (8-16 years) with CTDs participated in a randomized, waitlist-controlled pilot trial of CBIT-VoIP. The main outcome was pre- to post-treatment change in clinician-rated tic severity (Yale Global Tic Severity Scale). The secondary outcome was clinical responder rate (Clinical Global Impressions - Improvement Scale), assessed using ratings of 'very much improved' or 'much improved' indicating positive treatment response. Intention-to-treat analyses with the last observation carried forward were performed. At post-treatment (10-weeks), significantly greater reductions in clinician-rated, (F(1,18) = 3.05, p < 0.05, partial η(2 )= 0.15), and parent-reported tic severity, (F(1,18) = 6.37, p < 0.05, partial η(2 )= 0.26) were found in CBIT-VoIP relative to waitlist. One-third (n = 4) of those in CBIT-VoIP were considered treatment responders. Treatment satisfaction and therapeutic alliance were high. CBIT can be delivered via VoIP with high patient satisfaction, using accessible, low-cost equipment. CBIT-VoIP was generally feasible to implement, with some audio and visual challenges. Modifications to enhance treatment delivery are suggested. © The Author(s) 2015.

Web-Based Alcohol Intervention in First-Year College Students: Efficacy of Full-Program Administration Prior to Second Semester.

PubMed

Gilbertson, Rebecca J; Norton, Tina R; Beery, Susan H; Lee, Kassandra R

2018-05-12

Commercially available, web-based interventions for the prevention of alcohol use are being adopted for universal use with first-year college students, yet few have received empirical evaluation. This randomized controlled trial investigated the effectiveness of a novel, commercially available, personalized web-based alcohol intervention, Alcohol-Wise (version 4.0, 3 rd Millennium Classrooms), on multiple measures of alcohol consumption, alcohol consequences, alcohol expectancies, academic achievement, and adaptation to college in first-year students. Participants received Alcohol-Wise either prior to first semester or were waitlisted and received the intervention second semester. As longitudinal effectiveness was of interest, follow-up surveys were conducted 10 weeks (n = 76) and 24 weeks (n = 64) following the web-based alcohol intervention. Completion of Alcohol-Wise had effects on academic achievement. Specifically, at the 24 week follow-up, academic achievement was higher in participants who received the intervention first semester of their freshman year as compared to the waitlist control. The incremental rise in heavy episodic drinking during the first semester of college was also reduced in waitlisted participants by Alcohol-Wise administration prior to second semester. Conclusion/Importance: Implications for the timing of web-based alcohol interventions to include administration prior to both first and second semesters of the freshman year are discussed.

Acceptance and Commitment Therapy for Problematic Internet Pornography Use: A Randomized Trial.

PubMed

Crosby, Jesse M; Twohig, Michael P

2016-05-01

Problematic Internet pornography use is the inability to control the use of pornography, the experience of negative cognitions or emotions regarding pornography use, and the resulting negative effects on quality of life or general functioning. This study compared a 12-session individual protocol of acceptance and commitment therapy (ACT) for problematic Internet pornography use to a waitlist control condition with 28 adult males, all but 1 of whom were members of the Church of Jesus Christ of Latter-day Saints. Measures of self-reported pornography viewing, standardized measures of compulsive sexual behavior and related cognitions, and quality of life occurred at pretreatment, posttreatment, and 3-month follow-up. Results demonstrate significant between-condition reductions in pornography viewing compared to the waitlist condition (93% reduction ACT vs. 21% waitlist). When combining all participants (N=26), a 92% reduction was seen at posttreatment and an 86% reduction at 3-month follow-up. Complete cessation was seen in 54% of participants at posttreatment and at least a 70% reduction was seen in 93% of participants. At the 3-month follow-up assessment, 35% of participants showed complete cessation, with 74% of participants showing at least 70% reduction in viewing. Treatment suggestions and future directions are discussed. Copyright © 2016. Published by Elsevier Ltd.

Piloting relationship education for female same-sex couples: Results of a small randomized waitlist-control trial.

PubMed

Whitton, Sarah W; Scott, Shelby B; Dyar, Christina; Weitbrecht, Eliza M; Hutsell, David W; Kuryluk, Amanda D

2017-10-01

Relationship education represents a promising, nonstigmatizing approach to promoting the health and stability of same-sex couples. A new culturally sensitive adaptation of relationship education was developed specifically for female same-sex couples (The Strengthening Same-Sex Relationships Program, Female version; SSSR-F). SSSR-F includes adaptations of evidence-based strategies to build core relationship skills (e.g., communication skills training) as well as new content to address unique challenges faced by this population (e.g., discrimination; low social support). A small randomized waitlist-control trial (N = 37 couples) was conducted to evaluate program feasibility, acceptability, and efficacy. Three proximal outcomes targeted by SSSR-F (communication, perceived stress, social support) and 3 distal outcomes (global relationship satisfaction, instability, and confidence) were assessed at pre- and posttreatment and 3-month follow-up. Results of multilevel models accounting for nonindependence in dyadic data indicated statistically significant program effects on positive and negative couple communication, relationship satisfaction, and relationship confidence and small, nonsignificant program effects on stress, social support, and relationship instability. Analyses of follow-up data suggest maintenance of effects on the proximal but not the distal outcomes. Ratings of program satisfaction were high. Overall, findings support the feasibility, acceptability, and initial efficacy of SSSR-F, highlighting the potential value of culturally sensitive relationship education for same-sex couples. Continued efforts are needed to increase sustainability of program effects on global relationship quality over time. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Effect of a mobile app intervention on vegetable consumption in overweight adults: a randomized controlled trial.

PubMed

Mummah, Sarah; Robinson, Thomas N; Mathur, Maya; Farzinkhou, Sarah; Sutton, Stephen; Gardner, Christopher D

2017-09-15

Mobile applications (apps) have been heralded as transformative tools to deliver behavioral health interventions at scale, but few have been tested in rigorous randomized controlled trials. We tested the effect of a mobile app to increase vegetable consumption among overweight adults attempting weight loss maintenance. Overweight adults (n=135) aged 18-50 years with BMI=28-40 kg/m 2 near Stanford, CA were recruited from an ongoing 12-month weight loss trial (parent trial) and randomly assigned to either the stand-alone, theory-based Vegethon mobile app (enabling goal setting, self-monitoring, and feedback and using "process motivators" including fun, surprise, choice, control, social comparison, and competition) or a wait-listed control condition. The primary outcome was daily vegetables servings, measured by an adapted Harvard food frequency questionnaire (FFQ) 8 weeks post-randomization. Daily vegetable servings from 24-hour dietary recalls, administered by trained, certified, and blinded interviewers 5 weeks post-randomization, was included as a secondary outcome. All analyses were conducted according to principles of intention-to-treat. Daily vegetable consumption was significantly greater in the intervention versus control condition for both measures (adjusted mean difference: 2.0 servings; 95% CI: 0.1, 3.8, p=0.04 for FFQ; and 1.0 servings; 95% CI: 0.2, 1.9; p=0.02 for 24-hour recalls). Baseline vegetable consumption was a significant moderator of intervention effects (p=0.002) in which effects increased as baseline consumption increased. These results demonstrate the efficacy of a mobile app to increase vegetable consumption among overweight adults. Theory-based mobile interventions may present a low-cost, scalable, and effective approach to improving dietary behaviors and preventing associated chronic diseases. ClinicalTrials.gov NCT01826591. Registered 27 March 2013.

INDIVIDUALIZED YOGA FOR REDUCING DEPRESSION AND ANXIETY, AND IMPROVING WELL-BEING: A RANDOMIZED CONTROLLED TRIAL.

PubMed

de Manincor, Michael; Bensoussan, Alan; Smith, Caroline A; Barr, Kylie; Schweickle, Monica; Donoghoe, Lee-Lee; Bourchier, Suzannah; Fahey, Paul

2016-09-01

Depression and anxiety are leading causes of disability worldwide. Current treatments are primarily pharmaceutical and psychological. Questions remain about effectiveness and suitability for different people. Previous research suggests potential benefits of yoga for reducing depression and anxiety. The aim of this study is to investigate the effects of an individualized yoga intervention. A sample of 101 people with symptoms of depression and/or anxiety participated in a randomized controlled trial comparing a 6-week yoga intervention with waitlist control. Yoga was additional to usual treatment. The control group was offered the yoga following the waitlist period. Measures included Depression Anxiety Stress Scale (DASS-21), Kessler Psychological Distress Scale (K10), Short-Form Health Survey (SF12), Scale of Positive and Negative Experience (SPANE), Flourishing Scale (FS), and Connor-Davidson Resilience Scale (CD-RISC2). There were statistically significant differences between yoga and control groups on reduction of depression scores (-4.30; 95% CI: -7.70, -0.01; P = .01; ES -.44). Differences in reduced anxiety scores were not statistically significant (-1.91; 95% CI: -4.58, 0.76; P = .16). Statistically significant differences in favor of yoga were also found on total DASS (P = .03), K10, SF12 mental health, SPANE, FS, and resilience scores (P < .01 for each). Differences in stress and SF12 physical health scores were not statistically significant. Benefits were maintained at 6-week follow-up. Yoga plus regular care was effective in reducing symptoms of depression compared with regular care alone. Further investigation is warranted regarding potential benefits in anxiety. Individualized yoga may be particularly beneficial in mental health care in the broader community. © 2016 Wiley Periodicals, Inc.

Brief mindfulness-based therapy for chronic tension-type headache: a randomized controlled pilot study.

PubMed

Cathcart, Stuart; Galatis, Nicola; Immink, Maarten; Proeve, Michael; Petkov, John

2014-01-01

Mindfulness-based therapy (MBT) has been demonstrated to be effective for reducing chronic pain symptoms; however, the use of MBT for Chronic Tension-Type Headache (CTH) exclusively has to date not been examined. Typically, MBT for chronic pain has involved an 8-week program based on Mindfulness Based Stress Reduction. Recent research suggests briefer mindfulness-based treatments may be effective for chronic pain. To conduct a pilot study into the efficacy of brief MBT for CTH. We conducted a randomized controlled trial of a brief (6-session, 3-week) MBT for CTH. Results indicated a significant decrease in headache frequency and an increase in the mindfulness facet of Observe in the treatment but not wait-list control group. Brief MBT may be an effective intervention for CTH.

Effects of cognitive-behavioral conjoint therapy for PTSD on partners' psychological functioning.

PubMed

Shnaider, Philippe; Pukay-Martin, Nicole D; Fredman, Steffany J; Macdonald, Alexandra; Monson, Candice M

2014-04-01

A number of studies have documented that posttraumatic stress disorder (PTSD) symptoms in "one" partner are negatively associated with their intimate partner's psychological functioning. The present study investigated intimate partners' mental health outcomes (i.e., depression, anxiety, and anger) in a sample of 40 partners of individuals with PTSD within a randomized waitlist controlled trial of cognitive-behavioral conjoint therapy for PTSD (Monson & Fredman, 2012). There were no significant differences between active treatment and waitlist in intimate partners' psychological functioning at posttreatment. Subgroup analyses, however, of partners exhibiting clinical levels of distress at pretreatment on several measures showed reliable and clinically significant improvements in their psychological functioning at posttreatment and no evidence of worsening. Results suggest that cognitive-behavioral conjoint therapy for PTSD may have additional benefits for partners presenting with psychological distress. Copyright © 2014 International Society for Traumatic Stress Studies.

Comparative efficacy and acceptability of psychotherapies for depression in children and adolescents: A systematic review and network meta-analysis

PubMed Central

Zhou, Xinyu; Hetrick, Sarah E; Cuijpers, Pim; Qin, Bin; Barth, Jürgen; Whittington, Craig J; Cohen, David; Del Giovane, Cinzia; Liu, Yiyun; Michael, Kurt D; Zhang, Yuqing; Weisz, John R; Xie, Peng

2015-01-01

Previous meta-analyses of psychotherapies for child and adolescent depression were limited because of the small number of trials with direct comparisons between two treatments. A network meta-analysis, a novel approach that integrates direct and indirect evidence from randomized controlled studies, was undertaken to investigate the comparative efficacy and acceptability of psychotherapies for depression in children and adolescents. Systematic searches resulted in 52 studies (total N=3805) of nine psychotherapies and four control conditions. We assessed the efficacy at post-treatment and at follow-up, as well as the acceptability (all-cause discontinuation) of psychotherapies and control conditions. At post-treatment, only interpersonal therapy (IPT) and cognitive-behavioral therapy (CBT) were significantly more effective than most control conditions (standardized mean differences, SMDs ranged from −0.47 to −0.96). Also, IPT and CBT were more beneficial than play therapy. Only psychodynamic therapy and play therapy were not significantly superior to waitlist. At follow-up, IPT and CBT were significantly more effective than most control conditions (SMDs ranged from −0.26 to −1.05), although only IPT retained this superiority at both short-term and long-term follow-up. In addition, IPT and CBT were more beneficial than problem-solving therapy. Waitlist was significantly inferior to other control conditions. With regard to acceptability, IPT and problem-solving therapy had significantly fewer all-cause discontinuations than cognitive therapy and CBT (ORs ranged from 0.06 to 0.33). These data suggest that IPT and CBT should be considered as the best available psychotherapies for depression in children and adolescents. However, several alternative psychotherapies are understudied in this age group. Waitlist may inflate the effect of psychotherapies, so that psychological placebo or treatment-as-usual may be preferable as a control condition in psychotherapy trials. PMID:26043339

The effect of a family-based mindfulness intervention on children with attention deficit and hyperactivity symptoms and their parents: design and rationale for a randomized, controlled clinical trial (Study protocol).

PubMed

Lo, Herman H M; Wong, Samuel Y S; Wong, Janet Y H; Wong, Simpson W L; Yeung, Jerf W K

2016-03-15

About 4 % of children in Hong Kong have attention deficit hyperactivity disorder (ADHD). The parents of children with ADHD report higher levels of stress and show more negative parenting behavior. Medication and behavior training are evidence-based treatments, but both show significant limitations. In short, medical treatment is not suitable for preschool children and would suppress growth, whereas parents under stress may not be capable of consistently applying behavior management skills. Mindfulness training can improve attention and facilitate cognitive development and overall functioning. It has been widely adopted as a treatment option in health care, but its application in a family context is limited. In this context, a family-based mindfulness intervention (FBMI) has been developed to promote the attention and mental health of children with attention symptoms and to reduce the stress experienced by their parents. This article describes the design and conduct of the trial. A multicenter, 8-week, waitlist, randomized controlled trial of FBMI is currently being conducted in Hong Kong (from mid-2015 to mid-2016). Its effectiveness will be examined by comparing the participants who receive treatment to those in a waitlist control group. The study population consists of one hundred twenty children with ADHD, or with symptoms of inattention and hyperactivity, between 5 and 7 years of age and their parents. To be included in the study, the children are required to meet or exceed the borderline cutoff score of the Chinese version of the Strengths and Weaknesses of ADHD Symptoms and Normal Behaviors Rating Scale (SWAN-C). The primary outcome measures are the children's ADHD symptoms and behavior and the parents' stress. The secondary outcome measures include the children's overall behavioral problems and performance on the Attention Network Test, the parents' ADHD symptoms, the parents' mindful parenting scores, and heart rate variability of parents. This study is probably the first randomized controlled trial of FBMI for young children and their caregivers. A rigorous design and multiple outcome measures are used to examine the effectiveness of FBMI. If the hypotheses are confirmed, FBMI may serve as an additional treatment option for children with ADHD. This study is registered with the Chinese Clinical Trial Registry (reference number: ChiCTR-IOR-15007292 ). Registered 28 October 2015.

We cannot change the past, but we can change its meaning. A randomized controlled trial on the effects of self-help imagery rescripting on depression.

PubMed

Moritz, Steffen; Ahlf-Schumacher, Jana; Hottenrott, Birgit; Peter, Ulrike; Franck, Stephanie; Schnell, Thomas; Peter, Helmut; Schneider, Brooke C; Jelinek, Lena

2018-05-01

Imagery rescripting is a psychotherapeutic technique that aims to ameliorate negative emotions by altering (i.e., rescripting) inner representations of negative memories and images. Although the treatment was initially developed for traumatized individuals, face-to-face interventions have yielded promising results for patients with other diagnoses as well. The present study explored the feasibility and efficacy of the approach when used as a self-help intervention for depression. A total of 127 individuals with diagnosed depression were randomly allocated to either a wait-list control condition or received a brief or long version of a manual teaching imagery rescripting. Six weeks after inclusion, patients were invited to participate in the post assessment. The Beck Depression Inventory (BDI-II) served as the primary outcome (registered at ClinicalTrials.gov (NCT03299127). The long version was superior to the wait-list control condition on the BDI-II, self-esteem, and quality of life at a medium effect size. No effects emerged for anxiety. No significant between-group differences were found for the brief version. Moderation analyses indicated that the self-help approach seems particularly beneficial for those scoring high on symptoms, willingness to change, and expectancy (baseline). Most patients indicated they would use the technique in the future. The efficacy of imagery rescripting was confirmed when applied via self-help. Use of the long form of the manual is recommended. Future studies are needed to ascertain whether treatment effects are sustained over time. Copyright © 2018. Published by Elsevier Ltd.

Mindfulness-Based Cognitive Therapy Improves Emotional Reactivity to Social Stress: Results from A Randomized Controlled Trial

PubMed Central

Britton, Willoughby B.; Shahar, Ben; Szepsenwol, Ohad; Jacobs, W. Jake

2012-01-01

Objectives The high likelihood of recurrences in depression is linked to progressive increase in emotional reactivity to stress (stress sensitization). Mindfulness-based therapies teach mindfulness skills designed to decrease emotional reactivity in the face of negative-affect producing stressors. The primary aim of the current study was to assess whether Mindfulness-Based Cognitive Therapy (MBCT) is efficacious in reducing emotional reactivity to social evaluative threat in a clinical sample with recurrent depression. A secondary aim was to assess whether improvement in emotional reactivity mediates improvements in depressive symptoms. Methods Fifty-two individuals with partially-remitted depression were randomized into an 8-week MBCT course or a waitlist control condition. All participants underwent the Trier Social Stress Test (TSST) before and after the 8-week trial period. Emotional reactivity to stress was assessed with the Spielberger State Anxiety Inventory at several time points before, during and after the stressor. Results MBCT was associated with decreased emotional reactivity to social stress, specifically during the recovery (post-stressor) phase of the TSST. Waitlist controls showed an increase in anticipatory (pre-stressor) anxiety, which was absent in the MBCT group. Improvements in emotional reactivity partially mediated improvements in depressive symptoms. Limitations Limitations include small sample size, lack of objective or treatment adherence measures, and non-generalizability to more severely depressed populations. Conclusions Given that emotional reactivity to stress is an important psychopathological process underlying the chronic and recurrent nature of depression, these findings suggest that mindfulness skills are important in adaptive emotion regulation when coping with stress. PMID:22440072

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.

A Randomized Trial of Motivational Interviewing to Improve Middle School Students' Academic Performance

ERIC Educational Resources Information Center

Strait, Gerald Gill; Smith, Bradley H.; McQuillin, Sam; Terry, John; Swan, Suzanne; Malone, Patrick S.

2012-01-01

Motivational interviewing (MI) is an effective method of promoting change in adults, but research on adolescents is limited. This study tests the efficacy of MI for promoting academic achievement in middle school students. Participants were 103 6th-, 7th-, and 8th-grade students randomly assigned to either a MI (n = 50) or a waitlist control…

Randomized Controlled Trial of an Internet-Based Cognitive-Behavioral Treatment Program for Binge-Eating Disorder.

PubMed

Wagner, Birgit; Nagl, Michaela; Dölemeyer, Ruth; Klinitzke, Grit; Steinig, Jana; Hilbert, Anja; Kersting, Anette

2016-07-01

Binge-eating disorder (BED) is a prevalent health condition associated with obesity. Few people with BED receive appropriate treatment. Personal barriers include shame, fear of stigma, geographic distance to mental health services, and long wait-lists. The aims of this study were to examine the efficacy of an Internet-based cognitive-behavioral intervention for adults with threshold BED (DSM-IV) and to examine the stability of treatment effects over 12months. Participants were randomly assigned to a 16-week Internet-based cognitive-behavioral intervention (n=69) or a wait-list condition (n=70). Binge-eating frequency and eating disorder psychopathology were measured with the Eating Disorder Examination-Questionnaire and the Eating Disorder Examination administered over the telephone. Additionally, body weight and body mass index, depression, and anxiety were assessed before and immediately after treatment. Three-, 6-, and 12-month follow-up data were recorded in the treatment group. Immediately after the treatment the number of binge-eating episodes showed significant improvement (d=1.02, between group) in the treatment group relative to the wait-list condition. The treatment group had also significantly reduced symptoms of all eating psychopathology outcomes relative to the wait-list condition (0.82≤d≤1.11). In the treatment group significant improvement was still observed for all measures 1year after the intervention relative to pretreatment levels. The Internet-based intervention proved to be efficacious, significantly reducing the number of binge-eating episodes and eating disorder pathology long term. Low-threshold e-health interventions should be further evaluated to improve treatment access for patients suffering from BED. Copyright © 2016. Published by Elsevier Ltd.

Myofascial trigger point-focused head and neck massage for recurrent tension-type headache: A randomized, placebo-controlled clinical trial

PubMed Central

Moraska, Albert F.; Stenerson, Lea; Butryn, Nathan; Krutsch, Jason P.; Schmiege, Sarah J.; Mann, J. Douglas

2014-01-01

Objective Myofascial trigger points (MTrPs) are focal disruptions in skeletal muscle that can refer pain to the head and reproduce the pain patterns of tension-type headache (TTH). The present study applied massage focused on MTrPs of subjects with TTH in a placebo-controlled, clinical trial to assess efficacy on reducing headache pain. Methods Fifty-six subjects with TTH were randomized to receive 12 massage or placebo (detuned ultrasound) sessions over six weeks, or to wait-list. Trigger point release (TPR) massage focused on MTrPs in cervical musculature. Headache pain (frequency, intensity and duration) was recorded in a daily headache diary. Additional outcome measures included self-report of perceived clinical change in headache pain and pressure-pain threshold (PPT) at MTrPs in the upper trapezius and sub-occipital muscles. Results From diary recordings, group differences across time were detected in headache frequency (p=0.026), but not for intensity or duration. Post hoc analysis indicated headache frequency decreased from baseline for both massage (p<0.0003) and placebo (p=0.013), but no difference was detected between massage and placebo. Subject report of perceived clinical change was a greater reduction in headache pain for massage than placebo or wait-list groups (p=0.002). PPT improved in all muscles tested for massage only (all p's<0.002). Discussion Two findings from this study are apparent: 1) MTrPs are important components in the treatment of TTH, and 2) TTH, like other chronic conditions, is responsive to placebo. Clinical trials on headache that do not include a placebo group are at risk for overestimating the specific contribution from the active intervention. PMID:25329141

Myofascial trigger point-focused head and neck massage for recurrent tension-type headache: a randomized, placebo-controlled clinical trial.

PubMed

Moraska, Albert F; Stenerson, Lea; Butryn, Nathan; Krutsch, Jason P; Schmiege, Sarah J; Mann, John D

2015-02-01

Myofascial trigger points (MTrPs) are focal disruptions in the skeletal muscle that can refer pain to the head and reproduce the pain patterns of tension-type HA (TTH). The present study applied massage focused on MTrPs of patients with TTH in a placebo-controlled, clinical trial to assess efficacy on reducing headache (HA) pain. Fifty-six patients with TTH were randomized to receive 12 massage or placebo (detuned ultrasound) sessions over 6 weeks, or to wait-list. Trigger point release massage focused on MTrPs in cervical musculature. HA pain (frequency, intensity, and duration) was recorded in a daily HA diary. Additional outcome measures included self-report of perceived clinical change in HA pain and pressure-pain threshold at MTrPs in the upper trapezius and suboccipital muscles. From diary recordings, group differences across time were detected in HA frequency (P=0.026), but not for intensity or duration. Post hoc analysis indicated that HA frequency decreased from baseline for both massage (P<0.0003) and placebo (P=0.013), but no difference was detected between massage and placebo. Patient report of perceived clinical change was greater reduction in HA pain for massage than placebo or wait-list groups (P=0.002). Pressure-pain threshold improved in all muscles tested for massage only (all P's<0.002). Two findings from this study are apparent: (1) MTrPs are important components in the treatment of TTH, and (2) TTH, like other chronic conditions, is responsive to placebo. Clinical trials on HA that do not include a placebo group are at risk for overestimating the specific contribution from the active intervention.

Improvement in Social Competence Using a Randomized Trial of a Theatre Intervention for Children with Autism Spectrum Disorder.

PubMed

Corbett, Blythe A; Key, Alexandra P; Qualls, Lydia; Fecteau, Stephanie; Newsom, Cassandra; Coke, Catherine; Yoder, Paul

2016-02-01

The efficacy of a peer-mediated, theatre-based intervention on social competence in participants with autism spectrum disorder (ASD) was tested. Thirty 8-to-14 year-olds with ASD were randomly assigned to the treatment (n = 17) or a wait-list control (n = 13) group. Immediately after treatment, group effects were seen on social ability, (d = .77), communication symptoms (d = -.86), group play with toys in the company of peers (d = .77), immediate memory of faces as measured by neuropsychological (d = .75) and ERP methods (d = .93), delayed memory for faces (d = .98), and theory of mind (d = .99). At the 2 month follow-up period, group effects were detected on communication symptoms (d = .82). The results of this pilot clinical trial provide initial support for the efficacy of the theatre-based intervention.

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.

Enhanced cognitive behavioral therapy for eating disorders adapted for a group setting.

PubMed

Wade, Stephanie; Byrne, Sue; Allen, Karina

2017-08-01

This randomized control trial is an evaluation of the effectiveness of enhanced cognitive behavioral treatment (CBT-E) for eating disorders adapted for a group setting. The study aimed to examine the effects of group CBT-E on eating disorder psychopathology and additional maintaining pathology. A transdiagnostic sample of individuals with eating disorders with a BMI ≥ 18 kg/m 2 (N = 40) were randomized to an immediate-start or delayed-start condition so as to compare therapeutic effects of group CBT-E with a waitlist control. Global Eating Disorder Examination Questionnaire (EDE-Q) scores, BMI, and measures of Clinical Perfectionism, Self-Esteem, Interpersonal Difficulties, and Mood Intolerance were measured across the 8-week control period, throughout the group treatment and at 3-months post-treatment. Over 70% of those who entered the trial completed treatment. The first eight weeks of group CBT-E were more effective at reducing Global EDE-Q scores than no treatment (waitlist control). By post-treatment, good outcome (a Global EDE-Q within 1 SD of Australian community norms plus BMI ≥ 18.5) was achieved by 67.9% of treatment completers and 66.7% of the total sample. Symptom abstinence within the previous month was reported by 14.3% of treatment completers and 10.3% of the total sample. Significant reductions in Clinical Perfectionism, Self-Esteem, Interpersonal Difficulties, and Mood Intolerance were also observed. This study demonstrated that a group version of CBT-E can be effective at reducing eating disorder psychopathology in a transdiagnostic sample of individuals with eating disorders. Group CBT-E could provide a means of increasing availability of evidence-based treatment for eating disorders. © 2017 Wiley Periodicals, Inc.

School-based intervention for childhood disruptive behavior in disadvantaged settings: a randomized controlled trial with and without active teacher support.

PubMed

Liber, Juliette M; De Boo, Gerly M; Huizenga, Hilde; Prins, Pier J M

2013-12-01

In this randomized controlled trial, we investigated the effectiveness of a school-based targeted intervention program for disruptive behavior. A child-focused cognitive behavioral therapy (CBT) program was introduced at schools in disadvantaged settings and with active teacher support (ATS) versus educational teacher support (ETS) (CBT + ATS vs. CBT + ETS). Screening (n = 1,929) and assessment (n = 224) led to the inclusion of 173 children ages 8-12 years from 17 elementary schools. Most of the children were boys (n = 136, 79%) of low or low-to-middle class socioeconomic status (87%); the sample was ethnically diverse (63% of non-Western origin). Children received CBT + ATS (n = 29) or CBT + ETS (n = 41) or were entered into a waitlist control condition (n = 103) to be treated afterward (CBT + ATS, n = 39, and CBT + ETS, n = 64). Effect sizes (ES), clinical significance (reliable change), and the results of multilevel modeling are reported. Ninety-seven percent of children completed treatment. Teachers and parents reported positive posttreatment effects (mean ES = .31) for CBT compared with the waitlist control condition on disruptive behavior. Multilevel modeling showed similar results. Clinical significance was modest. Changes had remained stable or had increased at 3-months follow-up (mean ES = .39). No consistent effect of teacher condition was found at posttreatment; however, at follow-up, children who received ETS fared significantly better. This study shows that a school-based CBT program is beneficial for difficult-to-reach children with disruptive behavior: The completion rate was remarkably high, ESs (mean ES = .31) matched those of previous studies with targeted intervention, and effects were maintained or had increased at follow-up.

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

PubMed

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

2017-05-15

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

Virtual Reality Job Interview Training for Veterans with Posttraumatic Stress Disorder.

PubMed

Smith, Matthew J; Humm, Laura Boteler; Fleming, Michael F; Jordan, Neil; Wright, Michael A; Ginger, Emily J; Wright, Katherine; Olsen, Dale; Bell, Morris D

2015-01-01

Veterans with posttraumatic stress disorder (PTSD) have low employment rates and the job interview presents a critical barrier for them to obtain competitive employment. To evaluate the acceptability and efficacy of virtual reality job interview training (VR-JIT) among veterans with PTSD via a small randomized controlled trial (n=23 VR-JIT trainees, n=10 waitlist treatment-as-usual (TAU) controls). VR-JIT trainees completed up to 10 hours of simulated job interviews and reviewed information and tips about job interviewing, while wait-list TAU controls received services as usual. Primary outcome measures included two pre-test and two post-test video-recorded role-play interviews scored by blinded human resource experts and self-reported interviewing self-confidence. Trainees attended 95% of lab-based VR-JIT sessions and found the intervention easy-to-use, helpful, and prepared them for future interviews. VR-JIT trainees demonstrated significantly greater improvement on role-play interviews compared with wait-list TAU controls (p=0.04) and demonstrated a large effect for within-subject change (Cohen's d=0.76). VR-JIT performance scores increased significantly over time (R-Squared=0.76). Although VR-JIT trainees showed a moderate effect for within-subject change on self-confidence (Cohen's d=0.58), the observed difference between conditions did not reach significance (p=0.09). Results provide preliminary support that VR-JIT is acceptable to trainees and may be efficacious for improving job interview skills and self-confidence in veterans with PTSD.

The effectiveness of mindfulness-based stress reduction (MBSR) for survivors of breast cancer: study protocol for a randomized controlled trial.

PubMed

Huang, Jiayan; Shi, Lu

2016-04-22

After treatment completion, breast cancer (BC) survivors frequently experience residual symptoms of pain, fatigue, high levels of psychological stress, anxiety, depression, fear of recurrence, and metastasis. Post-treatment stress, in particular, can adversely affect health-related quality of life, which, in turn, induces onset or recurrence of chronic diseases. Effective interventions that target these psychological symptoms and their physiological consequences are needed, especially for economically disadvantaged patients. However, in China, few evidence-based intervention strategies have been established among BC survivors. This study will formally adapt, develop, and evaluate an intensive mindfulness-based stress reduction (MBSR) intervention protocol to improve mental health, quality of life, and compliance with medication among Chinese BC survivors. A randomized, waitlist-controlled clinical trial will be conducted. Based on our power calculation, 418 BC survivors will be recruited from 10 low-income communities in Shanghai. All subjects will be randomly assigned either to the MBSR program or to a waitlisted usual care regimen that will offer the MBSR program after the completion of the other trial arm (after 6 months follow-up). Our 8-week MBSR intervention program will provide systematic training to promote stress reduction by self-regulating arousal to stress. Assessments will be made at baseline, 4 weeks (in the middle of the first MBSR intervention), 8 weeks (at the end of the first MBSR intervention), 6 months, and 12 months, and will include measures of psychological symptoms (depression, anxiety, and perceived stress), quality of life, and medication adherence. The expected outcome will be the improvement in psychological symptoms, quality of life, and medication compliance in the MBSR intervention group. This study will help develop an affordable, self-care psychological intervention protocol to help Chinese BC survivors improve their quality of life, and could be helpful in further developing affordable disease management plans for patients of other chronic diseases. ChiCTR-IOR-14005390 (10/27/2014).

Improving chronic disease prevention and screening in primary care: results of the BETTER pragmatic cluster randomized controlled trial.

PubMed

Grunfeld, Eva; Manca, Donna; Moineddin, Rahim; Thorpe, Kevin E; Hoch, Jeffrey S; Campbell-Scherer, Denise; Meaney, Christopher; Rogers, Jess; Beca, Jaclyn; Krueger, Paul; Mamdani, Muhammad

2013-11-20

Primary care provides most of the evidence-based chronic disease prevention and screening services offered by the healthcare system. However, there remains a gap between recommended preventive services and actual practice. This trial (the BETTER Trial) aimed to improve preventive care of heart disease, diabetes, colorectal, breast and cervical cancers, and relevant lifestyle factors through a practice facilitation intervention set in primary care. Pragmatic two-way factorial cluster RCT with Primary Care Physicians' practices as the unit of allocation and individual patients as the unit of analysis. The setting was urban Primary Care Team practices in two Canadian provinces. Eight Primary Care Team practices were randomly assigned to receive the practice-level intervention or wait-list control; 4 physicians in each team (32 physicians) were randomly assigned to receive the patient-level intervention or wait-list control. Patients randomly selected from physicians' rosters were stratified into two groups: 1) general and 2) moderate mental illness. The interventions involved a multifaceted, evidence-based, tailored practice-level intervention with a Practice Facilitator, and a patient-level intervention involving a one-hour visit with a Prevention Practitioner where patients received a tailored 'prevention prescription'. The primary outcome was a composite Summary Quality Index of 28 evidence-based chronic disease prevention and screening actions with pre-defined targets, expressed as the ratio of eligible actions at baseline that were met at follow-up. A cost-effectiveness analysis was conducted. 789 of 1,260 (63%) eligible patients participated. On average, patients were eligible for 8.96 (SD 3.2) actions at baseline. In the adjusted analysis, control patients met 23.1% (95% CI: 19.2% to 27.1%) of target actions, compared to 28.5% (95% CI: 20.9% to 36.0%) receiving the practice-level intervention, 55.6% (95% CI: 49.0% to 62.1%) receiving the patient-level intervention, and 58.9% (95% CI: 54.7% to 63.1%) receiving both practice- and patient-level interventions (patient-level intervention versus control, P < 0.001). The benefit of the patient-level intervention was seen in both strata. The extra cost of the intervention was $26.43CAN (95% CI: $16 to $44) per additional action met. A Prevention Practitioner can improve the implementation of clinically important prevention and screening for chronic diseases in a cost-effective manner.

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

PubMed

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

2015-01-01

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

Habit Reversal as a Treatment for Chronic Skin Picking: A Pilot Investigation

ERIC Educational Resources Information Center

Teng, Ellen J.; Woods, Douglas W.; Twohig, Michael P.

2006-01-01

The purpose of this study was to compare the effectiveness of habit reversal (HR) to a wait-list control as a treatment for chronic skin picking in adults. Twenty-five adults with a chronic skin-picking problem were randomly assigned to a wait-list control or HR group. At pretreatment, posttreatment, and a 3-month follow-up, self-reported skin…

Efficacy of Adolescent Suicide Prevention E-Learning Modules for Gatekeepers: A Randomized Controlled Trial.

PubMed

Ghoncheh, Rezvan; Gould, Madelyn S; Twisk, Jos Wr; Kerkhof, Ad Jfm; Koot, Hans M

2016-01-29

Face-to-face gatekeeper training can be an effective strategy in the enhancement of gatekeepers' knowledge and self-efficacy in adolescent suicide prevention. However, barriers related to access (eg, time, resources) may hamper participation in face-to-face training sessions. The transition to a Web-based setting could address obstacles associated with face-to-face gatekeeper training. Although Web-based suicide prevention training targeting adolescents exists, so far no randomized controlled trials (RCTs) have been conducted to investigate their efficacy. This RCT study investigated the efficacy of a Web-based adolescent suicide prevention program entitled Mental Health Online, which aimed to improve the knowledge and self-confidence of gatekeepers working with adolescents (12-20 years old). The program consisted of 8 short e-learning modules each capturing an important aspect of the process of early recognition, guidance, and referral of suicidal adolescents, alongside additional information on the topic of (adolescent) suicide prevention. A total of 190 gatekeepers (ages 21 to 62 years) participated in this study and were randomized to either the experimental group or waitlist control group. The intervention was not masked. Participants from both groups completed 3 Web-based assessments (pretest, posttest, and 3-month follow-up). The outcome measures of this study were actual knowledge, and participants' ratings of perceived knowledge and perceived self-confidence using questionnaires developed specifically for this study. The actual knowledge, perceived knowledge, and perceived self-confidence of gatekeepers in the experimental group improved significantly compared to those in the waitlist control group at posttest, and the effects remained significant at 3-month follow-up. The overall effect sizes were 0.76, 1.20, and 1.02, respectively, across assessments. The findings of this study indicate that Web-based suicide prevention e-learning modules can be an effective educational method to enhance knowledge and self-confidence of gatekeepers with regard to adolescent suicide prevention. Gatekeepers with limited time and resources can benefit from the accessibility, simplicity, and flexibility of Web-based training. Netherlands Trial Register NTR3625; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3625 (Archived by WebCite at http://www.webcitation.org/6eHvyRh6M).

Internet-delivered cognitive-behavioral therapy for social anxiety disorder in Romania: a randomized controlled trial.

PubMed

Tulbure, Bogdan Tudor; Szentagotai, Aurora; David, Oana; Ștefan, Simona; Månsson, Kristoffer N T; David, Daniel; Andersson, Gerhard

2015-01-01

Internet-based cognitive-behavioral therapy (iCBT) for social anxiety disorder has been found effective, as attested by independently conducted randomized controlled trials in four languages. The study aim is to test the efficacy of an iCBT program in a culture where it was not tested before (i.e. Romania). Participants (n = 76) were recruited, screened and randomized to either a nine-week guided iCBT or a wait-list control group in April and May 2012. Self-report measures were collected before (April 2012) and after the intervention (July 2012), as well as six months later (January 2013). Although social anxiety was assessed with multiple measures, the Liebowitz Social Anxiety Scale - Self Report version (LSAS-SR) and Social Phobia Inventory (SPIN) were used as the primary outcome measures. A significant difference with a large between-group effect size in favor of iCBT was found (Cohen's d = 1.19 for LSAS-SR and d = 1.27 for SPIN). Recovery rates show that 36.8% (n = 14) in the treatment group score below the SPIN clinical cut-off compared to only 2.6% (n = 1) in the wait-list control group. Post-intervention clinical interviews also revealed that 34.2% (n = 13) of the treatment group was completely recovered (full remission) while additionally 36.8% (n = 14) retained some social anxiety symptoms (partial remission). However, an important study limitation is that post-intervention interviewers were not blinded to the study conditions. The program also effectively reduced depression and dysfunctional thinking (between-group Cohen's d = 0.84 for depression and d = 0.63 for dysfunctional thinking). Moreover, the iCBT intervention appears to have a long-term impact for participants' functioning, as the treatment gains were maintained six months later. Internet-delivered interventions display a high potential to quickly and widely disseminate effective evidence-based programs around the world. This study provides support for guided iCBT as a promising treatment approach in Romania. ClinicalTrials.gov NCT01557894.

Web-Based and Mobile Stress Management Intervention for Employees: A Randomized Controlled Trial.

PubMed

Heber, Elena; Lehr, Dirk; Ebert, David Daniel; Berking, Matthias; Riper, Heleen

2016-01-27

Work-related stress is highly prevalent among employees and is associated with adverse mental health consequences. Web-based interventions offer the opportunity to deliver effective solutions on a large scale; however, the evidence is limited and the results conflicting. This randomized controlled trial evaluated the efficacy of guided Web- and mobile-based stress management training for employees. A total of 264 employees with elevated symptoms of stress (Perceived Stress Scale-10, PSS-10≥22) were recruited from the general working population and randomly assigned to an Internet-based stress management intervention (iSMI) or waitlist control group. The intervention (GET.ON Stress) was based on Lazarus's transactional model of stress, consisted of seven sessions, and applied both well-established problem solving and more recently developed emotion regulation strategies. Participants also had the opportunity to request automatic text messages on their mobile phone along with the iSMI. Participants received written feedback on every completed session from an e-coach. The primary outcome was perceived stress (PSS-10). Web-based self-report assessments for both groups were scheduled at baseline, 7 weeks, and 6 months. At 12 months, an extended follow-up was carried out for the iSMI group only. An intention-to-treat analysis of covariance revealed significantly large effect differences between iSMI and waitlist control groups for perceived stress at posttest (F1,261=58.08, P<.001; Cohen's d=0.83) and at the 6-month follow-up (F1,261=80.17, P<.001; Cohen's d=1.02). The effects in the iSMI group were maintained at 12-month follow-up. This Web- and mobile-based intervention has proven effective in reducing stress in employees in the long term. Internet-based stress management interventions should be further pursued as a valuable alternative to face-to-face interventions. German Clinical Trials Register (DRKS): 00004749; http://drks-neu.uniklinik-freiburg.de/ drks_web/setLocale_EN.do (Archived by WebCite at http://www.webcitation.org/6e8rl98nl).

Economic evaluations of Internet interventions for mental health: a systematic review.

PubMed

Donker, T; Blankers, M; Hedman, E; Ljótsson, B; Petrie, K; Christensen, H

2015-12-01

Internet interventions are assumed to be cost-effective. However, it is unclear how strong this evidence is, and what the quality of this evidence is. A comprehensive literature search (1990-2014) in Medline, EMBASE, the Cochrane Central Register of Controlled Trials, NHS Economic Evaluations Database, NHS Health Technology Assessment Database, Office of Health Economics Evaluations Database, Compendex and Inspec was conducted. We included economic evaluations alongside randomized controlled trials of Internet interventions for a range of mental health symptoms compared to a control group, consisting of a psychological or pharmaceutical intervention, treatment-as-usual (TAU), wait-list or an attention control group. Of the 6587 abstracts identified, 16 papers met the inclusion criteria. Nine studies featured a societal perspective. Results demonstrated that guided Internet interventions for depression, anxiety, smoking cessation and alcohol consumption had favourable probabilities of being more cost-effective when compared to wait-list, TAU, group cognitive behaviour therapy (CBGT), attention control, telephone counselling or unguided Internet CBT. Unguided Internet interventions for suicide prevention, depression and smoking cessation demonstrated cost-effectiveness compared to TAU or attention control. In general, results from cost-utility analyses using more generic health outcomes (quality of life) were less favourable for unguided Internet interventions. Most studies adhered reasonably to economic guidelines. Results of guided Internet interventions being cost-effective are promising with most studies adhering to publication standards, but more economic evaluations are needed in order to determine cost-effectiveness of Internet interventions compared to the most cost-effective treatment currently available.

Smoking Cessation Intervention for Female Prisoners: Addressing an Urgent Public Health Need

PubMed Central

Eldridge, Gloria; Weaver, Michael; Villalobos, Gabriela; Stitzer, Maxine; Best, Al

2008-01-01

Objectives. We tested the efficacy of a combined pharmacologic and behavioral smoking cessation intervention among women in a state prison in the southern United States. Methods. The study design was a randomized controlled trial with a 6-month waitlist control group. The intervention was a 10-week group intervention combined with nicotine replacement therapy. Two hundred and fifty participants received the intervention, and 289 were in the control group. Assessments occurred at baseline; end of treatment; 3, 6, and 12 months after treatment; and at weekly sessions for participants in the intervention group. Results. The intervention was efficacious compared with the waitlist control group. Point prevalence quit rates for the intervention group were 18% at end of treatment, 17% at 3-month follow-up, 14% at 6-month follow-up, and 12% at 12-month follow-up, quit rates that are consistent with outcomes from community smoking-cessation interventions. Conclusions. Female prisoners are interested in smoking cessation interventions and achieved point-prevalence quit rates similar to community samples. Augmenting tobacco control policies in prison with smoking cessation interventions has the potential to address a significant public health need. PMID:18703440

Effects of horticultural therapy on elderly' health: protocol of a randomized controlled trial.

PubMed

Chan, Hui Yu; Ho, Roger Chun-Man; Mahendran, Rathi; Ng, Kheng Siang; Tam, Wilson Wai-San; Rawtaer, Iris; Tan, Chay Hoon; Larbi, Anis; Feng, Lei; Sia, Angelia; Ng, Maxel Kian-Wee; Gan, Goh Lee; Kua, Ee Heok

2017-08-29

Due to a rapidly ageing population in the world, it is increasingly pertinent to promote successful ageing strategies which are cost-effective, easily accessible, and more likely to be acceptable to the elderly. Past research associates exposure to natural environments and horticultural therapy (HT) with positive psychological, social and physical health benefits. This Randomized Controlled Trial (RCT) is designed to evaluate the efficacy of HT in promoting Asian elderly' mental health, cognitive functioning and physical health. 70 elderly participants aged 60 to 85 years old will be randomized to participate in either the active horticultural therapy group or be in the waitlist control. Sessions will be weekly for 12 weeks, and monthly for 3 months. Mental health will be assessed through self-reports of depressive and anxiety symptomatology, life satisfaction, social connectedness and psychological well-being, collaborated with immunological markers. Outcome measures of cognitive functioning and physical health include neuropsychological tests of cognitive function and basic health screening. Outcomes will be assessed at baseline, 3 months and 6 months post-intervention. This RCT comprehensively investigates the efficacy of a non-invasive intervention, HT, in enhancing mental health, cognitive functioning and physical health. The results have tremendous potential for supporting future successful ageing programs and applicability to larger populations. ClinicalTrials.gov NCT02495194 . Trial registration date: July 13, 2015. Retrospectively registered.

Randomized Trial of Prolonged Exposure for Posttraumatic Stress Disorder with and without Cognitive Restructuring: Outcome at Academic and Community Clinics

ERIC Educational Resources Information Center

Foa, Edna B.; Hembree, Elizabeth A.; Cahill, Shawn P.; Rauch, Sheila A. M.; Riggs, David S.; Feeny, Norah C.; Yadin, Elna

2005-01-01

Female assault survivors (N = 171) with chronic posttraumatic stress disorder (PTSD) were randomly assigned to prolonged exposure (PE) alone, PE plus cognitive restructuring (PE/CR), or wait-list (WL). Treatment, which consisted of 9-12 sessions, was conducted at an academic treatment center or at a community clinic for rape survivors. Evaluations…

The Improvement of Emotion and Attention Regulation after a 6-Week Training of Focused Meditation: A Randomized Controlled Trial

PubMed Central

Menezes, Carolina Baptista; Buratto, Luciano G.; Erthal, Fátima; Pereira, Mirtes G.; Bizarro, Lisiane

2013-01-01

Self-regulatory trainings can be an effective complementary treatment for mental health disorders. We investigated the effects of a six-week-focused meditation training on emotion and attention regulation in undergraduates randomly allocated to a meditation, a relaxation, or a wait-list control group. Assessment comprised a discrimination task that investigates the relationship between attentional load and emotional processing and self-report measures. For emotion regulation, results showed greater reduction in emotional interference in the low attentional load condition in meditators, particularly compared to relaxation. Only meditators presented a significant association between amount of weekly practice and the reduction in emotion interference in the task and significantly reduced image ratings of negative valence and arousal, perceived anxiety and difficulty during the task, and state and trait-anxiety. For attention regulation, response bias during the task was analyzed through signal detection theory. After training, meditation and relaxation significantly reduced bias in the high attentional load condition. Importantly, there was a dose-response effect on general bias: the lowest in meditation, increasing linearly across relaxation and wait-list. Only meditators reduced omissions in a concentrated attention test. Focused meditation seems to be an effective training for emotion and attention regulation and an alternative for treatments in the mental health context. PMID:23935694

A web-based approach to managing stress and mood disorders in the workforce.

PubMed

Billings, Douglas W; Cook, Royer F; Hendrickson, April; Dove, David C

2008-08-01

To evaluate the effectiveness of a web-based multimedia health promotion program for the workplace, designed to help reduce stress and to prevent depression, anxiety, and substance abuse. Using a randomized controlled trial design, 309 working adults were randomly assigned to the web-based condition or to a wait-list control condition. All participants were assessed on multiple self-reported outcomes at pretest and posttest. Relative to controls, the web-based group reduced their stress, increased their knowledge of depression and anxiety, developed more positive attitudes toward treatment, and adopted a more healthy approach to alcohol consumption. We found that a brief and easily adaptable web-based stress management program can simultaneously reduce worker stress and address stigmatized behavioral health problems by embedding this prevention material into a more positive stress management framework.

Moderating Effects of Parental Characteristics on the Effectiveness of a Theory of Mind Training for Children with Autism: A Randomized Controlled Trial.

PubMed

de Veld, Danielle M J; Howlin, Patricia; Hoddenbach, Elske; Mulder, Fleur; Wolf, Imke; Koot, Hans M; Lindauer, Ramón; Begeer, Sander

2017-07-01

This RCT investigated whether the effect of a Theory of Mind (ToM) intervention for children with ASD was moderated by parental education level and employment, family structure, and parental ASD. Children with autism aged 8-13 years (n = 136) were randomized over a waitlist control or treatment condition. At posttest, children in the treatment condition had more ToM knowledge, showed fewer autistic features, and more ToM-related behavior than children in the control condition. Children who had one or two parents with at least a college degree, and children with parents not diagnosed with/suspected of having ASD themselves benefitted from the training. These findings provide valuable information about family variables that need to be taken into account in treatment design and implementation.

Effects of therapeutic horseback riding on post-traumatic stress disorder in military veterans.

PubMed

Johnson, Rebecca A; Albright, David L; Marzolf, James R; Bibbo, Jessica L; Yaglom, Hayley D; Crowder, Sandra M; Carlisle, Gretchen K; Willard, Amy; Russell, Cynthia L; Grindler, Karen; Osterlind, Steven; Wassman, Marita; Harms, Nathan

2018-01-19

Large numbers of post-deployment U.S. veterans are diagnosed with post-traumatic stress disorder (PTSD) and/or traumatic brain injury (TBI), leading to an urgent need for effective interventions to reduce symptoms and increase veterans' coping. PTSD includes anxiety, flashbacks, and emotional numbing. The symptoms increase health care costs for stress-related illnesses and can make veterans' civilian life difficult. We used a randomized wait-list controlled design with repeated measures of U.S. military veterans to address our specific aim to test the efficacy of a 6-week therapeutic horseback riding (THR) program for decreasing PTSD symptoms and increasing coping self-efficacy, emotion regulation, social and emotional loneliness. Fifty-seven participants were recruited and 29 enrolled in the randomized trial. They were randomly assigned to either the horse riding group (n = 15) or a wait-list control group (n = 14). The wait-list control group experienced a 6-week waiting period, while the horse riding group began THR. The wait-list control group began riding after 6 weeks of participating in the control group. Demographic and health history information was obtained from all the participants. PTSD symptoms were measured using the standardized PTSD Checklist-Military Version (PCL-M). The PCL-M as well as other instruments including, The Coping Self Efficacy Scale (CSES), The Difficulties in Emotion Regulation Scale (DERS) and The Social and Emotional Loneliness Scale for Adults-short version (SELSA) were used to access different aspects of individual well-being and the PTSD symptoms. Participants had a statistically significant decrease in PTSD scores after 3 weeks of THR (P ≤ 0.01) as well as a statistically and clinically significant decrease after 6 weeks of THR (P ≤ 0.01). Logistic regression showed that participants had a 66.7% likelihood of having lower PTSD scores at 3 weeks and 87.5% likelihood at 6 weeks. Under the generalized linear model(GLM), our ANOVA findings for the coping self-efficacy, emotion regulation, and social and emotional loneliness did not reach statistical significance. The results for coping self-efficacy and emotion regulation trended in the predicted direction. Results for emotional loneliness were opposite the predicted direction. Logistic regression provided validation that outcome effects were caused by riding longer. The findings suggest that THR may be a clinically effective intervention for alleviating PTSD symptoms in military veterans.

Efficacy of Adolescent Suicide Prevention E-Learning Modules for Gatekeepers: A Randomized Controlled Trial

PubMed Central

Gould, Madelyn S; Twisk, Jos WR; Kerkhof, Ad JFM; Koot, Hans M

2016-01-01

Background Face-to-face gatekeeper training can be an effective strategy in the enhancement of gatekeepers’ knowledge and self-efficacy in adolescent suicide prevention. However, barriers related to access (eg, time, resources) may hamper participation in face-to-face training sessions. The transition to a Web-based setting could address obstacles associated with face-to-face gatekeeper training. Although Web-based suicide prevention training targeting adolescents exists, so far no randomized controlled trials (RCTs) have been conducted to investigate their efficacy. Objective This RCT study investigated the efficacy of a Web-based adolescent suicide prevention program entitled Mental Health Online, which aimed to improve the knowledge and self-confidence of gatekeepers working with adolescents (12-20 years old). The program consisted of 8 short e-learning modules each capturing an important aspect of the process of early recognition, guidance, and referral of suicidal adolescents, alongside additional information on the topic of (adolescent) suicide prevention. Methods A total of 190 gatekeepers (ages 21 to 62 years) participated in this study and were randomized to either the experimental group or waitlist control group. The intervention was not masked. Participants from both groups completed 3 Web-based assessments (pretest, posttest, and 3-month follow-up). The outcome measures of this study were actual knowledge, and participants’ ratings of perceived knowledge and perceived self-confidence using questionnaires developed specifically for this study. Results The actual knowledge, perceived knowledge, and perceived self-confidence of gatekeepers in the experimental group improved significantly compared to those in the waitlist control group at posttest, and the effects remained significant at 3-month follow-up. The overall effect sizes were 0.76, 1.20, and 1.02, respectively, across assessments. Conclusions The findings of this study indicate that Web-based suicide prevention e-learning modules can be an effective educational method to enhance knowledge and self-confidence of gatekeepers with regard to adolescent suicide prevention. Gatekeepers with limited time and resources can benefit from the accessibility, simplicity, and flexibility of Web-based training. Trial Registration Netherlands Trial Register NTR3625; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3625 (Archived by WebCite at http://www.webcitation.org/6eHvyRh6M) PMID:26825006

A randomized controlled trial of a peer co-led dissonance-based eating disorder prevention program for gay men.

PubMed

Brown, Tiffany A; Keel, Pamela K

2015-11-01

Gay males have increased risk for eating disorders compared to heterosexual males, establishing a need to develop and empirically evaluate programs to reduce risk for this population. The present study investigated the acceptability and efficacy of a cognitive dissonance-based (DB) intervention (The PRIDE Body Project(©)) in reducing eating disorder risk factors among gay males in a university-based setting. Eighty-seven gay males were randomized to either a 2-session DB intervention (n = 47) or a waitlist control condition (n = 40). Participants completed eating disorder risk factor assessments pre-intervention, post-intervention, and at 4-week follow-up, and those receiving the intervention completed post-treatment acceptability measures. Acceptability ratings were highly favorable. Regarding efficacy, the DB condition was associated with significantly greater decreases in body dissatisfaction, drive for muscularity, self-objectification, partner-objectification, body-ideal internalization, dietary restraint, and bulimic symptoms compared to waitlist control from pre- to post-intervention. Improvements in the DB group were maintained at 4-week follow-up, with the exception of body-ideal internalization. Body-ideal internalization mediated treatment effects on bulimic symptoms. Results support the acceptability and efficacy of The PRIDE Body Project(©) and provide support for theoretical models of eating pathology in gay men. Copyright © 2015 Elsevier Ltd. All rights reserved.

Effects of psychotherapies for posttraumatic stress disorder on sleep disturbances: Results from a randomized clinical trial.

PubMed

Woodward, Elizabeth; Hackmann, Ann; Wild, Jennifer; Grey, Nick; Clark, David M; Ehlers, Anke

2017-10-01

The effectiveness and mechanisms of psychotherapies for posttraumatic stress disorder (PTSD) in treating sleep problems is of interest. This study compared the effects of a trauma-focused and a non-trauma-focused psychotherapy on sleep, to investigate whether 1) sleep improves with psychotherapy for PTSD; 2) the degree of sleep improvement depends on whether the intervention is trauma or nontrauma-focused; 3) the memory-updating procedure in cognitive therapy for PTSD (CT-PTSD) is associated with sleep improvements; 4) initial sleep duration affects PTSD treatment outcome; and 5) which symptom changes are associated with sleep duration improvements. Self-reported sleep was assessed during a randomized controlled trial (Ehlers et al., 2014) comparing CT-PTSD (delivered weekly or intensively over 7-days) with emotion-focused supportive therapy, and a waitlist. Sleep duration was reported daily in sleep diaries during intensive CT-PTSD. CT-PTSD led to greater increases in sleep duration (55.2 min) and reductions in insomnia symptoms and nightmares than supportive therapy and the waitlist. In intensive CT-PTSD, sleep duration improved within 7 days, and sleep diaries indicated a 40-min sleep duration increase after updating trauma memories. Initial sleep duration was not related to CT-PTSD treatment outcome when initial PTSD symptom severity was controlled. The results suggest that trauma-focused psychotherapy for PTSD is more effective than nontrauma-focused therapy in improving self-reported sleep, and that CT-PTSD can still be effective in the presence of reduced sleep duration. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

The PLUNGE randomized controlled trial: evaluation of a games-based physical activity professional learning program in primary school physical education.

PubMed

Miller, Andrew; Christensen, Erin M; Eather, Narelle; Sproule, John; Annis-Brown, Laura; Lubans, David Revalds

2015-05-01

To evaluate the efficacy of the Professional Learning for Understanding Games Education (PLUNGE) program on fundamental movement skills (FMS), in-class physical activity and perceived sporting competence. A cluster-randomized controlled trial involving one year six class each from seven primary schools (n=168; mean age=11.2 years, SD=1.0) in the Hunter Region, NSW, Australia. In September (2013) participants were randomized by school into the PLUNGE intervention (n=97 students) or the 7-week wait-list control (n=71) condition. PLUNGE involved the use of Game Centered curriculum delivered via an in-class teacher mentoring program. Students were assessed at baseline and 8-week follow-up for three object control FMS (Test of Gross Motor Development 2), in-class physical activity (pedometer steps/min) and perceived sporting competence (Self-perception Profile for Children). Linear mixed models revealed significant group-by-time intervention effects (all p<0.05) for object control competency (effect size: d=0.9), and in-class pedometer steps/min (d=1.0). No significant intervention effects (p>0.05) were observed for perceived sporting competence. The PLUNGE intervention simultaneously improved object control FMS proficiency and in-class PA in stage three students. Copyright © 2015 Elsevier Inc. All rights reserved.

Hypnotherapy for insomnia: a systematic review and meta-analysis of randomized controlled trials.

PubMed

Lam, Tak-Ho; Chung, Ka-Fai; Yeung, Wing-Fai; Yu, Branda Yee-Man; Yung, Kam-Ping; Ng, Tommy Ho-Yee

2015-10-01

To examine the efficacy and safety of hypnotherapy for insomnia as compared to placebo, pharmacological or non-pharmacological intervention, or no treatment. A systematic search on major electronic databases was conducted up until March 2014. Inclusion criteria are: (1) randomized controlled trials (RCTs) or quasi-RCTs; (2) intervention targeted at improving sleep; (3) hypnosis as an intervention; and (4) English language articles. Sleep diary variable is the primary outcome measure. Six RCTs of hypnotherapy and seven on autogenic training or guided imagery, comprising 502 subjects, were included. Eleven of the 13 studies had low methodological quality, as indicated by a modified Jadad score below 3, and high risks of bias in blinding and design of the control interventions. No adverse events related to hypnosis were reported, though seldom investigated. Meta-analyses found hypnotherapy significantly shortened sleep latency compared to waitlist (standardized mean difference, SMD=-0.88, 95% confidence interval (CI): -1.56, -0.19, P=0.01, I(2)=15%), but no difference compared to sham intervention (SMD: -1.08, 95% CI: -3.15, 0.09, P=0.31, I(2)=90%). Similar results were found for autogenic training or guided imagery (SMD with waitlist=-1.16, 95% CI: -1.92, -0.40, P=0.003, I(2)=0%; SMD with sham intervention=-0.50, 95% CI: -1.19, 0.19, P=0.15, I(2)=0%). Generalizability of the positive results is doubtful due to the relatively small sample size and methodological limitations. Future studies with larger sample size and better study design and methodology are called for. Copyright © 2015 Elsevier Ltd. All rights reserved.

The efficacy of eye movement desensitization and reprocessing for post-traumatic stress disorder and depression among Syrian refugees: results of a randomized controlled trial.

PubMed

Acarturk, C; Konuk, E; Cetinkaya, M; Senay, I; Sijbrandij, M; Gulen, B; Cuijpers, P

2016-09-01

Previous research indicates a high prevalence of post-traumatic stress disorder (PTSD) and depression among refugees. Eye movement desensitization and reprocessing (EMDR) is an effective treatment for PTSD for victims of natural disasters, car accidents or other traumatic events. The current study examined the effect of EMDR on symptoms of PTSD and depression by comparing the treatment with a wait-list control condition in Syrian refugees. Adult refugees located in Kilis Refugee Camp at the Turkish-Syrian border with a PTSD diagnosis were randomly allocated to either EMDR (n = 37) or wait-list control (n = 33) conditions. All participants were assessed with the Mini-International Neuropsychiatric Interview Plus at pre-intervention, at 1 week after finishing the intervention and at 5 weeks after finishing the intervention. The main outcome measures were the Harvard Trauma Questionnaire (HTQ) and the Impact of Event Scale-Revised. The Beck Depression Inventory and the Hopkins Symptoms Checklist-25 were included as secondary outcome measures. The Trial Registration no. is NCT01847742. Mixed-model analyses adjusted for the baseline scores indicated a significant effect of group at post-treatment indicating that the EMDR therapy group showed a significantly larger reduction of PTSD symptoms as assessed with the HTQ. Similar findings were found on the other outcome measures. There was no effect of time or group × time interaction on any measure, showing that the difference between the groups at the post-treatment was maintained to the 5-week follow-up. EMDR may be effective in reducing PTSD and depression symptoms among Syrian refugees with PTSD located in a refugee camp.

Impact of the Cognitive-Functional (Cog-Fun) Intervention on Executive Functions and Participation Among Children With Attention Deficit Hyperactivity Disorder: A Randomized Controlled Trial.

PubMed

Hahn-Markowitz, Jeri; Berger, Itai; Manor, Iris; Maeir, Adina

We examined the effect of the Cognitive-Functional (Cog-Fun) occupational therapy intervention on executive functions and participation among children with attention deficit hyperactivity disorder (ADHD). We used a randomized, controlled study with a crossover design. One hundred and seven children age 7-10 yr diagnosed with ADHD were allocated to treatment or wait-list control group. The control group received treatment after a 3-mo wait. Outcome measures included the Behavior Rating Inventory of Executive Function (BRIEF) and the Canadian Occupational Performance Measure (COPM). Significant improvements were found on both the BRIEF and COPM after intervention with large treatment effects. Before crossover, significant Time × Group interactions were found on the BRIEF. This study supports the effectiveness of the Cog-Fun intervention in improving executive functions and participation among children with ADHD. Copyright © 2017 by the American Occupational Therapy Association, Inc.

Improvement in social competence using a randomized trial of a theatre intervention for children with autism spectrum disorder

PubMed Central

Corbett, Blythe A.; Key, Alexandra P.; Qualls, Lydia; Fecteau, Stephanie; Newsom, Cassandra; Coke, Catherine; Yoder, Paul

2017-01-01

The efficacy of a peer-mediated, theatre-based intervention on social competence in participants with autism spectrum disorder (ASD) was tested. Thirty 8-to-14 year-olds with ASD were randomly assigned to the treatment (n = 17) or a wait-list control (n = 13) group. Immediately after treatment, group effects were seen on social ability (d = .77), communication symptoms (d = −.86), group play with toys in the company of peers (d = .77), immediate memory for faces as measured by neuropsychological (d = .75) and ERP methods (d = .93), delayed memory for faces (d = .98), and theory of mind (d = .99). At the 2-month follow-up period, group effects were detected on communication symptoms (d = .82). The results of this pilot clinical trial provide initial support for the efficacy of the theatre-based intervention. PMID:26419766

Effects of Assertiveness Training and Expressive Writing on Acculturative Stress in International Students: A Randomized Trial

PubMed Central

Tavakoli, Shedeh; Lumley, Mark A.; Hijazi, Alaa M.; Slavin-Spenny, Olga M.; Parris, George P.

2010-01-01

International university students often experience acculturative stress, and culturally appropriate techniques to manage stress are needed. This randomized trial tested the effects of group assertiveness training, private expressive writing, their combination, and a wait-list control on the acculturative stress, affect, and health of 118 international students at an urban, American university. Interventions were conducted at the start of a semester, and assessments were conducted at baseline and the end of the semester. Group assertiveness training was rated positively by students and led to lower negative affect, whereas expressive writing was less well received and led to higher homesickness and fear, but also higher positive affect. The combined intervention had no effects, perhaps because the two components negated each other. It is concluded that group assertiveness training improves emotional adjustment of international students, but expressive writing has mixed effects and needs further development and study. PMID:20357910

Outcomes and moderators of a preventive school-based mental health intervention for children affected by war in Sri Lanka: a cluster randomized trial

PubMed Central

TOL, WIETSE A.; KOMPROE, IVAN H.; JORDANS, MARK J.D.; VALLIPURAM, ANAVARATHAN; SIPSMA, HEATHER; SIVAYOKAN, SAMBASIVAMOORTHY; MACY, ROBERT D.; DE JONG, JOOP T.

2012-01-01

We aimed to examine outcomes, moderators and mediators of a preventive school-based mental health intervention implemented by paraprofessionals in a war-affected setting in northern Sri Lanka. A cluster randomized trial was employed. Subsequent to screening 1,370 children in randomly selected schools, 399 children were assigned to an intervention (n=199) or waitlist control condition (n=200). The intervention consisted of 15 manualized sessions over 5 weeks of cognitive behavioral techniques and creative expressive elements. Assessments took place before, 1 week after, and 3 months after the intervention. Primary outcomes included post-traumatic stress disorder (PTSD), depressive, and anxiety symptoms. No main effects on primary outcomes were identified. A main effect in favor of intervention for conduct problems was observed. This effect was stronger for younger children. Furthermore, we found intervention benefits for specific subgroups. Stronger effects were found for boys with regard to PTSD and anxiety symptoms, and for younger children on pro-social behavior. Moreover, we found stronger intervention effects on PTSD, anxiety, and function impairment for children experiencing lower levels of current war-related stressors. Girls in the intervention condition showed smaller reductions on PTSD symptoms than waitlisted girls. We conclude that preventive school-based psychosocial interventions in volatile areas characterized by ongoing war-related stressors may effectively improve indicators of psychological wellbeing and posttraumatic stress-related symptoms in some children. However, they may undermine natural recovery for others. Further research is necessary to examine how gender, age and current war-related experiences contribute to differential intervention effects. PMID:22654944

Intensive, Manual-based Intervention for Pediatric Feeding Disorders: Results From a Randomized Pilot Trial.

PubMed

Sharp, William G; Stubbs, Kathryn H; Adams, Heyward; Wells, Brian M; Lesack, Roseanne S; Criado, Kristen K; Simon, Elizabeth L; McCracken, Courtney E; West, Leanne L; Scahill, Larry D

2016-04-01

The aim of this pilot study was to investigate feasibility and preliminary efficacy of an intensive, manual-based behavioral feeding intervention for children with chronic food refusal and dependence on enteral feeding or oral nutritional formula supplementation. Twenty children ages 13 to 72 months (12 boys and 8 girls) meeting criteria for avoidant/restrictive food intake disorder were randomly assigned to receive treatment for 5 consecutive days in a day treatment program (n = 10) or waitlist (n = 10). A team of trained therapists implemented treatment under the guidance of a multidisciplinary team. Parent training was delivered to support generalization of treatment gains. We tracked parental attrition and attendance, as well as therapist fidelity. Primary outcome measures were bite acceptance, disruptions, and grams consumed during meals. Caregivers reported high satisfaction and acceptability of the intervention. Three participants (1 intervention; 2 waitlist) dropped out of the study before endpoint. Of the expected 140 treatment meals for the intervention group, 137 (97.8%) were actually attended. The intervention group showed significantly greater improvements (P < 0.05) on all primary outcome measures (d = 1.03-2.11) compared with waitlist (d = -1.13-0.24). A 1-month follow-up suggested stability in treatment gains. Results from this pilot study corroborate evidence from single-subject and nonrandomized studies on the positive effects of behavioral intervention. Findings support the feasibility and preliminary efficacy of this manual-based approach to intervention. These results warrant a large-scale randomized trial to test the safety and efficacy of this intervention.

Internet-Delivered Exposure Therapy for Fibromyalgia: A Randomized Controlled Trial.

PubMed

Hedman-Lagerlöf, Maria; Hedman-Lagerlöf, Erik; Axelsson, Erland; Ljótsson, Brjánn; Engelbrektsson, Johanna; Hultkrantz, Sofia; Lundbäck, Karolina; Björkander, Daniel; Wicksell, Rikard K; Flink, Ida; Andersson, Erik

2018-06-01

Fibromyalgia (FM) is a common and disabling chronic pain disorder, for which existing pharmacological and psychological treatments have yet yielded insufficient effects. Previous literature has shown that exposure therapy may be an effective treatment for chronic pain. This study constitutes the first randomized controlled trial evaluating exposure therapy for FM. A total of 140 participants with diagnosed FM were randomized to a 10-week Internet-delivered exposure treatment (iExp; n=70) or a waitlist control condition (WLC; n=70). Primary outcome measure were FM symptoms and impact, and secondary outcome measures were fatigue, disability, quality of life, pain-related distress and avoidance behaviors, insomnia, depression, and anxiety. Data retention was high (100% data completion at posttreatment for primary outcome, 96% at 6-month follow-up and 94% at 12-month follow-up). Results showed that participants in the iExp group made large and superior improvements compared with WLC on FM symptoms and impact (B, -1.93; z, -10.14; P<0.001, between-group Cohen d=0.90), as well as all secondary outcomes (between-group Cohen d ranging from 0.44 to 1.38) with sustained results. We conclude that iExp seems to be an efficacious treatment for FM compared with no treatment, and the results also highlight the potential increase of accessibility by using the Internet format to deliver psychological treatments for these patients. Future trials with active control conditions are warranted.

Teacher coaching supported by formative assessment for improving classroom practices.

PubMed

Fabiano, Gregory A; Reddy, Linda A; Dudek, Christopher M

2018-06-01

The present study is a wait-list controlled, randomized study investigating a teacher coaching approach that emphasizes formative assessment and visual performance feedback to enhance elementary school teachers' classroom practices. The coaching model targeted instructional and behavioral management practices as measured by the Classroom Strategies Assessment System (CSAS) Observer and Teacher Forms. The sample included 89 general education teachers, stratified by grade level, and randomly assigned to 1 of 2 conditions: (a) immediate coaching, or (b) waitlist control. Results indicated that, relative to the waitlist control, teachers in immediate coaching demonstrated significantly greater improvements in observations of behavior management strategy use but not for observations of instructional strategy use. Observer- and teacher-completed ratings of behavioral management strategy use at postassessment were significantly improved by both raters; ratings of instructional strategy use were significantly improved for teacher but not observer ratings. A brief coaching intervention improved teachers' use of observed behavior management strategies and self-reported use of behavior management and instructional strategies. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

The clinical impact and cost-effectiveness of essential oils and aromatherapy for the treatment of acne vulgaris: a protocol for a randomized controlled trial.

PubMed

Agnew, Tamara; Leach, Matthew; Segal, Leonie

2014-05-01

Acne is a prevalent, chronic, and sometimes severe skin disorder affecting an estimated 85% of adolescents and 50% of adults older than age 20 years. The psychosocial implications of acne can be considerable, often continuing long after physical symptoms resolve. Although effective acne medications are available, most exhibit adverse-effect profiles that can leave the patient with few effective treatment options. Emerging evidence indicates that plant-derived essential oils may be a biologically plausible treatment for acne, although high-quality evidence of effectiveness and safety is lacking. To examine the clinical effectiveness and cost-effectiveness of essential oils and aromatherapy for the treatment of acne. This randomized, wait-list controlled trial will have three parallel groups; 192 participants with acne vulgaris, aged 16-45 years, will be recruited primarily through eight Technical and Further Education campuses across Adelaide, South Australia. Participants will be randomly assigned to standard essential oil blend, customized aromatherapy treatment, or wait-list control. Changes in the physical and psychosocial symptoms of acne will be assessed at baseline and 6 and 12 weeks by using the Leeds Acne Grading System, Assessment of Quality of Life-8 Dimension instrument, and Acne-Specific Quality of Life instrument. Costs of treatment will be measured on the basis of resource inputs and unit costs and will be limited to acne treatment. The clinical effectiveness and cost-effectiveness will be compared between each intervention and against usual care, using standard health economic techniques. The provision of high-quality evidence of the effectiveness of essential oils and aromatherapy in the treatment of acne may help consumers make better-informed choices about acne management. Insights gained from this research will also contribute to the academic field of complementary medicine, specifically aromatherapy, for which the evidence base is extremely limited.

The Impact of Curtin University's Activity, Food and Attitudes Program on Physical Activity, Sedentary Time and Fruit, Vegetable and Junk Food Consumption among Overweight and Obese Adolescents: A Waitlist Controlled Trial

PubMed Central

Straker, Leon M.; Howie, Erin K.; Smith, Kyla L.; Fenner, Ashley A.; Kerr, Deborah A.; Olds, Tim S.; Abbott, Rebecca A.; Smith, Anne J.

2014-01-01

Background To determine the effects of participation in Curtin University's Activity, Food and Attitudes Program (CAFAP), a community-based, family-centered behavioural intervention, on the physical activity, sedentary time, and healthy eating behaviours of overweight and obese adolescents. Methods In this waitlist controlled clinical trial in Western Australia, adolescents (n = 69, 71% female, mean age 14.1 (SD 1.6) years) and parents completed an 8-week intervention followed by 12 months of telephone and text message support. Assessments were completed at baseline, before beginning the intervention, immediately following the intervention, and at 3-, 6-, and 12- months follow-up. The primary outcomes were physical activity and sedentary time assessed by accelerometers and servings of fruit, vegetables and junk food assessed by 3-day food records. Results During the intensive 8-week intervention sedentary time decreased by −5.1 min/day/month (95% CI: −11.0, 0.8) which was significantly greater than the rate of change during the waitlist period (p = .014). Moderate physical activity increased by 1.8 min/day/month (95% CI: −0.04, 3.6) during the intervention period, which was significantly greater than the rate of change during the waitlist period (p = .041). Fruit consumption increased during the intervention period (monthly incidence rate ratio (IRR) 1.3, 95% CI: 1.10, 1.56) and junk food consumption decreased (monthly IRR 0.8, 95% CI: 0.74, 0.94) and these changes were different to those seen during the waitlist period (p = .004 and p = .020 respectively). Conclusions Participating in CAFAP appeared to have a positive influence on the physical activity, sedentary and healthy eating behaviours of overweight and obese adolescents and many of these changes were maintained for one year following the intensive intervention. Trial Registration Australia and New Zealand Clinical Trials Registry ACTRN12611001187932 PMID:25375109

Does poverty alleviation decrease depression symptoms in post-conflict settings? A cluster-randomized trial of microenterprise assistance in Northern Uganda.

PubMed

Green, E P; Blattman, C; Jamison, J; Annan, J

2016-01-01

By 2009, two decades of war and widespread displacement left the majority of the population of Northern Uganda impoverished. This study used a cluster-randomized design to test the hypothesis that a poverty alleviation program would improve economic security and reduce symptoms of depression in a sample of mostly young women. Roughly 120 villages in Northern Uganda were invited to participate. Community committees were asked to identify the most vulnerable women (and some men) to participate. The implementing agency screened all proposed participants, and a total of 1800 were enrolled. Following a baseline survey, villages were randomized to a treatment or wait-list control group. Participants in treatment villages received training, start-up capital, and follow-up support. Participants, implementers, and data collectors were not blinded to treatment status. Villages were randomized to the treatment group (60 villages with 896 participants) or the wait-list control group (60 villages with 904 participants) with an allocation ration of 1:1. All clusters participated in the intervention and were included in the analysis. The intent-to-treat analysis included 860 treatment participants and 866 control participants (4.1% attrition). Sixteen months after the program, monthly cash earnings doubled from UGX 22 523 to 51 124, non-household and non-farm businesses doubled, and cash savings roughly quadrupled. There was no measurable effect on a locally derived measure of symptoms of depression. Despite finding large increases in business, income, and savings among the treatment group, we do not find support for an indirect effect of poverty alleviation on symptoms of depression.

School-based mental health intervention for children in war-affected Burundi: a cluster randomized trial

PubMed Central

2014-01-01

Background Armed conflicts are associated with a wide range of impacts on the mental health of children and adolescents. We evaluated the effectiveness of a school-based intervention aimed at reducing symptoms of posttraumatic stress disorder, depression, and anxiety (treatment aim); and improving a sense of hope and functioning (preventive aim). Methods We conducted a cluster randomized trial with 329 children in war-affected Burundi (aged 8 to 17 (mean 12.29 years, standard deviation 1.61); 48% girls). One group of children (n = 153) participated in a 15-session school-based intervention implemented by para-professionals, and the remaining 176 children formed a waitlist control condition. Outcomes were measured before, one week after, and three months after the intervention. Results No main effects of the intervention were identified. However, longitudinal growth curve analyses showed six favorable and two unfavorable differences in trajectories between study conditions in interaction with several moderators. Children in the intervention condition living in larger households showed decreases on depressive symptoms and function impairment, and those living with both parents showed decreases on posttraumatic stress disorder and depressive symptoms. The groups of children in the waitlist condition showed increases in depressive symptoms. In addition, younger children and those with low levels of exposure to traumatic events in the intervention condition showed improvements on hope. Children in the waitlist condition who lived on their original or newly bought land showed improvements in hope and function impairment, whereas children in the intervention condition showed deterioration on these outcomes. Conclusions Given inconsistent effects across studies, findings do not support this school-based intervention as a treatment for posttraumatic stress disorder and depressive symptoms in conflict-affected children. The intervention appears to have more consistent preventive benefits, but these effects are contingent upon individual (for example, age, gender) and contextual (for example, family functioning, state of conflict, displacement) variables. Results suggest the potential benefit of school-based preventive interventions particularly in post-conflict settings. Trial registration The study was registered as ISRCTN42284825 PMID:24690470

Ashtanga-Based Yoga Therapy Increases the Sensory Contribution to Postural Stability in Visually-Impaired Persons at Risk for Falls as Measured by the Wii Balance Board: A Pilot Randomized Controlled Trial

PubMed Central

Haaz Moonaz, Steffany; Bittner, Ava K.

2015-01-01

Objective Persons with visual impairment (VI) are at greater risk for falls due to irreparable damage to visual sensory input contributing to balance. Targeted training may significantly improve postural stability by strengthening the remaining sensory systems. Here, we evaluate the Ashtanga-based Yoga Therapy (AYT) program as a multi-sensory behavioral intervention to develop postural stability in VI. Design A randomized, waitlist-controlled, single-blind clinical trial Methods The trial was conducted between October 2012 and December 2013. Twenty-one legally blind participants were randomized to an 8-week AYT program (n = 11, mean (SD) age = 55(17)) or waitlist control (n=10, mean (SD) age = 55(10)). AYT subjects convened for one group session at a local yoga studio with an instructor and two individual home-based practice sessions per week for a total of 8 weeks. Subjects completed outcome measures at baseline and post-8 weeks of AYT. The primary outcome, absolute Center of Pressure (COP), was derived from the Wii Balance Board (WBB), a standalone posturography device, in 4 sensory conditions: firm surface, eyes open (EO); firm surface, eyes closed (EC); foam surface, EO; and foam surface, EC. Stabilization Indices (SI) were computed from COP measures to determine the relative visual (SIfirm, SIfoam), somatosensory (SIEO, SIEC) and vestibular (SIV, i.e., FoamEC vs. FirmEO) contributions to balance. This study was not powered to detect between group differences, so significance of pre-post changes was assessed by paired samples t-tests within each group. Results Groups were equivalent at baseline (all p > 0.05). In the AYT group, absolute COP significantly increased in the FoamEO (t(8) = -3.66, p = 0.01) and FoamEC (t(8) = -3.90, p = 0.01) conditions. Relative somatosensory SIEO (t(8) = -2.42, p = 0.04) and SIEC (t(8) = -3.96, p = 0.01), and vestibular SIV (t(8) = -2.47, p = 0.04) contributions to balance increased significantly. As expected, no significant changes from EO to EC conditions were found indicating an absence of visual dependency in VI. No significant pre-post changes were observed in the control group (all p > 0.05). Conclusions These preliminary results establish the potential for AYT training to develop the remaining somatosensory and vestibular responses used to optimize postural stability in a VI population. Trial Registration www.ClinicalTrials.gov NCT01366677 PMID:26107256

The effects of computer-based mindfulness training on Self-control and Mindfulness within Ambulatorily assessed network Systems across Health-related domains in a healthy student population (SMASH): study protocol for a randomized controlled trial.

PubMed

Rowland, Zarah; Wenzel, Mario; Kubiak, Thomas

2016-12-01

Self-control is an important ability in everyday life, showing associations with health-related outcomes. The aim of the Self-control and Mindfulness within Ambulatorily assessed network Systems across Health-related domains (SMASH) study is twofold: first, the effectiveness of a computer-based mindfulness training will be evaluated in a randomized controlled trial. Second, the SMASH study implements a novel network approach in order to investigate complex temporal interdependencies of self-control networks across several domains. The SMASH study is a two-armed, 6-week, non-blinded randomized controlled trial that combines seven weekly laboratory meetings and 40 days of electronic diary assessments with six prompts per day in a healthy undergraduate student population at the Johannes Gutenberg University Mainz, Germany. Participants will be randomly assigned to (1) receive a computer-based mindfulness intervention or (2) to a wait-list control condition. Primary outcomes are self-reported momentary mindfulness and self-control assessed via electronic diaries. Secondary outcomes are habitual mindfulness and habitual self-control. Further measures include self-reported behaviors in specific self-control domains: emotion regulation, alcohol consumption and eating behaviors. The effects of mindfulness training on primary and secondary outcomes are explored using three-level mixed models. Furthermore, networks will be computed with vector autoregressive mixed models to investigate the dynamics at participant and group level. This study was approved by the local ethics committee (reference code 2015_JGU_psychEK_011) and follows the standards laid down in the Declaration of Helsinki (2013). This randomized controlled trial combines an intensive Ambulatory Assessment of 40 consecutive days and seven laboratory meetings. By implementing a novel network approach, underlying processes of self-control within different health domains will be identified. These results will deepen the understanding of self-control performance and will guide to just-in-time individual interventions for several health-related behaviors. ClinicalTrials.gov, NCT02647801 . Registered on 15 December 2015 (registered retrospectively). .

School-based mental health intervention for children in war-affected Burundi: a cluster randomized trial.

PubMed

Tol, Wietse A; Komproe, Ivan H; Jordans, Mark J D; Ndayisaba, Aline; Ntamutumba, Prudence; Sipsma, Heather; Smallegange, Eva S; Macy, Robert D; de Jong, Joop T V M

2014-04-01

Armed conflicts are associated with a wide range of impacts on the mental health of children and adolescents. We evaluated the effectiveness of a school-based intervention aimed at reducing symptoms of posttraumatic stress disorder, depression, and anxiety (treatment aim); and improving a sense of hope and functioning (preventive aim). We conducted a cluster randomized trial with 329 children in war-affected Burundi (aged 8 to 17 (mean 12.29 years, standard deviation 1.61); 48% girls). One group of children (n = 153) participated in a 15-session school-based intervention implemented by para-professionals, and the remaining 176 children formed a waitlist control condition. Outcomes were measured before, one week after, and three months after the intervention. No main effects of the intervention were identified. However, longitudinal growth curve analyses showed six favorable and two unfavorable differences in trajectories between study conditions in interaction with several moderators. Children in the intervention condition living in larger households showed decreases on depressive symptoms and function impairment, and those living with both parents showed decreases on posttraumatic stress disorder and depressive symptoms. The groups of children in the waitlist condition showed increases in depressive symptoms. In addition, younger children and those with low levels of exposure to traumatic events in the intervention condition showed improvements on hope. Children in the waitlist condition who lived on their original or newly bought land showed improvements in hope and function impairment, whereas children in the intervention condition showed deterioration on these outcomes. Given inconsistent effects across studies, findings do not support this school-based intervention as a treatment for posttraumatic stress disorder and depressive symptoms in conflict-affected children. The intervention appears to have more consistent preventive benefits, but these effects are contingent upon individual (for example, age, gender) and contextual (for example, family functioning, state of conflict, displacement) variables. Results suggest the potential benefit of school-based preventive interventions particularly in post-conflict settings. The study was registered as ISRCTN42284825.

Social skills treatment for people with severe, chronic acquired brain injuries: a multicenter trial.

PubMed

McDonald, Skye; Tate, Robyn; Togher, Leanne; Bornhofen, Cristina; Long, Esther; Gertler, Paul; Bowen, Rebecca

2008-09-01

To determine whether social skills deficits including unskilled, inappropriate behavior, problems reading social cues (social perception), and mood disturbances (such as depression and anxiety) could be remediated after severe traumatic brain injuries. Randomized controlled trial comparing a social skills program with social activity alone or with waitlist control. Several participants were reassigned after randomization. Hospital outpatient and community facilities. Fifty-one outpatients from 3 brain injury units in Sydney, Australia, with severe, chronic acquired brain injuries were recruited. A total of 39 people (13 in skills training, 13 in social activity, 13 in waitlist) completed all phases of the study. Twelve-week social skills treatment program encompassing weekly 3-hour group sessions focused on shaping social behavior and remediating social perception and 1-hour individual sessions to address psychologic issues with mood, self-esteem, etc. Primary outcomes were: (1) social behavior during encounters with a confederate as rated on the Behaviorally Referenced Rating System of Intermediary Social Skills-Revised (BRISS-R), (2) social perception as measured by The Awareness of Social Inference Test, and (3) depression and anxiety as measured by the Depression, Anxiety and Stress Scale. Secondary outcomes were: relative report on social behavior and participation using: the Katz Adjustment Scale-R1; the Social Performance Survey Schedule; the La Trobe Communication Questionnaire; and the Sydney Psychosocial Reintegration Scale (both relative and self-report). Repeated-measures analysis of variance indicated that social activity alone did not lead to improved performance relative to waitlist (placebo effect) on any outcome variable. On the other hand, the skills training group improved differentially on the Partner Directed Behavior Scale of the BRISS-R, specifically the self-centered behavior and partner involvement behavior subscales. No treatment effects were found for the remaining primary outcomes (social perception, emotional adjustment) or for secondary outcome variables (relative and self-report measures of social function). This study suggested that treatment effects after social skills training in people with severe, chronic brain injuries are modest and are limited to direct measures of social behavior.

The effect of chiropractic treatment on the reaction and response times of special operation forces military personnel: study protocol for a randomized controlled trial.

PubMed

DeVocht, James W; Smith, Dean L; Long, Cynthia R; Corber, Lance; Kane, Bridget; Jones, Thomas M; Goertz, Christine M

2016-09-20

Chiropractic care is commonly used to treat musculoskeletal conditions and has been endorsed by clinical practice guidelines as being evidence-based and cost-effective for the treatment of patients with low back pain. Gaps in the literature exist regarding the physiological outcomes of chiropractic treatment. Previous pilot work has indicated the possibility of improvements in response time following the application of chiropractic treatment. However, it is unknown whether or not chiropractic treatment is able to improve reaction and response times in specific populations of interest. One such population is the U.S. military special operation forces' (SOF) personnel. This study is a randomized controlled trial of 120 asymptomatic volunteer SOF personnel. All participants are examined by a study doctor of chiropractic (DC) for eligibility prior to randomization. The participants are randomly allocated to either a treatment group receiving four treatments of chiropractic manipulative therapy (CMT) over 2 weeks or to a wait-list control group. The wait-list group does not receive any treatment but has assessments at the same time interval as the treatment group. The outcome measures are simple reaction times for dominant hand and dominant foot, choice reaction time with prompts calling for either hand or either foot, response time using Fitts' law tasks for small movements involving eye-hand coordination, and brief whole body movements using the t-wall, a commercially available product. At the first visit, all five tests are completed so that participants can familiarize themselves with the equipment and protocol. Assessments at the second and the final visits are used for data analysis. SOF personnel are highly motivated and extremely physically fit individuals whose occupation requires reaction times that are as quick as possible during the course of their assigned duties. A goal of CMT is to maximize the functionality and integration of the neuromusculoskeletal systems. Therefore, chiropractic treatment may be able to optimize the capacity of the numerous components of those systems, resulting in improved reaction time. The objective of this study is to test the hypothesis that CMT improves reaction and response times in asymptomatic SOF personnel. ClinicalTrials.gov, NCT02168153 . Registered on 12 June 2014.

Protocol for the End-of-Life Social Action Study (ELSA): a randomised wait-list controlled trial and embedded qualitative case study evaluation assessing the causal impact of social action befriending services on end of life experience.

PubMed

Walshe, Catherine; Algorta, Guillermo Perez; Dodd, Steven; Hill, Matthew; Ockenden, Nick; Payne, Sheila; Preston, Nancy

2016-07-13

Compassionate support at the end of life should not be the responsibility of health and social care professionals alone and requires a response from the wider community. Volunteers, as community members, are a critical part of many end-of-life care services. The impact of their services on important outcomes such as quality of life is currently poorly understood. The purpose of this study is to evaluate a series of social action initiatives which use volunteers to deliver befriending services to people anticipated to be in their last year of life. The aim is to determine if receiving care from a social action volunteer befriending service plus usual care significantly improves quality of life in the last year of life. The research questions will be addressed through a wait-list randomised controlled trial (WLRCT) and qualitative case study evaluation across 12 sites in England. Participants will be randomly allocated to either receive the social action volunteer befriending service straight away or receive the intervention after a four week wait (wait-list arm). The impact of the intervention on end-of-life experience (quality of life as primary outcome, loneliness, social support) will be measured. Repeated assessments will be carried out at baseline and weeks 4 and 8 for the intervention arm and weeks 4, 8 and 12 for the wait-list arm. For selected sites case study evaluation will include interviews, observation and documentary analysis to understand the mechanisms underpinning any found impact. This study will address the need to both provide services which use social action models to support end-of-life care in community settings, and to robustly evaluate these models to determine if they influence the experience of end-of-life care. Such services could work to reduce isolation, help meet emotional needs and maintain a sense of connectedness to the community. ISRCTN 12929812 Registered 20.5.15.

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

PubMed

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

2015-03-01

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

Cognitive-Functional (Cog-Fun) Dyadic Intervention for Children with ADHD and Their Parents: Impact on Parenting Self-Efficacy.

PubMed

Hahn-Markowitz, Jeri; Berger, Itai; Manor, Iris; Maeir, Adina

2018-03-01

The family context of children with ADHD plays a role in intervention outcomes, especially when parents are involved in treatment. Parental participation in evidence-based treatment for ADHD may play a role in improving their own parenting self-efficacy (PSE) as well as child outcomes. This study examined the impact of Cognitive-Functional (Cog-Fun) intervention in occupational therapy (OT) for school-aged children with ADHD, on PSE. In this randomized controlled trial with crossover design, 107 children were allocated to intervention and waitlist control groups. Intervention participants (n = 50) received Cog-Fun after baseline assessment and waitlist controls (n = 49) received treatment 3 months later. Intervention participants received 3-month follow-up assessment. Treatment included 10 parent-child Cog-Fun weekly sessions. PSE was assessed with the Tool to measure Parenting Self-Efficacy (TOPSE). All children who began treatment completed it. Mixed ANOVA revealed significant Time x Group interaction effects on TOPSE scales of Play and Enjoyment, Control, Self-Acceptance, Knowledge and Learning and Total score, which showed significant improvement with moderate treatment effects for the intervention group. Results were replicated in the control group after crossover. The findings of this study suggest that Cog-Fun OT intervention may be effective for improving aspects of PSE among parents of children with ADHD.

Fall risk and incidence reduction in high risk individuals with multiple sclerosis: a pilot randomized control trial.

PubMed

Sosnoff, Jacob J; Moon, Yaejin; Wajda, Douglas A; Finlayson, Marcia L; McAuley, Edward; Peterson, Elizabeth W; Morrison, Steve; Motl, Robert W

2015-10-01

To determine the feasibility of three fall prevention programs delivered over 12 weeks among individuals with multiple sclerosis: (A) a home-based exercise program targeting physiological risk factors; (B) an educational program targeting behavioral risk factors; and (C) a combined exercise-and-education program targeting both factors. Randomized controlled trial. Home-based training with assessments at research laboratory. A total of 103 individuals inquired about the investigation. After screening, 37 individuals with multiple sclerosis who had fallen in the last year and ranged in age from 45-75 years volunteered for the investigation. A total of 34 participants completed postassessment following the 12-week intervention. Participants were randomly assigned into one of four conditions: (1) wait-list control (n = 9); (2) home-based exercise (n = 11); (3) education (n = 9); or (4) a combined exercise and education (n = 8) group. Before and after the 12-week interventions, participants underwent a fall risk assessment as determined by the physiological profile assessment and provided information on their fall prevention behaviors as indexed by the Falls Prevention Strategy Survey. Participants completed falls diaries during the three-months postintervention. A total of 34 participants completed postintervention testing. Procedures and processes were found to be feasible. Overall, fall risk scores were lower in the exercise groups (1.15 SD 1.31) compared with the non-exercise groups (2.04 SD 1.04) following the intervention (p < 0.01). There was no group difference in fall prevention behaviors (p > 0.05). Further examination of home-based exercise/education programs for reducing falls in individuals with multiple sclerosis is warranted. A total of 108 participants would be needed in a larger randomized controlled trial.ClinicalTrials.org #NCT01956227. © The Author(s) 2014.

A randomized waitlist control community study of Social Cognition and Interaction Training for people with schizophrenia.

PubMed

Gordon, Anne; Davis, Penelope J; Patterson, Susan; Pepping, Christopher A; Scott, James G; Salter, Kerri; Connell, Melissa

2018-03-01

Social Cognition and Interaction Training (SCIT) has demonstrated effectiveness in improving social cognition and functioning of people with schizophrenia. This pilot study examines the acceptability, feasibility, and effectiveness of SCIT with individuals who have schizophrenia-spectrum disorders and are receiving care through a public mental health service. In a pragmatic randomized waitlist controlled trial, 36 participants (aged 19-55 years) with a schizophrenia spectrum disorder were randomly allocated to SCIT or treatment as usual (TAU). Measures of theory of mind, emotion perception, attributional bias, social skills, quality of life, life skills, depression, anxiety, and stress were administered pre- and post-intervention with follow-up conducted 4 months later. All wait-list controls subsequently received the intervention and a secondary within-group analysis was conducted including these participants. While no significant differences were found between groups on any outcomes, there was strong engagement with the SCIT intervention. Of the 21 participants in the intervention group, the completion rate was 85.71% with a median attendance rate of 17 sessions. Within subject analyses of SCIT participants over time showed significant improvements in quality of life, emotion recognition, social skills, and a trend towards better life skills from pre- to post-intervention. These gains were sustained at the 4-month follow-up time. Although this study showed limited benefits in outcomes associated with SCIT compared with TAU, it demonstrated the acceptability of SCIT to participants in a real world public health setting shown by high retention, attendance, and positive feedback. This pilot shows SCIT can be implemented in routine clinical practice and lays the foundation for a larger pragmatic study. SCIT can be implemented successfully in a real-world community mental health setting. SCIT had high levels of acceptability to these participants. Limitations The small sample size meant there was insufficient power to detect differences between groups on outcome measures. The study did not include measures of psychiatric symptoms or neuropsychological functioning which may have influenced participants' capacity to benefit from SCIT. © 2017 The British Psychological Society.

EEG alpha power during maintenance of information in working memory in adults with ADHD and its plasticity due to working memory training: A randomized controlled trial.

PubMed

Liu, Zhong-Xu; Glizer, Daniel; Tannock, Rosemary; Woltering, Steven

2016-02-01

The present study examined whether neural indices of working memory maintenance differ between young adults with ADHD and their healthy peers (Study 1), and whether this neural index would change after working memory training (Study 2). Study 1 involved 136 college students with ADHD and 41 healthy peers (aged 18-35 years) and measured their posterior alpha activity during a visual delayed-match-to-sample task using electroencephalography (EEG). Study 2 involved 99 of the participants with ADHD who were randomized into a standard-length or shortened-length Cogmed working memory training program or a waitlist control group. The ADHD group tended to be less accurate than the peers. Similarly, the ADHD group exhibited lower posterior alpha power at a trend level compared to their healthy peers. There were no training effects on participants' performance and only marginal increases in posterior alpha power in training groups compared to the waitlist group. Considering that the training effects were small and there was no load and dose effect, we conclude that the current study provides no convincing evidence for specific effects of Cogmed. These findings provide unique insights into neuroplasticity, or lack thereof, with near-transfer tasks in individuals with ADHD. Copyright © 2015 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

Enhancing Father Engagement and Interparental Teamwork in an Evidence-Based Parenting Intervention: A Randomized-Controlled Trial of Outcomes and Processes.

PubMed

Frank, Tenille J; Keown, Louise J; Sanders, Matthew R

2015-11-01

This study examined the outcomes and process in a positive parenting program adapted to enhance father engagement and teamwork. A randomized control trial of the Group Triple P Program with additional father-relevant content was conducted with 42 families of children with conduct problems aged between 3 to 8years. Families were allocated to either the intervention or waitlist condition. Assessments of child behavior, self- and partner-reported parenting, and the interparental relationship were conducted at T1 (pre), T2 (post), and T3 (6-month follow-up). Observations were used to examine fathers' and mothers' unique and shared contributions to group process during participation in parenting group sessions. Following program completion (T2) intervention group fathers and mothers reported significantly fewer child behavior problems, dysfunctional parenting practices, and interparental conflict about child-rearing than waitlist parents. Intervention group mothers also reported increased parenting confidence and rated their partners as showing significantly fewer dysfunctional parenting practices. Intervention effects were maintained at 6-month follow-up. Observational data showed that fathers and mothers made similar contributions during the group sessions. The most frequent types of contributions were asking questions and sharing information with other parents about implementing parenting strategies. The key differences between parents were fathers' more frequent use of humor and mothers' more frequent sharing of personal stories and reporting co-parenting cooperation. The levels of session attendance and program satisfaction were high for both fathers and mothers. Findings highlight the potential benefits of efforts to engage both fathers and mothers for program adherence, satisfaction, and effectiveness. Copyright © 2015. Published by Elsevier Ltd.

Tailored activities to manage neuropsychiatric behaviors in persons with dementia and reduce caregiver burden: a randomized pilot study.

PubMed

Gitlin, Laura N; Winter, Laraine; Burke, Janice; Chernett, Nancy; Dennis, Marie P; Hauck, Walter W

2008-03-01

To test whether the Tailored Activity Program (TAP) reduces dementia-related neuropsychiatric behaviors, promotes activity engagement, and enhances caregiver well-being. Prospective, two-group (treatment, wait-list control), randomized, controlled pilot study with 4 months as main trial endpoint. At 4 months, controls received the TAP intervention and were reassessed 4 months later. Patients' homes. Sixty dementia patients and family caregivers. The eight-session occupational therapy intervention involved neuropsychological and functional testing, selection, and customization of activities to match capabilities identified in testing, and instruction to caregivers in use of activities. Behavioral occurrences, activity engagement, and quality of life in dementia patients; objective and subjective burden and skill enhancement in caregivers. At 4 months, compared with controls, intervention caregivers reported reduced frequency of problem behaviors, and specifically for shadowing and repetitive questioning, and greater activity engagement including the ability to keep busy. Fewer intervention caregivers reported agitation or argumentation. Caregiver benefits included fewer hours doing things and being on duty, greater mastery, self-efficacy, and skill enhancement. Wait-list control participants following intervention showed similar benefits for reductions in behavioral frequency and caregiver hours doing things for the patient and mastery. Caregivers with depressed symptoms derived treatment benefits similar to nondepressed caregivers. Tailoring activities to the capabilities of dementia patients and training families in activity use resulted in clinically relevant benefits for patients and caregivers. Treatment minimized trigger behaviors for nursing home placement and reduced objective caregiver burden. Noteworthy is that depressed caregivers effectively engaged in and benefited from the intervention.

Tailored Activities to Manage Neuropsychiatric Behaviors in Persons with Dementia and Reduce Caregiver Burden: A Randomized Pilot Study

PubMed Central

Gitlin, Laura N.; Winter, Laraine; Burke, Janice; Chernett, Nancy; Dennis, Marie P.; Hauck, Walter W.

2009-01-01

Objective To test whether the Tailored Activity Program for at-home dementia patients reduces neuropsychiatric behaviors and caregiver burden. Method A prospective, two-group controlled pilot study with 60 dyads randomized to treatment or wait-list control. Dyads were interviewed at baseline and 4 months (trial endpoint); control participants then received intervention and were reassessed 4 months later. The 8-session occupational therapy intervention involved neuropsychological and functional testing from which activities were customized and instruction in use provided to caregivers. Results At 4-months, compared to controls, intervention caregivers reported reduced frequency of behaviors (p = .010; Cohen’s d = .72), specifically for shadowing (p = .003, Cohen’s d = 3.10) and repetitive questioning (p = .23, Cohen’s d = 1.22); greater activity engagement (p = .029, Cohen’s d = .61); and ability to keep busy (p = .017, Cohen’s d = .71). Also, fewer intervention caregivers reported agitation (p = .014, Cohen’s d = .75) or argumentation (p = .010, Cohen’s d = .77). Caregiver benefits included fewer hours doing things (p = .005, Cohen’s d = 1.14) and being on duty (p = .001, Cohen’s d = 1.01), greater mastery (p = .013, Cohen’s d = .55), self-efficacy (p = .011, Cohen’s d = .74), and use of simplification techniques (p = .023, Cohen’s d = .71). Wait-list control participants showed similar benefits for behavioral frequency following intervention. Conclusions Results suggest clinically-relevant benefits for both dementia patients and caregivers, with treatment minimizing the occurrence of behaviors that commonly trigger nursing home placement. PMID:18310553

A Brief Manualized Treatment for Problematic Caffeine Use: A Randomized Control Trial

PubMed Central

Evatt, Daniel P.; Juliano, Laura M.; Griffiths, Roland R.

2015-01-01

Objective The goal of the present investigation was to develop and test a brief therapist-guided manualized treatment for problematic caffeine use including cognitive-behavioral strategies and 5-weeks of progressively decreased consumption. Methods Individuals seeking treatment for problematic caffeine use (mean daily caffeine consumption of 666.0 mg at baseline) were randomized using a waitlist-control design to receive immediate (N = 33) treatment or delayed (N = 34) treatment (∼6 weeks later). A one-hour long treatment session designed to help individuals quit or reduce caffeine consumption was provided by a trained counselor along with a take-home booklet. After the treatment session, participants completed daily diaries of caffeine consumption for 5 weeks. They returned for follow-up assessments at 6, 12, and 26 weeks and had a telephone interview at 52-weeks post-treatment. Results Treatment resulted in a significant reduction in self reported caffeine use and salivary caffeine levels. No significant post-treatment increases in caffeine use were observed for up to one year follow-up. Comparisons to the waitlist control condition revealed that reductions in caffeine consumption were due to treatment and not the passing of time, with a treatment effect size of R2 = .35 for the model. Conclusions A brief one-session manualized intervention with follow-up was efficacious at reducing caffeine consumption. Future research should replicate and extend these findings, as well as consider factors affecting dissemination of treatment for problematic caffeine use to those in need. PMID:26501499

Promoting gross motor skills and physical activity in childcare: A translational randomized controlled trial.

PubMed

Jones, Rachel A; Okely, Anthony D; Hinkley, Trina; Batterham, Marijka; Burke, Claire

2016-09-01

Educator-led programs for physical activity and motor skill development show potential but few have been implemented and evaluated using a randomized controlled design. Furthermore, few educator-led programs have evaluated both gross motor skills and physical activity. Therefore, the aim of this study was to evaluate a gross motor skill and physical activity program for preschool children which was facilitated solely by childcare educators. A six-month 2-arm randomized controlled trial was implemented between April and September 2012 in four early childhood centers in Tasmania, Australia. Educators participated in ongoing professional development sessions and children participated in structured physical activity lessons and unstructured physical activity sessions. In total, 150 children were recruited from four centers which were randomized to intervention or wait-list control group. Six early childhood educators from the intervention centers were trained to deliver the intervention. Gross motor skills were assessed using the Test of Gross Motor Development (2nd edition) and physical activity was measured objectively using GT3X+ Actigraph accelerometers. No statistically significant differences were identified. However, small to medium effect sizes, in favor of the intervention group, were evident for four of the five gross motor skills and the total gross motor skill score and small to medium effect sizes were reported for all physical activity outcomes. This study highlights the potential of educator-led physical activity interventions and supports the need for further translational trials within the early childhood sector. Copyright © 2015 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

The efficacy of prospective memory rehabilitation plus metacognitive skills training for adults with traumatic brain injury: study protocol for a randomized controlled trial.

PubMed

Fleming, Jennifer; Ownsworth, Tamara; Doig, Emmah; Hutton, Lauren; Griffin, Janelle; Kendall, Melissa; Shum, David H K

2017-01-05

Impairment of prospective memory (PM) is common following traumatic brain injury (TBI) and negatively impacts on independent living. Compensatory approaches to PM rehabilitation have been found to minimize the impact of PM impairment in adults with TBI; however, poor self-awareness after TBI poses a major barrier to the generalization of compensatory strategies in daily life. Metacognitive skills training (MST) is a cognitive rehabilitation approach that aims to facilitate the development of self-awareness in adults with TBI. This paper describes the protocol of a study that aims to evaluate the efficacy of a MST approach to compensatory PM rehabilitation for improving everyday PM performance and psychosocial outcomes after TBI. This randomized controlled trial has three treatment groups: compensatory training plus metacognitive skills training (COMP-MST), compensatory training only (COMP), and waitlist control. Participants in the COMP-MST and COMP groups will complete a 6-week intervention consisting of six 2-h weekly training sessions. Each 1.5-h session will involve compensatory strategy training and 0.5 h will incorporate either MST (COMP-MST group) or filler activity as an active control (COMP group). Participants in the waitlist group receive care as usual for 6 weeks, followed by the COMP-MST intervention. Based on the sample size estimate, 90 participants with moderate to severe TBI will be randomized into the three groups using a stratified sampling approach. The primary outcomes include measures of PM performance in everyday life and level of psychosocial reintegration. Secondary outcomes include measures of PM function on psychometric testing, strategy use, self-awareness, and level of support needs following TBI. Blinded assessments will be conducted pre and post intervention, and at 3-month and 6-month follow-ups. This study seeks to determine the efficacy of COMP-MST for improving and maintaining everyday PM performance and level of psychosocial integration in adults with moderate to severe TBI. The findings will advance theoretical understanding of the role of self-awareness in compensatory PM rehabilitation and skills generalization. COMP-MST has the potential to reduce the cost of rehabilitation and lifestyle support following TBI because the intervention could enhance generalization success and lifelong application of PM compensatory strategies. New Zealand Clinical Trials Registry, ACTRN12615000996561 . Registered on 23 September 2015; retrospectively registered 2 months after commencement.

Effects of the FITKids randomized controlled trial on executive control and brain function.

PubMed

Hillman, Charles H; Pontifex, Matthew B; Castelli, Darla M; Khan, Naiman A; Raine, Lauren B; Scudder, Mark R; Drollette, Eric S; Moore, Robert D; Wu, Chien-Ting; Kamijo, Keita

2014-10-01

To assess the effect of a physical activity (PA) intervention on brain and behavioral indices of executive control in preadolescent children. Two hundred twenty-one children (7-9 years) were randomly assigned to a 9-month afterschool PA program or a wait-list control. In addition to changes in fitness (maximal oxygen consumption), electrical activity in the brain (P3-ERP) and behavioral measures (accuracy, reaction time) of executive control were collected by using tasks that modulated attentional inhibition and cognitive flexibility. Fitness improved more among intervention participants from pretest to posttest compared with the wait-list control (1.3 mL/kg per minute, 95% confidence interval [CI]: 0.3 to 2.4; d = 0.34 for group difference in pre-to-post change score). Intervention participants exhibited greater improvements from pretest to posttest in inhibition (3.2%, 95% CI: 0.0 to 6.5; d = 0.27) and cognitive flexibility (4.8%, 95% CI: 1.1 to 8.4; d = 0.35 for group difference in pre-to-post change score) compared with control. Only the intervention group increased attentional resources from pretest to posttest during tasks requiring increased inhibition (1.4 µV, 95% CI: 0.3 to 2.6; d = 0.34) and cognitive flexibility (1.5 µV, 95% CI: 0.6 to 2.5; d = 0.43). Finally, improvements in brain function on the inhibition task (r = 0.22) and performance on the flexibility task correlated with intervention attendance (r = 0.24). The intervention enhanced cognitive performance and brain function during tasks requiring greater executive control. These findings demonstrate a causal effect of a PA program on executive control, and provide support for PA for improving childhood cognition and brain health. Copyright © 2014 by the American Academy of Pediatrics.

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

PubMed

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

2017-09-01

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

Managing stress and anxiety through qigong exercise in healthy adults: a systematic review and meta-analysis of randomized controlled trials

PubMed Central

2014-01-01

Background An increasing number of studies have documented the effectiveness of qigong exercise in helping people reduce psychological stress and anxiety, but there is a scarcity of systematic reviews evaluating evidence from randomized controlled trials (RCTs) conducted among healthy subjects. Methods Thirteen databases were searched for RCTs from their inception through June 2013. Effects of qigong exercise were pooled across trials. Standardized mean differences (SMDs) were calculated for the pooled effects. Heterogeneity was assessed using the I 2 test. The risk of bias was assessed using the Cochrane criteria. Results Seven RCTs met the inclusion criteria. Two RCTs suggested that qigong exercise immediately relieved anxiety among healthy adults, compared to lecture attendance and structured movements only. Four RCTs suggested qigong exercise relieved anxiety (pooled SMD = -0.75; 95% CI, -1.11 to -0.40), and three RCTs suggested that qigong exercise reduced stress (pooled SMD = -0.88; 95% CI, -1.22 to -0.55) among healthy subjects following one to three months of qigong practice, compared to wait-list controls. Conclusions The available evidence suggests that qigong exercise reduces stress and anxiety in healthy adults. However, given the limited number of RCTs and their methodological flaws, further rigorously designed RCTs are needed. PMID:24400778

Study protocol: evaluation of a parenting and stress management programme: a randomised controlled trial of Triple P Discussion Groups and Stress Control

PubMed Central

2013-01-01

Background Children displaying psychosocial problems are at an increased risk of negative developmental outcomes. Parenting practices are closely linked with child development and behaviour, and parenting programmes have been recommended in the treatment of child psychosocial problems. However, parental mental health also needs to be addressed when delivering parenting programmes as it is linked with parenting practices, child outcomes, and treatment outcomes of parenting programmes. This paper describes the protocol of a study examining the effects of a combined intervention of a parenting programme and a cognitive behavioural intervention for mental health problems. Methods/design The effects of a combined intervention of Triple P Discussion Groups and Stress Control will be examined using a randomised controlled trial design. Parents with a child aged 3–8 years will be recruited to take part in the study. After obtaining informed consent and pre-intervention measures, participants will be randomly assigned to either an intervention or a waitlist condition. The two primary outcomes for this study are change in dysfunctional/ineffective parenting practices and change in symptoms of depression, anxiety, and stress. Secondary outcomes are child behaviour problems, parenting experiences, parental self-efficacy, family relationships, and positive parental mental health. Demographic information, participant satisfaction with the intervention, and treatment fidelity data will also be collected. Data will be collected at pre-intervention, mid-intervention, post-intervention, and 3-month follow-up. Discussion The aim of this paper is to describe the study protocol of a randomised controlled trial evaluating the effects of a combined intervention of Triple P Discussion Groups and Stress Control in comparison to a waitlist condition. This study is important because it will provide evidence about the effects of this combined intervention for parents with 3–8 year old children. The results of the study could be used to inform policy about parenting support and support for parents with mental health problems. Trial registration ClinicalTrial.gov: NCT01777724, UTN: U1111-1137-1053. PMID:24066966

Prevention of depression and anxiety in adolescents: a randomized controlled trial testing the efficacy and mechanisms of Internet-based self-help problem-solving therapy.

PubMed

Hoek, Willemijn; Schuurmans, Josien; Koot, Hans M; Cuijpers, Pim

2009-10-12

Even though depression and anxiety are highly prevalent in adolescence, youngsters are not inclined to seek help in regular healthcare. Therapy through the Internet, however, has been found to appeal strongly to young people. The main aim of the present study is to examine the efficacy of preventive Internet-based guided self-help problem-solving therapy with adolescents reporting depressive and anxiety symptoms. A secondary objective is to test potential mediating and moderating variables in order to gain insight into how the intervention works and for whom it works best. This study is a randomized controlled trial with an intervention condition group and a wait-list control group. The intervention condition group receives Internet-based self-help problem-solving therapy. Support is provided by a professional and delivered through email. Participants in the wait-list control group receive the intervention four months later. The study population consists of adolescents (12-18-year-olds) from the general population who report mild to moderate depressive and/or anxiety symptoms and are willing to complete a self-help course. Primary outcomes are symptoms of depression and anxiety. Secondary outcomes are quality of life, social anxiety, and cost-effectiveness. The following variables are examined for their moderating role: demographics, motivation, treatment credibility and expectancy, externalizing behaviour, perceived social support from parents and friends, substance use, the experience of important life events, physical activity, the quality of the therapeutic alliance, and satisfaction. Mediator variables include problem-solving skills, worrying, mastery, and self-esteem. Data are collected at baseline and at 3 weeks, 5 weeks, 4 months, 8 months, and 12 months after baseline. Both intention-to-treat and completer analyses will be conducted. This study evaluates the efficacy and mechanisms of Internet-based problem-solving therapy for adolescents. If Internet-based problem-solving therapy is shown to reduce depressive and anxiety symptoms in adolescents, the implication is to implement the intervention in clinical practice. Strengths and limitations of the study are discussed. Netherlands Trial Register NTR1322.

Efficacy of Guided iCBT for Depression and Mediation of Change by Cognitive Skill Acquisition.

PubMed

Forand, Nicholas R; Barnett, Jeffrey G; Strunk, Daniel R; Hindiyeh, Mohammed U; Feinberg, Jason E; Keefe, John R

2018-03-01

Guided internet CBT (iCBT) is a promising treatment for depression; however, it is less well known through what mechanisms iCBT works. Two possible mediators of change are the acquisition of cognitive skills and increases in behavioral activation. We report results of an 8-week waitlist controlled trial of guided iCBT, and test whether early change in cognitive skills or behavioral activation mediated subsequent change in depression. The sample was 89 individuals randomized to guided iCBT (n = 59) or waitlist (n = 30). Participants were 75% female, 72% Caucasian, and 33 years old on average. The PHQ9 was the primary outcome measure. Mediators were the Competencies of Cognitive Therapy Scale-Self Report and the Behavioral Activation Scale for Depression-Short Form. Treatment was Beating the Blues plus manualized coaching. Outcomes were analyzed using linear mixed models, and mediation with a bootstrap resampling approach. The iCBT group was superior to waitlist, with large effect sizes at posttreatment (Hedges' g = 1.45). Dropout of iCBT was 29% versus 10% for waitlist. In the mediation analyses, the acquisition of cognitive skills mediated subsequent depression change (indirect effect = -.61, 95% bootstrapped biased corrected CI: -1.47, -0.09), but increases in behavioral activation did not. iCBT is an effective treatment for depression, but dropout rates remain high. Change in iCBT appears to be mediated by improvements in the use of cognitive skills, such as critically evaluating and restructuring negative thoughts. Copyright © 2017. Published by Elsevier Ltd.

Combining child social skills training with a parent early intervention program for inhibited preschool children.

PubMed

Lau, Elizabeth X; Rapee, Ronald M; Coplan, Robert J

2017-10-01

Previous studies have demonstrated the efficacy of early intervention for anxiety in preschoolers through parent-education. The current study evaluated a six-session early intervention program for preschoolers at high risk of anxiety disorders in which a standard educational program for parents was supplemented by direct training of social skills to the children. Seventy-two children aged 3-5 years were selected based on high behavioural inhibition levels and concurrently having a parent with high emotional distress. Families were randomly assigned to either the intervention group, which consisted of six parent-education group sessions and six child social skills training sessions, or waitlist. After six months, families on waitlist were offered treatment consisting of parent-education only. Relative to waitlist, children in the combined condition showed significantly fewer clinician-rated anxiety disorders and diagnostic severity and maternal (but not paternal) reported anxiety symptoms and life interference at six months. Mothers also reported less overprotection. These gains were maintained at 12-month follow-up. Parent only education following waitlist produced similar improvements among children. Quasi-experimental comparison between combined and parent-only interventions indicated greater reductions from combined intervention according to clinician reports, but no significant differences on maternal reports. Results suggest that this brief early intervention program for preschoolers with both parent and child components significantly reduces risk and disorder in vulnerable children. The inclusion of a child component might have the potential to increase effects over parent-only intervention. However, future support for this conclusion through long-term, randomised controlled trials is needed. Copyright © 2017 Elsevier Ltd. All rights reserved.

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

PubMed

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

2011-07-01

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

The carry-over effects of school gardens on fruit and vegetable availability at home: A randomized controlled trial with low-income elementary schools.

PubMed

Wells, Nancy M; Meyers, Beth M; Todd, Lauren E; Henderson, Charles R; Barale, Karen; Gaolach, Brad; Ferenz, Gretchen; Aitken, Martha; Tse, Caroline C; Pattison, Karen Ostlie; Hendrix, Laura; Carson, Janet B; Taylor, Cayla; Franz, Nancy K

2018-07-01

This group-randomized controlled trial examines the effects of a school garden intervention on availability of fruits and vegetables (FV) in elementary school children's homes. Within each region, low income U.S. schools in Arkansas, Iowa, New York, and Washington State were randomly assigned to intervention group (n = 24) or waitlist control group (n = 22). Children were in grades 2, 4, and 5 at baseline (n = 2768). The garden intervention consisted of both raised-bed garden kits and a series of grade-appropriate lessons. FV availability at home was measured with a modified version of the GEMS FJV Availability Questionnaire. The instrument was administered at baseline (Fall 2011) and throughout the intervention (Spring 2012, Fall 2012, Spring 2013). Analyses were completed using general linear mixed models. The garden intervention led to an overall increase in availability of low-fat vegetables at home. Among younger children (2nd grade at baseline), the garden intervention led to greater home availability of vegetables, especially, low-fat vegetables. Moreover, for the younger group, garden intervention fidelity (GIF) or robustness predicted home availability of fruit, vegetables, and low-fat vegetables. School gardens have potential to affect FV availability in the home environment. Copyright © 2018 Elsevier Inc. All rights reserved.

Effects of a depression-focused internet intervention in slot machine gamblers: A randomized controlled trial.

PubMed

Bücker, Lara; Bierbrodt, Julia; Hand, Iver; Wittekind, Charlotte; Moritz, Steffen

2018-01-01

Problematic and pathological gambling have been linked to depression. Despite a high demand for treatment and negative financial consequences, only a small fraction of problematic and pathological gamblers seek professional help. The existing treatment gap could be narrowed by providing low-threshold, anonymous internet-based interventions. The aim of the present study was to examine the acceptance and efficacy of an online-intervention for depression ("Deprexis") in a sample of problematic and pathological slot-machine gamblers. We hypothesized that the intervention group would show a greater reduction in both depressive and gambling-related symptoms compared to a wait-list control group. A total of 140 individuals with self-reported gambling and mood problems were randomly allocated either to the intervention group or to a wait-list control group. After 8 weeks, all participants were invited for re-assessment. The Patient Health Questionnaire - 9 (PHQ-9) served as the primary outcome assessment. Problematic gambling was measured with the Pathological Gambling Adaptation of Yale-Brown Obsessive Compulsive Scale (PG-YBOCS) and the South Oaks Gambling Screen (SOGS). The trial is registered with the German Registry for Clinical Studies (DRKS00013888). ITT analyses showed that the intervention led to a significant reduction in depressive symptoms as well as gambling-related symptoms compared to the control group, with moderate to strong effect sizes. PP analyses failed to yield significant results due to high rates of non-completion and limited statistical power. Moderator analyses indicated that Deprexis was particularly beneficial in reducing problematic gambling for those scoring high on baseline gambling-related symptoms and for those who gamble due to loneliness. Results of the present study suggest that Deprexis might be a useful adjunct to traditional interventions for the treatment of problematic gambling. The potential of internet-based interventions that are more targeted at issues specific to gambling should be evaluated in future studies. German Registry for Clinical Studies DRKS00013888.

The effect of acupuncture on psychosocial outcomes for women experiencing infertility: a pilot randomized controlled trial.

PubMed

Smith, Caroline A; Ussher, Jane M; Perz, Janette; Carmady, Bridget; de Lacey, Sheryl

2011-10-01

The study objectives were to examine the effectiveness of acupuncture for reducing infertility-related stress. The study design was a randomized controlled trial of acupuncture compared with a wait-list control. The study was conducted at The University of Western Sydney. Thirty-two (32) women aged 20-45 years, with a diagnosis of infertility, or a history of unsuccessfully trying to conceive for 12 months or more, were the subjects of the study. Women received six sessions of acupuncture over 8 weeks. The primary outcomes were infertility self-efficacy, anxiety, and infertility-related stress. The women's experience of infertility and acupuncture is also reported. At the end of the 8-week intervention, women in the acupuncture group reported significant changes on two domains on the Fertility Problem Inventory with less social concern (mean difference [MD] -3.75, 95% confidence interval [CI] -7.58 to 0.84, p=0.05), and less relationship concern (MD -3.66, 95% CI -6.80 to -0.052, p=0.02). There were also trends toward a reduction of infertility stress on other domains, and a trend toward improved self-efficacy (MD 11.9, 95% CI -2.20 to 26.0, p=0.09) and less anxiety (MD -2.54, 95% CI -5.95 to 0.86, p=0.08) in the acupuncture group compared with the wait-list control. Women described the experience and impact of acupuncture as positive relating to a sense of relaxation and time out, the engagement with the practitioner, and an intervention that had very few negative side-effects. Changes were also perceived after treatment with women describing a physical and psychologic sense of relaxation and calmness, and a changed perspective in relation to coping. Acupuncture may be a useful intervention to assist with the reduction of infertility-related stress. Further research is justified.

Cost-effectiveness of therapist-guided internet-delivered cognitive behaviour therapy for paediatric obsessive–compulsive disorder: results from a randomised controlled trial

PubMed Central

Lenhard, Fabian; Ssegonja, Richard; Andersson, Erik; Feldman, Inna; Mataix-Cols, David; Serlachius, Eva

2017-01-01

Objectives To evaluate the cost-effectiveness of a therapist-guided internet-delivered cognitive behaviour therapy (ICBT) intervention for adolescents with obsessive–compulsive disorder (OCD) compared with untreated patients on a waitlist. Design Single-blinded randomised controlled trial. Setting A research clinic within the regular child and adolescent mental health service in Stockholm, Sweden. Participants Sixty-seven adolescents (12–17 years) with a Diagnostic and Statistical Manual of Mental Disorders Fifth Edition diagnosis of OCD. Interventions Either a 12-week, therapist-guided ICBT intervention or a wait list condition of equal duration. Primary outcome measures Cost data were collected at baseline and after treatment, including healthcare use, supportive resources, prescription drugs, prescription-free drugs, school absence and productivity loss, as well as the cost of ICBT. Health outcomes were defined as treatment responder rate and quality-adjusted life years gain. Bootstrapped mixed model analyses were conducted comparing incremental costs and health outcomes between the groups from the societal and healthcare perspectives. Results Compared with waitlist control, ICBT generated substantial societal cost savings averaging US$−144.98 (95% CI −159.79 to –130.16) per patient. The cost reductions were mainly driven by reduced healthcare use in the ICBT group. From the societal perspective, the probability of ICBT being cost saving compared with waitlist control was approximately 60%. From the healthcare perspective, the cost per additional responder to ICBT compared with waitlist control was approximately US$78. Conclusions The results suggest that therapist-guided ICBT is a cost-effective treatment and results in societal cost savings, compared with patients who do not receive evidence-based treatment. Since, at present, most patients with OCD do not have access to evidence-based treatments, the results have important implications for the increasingly strained national and healthcare budgets. Future studies should compare the cost-effectiveness of ICBT with regular face-to-face CBT. Trial registration number NCT02191631. PMID:28515196

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

PubMed

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

2018-04-23

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

Ashtanga-Based Yoga Therapy Increases the Sensory Contribution to Postural Stability in Visually-Impaired Persons at Risk for Falls as Measured by the Wii Balance Board: A Pilot Randomized Controlled Trial.

PubMed

Jeter, Pamela E; Haaz Moonaz, Steffany; Bittner, Ava K; Dagnelie, Gislin

2015-01-01

Persons with visual impairment (VI) are at greater risk for falls due to irreparable damage to visual sensory input contributing to balance. Targeted training may significantly improve postural stability by strengthening the remaining sensory systems. Here, we evaluate the Ashtanga-based Yoga Therapy (AYT) program as a multi-sensory behavioral intervention to develop postural stability in VI. A randomized, waitlist-controlled, single-blind clinical trial. The trial was conducted between October 2012 and December 2013. Twenty-one legally blind participants were randomized to an 8-week AYT program (n = 11, mean (SD) age = 55(17)) or waitlist control (n=10, mean (SD) age = 55(10)). AYT subjects convened for one group session at a local yoga studio with an instructor and two individual home-based practice sessions per week for a total of 8 weeks. Subjects completed outcome measures at baseline and post-8 weeks of AYT. The primary outcome, absolute Center of Pressure (COP), was derived from the Wii Balance Board (WBB), a standalone posturography device, in 4 sensory conditions: firm surface, eyes open (EO); firm surface, eyes closed (EC); foam surface, EO; and foam surface, EC. Stabilization Indices (SI) were computed from COP measures to determine the relative visual (SIfirm, SIfoam), somatosensory (SIEO, SIEC) and vestibular (SIV, i.e., FoamEC vs. FirmEO) contributions to balance. This study was not powered to detect between group differences, so significance of pre-post changes was assessed by paired samples t-tests within each group. Groups were equivalent at baseline (all p > 0.05). In the AYT group, absolute COP significantly increased in the FoamEO (t(8) = -3.66, p = 0.01) and FoamEC (t(8) = -3.90, p = 0.01) conditions. Relative somatosensory SIEO (t(8) = -2.42, p = 0.04) and SIEC (t(8) = -3.96, p = 0.01), and vestibular SIV (t(8) = -2.47, p = 0.04) contributions to balance increased significantly. As expected, no significant changes from EO to EC conditions were found indicating an absence of visual dependency in VI. No significant pre-post changes were observed in the control group (all p > 0.05). These preliminary results establish the potential for AYT training to develop the remaining somatosensory and vestibular responses used to optimize postural stability in a VI population. www.ClinicalTrials.gov NCT01366677.

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

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

PubMed

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

2016-01-01

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

Short- and Long-Term Effects of CBT-I in Groups for School-Age Children Suffering From Chronic Insomnia: The KiSS-Program.

PubMed

Schlarb, Angelika A; Bihlmaier, Isabel; Velten-Schurian, Kerstin; Poets, Christian F; Hautzinger, Martin

2018-01-01

This intervention study evaluates the short- and long-term effects of cognitive behavior therapy for insomnia (CBT-I) in groups for school-age children and their parents, named the KiSS-program. CBT-I was implemented in three sessions for children and three sessions for parents. All in all, 112 children with chronic childhood insomnia were randomly assigned to a wait-list (WL) control or treatment condition. According to subjective measures as well as objective wrist actigraphy, children in the CBT-I condition reported greater improvements in sleep behavior immediately after the treatment compared to the WL group. Improvements in sleep behavior after CBT-I persisted over the 3-, 6-, and 12-month follow-up assessments. The present study is the first randomized controlled trial that provides evidence for the long-term effectiveness of CBT-I in treating school-age children with chronic insomnia.

Animal-Assisted Therapies for Youth with or at risk for Mental Health Problems: A Systematic Review.

PubMed

Hoagwood, Kimberly Eaton; Acri, Mary; Morrissey, Meghan; Peth-Pierce, Robin

2017-01-01

To systematically review experimental evidence about animal-assisted therapies (AAT) for children or adolescents with or at risk for mental health conditions, we reviewed all experimental AAT studies published between 2000-2015, and compared studies by animal type, intervention, and outcomes. Studies were included if used therapeutically for children and adolescents (≤21 years) with or at risk for a mental health problem; used random assignment or a waitlist comparison/control group; and included child-specific outcome data. Of 1,535 studies, 24 met inclusion criteria. Of 24 studies identified, almost half were randomized controlled trials, with 9 of 11 published in the past two years. The largest group addresses equine therapies for autism. Findings are generally promising for positive effects associated with equine therapies for autism and canine therapies for childhood trauma. The AAT research base is slim; a more focused research agenda is outlined.

Randomized controlled trial of false safety behavior elimination therapy: a unified cognitive behavioral treatment for anxiety psychopathology.

PubMed

Schmidt, Norman B; Buckner, Julia D; Pusser, Andrea; Woolaway-Bickel, Kelly; Preston, Jennifer L; Norr, Aaron

2012-09-01

We tested the efficacy of a unified cognitive-behavioral therapy protocol for anxiety disorders. This group treatment protocol, termed false safety behavior elimination therapy (F-SET), is a cognitive-behavioral approach designed for use across various anxiety disorders such as panic disorder (PD), social anxiety disorder (SAD), and generalized anxiety disorder (GAD). F-SET simplifies, as well as broadens, key therapeutic elements of empirically validated treatments for anxiety disorders to allow for easier delivery to heterogeneous groups of patients with anxiety psychopathology. Patients with a primary anxiety disorder diagnosis (N=96) were randomly assigned to F-SET or a wait-list control. Data indicate that F-SET shows good efficacy and durability when delivered to mixed groups of patients with anxieties (i.e., PD, SAD, GAD) by relatively inexperienced clinicians. Findings are discussed in the context of balancing treatment efficacy and clinical utility. Copyright © 2012. Published by Elsevier Ltd.

Mindfulness-Based Stress Release Program for University Employees: A Pilot, Waitlist-Controlled Trial and Implementation Replication.

PubMed

Koncz, Rebecca; Wolfenden, Fiona; Hassed, Craig; Chambers, Richard; Cohen, Julia; Glozier, Nicholas

2016-10-01

The aim of this study was to evaluate the effectiveness of a 6-week mindfulness-based stress release program (SRP) on stress and work engagement in fulltime university employees. Perceived stress, workplace wellbeing, and engagement were measured at baseline and within 1 week of the SRP completion, and contemporaneously 6 weeks apart for a waitlist control group. A second program was implemented to examine reproducibility of results. Fifty participants undertook the SRPs, and 29 participants were waitlisted. A significant improvement in distress, workplace wellbeing, and vigor was observed within the first SRP group, when compared with the control group. The improvement in distress and wellbeing was reproduced in the second SRP group. This study adds to the growing body of research that mindfulness may be an effective method for reducing workplace stress, improving employee wellbeing, and enhancing work engagement.

The ASCENT (Allocation System Changes for Equity in Kidney Transplantation) Study: a Randomized Effectiveness-Implementation Study to Improve Kidney Transplant Waitlisting and Reduce Racial Disparity.

PubMed

Patzer, Rachel E; Smith, Kayla; Basu, Mohua; Gander, Jennifer; Mohan, Sumit; Escoffery, Cam; Plantinga, Laura; Melanson, Taylor; Kalloo, Sean; Green, Gary; Berlin, Alex; Renville, Gary; Browne, Teri; Turgeon, Nicole; Caponi, Susan; Zhang, Rebecca; Pastan, Stephen

2017-05-01

The United Network for Organ Sharing (UNOS) implemented a new Kidney Allocation System (KAS) in December 2014 that is expected to substantially reduce racial disparities in kidney transplantation among waitlisted patients. However, not all dialysis facility clinical providers and end stage renal disease (ESRD) patients are aware of how the policy change could improve access to transplant. We describe the ASCENT (Allocation System Changes for Equity in KidNey Transplantation) study, a randomized controlled effectiveness-implementation study designed to test the effectiveness of a multicomponent intervention to improve access to the early steps of kidney transplantation among dialysis facilities across the United States. The multicomponent intervention consists of an educational webinar for dialysis medical directors, an educational video for patients and an educational video for dialysis staff, and a dialysis-facility specific transplant performance feedback report. Materials will be developed by a multidisciplinary dissemination advisory board and will undergo formative testing in dialysis facilities across the United States. This study is estimated to enroll ~600 U.S. dialysis facilities with low waitlisting in all 18 ESRD Networks. The co-primary outcomes include change in waitlisting, and waitlist disparity at 1 year; secondary outcomes include changes in facility medical director knowledge about KAS, staff training regarding KAS, patient education regarding transplant, and a medical director's intent to refer patients for transplant evaluation. The results from the ASCENT study will demonstrate the feasibility and effectiveness of a multicomponent intervention designed to increase access to the deceased-donor kidney waitlist and reduce racial disparities in waitlisting.

Internet-Delivered Cognitive-Behavioral Therapy for Insomnia in Breast Cancer Survivors: A Randomized Controlled Trial.

PubMed

Zachariae, Robert; Amidi, Ali; Damholdt, Malene F; Clausen, Cecilie D R; Dahlgaard, Jesper; Lord, Holly; Thorndike, Frances P; Ritterband, Lee M

2018-02-20

Insomnia is two to three times more prevalent in cancer survivors than in the general population, where it is estimated to be 10% to 20%. Cognitive-behavioral therapy for insomnia (CBT-I) is the recommended treatment for chronic insomnia, but meeting survivor needs remains a challenge. Internet-delivered CBT-I (iCBT-I) has been shown efficacious in otherwise healthy adults. We tested the efficacy of iCBT-I in breast cancer survivors with clinically significant sleep disturbance. Women from a national sample of Danish breast cancer survivors who experienced clinically significant sleep disturbance were randomly allocated to iCBT-I or waitlist control (55:45). The fully automated iCBT-I program consisted of six cores. Online measures of insomnia severity, sleep quality, and fatigue were collected at baseline, postintervention (nine weeks), and follow-up (15 weeks). Online sleep diaries were completed over two-week periods pre- and postintervention. Intention-to-treat analyses (time × group interactions) were conducted with mixed linear models and corrected for multiple outcomes. All statistical tests were two-sided. A total of 255 women were randomly allocated to iCBT-I (n = 133) or waitlist control (n = 122). Statistically significant (P ≤ .02) time × group interactions were found for all sleep-related outcomes from pre- to postintervention. Effect sizes (Cohen's d) ranged from 0.33 (95% confidence interval [CI] = 0.06 to 0.61) for wake after sleep onset to 1.17 (95% CI = 0.87 to 1.47) for insomnia severity. Improvements were maintained for outcomes measured at follow-up (d = 0.66-1.10). iCBT-I appears to be effective in breast cancer survivors, with additional benefit in terms of reduced fatigue. This low-cost treatment could be incorporated in cancer rehabilitation programs.

Reconsolidation of Traumatic Memories for PTSD: A randomized controlled trial of 74 male veterans.

PubMed

Gray, Richard; Budden-Potts, Denise; Bourke, Frank

2017-12-14

A randomized waitlist-controlled design (n = 74) examined the efficacy of Reconsolidation of Traumatic Memories (RTM) among male veterans with current-month flashbacks and nightmares. Volunteers were randomly assigned to immediate treatment (three 120-minute sessions of RTM), or to a 3-week waiting condition before receiving the RTM treatment. Blinded psychometricians evaluated the symptoms at intake, 2 weeks, and 6 weeks post. Wait-listed participants were re-evaluated and then treated. Sixty-five volunteers completed the treatment. Of those treated, 46 (71%) lost DSM diagnosis for post-traumatic stress disorder (PTSD) by one of the following definitions: 42 persons (65%) were in complete remission (PTSD Symptom Scale Interview (PSS-I) ≤ 20 and DSM criteria not met). Four others (6%) lost the DSM diagnosis or were otherwise sub-clinical by dichotomous criteria (PSS-I < 20 and absence of flashbacks and nightmares) but non-ambiguous on the PTSD Checklist Military Version measures. Within-group RTM effect sizes (Hedges' g) for PSS-I score changes ranged from 1.5 to 2.2. The between-group comparison between the treatment group and the untreated controls was significant (p < .001) with an effect size equivalent to two standard deviations (g = -2.121; 95% CI [-4.693-0.453]). Patient satisfaction with the intervention was high. RTM shows promise as a brief, cost-effective intervention for PTSD characterized primarily by intrusive symptoms. Clinical or methodological significance of this article: The article provides evidence to support a fast (5 hours or fewer) robust intervention for PTSD characterized by intrusive symptoms including current-month flashbacks, nightmares, and accompanied by sympathetic arousal in response to trauma narratives. The intervention is well tolerated and has demonstrated efficacy up to one year.

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

PubMed

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

2015-09-30

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

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

PubMed

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

2016-02-01

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

The impact of Curtin University's activity, food and attitudes program on physical activity, sedentary time and fruit, vegetable and junk food consumption among overweight and obese adolescents: a waitlist controlled trial.

PubMed

Straker, Leon M; Howie, Erin K; Smith, Kyla L; Fenner, Ashley A; Kerr, Deborah A; Olds, Tim S; Abbott, Rebecca A; Smith, Anne J

2014-01-01

To determine the effects of participation in Curtin University's Activity, Food and Attitudes Program (CAFAP), a community-based, family-centered behavioural intervention, on the physical activity, sedentary time, and healthy eating behaviours of overweight and obese adolescents. In this waitlist controlled clinical trial in Western Australia, adolescents (n = 69, 71% female, mean age 14.1 (SD 1.6) years) and parents completed an 8-week intervention followed by 12 months of telephone and text message support. Assessments were completed at baseline, before beginning the intervention, immediately following the intervention, and at 3-, 6-, and 12- months follow-up. The primary outcomes were physical activity and sedentary time assessed by accelerometers and servings of fruit, vegetables and junk food assessed by 3-day food records. During the intensive 8-week intervention sedentary time decreased by -5.1 min/day/month (95% CI: -11.0, 0.8) which was significantly greater than the rate of change during the waitlist period (p = .014). Moderate physical activity increased by 1.8 min/day/month (95% CI: -0.04, 3.6) during the intervention period, which was significantly greater than the rate of change during the waitlist period (p = .041). Fruit consumption increased during the intervention period (monthly incidence rate ratio (IRR) 1.3, 95% CI: 1.10, 1.56) and junk food consumption decreased (monthly IRR 0.8, 95% CI: 0.74, 0.94) and these changes were different to those seen during the waitlist period (p = .004 and p = .020 respectively). Participating in CAFAP appeared to have a positive influence on the physical activity, sedentary and healthy eating behaviours of overweight and obese adolescents and many of these changes were maintained for one year following the intensive intervention. Australia and New Zealand Clinical Trials Registry ACTRN12611001187932.

A behavioral intervention for war-affected youth in Sierra Leone: a randomized controlled trial.

PubMed

Betancourt, Theresa S; McBain, Ryan; Newnham, Elizabeth A; Akinsulure-Smith, Adeyinka M; Brennan, Robert T; Weisz, John R; Hansen, Nathan B

2014-12-01

Youth in war-affected regions are at risk for poor psychological, social, and educational outcomes. Effective interventions are needed to improve mental health, social behavior, and school functioning. This randomized controlled trial tested the effectiveness of a 10-session cognitive-behavioral therapy (CBT)-based group mental health intervention for multisymptomatic war-affected youth (aged 15-24 years) in Sierra Leone. War-affected youth identified by elevated distress and impairment via community screening were randomized (stratified by sex and age) to the Youth Readiness Intervention (YRI) (n = 222) or to a control condition (n = 214). After treatment, youth were again randomized and offered an education subsidy immediately (n = 220) or waitlisted (n = 216). Emotion regulation, psychological distress, prosocial attitudes/behaviors, social support, functional impairment, and posttraumatic stress disorder (PTSD) symptoms were assessed at pre- and postintervention and at 6-month follow-up. For youth in school, enrollment, attendance, and classroom performance were assessed after 8 months. Linear mixed-effects regressions evaluated outcomes. The YRI showed significant postintervention effects on emotion regulation, prosocial attitudes/behaviors, social support, and reduced functional impairment, and significant follow-up effects on school enrollment, school attendance, and classroom behavior. In contrast, education subsidy was associated with better attendance but had no effect on mental health or functioning, school retention, or classroom behavior. Interactions between education subsidy and YRI were not significant. YRI produced acute improvements in mental health and functioning as well as longer-term effects on school engagement and behavior, suggesting potential to prepare war-affected youth for educational and other opportunities. Clinical trial registration information-Trial of the Youth Readiness Intervention (YRI); http://clinicaltrials.gov; NCT01684488. Copyright © 2014 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

A Behavioral Intervention for War-Affected Youth in Sierra Leone: A Randomized Controlled Trial

PubMed Central

Betancourt, Theresa S.; McBain, Ryan; Newnham, Elizabeth A.; Akinsulure-Smith, Adeyinka M.; Brennan, Robert T.; Weisz, John R.; Hansen, Nathan B.

2016-01-01

Objective Youth in war-affected regions are at risk for poor psychological, social, and educational outcomes. Effective interventions are needed to improve mental health, social behavior, and school functioning. This randomized controlled trial tested the effectiveness of a 10-session cognitive-behavioral therapy (CBT)–based group mental health intervention for multisymptomatic war-affected youth (aged 15–24 years) in Sierra Leone. Method War-affected youth identified by elevated distress and impairment via community screening were randomized (stratified by sex and age) to the Youth Readiness Intervention (YRI) (n = 222) or to a control condition (n = 214). After treatment, youth were again randomized and offered an education subsidy immediately (n = 220) or waitlisted (n = 216). Emotion regulation, psychological distress, prosocial attitudes/behaviors, social support, functional impairment, and posttraumatic stress disorder (PTSD) symptoms were assessed at pre- and postintervention and at 6-month follow-up. For youth in school, enrollment, attendance, and classroom performance were assessed after 8 months. Linear mixed-effects regressions evaluated outcomes. Results The YRI showed significant postintervention effects on emotion regulation, prosocial attitudes/behaviors, social support, and reduced functional impairment, and significant follow-up effects on school enrollment, school attendance, and classroom behavior. In contrast, education subsidy was associated with better attendance but had no effect on mental health or functioning, school retention, or classroom behavior. Interactions between education subsidy and YRI were not significant. Conclusion YRI produced acute improvements in mental health and functioning as well as longer-term effects on school engagement and behavior, suggesting potential to prepare war-affected youth for educational and other opportunities. Clinical trial registration information-Trial of the Youth Readiness Intervention (YRI); http://clinicaltrials.gov; NCT01684488. PMID:25457927

Internet-based cognitive behavioural therapy (iCBT) for posttraumatic stress disorder versus waitlist control: study protocol for a randomised controlled trial.

PubMed

Allen, Adrian R; Newby, Jill M; Smith, Jessica; Andrews, Gavin

2015-12-01

This randomised controlled trial (RCT) with two parallel arms will evaluate the efficacy of an internet-delivered six-lesson 10-week cognitive behavioural therapy (iCBT) intervention for posttraumatic stress disorder (PTSD). It will also investigate the association between changes in PTSD symptoms, intolerance of uncertainty (IU) and emotion regulation. Patients with PTSD will be recruited via the research arm of a not-for-profit clinical and research unit in Australia and randomised to a treatment group or waitlist control group. The minimum sample size for each group (alpha 0.05, power 0.80 for a g of 0.47) was identified as 72, but 10 % more will be recruited to hedge against expected attrition. PTSD diagnosis will be determined using the PTSD module from the Mini International Neuropsychiatric Interview version 5.0.0. The PTSD Checklist - Civilian version (PCL-C) will be used to measure PTSD symptoms (the primary outcome measure), with the Intolerance of Uncertainty Scale 12-item version (IUS-12) and the Emotion Regulation Questionnaire (ERQ) used to measure intolerance of uncertainty and emotion regulation, respectively. The PCL-C will be administered to the treatment group before each lesson of the PTSD program and at 3-month follow-up. The IUS-12 and ERQ will be administered before lessons 1 and 4, at post-treatment and at 3-month follow-up. The waitlist control group will complete these measures at week 1, week 5 and week 11 of the waitlist period. PTSD program efficacy will be determined using intent-to-treat mixed models. Maintenance of gains will be assessed at 3-month follow-up. Mediation analyses using PROCESS will be used to examine the association between change in PTSD symptoms over treatment and change in each of IU and emotion regulation ability in separate analyses. The current RCT seeks to replicate previous efficacy findings of iCBT for PTSD in a formally assessed PTSD sample from the general population. Findings may point to future lines of enquiry for the role of IU and emotion regulation in the mechanism of PTSD symptom change during CBT. Australian New Zealand Clinical Trials Registry: ACTRN12614001213639 , registered 18 November 2014. This trial protocol is written in compliance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines.

Suicide prevention after traumatic brain injury: a randomized controlled trial of a program for the psychological treatment of hopelessness.

PubMed

Simpson, Grahame K; Tate, Robyn L; Whiting, Diane L; Cotter, Rachel E

2011-01-01

To evaluate the efficacy of a psychological treatment to reduce moderate to severe hopelessness after severe traumatic brain injury (TBI). Randomized controlled trial. Participants were aged between 18 and 65 years, experienced posttraumatic amnesia more than 1day and moderate to severe hopelessness (Beck Hopelessness Scale [BHS]) and/or suicide ideation. Intervention comprised a 20-hour manualized group cognitive behavior therapy program. Participants were randomly allocated using concealed allocation (treatment n = 8; wait-list n = 9); all remained in their allocated group. Outcome variables were collected by assessors blind to group allocation. No between-groups differences were observed on demographic, injury, cognitive, and psychosocial variables at baseline (time 1). A significant group-by-time interaction was found for BHS in the treatment group (F1,15 = 13.20, P = .002), reflecting a reduction in mean BHS scores between time 1 and time 2 (posttreatment) with no main effects for group or time. At 3-month follow-up (time 3), the treatment gains were maintained or improved for 75% (6/8) of participants. Secondary outcome variables (suicide ideation, depression, social problem solving, self-esteem, hopefulness) displayed no significant group-by-time interactions or main effects. This trial provides initial evidence for the efficacy of a psychological intervention in reducing hopelessness among long-term survivors with severe TBI.

The Prince Henry Hospital dementia caregivers' training programme.

PubMed

Brodaty, H; Gresham, M; Luscombe, G

1997-02-01

To describe the theory, elements and practice of a successful caregiver training programme; and report the 8-year outcome. Prospective, randomized control trial and longitudinal follow-up over approximately 8 years. Psychiatry unit, general teaching hospital, Sydney, Australia. 96 persons less than 80 years old with mild to moderate dementia and their cohabiting caregivers. All patients received a 10-day structured memory retraining and activity programme. Caregivers in the immediate and wait-list caregiver training groups received a structured, residential, intensive 10-day training programme, boosted by follow-ups and telephone conferences over 12 months. Those in the wait-list group entered the programme after waiting 6 months. The third group of caregivers received 10 days' respite (while patients underwent their memory retraining programme) and 12 months booster sessions as for the other groups. Nursing home admission; time until patient death. 64% of patients whose caregivers were in the immediate training group, 53% of wait-list group patients and 70% of memory retraining patients had died. Nursing home admission had occurred in 79% of the immediate training, 83% of the delayed and 90% of the memory retraining group. Eight-year survival analysis indicated that patients whose caregivers received training stayed at home significantly longer (p = 0.037) and tended to live longer (p = 0.08). Caregiver training programmes demonstrably can delay institutionalization of people with dementia.

A Randomized Controlled Trial on Effects of the Transcendental Meditation Program on Blood Pressure, Psychological Distress, and Coping in Young Adults

PubMed Central

Nidich, Sanford I.; Rainforth, Maxwell V.; Haaga, David A.F.; Hagelin, John; Salerno, John W.; Travis, Fred; Tanner, Melissa; Gaylord-King, Carolyn; Grosswald, Sarina; Schneider, Robert H.

2009-01-01

Background Psychological distress contributes to the development of hypertension in young adults. This trial assessed the effects of a mind–body intervention on blood pressure (BP), psychological distress, and coping in college students. Methods This was a randomized controlled trial (RCT) of 298 university students randomly allocated to either the Transcendental Meditation (TM) program or wait-list control. At baseline and after 3 months, BP, psychological distress, and coping ability were assessed. A subgroup of 159 subjects at risk for hypertension was analyzed similarly. Results Changes in systolic BP (SBP)/diastolic BP (DBP) for the overall sample were −2.0/−1.2 mm Hg for the TM group compared to +0.4/+0.5 mm Hg for controls (P = 0.15, P = 0.15, respectively). Changes in SBP/DBP for the hypertension risk subgroup were −5.0/−2.8 mm Hg for the TM group compared to +1.3/+1.2 mm Hg for controls (P = 0.014, P = 0.028, respectively). Significant improvements were found in total psychological distress, anxiety, depression, anger/hostility, and coping (P values < 0.05). Changes in psychological distress and coping correlated with changes in SBP (P values < 0.05) and DBP (P values < 0.08). Conclusions This is the first RCT to demonstrate that a selected mind–body intervention, the TM program, decreased BP in association with decreased psychological distress, and increased coping in young adults at risk for hypertension. This mind–body program may reduce the risk for future development of hypertension in young adults. PMID:19798037

A randomized controlled trial on effects of the Transcendental Meditation program on blood pressure, psychological distress, and coping in young adults.

PubMed

Nidich, Sanford I; Rainforth, Maxwell V; Haaga, David A F; Hagelin, John; Salerno, John W; Travis, Fred; Tanner, Melissa; Gaylord-King, Carolyn; Grosswald, Sarina; Schneider, Robert H

2009-12-01

Psychological distress contributes to the development of hypertension in young adults. This trial assessed the effects of a mind-body intervention on blood pressure (BP), psychological distress, and coping in college students. This was a randomized controlled trial (RCT) of 298 university students randomly allocated to either the Transcendental Meditation (TM) program or wait-list control. At baseline and after 3 months, BP, psychological distress, and coping ability were assessed. A subgroup of 159 subjects at risk for hypertension was analyzed similarly. Changes in systolic BP (SBP)/diastolic BP (DBP) for the overall sample were -2.0/-1.2 mm Hg for the TM group compared to +0.4/+0.5 mm Hg for controls (P = 0.15, P = 0.15, respectively). Changes in SBP/DBP for the hypertension risk subgroup were -5.0/-2.8 mm Hg for the TM group compared to +1.3/+1.2 mm Hg for controls (P = 0.014, P = 0.028, respectively). Significant improvements were found in total psychological distress, anxiety, depression, anger/hostility, and coping (P values < 0.05). Changes in psychological distress and coping correlated with changes in SBP (P values < 0.05) and DBP (P values < 0.08). This is the first RCT to demonstrate that a selected mind-body intervention, the TM program, decreased BP in association with decreased psychological distress, and increased coping in young adults at risk for hypertension. This mind-body program may reduce the risk for future development of hypertension in young adults.

Treatment of child anxiety disorders via guided parent-delivered cognitive-behavioural therapy: randomised controlled trial.

PubMed

Thirlwall, Kerstin; Cooper, Peter J; Karalus, Jessica; Voysey, Merryn; Willetts, Lucy; Creswell, Cathy

2013-12-01

Promising evidence has emerged of clinical gains using guided self-help cognitive-behavioural therapy (CBT) for child anxiety and by involving parents in treatment; however, the efficacy of guided parent-delivered CBT has not been systematically evaluated in UK primary and secondary settings. To evaluate the efficacy of low-intensity guided parent-delivered CBT treatments for children with anxiety disorders. A total of 194 children presenting with a current anxiety disorder, whose primary carer did not meet criteria for a current anxiety disorder, were randomly allocated to full guided parent-delivered CBT (four face-to-face and four telephone sessions) or brief guided parent-delivered CBT (two face-to-face and two telephone sessions), or a wait-list control group (trial registration: ISRCTN92977593). Presence and severity of child primary anxiety disorder (Anxiety Disorders Interview Schedule for DSM-IV, child/parent versions), improvement in child presentation of anxiety (Clinical Global Impression - Improvement scale), and change in child anxiety symptoms (Spence Children's Anxiety Scale, child/parent version and Child Anxiety Impact scale, parent version) were assessed at post-treatment and for those in the two active treatment groups, 6 months post-treatment. Full guided parent-delivered CBT produced superior diagnostic outcomes compared with wait-list at post-treatment, whereas brief guided parent-delivered CBT did not: at post-treatment, 25 (50%) of those in the full guided CBT group had recovered from their primary diagnosis, compared with 16 (25%) of those on the wait-list (relative risk (RR) 1.85, 95% CI 1.14-2.99); and in the brief guided CBT group, 18 participants (39%) had recovered from their primary diagnosis post-treatment (RR = 1.56, 95% CI 0.89-2.74). Level of therapist training and experience was unrelated to child outcome. Full guided parent-delivered CBT is an effective and inexpensive first-line treatment for child anxiety.

Relationships between psychosocial outcomes in adolescents who are obese and their parents during a multi-disciplinary family-based healthy lifestyle intervention: One-year follow-up of a waitlist controlled trial (Curtin University's Activity, Food and Attitudes Program).

PubMed

Fenner, Ashley A; Howie, Erin K; Davis, Melissa C; Straker, Leon M

2016-07-07

Limited studies have investigated relationships in psychosocial outcomes between adolescents who are obese and their parents and how psychosocial outcomes change during participation in a physical activity and healthy eating intervention. This study examined both adolescent and parent psychosocial outcomes while participating in a one - year multi-disciplinary family-based intervention: Curtin University's Activity, Food, and Attitudes Program (CAFAP). Following a waitlist control period, the intervention was delivered to adolescent (n = 56, ages 11-16) and parent participants over 8 weeks, with one-year maintenance follow-up. Adolescent depression and quality of life, family functioning, and parent depression, anxiety, and stress were assessed at six time points: baseline and prior to intervention (e.g., waitlist control period), immediately following intervention, and at 3, 6, and 12 months post-intervention. Relationships between adolescent and parent psychosocial outcomes were assessed using Spearman correlations and changes in both adolescent and parent outcomes were assessed using linear mixed models. Changes in adolescent psychosocial outcomes were compared to changes in behavioural (physical activity and healthy eating) and physical (weight) outcomes using independent samples t-tests. The majority of psychosocial outcomes were significantly correlated between adolescents and parents across the one-year follow-up. Adolescent depression, psychosocial and physical quality of life outcomes significantly improved before or following intervention and were maintained at 6-months or one-year follow-up. Parent symptoms of depression, anxiety, and stress were reduced during waitlist and primarily remained improved. Changes in adolescent psychosocial outcomes were shown to be partially associated with behavioural changes and independent of physical changes. Adolescents in CAFAP improved psychosocial and physical quality of life and reversed the typical trajectory of depressive symptoms in adolescents who are obese during a one-year maintenance period. CAFAP was also effective at maintaining reductions in parent symptoms of depression, anxiety, and stress demonstrated during the waitlist period. The trial was registered with the Australian and New Zealand Clinical Trials Registry (No. 12611001187932 ).

The efficacy of problem solving therapy to reduce post stroke emotional distress in younger (18-65) stroke survivors.

PubMed

Chalmers, Charlotte; Leathem, Janet; Bennett, Simon; McNaughton, Harry; Mahawish, Karim

2017-11-26

To investigate the efficacy of problem solving therapy for reducing the emotional distress experienced by younger stroke survivors. A non-randomized waitlist controlled design was used to compare outcome measures for the treatment group and a waitlist control group at baseline and post-waitlist/post-therapy. After the waitlist group received problem solving therapy an analysis was completed on the pooled outcome measures at baseline, post-treatment, and three-month follow-up. Changes on outcome measures between baseline and post-treatment (n = 13) were not significantly different between the two groups, treatment (n = 13), and the waitlist control group (n = 16) (between-subject design). The pooled data (n = 28) indicated that receiving problem solving therapy significantly reduced participants levels of depression and anxiety and increased quality of life levels from baseline to follow up (within-subject design), however, methodological limitations, such as the lack of a control group reduce the validity of this finding. The between-subject results suggest that there was no significant difference between those that received problem solving therapy and a waitlist control group between baseline and post-waitlist/post-therapy. The within-subject design suggests that problem solving therapy may be beneficial for younger stroke survivors when they are given some time to learn and implement the skills into their day to day life. However, additional research with a control group is required to investigate this further. This study provides limited evidence for the provision of support groups for younger stroke survivors post stroke, however, it remains unclear about what type of support this should be. Implications for Rehabilitation Problem solving therapy is no more effective for reducing post stroke distress than a wait-list control group. Problem solving therapy may be perceived as helpful and enjoyable by younger stroke survivors. Younger stroke survivors may use the skills learnt from problem solving therapy to solve problems in their day to day lives. Younger stroke survivors may benefit from age appropriate psychological support; however, future research is needed to determine what type of support this should be.

Mindfulness-based cognitive therapy may reduce thought suppression in previously suicidal participants: findings from a preliminary study.

PubMed

Hepburn, Silvia R; Crane, Catherine; Barnhofer, Thorsten; Duggan, Danielle S; Fennell, Melanie J V; Williams, J Mark G

2009-06-01

Thought suppression is a strategy aimed at mental control that may paradoxically increase the frequency of unwanted thoughts. This preliminary study examined effects of mindfulness-based cognitive therapy (MBCT) on thought suppression and depression in individuals with past depression and suicidality. In a randomized controlled trial design, 68 participants were allocated to an MBCT group or a treatment-as-usual waitlist control. Measures of thought suppression and depression were taken pre- and post-treatment. MBCT did not reduce thought suppression as measured by the White Bear Suppression Inventory, but significantly reduced self-reported attempts to suppress in the previous week. Preliminary evidence suggests that MBCT for suicidality may reduce thought suppression, but differential effects on thought suppression measures warrant further studies.

Modular cognitive-behavioral therapy for body dysmorphic disorder: a randomized controlled trial.

PubMed

Wilhelm, Sabine; Phillips, Katharine A; Didie, Elizabeth; Buhlmann, Ulrike; Greenberg, Jennifer L; Fama, Jeanne M; Keshaviah, Aparna; Steketee, Gail

2014-05-01

There are few effective treatments for body dysmorphic disorder (BDD) and a pressing need to develop such treatments. We examined the feasibility, acceptability, and efficacy of a manualized modular cognitive-behavioral therapy for BDD (CBT-BDD). CBT-BDD utilizes core elements relevant to all BDD patients (e.g., exposure, response prevention, perceptual retraining) and optional modules to address specific symptoms (e.g., surgery seeking). Thirty-six adults with BDD were randomized to 22 sessions of immediate individual CBT-BDD over 24 weeks (n=17) or to a 12-week waitlist (n=19). The Yale-Brown Obsessive-Compulsive Scale Modified for BDD (BDD-YBOCS), Brown Assessment of Beliefs Scale, and Beck Depression Inventory-II were completed pretreatment, monthly, posttreatment, and at 3- and 6-month follow-up. The Sheehan Disability Scale and Client Satisfaction Inventory (CSI) were also administered. Response to treatment was defined as ≥30% reduction in BDD-YBOCS total from baseline. By week 12, 50% of participants receiving immediate CBT-BDD achieved response versus 12% of waitlisted participants (p=0.026). By posttreatment, 81% of all participants (immediate CBT-BDD plus waitlisted patients subsequently treated with CBT-BDD) met responder criteria. While no significant group differences in BDD symptom reduction emerged by Week 12, by posttreatment CBT-BDD resulted in significant decreases in BDD-YBOCS total over time (d=2.1, p<0.0001), with gains maintained during follow-up. Depression, insight, and disability also significantly improved. Patient satisfaction was high, with a mean CSI score of 87.3% (SD=12.8%) at posttreatment. CBT-BDD appears to be a feasible, acceptable, and efficacious treatment that warrants more rigorous investigation. Copyright © 2014. Published by Elsevier Ltd.

Increasing students' physical activity during school physical education: rationale and protocol for the SELF-FIT cluster randomized controlled trial.

PubMed

Ha, Amy S; Lonsdale, Chris; Lubans, David R; Ng, Johan Y Y

2017-07-11

The Self-determined Exercise and Learning For FITness (SELF-FIT) is a multi-component school-based intervention based on tenets of self-determination theory. SELF-FIT aims to increase students' moderate-to-vigorous physical activity (MVPA) during physical education lessons, and enhance their autonomous motivation towards fitness activities. Using a cluster randomized controlled trial, we aim to examine the effects of the intervention on students' MVPA during school physical education. Secondary 2 students (approximately aged 14 years) from 26 classes in 26 different schools will be recruited. After baseline assessments, students will be randomized into either the experimental group or wait-list control group using a matched-pair randomization. Teachers allocated to the experimental group will attend two half-day workshops and deliver the SELF-FIT intervention for 8 weeks. The main intervention components include training teachers to teach in more need supportive ways, and conducting fitness exercises using a fitness dice with interchangeable faces. Other motivational components, such as playing music during classes, are also included. The primary outcome of the trial is students' MVPA during PE lessons. Secondary outcomes include students' leisure-time MVPA, perceived need support from teachers, need satisfaction, autonomous motivation towards physical education, intention to engage in physical activity, psychological well-being, and health-related fitness (cardiorespiratory and muscular fitness). Quantitative data will be analyzed using multilevel modeling approaches. Focus group interviews will also be conducted to assess students' perceptions of the intervention. The SELF-FIT intervention has been designed to improve students' health and well-being by using high-intensity activities in classes delivered by teachers who have been trained to be autonomy needs supportive. If successful, scalable interventions based on SELF-FIT could be applied in physical education at large. The trial is registered at the Australia New Zealand Clinical Trial Registry (Trial ID: ACTRN12615000633583 ; date of registration: 18 June 2015).

A Single-Session, Web-Based Parenting Intervention to Prevent Adolescent Depression and Anxiety Disorders: Randomized Controlled Trial

PubMed Central

Cardamone-Breen, Mairead C; Jorm, Anthony F; Lawrence, Katherine A; Rapee, Ronald M; Mackinnon, Andrew J

2018-01-01

Background Depression and anxiety disorders are significant contributors to burden of disease in young people, highlighting the need to focus preventive efforts early in life. Despite substantial evidence for the role of parents in the prevention of adolescent depression and anxiety disorders, there remains a need for translation of this evidence into preventive parenting interventions. To address this gap, we developed a single-session, Web-based, tailored psychoeducation intervention that aims to improve parenting practices known to influence the development of adolescent depression and anxiety disorders. Objective The aim of this study was to evaluate the short-term effects of the intervention on parenting risk and protective factors and symptoms of depression and anxiety in adolescent participants. Methods We conducted a single-blind, parallel group, superiority randomized controlled trial comparing the intervention with a 3-month waitlist control. The intervention is fully automated and consists of two components: (1) completion of an online self-assessment of current parenting practices against evidence-based parenting recommendations for the prevention of adolescent depression and anxiety disorders and (2) an individually tailored feedback report highlighting each parent’s strengths and areas for improvement based on responses to the self-assessment. A community sample of 349 parents, together with 327 adolescents (aged 12-15 years), were randomized to either the intervention or waitlist control condition. Parents and adolescents completed online self-reported assessments of parenting and adolescent symptoms of depression and anxiety at baseline, 1-month (parent-report of parenting only), and 3-month follow-up. Results Compared with controls, intervention group parents showed significantly greater improvement in parenting risk and protective factors from baseline to 1-month and 3-month follow-up (F2,331.22=16.36, P<.001), with a small to medium effect size at 3-month follow-up (d=0.33). There were no significant effects of the intervention on adolescent-report of parenting or symptoms of depression or anxiety in the adolescents (all P>.05). Conclusions Findings suggest that a single-session, individually tailored, Web-based parenting intervention can improve parenting factors that are known to influence the development of depression and anxiety in adolescents. However, our results do not support the effectiveness of the intervention in improving adolescent depression or anxiety symptoms in the short-term. Long-term studies are required to adequately assess the relationship between improving parenting factors and adolescent depression and anxiety outcomes. Nonetheless, this is a promising avenue for the translation of research into a low-cost, sustainable, universal prevention approach. Trial Registration Australian New Zealand Clinical Trials Registry: ACTRN12615000247572; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12615000247572 (Archived by WebCite at http://www.webcitation.org/6v1ha19XG) PMID:29699964

Making Friends With Yourself: A Mixed Methods Pilot Study of a Mindful Self-Compassion Program for Adolescents

PubMed Central

Bluth, Karen; Gaylord, Susan A.; Campo, Rebecca A.; Mullarkey, Michael C.; Hobbs, Lorraine

2015-01-01

The aims of this mixed-method pilot study were to determine the feasibility, acceptability, and preliminary psychosocial outcomes of “Making Friends with Yourself: A Mindful Self-Compassion Program for Teens” (MFY), an adaptation of the adult Mindful Self-Compassion program. Thirty-four students age 14–17 enrolled in this waitlist controlled crossover study. Participants were randomized to either the waitlist or intervention group and administered online surveys at baseline, after the first cohort participated in the intervention, and after the waitlist crossovers participated in the intervention. Attendance and retention data were collected to determine feasibility, and audiorecordings of the 6-week class were analyzed to determine acceptability of the program. Findings indicated that MFY is a feasible and acceptable program for adolescents. Compared to the waitlist control, the intervention group had significantly greater self-compassion and life satisfaction and significantly lower depression than the waitlist control, with trends for greater mindfulness, greater social connectedness and lower anxiety. When waitlist crossovers results were combined with that of the first intervention group, findings indicated significantly greater mindfulness and self-compassion, and significantly less anxiety, depression, perceived stress and negative affect post-intervention. Additionally, regression results demonstrated that self-compassion and mindfulness predicted decreases in anxiety, depression, perceived stress, and increases in life satisfaction post-intervention. MFY shows promise as a program to increase psychosocial wellbeing in adolescents through increasing mindfulness and self-compassion. Further testing is needed to substantiate the findings. PMID:27110301

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

PubMed

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

2015-03-01

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

A community-based randomized trial of a faith-placed intervention to reduce cervical cancer burden in Appalachia.

PubMed

Studts, Christina R; Tarasenko, Yelena N; Schoenberg, Nancy E; Shelton, Brent J; Hatcher-Keller, Jennifer; Dignan, Mark B

2012-06-01

Faith Moves Mountains assessed the effectiveness of a faith-placed lay health advisor (LHA) intervention to increase Papanicolaou (Pap) test use among middle-aged and older women in a region disproportionately affected by cervical cancer and low screening rates (regionally, only 68% screened in prior 3 years). This community-based RCT was conducted in four Appalachian Kentucky counties (December 2005-June 2008). Women aged 40-64 and overdue for screening were recruited from churches and individually randomized to treatment (n=176) or wait-list control (n=169). The intervention provided LHA home visits and newsletters addressing barriers to screening. Self-reported Pap test receipt was the primary outcome. Intention-to-treat analyses revealed that treatment group participants (17.6% screened) had over twice the odds of wait-list controls (11.2% screened) of reporting Pap test receipt post-intervention, OR=2.56, 95% CI: 1.03-6.38, p=0.04. Independent of group, recently screened participants (last Pap >1 but <5 years ago) had significantly higher odds of obtaining screening during the study than rarely or never screened participants (last Pap ≥5 years ago), OR=2.50, 95% CI: 1.48-4.25, p=0.001. The intervention was associated with increased cervical cancer screening. The faith-placed LHA addressing barriers comprises a novel approach to reducing cervical cancer disparities among Appalachian women. Copyright © 2012 Elsevier Inc. All rights reserved.

A community-based randomized trial of a faith-placed intervention to reduce cervical cancer burden in Appalachia

PubMed Central

Studts, Christina R.; Tarasenko, Yelena N.; Schoenberg, Nancy E.; Shelton, Brent J.; Hatcher-Keller, Jennifer; Dignan, Mark B.

2012-01-01

Objective Faith Moves Mountains assessed the effectiveness of a faith-placed lay health advisor (LHA) intervention to increase Papanicolaou (Pap) test use among middle-aged and older women in a region disproportionately affected by cervical cancer and low screening rates (regionally, only 68% screened in prior 3 years). Method This community-based RCT was conducted in four Appalachian Kentucky counties (December 2005 – June 2008). Women aged 40–64 and overdue for screening were recruited from churches and individually randomized to treatment (n=176) or wait-list control (n=169). The intervention provided LHA home visits and newsletters addressing barriers to screening. Self-reported Pap test receipt was the primary outcome. Results Intention-to-treat analyses revealed that treatment group participants (17.6% screened) had over twice the odds of wait-list controls (11.2% screened) of reporting Pap test receipt post-intervention, OR=2.56, 95%CI: 1.03–6.38, p=0.04. Independent of group, recently screened participants (last Pap >1 but <5 years ago) had significantly higher odds of obtaining screening during the study than rarely or never screened participants (last Pap ≥5 years ago), OR=2.50, 95%CI: 1.48–4.25, p=0.001. Conclusions The intervention was associated with increased cervical cancer screening. The faith-placed LHA addressing barriers comprises a novel approach to reducing cervical cancer disparities among Appalachian women. PMID:22498022

Sex differences in response to targeted kyphosis specific exercise and posture training in community-dwelling older adults: a randomized controlled trial.

PubMed

Katzman, Wendy B; Parimi, Neeta; Gladin, Amy; Poltavskiy, Eduard A; Schafer, Anne L; Long, Roger K; Fan, Bo; Wong, Shirley S; Lane, Nancy E

2017-12-04

Hyperkyphosis, an excessive anterior curvature in the thoracic spine, is associated with reduced health status in older adults. Hyperkyphosis is highly prevalent, more common in older women than men. There is no standard intervention to reduce age-related hyperkyphosis. Sex differences in response to a kyphosis-specific exercise intervention are not known. We conducted a randomized controlled trial of a targeted kyphosis-specific exercise and postural training program on the primary outcome Cobb angle of kyphosis, and investigated whether the magnitude of change differed between men and women. One hundred twelve participants aged ≥60 years with kyphosis ≥40° were enrolled and randomized to exercise or waitlist control, and 101 participants had analyzable baseline and follow-up radiographs for Cobb angle measurements. A group intervention including 10 participants per group was delivered by a physical therapist, 1-h, twice a week for 3-months. Controls were placed on a waitlist for 3 months before receiving a delayed intervention. Primary outcome was change from baseline to 3-months in Cobb angle measured from standing lateral spine radiographs. Secondary outcomes included change over 3-months in kyphometer-measured kyphosis, physical function and quality of life. Groups were combined for analysis after both received the intervention, and sex differences in response to the intervention were tested with ANOVA. Participants (60 women, 41 men) were 70.0 (SD = 5.7) years old with mean Cobb angle 55.9 (SD = 12.2) degrees at baseline. The active group had higher baseline modified Physical Performance Test scores than control, p = 0.03. Men had greater baseline kyphometer-measured kyphosis, p = 0.09, and higher bone mineral density (BMD), spine strength, more vertebral fractures and diffuse idiopathic skeletal hyperostosis (DISH) than women, p ≤ 0.01. There was no statistically significant difference between groups in change in Cobb at 3-months, p = 0.09, however change in kyphometer-measured kyphosis differed by 4.8 (95% CI:-6.8,-2.7) degrees, p < 0.001, favoring the active group. There were no differences between men and women in change in either kyphosis measurement after intervention, p > 0.1. A 3-month targeted spine strengthening exercise and posture training program reduced kyphometer-measured, but not radiographic-measured kyphosis. Despite sex differences in baseline kyphosis, BMD, spine strength, fractures and DISH, sex did not affect treatment response. ClinicalTrials.gov Identifier: NCT01766674.

A Pilot Trial of Mindfulness Meditation Training for ADHD in Adulthood: Impact on Core Symptoms, Executive Functioning, and Emotion Dysregulation.

PubMed

Mitchell, John T; McIntyre, Elizabeth M; English, Joseph S; Dennis, Michelle F; Beckham, Jean C; Kollins, Scott H

2017-11-01

Mindfulness meditation training is garnering increasing empirical interest as an intervention for ADHD in adulthood, although no studies of mindfulness as a standalone treatment have included a sample composed entirely of adults with ADHD or a comparison group. The aim of this study was to assess the feasibility, acceptability, and preliminary efficacy of mindfulness meditation for ADHD, executive functioning (EF), and emotion dysregulation symptoms in an adult ADHD sample. Adults with ADHD were stratified by ADHD medication status and otherwise randomized into an 8-week group-based mindfulness treatment ( n = 11) or waitlist group ( n = 9). Treatment feasibility and acceptability were positive. In addition, self-reported ADHD and EF symptoms (assessed in the laboratory and ecological momentary assessment), clinician ratings of ADHD and EF symptoms, and self-reported emotion dysregulation improved for the treatment group relative to the waitlist group over time with large effect sizes. Improvement was not observed for EF tasks. Findings support preliminary treatment efficacy, though require larger trials.

Facilitating change in health-related behaviors and intentions: a randomized controlled trial of a multidimensional memory program for older adults.

PubMed

Wiegand, Melanie A; Troyer, Angela K; Gojmerac, Christina; Murphy, Kelly J

2013-01-01

Many older adults are concerned about memory changes with age and consequently seek ways to optimize their memory function. Memory programs are known to be variably effective in improving memory knowledge, other aspects of metamemory, and/or objective memory, but little is known about their impact on implementing and sustaining lifestyle and healthcare-seeking intentions and behaviors. We evaluated a multidimensional, evidence-based intervention, the Memory and Aging Program, that provides education about memory and memory change, training in the use of practical memory strategies, and support for implementation of healthy lifestyle behavior changes. In a randomized controlled trial, 42 healthy older adults participated in a program (n = 21) or a waitlist control (n = 21) group. Relative to the control group, participants in the program implemented more healthy lifestyle behaviors by the end of the program and maintained these changes 1 month later. Similarly, program participants reported a decreased intention to seek unnecessary medical attention for their memory immediately after the program and 1 month later. Findings support the use of multidimensional memory programs to promote healthy lifestyles and influence healthcare-seeking behaviors. Discussion focuses on implications of these changes for maximizing cognitive health and minimizing impact on healthcare resources.

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

PubMed

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

2013-07-01

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

Reduced knee joint loading with lateral and medial wedge insoles for management of knee osteoarthritis: a protocol for a randomized controlled trial.

PubMed

Lewinson, Ryan T; Collins, Kelsey H; Vallerand, Isabelle A; Wiley, J Preston; Woodhouse, Linda J; Reimer, Raylene A; Worobets, Jay T; Herzog, Walter; Stefanyshyn, Darren J

2014-12-03

Knee osteoarthritis (OA) progression has been linked to increased peak external knee adduction moments (KAMs). Although some trials have attempted to reduce pain and improve function in OA by reducing KAMs with a wedged footwear insole intervention, KAM reduction has not been specifically controlled for in trial designs, potentially explaining the mixed results seen in the literature. Therefore, the primary purpose of this trial is to identify the effects of reduced KAMs on knee OA pain and function. Forty-six patients with radiographically confirmed diagnosis medial knee OA will be recruited for this 3 month randomized controlled trial. Recruitment will be from Alberta and surrounding areas. Eligibility criteria include being between the ages of 40 and 85 years, have knee OA primarily localized to the medial tibiofemoral compartment, based on the American College of Rheumatology diagnostic criteria and be classified as having a Kellgren-Lawrence grade of 1 to 3. Patients will visit the laboratory at baseline for testing that includes dual x-ray absorptiometry, biomechanical testing, and surveys (KOOS, PASE activity scale, UCLA activity scale, comfort visual analog scale). At baseline, patients will be randomized to either a wedged insole group to reduce KAMs, or a waitlist control group where no intervention is provided. The survey tests will be repeated at 3 months, and response to wedged insoles over 3 months will be evaluated. This study represents the first step in systematically evaluating the effects of reduced KAMs on knee OA management by using a patient-specific wedged insole prescription procedure rather than providing the same insole to all patients. The results of this trial will provide indications as to whether reduced KAMs are an effective strategy for knee OA management, and whether a personalized approach to footwear insole prescription is warranted. NCT02067208.

Adherence to Internet-Based Mobile-Supported Stress Management: A Pooled Analysis of Individual Participant Data From Three Randomized Controlled Trials

PubMed Central

Lehr, Dirk; Berking, Matthias; Riper, Heleen; Cuijpers, Pim; Ebert, David Daniel

2016-01-01

Background Nonadherence to treatment is a prevalent issue in Internet interventions. Guidance from health care professionals has been found to increase treatment adherence rates in Internet interventions for a range of physical and mental disorders. Evaluating different guidance formats of varying intensity is important, particularly with respect to improvement of effectiveness and cost-effectiveness. Identifying predictors of nonadherence allows for the opportunity to better adapt Internet interventions to the needs of participants especially at risk for discontinuing treatment. Objective The goal of this study was to investigate the influence of different guidance formats (content-focused guidance, adherence-focused guidance, and administrative guidance) on adherence and to identify predictors of nonadherence in an Internet-based mobile-supported stress management intervention (ie, GET.ON Stress) for employees. Methods The data from the groups who received the intervention were pooled from three randomized controlled trials (RCTs) that evaluated the efficacy of the same Internet-based mobile-supported stress management intervention (N=395). The RCTs only differed in terms of the guidance format (content-focused guidance vs waitlist control, adherence-focused guidance vs waitlist control, administrative guidance vs waitlist control). Adherence was defined by the number of completed treatment modules (0-7). An ANOVA was performed to compare the adherence rates from the different guidance formats. Multiple hierarchical linear regression analysis was conducted to evaluate predictors of nonadherence, which included gender, age, education, symptom-related factors, and hope for improvement. Results In all, 70.5% (93/132) of the content-focused guidance sample, 68.9% (91/132) of the adherence-focused guidance sample, and 42.0% (55/131) of the participants in the administrative guidance sample completed all treatment modules. Guidance had a significant effect on treatment adherence (F2,392=11.64, P<.001; ω2=.05). Participants in the content-focused guidance (mean 5.70, SD 2.32) and adherence-focused guidance samples (mean 5.58, SD 2.33) completed significantly more modules than participants in the administrative guidance sample (mean 4.36, SD 2.78; t223=4.53, P<.001; r=.29). Content-focused guidance was not significantly associated with higher adherence compared to adherence-focused guidance (t262=0.42, P=.67; r=.03). The effect size of r=.03 (95% CI –0.09 to 0.15) did not pass the equivalence margin of r=.20 and the upper bound of the 95% CI lay below the predefined margin, indicating equivalence between adherence-focused guidance and content-focused guidance. Beyond the influence of guidance, none of the predictors significantly predicted nonadherence. Conclusions Guidance has been shown to be an influential factor in promoting adherence to an Internet-based mobile-supported stress management intervention. Adherence-focused guidance, which included email reminders and feedback on demand, was equivalent to content-focused guidance with regular feedback while requiring only approximately a quarter of the coaching resources. This could be a promising discovery in terms of cost-effectiveness. However, even after considering guidance, sociodemographic, and symptom-related characteristics, most interindividual differences in nonadherence remain unexplained. Clinical Trial DRKS00004749; http://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL _ID=DRKS00004749 (Archived by WebCite at http://www.webcitation.org/6QiDk9Zn8); DRKS00005112; http://drks-neu.uniklinik-freiburg. de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00005112 (Archived by WebCite at http://www.webcitation.org/6QiDysvev); DRKS00005384; http://drks-neu.uniklinik-freiburg.de/ drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00005384 (Archived by WebCite at http://www.webcitation.org/6QiE0xcpE) PMID:27357528

Mindfulness-based intervention for teenagers with cancer: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Individuals living with cancer must learn to face not only the physical symptoms of their condition, but also the anxiety and uncertainty related to the progression of the disease, the anticipation of physical and emotional pain related to illness and treatment, the significant changes implied in living with cancer, as well as the fear of recurrence after remission. Mindfulness-based meditation constitutes a promising option to alleviate these manifestations. Methods/Design This article presents the rationale and protocol development for a research project aimed at evaluating the effects of a mindfulness-based meditation intervention on quality of life, sleep, and mood in adolescents with cancer compared to a control group. A prospective, longitudinal, experimental design involving three time points (baseline, post-intervention, and follow-up) and two groups (experimental and control) was developed for this project. Participants will be assigned randomly to either group. Eligible participants are adolescents aged 11 to 18 years with a diagnosis of cancer, with no specific selection/exclusion based on type, stage, or trajectory of cancer. A final sample size of 28 participants is targeted. Adolescents in the experimental group will be completing the mindfulness meditation intervention, taught by two trained therapists. The intervention will comprise of eight weekly sessions, lasting 90 min each. Once the follow-up assessment is completed by the experimental group, wait-list controls will be offered to complete the mindfulness-based program. Intra-group analyses will serve to evaluate the impact of the mindfulness-based meditation intervention on quality of life, sleep, and mood pre-post intervention, as well as follow-up. Analyses will also be used to carry out inter-group comparisons between the experimental group and the wait-list controls. Voluntary participation, risk of attrition, and the small sample size are potential limitations of this project. In spite of possible limitations, this project will be one among very few aimed at improving quality of life, sleep, and mood in adolescents living with cancer, will evaluate the potential benefits of such a practice on both psychological and physical health of youth with cancer, and help in creating mindfulness-based intervention programs, in order to provide the necessary psychological help to adolescents living with cancer. Trial registration Trial registration number: NCT01783418 PMID:23663534

The Mental Health Impact of Computer and Internet Training on a Multi-ethnic Sample of Community-Dwelling Older Adults: Results of a Pilot Randomised Controlled Trial

PubMed Central

Laganá, Luciana; García, James J.

2013-01-01

Introduction: We preliminarily explored the effects of computer and internet training in older age and attempted to address the diversity gap in the ethnogeriatric literature, given that, in our study’s sample, only one-third of the participants self-identified as White. The aim of this investigation was to compare two groups - the control and the experimental conditions - regarding theme 1) computer attitudes and related self-efficacy, and theme 2) self-esteem and depressive symptomatology. Methods: Sixty non-institutionalized residents of Los Angeles County (mean age ± SD: 69.12 ± 10.37 years; age range: 51-92) were randomly assigned to either the experimental group (n=30) or the waitlist/control group (n=30). The experimental group was involved in 6 weeks of one-on-one computer and internet training for one 2-hour session per week. The same training was administered to the control participants after their post-test. Outcome measures included the four variables, organized into the two aforementioned themes. Results: There were no significant between-group differences in either post-test computer attitudes or self-esteem. However, findings revealed that the experimental group reported greater computer self-efficacy, compared to the waitlist/control group, at post-test/follow-up [F(1,56)=28.89, p=0.001, η2=0.01]. Additionally, at the end of the computer and internet training, there was a substantial and statistically significant decrease in depression scores among those in the experimental group when compared to the waitlist/control group [F(1,55)=9.06, p<0.004, η2=0.02]. Conclusions: There were significant improvements in favour of the experimental group in computer self-efficacy and, of noteworthy clinical relevance, in depression, as evidenced by a decreased percentage of significantly depressed experimental subjects from 36.7% at baseline to 16.7% at the end of our intervention. PMID:24151452

Feasibility and Acceptability of a Web-Based Treatment with Telephone Support for Postpartum Women With Anxiety: Randomized Controlled Trial.

PubMed

Ashford, Miriam T; Olander, Ellinor K; Rowe, Heather; Fisher, Jane Rw; Ayers, Susan

2018-04-20

Postpartum anxiety can have adverse effects on the mother and child if left untreated. Time constraints and stigma are common barriers to postpartum treatment. Web-based treatments offer potential flexibility and anonymity. What Am I Worried About (WaWa) is a self-guided treatment based on cognitive-behavioral and mindfulness principles for women experiencing postpartum anxiety. WaWa was developed in Australia and consists of 9 modules with optional weekly telephone support. WaWa was adapted to a Web-based version for use in England (Internet-based What Am I Worried About, iWaWa). This study aimed to investigate the feasibility (engagement and usability) and acceptability (usefulness, satisfaction, and helpfulness) of iWaWa among English postpartum women with anxiety. Postpartum (<12 months) women with mild-to-severe anxiety were recruited anonymously via social media during an 8-week period. Participants were randomized to the iWaWa treatment (8 weeks) or wait-list control group. Treatment and study feasibility and acceptability were assessed after the treatment, and anxiety symptoms were assessed at baseline, 8 weeks postrandomization, and 12 weeks postrandomization (treatment group only) using Web-based questionnaires. Semistructured telephone interviews were carried out after the treatment period for a more in-depth exploration of treatment acceptability and feasibility. A total of 89 eligible women were recruited through social media and randomized into the treatment (n=46) or wait-list control group (n=43). Women were predominantly Caucasian, well-educated, married, on maternity leave, first-time mothers and reported moderate levels of anxiety. Dropout rates were high, especially in the treatment group (treatment: 82%, 38/46; wait-list control: 51%, 22/43). A total of 26 women started iWaWa with only 2 women completing all 9 modules. Quantitative and qualitative data suggest iWaWa was experienced as generally useful and helpful. Participants enjoyed iWaWa's accessibility, anonymity, and weekly reminders, as well as the introduction to the principles of cognitive-behavioral therapy (CBT) and mindfulness. However, iWaWa was also experienced as not user-friendly enough, too long, and not smartphone-friendly. Parts of the content were experienced as not always relevant and appropriate. Participants felt that iWaWa could be improved by having it in a smartphone app format and by making the content more concise and inclusive of different parenting styles. Despite interest in iWaWa, the results suggest that both the study and iWaWa were not feasible in the current format. However, this first trial provides useful evidence about treatment format and content preferences that can inform iWaWa's future development, as well as research and development of Web-based postpartum anxiety treatments, in general, to optimize adherence. ClinicalTrials.gov NCT02434406; https://clinicaltrials.gov/ct2/show/NCT02434406 (Archived by WebCite at http://www.webcitation.org/6xTq7Bwmd). ©Miriam T Ashford, Ellinor K Olander, Heather Rowe, Jane RW Fisher, Susan Ayers. Originally published in JMIR Mental Health (http://mental.jmir.org), 20.04.2018.

A randomized controlled trial evaluating a low-intensity interactive online parenting intervention, Triple P Online Brief, with parents of children with early onset conduct problems.

PubMed

Baker, Sabine; Sanders, Matthew R; Turner, Karen M T; Morawska, Alina

2017-04-01

This randomized controlled trial examined the efficacy of Triple P Online Brief, a low-intensity online positive parenting program for parents of children with early onset disruptive behavior problems. Two hundred parents with 2-9-year-old children displaying early onset disruptive behavior difficulties were randomly assigned to either the intervention condition (n = 100) or a Waitlist Control group (n = 100). At 8-week post-assessment, parents in the intervention group displayed significantly less use of ineffective parenting strategies and significantly more confidence in dealing with a range of behavior concerns. These effects were maintained at 9-month follow-up assessment. A delayed effect was found for child behavior problems, with parents in the intervention group reporting significantly fewer and less frequent child behavior problems at follow-up, but not at post-assessment. All effect sizes were in the small to medium range. There were no significant improvements in observed negative parent and child behavior. No change was seen for parents' adjustment, anger, or conflict over parenting. Consumer satisfaction ratings for the program were high. A brief, low-intensity parenting program delivered via the Internet can bring about significant improvements in parenting and child behavior. Copyright © 2017 Elsevier Ltd. All rights reserved.

Paternal Lifestyle-Related Parenting Practices Mediate Changes in Children's Dietary and Physical Activity Behaviors: Findings From the Healthy Dads, Healthy Kids Community Randomized Controlled Trial.

PubMed

Lloyd, Adam B; Lubans, David R; Plotnikoff, Ronald C; Morgan, Philip J

2015-09-01

This study examined potential parenting-related mediators of children's physical activity and dietary behavior change in the Healthy Dads, Healthy Kids (HDHK) community program. A randomized controlled trial was conducted with 45 overweight/obese (mean [SD] age = 39.8 [5.4] years; BMI = 32.4 [3.8]) fathers and their children (n = 77; 58% boys; mean [SD] age = 7.7 [2.5] years). Families were randomized to either the HDHK program or wait-list control group. The program involved 7 sessions. Fathers and their children were assessed at baseline and at 14 weeks for physical activity (pedometery) and core food intake (Questionnaire). Fathers' lifestyle-related parenting practices included; self-efficacy, beliefs, modeling, logistic support, rules, cophysical activity, shared mealtime frequency and intentions. Significant intervention effects were found for cophysical activity and modeling physical activity. Cophysical activity mediated children's physical activity in the intervention ('mediated effect,' AB = 653, 95% CI = 4-2050) and was responsible for 59.5% of the intervention effect. Fathers' beliefs mediated children's percent energy from core foods (AB = 1.51, 95% CI = 0.05-5.55) and accounted for 72.9% of the intervention effect. Participation in the HDHK program positively impacted on fathers' cophysical activity with their child and beliefs about healthy eating which mediated changes in children's diet and physical activity behaviors.

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

PubMed

Maughan, Andrea L; Weiss, Jonathan A

2017-10-01

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

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

PubMed

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

2016-06-01

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

Higher-order cognitive training effects on processing speed-related neural activity: a randomized trial.

PubMed

Motes, Michael A; Yezhuvath, Uma S; Aslan, Sina; Spence, Jeffrey S; Rypma, Bart; Chapman, Sandra B

2018-02-01

Higher-order cognitive training has shown to enhance performance in older adults, but the neural mechanisms underlying performance enhancement have yet to be fully disambiguated. This randomized trial examined changes in processing speed and processing speed-related neural activity in older participants (57-71 years of age) who underwent cognitive training (CT, N = 12) compared with wait-listed (WLC, N = 15) or exercise-training active (AC, N = 14) controls. The cognitive training taught cognitive control functions of strategic attention, integrative reasoning, and innovation over 12 weeks. All 3 groups worked through a functional magnetic resonance imaging processing speed task during 3 sessions (baseline, mid-training, and post-training). Although all groups showed faster reaction times (RTs) across sessions, the CT group showed a significant increase, and the WLC and AC groups showed significant decreases across sessions in the association between RT and BOLD signal change within the left prefrontal cortex (PFC). Thus, cognitive training led to a change in processing speed-related neural activity where faster processing speed was associated with reduced PFC activation, fitting previously identified neural efficiency profiles. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Kā-HOLO Project: a protocol for a randomized controlled trial of a native cultural dance program for cardiovascular disease prevention in Native Hawaiians.

PubMed

Kaholokula, Joseph Keawe'aimoku; Look, Mele A; Wills, Thomas A; de Silva, Māpuana; Mabellos, Tricia; Seto, Todd B; Ahn, Hyeong Jun; Sinclair, Ka'imi A; Buchwald, Dedra

2017-04-17

As a major risk factor for cardiovascular and cerebrovascular disease (CVD), hypertension affects 33% of U.S. adults. Relative to other US races and ethnicities, Native Hawaiians have a high prevalence of hypertension and are 3 to 4 times more likely to have CVD. Effective, culturally-relevant interventions are needed to address CVD risk in this population. Investigators of the Kā-HOLO Project developed a study design to test the efficacy of an intervention that uses hula, a traditional Hawaiian dance, to increase physical activity and reduce CVD risk. A 2-arm randomized controlled trial with a wait-list control design will be implemented to test a 6-month intervention based on hula to manage blood pressure and reduce CVD risk in 250 adult Native Hawaiians with diagnosed hypertension. Half of the sample will be randomized to each arm, stratified across multiple study sites. Primary outcomes are reduction in systolic blood pressure and improvement in CVD risk as measured by the Framingham Risk Score. Other psychosocial and sociocultural measures will be included to determine mediators of intervention effects on primary outcomes. Assessments will be conducted at baseline, 3 months, and 6 months for all participants, and at 12 months for intervention participants only. This trial will elucidate the efficacy of a novel hypertension management program designed to reduce CVD risk in an indigenous population by using a cultural dance form as its physical activity component. The results of this culturally-based intervention will have implications for other indigenous populations globally and will offer a sustainable, culturally-relevant means of addressing CVD disparities. ClinicalTrials.gov: NCT02620709 , registration date November 23, 2015.

Hockey Fans in Training: A Pilot Pragmatic Randomized Controlled Trial.

PubMed

Petrella, Robert J; Gill, Dawn P; Zou, Guangyong; DE Cruz, Ashleigh; Riggin, Brendan; Bartol, Cassandra; Danylchuk, Karen; Hunt, Kate; Wyke, Sally; Gray, Cindy M; Bunn, Christopher; Zwarenstein, Merrick

2017-12-01

Hockey Fans in Training (Hockey FIT) is a gender-sensitized weight loss and healthy lifestyle program. We investigated 1) feasibility of recruiting and retaining overweight and obese men into a pilot pragmatic randomized controlled trial and 2) potential for Hockey FIT to lead to weight loss and improvements in other outcomes at 12 wk and 12 months. Male fans of two ice hockey teams (35-65 yr; body mass index ≥28 kg·m) located in Ontario (Canada) were randomized to intervention (Hockey FIT) or comparator (wait-list control). Hockey FIT includes a 12-wk active phase (weekly, coach-led group meetings including provision of dietary information, practice of behavior change techniques, and safe exercise sessions plus incremental pedometer walking) and a 40-wk minimally supported phase (smartphone app for sustaining physical activity, private online social network, standardized e-mails, booster session/reunion). Measurement at baseline and 12 wk (both groups) and 12 months (intervention group only) included clinical outcomes (e.g., weight) and self-reported physical activity, diet, and self-rated health. Eighty men were recruited in 4 wk; trial retention was >80% at 12 wk and >75% at 12 months. At 12 wk, the intervention group lost 3.6 kg (95% confidence interval, -5.26 to -1.90 kg) more than the comparator group (P < 0.001) and maintained this weight loss to 12 months. The intervention group also demonstrated greater improvements in other clinical measures, physical activity, diet, and self-rated health at 12 wk; most sustained to 12 months. Results suggest feasible recruitment/retention of overweight and obese men in the Hockey FIT program. Results provide evidence for the potential effectiveness of Hockey FIT for weight loss and improved health in at-risk men and, thus, evidence to proceed with a definitive trial.

A Single-Session, Web-Based Parenting Intervention to Prevent Adolescent Depression and Anxiety Disorders: Randomized Controlled Trial.

PubMed

Cardamone-Breen, Mairead C; Jorm, Anthony F; Lawrence, Katherine A; Rapee, Ronald M; Mackinnon, Andrew J; Yap, Marie Bee Hui

2018-04-26

Depression and anxiety disorders are significant contributors to burden of disease in young people, highlighting the need to focus preventive efforts early in life. Despite substantial evidence for the role of parents in the prevention of adolescent depression and anxiety disorders, there remains a need for translation of this evidence into preventive parenting interventions. To address this gap, we developed a single-session, Web-based, tailored psychoeducation intervention that aims to improve parenting practices known to influence the development of adolescent depression and anxiety disorders. The aim of this study was to evaluate the short-term effects of the intervention on parenting risk and protective factors and symptoms of depression and anxiety in adolescent participants. We conducted a single-blind, parallel group, superiority randomized controlled trial comparing the intervention with a 3-month waitlist control. The intervention is fully automated and consists of two components: (1) completion of an online self-assessment of current parenting practices against evidence-based parenting recommendations for the prevention of adolescent depression and anxiety disorders and (2) an individually tailored feedback report highlighting each parent’s strengths and areas for improvement based on responses to the self-assessment. A community sample of 349 parents, together with 327 adolescents (aged 12-15 years), were randomized to either the intervention or waitlist control condition. Parents and adolescents completed online self-reported assessments of parenting and adolescent symptoms of depression and anxiety at baseline, 1-month (parent-report of parenting only), and 3-month follow-up. Compared with controls, intervention group parents showed significantly greater improvement in parenting risk and protective factors from baseline to 1-month and 3-month follow-up (F 2,331.22 =16.36, P<.001), with a small to medium effect size at 3-month follow-up (d=0.33). There were no significant effects of the intervention on adolescent-report of parenting or symptoms of depression or anxiety in the adolescents (all P>.05). Findings suggest that a single-session, individually tailored, Web-based parenting intervention can improve parenting factors that are known to influence the development of depression and anxiety in adolescents. However, our results do not support the effectiveness of the intervention in improving adolescent depression or anxiety symptoms in the short-term. Long-term studies are required to adequately assess the relationship between improving parenting factors and adolescent depression and anxiety outcomes. Nonetheless, this is a promising avenue for the translation of research into a low-cost, sustainable, universal prevention approach. Australian New Zealand Clinical Trials Registry: ACTRN12615000247572; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12615000247572 (Archived by WebCite at http://www.webcitation.org/6v1ha19XG) ©Mairead C Cardamone-Breen, Anthony F Jorm, Katherine A Lawrence, Ronald M Rapee, Andrew J Mackinnon, Marie Bee Hui Yap. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 26.04.2018.

Mindfulness-based Intervention for Female Adolescents with Chronic Pain: A Pilot Randomized Trial

PubMed Central

Chadi, Nicholas; McMahon, Audrey; Vadnais, Majorie; Malboeuf-Hurtubise, Catherine; Djemli, Anissa; Dobkin, Patricia L.; Lacroix, Jacques; Luu, Thuy Mai; Haley, Nancy

2016-01-01

Objective To test the feasibility of a randomized-controlled trial measuring the impact of an adapted mindfulness-based intervention (MBI) in female adolescents with chronic pain. Methods This was a single center, single-blind, prospective, experimental, longitudinal trial conducted in a pediatric tertiary care center. Participants had a history of chronic pain during at least three months. They were randomized into an intervention group or a wait-list control group. Both groups successively followed an adapted eight-week MBI designed specifically for adolescents with chronic pain. Pre-determined criteria were established to assess the feasibility, validity and acceptability of the study model. Data evaluating changes in quality of life, depression, anxiety, pain perception, psychological distress and salivary cortisol were collected throughout the 4-month study period. Results Nineteen female participants completed the study and had a mean age of 15.8 years (range 13.9 -17.8). Attrition rate was low (17%). Attendance to mindfulness sessions (84%) and compliance to study protocol (100%) were high. All participants reported a positive change in the way they coped with pain. No changes in quality of life, depression, anxiety, pain perception, and psychological distress were detected. Significant reductions in pre-and post-mindfulness session salivary cortisol levels were observed (p<0.001). Conclusions Mindfulness is a promising therapeutic approach for which limited data exist in adolescents with chronic pain. Our study indicates the feasibility of conducting such interventions in teenage girls. A large trial is needed to demonstrate the efficacy and bio-physiological impacts of MBIs in teenagers with chronic pain. PMID:27924146

Adherence to Internet-Based Mobile-Supported Stress Management: A Pooled Analysis of Individual Participant Data From Three Randomized Controlled Trials.

PubMed

Zarski, Anna-Carlotta; Lehr, Dirk; Berking, Matthias; Riper, Heleen; Cuijpers, Pim; Ebert, David Daniel

2016-06-29

Nonadherence to treatment is a prevalent issue in Internet interventions. Guidance from health care professionals has been found to increase treatment adherence rates in Internet interventions for a range of physical and mental disorders. Evaluating different guidance formats of varying intensity is important, particularly with respect to improvement of effectiveness and cost-effectiveness. Identifying predictors of nonadherence allows for the opportunity to better adapt Internet interventions to the needs of participants especially at risk for discontinuing treatment. The goal of this study was to investigate the influence of different guidance formats (content-focused guidance, adherence-focused guidance, and administrative guidance) on adherence and to identify predictors of nonadherence in an Internet-based mobile-supported stress management intervention (ie, GET.ON Stress) for employees. The data from the groups who received the intervention were pooled from three randomized controlled trials (RCTs) that evaluated the efficacy of the same Internet-based mobile-supported stress management intervention (N=395). The RCTs only differed in terms of the guidance format (content-focused guidance vs waitlist control, adherence-focused guidance vs waitlist control, administrative guidance vs waitlist control). Adherence was defined by the number of completed treatment modules (0-7). An ANOVA was performed to compare the adherence rates from the different guidance formats. Multiple hierarchical linear regression analysis was conducted to evaluate predictors of nonadherence, which included gender, age, education, symptom-related factors, and hope for improvement. In all, 70.5% (93/132) of the content-focused guidance sample, 68.9% (91/132) of the adherence-focused guidance sample, and 42.0% (55/131) of the participants in the administrative guidance sample completed all treatment modules. Guidance had a significant effect on treatment adherence (F2,392=11.64, P<.001; ω(2)=.05). Participants in the content-focused guidance (mean 5.70, SD 2.32) and adherence-focused guidance samples (mean 5.58, SD 2.33) completed significantly more modules than participants in the administrative guidance sample (mean 4.36, SD 2.78; t223=4.53, P<.001; r=.29). Content-focused guidance was not significantly associated with higher adherence compared to adherence-focused guidance (t262=0.42, P=.67; r=.03). The effect size of r=.03 (95% CI -0.09 to 0.15) did not pass the equivalence margin of r=.20 and the upper bound of the 95% CI lay below the predefined margin, indicating equivalence between adherence-focused guidance and content-focused guidance. Beyond the influence of guidance, none of the predictors significantly predicted nonadherence. Guidance has been shown to be an influential factor in promoting adherence to an Internet-based mobile-supported stress management intervention. Adherence-focused guidance, which included email reminders and feedback on demand, was equivalent to content-focused guidance with regular feedback while requiring only approximately a quarter of the coaching resources. This could be a promising discovery in terms of cost-effectiveness. However, even after considering guidance, sociodemographic, and symptom-related characteristics, most interindividual differences in nonadherence remain unexplained. DRKS00004749; http://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL _ID=DRKS00004749 (Archived by WebCite at http://www.webcitation.org/6QiDk9Zn8); DRKS00005112; http://drks-neu.uniklinik-freiburg. de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00005112 (Archived by WebCite at http://www.webcitation.org/6QiDysvev); DRKS00005384; http://drks-neu.uniklinik-freiburg.de/ drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00005384 (Archived by WebCite at http://www.webcitation.org/6QiE0xcpE).

The effectiveness of a suicide prevention app for indigenous Australian youths: study protocol for a randomized controlled trial.

PubMed

Shand, Fiona L; Ridani, Rebecca; Tighe, Joe; Christensen, Helen

2013-11-20

Indigenous Australian youth (aged 15 to 34) have up to four times the risk of suicide compared with their non-Indigenous counterparts. Barriers to help-seeking include shame, feared loss of autonomy and negative attitudes towards healthcare providers. The use of mobile devices and apps continues to rise amongst young people, thus presenting opportunities to utilize these aids in overcoming help-seeking barriers. Apps have been shown to assist in several health-related areas, including weight loss and smoking cessation, although no apps have as yet been evaluated for suicide prevention. Moreover, there is a lack of research that scientifically evaluates suicide prevention interventions within Indigenous communities. In this study, a recently developed self-help app will be evaluated in a randomized controlled trial. The intervention is based on acceptance and commitment therapy and mindfulness-based cognitive behavioural therapy. It is aimed at participants who have suicidal thoughts but who are not actively suicidal. In total, 150 participants will be randomly allocated to the intervention-condition (N = 75) or to the wait-list control condition (N = 75). Questionnaires will be completed at baseline, post-test and 6 weeks follow-up. The primary outcome measure is a reduction in frequency and intensity of suicidal thoughts. Secondary outcome measures are the reduction of depression, anxiety and impulsivity. This study is the first to evaluate the effectiveness of a self-help app for suicidal thoughts amongst young Indigenous people. Several limitations and strengths of the design are discussed. Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12613000104752.

Breakingtheice: A protocol for a randomised controlled trial of an internet-based intervention addressing amphetamine-type stimulant use

PubMed Central

2012-01-01

Background The prevalence of amphetamine-type stimulant use is greater than that of opioids and cocaine combined. Currently, there are no approved pharmacotherapy treatments for amphetamine-type stimulant problems, but some face-to-face psychotherapies are of demonstrated effectiveness. However, most treatment services focus on alcohol or opioid disorders, have limited reach and may not appeal to users of amphetamine-type stimulants. Internet interventions have proven to be effective for some substance use problems but none has specifically targeted users of amphetamine-type stimulants. Design/method The study will use a randomized controlled trial design to evaluate the effect of an internet intervention for amphetamine-type stimulant problems compared with a waitlist control group. The primary outcome will be assessed as amphetamine-type stimulant use (baseline, 3 and 6 months). Other outcomes measures will include ‘readiness to change’, quality of life, psychological distress (K-10 score), days out of role, poly-drug use, help-seeking intention and help-seeking behavior. The intervention consists of three modules requiring an estimated total completion time of 90 minutes. The content of the modules was adapted from face-to-face clinical techniques based on cognitive behavior therapy and motivation enhancement. The target sample is 160 men and women aged 18 and over who have used amphetamine-type stimulants in the last 3 months. Discussion To our knowledge this will be the first randomized controlled trial of an internet intervention specifically developed for users of amphetamine-type stimulants. If successful, the intervention will offer greater reach than conventional therapies and may engage clients who do not generally seek treatment from existing service providers. Trial registration Australian and New Zealand Clinical Trials Registry (www.anzctr.org.au/) ACTRN12611000947909 PMID:22731926

Chronic pain self-management support with pain science education and exercise (COMMENCE): study protocol for a randomized controlled trial.

PubMed

Miller, Jordan; MacDermid, Joy C; Walton, David M; Richardson, Julie

2015-10-14

Previous research suggests that self-management programs for people with chronic pain improve knowledge and self-efficacy but result in negligible effects on function. This study will investigate the effectiveness self-management support with pain science education and exercise on improving function for people with chronic pain in comparison to a wait-list control. A secondary objective is to determine which variables help to predict response to the intervention. This study will be an unblinded, randomized controlled trial with 110 participants comparing a 6-week program that includes self-management support, pain science education and exercise to a wait-list control. The primary outcome will be function measured by the Short Musculoskeletal Function Assessment - Dysfunction Index. Secondary outcomes will include pain intensity measured by a numeric pain rating scale, pain interference measured by the eight-item PROMIS pain interference item-bank, how much patients are bothered by functional problems measured by the Short Musculoskeletal Function Assessment - Bother Index, catastrophic thinking measured by the Pain Catastrophizing Scale, fear of movement/re-injury measured by the 11-item Tampa Scale of Kinesiophobia, sense of perceived injustice measured by the Injustice Experience Questionnaire, self-efficacy measured by the Pain Self-Efficacy Questionnaire, pain sensitivity measured by pressure pain threshold and cold sensitivity testing, fatigue measured by a numeric fatigue rating scale, pain neurophysiology knowledge measured by the Neurophysiology of Pain Questionnaire, healthcare utilization measured by number of visits to a healthcare provider, and work status. Assessments will be completed at baseline, 7 and 18 weeks. After the 18-week assessment, the groups will crossover; however, we anticipate carry-over effects with the treatment. Therefore, data from after the crossover will be used to estimate within-group changes and to determine predictors of response that are not for direct between-group comparisons. Mixed effects modelling will be used to determine between-group differences for all primary and secondary outcomes. A series of multiple regression models will be used to determine predictors of treatment response. This study has the potential to inform future self-management programming through evaluation of a self-management program that aims to improve function as the primary outcome. ClinicalTrials.gov NCT02422459 , registered on 13 April 2015.

Evaluating a problem-based empowerment program for African Americans with diabetes: results of a randomized controlled trial.

PubMed

Anderson, Robert M; Funnell, Martha M; Nwankwo, Robin; Gillard, Mary Lou; Oh, Mary; Fitzgerald, J Thomas

2005-01-01

The objective of this study was to evaluate the impact of a problem-based empowerment patient education program specifically tailored for urban African Americans with type 2 diabetes. The study used a randomized controlled trial (RCT) pretest/post-test design with repeated measures. Patients were randomly assigned to either a six-week intervention group or a six-week wait-listed control group. After completing the six sessions, patients were invited to participate in one of two follow-up conditions; attend a monthly support group or receive a monthly phone call from a nurse. Assessment measures included HbA1C, lipids, blood pressure, weight, self-management behavior and psychosocial adaptation. Both control and intervention patients showed a broad array of small-to-modest positive changes during the six-week RCT. These gains were maintained or improved upon during the one-year follow-up period. For patients in the two follow-up conditions, a positive correlation was seen between the number of follow-up contacts and their one-year HbA1C values. We believe that results of this study can be attributed to volunteer bias, study effects (ie, providing study data on several occasions to patients and their physicians during the one-year study period), and impact of the interventions. However, the study design does not allow us to examine the relative impact of these three factors on the patient improvements seen over the one-year study period.

Effect Size in Efficacy Trials of Women With Decreased Sexual Desire.

PubMed

Pyke, Robert E; Clayton, Anita H

2018-03-22

Regarding hypoactive sexual desire disorder (HSDD) in women, some reviewers judge the effect size small for medications vs placebo, but substantial for cognitive behavior therapy (CBT) or mindfulness meditation training (MMT) vs wait list. However, we lack comparisons of the effect sizes for the active intervention itself, for the control treatment, and for the differential between the two. For efficacy trials of HSDD in women, compare effect sizes for medications (testosterone/testosterone transdermal system, flibanserin, and bremelanotide) and placebo vs effect sizes for psychotherapy and wait-list control. We conducted a literature search for mean changes and SD on main measures of sexual desire and associated distress in trials of medications, CBT, or MMT. Effect size was used as it measures the magnitude of the intervention without confounding by sample size. Cohen d was used to determine effect sizes. For medications, mean (SD) effect size was 1.0 (0.34); for CBT and MMT, 1.0 (0.36); for placebo, 0.55 (0.16); and for wait list, 0.05 (0.26). Recommendations of psychotherapy over medication for treatment of HSDD are premature and not supported by data on effect sizes. Active participation in treatment conveys considerable non-specific benefits. Caregivers should attend to biological and psychosocial elements, and patient preference, to optimize response. Few clinical trials of psychotherapies were substantial in size or utilized adequate control paradigms. Medications and psychotherapies had similar, large effect sizes. Effect size of placebo was moderate. Effect size of wait-list control was very small, about one quarter that of placebo. Thus, a substantial non-specific therapeutic effect is associated with receiving placebo plus active care and evaluation. The difference in effect size between placebo and wait-list controls distorts the value of the subtraction of effect of the control paradigms to estimate intervention effectiveness. Pyke RE, Clayton AH. Effect Size in Efficacy Trials of Women With Decreased Sexual Desire. Sex Med Rev 2018;XX:XXX-XXX. Copyright © 2018 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

Feasibility and acceptability of group music therapy vs wait-list control for treatment of patients with long-term depression (the SYNCHRONY trial): study protocol for a randomised controlled trial.

PubMed

Carr, Catherine Elizabeth; O'Kelly, Julian; Sandford, Stephen; Priebe, Stefan

2017-03-29

Depression is of significant global concern. Despite a range of effective treatment options it is estimated that around one in five diagnosed with an acute depressive episode continue to experience enduring symptoms for more than 2 years. There is evidence for effectiveness of individual music therapy for depression. However, no studies have as yet looked at a group intervention within an NHS context. This study aims to assess the feasibility of conducting a randomised controlled trial of group music therapy for patients with long-term depression (symptom durations of 1 year or longer) within the community. This is a single-centre randomised controlled feasibility trial of group music therapy versus wait-list control with a nested process evaluation. Thirty participants will be randomised with unbalanced allocation (20 to receive the intervention immediately, 10 as wait-list controls). Group music therapy will be offered three times per week in a community centre with a focus on songwriting. Data will be collected post-intervention, 3 and 6 months after the intervention finishes. We will examine the feasibility of recruitment processes including identifying the number of eligible participants, participation and retention rates and the intervention in terms of testing components, measuring adherence and estimation of the likely intervention effect. A nested process evaluation will consist of treatment fidelity analysis, exploratory analysis of process measures and end-of-participation interviews with participants and referring staff. Whilst group music therapy is an option in some community mental health settings, this will be the first study to examine group music therapy for this particular patient group. We will assess symptoms of depression, acceptability of the intervention and quality of life. We anticipate potential challenges in the recruitment and retention of participants. It is unclear whether offering the intervention three times per week will be acceptable to participants, particularly given participants' enduring symptoms and impact upon motivation. This study will provide data to inform both development of the intervention and to assess and inform the design of a full trial. ISRCTN.com, ISRCTN18164037 . Registered on 26 September 2016.

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.

Effects of Anger Awareness and Expression Training versus Relaxation Training on Headaches: A Randomized Trial

PubMed Central

Slavin-Spenny, Olga; Lumley, Mark A.; Thakur, Elyse R.; Nevedal, Dana C.; Hijazi, Alaa M.

2013-01-01

Background and purpose Stress contributes to headaches, and effective interventions for headaches routinely include relaxation training (RT) to directly reduce negative emotions and arousal. Yet, suppressing negative emotions, particularly anger, appears to augment pain, and experimental studies suggest that expressing anger may reduce pain. Therefore, we developed and tested anger awareness and expression training (AAET) on people with headaches. Methods Young adults with headaches (N = 147) were randomized to AAET, RT, or a wait-list control. We assessed affect during sessions, and process and outcome variables at baseline and 4 weeks after treatment. Results On process measures, both interventions increased self-efficacy to manage headaches, but only AAET reduced alexithymia and increased emotional processing and assertiveness. Yet, both interventions were equally effective at improving headache outcomes relative to controls. Conclusions Enhancing anger awareness and expression may improve chronic headaches, although not more than RT. Researchers should study which patients are most likely to benefit from emotional expression versus emotional reduction approaches to chronic pain. PMID:23620190

Effects of music therapy on drug avoidance self-efficacy in patients on a detoxification unit: a three-group randomized effectiveness study.

PubMed

Silverman, Michael J

2014-01-01

Self-efficacy is a component of Bandura's social cognitive theory and can lead to abstinence and a reduction of relapse potential for people who have substance abuse disorders. To date, no music therapy researcher has utilized this theoretical model to address abstinence and reduce the likelihood of relapse in people who have addictions. The purpose of this study was to determine the effects of music therapy on drug avoidance self-efficacy in a randomized three-group wait-list control design with patients on a detoxification unit. Participants (N = 131) were cluster randomized to one of three single-session conditions: music therapy, verbal therapy, or wait-list control. Music therapy participants received a group lyric analysis intervention, verbal therapy participants received a group talk therapy session, and wait-list control participants eventually received a group recreational music therapy intervention. Although there was no significant between-group difference in drug avoidance self-efficacy, participants in the music therapy condition tended to have the highest mean drug avoidance self-efficacy scores. Posttest written comments supported the use of both music therapy and verbal therapy sessions. Two music therapy participants specifically noted that their initial skepticism had dissipated after receiving music therapy. Despite a lack of significant differences, the theoretical support of self-efficacy for substance abuse rehabilitation suggests that this may be an area of continued clinical focus and empirical investigation. Clinical anecdotes, limitations of the study, and suggestions for future research are provided.

Parent Training With High-Risk Immigrant Chinese Families: A Pilot Group Randomized Trial Yielding Practice-Based Evidence

PubMed Central

Lau, Anna S.; Fung, Joey J.; Ho, Lori Y.; Liu, Lisa L.; Gudiño, Omar G.

2013-01-01

We studied the efficacy and implementation outcomes of a culturally responsive parent training (PT) program. Fifty-four Chinese American parents participated in a wait-list controlled group randomized trial (32 immediate treatment, 22 delayed treatment) of a 14-week intervention designed to address the needs of high-risk immigrant families. Parents were eligible for intervention if they were Chinese-speaking immigrants referred from schools, community clinics, or child protective services with concerns about parenting or child behavior problems. Retention and engagement were high with 83% of families attending 10 or more sessions. Results revealed that the treatment was efficacious in reducing negative discipline, increasing positive parenting, and decreasing child externalizing and internalizing problems. Treatment effects were larger among families with higher levels of baseline behavior problems and lower levels of parenting stress. Further augmentation of PT to address immigrant parent stress may be warranted. Qualitative impressions from group leaders suggested that slower pacing and increased rehearsal of skills may improve efficacy for immigrant parents unfamiliar with skills introduced in PT. PMID:21658524

Parent training with high-risk immigrant chinese families: a pilot group randomized trial yielding practice-based evidence.

PubMed

Lau, Anna S; Fung, Joey J; Ho, Lorinda Y; Liu, Lisa L; Gudiño, Omar G

2011-09-01

We studied the efficacy and implementation outcomes of a culturally responsive parent training (PT) program. Fifty-four Chinese American parents participated in a wait-list controlled group randomized trial (32 immediate treatment, 22 delayed treatment) of a 14-week intervention designed to address the needs of high-risk immigrant families. Parents were eligible for intervention if they were Chinese-speaking immigrants referred from schools, community clinics, or child protective services with concerns about parenting or child behavior problems. Retention and engagement were high with 83% of families attending 10 or more sessions. Results revealed that the treatment was efficacious in reducing negative discipline, increasing positive parenting, and decreasing child externalizing and internalizing problems. Treatment effects were larger among families with higher levels of baseline behavior problems and lower levels of parenting stress. Further augmentation of PT to address immigrant parent stress may be warranted. Qualitative impressions from group leaders suggested that slower pacing and increased rehearsal of skills may improve efficacy for immigrant parents unfamiliar with skills introduced in PT. Copyright © 2011. Published by Elsevier Ltd.

Cognitive-Behavioral Therapy for Anxiety in Children With High-Functioning Autism: A Meta-analysis

PubMed Central

Bloch, Michael H.; Panza, Kaitlyn E.; Reichow, Brian

2013-01-01

BACKGROUND Anxiety is a common and impairing problem in children and adolescents with autism spectrum disorder (ASD). There is emerging evidence that cognitive-behavioral therapy (CBT) could reduce anxiety in children with high-functioning ASD. OBJECTIVE: To systematically review the evidence of using CBT to treat anxiety in children and adolescents with ASD. Methods for this review were registered with PROSPERO (CRD42012002722). METHODS: We included randomized controlled trials published in English in peer-reviewed journals comparing CBT with another treatment, no treatment control, or waitlist control. Two authors independently screened 396 records obtained from database searches and hand searched relevant journals. Two authors independently extracted and reconciled all data used in analyses from study reports. RESULTS: Eight studies involving 469 participants (252 treatment, 217 comparison) met our inclusion criteria and were included in meta-analyses. Overall effect sizes for clinician- and parent-rated outcome measures of anxiety across all studies were d = 1.19 and d = 1.21, respectively. Five studies that included child self-report yielded an average d = 0.68 across self-reported anxiety. CONCLUSIONS: Parent ratings and clinician ratings of anxiety are sensitive to detecting treatment change with CBT for anxiety relative to waitlist and treatment-as-usual control conditions in children with high-functioning ASD. Clinical studies are needed to evaluate CBT for anxiety against attention control conditions in samples of children with ASD that are well characterized with regard to ASD diagnosis and co-occurring anxiety symptoms. PMID:24167175

Dismantling Multicomponent Behavioral Treatment for Insomnia in Older Adults: A Randomized Controlled Trial

PubMed Central

Epstein, Dana R.; Sidani, Souraya; Bootzin, Richard R.; Belyea, Michael J.

2012-01-01

Study Objective: Recently, the use of multicomponent insomnia treatment has increased. This study compares the effect of single component and multicomponent behavioral treatments for insomnia in older adults after intervention and at 3 months and 1 yr posttreatment. Design: A randomized, controlled study. Setting: Veterans Affairs medical center. Participants: 179 older adults (mean age, 68.9 yr ± 8.0; 115 women [64.2%]) with chronic primary insomnia. Interventions: Participants were randomly assigned to 6 wk of stimulus control therapy (SCT), sleep restriction therapy (SRT), the 2 therapies combined into a multicomponent intervention (MCI), or a wait-list control group. Measurements and Results: Primary outcomes were subjective (daily sleep diary) and objective (actigraphy) measures of sleep-onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), time in bed (TIB), and sleep efficiency (SE). Secondary outcomes were clinical measures including response and remission rates. There were no differences between the single and multicomponent interventions on primary sleep outcomes measured by diary and actigraphy. All treatments produced significant improvement in diary-reported sleep in comparison with the control group. Effect sizes for sleep diary outcomes were medium to large. Treatment gains were maintained at follow-up for diary and actigraph measured SOL, WASO, and SE. The MCI group had the largest proportion of treatment remitters. Conclusions: For older adults with chronic primary insomnia, the findings provide initial evidence that SCT, SRT, and MCI are equally efficacious and produce sustainable treatment gains on diary, actigraphy, and clinical outcomes. From a clinical perspective, MCI may be a preferred treatment due to its higher remission rate. Clinical Trial Information: Behavioral Intervention for Insomnia in Older Adults. NCT01154023. URL: http://clinicaltrials.gov/ct2/show/NCT01154023?term=Behavioral+Intervention+for+Insomnia+in+Older+Adults&rank=1. Citation: Epstein DR; Sidani S; Bootzin RR; Belyea MJ. Dismantling multicomponent behavioral treatment for insomnia in older adults: a randomized controlled trial. SLEEP 2012;35(6):797-805. PMID:22654199

Feasibility of Connecting, a Substance-Abuse Prevention Program for Foster Teens and their Caregivers.

PubMed

Haggerty, Kevin P; Barkan, Susan E; Skinner, Martie; Ben Packard, W; Cole, Janice J

2016-01-01

To test the feasibility, usability, and proximal outcomes of Connecting, an adaptation of a low-cost, self-directed, family-based substance use prevention program, Staying Connected with Your Teen, with foster families in a randomized, waitlist control pilot study. Families (n = 60) fostering teens between 11 and 15 years of age were recruited into the study and randomly assigned into the self-administered program with telephone support from a family consultant (n = 32) or a waitlist control condition (n = 28). Overall satisfaction with the program was high, with 100% of parents reporting they would recommend the program to other caregivers and reporting being "very satisfied" or "satisfied with the program. Program completion was good, with 62% of families completing all 91 specified tasks. Analyses of proximal outcomes revealed increased communication about sex and substance use (posttest1 OR = 1.97, and 2.03, respectively). Teens in the intervention vs. the waitlist condition reported lower family conflict (OR=.48), and more family rules related to monitoring (OR = 4.02) and media use (OR = 3.24). Caregivers in the waitlist group reported significant increases in the teen's positive involvements (partial eta sq = 17% increase) after receiving the intervention. Overall, program participation appeared to lead to stronger family management, better communication between teens and caregivers around monitoring and media use, teen participation in setting family rules, and decreased teen attitudes favorable to antisocial behavior. This small pilot study shows promising results for this adapted program.

The Buried in Treasures Workshop: waitlist control trial of facilitated support groups for hoarding.

PubMed

Frost, Randy O; Ruby, Dylan; Shuer, Lee J

2012-11-01

Hoarding is a serious form of psychopathology that has been associated with significant health and safety concerns, as well as the source of social and economic burden (Tolin, Frost, Steketee, & Fitch, 2008; Tolin, Frost, Steketee, Gray, & Fitch, 2008). Recent developments in the treatment of hoarding have met with some success for both individual and group treatments. Nevertheless, the cost and limited accessibility of these treatments leave many hoarding sufferers without options for help. One alternative is support groups that require relatively few resources. Frost, Pekareva-Kochergina, and Maxner (2011) reported significant declines in hoarding symptoms following a non-professionally run 13-week support group (The Buried in Treasures [BIT] Workshop). The BIT Workshop is a highly structured and short term support group. The present study extended these findings by reporting on the results of a waitlist control trial of the BIT Workshop. Significant declines in all hoarding symptom measures were observed compared to a waitlist control. The treatment response rate for the BIT Workshop was similar to that obtained by previous individual and group treatment studies, despite its shorter length and lack of a trained therapist. The BIT Workshop may be an effective adjunct to cognitive behavior therapy for hoarding disorder, or an alternative when cognitive behavior therapy is inaccessible. Copyright © 2012 Elsevier Ltd. All rights reserved.

Internet Delivered Support for Tobacco Control in Dental Practice: Randomized Controlled Trial

PubMed Central

Richman, Joshua S; Ray, Midge N; Allison, Jeroan J; Gilbert, Gregg H; Shewchuk, Richard M; Kohler, Connie L; Kiefe, Catarina I

2008-01-01

Background The dental visit is a unique opportunity for tobacco control. Despite evidence of effectiveness in dental settings, brief provider-delivered cessation advice is underutilized. Objective To evaluate an Internet-delivered intervention designed to increase implementation of brief provider advice for tobacco cessation in dental practice settings. Methods Dental practices (N = 190) were randomized to the intervention website or wait-list control. Pre-intervention and after 8 months of follow-up, each practice distributed exit cards (brief patient surveys assessing provider performance, completed immediately after the dental visit) to 100 patients. Based on these exit cards, we assessed: whether patients were asked about tobacco use (ASK) and, among tobacco users, whether they were advised to quit tobacco (ADVISE). All intervention practices with follow-up exit card data were analyzed as randomized regardless of whether they participated in the Internet-delivered intervention. Results Of the 190 practices randomized, 143 (75%) dental practices provided follow-up data. Intervention practices’ mean performance improved post-intervention by 4% on ASK (29% baseline, adjusted odds ratio = 1.29 [95% CI 1.17-1.42]), and by 11% on ADVISE (44% baseline, OR = 1.55 [95% CI 1.28-1.87]). Control practices improved by 3% on ASK (Adj. OR 1.18 [95% CI 1.07-1.29]) and did not significantly improve in ADVISE. A significant group-by-time interaction effect indicated that intervention practices improved more over the study period than control practices for ADVISE (P = 0.042) but not for ASK. Conclusion This low-intensity, easily disseminated intervention was successful in improving provider performance on advice to quit. Trial Registration clinicaltrials.gov NCT00627185; http://clinicaltrials.gov/ct2/show/NCT00627185 (Archived by WebCite at http://www.webcitation.org/5c5Kugvzj) PMID:18984559

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

Efficacy of brief telephone psychotherapy with callers to a suicide hotline.

PubMed

Rhee, Wayne K; Merbaum, Michael; Strube, Michael J; Self, Susan M

2005-06-01

The efficacy of two types of theapy conducted exclusively over the telephone was studied. Clients (N=55) were recruited from a pool of callers to a suicide hotline and were randomly assigned to a waiting list control (WC) or Solution Focused Brief Therapy (SFBT) or Common Factors Therapy (CFT). It was hypothesized that improvements would be significantly higher in the two therapy conditions compared to the waitlist control and SFBT would be significantly more efficacious than CFT. Results confirmed that improvement was significantly higher in the two treatment conditions compared to the waitlist control, but no difference in improvement was found between SFBT and CFT. The implications of these findings for suicide hotlines are discussed.

Happy Despite Pain

PubMed Central

Smeets, Elke; Feijge, Marion; van Breukelen, Gerard; Andersson, Gerhard; Buhrman, Monica; Linton, Steven J.

2017-01-01

Objectives: There is preliminary evidence for the efficacy of positive psychology interventions for pain management. The current study examined the effects of an internet-based positive psychology self-help program for patients with chronic musculoskeletal pain and compared it with an internet-based cognitive-behavioral program. Materials and Methods: A randomized controlled trial was carried out with 3 conditions: an internet-delivered positive psychology program, an internet-delivered cognitive-behavioral program and waitlist control. A total of 276 patients were randomized to 1 of the 3 conditions and posttreatment data were obtained from 206 patients. Primary outcomes were happiness, depression, and physical impairments at posttreatment and at 6-month follow-up. Intention-to-treat analyses were carried out using mixed regression analyses. Results: Both treatments led to significant increases in happiness and decreases in depression. Physical impairments did not significantly decrease compared with waitlist. Improvements in happiness and depression were maintained until 6-month follow-up. There were no overall differences in the efficacy of the 2 active interventions but effects seemed to be moderated by education. Patients with a higher level of education profited slightly more from the positive psychology intervention than from the cognitive-behavioral program. Discussion: The results suggest that an internet-based positive psychology and cognitive-behavioral self-help interventions for the management of chronic pain are clinically useful. Because the self-help exercises as used in the current program do not require therapist involvement, dissemination potential is large. Further studies should examine whether it can best be used as stand-alone or add-on treatment combined with established pain treatment programs. PMID:28379873

Internet-based treatment for panic disorder: A three-arm randomized controlled trial comparing guided (via real-time video sessions) with unguided self-help treatment and a waitlist control. PAXPD study results.

PubMed

Ciuca, Amalia M; Berger, Thomas; Crişan, Liviu G; Miclea, Mircea

2018-05-01

A growing body of evidence suggests that Internet-based cognitive behavioral treatments (ICBT) are effective to treat anxiety disorders. However, the effect of therapist guidance in ICBT is still under debate and guided ICBT offered in a real-time audio-video communication format has not yet been systematically investigated. This three-arm RCT compared the efficacy of guided with unguided ICBT (12 weeks intervention) and a waitlist (WL). A total of 111 individuals meeting the diagnostic criteria for panic disorder (PD) were randomly assigned to one of three conditions. Primary outcomes were the severity of self-report panic symptoms and diagnostic status. Secondary outcomes were symptoms of depression, functional impairment, catastrophic cognitions, fear of sensations and body vigilance. At post-treatment, both active conditions showed superior outcomes regarding PD and associated symptoms (guided ICBT vs. WL: d = 1.04-1.36; unguided ICBT vs. WL: d = 0.70-1.06). At post-treatment, the two active conditions did not differ significantly in self-reported symptom reduction (d = 0.21-0.54, all ps > 0.05), but the guided treatment was superior to the unguided treatment in terms of diagnostic status (χ 2 (1) = 13.15, p < 0.01). Treatment gains were maintained at successive follow-ups and the guided treatment became superior to the unguided treatment at 6 months follow-up (d = 0.72-1.05, all ps < 0.05). Copyright © 2018 Elsevier Ltd. All rights reserved.

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

PubMed

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

2017-01-01

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

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

PubMed Central

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

2017-01-01

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

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…

Internet-Delivered Parenting Program for Prevention and Early Intervention of Anxiety Problems in Young Children: Randomized Controlled Trial.

PubMed

Morgan, Amy J; Rapee, Ronald M; Salim, Agus; Goharpey, Nahal; Tamir, Elli; McLellan, Lauren F; Bayer, Jordana K

2017-05-01

The Cool Little Kids parenting group program is an effective intervention for preventing anxiety disorders in young children who are at risk because of inhibited temperament. The program has six group sessions delivered by trained psychologists to parents of 3- to 6-year-old children. An online adaptation (Cool Little Kids Online) has been developed to overcome barriers to its wide dissemination in the community. This study tested the efficacy of Cool Little Kids Online in a randomized controlled trial. A total of 433 parents of a child aged 3 to 6 years with an inhibited temperament were randomized to the online parenting program or to a 24-week waitlist. The online program has 8 interactive modules providing strategies that parents can implement with their child to manage their child's avoidant coping, reduce parental overprotection, and encourage child independence. Parents were provided telephone consultation support with a psychologist when requested. Parents completed self-report questionnaires at baseline and at 12 and 24 weeks after baseline. The intervention group showed significantly greater improvement over time in child anxiety symptoms compared to the control group (d = 0.38). The intervention group also showed greater reductions in anxiety life interference (ds = 0.33-0.35) and lower rates of anxiety disorders than the control group (40% versus 54%), but there were minimal effects on broader internalizing symptoms or overprotective parenting. Results provide empirical support for the efficacy of online delivery of the Cool Little Kids program. Online dissemination may improve access to an evidence-based prevention program for child anxiety disorders. Clinical trial registration information-Randomised Controlled Trial of Cool Little Kids Online: A Parenting Program to Prevent Anxiety Problems in Young Children; http://www.anzctr.org.au/; 12615000217505. Copyright © 2017 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

Creating opportunities through mentorship, parental involvement, and safe spaces (COMPASS) program: multi-country study protocol to protect girls from violence in humanitarian settings.

PubMed

Falb, Kathryn L; Tanner, Sophie; Ward, Leora; Erksine, Dorcas; Noble, Eva; Assazenew, Asham; Bakomere, Theresita; Graybill, Elizabeth; Lowry, Carmen; Mallinga, Pamela; Neiman, Amy; Poulton, Catherine; Robinette, Katie; Sommer, Marni; Stark, Lindsay

2016-03-05

Violence against adolescent girls in humanitarian settings is of urgent concern given their additional vulnerabilities to violence and unique health and well-being needs that have largely been overlooked by the humanitarian community. In order to understand what works to prevent violence against adolescent girls, a multi-component curriculum-based safe spaces program (Creating Opportunities through Mentorship, Parental involvement and Safe Spaces - COMPASS) will be implemented and evaluated. The objectives of this multi-country study are to understand the feasibility, acceptability and effectiveness of COMPASS programming to prevent violence against adolescent girls in diverse humanitarian settings. Two wait-listed cluster-randomized controlled trials are being implemented in conflict-affected communities in eastern Democratic Republic of Congo (N = 886 girls aged 10-14 years) and in refugee camps in western Ethiopia (N = 919 girls aged 13-19 years). The intervention consists of structured facilitated sessions delivered in safe spaces by young female mentors, caregiver discussion groups, capacity-building activities with service providers, and community engagement. In Ethiopia, the research centers on the overall impact of COMPASS compared to a wait-list group. In DRC, the research objective is to understand the incremental effectiveness of the caregiver component in addition to the other COMPASS activities as compared to a wait-list group. The primary outcome is change in sexual violence. Secondary outcomes include decreased physical and emotional abuse, reduced early marriage, improved gender norms, and positive interpersonal relationships, among others. Qualitative methodologies seek to understand girls' perceptions of safety within their communities, key challenges they face, and to identify potential pathways of change. These trials will add much needed evidence for the humanitarian community to meet the unique needs of adolescent girls and to promote their safety and well-being, as well as contributing to how multi-component empowerment programming for adolescent girls could be adapted across humanitarian settings. Clinical Trials NCT02384642 (Registered: 2/24/15) & NCT02506543 (Registered: 7/19/15).

A Randomized Controlled Study of Neurofeedback for Chronic PTSD

PubMed Central

van der Kolk, Bessel A.; Hodgdon, Hilary; Gapen, Mark; Musicaro, Regina; Suvak, Michael K.; Hamlin, Ed; Spinazzola, Joseph

2016-01-01

Introduction Brain/Computer Interaction (BCI) devices are designed to alter neural signals and, thereby, mental activity. This study was a randomized, waitlist (TAU) controlled trial of a BCI, EEG neurofeedback training (NF), in patients with chronic PTSD to explore the capacity of NF to reduce PTSD symptoms and increase affect regulation capacities. Study Design 52 individuals with chronic PTSD were randomized to either NF (n = 28) or waitlist (WL) (n = 24). They completed four evaluations, at baseline (T1), after week 6 (T2), at post-treatment (T3), and at one month follow up (T4). Assessment measures were:1. Traumatic Events Screening Inventory (T1); 2. the Clinician Administered PTSD Scale (CAPS; T1, T3, T4); 3. the Davidson Trauma Scale (DTS; T1-T4) and 4. the Inventory of Altered Self-Capacities (IASC; T1-T4). NF training occurred two times per week for 12 weeks and involved a sequential placement with T4 as the active site, P4 as the reference site. Results Participants had experienced an average of 9.29 (SD = 2.90) different traumatic events. Post-treatment a significantly smaller proportion of NF (6/22, 27.3%) met criteria for PTSD than the WL condition (15/22, 68.2%), χ2 (n = 44, df = 1) = 7.38, p = .007. There was a significant treatment condition x time interaction (b = -10.45, t = -5.10, p< .001). Measures of tension reduction activities, affect dysregulation, and affect instability exhibited a significant Time x Condition interaction. The effect sizes of NF (d = -2.33 within, d = - 1.71 between groups) are comparable to those reported for the most effective evidence based treatments for PTSD. Discussion Compared with the control group NF produced significant PTSD symptom improvement in individuals with chronic PTSD, as well as in affect regulation capacities. NF deserves further investigation for its potential to ameliorate PTSD and to improve affect regulation, and to clarify its mechanisms of action. PMID:27992435

A Pilot Randomized Controlled Trial of a Commercial Diet and Exercise Weight Loss Program in Minority Breast Cancer Survivors

PubMed Central

Greenlee, Heather A.; Crew, Katherine D.; Mata, Jennie M.; McKinley, Paula S.; Rundle, Andrew G.; Zhang, Wenfei; Liao, Yuyan; Tsai, Wei Y.; Hershman, Dawn L.

2015-01-01

Objective Obesity is associated with poorer breast cancer outcomes and losing weight postdiagnosis may improve survival. As Hispanic and black women have poorer breast cancer prognosis than non-Hispanic whites diagnosed at similar age and stage, and have higher rates of obesity, effective weight loss strategies are needed. We piloted a randomized, waitlist-controlled, crossover study to examine the effects and feasibility of the commercial Curves weight loss program among Hispanic, African American and Afro-Caribbean breast cancer survivors. Design and Methods Women with stage 0– IIIa breast cancer ≥6 months posttreatment, sedentary, and BMI ≥25 kg/m2 were randomized to the immediate arm (IA): 6 months of the Curves program followed by 6 months of observation; or the waitlist control arm (WCA): 6 months of observation followed by 6 months of the Curves program. The Curves program uses a 30-min exercise circuit and a high-vegetable/low-fat/calorie-restricted diet. Results A total of 42 women enrolled (79% Hispanic, 21% black), mean age 51 (range 32–69) and mean BMI 33.2(±5.9) kg/m2; 91% were retained at month 12. At month 6, women in the IA lost an average 3.3% (±3.5%) of body weight (range: 1.7% gain to 10.6% loss), as compared with 1.8% (±2.9%) weight loss in the WCA (P = 0.04). At month 12, on average women in the IA regained some but not all of the weight lost during the first 6 months (P = 0.02). Conclusions Minority breast cancer survivors were recruited and retained in a weight loss study. Six months of the Curves program resulted in moderate weight loss, but weight loss was not maintained postintervention. Future interventions should identify methods to increase uptake and maintenance of weight loss behaviors. PMID:23505170

A Randomized Controlled Trial of a Trauma-Informed Support, Skills, and Psychoeducation Intervention for Survivors of Torture and Related Trauma in Kurdistan, Northern Iraq

PubMed Central

Bass, Judith; Murray, Sarah McIvor; Mohammed, Thikra Ahmed; Bunn, Mary; Gorman, William; Ahmed, Ahmed Mohammed Amin; Murray, Laura; Bolton, Paul

2016-01-01

ABSTRACT Supportive counseling type interventions are frequently provided to meet the mental health needs of populations in emergency and post-conflicts contexts, but it has seldom been rigorously evaluated. Existing evaluations from low- and middle-income countries provide mixed evidence of effectiveness. While Iraqi Kurdistan experienced relative stability following the fall of Saddam Hussein’s government, the population in the northern Dohuk region has continued to experience periodic violence due to conflicts with neighboring Turkey as well as more recent ISIS-associated violence. We evaluated the impact of a trauma-informed support, skills, and psychoeducation intervention provided by community mental health workers (CMHWs) on depressive symptoms and dysfunction (primary outcomes) as well as post-traumatic stress, traumatic grief, and anxiety symptoms (secondary outcomes). Between June 2009 and June 2010, 295 adults were screened; 209 (71%) met eligibility criteria (trauma exposure and a symptom severity score indicating significant distress and functional impairment, among others) and consented to participate. Of these, 159 were randomized to supportive counseling while 50 were randomized to a waitlist control condition. Comparing average symptom severity scores post-treatment among those in the intervention group with those in the waitlist control group, the supportive counseling program had statistically and clinically significant impacts on the primary outcomes of depression (Cohen’s d, 0.57; P = .02) and dysfunction (Cohen’s d, 0.53; P = .03) and significant but smaller impacts on anxiety. Although studies by the same research team of psychotherapeutic interventions in other parts of Kurdistan and in southern Iraq found larger effects, this study adds to the global research literature on mental health and psychosocial support and shows that a well-trained and supervised program of trauma-informed support, skills, and psychoeducation that emphasizes the therapeutic relationship can also be effective. PMID:27609624

A Randomized Controlled Trial of a Trauma-Informed Support, Skills, and Psychoeducation Intervention for Survivors of Torture and Related Trauma in Kurdistan, Northern Iraq.

PubMed

Bass, Judith; Murray, Sarah McIvor; Mohammed, Thikra Ahmed; Bunn, Mary; Gorman, William; Ahmed, Ahmed Mohammed Amin; Murray, Laura; Bolton, Paul

2016-09-28

Supportive counseling type interventions are frequently provided to meet the mental health needs of populations in emergency and post-conflicts contexts, but it has seldom been rigorously evaluated. Existing evaluations from low- and middle-income countries provide mixed evidence of effectiveness. While Iraqi Kurdistan experienced relative stability following the fall of Saddam Hussein's government, the population in the northern Dohuk region has continued to experience periodic violence due to conflicts with neighboring Turkey as well as more recent ISIS-associated violence. We evaluated the impact of a trauma-informed support, skills, and psychoeducation intervention provided by community mental health workers (CMHWs) on depressive symptoms and dysfunction (primary outcomes) as well as post-traumatic stress, traumatic grief, and anxiety symptoms (secondary outcomes). Between June 2009 and June 2010, 295 adults were screened; 209 (71%) met eligibility criteria (trauma exposure and a symptom severity score indicating significant distress and functional impairment, among others) and consented to participate. Of these, 159 were randomized to supportive counseling while 50 were randomized to a waitlist control condition. Comparing average symptom severity scores post-treatment among those in the intervention group with those in the waitlist control group, the supportive counseling program had statistically and clinically significant impacts on the primary outcomes of depression (Cohen's d, 0.57; P = .02) and dysfunction (Cohen's d, 0.53; P = .03) and significant but smaller impacts on anxiety. Although studies by the same research team of psychotherapeutic interventions in other parts of Kurdistan and in southern Iraq found larger effects, this study adds to the global research literature on mental health and psychosocial support and shows that a well-trained and supervised program of trauma-informed support, skills, and psychoeducation that emphasizes the therapeutic relationship can also be effective. © Bass et al.

A pilot randomized controlled trial of a commercial diet and exercise weight loss program in minority breast cancer survivors.

PubMed

Greenlee, Heather A; Crew, Katherine D; Mata, Jennie M; McKinley, Paula S; Rundle, Andrew G; Zhang, Wenfei; Liao, Yuyan; Tsai, Wei Y; Hershman, Dawn L

2013-01-01

Obesity is associated with poorer breast cancer outcomes and losing weight postdiagnosis may improve survival. As Hispanic and black women have poorer breast cancer prognosis than non-Hispanic whites diagnosed at similar age and stage, and have higher rates of obesity, effective weight loss strategies are needed. We piloted a randomized, waitlist-controlled, crossover study to examine the effects and feasibility of the commercial Curves weight loss program among Hispanic, African American and Afro-Caribbean breast cancer survivors. Women with stage 0-IIIa breast cancer ≥ 6 months posttreatment, sedentary, and BMI ≥ 25 kg/m(2) were randomized to the immediate arm (IA): 6 months of the Curves program followed by 6 months of observation; or the waitlist control arm (WCA): 6 months of observation followed by 6 months of the Curves program. The Curves program uses a 30-min exercise circuit and a high-vegetable/low-fat/calorie-restricted diet. A total of 42 women enrolled (79% Hispanic, 21% black), mean age 51 (range 32-69) and mean BMI 33.2(± 5.9) kg/m(2); 91% were retained at month 12. At month 6, women in the IA lost an average 3.3% (± 3.5%) of body weight (range: 1.7% gain to 10.6% loss), as compared with 1.8% (± 2.9%) weight loss in the WCA (P = 0.04). At month 12, on average women in the IA regained some but not all of the weight lost during the first 6 months (P = 0.02). Minority breast cancer survivors were recruited and retained in a weight loss study. Six months of the Curves program resulted in moderate weight loss, but weight loss was not maintained postintervention. Future interventions should identify methods to increase uptake and maintenance of weight loss behaviors. Copyright © 2013 The Obesity Society.

The efficacy of aerobic exercise and resistance training as transdiagnostic interventions for anxiety-related disorders and constructs: A randomized controlled trial.

PubMed

LeBouthillier, Daniel M; Asmundson, Gordon J G

2017-12-01

Evidence supports exercise as an intervention for many mental health concerns; however, randomized controlled investigations of the efficacy of different exercise modalities and predictors of change are lacking. The purposes of the current trial were to: (1) quantify the effects of aerobic exercise and resistance training on anxiety-related disorder (including anxiety disorders, obsessive-compulsive disorder, and posttraumatic stress disorder) status, symptoms, and constructs, (2) evaluate whether both modalities of exercise were equivalent, and (3) to determine whether exercise enjoyment and physical fitness are associated with symptom reduction. A total of 48 individuals with anxiety-related disorders were randomized to aerobic exercise, resistance training, or a waitlist. Symptoms of anxiety-related disorders, related constructs, and exercise enjoyment were assessed at pre-intervention and weekly during the 4-week intervention. Participants were further assessed 1-week and 1-month post-intervention. Both exercise modalities were efficacious in improving disorder status. As well, aerobic exercise improved general psychological distress and anxiety, while resistance training improved disorder-specific symptoms, anxiety sensitivity, distress tolerance, and intolerance of uncertainty. Physical fitness predicted reductions in general psychological distress for both types of exercise and reductions in stress for aerobic exercise. Results highlight the efficacy of different exercise modalities in uniquely addressing anxiety-related disorder symptoms and constructs. Copyright © 2017 Elsevier Ltd. All rights reserved.

Trauma-Informed Mindfulness-Based Stress Reduction for Female Survivors of Interpersonal Violence: Results From a Stage I RCT.

PubMed

Kelly, Amber; Garland, Eric L

2016-04-01

This pilot randomized controlled trial evaluated a novel trauma-informed model of mindfulness-based stress reduction (TI-MBSR) as a phase I trauma intervention for female survivors of interpersonal violence (IPV). A community-based sample of women (mean age = 41.5, standard deviation = 14.6) with a history of IPV was randomly assigned to an 8-week TI-MBSR intervention (n = 23) or a waitlist control group (n = 22). Symptoms of posttraumatic stress disorder (PTSD) and depression as well as anxious and avoidant attachment were assessed pre- and postintervention. Relative to the control group, participation in TI-MBSR was associated with statistically and clinically significant decreases in PTSD and depressive symptoms and significant reductions in anxious attachment. Retention in the intervention was high, with most participants completing at least 5 of the 8 sessions for the intervention. Minutes of mindfulness practice per week significantly predicted reductions in PTSD symptoms. TI-MBSR appears to be a promising and feasible phase I intervention for female survivors of interpersonal trauma. © 2016 Wiley Periodicals, Inc.

Circle of Security–Parenting: A randomized controlled trial in Head Start

PubMed Central

CASSIDY, JUDE; BRETT, BONNIE E.; GROSS, JACQUELYN T.; STERN, JESSICA A.; MARTIN, DAVID R.; MOHR, JONATHAN J.; WOODHOUSE, SUSAN S.

2017-01-01

Although evidence shows that attachment insecurity and disorganization increase risk for the development of psychopathology (Fearon, Bakermans-Kranenburg, van IJzendoorn, Lapsley, & Roisman, 2010; Groh, Roisman, van IJzendoorn, Bakermans-Kranenburg, & Fearon, 2012), implementation challenges have precluded dissemination of attachment interventions on the broad scale at which they are needed. The Circle of Security–Parenting Intervention (COS-P; Cooper, Hoffman, & Powell, 2009), designed with broad implementation in mind, addresses this gap by training community service providers to use a manualized, video-based program to help caregivers provide a secure base and a safe haven for their children. The present study is a randomized controlled trial of COS-P in a low-income sample of Head Start enrolled children and their mothers. Mothers (N = 141; 75 intervention, 66 waitlist control) completed a baseline assessment and returned with their children after the 10-week intervention for the outcome assessment, which included the Strange Situation. Intent to treat analyses revealed a main effect for maternal response to child distress, with mothers assigned to COS-P reporting fewer unsupportive (but not more supportive) responses to distress than control group mothers, and a main effect for one dimension of child executive functioning (inhibitory control but not cognitive flexibility when maternal age and marital status were controlled), with intervention group children showing greater control. There were, however, no main effects of intervention for child attachment or behavior problems. Exploratory follow-up analyses suggested intervention effects were moderated by maternal attachment style or depressive symptoms, with moderated intervention effects emerging for child attachment security and disorganization, but not avoidance; for inhibitory control but not cognitive flexibility; and for child internalizing but not externalizing behavior problems. This initial randomized controlled trial of the efficacy of COS-P sets the stage for further exploration of “what works for whom” in attachment intervention. PMID:28401843

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.

Depression treatment for impoverished mothers by point-of-care providers: A randomized controlled trial.

PubMed

Segre, Lisa S; Brock, Rebecca L; O'Hara, Michael W

2015-04-01

Depression in low-income, ethnic-minority women of childbearing age is prevalent and compromises infant and child development. Yet numerous barriers prevent treatment delivery. Listening Visits (LV), an empirically supported intervention developed for delivery by British home-visiting nurses, could address this unmet mental health need. This randomized controlled trial (RCT) evaluated the effectiveness of LV delivered at a woman's usual point-of-care, including home visits or an ob-gyn office. Listening Visits were delivered to depressed pregnant women or mothers of young children by their point-of-care provider (e.g., home visitor or physician's assistant), all of whom had low levels of prior counseling experience. Three quarters of the study's participants were low-income. Of those who reported ethnicity, all identified themselves as minorities. Participants from 4 study sites (N = 66) were randomized in a 2:1 ratio, to LV or a wait-list control group (WLC). Assessments, conducted at baseline and 8 weeks, evaluated depression, quality of life, and treatment satisfaction. Depressive severity, depressive symptoms, and quality of life significantly improved among LV recipients as compared with women receiving standard social/health services. Women valued LV as evidenced by their high attendance rates and treatment satisfaction ratings. In a stepped model of depression care, LV can provide an accessible, acceptable, and effective first-line treatment option for at-risk women who otherwise are unlikely to receive treatment. (PsycINFO Database Record (c) 2015 APA, all rights reserved).

The 'Healthy Dads, Healthy Kids' community effectiveness trial: study protocol of a community-based healthy lifestyle program for fathers and their children

PubMed Central

2011-01-01

Background The 'Healthy Dads, Healthy Kids' program was designed to help overweight fathers lose weight and positively influence the health behaviors of their children. The aim of the current study was to evaluate the previously established program in a community setting, in a large effectiveness trial. Methods/Design The Healthy Dads, Healthy Kids community trial consists of three stages: (i) Stage 1 - program refinement and resource development (ii) Stage 2 - community randomized controlled trial (iii) Stage 3 - community effectiveness trial. The program will be evaluated in five Local Government Areas in the Hunter Valley Region of NSW, Australia. For the community randomized controlled trial, 50 overweight/obese men (aged 18-65 years) from one Local Government Area with a child aged between 5-12 years of age will be recruited. Families will be randomized to either the program or a 6-month wait-list control group. Fathers and their children will be assessed at baseline, post-intervention (3-months) and 6-months. Inclusion criteria are: body mass index 25-40 kg/m2; no participation in other weight loss programs during the study; pass a health-screening questionnaire; and access to a computer with Internet facilities. In the community trial, the program will be evaluated using a non-randomized, prospective design in five Local Government Areas. The exclusion criteria is body mass index < 25 kg/m2 or lack of doctor's approval. Measures will be collected at baseline, 3-, 6- and 12-months. The program involves fathers attending seven face-to-face group sessions (three with children) over 3-months. Measures: The primary outcome is fathers' weight. Secondary outcomes for both fathers and children include: waist circumference, blood pressure, resting heart rate, physical activity, sedentary behaviors and dietary intake. Father-only measures include portion size, alcohol consumption, parenting for physical activity and nutrition and parental engagement. Process evaluation will determine the fidelity, dose (delivered and received), reach, recruitment and context of the program. Discussion As a unique approach to reducing obesity prevalence in men and improving lifestyle behaviours in children, our findings will provide important evidence relating to the translation of Healthy Dads, Healthy Kids, which will enable it to be delivered on a larger scale. Trial registration Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12610000608066 PMID:22099889

A randomized controlled trial of tai chi for long-term low back pain (TAI CHI): study rationale, design, and methods.

PubMed

Hall, Amanda M; Maher, Chris G; Latimer, Jane; Ferreira, Manuela L; Lam, Paul

2009-05-28

Low back pain persisting for longer than 3 months is a common and costly condition for which many current treatments have low-moderate success rates at best. Exercise is among the more successful treatments for this condition, however, the type and dosage of exercise that elicits the best results is not clearly defined. Tai chi is a gentle form of low intensity exercise that uses controlled movements in combination with relaxation techniques and is currently used as a safe form of exercise for people suffering from other chronic pain conditions such as arthritis. To date, there has been no scientific evaluation of tai chi as an intervention for people with back pain. Thus the aim of this study will be to examine the effects of a tai chi exercise program on pain and disability in people with long-term low back pain. The study will recruit 160 healthy individuals from the community setting to be randomised to either a tai chi intervention group or a wait-list control group. Individuals in the tai chi group will attend 2 tai chi sessions (40 minutes)/week for 8 weeks followed by 1 tai chi session/week for 2 weeks. The wait-list control will continue their usual health care practices and have the opportunity to participate in the tai chi program once they have completed the follow-up assessments. The primary outcome will be bothersomeness of back symptoms measured with a 0-10 numerical rating scale. Secondary outcomes include, self-reports of pain-related disability, health-related quality of life and global perceived effect of treatment. Statistical analysis of primary and secondary outcomes will be based on the intention to treat principle. Linear mixed models will be used to test for the effect of treatment on outcome at 10 weeks follow up. This trial has received ethics approval from The University of Sydney Human Research Ethics Committee. HREC Approval No.10452 This study will be the first trial in this area and the information on its effectiveness will allow patients, clinicians and treatment funders to make informed choices regarding this treatment. This trial has been registered with Australian New Zealand Clinical Trials Registry. ACTRN12608000270314.

Study in Parkinson Disease of Exercise (SPARX): Translating high-intensity exercise from animals to humans

PubMed Central

Moore, Charity G.; Schenkman, Margaret; Kohrt, Wendy M.; Delitto, Anthony; Hall, Deborah A.; Corcos, Daniel

2013-01-01

A burgeoning literature suggests that exercise has a therapeutic benefit in persons with Parkinson disease (PD) and in animal models of PD, especially when animals exercise at high intensity. If exercise is to be prescribed as “first-line” or “add-on” therapy in patients with PD, we must demonstrate its efficacy and dose-response effects through testing phases similar to those used in the testing of pharmacologic agents. The SPARX Trial is a multicenter, randomized, controlled, single-blinded, Phase II study that we designed to test the feasibility of using high-intensity exercise to modify symptoms of PD and to simultaneously test the nonfutility of achieving a prespecified change in patients’ motor scores on the Unified Parkinson Disease Rating Scale (UPDRS). The trial began in May 2102 and is in the process of screening, enrolling, and randomly assigning 126 patients with early-stage PD to 1 of 3 groups: usual care (wait-listed controls), moderate-intensity exercise (4 days/week at 60%–65% maximal heart rate [HRmax]), or high-intensity exercise (4 days/week at 80%–85% HRmax). At 6-month follow-up, the trial is randomly reassigning usual care participants to a moderate-intensity or high-intensity exercise group for the remaining 6 months. The goals of the Phase II trial are to determine if participants can exercise at moderate and high intensities; to determine if either exercise yields benefits consistent with meaningful clinical change (nonfutility); and to document safety and attrition. The advantage of using a non-futility approach allows us to efficiently determine if moderate- or high-intensity exercise warrants further large-scale investigation in PD. PMID:23770108

The effectiveness of self-help mindfulness-based cognitive therapy in a student sample: a randomised controlled trial.

PubMed

Lever Taylor, Billie; Strauss, Clara; Cavanagh, Kate; Jones, Fergal

2014-12-01

Mindfulness-based cognitive therapy (MBCT) involves approximately twenty hours of therapist contact time and is not universally available. MBCT self-help (MBCT-SH) may widen access but little is known about its effectiveness. This paper presents a randomised controlled trial (RCT) of MBCT-SH for students. Eighty students were randomly assigned to an eight-week MBCT-SH condition or a wait-list control. ANOVAs showed significant group by time interactions in favour of MBCT-SH on measures of depression, anxiety, stress, satisfaction with life, mindfulness and self-compassion. Post-intervention between-group effect sizes ranged from Cohen's d = 0.22 to 1.07. Engagement with MBCT-SH was high: participants engaged in mindfulness practice a median of two to three times a week and 85% read at least half the intervention book. Only 5% of participants dropped out. This is the first published RCT of MBCT-SH and benefits were found relative to a control group. MBCT-SH has the potential to be a low-cost, readily available and highly acceptable intervention. Future research should include an active control condition and explore whether findings extend to clinical populations. Copyright © 2014 Elsevier Ltd. All rights reserved.

Effectiveness of the tailored EBP training program for Filipino physiotherapists: a randomised controlled trial.

PubMed

Dizon, Janine Margarita; Grimmer-Somers, Karen; Kumar, Saravana

2011-04-13

Evidence implementation continues to challenge health professionals most especially those from developing countries. Filipino physiotherapists represent a group of health professionals in a developing country who by tradition and historical practice, take direction from a doctor, on treatment options. Lack of autonomy in decision-making challenges their capacity to deliver evidence-based care. However, this scenario should not limit them from updating and up-skilling themselves on evidence- based practice (EBP). EBP training tailored to their needs and practice was developed to address this gap. This study will be conducted to assess the effectiveness of a tailored EBP-training program for Filipino physiotherapists, in improving knowledge, skills, attitudes and behaviour to EBP. Participation in this program aims to improve capacity to EBP and engage with referring doctors to determine the most effective treatments for their patients. A double blind randomised controlled trial, assessing the effectiveness of the EBP training intervention, compared with a waitlist control, will be conducted. An adequately powered sample of 54 physiotherapists from the Philippines will be recruited and randomly allocated to EBP intervention or waitlist control. The EBP program for Filipino physiotherapists is a one-day program on EBP principles and techniques, delivered using effective adult education strategies. It consists of lectures and practical workshops. A novel component in this program is the specially-developed recommendation form, which participants can use after completing their training, to assist them to negotiate with referring doctors regarding evidence-based treatment choices for their patients.Pre and post measures of EBP knowledge, skills and attitudes will be assessed in both groups using the Adapted Fresno Test and the Questions to EBP attitudes. Behaviour to EBP will be measured using activity diaries for a period of three months. Should the EBP-training program be found to be effective in improving EBP-uptake in Filipino physiotherapists, it will form the basis of a much needed national intervention which is contextually appropriate to Filipino physiotherapists. It will therefore form the genesis for a model for building EBP capacity of other health professionals in the Philippines as well as physiotherapists in developing countries. Current Controlled Trials: ISRCTN74485061.

Effect of volunteering on risk factors for cardiovascular disease in adolescents: a randomized controlled trial.

PubMed

Schreier, Hannah M C; Schonert-Reichl, Kimberly A; Chen, Edith

2013-04-01

The idea that individuals who help others incur health benefits themselves suggests a novel approach to improving health while simultaneously promoting greater civic orientation in our society. The present study is the first experimental trial, to our knowledge, of whether regular volunteering can reduce cardiovascular risk factors in adolescents. To test a novel intervention that assigned adolescents to volunteer with elementary school-aged children as a means of improving adolescents' cardiovascular risk profiles. Randomized controlled trial, with measurements taken at baseline and 4 months later (postintervention). Urban public high school in western Canada. One hundred six 10th-grade high school students who were fluent in English and free of chronic illnesses. Weekly volunteering with elementary school-aged children for 2 months vs wait-list control group. Cardiovascular risk markers of C-reactive protein level, interleukin 6 level, total cholesterol level, and body mass index. No statistically significant group differences were found at baseline. Postintervention, adolescents in the intervention group showed significantly lower interleukin 6 levels (log10 mean difference, 0.13; 95% CI, 0.004 to 0.251), cholesterol levels (log10 mean difference, 0.03; 95% CI, 0.003 to 0.059), and body mass index (mean difference, 0.39; 95% CI, 0.07 to 0.71) compared with adolescents in the control group. Effects for C-reactive protein level were marginal (log10 mean difference, 0.13; 95% CI, -0.011 to 0.275). Preliminary analyses within the intervention group suggest that those who increased the most in empathy and altruistic behaviors, and who decreased the most in negative mood, also showed the greatest decreases in cardiovascular risk over time. Adolescents who volunteer to help others also benefit themselves, suggesting a novel way to improve health. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01698034.

Breakingtheice: a protocol for a randomised controlled trial of an internet-based intervention addressing amphetamine-type stimulant use.

PubMed

Tait, Robert J; McKetin, Rebecca; Kay-Lambkin, Frances; Bennett, Kylie; Tam, Ada; Bennett, Anthony; Geddes, Jenny; Garrick, Adam; Christensen, Helen; Griffiths, Kathleen M

2012-06-25

The prevalence of amphetamine-type stimulant use is greater than that of opioids and cocaine combined. Currently, there are no approved pharmacotherapy treatments for amphetamine-type stimulant problems, but some face-to-face psychotherapies are of demonstrated effectiveness. However, most treatment services focus on alcohol or opioid disorders, have limited reach and may not appeal to users of amphetamine-type stimulants. Internet interventions have proven to be effective for some substance use problems but none has specifically targeted users of amphetamine-type stimulants. The study will use a randomized controlled trial design to evaluate the effect of an internet intervention for amphetamine-type stimulant problems compared with a waitlist control group. The primary outcome will be assessed as amphetamine-type stimulant use (baseline, 3 and 6 months). Other outcomes measures will include 'readiness to change', quality of life, psychological distress (K-10 score), days out of role, poly-drug use, help-seeking intention and help-seeking behavior. The intervention consists of three modules requiring an estimated total completion time of 90 minutes. The content of the modules was adapted from face-to-face clinical techniques based on cognitive behavior therapy and motivation enhancement. The target sample is 160 men and women aged 18 and over who have used amphetamine-type stimulants in the last 3 months. To our knowledge this will be the first randomized controlled trial of an internet intervention specifically developed for users of amphetamine-type stimulants. If successful, the intervention will offer greater reach than conventional therapies and may engage clients who do not generally seek treatment from existing service providers. Australian and New Zealand Clinical Trials Registry (http://www.anzctr.org.au/) ACTRN12611000947909.

Physiological Predictors of Response to Exposure, Relaxation, and Rescripting Therapy for Chronic Nightmares in a Randomized Clinical Trial

PubMed Central

Davis, Joanne L.; Rhudy, Jamie L.; Pruiksma, Kristi E.; Byrd, Patricia; Williams, Amy E.; McCabe, Klanci M.; Bartley, Emily J.

2011-01-01

Study Objectives: Evidence supports the use of cognitive behavioral therapies for nightmares in trauma-exposed individuals. This randomized clinical trial replicated a study of exposure, relaxation, and rescripting therapy(ERRT) and extended prior research by including broad measures of mental health difficulties, self-reported physical health problems, and quality of life. Additionally, physiological correlates of treatment-related change assessed from a script-driven imagery paradigm were examined. Methods: Forty-seven individuals were randomized to treatment or waitlist control. Results: The treatment group demonstrated improvements relative to the control group at the one-week post-treatment assessment. At the 6-month follow-up assessment, significant improvements were found for frequency and severity of nightmares, posttraumatic stress disorder symptoms, depression, sleep quality and quantity, physical health symptoms, anger, dissociation, and tension reduction behaviors. Participants also reported improved quality of life. Treatment-related decreases in heart rate to nightmare imagery were correlated with improvements in sleep quality and quantity; treatment-related decreases in skin conductance to nightmare imagery were correlated with improvements in nightmare severity, posttraumatic stress disorder symptom severity, sleep quality, and fear of sleep; and treatment-related decreases in corrugator activity to nightmare imagery were correlated with improved physical health. Conclusions: Findings provide additional support for the use of ERRT in treating nightmares and related difficulties and improving sleep. Citation: Davis JL; Rhudy JL; Pruiksma KE; Byrd P; Williams AE; McCabe KM; Bartley EJ. Physiological predictors of response to exposure, relaxation, and rescripting therapy for chronic nightmares in a randomized clinical trial. J Clin Sleep Med 2011;7(6):622-631. PMID:22171201

Evaluation of the Homework, Organization, and Planning Skills (HOPS) Intervention for Middle School Students with ADHD as Implemented by School Mental Health Providers.

PubMed

Langberg, Joshua M; Epstein, Jeffery N; Becker, Stephen P; Girio-Herrera, Erin; Vaughn, Aaron J

2012-09-01

The purpose of the study was to evaluate the Homework, Organization, and Planning Skills (HOPS) intervention for middle school students with Attention-Deficit/Hyperactivity Disorder (ADHD) as implemented by school mental health (SMH) providers using a randomized trial design. Seventeen SMH providers from five school districts implemented the HOPS intervention. Forty-seven middle school students with ADHD (grades 6-8) were randomly assigned to receive the HOPS intervention or to a waitlist comparison group. Parent and teacher ratings of organizational skills and homework problems were collected pre- and post-intervention and at a 3-monoth follow-up, and school grades were also collected. Intervention participants demonstrated significant improvements relative to the waitlist comparison across parent-rated organized action ( d = .88), materials management ( d = .63), planning ( d = 1.05), and homework completion behaviors ( d = .85). Intervention participants did not make significant improvements relative to the comparison group according to teacher ratings. SMH providers were able to implement the HOPS intervention with fidelity despite the fact that no formal ongoing consultation was provided.

Evaluation of the Homework, Organization, and Planning Skills (HOPS) Intervention for Middle School Students with ADHD as Implemented by School Mental Health Providers

PubMed Central

Langberg, Joshua M.; Epstein, Jeffery N.; Becker, Stephen P.; Girio-Herrera, Erin; Vaughn, Aaron J.

2013-01-01

The purpose of the study was to evaluate the Homework, Organization, and Planning Skills (HOPS) intervention for middle school students with Attention-Deficit/Hyperactivity Disorder (ADHD) as implemented by school mental health (SMH) providers using a randomized trial design. Seventeen SMH providers from five school districts implemented the HOPS intervention. Forty-seven middle school students with ADHD (grades 6–8) were randomly assigned to receive the HOPS intervention or to a waitlist comparison group. Parent and teacher ratings of organizational skills and homework problems were collected pre- and post-intervention and at a 3-monoth follow-up, and school grades were also collected. Intervention participants demonstrated significant improvements relative to the waitlist comparison across parent-rated organized action (d = .88), materials management (d = .63), planning (d = 1.05), and homework completion behaviors (d = .85). Intervention participants did not make significant improvements relative to the comparison group according to teacher ratings. SMH providers were able to implement the HOPS intervention with fidelity despite the fact that no formal ongoing consultation was provided. PMID:25355991

Recruiting seniors with chronic low back pain for a randomized controlled trial of a self-management program.

PubMed

Groupp, Elyse; Haas, Mitchell; Fairweather, Alisa; Ganger, Bonnie; Attwood, Michael

2005-02-01

To identify recruitment challenges and elucidate specific strategies that enabled recruitment of seniors for a randomized trial on low back pain comparing the Chronic Disease Self-management Program of the Stanford University to a 6-month wait-list control group. Recruitment for a randomized controlled trial. Community-based program offered at 12 locations. Community-dwelling seniors 60 years and older with chronic low back pain of mechanical origin. Passive recruitment strategies included advertisement in local and senior newspapers, in senior e-mail newsletters and listservs, in local community centers and businesses. Active strategies included meeting seniors at health fairs, lectures to the public and organizational meetings, and the help of trusted professionals in the community. A total of 100 white and 20 African American seniors were recruited. The program seemed to have the most appeal to white, middle-class older adults, educated through high school level. Advertisement failed to attract any participants to the program. Successful strategies included interaction with seniors at health fairs and lectures on health care, especially when the program was endorsed by a trusted community professional. Generating interest in the self-management program required keen communication skills because the idea of "self-management" was met with a myriad of responses, ranging from disinterest to disbelief. Generating interest also required active participation within the communities. Initial contacts had to be established with trusted professionals, whose endorsement enabled the project managers to present the concept of self-management to the seniors. More complex recruitment strategies were required for this study involving the self-management approach to back pain than for studies involving treatment.

Feasibility of Connecting, a Substance-Abuse Prevention Program for Foster Teens and their Caregivers

PubMed Central

Barkan, Susan E.; Skinner, Martie; Ben Packard, W.; Cole, Janice J.

2016-01-01

Objective To test the feasibility, usability, and proximal outcomes of Connecting, an adaptation of a low-cost, self-directed, family-based substance use prevention program, Staying Connected with Your Teen, with foster families in a randomized, waitlist control pilot study. Method Families (n = 60) fostering teens between 11 and 15 years of age were recruited into the study and randomly assigned into the self-administered program with telephone support from a family consultant (n = 32) or a waitlist control condition (n = 28). Results Overall satisfaction with the program was high, with 100% of parents reporting they would recommend the program to other caregivers and reporting being “very satisfied” or “satisfied with the program. Program completion was good, with 62% of families completing all 91 specified tasks. Analyses of proximal outcomes revealed increased communication about sex and substance use (posttest1 OR = 1.97, and 2.03, respectively). Teens in the intervention vs. the waitlist condition reported lower family conflict (OR=.48), and more family rules related to monitoring (OR = 4.02) and media use (OR = 3.24). Caregivers in the waitlist group reported significant increases in the teen’s positive involvements (partial eta sq = 17% increase) after receiving the intervention. Conclusions Overall, program participation appeared to lead to stronger family management, better communication between teens and caregivers around monitoring and media use, teen participation in setting family rules, and decreased teen attitudes favorable to antisocial behavior. This small pilot study shows promising results for this adapted program. PMID:27891209

CBT for children with depressive symptoms: a meta-analysis.

PubMed

Arnberg, Alexandra; Ost, Lars-Göran

2014-01-01

Pediatric depression entails a higher risk for psychiatric disorders, somatic complaints, suicide, and functional impairment later in life. Cognitive behavior therapy (CBT) is recommended for the treatment of depression in children, yet research is based primarily on adolescents. The present meta-analysis investigated the efficacy of CBT in children aged 8-12 years with regard to depressive symptoms. We included randomized controlled trials of CBT with participants who had an average age of  ≤ 12 years and were diagnosed with either depression or reported elevated depressive symptoms. The search resulted in 10 randomized controlled trials with 267 participants in intervention and 256 in comparison groups. The mean age of participants was 10.5 years. The weighted between-group effect size for CBT was moderate, Cohen's d = 0.66. CBT outperformed both attention placebo and wait-list, although there was a significant heterogeneity among studies with regard to effect sizes. The weighted within-group effect size for CBT was large, d = 1.02. Earlier publication year, older participants, and more treatment sessions were associated with a larger effect size. In conclusion, the efficacy of CBT in the treatment of pediatric depression symptoms was supported. Differences in efficacy, methodological shortcomings, and lack of follow-up data limit the present study and indicate areas in need of improvement.

A Chinese Chan-based mind-body intervention for patients with depression.

PubMed

Chan, Agnes S; Wong, Queenie Y; Sze, Sophia L; Kwong, Patrick P K; Han, Yvonne M Y; Cheung, Mei-Chun

2012-12-15

Given the recent growing interest and encouraging findings in studies of alternative treatments for depression, the present randomized controlled trial study aimed to compare the effect of a newly developed Chinese Chan-based Dejian Mind-Body Intervention (DMBI) with the Cognitive Behavioral Therapy (CBT) on improving depressive symptoms in patients with depression. Seventy-five participants diagnosed with major depressive disorder were randomly assigned to receive either 10-session CBT or DMBI, or placed on a waitlist. Pre-post measurements included record of anti-depressants treatment, ratings by psychiatrists who were blinded to the experimental design and self-report on mood measures, and performance in a cognitive test tapping concentration ability. Both the CBT and DMBI groups demonstrated significantly reduced overall depressive syndrome after intervention at large effect size (0.93-1.10). Furthermore, the DMBI group (p<0.05), but not the CBT or waitlist groups, demonstrated significant reduction in intake of anti-depressants, and significant improvement in specific depression-related symptoms including difficulty in concentration (p=0.002), and problems in gastrointestinal health (p=0.02) and overall sleep quality (p<0.001). This study has provided some evidence for the short-term effect of the DMBI on Chinese population. Its long-term effect on a larger sample and on Caucasian population warrants further investigation. The present findings suggest that a Chinese Chan-based Mind-Body intervention has positive effects on improving mood and health conditions of individuals with depression. Copyright © 2012 Elsevier B.V. All rights reserved.

Effectiveness of Cognitive-Behavioral Therapy in Decreasing Suicidal Ideation and Hopelessness of the Adolescents with Previous Suicidal Attempts

PubMed Central

Alavi, Ali; Sharifi, Bahare; Ghanizadeh, Ahmad; Dehbozorgi, Gholamreza

2013-01-01

Objective To evaluate the effectiveness of a Cognitive-Behavioral therapy (CBT) for suicide prevention in decreasing suicidal ideation and hopelessness in a sample of depressed 12 to 18 year-old adolescents who had at least one previous suicidal attempt. Methods In a clinical trial, 30 depressed adolescents who attempted suicide in the recent 3 months were selected using simple sampling method and divided randomly into intervention and wait-list control groups. Both groups received psychiatric interventions as routine. The intervention group received a 12 session (once a week) of CBT program according to the package developed by Stanley et al, including psychoeducational interventions and individual and family skills training modules. All of the patients were evaluated by Scale for Suicidal Ideation, Beck's hopelessness Inventory, and Beck's Depression Inventory before the intervention and after 12 weeks. Findings There were significant differences between the two groups regarding the scores of the above mentioned scales after 12 weeks. Fifty-four to 77 percent decreases in the mean scores of the used scales were observed in the invention group. There were no significant changes in the scores of the control wait-list group. The differences between pre- and post-intervention scores in the intervention group were significant. Conclusion CBT is an effective method in reducing suicidal ideation and hopelessness in the depressed adolescents with previous suicidal attempts. PMID:24427502

ParticiPAte CP: a protocol of a randomised waitlist controlled trial of a motivational and behaviour change therapy intervention to increase physical activity through meaningful participation in children with cerebral palsy

PubMed Central

Boyd, Roslyn N; Elliott, Catherine

2017-01-01

Introduction Children with cerebral palsy (CP) participate in leisure-time physical activities (PA) less often, with less intensity and reduced diversity than their typically developing peers. Participation in leisure-time physical activities may be an important source of habitual physical activity (HPA) for children with CP, who as a group have lower levels of HPA and increased sedentary time compared with their typically developing peers. The proposed study aims to compare the efficacy of a participation focused therapy (ParticiPAte CP) to usual care in a pragmatic, randomised waitlist controlled trial. Methods and analysis Thirty-six children with CP (18 in each group), classified as Gross Motor Function Classification System levels I to III, aged between 8 and 12 years will be recruited across South East Queensland, Australia. Children will be randomised to receive either ParticiPAte CP or waitlist usual care using concealed allocation. ParticiPAte CP is an individually tailored, goal-directed intervention model of pragmatic participation-focused therapy using a toolbox of evidence-based strategies in the treatment of children with CP. This will include goal-setting; identification of barriers and facilitators to participation goals, strategy formation and planning and communication guided by principles of Self-Determination Theory using strategies of Motivational Interviewing. The intervention comprises 8 weekly sessions of 1 hour duration conducted by a physiotherapist in the child's home or community. Trial registration number ACTRN12615001064594. PMID:28790038

Tuning in to Kids: an effectiveness trial of a parenting program targeting emotion socialization of preschoolers.

PubMed

Wilson, Katherine R; Havighurst, Sophie S; Harley, Ann E

2012-02-01

This article reports on an effectiveness trial of the Tuning in to Kids (TIK) parenting program. TIK aims to improve emotion socialization practices in parents of preschool children; it is a universal prevention program that teaches parents the skills of emotion coaching and also targets parents' own emotion awareness and regulation. The present study followed a 2 × 2 (Treatment Condition × Time) design. One hundred twenty-eight parents of children ages 4.0-5.11 years were recruited from preschools and randomized into intervention and waitlist conditions. Parents in the intervention condition (n = 62) attended a six-session group parenting program delivered by community practitioners who followed intervention fidelity protocols. Parents and preschool teachers completed questionnaires twice during the preschool year: at preintervention and at follow-up (approximately 7 months later). Parents reported on their emotion socialization beliefs and practices, other parenting practices, and on child behavior. Teachers reported on child behavior (Social Competence and Anger-Aggression). Data were analyzed using multilevel modeling. At follow-up, compared to the control group, intervention parents were significantly less emotionally dismissive in their beliefs, less dismissive and more coaching in their practices in response to children's negative emotions, and more positively involved. Although there were improvements in both conditions over time for parent-reported child behavior and teacher-reported social competence, compared to the waitlist group, intervention parents reported a significantly greater reduction in number of behavior problems. This trial demonstrates the potential for community agencies and practitioners in real-world settings to deliver a new parenting program that targets emotional communication in parent-child relationships.

Randomized controlled trial of physical activity, cognition, and walking in multiple sclerosis.

PubMed

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

2014-02-01

The present study adopted a randomized controlled trial design and examined the effect of a physical activity behavioral intervention on cognitive and walking performance among persons with MS who have mild or moderate disability status. A total of 82 MS patients were randomly allocated into intervention or wait-list control conditions. The intervention condition received a theory-based program for increasing physical activity behavior that was delivered via the Internet, and one-on-one video chat sessions with a behavior-change coach. Participants completed self-report measures of physical activity and disability status, and underwent the oral Symbol Digit Modalities Test (SDMT) and 6-minute walk (6MW) test before and after the 6-month period. Analysis using mixed-model ANOVA indicated a significant time × condition × disability group interaction on SDMT scores (p = 0.02, partial-η (2) = 0.08), such that persons with mild disability in the intervention condition demonstrated a clinically meaningful improvement in SDMT scores (~6 point change). There was a further significant time × condition interaction on 6MW distance (p = 0.02, partial-η (2) = 0.07), such that those in the intervention condition demonstrated an increase in 6MW distance relative to those in the control group. The current study supports physical activity as a promising tool for managing cognitive impairment and impaired walking performance in persons with MS, and suggests that physical activity might have specific effects on cognition and non-specific effects on walking performance in this population.

The Effects of School Gardens on Children's Science Knowledge: A randomized controlled trial of low-income elementary schools

NASA Astrophysics Data System (ADS)

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

2015-11-01

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 study (n = 24). The garden intervention consisted of both raised-bed garden kits and a series of 19 lessons. Schools, located in the US states of Arkansas, Iowa, Washington, and New York, were all low-income as defined by having 50% or more children qualifying for the federal school lunch program. Participants were students in second, fourth, and fifth grade (ages 6-12) at baseline (n = 3,061). Science knowledge was measured using a 7-item questionnaire focused on nutritional science and plant science. The survey was administered at baseline (Fall 2011) and at three time points during the intervention (Spring 2012, Fall 2012, and Spring 2013). Garden intervention fidelity (GIF) captured the robustness or fidelity of the intervention delivered in each classroom based on both lessons delivered and garden activities. Analyses were conducted using general linear mixed models. Survey data indicated that among children in the garden intervention, science knowledge increased from baseline to follow-up more than among control group children. However, science knowledge scores were uniformly poor and gains were very modest. GIF, which takes into account the robustness of the intervention, revealed a dose-response relation with science knowledge: more robust or substantial intervention implementations corresponded to stronger treatment effects.

The 'Healthy Dads, Healthy Kids' community randomized controlled trial: a community-based healthy lifestyle program for fathers and their children.

PubMed

Morgan, Philip J; Collins, Clare E; Plotnikoff, Ronald C; Callister, Robin; Burrows, Tracy; Fletcher, Richard; Okely, Anthony D; Young, Myles D; Miller, Andrew; Lloyd, Adam B; Cook, Alyce T; Cruickshank, Joel; Saunders, Kristen L; Lubans, David R

2014-04-01

To evaluate the effectiveness of the 'Healthy Dads, Healthy Kids (HDHK)' program when delivered by trained facilitators in community settings. A two-arm randomized controlled trial of 93 overweight/obese fathers (mean [SD] age=40.3 [5.3] years; BMI=32.5 [3.8] kg/m(2)) and their primary school-aged children (n=132) from the Hunter Region, Australia. In 2010-2011, families were randomized to either: (i) HDHK intervention (n=48 fathers, n=72 children) or (ii) wait-list control group. The 7-week intervention included seven sessions and resources (booklets, pedometers). Assessments were held at baseline and 14-weeks with fathers' weight (kg) as the primary outcome. Secondary outcomes for fathers and children included waist, BMI, blood pressure, resting heart rate, physical activity (pedometry), and self-reported dietary intake and sedentary behaviors. Linear mixed models (intention-to-treat) revealed significant between-group differences for fathers' weight (P<.001, d=0.24), with HDHK fathers losing more weight (-3.3 kg; 95%CI, -4.3, -2.4) than control fathers (0.1 kg; 95%CI, -0.9,1.0). Significant treatment effects (P<.05) were also found for fathers' waist (d=0.41), BMI (d=0.26), resting heart rate (d=0.59), energy intake (d=0.49) and physical activity (d=0.46) and for children's physical activity (d=0.50) and adiposity (d=0.07). HDHK significantly improved health outcomes and behaviors in fathers and children, providing evidence for program effectiveness when delivered in a community setting. Copyright © 2013. Published by Elsevier Inc.

Effects of online intervention for depression on mood and positive symptoms in schizophrenia.

PubMed

Moritz, Steffen; Schröder, Johanna; Klein, Jan Philipp; Lincoln, Tania M; Andreou, Christina; Fischer, Anja; Arlt, Sönke

2016-08-01

Depression is common in schizophrenia. Whereas the improvement of mood and self-esteem represents a subjective treatment priority for many patients, depression is rarely a primary target for clinical intervention. The present trial examined whether an online intervention for depression can ameliorate depressive symptoms in schizophrenia. A total of 58 individuals with schizophrenia were invited to participate in an online survey which encompassed the Center for Epidemiologic Studies-Depression Scale (CES-D, primary outcome), the Patient-Health-Questionnaire-9 (PHQ-9) and the Paranoia Checklist. Subsequently, telephone interviews were conducted to verify diagnostic status and assess symptoms (Positive and Negative Syndrome Scale, PANSS). Participants were randomized either to the experimental condition (online depression intervention) or to a waitlist control condition. Three months after inclusion, a reassessment was carried out (self-report and telephone interview blind for group condition). The trial was registered (registration: DRKS00007888). Participants in the treatment group showed a significant decline of depressive symptoms at a medium-to-large effect size, as assessed with the CES-D and the PANSS depression item, in comparison to the waitlist control group (completer (CC) and intention-to-treat analyses (ITT)). For the PHQ-9 (CC and ITT) and the PANSS distress subscale (CC only) significance was bordered at a medium effect size. Completion at the post-assessment after three months was 84%. Depression in schizophrenia is both underdiagnosed and undertreated. To reduce the large treatment gap in the disorder, low threshold strategies are urgently needed. Online treatment and bibliotherapy may represent valuable tools to address patients' needs beyond the treatment of the core positive syndrome. Copyright © 2016. Published by Elsevier B.V.

A Controlled Trial of Working Memory Training for Children and Adolescents with ADHD

ERIC Educational Resources Information Center

Beck, Steven J.; Hanson, Christine A.; Puffenberger, Synthia S.; Benninger, Kristen L.; Benninger, William B.

2010-01-01

This study assessed the efficacy of a 5-week, intensive working memory training program for 52 children and adolescents (ages 7-17) who had Attention-Deficit/Hyperactivity Disorder (ADHD) and other comorbid diagnoses. This study provided a treatment replication since the waitlist control group also completed training and was included in the…

Reducing sexual victimization among adolescent girls: a randomized controlled pilot trial of my voice, my choice.

PubMed

Rowe, Lorelei Simpson; Jouriles, Ernest N; McDonald, Renee

2015-05-01

Despite extensive efforts to develop and implement programs to prevent sexual violence, few programs have empirically-demonstrated efficacy. The primary exceptions are programs that emphasize risk-reduction skills; yet even these programs are not consistently effective. This study seeks to add to the literature by evaluating the effects of My Voice, My Choice (MVMC), a 90-minute assertive resistance training program that emphasizes skill practice in an immersive virtual environment (IVE). We hypothesized that MVMC would reduce male-to-female sexual victimization among adolescent girls over a 3-month follow-up period. We also examined whether these results would generalize to other forms of male-to-female relationship violence and to girls' psychological distress. Eighty-three female students from an urban public high school were randomized to MVMC (n=47) or to a wait-list control condition (n=36); 78 provided data over the 3-month follow-up period. Participants assigned to MVMC were less likely than control participants to report sexual victimization during the follow-up period. Our results also suggest that MVMC reduced risk for psychological victimization and for psychological distress among participants with greater prior victimization at baseline. The promising results of this pilot trial suggest that MVMC may help girls evade male-to-female relationship violence. Copyright © 2014. Published by Elsevier Ltd.

Internet-based information and support program for parents of children with burns: A randomized controlled trial.

PubMed

Sveen, Josefin; Andersson, Gerhard; Buhrman, Bo; Sjöberg, Folke; Willebrand, Mimmie

2017-05-01

The aim of the study was to evaluate the feasibility and effects of an internet-based information and self-help program with therapist contact for parents of children and adolescents with burns. The program aimed to reduce parents' symptoms of general and posttraumatic stress. Participants were parents of children treated for burns between 2009-2013 at either of the two specialized Swedish Burn centers. Sixty-two parents were included in a two-armed, randomized controlled trial with a six-week intervention group and a wait-list control group, including a pre and post-assessment, as well as a 3 and 12-month follow-up. The intervention contained psychoeducation, exercises and homework assignments, and the intervention group received weekly written feedback from a therapist. The main outcome was stress (post-traumatic stress, general stress and parental stress). The program had a beneficial effect on posttraumatic stress in the short term, but did not affect general stress or parental stress. The parents rated the program as being informative and meaningful, but some of them thought it was time-consuming. The program has the potential to support parents of children with burns. The intervention is easily accessible, cost-effective and could be implemented in burn care rehabilitation. Copyright © 2016 The Author(s). Published by Elsevier Ltd.. All rights reserved.

A Randomised Controlled Trial of a Brief Online Mindfulness-Based Intervention on Paranoia in a Non-Clinical Sample.

PubMed

Shore, Robert; Strauss, Clara; Cavanagh, Kate; Hayward, Mark; Ellett, Lyn

2018-01-01

Paranoia is common and distressing in the general population and can impact on health, emotional well-being and social functioning, such that effective interventions are needed. Brief online mindfulness-based interventions (MBIs) have been shown to reduce symptoms of anxiety and depression in non-clinical samples; however, at present, there is no research investigating whether they can reduce paranoia. The current study explored whether a brief online MBI increased levels of mindfulness and reduced levels of paranoia in a non-clinical population. The mediating effect of mindfulness on any changes in paranoia was also investigated. One hundred and ten participants were randomly allocated to either a 2-week online MBI including 10 min of daily guided mindfulness practice or to a waitlist control condition. Measures of mindfulness and paranoia were administered at baseline, post-intervention and 1-week follow-up. Participants in the MBI group displayed significantly greater reductions in paranoia compared to the waitlist control group. Mediation analysis demonstrated that change in mindfulness skills (specifically the observe, describe and non-react facets of the FFMQ) mediated the relationship between intervention type and change in levels of paranoia. This study provides evidence that a brief online MBI can significantly reduce levels of paranoia in a non-clinical population. Furthermore, increases in mindfulness skills from this brief online MBI can mediate reductions in non-clinical paranoia. The limitations of the study are discussed.

Mindfulness-based stress reduction for chronic insomnia in adults older than 75 years: a randomized, controlled, single-blind clinical trial.

PubMed

Zhang, Jia-Xu; Liu, Xiao-Hui; Xie, Xin-Hui; Zhao, Dan; Shan, Mo-Shui; Zhang, Xi-Liang; Kong, Xiao-Ming; Cui, Hong

2015-01-01

To assess the effectiveness of mindfulness-based stress reduction (MBSR) for chronic insomnia and combined depressive or anxiety symptoms of older adults aged 75 years and over. A randomized, controlled, single-blind clinical trial. Participants included 60 adults aged 75 years and over with chronic insomnia. Participants were randomly assigned to the eight-week MBSR group or the wait-list control group. Assessments using the Pittsburgh Sleep Quality Index (PSQI), Self-rating Anxiety Sale (SAS), and Geriatric Depression Scale (GDS) were taken at baseline and post-treatment. For each outcome measure, a repeated measures analysis of variance was used to detect changes across assessments. There was a significant time × group interaction for the PSQI global score (P = .006); the MBSR group had a decrease in the PSQI global score (Cohen׳s d = 1.12), while the control group did not (Cohen׳s d = -0.06). Among the PSQI components, there was a significant time × group interaction for daytime dysfunction (P = .048); Cohen׳s d of the MBSR group was 0.76, while Cohen׳s d of control group was -0.04. There was no significant time × group interaction for the SAS score (P = .116), while for the GDS there was a significant time × group interaction (P = .039); the Cohen׳s d value for the MBSR group was 1.20, and it was 0.12 for the control group. This study demonstrated that the MBSR program could be a beneficial treatment for chronic insomnia in adults aged 75 years and older. Copyright © 2015 Elsevier Inc. All rights reserved.

A randomized controlled trial of students for nutrition and eXercise: a community-based participatory research study.

PubMed

Bogart, Laura M; Cowgill, Burton O; Elliott, Marc N; Klein, David J; Hawes-Dawson, Jennifer; Uyeda, Kimberly; Elijah, Jacinta; Binkle, David G; Schuster, Mark A

2014-09-01

To conduct a randomized controlled trial of Students for Nutrition and eXercise, a 5-week middle school-based obesity-prevention intervention combining school-wide environmental changes, multimedia, encouragement to eat healthy school cafeteria foods, and peer-led education. We randomly selected schools (five intervention, five waitlist control) from the Los Angeles Unified School District. School records were obtained for number of fruits and vegetables served, students served lunch, and snacks sold per attending student, representing an average of 1,515 students (SD = 323) per intervention school and 1,524 students (SD = 266) per control school. A total of 2,997 seventh-graders (75% of seventh-graders across schools) completed pre- and postintervention surveys assessing psychosocial variables. Consistent with community-based participatory research principles, the school district was an equal partner, and a community advisory board provided critical input. Relative to control schools, intervention schools showed significant increases in the proportion of students served fruit and lunch and a significant decrease in the proportion of students buying snacks at school. Specifically, the intervention was associated with relative increases of 15.3% more fruits served (p = .006), 10.4% more lunches served (p < .001), and 11.9% fewer snacks sold (p < .001) than would have been expected in its absence. Pre-to-post intervention, intervention school students reported more positive attitudes about cafeteria food (p = .02) and tap water (p = .03), greater obesity-prevention knowledge (p = .006), increased intentions to drink water from the tap (p = .04) or a refillable bottle (p = .02), and greater tap water consumption (p = .04) compared with control school students. Multilevel school-based interventions may promote healthy adolescent dietary behaviors. Copyright © 2014 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

Coping with Work-Related Stress through Guided Imagery and Music (GIM): Randomized Controlled Trial.

PubMed

Beck, Bolette Daniels; Hansen, Åse Marie; Gold, Christian

2015-01-01

Long-term stress-related sick leave constitutes a serious health threat and an economic burden on both the single worker and the society. Effective interventions for the rehabilitation and facilitation of return to work are needed. The aim of the study was to examine the effects of Guided Imagery and Music (GIM), a psychotherapy intervention including relaxation, music listening, and imagery, on biopsychosocial measures of work-related stress. Twenty Danish workers on sick leave were randomized to music therapy versus wait-list control. Data collection was carried out at an occupational health ward in the period 2008-2010. Changes in salivary cortisol, testosterone, and melatonin were explored, and self-reported data on psychological stress symptoms (perceived stress, mood disturbance, sleep quality, physical distress symptoms, work readiness, well-being, anxiety, depression, immediate stress) were collected. Data regarding sick leave situation and job return were collected from participants throughout the study. Significant beneficial effects of GIM compared to wait-list after nine weeks with large effect sizes were found in well-being, mood disturbance, and physical distress, and in cortisol concentrations with a medium effect size. A comparison between early and late intervention as related to the onset of sick leave showed faster job return and significantly improved perceived stress, well-being, mood disturbance, depression, anxiety, and physical distress symptoms in favor of early intervention. In the whole sample, 83% of the participants had returned to work at nine weeks' follow-up. The results indicate that GIM is a promising treatment for work-related chronic stress, and further studies are recommended. © the American Music Therapy Association 2015. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

A Randomized Controlled Trial of the Web-Based OurRelationship Program: Effects on Relationship and Individual Functioning

PubMed Central

Doss, Brian D.; Cicila, Larisa N.; Georgia, Emily J.; Roddy, McKenzie K.; Nowlan, Kathryn M.; Benson, Lisa A.; Christensen, Andrew

2016-01-01

Objective Within the United States, one-third of married couples are distressed and almost half of first marriages (and more than half of unmarried cohabiting relationships) end in divorce/separation. Additionally, relationship distress has been linked to mental and physical health problems in partners and their children. Although couple therapy is effective in reducing relationship distress, it is utilized by less than one third of divorcing couples. Therefore, more accessible interventions for relationship distress are needed. Method This study tests the efficacy of the OurRelationship (OR) program, an eight-hour online program adapted from an empirically-based, in-person couple therapy. In the program, couples complete online activities and have four, 15-minute calls with project staff. Nationwide, 300 heterosexual couples (N = 600 participants) participated; couples were generally representative of the US in terms of race, ethnicity, and education. Couples were randomly assigned to begin the program immediately or to a two month waitlist control group. Results Compared to the waitlist group, intervention couples reported significant improvements in relationship satisfaction (Cohen’s d=0.69), relationship confidence (d=0.47), and negative relationship quality (d=0.57). Additionally, couples reported significant improvements in multiple domains of individual functioning, especially when individuals began the program with difficulties in that domain: depressive (d=0.71) and anxious symptoms (d=0.94), perceived health (d=0.51), work functioning (d=0.57), and quality of life (d=0.44). Conclusions In a nationally-representative sample of couples, the OR program was effective in significantly improving both relationship and individual functioning, suggesting it can substantially increase the reach of current interventions through its low-cost, web-based format. PMID:26999504

Use of a self-help book with weekly therapist contact to reduce tinnitus distress: a randomized controlled trial.

PubMed

Kaldo, Viktor; Cars, Sofia; Rahnert, Miriam; Larsen, Hans Christian; Andersson, Gerhard

2007-08-01

Tinnitus distress can be reduced by means of cognitive-behavior therapy (CBT). To compensate for the shortage of CBT therapists, we aimed, in this study, to investigate the effects of a CBT-based self-help book guided by brief telephone support. Seventy-two patients were randomized either to a self-help book and seven weekly phone calls or to a wait-list control condition, later on receiving the self-help book with less therapist support. The dropout rate was 7%. Follow-up data 1 year after completion of treatment were also collected (12% dropout). The Tinnitus Reaction Questionnaire (TRQ) was the main outcome measure, complemented with daily ratings of tinnitus and measures of insomnia, anxiety, and depression. On the TRQ, significant reductions were found in the treatment group both immediately following treatment and at 1-year follow-up. In the treatment group, 32% reached the criteria for clinical significance (at least 50% reduction of the TRQ) compared to 5% in the wait-list group. Directly after treatment, two out of five measures showed significant differences in favor of the treatment with more therapist support compared with the group who, after their waiting period, received little therapist support. The self-help treatment was estimated to be 2.6 (seven phone calls) and 4.8 (one phone call) times as cost-effective as regular CBT group treatment. Guided self-help can serve as an alternative way to administer CBT for tinnitus. Preliminary results cast some doubts on the importance of weekly therapist contact. The effect size was somewhat smaller than for regular CBT, but on the other hand, the self-help seems far more cost-effective. Future studies should compare treatment modalities directly and explore cost-effectiveness more thoroughly.

The Effects of an Afterschool Physical Activity Program on Working Memory in Preadolescent Children

ERIC Educational Resources Information Center

Kamijo, Keita; Pontifex, Matthew B.; O'Leary, Kevin C.; Scudder, Mark R.; Wu, Chien-Ting; Castelli, Darla M.; Hillman, Charles H.

2011-01-01

The present study examined the effects of a 9-month randomized control physical activity intervention aimed at improving cardiorespiratory fitness on changes in working memory performance in preadolescent children relative to a waitlist control group. Participants performed a modified Sternberg task, which manipulated working memory demands based…

Cognitive-behavioral therapy for body dysmorphic disorder: A systematic review and meta-analysis of randomized controlled trials.

PubMed

Harrison, Amy; Fernández de la Cruz, Lorena; Enander, Jesper; Radua, Joaquim; Mataix-Cols, David

2016-08-01

Body dysmorphic disorder (BDD) is a chronic and disabling psychiatric disorder unlikely to remit without treatment. A systematic review and meta-analysis of randomized controlled trials (RCTs) of cognitive-behavioral therapy (CBT) for BDD was conducted, including published and unpublished trials to 26th November 2015. Primary outcomes were validated BDD measures; secondary outcomes included depression and insight. Meta-regressions were conducted to examine potential effects of variables on the primary outcome, including socio-demographic variables, comorbidity, symptom severity/duration, concomitant medication, treatment duration, and methodological quality of the RCTs. Seven RCTs (N=299) met inclusion criteria. CBT was superior to waitlist or credible psychological placebo in reducing BDD (7 studies; delta=-1.22, 95% CI=-1.66 to -0.79) and depression symptoms (5 studies; delta=-0.49, 95% CI=-0.76 to -0.22). CBT was associated with improvements in insight/delusionality (4 studies; delta=-0.56, 95% CI=-0.93 to -0.19). Improvement in BDD was maintained after 2-4months follow-up (3 studies; delta=-0.89, 95% CI=-1.24 to -0.54). Meta-regression analyses did not reveal any significant predictors of outcome. CBT is an efficacious treatment for BDD but there is substantial room for improvement. The specificity and long-term effects of CBT for BDD require further evaluation using credible control conditions. Additional trials comparing CBT with pharmacological therapies, as well as their combination, are warranted. Tele-care options, such as Internet-based CBT, hold great promise to increase access to evidence-based treatment for a majority of patients who need it and should be evaluated further. Copyright © 2016 Elsevier Ltd. All rights reserved.

Can Low-Cost Strategies Improve Attendance Rates in Brief Psychological Therapy? Double-Blind Randomized Controlled Trial.

PubMed

Delgadillo, Jaime; Moreea, Omar; Murphy, Elizabeth; Ali, Shehzad; Swift, Joshua K

2015-12-01

To assess if telephone text message appointment reminders and orientation leaflets can increase the proportion of patients who attend brief interventions after being assessed as suitable for guided self-help following cognitive behavioral therapy principles. Attendance was operationally defined as having accessed at least 1 therapy appointment. A secondary outcome was the proportion of attenders who completed or dropped out of therapy. After initial assessment, 254 patients with depression and anxiety disorders were randomly assigned to 1 of 3 groups: (a) usual waitlist control, (b) leaflet, (c) leaflet plus text message. Differences in the proportions of patients who started and completed therapy across groups were assessed using chi-square and logistic regression analyses. Overall, 63% of patients in this sample attended therapy. Between-group differences were not significant for attendance, x(2) (2) = 3.94, p = .14, or completion rates, x(2) (2) = 2.98, p = .23. These results were not confounded by demographic or clinical characteristics. Low-cost strategies appear to make no significant difference to therapy attendance and completion rates. © 2015 Wiley Periodicals, Inc.

The clinical effectiveness of cognitive behavior therapy and an alternative medicine approach in reducing symptoms of depression in adolescents.

PubMed

Charkhandeh, Mansoureh; Talib, Mansor Abu; Hunt, Caroline Jane

2016-05-30

The main aim of the study was to investigate the effectiveness of two psychotherapeutic approaches, cognitive behavioral therapy (CBT) and a complementary medicine method Reiki, in reducing depression scores in adolescents. We recruited 188 adolescent patients who were 12-17 years old. Participants were randomly assigned to CBT, Reiki or wait-list. Depression scores were assessed before and after the 12 week interventions or wait-list. CBT showed a significantly greater decrease in Child Depression Inventory (CDI) scores across treatment than both Reiki (p<.001) and the wait-list control (p<.001). Reiki also showed greater decreases in CDI scores across treatment relative to the wait-list control condition (p=.031). The analyses indicated a significant interaction between gender, condition and change in CDI scores, such that male participants showed a smaller treatment effect for Reiki than did female participants. Both CBT and Reiki were effective in reducing the symptoms of depression over the treatment period, with effect for CBT greater than Reiki. These findings highlight the importance of early intervention for treatment of depression using both cognitive and complementary medicine approaches. However, research that tests complementary therapies over a follow-up period and against a placebo treatment is required. Copyright © 2016 Elsevier Ireland Ltd. 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 for all women. As hypothesized, in the prespecified stratum of women who were inactive at baseline (n=51), intervention participants significantly increased their activity by an average of 50 (95% CI 4.0-95.9, P=.03) MVPA minutes per week more than control participants. They had a corresponding statistically significant net increase of 19 (95% CI 3.2-34.8, P=.02) minutes of vigorous activity. Inactive women in the intervention arm also experienced promising reductions in depression, reporting a statistically significant net decrease in their depression score (−3.8, 95% CI −7.0 to −0.6; P=.02). Conclusions We found that a group exercise intervention using videoconferencing and mobile apps was a feasible and acceptable way to deliver a physical activity intervention to mothers. The intervention increased physical activity in inactive mothers. Further studies are needed to better establish how long these changes in physical activity can be maintained and whether these findings can be reproduced in a more diverse population. Trial Registration ClinicalTrials.gov NCT02805140; https://clinicaltrials.gov/ct2/show/NCT02805140 (Archived by WebCite at http://www.webcitation.org/6yYZwRveg) PMID:29776899

Effectiveness and acceptance of a web-based depression intervention during waiting time for outpatient psychotherapy: study protocol for a randomized controlled trial.

PubMed

Grünzig, Sasha-Denise; Baumeister, Harald; Bengel, Jürgen; Ebert, David; Krämer, Lena

2018-05-22

Due to limited resources, waiting periods for psychotherapy are often long and burdening for those in need of treatment and the health care system. In order to bridge the gap between initial contact and the beginning of psychotherapy, web-based interventions can be applied. The implementation of a web-based depression intervention during waiting periods has the potential to reduce depressive symptoms and enhance well-being in depressive individuals waiting for psychotherapy. In a two-arm randomized controlled trial, effectiveness and acceptance of a guided web-based intervention for depressive individuals on a waitlist for psychotherapy are evaluated. Participants are recruited in several German outpatient clinics. All those contacting the outpatient clinics with the wish to enter psychotherapy receive study information and a depression screening. Those adults (age ≥ 18) with depressive symptoms above cut-off (CES-D scale > 22) and internet access are randomized to either intervention condition (treatment as usual and immediate access to the web-based intervention) or waiting control condition (treatment as usual and delayed access to the web-based intervention). At three points of assessment (baseline, post-treatment, 3-months-follow-up) depressive symptoms and secondary outcomes, such as quality of life, attitudes towards psychotherapy and web-based interventions and adverse events are assessed. Additionally, participants' acceptance of the web-based intervention is evaluated, using measures of intervention adherence and satisfaction. This study investigates a relevant setting for the implementation of web-based interventions, potentially improving the provision of psychological health care. The results of this study contribute to the evaluation of innovative and resource-preserving health care models for outpatient psychological treatment. This trial has been registered on 13 February 2017 in the German clinical trials register (DRKS); registration number DRKS00010282 .

Hockey Fans in Training: A Pilot Pragmatic Randomized Controlled Trial

PubMed Central

PETRELLA, ROBERT J.; GILL, DAWN P.; ZOU, GUANGYONG; DE CRUZ, ASHLEIGH; RIGGIN, BRENDAN; BARTOL, CASSANDRA; DANYLCHUK, KAREN; HUNT, KATE; WYKE, SALLY; GRAY, CINDY M.; BUNN, CHRISTOPHER; ZWARENSTEIN, MERRICK

2017-01-01

ABSTRACT Introduction Hockey Fans in Training (Hockey FIT) is a gender-sensitized weight loss and healthy lifestyle program. We investigated 1) feasibility of recruiting and retaining overweight and obese men into a pilot pragmatic randomized controlled trial and 2) potential for Hockey FIT to lead to weight loss and improvements in other outcomes at 12 wk and 12 months. Methods Male fans of two ice hockey teams (35–65 yr; body mass index ≥28 kg·m−2) located in Ontario (Canada) were randomized to intervention (Hockey FIT) or comparator (wait-list control). Hockey FIT includes a 12-wk active phase (weekly, coach-led group meetings including provision of dietary information, practice of behavior change techniques, and safe exercise sessions plus incremental pedometer walking) and a 40-wk minimally supported phase (smartphone app for sustaining physical activity, private online social network, standardized e-mails, booster session/reunion). Measurement at baseline and 12 wk (both groups) and 12 months (intervention group only) included clinical outcomes (e.g., weight) and self-reported physical activity, diet, and self-rated health. Results Eighty men were recruited in 4 wk; trial retention was >80% at 12 wk and >75% at 12 months. At 12 wk, the intervention group lost 3.6 kg (95% confidence interval, −5.26 to −1.90 kg) more than the comparator group (P < 0.001) and maintained this weight loss to 12 months. The intervention group also demonstrated greater improvements in other clinical measures, physical activity, diet, and self-rated health at 12 wk; most sustained to 12 months. Conclusions Results suggest feasible recruitment/retention of overweight and obese men in the Hockey FIT program. Results provide evidence for the potential effectiveness of Hockey FIT for weight loss and improved health in at-risk men and, thus, evidence to proceed with a definitive trial. PMID:28719494

Cost-effectiveness of therapist-guided internet-delivered cognitive behaviour therapy for paediatric obsessive-compulsive disorder: results from a randomised controlled trial.

PubMed

Lenhard, Fabian; Ssegonja, Richard; Andersson, Erik; Feldman, Inna; Rück, Christian; Mataix-Cols, David; Serlachius, Eva

2017-05-17

To evaluate the cost-effectiveness of a therapist-guided internet-delivered cognitive behaviour therapy (ICBT) intervention for adolescents with obsessive-compulsive disorder (OCD) compared with untreated patients on a waitlist. Single-blinded randomised controlled trial. A research clinic within the regular child and adolescent mental health service in Stockholm, Sweden. Sixty-seven adolescents (12-17 years) with a Diagnostic and Statistical Manual of Mental Disorders Fifth Edition diagnosis of OCD. Either a 12-week, therapist-guided ICBT intervention or a wait list condition of equal duration. Cost data were collected at baseline and after treatment, including healthcare use, supportive resources, prescription drugs, prescription-free drugs, school absence and productivity loss, as well as the cost of ICBT. Health outcomes were defined as treatment responder rate and quality-adjusted life years gain. Bootstrapped mixed model analyses were conducted comparing incremental costs and health outcomes between the groups from the societal and healthcare perspectives. Compared with waitlist control, ICBT generated substantial societal cost savings averaging US$-144.98 (95% CI -159.79 to -130.16) per patient. The cost reductions were mainly driven by reduced healthcare use in the ICBT group. From the societal perspective, the probability of ICBT being cost saving compared with waitlist control was approximately 60%. From the healthcare perspective, the cost per additional responder to ICBT compared with waitlist control was approximately US$78. The results suggest that therapist-guided ICBT is a cost-effective treatment and results in societal cost savings, compared with patients who do not receive evidence-based treatment. Since, at present, most patients with OCD do not have access to evidence-based treatments, the results have important implications for the increasingly strained national and healthcare budgets. Future studies should compare the cost-effectiveness of ICBT with regular face-to-face CBT. NCT02191631. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

A Cluster Randomized Trial of Tailored Breastfeeding Support for Women with Gestational Diabetes

PubMed Central

Bonuck, Karen; Adatorwovor, Reuben; Schwartz, Todd A.; Berry, Diane C.

2016-01-01

Abstract Background: Women with gestational diabetes mellitus (GDM) and their infants are at increased risk of developing metabolic disease; however, longer breastfeeding is associated with a reduction in these risks. We tested an intervention to increase breastfeeding duration among women with GDM. Materials and Methods: We conducted a cluster randomized trial to determine the efficacy of a breastfeeding education and support program for women with GDM. Women were enrolled between 22 and 36 weeks of pregnancy and cluster randomized to an experimental lifestyle intervention or wait-list control group. Breastfeeding duration and intensity were prespecified secondary outcomes of the trial. Duration of exclusive and any breastfeeding was assessed at 6 weeks and at 4, 7, and 10 months postpartum. We quantified differences in breastfeeding rates using Kaplan–Meier estimates, log-rank tests, and Cox regression models. Results: We enrolled 100 women, of whom 52% were African American, 31% non-Hispanic white, 11% Hispanic, 9% American Indian or Alaskan Native, 2% Asian, 2% other, and 4% more than one race. In models accounting for within-cluster correlation and adjusted for study site, breastfeeding intention, and African American race, women allocated to the intervention group were less likely to stop breastfeeding (adjusted hazard ratio [HR] 0.40, 95% confidence interval [CI] 0.21–0.74) or to introduce formula (adjusted HR 0.50, 95% CI 0.34–0.72). Conclusion: Our results suggest that targeted breastfeeding education for women with GDM is feasible and efficacious. Clinical Trials Registration: http://clinicaltrials.gov/ct2/show/NCT01809431 PMID:27782758

Tai-Chi for Residential Patients with Schizophrenia on Movement Coordination, Negative Symptoms, and Functioning: A Pilot Randomized Controlled Trial

PubMed Central

Ho, Rainbow T. H.; Au Yeung, Friendly S. W.; Lo, Phyllis H. Y.; Law, Kit Ying; Wong, Kelvin O. K.; Cheung, Irene K. M.; Ng, Siu Man

2012-01-01

Objective. Patients with schizophrenia residing at institutions often suffer from negative symptoms, motor, and functional impairments more severe than their noninstitutionalized counterparts. Tai-chi emphasizes body relaxation, alertness, and movement coordination with benefits to balance, focus, and stress relief. This pilot study explored the efficacy of Tai-chi on movement coordination, negative symptoms, and functioning disabilities towards schizophrenia. Methods. A randomized waitlist control design was adopted, where participants were randomized to receive either the 6-week Tai-chi program and standard residential care or only the latter. 30 Chinese patients with schizophrenia were recruited from a rehabilitation residency. All were assessed on movement coordination, negative symptoms, and functional disabilities at baseline, following intervention and 6 weeks after intervention. Results. Tai-chi buffered from deteriorations in movement coordination and interpersonal functioning, the latter with sustained effectiveness 6 weeks after the class was ended. Controls showed marked deteriorations in those areas. The Tai-chi group also experienced fewer disruptions to life activities at the 6-week maintenance. There was no significant improvement in negative symptoms after Tai-chi. Conclusions. This study demonstrated encouraging benefits of Tai-chi in preventing deteriorations in movement coordination and interpersonal functioning for residential patients with schizophrenia. The ease of implementation facilitates promotion at institutional psychiatric services. PMID:23304224

Tai-chi for residential patients with schizophrenia on movement coordination, negative symptoms, and functioning: a pilot randomized controlled trial.

PubMed

Ho, Rainbow T H; Au Yeung, Friendly S W; Lo, Phyllis H Y; Law, Kit Ying; Wong, Kelvin O K; Cheung, Irene K M; Ng, Siu Man

2012-01-01

Objective. Patients with schizophrenia residing at institutions often suffer from negative symptoms, motor, and functional impairments more severe than their noninstitutionalized counterparts. Tai-chi emphasizes body relaxation, alertness, and movement coordination with benefits to balance, focus, and stress relief. This pilot study explored the efficacy of Tai-chi on movement coordination, negative symptoms, and functioning disabilities towards schizophrenia. Methods. A randomized waitlist control design was adopted, where participants were randomized to receive either the 6-week Tai-chi program and standard residential care or only the latter. 30 Chinese patients with schizophrenia were recruited from a rehabilitation residency. All were assessed on movement coordination, negative symptoms, and functional disabilities at baseline, following intervention and 6 weeks after intervention. Results. Tai-chi buffered from deteriorations in movement coordination and interpersonal functioning, the latter with sustained effectiveness 6 weeks after the class was ended. Controls showed marked deteriorations in those areas. The Tai-chi group also experienced fewer disruptions to life activities at the 6-week maintenance. There was no significant improvement in negative symptoms after Tai-chi. Conclusions. This study demonstrated encouraging benefits of Tai-chi in preventing deteriorations in movement coordination and interpersonal functioning for residential patients with schizophrenia. The ease of implementation facilitates promotion at institutional psychiatric services.

Evaluation of mindfulness-based cognitive therapy for life and a cognitive behavioural therapy stress-management workshop to improve healthcare staff stress: study protocol for two randomised controlled trials.

PubMed

Strauss, Clara; Gu, Jenny; Pitman, Nikki; Chapman, Cavita; Kuyken, Willem; Whittington, Adrian

2018-04-02

Healthcare workers experience higher levels of work-related stress and higher rates of sickness absence than workers in other sectors. Psychological approaches have potential in providing healthcare workers with the knowledge and skills to recognise stress and to manage stress effectively. The strongest evidence for effectiveness in reducing stress in the workplace is for stress-management courses based on cognitive behavioural therapy (CBT) principles and mindfulness-based interventions (MBIs). However, research examining effects of these interventions on sickness absence (an objective indicator of stress) and compassion for others (an indicator of patient care) is limited, as is research on brief CBT stress-management courses (which may be more widely accessible) and on MBIs adapted for workplace settings. This protocol is for two randomised controlled trials with participant preference between the two trials and 1:1 allocation to intervention or wait-list within the preferred choice. The first trial is examining a one-day CBT stress-management workshop and the second trial an 8-session Mindfulness-Based Cognitive Therapy for Life (MBCT-L) course, with both trials comparing intervention to wait-list. The primary outcome for both trials is stress post-intervention with secondary outcomes being sickness absence, compassion for others, depression symptoms, anxiety symptoms, wellbeing, work-related burnout, self-compassion, presenteeism, and mindfulness (MBCT-L only). Both trials aim to recruit 234 staff working in the National Health Service in the UK. This trial will examine whether a one-day CBT stress-management workshop and an 8-session MBCT-L course are effective at reducing healthcare staff stress and other mental health outcomes compared to wait-list, and, whether these interventions are effective at reducing sickness absence and presenteeism and at enhancing wellbeing, self-compassion, mindfulness and compassion for others. Findings will help inform approaches offered to reduce healthcare staff stress and other key variables. A note of caution is that individual-level approaches should only be part of the solution to reducing healthcare staff stress within a broader focus on organisational-level interventions and support. ISRCTN Registry, ISRCTN11723441 . Registered on 16 June 2017. Protocol Version 1: 24 April 2017. Trial Sponsor: Sussex Partnership NHS Foundation Trust (ResearchGovernance@sussexpartnership.nhs.uk).

Can smartphone mental health interventions reduce symptoms of anxiety? A meta-analysis of randomized controlled trials.

PubMed

Firth, Joseph; Torous, John; Nicholas, Jennifer; Carney, Rebekah; Rosenbaum, Simon; Sarris, Jerome

2017-08-15

Various psychological interventions are effective for reducing symptoms of anxiety when used alone, or as an adjunct to anti-anxiety medications. Recent studies have further indicated that smartphone-supported psychological interventions may also reduce anxiety, although the role of mobile devices in the treatment and management of anxiety disorders has yet to be established. We conducted a systematic review and meta-analysis of all randomized clinical trials (RCTs) reporting the effects of psychological interventions delivered via smartphone on symptoms of anxiety (sub-clinical or diagnosed anxiety disorders). A systematic search of major electronic databases conducted in November 2016 identified 9 eligible RCTs, with 1837 participants. Random-effects meta-analyses were used to calculate the standardized mean difference (as Hedges' g) between smartphone interventions and control conditions. Significantly greater reductions in total anxiety scores were observed from smartphone interventions than control conditions (g=0.325, 95% C.I.=0.17-0.48, p<0.01), with no evidence of publication bias. Effect sizes from smartphone interventions were significantly greater when compared to waitlist/inactive controls (g=0.45, 95% C.I.=0.30-0.61, p<0.01) than active control conditions (g=0.19, 95% C.I.=0.07-0.31, p=0.003). The extent to which smartphone interventions can match (or exceed) the efficacy of recognised treatments for anxiety has yet to established. This meta-analysis shows that psychological interventions delivered via smartphone devices can reduce anxiety. Future research should aim to develop pragmatic methods for implementing smartphone-based support for people with anxiety, while also comparing the efficacy of these interventions to standard face-to-face psychological care. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

Effectiveness of an Energy Management Training Course on Employee Well-Being: A Randomized Controlled Trial.

PubMed

Das, Sai Krupa; Mason, Shawn T; Vail, Taylor A; Rogers, Gail V; Livingston, Kara A; Whelan, Jillian G; Chin, Meghan K; Blanchard, Caroline M; Turgiss, Jennifer L; Roberts, Susan B

2018-01-01

Programs focused on employee well-being have gained momentum in recent years, but few have been rigorously evaluated. This study evaluates the effectiveness of an intervention designed to enhance vitality and purpose in life by assessing changes in employee quality of life (QoL) and health-related behaviors. A worksite-based randomized controlled trial. Twelve eligible worksites (8 randomized to the intervention group [IG] and 4 to the wait-listed control group [CG]). Employees (n = 240) at the randomized worksites. A 2.5-day group-based behavioral intervention. Rand Medical Outcomes Survey (MOS) 36-item Short-Form (SF-36) vitality and QoL measures, Ryff Purpose in Life Scale, Center for Epidemiologic Studies questionnaire for depression, MOS sleep, body weight, physical activity, diet quality, and blood measures for glucose and lipids (which were used to calculate a cardiometabolic risk score) obtained at baseline and 6 months. General linear mixed models were used to compare least squares means or prevalence differences in outcomes between IG and CG participants. As compared to CG, IG had a significantly higher mean 6-month change on the SF-36 vitality scale ( P = .003) and scored in the highest categories for 5 of the remaining 7 SF-36 domains: general health ( P = .014), mental health ( P = .027), absence of role limitations due to physical problems ( P = .026), and social functioning ( P = .007). The IG also had greater improvements in purpose in life ( P < .001) and sleep quality (index I, P = .024; index II, P = .021). No statistically significant changes were observed for weight, diet, physical activity, or cardiometabolic risk factors. An intensive 2.5-day intervention showed improvement in employee QoL and well-being over 6 months.

Self-help cognitive behavior therapy for working women with problematic hot flushes and night sweats (MENOS@Work): a multicenter randomized controlled trial.

PubMed

Hardy, Claire; Griffiths, Amanda; Norton, Sam; Hunter, Myra S

2018-05-01

The aim of the study was to examine the efficacy of an unguided, self-help cognitive behavior therapy (SH-CBT) booklet on hot flush and night sweat (HFNS) problem rating, delivered in a work setting. Women aged 45 to 60 years, having 10 or more problematic HFNS a week, were recruited to a multicenter randomized controlled trial, via the occupational health/human resources departments of eight organizations. Participants were 1:1 randomized to SH-CBT or no treatment waitlist control (NTWC). The primary outcome was HFNS problem rating; secondary outcomes included HFNS frequency, work and social adjustment, sleep, mood, beliefs and behaviors, and work-related variables (absence, performance, turnover intention, and work impairment due to presenteeism). Intention-to-treat analysis was used, and between-group differences estimated using linear mixed models. A total of 124 women were randomly allocated to SH-CBT (n = 60) and NTWC (n = 64). 104 (84%) were assessed for primary outcome at 6 weeks and 102 (82%) at 20 weeks. SH-CBT significantly reduced HFNS problem rating at 6 weeks (SH-CBT vs NTWC adjusted mean difference, -1.49; 95% CI, -2.11 to -0.86; P < 0.001) and at 20 weeks (-1.09; 95% CI, -1.87 to -0.31; P < 0.01). SH-CBT also significantly reduced HFNS frequency, improved work and social adjustment; sleep, menopause beliefs, HFNS beliefs/behaviors at 6 and 20 weeks; improved wellbeing and somatic symptoms and reduced work impairment due to menopause-related presenteeism at 20 weeks, compared with the NTWC. There was no difference between groups in other work-related outcomes. A brief, unguided SH-CBT booklet is a potentially effective management option for working women experiencing problematic HFNS.

Doing Anger Differently: Two Controlled Trials of Percussion Group Psychotherapy for Adolescent Reactive Aggression

ERIC Educational Resources Information Center

Currie, Michael; Startup, Mike

2012-01-01

This study evaluates efficacy and effectiveness of "Doing Anger Differently" (DAD), a group treatment for reactively aggressive 12-15 year old males. DAD uses percussion exercises to aid treatment. Study 1 compared a ten-week treatment with a waitlist control at pre, post and 6 month (treatment group only) follow-up. Study 2 replicated Study 1,…

World Health Organization "School Mental Health Manual"-based training for school teachers in Urban Lahore, Pakistan: study protocol for a randomized controlled trial.

PubMed

Imran, Nazish; Rahman, Atif; Chaudhry, Nakhshab; Asif, Aftab

2018-05-24

The teacher's role in school mental health initiatives cannot be overemphasized. Despite global evidence of educational interventions in improving teachers' knowledge and attitudes regarding mental health, this area remains under researched in Pakistan. This paper presents a study protocol of a pilot randomized controlled trial to examine the effectiveness of a teacher training intervention for improving mental health literacy and self-efficacy among school teachers in urban Lahore, Pakistan. The randomized controlled trial will follow the CONSORT guidelines. Participants will be allocated to the Intervention group (receiving the World Health Organization, Eastern Mediterranean Region (WHO-EMRO) School Mental Health Manual-based intervention in three 6-h, face-to-face sessions) or a waitlist control group (not receiving training during the study period). Participants will be teachers of private schools with similar broad demographic characteristics in an inner city area of Lahore. The primary outcome measures for the trial is teachers' mental health literacy. It will be assessed by using the previously applied (during WHO training of Master Trainers) self-administered questionnaire in both groups pre and post training and at 3 months' follow-up. Secondary outcomes include: for teachers: Teachers' self-efficacy (assessed by the Teachers' Sense of Self Efficacy Scale (TSES) short form.); for students (11-16 years): socio-emotional skills and psychological problems measured by the Strengths and Difficulties Questionnaire (assessed at baseline and 3 months post intervention); for schools: the WHO School Psychosocial Profile Questionnaire (baseline and 3 months post intervention). Given the high prevalence of child mental health problems, stigma and lack of services, it is important to consider alternate avenues for promoting positive mental health among youth. This pilot study should establish the effectiveness of the WHO-EMRO School Mental Health Manual-based Intervention improving teacher's mental health literacy and helping them to learn practical steps that can be implemented at low cost in school settings. It will also provide information regarding intervention implementation and sustainability. ClinicalTrials.gov, ID: NCT02937714 . Registered on 18 October 2016.

Narrative exposure therapy for immigrant children traumatized by war: study protocol for a randomized controlled trial of effectiveness and mechanisms of change.

PubMed

Kangaslampi, Samuli; Garoff, Ferdinand; Peltonen, Kirsi

2015-06-17

Millions of children worldwide suffer from posttraumatic stress disorder (PTSD) symptoms and other mental health problems due to repeated exposure to war or organized violence. Forms of cognitive-behavioral therapy (CBT) are the most commonly used treatment for PTSD and appear to be effective for children as well, but little is known about the mechanisms of change through which they achieve their effectiveness. Here we present the study protocol of a randomized controlled trial (RCT) studying the effectiveness and mechanisms of change of Narrative Exposure Therapy (NET), a CBT-based, manualized, short-term intervention for PTSD symptoms resulting from repeated traumatization, in immigrant children traumatized by war. We are conducting a multicentre, pragmatic RCT in a usual care setting. Up to 80 9-17-year-old immigrant children who have experienced war and suffer from PTSD symptoms will be randomized into intervention (NET) and control (treatment as usual, TAU) groups of equal sizes. The effectiveness of NET treatment will be compared to both a waiting list and the parallel TAU positive control group, on the primary outcomes of PTSD and depressive symptoms, psychological distress, resilience, and level of cognitive performance. The effects of the intervention on traumatic memories and posttraumatic cognitions will be studied as potential mechanisms of change mediating overall treatment effectiveness. The possible moderating effects of peritraumatic dissociation, level of cognitive performance, and gender on treatment effectiveness will also be considered. We hypothesize that NET will be more effective than a waitlist condition or TAU in reducing PTSD and other symptoms and improving resilience, and that these effects will be mediated by changes in traumatic memories and posttraumatic cognitions. The results of this trial will provide evidence for the effectiveness of NET in treating trauma-related symptoms in immigrant children affected by war. The trial will also generate insights into the complex relationships between PTSD, memory functions, posttraumatic cognitions and cognitive performance in children, and help guide the future development and implementation of therapeutic interventions for PTSD in children. ClinicalTrials.gov NCT02425280 . Registered 15 April 2015.

A Cluster Randomized Trial of Tailored Breastfeeding Support for Women with Gestational Diabetes.

PubMed

Stuebe, Alison M; Bonuck, Karen; Adatorwovor, Reuben; Schwartz, Todd A; Berry, Diane C

2016-12-01

Women with gestational diabetes mellitus (GDM) and their infants are at increased risk of developing metabolic disease; however, longer breastfeeding is associated with a reduction in these risks. We tested an intervention to increase breastfeeding duration among women with GDM. We conducted a cluster randomized trial to determine the efficacy of a breastfeeding education and support program for women with GDM. Women were enrolled between 22 and 36 weeks of pregnancy and cluster randomized to an experimental lifestyle intervention or wait-list control group. Breastfeeding duration and intensity were prespecified secondary outcomes of the trial. Duration of exclusive and any breastfeeding was assessed at 6 weeks and at 4, 7, and 10 months postpartum. We quantified differences in breastfeeding rates using Kaplan-Meier estimates, log-rank tests, and Cox regression models. We enrolled 100 women, of whom 52% were African American, 31% non-Hispanic white, 11% Hispanic, 9% American Indian or Alaskan Native, 2% Asian, 2% other, and 4% more than one race. In models accounting for within-cluster correlation and adjusted for study site, breastfeeding intention, and African American race, women allocated to the intervention group were less likely to stop breastfeeding (adjusted hazard ratio [HR] 0.40, 95% confidence interval [CI] 0.21-0.74) or to introduce formula (adjusted HR 0.50, 95% CI 0.34-0.72). Our results suggest that targeted breastfeeding education for women with GDM is feasible and efficacious. http://clinicaltrials.gov/ct2/show/NCT01809431.

Medium-term effectiveness of online behavioral training in migraine self-management: A randomized trial controlled over 10 months.

PubMed

Sorbi, M J; Kleiboer, A M; van Silfhout, H G; Vink, G; Passchier, J

2015-06-01

This randomized, controlled trial examined the medium-term effectiveness of online behavioral training in migraine self-management (oBT; N = 195) versus waitlist control (WLC; N = 173) on attack frequency, indicators of self-management (primary outcomes), headache top intensity, use of rescue medications, quality of life and disability (secondary outcomes). An online headache diary following the ICHD-II and questionnaires were completed at baseline (T0), post-training (T1) and six months later (T2). Missing data (T1: 24%; T2: 37%) were handled by multiple imputation. We established effect sizes (ES) and tested between-group differences over time with linear mixed modelling techniques based on the intention-to-treat principle. At T2, attack frequency had improved significantly in oBT (-23%, ES = 0.66) but also in WLC (-19%; ES = 0.52). Self-efficacy, internal and external control in migraine management--and triptan use--improved only in oBT, however. This indicates different processes in both groups and could signify (the start of) active self-management in oBT. Also, only oBT improved migraine-specific quality of life to a sizable extent. oBT produced self-management gains but could not account for improved attack frequency, because WLC improved as well. The perspective that BT effects develop gradually, and that online delivery will boost BT outreach, justifies further research. © International Headache Society 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

A mental health intervention for schoolchildren exposed to violence: a randomized controlled trial.

PubMed

Stein, Bradley D; Jaycox, Lisa H; Kataoka, Sheryl H; Wong, Marleen; Tu, Wenli; Elliott, Marc N; Fink, Arlene

2003-08-06

No randomized controlled studies have been conducted to date on the effectiveness of psychological interventions for children with symptoms of posttraumatic stress disorder (PTSD) that has resulted from personally witnessing or being personally exposed to violence. To evaluate the effectiveness of a collaboratively designed school-based intervention for reducing children's symptoms of PTSD and depression that has resulted from exposure to violence. A randomized controlled trial conducted during the 2001-2002 academic year. Sixth-grade students at 2 large middle schools in Los Angeles who reported exposure to violence and had clinical levels of symptoms of PTSD. Students were randomly assigned to a 10-session standardized cognitive-behavioral therapy (the Cognitive-Behavioral Intervention for Trauma in Schools) early intervention group (n = 61) or to a wait-list delayed intervention comparison group (n = 65) conducted by trained school mental health clinicians. Students were assessed before the intervention and 3 months after the intervention on measures assessing child-reported symptoms of PTSD (Child PTSD Symptom Scale; range, 0-51 points) and depression (Child Depression Inventory; range, 0-52 points), parent-reported psychosocial dysfunction (Pediatric Symptom Checklist; range, 0-70 points), and teacher-reported classroom problems using the Teacher-Child Rating Scale (acting out, shyness/anxiousness, and learning problems; range of subscales, 6-30 points). Compared with the wait-list delayed intervention group (no intervention), after 3 months of intervention students who were randomly assigned to the early intervention group had significantly lower scores on symptoms of PTSD (8.9 vs 15.5, adjusted mean difference, - 7.0; 95% confidence interval [CI], - 10.8 to - 3.2), depression (9.4 vs 12.7, adjusted mean difference, - 3.4; 95% CI, - 6.5 to - 0.4), and psychosocial dysfunction (12.5 vs 16.5, adjusted mean difference, - 6.4; 95% CI, -10.4 to -2.3). Adjusted mean differences between the 2 groups at 3 months did not show significant differences for teacher-reported classroom problems in acting out (-1.0; 95% CI, -2.5 to 0.5), shyness/anxiousness (0.1; 95% CI, -1.5 to 1.7), and learning (-1.1, 95% CI, -2.9 to 0.8). At 6 months, after both groups had received the intervention, the differences between the 2 groups were not significantly different for symptoms of PTSD and depression; showed similar ratings for psychosocial function; and teachers did not report significant differences in classroom behaviors. A standardized 10-session cognitive-behavioral group intervention can significantly decrease symptoms of PTSD and depression in students who are exposed to violence and can be effectively delivered on school campuses by trained school-based mental health clinicians.

Efficacy of a workplace-based weight loss program for overweight male shift workers: the Workplace POWER (Preventing Obesity Without Eating like a Rabbit) randomized controlled trial.

PubMed

Morgan, Philip J; Collins, Clare E; Plotnikoff, Ronald C; Cook, Alyce T; Berthon, Bronwyn; Mitchell, Simon; Callister, Robin

2011-05-01

To evaluate the feasibility and efficacy of a workplace-based weight loss program (Workplace POWER-WP) for male shift workers. A prospective, two-armed randomized controlled trial of 110 overweight/obese (BMI 25-40) (mean [SD] age = 44.4 [8.6] years; BMI = 30.5 [3.6]) male employees at Tomago Aluminium aged 18-65. In October (2009) men were randomized to either (i) WP program (n=65) or (ii) a 14-week wait-list control group (n=45). The 3-month program involved one information session, program booklets, group-based financial incentives and an online component. Men were assessed at baseline and at 14-week follow-up for weight (primary outcome), waist circumference, BMI, blood pressure, resting heart rate, self-reported physical activity and dietary variables, and physical activity and dietary cognitions. Intention-to-treat analysis using linear mixed models revealed significant between group differences for weight loss after 14 weeks (P < .001, Cohen's d = 0.34). Significant intervention effects were also found for waist circumference (P < .001, d = 0.63), BMI (P < .001, d = 0.41), systolic blood pressure (P = .02, d = 0.48), resting heart rate (P < .001, d = 0.81), physical activity (P = .03, d = 0.77), sweetened beverages (P < .02, d = 0.5-0.6) and physical activity-related cognitions (P < .02, d=0.6). The WP program was feasible and efficacious and resulted in significant weight loss and improved health-related outcomes and behaviours in overweight male shift workers. Copyright © 2011 Elsevier Inc. All rights reserved.

Evaluation of an Australian Alcohol Media Literacy Program.

PubMed

Gordon, Chloe S; Howard, Steven J; Jones, Sandra C; Kervin, Lisa K

2016-11-01

A 10-lesson alcohol media literacy program was developed, underpinned by the message interpretation processing model, inoculation theory, and constructivist learning theory, and was tailored to be culturally relevant to the Australian context. This program aimed to increase students' media deconstruction skills and reduce intent to drink alcohol. The purpose of this study was to evaluate the effectiveness of the program in achieving these goals through a short-term quasi-experimental trial. Elementary schools were assigned to either the intervention group (83 students) or a wait-list control group (82 students). Student questionnaires were administered at three time points (baseline, after the intervention group completed the program, and after the wait-list control group completed the program) to evaluate the effectiveness of the intervention. The intervention and wait-list control groups reported significantly higher media deconstruction skills as a result of the intervention. Both groups reported significantly lower social norms, whereas the wait-list control group reported significantly lower positive alcohol expectancies. There were no significant changes to self-efficacy to refuse alcohol, preference for alcohol-branded merchandise, and understanding of persuasive intent as a result of the intervention. To date, the majority of alcohol media literacy studies have been conducted in the United States and have focused on deconstructing television and print-based ads. This evaluation provides evidence that an alcohol media literacy program that was developed for a specific cultural context, and that incorporates a broad range of multimodal advertisements, can have a positive impact on beliefs and attitudes that are known predictors/precursors of drinking behaviors.

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

PubMed

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

2013-04-01

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

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

PubMed Central

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

2013-01-01

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

A pilot study of the efficacy of a computerized executive functioning remediation training with game elements for children with ADHD in an outpatient setting: outcome on parent- and teacher-rated executive functioning and ADHD behavior.

PubMed

van der Oord, S; Ponsioen, A J G B; Geurts, H M; Ten Brink, E L; Prins, P J M

2014-11-01

This pilot study tested the short- and long-term efficacy (9 weeks follow-up) of an executive functioning (EF) remediation training with game elements for children with ADHD in an outpatient clinical setting, using a randomized controlled wait-list design. Furthermore, in a subsample, that is, those treated with methylphenidate, additive effects of the EF training were assessed. A total of 40 children (aged 8-12 years) were randomized to the EF training or wait-list. The training consisted of a 25-session training of inhibition, cognitive flexibility, and working memory. Treatment outcome was assessed by parent- and teacher-rated EF, ADHD, oppositional deviant disorder, and conduct disorder symptoms. Children in the EF training showed significantly more improvement than those in the wait-list condition on parent-rated EF and ADHD behavior in the total sample and in the subsample treated with methylphenidate. Effects were maintained at follow-up. This pilot study shows promising evidence for the efficacy of an EF training with game elements. © 2012 SAGE Publications.

Integrating fragmented evidence by network meta-analysis: relative effectiveness of psychological interventions for adults with post-traumatic stress disorder.

PubMed

Gerger, H; Munder, T; Gemperli, A; Nüesch, E; Trelle, S; Jüni, P; Barth, J

2014-11-01

To summarize the available evidence on the effectiveness of psychological interventions for patients with post-traumatic stress disorder (PTSD). We searched bibliographic databases and reference lists of relevant systematic reviews and meta-analyses for randomized controlled trials that compared specific psychological interventions for adults with PTSD symptoms either head-to-head or against control interventions using non-specific intervention components, or against wait-list control. Two investigators independently extracted the data and assessed trial characteristics. The analyses included 4190 patients in 66 trials. An initial network meta-analysis showed large effect sizes (ESs) for all specific psychological interventions (ESs between -1.10 and -1.37) and moderate effects of psychological interventions that were used to control for non-specific intervention effects (ESs -0.58 and -0.62). ES differences between various types of specific psychological interventions were absent to small (ES differences between 0.00 and 0.27). Considerable between-trial heterogeneity occurred (τ²= 0.30). Stratified analyses revealed that trials that adhered to DSM-III/IV criteria for PTSD were associated with larger ESs. However, considerable heterogeneity remained. Heterogeneity was reduced in trials with adequate concealment of allocation and in large-sized trials. We found evidence for small-study bias. Our findings show that patients with a formal diagnosis of PTSD and those with subclinical PTSD symptoms benefit from different psychological interventions. We did not identify any intervention that was consistently superior to other specific psychological interventions. However, the robustness of evidence varies considerably between different psychological interventions for PTSD, with most robust evidence for cognitive behavioral and exposure therapies.

Weight management for overweight and obese men delivered through professional football clubs: a pilot randomized trial

PubMed Central

2013-01-01

Background The prevalence of male obesity is increasing, but men are less likely than women to attend existing weight management programmes. We have taken a novel approach to reducing perceived barriers to weight loss for men by using professional football (soccer) clubs to encourage participation in a weight management group programme, gender-sensitised in content and style of delivery. Football Fans in Training (FFIT) provides 12 weeks of weight loss, physical activity and healthy eating advice at top professional football clubs in Scotland. This pilot randomized trial explored the feasibility of using these clubs as a setting for a randomized controlled trial of 12 month weight loss following men’s participation in FFIT. Methods A two-arm pilot trial at two Scottish Premier League football clubs (one large, one smaller), with 103 men (aged 35–65, body mass index (BMI) ≥27 kg/m2) individually randomized to the intervention (n=51, received the pilot programme (p-FFIT) immediately) and waitlist comparison (n=52, received p-FFIT after four months) groups. Feasibility of recruitment, randomization, data collection and retention were assessed. Objective physical measurements (weight, waist circumference, blood pressure, body composition) and questionnaires (self-reported physical activity, diet, alcohol consumption, psychological outcomes) were obtained from both groups by fieldworkers trained to standard protocols at baseline and 12 weeks, and from the intervention group at 6 and 12 months. Qualitative methods elicited men’s experiences of participation in the pilot trial. Results Following a short recruitment period, the recruitment target was achieved at the large, but not smaller, club. Participants’ mean age was 47.1±8.4 years; mean BMI 34.5±5.0 kg/m2. Retention through the trial was good (>80% at 12 weeks and 6 months; >75% at 12 months), and 76% attended at least 80% of available programme delivery sessions. At 12 weeks, the intervention group lost significantly more weight than the comparison group (4.6% c.f. -0.6%, p<.001) and many maintained this to 12 months (intervention group baseline-12 month weight loss: 3.5%, p<.001). There were also improvements in self-reported physical activity and diet, many sustained long term. Conclusions The results demonstrated the feasibility of trial procedures and the potential of FFIT to engage men in sustained weight loss and positive lifestyle change. They supported the conduct of a fully-powered randomized controlled trial. PMID:24171842

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

PubMed

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

2016-01-01

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

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

PubMed Central

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

2016-01-01

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

Effectiveness of a Web-Based Guided Self-help Intervention for Outpatients With a Depressive Disorder: Short-term Results From a Randomized Controlled Trial

PubMed Central

Cuijpers, Pim; Beekman, Aartjan; van Straten, Annemieke

2016-01-01

Background Research has convincingly demonstrated that symptoms of depression can be reduced through guided Internet-based interventions. However, most of those studies recruited people form the general population. There is insufficient evidence for the effectiveness when delivered in routine clinical practice in outpatient clinics. Objective The objective of this randomized controlled trial was to study patients with a depressive disorder (as defined by the Diagnostic and Statistical Manual of Disorders, fourth edition), as assessed by trained interviewers with the Composite International Diagnostic Interview, who registered for treatment at an outpatient mental health clinic. We aimed to examine the effectiveness of guided Internet-based self-help before starting face-to-face treatment. Methods We recruited 269 outpatients, aged between 18 and 79 years, from outpatient clinics and randomly allocated them to Internet-based problem solving therapy (n=136), with weekly student support, or to a control condition, who remained on the waitlist with a self-help booklet (control group; n=133). Participants in both conditions were allowed to take up face-to-face treatment at the outpatient clinics afterward. We measured the primary outcome, depressive symptoms, by Center for Epidemiological Studies Depression scale (CES-D). Secondary outcome measures were the Hospital Anxiety and Depression Scale Anxiety subscale (HADS-A), Insomnia Severity Index questionnaire (ISI), and EuroQol visual analog scale (EQ-5D VAS). All outcomes were assessed by telephone at posttest (8 weeks after baseline). Results Posttest measures were completed by 184 (68.4%) participants. We found a moderate to large within-group effect size for both the intervention (d=0.75) and the control (d=0.69) group. However, the between-group effect size was very small (d=0.07), and regression analysis on posttreatment CES-D scores revealed no significant differences between the groups (b=1.134, 95% CI –2.495 to 4.763). The per-protocol analysis (≥4 sessions completed) results were also not significant (b=1.154, 95% CI –1.978 to 7.637). Between-group differences were small and not significant for all secondary outcomes. Adherence to the intervention was low. Only 36% (49/136) received an adequate dosage of the intervention (≥4 of 5 sessions). The overall treatment satisfaction was moderate. Conclusions Internet-based problem solving therapy is not more effective in reducing symptoms of depression than receiving an unguided self-help book during the waitlist period at outpatient mental health clinics. The effect sizes are much smaller than those found in earlier research in the general population, and the low rates of adherence indicate that the acceptability of the intervention at this stage of treatment for depressed outpatients is low. However, taking into account that there is much evidence for the efficacy of Internet-based treatments, it is too early to draw firm conclusions about the effectiveness of these treatments in outpatient clinics as a whole. Trial Registration Netherlands Trial Register NTR2824; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2824 (Archived by WebCite at http://www.webcitation/ 6g3WEuiqH) PMID:27032449

Acceptability and feasibility of an e-mental health intervention for parents of childhood cancer survivors: "Cascade".

PubMed

Wakefield, Claire E; Sansom-Daly, Ursula M; McGill, Brittany C; Ellis, Sarah J; Doolan, Emma L; Robertson, Eden G; Mathur, Sanaa; Cohn, Richard J

2016-06-01

The aim of this study was to evaluate the feasibility and acceptability of "Cascade": an online, group-based, cognitive behavioral therapy intervention, delivered "live" by a psychologist, to assist parents of children who have completed cancer treatment. Forty-seven parents were randomized to Cascade (n = 25) or a 6-month waitlist (n = 22). Parents completed questionnaires at baseline, 1-2 weeks and 6 months post-intervention. Thirty parents completed full evaluations of the Cascade program (n = 21 randomized to Cascade, n = 9 completed Cascade post-waitlist). Ninety-six percent of Cascade participants completed the intervention (n = 24/25). Eighty percent of parents completed every questionnaire (mean completion time 25 min (SD = 12)). Cascade was described as at least "somewhat" helpful by all parents. None rated Cascade as "very/quite" burdensome. Parents reported that the "online format was easy to use" (n = 28, 93.3 %), "I learnt new skills" (n = 28, 93.3 %), and "I enjoyed talking to others" (n = 29, 96.7 %). Peer-to-peer benefits were highlighted by good group cohesion scores. Cascade is highly acceptable and feasible. Its online delivery mechanism may address inequities in post-treatment support for parents, a particularly acute concern for rural/remote families. Future research needs to establish the efficacy of the intervention. ACTRN12613000270718, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12613000270718.

Effect of YH0618 soup on chemotherapy-induced toxicity in patients with cancer who have completed chemotherapy: study protocol for a randomized controlled trial.

PubMed

You, Jie-Shu; Chen, Jian-Ping; Chan, Jessie S M; Lee, Ho-Fun; Wong, Mei-Kuen; Yeung, Wing-Fai; Lao, Li-Xing

2016-07-26

The incidence of cancer has been staying at a high level worldwide in recent years. With advances in cancer diagnosis and therapy strategy, the survival rate of patients with cancer has been increasing, but the side effects of these treatments, especially chemotherapy, are obvious even when the chemotherapy ceases. YH0618, a prescription, has showed efficacy in reducing chemotherapy-induced toxicity through long clinical practice. However, there is no scientific research exploring the effects of YH0618 in patients with cancer. Therefore, using a randomized controlled trial, this study will explore the efficacy of YH0618 on ameliorating chemotherapy-induced toxicity including dermatologic toxicity, myelosuppression, hepatotoxicity and nephrotoxicity and improving fatigue in cancer patients who have completed chemotherapy. This is a prospective assessor-blinded, parallel, randomized controlled trial. Patients with cancer at any stage who have completed chemotherapy within two weeks will be randomly divided into group A (YH0618) and group B (wait-list) using a 1:1 allocation ratio. The chemotherapeutic agents include taxanes or anthracyclines. Subjects assigned to group A will receive YH0618 soup 6 days a week for 6 weeks and uncontrolled follow-up for 6 weeks, while group B are required to wait for 6 weeks before receiving YH0618 intervention. The primary outcome of this study is the incidence of protocol-specified grade ≥2 dermatologic toxicities graded by NCI CTCAE Chinese version 4.0 and changes of fingernail color, face skin color and tongue color evaluated by the L*a*b system within 6 weeks. There are some secondary outcomes associated with dermatologic toxicity including fatigue and clinical objective examination. There are few scientific and safe methods in ameliorating chemotherapy-induced toxicity. The proposed study may provide direct and convincing evidence to support YH0618 as an adjuvant treatment for reducing chemotherapy-induced toxicity, which could be introduced into clinical settings. Chinese Clinical Trial Registry: ChiCTR-IOR-15006486 . Registered on 21 May 2015.

Running versus Weight Lifting in the Treatment of Depression.

ERIC Educational Resources Information Center

Doyne, Elizabeth J.; And Others

1987-01-01

Compared effectiveness of aerobic and nonaerobic exercise in treatment of clinical depression in women. Forty women with a depressive disorder were randomly assigned to eight-week running (aerobic), weight-lifting (nonaerobic), or wait-list control condition. Both exercise conditions significantly reduced depression; exercise conditions appeared…

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.

Cognitive-Behavioral Therapy for PANDAS-Related Obsessive-Compulsive Disorder: Findings From A Preliminary Waitlist Controlled Open Trial

ERIC Educational Resources Information Center

Storch, Eric A.; Murphy, Tanya K.; Geffken, Gary R.; Mann, Giselle; Adkins, Jennifer; Merlo, Lisa J.; Duke, Danny; Munson, Melissa; Swaine, Zoe; Goodman, Wayne K.

2006-01-01

Objective: To provide preliminary estimates of the effectiveness of cognitive-behavioral therapy (CBT) in treating pediatric obsessive-compulsive disorder (OCD) of the pediatric autoimmune neuropsychiatric disorders associated with streptococcus (PANDAS) subtype. Method: Seven children with OCD of the PANDAS subtype (range 9-13 years) were treated…

Anxiety trajectories in response to a speech task in social anxiety disorder: Evidence from a randomized controlled trial of CBT

PubMed Central

Morrison, Amanda S.; Brozovich, Faith A.; Lee, Ihno A.; Jazaieri, Hooria; Goldin, Philippe R.; Heimberg, Richard G.; Gross, James J.

2016-01-01

The subjective experience of anxiety plays a central role in cognitive behavioral models of social anxiety disorder (SAD). However, much remains to be learned about the temporal dynamics of anxiety elicited by feared social situations. The aims of the current study were: 1) to compare anxiety trajectories during a speech task in individuals with SAD (n = 135) versus healthy controls (HCs; n = 47), and 2) to compare the effects of CBT on anxiety trajectories with a waitlist control condition. SAD was associated with higher levels of anxiety and greater increases in anticipatory anxiety compared to HCs, but not differential change in anxiety from pre- to post-speech. CBT was associated with decreases in anxiety from pre- to post-speech but not with changes in absolute levels of anticipatory anxiety or rates of change in anxiety during anticipation. The findings suggest that anticipatory experiences should be further incorporated into exposures. PMID:26760456

Anxiety trajectories in response to a speech task in social anxiety disorder: Evidence from a randomized controlled trial of CBT.

PubMed

Morrison, Amanda S; Brozovich, Faith A; Lee, Ihno A; Jazaieri, Hooria; Goldin, Philippe R; Heimberg, Richard G; Gross, James J

2016-03-01

The subjective experience of anxiety plays a central role in cognitive behavioral models of social anxiety disorder (SAD). However, much remains to be learned about the temporal dynamics of anxiety elicited by feared social situations. The aims of the current study were: (1) to compare anxiety trajectories during a speech task in individuals with SAD (n=135) versus healthy controls (HCs; n=47), and (2) to compare the effects of CBT on anxiety trajectories with a waitlist control condition. SAD was associated with higher levels of anxiety and greater increases in anticipatory anxiety compared to HCs, but not differential change in anxiety from pre- to post-speech. CBT was associated with decreases in anxiety from pre- to post-speech but not with changes in absolute levels of anticipatory anxiety or rates of change in anxiety during anticipation. The findings suggest that anticipatory experiences should be further incorporated into exposures. Copyright © 2015 Elsevier Ltd. All rights reserved.

Effects of a Cognitive Rehearsal Program on Interpersonal Relationships, Workplace Bullying, Symptom Experience, and Turnover Intention among Nurses: A Randomized Controlled Trial.

PubMed

Kang, Jiyeon; Kim, Jeung Im; Yun, Seonyoung

2017-10-01

This research aimed to investigate the effects of a cognitive rehearsal program (CRP) on workplace bullying among nurses. A randomized controlled trial was performed. Participants were 40 nurses working in different university hospitals in B city, South Korea. The experimental group was provided with a 20-hour CRP comprising scenarios on bullying situations, standard communication, and role-playing. To evaluate effects of the CRP, we measured interpersonal relationships, workplace bullying, symptom experience, and turnover intention at preand post-intervention. Follow-up effect was measured in the experimental group only at 4 weeks after the intervention. After the intervention, there were significant differences in interpersonal relationships (F=6.21, p=.022) and turnover intention (F=5.55, p=.024) between experimental and wait-list groups. However, there was no significant difference in workplace bullying or symptom experience between the 2 groups. The beneficial effects on interpersonal relationships and turnover intention lasted at least up to 4 weeks after CRP. The CRP for workplace bullying improves interpersonal relationships and decreases turnover intention. So it can be utilized as one of the personal coping strategies to reduce the the turnover among nurses. Further studies on the effects of unit- or hospital-based CRP and on the long-term effects of CRP are necessary. © 2017 Korean Society of Nursing Science

Promoting young children's interpersonal safety knowledge, intentions, confidence, and protective behavior skills: Outcomes of a randomized controlled trial.

PubMed

White, Codi; Shanley, Dianne C; Zimmer-Gembeck, Melanie J; Walsh, Kerryann; Hawkins, Russell; Lines, Katrina; Webb, Haley

2018-06-11

Promoting young children's interpersonal safety knowledge, intentions confidence and skills is the goal of many child maltreatment prevention programs; however, evaluation of their effectiveness has been limited. In this study, a randomized controlled trial was conducted examining the effectiveness of the Australian protective behaviors program, Learn to be safe with Emmy and friends™ compared to a waitlist condition. In total, 611 Australian children in Grade 1 (5-7 years; 50% male) participated, with assessments at Pre-intervention, Post-intervention and a 6-month follow-up. This study also included a novel assessment of interpersonal safety skills through the Observed Protective Behaviors Test (OPBT). Analyses showed participating in Learn to be safe with Emmy and friends™ was effective post-program in improving interpersonal safety knowledge (child and parent-rated) and parent-rated interpersonal safety skills. These benefits were retained at the 6-month follow-up, with participating children also reporting increased disclosure confidence. However, Learn to be safe with Emmy and friends™ participation did not significantly impact children's disclosure intentions, safety identification skills, or interpersonal safety skills as measured by the OPBT. Future research may seek to evaluate the effect of further parent and teacher integration into training methods and increased use of behavioral rehearsal and modelling to more effectively target specific disclosure intentions and skills. Copyright © 2018 Elsevier Ltd. All rights reserved.

The effects of video-game training on broad cognitive transfer in multiple sclerosis: A pilot randomized controlled trial.

PubMed

Janssen, Alisha; Boster, Aaron; Lee, HyunKyu; Patterson, Beth; Prakash, Ruchika Shaurya

2015-01-01

Multiple sclerosis (MS) is a neurodegenerative disease of the central nervous system that results in diffuse nerve damage and associated physical and cognitive impairments. Of the few comprehensive rehabilitation options that exist for populations with lower baseline cognitive functioning, those that have been successful at eliciting broad cognitive improvements have focused on a multimodal training approach, emphasizing complex cognitive processing that utilizes multiple domains simultaneously. The current study sought to determine the feasibility of an 8-week, hybrid-variable priority training (HVT) program, with a secondary aim to assess the success of this training paradigm at eliciting broad cognitive transfer effects. Capitalizing on the multimodal training modalities offered by the Space Fortress platform, we compared the HVT strategy-based intervention with a waitlist control group, to primarily assess skill acquisition and secondarily determine presence of cognitive transfer. Twenty-eight participants met inclusionary criteria for the study and were randomized to either training or waitlist control groups. To assess broad transfer effects, a battery of neuropsychological tests was administered pre- and post-intervention. The results indicated an overall improvement in skill acquisition and evidence for the feasibility of the intervention, but a lack of broad transfer to tasks of cognitive functioning. Participants in the training group, however, did show improvements on a measure of spatial short-term memory. The current investigation provided support for the feasibility of a multimodal training approach, using the HVT strategy, within the MS population, but lacked broad transfer to multiple domains of cognitive functioning. Future improvements to obtain greater cognitive transfer efficacy would include a larger sample size, a longer course of training to evoke greater game score improvement, the inclusion of only cognitively impaired individuals, and integration of subjective measures of improvement in addition to objective tests of cognitive performance.

Structuring Process Evaluation to Forecast Use and Sustainability of an Intervention: Theory and Data From the Efficacy Trial for Lunch Is in the Bag.

PubMed

Roberts-Gray, Cindy; Sweitzer, Sara J; Ranjit, Nalini; Potratz, Christa; Rood, Magdalena; Romo-Palafox, Maria Jose; Byrd-Williams, Courtney E; Briley, Margaret E; Hoelscher, Deanna M

2017-08-01

A cluster-randomized trial at 30 early care and education centers (Intervention = 15, waitlist Control = 15) showed the Lunch Is in the Bag intervention increased parents' packing of fruits, vegetables, and whole grains in their preschool children's bag lunches (parent-child dyads = 351 Intervention, 282 Control). To examine the utility of structuring the trial's process evaluation to forecast use, sustainability, and readiness of the intervention for wider dissemination and implementation. Pretrial, the research team simulated user experience to forecast use of the intervention. Multiattribute evaluation of user experience measured during the trial assessed use and sustainability of the intervention. Thematic analysis of posttrial interviews with users evaluated sustained use and readiness for wider dissemination. Moderate use was forecast by the research team. Multiattribute evaluation of activity logs, surveys, and observations during the trial indicated use consistent with the forecast except that prevalence of parents reading the newsletters was greater (83% vs. 50%) and hearing their children talk about the classroom was less (4% vs. 50%) than forecast. Early care and education center-level likelihood of sustained use was projected to be near zero. Posttrial interviews indicated use was sustained at zero centers. Structuring the efficacy trial's process evaluation as a progression of assessments of user experience produced generally accurate forecasts of use and sustainability of the intervention at the trial sites. This approach can assist interpretation of trial outcomes, aid decisions about dissemination of the intervention, and contribute to translational science for improving health.

Internet-Based, Culturally Sensitive, Problem-Solving Therapy for Turkish Migrants With Depression: Randomized Controlled Trial

PubMed Central

van 't Hof, Edith; van Ballegooijen, Wouter; Christensen, Helen; Riper, Heleen

2013-01-01

Background Turkish migrants living in the Netherlands have a high prevalence of depressive disorders, but experience considerable obstacles to accessing professional help. Providing easily accessible Internet treatments may help to overcome these barriers. Objective The aim of this study was to evaluate the effectiveness of a culturally sensitive, guided, self-help, problem-solving intervention through the Internet for reducing depressive symptoms in Turkish migrants. Methods A two-armed randomized controlled trial was conducted. The primary outcome measure was the severity of depressive symptoms; secondary outcome measures were somatic symptoms, anxiety, quality of life, and satisfaction with the treatment. Participants were assessed online at baseline, posttest (6 weeks after baseline), and 4 months after baseline. Posttest results were analyzed on the intention-to-treat sample. Missing values were estimated by means of multiple imputation. Differences in clinical outcome between groups were analyzed with a t test. Cohen’s d was used to determine the between-groups effect size at posttreatment and follow-up. Results Turkish adults (N=96) with depressive symptoms were randomized to the experimental group (n=49) or to a waitlist control group (n=47). High attrition rates were found among the 96 participants of which 42% (40/96) did not complete the posttest (6 weeks) and 62% (59/96) participants did not complete the follow-up assessment at 4 months. No significant difference between the experimental group and the control group was found for depression at posttest. Recovery occurred significantly more often in the experimental group (33%, 16/49) than in the control group (9%, 4/47) at posttest (P=.02). Because of the high attrition rate, a completers-only analysis was conducted at follow-up. The experimental group showed significant improvement in depression compared to the control group both at posttest (P=.01) and follow-up (P=.01). Conclusions The results of this study did not show a significant effect on the reduction of depressive symptoms. However, the effect size at posttest was high, which might be an indicator of the possible effectiveness of the intervention when assessed in a larger sample and robust trial. Future research should replicate our study with adequately powered samples. Trial Registration Dutch Trial Register: NTR2303. http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2303 (Archived by WebCite at http://www.webcitation.org/6IOxNgoDu). PMID:24121307

Do Mothers Benefit from a Child-Focused Cognitive Behavioral Treatment (CBT) for Childhood Functional Abdominal Pain? A Randomized Controlled Pilot Trial

PubMed Central

Calvano, Claudia; Groß, Martina; Warschburger, Petra

2017-01-01

While the efficacy of cognitive-behavioral treatment (CBT) approaches for childhood functional abdominal pain (FAP) is well-established for child outcomes, only a few studies have reported on parent-specific outcomes. This randomized controlled pilot trial analyzed effects of a group CBT on maternal variables (i.e., pain-related behavior, worries and self-efficacy, as well as general psychosocial strain). Methods: The sample constituted of 15 mothers in the intervention group (IG) and 14 mothers in the waitlist control group (WLC). Outcome measures were assessed pre-treatment, post-treatment and at three months follow-up. Results: Analyses revealed significant, large changes in maladaptive maternal reactions related to the child’s abdominal pain in the IG compared to the WLC—i.e., reduced attention (d = 0.95), medical help-seeking (d = 0.92), worries (d = 1.03), as well as a significant increase in behaviors that encourage the child’s self-management (d = 1.03). In addition, maternal self-efficacy in dealing with a child’s pain significantly increased in the IG as well (d = 0.92). Treatment effects emerged post-treatment and could be maintained until three months follow-up. There were no effects on general self-efficacy and maternal quality of life. Conclusion: While these results are promising, and underline the efficacy of the CBT approach for both the child and mothers, further studies, including long-term follow-ups, are warranted. PMID:28212279

Demographic factors and weight change in a worksite weight loss intervention

USDA-ARS?s Scientific Manuscript database

Worksites are increasingly being considered as locations for weight loss programs. We examined predictors of weight loss in employees participating in a 6 month randomized study of a weight loss intervention versus wait-listed control at 4 worksites (2 for-profit and 2 non-profit). Measures included...

Treatment Outcome and Maintenance in Systematic Desensitization: Professional versus Paraprofessional Effectiveness.

ERIC Educational Resources Information Center

Shelton, John L.; Madrazo-Peterson, Rita

1978-01-01

Anxious students were randomly assigned to a wait-list control group; to three groups aided by experienced behavior therapists; or to three groups led by paraprofessionals. Results show paraprofessionals can achieve outcome and maintenance effects equivalent to more rigorously trained professionals. Paraprofessionals can conduct desensitization in…

Changes in Self-Perception During Treatment of Social Phobia

ERIC Educational Resources Information Center

Hofmann, Stefan G.; Moscovitch, David A.; Kim, Hyo-Jin; Taylor, Andrea N.

2004-01-01

Ninety individuals with social phobia were randomly assigned to a waitlist control group, a cognitive-behavioral therapy group, or an exposure therapy group without explicit cognitive intervention. Two independent raters classified more than 2,000 thoughts that were reported by participants while anticipating socially stressful situations at…

Effect of peer education on stroke prevention: the prevent recurrence of all inner-city strokes through education randomized controlled trial.

PubMed

Kronish, Ian M; Goldfinger, Judith Z; Negron, Rennie; Fei, Kezhen; Tuhrim, Stanley; Arniella, Guedy; Horowitz, Carol R

2014-11-01

Efforts to reduce disparities in recurrent stroke among Black and Latino stroke survivors have met with limited success. We aimed to determine the effect of peer education on secondary stroke prevention among predominantly minority stroke survivors. Between 2009 and 2012, we enrolled 600 stroke or transient ischemic attack survivors from diverse, low-income communities in New York City into a 2-arm randomized clinical trial that compared a 6 week (1 session/week), peer-led, community-based, stroke prevention self-management group workshop (N=301) to a wait-list control group (N=299). The primary outcome was the proportion with a composite of controlled blood pressure (<140/90 mm Hg), low-density lipoprotein cholesterol <100 mg/dL, and use of antithrombotic medications at 6 months. Secondary outcomes included control of the individual stroke risk factors. All analyses were by intent-to-treat. There was no difference in the proportion of intervention and control group participants achieving the composite outcome (34% versus 34%; P=0.98). The proportion with controlled blood pressure at 6 months was greater in the intervention group than in the control group (76% versus 67%; P=0.02). This corresponded to a greater change in systolic blood pressure in the intervention versus control group (-3.63 SD, 19.81 mm Hg versus +0.34 SD, 23.76 mm Hg; P=0.04). There were no group differences in the control of cholesterol or use of antithrombotics. A low-cost peer education self-management workshop modestly improved blood pressure, but not low-density lipoprotein cholesterol or antithrombotic use, among stroke and transient ischemic attack survivors from vulnerable, predominantly minority urban communities. http://www.clinicaltrials.gov/show/NCT0102727. Unique identifier: NCT01027273. © 2014 American Heart Association, Inc.

Effects of group songwriting on motivation and readiness for treatment on patients in detoxification: a randomized wait-list effectiveness study.

PubMed

Silverman, Michael J

2012-01-01

Songwriting is a commonly utilized music therapy technique for clients in substance abuse rehabilitation. For these patients, motivation and readiness for treatment remain two key treatment areas. Moreover, there is a lack of randomized and controlled music therapy studies systematically investigating how group songwrit-ing can affect patients on a detoxification unit. The purposes of this study were to measure the effects of a single group songwriting session on motivation and readiness for treatment and determine emerging themes from patient-composed songs with patients on a detoxification unit. Participants (N = 99) were randomized to experimental (posttest only) or wait-list control (pretest only) conditions to provide treatment to all participants in an inclusive single-session design. There were significant between-group differences in motivation and readiness for treatment, with experimental participants having higher means than control participants. Code categorizations from patients' composed song lyrics concerned "action," "emotions and feelings," "change," "reflection," "admission," and "responsibility." From the results of this study, it seems that a single group songwriting session can be an effective intervention concerning motivation and readiness for treatment in patients on a detoxification unit. Implications for clinical practice, suggestions for future research, and limitations are provided.

Comparison of eye movement desensitization and reprocessing therapy, cognitive behavioral writing therapy, and wait-list in pediatric posttraumatic stress disorder following single-incident trauma: a multicenter randomized clinical trial.

PubMed

de Roos, Carlijn; van der Oord, Saskia; Zijlstra, Bonne; Lucassen, Sacha; Perrin, Sean; Emmelkamp, Paul; de Jongh, Ad

2017-11-01

Practice guidelines for childhood posttraumatic stress disorder (PTSD) recommend trauma-focused psychotherapies, mainly cognitive behavioral therapy (CBT). Eye movement desensitization and reprocessing (EMDR) therapy is a brief trauma-focused, evidence-based treatment for PTSD in adults, but with few well-designed trials involving children and adolescents. We conducted a single-blind, randomized trial with three arms (n = 103): EMDR (n = 43), Cognitive Behavior Writing Therapy (CBWT; n = 42), and wait-list (WL; n = 18). WL participants were randomly reallocated to CBWT or EMDR after 6 weeks; follow-ups were conducted at 3 and 12 months posttreatment. Participants were treatment-seeking youth (aged 8-18 years) with a DSM-IV diagnosis of PTSD (or subthreshold PTSD) tied to a single trauma, who received up to six sessions of EMDR or CBWT lasting maximally 45 min each. Both treatments were well-tolerated and relative to WL yielded large, intent-to-treat effect sizes for the primary outcomes at posttreatment: PTSD symptoms (EMDR: d = 1.27; CBWT: d = 1.24). At posttreatment 92.5% of EMDR, and 90.2% of CBWT no longer met the diagnostic criteria for PTSD. All gains were maintained at follow-up. Compared to WL, small to large (range d = 0.39-1.03) intent-to-treat effect sizes were obtained at posttreatment for negative trauma-related appraisals, anxiety, depression, and behavior problems with these gains being maintained at follow-up. Gains were attained with significantly less therapist contact time for EMDR than CBWT (mean = 4.1 sessions/140 min vs. 5.4 sessions/227 min). EMDR and CBWT are brief, trauma-focused treatments that yielded equally large remission rates for PTSD and reductions in the severity of PTSD and comorbid difficulties in children and adolescents seeking treatment for PTSD tied to a single event. Further trials of both treatments with PTSD tied to multiple traumas are warranted. © 2017 Association for Child and Adolescent Mental Health.

Randomized Trial of a Social Networking Intervention for Cancer-Related Distress.

PubMed

Owen, Jason E; O'Carroll Bantum, Erin; Pagano, Ian S; Stanton, Annette

2017-10-01

Web and mobile technologies appear to hold promise for delivering evidence-informed and evidence-based intervention to cancer survivors and others living with trauma and other psychological concerns. Health-space.net was developed as a comprehensive online social networking and coping skills training program for cancer survivors living with distress. The purpose of this study was to evaluate the effects of a 12-week social networking intervention on distress, depression, anxiety, vigor, and fatigue in cancer survivors reporting high levels of cancer-related distress. We recruited 347 participants from a local cancer registry and internet, and all were randomized to either a 12-week waiting list control group or to immediate access to the intervention. Intervention participants received secure access to the study website, which provided extensive social networking capabilities and coping skills training exercises facilitated by a professional facilitator. Across time, the prevalence of clinically significant depression symptoms declined from 67 to 34 % in both conditions. The health-space.net intervention had greater declines in fatigue than the waitlist control group, but the intervention did not improve outcomes for depression, trauma-related anxiety symptoms, or overall mood disturbance. For those with more severe levels of anxiety at baseline, greater engagement with the intervention was associated with higher levels of symptom reduction over time. The intervention resulted in small but significant effects on fatigue but not other primary or secondary outcomes. Results suggest that this social networking intervention may be most effective for those who have distress that is not associated with high levels of anxiety symptoms or very poor overall psychological functioning. The trial was registered with the ClinicalTrials.gov database ( ClinicalTrials.gov #NCT01976949).

Effects and Moderators of a Short Theory of Mind Intervention for Children with Autism Spectrum Disorder: A Randomized Controlled Trial.

PubMed

Begeer, Sander; Howlin, Patricia; Hoddenbach, Elske; Clauser, Cassandra; Lindauer, Ramon; Clifford, Pamela; Gevers, Carolien; Boer, Frits; Koot, Hans M

2015-12-01

Limited perspective taking or "Theory of Mind" (ToM) abilities are a core deficit of autism, and many interventions are aimed to improve ToM abilities. In this study, we investigated the effectiveness of a ToM treatment for children with autism spectrum disorders (ASD) and, for the first time, the moderating roles of social interaction style (SIS) and disruptive behavior (DB), to determine which children are most likely to respond to this intervention. The trial protocol is registered at www.trialregister.nl, trial number 2327 and published before the data collection was finished (www.trialsjournal.com). Children with autism aged 7-12 years (n = 97) were randomized over a waitlist control or a treatment condition. Outcome measures included ToM and emotion understanding, parent and teacher questionnaires on children's social skills, ToM-related social behavior, and autistic traits. Six-month follow-up parent reported data were collected for the treatment group. The treatment had a positive effect on ToM understanding, parent-reported ToM behavior, and autistic traits, but not on parent or teacher-reported social behavior. Passive SIS was associated with diminished treatment effects on autistic traits, but DB was unrelated to outcomes. The ToM intervention improved conceptual social understanding and ToM-related behavior of children with ASD. However, broader application of learned skills to other domains of functioning was limited. Individual differences with regard to treatment response are discussed. © 2015 International Society for Autism Research, Wiley Periodicals, Inc.

Internet-Based Guided Self-Help for Vaginal Penetration Difficulties: Results of a Randomized Controlled Pilot Trial.

PubMed

Zarski, Anna-Carlotta; Berking, Matthias; Fackiner, Christina; Rosenau, Christian; Ebert, David Daniel

2017-02-01

Difficulties with vaginal penetration can severely affect a woman's desire to have sexual intercourse, her sexual and general well-being, or her partnership. However, treatment opportunities for vaginismus are scarce. To evaluate the efficacy of an internet-based guided self-help intervention for vaginismus in a randomized controlled pilot trial. Seventy-seven women with vaginismus (primary inclusion criterion = no intercourse ≥ 6 months) were randomly assigned to an intervention group (IG) and a waitlist control group (WCG). The intervention consisted of 10 sessions involving psychoeducation, relaxation exercises, sensate focus, and gradual exposure with dilators. Participants received written feedback on completed sessions from an eCoach. The primary outcome was successful sexual intercourse. Secondary outcomes were non-intercourse penetration, fear of coitus, sexual functioning, and dyadic coping. Self-reported assessments were scheduled at baseline, 10 weeks, and 6 months. More participants (10 of 40, 34.48%) in the IG had intercourse compared with those in the WCG (6 of 37, 20.69%) at least once at 10 weeks or 6 months (odds ratio = 2.02). The difference was not significant (χ 2 1  = 1.38, P = .38), but in the IG, there was a significant increase in intercourse penetration from baseline to 6 months (d = 0.65). No such increase was found in the WCG (d = 0.21). There were significant between-group effects concerning non-intercourse penetration (self-insertion of a finger or dilator or insertion by the partner) in favor of the IG. Fear of coitus and dyadic coping significantly decreased in the IG. Overall satisfaction with the training was high. This randomized controlled trial showed promising effects of an internet-based intervention by increasing participants' ability to have intercourse and non-intercourse penetration while experiencing high treatment satisfaction. The WCG also showed improvement, although participants had vaginismus for an average duration of 6 years. Internet-based interventions could be a treatment modality to complement other methods in stepped care for vaginal penetration difficulties. Copyright © 2017 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

Designs for Testing Group-Based Interventions with Limited Numbers of Social Units: The Dynamic Wait-Listed and Regression Point Displacement Designs.

PubMed

Wyman, Peter A; Henry, David; Knoblauch, Shannon; Brown, C Hendricks

2015-10-01

The dynamic wait-listed design (DWLD) and regression point displacement design (RPDD) address several challenges in evaluating group-based interventions when there is a limited number of groups. Both DWLD and RPDD utilize efficiencies that increase statistical power and can enhance balance between community needs and research priorities. The DWLD blocks on more time units than traditional wait-listed designs, thereby increasing the proportion of a study period during which intervention and control conditions can be compared, and can also improve logistics of implementing intervention across multiple sites and strengthen fidelity. We discuss DWLDs in the larger context of roll-out randomized designs and compare it with its cousin the Stepped Wedge design. The RPDD uses archival data on the population of settings from which intervention unit(s) are selected to create expected posttest scores for units receiving intervention, to which actual posttest scores are compared. High pretest-posttest correlations give the RPDD statistical power for assessing intervention impact even when one or a few settings receive intervention. RPDD works best when archival data are available over a number of years prior to and following intervention. If intervention units were not randomly selected, propensity scores can be used to control for non-random selection factors. Examples are provided of the DWLD and RPDD used to evaluate, respectively, suicide prevention training (QPR) in 32 schools and a violence prevention program (CeaseFire) in two Chicago police districts over a 10-year period. How DWLD and RPDD address common threats to internal and external validity, as well as their limitations, are discussed.

A Methodological Analysis of Randomized Clinical Trials of Computer-Assisted Therapies for Psychiatric Disorders: Toward Improved Standards for an Emerging Field

PubMed Central

Kiluk, Brian D.; Sugarman, Dawn E.; Nich, Charla; Gibbons, Carly J.; Martino, Steve; Rounsaville, Bruce J.; Carroll, Kathleen M.

2013-01-01

Objective Computer-assisted therapies offer a novel, cost-effective strategy for providing evidence-based therapies to a broad range of individuals with psychiatric disorders. However, the extent to which the growing body of randomized trials evaluating computer-assisted therapies meets current standards of methodological rigor for evidence-based interventions is not clear. Method A methodological analysis of randomized clinical trials of computer-assisted therapies for adult psychiatric disorders, published between January 1990 and January 2010, was conducted. Seventy-five studies that examined computer-assisted therapies for a range of axis I disorders were evaluated using a 14-item methodological quality index. Results Results indicated marked heterogeneity in study quality. No study met all 14 basic quality standards, and three met 13 criteria. Consistent weaknesses were noted in evaluation of treatment exposure and adherence, rates of follow-up assessment, and conformity to intention-to-treat principles. Studies utilizing weaker comparison conditions (e.g., wait-list controls) had poorer methodological quality scores and were more likely to report effects favoring the computer-assisted condition. Conclusions While several well-conducted studies have indicated promising results for computer-assisted therapies, this emerging field has not yet achieved a level of methodological quality equivalent to those required for other evidence-based behavioral therapies or pharmacotherapies. Adoption of more consistent standards for methodological quality in this field, with greater attention to potential adverse events, is needed before computer-assisted therapies are widely disseminated or marketed as evidence based. PMID:21536689

Evaluating the Effectiveness of a School-Based Cognitive Behavioural Therapy Intervention for Anxiety in Adolescents Diagnosed with Autism Spectrum Disorder.

PubMed

Luxford, Sarah; Hadwin, Julie A; Kovshoff, Hanna

2017-12-01

This study evaluated the effectiveness of a school-based Cognitive Behavioural Therapy (CBT) on symptoms of anxiety, social worry and social responsiveness, and indices of attentional control and attentional biases to threat in adolescents diagnosed with Autism Spectrum Disorder. Thirty-five young people (11-14 years; IQ > 70) with ASD and elevated teacher or parent reported anxiety were randomly assigned to 6 sessions of the Exploring Feelings CBT intervention (Attwood in Exploring feelings (anxiety). Future Horizons, Arlington, 2004) (n = 18) or a wait-list control group (n = 17). The intervention (compared to the wait-list control) group showed positive change for parent, teacher and self-reported anxiety symptoms, and more marginal effects of increased teacher-reported social responsiveness. The discussion highlights the potential value and limitations of school-based CBT for young people with ASD.

A systems biology approach to studying Tai Chi, physiological complexity and healthy aging: design and rationale of a pragmatic randomized controlled trial.

PubMed

Wayne, Peter M; Manor, Brad; Novak, Vera; Costa, Madelena D; Hausdorff, Jeffrey M; Goldberger, Ary L; Ahn, Andrew C; Yeh, Gloria Y; Peng, C-K; Lough, Matthew; Davis, Roger B; Quilty, Mary T; Lipsitz, Lewis A

2013-01-01

Aging is typically associated with progressive multi-system impairment that leads to decreased physical and cognitive function and reduced adaptability to stress. Due to its capacity to characterize complex dynamics within and between physiological systems, the emerging field of complex systems biology and its array of quantitative tools show great promise for improving our understanding of aging, monitoring senescence, and providing biomarkers for evaluating novel interventions, including promising mind-body exercises, that treat age-related disease and promote healthy aging. An ongoing, two-arm randomized clinical trial is evaluating the potential of Tai Chi mind-body exercise to attenuate age-related loss of complexity. A total of 60 Tai Chi-naïve healthy older adults (aged 50-79) are being randomized to either six months of Tai Chi training (n=30), or to a waitlist control receiving unaltered usual medical care (n=30). Our primary outcomes are complexity-based measures of heart rate, standing postural sway and gait stride interval dynamics assessed at 3 and 6months. Multiscale entropy and detrended fluctuation analysis are used as entropy- and fractal-based measures of complexity, respectively. Secondary outcomes include measures of physical and psychological function and tests of physiological adaptability also assessed at 3 and 6months. Results of this study may lead to novel biomarkers that help us monitor and understand the physiological processes of aging and explore the potential benefits of Tai Chi and related mind-body exercises for healthy aging. Copyright © 2012 Elsevier Inc. All rights reserved.

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

PubMed Central

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

2015-01-01

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

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

PubMed

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

2015-05-01

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

Improving homework performance among children with ADHD: A randomized clinical trial.

PubMed

Merrill, Brittany M; Morrow, Anne S; Altszuler, Amy R; Macphee, Fiona L; Gnagy, Elizabeth M; Greiner, Andrew R; Coles, Erika K; Raiker, Joseph S; Coxe, Stefany; Pelham, William E

2017-02-01

Evidence indicates that children with Attention Deficit Hyperactivity Disorder (ADHD) experience acute and prolonged academic impairment and underachievement including marked difficulty with completing homework. This study is the first to examine the effects of behavioral, psychostimulant, and combined treatments on homework problems, which have been shown to predict academic performance longitudinally. Children with ADHD (ages 5-12, N = 75, 71% male, 83% Hispanic/Latino) and their families were randomly assigned to either behavioral treatment (homework-focused parent training and a daily report card; BPT + DRC) or a waitlist control group. Children also participated in a concurrent psychostimulant crossover trial conducted in a summer treatment program. Children's objective homework completion and accuracy were measured as well as parent-reported child homework behaviors and parenting skills. BPT + DRC had large effects on objective measures of homework completion and accuracy (Cohen's ds from 1.40 to 2.21, ps < .001). Other findings, including unimodal medication and incremental combined treatment benefits, were not significant. Behavioral treatment focused on homework problems results in clear benefits for children's homework completion and accuracy (the difference between passing and failing, on average), whereas long-acting stimulant medication resulted in limited and largely nonsignificant acute effects on homework performance. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Improving Homework Performance Among Children with ADHD: A Randomized Clinical Trial

PubMed Central

Merrill, Brittany M.; Morrow, Anne S.; Altszuler, Amy R.; Macphee, Fiona L.; Gnagy, Elizabeth M.; Greiner, Andrew R.; Coles, Erika K.; Raiker, Joseph S.; Coxe, Stefany; Pelham, William E.

2016-01-01

Objective Evidence indicates that children with Attention Deficit Hyperactivity Disorder (ADHD) experience acute and prolonged academic impairment and underachievement including marked difficulty with completing homework. This study is the first to examine the effects of behavioral, psychostimulant, and combined treatments on homework problems, which have been shown to predict academic performance longitudinally. Method Children with ADHD (ages 5-12, N = 75, 71% male, 83% Hispanic/Latino) and their families were randomly assigned to either behavioral treatment (homework-focused parent training and a daily report card; BPT+DRC) or a waitlist control group. Children also participated in a concurrent psychostimulant crossover trial conducted in a summer treatment program. Children's objective homework completion and accuracy were measured as well as parent-reported child homework behaviors and parenting skills. Results BPT+DRC had large effects on objective measures of homework completion and accuracy (Cohen's ds from 1.40, to 2.21, ps < .001). Other findings, including unimodal medication and incremental combined treatment benefits, were not significant. Conclusions Behavioral treatment focused on homework problems results in clear benefits for children's homework completion and accuracy (the difference between passing failing, on average) whereas long-acting stimulant medication resulted in limited and largely non-significant acute effects on homework performance. PMID:27618639

Log in and breathe out: efficacy and cost-effectiveness of an online sleep training for teachers affected by work-related strain--study protocol for a randomized controlled trial.

PubMed

Thiart, Hanne; Lehr, Dirk; Ebert, David Daniel; Sieland, Bernhard; Berking, Matthias; Riper, Heleen

2013-06-11

Insomnia and work-related stress often co-occur. Both are associated with personal distress and diminished general functioning, as well as substantial socio-economic costs due to, for example, reduced productivity at the work place and absenteeism. Insomnia complaints by people experiencing work-related stress are correlated with a deficient cognitive detachment from work. Diffuse boundaries between work and private life can additionally complicate the use of recreational activities that facilitate cognitive detachment.Cognitive behavioral therapy for insomnia is effective but rarely implemented. Internet-based cognitive behavioral therapy for insomnia could potentially reduce this deficit given its demonstrated effectiveness. Less is known, however, about the efficacy of internet-based cognitive behavioral therapy for insomnia in populations affected by high work stress. Thus, the aim of the present study is to evaluate the efficacy and cost-effectiveness of a newly developed, guided online training which is based on Cognitive Behavioral Therapy for insomnia and tailored to teachers affected by occupational stress. In a two-arm randomized controlled trial (N = 128), the effects of a guided online sleep training will be compared to a waitlist-control condition. German teachers with significant clinical insomnia complaints (Insomnia Severity Index ≥ 15) and work-related rumination (Irritation Scale, subscale Cognitive Irritation ≥ 15) will be included in the study. The primary outcome measure will be insomnia severity. Additionally, an economic evaluation from a societal perspective will be conducted. Data from the intention-to-treat sample will be analyzed two and six months after randomization. To the best of our knowledge, this is the first study to evaluate an online sleep training tailored to a specific population with work stress, that is, teachers. If this type of intervention is effective, it could reduce the paucity of cognitive behavioral therapy for insomnia and augment the support for teachers in coping with their insomnia problems. German Clinical Trial Register (DRKS): DRKS00004700.

Efficacy of an internet-based problem-solving training for teachers: results of a randomized controlled trial.

PubMed

Ebert, David Daniel; Lehr, Dirk; Boß, Leif; Riper, Heleen; Cuijpers, Pim; Andersson, Gerhard; Thiart, Hanne; Heber, Elena; Berking, Matthias

2014-11-01

The primary purpose of this randomized controlled trial (RCT) was to evaluate the efficacy of internet-based problem-solving training (iPST) for employees in the educational sector (teachers) with depressive symptoms. The results of training were compared to those of a waitlist control group (WLC). One-hundred and fifty teachers with elevated depressive symptoms (Center for Epidemiologic Studies Depression Scale, CES-D ≥16) were assigned to either the iPST or WLC group. The iPST consisted of five lessons, including problem-solving and rumination techniques. Symptoms were assessed before the intervention began and in follow-up assessments after seven weeks, three months, and six months. The primary outcome was depressive symptom severity (CES-D). Secondary outcomes included general and work-specific self-efficacy, perceived stress, pathological worries, burnout symptoms, general physical and mental health, and absenteeism. iPST participants displayed a significantly greater reduction in depressive symptoms after the intervention (d=0.59, 95% CI 0.26-0.92), after three months (d=0.37, 95% CI 0.05-0.70) and after six months (d=0.38, 95% CI 0.05-0.70) compared to the control group. The iPST participants also displayed significantly higher improvements in secondary outcomes. However, workplace absenteeism was not significantly affected. iPST is effective in reducing symptoms of depression among teachers. Disseminated on a large scale, iPST could contribute to reducing the burden of stress-related mental health problems among teachers. Future studies should evaluate iPST approaches for use in other working populations.

Emotional health and coping in spina bifida after goal management training: a randomized controlled trial.

PubMed

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

2015-02-01

Executive function impairments are common after spina bifida (SB) and potentially have a detrimental effect on the individual's emotional health and coping. Goal management training (GMT) is a cognitive rehabilitation method for improving executive function. The purpose of this study was to determine the efficacy of GMT on aspects of perceived emotional health and coping in individuals with SB. Thirty-eight adult subjects with SB were included in this randomized controlled trial. Inclusion was based upon the presence of executive functioning complaints. Experimental subjects (n = 24) received 21 hr of GMT, with efficacy of GMT being compared with results of subjects in a wait-list condition (n = 14). Four self-report questionnaires assessing emotional health and coping were utilized as outcome measures. All subjects were assessed at baseline, postintervention, and at 6-month follow-up. Findings indicated positive effects of GMT relative to the control group on measures of emotional health. Of note, the GMT group showed significant improvement, compared with control subjects, on a self-report inventory of depressive and anxiety symptoms after training, lasting at least 6 months posttreatment. Furthermore, both groups showed improvements after training on mental health components of health-related quality of life. Finally, the GMT group showed a significant increase in task-focused coping and a decrease in avoidant coping after training compared with pretreatment baseline assessment scores. Overall, findings indicate that by us a compensatory intervention to manage executive dysfunction, effective and lasting benefits can be achieved with regard to aspects of perceived emotional health and coping. PsycINFO Database Record (c) 2015 APA, all rights reserved.

Trajectories of Change in Emotion Regulation and Social Anxiety During Cognitive-Behavioral Therapy for Social Anxiety Disorder

PubMed Central

Goldin, Philippe R.; Lee, Ihno; Ziv, Michal; Jazaieri, Hooria; Heimberg, Richard G.; Gross, James J.

2014-01-01

Cognitive-behavioral therapy (CBT) for social anxiety disorder (SAD) may decrease social anxiety by training emotion regulation skills. This randomized controlled trial of CBT for SAD examined changes in weekly frequency and success of cognitive reappraisal and expressive suppression, as well as weekly intensity of social anxiety among patients receiving 16 weekly sessions of individual CBT. We expected these variables to (1) differ from pre-to-post-CBT vs. Waitlist, (2) have differential trajectories during CBT, and (3) covary during CBT. We also expected that weekly changes in emotion regulation would predict (4) subsequent weekly changes in social anxiety, and (5) changes in social anxiety both during and post-CBT. Compared to Waitlist, CBT increased cognitive reappraisal frequency and success, decreased social anxiety, but had no impact on expressive suppression. During CBT, weekly cognitive reappraisal frequency and success increased, whereas weekly expressive suppression frequency and social anxiety decreased. Weekly decreases in social anxiety were associated with concurrent increases in reappraisal success and decreases in suppression frequency. Granger causality analysis showed that only reappraisal success increases predicted decreases in subsequent social anxiety during CBT. Reappraisal success increases pre-to-post-CBT predicted reductions in social anxiety symptom severity post-CBT. The trajectory of weekly changes in emotion regulation strategies may help clinicians understand whether CBT is effective and predict decreases in social anxiety. PMID:24632110

Predicting OptimaL cAncer RehabIlitation and Supportive care (POLARIS): rationale and design for meta-analyses of individual patient data of randomized controlled trials that evaluate the effect of physical activity and psychosocial interventions on health-related quality of life in cancer survivors

PubMed Central

2013-01-01

Background Effective interventions to improve quality of life of cancer survivors are essential. Numerous randomized controlled trials have evaluated the effects of physical activity or psychosocial interventions on health-related quality of life of cancer survivors, with generally small sample sizes and modest effects. Better targeted interventions may result in larger effects. To realize such targeted interventions, we must determine which interventions that are presently available work for which patients, and what the underlying mechanisms are (that is, the moderators and mediators of physical activity and psychosocial interventions). Individual patient data meta-analysis has been described as the ‘gold standard’ of systematic review methodology. Instead of extracting aggregate data from study reports or from authors, the original research data are sought directly from the investigators. Individual patient data meta-analyses allow for adequate statistical analysis of intervention effects and moderators of such effects. Here, we report the rationale and design of the Predicting OptimaL cAncer RehabIlitation and Supportive care (POLARIS) Consortium. The primary aim of POLARIS is 1) to conduct meta-analyses based on individual patient data to evaluate the effect of physical activity and psychosocial interventions on the health-related quality of life of cancer survivors; 2) to identify important demographic, clinical, personal, or intervention-related moderators of the effect; and 3) to build and validate clinical prediction models identifying the most relevant predictors of intervention success. Methods/Design We will invite investigators of randomized controlled trials that evaluate the effects of physical activity and/or psychosocial interventions on health-related quality of life compared with a wait-list, usual care or attention control group among adult cancer survivors to join the POLARIS consortium and share their data for use in pooled analyses that will address the proposed aims. We are in the process of identifying eligible randomized controlled trials through literature searches in four databases. To date, we have identified 132 eligible and unique trials. Discussion The POLARIS consortium will conduct the first individual patient data meta-analyses in order to generate evidence essential to targeting physical activity and psychosocial programs to the individual survivor’s characteristics, capabilities, and preferences. Registration PROSPERO: International prospective register of systematic reviews, CRD42013003805 PMID:24034173

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 the prespecified stratum of women who were inactive at baseline (n=51), intervention participants significantly increased their activity by an average of 50 (95% CI 4.0-95.9, P=.03) MVPA minutes per week more than control participants. They had a corresponding statistically significant net increase of 19 (95% CI 3.2-34.8, P=.02) minutes of vigorous activity. Inactive women in the intervention arm also experienced promising reductions in depression, reporting a statistically significant net decrease in their depression score (-3.8, 95% CI -7.0 to -0.6; P=.02). We found that a group exercise intervention using videoconferencing and mobile apps was a feasible and acceptable way to deliver a physical activity intervention to mothers. The intervention increased physical activity in inactive mothers. Further studies are needed to better establish how long these changes in physical activity can be maintained and whether these findings can be reproduced in a more diverse population. ClinicalTrials.gov NCT02805140; https://clinicaltrials.gov/ct2/show/NCT02805140 (Archived by WebCite at http://www.webcitation.org/6yYZwRveg). ©Maya Nina Mascarenhas, June Maylin Chan, Eric Vittinghoff, Erin Lynn Van Blarigan, Frederick Hecht. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 18.05.2018.

The effect of active video games on cognitive functioning in clinical and non-clinical populations: A meta-analysis of randomized controlled trials.

PubMed

Stanmore, Emma; Stubbs, Brendon; Vancampfort, Davy; de Bruin, Eling D; Firth, Joseph

2017-07-01

Physically-active video games ('exergames') have recently gained popularity for leisure and entertainment purposes. Using exergames to combine physical activity and cognitively-demanding tasks may offer a novel strategy to improve cognitive functioning. Therefore, this systematic review and meta-analysis was performed to establish effects of exergames on overall cognition and specific cognitive domains in clinical and non-clinical populations. We identified 17 eligible RCTs with cognitive outcome data for 926 participants. Random-effects meta-analyses found exergames significantly improved global cognition (g=0.436, 95% CI=0.18-0.69, p=0.001). Significant effects still existed when excluding waitlist-only controlled studies, and when comparing to physical activity interventions. Furthermore, benefits of exergames where observed for both healthy older adults and clinical populations with conditions associated with neurocognitive impairments (all p<0.05). Domain-specific analyses found exergames improved executive functions, attentional processing and visuospatial skills. The findings present the first meta-analytic evidence for effects of exergames on cognition. Future research must establish which patient/treatment factors influence efficacy of exergames, and explore neurobiological mechanisms of action. Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.

The Effects of Personal Construct Group Therapy on Breast Cancer Survivors

ERIC Educational Resources Information Center

Lane, Lisbeth G.; Viney, Linda L.

2005-01-01

In this study, the authors evaluated the effects of a brief personal construct group therapy on breast cancer survivors (N = 42) randomly assigned to either the treatment or wait-list control condition. The Gottschalk Gleser Content Analysis Scales were used to measure the effects for group across time (preand posttreatment, pretreatment, and…

A School-Based Mindfulness Intervention for Urban Youth: Exploring Moderators of Intervention Effects

ERIC Educational Resources Information Center

Gould, Laura Feagans; Dariotis, Jacinda K.; Mendelson, Tamar; Greenberg, Mark. T.

2012-01-01

This study examines gender, grade-level, and baseline depressive symptoms as potential moderators of a school-based mindfulness intervention's impact on the self-regulatory outcomes of urban youth. Ninety-seven participants from four urban public schools were randomly assigned to an intervention or wait-list control condition. Fourth and fifth…

Assessing the Impact of a School-Based Group Approach with Adolescent Males

ERIC Educational Resources Information Center

Liddell, T. Michael; Kurpius, Sharon Robinson

2014-01-01

This study assessed the impact of a school-based group intervention, "The Council for Boys and Young Men," specifically designed for adolescent males. The participants who attended an alternative school in a metropolitan area were randomly assigned to the intervention or to waitlist control groups. Measures assessed self-esteem, future…

Silent Illumination: A Study on Chan (Zen) Meditation, Anxiety, and Musical Performance Quality

ERIC Educational Resources Information Center

Lin, Peter; Chang, Joanne; Zemon, Vance; Midlarsky, Elizabeth

2008-01-01

This study investigated the effects of Chan (Zen) meditation on musical performance anxiety and musical performance quality. Nineteen participants were recruited from music conservatories and randomly assigned to either an eight-week meditation group or a wait-list control group. After the intervention, all participants performed in a public…

Short-term effectiveness of web-based guided self-help for phobic outpatients: randomized controlled trial.

PubMed

Kok, Robin N; van Straten, Annemieke; Beekman, Aartjan T F; Cuijpers, Pim

2014-09-29

Internet-based guided self-help has been successfully used in the general population, but it is unknown whether this method can be effectively used in outpatient clinics for patients waiting for face-to-face psychotherapy for phobias. The aim was to assess the clinical effectiveness of Phobias Under Control, an Internet-based intervention based on exposure therapy with weekly guidance. We conducted a randomized controlled trial, recruiting 212 outpatients scheduled to receive face-to-face psychotherapy for any type of phobia at an outpatient clinic. Participants suffering from at least 1 DSM-IV or ICD-10 classified phobia (social phobia, agoraphobia with or without panic disorder, and/or specific phobia as ascertained by a telephone interview at baseline) were randomly allocated to either a 5-week Internet-based guided self-help program based on exposure therapy with weekly student support followed by face-to-face psychotherapy (n=105) or a wait-list control group followed by face-to-face psychotherapy (n=107). Primary outcome was the Fear Questionnaire (FQ). Secondary outcomes were the Beck Anxiety Inventory (BAI) and Center of Epidemiological Studies-Depression scale (CES-D). Assessments took place by telephone at baseline (T0) and on the Internet at posttest (T1, self-assessment at 5 weeks after baseline). Missing data at T1 were imputed. At posttest, analysis of covariance on the intention-to-treat sample showed significant but small effect sizes between intervention and control groups on the FQ (d=0.35, P=.02), CES-D (d=0.34, P=.03), and a nonsignificant effect size on the BAI (d=0.28. P=.05). Although initial acceptance was good, high nonresponse was observed, with 86 of 212 participants (40.5%) lost to follow-up at T1 and only 14 of 105 (13.3%) intervention participants finishing all 5 weeks. Phobias Under Control is modestly effective in lowering phobic and depressive symptoms in a relatively short period and may be clinically beneficial when implemented in routine outpatient practice. Netherlands Trial Register NTR2233; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2233 (Archived by WebCite at http://www.webcitation.org/6O2ioOQSs).

A pilot trial of text-delivered peer network counseling to treat young adults with cannabis use disorder.

PubMed

Mason, Michael J; Zaharakis, Nikola M; Russell, Michael; Childress, Victoria

2018-06-01

Approximately 1.8 million young adults aged 18 to 25 had a Cannabis Use Disorder (CUD) in the past year. Unfortunately, engaging young adults in treatment is very challenging. Creative approaches to treat cannabis disorders such as integrating mobile technology with evidence-based treatments are warranted. In light of these challenges, we developed a text message-delivered version of Peer Network Counseling (PNC-txt), which is a substance use intervention that focuses on peer relations. PNC-txt engages participants in 16 automated, personalized text interactions over 4weeks. We conducted a randomized controlled trial to test the efficacy of PNC-txt against a waitlist control group with 30 treatment seeking young adults (ages 18-25) who met DSM-5 criteria for CUD. Self-report and urine analyses were used to test outcomes at the three-month follow-up. The PNC-txt group significantly reduced their cannabis use related problems as well as cannabis cravings, compared to the control group. PNC-txt participants also had a significantly greater percentage with urines negative for cannabis metabolites compared to controls. Moderation analysis showed that CUD severity level moderated treatment, suggesting that PNC-txt is more effective for participants with medium and high levels of CUD severity. All effect sizes ranged from medium to large. Results from this pilot trial are promising and warrant further research on PNC-txt for addressing cannabis use disorder. Copyright © 2018 Elsevier Inc. All rights reserved.

Impact of the Educational Boost Your Brain and Memory Program Among Senior Living Residents.

PubMed

Nicholson, Roscoe; O'Brien, Catherine

2017-12-01

This random assignment waitlist control intervention study examined an implementation of the educational Boost Your Brain and Memory cognitive fitness intervention in 12 senior living organizations. Older adult participants ( n = 166) completed measures of brain health knowledge, use of memory techniques, physical and intellectual activity, and mindfulness, at baseline and after the intervention group's completion of the course. Changes in knowledge scores and in self-reported physical and intellectual activity increased significantly more for intervention participants than for waitlist controls at the conclusion of the course. There were no significant changes between the groups in mindfulness or use of memory techniques. This suggests that in senior living settings Boost Your Brain and Memory is effective in educating participants about brain healthy behaviors and in motivating behavioral change in the areas of physical and intellectual activity.

Mitii™ ABI: study protocol of a randomised controlled trial of a web-based multi-modal training program for children and adolescents with an Acquired Brain Injury (ABI).

PubMed

Boyd, Roslyn N; Baque, Emmah; Piovesana, Adina; Ross, Stephanie; Ziviani, Jenny; Sakzewski, Leanne; Barber, Lee; Lloyd, Owen; McKinlay, Lynne; Whittingham, Koa; Smith, Anthony C; Rose, Stephen; Fiori, Simona; Cunnington, Ross; Ware, Robert; Lewis, Melinda; Comans, Tracy A; Scuffham, Paul A

2015-08-19

Acquired brain injury (ABI) refers to multiple disabilities arising from damage to the brain acquired after birth. Children with an ABI may experience physical, cognitive, social and emotional-behavioural impairments which can impact their ability to participate in activities of daily living (ADL). Recent developments in technology have led to the emergence of internet-delivered therapy programs. "Move it to improve it" (Mitii™) is a web-based multi-modal therapy that comprises upper limb (UL) and cognitive training within the context of meaningful physical activity. The proposed study aims to compare the efficacy of Mitii™ to usual care to improve ADL motor and processing skills, gross motor capacity, UL and executive functioning in a randomised waitlist controlled trial. Sixty independently ambulant children (30 in each group) at least 12 months post ABI will be recruited to participate in this trial. Children will be matched in pairs at baseline and randomly allocated to receive either 20 weeks of Mitii™ training (30 min per day, six days a week, with a potential total dose of 60 h) immediately, or be waitlisted for 20 weeks. Outcomes will be assessed at baseline, immediately post-intervention and at 20 weeks post-intervention. The primary outcomes will be the Assessment of Motor and Process Skills and 30 s repetition maximum of functional strength exercises (sit-to-stand, step-ups and half kneel to stand). Measures of body structure and functions, activity, participation and quality of life will assess the efficacy of Mitii™ across all domains of the International Classification of Functioning, Disability and Health framework. A subset of children will undertake three tesla (3T) magnetic resonance imaging scans to evaluate functional neurovascular changes, structural imaging, diffusion imaging and resting state functional connectivity before and after intervention. Mitii™ provides an alternative approach to deliver intensive therapy for children with an ABI in the convenience of the home environment. If Mitii™ is found to be effective, it may offer an accessible and inexpensive intervention option to increase therapy dose. ANZCTR12613000403730.

Move it to improve it (Mitii): study protocol of a randomised controlled trial of a novel web-based multimodal training program for children and adolescents with cerebral palsy

PubMed Central

Boyd, Roslyn N; Mitchell, Louise E; James, Sarah T; Ziviani, Jenny; Sakzewski, Leanne; Smith, Anthony; Rose, Stephen; Cunnington, Ross; Whittingham, Koa; Ware, Robert S; Comans, Tracey A; Scuffham, Paul A

2013-01-01

Introduction Persons with cerebral palsy require a lifetime of costly and resource intensive interventions which are often limited by equity of access. With increasing burden being placed on health systems, new methods to deliver intensive rehabilitation therapies are needed. Move it to improve it (Mitii) is an internet-based multimodal programme comprising upper-limb and cognitive training with physical activity. It can be accessed in the client's home at their convenience. The proposed study aims to test the efficacy of Mitii in improving upper-limb function and motor planning. Additionally, this study hopes to further our understanding of the central neurovascular mechanisms underlying the proposed changes and determine the cost effectiveness of Mitii. Methods and analysis Children with congenital hemiplegia will be recruited to participate in this waitlist control, matched pairs, single-blind randomised trial. Children be matched at baseline and randomly allocated to receive 20 weeks of 30 min of daily Mitii training immediately, or waitlisted for 20 weeks before receiving the same Mitii training (potential total dose=70 h). Outcomes will be assessed at 20 weeks after the start of Mitii, and retention effects tested at 40 weeks. The primary outcomes will be the Assessment of Motor and Process Skills (AMPS), the Assisting Hand Assessment (AHA) and unimanual upper-limb capacity using the Jebsen-Taylor Test of Hand Function (JTTHF). Advanced brain imaging will assess use-dependant neuroplasticity. Measures of body structure and functions, activity, participation and quality of life will be used to assess Mitii efficacy across all domains of the International Classification of Functioning, Disability and Health framework. Ethics and dissemination This project has received Ethics Approval from the Medical Ethics Committee of The University of Queensland (2011000608) and the Royal Children's Hospital Brisbane (HREC/11/QRCH/35). Findings will be disseminated widely through conference presentations, seminars and peer-reviewed scientific journals. Trial registration ACTRN12611001174976 PMID:23578686

The Spanish Version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) Adapted as a School-Based Anxiety and Depression Prevention Program: Study Protocol for a Cluster Randomized Controlled Trial

PubMed Central

García-Escalera, Julia; Valiente, Rosa M; Ehrenreich-May, Jill; Kennedy, Sarah M; Sandín, Bonifacio

2017-01-01

Background Anxiety and depression are common, impairing conditions that evidence high comorbidity rates in adolescence. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) is one of the few existing resources aimed at applying transdiagnostic treatment principles to target core dysfunctions associated with both anxiety and depression within a single protocol. To our knowledge, this is the first study examining the efficacy of the UP-A adapted as a universal preventive intervention program. Objective The primary aim of this study is to examine whether the Spanish version of the UP-A is more effective than a waitlist (WL) control group in reducing and preventing symptoms of anxiety and depression when employed as a universal, classroom-based preventive intervention. The secondary aim is to investigate changes in a broad range of secondary outcome measures, including negative and positive affect, anxiety sensitivity, emotional avoidance, top problems ratings, school grades, depression and anxiety-related interference, self-esteem, life satisfaction, quality of life, conduct problems, hyperactivity/inattention symptoms, peer problems, prosocial behavior, school adjustment, and discipline problems. Other aims are to assess a range of possible predictors of intervention effects and to examine the feasibility and the acceptability of implementing UP-A in a prevention group format and in a school setting. Methods A cluster, randomized, WL, controlled trial design with classroom as the unit of randomization was used in this study. Five classes including a total of 152 adolescents were randomized to the experimental or WL control groups. Participants in the experimental group received 9 55-minute sessions delivered by advanced doctoral and masters students in clinical psychology. The WL control group will receive the intervention once the 3-month follow-up assessment is completed. Results We have recruited participants to the cluster randomized controlled trial (RCT) and have conducted the intervention with the experimental group. We expect the WL control group to complete the intervention in July 2017. Data analysis will take place during the second semester of 2017. Conclusions We expect the experimental group to outperform the WL control group at post-intervention and 3-month follow-up. We also expect the WL control group to show improvements in primary and secondary outcome measures after receiving the intervention. Results will have implications for researchers, families, and education providers. Trial Registration Clinicaltrials.gov NCT03123991; https://clinicaltrials.gov/ct2/show/NCT03123991 (Archived by WebCite at http://www.webcitation.org/6qp7GIzcR) PMID:28827212

Effectiveness of a smartphone-based worry-reduction training for stress reduction: A randomized-controlled trial.

PubMed

Versluis, Anke; Verkuil, Bart; Spinhoven, Philip; F Brosschot, Jos

2018-04-03

Perseverative cognition (e.g. worry) and unconscious stress are suggested to be important mediators in the relation between stressors and physiological health. We examined whether a smartphone-based worry-reduction training improved a physiological marker of stress (i.e. increased heart rate variability [HRV]) and unconscious stress. Randomised-controlled trial was conducted with individuals reporting work stress (n = 136). Participants were randomised to the experimental, control or waitlist condition (resp. EC, CC, WL). The EC and CC registered emotions five times daily for four weeks. The EC additionally received a worry-reduction training with mindfulness exercises. Primary outcome was 24-h assessments of HRV measured at pre-, mid- and post-intervention. Secondary outcomes were implicit affect and stress. Effects on heart rate and other psychological outcomes were explored. A total of 118 participants completed the study. No change from pre- to post-intervention was observed for the primary or secondary outcomes. The change over time was not different between conditions. Findings suggest that the training was ineffective for improving HRV or psychological stress. Future studies may focus on alternative smartphone-based stress interventions, as stress levels are high in society. There is need for easy interventions and smartphones offer possibilities for this.

Stress reduction at the work-family interface: positive parenting and self-efficacy as mechanisms of change in Workplace Triple P.

PubMed

Hartung, Doreen; Hahlweg, Kurt

2011-01-01

Workplace Triple P (WPTP) is a group-based parenting skills training specifically designed to meet the needs of employed parents. Several randomized controlled trials have demonstrated the training's efficacy. This study examined possible mechanisms of change that account for the stress reduction effects of this parenting skills training at the work-family interface. It was hypothesized that reductions in dysfunctional parenting (DP) behavior and increases in parental self-efficacy would mediate the stress-reducing effects of WPTP. The mediator effects were analyzed in a German pre- and postcompleter sample (N = 97 parents; 74 mothers and 23 fathers; treatment condition: n = 42 parents; waitlist-control condition n = 55 parents). The results indicate that individual stress- (IS) level reductions were mediated by decreased levels of DP. In addition, changes in IS levels mediated the effects of the training on work-related stress. The discussion focuses on the importance of understanding mechanisms of change to effectively implement interventions at the work-family interface.

Virtual reality-based cognitive training for drug abusers: A randomised controlled trial.

PubMed

Man, David W K

2018-05-08

Non-pharmacological means are being developed to enhance cognitive abilities in drug abusers. This study evaluated virtual reality (VR) as an intervention tool for enhancing cognitive and vocational outcomes in 90 young ketamine users (KU) randomly assigned to a treatment group (virtual reality group, VRG; tutor-administered group, TAG) or wait-listed control group (CG). Two training programmes with similar content but different delivery modes (VR-based and manual-based) were applied using a virtual boutique as a training scenario. Outcome assessments comprised the Digit Vigilance Test, Rivermead Behavioural Memory Test, Wisconsin Cart Sorting Test, work-site test and self-efficacy pre- and post-test and during 3- and 6-month follow-ups. The VRG exhibited significant improvements in attention and improvements in memory that were maintained after 3 months. Both the VRG and TAG exhibited significantly improved vocational skills after training which were maintained during follow-up, and improved self-efficacy. VR-based cognitive training might target cognitive problems in KU.

Evaluation of the COPING parent online universal programme: study protocol for a pilot randomised controlled trial

PubMed Central

Owen, Dawn Adele; Griffith, Nia; Hutchings, Judy

2017-01-01

Trial sponsor Bangor University, Brigantia Building, College Road, Bangor, LL57 2AS, UK Introduction The COPING parent online universal programme is a web-based parenting intervention for parents of children aged 3-8 years with an interest in positive parenting. The programme focuses on strengthening parent-child relationships and encouraging positive child behaviour. This trial will evaluate whether the intervention is effective in increasing the use of positive parenting strategies outlined in the programme using parent report and blind observation measures. Methods and analysis This is a pilot randomised controlled trial with intervention and wait-list control conditions. The intervention is a 10-week online parenting programme to promote positive parent-child relations by teaching core social learning theory principles that encourage positive child behaviour, primarily through the use of praise and rewards. Health visitors and school nurses will circulate a recruitment poster to parents of children aged 3–8 years on their current caseloads. Recruitment posters will also be distributed via local primary schools and nurseries. Parents recruited to the trial will be randomised on a 2:1 ratio to intervention or wait-list control conditions (stratified according to child gender and age). The primary outcome measure is positive parenting as measured by a behavioural observation of parent-child interactions using the Dyadic Parent-Child Interaction Coding System. Secondary outcomes include parent report of child behaviour, and self-reported parental sense of competence, parenting behaviour and parental mental health. Data will be collected at baseline and 3 months later (postintervention) for all participants and 6 months postbaseline for the intervention group only. Analysis of covariance will be the main statistical method used. Ethics and dissemination The trial has received ethical approval from the NHS Betsi Cadwaladr University Health Board Ethics Committee (REC) and the School of Psychology, Bangor University REC (15/WA/0463). Publication of all outcomes will be in peer-reviewed journals and conference presentations. Trial registration number Current Controlled Trials ISRCTN89370147 (5 May 2016). PMID:28446523

A Randomized Controlled Trial of Students for Nutrition and eXercise (SNaX): A Community-Based Participatory Research Study

PubMed Central

Bogart, Laura M.; Cowgill, Burton O.; Elliott, Marc N.; Klein, David J.; Hawes-Dawson, Jennifer; Uyeda, Kimberly; Elijah, Jacinta; Binkle, David G.; Schuster, Mark A.

2014-01-01

Purpose To conduct a randomized controlled trial of Students for Nutrition and eXercise (SNaX), a 5-week middle-school-based obesity-prevention intervention combining school-wide environmental changes, multimedia, encouragement to eat healthy school cafeteria foods, and peer-led education. Methods We randomly selected schools (five intervention, five wait-list control) from the Los Angeles Unified School District. School records were obtained for number of fruits and vegetables served, students served lunch, and snacks sold per attending student, representing an average of 1,515 students (SD=323) per intervention school and 1,524 students (SD=266) per control school. A total of 2,997 seventh-graders (75% of seventh-graders across schools) completed pre-and post-intervention surveys assessing psychosocial variables. Consistent with community-based participatory research principles, the school district was an equal partner and a community advisory board provided critical input. Results Relative to control schools, intervention schools showed significant increases in the proportion of students served fruit and lunch and a significant decrease in proportion of students buying snacks at school. Specifically, the intervention was associated with relative increases of 15.3% more fruit served (p=0.006), 10.4% more lunches served (p<0.001), and 11.9% fewer snacks sold (p<0.001) than would have been expected in its absence. Pre-to-post intervention, intervention school students reported more positive attitudes about cafeteria food (p=0.02) and tap water (p=0.03), greater obesity-prevention knowledge (p=0.006), increased intentions to drink water from the tap (p=0.04) or a refillable bottle (p=0.02), and greater tap water consumption (p=0.04) compared to control school students. Conclusions Multi-level school-based interventions may promote healthy adolescent dietary behaviors. PMID:24784545

A Transdiagnostic Community-Based Mental Health Treatment for Comorbid Disorders: Development and Outcomes of a Randomized Controlled Trial among Burmese Refugees in Thailand

PubMed Central

Bolton, Paul; Lee, Catherine; Haroz, Emily E.; Murray, Laura; Dorsey, Shannon; Robinson, Courtland; Ugueto, Ana M.; Bass, Judith

2014-01-01

Background Existing studies of mental health interventions in low-resource settings have employed highly structured interventions delivered by non-professionals that typically do not vary by client. Given high comorbidity among mental health problems and implementation challenges with scaling up multiple structured evidence-based treatments (EBTs), a transdiagnostic treatment could provide an additional option for approaching community-based treatment of mental health problems. Our objective was to test such an approach specifically designed for flexible treatments of varying and comorbid disorders among trauma survivors in a low-resource setting. Methods and Findings We conducted a single-blinded, wait-list randomized controlled trial of a newly developed transdiagnostic psychotherapy, Common Elements Treatment Approach (CETA), for low-resource settings, compared with wait-list control (WLC). CETA was delivered by lay workers to Burmese survivors of imprisonment, torture, and related traumas, with flexibility based on client presentation. Eligible participants reported trauma exposure and met severity criteria for depression and/or posttraumatic stress (PTS). Participants were randomly assigned to CETA (n = 182) or WLC (n = 165). Outcomes were assessed by interviewers blinded to participant allocation using locally adapted standard measures of depression and PTS (primary outcomes) and functional impairment, anxiety symptoms, aggression, and alcohol use (secondary outcomes). Primary analysis was intent-to-treat (n = 347), including 73 participants lost to follow-up. CETA participants experienced significantly greater reductions of baseline symptoms across all outcomes with the exception of alcohol use (alcohol use analysis was confined to problem drinkers). The difference in mean change from pre-intervention to post-intervention between intervention and control groups was −0.49 (95% CI: −0.59, −0.40) for depression, −0.43 (95% CI: −0.51, −0.35) for PTS, −0.42 (95% CI: −0.58, −0.27) for functional impairment, −0.48 (95% CI: −0.61, −0.34) for anxiety, −0.24 (95% CI: −0.34, −0.15) for aggression, and −0.03 (95% CI: −0.44, 0.50) for alcohol use. This corresponds to a 77% reduction in mean baseline depression score among CETA participants compared to a 40% reduction among controls, with respective values for the other outcomes of 76% and 41% for anxiety, 75% and 37% for PTS, 67% and 22% for functional impairment, and 71% and 32% for aggression. Effect sizes (Cohen's d) were large for depression (d = 1.16) and PTS (d = 1.19); moderate for impaired function (d = 0.63), anxiety (d = 0.79), and aggression (d = 0.58); and none for alcohol use. There were no adverse events. Limitations of the study include the lack of long-term follow-up, non-blinding of service providers and participants, and no placebo or active comparison intervention. Conclusions CETA provided by lay counselors was highly effective across disorders among trauma survivors compared to WLCs. These results support the further development and testing of transdiagnostic approaches as possible treatment options alongside existing EBTs. Trial registration ClinicalTrials.gov NCT01459068 Please see later in the article for the Editors' Summary PMID:25386945

A Randomized Controlled Trial of Cognitive-Behavior Therapy Plus Bright Light Therapy for Adolescent Delayed Sleep Phase Disorder

PubMed Central

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

2011-01-01

Objective: To evaluate cognitive-behavior therapy plus bright light therapy (CBT plus BLT) for adolescents diagnosed with delayed sleep phase disorder (DSPD). Design: Randomized controlled trial of CBT plus BLT vs. waitlist (WL) control with comparisons at pre- and post-treatment. There was 6-month follow-up for the CBT plus BLT group only. Setting: Flinders University Child & Adolescent Sleep Clinic, Adelaide, South Australia. Patients: 49 adolescents (mean age 14.6 ± 1.0 y, 53% males) diagnosed with DSPD; mean chronicity 4 y 8 months; 16% not attending school. Eighteen percent of adolescents dropped out of the study (CBT plus BLT: N = 23 vs WL: N = 17). Interventions: CBT plus BLT consisted of 6 individual sessions, including morning bright light therapy to advance adolescents' circadian rhythms, and cognitive restructuring and sleep education to target associated insomnia and sleep hygiene. Measurements and Results: DSPD diagnosis was performed via a clinical interview and 7-day sleep diary. Measurements at each time-point included online sleep diaries and scales measuring sleepiness, fatigue, and depression symptoms. Compared to WL, moderate-to-large improvements (d = 0.65-1.24) were found at post-treatment for CBT plus BLT adolescents, including reduced sleep latency, earlier sleep onset and rise times, total sleep time (school nights), wake after sleep onset, sleepiness, and fatigue. At 6-month follow-up (N = 15), small-to-large improvements (d = 0.24-1.53) continued for CBT plus BLT adolescents, with effects found for all measures. Significantly fewer adolescents receiving CBT plus BLT met DPSD criteria at post-treatment (WL = 82% vs. CBT plus BLT = 13%, P < 0.0001), yet 13% still met DSPD criteria at the 6-month follow-up. Conclusions: CBT plus BLT for adolescent DSPD is effective for improving multiple sleep and daytime impairments in the immediate and long-term. Studies evaluating the treatment effectiveness of each treatment component are needed. Clinical Trial Information: Australia – New Zealand Trials Registry Number: ACTRN12610001041044. Citation: Gradisar M; Dohnt H; Gardner G; Paine S; Starkey K; Menne A; Slater A; Wright H; Hudson JL; Weaver E; Trenowden S. A randomized controlled trial of cognitive-behavior therapy plus bright light therapy for adolescent delayed sleep phase disorder. SLEEP 2011;34(12):1671-1680. PMID:22131604

A Web-Based, Social Networking Physical Activity Intervention for Insufficiently Active Adults Delivered via Facebook App: Randomized Controlled Trial

PubMed Central

Ferguson, Monika; Vandelanotte, Corneel; Plotnikoff, Ron; De Bourdeaudhuij, Ilse; Thomas, Samantha; Nelson-Field, Karen; Olds, Tim

2015-01-01

Background Online social networks offer considerable potential for delivery of socially influential health behavior change interventions. Objective To determine the efficacy, engagement, and feasibility of an online social networking physical activity intervention with pedometers delivered via Facebook app. Methods A total of 110 adults with a mean age of 35.6 years (SD 12.4) were recruited online in teams of 3 to 8 friends. Teams were randomly allocated to receive access to a 50-day online social networking physical activity intervention which included self-monitoring, social elements, and pedometers (“Active Team” Facebook app; n=51 individuals, 12 teams) or a wait-listed control condition (n=59 individuals, 13 teams). Assessments were undertaken online at baseline, 8 weeks, and 20 weeks. The primary outcome measure was self-reported weekly moderate-to-vigorous physical activity (MVPA). Secondary outcomes were weekly walking, vigorous physical activity time, moderate physical activity time, overall quality of life, and mental health quality of life. Analyses were undertaken using random-effects mixed modeling, accounting for potential clustering at the team level. Usage statistics were reported descriptively to determine engagement and feasibility. Results At the 8-week follow-up, the intervention participants had significantly increased their total weekly MVPA by 135 minutes relative to the control group (P=.03), due primarily to increases in walking time (155 min/week increase relative to controls, P<.001). However, statistical differences between groups for total weekly MVPA and walking time were lost at the 20-week follow-up. There were no significant changes in vigorous physical activity, nor overall quality of life or mental health quality of life at either time point. High levels of engagement with the intervention, and particularly the self-monitoring features, were observed. Conclusions An online, social networking physical activity intervention with pedometers can produce sizable short-term physical activity changes. Future work is needed to determine how to maintain behavior change in the longer term, how to reach at-need populations, and how to disseminate such interventions on a mass scale. Trial Registration Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12614000488606; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366239 (Archived by WebCite at http://www.webcitation.org/6ZVtu6TMz). PMID:26169067

High- and Low-Level Dissonance-Based Eating Disorder Prevention Programs with Young Women with Body Image Concerns: An Experimental Trial

ERIC Educational Resources Information Center

McMillan, Whitney; Stice, Eric; Rohde, Paul

2011-01-01

Objective: As cognitive dissonance is theorized to contribute to the effects of dissonance-based eating disorder prevention programs, we evaluated a high-dissonance version of this program against a low-dissonance version and a wait-list control condition to provide an experimental test of the mechanism of intervention effects. Method: Female…

Short-Term Effectiveness of Web-Based Guided Self-Help for Phobic Outpatients: Randomized Controlled Trial

PubMed Central

van Straten, Annemieke; Beekman, Aartjan T F; Cuijpers, Pim

2014-01-01

Background Internet-based guided self-help has been successfully used in the general population, but it is unknown whether this method can be effectively used in outpatient clinics for patients waiting for face-to-face psychotherapy for phobias. Objective The aim was to assess the clinical effectiveness of Phobias Under Control, an Internet-based intervention based on exposure therapy with weekly guidance. Methods We conducted a randomized controlled trial, recruiting 212 outpatients scheduled to receive face-to-face psychotherapy for any type of phobia at an outpatient clinic. Participants suffering from at least 1 DSM-IV or ICD-10 classified phobia (social phobia, agoraphobia with or without panic disorder, and/or specific phobia as ascertained by a telephone interview at baseline) were randomly allocated to either a 5-week Internet-based guided self-help program based on exposure therapy with weekly student support followed by face-to-face psychotherapy (n=105) or a wait-list control group followed by face-to-face psychotherapy (n=107). Primary outcome was the Fear Questionnaire (FQ). Secondary outcomes were the Beck Anxiety Inventory (BAI) and Center of Epidemiological Studies-Depression scale (CES-D). Assessments took place by telephone at baseline (T0) and on the Internet at posttest (T1, self-assessment at 5 weeks after baseline). Missing data at T1 were imputed. Results At posttest, analysis of covariance on the intention-to-treat sample showed significant but small effect sizes between intervention and control groups on the FQ (d=0.35, P=.02), CES-D (d=0.34, P=.03), and a nonsignificant effect size on the BAI (d=0.28. P=.05). Although initial acceptance was good, high nonresponse was observed, with 86 of 212 participants (40.5%) lost to follow-up at T1 and only 14 of 105 (13.3%) intervention participants finishing all 5 weeks. Conclusions Phobias Under Control is modestly effective in lowering phobic and depressive symptoms in a relatively short period and may be clinically beneficial when implemented in routine outpatient practice. Trial Registration Netherlands Trial Register NTR2233; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2233 (Archived by WebCite at http://www.webcitation.org/6O2ioOQSs). PMID:25266929

Internet-based, culturally sensitive, problem-solving therapy for Turkish migrants with depression: randomized controlled trial.

PubMed

Ünlü Ince, Burçin; Cuijpers, Pim; van 't Hof, Edith; van Ballegooijen, Wouter; Christensen, Helen; Riper, Heleen

2013-10-11

Turkish migrants living in the Netherlands have a high prevalence of depressive disorders, but experience considerable obstacles to accessing professional help. Providing easily accessible Internet treatments may help to overcome these barriers. The aim of this study was to evaluate the effectiveness of a culturally sensitive, guided, self-help, problem-solving intervention through the Internet for reducing depressive symptoms in Turkish migrants. A two-armed randomized controlled trial was conducted. The primary outcome measure was the severity of depressive symptoms; secondary outcome measures were somatic symptoms, anxiety, quality of life, and satisfaction with the treatment. Participants were assessed online at baseline, posttest (6 weeks after baseline), and 4 months after baseline. Posttest results were analyzed on the intention-to-treat sample. Missing values were estimated by means of multiple imputation. Differences in clinical outcome between groups were analyzed with a t test. Cohen's d was used to determine the between-groups effect size at posttreatment and follow-up. Turkish adults (N=96) with depressive symptoms were randomized to the experimental group (n=49) or to a waitlist control group (n=47). High attrition rates were found among the 96 participants of which 42% (40/96) did not complete the posttest (6 weeks) and 62% (59/96) participants did not complete the follow-up assessment at 4 months. No significant difference between the experimental group and the control group was found for depression at posttest. Recovery occurred significantly more often in the experimental group (33%, 16/49) than in the control group (9%, 4/47) at posttest (P=.02). Because of the high attrition rate, a completers-only analysis was conducted at follow-up. The experimental group showed significant improvement in depression compared to the control group both at posttest (P=.01) and follow-up (P=.01). The results of this study did not show a significant effect on the reduction of depressive symptoms. However, the effect size at posttest was high, which might be an indicator of the possible effectiveness of the intervention when assessed in a larger sample and robust trial. Future research should replicate our study with adequately powered samples. Dutch Trial Register: NTR2303. http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2303 (Archived by WebCite at http://www.webcitation.org/6IOxNgoDu).

Effectiveness of an Internet-based preparation for psychosomatic treatment: Results of a controlled observational study.

PubMed

Zimmer, Benjamin; Moessner, Markus; Wolf, Markus; Minarik, Carla; Kindermann, Sally; Bauer, Stephanie

2015-11-01

Patients often have to sustain long waiting periods between the time they first apply for psychotherapy and the actual uptake of the treatment. To support patients who are on a wait-list for inpatient psychosomatic treatment an Internet-based preparatory treatment (VORSTAT) was developed. In a randomized controlled trial, VORSTAT proved to increase treatment motivation prior to intake and to accelerate the accommodation phase at the beginning of inpatient treatment. No impact of VORSTAT on inpatient treatment outcome was found. The aim of the present study was to investigate the effectiveness of VORSTAT after implementing the service into routine care. A large naturalistic observational study comparing VORSTAT participants (N=911) against non-participants (N=1721) was conducted. Propensity scores were used to control for potential confounding variables due to the non-randomized group allocation. Reliable improvement of self-reported impairment achieved during inpatient treatment was used as outcome measure. VORSTAT participants showed higher rates of reliable improvement in physical impairment (50.8% vs. 44.9%), psychological impairment (41.2% vs. 29.9%), and social problems (22.3% vs. 15.2%). An Internet-based preparation for psychotherapy is an effective approach to improve outcome of inpatient psychosomatic treatment. Copyright © 2015 Elsevier Inc. All rights reserved.

Mindfulness meditation for the treatment of chronic low back pain in older adults: A randomized controlled pilot study

PubMed Central

Morone, Natalia E.; Greco, Carol M.; Weiner, Debra K.

2008-01-01

The objectives of this pilot study were to assess the feasibility of recruitment and adherence to an eight-session mindfulness meditation program for community-dwelling older adults with chronic low back pain (CLBP) and to develop initial estimates of treatment effects. It was designed as a randomized, controlled clinical trial. Participants were 37 community-dwelling older adults aged 65 years and older with CLBP of moderate intensity occurring daily or almost every day. Participants were randomized to an 8-week mindfulness-based meditation program or to a wait-list control group. Baseline, 8-week and 3-month follow-up measures of pain, physical function, attention, and quality of life were assessed. Eighty-nine older adults were screened and 37 found to be eligible and randomized within a 6-month period. The mean age of the sample was 74.9 years, 21/37 (57%) of participants were female and 33/37 (89%) were white. At the end of the intervention 30/37 (81%) participants completed 8-week assessments. Average class attendance of the intervention arm was 6.7 out of 8. They meditated an average of 4.3 days a week and the average minutes per day was 31.6. Compared to the control group, the intervention group displayed significant improvement in the Chronic Pain Acceptance Questionnaire Total Score and Activities Engagement subscale (P = .008, P = .004) and SF-36 Physical Function (P = .03). An 8-week mindfulness-based meditation program is feasible for older adults with CLBP. The program may lead to improvement in pain acceptance and physical function. PMID:17544212

Log in and breathe out: efficacy and cost-effectiveness of an online sleep training for teachers affected by work-related strain - study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Insomnia and work-related stress often co-occur. Both are associated with personal distress and diminished general functioning, as well as substantial socio-economic costs due to, for example, reduced productivity at the work place and absenteeism. Insomnia complaints by people experiencing work-related stress are correlated with a deficient cognitive detachment from work. Diffuse boundaries between work and private life can additionally complicate the use of recreational activities that facilitate cognitive detachment. Cognitive behavioral therapy for insomnia is effective but rarely implemented. Internet-based cognitive behavioral therapy for insomnia could potentially reduce this deficit given its demonstrated effectiveness. Less is known, however, about the efficacy of internet-based cognitive behavioral therapy for insomnia in populations affected by high work stress. Thus, the aim of the present study is to evaluate the efficacy and cost-effectiveness of a newly developed, guided online training which is based on Cognitive Behavioral Therapy for insomnia and tailored to teachers affected by occupational stress. Methods/Design In a two-arm randomized controlled trial (N = 128), the effects of a guided online sleep training will be compared to a waitlist-control condition. German teachers with significant clinical insomnia complaints (Insomnia Severity Index ≥15) and work-related rumination (Irritation Scale, subscale Cognitive Irritation ≥15) will be included in the study. The primary outcome measure will be insomnia severity. Additionally, an economic evaluation from a societal perspective will be conducted. Data from the intention-to-treat sample will be analyzed two and six months after randomization. Discussion To the best of our knowledge, this is the first study to evaluate an online sleep training tailored to a specific population with work stress, that is, teachers. If this type of intervention is effective, it could reduce the paucity of cognitive behavioral therapy for insomnia and augment the support for teachers in coping with their insomnia problems. Trial registration German Clinical Trial Register (DRKS): DRKS00004700 PMID:23759035

Does a fall prevention educational programme improve knowledge and change exercise prescribing behaviour in health and exercise professionals? A study protocol for a randomised controlled trial.

PubMed

Tiedemann, A; Sturnieks, D L; Hill, A-M; Lovitt, L; Clemson, L; Lord, S R; Harvey, L; Sherrington, C

2014-11-19

Falling in older age is a serious and costly problem. At least one in three older people fall annually. Although exercise is recognised as an effective fall prevention intervention, low numbers of older people engage in suitable programmes. Health and exercise professionals play a crucial role in addressing fall risk in older adults. This trial aims to evaluate the effect of participation in a fall prevention educational programme, compared with a wait-list control group, on health and exercise professionals' knowledge about fall prevention and the effect on fall prevention exercise prescription behaviour and confidence to prescribe the exercises to older people. A randomised controlled trial involving 220 consenting health and exercise professionals will be conducted. Participants will be individually randomised to an intervention group (n=110) to receive an educational workshop plus access to internet-based support resources, or a wait-list control group (n=110). The two primary outcomes, measured 3 months after randomisation, are: (1) knowledge about fall prevention and (2) self-perceived change in fall prevention exercise prescription behaviour. Secondary outcomes include: (1) participants' confidence to prescribe fall prevention exercises; (2) the proportion of people aged 60+ years seen by trial participants in the past month who were prescribed fall prevention exercise; and (3) the proportion of fall prevention exercises prescribed by participants to older people in the past month that comply with evidence-based guidelines. Outcomes will be measured with a self-report questionnaire designed specifically for the trial. The trial protocol was approved by the Human Research Ethics Committee, The University of Sydney, Australia. Trial results will be disseminated via peer reviewed journals, presentations at international conferences and participants' newsletters. Trial protocol was registered with the Australian and New Zealand Clinical Trials Registry (Number ACTRN12614000224628) on 3 March 2014. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Effects of a stress management intervention on absenteeism and return to work--results from a randomized wait-list controlled trial.

PubMed

Willert, Morten Vejs; Thulstrup, Ane Marie; Bonde, Jens Peter

2011-05-01

High levels of work-related stress are associated with increased absenteeism from work and reduced work ability. In this study, we investigated the effects of a stress management intervention on absenteeism and return to work. We randomized 102 participants into either the intervention or wait-list control (WLC) group. The intervention group received the intervention in weeks 1-16 from baseline, and the WLC group received the intervention in weeks 17-32. Self-reported data on absenteeism (number of days full- or part-time absent from work within the previous three months) were obtained at 16, 32, and 48 weeks follow-up. Register-based data on long-term absence from work were drawn from the Danish public transfer payments (DREAM) database from baseline and 48 weeks onwards. The DREAM database contains weekly information on long-term sickness absence compensation. The threshold to enter DREAM is sick leave for two consecutive weeks. At follow-up in week 16, self-reported absenteeism in the intervention group [median 11 days (range 3-25)] was lower (P=0.02) than in the WLC group [median 45 days (range 19-60)], corresponding to a 29% [95% confidence interval (95% CI) 5-52] reduction. On register-based data (cumulated weeks in DREAM, weeks 1-16), the intervention group median [6 weeks (range 0-11)] was lower than that of the WLC group [median 12 weeks (range 8-16)], though not significantly (P=0.06), corresponding to a 21% (95% CI 0-42) reduction. For return to work, a hazard ratio of 1.58 (95% CI 0.89-2.81) favoring the intervention group was found (P=0.12). The intervention reduces self-reported absenteeism from work. A similar trend was found from register-based records. No conclusive evidence was found for return to work.

A randomised controlled trial of face to face versus pure online self-help cognitive behavioural treatment for perfectionism.

PubMed

Egan, Sarah J; van Noort, Emily; Chee, Abby; Kane, Robert T; Hoiles, Kimberley J; Shafran, Roz; Wade, Tracey D

2014-12-01

Previous research has shown cognitive-behavioural treatment (CBT) to be effective in reducing perfectionism. The present study investigated the efficacy of two formats of CBT for perfectionism (CBT-P), face-to-face and pure online self-help, in reducing perfectionism and associated psychological symptoms. Participants were randomly allocated to face-to-face CBT-P (n = 18), pure online self-help CBT-P (n = 16), or a waitlist control period (n = 18). There was no significant change for the waitlist group on any of the outcome measures at the end of treatment. Both the face-to-face and pure online self-help groups reported significant reductions at the end of treatment for the perfectionism variables which were maintained at the 6-month follow-up. The face-to-face group also reported significant reductions over this time in depression, anxiety, and stress, and a significant pre-post increase in self-esteem, all of which were maintained at the 6-month follow-up. In contrast, the pure online self-help group showed no significant changes on these outcomes. The face-to-face group was statistically superior to the pure online self-help group at follow-up on the perfectionism measures, concern over mistakes and personal standards. The results show promising evidence for CBT for perfectionism, especially when offered face to face, where sustained benefit across a broad range of outcomes can be expected. Crown Copyright © 2014. Published by Elsevier Ltd. All rights reserved.

Effects of prolonged exposure and virtual reality exposure on suicidal ideation in active duty soldiers: An examination of potential mechanisms.

PubMed

Norr, Aaron M; Smolenski, Derek J; Reger, Greg M

2018-05-12

The current study sought to investigate the effects of exposure therapy on suicidal ideation (SI), as well as potential mechanistic pathways of SI reduction among active duty military personnel. Active duty army soldiers (N = 162) were recruited from a military base in the U.S. and were enrolled in a randomized clinical trial comparing Prolonged Exposure (PE), Virtual Reality Exposure (VRE), and a wait-list control for the treatment of posttraumatic stress disorder (PTSD) stemming from deployments to Iraq or Afghanistan. PTSD diagnosis followed DSM-IV-TR criteria. Outcome measures were assessed via self-report and clinician interview. PTSD symptoms, depressive symptoms, and SI were included in an autoregressive cross-lagged panel model to examine mechanistic pathways. Analyses revealed that PE/VRE had a lower probability of post-treatment suicidal ideation (OR = 0.23, 95% CI [0.06, 0.86]) compared to the waitlist control. Mediation analyses revealed a significant indirect effect from treatment condition to post-treatment PTSD symptoms through mid-treatment SI (Estimate = -1.420, 95% CI -3.559, -0.223]). Baseline suicidal ideation did not interact with treatment condition to predict PTSD symptom change at mid-treatment (p = .231) or post-treatment (p = .672). PE/VRE successfully reduced SI, and the presence of SI at baseline did not affect PTSD symptom reduction, promoting the utility of using PE/VRE to address suicidality among individuals with PTSD. Mediation analyses suggest that reductions in SI were achieved early in treatment. Published by Elsevier Ltd.

Exercise and manual physiotherapy arthritis research trial (EMPART) for osteoarthritis of the hip: a multicenter randomized controlled trial.

PubMed

French, Helen P; Cusack, Tara; Brennan, Aisling; Caffrey, Aoife; Conroy, Ronán; Cuddy, Vanessa; FitzGerald, Oliver M; Fitzpatrick, Martina; Gilsenan, Clare; Kane, David; O'Connell, Paul G; White, Breon; McCarthy, Geraldine M

2013-02-01

To determine the effectiveness of exercise therapy (ET) compared with ET with adjunctive manual therapy (MT) for people with hip osteoarthritis (OA); and to identify if immediate commencement of treatment (ET or ET+MT) was more beneficial than a 9-week waiting period for either intervention. Assessor-blind randomized controlled trial with a 9-week and 18-week follow-up. Four academic teaching hospitals in Dublin, Ireland. Patients (N=131) with hip OA recruited from general practitioners, rheumatologists, orthopedic surgeons, and other hospital consultants were randomized to 1 of 3 groups: ET (n=45), ET+MT (n=43), and waitlist controls (n=43). Participants in both the ET and ET+MT groups received up to 8 treatments over 8 weeks. Control group participants were rerandomized into either ET or ET+MT groups after 9 week follow-up. Their data were pooled with original treatment group data: ET (n=66) and ET+MT (n=65). The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function (PF) subscale. Secondary outcomes included physical performance, pain severity, hip range of motion (ROM), anxiety/depression, quality of life, medication usage, patient-perceived change, and patient satisfaction. There was no significant difference in WOMAC PF between the ET (n=66) and ET+MT (n=65) groups at 9 weeks (mean difference, .09; 95% confidence interval [CI] -2.93 to 3.11) or 18 weeks (mean difference, .42; 95% CI, -4.41 to 5.25), or between other outcomes, except patient satisfaction with outcomes, which was higher in the ET+MT group (P=.02). Improvements in WOMAC, hip ROM, and patient-perceived change occurred in both treatment groups compared with the control group. Self-reported function, hip ROM, and patient-perceived improvement occurred after an 8-week program of ET for patients with OA of the hip. MT as an adjunct to exercise provided no further benefit, except for higher patient satisfaction with outcome. Copyright © 2013 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Effectiveness of a Web-Based Guided Self-help Intervention for Outpatients With a Depressive Disorder: Short-term Results From a Randomized Controlled Trial.

PubMed

Kenter, Robin Maria Francisca; Cuijpers, Pim; Beekman, Aartjan; van Straten, Annemieke

2016-03-31

Research has convincingly demonstrated that symptoms of depression can be reduced through guided Internet-based interventions. However, most of those studies recruited people form the general population. There is insufficient evidence for the effectiveness when delivered in routine clinical practice in outpatient clinics. The objective of this randomized controlled trial was to study patients with a depressive disorder (as defined by the Diagnostic and Statistical Manual of Disorders, fourth edition), as assessed by trained interviewers with the Composite International Diagnostic Interview, who registered for treatment at an outpatient mental health clinic. We aimed to examine the effectiveness of guided Internet-based self-help before starting face-to-face treatment. We recruited 269 outpatients, aged between 18 and 79 years, from outpatient clinics and randomly allocated them to Internet-based problem solving therapy (n=136), with weekly student support, or to a control condition, who remained on the waitlist with a self-help booklet (control group; n=133). Participants in both conditions were allowed to take up face-to-face treatment at the outpatient clinics afterward. We measured the primary outcome, depressive symptoms, by Center for Epidemiological Studies Depression scale (CES-D). Secondary outcome measures were the Hospital Anxiety and Depression Scale Anxiety subscale (HADS-A), Insomnia Severity Index questionnaire (ISI), and EuroQol visual analog scale (EQ-5D VAS). All outcomes were assessed by telephone at posttest (8 weeks after baseline). Posttest measures were completed by 184 (68.4%) participants. We found a moderate to large within-group effect size for both the intervention (d=0.75) and the control (d=0.69) group. However, the between-group effect size was very small (d=0.07), and regression analysis on posttreatment CES-D scores revealed no significant differences between the groups (b=1.134, 95% CI -2.495 to 4.763). The per-protocol analysis (≥4 sessions completed) results were also not significant (b=1.154, 95% CI -1.978 to 7.637). Between-group differences were small and not significant for all secondary outcomes. Adherence to the intervention was low. Only 36% (49/136) received an adequate dosage of the intervention (≥4 of 5 sessions). The overall treatment satisfaction was moderate. Internet-based problem solving therapy is not more effective in reducing symptoms of depression than receiving an unguided self-help book during the waitlist period at outpatient mental health clinics. The effect sizes are much smaller than those found in earlier research in the general population, and the low rates of adherence indicate that the acceptability of the intervention at this stage of treatment for depressed outpatients is low. However, taking into account that there is much evidence for the efficacy of Internet-based treatments, it is too early to draw firm conclusions about the effectiveness of these treatments in outpatient clinics as a whole. Netherlands Trial Register NTR2824; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2824 (Archived by WebCite at http://www.webcitation/ 6g3WEuiqH).

ENHANCE: Design and rationale of a randomized controlled trial for promoting enduring happiness & well-being.

PubMed

Kushlev, Kostadin; Heintzelman, Samantha J; Lutes, Lesley D; Wirtz, Derrick; Oishi, Shigehiro; Diener, Ed

2017-01-01

Individuals who are higher in subjective well-being not only feel happier, they are more likely have fulfilling relationships, increased work performance and income, better physical health, and longer lives. Over the past several decades, the science of subjective well-being has produced insights into these benefits of happiness, and-recognizing their importance-has begun to examine the factors that lead to greater well-being, from cultivating strong relationships to pursuing meaningful goals. However, studies to date have typically focused on improving subjective well-being by intervening with singular constructs, using primarily college student populations, and were short-term in nature. Moreover, little is understood about the impact of a well-being treatment delivered online vs. in-person. In the present article, we describe a comprehensive intervention program including 3-month initial treatment followed by a 3-month follow-up, ENHANCE: Enduring Happiness and Continued Self-Enhancement. One-hundred and sixty participants will be recruited from two different sites to participate in one of two versions of ENHANCE: in-person (n=30) vs. wait-list control (n=30); or online (n=50) vs. wait-list control (n=50). Assessments will be completed at baseline, three months and six months. Our primary outcome is change in subjective well-being across treatment (3months) and follow-up (6months). Secondary outcomes include self-report and objective measures of health, as well as a psychological mediators (e.g., psychological needs) and moderators (e.g., personality) of treatment outcomes. We hope to provide researchers, practitioners, and individuals with an evidence-based treatment to improve happiness and subjective well-being. Copyright © 2016 Elsevier Inc. All rights reserved.

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

PubMed

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

2015-11-20

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

Efficacy of Mobile Serious Games in Increasing HIV Risk Perception in Swaziland: A Randomized Control Trial (SGprev Trial) Research Protocol

PubMed Central

Musumari, Patou; El-Saaidi, Christina; Techasrivichien, Teeranee; Suguimoto, S. Pilar; Ono Kihara, Masako; Kihara, Masahiro

2016-01-01

Background The human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS) continue to be a major public health problem in Sub-Saharan Africa (SSA), particularly in Swaziland, which has the highest HIV prevalence in this region. A wide range of strategies and interventions have been used to promote behavior change, though almost all such interventions have involved mass media. Therefore, innovative behavior change strategies beyond mass media communication are urgently needed. Serious games have demonstrated effectiveness in advancing health in the developed world; however, no rigorous serious games interventions have been implemented in HIV prevention in SSA. Objective We plan to test whether a serious game intervention delivered on mobile phones to increase HIV risk perception, increase intention to reduce sexual partnerships, and increase intention to know own and partners HIV status will be more effective compared with current prevention efforts. Methods This is a two-arm randomized intervention trial. We will recruit 380 participants who meet the following eligibility criteria: 18-29 years of age, own a smartphone running an Android-based operating system, have the WhatsApp messaging app, live in Swaziland, and can adequately grant informed consent. Participants will be allocated into a smartphone interactive, educational story game, and a wait-list control group in a 1:1 allocation ratio. Subsequently, a self-administered Web-based questionnaire will be issued at baseline and after 4 weeks of exposure to the game. We hypothesize that the change in HIV risk perception between pre- and post-intervention assessment is greater in the intervention group compared with the change in the control group. Our primary hypothesis is based on the assumption that increased perceived risk of HIV provides cues to engage in protective behavior. Our primary outcome measure is HIV risk perceived mean change between pre- and post-intervention compared with the mean change in the wait-list control group at 4-weeks post-intervention. We will use standardized regression coefficients to calculate the effect of the intervention on our primary outcome with P values. We will conduct both intention to treat and as treated analysis. Results This study is funded by Hayao Nakayama Foundation for Science & Technology and Culture; Grant number H26-A2-41. The research and development approval has been obtained from Kyoto University Graduate School and Faculty of Medicine Ethics Committee, Japan, and Swaziland’s Ministry of Health Ethics and Scientific committee. Results are expected in February 2017. Conclusions This study will provide evidence on the efficiency of a mobile phone interactive game in increasing HIV risk perception in Swaziland. Our findings may also be generalizable to similar settings in SSA. Trial Registration University Hospital Medical Information Network Clinical Trial Registry ID number (UMIN-CTR):UMIN000021781; URL:https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025103 (Archived by WebCite at http://www.webcitation.org/6hOphB11a). PMID:27876685

Efficacy of a hybrid online training for panic symptoms and agoraphobia: study protocol for a randomized controlled trial.

PubMed

Ebenfeld, Lara; Kleine Stegemann, Stefan; Lehr, Dirk; Ebert, David Daniel; Jazaieri, Hooria; van Ballegooijen, Wouter; Funk, Burkhardt; Riper, Heleen; Berking, Matthias

2014-11-04

Recently, internet-based interventions have been proposed as effective treatments for people with panic disorder (PD). However, little is known about the clinical effects of integrating mobile technology into these interventions. Because users carry their smartphones with them throughout the day, we hypothesize that this technology can be used to significantly support individuals with monitoring and overcoming their PD symptoms. The aim of the present study is to evaluate the efficacy and cost-effectiveness of a newly developed hybrid intervention that combines internet/PC with smartphone delivery to treat the symptoms of PD. The intervention is based on cognitive behavioral therapy and consists of six modules over a total of six weeks. A two-arm randomized controlled trial (RCT) will be conducted to evaluate the effects of a hybrid online training module for PD. Based on a power calculation (d =0.60; 1-β of 80%; α =0.05), 90 participants with mild to moderate panic symptoms with or without agoraphobia (as assessed by the Panic and Agoraphobia Scale) will be recruited from the general population and randomly assigned to either the intervention group or a six-month waitlist control group. The primary outcome measure will be the severity of panic symptoms. Secondary outcomes will include depression, quality of life, and an observer-based rating of panic severity. Furthermore, data regarding acceptance and the usability of the smartphone app will be assessed. Assessments will take place at baseline as well as eight weeks, three months, and six months after randomization. Moreover, a cost-effectiveness analysis will be performed from a societal perspective. Data will be analyzed on an intention-to-treat basis and per protocol. To our knowledge, this RCT is one of the first to examine the efficacy of a hybrid online training for adult PD. This study seeks to contribute to the emerging field of hybrid online training. If the intervention is efficacious, then research on this hybrid online training should be extended. The cost-effectiveness analysis will also indicate whether online training is an economical tool for treating PD among adults. German Clinical Trial Register: DRKS00005223 (registered on 15 August 2013).

The effects of a 12-week strength-training program on strength and functionality in women with fibromyalgia.

PubMed

Kingsley, J Derek; Panton, Lynn B; Toole, Tonya; Sirithienthad, Prawee; Mathis, Reed; McMillan, Victor

2005-09-01

To determine whether women with fibromyalgia benefit from strength training. Randomized controlled trial. Testing was completed at the university and training was completed at a local community wellness facility. Twenty-nine women (age range, 18-54 y) with fibromyalgia participated. Subjects were randomly assigned to a control (n=14; wait-listed for exercise) or strength (n=15) group. After the first 4 weeks, 7 (47%) women dropped from the strength group. Subjects underwent 12 weeks of training on 11 exercises, 2 times a week, performing 1 set of 8 to 12 repetitions at 40% to 60% of their maximal lifts and were progressed to 60% to 80%. Subjects were measured for strength, functionality, tender point sensitivity, and fibromyalgia impact. The strength group significantly (P< or =.05) improved upper- (strength, 39+/-11 to 42+/-12 kg; control, 38+/-13 to 38+/-12 kg) and lower- (strength, 68+/-28 to 82+/-25 kg; control, 61+/-25 to 61+/-26 kg) body strength. Upper-body functionality measured by the Continuous-Scale Physical Functional Performance test improved significantly (strength, 44+/-11 to 50+/-16U; control, 51+/-11 to 49+/-13U) after training. Tender point sensitivity and fibromyalgia impact did not change. Strength training improved strength and some functionality in women with fibromyalgia. Interventions with resistance have important implications on independence and quality of life issues for women with fibromyalgia.

Randomized controlled trial of cognitive behavioral therapy and acceptance and commitment therapy for social phobia: outcomes and moderators.

PubMed

Craske, Michelle G; Niles, Andrea N; Burklund, Lisa J; Wolitzky-Taylor, Kate B; Vilardaga, Jennifer C Plumb; Arch, Joanna J; Saxbe, Darby E; Lieberman, Matthew D

2014-12-01

Cognitive behavioral therapy (CBT) is an empirically supported treatment for social phobia. However, not all individuals respond to treatment and many who show improvement do not maintain their gains over the long-term. Thus, alternative treatments are needed. The current study (N = 87) was a 3-arm randomized clinical trial comparing CBT, acceptance and commitment therapy (ACT), and a wait-list control group (WL) in participants with a diagnosis of social phobia based on criteria of the Diagnostic and Statistical Manual of Mental Disorders (4th ed.; American Psychiatric Association, 1994). Participants completed 12 sessions of CBT or ACT or a 12-week waiting period. All participants completed assessments at baseline and posttreatment, and participants assigned to CBT and ACT also completed assessments 6 and 12 months following baseline. Assessments consisted of self-report measures, a public-speaking task, and clinician ratings. Multilevel modeling was used to examine between-group differences on outcomes measures. Both treatment groups outperformed WL, with no differences observed between CBT and ACT on self-report, independent clinician, or public-speaking outcomes. Lower self-reported psychological flexibility at baseline was associated with greater improvement by the 12-month follow-up in CBT compared with ACT. Self-reported fear of negative evaluation significantly moderated outcomes as well, with trends for both extremes to be associated with superior outcomes from CBT and inferior outcomes from ACT. Across treatment groups, higher perceived control and extraversion were associated with greater improvement, whereas comorbid depression was associated with poorer outcomes. Implications for clinical practice and future research are discussed.

Confident body, confident child: A randomized controlled trial evaluation of a parenting resource for promoting healthy body image and eating patterns in 2- to 6-year old children.

PubMed

Hart, Laura M; Damiano, Stephanie R; Paxton, Susan J

2016-05-01

Body image and eating patterns develop in early childhood and are influenced by the family environment. This research evaluated Confident Body, Confident Child (CBCC), an intervention for parents of 2- to 6-year-old children, designed to promote body satisfaction, healthy eating, and weight management in early childhood. A randomized controlled trial compared four groups: (A) received the CBCC resource pack and a workshop, (B) received the CBCC resource pack only, (C) received a nutrition-only resource and (D) received no interventions until all questionnaires were completed (i.e., functioned as waitlist control). Measures of parenting variables relevant to child body image and eating patterns, parent-report of child weight, and evaluation questions about the resource, were implemented pre- and post-intervention. At 6-weeks post-intervention, the CBCC resource was associated with significant reductions in parents' intentions to use behaviors that increase the risk of negative body attitudes or unhealthy eating in their children, in parents' use of feeding practices associated with childhood overweight, and in television watching during family meals. Significant increases in parents' intentions to use positive behaviors and knowledge of child body image and healthy eating patterns were also found. Superior results were found for the CBCC resource + workshop condition, suggesting it is the preferred delivery method. CBCC positively impacts parenting variables associated with childhood risk for body dissatisfaction, unhealthy eating and weight. © 2016 Wiley Periodicals, Inc. (Int J Eat Disord 2016; 49:458-472). © 2016 Wiley Periodicals, Inc.

Randomized controlled trial of cognitive behavioral therapy and acceptance and commitment therapy for social phobia: outcomes and moderators

PubMed Central

Craske, Michelle G; Niles, Andrea N.; Burklund, Lisa J.; Wolitzky-Taylor, Kate B.; Vilardaga, Jennifer C. Plumb; Arch, Joanna J.; Saxbe, Darby E.; Lieberman, Matthew D.

2014-01-01

Objective Cognitive behavioral therapy (CBT) is an empirically supported treatment for social phobia. However, not all individuals respond to treatment and many who show improvement do not maintain their gains over the long-term. Thus, alternative treatments are needed. Method The current study (N=87) was a 3-arm randomized clinical trial comparing CBT, Acceptance and Commitment therapy (ACT), and a waitlist control group (WL) in participants with a DSM-IV diagnosis of social phobia. Participants completed 12 sessions of CBT or ACT or a 12-week waiting period. All participants completed assessments at baseline and post-treatment, and participants assigned to CBT and ACT also completed assessments at 6 and 12 months following baseline. Assessments consisted of self-report measures, a public speaking task, and clinician ratings. Results Multilevel modeling was used to examine between-group differences on outcomes measures. Both treatment groups outperformed WL, with no differences observed between CBT and ACT on self-report, independent clinician, or public speaking outcomes. Lower self-reported psychological flexibility at baseline was associated with greater improvement by the 12-mo follow-up in CBT compared to ACT. Self-reported fear of negative evaluation significantly moderated outcomes as well, with trends for both extremes to be associated with superior outcomes from CBT and inferior outcomes from ACT. Across treatment groups, higher perceived control, and extraversion were associated with greater improvement, whereas comorbid depression was associated with poorer outcomes. Conclusions Implications for clinical practice and future research are discussed. PMID:24999670

Enhancing Web-based mindfulness training for mental health promotion with the health action process approach: randomized controlled trial.

PubMed

Mak, Winnie W S; Chan, Amy T Y; Cheung, Eliza Y L; Lin, Cherry L Y; Ngai, Karin C S

2015-01-19

With increasing evidence demonstrating the effectiveness of Web-based interventions and mindfulness-based training in improving health, delivering mindfulness training online is an attractive proposition. The aim of this study was to evaluate the efficacy of two Internet-based interventions (basic mindfulness and Health Action Process Approach enhanced mindfulness) with waitlist control. Health Action Process Approach (HAPA) principles were used to enhance participants' efficacy and planning. Participants were recruited online and offline among local universities; 321 university students and staff were randomly assigned to three conditions. The basic and HAPA-enhanced groups completed the 8-week fully automated mindfulness training online. All participants (including control) were asked to complete an online questionnaire pre-program, post-program, and at 3-month follow-up. Significant group by time interaction effect was found. The HAPA-enhanced group showed significantly higher levels of mindfulness from pre-intervention to post-intervention, and such improvement was sustained at follow-up. Both the basic and HAPA-enhanced mindfulness groups showed better mental well-being from pre-intervention to post-intervention, and improvement was sustained at 3-month follow-up. Online mindfulness training can improve mental health. An online platform is a viable medium to implement and disseminate evidence-based interventions and is a highly scalable approach to reach the general public. Chinese Clinical Trial Registry (ChiCTR): ChiCTR-TRC-12002954; http://www.chictr.org/en/proj/show.aspx?proj=3904 (Archived by WebCite at http://www.webcitation.org/6VCdG09pA).

Evaluation of a Sexual Abuse Prevention Education for Chinese Preschoolers

ERIC Educational Resources Information Center

Zhang, Wenjing; Chen, Jingqi; Feng, Yanan; Li, Jingyi; Liu, Chengfeng; Zhao, Xiaoxia

2014-01-01

Objectives: The purpose of this study was to test the feasibility of a sexual abuse prevention education in a sample of Chinese preschool children in Beijing, China. Method: One hundred and fifty preschool children were randomly assigned to either the intervention group (N = 78) or the wait-list control group (N = 72). Children were posttested on…

Reducing Preschoolers' Disruptive Behavior in Public with a Brief Parent Discussion Group

ERIC Educational Resources Information Center

Joachim, Sabine; Sanders, Matthew R.; Turner, Karen M. T.

2010-01-01

This study examined the efficacy of a brief 2-h discussion group for parents of preschool children that show disruptive behavior on shopping trips. Forty-six parents with children aged 2-6 years were randomly assigned to either the intervention condition or a waitlist control group. Significant intervention effects were found for measures of…

Gender-Specific HIV Prevention with Urban Early-Adolescent Girls: Outcomes of the Keepin' It Safe Program

ERIC Educational Resources Information Center

Di Noia, Jennifer; Schinke, Steven P.

2007-01-01

This study evaluates the efficacy of Keepin' It Safe, a theory-based, gender-specific, CD-ROM-mediated HIV prevention program for urban, early adolescent girls. Intervention effects were examined in a randomized, pretest-posttest wait-list control-group design. Changes in HIV/AIDS knowledge, protective attitudes, and skills for reducing HIV…

Child-Centered Group Play Therapy: Impact on Social-Emotional Assets of Kindergarten Children

ERIC Educational Resources Information Center

Cheng, Yi-Ju; Ray, Dee C.

2016-01-01

The current study explored the effects of child-centered group play therapy (CCGPT) on social-emotional assets of kindergarten children and the therapeutic aspect of group sizes in CCGPT outcome. A total of 43 participants were randomly assigned to either the intervention or waitlist control groups. We used Parent and Teacher forms of Social…

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

ERIC Educational Resources Information Center

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

2018-01-01

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

Computerized Silent Reading Rate and Strategy Instruction for Fourth Graders at Risk in Silent Reading Rate

ERIC Educational Resources Information Center

Niedo, Jasmin; Lee, Yen-Ling; Breznitz, Zvia; Berninger, Virginia W.

2014-01-01

Fourth graders whose silent word reading and/or sentence reading rate was, on average, two-thirds standard deviation below their oral reading of real and pseudowords and reading comprehension accuracy were randomly assigned to treatment ("n" = 7) or wait-listed ("n" = 7) control groups. Following nine sessions combining…

The Value of Workshops on Psychological Flexibility for Early Childhood Special Education Staff

ERIC Educational Resources Information Center

Biglan, Anthony; Layton, Georgia L.; Jones, Laura Backen; Hankins, Martin; Rusby, Julie C.

2013-01-01

High stress and burnout are common for early childhood special educators, contributing to high rates of attrition, diminished educational effectiveness, and high turnover. Acceptance and Commitment Therapy (ACT) is a promising approach for the prevention and treatment of a wide variety of problems. Using a randomized wait-list control design, this…

Parent training for preschool ADHD: A randomized controlled trial of specialized and generic programs

PubMed Central

Abikoff, Howard B.; Thompson, Margaret; Laver-Bradbury, Cathy; Long, Nicholas; Forehand, Rex L.; Brotman, Laurie Miller; Klein, Rachel G.; Reiss, Philip; Huo, Lan; Sonuga-Barke, Edmund

2014-01-01

Background The ‘New Forest Parenting Package’ (NFPP), an 8-week home-based intervention for parents of preschoolers with ADHD, fosters constructive parenting to target ADHD-related dysfunctions in attention and impulse control.Although NFPP has improved parent and laboratory measures of ADHD in community samples of children with ADHD-like problems, its efficacy in a clinical sample, and relative to an active treatment comparator, is unknown. The aims are to evaluate the short and long-term efficacy and generalization effects of NFPP compared to an established clinic-based parenting intervention for treating noncompliant behavior (‘Helping the Noncompliant Child’ [HNC]) in young children with ADHD. Methods A randomized controlled trial with three parallel arms was the design for this study. 164 3-4-year-olds, 73.8% male, meeting DSM-IV ADHD diagnostic criteria were randomized to NFPP (N = 67), HNC (N = 63), or wait-list control (WL, N = 34). All participants were assessed at post-treatment. NFPP and HNC participants were assessed at follow-up in the next school year. Primary outcomes were ADHD ratings by teachers blind to and uninvolved in treatment, and by parents. Secondary ADHD outcomes included clinician assessments, and laboratory measures of on-task behavior and delay of gratification. Other outcomes included parent and teacher ratings of oppositional behavior, and parenting measures. (Trial name: Home-Based Parent Training in ADHD Preschoolers; Registry: ClinicalTrials.gov Identifier: NCT01320098; URL: http://www/clinicaltrials.gov/ct2/show/NCT01320098). Results In both treatment groups, children's ADHD and ODD behaviors, as well as aspects of parenting, were rated improved by parents at the end of treatment compared to controls. Most of these gains in the children's behavior and in some parenting practices were sustained at follow-up. However, these parent-reported improvements were not corroborated by teacher ratings or objective observations. NFPP was not significantly better, and on a few outcomes significantly less effective, than HNC. Conclusions The results do not support the claim that NFPP addresses putative dysfunctions underlying ADHD, bringing about generalized change in ADHD, and its underpinning self-regulatory processes. The findings support documented difficulties in achieving generalization across non-targeted settings, and the importance of using blinded measures to provide meaningful assessments of treatment effects. PMID:25318650

Evaluation of active living every day in adults with arthritis.

PubMed

Callahan, Leigh F; Cleveland, Rebecca J; Shreffler, Jack; Hootman, Jennifer M; Mielenz, Thelma J; Schoster, Britta; Brady, Teresa; Schwartz, Todd

2014-02-01

Adults with arthritis can benefit from participation in physical activity and may be assisted by organized programs. The purpose of this study was to evaluate the effectiveness of a 20-week behavioral lifestyle intervention, Active Living Every Day (ALED), for improvements in primary outcomes (physical activity levels, aerobic endurance, function, symptoms). A 20-week randomized controlled community trial was conducted in 354 adults. Outcomes were assessed at baseline and 20 weeks in the intervention and wait-list control groups. The intervention group was also assessed at 6 and 12 months. Mean outcomes were determined by multilevel regression models in the intervention and control groups at follow-up points. At 20 weeks, the intervention group significantly increased participation in physical activity, and improved aerobic endurance, and select measures of function while pain, fatigue and stiffness remained status quo. In the intervention group, significant improvements in physical activity at 20 weeks were maintained at 6 and 12 months, and stiffness decreased. ALED appears to improve participation in physical activity, aerobic endurance, and function without exacerbating disease symptoms in adults with arthritis.

Meta-analysis of interventions for posttraumatic stress disorder and depression in adult survivors of mass violence in low- and middle-income countries.

PubMed

Morina, Nexhmedin; Malek, Mina; Nickerson, Angela; Bryant, Richard A

2017-08-01

Most survivors of mass violence live in low- and middle-income countries (LMICs). We conducted a meta-analysis of randomized controlled psychotherapy trials for adult posttraumatic stress disorder (PTSD) and/or depression in LMICs. We included 18 clinical trials (3,058 participants), in which 25 and 18 treatment arms measured symptoms of PTSD and depression, respectively. Active treatments for PTSD yielded a large aggregated pre-post effect size (g = 1.29; 95% CI = [0.99; 1.59]) and a small to medium effect size at posttreatment when compared to control conditions (g = 0.39; 95% CI = [0.24; 0.55]). Effect sizes were similar for pretreatment versus follow-up (g = 1.75; 95% CI = [1.17; 2.32]) and in comparison to waitlist at follow-up (g = 0.93; 95% CI = [0.56; 1.31]). Active treatments for depression produced large pre-post (g = 1.28; 95% CI = [0.96; 1.61]) and controlled effect sizes (posttreatment, comparison to control conditions, g = 0.86; 95% CI = [0.54; 1.18]). Our findings suggest that psychological interventions can effectively reduce symptoms of PTSD and depression in LMICs. Future research needs to focus on cost-effective interventions that are likely to be disseminated to the large numbers of war survivors in LMICs. © 2017 Wiley Periodicals, Inc.

A Web-Based Intervention for Users of Amphetamine-Type Stimulants: 3-Month Outcomes of a Randomized Controlled Trial.

PubMed

Tait, Robert J; McKetin, Rebecca; Kay-Lambkin, Frances; Carron-Arthur, Bradley; Bennett, Anthony; Bennett, Kylie; Christensen, Helen; Griffiths, Kathleen M

2014-01-01

Among illicit drugs, the prevalence of amphetamine-type stimulant (ATS) use is second only to cannabis. Currently, there are no approved pharmacotherapies for ATS problems, but some face-to-face psychotherapies are effective. Web-based interventions have proven to be effective for some substance use problems, but none has specifically targeted ATS users. The objective of the study was to evaluate the effectiveness of a Web-based intervention for ATS problems on a free-to-access site compared with a waitlist control group. We used a randomized controlled trial design. The primary outcome measure was self-reported ATS use in the past three months assessed using the Alcohol, Smoking, Substance Involvement Screening Test (ASSIST). Other measures included quality of life (EUROHIS score), psychological distress (K-10 score), days out of role, poly-drug use, general help-seeking intentions, actual help-seeking, and "readiness to change". The intervention consisted of three fully automated, self-guided modules based on cognitive behavioral therapy and motivation enhancement. The analysis was an intention-to-treat analysis using generalized estimating equation models, with a group by time interaction as the critical assessment. We randomized 160 people (intervention n=81, control n=79). At three months, 35/81 (43%) intervention and 45/79 (57%) control participants provided follow-up data. In the intervention group, 51/81 (63%) completed at least one module. The only significant group by time interaction was for days out of role. The pre/post change effect sizes showed small changes (range d=0.14 to 0.40) favoring the intervention group for poly-drug use, distress, actual help-seeking, and days out of role. In contrast, the control group was favored by reductions in ATS use, improvements in quality of life, and increases in help-seeking intentions (range d=0.09 to 0.16). This Web-based intervention for ATS use produced few significant changes in outcome measures. There were moderate, but nonsignificant reductions in poly-drug use, distress, days partially out of role, and increases in help-seeking. However, high levels of participant attrition, plus low levels of engagement with the modules, preclude firm conclusions being drawn on the efficacy of the intervention and emphasize the problems of engaging this group of clients in a fully automated program. Australian and New Zealand Clinical Trials Registry: ACTRN 12611000947909; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12611000947909 (Archived by WebCite at http://www.webcitation.org/6SHTxEnzP).

A 12-week commercial web-based weight-loss program for overweight and obese adults: randomized controlled trial comparing basic versus enhanced features.

PubMed

Collins, Clare E; Morgan, Philip J; Jones, Penelope; Fletcher, Kate; Martin, Julia; Aguiar, Elroy J; Lucas, Ashlee; Neve, Melinda J; Callister, Robin

2012-04-25

The development and use of Web-based programs for weight loss is increasing rapidly, yet they have rarely been evaluated using randomized controlled trials (RCTs). Interestingly, most people who attempt weight loss use commercially available programs, yet it is very uncommon for commercial programs to be evaluated independently or rigorously. To compare the efficacy of a standard commercial Web-based weight-loss program (basic) versus an enhanced version of this Web program that provided additional personalized e-feedback and contact from the provider (enhanced) versus a wait-list control group (control) on weight outcomes in overweight and obese adults. This purely Web-based trial using a closed online user group was an assessor-blinded RCT with participants randomly allocated to the basic or enhanced 12-week Web-based program, based on social cognitive theory, or the control, with body mass index (BMI) as the primary outcome. We enrolled 309 adults (129/309, 41.8% male, BMI mean 32.3, SD 4 kg/m(2)) with 84.1% (260/309) retention at 12 weeks. Intention-to-treat analysis showed that both intervention groups reduced their BMI compared with the controls (basic: -0.72, SD 1.1 kg/m(2), enhanced: -1.0, SD 1.4, control: 0.15, SD 0.82; P < .001) and lost significant weight (basic: -2.1, SD 3.3 kg, enhanced: -3.0, SD 4.1, control: 0.4, SD 2.3; P < .001) with changes in waist circumference (basic: -2.0, SD 3.5 cm, enhanced: -3.2, SD 4.7, control: 0.5, SD 3.0; P < .001) and waist-to-height ratio (basic: -0.01, SD 0.02, enhanced: -0.02, SD 0.03, control: 0.0, SD 0.02; P < .001), but no differences were observed between the basic and enhanced groups. The addition of personalized e-feedback and contact provided limited additional benefits compared with the basic program. A commercial Web-based weight-loss program can be efficacious across a range of weight-related outcomes and lifestyle behaviors and achieve clinically important weight loss. Although the provision of additional personalized feedback did not facilitate greater weight loss after 12 weeks, the impact of superior participant retention on longer-term outcomes requires further study. Further research is required to determine the optimal mix of program features that lead to the biggest treatment impact over time. Australian New Zealand Clinical Trials Registry (ANZCTR): 12610000197033.

ParticiPAte CP: a protocol of a randomised waitlist controlled trial of a motivational and behaviour change therapy intervention to increase physical activity through meaningful participation in children with cerebral palsy.

PubMed

Reedman, Sarah Elizabeth; Boyd, Roslyn N; Elliott, Catherine; Sakzewski, Leanne

2017-08-07

Children with cerebral palsy (CP) participate in leisure-time physical activities (PA) less often, with less intensity and reduced diversity than their typically developing peers. Participation in leisure-time physical activities may be an important source of habitual physical activity (HPA) for children with CP, who as a group have lower levels of HPA and increased sedentary time compared with their typically developing peers. The proposed study aims to compare the efficacy of a participation focused therapy (ParticiPAte CP) to usual care in a pragmatic, randomised waitlist controlled trial. Thirty-six children with CP (18 in each group), classified as Gross Motor Function Classification System levels I to III, aged between 8 and 12 years will be recruited across South East Queensland, Australia. Children will be randomised to receive either ParticiPAte CP or waitlist usual care using concealed allocation. ParticiPAte CP is an individually tailored, goal-directed intervention model of pragmatic participation-focused therapy using a toolbox of evidence-based strategies in the treatment of children with CP. This will include goal-setting; identification of barriers and facilitators to participation goals, strategy formation and planning and communication guided by principles of Self-Determination Theory using strategies of Motivational Interviewing. The intervention comprises 8 weekly sessions of 1 hour duration conducted by a physiotherapist in the child's home or community. ACTRN12615001064594. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Electroacupuncture for fatigue, sleep, and psychological distress in breast cancer patients with aromatase inhibitor-related arthralgia: a randomized trial.

PubMed

Mao, Jun J; Farrar, John T; Bruner, Deborah; Zee, Jarcy; Bowman, Marjorie; Seluzicki, Christina; DeMichele, Angela; Xie, Sharon X

2014-12-01

Although fatigue, sleep disturbance, depression, and anxiety are associated with pain in breast cancer patients, it is unknown whether acupuncture can decrease these comorbid symptoms in cancer patients with pain. The objective of this study was to evaluate the effect of electroacupuncture (EA) on fatigue, sleep, and psychological distress in breast cancer survivors who experience joint pain related to aromatase inhibitors (AIs). The authors performed a randomized controlled trial of an 8-week course of EA compared with a waitlist control (WLC) group and a sham acupuncture (SA) group in postmenopausal women with breast cancer who self-reported joint pain attributable to AIs. Fatigue, sleep disturbance, anxiety, and depression were measured using the Brief Fatigue Inventory (BFI), the Pittsburgh Sleep Quality Index (PSQI), and the Hospital Anxiety and Depression Scale (HADS). The effects of EA and SA versus WLC on these outcomes were evaluated using mixed-effects models. Of the 67 randomly assigned patients, baseline pain interference was associated with fatigue (Pearson correlation coefficient [r]=0.75; P < .001), sleep disturbance (r=0.38; P=.0026), and depression (r=0.58; P < .001). Compared with the WLC condition, EA produced significant improvements in fatigue (P=.0095), anxiety (P=.044), and depression (P=.015) and a nonsignificant improvement in sleep disturbance (P=.058) during the 12-week intervention and follow-up period. In contrast, SA did not produce significant reductions in fatigue or anxiety symptoms but did produce a significant improvement in depression compared with the WLC condition (P=.0088). Compared with usual care, EA produced significant improvements in fatigue, anxiety, and depression; whereas SA improved only depression in women experiencing AI-related arthralgia. © 2014 American Cancer Society.

Improving fundamental movement skills in Hong Kong students through an assessment for learning intervention that emphasizes fun, mastery, and support: the A + FMS randomized controlled trial study protocol.

PubMed

Chan, Cecilia; Ha, Amy; Ng, Johan Y Y

2016-01-01

Assessment for learning has been identified as an effective strategy to help children learn more effectively. Developing children to master basic movement skills in primary school requires formative assessments to inform instruction and learning. This study reports the rationale and methods for an assessment-based intervention that emphasizes fun, mastery and support (A + FMS) designed to improve fundamental movement skill (FMS) proficiency of primary schoolchildren. Utilizing a cluster randomized controlled trial, the A + FMS intervention was designed to improve FMS proficiency of Hong Kong Chinese schoolchildren. A target sample of 282 students or more from 10 Grade 3 classes (from five schools) will be recruited and randomly assigned into an experimental group or a wait-list control group. Competence motivation theory provided a framework for the intervention that emphasizes fun activities to develop basic fundamentals, improving mastery of movement, and providing support for teaching and learning skills. Primary outcome measures are the raw scores of six objectively measured FMS (i.e., jump, hop, skip, dribble, catch, and overhand throw). Secondary outcomes include self-reported measures: enjoyment in physical education, perceived physical competence, perceived skill competence, and perceived social support. Teachers in the experimental group are required to attend a six-h training workshop and integrate 550 min of assessment for learning strategies into their physical education lessons. Resources such as videos, skills checklists, and equipment will also be provided to support children to accumulate extra learning and practice time after school. The rate of changes in primary and secondary outcomes across the experimental and control groups will be compared to determine the effectiveness of the program. The A + FMS is an innovative school-based intervention targeting improvements in movement mastery by supporting physical education teachers in FMS instruction and assessment practices. The findings from the study may be used to guide pre-service teacher education and continuous professional development in FMS teaching and assessment. Trial registration CUHK_CCRB00479.

The impact of a family skills training intervention among Burmese migrant families in Thailand: A randomized controlled trial

PubMed Central

2017-01-01

Objective To conduct a randomized controlled trial assessing the impact of a family-based intervention delivered to Burmese migrant families displaced in Thailand on parenting and family functioning. Participants and procedures Participants included 479 Burmese migrant families from 20 communities in Thailand. Families, including 513 caregivers and 479 children aged 7 to 15 years, were randomized to treatment and waitlist control groups. The treatment group received a 12-session family-based intervention delivered to groups of families by lay facilitators. Adapted standardized and locally derived measures were administered before and after the intervention to assess parent-child relationship quality, discipline practices, and family functioning. Results Compared with controls, intervention families demonstrated improved quality of parent-child interactions on scales of parental warmth and affection (Effect size (ES) = 0.25 caregivers; 0.26 children, both p < 0.05) and negative relationship quality (ES = -0.37, p < 0.001 caregivers; -0.22 children, p < 0.05). Both children and caregivers also reported an effect on relationship quality based on a locally derived measure (ES = 0.40 caregivers, p < .001; 0.43 children, p < .05). Family functioning was improved, including family cohesion (ES = 0.46 caregivers; 0.36 children; both p < 0.001) and decreased negative interactions (ES = -0.30 caregivers, p < 0.01; -0.24 children, p < 0.05). Family communication also improved according to children only (ES = 0.29, p < 0.01). Caregivers, but not children, reported decreased harsh discipline (ES = -0.39, p < 0.001), and no effects were observed on use of positive discipline strategies. Treatment attendance was high, with participants attending a mean of 9.7 out of 12 sessions. Conclusion The intervention increased protective aspects of family well-being for migrant children and caregivers in a middle-income country. The strongest effects were on parent-child relationship quality and family functioning, while results were mixed on changes in discipline practices. Results suggest that a behavioral family-based approach implemented by lay providers in community settings is a promising intervention approach for strengthening families in highly stressed contexts. Trial registration Clinicaltrials.gov: NCT01668992 PMID:28350809