scholarly journals Reducing Stress and Preventing Depression (RESPOND): Randomized Controlled Trial of Web-Based Rumination-Focused Cognitive Behavioral Therapy for High-Ruminating University Students (Preprint)

2018 ◽  
Author(s):  
Lorna Cook ◽  
Mohammod Mostazir ◽  
Edward Watkins
Keyword(s):  
University Students ◽  
Usual Care ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Primary Objective ◽  
Effect Sizes ◽  
Phase Iii ◽  
Web Based ◽  
Randomized Controlled ◽  
Secondary Objective

BACKGROUND Prevention of depression is a priority to reduce its global disease burden. Targeting specific risk factors, such as rumination, may improve prevention. Rumination-focused Cognitive Behavioral Therapy (RFCBT) was developed to specifically target depressive rumination. OBJECTIVE The primary objective of this study was to test whether guided Web-based RFCBT (i-RFCBT) would prevent the incidence of major depression relative to usual care in UK university students. The secondary objective was to test the feasibility and estimated effect sizes of unguided i-RFCBT. METHODS To address the primary objective, a phase III randomized controlled trial was designed and powered to compare high risk university students (N=235), selected with elevated worry/rumination, recruited via an open access website in response to circulars within universities and internet advertisements, randomized to receive either guided i-RFCBT (interactive Web-based RFCBT, supported by asynchronous written Web-based support from qualified therapists) or usual care control. To address the secondary objective, participants were also randomized to an adjunct arm of unguided (self-administered) i-RFCBT. The primary outcome was the onset of a major depressive episode over 15 months, assessed with structured diagnostic interviews at 3 (postintervention), 6, and 15 months post randomization, conducted by telephone, blind to the condition. Secondary outcomes of symptoms of depression and anxiety and levels of worry and rumination were self-assessed through questionnaires at baseline and the same follow-up intervals. RESULTS Participants were randomized to guided i-RFCBT (n=82), unguided i-RFCBT (n=76), or usual care (n=77). Guided i-RFCBT reduced the risk of depression by 34% relative to usual care (hazard ratio [HR] 0.66, 95% CI 0.35 to 1.25; P=.20). Participants with higher levels of baseline stress benefited most from the intervention (HR 0.43, 95% CI 0.21 to 0.87; P=.02). Significant improvements in rumination, worry, and depressive symptoms were found in the short-to-medium term. Of the 6 modules, guided participants completed a mean of 3.46 modules (SD 2.25), with 46% (38/82) being compliant (completing ≥4 modules). Similar effect sizes and compliance rates were found for unguided i-RFCBT. CONCLUSIONS Guided i-RFCBT can reduce the onset of depression in high-risk young people reporting high levels of worry/rumination and stress. The feasibility study argues for formally testing unguided i-RFCBT for prevention: if the observed effect sizes are robustly replicated in a phase III trial, it has potential as a scalable prevention intervention. CLINICALTRIAL ISRCTN Registry ISRCTN12683436; https://www.isrctn.com/ISRCTN12683436 (Archived by WebCite at http://www.webcitation.org/77fqycyBX) INTERNATIONAL REGISTERED REPOR RR2-10.1186/s13063-015-1128-9

scholarly journals Mindfulness-based cognitive therapy and cognitive behavioral therapy for chronic pain in multiple sclerosis: a randomized controlled trial protocol

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Dawn M. Ehde ◽  
Kevin N. Alschuler ◽  
Melissa A. Day ◽  
Marcia A. Ciol ◽  
Makena L. Kaylor ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Usual Care ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Average Pain Intensity ◽  
Average Pain ◽  
Pre Treatment ◽  
Management Approaches

Abstract Background Chronic pain is one of the most prevalent and disabling symptoms associated with multiple sclerosis (MS). Individuals with MS are interested in nonpharmacologic pain management approaches. Cognitive-behavioral therapy (CBT) is efficacious in improving MS-related pain outcomes. Mindfulness-based cognitive therapy (MBCT) is a promising, alternative approach. Little is known about moderators of these treatments’ outcomes, however. This article describes the study protocol for the first randomized controlled trial comparing MBCT, CBT, and usual care and examining treatment effect moderators in individuals with chronic pain and MS. Methods We will conduct a single-center, randomized, single blind, parallel-group trial comparing MBCT, CBT, and usual care in adults with MS and chronic pain. Both interventions will be delivered via eight group sessions using videoconferencing technology. Primary (average pain intensity) and secondary outcomes (including pain interference, depressive symptoms, fatigue, and sleep) will be assessed pre-treatment, mid-treatment, post-treatment, and at 6-month follow up. Potential treatment moderators will be assessed pre-treatment. We hypothesize that participants randomly assigned to MBCT or CBT will report significantly greater reductions in average pain intensity than participants assigned to usual care at post-treatment (primary study endpoint) and 6-month follow up. We also hypothesize that mindfulness, pain catastrophizing, and behavioral activation pre-treatment will moderate response to both active treatments, but not response to usual care. Discussion Findings will provide important new information about the efficacy and moderators of two nonpharmacologic pain management approaches delivered using technology to overcome common barriers to treatment access. The knowledge gained may lead to better patient-treatment matching and, ultimately, better pain treatment outcomes in MS. Trial registration ClinicalTrials.gov, NCT03782246. Registered on 20 December 2018.

scholarly journals Efficacy of a Parent-Based, Indicated Prevention for Anorexia Nervosa: Randomized Controlled Trial (Preprint)

2017 ◽  
Author(s):  
Corinna Jacobi ◽  
Kristian Hütter ◽  
Ulrike Völker ◽  
Katharina Möbius ◽  
Robert Richter ◽  
...  
Keyword(s):  
Risk Factors ◽  
At Risk ◽  
Randomized Controlled Trial ◽  
Anorexia Nervosa ◽  
Controlled Trial ◽  
Primary Objective ◽  
Preventive Program ◽  
Web Based ◽  
Indicated Prevention ◽  
Randomized Controlled

BACKGROUND Web-based preventive interventions can reduce risk and incidence of bulimia and binge eating disorders among young high-risk women. However, their specific effects on core symptoms of anorexia nervosa (AN) are rather weak. OBJECTIVE The primary objective of this study was to evaluate the efficacy of an indicated, parent-based, Web-based preventive program Eltern als Therapeuten (E@T) in reducing risk factors and symptoms of AN. METHODS Girls aged between 11 and 17 years were screened by selected risk factors and early symptoms of AN. At-risk families were then randomized to E@T or an assessment-only control condition. Assessments took place at pre- and postintervention (6 weeks later) and at 6- and 12-month follow-up (FU). RESULTS A total of 12,377 screening questionnaires were handed out in 86 German schools, and 3941 including consent returned. Overall, 477 (447/3941, 12.10%) girls were identified as at risk for AN and 256 of those could be contacted. In all, 66 families (66/256, 25.8% of those contacted) were randomized to the E@T or a wait-list control condition, 43 (43/66, 65%) participated in postassessments, and 27 (27/66, 41%) in 12-month FUs. Due to low participation and high dropout rates of parents, recruitment was terminated prematurely. At 12-month FU, girls’ expected body weight (EBW) percentage was significantly greater for intervention participants compared with control participants (group by time interaction beta=21.0 [CI 5.81 to 36.13], P=.007; group by time squared interaction beta=−15.5 [CI −26.6 to −4.49], P=.007; estimated Cohen d=0.42]. No other significant effects were found on risk factors and attitudes of disturbed eating. CONCLUSIONS Despite a significant increase in girls’ EBW percentage, parental participation and adherence to the intervention were low. Overall, parent-based, indicated prevention for children at risk for AN does not seem very promising, although it might be useful for parents who engage in the intervention. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN): 18614564; http://www.isrctn.com/ISRCTN18614564 (Archived by WebCite at http://www.webcitation.org/74FTV1EpF).

scholarly journals A Self-Administered Multicomponent Web-Based Mental Health Intervention for the Mexican Population During the COVID-19 Pandemic: Protocol for a Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Alejandro Dominguez-Rodriguez ◽  
Anabel De La Rosa-Gómez ◽  
M Jesús Hernández Jiménez ◽  
Paulina Arenas-Landgrave ◽  
Sofía Cristina Martínez-Luna ◽  
...  
Keyword(s):  
Mental Health ◽  
Positive Psychology ◽  
Behavioral Activation ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Well Being ◽  
Web Based ◽  
Significance Level ◽  
Randomized Controlled

BACKGROUND The COVID-19 pandemic has become a public health emergency of international concern; it has not only threatened people's physical health but has also affected their mental health and psychological well-being. It is necessary to develop and offer strategies to reduce the psychological impact of the outbreak and promote adaptive coping. OBJECTIVE This study protocol aims to describe a self-administered web-based intervention (Mental Health COVID-19) based on the principles of positive psychology supported by elements of cognitive behavioral therapy and behavioral activation therapy to reduce the symptoms of anxiety and depression and increase positive emotions and sleep quality during and after the COVID-19 outbreak through a telepsychology system. METHODS A randomized controlled clinical superiority trial with two independent groups will be performed, with intrasubject measures at four evaluation periods: pretest, posttest, 3-month follow-up, and 6-month follow-up. Participants will be randomly assigned to one of two groups: self-administered intervention with assistance via chat or self-administered intervention without assistance via chat. The total required sample size will be 166 participants (83 per group). RESULTS The clinical trial is ongoing. This protocol was approved by the Research Ethics Board of the Free School of Psychology-University of Behavioral Sciences (Escuela libre de Psicología-Universidad de Ciencias del Comportamiento). The aim is to publish the preliminary results in December 2020. A conservative approach will be adopted, and the size effect will be estimated using the Cohen <i>d</i> index with a significance level (α) of .05 (95% reliability) and a conventional 80% power statistic. CONCLUSIONS The central mechanism of action will be to investigate the effectiveness of an intervention based on positive psychology through a web platform that can be delivered through computers and tablets, with content that has been rigorously contextualized to the Mexican culture to provide functional strategies to help the target users cope with the COVID-19 pandemic. CLINICALTRIAL ClinicalTrials.gov NCT04468893; https://clinicaltrials.gov/ct2/show/NCT04468893 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/23117

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