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Efficacy and cost-effectiveness of Internet-based selective eating disorder prevention: study protocol for a randomized controlled trial within the ProHEAD Consortium.

ABSTRACT: BACKGROUND:The development of efficacious, cost-effective, and widely accessible programs for the prevention of eating disorders (EDs) is crucial in order to reduce the ED-related burden of illness. Programs using dissonance-based and cognitive behavioral approaches are most effective for the selective prevention of ED. Internet-based delivery is assumed to maximize the reach and impact of preventive efforts. However, the current evidence for Internet-based ED prevention is limited. The present trial evaluates the efficacy and cost-effectiveness of two new interventions (based on dissonance theory and principles of cognitive behavioral therapy (CBT)) that are implemented as add-ons to the existing Internet-based ED prevention program ProYouth. METHODS:The trial is one of five sub-projects of the German multicenter consortium ProHEAD. It is a three-arm, parallel, randomized controlled superiority trial. Participants will be randomized to (1) the online program ProYouth (active control condition) or (2) ProYouth plus a structured dissonance-based module or (3) ProYouth plus a CBT-based chat group intervention. As part of ProHEAD, a representative school-based sample of N?=?15,000 students (??12?years) will be screened for mental health problems. N?=?309 participants at risk for ED (assessed with the Weight Concerns Scale (WCS) and the Short Evaluation of Eating Disorders (SEED)) will be included in the present trial. Online assessments will be conducted at baseline, at end of intervention (6?weeks), at 6 months follow-up, and - as part of ProHEAD - at 12 and 24 months follow-up. The primary outcome is ED-related impairment (assessed with the Child version of the Eating Disorder Examination-Questionnaire (ChEDE-Q)) at the end of the intervention. Secondary outcomes include ED-related symptomatology at follow-up, ED-related stigma, ED-related help-seeking, and acceptance of and compliance with the interventions. For the health economic evaluation data on costs of the interventions, healthcare utilization and health-related quality of life will be assessed. DISCUSSION:This is the first study augmenting a flexible prevention approach such as ProYouth with structured evidence-based modules in order to overcome some of the key limitations in the current practice of ED prevention. TRIAL REGISTRATION:German Clinical Trials Register (DRKS), DRKS00014679 . Registered on 25 April 2018.

SUBMITTER: Bauer S

PROVIDER: S-EPMC6354385 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Efficacy and cost-effectiveness of Internet-based selective eating disorder prevention: study protocol for a randomized controlled trial within the ProHEAD Consortium.

Bauer Stephanie S Bilić Sally S Reetz Christina C Ozer Fikret F Becker Katja K Eschenbeck Heike H Kaess Michael M Rummel-Kluge Christine C Salize Hans-Joachim HJ Diestelkamp Silke S Moessner Markus M

Trials 20190130 1

<h4>Background</h4>The development of efficacious, cost-effective, and widely accessible programs for the prevention of eating disorders (EDs) is crucial in order to reduce the ED-related burden of illness. Programs using dissonance-based and cognitive behavioral approaches are most effective for the selective prevention of ED. Internet-based delivery is assumed to maximize the reach and impact of preventive efforts. However, the current evidence for Internet-based ED prevention is limited. The ...[more]

PMID: 30700318

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Project description:BackgroundDepression is a serious mental health problem and is common in children and adolescents. Online interventions are promising in overcoming the widespread undertreatment of depression and in improving the help-seeking behavior in children and adolescents.MethodsThe multicentre, randomized controlled E.motion trial is part of the German ProHEAD consortium (Promoting Help-seeking using E-technology for ADolescents). The objective of the trial is to investigate the efficacy and cost-effectiveness of two online interventions to reduce depressive symptomatology in high-risk children and adolescents with subsyndromal symptoms of depression in comparison to an active control group. Participants will be randomized to one of three conditions: (1) Intervention 1, a clinician-guided self-management program (iFightDepression®); (2) Intervention 2, a clinician-guided group chat intervention; and (3) Control intervention, a psycho-educational website on depressive symptoms. Interventions last six weeks. In total, N = 363 children and adolescents aged ≥ 12 years with Patient Health Questionnaire-9 modified for Adolescents (PHQ-A) scores in the range of 5-9 will be recruited at five study sites across Germany. Online questionnaires will be administered before onset of the intervention, at the end of the intervention, and at the six-month follow-up. Further, children and adolescents will participate in the baseline screening and the one- and two-year school-based follow-up assessments integrated in the ProHEAD consortium. The primary endpoint is depression symptomatology at the end of intervention as measured by the PHQ-A score. Secondary outcomes include depression symptomatology at all follow-ups, help-seeking attitudes, and actual face-to-face help-seeking, adherence to and satisfaction with the interventions, depression stigma, and utilization and cost of interventions.DiscussionThis study represents the first randomized controlled trial (RCT) investigating efficacy and cost-effectiveness of two online interventions in children and adolescents aged ≥ 12 years at risk for depression. It aims to provide a better understanding of the help-seeking behavior of children and adolescents, potential benefits of E-mental health interventions for this age group, and new insights into so far understudied aspects of E-mental health programs, such as potential negative effects of online interventions. This knowledge will be used to tailor and improve future help offers and programs for children and adolescents and ways of treatment allocation.Trial registrationGerman Register for Clinical Trials (DRKS), DRKS00014668 . Registered on 4 May 2018. International trial registration took place through the "international clinical trials registry platform" with the secondary ID S-086/2018.

Dataset Information

Efficacy and cost-effectiveness of Internet-based selective eating disorder prevention: study protocol for a randomized controlled trial within the ProHEAD Consortium.

Publications

Efficacy and cost-effectiveness of Internet-based selective eating disorder prevention: study protocol for a randomized controlled trial within the ProHEAD Consortium.

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