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

• Published in: Current controlled trials in cardiovascular medicine 2019-01, Vol.20 (1), p.91-11, Article 91
• Main Authors: Bauer, Stephanie, Bilić, Sally, Reetz, Christina, Ozer, Fikret, Becker, Katja, Eschenbeck, Heike, Kaess, Michael, Rummel-Kluge, Christine, Salize, Hans-Joachim, Diestelkamp, Silke, Moessner, Markus
• Format: Article
• Language: English
• Subjects: Adolescent; Adolescent Behavior; Age Factors; Analysis; Anorexia; Behavioral medicine; Body image; Care and treatment; CBT; Child; Child Behavior; Clinical trials; Cognitive behavioral therapy; Cognitive Behavioral Therapy - economics; Cognitive Behavioral Therapy - methods; Cognitive Dissonance; Consortia; Control; Cost analysis; Cost-Benefit Analysis; Dissonance; Early intervention; Eating disorders; Equivalence Trials as Topic; Feeding and Eating Disorders - diagnosis; Feeding and Eating Disorders - economics; Feeding and Eating Disorders - prevention & control; Feeding and Eating Disorders - psychology; Feeding Behavior; Female; Germany; Habits; Health aspects; Health Care Costs; Health screening; Humans; Internet; Internet - economics; Male; Medical care quality; Medical research; Mental disorders; Multicenter Studies as Topic; Planning; Prevention; Prevention programs; ProHEAD; Quality of life; Risk factors; Study Protocol; Surveys and Questionnaires; Teenagers; Therapy, Computer-Assisted - economics; Therapy, Computer-Assisted - methods; Time Factors; Treatment Outcome; Wellness programs; Young adults
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-018-3161-y

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. 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. 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. German Clinical Trials Register (DRKS), DRKS00014679 . Registered on 25 April 2018.