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.
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Details
; Bilić, Sally 1 ; Reetz, Christina 1 ; Ozer, Fikret 1 ; Becker, Katja 2 ; Eschenbeck, Heike 3 ; Kaess, Michael 4 ; Rummel-Kluge, Christine 5 ; Salize, Hans-Joachim 6 ; Diestelkamp, Silke 7 ; Moessner, Markus 1 ; Thomasius, Rainer; Bertsch, Katja; Brunner, Romuald; Feldhege, Johannes; Gallinat, Christina; Herpertz, Sabine C.; Koenig, Julian; Lustig, Sophia; Parzer, Peter; Resch, Franz; Ritter, Sabrina; Spinner, Jens; Wille, Kristina; Baldofski, Sabrina; Kohls, Elisabeth; Peter, Lina-Jolien; Gillé, Vera; Hofmann, Hanna; Lehner, Laya; Voss, Elke; Pfeiffer, Jens; Samel, Alisa1 University Hospital Heidelberg, Center for Psychotherapy Research, Heidelberg, Germany (GRID:grid.5253.1) (ISNI:0000 0001 0328 4908)
2 Philipps-University Marburg and Marburg Center for Mind, Brain and Behavior (MCMBB), Philipps-University Marburg, Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Marburg, Germany (GRID:grid.10253.35) (ISNI:0000 0004 1936 9756)
3 University of Education Schwäbisch Gmünd, Department of Psychology, Schwäbisch Gmünd, Germany (GRID:grid.460114.6)
4 University Hospital Heidelberg, Section for Translational Psychobiology in Child and Adolescent Psychiatry, Department of Child and Adolescent Psychiatry, Heidelberg, Germany (GRID:grid.5253.1) (ISNI:0000 0001 0328 4908); University Hospital of Child and Adolescent Psychiatry and Psychotherapy, University of Bern, Bern 60, Switzerland (GRID:grid.5734.5) (ISNI:0000 0001 0726 5157)
5 Leipzig University, Department of Psychiatry and Psychotherapy, Medical Faculty, Leipzig, Germany (GRID:grid.9647.c) (ISNI:0000 0001 2230 9752)
6 Medical Faculty Mannheim/Heidelberg University, Mental Health Services Research Group, Central Institute of Mental Health, Mannheim, Germany (GRID:grid.7700.0) (ISNI:0000 0001 2190 4373)
7 University Medical Center Hamburg-Eppendorf, German Center for Addiction Research in Childhood and Adolescence, Hamburg, Germany (GRID:grid.13648.38) (ISNI:0000 0001 2180 3484)




