Efficacy and cost-effectiveness of Internet-based selective eating disorder prevention

TY - JOUR

T1 - Efficacy and cost-effectiveness of Internet-based selective eating disorder prevention

T2 - study protocol for a randomized controlled trial within the ProHEAD Consortium

AU - Bauer, Stephanie

AU - Bilić, Sally

AU - Reetz, Christina

AU - Ozer, Fikret

AU - Becker, Katja

AU - Eschenbeck, Heike

AU - Kaess, Michael

AU - Rummel-Kluge, Christine

AU - Salize, Hans-Joachim

AU - Diestelkamp, Silke

AU - Moessner, Markus

AU - ProHEAD consortium

PY - 2019/1/30

Y1 - 2019/1/30

N2 - 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.

AB - 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.

KW - Adolescent

KW - Adolescent Behavior

KW - Age Factors

KW - Child

KW - Child Behavior

KW - Cognitive Behavioral Therapy/economics

KW - Cognitive Dissonance

KW - Cost-Benefit Analysis

KW - Equivalence Trials as Topic

KW - Feeding Behavior

KW - Feeding and Eating Disorders/diagnosis

KW - Female

KW - Germany

KW - Habits

KW - Health Care Costs

KW - Humans

KW - Internet/economics

KW - Male

KW - Multicenter Studies as Topic

KW - Surveys and Questionnaires

KW - Therapy, Computer-Assisted/economics

KW - Time Factors

KW - Treatment Outcome

U2 - 10.1186/s13063-018-3161-y

DO - 10.1186/s13063-018-3161-y

M3 - SCORING: Journal article

C2 - 30700318

VL - 20

SP - 91

EP - 102

JO - TRIALS

JF - TRIALS

SN - 1745-6215

IS - 1

ER -