Efficacy and cost-effectiveness of Internet-based selective eating disorder prevention
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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. / ProHEAD consortium.
in: TRIALS, Jahrgang 20, Nr. 1, 30.01.2019, S. 91-102.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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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 -