Peer-reviewed article
Efficacy and cost-effectiveness of Internet-delivered cognitive-behavior therapy for children and adolescents with body dysmorphic disorder: study protocol for a randomized controlled trial.
Fernández de la Cruz L, Birovecz A, Andrén P, Melin K, Aspvall K et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This is a study protocol for a randomized controlled trial testing Internet-delivered cognitive-behavior therapy (CBT) for children and adolescents with body dysmorphic disorder in Sweden. Body dysmorphic disorder is a mental health condition that typically starts in adolescence and causes significant distress. The study will compare therapist-guided online CBT focused on exposure therapy against online relaxation training in 154 young people aged 12-17. Researchers will measure treatment effectiveness, how long effects last, and whether the treatment is cost-effective.
Key points
- Body dysmorphic disorder typically onsets in adolescence and is both prevalent and impairing
- CBT is a specialized treatment with limited evidence in young people and creates gaps in access to care
- The trial randomizes 154 participants 1:1 to either therapist-supported ICBT with exposure and response prevention or therapist-supported Internet-delivered relaxation training
- Primary outcome is BDD symptom severity measured at 1 month post-treatment, with follow-ups at 3 and 6 months
- Assessors conducting post-treatment and follow-up assessments are blinded to group allocation and study aims
Limitations
This is a study protocol, not results. The document describes a trial that is currently recruiting participants (started February 2024), so no efficacy data, cost-effectiveness findings, or durability outcomes have yet been generated. The effectiveness of the intervention cannot be determined from this protocol alone.
Abstract
Background Body dysmorphic disorder (BDD) is a prevalent and impairing mental disorder that typically onsets in adolescence. Cognitive-behavior therapy (CBT) may be effective for adolescent BDD, although the supporting evidence is currently limited. CBT for BDD is a highly specialized treatment, creating a considerable gap in access to care for young people. Therapist-guided Internet-delivered CBT (ICBT) may help bridge this gap. The primary aim of this study is to determine the efficacy of a therapist-guided ICBT program for children and adolescents with BDD versus an active comparator. Secondary aims are to examine the 6-month durability of the treatment effects and to evaluate its relative cost-effectiveness from multiple perspectives. Methods This is a 3-site superiority randomized controlled trial including 154 young people (12-17 years) with BDD recruited throughout Sweden. Participants are randomized 1:1 to 12 weekly modules of either therapist-supported ICBT primarily based on exposure with response prevention or an active comparator consisting of therapist-supported Internet-delivered relaxation training. Data will be collected at baseline, mid-treatment, post-treatment, and 1 month (primary endpoint), 3 months, and 6 months post-treatment. The primary outcome is BDD symptom severity measured with the Yale-Brown Obsessive-Compulsive Scale Modified for Body Dysmorphic Disorder, Adolescent version. All study personnel who can be blinded to study aims/hypotheses and group allocation will be blinded. Assessors conducting post-treatment and follow-up assessments will be external to the research team and blinded to study aims/hypotheses and group allocation at all assessment points. Analyses will be conducted according to the intention-to-treat principle and will follow a pre-specified statistical and health economic analysis plan. Discussion Participant recruitment started on 22 February 2024 and is currently ongoing. Data analysis for the primary aim will commence after the last participant reaches the primary endpoint. Trial registration ClinicalTrials.gov NCT06262412. Registered on 16 February 2024, https://clinicaltrials.gov/study/NCT06262412 .
Findings the Hub has extracted
Each claim below is labelled by its type of design and links back to this report.
- Intervention
- Therapist-guided Internet-delivered cognitive-behavior therapy (ICBT) comprising 12 weekly modules primarily based on exposure with response prevention
- Population
- Children and adolescents aged 12-17 years with body dysmorphic disorder recruited throughout Sweden (n=154)
Key finding
Study protocol registered and recruitment ongoing as of February 2024