Internet-delivered Cognitive-behaviour Therapy for Adolescents With Body Dysmorphic Disorder

Body Dysmorphic Disorders Clinical Trial

Official title: Internet-delivered Cognitive-behaviour Therapy for Adolescents With Body Dysmorphic Disorder: A Feasibility Trial

Status Completed

Clinical Trial Summary

The purpose of this trial is to investigate whether a therapist-guided Internet-delivered cognitive behaviour therapy (ICBT) programme is feasible for adolescents with body dysmorphic disorder (BDD). The aim is to evaluate feasibility and provide preliminary efficacy data.

Clinical Trial Description

Rationale for study: BDD is a prevalent and impairing condition that can be effectively treated with cognitive-behaviour therapy (CBT). However, CBT for BDD is a highly specialised treatment and a majority of adolescents do not have access to it. ICBT can be a way to increase the availability of effective psychological treatments. No study to date has evaluated the feasibility of ICBT for adolescent BDD, but the experience in adults with BDD treated with ICBT is encouraging.

Objectives: To investigate whether a therapist-guided Internet-delivered cognitive behaviour therapy (ICBT) programme is feasible for adolescents with body dysmorphic disorder (BDD). Specifically, the aim is to:(a) establish participant retention, ease of recruitment, acceptability, credibility, and satisfaction, (b) evaluate potential adverse events, and (c) provide preliminary efficacy data.

Trial design and methods: Participants will be recruited nationally and will be offered 12 modules of ICBT for BDD, delivered over a period of 14 weeks. Participants will be assessed before, during, and after treatment, and up to 12 months after the end of the treatment. ICBT non-responders, assessed at post-treatment and one-, two-, and three-months after completing treatment, will be offered CBT delivered via video format (at post-treatment and after the 1MFU and the 2MFU) or traditional face-to-face (F2F) CBT at the OCD and Related Disorders Clinic for Children and Adolescents in Stockholm (after the 3MFU).

The primary outcome is feasibility, as measured by examining rates of participant retention, treatment completion and adherence to treatment content, treatment acceptability, treatment credibility, treatment satisfaction and adverse events during the treatment.

Secondary outcomes include improvement in clinician-reported BDD symptoms, as well as improvement in other clinical measures assessing disorder severity, disorder improvement, self-reported BDD symptoms, depressive symptoms, and functional impairment.

Sample: 20 adolescents and their primary caregivers.

Statistical analysis: Retention, acceptability, credibility, and treatment satisfaction. For retention and acceptability, information on ease of recruitment, number of completed modules, and attrition rates will collected and presented in a descriptive manner. Results from a credibility scale will be summarized in group means and standard deviations. Results from a treatment satisfaction scale will be summarized in group means and standard deviation. Potential adverse events: Type and impact of all potential adverse events will be measured with a specific scale and presented descriptively. Preliminary efficacy: Clinical measures of treatment outcomes will be measured via clinician-reported and self- and parent-reported measures and analysed through linear mixed models to detect within group change over time. Within-group effect sizes will be estimated with Cohen's d. Treatment response: The proportion of treatment responders will be calculated. Treatment response will be defined as a ≥30% reduction on the BDD-YBOCS-A, respective to the baseline score. Further, the investigators will also calculate how many participants are on full or partial symptom remission, defined as a score ⩽16 on the BDD-YBOCS-A. ;

Related Conditions & MeSH terms

• Body Dysmorphic Disorders
• Dysmorphophobia

• NCT number: NCT05078320
• Study type: Interventional
• Source: Karolinska Institutet
• Status: Completed
• Phase: N/A
• Start date: October 22, 2021
• Completion date: June 26, 2023