Internet-delivered Cognitive-behaviour Therapy for Child and Adolescent Body Dysmorphic Disorder

NCT06262412 | Recruiting DMC

• 1 other identifier: 2023-02193-01
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this trial is to evaluate the clinical efficacy, the cost-effectiveness and the 6-month durability of a therapist-guided, Internet-delivered cognitive-behavior therapy programme for children and adolescents with body dysmorphic disorder.

Conditions

Body Dysmorphic Disorders

Keywords

Body dysmorphic disorder; Cognitive-behavior therapy; Exposure and response prevention; Internet

Outcome Measures

Primary Outcomes (1)

• Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder, Adolescent version (BDD-YBOCS-A)

  The BDD-YBOCS-A is a clinician-rated, semi-structured interview. It is used to assess BDD symptom severity. It contains twelve items ranging from 0 to 4. It includes five questions on obsessions, five on compulsions, one about insight, and one to measure behavioural avoidance. Range: 0-48, lower scores mean better outcome.

  Baseline (week 0), post treatment (week 12), 1-month follow-up, 3-months follow-up, 6-months follow up.

Secondary Outcomes (17)

• Treatment response and full or partial remission

  Post treatment (week 12), 1-month follow-up, 3-months follow-up, 6-months follow up.

• Clinical Global Impression - Severity (CGI-S)

  Baseline (week 0), post treatment (week 12), 1-month follow-up, 3-months follow-up, 6-months follow up.

• Clinical Global Impression - Improvement (CGI-I)

  Post treatment (week 12), 1-month follow-up, 3-months follow-up, 6-months follow up.

• Children's Global Assessment Scale (CGAS)

  Baseline (week 0), post treatment (week 12), 1-month follow-up, 3-months follow-up, 6-months follow up.

• Appearance Anxiety Index (AAI)

  Baseline (week 0), post treatment (week 12), 1-month follow-up, 3-months follow-up, 6-months follow up.

Other Outcomes (6)

• Areas of concern and cosmetic procedures

  Baseline (week 0), post treatment (week 12), 1-month follow-up, 3-months follow-up, 6-months follow up.

• School absenteeism

  Baseline (week 0), post treatment (week 12), 1-month follow-up, 3-months follow-up, 6-months follow up.

• Concurrent interventions

  Baseline (week 0), post treatment (week 12), 1-month follow-up, 3-months follow-up, 6-months follow up.

Study Arms (2)

Internet-delivered cognitive-behaviour therapy (ICBT)

EXPERIMENTAL

A therapist-guided, Internet-delivered cognitive-behaviour therapy (ICBT) programme for children and adolescents with BDD. Cognitive-behaviour therapy, Exposure and response prevention (ERP)

Behavioral: Internet-delivered cognitive-behaviour therapy (ICBT)

Internet-delivered relaxation treatment (IRT)

ACTIVE COMPARATOR

A therapist-guided, Internet-delivered relaxation treatment (IRT) programme for children and adolescents with BDD. Relaxation training (deep breathing, progressive muscle relaxation, imagery)

Behavioral: Internet-delivered relaxation treatment (IRT)

Interventions

Internet-delivered cognitive-behaviour therapy (ICBT) BEHAVIORAL

The intervention is Internet-delivered and therapist-guided, involving both the adolescent and at least one caregiver. It consists of two separate sets of modules, one for the adolescent and one for the caregiver. The intervention consists of 12 modules, delivered over a maximum of 14 weeks. The first part includes psychoeducation about BDD and strategies to resolve possible ambivalence towards psychological treatment. The main goal of the treatment is to help the young person to stop avoiding anxiety-provoking situations (e.g., going to school or participating in social situations) by undertaking exposure tasks and to stop doing unhelpful repetitive behaviours and rituals (e.g., excessive mirror-checking, camouflaging), known as response prevention. Every module also contains homework tasks that are meant to be completed between modules and mainly consist of exposure and response prevention (ERP) tasks based on the young person's individual goals.

Internet-delivered cognitive-behaviour therapy (ICBT)

Internet-delivered relaxation treatment (IRT) BEHAVIORAL

The intervention is Internet-delivered and therapist-guided, involving both the adolescent and at least one caregiver. It consists of two separate sets of modules, one for the adolescent and one for the caregiver. The intervention consists of 12 modules, delivered over a maximum of 14 weeks. The first part includes psychoeducation about BDD, how anxiety and stress are major contributors to BDD symptoms, and that targeting and reducing stress will have a beneficial impact on those symptoms. The main goal of the treatment is to teach the young person to relax in order to cope with anxiety and appearance concerns. The intervention mainly consists of a relaxation treatment and includes different relaxation skills such as deep breathing, progressive muscle relaxation, and imagery (cognitive relaxation). Every module also contains homework tasks that are meant to be completed between modules and mainly consist of relaxation tasks.

Internet-delivered relaxation treatment (IRT)

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age between 12 and 17 years. Confirmed by the caregiver/parent and subsequently by the medical record.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator
• Vastra Gotaland Region: collaborator
• Region Skane: collaborator

Study Sites (3)

BUP Specialmottagning, Sahlgrenska Universitetssjukhuset

Gothenburg, 416 85, Sweden

RECRUITING

Barn- och ungdomspsykiatrin, Region Skåne

Malmö, 214 32, Sweden

RECRUITING

BUP OCD och relaterade tillstånd

Stockholm, 113 30, Sweden

RECRUITING

MeSH Terms

Conditions

Body Dysmorphic Disorders

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Study Officials

• Lorena Fernández de la Cruz, PhD

  Department of Clinical Neuroscience (CNS), K8, CPF Mataix-Cols,

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorena Fernández de la Cruz, PhD

CONTACT

+46 76 847 79 99; lorena.fernandez.de.la.cruz@ki.se

Anita Birovecz, MSc

CONTACT

+46 70 275 61 25; anita.birovecz@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All study personnel who can be blind to study aims/hypotheses and group allocation, will be blind. Assessors conducting post-treatment and follow-up assessments will be external to the research team and blind to study aims/hypotheses and treatment allocation for the full duration of the trial (up to the 6-month follow-up). The assessors will not receive any information about the study design, objectives or treatment conditions in order to maximise the blinding integrity. At each follow-up assessment, participants will be reminded by their assessor to not reveal details about their treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Multisite parallel-group randomised controlled superiority trial.

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: February 16, 2024
• Study Start: February 19, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)