Online therapy for children and teens with body dysmorphic disorder

Clinical Efficacy and Cost-effectiveness of Internet-delivered Cognitive-behaviour Therapy for Children and Adolescents With Body Dysmorphic Disorder: a Randomised Controlled Trial

This study is testing if an online therapy program can help children and teens with body dysmorphic disorder feel better compared to those who receive a relaxation treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 154 (estimated)
• Ages: 12 Years to 17 Years
• Sex: All
• Sponsor: Karolinska Institutet (Academic / other)
• Locations: 3 sites (Gothenburg and 2 other locations)
• Trial ID: NCT06262412 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effectiveness and cost-efficiency of a therapist-guided, Internet-delivered cognitive-behavior therapy (ICBT) program for children and adolescents diagnosed with body dysmorphic disorder (BDD). Participants will be compared to a control group receiving Internet-delivered relaxation treatment. The study aims to determine how well ICBT reduces BDD symptoms and assesses the durability of treatment effects over six months. Additionally, it will conduct a health-economic evaluation from various perspectives to understand the broader impact of ICBT.

Who should consider this trial

Good fit: Ideal candidates are children and adolescents aged 12 to 17 with a primary diagnosis of body dysmorphic disorder and a symptom severity score of 24 or higher.

Not a fit: Patients with significant physical defects that are clearly noticeable may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide accessible and effective treatment options for young individuals suffering from body dysmorphic disorder.

How similar studies have performed: Other studies have shown promise in using Internet-delivered cognitive-behavior therapy for various mental health conditions, suggesting potential success for this approach in treating BDD.

Eligibility criteria

Inclusion Criteria:

1. A primary diagnosis of BDD, based on the diagnostic criteria of the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders. Confirmed by the assessor at the inclusion assessment using a semi-structured diagnostic interview. In cases where it is challenging to rule out the presence of actual physical defects that are clearly noticeable (e.g., if the area of concern is the genitalia), we will make a referral to an appropriate service for an expert opinion.
2. A total BDD symptom severity score on the BDD-YBOCS-A ≥24. Confirmed by the assessor at the inclusion assessment.
3. Age between 12 and 17 years. Confirmed by the caregiver/parent and subsequently by the medical record.
4. A minimum of one available caregiver/parent being able to co-participate and support the child/adolescent throughout the treatment. Confirmed by the caregiver/parent at the inclusion assessment.
5. Regular access to a computer connected to the Internet and a mobile phone to receive SMS messages (one of each per family is enough). Confirmed by the caregiver/parent at the inclusion assessment.

Exclusion Criteria:

1. Previous CBT for BDD for a minimum of five sessions with a qualified therapist within the 12 months prior to the inclusion assessment. Confirmed by the caregiver/parent at the telephone screening and/or the inclusion assessment and by the medical record.
2. Simultaneous psychological treatment for BDD or for any psychiatric comorbidity. Confirmed by the caregiver/parent at the telephone screening and/or the inclusion assessment and by the medical record.
3. Initiation, change of dosage or cessation of any selective serotonin reuptake inhibitors (SSRI) or antipsychotic drugs within the six weeks prior to the inclusion assessment. Confirmed by the caregiver/parent at the telephone screening and/or the inclusion assessment and by the medical record.
4. A diagnosis of organic brain disorder, intellectual disability, psychosis, bipolar disorder, eating disorder, severe depression or alcohol/substance dependence. Confirmed by the caregiver/parent at the telephone screening and/or the inclusion assessment, with supplemental information from the semi-structured diagnostic interview and by the medical record.
5. Immediate risk to self or others requiring urgent medical attention or inpatient care, such as suicidality, or repeated self-injurious behaviours. Confirmed by the caregiver/parent at the telephone screening and/or the inclusion assessment.
6. A documented suicide attempt in the last 12 months. Confirmed by the caregiver/parent at the telephone screening and/or the inclusion assessment or by documentation in the medical record.
7. Child/adolescent and caregiver/parent not able to read and communicate in Swedish. Confirmed by the caregiver/parent at the telephone screening and/or the inclusion assessment.
8. Having a close relationship to an already included participant (e.g., sibling, cousin), to avoid being randomised into two different arms, with the risk of information "leaking" between the groups. Confirmed by the caregiver/parent or assessor at the telephone screening and/or at the face-to-face or video conference inclusion assessment.

Where this trial is running

Gothenburg and 2 other locations

• BUP Specialmottagning, Sahlgrenska Universitetssjukhuset — Gothenburg, Sweden (Recruiting)
• Barn- och ungdomspsykiatrin, Region Skåne — Malmö, Sweden (Recruiting)
• BUP OCD och relaterade tillstånd — Stockholm, Sweden (Recruiting)

Study contacts

• Principal investigator: Lorena Fernández de la Cruz, PhD — Department of Clinical Neuroscience (CNS), K8, CPF Mataix-Cols,
• Study coordinator: Lorena Fernández de la Cruz, PhD

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