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.
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.
A total BDD symptom severity score on the BDD-YBOCS-A ≥24. Confirmed by the assessor at the inclusion assessment.
Age between 12 and 17 years. Confirmed by the caregiver/parent and subsequently by the medical record.
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.
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.
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.
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.
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.
Parallel
Internet-delivered cognitive-behaviour therapy (ICBT)
BehavioralThe 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 relaxation treatment (IRT)
BehavioralThe 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.
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.
Treatment response and full or partial remission
Treatment response and full or partial remission rates will be calculated at each follow-up point. Response will be defined as a reduction ≥30% on the BDD-YBOCS-A from baseline. Full or partial remission will be defined as a total score ≤16 on the BDD-YBOCS-A.
Clinical Global Impression - Severity (CGI-S)
Used to provide an overall rating of the BDD severity. Clinician-rated. Range: 1-7, lower scores mean better outcome.
Clinical Global Impression - Improvement (CGI-I)
Used to assess global improvement. Clinician-rated. Range: 1-7, lower scores mean better outcome.
Children's Global Assessment Scale (CGAS)
Used to assess global improvement. Clinician-rated. Range: 1-100, higher scores mean better outcome.
Areas of concern and cosmetic procedures
Clinicians will ask about areas of concern through a standardized checklist of 28 different parts of the body . They will also ask about current desire for and/or whether the patient had undergone any past cosmetic/surgical procedure related to their BDD concerns. Clinician rated.
School absenteeism
Clinicians will ask the participant and the caregiver if the participant has full, partial or no school attendance (i.e., school drop-out) during the last month.
Concurrent interventions
Clinicians will ask the participant questions about medications (type, dose, indication, and time period) and psychological treatment (type, number of sessions, indication, and time period).
BASS platform usage data
Usage data will be extracted from the BASS platform and entered into the trial database. The data includes number of completed modules, number of logins, number of messages sent to the therapist, and the name of the therapist.
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Karolinska Institutet
Lead sponsor
Region Stockholm
Collaborator
Vastra Gotaland Region
Collaborator
Region Skane
Collaborator
