Internet-delivered Cognitive-behaviour Therapy for Child and Adolescent Body Dysmorphic Disorder
NCT ID: NCT06262412
Last Updated: 2025-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
154 participants
INTERVENTIONAL
2024-02-19
2026-10-31
Brief Summary
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Detailed Description
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Secondary objective: To establish the 6-month durability of the treatment effects and to assess the cost-effectiveness of ICBT, compared with IRT, from multiple perspectives and to conduct a health-economic evaluation of ICBT for BDD at the primary endpoint from a health organisation payer, healthcare resource use, and societal perspective.
Type of trial: A multisite parallel-group randomised controlled superiority trial.
Rationale: BDD is a prevalent and impairing disorder that tends to have a chronic course if left untreated. Adolescent-onset BDD is associated with more severe symptoms, greater lifetime comorbidity, and higher rates of attempted suicide compared to adult-onset BDD. Therefore, early intervention is crucial. BDD can be effectively treated with cognitive-behaviour therapy (CBT), although the current evidence is rather weak and more evidence is needed. Furthermore, CBT for BDD is a highly specialised treatment and many young people do not have access to it. ICBT can be a way to increase the availability of an effective, evidence-based treatment for children and adolescents with BDD.
Trial design and methods: Participants will be recruited nationally across Sweden and will be offered 12 modules of therapist-guided ICBT or 12 modules of therapist-guided IRT delivered over 12 weeks. Under certain circumstances, such as illness or holidays, the design allows participants to pause their therapist-support for a maximum of two weeks, which may extend the treatment length to a maximum of 14 weeks. All potential participants will be initially screened via the telephone or at one of the three participating sites. This will be followed by an inclusion/baseline assessment conducted either at one of the three clinics (BUP OCD och relaterade tillstånd, BUP Specialmottagning or BUP Skåne) or, if face-to-face assessments are not feasible, via a secure video application. Participants who are eligible and have consented will be randomised to one of two trial arms. Participants in the comparator group (IRT) will be offered to cross-over to the ICBT intervention after the primary endpoint.
The primary outcome variable: The primary outcome variable is BDD symptom severity measured by the Yale-Brown Obsessive Compulsive Scale modified for BDD, Adolescent version (BDD-YBOCS-A) at the primary endpoint (1-month follow-up post-treatment). Based on BDD-YBOCS-A scores, responder and remission rates at all follow-up points will be calculated. Response will be defined as ≥30% reduction from baseline; full or partial remission will be defined as a score ≤16.
Planned trial sites: The study will be coordinated from the Department of Clinical Neuroscience at Karolinska Institutet (the Sponsor). There will be 3 collaborating study sites: BUP OCD och relaterade tillstånd (Region Stockholm), BUP Specialmottagning (Västra Götalandsregionen), and BUP Skåne (Region Skåne). Each of the three sites will assess and treat participants from their own region, and occasionally from other regions.
Sample: A total of 154 children and adolescents diagnosed with BDD and their primary caregivers.
Statistical methodology and analysis: Data will be analysed using a pre-specified intention-to-treat statistical analysis plan.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Internet-delivered cognitive-behaviour therapy (ICBT)
A therapist-guided, Internet-delivered cognitive-behaviour therapy (ICBT) programme for children and adolescents with BDD.
Cognitive-behaviour therapy, Exposure and response prevention (ERP)
Internet-delivered cognitive-behaviour therapy (ICBT)
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 relaxation treatment (IRT)
A therapist-guided, Internet-delivered relaxation treatment (IRT) programme for children and adolescents with BDD.
Relaxation training (deep breathing, progressive muscle relaxation, imagery)
Internet-delivered relaxation treatment (IRT)
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.
Interventions
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Internet-delivered cognitive-behaviour therapy (ICBT)
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 relaxation treatment (IRT)
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
12 Years
17 Years
ALL
No
Sponsors
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Region Stockholm
OTHER_GOV
Vastra Gotaland Region
OTHER_GOV
Region Skane
OTHER
Karolinska Institutet
OTHER
Responsible Party
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Lorena Fernández de la Cruz, PhD
Principal Investigator
Principal Investigators
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Lorena Fernández de la Cruz, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Clinical Neuroscience (CNS), K8, CPF Mataix-Cols,
Locations
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BUP Specialmottagning, Sahlgrenska Universitetssjukhuset
Gothenburg, , Sweden
Barn- och ungdomspsykiatrin, Region Skåne
Malmo, , Sweden
BUP OCD och relaterade tillstånd
Stockholm, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-02193-01
Identifier Type: -
Identifier Source: org_study_id
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