RecruitingNot ApplicableNCT06262412

Internet-delivered Cognitive-behaviour Therapy for Child and Adolescent 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


Sponsor

Karolinska Institutet

Enrollment

154 participants

Start Date

Feb 19, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 12 YearsMax Age: 17 Years

Inclusion Criteria5

  • 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.
  • 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 Criteria8

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

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Interventions

BEHAVIORALInternet-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.

BEHAVIORALInternet-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.


Locations(3)

BUP Specialmottagning, Sahlgrenska Universitetssjukhuset

Gothenburg, Sweden

Barn- och ungdomspsykiatrin, Region Skåne

Malmö, Sweden

BUP OCD och relaterade tillstånd

Stockholm, Sweden

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NCT06262412


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