nctId: NCT06262412 id: 2023-02193-01 briefTitle: Internet-delivered Cognitive-behaviour Therapy for Child and Adolescent Body Dysmorphic Disorder overallStatus: RECRUITING date: 2024-02-19 date: 2026-04-30 date: 2026-10-31 date: 2024-02-16 date: 2024-02-26 name: Karolinska Institutet class: OTHER name: Region Stockholm name: Vastra Gotaland Region name: Region Skane briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multisite parallel-group randomised controlled superiority trial. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: 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. whoMasked: OUTCOMES_ASSESSOR count: 154 type: ESTIMATED name: Internet-delivered cognitive-behaviour therapy (ICBT) name: Internet-delivered relaxation treatment (IRT) measure: Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder, Adolescent version (BDD-YBOCS-A) measure: Treatment response and full or partial remission measure: Clinical Global Impression - Severity (CGI-S) measure: Clinical Global Impression - Improvement (CGI-I) measure: Children's Global Assessment Scale (CGAS) measure: Appearance Anxiety Index (AAI) measure: Short Mood and Feeling Questionnaire - child version and parent version (SMFQ) + additional suicide item (only child/adolescent) measure: Generalized Anxiety Disorder - 7 item scale (GAD-7) measure: Deliberate Self-Harm Inventory - Youth version (DSHI-Y-7) measure: CRAFFT (acronym for the key words Car, Relax, Alone, Forget, Friends and Trouble) measure: Work and Social Adjustment Scale - youth (WSAS-Y) and parent version (WSAS-P) measure: Child Health Utility 9D (CHU9D) measure: Trimbos/iMTA Questionnaire for Costs associated with Psychiatric Illness (TiC-P) measure: Working Alliance Inventory - child (WAI-C) and parent version (WAI-P) measure: Client Satisfaction Questionnaire (CSQ-8) measure: Treatment Credibility and Expectancy Scale (TCES) measure: Patient Exposure/Relaxation Adherence Scale (PEAS/PRAS) measure: Treatment preference measure: Areas of concern and cosmetic procedures measure: School absenteeism measure: Concurrent interventions measure: BASS platform usage data measure: Completed modules measure: Adverse events questionnaire sex: ALL minimumAge: 12 Years maximumAge: 17 Years stdAges: CHILD facility: BUP OCD och relaterade tillstånd status: RECRUITING city: Stockholm zip: 113 30 country: Sweden name: Anita Birovecz, MSc role: CONTACT phone: +46 70 275 61 25 email: anita.birovecz@ki.se lat: 59.33258 lon: 18.0649 hasResults: False