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