[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536252":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":43,"responsibleParty":87,"collaborators":89,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":25,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":25,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Karolinska Institutet","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Internet-delivered cognitive-behaviour therapy (ICBT)","EXPERIMENTAL","A therapist-guided, Internet-delivered cognitive-behaviour therapy (ICBT) programme for children and adolescents with BDD.\n\nCognitive-behaviour therapy, Exposure and response prevention (ERP)",[13],"Behavioral: Internet-delivered cognitive-behaviour therapy (ICBT)",{"label":15,"type":16,"description":17,"interventionNames":18},"Internet-delivered relaxation treatment (IRT)","ACTIVE_COMPARATOR","A therapist-guided, Internet-delivered relaxation treatment (IRT) programme for children and adolescents with BDD.\n\nRelaxation training (deep breathing, progressive muscle relaxation, imagery)",[19],"Behavioral: Internet-delivered relaxation treatment (IRT)",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","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.\n\nThe 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.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"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.\n\nThe 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.",[15],[30],{"name":31,"affiliation":32,"role":33},"Lorena Fernández de la Cruz, PhD","Department of Clinical Neuroscience (CNS), K8, CPF Mataix-Cols,","PRINCIPAL_INVESTIGATOR",[35,39],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","+46 76 847 79 99","lorena.fernandez.de.la.cruz@ki.se",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},"Anita Birovecz, MSc","+46 70 275 61 25","anita.birovecz@ki.se",[44,62,76],{"facility":45,"status":46,"city":47,"state":25,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"BUP Specialmottagning, Sahlgrenska Universitetssjukhuset","RECRUITING","Gothenburg","416 85","Sweden","SE",{"type":52,"coordinates":53},"Point",[54,55],11.96679,57.70716,{"lat":55,"lon":54},[58],{"name":59,"role":36,"phone":60,"phoneExt":25,"email":61},"Karin Melin Dr","+45 73 049 43 48","karin.a.melin@vgregion.se",{"facility":63,"status":46,"city":64,"state":25,"zip":65,"country":49,"countryCode":50,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Barn- och ungdomspsykiatrin, Region Skåne","Malmö","214 32",{"type":52,"coordinates":67},[68,69],13.00073,55.60587,{"lat":69,"lon":68},[72],{"name":73,"role":36,"phone":74,"phoneExt":25,"email":75},"Per Andrén Dr","+46 70 435 17 40","per.andren@med.lu.se",{"facility":77,"status":46,"city":78,"state":25,"zip":79,"country":49,"countryCode":50,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"BUP OCD och relaterade tillstånd","Stockholm","113 30",{"type":52,"coordinates":81},[82,83],18.06871,59.32938,{"lat":83,"lon":82},[86],{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},{"type":33,"investigatorFullName":31,"investigatorTitle":88,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Principal Investigator",[90,93,95],{"name":91,"class":92},"Region Stockholm","OTHER_GOV",{"name":94,"class":92},"Vastra Gotaland Region",{"name":96,"class":6},"Region Skane","100536252","internet-delivered-cognitive-behaviour-therapy-for-child-and-adolescent-body-dysmorphic-disorder-100536252",false,"NCT06262412","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","Inclusion Criteria:\n\n1. 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.\n2. A total BDD symptom severity score on the BDD-YBOCS-A ≥24. Confirmed by the assessor at the inclusion assessment.\n3. Age between 12 and 17 years. Confirmed by the caregiver\u002Fparent and subsequently by the medical record.\n4. A minimum of one available caregiver\u002Fparent being able to co-participate and support the child\u002Fadolescent throughout the treatment. Confirmed by the caregiver\u002Fparent at the inclusion assessment.\n5. 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\u002Fparent at the inclusion assessment.\n\nExclusion Criteria:\n\n1. 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\u002Fparent at the telephone screening and\u002For the inclusion assessment and by the medical record.\n2. Simultaneous psychological treatment for BDD or for any psychiatric comorbidity. Confirmed by the caregiver\u002Fparent at the telephone screening and\u002For the inclusion assessment and by the medical record.\n3. 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\u002Fparent at the telephone screening and\u002For the inclusion assessment and by the medical record.\n4. A diagnosis of organic brain disorder, intellectual disability, psychosis, bipolar disorder, eating disorder, severe depression or alcohol\u002Fsubstance dependence. Confirmed by the caregiver\u002Fparent at the telephone screening and\u002For the inclusion assessment, with supplemental information from the semi-structured diagnostic interview and by the medical record.\n5. 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\u002Fparent at the telephone screening and\u002For the inclusion assessment.\n6. A documented suicide attempt in the last 12 months. Confirmed by the caregiver\u002Fparent at the telephone screening and\u002For the inclusion assessment or by documentation in the medical record.\n7. Child\u002Fadolescent and caregiver\u002Fparent not able to read and communicate in Swedish. Confirmed by the caregiver\u002Fparent at the telephone screening and\u002For the inclusion assessment.\n8. 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\u002Fparent or assessor at the telephone screening and\u002For at the face-to-face or video conference inclusion assessment.","ALL","12 Years","17 Years",{"count":108,"type":109},154,"ESTIMATED","INTERVENTIONAL",[112],"NA","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.",[115],"Body Dysmorphic Disorders",[117,118,119,120],"Body dysmorphic disorder","Cognitive-behavior therapy","Exposure and response prevention","Internet","2026-04-29",{"date":123,"type":124},"2026-04-30","ACTUAL",{"date":126,"type":124},"2024-02-19",{"date":128,"type":109},"2027-12-31",{"name":5,"class":6},3]