An interventional study of Internet-delivered cognitive-behaviour therapy (ICBT) and Internet-delivered relaxation treatment (IRT) in Body Dysmorphic Disorders, sponsored by Karolinska Institutet. Recruiting at 3 sites in Sweden. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
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.
Primary objective: To determine the clinical efficacy of a therapist-guided, Internet-delivered cognitive-behaviour therapy (ICBT) programme for body dysmorphic disorder (BDD) in reducing BDD symptom severity in children and adolescents with BDD, compared to a control intervention consisting of a therapist-guided, Internet-delivered relaxation treatment (IRT) for BDD.
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.
56 studies on the registry are indexed under Body Dysmorphic Disorders; 11 are open to participants now.
This study's planned enrollment of 154 is above the median of 52 across 44 interventional studies indexed under Body Dysmorphic Disorders.
Browse Body Dysmorphic Disorders studies →Karolinska Institutet is the lead sponsor of 1,148 studies on the registry; 276 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A therapist-guided, Internet-delivered cognitive-behaviour therapy (ICBT) programme for children and adolescents with BDD. Cognitive-behaviour therapy, Exposure and response prevention (ERP)
Behavioral: Internet-delivered cognitive-behaviour therapy (ICBT)
A therapist-guided, Internet-delivered relaxation treatment (IRT) programme for children and adolescents with BDD. Relaxation training (deep breathing, progressive muscle relaxation, imagery)
Behavioral: 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 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.
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.
Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder, Adolescent version (BDD-YBOCS-A)
The BDD-YBOCS-A is a clinician-rated, semi-structured interview. It is used to assess BDD symptom severity. It contains twelve items ranging from 0 to 4. It includes five questions on obsessions, five on compulsions, one about insight, and one to measure behavioural avoidance. Range: 0-48, lower scores mean better outcome.
Time frame: Baseline (week 0), post treatment (week 12), 1-month follow-up, 3-months follow-up, 6-months follow up.
Treatment response and full or partial remission
Treatment response and full or partial remission rates will be calculated at each follow-up point. Response will be defined as a reduction ≥30% on the BDD-YBOCS-A from baseline. Full or partial remission will be defined as a total score ≤16 on the BDD-YBOCS-A.
Time frame: Post treatment (week 12), 1-month follow-up, 3-months follow-up, 6-months follow up.
Clinical Global Impression - Severity (CGI-S)
Used to provide an overall rating of the BDD severity. Clinician-rated. Range: 1-7, lower scores mean better outcome.
Time frame: Baseline (week 0), post treatment (week 12), 1-month follow-up, 3-months follow-up, 6-months follow up.
Clinical Global Impression - Improvement (CGI-I)
Used to assess global improvement. Clinician-rated. Range: 1-7, lower scores mean better outcome.
Time frame: Post treatment (week 12), 1-month follow-up, 3-months follow-up, 6-months follow up.
Children's Global Assessment Scale (CGAS)
Used to assess global improvement. Clinician-rated. Range: 1-100, higher scores mean better outcome.
Time frame: Baseline (week 0), post treatment (week 12), 1-month follow-up, 3-months follow-up, 6-months follow up.
Appearance Anxiety Index (AAI)
A self-reported measure that covers cognitions and behaviours typical of BDD. Range: 0-40, lower scores mean better outcome.
Time frame: Baseline (week 0), post treatment (week 12), 1-month follow-up, 3-months follow-up, 6-months follow up.
Short Mood and Feeling Questionnaire - child version and parent version (SMFQ) + additional suicide item (only child/adolescent)
Used to assess depressive symptoms and suicidal ideation. Child/adolescent-reported. Range: 0-29, lower scores mean better outcome.
Time frame: Baseline (week 0), weekly during treatment (week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11), post treatment (week 12), 1-month follow-up, 3-months follow-up, 6-months follow up.
Generalized Anxiety Disorder - 7 item scale (GAD-7)
Used to assess anxiety symptoms. Range: 0-21, lower score mean better outcome. Child/adolescent-reported.
Time frame: Baseline (week 0), post treatment (week 12), 1-month follow-up, 3-months follow-up, 6-months follow up.
Deliberate Self-Harm Inventory - Youth version (DSHI-Y-7)
A 7-item self-reported measure to assess the presence and frequency of participants' non-suicidal self-injury. It will help the investigators to assess risk behaviours throughout the trial. Range: 0-7, lower scores mean better outcome. At baseline (week 0) the complete DSHI-Y-7 will be administered. At the post-treatment assessment (week 12) and the follow-up assessments, only questions about self-harm during the last month will be asked and not during the last 12 months. Range: 0-7, low score means better outcome. Child/adolescent-reported.
Time frame: Baseline (week 0), post treatment (week 12), 1-month follow-up, 3-months follow-up, 6-months follow up.
CRAFFT (acronym for the key words Car, Relax, Alone, Forget, Friends and Trouble)
A short self-reported instrument used to identify substance use and substance use disorder. Range: 0-6, lower scores mean better outcome. Child/adolescent-reported.
Time frame: Baseline (week 0), post treatment (week 12), 1-month follow-up, 3-months follow-up, 6-months follow up.
Work and Social Adjustment Scale - youth (WSAS-Y) and parent version (WSAS-P)
A self-, and parent-reported instrument assessing functional impairment. Range: 0-40, lower scores mean better outcome. Child/adolescent and parent-reported.
Time frame: Baseline (week 0), post treatment (week 12), 1-month follow-up, 3-months follow-up, 6-months follow up.
Child Health Utility 9D (CHU9D)
A self-reported generic preference-based measure of health-related quality of life designed specifically for use in economic evaluation targeting children and adolescents. Range: 9-45, lower score mean better outcome. Child/adolescent-reported.
Time frame: Baseline (week 0), post treatment (week 12), 1-month follow-up, 3-months follow-up, 6-months follow up.
Trimbos/iMTA Questionnaire for Costs associated with Psychiatric Illness (TiC-P)
The TiC-P collects information on healthcare and societal resource use, including for example items on healthcare resource use, medications, school absenteeism, and parental productivity loss. The use of resources will be translated into corresponding costs. No scores as such are available for this measure. Parent-reported.
Time frame: Baseline (week 0), post treatment (week 12), 1-month follow-up, 3-months follow-up, 6-months follow up.
Working Alliance Inventory - child (WAI-C) and parent version (WAI-P)
A 6-item scale measuring the child/adolescent and the caregivers/parents perceived working alliance with their therapist. The scale is rated from 1 to 7, yielding a total score of 7-49. Higher scores mean better working alliance. Child/adolescent and parent-reported.
Time frame: After 3 weeks.
Client Satisfaction Questionnaire (CSQ-8)
Used to assess treatment satisfaction. The scale has 8 items rated from 1 to 4, yielding a total score of 9-36. Higher scores mean more satisfaction. Child/adolescent and parent-reported.
Time frame: Post treatment (week 12).
Treatment Credibility and Expectancy Scale (TCES)
Used to measure treatment credibility or expectancy of treatment outcome. The TCES includes 5 items rated from 0 to 10, yielding a total score of 0-40, where higher scores indicate higher credibility. Child/adolescent and parent-reported.
Time frame: After 3 weeks.
Patient Exposure/Relaxation Adherence Scale (PEAS/PRAS)
The PEAS/PRAS is a 3-item measure of patient adherence to exposure and response prevention (PEAS) or relaxation training (PRAS). The PEAS/PRAS is one single measure but it is adapted to each of the two arms. The PEAS/PRAS has 3 items rated from 0 to 6, yielding a total score of 0-18. Higher scores mean better outcome. For the current trial, the PEAS will be administered as a self-rated version in the ICBT group and the PRAS will be administered as a self-rated version in the control group. Child/adolescent-reported.
Time frame: After 4 and 12 weeks.
Treatment preference
Two items will be administered to the caregiver and to the child/adolescent to assess treatment format preference (i.e., if the participant would have preferred to receive Internet-delivered treatment or in-person treatment for his/her symptoms or if it does not matter), as well as how important the participant believe it is to be able to choose which treatment format he/she receives (rated on a 5-point scale). The questionnaire has been developed by the research team.
Time frame: Baseline (week 0) and post treatment (week 12).
Areas of concern and cosmetic procedures
Clinicians will ask about areas of concern through a standardized checklist of 28 different parts of the body . They will also ask about current desire for and/or whether the patient had undergone any past cosmetic/surgical procedure related to their BDD concerns. Clinician rated.
Time frame: Baseline (week 0), post treatment (week 12), 1-month follow-up, 3-months follow-up, 6-months follow up.
School absenteeism
Clinicians will ask the participant and the caregiver if the participant has full, partial or no school attendance (i.e., school drop-out) during the last month.
Time frame: Baseline (week 0), post treatment (week 12), 1-month follow-up, 3-months follow-up, 6-months follow up.
Concurrent interventions
Clinicians will ask the participant questions about medications (type, dose, indication, and time period) and psychological treatment (type, number of sessions, indication, and time period).
Time frame: Baseline (week 0), post treatment (week 12), 1-month follow-up, 3-months follow-up, 6-months follow up.
BASS platform usage data
Usage data will be extracted from the BASS platform and entered into the trial database. The data includes number of completed modules, number of logins, number of messages sent to the therapist, and the name of the therapist.
Time frame: Post treatment (week 12).
Completed modules
In this trial, and for both treatment conditions, the first four modules contain the minimum amount of information required for the participants to understand the treatment rationale and the tasks that they are supposed to carry out. We will report descriptive statistics on the proportion of individuals in each group having completed at least four modules.
Time frame: Post treatment (week 12).
Adverse events questionnaire
A questionnaire will be administered to systematically assess adverse events during the trial. The questionnaire is developed by the research team and includes a checklist with expected adverse events based on previous trials as well as a free text box where other, not listed adverse events can be registered.
Time frame: After 6 weeks, post treatment (week 12), 1-month follow-up, 3-months follow-up, 6-months follow up.
Plan to share: No
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