Body Dysmorphic DisordersNCT06262412
Internet-delivered Cognitive-behaviour Therapy for Child and Adolescent Body Dysmorphic Disorder
A study testing Internet-delivered cognitive-behaviour therapy (ICBT) and Internet-delivered relaxation treatment (IRT) in people with Body Dysmorphic Disorders, run by Karolinska Institutet at 3 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Body Dysmorphic Disorders
- What is being tested?
- Internet-delivered cognitive-behaviour therapy (ICBT) and Internet-delivered relaxation treatment (IRT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 3 sitesSweden
- Study dates
- 19 Feb 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden3 sites, 3 recruiting
- Recruiting
BUP Specialmottagning, Sahlgrenska Universitetssjukhuset
Gothenburg, 416 85
Karin Melin Dr, +45 73 049 43 48, karin.a.melin@vgregion.se
- Recruiting
Barn- och ungdomspsykiatrin, Region Skåne
Malmö, 214 32
Per Andrén Dr, +46 70 435 17 40, per.andren@med.lu.se
- Recruiting
BUP OCD och relaterade tillstånd
Stockholm, 113 30
Anita Birovecz, MSc, +46 70 275 61 25, anita.birovecz@ki.se
About this study
Official title: Clinical Efficacy and Cost-effectiveness of Internet-delivered Cognitive-behaviour Therapy for Children and Adolescents With Body Dysmorphic Disorder: a Randomised Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Body Dysmorphic Disorders
- Being tested
- Internet-delivered cognitive-behaviour therapy (ICBT), Internet-delivered relaxation treatment (IRT)
- Keywords
- Body dysmorphic disorder, Cognitive-behavior therapy, Exposure and response prevention, Internet
- Medical subject headings
- Body Dysmorphic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered cognitive-behaviour therapy (ICBT)Behavioural
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.
Internet-delivered relaxation treatment (IRT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Internet-delivered cognitive-behaviour therapy (ICBT) | Experimental | A therapist-guided, Internet-delivered cognitive-behaviour therapy (ICBT) programme for children and adolescents with BDD.
Cognitive-behaviour therapy, Exposure and response prevention (ERP) Receives: Behavioral: Internet-delivered cognitive-behaviour therapy (ICBT) |
| Internet-delivered relaxation treatment (IRT) | Active comparator | A therapist-guided, Internet-delivered relaxation treatment (IRT) programme for children and adolescents with BDD.
Relaxation training (deep breathing, progressive muscle relaxation, imagery) Receives: Behavioral: Internet-delivered relaxation treatment (IRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (week 0), post treatment (week 12), 1-month follow-up, 3-months follow-up, 6-months follow up.
Secondary outcomes (17)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (week 0) and post treatment (week 12).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start19 Feb 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Body Dysmorphic DisordersStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multisite parallel-group randomised controlled superiority trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm, Vastra Gotaland Region, Region Skane
- Responsible party
- Principal investigator, Lorena Fernández de la Cruz, PhD, Karolinska Institutet
- Investigators
- Lorena Fernández de la Cruz, PhD, Principal investigator, Department of Clinical Neuroscience (CNS), K8, CPF Mataix-Cols,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262412
- Sponsor's protocol ID
- 2023-02193-01
- Other IDs
- 2023
- Status last verified
- Apr 2026
- First submitted
- 12 Jan 2024
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fernandez de la Cruz L, Birovecz A, Andren P, Melin K, Aspvall K, Cervin M, Andersson E, Silverberg-Morse M, Gumpert M, Wickberg F, Bottai M, Serlachius E, Rautio D, Mataix-Cols D. Efficacy and cost-effectiveness of Internet-delivered cognitive-behavior therapy for children and adolescents with body dysmorphic disorder: study protocol for a randomized controlled trial. Trials. 2026 Aug 31;27(1):557. doi: 10.1186/s13063-026-09974-z.
PubMed 42675507
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Cost-effectiveness of Internet-delivered Cognitive-behaviour Therapy for Children and Adolescents With Body Dysmorphic Disorder: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06262412
- Acronym / sponsor ID
- 2023-02193-01
- Conditions
- Body Dysmorphic Disorders
- Keywords
- Body dysmorphic disorder, Cognitive-behavior therapy, Exposure and response prevention, Internet
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm, Vastra Gotaland Region, Region Skane
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Multisite parallel-group randomised controlled superiority trial.
| Arm | Type | Receives |
|---|---|---|
| Internet-delivered cognitive-behaviour therapy (ICBT) | Experimental | Behavioral: Internet-delivered cognitive-behaviour therapy (ICBT)A therapist-guided, Internet-delivered cognitive-behaviour therapy (ICBT) programme for children and adolescents with BDD. Cognitive-behaviour therapy, Exposure and response prevention (ERP) |
| Internet-delivered relaxation treatment (IRT) | Active comparator | Behavioral: Internet-delivered relaxation treatment (IRT)A therapist-guided, Internet-delivered relaxation treatment (IRT) programme for children and adolescents with BDD. Relaxation training (deep breathing, progressive muscle relaxation, imagery) |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-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. | Behavioural | Internet-delivered cognitive-behaviour therapy (ICBT) |
| 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, 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. | Behavioural | Internet-delivered relaxation treatment (IRT) |
Primary outcome
Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder, Adolescent version (BDD-YBOCS-A)
Time frame: Baseline (week 0), post treatment (week 12), 1-month follow-up, 3-months follow-up, 6-months follow up.
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.
17 secondary outcomes
Treatment response and full or partial remission
Time frame: Post treatment (week 12), 1-month follow-up, 3-months follow-up, 6-months follow up.
Clinical Global Impression - Severity (CGI-S)
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)
Time frame: Post treatment (week 12), 1-month follow-up, 3-months follow-up, 6-months follow up.
Children's Global Assessment Scale (CGAS)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Time frame: After 3 weeks.
Client Satisfaction Questionnaire (CSQ-8)
Time frame: Post treatment (week 12).
Treatment Credibility and Expectancy Scale (TCES)
Time frame: After 3 weeks.
Patient Exposure/Relaxation Adherence Scale (PEAS/PRAS)
Time frame: After 4 and 12 weeks.
Treatment preference
Time frame: Baseline (week 0) and post treatment (week 12).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Derived from this study: PubMed 42675507Fernandez de la Cruz L, Birovecz A, Andren P, Melin K, Aspvall K, Cervin M, Andersson E, Silverberg-Morse M, Gumpert M, Wickberg F, Bottai M, Serlachius E, Rautio D, Mataix-Cols D. Efficacy and cost-effectiveness of Internet-delivered cognitive-behavior therapy for children and adolescents with body dysmorphic disorder: study protocol for a randomized controlled trial. Trials. 2026 Aug 31;27(1):557. doi: 10.1186/s13063-026-09974-z.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lorena Fernández de la Cruz, PhD principal investigator
Department of Clinical Neuroscience (CNS), K8, CPF Mataix-Cols,
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-delivered cognitive-behaviour therapy (ICBT) and Internet-delivered relaxation treatment (IRT) in people with Body Dysmorphic Disorders, run by Karolinska Institutet at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lorena Fernández de la Cruz, PhD (+46 76 847 79 99, lorena.fernandez.de.la.cruz@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder, Adolescent version (BDD-YBOCS-A) (time frame: Baseline (week 0), post treatment (week 12), 1-month follow-up, 3-months follow-up, 6-months follow up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06262412, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.