An interventional study of Exposure and response prevention (ERP) in Body Dysmorphic Disorders and Dysmorphophobia, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-10-04.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
The purpose of this trial is to investigate whether a therapist-guided Internet-delivered cognitive behaviour therapy (ICBT) programme is feasible for adolescents with body dysmorphic disorder (BDD). The aim is to evaluate feasibility and provide preliminary efficacy data.
Rationale for study: BDD is a prevalent and impairing condition that can be effectively treated with cognitive-behaviour therapy (CBT). However, CBT for BDD is a highly specialised treatment and a majority of adolescents do not have access to it. ICBT can be a way to increase the availability of effective psychological treatments. No study to date has evaluated the feasibility of ICBT for adolescent BDD, but the experience in adults with BDD treated with ICBT is encouraging.
Objectives: To investigate whether a therapist-guided Internet-delivered cognitive behaviour therapy (ICBT) programme is feasible for adolescents with body dysmorphic disorder (BDD). Specifically, the aim is to:(a) establish participant retention, ease of recruitment, acceptability, credibility, and satisfaction, (b) evaluate potential adverse events, and (c) provide preliminary efficacy data.
Trial design and methods: Participants will be recruited nationally and will be offered 12 modules of ICBT for BDD, delivered over a period of 14 weeks. Participants will be assessed before, during, and after treatment, and up to 12 months after the end of the treatment. ICBT non-responders, assessed at post-treatment and one-, two-, and three-months after completing treatment, will be offered CBT delivered via video format (at post-treatment and after the 1MFU and the 2MFU) or traditional face-to-face (F2F) CBT at the OCD and Related Disorders Clinic for Children and Adolescents in Stockholm (after the 3MFU).
The primary outcome is feasibility, as measured by examining rates of participant retention, treatment completion and adherence to treatment content, treatment acceptability, treatment credibility, treatment satisfaction and adverse events during the treatment.
Secondary outcomes include improvement in clinician-reported BDD symptoms, as well as improvement in other clinical measures assessing disorder severity, disorder improvement, self-reported BDD symptoms, depressive symptoms, and functional impairment.
Sample: 20 adolescents and their primary caregivers.
Statistical analysis: Retention, acceptability, credibility, and treatment satisfaction. For retention and acceptability, information on ease of recruitment, number of completed modules, and attrition rates will collected and presented in a descriptive manner. Results from a credibility scale will be summarized in group means and standard deviations. Results from a treatment satisfaction scale will be summarized in group means and standard deviation. Potential adverse events: Type and impact of all potential adverse events will be measured with a specific scale and presented descriptively. Preliminary efficacy: Clinical measures of treatment outcomes will be measured via clinician-reported and self- and parent-reported measures and analysed through linear mixed models to detect within group change over time. Within-group effect sizes will be estimated with Cohen's d. Treatment response: The proportion of treatment responders will be calculated. Treatment response will be defined as a ≥30% reduction on the BDD-YBOCS-A, respective to the baseline score. Further, the investigators will also calculate how many participants are on full or partial symptom remission, defined as a score ⩽16 on the BDD-YBOCS-A.
56 studies on the registry are indexed under Body Dysmorphic Disorders; 11 are open to participants now.
This study's enrollment of 20 is below 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.
Cognitive-behaviour therapy, Exposure and response prevention (ERP)
Behavioral: Exposure and response prevention (ERP)
The treatment is Internet-delivered and therapist-guided, involving both the adolescent and at least one parent. The treatment consists of two separate sets of modules, one for the adolescent and one for the parent, each with separate logins. The ICBT intervention consists of 12 modules, delivered over a maximum of 14 weeks. The main goal of treatment is to help the young person to stop avoiding anxiety-provoking situations by undertaking exposure tasks and to stop doing unhelpful repetitive behaviours and rituals, known as response prevention. Every module also contains homework tasks that mainly consists of exposure and response prevention (ERP). Parents are also often involved in the patients' rituals and avoidant behaviours (known as family accommodation), which may contribute to maintain the BDD symptoms. Involving parents facilitates modification of these unhelpful patterns.
Treatment credibility questionnaire
Questionnaire developed by the research team. Used to assess treatment credibility. Separate versions for the child/adolescent and the parent are used. Range: 0-12, high scores means better outcome.
Time frame: Mid-treatment (3 weeks post-baseline)
Treatment satisfaction questionnaire
Questionnaire developed by the research team. Used to assess treatment satisfaction. Separate versions for the child/adolescent and the parent are used. Range: 0-36, high scores means better outcome.
Time frame: 3-month follow-up.
internet intervention Patient Adherence Scale (iiPAS) Mid-treatment
Used to assess the child/adolescent's adherence to the internet-delivered treatment. Range: 0-20, high scores means better outcome.
Time frame: Mid-treatment (6 weeks post-baseline)
internet intervention Patient Adherence Scale (iiPAS) Post-treatment
Used to assess the child/adolescent's adherence to the internet-delivered treatment. Range: 0-20, high scores means better outcome.
Time frame: Week 14.
Negative effects questionnaire - Mid-treatment
Used to assess side effects/adverse events for the child/adolescent. Parent-reported. Range: 0-100, low scores means better outcome.
Time frame: Week 6
Negative effects questionnaire - Post-treatment
Used to assess side effects/adverse events for the child/adolescent. Parent-reported. Range: 0-100, low scores means better outcome.
Time frame: Week 14
Negative effects questionnaire - 3 months follow-up
Used to assess side effects/adverse events for the child/adolescent. Parent-reported. Range: 0-100, low scores means better outcome.
Time frame: 3 months follow-up
Ease of recruitment: Time to recruit
Time to recruit 20 participants.
Time frame: From start of recruitment until 20 participants have been included. Anticipated time frame: 2-3 months
Ease of recruitment: Amount of participants accepting participation after screening
Amount of participants accepting/declining participation after telephone screening
Time frame: From start of recruitment until 20 participants have been included. Anticipated time frame: 2-3 months
Ease of recruitment: Amount of participants accepting participation after assessment
Amount of participants accepting/declining participation after initial assessment.
Time frame: From start of recruitment until 20 participants have been included. Anticipated time frame: 2-3 months
Number of completed chapters in the internet treatment platform
Number of completed chapters is automatically logged in the internet treatment platform. Separate data for children and parents.
Time frame: Week 14
Participant retention
Number of included participants completing treatment.
Time frame: Week 14.
Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder, Adolescent version (BDD-YBOCS-A)
Used to assess BDD symptom severity. Clinician-rated, semi-structured interview. Range: 0-48, low scores means better outcome.
Time frame: Baseline; week 14; 1-, 2-, 3-, 6- and 12-month follow-up.
Clinical Global Impression - Severity (CGI-S)
Used to provide an overall rating of the BDD severity. Clinician-rated. Range: 1-7, low scores means better outcome.
Time frame: Baseline; week 14; 3-, 6- and 12-month follow-up.
Clinical Global Impression - Improvement (CGI-I)
Used to assess global improvement. Clinician-rated. Range: 1-7, low scores means better outcome.
Time frame: Week 14; 3-, 6- and 12-month follow-up.
Children's Global Assessment Scale (CGAS)
Used to assess global improvement. Clinician-rated. Range: 1-100, high scores means better outcome.
Time frame: Baseline; week 14; 3-, 6- and 12-month follow-up.
Appearance Anxiety Index (AAI)
A self-reported measure that covers cognitions and behaviours typical of BDD. Range: 0-40, low scores means better outcome.
Time frame: Baseline; week 3, 6, 9, 14; 3-, 6- and 12-month follow-up.
Short Mood and Feeling Questionnaire - child version (SMFQ) + additional suicide item
Used to assess depressive symptoms and suicidal ideation. Child/adolescent-reported. Range: 0-29, low scores means better outcome.
Time frame: Baseline; week 3, 6, 9, 14; 3-, 6- and 12-month follow-up.
Short Mood and Feeling Questionnaire - parental version (SMFQ) + additional suicide item
Used to assess depressive symptoms and suicidal ideation in the adolescent. Parent-reported. Range: 0-29, low scores means better outcome.
Time frame: Baseline; week 3, 6, 9, 14; 3-, 6- and 12-month follow-up.
The Work and Social Adjustment Scale - Youth Version (WSAS-Y)
A self-reported instrument assessing functional impairment. Range: 0-40, low scores means better outcome.
Time frame: Baseline; week 6, 14; 3-, 6- and 12-month follow-up.
The Work and Social Adjustment Scale - Parent Version (WSAS-P)
A parent-reported instrument assessing functional impairment in the adolescent. Range: 0-40, low scores means better outcome.
Time frame: Baseline; week 6, 14; 3-, 6- and 12-month 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, low scores means better outcome.
Time frame: Baseline; week 14; 3-, 6- and 12-month follow-up.
KIDSCREEN-10
Used to assess quality of life. Separate versions for the child/adolescent and the parent are used. Range: 10-50, high scores means better outcome.
Time frame: Baseline; week 14; 3-, 6- and 12-month follow-up.
Therapist platform time
Therapist platform time is automatically logged in the internet treatment platform. Separate data for children and parents.
Time frame: Week 14
Therapist telephone time
Therapist telephone time is manually logged in a spreadsheet throughout the trial. Separate data for children and parents.
Time frame: Week 14
Plan to share: No
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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