Body Dysmorphic DisordersNCT05078320
Internet-delivered Cognitive-behaviour Therapy for Adolescents With Body Dysmorphic Disorder
A study testing Exposure and response prevention (ERP) in people with Body Dysmorphic Disorders and Dysmorphophobia, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Body Dysmorphic Disorders, Dysmorphophobia
- What is being tested?
- Exposure and response prevention (ERP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 22 Oct 2021to 26 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age 12 to 17 years, confirmed by the caregiver and subsequently by the patient record system Take Care.
- A diagnosis of BDD, based on the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), confirmed by the assessor at the pre-treatment assessment.
- A total BDD severity score on the BDD-YBOCS-A ≥24. confirmed by the clinician-reported BDD-YBOCS-A performed at the pre-treatment assessment.
- A minimum of one available caregiver (parent) to support the child/adolescent throughout the treatment. Confirmed by the caregiver at the telephone screening or/and pre-treatment assessment.
- Regular access to a desktop or laptop computer connected to the Internet, with the ability to receive e-mails, as well as a mobile phone to receive SMS (one of each per family is enough). Confirmed by the caregiver at the telephone screening or/and pre-treatment assessment.
Who cannot join
- Previous CBT for BDD for a minimum of eight sessions with a qualified therapist within the 12 months prior to assessment. Confirmed by the caregiver at the telephone screening and/or pre-treatment assessment.
- Simultaneous psychological treatment for BDD, confirmed by the caregiver at the telephone screening and/or pre-treatment assessment.
- Initiation, adjustment or change of any selective serotonin reuptake inhibitors (SSRI) within the six weeks prior to the pre-treatment assessment. Confirmed by the caregiver at the telephone screening and/or pre-treatment assessment.
- A diagnosis of organic brain disorder, intellectual disability or a psychiatric disorder (such as psychosis, bipolar disorder or eating disorder) that could interfere with the completion of the treatment. Confirmed by the caregiver at the telephone screening and/or pre-treatment assessment, with help of information from the caregiver and the child/adolescent, and the MINI-KID interview.
- Immediate risk to self or others requiring urgent medical attention, such as current risk of suicide or self-injurious behaviours. Confirmed by the assessor at the telephone screening and/or face-to-face or video conference pre-treatment assessment, with help of information from the caregiver and the child/adolescent, and the suicide questions on the MINI-KID interview.
- Child and caregiver not able to read and communicate in Swedish. Confirmed by the caregiver or assessor at the telephone screening and/or pre-treatment assessment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internet-delivered Cognitive-behaviour Therapy for Adolescents With Body Dysmorphic Disorder: A Feasibility Trial
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.
Read the detailed description
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.
- Conditions
- Body Dysmorphic Disorders, Dysmorphophobia
- Being tested
- Exposure and response prevention (ERP)
- Keywords
- Body dysmorphic disorder, Dysmorphophobia, Cognitive-behavioral therapy, Internet-delivered treatments, Adolescents, Treatment outcomes
- 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.
Exposure and response prevention (ERP)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Internet-delivered cognitive-behaviour therapy for adolescents with body dysmorphic disorder | Experimental | Cognitive-behaviour therapy, Exposure and response prevention (ERP) Receives: Behavioral: Exposure and response prevention (ERP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months follow-up
Ease of recruitment: Time to recruit
Time to recruit 20 participants.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Week 14
Participant retention
Number of included participants completing treatment.
Measured: Week 14.
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline; week 14; 3-, 6- and 12-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start22 Oct 2021
- Primary completion6 Sep 2022
- Study completion26 Jun 2023
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorena Fernández de la Cruz, PhD, Karolinska Institutet
- Investigators
- Lorena Fernández de la Cruz, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078320
- Sponsor's protocol ID
- 2021-01942
- Status last verified
- Oct 2023
- First submitted
- 20 Sep 2021
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mataix-Cols D, Fernandez de la Cruz L, Isomura K, Anson M, Turner C, Monzani B, Cadman J, Bowyer L, Heyman I, Veale D, Krebs G. A Pilot Randomized Controlled Trial of Cognitive-Behavioral Therapy for Adolescents With Body Dysmorphic Disorder. J Am Acad Child Adolesc Psychiatry. 2015 Nov;54(11):895-904. doi: 10.1016/j.jaac.2015.08.011. Epub 2015 Sep 3.
PubMed 26506580
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Cognitive-behaviour Therapy for Adolescents With Body Dysmorphic Disorder: A Feasibility Trial
- ClinicalTrials.gov ID
- NCT05078320
- Acronym / sponsor ID
- 2021-01942
- Conditions
- Body Dysmorphic Disorders, Dysmorphophobia
- Keywords
- Body dysmorphic disorder, Dysmorphophobia, Cognitive-behavioral therapy, Internet-delivered treatments, Adolescents, Treatment outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 22 Oct 2021 (actual)
- Primary completion
- 6 Sep 2022 (actual)
- Study completion
- 26 Jun 2023 (actual)
- First posted
- 14 Oct 2021 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Internet-delivered cognitive-behaviour therapy for adolescents with body dysmorphic disorder | Experimental | Behavioral: Exposure and response prevention (ERP)Cognitive-behaviour therapy, Exposure and response prevention (ERP) |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 12 to 17 years, confirmed by the caregiver and subsequently by the patient record system Take Care.
- A diagnosis of BDD, based on the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), confirmed by the assessor at the pre-treatment assessment.
- A total BDD severity score on the BDD-YBOCS-A ≥24. confirmed by the clinician-reported BDD-YBOCS-A performed at the pre-treatment assessment.
- A minimum of one available caregiver (parent) to support the child/adolescent throughout the treatment. Confirmed by the caregiver at the telephone screening or/and pre-treatment assessment.
- Regular access to a desktop or laptop computer connected to the Internet, with the ability to receive e-mails, as well as a mobile phone to receive SMS (one of each per family is enough). Confirmed by the caregiver at the telephone screening or/and pre-treatment assessment.
Key exclusion criteria (6 listed)
- Previous CBT for BDD for a minimum of eight sessions with a qualified therapist within the 12 months prior to assessment. Confirmed by the caregiver at the telephone screening and/or pre-treatment assessment.
- Simultaneous psychological treatment for BDD, confirmed by the caregiver at the telephone screening and/or pre-treatment assessment.
- Initiation, adjustment or change of any selective serotonin reuptake inhibitors (SSRI) within the six weeks prior to the pre-treatment assessment. Confirmed by the caregiver at the telephone screening and/or pre-treatment assessment.
- A diagnosis of organic brain disorder, intellectual disability or a psychiatric disorder (such as psychosis, bipolar disorder or eating disorder) that could interfere with the completion of the treatment. Confirmed by the caregiver at the telephone screening and/or pre-treatment assessment, with help of information from the caregiver and the child/adolescent, and the MINI-KID interview.
- Immediate risk to self or others requiring urgent medical attention, such as current risk of suicide or self-injurious behaviours. Confirmed by the assessor at the telephone screening and/or face-to-face or video conference pre-treatment assessment, with help of information from the caregiver and the child/adolescent, and the suicide questions on the MINI-KID interview.
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 |
|---|---|---|
| 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. | Behavioural | Internet-delivered cognitive-behaviour therapy for adolescents with body dysmorphic disorder |
Primary outcome
Treatment credibility questionnaire
Time frame: Mid-treatment (3 weeks post-baseline)
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.
Treatment satisfaction questionnaire
Time frame: 3-month follow-up.
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.
internet intervention Patient Adherence Scale (iiPAS) Mid-treatment
Time frame: Mid-treatment (6 weeks post-baseline)
Used to assess the child/adolescent's adherence to the internet-delivered treatment. Range: 0-20, high scores means better outcome.
internet intervention Patient Adherence Scale (iiPAS) Post-treatment
Time frame: Week 14.
Used to assess the child/adolescent's adherence to the internet-delivered treatment. Range: 0-20, high scores means better outcome.
Negative effects questionnaire - Mid-treatment
Time frame: Week 6
Used to assess side effects/adverse events for the child/adolescent. Parent-reported. Range: 0-100, low scores means better outcome.
Negative effects questionnaire - Post-treatment
Time frame: Week 14
Used to assess side effects/adverse events for the child/adolescent. Parent-reported. Range: 0-100, low scores means better outcome.
Negative effects questionnaire - 3 months follow-up
Time frame: 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.
Ease of recruitment: Time to recruit
Time frame: From start of recruitment until 20 participants have been included. Anticipated time frame: 2-3 months
Time to recruit 20 participants.
Ease of recruitment: Amount of participants accepting participation after screening
Time frame: From start of recruitment until 20 participants have been included. Anticipated time frame: 2-3 months
Amount of participants accepting/declining participation after telephone screening
Ease of recruitment: Amount of participants accepting participation after assessment
Time frame: From start of recruitment until 20 participants have been included. Anticipated time frame: 2-3 months
Amount of participants accepting/declining participation after initial assessment.
Number of completed chapters in the internet treatment platform
Time frame: Week 14
Number of completed chapters is automatically logged in the internet treatment platform. Separate data for children and parents.
Participant retention
Time frame: Week 14.
Number of included participants completing treatment.
11 secondary outcomes
Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder, Adolescent version (BDD-YBOCS-A)
Time frame: Baseline; week 14; 1-, 2-, 3-, 6- and 12-month follow-up.
Clinical Global Impression - Severity (CGI-S)
Time frame: Baseline; week 14; 3-, 6- and 12-month follow-up.
Clinical Global Impression - Improvement (CGI-I)
Time frame: Week 14; 3-, 6- and 12-month follow-up.
Children's Global Assessment Scale (CGAS)
Time frame: Baseline; week 14; 3-, 6- and 12-month follow-up.
Appearance Anxiety Index (AAI)
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
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
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)
Time frame: Baseline; week 6, 14; 3-, 6- and 12-month follow-up.
The Work and Social Adjustment Scale - Parent Version (WSAS-P)
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)
Time frame: Baseline; week 14; 3-, 6- and 12-month follow-up.
KIDSCREEN-10
Time frame: Baseline; week 14; 3-, 6- and 12-month follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Background: PubMed 26506580Mataix-Cols D, Fernandez de la Cruz L, Isomura K, Anson M, Turner C, Monzani B, Cadman J, Bowyer L, Heyman I, Veale D, Krebs G. A Pilot Randomized Controlled Trial of Cognitive-Behavioral Therapy for Adolescents With Body Dysmorphic Disorder. J Am Acad Child Adolesc Psychiatry. 2015 Nov;54(11):895-904. doi: 10.1016/j.jaac.2015.08.011. Epub 2015 Sep 3.
- 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. This study is not recruiting at the moment.
Lorena Fernández de la Cruz, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure and response prevention (ERP) in people with Body Dysmorphic Disorders and Dysmorphophobia, run by Karolinska Institutet at 1 site 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 6 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: finished, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment credibility questionnaire (time frame: Mid-treatment (3 weeks post-baseline)). The study lists 12 primary outcomes in all. 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 NCT05078320, 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 4 Oct 2023.