- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03517384
Feasibility Pilot Study of Internet-based Cognitive Behavioral Therapy (CBT) for Body Dysmorphic Disorder With Global Recruitment (BDD-G)
September 14, 2020 updated by: Christian Rück, Karolinska Institutet
Feasibility Pilot Study of Internet-based CBT for Body Dysmorphic Disorder With Global Recruitment
The aim of the study is to study an english-language version of BDD-NET (Enander, et al., 2014; Enander, et al., 2016), an internet-based treatment for Body Dysmorphic Disorder, on a globally recruited sample.
This is an uncontrolled pilot study where a within-subjects repeated measures design was used to assess the feasibility of conducting all aspects of the study remotely, including recruitment, assessment, and treatment delivery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Huddinge
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Stockholm, Huddinge, Sweden, 141 86
- M46: Karolinska Universitetssjukhuset, Psykiatri Sydväst
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Current outpatient status (not currently admitted for inpatient care)
- Patient is fluent in English
- Patient has regular access to a computer with an Internet connection
- Patient has adequate skills to use the Internet effectively.
- Patient provides informed consent (both verbal, and click yes to consent on secure web page)
- Patient is 18 years of age or older (able to provide government issued photo ID)
- Patient has primary diagnosis of DSM-5 Body Dysmorphic Disorder, (determined using the SCID-5 module "G" which assesses diagnostic criteria on obsessive compulsive spectrum disorders)
- score ≥ 4 on the Body Dysmorphic Disorder Questionnaire (BDDQ),
- score ≥ 9 on the Dysmorphic Concern Questionnaire (DCQ)
- score ≥ 20 on the Body Dysmorphic Disorder Modification of the Yale Brown Obsessive Compulsive Scale (BDD-YBOCS).
Exclusion Criteria:
- Patient received Cognitive Behavior Therapy for Body Dysmporphic Disorder in the 12 months preceding treatment
- Patient changed psychotropic medications within the 12 weeks before treatment
- Patient receiving other ongoing psychotherapy at the time,
- Patient did not have access to a 24 hour psychiatric emergency center
- Patient could not provide an emergency contact person.
- Current substance dependence (assessed with M.I.N.I. 7.0, AUDIT, DUDIT)
- Lifetime bipolar disorder diagnosis (assessed with M.I.N.I. 7.0 and self-report)
- Psychosis present
- Severe depression (assessed with M.I.N.I., MADRS-S score ≥ 35)
- Personality disorder diagnosis (self-report and video-conference diagnostic interview),
- Lifetime history of suicide attempts (self-report) or clinically significant current suicidal ideation (≥ 5 on item 9 of MADRS-S; Columbia Suicide Severity Rating Scale (C-SSRS Lifetime Recent) - Clinical Version: Recent (past month) - Most Severe Ideation score ≥ 4).
- Additionally, eligibility continues to be assessed on an ongoing basis after initial inclusion. The MADRS-S, Appearance Anxiety Questionnaire (AAI), and Adverse Events Questionnaire (AEQ) are administered weekly in order to ensure that the treatment study continues to be a safe and appropriate level of care for participants.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: I-CBT for Body Dysmorphic Disorder
All participants will receive our Internet-Cognitive Behavioral Therapy treatment for Body Dysmorphic Disorder.
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The current intervention, is a therapist guided, Internet Cognitive Behavioral Therapy treatment for Body Dysmporhic Disorder which consists of 8 treatment modules administered over the course of 12 weeks.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptom Change using the Clinician-rated, Body Dysmporhic Disorder Modification of Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS)
Time Frame: baseline, week 6, post (week 12), 3 month follow-up, 12 month follow-up
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A measure of BDD symptom severity.
Scores range from 0-48 with higher scores indicating greater severity.
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baseline, week 6, post (week 12), 3 month follow-up, 12 month follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Structured Clinical Interview for Diagnostic Statistical Manual 5th edition (DSM 5) - Research Version (SCID-5-RV) module G
Time Frame: baseline, post (week 12), 3 month follow-up, 12 month follow-up
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assessment of BDD diagnostic status
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baseline, post (week 12), 3 month follow-up, 12 month follow-up
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Mini-International Neuropsychiatric Interview - version 7.0 (M.I.N.I. 7.0)
Time Frame: baseline, post (week 12), 3 month follow-up, 12 month follow-up
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assessment of current major depressive episode and other comorbid anxiety diagnoses
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baseline, post (week 12), 3 month follow-up, 12 month follow-up
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Dysmorphic Concerns Questionnaire (DCQ)
Time Frame: screening, baseline, post (week 12), 3 month follow-up, 12 month follow-up
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used for BDD screening/ measuring dysmorphic concerns.
Scores range from 0 to 28 with higher scores indicating higher severity
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screening, baseline, post (week 12), 3 month follow-up, 12 month follow-up
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Appearance Anxiety Inventory (AAI)
Time Frame: screening, baseline, weeks 1-11, post (week 12), 3 month follow-up, 12 month follow-up
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A measure of BDD symptoms.
The maximum total score is 40, with higher scores indicating greater frequency of a process
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screening, baseline, weeks 1-11, post (week 12), 3 month follow-up, 12 month follow-up
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Brown Assessment of Beliefs Scale (BABS)
Time Frame: baseline, post (week 12), 3 month follow-up, 12 month follow-up
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Measures conviction and insight regarding beliefs/ obsessions.
Scores can range from 0 to 24 with higher scores indicating poorer insight.
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baseline, post (week 12), 3 month follow-up, 12 month follow-up
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Montgomery-Åsberg Depression Rating Scale, self-report (MADRS-S)
Time Frame: screening, baseline, weeks 1-11, post (week 12), 3 month follow-up, 12 month follow-up
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measures depressive symptoms and suicidal ideation.
Scores range from 0-54 with higher scores indicating higher severity.
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screening, baseline, weeks 1-11, post (week 12), 3 month follow-up, 12 month follow-up
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Skin-Picking Scale - Revised (SPS-R)
Time Frame: baseline, post (week 12), 3 month follow-up, 12 month follow-up
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Measures skin picking severity.
Scores range from 0 to 32 with higher scores indicating higher severity
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baseline, post (week 12), 3 month follow-up, 12 month follow-up
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Global Assessment of Functioning (GAF)
Time Frame: baseline, post (week 12), 3 month follow-up, 12 month follow-up
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A measure of global functioning.
Scores range from 0-100 with higher scores indicating better functioning.
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baseline, post (week 12), 3 month follow-up, 12 month follow-up
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Clinical Global Impressions Scale - Severity (CGI-S)
Time Frame: baseline, post (week 12), 3 month follow-up, 12 month follow-up
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measures global severity.
Scores range from 1-7 with higher scores indicating more severity.
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baseline, post (week 12), 3 month follow-up, 12 month follow-up
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Clinical Global Impressions Scale - Improvement (CGI-I)
Time Frame: post (week 12), 3 month follow-up, 12 month follow-up
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measures global improvement.
Scores range from 1-7 with low scores indicating more improvement.
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post (week 12), 3 month follow-up, 12 month follow-up
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EuroQol - 5 Dimension Questionnaire (EQ-5D)
Time Frame: baseline, post (week 12), 3 month follow-up, 12 month follow-up
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Measures quality of life and functioning.
Scores range between 0 (dead) and 1 (perfect health).
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baseline, post (week 12), 3 month follow-up, 12 month follow-up
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Sheehan Disability Scale (SDS)
Time Frame: baseline, post (week 12), 3 month follow-up, 12 month follow-up
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The SDS has 3 items measuring functional impairment and disability regarding work/school, social life/leisure, and family life/home responsibilities on a likert scale between 0 (no interference) to 10 (extreme impairment).
Two items measure days lost at work/school and days being underproductive at work/school.
Items are on a likert scale of 0 (not at all) to 10 (very severe).
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baseline, post (week 12), 3 month follow-up, 12 month follow-up
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Client Satisfaction Inventory (CSI)
Time Frame: weeks 2, 7, and 12 (post)
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Measures participants' satisfaction with treatment.
Total raw scores on this measure range 0 to 175 with higher scores indicating higher satisfaction
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weeks 2, 7, and 12 (post)
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Working Alliance Inventory - Short Revised (WAI-SR)
Time Frame: weeks 2, 4, 6, 8, 10, and 12 (post)
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Measures working alliance between therapist and patient.
Scores range from 0-60 with higher scores indicating better working alliance.
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weeks 2, 4, 6, 8, 10, and 12 (post)
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Credibility Scale (Credibility/Expectancy Questionnaire)
Time Frame: baseline, weeks 2, 4, 6, 8, 10, and 12 (post)
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Measures patients' perception of the credibility of treatment and expectations for treatment outcome.
Scores range from 0-55 with higher scores indicating better expectations of treatment outcome and higher perceptions that the treatment is credible.
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baseline, weeks 2, 4, 6, 8, 10, and 12 (post)
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Internet Cognitive Behavioral Therapy -- Exposure and Response Prevention Adherence Scale (ICBT - EX/RP Adherence Scale, modified from the Patient EX/RP Adherence Scale (PEAS))
Time Frame: weeks 2-11, and week 12 (post)
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Measures patients adherence to treatment.
Raw scores range from 0-62 with higher scores indicating more adherence to treatment.
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weeks 2-11, and week 12 (post)
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Completion of Core Treatment Modules
Time Frame: Post treatment (Week 12)
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Have participants completed modules 1-5?
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Post treatment (Week 12)
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Early Termination Checklist
Time Frame: Post treatment (Week 12)
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indicates possible reasons for participants early termination from treatment.
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Post treatment (Week 12)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christian Rück, MD PhD, Karolinska Institutet
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Enander J, Andersson E, Mataix-Cols D, Lichtenstein L, Alstrom K, Andersson G, Ljotsson B, Ruck C. Therapist guided internet based cognitive behavioural therapy for body dysmorphic disorder: single blind randomised controlled trial. BMJ. 2016 Feb 2;352:i241. doi: 10.1136/bmj.i241.
- Enander J, Ivanov VZ, Andersson E, Mataix-Cols D, Ljotsson B, Ruck C. Therapist-guided, Internet-based cognitive-behavioural therapy for body dysmorphic disorder (BDD-NET): a feasibility study. BMJ Open. 2014 Sep 25;4(9):e005923. doi: 10.1136/bmjopen-2014-005923.
- Gentile AJ, La Lima C, Flygare O, Enander J, Wilhelm S, Mataix-Cols D, Ruck C. Internet-based, therapist-guided, cognitive-behavioural therapy for body dysmorphic disorder with global eligibility for inclusion: an uncontrolled pilot study. BMJ Open. 2019 Mar 23;9(3):e024693. doi: 10.1136/bmjopen-2018-024693.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 20, 2016
Primary Completion (Actual)
November 1, 2017
Study Completion (Actual)
June 15, 2018
Study Registration Dates
First Submitted
April 10, 2018
First Submitted That Met QC Criteria
April 24, 2018
First Posted (Actual)
May 7, 2018
Study Record Updates
Last Update Posted (Actual)
September 16, 2020
Last Update Submitted That Met QC Criteria
September 14, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BDD-GLOBAL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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