- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02010619
Internet Delivered CBT for Body Dysmorphic Disorder
August 15, 2017 updated by: Christian Rück, Karolinska Institutet
Internet Delivered Cognitive Behavior Therapy for Body Dysmorphic Disorder - a Randomized Controlled Trial
To evaluate if Internet delivered cognitive behavior therapy is an efficacious treatment when compared to a control group consisting of supportive therapy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
94
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:
- outpatient
- ≥ 18 years
- primary diagnosis of BDD according to the DSM-5
- BDD-YBOCS ≥20
- regular access to a computer with Internet access and skills to use the web.
Exclusion Criteria:
- psychotropic medication changes within two months prior to the treatment,
- completed CBT for BDD within the last 12 months,
- other primary axis I diagnosis
- current substance dependence
- lifetime bipolar disorder or psychosis
- suicidal ideation
- Axis II diagnosis that could jeopardize treatment participation,
- other current psychological treatment that could affect BDD symptoms
- A serious medical illness that precludes participation in the study
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Supportive therapy
|
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Experimental: Cognitive behavior therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Body Dysmorphic Disorder Modification of the Y-BOCS (BDD-YBOCS)
Time Frame: Change in BDD-YBOCS from baseline (week 0) to post-treatment (week 12)
|
Change in BDD-YBOCS from baseline (week 0) to post-treatment (week 12)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The Montgomery Åsberg Depression Rating Scale - self report (MADRS-S)
Time Frame: Change in MADRS-S from baseline (week 0) to post-treatment (week 12)
|
Change in MADRS-S from baseline (week 0) to post-treatment (week 12)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
- Flygare O, Enander J, Andersson E, Ljotsson B, Ivanov VZ, Mataix-Cols D, Ruck C. Predictors of remission from body dysmorphic disorder after internet-delivered cognitive behavior therapy: a machine learning approach. BMC Psychiatry. 2020 May 19;20(1):247. doi: 10.1186/s12888-020-02655-4.
- Enander J, Ljotsson B, Anderhell L, Runeborg M, Flygare O, Cottman O, Andersson E, Dahlen S, Lichtenstein L, Ivanov VZ, Mataix-Cols D, Ruck C. Long-term outcome of therapist-guided internet-based cognitive behavioural therapy for body dysmorphic disorder (BDD-NET): a naturalistic 2-year follow-up after a randomised controlled trial. BMJ Open. 2019 Jan 15;9(1):e024307. doi: 10.1136/bmjopen-2018-024307.
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)
November 1, 2013
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
November 18, 2013
First Submitted That Met QC Criteria
December 12, 2013
First Posted (Estimate)
December 13, 2013
Study Record Updates
Last Update Posted (Actual)
August 18, 2017
Last Update Submitted That Met QC Criteria
August 15, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BDD RCT
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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-
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-
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-
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