- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02635152
Interpretation Bias Modification for Body Dysmorphic Disorder
January 26, 2021 updated by: Jesse Cougle, Florida State University
Evaluation of an Internet-Based Treatment for Body Dysmorphic Disorder
The purpose of this study is to determine whether a computerized intervention designed to reduce appearance and evaluation related interpretation biases will reduce symptoms associated with body dysmorphic disorder.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The present study aims to examine the feasibility of a remote treatment for body dysmorphic disorder delivered via the Internet.
To evaluate the efficacy of the IBM protocol we have developed in reducing negative appearance and evaluative related interpretations, we will conduct a two-arm randomized controlled trial over the internet.
Individuals with a diagnosis of body dysmorphic disorder (N = 40) will be randomized to one of two conditions: 1) IBM or 2) progressive muscle relaxation.
Each condition will consist of eight 10-25 minute treatment sessions.
Participants will complete two sessions per week for four weeks and will be administered assessments at pre-treatment, one week post-treatment and at 3-month follow-up.
We hypothesize that: 1) IBM will lead to greater reductions in BDD symptoms than the PMR condition; 2) IBM will lead to greater reductions in depression, anxiety and suicidal ideation than the PMR condition; 3) IBM will lead to greater reductions in threat interpretations and greater increases in benign interpretations than the PMR condition; 4) The effects of condition on BDD symptoms will be mediated by changes in BDD-related interpretation bias; and 5) The effects of training in the IBM condition will be maintained at the 3-month follow-up assessments.
Study Type
Interventional
Enrollment (Actual)
50
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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Florida
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Tallahassee, Florida, United States, 32304
- Florida State University Psychology Department
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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
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Current diagnosis of Body Dysmorphic Disorder according to DSM-5 criteria
- BDD-YBOCS score greater than or equal to 20
- Fluent in English
- No significant physical defect or flaw in appearance (e.g., disfiguration)
Exclusion Criteria:
- History of psychotic disorder, bipolar disorder, borderline personality disorder
- Current substance use disorder
- Unstable medication status (i.e. change in medication within the last month)
- Concurrent psychotherapy for appearance concerns
- Active and clinically significant suicidality
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 |
---|---|
Experimental: Interpretation Bias Modification (IBM)
Treatment consists of eight brief sessions.
In Task 1, participants read unique scenarios ("You notice someone pointing in your direction").
A sentence meant to resolve the ambiguity will appear ("This person thinks they reco_nize you").
After filling in the missing letter, the interpretation is reinforced by requiring the participants to correctly answer "yes" or "no" to a comprehension question ("Is this person mocking you?").
In Task 2, participants are shown a word denoting a threatening ("mocking") or benign ("cheerful") interpretation.
Participants are presented with an ambiguous scenario ("You hear people at a nearby table laughing") and asked to denote whether the word and the sentence are related.
Participants will receive positive or negative feedback based on their response.
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Eight 10-25 minute sessions of interpretation modification to reduce negative interpretation biases related to appearance.
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Active Comparator: Progressive Muscle Relaxation (PMR)
Participants will receive eight brief sessions of PMR.
They will listen to a PMR script (Kassinove & Tafrate, 2002).
Participants will be asked to make sure they are sitting comfortably, close their eyes, and systematically tense and release 10 different muscle groups.
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Eight 15-minute sessions of progressive muscle relaxation (PMR).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS; Phillips et al., 1997)
Time Frame: change from baseline at one-week post treatment and 3-months post-treatment
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Measures past-week BDD symptom severity
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change from baseline at one-week post treatment and 3-months post-treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Beck Depression Inventory (BDI-II; Beck, Steer, & Brown, 1996)
Time Frame: change from baseline at one-week post treatment and 3-months post-treatment
|
Measures depressive symptom severity
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change from baseline at one-week post treatment and 3-months post-treatment
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Beck Anxiety Inventory (BAI; Steer & Beck, 1997)
Time Frame: change from baseline at one-week post treatment and 3-months post-treatment
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Measure anxious symptom severity
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change from baseline at one-week post treatment and 3-months post-treatment
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Depressive Symptom Index-Suicidality Subscale
Time Frame: change from baseline at one-week post treatment and 3-months post-treatment
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Measure severity of recent suicidality
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change from baseline at one-week post treatment and 3-months post-treatment
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Body Dysmorphic Disorder Word Sentence Association Paradigm (BDD-WSAP; modified from Hindash & Amir, 2011)
Time Frame: change from baseline at one-week post treatment and 3-months post-treatment
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Measure of strength of BDD-related (i.e.
evaluation- and appearance- related threat interpretation biases)
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change from baseline at one-week post treatment and 3-months post-treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Natalie L. Matheny, BA, Florida State University
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.
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
September 1, 2015
Primary Completion (Actual)
March 1, 2018
Study Completion (Actual)
March 1, 2018
Study Registration Dates
First Submitted
December 16, 2015
First Submitted That Met QC Criteria
December 17, 2015
First Posted (Estimate)
December 18, 2015
Study Record Updates
Last Update Posted (Actual)
January 29, 2021
Last Update Submitted That Met QC Criteria
January 26, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017.20244
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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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