- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03773549
A Virtual Reality Study of Cognitive Biases in Body Dysmorphic Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 18+,
- Fluent in English,
- Meet DSM-5 criteria for principal BDD (BDD group) or no other current psychiatric diagnosis (HC group; assessed via clinical interview).
Exclusion Criteria:
- Lifetime psychosis; current bipolar disorder in acute or hypomanic episode; current severe substance use disorder; acute, active suicidal ideation
- Intellectual disability or cognitive impairment that would interfere with participation
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Body dysmorphic disorder
Meet DSM-5 criteria for principal body dysmorphic disorder, assessed via the Structured Clinical Interview for the DSM-V Axis I Disorders (SCID)
|
Expose all participants (healthy and control) to virtual reality videos while collecting reactivity and self-report outcome measures.
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|
Healthy control
Individuals who do not have a current psychiatric diagnosis, assessed via the Mini-International Neuropsychiatric Interview (MINI)
|
Expose all participants (healthy and control) to virtual reality videos while collecting reactivity and self-report outcome measures.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reactivity/arousal of heart rate (HR) during during VR socially ambiguous scenarios
Time Frame: Day 1
|
Assessed by using iMotions software to measure heart rate (HR) while watching the virtual reality scenes.
We hypothesize that compared to healthy controls, participants with BDD will show greater reactivity/arousal via HR measurements for these socially ambiguous scenarios.
|
Day 1
|
|
Reactivity/arousal of galvanic skin conductance (GSC) during VR socially ambiguous scenarios
Time Frame: Day 1
|
Assessed by using to iMotions software to measure galvanic skin conductance (GSC) while watching the virtual reality scenes.
We hypothesize that compared to healthy controls, participants with BDD will show greater reactivity/arousal via GSC measurements for these socially ambiguous scenarios.
|
Day 1
|
|
Distress ratings
Time Frame: Day 1
|
Measured using a brief Likert scale self-report form (author-created distress rating questionnaire) to assess distress, threat, urge to check appearance, and urge to avoid the situation. Ratings will be measured 0-10, with 0 indicating no distress, threat, or urge to check appearance/situation and 10 indicating extreme distress, threat, or urge to check appearance/situation. A maximum score of 40 (a score of 10 on all 4 questions, summed) would indicate extreme distress, while a minimum score of 0 would indicate no distress. Higher scores would indicate greater reactivity. We hypothesize that individuals with BDD will score higher on distress ratings than healthy individuals. |
Day 1
|
|
Social and appearance-related interpretation biases
Time Frame: Day 1
|
We will use the Word-Sentence Association Paradigm (WSAP-BDD) to assess automatic BDD-related threat biases. Participants see ambiguous appearance and/or social sentences paired with a negative/threat and positive/benign interpretation words. Participants rate how related the word and the sentence are; ratings are summed to create "threat" and "benign" subscales. We will also use the Interpretation Questionnaire (IQ) to measure interpretations of everyday situations. We hypothesize that compared to healthy controls, BDD participants will show greater endorsement of threat interpretations and lower endorsement of benign interpretations than healthy controls for these interpretation bias measures. |
Day 1
|
|
In vivo interpretations
Time Frame: Day 1
|
Participants will be presented with two statements for each video exposure; one that articulates a "healthier" benign interpretation and one that articulates a "BDD" interpretation. They will be asked to rate each of the statements for each video. We hypothesize that participants with BDD will score higher on BDD interpretations than healthy controls, and that healthy controls will score higher on healthy interpretations than BDD participants. |
Day 1
|
|
Correlation of interpretation bias measures
Time Frame: Day 1
|
We will look at the correlation between the Word-Sentence Association Paradigm (WSAP-BDD) and the Interpretation Questionnaire (IQ), both established measures of interpretation biases, with our own in vivo bias assessments following the socially ambiguous situations. We hypothesize that scores on the previously established WSAP-BDD and IQ will correlate with interpretations on the in vivo bias assessment measures. |
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exploratory investigation of acceptability and presence for future treatment using virtual reality methodology
Time Frame: Day 1
|
Measured using a brief Likert scale self-report form (author-created measures of acceptability and presence questionnaire) to assess the acceptability of VR technology and presence in VR environment.
Ratings will be measured 0-10, with scores of 0 indicating that the participant was not at all engaged with or present in the scenario and that the environment did not at all feel realistic or similar to the real world.
Scores of 10 indicate that the participant was completely engaged with or present in the scenario and that the environment felt very realistic or similar to the real world.
A maximum score of 50 (a score of 10 on all 5 questions, summed) would indicate complete engagement and high acceptability, while a minimum score of 0 would indicate that the environment was not at all realistic or engaging.
Higher scores would show promising future directions for the use of virtual reality technology in this area of research.
|
Day 1
|
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Exploratory investigation for future treatment using virtual reality methodology using participant interpretations and feedback on the saliency of the different social contexts.
Time Frame: Day 1
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Measured through a series of open-ended questions regarding particular aspects of the scenes, which were the most/least provocative and realistic, and any alternate interpretations of the ambiguous situations.
The open-ended questions are meant to improve future iterations of this work, as the next step will hopefully be a treatment trial.
|
Day 1
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sabine Wilhelm, Ph.D, Massachusetts General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018P001894
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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