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Trial record 2 of 15 for:    virtual reality | ( Map: Massachusetts, United States )

A Virtual Reality Study of Cognitive Biases in Body Dysmorphic Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03773549
Recruitment Status : Completed
First Posted : December 12, 2018
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Sabine Wilhelm, PhD, Massachusetts General Hospital

Brief Summary:
Previous research shows that individuals with Body Dysmorphic Disorder (BDD) misinterpret ambiguous social information in a negative and threatening manner. These erroneous threat appraisals are thought to maintain disorder symptomatology and psychosocial impairment by reinforcing individuals' distorted self-image and ideas of social undesirability. Thus, maladaptive interpretation biases represent an important treatment target for this population; however, existing bias assessments and modification protocols are limited by the hypothetical and distal nature of scenarios and do not capture momentary experiential threat processes. The proposed study seeks to test virtual reality (VR) technology as a novel, in vivo means of eliciting, identifying, and measuring threat interpretation biases in a clinical sample to better understand the fear/threat structure activated during social interactions in BDD. Findings have the potential to enhance our understanding of disorder maintenance and identify more nuanced treatment targets. This study represents a critical first step in the long-term goal of harnessing VR gaming technology to supercharge existing treatment approaches for this debilitating illness.

Condition or disease Intervention/treatment
Body Dysmorphic Disorders Healthy Other: Virtual reality experience

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Study Type : Observational
Actual Enrollment : 58 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: A Virtual Reality Study of Cognitive Biases in Body Dysmorphic Disorder
Actual Study Start Date : March 1, 2019
Actual Primary Completion Date : September 20, 2019
Actual Study Completion Date : September 20, 2019

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)
Other: Virtual reality experience
Expose all participants (healthy and control) to virtual reality videos while collecting reactivity and self-report outcome measures.

Healthy control
Individuals who do not have a current psychiatric diagnosis, assessed via the Mini-International Neuropsychiatric Interview (MINI)
Other: Virtual reality experience
Expose all participants (healthy and control) to virtual reality videos while collecting reactivity and self-report outcome measures.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


  4. 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.


  5. 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.


  6. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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 ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Adults with either body dysmorphic disorder or no current psychiatric illness.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03773549


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Sabine Wilhelm, Ph.D Massachusetts General Hospital
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Responsible Party: Sabine Wilhelm, PhD, Chief of Psychology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03773549    
Other Study ID Numbers: 2018P001894
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Body Dysmorphic Disorders
Somatoform Disorders
Mental Disorders