NCT03773549

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 12, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2019

Completed
Last Updated

September 26, 2019

Status Verified

September 1, 2019

Enrollment Period

7 months

First QC Date

December 6, 2018

Last Update Submit

September 25, 2019

Conditions

Outcome Measures

Primary Outcomes (6)

  • Reactivity/arousal of heart rate (HR) during during VR socially ambiguous scenarios

    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

    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

    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

    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

    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

    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 Outcomes (2)

  • Exploratory investigation of acceptability and presence for future treatment using virtual reality methodology

    Day 1

  • Exploratory investigation for future treatment using virtual reality methodology using participant interpretations and feedback on the saliency of the different social contexts.

    Day 1

Study Arms (2)

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

Healthy control

Individuals who do not have a current psychiatric diagnosis, assessed via the Mini-International Neuropsychiatric Interview (MINI)

Other: Virtual reality experience

Interventions

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

Body dysmorphic disorderHealthy control

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with either body dysmorphic disorder or no current psychiatric illness.

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Body Dysmorphic Disorders

Condition Hierarchy (Ancestors)

Somatoform DisordersMental Disorders

Study Officials

  • Sabine Wilhelm, Ph.D

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Psychology

Study Record Dates

First Submitted

December 6, 2018

First Posted

December 12, 2018

Study Start

March 1, 2019

Primary Completion

September 20, 2019

Study Completion

September 20, 2019

Last Updated

September 26, 2019

Record last verified: 2019-09

Locations