ClinicalTrials.gg
CompletedNCT03773549Updated Sep 26, 2019

A Virtual Reality Study of Cognitive Biases in Body Dysmorphic Disorder

An observational study in Body Dysmorphic Disorders and Healthy, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-26.

Sponsored by Massachusetts General Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
58
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Body Dysmorphic Disorders
  • Healthy
03

In context

Body Dysmorphic Disorders

56 studies on the registry are indexed under Body Dysmorphic Disorders; 11 are open to participants now.

This study's enrollment of 58 is below the median of 150 across 11 observational studies indexed under Body Dysmorphic Disorders.

Browse Body Dysmorphic Disorders studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.

Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18+,
  • Fluent in English,
  • Meet criteria for principal BDD (BDD group) or no other current psychiatric diagnosis (HC group; assessed via clinical interview).

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
58 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherVirtual reality experience

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 1

  2. 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.

    Time frame: Day 1

  3. 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.

    Time frame: Day 1

  4. 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.

    Time frame: Day 1

  5. 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.

    Time frame: Day 1

  6. 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.

    Time frame: Day 1

Secondary outcomes

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

    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.

    Time frame: Day 1

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

    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.

    Time frame: Day 1

07

Study locations

1 site
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2019 to primary completion in Sep 2019, 6 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 6, 2018
First posted
Dec 12, 2018
StartActual
Mar 1, 2019
Primary completionActual
Sep 20, 2019
CompletionActual
Sep 20, 2019
Last update
Sep 26, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03773549
Responsible party
Sabine Wilhelm, PhD (Chief of Psychology, Massachusetts General Hospital) — Principal investigator
First posted
Dec 12, 2018
Start date
Mar 1, 2019
Primary completion
Sep 20, 2019
Completion
Sep 20, 2019
Last update
Sep 26, 2019

Study contacts

Sabine Wilhelm, Ph.D
principal investigator · Massachusetts General Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion