<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03773549</url>
  </required_header>
  <id_info>
    <org_study_id>2018P001894</org_study_id>
    <nct_id>NCT03773549</nct_id>
  </id_info>
  <brief_title>A Virtual Reality Study of Cognitive Biases in Body Dysmorphic Disorder</brief_title>
  <official_title>A Virtual Reality Study of Cognitive Biases in Body Dysmorphic Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Previous research shows that individuals with Body Dysmorphic Disorder (BDD) misinterpret&#xD;
      ambiguous social information in a negative and threatening manner. These erroneous threat&#xD;
      appraisals are thought to maintain disorder symptomatology and psychosocial impairment by&#xD;
      reinforcing individuals' distorted self-image and ideas of social undesirability. Thus,&#xD;
      maladaptive interpretation biases represent an important treatment target for this&#xD;
      population; however, existing bias assessments and modification protocols are limited by the&#xD;
      hypothetical and distal nature of scenarios and do not capture momentary experiential threat&#xD;
      processes. The proposed study seeks to test virtual reality (VR) technology as a novel, in&#xD;
      vivo means of eliciting, identifying, and measuring threat interpretation biases in a&#xD;
      clinical sample to better understand the fear/threat structure activated during social&#xD;
      interactions in BDD. Findings have the potential to enhance our understanding of disorder&#xD;
      maintenance and identify more nuanced treatment targets. This study represents a critical&#xD;
      first step in the long-term goal of harnessing VR gaming technology to supercharge existing&#xD;
      treatment approaches for this debilitating illness.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">September 20, 2019</completion_date>
  <primary_completion_date type="Actual">September 20, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Reactivity/arousal of heart rate (HR) during during VR socially ambiguous scenarios</measure>
    <time_frame>Day 1</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reactivity/arousal of galvanic skin conductance (GSC) during VR socially ambiguous scenarios</measure>
    <time_frame>Day 1</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Distress ratings</measure>
    <time_frame>Day 1</time_frame>
    <description>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.&#xD;
We hypothesize that individuals with BDD will score higher on distress ratings than healthy individuals.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Social and appearance-related interpretation biases</measure>
    <time_frame>Day 1</time_frame>
    <description>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 &quot;threat&quot; and &quot;benign&quot; subscales. We will also use the Interpretation Questionnaire (IQ) to measure interpretations of everyday situations.&#xD;
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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>In vivo interpretations</measure>
    <time_frame>Day 1</time_frame>
    <description>Participants will be presented with two statements for each video exposure; one that articulates a &quot;healthier&quot; benign interpretation and one that articulates a &quot;BDD&quot; interpretation. They will be asked to rate each of the statements for each video.&#xD;
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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation of interpretation bias measures</measure>
    <time_frame>Day 1</time_frame>
    <description>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.&#xD;
We hypothesize that scores on the previously established WSAP-BDD and IQ will correlate with interpretations on the in vivo bias assessment measures.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Exploratory investigation of acceptability and presence for future treatment using virtual reality methodology</measure>
    <time_frame>Day 1</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exploratory investigation for future treatment using virtual reality methodology using participant interpretations and feedback on the saliency of the different social contexts.</measure>
    <time_frame>Day 1</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">58</enrollment>
  <condition>Body Dysmorphic Disorders</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Body dysmorphic disorder</arm_group_label>
    <description>Meet DSM-5 criteria for principal body dysmorphic disorder, assessed via the Structured Clinical Interview for the DSM-V Axis I Disorders (SCID)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy control</arm_group_label>
    <description>Individuals who do not have a current psychiatric diagnosis, assessed via the Mini-International Neuropsychiatric Interview (MINI)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Virtual reality experience</intervention_name>
    <description>Expose all participants (healthy and control) to virtual reality videos while collecting reactivity and self-report outcome measures.</description>
    <arm_group_label>Body dysmorphic disorder</arm_group_label>
    <arm_group_label>Healthy control</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adults with either body dysmorphic disorder or no current psychiatric illness.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18+,&#xD;
&#xD;
          -  Fluent in English,&#xD;
&#xD;
          -  Meet DSM-5 criteria for principal BDD (BDD group) or no other current psychiatric&#xD;
             diagnosis (HC group; assessed via clinical interview).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lifetime psychosis; current bipolar disorder in acute or hypomanic episode; current&#xD;
             severe substance use disorder; acute, active suicidal ideation&#xD;
&#xD;
          -  Intellectual disability or cognitive impairment that would interfere with&#xD;
             participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Sabine Wilhelm, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>September 25, 2019</last_update_submitted>
  <last_update_submitted_qc>September 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Sabine Wilhelm, PhD</investigator_full_name>
    <investigator_title>Chief of Psychology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Body Dysmorphic Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03773549
org study id: 2018P001894
nct id: NCT03773549
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Reactivity/arousal of heart rate (HR) during during VR socially ambiguous scenarios
time frame: Day 1
description: 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.
measure: Reactivity/arousal of galvanic skin conductance (GSC) during VR socially ambiguous scenarios
time frame: Day 1
description: 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.
measure: Distress ratings
time frame: Day 1
description: 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.
measure: Social and appearance-related interpretation biases
time frame: Day 1
description: 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.
measure: In vivo interpretations
time frame: Day 1
description: 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.
measure: Correlation of interpretation bias measures
time frame: Day 1
description: 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.
measure: Exploratory investigation of acceptability and presence for future treatment using virtual reality methodology
time frame: Day 1
description: 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.
measure: 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
description: 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.
arm group label: Body dysmorphic disorder
description: Meet DSM-5 criteria for principal body dysmorphic disorder, assessed via the Structured Clinical Interview for the DSM-V Axis I Disorders (SCID)
arm group label: Healthy control
description: Individuals who do not have a current psychiatric diagnosis, assessed via the Mini-International Neuropsychiatric Interview (MINI)
intervention type: Other
intervention name: Virtual reality experience
description: Expose all participants (healthy and control) to virtual reality videos while collecting reactivity and self-report outcome measures.
arm group label: Body dysmorphic disorder
arm group label: Healthy control
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Sabine Wilhelm, Ph.D
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Sabine Wilhelm, PhD
investigator title: Chief of Psychology
mesh term: Body Dysmorphic Disorders