- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04288180
Social Anxiety Virtual Reality Study (SAVR)
Maladaptive Avoidance and Fear Conditioning in Social Anxiety Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Although occasional mild social anxiety is a common human experience, social anxiety disorder has a devastating impact on patients' lives, leaving them vulnerable to medical, psychiatric, and socioeconomic complications. A key feature of social anxiety disorder is avoidance of social and/or performance situations in which judgment and evaluation from others might occur. Reducing avoidance is therefore an important treatment goal.
Despite the importance of avoidance, however, it is very difficult to assess a patient's tendency to avoid. Many prior assessments of avoidance measure adaptive (i.e., helpful) avoidance, in which an individual learns to avoid a truly noxious stimulus. However, anxiety disorders are characterized by maladaptive avoidance, in which a relatively safe stimulus is avoided resulting in interference with the individual's goals. In this study, the first aim is to validate a virtual reality paradigm to measure maladaptive avoidance behavior in adults with social anxiety disorder. The second aim is to test whether maladaptive avoidance behavior relates to safety learning (measured by a fear extinction task).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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California
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Palo Alto, California, United States, 94304
- Stanford University
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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+
- primary diagnosis of social anxiety disorder
- fluent spoken and written English
- able to provide informed consent
Exclusion Criteria:
- history of manic episode, hypomanic episode, or psychosis
- moderate or severe substance use disorder in the past 12 months
- current major depressive episode greater than moderate severity (PHQ-9 score >14)
- high risk for suicide (>8 on the MINI Suicidality section and/or clinician judgment that immediate medical attention is necessary)
- general medical condition or impediment to vision, hearing, or motor function likely to interfere with assessments
- benzodiazepine use in the past 2 weeks
- cannabis use for anxiety management in the past 2 weeks
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Social Anxiety Disorder
A group of adults with social anxiety disorder will be recruited for a psychological/behavioral research study.
|
There will be no intervention in this study.
Adults with social anxiety disorder will complete research assessments related to fear and safety learning.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maladaptive Avoidance Behavior
Time Frame: Baseline
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Latency (in milliseconds) to enter the quadrant of the avoidance task containing the image from the fear learning task
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Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maladaptive Avoidance Behavior (alternate measure)
Time Frame: Baseline
|
Amount of time (in milliseconds) spent in the quadrant of the avoidance task containing the image from the fear learning task
|
Baseline
|
Maladaptive Avoidance Behavior (2nd alternate measure)
Time Frame: Baseline
|
Amount of time (in milliseconds) with center of gaze on the image from the fear learning task
|
Baseline
|
Collaborators and Investigators
Sponsor
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
- IRB-48367
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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