SAVR: Social Anxiety Virtual Reality Study

Sponsor
Stanford University (Other)
Overall Status
Terminated
CT.gov ID
NCT04288180
Collaborator
(none)
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Study Details

Study Description

Brief Summary

This project aims to validate a virtual reality paradigm that assesses maladaptive avoidance behavior in social anxiety disorder. It also aims to generate a significant scientific advance by testing the hypothesis that maladaptive avoidance maintains anxiety through disruptions in safety learning.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

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 Design

Study Type:
Observational
Actual Enrollment :
4 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Maladaptive Avoidance and Fear Conditioning in Social Anxiety Disorder
Actual Study Start Date :
Jan 15, 2020
Actual Primary Completion Date :
Feb 28, 2020
Actual Study Completion Date :
Feb 28, 2020

Arms and Interventions

Arm Intervention/Treatment
Social Anxiety Disorder

A group of adults with social anxiety disorder will be recruited for a psychological/behavioral research study.

Other: No intervention
There will be no intervention in this study. Adults with social anxiety disorder will complete research assessments related to fear and safety learning.

Outcome Measures

Primary Outcome Measures

  1. Maladaptive Avoidance Behavior [Baseline]

    Latency (in milliseconds) to enter the quadrant of the avoidance task containing the image from the fear learning task

Secondary Outcome Measures

  1. Maladaptive Avoidance Behavior (alternate measure) [Baseline]

    Amount of time (in milliseconds) spent in the quadrant of the avoidance task containing the image from the fear learning task

  2. Maladaptive Avoidance Behavior (2nd alternate measure) [Baseline]

    Amount of time (in milliseconds) with center of gaze on the image from the fear learning task

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanford University Palo Alto California United States 94304

Sponsors and Collaborators

  • Stanford University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tali Manber Ball, PhD, Instructor, Stanford University
ClinicalTrials.gov Identifier:
NCT04288180
Other Study ID Numbers:
  • IRB-48367
First Posted:
Feb 28, 2020
Last Update Posted:
Oct 8, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 8, 2021