Social Anxiety Virtual Reality Study (SAVR)

Maladaptive Avoidance and Fear Conditioning in Social Anxiety Disorder

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.

Study Overview

• Status: Terminated
• Conditions: Social Anxiety Disorder
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 4

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults with primary social anxiety disorder, community sample

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?

Number of groups / cohorts

1

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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maladaptive Avoidance Behavior	Latency (in milliseconds) to enter the quadrant of the avoidance task containing the image from the fear learning task	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maladaptive Avoidance Behavior (alternate measure)	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)	Amount of time (in milliseconds) with center of gaze on the image from the fear learning task	Baseline

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2020
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): February 28, 2020

Study Registration Dates

• First Submitted: February 25, 2020
• First Submitted That Met QC Criteria: February 25, 2020
• First Posted (Actual): February 28, 2020

Study Record Updates

• Last Update Posted (Actual): October 8, 2021
• Last Update Submitted That Met QC Criteria: September 30, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Phobic Disorders; Anxiety Disorders; Phobia, Social
• Other Study ID Numbers: IRB-48367

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No