Social Anxiety Virtual Reality Study

Social Anxiety Disorder Clinical Trial

— SAVR  

Official title:

Maladaptive Avoidance and Fear Conditioning in Social Anxiety Disorder

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04288180
• Other study ID #: IRB-48367
• Status: Terminated
• Start date: January 15, 2020
• Est. completion date: February 28, 2020

Study information

• Verified date: September 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobia, Social
• Social Anxiety Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maladaptive Avoidance Behavior	Latency (in milliseconds) to enter the quadrant of the avoidance task containing the image from the fear learning task	Baseline
Secondary	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
Secondary	Maladaptive Avoidance Behavior (2nd alternate measure)	Amount of time (in milliseconds) with center of gaze on the image from the fear learning task	Baseline