Clinical trial NCT04288180: Social Anxiety Virtual Reality Study
Official title: Maladaptive Avoidance and Fear Conditioning in Social Anxiety Disorder
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Social Anxiety Disorder
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with primary social anxiety disorder, community sample

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Maladaptive Avoidance Behavior
timeFrame: Baseline
Secondary outcomes:
measure: Maladaptive Avoidance Behavior (alternate measure)
timeFrame: Baseline
measure: Maladaptive Avoidance Behavior (2nd alternate measure)
timeFrame: Baseline
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
References: