NCT04288180

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 25, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
Last Updated

October 8, 2021

Status Verified

September 1, 2021

Enrollment Period

1 month

First QC Date

February 25, 2020

Last Update Submit

September 30, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Maladaptive Avoidance Behavior

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

    Baseline

Secondary Outcomes (2)

  • Maladaptive Avoidance Behavior (alternate measure)

    Baseline

  • Maladaptive Avoidance Behavior (2nd alternate measure)

    Baseline

Study Arms (1)

Social Anxiety Disorder

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

Other: No intervention

Interventions

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

Social Anxiety Disorder

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with primary social anxiety disorder, community sample

You may qualify if:

  • age 18+
  • primary diagnosis of social anxiety disorder
  • fluent spoken and written English
  • able to provide informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor

Study Record Dates

First Submitted

February 25, 2020

First Posted

February 28, 2020

Study Start

January 15, 2020

Primary Completion

February 28, 2020

Study Completion

February 28, 2020

Last Updated

October 8, 2021

Record last verified: 2021-09

Locations