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Clinical Trials/NCT03683823
NCT03683823
Terminated
Not Applicable

Efficacy of an Attention Guidance VR Intervention for Social Anxiety Disorder

University of Texas at Austin1 site in 1 country21 target enrollmentFebruary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Social Anxiety Disorder
Sponsor
University of Texas at Austin
Enrollment
21
Locations
1
Primary Endpoint
Personal Report of Public Speaking Anxiety Scale Post-intervention
Status
Terminated
Last Updated
4 years ago

Overview

Brief Summary

Social anxiety disorder (SAD) is a prevalent mental health concern that impacts approximately 12% of the population. One mechanism thought to maintain SAD is avoidance of faces (i.e. avoidance of negative evaluative threat). However, research on attentional processes in SAD has been confined to paradigms presented on computer monitors. To investigate attentional processes in a more naturalistic way the investigators developed an immersive, 360º-video virtual reality environment using real actors, as part of a pilot study. Participants with a range of social anxiety symptoms (from none to severe) completed a 5-minute speech in this virtual reality environment while their eye movements were recorded. Results from the study showed that greater symptoms of social anxiety were associated with avoidance of looking at faces (i.e. fewer fixations on faces). While existing treatments for SAD are moderately effective, a large number of individuals do not experience meaningful reductions in their symptoms. The overarching goal of this project is inform future treatment research for SAD. The investigators will test a brief attention guidance intervention for SAD that specifically targets avoidance of faces as a potential mechanism maintaining the disorder. The proposed research will use the eye tracking hardware and naturalistic virtual reality environment from the pilot study. The investigators will also collect eye tracking data prior to the intervention in order to investigate potential heterogeneity in the attentional processes of SAD. The investigators will test the hypotheses that (a) the attention guidance intervention, compared to the control intervention, will result in a greater reduction in symptoms of social anxiety, and (b) this effect will be mediated by the number of fixations on faces during a brief public speaking challenge following the intervention. These results will provide causal evidence related to a hypothesized mechanism maintaining SAD.

Registry
clinicaltrials.gov
Start Date
February 1, 2019
End Date
March 25, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael J. Telch

Professor

University of Texas at Austin

Eligibility Criteria

Inclusion Criteria

  • Fluent in English;
  • Personal Report of Public Speaking Anxiety score \> 98;
  • Leibowitz Social Anxiety Scale \> 30;
  • Peak fear ≥ 50 on the behavioral approach task during the baseline assessment;
  • Meets DSM-5 Criteria for Social Anxiety Disorder.

Exclusion Criteria

  • Currently receiving CBT for Social Anxiety Disorder;
  • Significant visual impairment precluding the use of virtual reality equipment;
  • Unstable dose of psychotropic medications within 3 weeks prior to baseline assessment;
  • Current alcohol or substance use disorders;
  • Current, or history of bipolar disorder; current, or history of psychosis;
  • Serious suicidal risk, as determined by clinical interview.

Outcomes

Primary Outcomes

Personal Report of Public Speaking Anxiety Scale Post-intervention

Time Frame: Immediately following the end of the 1-week intervention

Questionnaire that assesses fear of public speaking Score range (total summed score): 34-170; Higher score reflects greater public speaking anxiety

Personal Report of Public Speaking Anxiety Scale at 1-week

Time Frame: 1-week follow-up

Questionnaire that assesses fear of public speaking Score range: 34-170 (total summed score); Higher score reflects greater public speaking anxiety

Secondary Outcomes

  • Speech Anxiety Thoughts Inventory Post-intervention(Immediately following the end of the 1-week intervention)
  • Speech Anxiety Thoughts Inventory at 1-week(1-week follow-up)
  • Leibowitz Social Anxiety Scale Post-intervention(Immediately following the end of the 1-week intervention)
  • Leibowitz Social Anxiety Scale at 1-week(1-week follow-up)

Study Sites (1)

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