Efficacy of an Attention Guidance VR Intervention for Social Anxiety Disorder

Social Anxiety Disorder Clinical Trial

Official title:

Efficacy of an Attention Guidance VR Intervention for Social Anxiety Disorder

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03683823
• Other study ID #: 2018-04-0011
• Status: Terminated
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: March 25, 2020

Study information

• Verified date: December 2021
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: March 25, 2020
• Est. primary completion date: March 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age 18-65;

2. Fluent in English;

3. Personal Report of Public Speaking Anxiety score > 98;

4. Leibowitz Social Anxiety Scale > 30;

5. Peak fear = 50 on the behavioral approach task during the baseline assessment;

6. Meets DSM-5 Criteria for Social Anxiety Disorder.

Exclusion Criteria:

1. Currently receiving CBT for Social Anxiety Disorder;

2. Significant visual impairment precluding the use of virtual reality equipment;

3. Unstable dose of psychotropic medications within 3 weeks prior to baseline assessment;

4. Current alcohol or substance use disorders;

5. Current, or history of bipolar disorder; current, or history of psychosis;

6. Serious suicidal risk, as determined by clinical interview.

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobia, Social
• Social Anxiety Disorder

Intervention

Behavioral:
• Attention guidance
Explicitly guiding attention towards faces during public speaking exposures
• Control intervention
Public speaking exposures

Locations

Country	Name	City	State
United States	The University of Texas at Austin	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Personal Report of Public Speaking Anxiety Scale Post-intervention	Questionnaire that assesses fear of public speaking Score range (total summed score): 34-170; Higher score reflects greater public speaking anxiety	Immediately following the end of the 1-week intervention
Primary	Personal Report of Public Speaking Anxiety Scale at 1-week	Questionnaire that assesses fear of public speaking Score range: 34-170 (total summed score); Higher score reflects greater public speaking anxiety	1-week follow-up
Secondary	Leibowitz Social Anxiety Scale Post-intervention	Questionnaire that assesses generalized social anxiety Score range (total summed score): 0-144; Higher scores reflect greater social anxiety	Immediately following the end of the 1-week intervention
Secondary	Leibowitz Social Anxiety Scale at 1-week	Questionnaire that assesses generalized social anxiety Score range (total summed score): 0-144; Higher scores reflect greater social anxiety	1-week follow-up
Secondary	Speech Anxiety Thoughts Inventory Post-intervention	Assesses cognitions associated with social anxiety Score range (total summed score): 23-115; Higher scores reflect greater severity	Immediately following the end of the 1-week intervention
Secondary	Speech Anxiety Thoughts Inventory at 1-week	Assesses cognitions associated with social anxiety Score range (total summed score): 23-115; Higher scores reflect greater severity	1-week follow-up