Clinical trial NCT03683823: Efficacy of an Attention Guidance VR Intervention for Social Anxiety Disorder
Official title: Efficacy of an Attention Guidance VR Intervention for Social Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Social Anxiety Disorder
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Personal Report of Public Speaking Anxiety Scale Post-intervention
timeFrame: Immediately following the end of the 1-week intervention
measure: Personal Report of Public Speaking Anxiety Scale at 1-week
timeFrame: 1-week follow-up
Secondary outcomes:
measure: Leibowitz Social Anxiety Scale Post-intervention
timeFrame: Immediately following the end of the 1-week intervention
measure: Leibowitz Social Anxiety Scale at 1-week
timeFrame: 1-week follow-up
measure: Speech Anxiety Thoughts Inventory Post-intervention
timeFrame: Immediately following the end of the 1-week intervention
measure: Speech Anxiety Thoughts Inventory at 1-week
timeFrame: 1-week follow-up
Other outcomes:
Locations:
city: Austin
country: United States
facility: The University of Texas at Austin
state: Texas
Study officials:
References: