Efficacy of an Attention Guidance VR Intervention for Social Anxiety Disorder

NCT ID: NCT03683823

Last Updated: 2022-03-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2020-03-25

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.

Conditions

Social Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Attention guidance

In addition to the components included in the control intervention the experimental attention guidance condition consists of three unique components: (1) the rationale will include information about the importance of visually attending to the faces of the audience; (2) in addition to being given a speech topic, participants will be given target audience members to focus their gaze on during the speech. They will be told that they should look at and focus on the target audience member for the whole speech; (3) between speeches, the researcher will tell participants the percentage of time they were focused on the target face.

Group Type: EXPERIMENTAL

Attention guidance

Intervention Type: BEHAVIORAL

Explicitly guiding attention towards faces during public speaking exposures

Control intervention

Participants will complete two intervention sessions within one week. The intervention will use a manualized protocol.

1. On the first session, participants will receive a brief standardized psychoeducation module, presented via a 15-minute video recording. This video will explain the intervention, its rationale, and the procedure.

2. Participants will then have 5 minutes to plan and outline a speech based on a topic given to them. All participants will receive the same topic. Participants will not be allowed to use the outline during the public speaking exposure trials.

3. Participants will then give six speeches that are each 3 minutes long on the same topic. Participants will give all the speeches in the immersive 360º-video environment.

4. Between speeches participants will have a 1-minute break.

Group Type: ACTIVE_COMPARATOR

Control intervention

Intervention Type: BEHAVIORAL

Public speaking exposures

Interventions

Attention guidance

Explicitly guiding attention towards faces during public speaking exposures

Intervention Type: BEHAVIORAL

Control intervention

Public speaking exposures

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Michael J. Telch

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The University of Texas at Austin

Austin, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2018-04-0011

Identifier Type: -

Identifier Source: org_study_id