search
Back to results

Efficacy of an Attention Guidance VR Intervention for Social Anxiety Disorder

Primary Purpose

Social Anxiety Disorder

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Attention guidance
Control intervention
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The University of Texas at Austin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Attention guidance

Control intervention

Arm Description

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.

Participants will complete two intervention sessions within one week. The intervention will use a manualized protocol. 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. 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. 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. Between speeches participants will have a 1-minute break.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
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
Speech Anxiety Thoughts Inventory Post-intervention
Assesses cognitions associated with social anxiety Score range (total summed score): 23-115; Higher scores reflect greater severity
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

Full Information

First Posted
July 20, 2018
Last Updated
December 28, 2021
Sponsor
University of Texas at Austin
search

1. Study Identification

Unique Protocol Identification Number
NCT03683823
Brief Title
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

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
Due to COVID-19 the study was intitially paused and eventually ended.
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
March 11, 2020 (Actual)
Study Completion Date
March 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Attention guidance
Arm Type
Experimental
Arm Description
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.
Arm Title
Control intervention
Arm Type
Active Comparator
Arm Description
Participants will complete two intervention sessions within one week. The intervention will use a manualized protocol. 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. 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. 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. Between speeches participants will have a 1-minute break.
Intervention Type
Behavioral
Intervention Name(s)
Attention guidance
Intervention Description
Explicitly guiding attention towards faces during public speaking exposures
Intervention Type
Behavioral
Intervention Name(s)
Control intervention
Intervention Description
Public speaking exposures
Primary Outcome Measure Information:
Title
Personal Report of Public Speaking Anxiety Scale Post-intervention
Description
Questionnaire that assesses fear of public speaking Score range (total summed score): 34-170; Higher score reflects greater public speaking anxiety
Time Frame
Immediately following the end of the 1-week intervention
Title
Personal Report of Public Speaking Anxiety Scale at 1-week
Description
Questionnaire that assesses fear of public speaking Score range: 34-170 (total summed score); Higher score reflects greater public speaking anxiety
Time Frame
1-week follow-up
Secondary Outcome Measure Information:
Title
Leibowitz Social Anxiety Scale Post-intervention
Description
Questionnaire that assesses generalized social anxiety Score range (total summed score): 0-144; Higher scores reflect greater social anxiety
Time Frame
Immediately following the end of the 1-week intervention
Title
Leibowitz Social Anxiety Scale at 1-week
Description
Questionnaire that assesses generalized social anxiety Score range (total summed score): 0-144; Higher scores reflect greater social anxiety
Time Frame
1-week follow-up
Title
Speech Anxiety Thoughts Inventory Post-intervention
Description
Assesses cognitions associated with social anxiety Score range (total summed score): 23-115; Higher scores reflect greater severity
Time Frame
Immediately following the end of the 1-week intervention
Title
Speech Anxiety Thoughts Inventory at 1-week
Description
Assesses cognitions associated with social anxiety Score range (total summed score): 23-115; Higher scores reflect greater severity
Time Frame
1-week follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-65; 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.
Facility Information:
Facility Name
The University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Efficacy of an Attention Guidance VR Intervention for Social Anxiety Disorder

We'll reach out to this number within 24 hrs