- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03683823
Efficacy of an Attention Guidance VR Intervention for Social Anxiety Disorder
December 28, 2021 updated by: Michael J. Telch, University of Texas at Austin
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78712
- The University of Texas at Austin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Explicitly guiding attention towards faces during public speaking exposures
|
Active Comparator: Control intervention
Participants will complete two intervention sessions within one week. The intervention will use a manualized protocol.
|
Public speaking exposures
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Immediately following the end of the 1-week intervention
|
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
|
1-week follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Leibowitz Social Anxiety Scale Post-intervention
Time Frame: Immediately following the end of the 1-week 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
|
Leibowitz Social Anxiety Scale at 1-week
Time Frame: 1-week follow-up
|
Questionnaire that assesses generalized social anxiety Score range (total summed score): 0-144; Higher scores reflect greater social anxiety
|
1-week follow-up
|
Speech Anxiety Thoughts Inventory Post-intervention
Time Frame: Immediately following the end of the 1-week 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
|
Speech Anxiety Thoughts Inventory at 1-week
Time Frame: 1-week follow-up
|
Assesses cognitions associated with social anxiety Score range (total summed score): 23-115; Higher scores reflect greater severity
|
1-week follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2019
Primary Completion (Actual)
March 11, 2020
Study Completion (Actual)
March 25, 2020
Study Registration Dates
First Submitted
July 20, 2018
First Submitted That Met QC Criteria
September 22, 2018
First Posted (Actual)
September 25, 2018
Study Record Updates
Last Update Posted (Actual)
March 11, 2022
Last Update Submitted That Met QC Criteria
December 28, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-04-0011
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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