- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07437872
Testing Mechanisms of Virtual Reality Exposure Therapy for Social Anxiety
March 2, 2026 updated by: Mikael Rubin, Palo Alto University
The purpose of this study is to test mechanisms and processes of virtual reality and augmented reality exposure therapy for social anxiety.
There is substantial evidence that virtual reality exposure therapy is an effective treatment for social anxiety.
However, it can be difficult to access treatment that needs to be conducted in person.
Tests of self-guided (without therapist assistance) virtual reality exposure therapy have had mixed efficacy and tests of augmentation offer an important method to optimize brief interventions.
The study objectives are to test a wide range of possible mechanisms and approaches (ranging from single sessions in person to remotely conducted virtual reality exposure therapy) in order to advance the field.
The broadness of the proposed research is to provide multiple avenues for inquiry per discussion with IRB chair Dr. Kuo.
Depending on the specific line of inquiry some variations will be documented (e.g., multiple consent forms for answering different sub questions of the primary questions listed below).
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
45
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
-
-
California
-
Palo Alto, California, United States, 94304
- Recruiting
- Palo Alto University Mountain View Campus
-
Contact:
- Mikael Rubin, PhD
- Phone Number: 650-433-3805
- Email: mrubin@paloaltou.edu
-
Principal Investigator:
- Mikael Rubin, PhD
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Individuals at least 18 years of age
- Located in the U.S. with sufficient proximity to Mountain View Campus to attend in person visit(s).
- Able to give consent
- Social Anxiety Disorder based on Structured Clinical Interview AND/OR self-report score cutoff (LSAS > 47).
Exclusion Criteria:
- Current Alcohol or Substance Use Disorder (based on self-report)
- Current or prior psychotic related or bipolar disorder (based on self-report)
- Unstable psychotropic medication (starting/stopping medication in past 6 weeks based on selfreport)
- Current cognitive behavioral therapy for social anxiety
- Impaired vision such that cannot see in VR headset without glasses (contacts okay)
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 |
|---|---|
|
Active Comparator: no interaction Virtual Reality Exposure Therapy
|
An Mixed Reality Exposure Therapy platform for the Apple Vision Pro
|
|
Experimental: structured interaction Virtual Reality Exposure Therapy
|
An Mixed Reality Exposure Therapy platform for the Apple Vision Pro
|
|
Experimental: personalized interaction Virtual Reality Exposure Therapy
|
An Mixed Reality Exposure Therapy platform for the Apple Vision Pro
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Liebowitz Social Anxiety Scale Self Report Version
Time Frame: 21 days
|
The Liebowitz Social Anxiety Scale Self Report Version is a 48-item self-report measure of fear and avoidance concerning social interactions and performance situations (e.g., telephoning in public, talking to people in authority).
The range of scores is 0-144; higher scores are worse.
|
21 days
|
|
Liebowitz Social Anxiety Scale Self Report Version
Time Frame: 51 days
|
The Liebowitz Social Anxiety Scale Self Report Version is a 48-item self-report measure of fear and avoidance concerning social interactions and performance situations (e.g., telephoning in public, talking to people in authority).
The range of scores is 0-144; higher scores are worse.
|
51 days
|
|
Liebowitz Social Anxiety Scale Self Report Version
Time Frame: 111 days
|
The Liebowitz Social Anxiety Scale Self Report Version is a 48-item self-report measure of fear and avoidance concerning social interactions and performance situations (e.g., telephoning in public, talking to people in authority).
The range of scores is 0-144; higher scores are worse.
|
111 days
|
|
Personal Report of Communication Apprehension (PRCA)
Time Frame: 21 days
|
The Personal Report of Communication Apprehension is a 24-item that assesses anxiety related to speaking in a variety of situation.
The range of scores is 24-120; higher scores are worse.
|
21 days
|
|
Personal Report of Communication Apprehension (PRCA)
Time Frame: 51 days
|
The Personal Report of Communication Apprehension is a 24-item that assesses anxiety related to speaking in a variety of situation.
The range of scores is 24-120; higher scores are worse.
|
51 days
|
|
Personal Report of Communication Apprehension (PRCA)
Time Frame: 111 days
|
The Personal Report of Communication Apprehension is a 24-item that assesses anxiety related to speaking in a variety of situation.
The range of scores is 24-120; higher scores are worse.
|
111 days
|
|
Liebowitz Social Anxiety Scale Self Report Version
Time Frame: Baseline
|
The Liebowitz Social Anxiety Scale Self Report Version is a 48-item self-report measure of fear and avoidance concerning social interactions and performance situations (e.g., telephoning in public, talking to people in authority).
The range of scores is 0-144; higher scores are worse.
|
Baseline
|
|
Personal Report of Communication Apprehension (PRCA)
Time Frame: Baseline
|
The Personal Report of Communication Apprehension is a 24-item that assesses anxiety related to speaking in a variety of situation.
The range of scores is 24-120; higher scores are worse.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Speech Anxiety Thoughts Inventory
Time Frame: 21 days
|
The Speech Anxiety Thoughts Inventory is a 23-item self-report measure of assessing the intensity of belief in maladaptive, negative thoughts categorized into two main factors: prediction of poor performance and fear of negative evaluation by the audience.
The range of scores is 23-115 with higher scores reflecting greater endorsement of maladaptive thoughts.
|
21 days
|
|
Speech Anxiety Thoughts Inventory
Time Frame: 51 days
|
The Speech Anxiety Thoughts Inventory is a 23-item self-report measure of assessing the intensity of belief in maladaptive, negative thoughts categorized into two main factors: prediction of poor performance and fear of negative evaluation by the audience.
The range of scores is 23-115 with higher scores reflecting greater endorsement of maladaptive thoughts.
|
51 days
|
|
Speech Anxiety Thoughts Inventory
Time Frame: 111 days
|
The Speech Anxiety Thoughts Inventory is a 23-item self-report measure of assessing the intensity of belief in maladaptive, negative thoughts categorized into two main factors: prediction of poor performance and fear of negative evaluation by the audience.
The range of scores is 23-115 with higher scores reflecting greater endorsement of maladaptive thoughts.
|
111 days
|
|
Speech Anxiety Thoughts Inventory
Time Frame: Baseline
|
The Speech Anxiety Thoughts Inventory is a 23-item self-report measure of assessing the intensity of belief in maladaptive, negative thoughts categorized into two main factors: prediction of poor performance and fear of negative evaluation by the audience.
The range of scores is 23-115 with higher scores reflecting greater endorsement of maladaptive thoughts.
|
Baseline
|
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 (Estimated)
February 24, 2026
Primary Completion (Estimated)
February 1, 2028
Study Completion (Estimated)
March 1, 2028
Study Registration Dates
First Submitted
February 20, 2026
First Submitted That Met QC Criteria
February 20, 2026
First Posted (Actual)
February 27, 2026
Study Record Updates
Last Update Posted (Actual)
March 4, 2026
Last Update Submitted That Met QC Criteria
March 2, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 2025-077-PAU
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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