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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Palo Alto University Mountain View Campus
        • Contact:
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: no interaction Virtual Reality Exposure Therapy
Behavioral: ExpandXR
An Mixed Reality Exposure Therapy platform for the Apple Vision Pro
Experimental: structured interaction Virtual Reality Exposure Therapy
Behavioral: ExpandXR
An Mixed Reality Exposure Therapy platform for the Apple Vision Pro
Experimental: personalized interaction Virtual Reality Exposure Therapy
Behavioral: ExpandXR
An Mixed Reality Exposure Therapy platform for the Apple Vision Pro

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Palo Alto University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 24, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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