Application of Virtual Reality Technology to Treatment of Social Anxiety

The purpose of this study is to compare CBT VR exposure + VR social skills treatment to CBT Imaginal exposure + mindfulness, in reducing the severity of social anxiety in adults with autism and social anxiety (SA), to identify characteristics associated with benefitting from the CBT-VR treatment and to assess acceptability and feasibility of the VR intervention for patients receiving it and use findings to improve methods and to prepare for a community based pragmatic trial.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder; Social Anxiety Disorder
• Intervention / Treatment: Behavioral: CBT; Device: VR

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katherine Loveland, PhD; Phone Number: 713-486-2587; Email: Katherine.A.Loveland@uth.tmc.edu
• Study Contact Backup: Name: Craig Motsenbocker, PhD; Phone Number: (713) 486-2700; Email: craig.m.motsenbocker@uth.tmc.edu)

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Craig Motsenbocker, PhD; Phone Number: (713) 486-2700; Email: craig.m.motsenbocker@uth.tmc.edu)
      • Contact: Katherine Loveland, PhD; Phone Number: (713) 486-2587; Email: Katherine.A.Loveland@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Autism Spectrum Disorder (ASD) (diagnosed by a qualified professional)
• verbal and literate in English or Spanish
• average or greater intellectual ability, based on history and interview
• able to operate a computer (Windows or Mac).

Exclusion Criteria:

• current or historical severe mental illness such as schizophrenia, bipolar disorder, or severe depression
• intellectual disability or a learning disability that would interfere with participating (e.g., unable to read)
• unable use the technology or do not have access to the technology
• unable to read

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CBT alone	Behavioral: CBT; Participants will receive will receive 12 weeks of weekly CBT for Social Anxiety, including an intervention to improve conversational skills. The CBT for Social Anxiety will include "imaginal exposure", which is a way of using the imagination to work with situations that produce anxiety. Participants will also receive a mindfulness intervention.
Experimental: Virtual Reality (VR) assisted Cognitive Behavior Therapy (CBT)	Behavioral: CBT; Participants will receive will receive 12 weeks of weekly CBT for Social Anxiety, including an intervention to improve conversational skills. The CBT for Social Anxiety will include "imaginal exposure", which is a way of using the imagination to work with situations that produce anxiety. Participants will also receive a mindfulness intervention.; Device: VR; The VR software, the Virtual Communicator (VC) consists of a highly realistic avatar that interacts with the client in one of several situations. The therapist controls its gestures, facial expressions, body movements, and speech and builds and saves modular combinations of gestures and facial expressions that can be assembled in any order to create a conversational interaction. The software has two adult avatars of ambiguous race/ethnicity, male and female. The VC is delivered without a headset interactively over the internet, on a secure, password-protected connection that increase access by not requiring headsets and not requiring the client to come to the office. The VC can be done in English, or in Spanish where appropriate. Treatment will be done for 12 sessions. The VR software is used to provide CBT exposures to reduce anxiety and also to practice social interactions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in anxiety as assessed by the Liebowitz Social Anxiety Scale (LSAS)	This is a 24 item questionnaire, each is assessed in 2 ways measuring both fear/anxiety and avoidance related to specific social situations, giving a total of 48 ratings across the scale. The questions are scored from 0 (none) to 3 (severe) for a score range of 0-144 higher score indicating worse outcome.	Baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, post treatment (about 4 weeks after end of treatment))
Change in anxiety as assessed by the Social Interaction Anxiety Scale (SIAS)	This is a 20 item questionnaire and each is scored on a likert scale from 0(not at all characteristic of me)-4(Extremely characteristic of me), maximum score of 80,higher score indicating worse outcome	Baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, post treatment (about 4 weeks after end of treatment)
Change in anxiety as assessed by the Social Phobia Scale (SPS)	This is a 20 item questionnaire and each is scored on a likert scale from 0-4, maximum score of 80 , higher score indicating worse outcome	Baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, post treatment (about 4 weeks after end of treatment)
Change in anxiety as assessed by the The Severity Measure for Social Anxiety Disorder (SMSAD) scale	This is a 10 item questionnaire and each is scored from 0(never) to 4(all of the time) for a maximum score of 40, higher score indicating worse outcome	Baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, post treatment (about 4 weeks after end of treatment)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Katherine Loveland, PhD, The University of Texas Health Science Center at Houstom

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: February 19, 2025
• First Submitted That Met QC Criteria: February 19, 2025
• First Posted (Actual): February 25, 2025

Study Record Updates

• Last Update Posted (Actual): July 15, 2025
• Last Update Submitted That Met QC Criteria: July 11, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: psychotherapy; Virtual reality
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Phobic Disorders; Autism Spectrum Disorder; Phobia, Social; Anxiety Disorders
• Other Study ID Numbers: HSC-MS-16-0518

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No