Application of Virtual Reality Technology to Treatment of Social Anxiety

NCT06845488 | Recruiting FDA Device

• 1 other identifier: HSC-MS-16-0518
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism Spectrum Disorder; Social Anxiety Disorder

Keywords

Virtual reality; psychotherapy

Outcome Measures

Primary Outcomes (4)

• 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)

Study Arms (2)

Virtual Reality (VR) assisted Cognitive Behavior Therapy (CBT)

EXPERIMENTAL

Behavioral: CBT; Device: VR

CBT alone

ACTIVE COMPARATOR

Behavioral: CBT

Interventions

CBT BEHAVIORAL

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.

CBT alone; Virtual Reality (VR) assisted Cognitive Behavior Therapy (CBT)

VR DEVICE

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.

Virtual Reality (VR) assisted Cognitive Behavior Therapy (CBT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Phobia, Social

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Phobic Disorders; Anxiety Disorders

Study Officials

• Katherine Loveland, PhD

  The University of Texas Health Science Center at Houstom

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine Loveland, PhD

CONTACT

713-486-2587; Katherine.A.Loveland@uth.tmc.edu

Craig Motsenbocker, PhD

CONTACT

(713) 486-2700; craig.m.motsenbocker@uth.tmc.edu)

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 25, 2025
• Study Start: November 7, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 31, 2026
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)