Application of Virtual Reality Technology to Treatment of Social Anxiety

NCT ID: NCT06845488

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-07
• Study Completion Date: 2026-03-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

CBT

Intervention Type: 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.

VR

Intervention Type: 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.

CBT alone

Group Type: ACTIVE_COMPARATOR

CBT

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Katherine A. Loveland

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katherine Loveland, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at Houstom

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Katherine Loveland, PhD

Role: CONTACT

Katherine.A.Loveland@uth.tmc.edu

713-486-2587

Craig Motsenbocker, PhD

Role: CONTACT

craig.m.motsenbocker@uth.tmc.edu)

(713) 486-2700

Facility Contacts

Katherine Loveland, PhD

Role: primary

Katherine.A.Loveland@uth.tmc.edu

(713) 486-2587

Craig Motsenbocker, PhD

Role: backup

craig.m.motsenbocker@uth.tmc.edu)

(713) 486-2700

Other Identifiers

HSC-MS-16-0518

Identifier Type: -

Identifier Source: org_study_id