Recruiting

CBT VR & CBT Imaginal

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06845488

Conditions

Autism Spectrum Disorder

Social Anxiety Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CBT

VR

Study Details

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 ID

NCT06845488

Start date

Nov 7, 2024

Status verified date

Jul, 2025

Completion date

Mar 31, 2026

Anticipated

Primary completion date

Mar 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

active comparator: CBT alone

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.

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.

Primary outcome measure

  • Change in anxiety as assessed by the Liebowitz Social Anxiety Scale (LSAS) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, post treatment (about 4 weeks after end of treatment) ]

Central Contacts and Locations

Central contacts

Katherine Loveland, PhD

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

Craig Motsenbocker, PhD

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

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Katherine Loveland, PhD

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

Craig Motsenbocker, PhD

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

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Jul 15, 2025

Last verified

Jul, 2025

Keywords

  • Virtual reality
  • psychotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2025-07-15.