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NCT Number: NCT06845488

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.

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Key information

Conditions

Autism Spectrum Disorder Anxiety Disorders Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders Phobia, Social Phobic Disorders Social Anxiety Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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))

    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.

  2. 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)

    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

  3. 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)

    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

  4. 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)

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Craig Motsenbocker, PhD

CONTACT

[email protected])

(713) 486-2700

Katherine Loveland, PhD

CONTACT

[email protected]

713-486-2587

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 25, 2025
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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