Application of Virtual Reality Technology to Treatment of Social Anxiety
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CBT, VR.
- Who it may be relevant to
- Registry conditions: Autism Spectrum Disorder, Social Anxiety Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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
Primary outcome measures
- 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)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- The University of Texas Health Science Center at Houston — Houston
Identifiers
NCT: NCT06845488 · HSC-MS-16-0518