Application of Virtual Reality Technology to Treatment of Social Anxiety

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 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.

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.

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

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

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

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.