A Randomized, Controlled Study of Two At-Home Self-Guided Virtual Reality Interventions for Adults With Social Anxiety Disorder.

Study Overview
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Brief Summary
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This study is to compare two Virtual Reality (VR)-based interventions, BVR-100 and BES-100, for the treatment of Social Anxiety Disorder (SAD).

Official Title
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BVR-100 and BES-100 Validation Trial: A Randomized, Double-Blind, Parallel-Group, Controlled Study of Two At-Home Self-Guided Virtual Reality Interventions for Adults With Social Anxiety Disorder.

Conditions
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Social Anxiety Disorder (SAD)

Intervention / Treatment
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* Device: BVR-100
* Device: BES-100


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is male or female, aged 18 or above. Subject has English fluency and literacy. Subject meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-5) criteria for Social Anxiety Disorder Subject has a total Liebowitz Social Anxiety Scale (LSAS) score at Screening of ≥ 70. Exclusion Criteria: Subject has significant visual, auditory or balance impairment Subject has history of photosensitive epilepsy or seizure disorder Subject has history of motion sickness or medical condition predisposing to nausea or dizziness. Subject has injuries, inflammation or infection affecting the eyes, ears or face that would make the use of the hardware uncomfortable. Subject has, current or lifetime history of meeting DSM-5 criteria for schizophrenia spectrum or other psychotic disorder, bipolar or related disorder, major neurocognitive disorder, neurodevelopmental disorder of greater than mild severity or of a severity that impacts the subject's ability to consent, follow study directions, or otherwise safely participate in the study; posttraumatic stress disorder, major depressive disorder (MDD) with psychotic features, borderline or antisocial personality disorder Subject has met DSM-5-based criteria for Alcohol or Substance Use Disorder (other than nicotine or caffeine) within one (1) year prior to Screening. Subject has received ketamine, esketamine, arketamine, or psychedelic therapies (eg, psilocybin, methylenedioxymethamphetamine [MDMA]) for MDD or any psychiatric condition within one (1) year prior to Screening. In the opinion of the Investigator: (a) study participation may pose a significant or undue risk to the subject; (b) the subject is unlikely to successfully complete all of the requirements of the study per protocol; or (c) study participation may adversely impact the integrity of the data or the validity of the study results.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BVR-100<br>Experimental at-home VR intervention for the treatment of SAD | Device: BVR-100<br>* Experimental self-guided VR intervention for the treatment of SAD<br>|
| Active Comparator: BES-100<br>Active at-home VR intervention comparator | Device: BES-100<br>* Active at-home VR intervention comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The measurement of intervention credibility and expectancy of benefit, assessed with the Credibility / Expectancy Questionnaire (CEQ) scores |  | baseline, week 6, week 8 (EOS) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subject retention of BVR-100 and BES-100 |  | week 6, week 8 (EOS) | 
| time-on-task of BVR-100 and BES-100 |  | week 6, week 8 (EOS) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Social Anxiety Disorder, Social Phobia