A Randomized, Controlled Study of Two At-Home Self-Guided Virtual Reality Interventions for Adults With Social Anxiety Disorder. (BVR-100-102)
Social Anxiety Disorder (SAD)
About this trial
This is an interventional treatment trial for Social Anxiety Disorder (SAD) focused on measuring Social Anxiety Disorder, Social Phobia
Eligibility Criteria
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.
Sites / Locations
- Curavit Clinical ResearchRecruiting
- Midwest Research GroupRecruiting
- Cedar Clinical ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
BVR-100
BES-100
Experimental at-home VR intervention for the treatment of SAD
Active at-home VR intervention comparator