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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-08

Study Completion Date

2024-01-10

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).

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Detailed Description

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Conditions

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Social Anxiety Disorder (SAD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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BVR-100

Experimental at-home VR intervention for the treatment of SAD

Group Type EXPERIMENTAL

BVR-100

Intervention Type DEVICE

Experimental self-guided VR intervention for the treatment of SAD

BES-100

Active at-home VR intervention comparator

Group Type ACTIVE_COMPARATOR

BES-100

Intervention Type DEVICE

Active at-home VR intervention comparator

Interventions

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BVR-100

Experimental self-guided VR intervention for the treatment of SAD

Intervention Type DEVICE

BES-100

Active at-home VR intervention comparator

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No