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Completed

NCT Number: NCT06037668

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

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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Key information

Conditions

Social Anxiety Disorder (SAD) Anxiety Disorders Mental Disorders Phobia, Social Phobic Disorders

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CNS Healthcare, Orlando, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BVR-100

Device

Experimental self-guided VR intervention for the treatment of SAD

BES-100

Device

Active at-home VR intervention comparator

Primary outcomes

  1. Measurement of Intervention Credibility Assessed With the Credibility Score, at Baseline

    Time frame: Baseline

    The Credibility/Expectation Questionnaire (CEQ) asks about the improvements that subjects believe will be achieved as a result of treatment, and how believable, convincing,and logical the treatment seems.It contains six items rated on a 1-9 scale. The first three items load onto the credibility factor. Higher scores suggest better experience, lower scores suggest poor experience.Credibility score is calculated by taking the sum of score of the first 3 items of the CEQ scale ranging from 3 to 27.

  2. Measurement of Intervention Credibility Assessed With the Credibility Score, at Week 6

    Time frame: 6 weeks

    The Credibility/Expectation Questionnaire (CEQ) asks about the improvements that subjects believe will be achieved as a result of treatment, and how believable, convincing,and logical the treatment seems.It contains six items rated on a 1-9 scale. The first three items load onto the credibility factor. Higher scores suggest better experience, lower scores suggest poor experience.Credibility score is calculated by taking the sum of score of the first 3 items of the CEQ scale ranging from 3 to 27.

  3. Measurement of Intervention Credibility Assessed With the Credibility Score, at Week 8

    Time frame: 8 weeks

    The Credibility/Expectation Questionnaire (CEQ) asks about the improvements that subjects believe will be achieved as a result of treatment, and how believable, convincing,and logical the treatment seems.It contains six items rated on a 1-9 scale. The first three items load onto the credibility factor. Higher scores suggest better experience, lower scores suggest poor experience.Credibility score is calculated by taking the sum of score of the first 3 items of the CEQ scale ranging from 3 to 27.

  4. Measurement of Intervention Credibility Assessed With Expectancy Score, at Baseline

    Time frame: Baseline

    The Credibility/Expectation Questionnaire (CEQ) asks about the improvements that subjects believe will be achieved as a result of treatment, and how believable, convincing,and logical the treatment seems.It contains six items rated on a 1-9 scale. The final three items load onto the expectancy factor. Higher scores suggest better experience, lower scores suggest poor experience.Expectancy score is calculated by taking the sum of score of the last 3 items of the CEQ scale ranging from 3 to 27.

  5. Measurement of Intervention Credibility Assessed With the Expectancy Score, at Week 6

    Time frame: 6 weeks

    The Credibility/Expectation Questionnaire (CEQ) asks about the improvements that subjects believe will be achieved as a result of treatment, and how believable, convincing,and logical the treatment seems.It contains six items rated on a 1-9 scale. The final three items load onto the expectancy factor. Higher scores suggest better experience, lower scores suggest poor experience.Expectancy score is calculated by taking the sum of score of the last 3 items of the CEQ scale ranging from 3 to 27.

  6. Measurement of Intervention Credibility Assessed With the ExpectancyScore, at Week 8

    Time frame: 8 weeks

    The Credibility/Expectation Questionnaire (CEQ) asks about the improvements that subjects believe will be achieved as a result of treatment, and how believable, convincing,and logical the treatment seems.It contains six items rated on a 1-9 scale. The final three items load onto the expectancy factor. Higher scores suggest better experience, lower scores suggest poor experience.Expectancy score is calculated by taking the sum of score of the last 3 items of the CEQ scale ranging from 3 to 27.

Secondary outcomes

  1. Subject Retention Rate at Week 6

    Time frame: 6 weeks

    Subject retention in each group were assessed by percentage of subjects who remain on the study at Week 6

  2. Subject Retention Rate at Week 8

    Time frame: 8 weeks

    Subject retention in each group were assessed by percentage of subjects who remain on the study at Week 8

  3. Summary of Time-on-Task

    Time frame: 8 weeks

    Time-on-task, averaged over all VR sessions from baseline to Week 8/EOS. Time on task will be automatically recorded by the VR system after each session.

Sponsors and collaborators

Lead sponsor

Sumitomo Pharma America, Inc.

Industry

Collaborators

  • BehaVR LLC

Registry information

Official study title

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.

Acronym: BVR-100-102

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Sep 14, 2023
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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