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

NCT06037668 | Completed Results FDA Device

• 1 other identifier: BVR-100-102
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Social Anxiety Disorder (SAD)

Keywords

Social Anxiety Disorder, Social Phobia

Outcome Measures

Primary Outcomes (6)

• Measurement of Intervention Credibility Assessed With the Credibility Score, at 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.

  Baseline

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

  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.

  6 weeks

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

  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.

  8 weeks

• Measurement of Intervention Credibility Assessed With Expectancy Score, at 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.

  Baseline

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

  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 weeks

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

  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.

  8 weeks

Secondary Outcomes (3)

• Subject Retention Rate at Week 6

  6 weeks

• Subject Retention Rate at Week 8

  8 weeks

• Summary of Time-on-Task

  8 weeks

Study Arms (2)

BVR-100

EXPERIMENTAL

Experimental at-home VR intervention for the treatment of SAD

Device: BVR-100

BES-100

ACTIVE COMPARATOR

Active at-home VR intervention comparator

Device: BES-100

Interventions

BVR-100 DEVICE

Experimental self-guided VR intervention for the treatment of SAD

BVR-100

BES-100 DEVICE

Active at-home VR intervention comparator

BES-100

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead
• BehaVR LLC: collaborator

Study Sites (6)

CNS Healthcare

Orlando, Florida, 32801, United States

Location

Curavit Clinical Research

Boston, Massachusetts, 02116, United States

Location

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

Location

Midwest Research Group

Saint Charles, Missouri, 63304, United States

Location

Alivation Health, LLC

Lincoln, Nebraska, 68526, United States

Location

Cedar Clinical Research

Draper, Utah, 84020, United States

Location

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Results Point of Contact

• Title: Director, Frontier Business Office
• Organization: Sumitomo Pharma America

gazeleh.vakili@us.sumitomo-pharma.com

1-866-503-6351

Study Officials

• Robert Hayes, PhD

  Sumitomo Pharma America, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 14, 2023
• Study Start: September 8, 2023
• Primary Completion: December 22, 2023
• Study Completion: January 10, 2024
• Last Updated: March 12, 2025
• Results First Posted: March 12, 2025

Record last verified: 2025-02

Locations

US (6)