Clinical trial NCT06037668: A Randomized, Controlled Study of Two At-Home Self-Guided Virtual Reality Interventions for Adults With Social Anxiety Disorder.
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety Disorder (SAD)
Keywords: Social Anxiety Disorder, Social Phobia
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
Collaborators: name: BehaVR LLC
First posted: 2023-09-14
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Measurement of Intervention Credibility Assessed With the Credibility Score, at Baseline
timeFrame: Baseline
measure: Measurement of Intervention Credibility Assessed With the Credibility Score, at Week 6
timeFrame: 6 weeks
measure: Measurement of Intervention Credibility Assessed With the Credibility Score, at Week 8
timeFrame: 8 weeks
measure: Measurement of Intervention Credibility Assessed With Expectancy Score, at Baseline
timeFrame: Baseline
measure: Measurement of Intervention Credibility Assessed With the Expectancy Score, at Week 6
timeFrame: 6 weeks
measure: Measurement of Intervention Credibility Assessed With the ExpectancyScore, at Week 8
timeFrame: 8 weeks
Secondary outcomes:
measure: Subject Retention Rate at Week 6
timeFrame: 6 weeks
measure: Subject Retention Rate at Week 8
timeFrame: 8 weeks
measure: Summary of Time-on-Task
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Orlando
country: United States
facility: CNS Healthcare
state: Florida
city: Boston
country: United States
facility: Curavit Clinical Research
state: Massachusetts
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Saint Charles
country: United States
facility: Midwest Research Group
state: Missouri
city: Lincoln
country: United States
facility: Alivation Health, LLC
state: Nebraska
city: Draper
country: United States
facility: Cedar Clinical Research
state: Utah
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: Robert Hayes, PhD
role: STUDY_DIRECTOR
References: