Social Anxiety Disorder (SAD)
Conditions
Keywords
Social Anxiety Disorder, Social Phobia
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).
Interventions
DEVICEBVR-100
Experimental self-guided VR intervention for the treatment of SAD
DEVICEBES-100
Active at-home VR intervention comparator
Sponsors
BehaVR LLC
Sumitomo Pharma America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of Intervention Credibility Assessed With the ExpectancyScore, at Week 8 | 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. |
| Measurement of Intervention Credibility Assessed With the Credibility Score, at Week 8 | 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. |
| Measurement of Intervention Credibility Assessed With Expectancy Score, at Baseline | 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. |
| Measurement of Intervention Credibility Assessed With the Expectancy Score, at Week 6 | 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. |
| Measurement of Intervention Credibility Assessed With the Credibility Score, at Baseline | 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. |
| Measurement of Intervention Credibility Assessed With the Credibility Score, at Week 6 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Retention Rate at Week 8 | 8 weeks | Subject retention in each group were assessed by percentage of subjects who remain on the study at Week 8 |
| Summary of Time-on-Task | 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. |
| Subject Retention Rate at Week 6 | 6 weeks | Subject retention in each group were assessed by percentage of subjects who remain on the study at Week 6 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BVR-100 Experimental at-home VR intervention for the treatment of SAD | 25 |
| BES-100 Active at-home VR intervention comparator | 27 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Other Study Discontinuation Reason | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | BVR-100 | BES-100 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 2 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 25 Participants | 50 Participants |
| Baseline Credibility/Expectancy score | 35.1 units on a scale STANDARD_DEVIATION 8.13 | 30.2 units on a scale STANDARD_DEVIATION 6.58 | 32.9 units on a scale STANDARD_DEVIATION 7.77 |
| Baseline Credibility score | 18 units on a scale STANDARD_DEVIATION 4.31 | 15.4 units on a scale STANDARD_DEVIATION 4.57 | 16.9 units on a scale STANDARD_DEVIATION 4.54 |
| Baseline Expectancy score | 17.1 units on a scale STANDARD_DEVIATION 4.43 | 14.8 units on a scale STANDARD_DEVIATION 3.24 | 16.1 units on a scale STANDARD_DEVIATION 4.06 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 22 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 22 Participants | 42 Participants |
| Region of Enrollment United States | 25 Participants | 27 Participants | 52 Participants |
| Sex: Female, Male Female | 15 Participants | 25 Participants | 40 Participants |
| Sex: Female, Male Male | 10 Participants | 2 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 27 |
| other Total, other adverse events | 3 / 25 | 0 / 27 |
| serious Total, serious adverse events | 0 / 25 | 0 / 27 |
Outcome results
Primary
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.
Time frame: Baseline
Population: ITT Population who had measurement of Credibility / Expectancy Score completed at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BVR-100 | Measurement of Intervention Credibility Assessed With Expectancy Score, at Baseline | 17.1 units on a scale | Standard Deviation 4.43 |
| BES-100 | Measurement of Intervention Credibility Assessed With Expectancy Score, at Baseline | 14.8 units on a scale | Standard Deviation 3.24 |
p-value: 0.1178Independent t-test
Primary
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.
Time frame: Baseline
Population: ITT Population who had measurement of Credibility / Expectancy Score completed at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BVR-100 | Measurement of Intervention Credibility Assessed With the Credibility Score, at Baseline | 18 units on a scale | Standard Deviation 4.31 |
| BES-100 | Measurement of Intervention Credibility Assessed With the Credibility Score, at Baseline | 15.4 units on a scale | Standard Deviation 4.57 |
p-value: 0.1134Independent t-test
Primary
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.
Time frame: 6 weeks
Population: ITT Population who had measurement of Credibility / Expectancy Score completed at Week 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BVR-100 | Measurement of Intervention Credibility Assessed With the Credibility Score, at Week 6 | 18.9 units on a scale | Standard Deviation 5.37 |
| BES-100 | Measurement of Intervention Credibility Assessed With the Credibility Score, at Week 6 | 12.3 units on a scale | Standard Deviation 6.56 |
p-value: 0.0031Independent t-test
Primary
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.
Time frame: 8 weeks
Population: ITT Population who had measurement of Credibility / Expectancy Score completed at Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BVR-100 | Measurement of Intervention Credibility Assessed With the Credibility Score, at Week 8 | 18.7 units on a scale | Standard Deviation 6.31 |
| BES-100 | Measurement of Intervention Credibility Assessed With the Credibility Score, at Week 8 | 13.7 units on a scale | Standard Deviation 7.68 |
p-value: 0.0503Independent t-test
Primary
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.
Time frame: 6 weeks
Population: ITT Population who had measurement of Credibility / Expectancy Score completed at Week 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BVR-100 | Measurement of Intervention Credibility Assessed With the Expectancy Score, at Week 6 | 15.4 units on a scale | Standard Deviation 5.75 |
| BES-100 | Measurement of Intervention Credibility Assessed With the Expectancy Score, at Week 6 | 11.6 units on a scale | Standard Deviation 7.14 |
p-value: 0.1003Independent t-test
Primary
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.
Time frame: 8 weeks
Population: ITT Population who had measurement of Credibility / Expectancy Score completed at Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BVR-100 | Measurement of Intervention Credibility Assessed With the ExpectancyScore, at Week 8 | 15.3 units on a scale | Standard Deviation 6.21 |
| BES-100 | Measurement of Intervention Credibility Assessed With the ExpectancyScore, at Week 8 | 13.6 units on a scale | Standard Deviation 7.47 |
p-value: 0.4832Independent t-test
Secondary
Subject Retention Rate at Week 6
Subject retention in each group were assessed by percentage of subjects who remain on the study at Week 6
Time frame: 6 weeks
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BVR-100 | Subject Retention Rate at Week 6 | 96 percentage of participants |
| BES-100 | Subject Retention Rate at Week 6 | 100 percentage of participants |
Secondary
Subject Retention Rate at Week 8
Subject retention in each group were assessed by percentage of subjects who remain on the study at Week 8
Time frame: 8 weeks
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BVR-100 | Subject Retention Rate at Week 8 | 96 percentage of participants |
| BES-100 | Subject Retention Rate at Week 8 | 100 percentage of participants |
Secondary
Summary of Time-on-Task
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.
Time frame: 8 weeks
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BVR-100 | Summary of Time-on-Task | 4.97 minutes | Standard Deviation 1.886 |
| BES-100 | Summary of Time-on-Task | 6.59 minutes | Standard Deviation 0.359 |