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| Name | Class |
|---|---|
| BehaVR LLC | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BVR-100 | Experimental | Experimental at-home VR intervention for the treatment of SAD |
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| BES-100 | Active Comparator | Active at-home VR intervention comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BVR-100 | Device | Experimental self-guided VR intervention for the treatment of SAD |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Hayes, PhD | Sumitomo Pharma America, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CNS Healthcare | Orlando | Florida | 32801 | United States | ||
| Curavit Clinical Research |
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| ID | Title | Description |
|---|---|---|
| FG000 | BVR-100 | Experimental at-home VR intervention for the treatment of SAD |
| FG001 | BES-100 | Active at-home VR intervention comparator |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 21, 2023 | Dec 3, 2024 |
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| BES-100 |
| Device |
Active at-home VR intervention comparator |
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| 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 |
| 8 weeks |
| 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. | 8 weeks |
| Boston |
| Massachusetts |
| 02116 |
| United States |
| Boston Clinical Trials | Boston | Massachusetts | 02131 | United States |
| Midwest Research Group | Saint Charles | Missouri | 63304 | United States |
| Alivation Health, LLC | Lincoln | Nebraska | 68526 | United States |
| Cedar Clinical Research | Draper | Utah | 84020 | United States |
| COMPLETED |
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| NOT COMPLETED |
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ITT Population
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| ID | Title | Description |
|---|---|---|
| BG000 | BVR-100 | Experimental at-home VR intervention for the treatment of SAD |
| BG001 | BES-100 | Active at-home VR intervention comparator |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Categorical | ITT Population | Count of Participants | Participants |
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| Sex: Female, Male | ITT Population | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | ITT Population | Count of Participants | Participants |
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| Race (NIH/OMB) | ITT Population | Count of Participants | Participants |
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| Region of Enrollment | ITT Population | Count of Participants | Participants |
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| Baseline Credibility/Expectancy score | 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 6 items (each item is rated on a 1-9 scale). Total CEQ score is calculated for each subject at each visit by taking the sum of score of all 6 items of the scale ranging from 6 to 54. Higher score corresponds to better credibility and expectancy. | ITT Population | Mean | Standard Deviation | units on a scale |
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| Baseline Credibility score | The Credibility scale asks about the improvements that subjects think will be achieved as a result of treatment, and how believable, convincing,and logical the treatment seems.It contains three items rated on a 1-9 scale. 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 scale ranging from 3 to 27. | ITT Population | Mean | Standard Deviation | units on a scale |
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| Baseline Expectancy score | The Expectancy Score asks about the improvements that subjects feel will be achieved as a result of treatment.It contains three items rated on a 1-9 scale.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 scale ranging from 3 to 27. | ITT Population | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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. | ITT Population who had measurement of Credibility / Expectancy Score completed at Baseline | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| 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. | ITT Population who had measurement of Credibility / Expectancy Score completed at Week 6 | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
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| 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. | ITT Population who had measurement of Credibility / Expectancy Score completed at Week 8 | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
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| 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. | ITT Population who had measurement of Credibility / Expectancy Score completed at Baseline | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| 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. | ITT Population who had measurement of Credibility / Expectancy Score completed at Week 6 | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
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| 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. | ITT Population who had measurement of Credibility / Expectancy Score completed at Week 8 | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
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| 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 | ITT Population | Posted | Number | percentage of participants | 6 weeks |
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| 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 | ITT Population | Posted | Number | percentage of participants | 8 weeks |
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| 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. | ITT Population | Posted | Mean | Standard Deviation | minutes | 8 weeks |
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Up to 8 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BVR-100 | Experimental at-home VR intervention for the treatment of SAD | 0 | 25 | 0 | 25 | 3 | 25 |
| EG001 | BES-100 | Active at-home VR intervention comparator | 0 | 27 | 0 | 27 | 0 | 27 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedRA 26.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedRA 26.0 | Systematic Assessment |
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In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Frontier Business Office | Sumitomo Pharma America | 1-866-503-6351 | gazeleh.vakili@us.sumitomo-pharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 31, 2024 | Dec 6, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000072861 | Phobia, Social |
| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| Between 18 and 65 years |
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| >=65 years |
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