Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2025-12-28 @ 6:45 PM
Study NCT ID:
NCT06037668
Status:
COMPLETED
Last Update Posted:
2025-03-12
First Post:
2023-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Randomized, Controlled Study of Two At-Home Self-Guided Virtual Reality Interventions for Adults With Social Anxiety Disorder.
Sponsor:
Organization:
Raw JSON
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'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'ITT Population'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 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[{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'ITT Population'}, {'title': 'Baseline Credibility/Expectancy score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '35.1', 'spread': '8.13', 'groupId': 'BG000'}, {'value': '30.2', 'spread': '6.58', 'groupId': 'BG001'}, {'value': '32.9', 'spread': '7.77', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '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. 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Higher score corresponds to better credibility and expectancy.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'ITT Population'}, {'title': 'Baseline Credibility score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '18', 'spread': '4.31', 'groupId': 'BG000'}, {'value': '15.4', 'spread': '4.57', 'groupId': 'BG001'}, {'value': '16.9', 'spread': '4.54', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '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. 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Expectancy Score is calculated by taking the sum of score of the last 3 items of the scale ranging from 3 to 27.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'ITT Population'}], 'populationDescription': 'ITT Population'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-06-21', 'size': 645671, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-12-03T16:43', 'hasProtocol': True}, {'date': '2024-01-31', 'size': 1164819, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-12-06T15:11', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-20', 'studyFirstSubmitDate': '2023-09-07', 'resultsFirstSubmitDate': '2024-12-06', 'studyFirstSubmitQcDate': '2023-09-07', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-20', 'studyFirstPostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of Intervention Credibility Assessed With the Credibility Score, at Baseline', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Measurement of Intervention Credibility Assessed With the Credibility Score, at Week 6', 'timeFrame': '6 weeks', 'description': '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.'}, {'measure': 'Measurement of Intervention Credibility Assessed With the Credibility Score, at Week 8', 'timeFrame': '8 weeks', 'description': '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.'}, {'measure': 'Measurement of Intervention Credibility Assessed With Expectancy Score, at Baseline', 'timeFrame': 'Baseline', 'description': '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': 'Measurement of Intervention Credibility Assessed With the Expectancy Score, at Week 6', 'timeFrame': '6 weeks', 'description': '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': 'Measurement of Intervention Credibility Assessed With the ExpectancyScore, at Week 8', 'timeFrame': '8 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Subject Retention Rate at Week 6', 'timeFrame': '6 weeks', 'description': 'Subject retention in each group were assessed by percentage of subjects who remain on the study at Week 6'}, {'measure': 'Subject Retention Rate at Week 8', 'timeFrame': '8 weeks', 'description': 'Subject retention in each group were assessed by percentage of subjects who remain on the study at Week 8'}, {'measure': 'Summary of Time-on-Task', 'timeFrame': '8 weeks', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Social Anxiety Disorder, Social Phobia'], 'conditions': ['Social Anxiety Disorder (SAD)']}, 'descriptionModule': {'briefSummary': 'This study is to compare two Virtual Reality (VR)-based interventions, BVR-100 and BES-100, for the treatment of Social Anxiety Disorder (SAD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is male or female, aged 18 or above.\n* Subject has English fluency and literacy.\n* Subject meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-5) criteria for Social Anxiety Disorder\n* Subject has a total Liebowitz Social Anxiety Scale (LSAS) score at Screening of ≥ 70.\n\nExclusion Criteria:\n\n* Subject has significant visual, auditory or balance impairment\n* Subject has history of photosensitive epilepsy or seizure disorder\n* Subject has history of motion sickness or medical condition predisposing to nausea or dizziness.\n* Subject has injuries, inflammation or infection affecting the eyes, ears or face that would make the use of the hardware uncomfortable.\n* 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\n* 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.\n* 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.\n* 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."}, 'identificationModule': {'nctId': 'NCT06037668', 'acronym': 'BVR-100-102', 'briefTitle': 'A Randomized, Controlled Study of Two At-Home Self-Guided Virtual Reality Interventions for Adults With Social Anxiety Disorder.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sumitomo Pharma America, Inc.'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'BVR-100-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BVR-100', 'description': 'Experimental at-home VR intervention for the treatment of SAD', 'interventionNames': ['Device: BVR-100']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BES-100', 'description': 'Active at-home VR intervention comparator', 'interventionNames': ['Device: BES-100']}], 'interventions': [{'name': 'BVR-100', 'type': 'DEVICE', 'description': 'Experimental self-guided VR intervention for the treatment of SAD', 'armGroupLabels': ['BVR-100']}, {'name': 'BES-100', 'type': 'DEVICE', 'description': 'Active at-home VR intervention comparator', 'armGroupLabels': ['BES-100']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32801', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'CNS Healthcare', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '02116', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Curavit Clinical Research', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02131', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Clinical Trials', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63304', 'city': 'Saint Charles', 'state': 'Missouri', 'country': 'United States', 'facility': 'Midwest Research Group', 'geoPoint': {'lat': 38.78394, 'lon': -90.48123}}, {'zip': '68526', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Alivation Health, LLC', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '84020', 'city': 'Draper', 'state': 'Utah', 'country': 'United States', 'facility': 'Cedar Clinical Research', 'geoPoint': {'lat': 40.52467, 'lon': -111.86382}}], 'overallOfficials': [{'name': 'Robert Hayes, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sumitomo Pharma America, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sumitomo Pharma America, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'BehaVR LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}