Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-27 @ 11:36 PM
Study NCT ID:
NCT04820634
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2021-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Virtual Reality to Improve Job Reentry in Adults With TBI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-07-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-19', 'studyFirstSubmitDate': '2021-02-03', 'studyFirstSubmitQcDate': '2021-03-26', 'lastUpdatePostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Mock Job Interview Score at 1 month', 'timeFrame': '1 month', 'description': 'Participants will complete a mock job interview at follow-up which will be compared to their initial interview and rated by blinded assessors on their job interview performance.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to investigate the effectiveness of virtual reality (VR) to improve job reentry skills in individuals with TBI.', 'detailedDescription': 'The current study will examine a virtual reality (VR) intervention entitled "Virtual Reality Job Interview Training (VR-JIT)" which targets social competency skills needed for successful job interviewing, and its efficacy when applied to individuals with traumatic brain injury (TBI). Preliminary evidence suggests that the VR-JIT is successful in individuals with autism spectrum disorder and schizophrenia in improving interview abilities. However, the efficacy of VR-JIT has not been evaluated in TBI populations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* I am between the ages of 18 and 65.\n* I have a diagnosis with moderate to severe TBI.\n* I am at least one year post injury.\n* I am able to speak and read English fluently.\n\nExclusion Criteria:\n\n* I have a history of multiple sclerosis, stroke, seizures or another neurological injury or disease in the past (like brain tumor or epilepsy).\n* I have a history of significant psychiatric illness (like bipolar disorder, schizophrenia or psychosis).\n* I am currently taking steroids and/or benzodiazepines as determined by study staff review of my medications.'}, 'identificationModule': {'nctId': 'NCT04820634', 'briefTitle': 'Using Virtual Reality to Improve Job Reentry in Adults With TBI', 'organization': {'class': 'OTHER', 'fullName': 'Kessler Foundation'}, 'officialTitle': 'Using Virtual Reality to Improve Job Reentry in Adults With TBI', 'orgStudyIdInfo': {'id': 'R-1090-19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VR-JIT', 'description': 'In this arm, participants would participate in simulated interviews utilizing a software program and virtual interviewer, once a week for 90 minutes.', 'interventionNames': ['Other: Virtual Reality Job Interview Training']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Wonderworks', 'description': 'In this arm, participants would participate in a similar intervention, also once a week for 90 minutes. However, in this arm, the intervention would be in a virtual office environment completing office tasks.', 'interventionNames': ['Other: Wonderworks']}], 'interventions': [{'name': 'Virtual Reality Job Interview Training', 'type': 'OTHER', 'description': 'The treatment group (TX) will complete 7 sessions of VR-JIT (1 sessions per week for 7 weeks), designed to teach the skills \\& concepts of job interviews. Sessions are approximately 90 minutes long.', 'armGroupLabels': ['VR-JIT']}, {'name': 'Wonderworks', 'type': 'OTHER', 'description': 'The control group (CT) will complete 7 sessions of Wonderworks (1 session per week for 7 weeks) using skills in an office environment.', 'armGroupLabels': ['Wonderworks']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07936', 'city': 'East Hanover', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nancy Moore, MA', 'role': 'CONTACT', 'email': 'nmoore@kesslerfoundation.org', 'phone': '973-323-8450'}, {'name': 'Katarina Reduzzi, BA', 'role': 'CONTACT', 'email': 'kreduzzi@kesslerfoundation.org'}, {'name': 'Helen Genova, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kessler Foundation', 'geoPoint': {'lat': 40.8201, 'lon': -74.36487}}], 'centralContacts': [{'name': 'Helen Genova, Ph.D.', 'role': 'CONTACT', 'email': 'hgenova@kesslerfoundation.org', 'phone': '973-324-8390'}], 'overallOfficials': [{'name': 'John DeLuca, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Lab Director'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kessler Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}