Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:58 PM
Study NCT ID:
NCT00704067
Status:
COMPLETED
Last Update Posted:
2015-02-12
First Post:
2008-06-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improving Work Outcomes for Veterans With Traumatic Brain Injury
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016832', 'term': 'Employment, Supported'}, {'id': 'D000091942', 'term': 'Cognitive Training'}], 'ancestors': [{'id': 'D004651', 'term': 'Employment'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D012050', 'term': 'Rehabilitation, Vocational'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D000066530', 'term': 'Neurological Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-11', 'studyFirstSubmitDate': '2008-06-20', 'studyFirstSubmitQcDate': '2008-06-20', 'lastUpdatePostDateStruct': {'date': '2015-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weeks worked', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Hours worked', 'timeFrame': '12 months'}, {'measure': 'Dollars earned from working', 'timeFrame': '12 months'}, {'measure': 'Cognitive performance', 'timeFrame': '3, 6, and 12 months'}, {'measure': 'Neurobehavioral symptoms', 'timeFrame': '3, 6, and 12 months'}, {'measure': 'Quality of life', 'timeFrame': '3, 6, and 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['vocational rehabilitation', 'supported employment', 'cognitive training', 'cognitive remediation', 'cognitive rehabilitation', 'veterans'], 'conditions': ['Traumatic Brain Injury']}, 'referencesModule': {'references': [{'pmid': '26147236', 'type': 'DERIVED', 'citation': 'Walter KH, Jak AJ, Twamley EW. Psychiatric comorbidity effects on compensatory cognitive training outcomes for veterans with traumatic brain injuries. Rehabil Psychol. 2015 Aug;60(3):303-8. doi: 10.1037/rep0000049. Epub 2015 Jul 6.'}]}, 'descriptionModule': {'briefSummary': 'The 12-month study will investigate a cognitive training augmentation of supported employment to improve cognitive performance and work outcomes, which are expected to result in improved quality of life and community integration for veterans with mild to moderate traumatic brain injuries. The primary hypothesis is that compared to veterans who receive enhanced supported employment, those who receive supported employment plus cognitive training will work more weeks during the 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* OEF/OIF veteran\n* History of mild-to-moderate TBI (loss of consciousness \\<6 hours; post-traumatic amnesia \\<7 days)\n* Documented impairment in at least one neuropsychological domain\n* Unemployed, but stating a goal of work\n* Written informed consent to participate in the study\n\nExclusion Criteria:\n\n* Current alcohol/substance abuse or dependence\n* Participation in other intervention studies'}, 'identificationModule': {'nctId': 'NCT00704067', 'briefTitle': 'Improving Work Outcomes for Veterans With Traumatic Brain Injury', 'organization': {'class': 'FED', 'fullName': 'United States Department of Defense'}, 'officialTitle': 'Improving Work Outcomes for Veterans With Traumatic Brain Injury', 'orgStudyIdInfo': {'id': 'PT075291'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Supported employment for 12 months plus cognitive training for the first 12 weeks', 'interventionNames': ['Behavioral: Supported employment plus cognitive training']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Supported employment for 12 months plus one additional supported employment session per week for the first 12 weeks', 'interventionNames': ['Behavioral: Enhanced supported employment']}], 'interventions': [{'name': 'Supported employment plus cognitive training', 'type': 'BEHAVIORAL', 'description': 'Supported employment for 12 months plus cognitive training for the first 12 weeks', 'armGroupLabels': ['1']}, {'name': 'Enhanced supported employment', 'type': 'BEHAVIORAL', 'description': 'Supported employment for 12 months plus one additional supported employment session per week for the first 12 weeks.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92161', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'VA San Diego Healthcare System', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Elizabeth W Twamley, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego, VA San Diego Healthcare System, and Veterans Medical Research Foundation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'United States Department of Defense', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Elizabeth W. Twamley, PhD', 'investigatorAffiliation': 'United States Department of Defense'}}}}