Ignite Creation Date:
2025-12-26 @ 12:15 PM
Ignite Modification Date:
2025-12-26 @ 12:15 PM
Study NCT ID:
NCT00829400
Status:
COMPLETED
Last Update Posted:
2018-08-20
First Post:
2009-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cognitive Training to Enhance VA Work Program Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072466', 'term': 'Cognitive Remediation'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-16', 'studyFirstSubmitDate': '2009-01-24', 'studyFirstSubmitQcDate': '2009-01-26', 'lastUpdatePostDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Work Activity', 'timeFrame': '6 month and 12 month'}], 'secondaryOutcomes': [{'measure': 'Neuropsychological Assessment', 'timeFrame': '6 month and 12 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Neuropsychology', 'Cognitive Remediation', 'Vocational Rehabilitation', 'Schizophrenia', 'Severe and persistent mental illness', 'Chronic and disabling mental illness'], 'conditions': ['Mental Illness', 'Schizophrenia', 'Depression', 'PTSD', 'Bipolar Disorder']}, 'referencesModule': {'references': [{'pmid': '11483142', 'type': 'BACKGROUND', 'citation': 'Bell M, Bryson G, Greig T, Corcoran C, Wexler BE. Neurocognitive enhancement therapy with work therapy: effects on neuropsychological test performance. Arch Gen Psychiatry. 2001 Aug;58(8):763-8. doi: 10.1001/archpsyc.58.8.763.'}, {'pmid': '17943687', 'type': 'BACKGROUND', 'citation': 'Bell M, Fiszdon J, Greig T, Wexler B, Bryson G. Neurocognitive enhancement therapy with work therapy in schizophrenia: 6-month follow-up of neuropsychological performance. J Rehabil Res Dev. 2007;44(5):761-70. doi: 10.1682/jrrd.2007.02.0032.'}, {'pmid': '33539561', 'type': 'DERIVED', 'citation': 'Roberts MT, Lloyd J, Valimaki M, Ho GW, Freemantle M, Bekefi AZ. Video games for people with schizophrenia. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD012844. doi: 10.1002/14651858.CD012844.pub2.'}, {'pmid': '29379114', 'type': 'DERIVED', 'citation': 'Bell MD, Laws H, Pittman B, Johannesen JK. Comparison of focused cognitive training and portable "brain-games" on functional outcomes for vocational rehabilitation participants. Sci Rep. 2018 Jan 29;8(1):1779. doi: 10.1038/s41598-018-20094-w.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether augmenting work services with cognitive remediation can improve vocational outcomes for psychiatrically disabled participants in VA work services.', 'detailedDescription': 'Background: Our previous RR\\&D funded study demonstrated significantly better vocational outcomes for people with schizophrenia when cognitive training supplemented their participation in Incentive Therapy. We have found in a subsequent NIMH funded study involving cognitive training and supported employment that competitive employment outcomes were better for those who received cognitive training. Moreover, we found that patients with the poorest community function at intake were very unlikely to obtain competitive employment unless they received the cognitive training. The current study will test the effectiveness of cognitive training by extending it to a broader range of VA patients with psychotic disorders participating in all types of VA work services currently available, including Incentive Therapy, Compensated Work Therapy, and Supported Employment. We plan to offer it to any patient with a psychotic disorder who is unlikely to obtain competitive employment without additional services. We will also compare two types of cognitive training to determine whether cognitive game software works as well narrowly focused cognitive exercises.\n\nDesign and Method: This is a randomized clinical trial in which 80 VA patients referred for VA work services and who meet criteria for psychotic disorder and impaired community function will be randomized to one of two types of cognitive training. There will be two conditions with approximately 40 subjects per condition. Intake procedures will include psychosocial, neuropsychological, and psychiatric assessments. These assessments will be repeated at 6-months and 12 month follow-up. Cognitive training will consist of computer-based cognitive exercises of attention, memory and problem-solving and a weekly group that focuses on improving work behaviors. One of the computer-based systems employs engaging cognitive game software and the other uses specially designed exercises that narrowly focus on discrete cognitive processes. Work services will be provided as usual to both conditions. Primary endpoints are measures of productive activity including obtaining competitive employment, total hours worked, and money earned. Secondary endpoints include neuropsychological, quality of life and health status changes. The study will be for three years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant in VA work services\n* Chronic and disabling psychiatric illness\n\nExclusion Criteria:\n\n* Neurological Disease that may affect cognition\n* Primary substance abuse\n* Developmental Disability'}, 'identificationModule': {'nctId': 'NCT00829400', 'briefTitle': 'Cognitive Training to Enhance VA Work Program Outcomes', 'organization': {'class': 'FED', 'fullName': 'VA Connecticut Healthcare System'}, 'officialTitle': 'Cognitive Training to Enhance VA Work Program Outcomes', 'orgStudyIdInfo': {'id': 'MDB0010-01101'}, 'secondaryIdInfos': [{'id': 'D4752R', 'type': 'OTHER_GRANT', 'domain': 'VA RR&D'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Posit Science', 'description': 'Brain Fitness, Insight, and Aristotle Cognitive Software Training Suites Targeting 100 hours of training', 'interventionNames': ['Behavioral: Cognitive Remediation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nintendo Brain Age', 'description': 'Brain Age 2 Nintendo DS Portable Device for home or office use, targeting 100 hours of training', 'interventionNames': ['Behavioral: Nintendo Brain Age']}], 'interventions': [{'name': 'Cognitive Remediation', 'type': 'BEHAVIORAL', 'otherNames': ['Posit Science'], 'description': 'Brain Fitness, Insight, and Aristotle Cognitive Remediation Software Suites Targeting 100 hours of training', 'armGroupLabels': ['Posit Science']}, {'name': 'Nintendo Brain Age', 'type': 'BEHAVIORAL', 'otherNames': ['Nintendo'], 'description': 'Brain Age 2 Software Nintendo DS Portable for home or office use Targeting 100 hours of training', 'armGroupLabels': ['Nintendo Brain Age']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06516', 'city': 'West Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'VA Connecticut Healthcare System', 'geoPoint': {'lat': 41.27065, 'lon': -72.94705}}], 'overallOfficials': [{'name': 'Morris D Bell, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA RR&D, Yale University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Connecticut Healthcare System', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}