Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-28 @ 12:03 AM
Study NCT ID:
NCT00430560
Status:
COMPLETED
Last Update Posted:
2017-09-11
First Post:
2007-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Work Activity Augmented by Cognitive Rehabilitation for Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000091942', 'term': 'Cognitive Training'}], 'ancestors': [{'id': 'D000066530', 'term': 'Neurological Rehabilitation'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-07', 'studyFirstSubmitDate': '2007-01-31', 'studyFirstSubmitQcDate': '2007-01-31', 'lastUpdatePostDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neuropsychological test performance', 'timeFrame': 'data collection completed'}], 'secondaryOutcomes': [{'measure': 'Hours of productive activity', 'timeFrame': 'data collection completed'}, {'measure': 'Hours worked', 'timeFrame': 'data collection completed'}, {'measure': 'Quality of life', 'timeFrame': 'data collection completed'}, {'measure': 'Psychiatric symptoms', 'timeFrame': 'data collection completed'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['work therapy', 'cognitive rehabilitation', 'schizophrenia', 'schizoaffective disorder', 'treatment outcome'], 'conditions': ['Schizophrenia', 'Schizoaffective Disorder']}, 'referencesModule': {'references': [{'pmid': '16079390', 'type': 'BACKGROUND', 'citation': 'Wexler BE, Bell MD. Cognitive remediation and vocational rehabilitation for schizophrenia. Schizophr Bull. 2005 Oct;31(4):931-41. doi: 10.1093/schbul/sbi038. Epub 2005 Aug 3.'}, {'pmid': '12823166', 'type': 'RESULT', 'citation': 'Bell M, Bryson G, Wexler BE. Cognitive remediation of working memory deficits: durability of training effects in severely impaired and less severely impaired schizophrenia. Acta Psychiatr Scand. 2003 Aug;108(2):101-9. doi: 10.1034/j.1600-0447.2003.00090.x.'}, {'pmid': '11483142', 'type': 'RESULT', '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': '16131943', 'type': 'RESULT', 'citation': 'Fiszdon JM, Cardenas AS, Bryson GJ, Bell MD. Predictors of remediation success on a trained memory task. J Nerv Ment Dis. 2005 Sep;193(9):602-8. doi: 10.1097/01.nmd.0000177790.23311.ba.'}, {'pmid': '16095473', 'type': 'RESULT', 'citation': 'Fiszdon JM, Whelahan H, Bryson GJ, Wexler BE, Bell MD. Cognitive training of verbal memory using a dichotic listening paradigm: impact on symptoms and cognition. Acta Psychiatr Scand. 2005 Sep;112(3):187-93. doi: 10.1111/j.1600-0447.2005.00565.x.'}, {'pmid': '15870612', 'type': 'RESULT', 'citation': 'Bell MD, Fiszdon JM, Greig TC, Bryson GJ. Can older people with schizophrenia benefit from work rehabilitation? J Nerv Ment Dis. 2005 May;193(5):293-301. doi: 10.1097/01.nmd.0000161688.47164.71.'}, {'pmid': '16680620', 'type': 'RESULT', 'citation': 'Bell MD, Bryson GJ, Greig TC, Fiszdon JM, Wexler BE. Neurocognitive enhancement therapy with work therapy: Productivity outcomes at 6- and 12-month follow-ups. J Rehabil Res Dev. 2005 Nov-Dec;42(6):829-38. doi: 10.1682/jrrd.2005.03.0061.'}, {'pmid': '16737798', 'type': 'RESULT', 'citation': 'Fiszdon JM, Choi J, Bryson GJ, Bell MD. Impact of intellectual status on response to cognitive task training in patients with schizophrenia. Schizophr Res. 2006 Oct;87(1-3):261-9. doi: 10.1016/j.schres.2006.04.011. Epub 2006 Jun 5.'}, {'pmid': '16571581', 'type': 'RESULT', 'citation': 'Bell MD, Fiszdon J, Bryson G, Wexler BE. Effects of neurocognitive enhancement therapy in schizophrenia: normalisation of memory performance. Cogn Neuropsychiatry. 2004 Aug;9(3):199-211. doi: 10.1080/13546800344000084.'}]}, 'descriptionModule': {'briefSummary': 'This research investigates the benefits of productive activity and cognitive rehabilitation for patients with schizophrenia. Key questions are:\n\n1. does cognitive rehabilitation plus work activity produce better outcomes than work activity alone?\n2. Is cognitive rehabilitation more helpful for individuals with moderate or greater cognitive impairment than for individuals without such impairment?\n3. Does cognitive rehabilitation reduce the dropout rate and increase participation in work activity for cognitively impaired subjects?\n4. What features of cognitive rehabilitation are most important for clinical and rehabilitation outcomes?', 'detailedDescription': 'This is a randomized, matching study in which subjects are stratified by degree of cognitive impairment, then randomly assigned to one of two conditions: Work Services Only vs. Work Services plus cognitive rehabilitation. Longitudinal analysis of work activity, work performance, symptoms, quality of life, cognitive function and service utilization are made.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of schizophrenia or schizoaffective disorder\n\nExclusion Criteria:\n\n* change in psychiatric medications or housing within 30 days of study intake\n* episode of drug abuse within 30 days of study intake\n* GAF score 30 or less\n* known neurological disease or developmental disability'}, 'identificationModule': {'nctId': 'NCT00430560', 'briefTitle': 'Work Activity Augmented by Cognitive Rehabilitation for Schizophrenia', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Work Activity Augmented by Cognitive Rehabilitation: Continuation and Follow-up', 'orgStudyIdInfo': {'id': 'D2356-R'}, 'secondaryIdInfos': [{'id': 'MDB0003'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'work therapy', 'interventionNames': ['Procedure: work therapy', 'Behavioral: work therapy']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'work therapy plus cognitive remediation', 'interventionNames': ['Behavioral: cognitive rehabilitation']}], 'interventions': [{'name': 'cognitive rehabilitation', 'type': 'BEHAVIORAL', 'otherNames': ['computer training'], 'description': 'computer training', 'armGroupLabels': ['2']}, {'name': 'work therapy', 'type': 'PROCEDURE', 'otherNames': ['IWT'], 'description': 'opportunity to work in carefully supervised hospital job', 'armGroupLabels': ['1']}, {'name': 'work therapy', 'type': 'BEHAVIORAL', 'description': 'work therapy', 'armGroupLabels': ['1']}]}, '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, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Connecticut Healthcare System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'collaborators': [{'name': 'VA Connecticut Healthcare System', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}