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Study 4 of 594 for search of: | received on or after 01/16/2009 |
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Sponsored by: |
VA Connecticut Healthcare System |
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Information provided by: | VA Connecticut Healthcare System |
ClinicalTrials.gov Identifier: | NCT00829400 |
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.
Condition | Intervention | Phase |
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Mental Illness Schizophrenia Depression PTSD Bipolar Disorder |
Behavioral: Cognitive Remediation Behavioral: Nintendo Brain Age |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Cognitive Training to Enhance VA Work Program Outcomes |
Estimated Enrollment: | 80 |
Study Start Date: | May 2008 |
Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Posit Science: Experimental
Brain Fitness, Insight, and Aristotle Cognitive Software Training Suites Targeting 100 hours of training
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Behavioral: Cognitive Remediation
Brain Fitness, Insight, and Aristotle Cognitive Remediation Software Suites Targeting 100 hours of training
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Nintendo Brain Age: Active Comparator
Brain Age 2 Nintendo DS Portable Device for home or office use, targeting 100 hours of training
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Behavioral: Nintendo Brain Age
Brain Age 2 Software Nintendo DS Portable for home or office use Targeting 100 hours of training
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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.
Design 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Morris D Bell, PhD | 203-932-5711 ext 2281 | morris.bell@yale.edu |
Contact: Jason Johannesen, PhD | 203-932-5711 ext 2224 | jason.johannesen@yale.edu |
United States, Connecticut | |
VA Connecticut Healthcare System | Recruiting |
West Haven, Connecticut, United States, 06516 | |
Principal Investigator: Morris D Bell, PhD |
Principal Investigator: | Morris D Bell, PhD | VA RR&D, Yale University School of Medicine |
Responsible Party: | Rehabilitation Research and Development Department of Veterans Affairs ( Morris D. Bell ) |
Study ID Numbers: | MDB0010, D4752R |
Study First Received: | January 24, 2009 |
Last Updated: | January 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00829400 |
Health Authority: | United States: Federal Government |
Neuropsychology Cognitive Remediation Vocational Rehabilitation |
Schizophrenia Severe and persistent mental illness Chronic and disabling mental illness |
Schizophrenia Affective Disorders, Psychotic Depression Mental Disorders Bipolar Disorder |
Mood Disorders Psychotic Disorders Depressive Disorder Schizophrenia and Disorders with Psychotic Features Behavioral Symptoms |