Cognitive Training to Enhance VA Work Program Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00829400
Recruitment Status : Completed
First Posted : January 27, 2009
Last Update Posted : December 21, 2016
Information provided by (Responsible Party):
VA Connecticut Healthcare System

Brief Summary:
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 or disease Intervention/treatment Phase
Mental Illness Schizophrenia Depression PTSD Bipolar Disorder Behavioral: Cognitive Remediation Behavioral: Nintendo Brain Age Phase 3

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cognitive Training to Enhance VA Work Program Outcomes
Study Start Date : May 2008
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Posit Science
Brain Fitness, Insight, and Aristotle Cognitive Software Training Suites Targeting 100 hours of training
Behavioral: Cognitive Remediation
Brain Fitness, Insight, and Aristotle Cognitive Remediation Software Suites Targeting 100 hours of training
Other Name: Posit Science
Active Comparator: Nintendo Brain Age
Brain Age 2 Nintendo DS Portable Device for home or office use, targeting 100 hours of training
Behavioral: Nintendo Brain Age
Brain Age 2 Software Nintendo DS Portable for home or office use Targeting 100 hours of training
Other Name: Nintendo

Primary Outcome Measures :
  1. Work Activity [ Time Frame: 6 month and 12 month ]

Secondary Outcome Measures :
  1. Neuropsychological Assessment [ Time Frame: 6 month and 12 month ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Participant in VA work services
  • Chronic and disabling psychiatric illness

Exclusion Criteria:

  • Neurological Disease that may affect cognition
  • Primary substance abuse
  • Developmental Disability

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00829400

United States, Connecticut
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
VA Connecticut Healthcare System
Principal Investigator: Morris D Bell, PhD VA RR&D, Yale University School of Medicine

Responsible Party: VA Connecticut Healthcare System Identifier: NCT00829400     History of Changes
Other Study ID Numbers: MDB0010-01101
D4752R ( Other Grant/Funding Number: VA RR&D )
First Posted: January 27, 2009    Key Record Dates
Last Update Posted: December 21, 2016
Last Verified: December 2016

Keywords provided by VA Connecticut Healthcare System:
Cognitive Remediation
Vocational Rehabilitation
Severe and persistent mental illness
Chronic and disabling mental illness

Additional relevant MeSH terms:
Bipolar Disorder
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Bipolar and Related Disorders