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Cognitive Training to Enhance VA Work Program Outcomes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by VA Connecticut Healthcare System.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
VA Connecticut Healthcare System
ClinicalTrials.gov Identifier:
NCT00829400
First received: January 24, 2009
Last updated: March 28, 2013
Last verified: September 2012

January 24, 2009
March 28, 2013
May 2008
May 2014   (final data collection date for primary outcome measure)
Work Activity [ Time Frame: 6 month and 12 month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00829400 on ClinicalTrials.gov Archive Site
Neuropsychological Assessment [ Time Frame: 6 month and 12 month ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Cognitive Training to Enhance VA Work Program Outcomes
Cognitive Training to Enhance VA Work Program Outcomes

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Mental Illness
  • Schizophrenia
  • Depression
  • PTSD
  • Bipolar Disorder
  • Behavioral: Cognitive Remediation
    Brain Fitness, Insight, and Aristotle Cognitive Remediation Software Suites Targeting 100 hours of training
    Other Name: Posit Science
  • Behavioral: Nintendo Brain Age
    Brain Age 2 Software Nintendo DS Portable for home or office use Targeting 100 hours of training
    Other Name: Nintendo
  • Experimental: Posit Science
    Brain Fitness, Insight, and Aristotle Cognitive Software Training Suites Targeting 100 hours of training
    Intervention: Behavioral: Cognitive Remediation
  • Active Comparator: Nintendo Brain Age
    Brain Age 2 Nintendo DS Portable Device for home or office use, targeting 100 hours of training
    Intervention: Behavioral: Nintendo Brain Age

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
Not Provided
May 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Morris D Bell, PhD 203-932-5711 ext 2281 morris.bell@yale.edu
Contact: Andrea Weinstein, MA 203-932-5711 ext 4155 andrea.weinstein@yale.edu
United States
 
NCT00829400
MDB0010-01101, D4752R
No
VA Connecticut Healthcare System
VA Connecticut Healthcare System
Not Provided
Principal Investigator: Morris D Bell, PhD VA RR&D, Yale University School of Medicine
VA Connecticut Healthcare System
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP