Cognitive Training to Enhance VA Work Program Outcomes

This study is currently recruiting participants.
Verified September 2012 by VA Connecticut Healthcare System
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
  Purpose

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
Mental Illness
Schizophrenia
Depression
PTSD
Bipolar Disorder
Behavioral: Cognitive Remediation
Behavioral: Nintendo Brain Age
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cognitive Training to Enhance VA Work Program Outcomes

Resource links provided by NLM:


Further study details as provided by VA Connecticut Healthcare System:

Primary Outcome Measures:
  • Work Activity [ Time Frame: 6 month and 12 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neuropsychological Assessment [ Time Frame: 6 month and 12 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: May 2008
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00829400

Contacts
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

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

Publications:
Responsible Party: VA Connecticut Healthcare System
ClinicalTrials.gov Identifier: NCT00829400     History of Changes
Other Study ID Numbers: MDB0010-01101, D4752R
Study First Received: January 24, 2009
Last Updated: March 28, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Mental Disorders
Bipolar Disorder
Depression
Depressive Disorder
Schizophrenia
Affective Disorders, Psychotic
Mood Disorders
Behavioral Symptoms
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on April 22, 2014