Cognitive Training to Enhance VA Work Program Outcomes

August 16, 2018 updated by: VA Connecticut Healthcare System
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

77

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • West Haven, Connecticut, United States, 06516
        • VA Connecticut Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Nintendo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Work Activity
Time Frame: 6 month and 12 month
6 month and 12 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Neuropsychological Assessment
Time Frame: 6 month and 12 month
6 month and 12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Connecticut Healthcare System

Investigators

  • Principal Investigator: Morris D Bell, PhD, VA RR&D, Yale University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

January 24, 2009

First Submitted That Met QC Criteria

January 26, 2009

First Posted (Estimate)

January 27, 2009

Study Record Updates

Last Update Posted (Actual)

August 20, 2018

Last Update Submitted That Met QC Criteria

August 16, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDB0010-01101
  • D4752R (Other Grant/Funding Number: VA RR&D)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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