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Cognitive Training to Enhance VA Work Program Outcomes

Primary Purpose

Mental Illness, Schizophrenia, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Remediation
Nintendo Brain Age
Sponsored by
VA Connecticut Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Illness focused on measuring Neuropsychology, Cognitive Remediation, Vocational Rehabilitation, Schizophrenia, Severe and persistent mental illness, Chronic and disabling mental illness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Connecticut Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Posit Science

Nintendo Brain Age

Arm Description

Brain Fitness, Insight, and Aristotle Cognitive Software Training Suites Targeting 100 hours of training

Brain Age 2 Nintendo DS Portable Device for home or office use, targeting 100 hours of training

Outcomes

Primary Outcome Measures

Work Activity

Secondary Outcome Measures

Neuropsychological Assessment

Full Information

First Posted
January 24, 2009
Last Updated
August 16, 2018
Sponsor
VA Connecticut Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT00829400
Brief Title
Cognitive Training to Enhance VA Work Program Outcomes
Official Title
Cognitive Training to Enhance VA Work Program Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Connecticut Healthcare System

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Illness, Schizophrenia, Depression, PTSD, Bipolar Disorder
Keywords
Neuropsychology, Cognitive Remediation, Vocational Rehabilitation, Schizophrenia, Severe and persistent mental illness, Chronic and disabling mental illness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Posit Science
Arm Type
Experimental
Arm Description
Brain Fitness, Insight, and Aristotle Cognitive Software Training Suites Targeting 100 hours of training
Arm Title
Nintendo Brain Age
Arm Type
Active Comparator
Arm Description
Brain Age 2 Nintendo DS Portable Device for home or office use, targeting 100 hours of training
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Remediation
Other Intervention Name(s)
Posit Science
Intervention Description
Brain Fitness, Insight, and Aristotle Cognitive Remediation Software Suites Targeting 100 hours of training
Intervention Type
Behavioral
Intervention Name(s)
Nintendo Brain Age
Other Intervention Name(s)
Nintendo
Intervention Description
Brain Age 2 Software Nintendo DS Portable for home or office use Targeting 100 hours of training
Primary Outcome Measure Information:
Title
Work Activity
Time Frame
6 month and 12 month
Secondary Outcome Measure Information:
Title
Neuropsychological Assessment
Time Frame
6 month and 12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morris D Bell, PhD
Organizational Affiliation
VA RR&D, Yale University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Connecticut Healthcare System
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11483142
Citation
Bell M, Bryson G, Greig T, Corcoran C, Wexler BE. Neurocognitive enhancement therapy with work therapy: effects on neuropsychological test performance. Arch Gen Psychiatry. 2001 Aug;58(8):763-8. doi: 10.1001/archpsyc.58.8.763.
Results Reference
background
PubMed Identifier
17943687
Citation
Bell M, Fiszdon J, Greig T, Wexler B, Bryson G. Neurocognitive enhancement therapy with work therapy in schizophrenia: 6-month follow-up of neuropsychological performance. J Rehabil Res Dev. 2007;44(5):761-70. doi: 10.1682/jrrd.2007.02.0032.
Results Reference
background
PubMed Identifier
33539561
Citation
Roberts MT, Lloyd J, Valimaki M, Ho GW, Freemantle M, Bekefi AZ. Video games for people with schizophrenia. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD012844. doi: 10.1002/14651858.CD012844.pub2.
Results Reference
derived
PubMed Identifier
29379114
Citation
Bell MD, Laws H, Pittman B, Johannesen JK. Comparison of focused cognitive training and portable "brain-games" on functional outcomes for vocational rehabilitation participants. Sci Rep. 2018 Jan 29;8(1):1779. doi: 10.1038/s41598-018-20094-w.
Results Reference
derived

Learn more about this trial

Cognitive Training to Enhance VA Work Program Outcomes

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