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CompletedNCT00829400Updated Aug 20, 2018

Cognitive Training to Enhance VA Work Program Outcomes

An interventional study of Cognitive Remediation and Nintendo Brain Age in Mental Illness, Schizophrenia and Depression, sponsored by VA Connecticut Healthcare System. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-20.

Sponsored by VA Connecticut Healthcare System · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
77
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Mental Illness
  • Schizophrenia
  • Depression
  • PTSD
  • Bipolar Disorder

Keywords

  • Neuropsychology
  • Cognitive Remediation
  • Vocational Rehabilitation
  • Schizophrenia
  • Severe and persistent mental illness
  • Chronic and disabling mental illness
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In context

Schizophrenia

3,470 studies on the registry are indexed under Schizophrenia; 471 are open to participants now.

This study's enrollment of 77 is close to the median of 70 across 2,871 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

VA Connecticut Healthcare System is the lead sponsor of 40 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Neurological Disease that may affect cognition
  • Primary substance abuse
  • Developmental Disability
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
77 participants (actual)

Study arms

  • Experimental
    Posit Science

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

    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

    Behavioral: Nintendo Brain Age

Interventions

  • BehavioralCognitive Remediation

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

    Also known as: Posit Science

  • BehavioralNintendo Brain Age

    Brain Age 2 Software Nintendo DS Portable for home or office use Targeting 100 hours of training

    Also known as: Nintendo

06

What researchers measure

Primary outcomes

  1. Work Activity

    Time frame: 6 month and 12 month

Secondary outcomes

  1. Neuropsychological Assessment

    Time frame: 6 month and 12 month

07

Study locations

1 site
  • VA Connecticut Healthcare System
    West Haven, Connecticut 06516, United States
08

References and documents

Publications

  • 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. PubMed 11483142 ↗
  • 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. PubMed 17943687 ↗
  • 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. PubMed 33539561 ↗
  • 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. PubMed 29379114 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00829400
Lead sponsor
VA Connecticut Healthcare System
Responsible party
Sponsor
First posted
Jan 27, 2009
Start date
May 2008
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Aug 20, 2018

Study contacts

Morris D Bell, PhD
principal investigator · VA RR&D, Yale University School of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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