Cognitive Training to Enhance VA Work Program Outcomes

NCT ID: NCT00829400

Last Updated: 2018-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Mental Illness Schizophrenia Depression PTSD Bipolar Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Posit Science

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

Group Type EXPERIMENTAL

Cognitive Remediation

Intervention Type BEHAVIORAL

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

Nintendo Brain Age

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

Group Type ACTIVE_COMPARATOR

Nintendo Brain Age

Intervention Type BEHAVIORAL

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

Interventions

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Cognitive Remediation

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

Intervention Type BEHAVIORAL

Nintendo Brain Age

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Posit Science Nintendo

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Connecticut Healthcare System

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Morris D Bell, PhD

Role: PRINCIPAL_INVESTIGATOR

VA RR&D, Yale University School of Medicine

Locations

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VA Connecticut Healthcare System

West Haven, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 11483142 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17943687 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33539561 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29379114 (View on PubMed)

Other Identifiers

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D4752R

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MDB0010-01101

Identifier Type: -

Identifier Source: org_study_id

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