NCT00829400

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2009

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 20, 2018

Status Verified

August 1, 2018

Enrollment Period

8.6 years

First QC Date

January 24, 2009

Last Update Submit

August 16, 2018

Conditions

Mental IllnessSchizophreniaDepressionPTSDBipolar Disorder

Keywords

NeuropsychologyCognitive RemediationVocational RehabilitationSchizophreniaSevere and persistent mental illnessChronic and disabling mental illness

Outcome Measures

Primary Outcomes (1)

  • Work Activity

    6 month and 12 month

Secondary Outcomes (1)

  • Neuropsychological Assessment

    6 month and 12 month

Study Arms (2)

Posit Science

EXPERIMENTAL

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

Behavioral: Cognitive Remediation

Nintendo Brain Age

ACTIVE COMPARATOR

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

Behavioral: Nintendo Brain Age

Interventions

Cognitive RemediationBEHAVIORAL

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

Also known as: Posit Science
Posit Science
Nintendo Brain AgeBEHAVIORAL

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

Also known as: Nintendo
Nintendo Brain Age

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

Related Publications (4)

  • 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.

    PMID: 11483142BACKGROUND

  • 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.

    PMID: 17943687BACKGROUND

  • 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.

    PMID: 33539561DERIVED

  • 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.

    PMID: 29379114DERIVED

MeSH Terms

Conditions

Mental DisordersSchizophreniaDepressionStress Disorders, Post-TraumaticBipolar DisorderBronchiolitis Obliterans Syndrome

Interventions

Cognitive Remediation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersBehavioral SymptomsBehaviorStress Disorders, TraumaticTrauma and Stressor Related DisordersBipolar and Related DisordersMood DisordersOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Morris D Bell, PhD

    VA RR&D, Yale University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2009

First Posted

January 27, 2009

Study Start

May 1, 2008

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

August 20, 2018

Record last verified: 2018-08

Locations

US(1)