Work Activity Augmented by Cognitive Rehabilitation for Schizophrenia

NCT ID: NCT00430560

Last Updated: 2017-09-11

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

PHASE2/PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-10-31

Study Completion Date

2015-10-31

Brief Summary

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This research investigates the benefits of productive activity and cognitive rehabilitation for patients with schizophrenia. Key questions are:

1. does cognitive rehabilitation plus work activity produce better outcomes than work activity alone?
2. Is cognitive rehabilitation more helpful for individuals with moderate or greater cognitive impairment than for individuals without such impairment?
3. Does cognitive rehabilitation reduce the dropout rate and increase participation in work activity for cognitively impaired subjects?
4. What features of cognitive rehabilitation are most important for clinical and rehabilitation outcomes?

Detailed Description

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This is a randomized, matching study in which subjects are stratified by degree of cognitive impairment, then randomly assigned to one of two conditions: Work Services Only vs. Work Services plus cognitive rehabilitation. Longitudinal analysis of work activity, work performance, symptoms, quality of life, cognitive function and service utilization are made.

Conditions

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Schizophrenia Schizoaffective 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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1

work therapy

Group Type ACTIVE_COMPARATOR

work therapy

Intervention Type PROCEDURE

opportunity to work in carefully supervised hospital job

work therapy

Intervention Type BEHAVIORAL

work therapy

2

work therapy plus cognitive remediation

Group Type EXPERIMENTAL

cognitive rehabilitation

Intervention Type BEHAVIORAL

computer training

Interventions

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cognitive rehabilitation

computer training

Intervention Type BEHAVIORAL

work therapy

opportunity to work in carefully supervised hospital job

Intervention Type PROCEDURE

work therapy

work therapy

Intervention Type BEHAVIORAL

Other Intervention Names

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computer training IWT

Eligibility Criteria

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Inclusion Criteria

* diagnosis of schizophrenia or schizoaffective disorder

Exclusion Criteria

* change in psychiatric medications or housing within 30 days of study intake
* episode of drug abuse within 30 days of study intake
* GAF score 30 or less
* known neurological disease or developmental disability
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Connecticut Healthcare System

FED

Sponsor Role collaborator

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Morris D Bell, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

VA Connecticut Healthcare System

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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Wexler BE, Bell MD. Cognitive remediation and vocational rehabilitation for schizophrenia. Schizophr Bull. 2005 Oct;31(4):931-41. doi: 10.1093/schbul/sbi038. Epub 2005 Aug 3.

Reference Type BACKGROUND
PMID: 16079390 (View on PubMed)

Bell M, Bryson G, Wexler BE. Cognitive remediation of working memory deficits: durability of training effects in severely impaired and less severely impaired schizophrenia. Acta Psychiatr Scand. 2003 Aug;108(2):101-9. doi: 10.1034/j.1600-0447.2003.00090.x.

Reference Type RESULT
PMID: 12823166 (View on PubMed)

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 RESULT
PMID: 11483142 (View on PubMed)

Fiszdon JM, Cardenas AS, Bryson GJ, Bell MD. Predictors of remediation success on a trained memory task. J Nerv Ment Dis. 2005 Sep;193(9):602-8. doi: 10.1097/01.nmd.0000177790.23311.ba.

Reference Type RESULT
PMID: 16131943 (View on PubMed)

Fiszdon JM, Whelahan H, Bryson GJ, Wexler BE, Bell MD. Cognitive training of verbal memory using a dichotic listening paradigm: impact on symptoms and cognition. Acta Psychiatr Scand. 2005 Sep;112(3):187-93. doi: 10.1111/j.1600-0447.2005.00565.x.

Reference Type RESULT
PMID: 16095473 (View on PubMed)

Bell MD, Fiszdon JM, Greig TC, Bryson GJ. Can older people with schizophrenia benefit from work rehabilitation? J Nerv Ment Dis. 2005 May;193(5):293-301. doi: 10.1097/01.nmd.0000161688.47164.71.

Reference Type RESULT
PMID: 15870612 (View on PubMed)

Bell MD, Bryson GJ, Greig TC, Fiszdon JM, Wexler BE. Neurocognitive enhancement therapy with work therapy: Productivity outcomes at 6- and 12-month follow-ups. J Rehabil Res Dev. 2005 Nov-Dec;42(6):829-38. doi: 10.1682/jrrd.2005.03.0061.

Reference Type RESULT
PMID: 16680620 (View on PubMed)

Fiszdon JM, Choi J, Bryson GJ, Bell MD. Impact of intellectual status on response to cognitive task training in patients with schizophrenia. Schizophr Res. 2006 Oct;87(1-3):261-9. doi: 10.1016/j.schres.2006.04.011. Epub 2006 Jun 5.

Reference Type RESULT
PMID: 16737798 (View on PubMed)

Bell MD, Fiszdon J, Bryson G, Wexler BE. Effects of neurocognitive enhancement therapy in schizophrenia: normalisation of memory performance. Cogn Neuropsychiatry. 2004 Aug;9(3):199-211. doi: 10.1080/13546800344000084.

Reference Type RESULT
PMID: 16571581 (View on PubMed)

Other Identifiers

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MDB0003

Identifier Type: -

Identifier Source: secondary_id

D2356-R

Identifier Type: -

Identifier Source: org_study_id

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