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NCT00430560 Clinical Trial

Work Activity Augmented by Cognitive Rehabilitation for Schizophrenia

Schizophrenia Clinical Trial

Official title:
Work Activity Augmented by Cognitive Rehabilitation: Continuation and Follow-up

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00430560
Other study ID # D2356-R
Secondary ID MDB0003
Status Completed
Phase Phase 2/Phase 3
First received January 31, 2007
Last updated September 7, 2017
Start date October 2000
Est. completion date October 2015

Study information
Verified date September 2017
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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?

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date October 2015
Est. primary completion date October 2005
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• cognitive rehabilitation
computer training
Procedure:
• work therapy
opportunity to work in carefully supervised hospital job
Behavioral:
• work therapy
work therapy

Locations
Country Name City State
United States VA Connecticut Healthcare System West Haven Connecticut

Sponsors (2)
Lead Sponsor Collaborator
VA Office of Research and Development VA Connecticut Healthcare System

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 Jun 5. — View Citation

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. — View Citation

Wexler BE, Bell MD. Cognitive remediation and vocational rehabilitation for schizophrenia. Schizophr Bull. 2005 Oct;31(4):931-41. Epub 2005 Aug 3. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Neuropsychological test performance data collection completed
Secondary Hours of productive activity data collection completed
Secondary Hours worked data collection completed
Secondary Quality of life data collection completed
Secondary Psychiatric symptoms data collection completed
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