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Work Activity Augmented by Cognitive Rehabilitation for Schizophrenia

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cognitive rehabilitation
work therapy
work therapy
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring work therapy, cognitive rehabilitation, schizophrenia, schizoaffective disorder, treatment outcome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Connecticut Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

work therapy

work therapy plus cognitive remediation

Outcomes

Primary Outcome Measures

Neuropsychological test performance

Secondary Outcome Measures

Hours of productive activity
Hours worked
Quality of life
Psychiatric symptoms

Full Information

First Posted
January 31, 2007
Last Updated
September 7, 2017
Sponsor
VA Office of Research and Development
Collaborators
VA Connecticut Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT00430560
Brief Title
Work Activity Augmented by Cognitive Rehabilitation for Schizophrenia
Official Title
Work Activity Augmented by Cognitive Rehabilitation: Continuation and Follow-up
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
October 2000 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
VA Connecticut Healthcare System

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This research investigates the benefits of productive activity and cognitive rehabilitation for patients with schizophrenia. Key questions are: does cognitive rehabilitation plus work activity produce better outcomes than work activity alone? Is cognitive rehabilitation more helpful for individuals with moderate or greater cognitive impairment than for individuals without such impairment? Does cognitive rehabilitation reduce the dropout rate and increase participation in work activity for cognitively impaired subjects? What features of cognitive rehabilitation are most important for clinical and rehabilitation outcomes?
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
work therapy, cognitive rehabilitation, schizophrenia, schizoaffective disorder, treatment outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
work therapy
Arm Title
2
Arm Type
Experimental
Arm Description
work therapy plus cognitive remediation
Intervention Type
Behavioral
Intervention Name(s)
cognitive rehabilitation
Other Intervention Name(s)
computer training
Intervention Description
computer training
Intervention Type
Procedure
Intervention Name(s)
work therapy
Other Intervention Name(s)
IWT
Intervention Description
opportunity to work in carefully supervised hospital job
Intervention Type
Behavioral
Intervention Name(s)
work therapy
Intervention Description
work therapy
Primary Outcome Measure Information:
Title
Neuropsychological test performance
Time Frame
data collection completed
Secondary Outcome Measure Information:
Title
Hours of productive activity
Time Frame
data collection completed
Title
Hours worked
Time Frame
data collection completed
Title
Quality of life
Time Frame
data collection completed
Title
Psychiatric symptoms
Time Frame
data collection completed

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morris D Bell, Ph.D.
Organizational Affiliation
VA Connecticut Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Connecticut Healthcare System
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16079390
Citation
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.
Results Reference
background
PubMed Identifier
12823166
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. doi: 10.1034/j.1600-0447.2003.00090.x.
Results Reference
result
PubMed Identifier
11483142
Citation
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.
Results Reference
result
PubMed Identifier
16131943
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. doi: 10.1097/01.nmd.0000177790.23311.ba.
Results Reference
result
PubMed Identifier
16095473
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. doi: 10.1111/j.1600-0447.2005.00565.x.
Results Reference
result
PubMed Identifier
15870612
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. doi: 10.1097/01.nmd.0000161688.47164.71.
Results Reference
result
PubMed Identifier
16680620
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. doi: 10.1682/jrrd.2005.03.0061.
Results Reference
result
PubMed Identifier
16737798
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. doi: 10.1016/j.schres.2006.04.011. Epub 2006 Jun 5.
Results Reference
result
PubMed Identifier
16571581
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. doi: 10.1080/13546800344000084.
Results Reference
result

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Work Activity Augmented by Cognitive Rehabilitation for Schizophrenia

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