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Cognitive Remediation for Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
computer-assisted cognitive remediation (CACR)
manualized computer control condition (RC).
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring cognition, schizophrenia, treatment

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Current DSM-IV diagnoses of schizophrenia or schizoaffective disorder Stable clinical course and antipsychotic treatment on a new generation antipsychotic other than clozapine and/or a dose of first generation antipsychotic equivalent to 10 mg. or less of haloperidol for one month prior to enrollment Age between 18 and 64 years Voluntary consent after receiving full information about the study Exclusion Criteria: Documented history of neurological disorder or significant head trauma with extended loss of consciousness Physical limitations (e.g., with hearing or vision) that would interfere substantially with the use of computer-based exercises Current treatment with a first generation antipsychotic medication at a dose equivalent to more than 10 mg. of haloperidol Current treatment with benztropine mesylate at a daily does greater than 4 mg Current treatment with trihexyphenidyl at a daily dose greater than 15 mg Current treatment that combines benztropine mesylate with trihexyphenidyl Current treatment with diphenhydramine Current competitive employment or participation (current or within past 3 months) in a program designed to secure competitive employment (e.g., CWT) Mini Mental Status Examination (MMSE) score of less than 23 Diagnosis of current Substance Dependence according to DSM-IV criteria

Sites / Locations

  • VA Maryland Health Care System, Baltimore

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

computer-assisted cognitive remediation (CACR)

computer-based cognitive activity

Outcomes

Primary Outcome Measures

cognitive performance and every day problem solving

Secondary Outcome Measures

Full Information

First Posted
December 1, 2005
Last Updated
January 5, 2010
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00261794
Brief Title
Cognitive Remediation for Schizophrenia
Official Title
Computer Assisted Cognitive Remediation for Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy of an innovative, computer driven cognitive rehabilitation program for unemployed veterans with schizophrenia.
Detailed Description
Schizophrenia leads to a striking array of negative outcomes, including profound deficits in the ability to fulfill desired and expected community roles. Chronic under employment and unemployment are among the most serious of these consequences. VA treats over 100,000 veterans with schizophrenia spectrum disorders, the majority of whom are unable to work competitively and do not participate in VA vocational rehabilitation programs despite the fact that VA is committed to enhancing the ability of these veterans to work. Within VA, a major vehicle for helping veterans to become employed is the Compensated Work Therapy (CWT) program, yet in FY2001 only 800 of the roughly 14000 veterans treated in CWT had SMI diagnoses, and only a subset of those 800 had schizophrenia. A number of factors contribute to low participation in vocational rehabilitation and poor work outcomes, but recent data suggest that one of the most important is cognitive impairment. People with schizophrenia have significant deficits in multiple areas of neurocognition, including secondary and working memory, attention, and executive functioning. These impairments have been shown to play a major role in functional outcome, including the ability to benefit from rehabilitation and to work. As a result, there has been increasing interest in the potential for improving neurocognitive functioning via cognitive rehabilitation. While several programs have yielded promising data, currently there is no empirically validated approach.The purpose of this project is to evaluate the efficacy of an innovative, computer driven cognitive rehabilitation program we have developed: Computer Assisted Cognitive Remediation (CACR). Veterans with schizophrenia who are unemployed and not participating in vocational rehabilitation will be recruited and randomly assigned to one of two conditions: a) 36 sessions of CACR; or b) 36 sessions of a manualized computer control condition (RC). The efficacy of CACR will be assessed on a range of outcome domains, including neuropsychological test, measures of every day and social problem solving, self-reported cognitive functioning and self-efficacy, and work readiness. All subjects will be referred to CWT at the conclusion of treatment and we will assess how many receive work assignments, and work performance (over 3-months) of those who begin work. We hypothesize that CACR will be more effective than the control treatment in each domain.The results of this project could have important implications for treatment of veterans with schizophrenia. CACR is a manualized program that can be administered by BA level staff. If demonstrated to be efficacious, it could be disseminated throughout VA and have a beneficial impact on vocational outcomes and the quality of life of veterans with schizophrenia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
cognition, schizophrenia, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
computer-assisted cognitive remediation (CACR)
Arm Title
2
Arm Type
Active Comparator
Arm Description
computer-based cognitive activity
Intervention Type
Behavioral
Intervention Name(s)
computer-assisted cognitive remediation (CACR)
Other Intervention Name(s)
CACR
Intervention Description
36 individual computer sessions with a staff clinician. computer activities consist of commercially available educational software designed for use in the classroom.
Intervention Type
Behavioral
Intervention Name(s)
manualized computer control condition (RC).
Other Intervention Name(s)
RC
Intervention Description
36 sessions of a manualized computer control condition.
Primary Outcome Measure Information:
Title
cognitive performance and every day problem solving
Time Frame
post-treatment and 3-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Current DSM-IV diagnoses of schizophrenia or schizoaffective disorder Stable clinical course and antipsychotic treatment on a new generation antipsychotic other than clozapine and/or a dose of first generation antipsychotic equivalent to 10 mg. or less of haloperidol for one month prior to enrollment Age between 18 and 64 years Voluntary consent after receiving full information about the study Exclusion Criteria: Documented history of neurological disorder or significant head trauma with extended loss of consciousness Physical limitations (e.g., with hearing or vision) that would interfere substantially with the use of computer-based exercises Current treatment with a first generation antipsychotic medication at a dose equivalent to more than 10 mg. of haloperidol Current treatment with benztropine mesylate at a daily does greater than 4 mg Current treatment with trihexyphenidyl at a daily dose greater than 15 mg Current treatment that combines benztropine mesylate with trihexyphenidyl Current treatment with diphenhydramine Current competitive employment or participation (current or within past 3 months) in a program designed to secure competitive employment (e.g., CWT) Mini Mental Status Examination (MMSE) score of less than 23 Diagnosis of current Substance Dependence according to DSM-IV criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan S. Bellack, PhD
Organizational Affiliation
VA Maryland Health Care System, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Maryland Health Care System, Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
10416730
Citation
Bellack AS, Gold JM, Buchanan RW. Cognitive rehabilitation for schizophrenia: problems, prospects, and strategies. Schizophr Bull. 1999;25(2):257-74. doi: 10.1093/oxfordjournals.schbul.a033377.
Results Reference
result
PubMed Identifier
15222149
Citation
Bellack AS. Skills training for people with severe mental illness. Psychiatr Rehabil J. 2004 Spring;27(4):375-91. doi: 10.2975/27.2004.375.391.
Results Reference
result
PubMed Identifier
20008941
Citation
Dickinson D, Tenhula W, Morris S, Brown C, Peer J, Spencer K, Li L, Gold JM, Bellack AS. A randomized, controlled trial of computer-assisted cognitive remediation for schizophrenia. Am J Psychiatry. 2010 Feb;167(2):170-80. doi: 10.1176/appi.ajp.2009.09020264. Epub 2009 Dec 15.
Results Reference
result

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Cognitive Remediation for Schizophrenia

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