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Cognitive Remediation for Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00295048
Recruitment Status : Completed
First Posted : February 22, 2006
Last Update Posted : April 20, 2017
National Institute of Mental Health (NIMH)
VISN 5 Mental Illness Research, Education and Clinical Center
Information provided by (Responsible Party):
University of Maryland

Brief Summary:
The purpose of this study is to evaluate the efficacy of an innovative, computer driven cognitive rehabilitation program for individuals with schizophrenia and related disorders.

Condition or disease Intervention/treatment Phase
Schizophrenia Behavioral: Computer Assisted Cognitive Remediation (CACR) Not Applicable

Detailed Description:

Schizophrenia is associated with neurocognitive impairment, diminished life satisfaction, lack of independence, and poor functioning in social, occupational and other desired and expected community roles. The personal, social and economic costs of this illness are enormous. Neurocognitive deficits (e.g., slowed thinking, poor attention and memory, inadequate problem solving) are now recognized as core features of the illness, and primary contributors to functional impairment among patients (Bellack, Gold & Buchanan; 1999; Green, 1996). While standard antipsychotic medications improve psychotic symptomatology in many patients, their impact on neurocognition is modest, at best, and dramatic functional deficits remain even after adequate pharmacological treatment (Keefe et al., 1999). Hence, there is growing interest in alternative treatment strategies to address cognitive deficits, including computer-assisted cognitive remediation.

The purpose of this project is to assess the efficacy of a computer-assisted cognitive remediation program we have developed: Computer Assisted Cognitive Remediation (CACR). Fifty individuals with schizophrenia and related disorders 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 behavioral performance in three dimensions: (1) on the trained learning exercises, (2) on neuropsychological measures, and (3) on role play based assessments of everyday problem solving. We hypothesize that CACR will be more effective than the control treatment in each domain.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Cognitive Remediation for Schizophrenia
Actual Study Start Date : November 2004
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Primary Outcome Measures :
  1. broad cognitive performance (as indexed by a composite of the neuropsychological measures) and on a composite of everyday problem solving

Secondary Outcome Measures :
  1. individual cognitive domains and individual everyday problem solving domains, the interaction of treatment with various other variables

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Diagnosis of either schizophrenia or schizoaffective disorder according to DSM-IV criteria
  2. Age 18 through 50
  3. Subjects will be clinically stable as judged by current outpatient or inpatient treatment staff
  4. Primary psychiatric medication is a new generation antipsychotic other than Clozapine and/or a dose of first generation antipsychotic equivalent to 10 mg. of less of haloperidol for one month prior to enrollment.

Exclusion Criteria:

  1. Documented history of organic brain disease
  2. Documented history of mental retardation
  3. Physical limitations (e.g., with hearing or vision) that would interfere substantially with use of computer-based exercises
  4. Diagnosis of current Substance Dependence according to DSM-IV criteria
  5. Participation in the prior full trial of this remediation program (this exclusion is meant to apply to individuals participating in the full controlled trial, and not to individuals participating in the preliminary sub-study).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00295048

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United States, Maryland
University of Maryland - Walter P. Carter Center
Baltimore, Maryland, United States, 21201
VA Maryland Health Care Systen
Baltimore, Maryland, United States, 21201
MOSAIC Community Services
Catonsville, Maryland, United States, 21228
Sponsors and Collaborators
University of Maryland
National Institute of Mental Health (NIMH)
VISN 5 Mental Illness Research, Education and Clinical Center
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Principal Investigator: Dwight Dickinson, PhD University of Maryland

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Maryland Identifier: NCT00295048     History of Changes
Other Study ID Numbers: H-24292
First Posted: February 22, 2006    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017

Keywords provided by University of Maryland:

Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders