Cognitive Remediation for Schizophrenia

This study has been completed.
Sponsor:
Collaborators:
VISN 5 Mental Illness Research, Education and Clinical Center
Information provided by:
University of Maryland
ClinicalTrials.gov Identifier:
NCT00295048
First received: February 19, 2006
Last updated: June 26, 2007
Last verified: May 2007
  Purpose

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 Intervention
Schizophrenia
Behavioral: Computer Assisted Cognitive Remediation (CACR)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Cognitive Remediation for Schizophrenia

Resource links provided by NLM:


Further study details as provided by University of Maryland:

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

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

Enrollment: 50
Study Start Date: November 2004
Study Completion Date: May 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295048

Locations
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
VISN 5 Mental Illness Research, Education and Clinical Center
Investigators
Principal Investigator: Dwight Dickinson, PhD University of Maryland
  More Information

No publications provided by University of Maryland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00295048     History of Changes
Other Study ID Numbers: 24292
Study First Received: February 19, 2006
Last Updated: June 26, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
treatment
cognition
schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014