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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)
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Outcomes
Full info

About this trial

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

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of either schizophrenia or schizoaffective disorder according to DSM-IV criteria Age 18 through 50 Subjects will be clinically stable as judged by current outpatient or inpatient treatment staff 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: Documented history of organic brain disease Documented history of mental retardation Physical limitations (e.g., with hearing or vision) that would interfere substantially with use of computer-based exercises Diagnosis of current Substance Dependence according to DSM-IV criteria 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).

Sites / Locations

  • University of Maryland - Walter P. Carter Center
  • VA Maryland Health Care Systen
  • MOSAIC Community Services

Outcomes

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

Full Information

First Posted
February 19, 2006
Last Updated
July 14, 2021
Sponsor
University of Maryland, Baltimore
Collaborators
National Institute of Mental Health (NIMH), VISN 5 Mental Illness Research, Education and Clinical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00295048
Brief Title
Cognitive Remediation for Schizophrenia
Official Title
Cognitive Remediation for Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
November 2004 (Actual)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
National Institute of Mental Health (NIMH), VISN 5 Mental Illness Research, Education and Clinical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Computer Assisted Cognitive Remediation (CACR)
Primary Outcome Measure Information:
Title
broad cognitive performance (as indexed by a composite of the neuropsychological measures) and on a composite of everyday problem solving
Secondary Outcome Measure Information:
Title
individual cognitive domains and individual everyday problem solving domains, the interaction of treatment with various other variables

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of either schizophrenia or schizoaffective disorder according to DSM-IV criteria Age 18 through 50 Subjects will be clinically stable as judged by current outpatient or inpatient treatment staff 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: Documented history of organic brain disease Documented history of mental retardation Physical limitations (e.g., with hearing or vision) that would interfere substantially with use of computer-based exercises Diagnosis of current Substance Dependence according to DSM-IV criteria 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dwight Dickinson, PhD
Organizational Affiliation
University of Maryland, College Park
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland - Walter P. Carter Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
VA Maryland Health Care Systen
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
MOSAIC Community Services
City
Catonsville
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States

12. IPD Sharing Statement

Citations:
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
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Cognitive Remediation for Schizophrenia

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