Computer Assisted Cognitive Remediation (CACR) in Schizophrenia - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Schizophrenia

Intervention / Treatment

Behavioral: Computer Assisted Cognitive Remediation (CACR)

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Maryland
  - Baltimore, Maryland, United States, 21201
    - University of Maryland - Walter P. Carter Center
  - Baltimore, Maryland, United States, 21201
    - VA Maryland Health Care Systen
  - Catonsville, Maryland, United States, 21228
    - MOSAIC Community Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Single Group Assignment
Masking: Single

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
individual cognitive domains and individual everyday problem solving domains, the interaction of treatment with various other variables

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Collaborators

National Institute of Mental Health (NIMH)

VISN 5 Mental Illness Research, Education and Clinical Center

Investigators

Principal Investigator: Dwight Dickinson, PhD, University of Maryland, College Park

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2004

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)