Remediation of Working Memory in Schizophrenia

NCT00995553 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2016-04-25

Study results available
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Summary

The primary aim of the study is to test the efficacy of a novel cognitive remediation intervention that targets working memory-related functions. To accomplish this goal, 80 volunteer patients with schizophrenia will be enrolled and randomized to either a cognitive remediation condition that targets working memory or a computer skills training intervention that teaches computer applications. In both conditions participants will receive computer training three times a week for 4 months. The investigators hypothesize that patients who receive the cognitive remediation intervention will demonstrate significantly greater change on neuropsychological measures of working memory and executive abilities than patients who receive the computer skills course. In addition, the investigators hypothesize that the intervention-induced cognitive change will be associated with concurrent improvements in functional capacity and psychosocial functioning in the community. A second study goal is to examine the stability of the intervention-induced changes in cognition. Cognition and psychosocial functioning will be reassessed 4 and 8 months after treatment termination to examine the stability of treatment effects and to assess whether a less intense maintenance training (once a week sessions) provides any additional benefit to participants. Lastly, this study will examine in an exploratory manner whether there are individual differences in treatment response. The Val158Met polymorphism of the COMT gene has been found to be associated with working memory and prefrontal dysfunction in schizophrenia. The study will test whether the COMT polymorphism is predictive of response to cognitive remediation.

Conditions

Interventions

BEHAVIORAL

Cognitive Remediation

This is an adaptive, computer-based cognitive training intervention. Participants will complete 3 1-hour cognitive training sessions focused on attention and working memory processes weekly for 4 months.

BEHAVIORAL

Computer Skills

This is a computer-based course in which participants will be taught how to use Microsoft Office applications and typing skills. Participants will attend a 1-hour course three times a week four 4-months.

Sponsors & Collaborators

  • Veterans Medical Research Foundation

    collaborator OTHER
  • Minneapolis Veterans Affairs Medical Center

    collaborator FED
  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Tasha Marie Nienow, PhD · Minneapolis VA Health Care System, Minneapolis, MN

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2015-04-30
Completion
2015-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00995553 on ClinicalTrials.gov