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Completed

NCT Number: NCT00995553

Remediation of Working Memory in Schizophrenia

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.

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Key information

Conditions

Schizophrenia Mental Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Veterans with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder
  • No hospitalizations in the previous 4 weeks
  • No antipsychotic medication changes in the previous 4 weeks
  • Age 18-60
  • Does not meet DSM-IV criteria for substance dependence in the previous 6 months or substance abuse in the previous month

Exclusion criteria

  • History of clinically significant head injury or neurological disease
  • Poor comprehension of the English language
  • History of diagnosis of mental retardation or pervasive developmental disorder
  • Unable to give informed consent

Treatment and study plan

Cognitive Remediation

Behavioral

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.

Computer Skills

Behavioral

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.

Primary outcomes

  1. Cognitive Assessment - MATRICS Consensus Cognitive Battery

    Time frame: Post-intervention, within 2 weeks of completion of the 4 month intervention

    The Working Memory and Attention indexes of the MATRICS Consensus Cognitive Battery was used to assess near generalization of training with untrained tasks that were conceptually similar to training tasks. Each scale provide an age and gender corrected T-score. Thus, scores can range from 0-100, with a higher score indicating better performance.

Secondary outcomes

  1. Functional Capacity - University of California, San Diego Performance-Based Skills Assessment

    Time frame: Post-intervention, within 2 weeks of completion of the 4 month intervention

    The UPSA is a measure of the ability to apply cognitive skills to functional tasks. The total score from this scale was used. Scores may range from 0 - 100, with higher scores being better.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • Minneapolis Veterans Affairs Medical Center
  • Veterans Medical Research Foundation

Registry information

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Oct 15, 2009
Registry last updated
Apr 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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