Remediation of Working Memory in Schizophrenia

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease	Intervention/treatment	Phase
Schizophrenia; Schizoaffective Disorder	Behavioral: Cognitive Remediation; Behavioral: Computer Skills	Not Applicable

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	86 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Remediation of Working Memory in Schizophrenia
Study Start Date :	January 2010
Actual Primary Completion Date :	April 2015
Actual Study Completion Date :	December 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Cognitive Remediation; A 48-session working memory focused cognitive remediation program is conducted. Training tasks have been selected from 3 software programs, PSS CogRehab, BrainTrain, and custom made N-back tasks.	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.
Placebo Comparator: Computer Skills; This is a 48-session, time matched comparison group in which participants practice keyboarding skills and the fundamentals of Microsoft Office Word, Powerpoint, and Excel programs.	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.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

United States, Minnesota
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States, 55417

Sponsors and Collaborators

VA Office of Research and Development

Veterans Medical Research Foundation

Minneapolis Veterans Affairs Medical Center

Investigators

Principal Investigator:	Tasha Marie Nienow, PhD	Minneapolis VA Health Care System, Minneapolis, MN

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ramsay IS, Nienow TM, Marggraf MP, MacDonald AW. Neuroplastic changes in patients with schizophrenia undergoing cognitive remediation: triple-blind trial. Br J Psychiatry. 2017 Mar;210(3):216-222. doi: 10.1192/bjp.bp.115.171496. Epub 2017 Feb 2.

Responsible Party:	VA Office of Research and Development
ClinicalTrials.gov Identifier:	NCT00995553 History of Changes
Other Study ID Numbers:	D6981-R; 1I01RX000180-01 ( U.S. NIH Grant/Contract )
First Posted:	October 15, 2009
Results First Posted:	April 25, 2016
Last Update Posted:	April 25, 2016
Last Verified:	April 2016

Additional relevant MeSH terms:

Schizophrenia; Psychotic Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders