Remediation of Working Memory in Schizophrenia

This study has been completed.
Sponsor:
Collaborators:
Veterans Medical Research Foundation
Minneapolis Veterans Affairs Medical Center
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00995553
First received: October 14, 2009
Last updated: April 12, 2016
Last verified: April 2016
  Purpose
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 Intervention
Schizophrenia
Schizoaffective Disorder
Behavioral: Cognitive Remediation
Behavioral: Computer Skills

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Remediation of Working Memory in Schizophrenia

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Cognitive Assessment - MATRICS Consensus Cognitive Battery [ Time Frame: Post-intervention, within 2 weeks of completion of the 4 month intervention ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 86
Study Start Date: January 2010
Study Completion Date: December 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00995553

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

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00995553     History of Changes
Other Study ID Numbers: D6981-R  1I01RX000180-01 
Study First Received: October 14, 2009
Results First Received: February 25, 2016
Last Updated: April 12, 2016
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 28, 2016