Remediation of Working Memory in Schizophrenia
2 other identifiers
interventional
86
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable schizophrenia
Started Jan 2010
Longer than P75 for not_applicable schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2009
CompletedFirst Posted
Study publicly available on registry
October 15, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedResults Posted
Study results publicly available
April 25, 2016
CompletedApril 25, 2016
April 1, 2016
5.2 years
October 14, 2009
February 25, 2016
April 12, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Cognitive Assessment - MATRICS Consensus Cognitive Battery
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.
Post-intervention, within 2 weeks of completion of the 4 month intervention
Secondary Outcomes (1)
Functional Capacity - University of California, San Diego Performance-Based Skills Assessment
Post-intervention, within 2 weeks of completion of the 4 month intervention
Study Arms (2)
Cognitive Remediation
EXPERIMENTALA 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.
Computer Skills
PLACEBO COMPARATORThis 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.
Interventions
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.
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417, United States
Related Publications (1)
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.
PMID: 28153927DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Tasha Nienow
- Organization
- Minneapolis VA Health Care System
Study Officials
- PRINCIPAL INVESTIGATOR
Tasha Marie Nienow, PhD
Minneapolis VA Health Care System, Minneapolis, MN
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2009
First Posted
October 15, 2009
Study Start
January 1, 2010
Primary Completion
April 1, 2015
Study Completion
December 1, 2015
Last Updated
April 25, 2016
Results First Posted
April 25, 2016
Record last verified: 2016-04