Skills Training With Computers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Minneapolis Veterans Affairs Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT00995553
First received: October 14, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  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 Minneapolis Veterans Affairs Medical Center:

Primary Outcome Measures:
  • Cognitive Assessment - MATRICS Consensus Cognitive Battery and N-back tasks [ Time Frame: Pre-and Post-intervention and 4 and 8-month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional Capacity - University of California, San Diego Performance-Based Skills Assessment and Social Skills Performance Assessment Community Functioning - Social Functioning Scale [ Time Frame: Pre-and Post-intervention and 4 and 8-month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: January 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Remediation 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 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00995553

Contacts
Contact: Tasha M Nienow, PhD 612-467-1004 Tasha.Nienow@va.gov

Locations
United States, Minnesota
Minneapolis VA Medical Center Not yet recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Tasha M Nienow, PhD    612-467-1004    Tasha.Nienow@va.gov   
Principal Investigator: Tasha M Nienow, PhD         
Sponsors and Collaborators
Minneapolis Veterans Affairs Medical Center
Investigators
Principal Investigator: Tasha M Nienow, PhD Minneapolis Veterans Affairs Medical Center
  More Information

No publications provided

Responsible Party: Tasha Nienow, Principal Investigator, Minneapolis VA Medical Center
ClinicalTrials.gov Identifier: NCT00995553     History of Changes
Other Study ID Numbers: 1I01RX000180-01
Study First Received: October 14, 2009
Last Updated: October 14, 2009
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on April 22, 2014