Clinical Trials Directory

Trials / Completed

CompletedNCT00995553

Remediation of Working Memory in Schizophrenia

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
86 (actual)
Sponsor
VA Office of Research and Development · Federal
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCognitive RemediationThis 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.
BEHAVIORALComputer SkillsThis 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.

Timeline

Start date
2010-01-01
Primary completion
2015-04-01
Completion
2015-12-01
First posted
2009-10-15
Last updated
2016-04-25
Results posted
2016-04-25

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00995553. Inclusion in this directory is not an endorsement.