CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 86 enrolled
Drug / intervention
Cognitive Remediation +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00995553
NCT00995553N/ACompleted

Remediation of Working Memory in Schizophrenia

VA Office of Research and Development·interventional·Posted Oct 15, 2009·Updated Apr 25, 2016

In Brief

A clinical study evaluating Cognitive Remediation and Computer Skills for Schizophrenia and Schizoaffective Disorder. Completed, enrolled 86 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 15, 2009
Enrollment StartJan 1, 2010
Primary CompletionApr 1, 2015
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 16.7 years ago

Interventions

Cognitive Remediationbehavioral

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.

Computer Skillsbehavioral

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.