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Clinical Trials/NCT02105779
NCT02105779
Completed
Not Applicable

Optimizing Cognitive Remediation Outcomes in Schizophrenia

University of California, San Francisco1 site in 1 country172 target enrollmentDecember 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
University of California, San Francisco
Enrollment
172
Locations
1
Primary Endpoint
Change from Baseline Social Cognition at 6 months
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The purpose of this study is to drive an optimal response to neuroplasticity-based cognitive remediation in schizophrenia in order to maximize treatment response. The investigators will investigate factors that have generally been ignored in prior computer-based cognitive remediation programs-those related to social cognition-- and will delineate their relationship to motivation, functional outcome, and the neural substrates of reward anticipation and emotion processing. Current research indicates that, unless the investigators fully understand and harness these factors, the investigators will not achieve meaningful treatment gains for individuals with schizophrenia.

Detailed Description

The purpose of this study is to explicitly and aggressively drive an optimal response to neuroplasticity- based cognitive remediation in schizophrenia in order to maximize treatment response. We will investigate factors that have generally been ignored in computer-based cognitive remediation programs-those related to social cognition-- and will delineate their relationship to motivation, functional outcome, and the neural substrates of reward anticipation and emotion processing. Current research indicates that, unless we fully understand and harness these factors, we will not achieve meaningful treatment gains for individuals with schizophrenia. Our specific aims are: 1. To perform an RCT in which 100 schizophrenia subjects are assigned to either 60 hours of neuroplasticity- based computerized targeted cognitive training (TCT) that focuses exclusively on "cold cognition" (a program which trains early sensory processing, attention, working memory and cognitive control in auditory and visual domains), or to 60 hours of training that combines the TCT program with 20 minutes per day of adaptive computerized social cognition training (SCT) exercises. 2. To compare the outcomes of these two groups of subjects on measures of neurocognition, social cognition, motivation, and functional outcome. 3. To assess subjects six months after the intervention to determine the durability of training effects. 4. To identify changes in brain activation patterns in key neural regions as a result of TCT alone vs. TCT+SCT: during reward anticipation, and during emotion recognition. The timeliness of this approach is supported by recent evidence demonstrating only weak associations between traditional cognitive remediation approaches and functional outcome in schizophrenia, but a strong, direct relationship between social cognition and functional outcome. Thus we must now examine the clinical, functional, and neural effects of a well-designed state-of-the-art cognitive training program that combines neurocognition with social cognition training.

Registry
clinicaltrials.gov
Start Date
December 2009
End Date
July 26, 2016
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Clinical diagnosis of schizophrenia or schizoaffective disorder
  • Between 18-65 years of age
  • Clinically stable
  • Fluent in English

Exclusion Criteria

  • Recent hospitalization, in the past 3 months
  • History of traumatic brain injury
  • Neurological disorders
  • Inability to participate in the study soberly

Outcomes

Primary Outcomes

Change from Baseline Social Cognition at 6 months

Time Frame: Baseline (Intake)/6 months follow-up after trianing completion

Social functioning scale

Study Sites (1)

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