Optimizing Cognitive Remediation Outcomes in Schizophrenia

Not Applicable

Completed

• Conditions: Psychosis; Schizophrenia
• Interventions: Other: Targeted Cognitive Training; Other: Social Cognitive Training

• Registration Number: NCT02105779
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2014-03-11
• Study First Submitted QC: 2014-04-02
• Study First Posted: 2014-04-07
• Primary Completion: 2016-05
• Study Completion: 2016-07-26
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-03
• Last Update Posted: 2019-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Targeted Cognitive Training	Targeted Cognitive Training	40 hours of BFP auditory training
Social Cognitive Training	Social Cognitive Training	40 hours of auditory training and 10 hours social exercises

Primary Outcome Measures

Name	Time	Method
Change from Baseline Social Cognition at 6 months	Baseline (Intake)/6 months follow-up after trianing completion	Social functioning scale

Trial Locations

Locations (1)

San Francisco Veterans Medical Center; 🇺🇸 San Francisco, California, United States