Optimizing Cognitive Remediation Outcomes in Schizophrenia (CAST)
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|ClinicalTrials.gov Identifier: NCT02105779|
Recruitment Status : Completed
First Posted : April 7, 2014
Last Update Posted : April 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Psychosis||Other: Targeted Cognitive Training Other: Social Cognitive Training||Not Applicable|
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:
- 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.
- To compare the outcomes of these two groups of subjects on measures of neurocognition, social cognition, motivation, and functional outcome.
- To assess subjects six months after the intervention to determine the durability of training effects.
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||172 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Optimizing Cognitive Remediation Outcomes in Schizophrenia|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||July 26, 2016|
Experimental: Targeted Cognitive Training
40 hours of BFP auditory training
Other: Targeted Cognitive Training
At present, the TCT exercises consist of three modules: an Auditory Processing Module (40-50 hours of training); a Visual Processing Module (30 hours); a Cognitive Control Module prototype (20 hours). [Based on the results of our current RCT, Posit Science has revised aspects of the training modules in order to further optimize its effectiveness for treatment of schizophrenia. In this study, we will use updated versions of the training software: an Auditory Module (30 hours), and a Visual Module (30 hours). Features from the Cognitive Control module prototype have been expanded and incorporated into these new modules.
Experimental: Social Cognitive Training
40 hours of auditory training and 10 hours social exercises
Other: Social Cognitive Training
We developed a systematic approach to basic training in facial emotion identification and discrimination and simple social perception and theory of mind tasks using components drawn from three commercially available software packages: the MicroExpressions Training Tool and The Subtle Expressions Training Tool (METT and SETT), plus the MindReading program. Training begins with simple emotion identification tasks, and slowly progressed to more difficult tasks that required subjects to discriminate between two subtle emotion expressions, and to correctly interpret the emotional significance of brief social scenes. A total of 10 hours of training occurred over 8 weeks.
- Change from Baseline Social Cognition at 6 months [ Time Frame: Baseline (Intake)/6 months follow-up after trianing completion ]Social functioning scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105779
|United States, California|
|San Francisco Veterans Medical Center|
|San Francisco, California, United States, 94121|
|Principal Investigator:||Sophia Vinogradov, MD||University of California, San Francisco|