Optimizing Cognitive Remediation Outcomes in Schizophrenia

Schizophrenia Clinical Trial

— CAST  

Official title:

Optimizing Cognitive Remediation Outcomes in Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02105779
• Other study ID #: R01MH082818
• Status: Completed
• Phase: N/A
• Start date: December 2009
• Est. completion date: July 26, 2016

Study information

• Verified date: April 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: July 26, 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Psychosis
• Schizophrenia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	San Francisco Veterans Medical Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Social Cognition at 6 months	Social functioning scale	Baseline (Intake)/6 months follow-up after trianing completion