Cognitive Remediation of Schizophrenia in a Community Mental Health Setting

Not Applicable

Completed

• Conditions: Experimental Condition TCT; Controlled Condition CG
• Interventions: Other: (TCT) plus evidence-based SE; Other: (CG) plus evidence-based SE

• Registration Number: NCT01988714
• Lead Sponsor: University of California, San Francisco

Brief Summary

The purpose of this study is to investigate the usefulness of neuroscience-guided cognitive training combined with community-based supported employment for people with schizophrenia. The investigators will examine the effectiveness of moving our study of neuroplasticity-based restorative targeted cognitive training out of the laboratory and into the community setting; and the investigators will also investigate its utility in enhancing functional outcome in chronically mentally ill adults who are participating in supported employment.

Detailed Description

Neurocognitive functioning will be assessed at baseline (study entry), after cognitive training (6 months), and at 12 month follow-up, using the MATRICS Consensus Cognitive Battery (MCCB). The investigators will assess the following six constructs identified by MATRICS as separable, fundamental dimensions of cognitive impairment in schizophrenia, with a likely sensitivity to intervention \[26\]: 1) Speed of Processing, 2) Attention/Vigilance, 3) Working Memory, 4) Verbal Learning and Memory, 5) Visual Learning and Memory, and 6) Reasoning and Problem Solving (executive functioning). The investigators will also administer the delayed memory trials of HVLT and BVMT, Trails B, and D-KEFS Color-Word Interference Test \[27\], and will make one modification to the MCCB in utilizing BACS Tower of London \[28\] in place of NAB Mazes.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2013-11-13
• Study First Submitted QC: 2013-11-19
• Study First Posted: 2013-11-20
• Primary Completion: 2016-09-26
• Study Completion: 2016-09-26
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-03
• Last Update Posted: 2019-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

• diagnosis of schizophrenia or schizoaffective disorder(DSM-IV criteria)
• between the ages of 18-65
• English as primary language (learned before age 12)
• no major medical or neurological disorder that precludes participation in the study

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Exclusion Criteria

• We will not exclude subjects with substance abuse or dependence as we wish to investigate the real-world effectiveness of this cognitive remediation approach when combined with SE. As per the clinical policy at Community Services, however, patients will not be permitted to attend the SE program or to participate in the study if they are acutely intoxicated. Subjects who miss 5 consecutive days of participation due to intoxication will be dropped and a replacement subject will be recruited.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
(CG) plus evidence-based SE	(TCT) plus evidence-based SE	(CG) plus evidence-based SE
(TCT) plus evidence-based SE	(CG) plus evidence-based SE	(TCT) plus evidence-based SE

Primary Outcome Measures

Name	Time	Method
Neurocognition improvement	24 months	Schizophrenia subjects who receive 80 hours of targeted cognitive training (TCT) plus evidence-based SE in a community setting will show, compared to baseline, greater improvements in neurocognition at 10 weeks, 20 weeks, 6 months, 12 months, 18 months, and 24 months than subjects who receive 80 hours of computer games (CG) plus SE.

Secondary Outcome Measures

Name	Time	Method
employment	24 months	Schizophrenia participants who receive 80 hours of TCT plus SE will have higher rates of employment 12, 18, and 24 months than those who receive 80 hours of CG plus SE.

Trial Locations

Locations (1)

vinogradov research lab SFVAMC; 🇺🇸 San Francisco, California, United States