Cognitive Remediation of Schizophrenia in a Community Mental Health Setting

Controlled Condition CG Clinical Trial

— SECT  

Official title:

Cognitive Remediation of Schizophrenia in a Community Mental Health Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01988714
• Other study ID #: R01MH068725
• Status: Completed
• Phase: N/A
• Start date: September 2009
• Est. completion date: September 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: September 26, 2016
• Est. primary completion date: September 26, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

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.

Related Conditions & MeSH terms

• Controlled Condition CG
• Disease
• Experimental Condition TCT
• Schizophrenia

Intervention

Other:
• (TCT) plus evidence-based SE
Targeted cognitive computer training (TCT) plus evidence-based SE in a community setting
• (CG) plus evidence-based SE
(CG) plus evidence-based SE

Locations

Country	Name	City	State
United States	vinogradov research lab SFVAMC	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	Neurocognition improvement	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.	24 months
Secondary	employment	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.	24 months