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OpenTrials
Completed

NCT Number: NCT01988714

Cognitive Remediation of Schizophrenia in a Community Mental Health Setting

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

vinogradov research lab SFVAMC

San Francisco, California, 94115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

(TCT) plus evidence-based SE

Other

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

(CG) plus evidence-based SE

Other

(CG) plus evidence-based SE

Primary outcomes

  1. Neurocognition improvement

    Time frame: 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 outcomes

  1. employment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Acronym: SECT

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Nov 20, 2013
Registry last updated
Apr 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.