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CompletedNCT01988714SECTUpdated Apr 5, 2019

Cognitive Remediation of Schizophrenia in a Community Mental Health Setting

An interventional study of (TCT) plus evidence-based SE and (CG) plus evidence-based SE in Experimental Condition TCT and Controlled Condition CG, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-04-05.

Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
112
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Experimental Condition TCT
  • Controlled Condition CG

Keywords

  • Targeted cognitive training (TCT) plus evidence-based SE
  • Computer games (CG) plus evidence-based SE
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In context

Disease

1,327 studies on the registry are indexed under Disease; 596 are open to participants now.

This study's enrollment of 112 is above the median of 80 across 732 interventional studies indexed under Disease.

Browse Disease studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
112 participants (actual)

Study arms

  • Experimental
    (TCT) plus evidence-based SE

    (TCT) plus evidence-based SE

    Other: (CG) plus evidence-based SE

  • Placebo comparator
    (CG) plus evidence-based SE

    (CG) plus evidence-based SE

    Other: (TCT) plus evidence-based SE

Interventions

  • Other(TCT) plus evidence-based SE

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

  • Other(CG) plus evidence-based SE

    (CG) plus evidence-based SE

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 24 months

Secondary outcomes

  1. 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.

    Time frame: 24 months

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Study locations

1 site
  • vinogradov research lab SFVAMC
    San Francisco, California 94115, United States
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References and documents

Publications

  • Roberts MT, Lloyd J, Valimaki M, Ho GW, Freemantle M, Bekefi AZ. Video games for people with schizophrenia. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD012844. doi: 10.1002/14651858.CD012844.pub2. PubMed 33539561 ↗
  • Biagianti B, Fisher M, Neilands TB, Loewy R, Vinogradov S. Engagement with the auditory processing system during targeted auditory cognitive training mediates changes in cognitive outcomes in individuals with schizophrenia. Neuropsychology. 2016 Nov;30(8):998-1008. doi: 10.1037/neu0000311. Epub 2016 Sep 12. PubMed 27617637 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01988714
Lead sponsor
University of California, San Francisco
Responsible party
Sponsor
First posted
Nov 20, 2013
Start date
Sep 2009
Primary completion
Sep 26, 2016
Completion
Sep 26, 2016
Last update
Apr 5, 2019

Study contacts

Sophia Vinogradov, MD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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