Cognitive Remediation of Schizophrenia in a Community Mental Health Setting

NCT ID: NCT01988714

Last Updated: 2019-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2016-09-26

Brief Summary

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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

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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.

Conditions

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Experimental Condition TCT Controlled Condition CG

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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(TCT) plus evidence-based SE

(TCT) plus evidence-based SE

Group Type EXPERIMENTAL

(CG) plus evidence-based SE

Intervention Type OTHER

(CG) plus evidence-based SE

(CG) plus evidence-based SE

(CG) plus evidence-based SE

Group Type PLACEBO_COMPARATOR

(TCT) plus evidence-based SE

Intervention Type OTHER

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

Interventions

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(TCT) plus evidence-based SE

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

Intervention Type OTHER

(CG) plus evidence-based SE

(CG) plus evidence-based SE

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sophia Vinogradov, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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vinogradov research lab SFVAMC

San Francisco, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33539561 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27617637 (View on PubMed)

Other Identifiers

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R01MH068725

Identifier Type: NIH

Identifier Source: org_study_id

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