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Cognitive Remediation of Schizophrenia in a Community Mental Health Setting (SECT)

Primary Purpose

Experimental Condition TCT, Controlled Condition CG

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
(TCT) plus evidence-based SE
(CG) plus evidence-based SE
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Experimental Condition TCT focused on measuring Targeted cognitive training (TCT) plus evidence-based SE, Computer games (CG) plus evidence-based SE

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • vinogradov research lab SFVAMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

(TCT) plus evidence-based SE

(CG) plus evidence-based SE

Arm Description

(TCT) plus evidence-based SE

(CG) plus evidence-based SE

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 13, 2013
Last Updated
April 3, 2019
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT01988714
Brief Title
Cognitive Remediation of Schizophrenia in a Community Mental Health Setting
Acronym
SECT
Official Title
Cognitive Remediation of Schizophrenia in a Community Mental Health Setting
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 26, 2016 (Actual)
Study Completion Date
September 26, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Experimental Condition TCT, Controlled Condition CG
Keywords
Targeted cognitive training (TCT) plus evidence-based SE, Computer games (CG) plus evidence-based SE

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
(TCT) plus evidence-based SE
Arm Type
Experimental
Arm Description
(TCT) plus evidence-based SE
Arm Title
(CG) plus evidence-based SE
Arm Type
Placebo Comparator
Arm Description
(CG) plus evidence-based SE
Intervention Type
Other
Intervention Name(s)
(TCT) plus evidence-based SE
Intervention Description
Targeted cognitive computer training (TCT) plus evidence-based SE in a community setting
Intervention Type
Other
Intervention Name(s)
(CG) plus evidence-based SE
Intervention Description
(CG) plus evidence-based SE
Primary Outcome Measure Information:
Title
Neurocognition improvement
Description
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 Outcome Measure Information:
Title
employment
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophia Vinogradov, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
vinogradov research lab SFVAMC
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33539561
Citation
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.
Results Reference
derived
PubMed Identifier
27617637
Citation
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.
Results Reference
derived

Learn more about this trial

Cognitive Remediation of Schizophrenia in a Community Mental Health Setting

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