Clinical trial NCT01988714: Cognitive Remediation of Schizophrenia in a Community Mental Health Setting
Official title: Cognitive Remediation of Schizophrenia in a Community Mental Health Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Experimental Condition TCT
Controlled Condition CG
Keywords: Targeted cognitive training (TCT) plus evidence-based SE
Computer games (CG) plus evidence-based SE
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2013-11-20
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Neurocognition improvement
timeFrame: 24 months
Secondary outcomes:
measure: employment
timeFrame: 24 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: vinogradov research lab SFVAMC
state: California
Study officials:
affiliation: University of California, San Francisco
name: Sophia Vinogradov, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.