Clinical trial NCT02105779: Optimizing Cognitive Remediation Outcomes in Schizophrenia
Official title: Optimizing Cognitive Remediation Outcomes in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Psychosis
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2014-04-07
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to drive an optimal response to neuroplasticity-based cognitive remediation in schizophrenia in order to maximize treatment response. The investigators will investigate factors that have generally been ignored in prior computer-based cognitive remediation programs-those related to social cognition-- and will delineate their relationship to motivation, functional outcome, and the neural substrates of reward anticipation and emotion processing. Current research indicates that, unless the investigators fully understand and harness these factors, the investigators will not achieve meaningful treatment gains for individuals with schizophrenia.

Detailed description: The purpose of this study is to explicitly and aggressively drive an optimal response to neuroplasticity- based cognitive remediation in schizophrenia in order to maximize treatment response. We will investigate factors that have generally been ignored in computer-based cognitive remediation programs-those related to social cognition-- and will delineate their relationship to motivation, functional outcome, and the neural substrates of reward anticipation and emotion processing. Current research indicates that, unless we fully understand and harness these factors, we will not achieve meaningful treatment gains for individuals with schizophrenia.

Our specific aims are:

1. To perform an RCT in which 100 schizophrenia subjects are assigned to either 60 hours of neuroplasticity- based computerized targeted cognitive training (TCT) that focuses exclusively on "cold cognition" (a program which trains early sensory processing, attention, working memory and cognitive control in auditory and visual domains), or to 60 hours of training that combines the TCT program with 20 minutes per day of adaptive computerized social cognition training (SCT) exercises.
2. To compare the outcomes of these two groups of subjects on measures of neurocognition, social cognition, motivation, and functional outcome.
3. To assess subjects six months after the intervention to determine the durability of training effects.
4. To identify changes in brain activation patterns in key neural regions as a result of TCT alone vs. TCT+SCT: during reward anticipation, and during emotion recognition.

The timeliness of this approach is supported by recent evidence demonstrating only weak associations between traditional cognitive remediation approaches and functional outcome in schizophrenia, but a strong, direct relationship between social cognition and functional outcome. Thus we must now examine the clinical, functional, and neural effects of a well-designed state-of-the-art cognitive training program that combines neurocognition with social cognition training.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of schizophrenia or schizoaffective disorder
* Between 18-65 years of age
* Clinically stable
* Fluent in English

Exclusion Criteria:

* Recent hospitalization, in the past 3 months
* History of traumatic brain injury
* Neurological disorders
* Inability to participate in the study soberly

Primary outcomes:
measure: Change from Baseline Social Cognition at 6 months
timeFrame: Baseline (Intake)/6 months follow-up after trianing completion
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco Veterans Medical Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Sophia Vinogradov, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fisher M, Nahum M, Howard E, Rowlands A, Brandrett B, Kermott A, Woolley J, Vinogradov S. Supplementing intensive targeted computerized cognitive training with social cognitive exercises for people with schizophrenia: An interim report. Psychiatr Rehabil J. 2017 Mar;40(1):21-32. doi: 10.1037/prj0000244.
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.