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The purpose of this study is to determine whether cognitive training exercises can improve cognitive functioning in young patients with recent-onset schizophrenia, schizoaffective, schizophreniform, and psychosis NOS who are being treated in community mental health settings. We will investigate the effects of web-based cognitive training exercises delivered on a portable laptop computer. The findings will provide us with valuable information on whether cognitive training can improve the cognition and functioning of young individuals early in the course of schizophrenia.
The purpose of this study is to perform a double-blind randomized controlled trial (RCT) in young patients with recent-onset (RO) schizophrenia to target improvement in cognitive functioning within real-world treatment settings. This multi-site study will be performed in 4 community mental health centers with specialized Early Intervention Services (EIS). We will compare the effects of web-based targeted cognitive training (TCT) vs. web-based general cognitive exercises (GCE), both delivered via portable laptop computers. We will investigate the behavioral and functional changes seen immediately after the intervention as well as at 6-month follow-up, compared to a no-training control group (NTC). This will be the first study to investigate cognitive enhancement for young RO schizophrenia patients in community mental health settings, using scalable interactive neurotechnology, and the first to compare two distinct cognitive training approaches. This study will generate high impact data on the potential for targeted pre-emotion of the downward spiral of in cognitive and functional disability that often characterizes psychotic illness. It will also generate valuable data on the relative effects of two distinct cognitive training approaches in schizophrenia, each derived from a very different theoretical rationale, providing much-needed information on the efficacy of a targeted "distributed neural system" training model derived from systems neuroscience vs. a "general cognitive stimulation" training model derived from neuropsychological rehabilitation approaches. The aims of this project are based on the current state of early psychosis research, as well as our own experience successfully applying neuroscience-informed cognitive training in schizophrenia. It is now abundantly clear that cognitive/neural system dysfunction represents a significant risk factor for schizophrenia as well as a poor prognostic indicator. Functional outcome in RO schizophrenia is predicted by level of cognitive impairment and baseline cognitive reserve, and recent findings suggest that specialized EIS programs focusing only on symptom reduction and psychosocial support may not robustly improve long-term outcomes- indicating that critical treatment targets are not being addressed at present in early psychosis interventions. Cognitive dysfunction and underlying neural system inefficiency should therefore be one of the primary targets for pre-emptive intervention in early psychosis. In this study, we will determine whether we can achieve this goal using cognitive training delivered via a portable computer, in order to improve functional outcome in young individuals with RO schizophrenia.
Age
18 - 35 years
Sex
ALL
Healthy Volunteers
No
Prevention and Recovery in Early Psychosis (PREP) Program
San Francisco, California, United States
Start Date
December 1, 2013
Primary Completion Date
August 21, 2019
Completion Date
August 21, 2019
Last Updated
September 17, 2019
174
ACTUAL participants
Neuroadaptive cognitive training
BEHAVIORAL
Lead Sponsor
University of California, San Francisco
NCT07226895
NCT06159673
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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View ClinicalTrials.gov Terms and ConditionsNCT07455929