Community-Based Cognitive Training in Early Schizophrenia
Condition: Schizophrenia; Psychosis
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Neuroadaptive cognitive training
Intervention type(s): Behavioral
Intervention description(s): TCT exercises consist of three modules: an Auditory Processing Module (40-50 hours of training); a Visual Processing Module (30 hours); a Cognitive Control Module prototype (20 hours). [Based on the results of our current RCT, Posit Science has revised aspects of the training modules in order to further optimize its effectiveness for treatment of schizophrenia. In this study, we will use updated versions of the training software: an Auditory Module (20 hours), and a Social Module (10 hours). Features from the Cognitive Control module prototype have been expanded and incorporated into these new modules.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment