Does the Addition of Cognitive Remediation to Coordinated Specialty Care Services Improve Functional Outcome?

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Cognitive impairment is evident at first episode in most people with schizophrenia and is a key driver of poor community functioning. Early intervention to reduce cognitive deficit has the potential to impact recovery and quality of life. Cognitive remediation (CR) is an evidence-based behavioral skills intervention that directly targets the cognitive processes underlying functioning in everyday life. Efficacy trials suggest that provision of CR during an early stage of schizophrenia, and in the context of a rehabilitation program, results in greater cognitive and functional gains than when it is provided later in the course of the illness and independent of a recovery program. What is less clear is whether CR for first episode psychosis can enhance the outcomes of coordinated specialty care (CSC), an evidence-based rehabilitation approach for people with recent onset psychosis. Across CSC programs, about half of early psychosis consumers do not achieve vocational, educational and/or social recovery. Adding CR to the menu of services could potentially improve these outcomes but mechanism of CR delivery needs to be studied. It is unclear whether delivery of CR needs to be done exclusively in the clinic with a clinician, or if some of the cognitive exercises can be done remotely and independently. In this pilot research we aim to adapt an efficacious model of CR which is implemented in a statewide system of care for adults with chronic mental illness, so as to optimize its feasibility and effectiveness for people with early psychosis in CSC treatment settings. The hypotheses are that (1) adding CR to CSC treatment as usual (TAU) will improve cognitive and functional outcomes, (2) delivering CR exclusively in-clinic will yield better retention than delivering part of CR remotely, and (3) cognitive improvement is associated with improvement in functional outcome. In Phase 1 (months 1-5), consultation with CSC experts will guide CR adaptations to be developmentally and programmatically appropriate for use in CSCs treating an early psychosis population. In Phase 2 (months 6-15), we will conduct an open feasibility trial (N=16) of the adapted interventions in two CSC programs, one randomized to deliver CR exclusively in-clinic and the other randomized to partial-remote delivery. Using data on acceptability, tolerability, treatment adherence, treatment fidelity, and target engagement (i.e. change in cognition), we will make final adjustments to the intervention content and structure. In Phase 3 (months 16-36), we will conduct a cluster randomized pilot feasibility trial of the adapted CR interventions with 3 CSC programs providing TAU, and six programs providing TAU+CR, either in-clinic (3 programs) or partial-remote (3 programs). The goal of this phase is to test the feasibility of the adapted CR interventions and impact on functional outcome, compare impact of CR delivery methods on treatment retention and effectiveness, and examine whether cognitive gains are associated with improvements in functional outcome (e.g. work, school) for those receiving CR. These data will serve as a prerequisite to a later, larger-scale intervention study of adding CR to the current array of CSC services for early psychosis.