Cognitive Remediation for Coordinated Specialty Care
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      Cognitive remediation (CR) is an evidence-based behavioral skills intervention that targets
      the cognitive processes underlying functioning in everyday life. It can be used as part of
      early intervention to reduce cognitive deficits evident at the first episode of psychosis,
      and has the potential to impact recovery and quality of life. Across Coordinated Specialty
      Care (CSC) programs, about half of early psychosis participants do not achieve sustained
      vocational, educational, and/or social recovery; adding CR to CS programs could improve these
      outcomes. However, models of CR need to be adapted to meet the developmental needs of a
      younger population and to better fit the CSC model of service delivery. This study of CR
      implementation will be conducted within the context of OnTrackNY, a network of first-episode
      psychosis programs that currently offers basic cognitive health evaluation and supportive
      treatment but not CR.

      Intervention content will be designed and refined based on input from multiple stakeholders.
      The study will assess two delivery approaches to CR, one that delivers CR exclusively
      "in-clinic/clinician-led" and the other that is "partial-remote/independent" with one
      in-clinic/clinician-led session per week plus out-of-clinic independent cognitive practice.
      Nine OnTrackNY programs will be selected and OnTrackNY clinicians will be trained to conduct
      a cognitive assessment battery and CR. Three programs will be randomly assigned to provide
      treatment as usual (TAU) and six programs will be randomly assigned to provide both TAU and
      CR (either "in-clinic/clinician-led" or "partial-remote/independent"). Using de-identified
      data collected routinely by OnTrackNY for quality improvement/program evaluation, the
      investigators will examine whether the addition of CR improves functional outcomes for
      clients with first-episode psychosis, compare the effectiveness of CR delivery methods, and
      explore whether cognitive improvement is associated with improvement in functioning.
    

Detailed description: 
      At the time of first-episode, most people with schizophrenia have cognitive impairments that
      significantly contribute to poor functioning. Early intervention with cognitive remediation
      (CR), an evidence-based skills intervention that targets cognitive processes, is designed to
      enhance cognition and functional recovery in people identified as having cognitive health
      needs. Evidence suggests that provision of CR to those in the early stage of schizophrenia,
      and in the context of rehabilitation services, results in greater cognitive and functional
      gains.

      OnTrackNY (OTNY) is a New York-based Coordinated Specialty Care (CSC) program that provides
      early psychosis treatment to young people, between 16 and 30 years of age, who have
      experienced the onset of non-affective psychosis within two years of beginning treatment. CSC
      programs provide a significant benefit over usual care, but on average 50% of patients remain
      disabled after two years. OTNY, like many other CSC programs, provides cognitive health
      evaluation and supportive treatment but does not routinely offer CR. However, evidence
      suggests that when cognitive disability is promptly addressed, people show increased
      self-esteem, engagement in the community and sense of well-being. Therefore, the addition of
      CR to OTNY may allow treatment to proceed at a faster rate, promote more rapid engagement and
      mitigate challenges experienced by clients in school or work.

      This study aims to:

        1. Adapt a 12-week long CR intervention to 2 delivery methods using the input of experts,
           OnTrackNY mental health clinicians, and clients to improve the acceptability of the
           intervention content.

        2. Examine whether CR can enhance the cognitive and functional outcomes for people with
           first episode psychosis (FEP) receiving treatment in a CSC program and identified as
           having cognitive health needs.

        3. Compare the effectiveness of "in clinic/clinician-led" and "partial-remote/independent"
           CR delivery approaches.

      This study will occur in phases. In Phase 1, CR content and delivery will be adapted using
      the input of experts, and training manuals will be created for two intervention approaches.
      Phase 2 will involve training of mental health clinicians at two OnTrackNY programs to add a
      formal battery of cognitive assessments and adapted CR. One program will be assigned to
      deliver CR exclusively "in-clinic" with the aid of a clinician and the other
      "partial-remote/independent" (one in-clinic session per week with independent cognitive
      practice). Following quality improvement/program evaluation procedures, the investigators
      will refine CR based on feedback from providers and clients. Phase 3 will involve nine
      OnTrackNY programs where clinicians will be trained by researchers to conduct the formal
      cognitive assessment battery and CR, if applicable. Three programs will be randomly assigned
      to provide treatment as usual (TAU) and six will be assigned to TAU and CR (either
      "in-clinic/clinician-led" or "partial-remote/independent").

      Referral for cognitive health services will follow routine clinical practice through which
      clients and their clinicians document cognitive health needs and decide what intervention
      suits their needs. Clients will be given the option of enrolling in the program's CR
      intervention. Client characteristics, CR enrollment and outcomes will be made available for
      quality improvement monitoring and program evaluation in de-identified form. The
      investigators will examine outcomes for clients identified as having cognitive health needs.
      To address whether adding CR improves functional outcomes in CSC programs, the investigators
      will compare measures of community functioning and psychiatric symptom severity across
      groups. Functional outcome measures will be examined for the time most proximal to CR
      enrollment and every three months thereafter until study end (range 3-12 months of follow-up
      depending upon rolling enrollment). Cognition will be measured before and after completion of
      CR (an average of 3 months) to compare the effectiveness of the two CR delivery approaches
      and examine whether cognitive improvement is associated with improvement in functioning.
    

Intervention name(s): Clinic-Based Cognitive Remediation; Partial-Remote Cognitive Remediation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Computer-based exercises targeting impairments in cognitive domains (sensory processing, processing speed, attention, working memory, executive functions) are paired with verbal discussions and group-based activities to strengthen metacognition and bridge newly learned cognitive skills to everyday life. Sessions are led twice weekly by a clinician in small groups.; Computer-based exercises targeting impairments in cognitive domains (sensory processing, processing speed, attention, working memory, executive functions) are paired with verbal discussions and group-based activities to strengthen metacognition and bridge newly learned cognitive skills to everyday life. Sessions are led once weekly by a clinician in small groups and clients gain additional practice by accessing clinician-assigned computer-based exercises independently.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cognitive Remediation