Improving Accessibility and Personalization of CR for Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      This project will explore adaptations of treatments for schizophrenia, with the goal of
      optimizing their effectiveness in real-world clinical settings and readiness for broad
      deployment. Schizophrenia is associated with cognitive deficits that negatively impact
      essential areas of daily functioning. NY State Office of Mental Health (OMH) is the first and
      largest state system of care to implement a statewide program of cognitive remediation (CR),
      an evidence-based practice for improving cognition and aiding functional recovery. Through
      Cognitive Remediation to Promote Recovery (CR2PR), CR is now offered in outpatient programs,
      with plans to expand to more services and further adapt implementation to improve treatment
      outcomes. This project will work directly with OMH clinics and clinicians to build upon and
      improve current CR delivery methods. This project will study the impact of two adaptations.
      One focuses on increasing the accessibility of the program, which participants report is
      limited by the requirement of twice weekly attendance. This project will compare the
      feasibility and acceptability of delivering CR in either two clinic-based sessions (Clinic)
      or one clinic and one remote session (Hybrid) per week. Qualitative interviews will be
      conducted with stakeholders to explore the impact of the adaptation. The second adaptation is
      intended to improve personalization of CR by systematically accounting for individual
      differences in neurocognitive needs. Drawing upon convergent evidence for tailoring CR based
      on need for early auditory processing (EAP) training, this project examines whether
      integrating a measure of EAP into the current baseline assessment facilitates personalization
      of the menu of restorative computer-based exercises used in CR. Feasibility parameters and
      qualitative/quantitative data analyses of facilitators and barriers to Hybrid CR delivery
      will together inform further treatment refinement and the design of a larger effectiveness
      trial of Clinic versus Hybrid CR. This project will examine how EAP assessment is employed by
      practitioners to personalize the CR treatment plan and examine if EAP improvement is
      associated with cognitive outcomes in public practice CR settings. Finally cognitive,
      functional, and service use outcomes in Hybrid versus Clinic CR will be compared.
    

Detailed description: 
      Cognitive remediation (CR) is an evidence-based practice to treat the pervasive and
      significant cognitive deficits that contribute to functional decline in schizophrenia. The
      New York State Office of Mental Health (OMH) has teamed with the Principal Investigator to be
      the first, and largest state system of care to implement a statewide program of CR tied to
      recovery programming. Through Cognitive Remediation to Promote Recovery (CR2PR), CR is now
      offered in outpatient programs throughout the state, with plans to expand to more services
      and further adapt implementation to improve treatment outcomes. To proceed systematically,
      this project will work directly with CR2PR programs, guided by practice-based evidence
      gathered during CR2PR to build upon and improve current CR delivery methods in two ways.

        1. Ongoing program evaluation indicates that the burden of attending clinic twice per week
           for CR limits the number of people who enroll. This project will test the feasibility
           and collect preliminary data on the effectiveness of personalized CR delivery that
           involves one clinic visit and one remote session per week. Demonstrating the
           effectiveness of incorporating remotely delivered CR would double the number of patients
           who could access the OMH CR program and reduce treatment costs.

        2. Current effect sizes for cognition and functional outcomes may remain limited if
           personalization, mechanisms of action, and relevant targets are not better addressed.
           Given evidence that early auditory information processing ability (EAP) works as a
           neurobehavioral marker of need for sensory processing training, this study will test the
           potential to use baseline EAP assessment to tailor CR, incorporating EAP with other
           cognitive skills training as clinically indicated. The ultimate goal of integrating
           scalable assessment practices to personalize CR is to improve recovery outcomes.

      The study will use a repeated measures, randomized design. Eligible participants who are
      referred to CR2PR will complete a routine baseline neurocognitive assessment with the
      addition of a EAP measure, and will then be randomized to either all-clinic CR (Clinic) or
      clinic+remote (Hybrid) CR. The Clinic research arm consists of 30 sessions delivered twice
      weekly in a group format of up to 8 participants with rolling admission. The Hybrid condition
      consists of 15 clinic sessions in the above format, and independent homework on cognitive
      exercises for 60 minutes per week for 15 weeks using a laptop, PC or tablet available to
      them. All clinic sessions consist of 45 minutes of working on 3-4 computerized exercises
      selected by a clinician from a menu of web-based programs to improve the cognitive functions
      identified as impaired on the assessment. Computer exercises are followed by 15 minute
      manualized discussion groups based on the concept of "Bridging".

      All participants will complete a treatment satisfaction survey and will be re-tested on
      outcome measures approximately 1 week following end of treatment. Additional data on the
      feasibility and acceptability of the Hybrid approach will be gathered through a qualitative
      interview with participants at treatment endpoint.
    

Intervention name(s): Cognitive Remediation
Intervention type(s): Behavioral
Intervention description(s): Computer-based exercises targeting impairments in cognitive domains (sensory processing, processing speed, attention, working memory, memory, executive functions) are paired with verbal discussions and group-based activities to strengthen metacognition to and bridge newly learned cognitive skills to everyday life.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive Remediation