Improving Accessibility and Personalization of CR for Schizophrenia



Status:Recruiting
Conditions:Schizophrenia, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:7/19/2018
Start Date:July 16, 2018
End Date:March 30, 2021
Contact:Alice Medalia, PhD
Email:am2938@cumc.columbia.edu
Phone:212-305-3747

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Improving Accessibility and Personalization of Cognitive Remediation for Schizophrenia

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.

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.

Inclusion Criteria:

- Referred for participation in Cognitive Remediation to Promote Recovery by outpatient
clinic teams

- A primary DSM-5 diagnosis of schizophrenia or schizoaffective disorder

- Verbal IQ estimate of 70 or above

- Stabilized on any psychotropic medication

- English-speaking

Exclusion Criteria:

- Unremitted substance dependence

- Neurological illness affecting brain functioning

- Traumatic brain injury within 2 years

- Auditory or visual impairment (uncorrected)
We found this trial at
5
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16 Sumner Place
Brooklyn, New York 11206
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Brooklyn, New York 11217
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Brooklyn, New York 11230
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New York, New York 10040
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