Improving Accessibility and Personalization of CR for Schizophrenia

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Schizoaffective Disorder
• Intervention / Treatment: Behavioral: Cognitive Remediation

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.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11206
      • Williamsburg Clinic
    • Brooklyn, New York, United States, 11217
      • Heights Hill Clinic
    • Brooklyn, New York, United States, 11230
      • Mapleton Mental Health Services
    • New York, New York, United States, 10027
      • Manhattan Psychiatric Center 125th St Outpatient Clinic
    • New York, New York, United States, 10040
      • Inwood Clinic
    • Orangeburg, New York, United States, 10962
      • Rockland Psychiatric Center
    • Queens Village, New York, United States, 11427
      • Creedmoor Psychiatric Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Clinic-based Cognitive Remediation; Clinic-based cognitive remediation is the current standard of care in NY State outpatient programs. It consists of twice weekly group-based and clinician-led sessions.	Behavioral: Cognitive Remediation; 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.
Experimental: Hybrid Cognitive Remediation; Hybrid cognitive remediation consists of one weekly group-based, clinician-led session plus independent cognitive practice.	Behavioral: Cognitive Remediation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Satisfaction	Treatment satisfaction will be measured using a self-report Likert-type rating scale questionnaire reflecting the specific components of the treatments used for this study. The outcome measure will be an average of the scale items, ranging from 1 to 6, with 1 reflecting strong dissatisfaction with the treatment and 6 reflecting strong satisfaction with the treatment.	Through study completion, 15 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Neurocognition	Neurocognition will be measured with subtests from the Brief Assessment of Cognition in Schizophrenia (BACS): Verbal Memory (verbal memory and learning), Digit Sequencing (working memory), Symbol Coding (speed of processing), and Tower of London (executive function) and the Continuous Performance Test - Identical Pairs (CPT-IP; attention/vigilance). A T score for each subtest is obtained where the population mean is 50 and the standard deviation is 10. For all subtests higher scores indicate better outcome. An average T score is generated to capture neurocognition at each assessment time point. The secondary outcome measure is change in the average T score from baseline to post-treatment.	Baseline and 15 weeks

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute
• Collaborators: National Institute of Mental Health (NIMH)

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2018
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): May 30, 2022

Study Registration Dates

• First Submitted: May 25, 2018
• First Submitted That Met QC Criteria: June 22, 2018
• First Posted (Actual): July 5, 2018

Study Record Updates

• Last Update Posted (Actual): July 13, 2022
• Last Update Submitted That Met QC Criteria: June 22, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Cognitive Remediation
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders
• Other Study ID Numbers: 7638 (DUMC); 1P50MH115843-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Raw data will be made available for research to investigators working under a Federal Wide Assurance who meet security measures and data use agreement criteria associated with public repositories including the National Database for Clinical Trials related to Mental Illness (NDCT) and the NIMH Database of Cognitive Training and Remediation Studies (DoCTRS). Data will include baseline demographic data, and baseline and post raw data derived from cognitive, quality of life, functioning and symptom measures.
• IPD Sharing Time Frame: A list of all data expected to be collected in the project will be submitted within 6 months of award. Subsequently, descriptive and raw data will be submitted on a semi-annual basis. Unpublished de-identified data will be submitted prior to study completion and will be shared within one year after project completion, or when the data are published, whichever is earlier.
• IPD Sharing Access Criteria: Data in NIH repositories may be accessed through the NIH Data Access Committee which reviews data access and submission requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No