Improving Accessibility and Personalization of CR for Schizophrenia

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-16

Study Completion Date

2022-05-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Personalized and Scalable Cognitive Remediation Approaches

NCT01945333

Schizophrenia Schizoaffective Disorder

COMPLETED NA

Efficacy of Personalizing Cognitive Remediation for Schizophrenia by Targeting Impairments in Early Auditory Processing

NCT04554121

Schizophrenia Schizoaffective Disorder

COMPLETED NA

Feasibility of Providing Cognitive Remediation to People With Schizophrenia in a Clinical Network

NCT00930150

Schizophrenia

COMPLETED PHASE4

Treatment Response to Rehabilitation in Patients With Schizophrenia

NCT00063336

Schizophrenia

COMPLETED NA

Cognitive Remediation for Coordinated Specialty Care

NCT03930251

Schizophrenia Schizoaffective Disorder

SUSPENDED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia Schizoaffective Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Cognitive Remediation

Intervention Type BEHAVIORAL

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.

Hybrid Cognitive Remediation

Hybrid cognitive remediation consists of one weekly group-based, clinician-led session plus independent cognitive practice.

Group Type EXPERIMENTAL

Cognitive Remediation

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No