New York, New York 10027

  • Schizoaffective Disorder

Purpose:

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 summary:

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.


Criteria:

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 is Available At:


Original ID:

7638


NCT ID:

NCT03576976


Secondary ID:

1P50MH115843-01


Study Acronym:


Brief Title:

Improving Accessibility and Personalization of CR for Schizophrenia


Official Title:

Improving Accessibility and Personalization of Cognitive Remediation for Schizophrenia


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

New York State Psychiatric Institute


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

67


Enrollment Type:

Actual


Overall Contact Information

Official Name:Alice Medalia, PhD
Principal Investigator
New York State Psychiatric Institute

Study Dates

Start Date:July 16, 2018
Completion Date:May 30, 2022
Completion Type:Anticipated
Primary Completion Date:December 31, 2020
Primary Completion Type:Actual
Verification Date:January 2021
Last Changed Date:January 29, 2021
First Received Date:May 25, 2018

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Neurocognition
Time Frame:15 weeks
Safety Issues:False
Description:Neurocognition will be measured with subtests from the Brief Assessment of Cognition in Schizophrenia (BACS) assessing verbal memory, working memory, speed of processing, and executive function and the Continuous Performance Test - Identical Pairs (CPT-IP
Outcome Type:Primary Outcome
Measure:Treatment Satisfaction
Time Frame:Through study completion, 15 weeks
Safety Issues:False
Description: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, wi

Study Interventions

Intervention Type:Behavioral
Name:Cognitive Remediation
Description: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.
Arm Name:Clinic-based Cognitive Remediation

Study Arms

Study Arm Type:Active Comparator
Arm Name:Clinic-based Cognitive Remediation
Description: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.
Study Arm Type:Experimental
Arm Name:Hybrid Cognitive Remediation
Description:Hybrid cognitive remediation consists of one weekly group-based, clinician-led session plus independent cognitive practice.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:New York State Psychiatric Institute
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Mental Health (NIMH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

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