Study Stopped
U.S. Department of Health and Human Services OHRP issued an FWA restriction on NYSPI research that included a pause of human subjects research as of June 23, 2023.
Cognitive Remediation for Coordinated Specialty Care
Does the Addition of Cognitive Remediation to Coordinated Specialty Care Services Improve Functional Outcome
2 other identifiers
interventional
117
1 country
9
Brief Summary
Cognitive remediation (CR) is an evidence-based behavioral skills intervention that targets the cognitive processes underlying functioning in everyday life. It can be used as part of early intervention to reduce cognitive deficits evident at the first episode of psychosis, and has the potential to impact recovery and quality of life. Across Coordinated Specialty Care (CSC) programs, about half of early psychosis participants do not achieve sustained vocational, educational, and/or social recovery; adding CR to CS programs could improve these outcomes. However, models of CR need to be adapted to meet the developmental needs of a younger population and to better fit the CSC model of service delivery. This study of CR implementation will be conducted within the context of OnTrackNY, a network of first-episode psychosis programs that currently offers basic cognitive health evaluation and supportive treatment but not CR. Intervention content will be designed and refined based on input from multiple stakeholders. The study will assess two delivery approaches to CR, one that delivers CR exclusively "in-clinic/clinician-led" and the other that is "partial-remote/independent" with one in-clinic/clinician-led session per week plus out-of-clinic independent cognitive practice. Nine OnTrackNY programs will be selected and OnTrackNY clinicians will be trained to conduct a cognitive assessment battery and CR. Three programs will be randomly assigned to provide treatment as usual (TAU) and six programs will be randomly assigned to provide both TAU and CR (either "in-clinic/clinician-led" or "partial-remote/independent"). Using de-identified data collected routinely by OnTrackNY for quality improvement/program evaluation, the investigators will examine whether the addition of CR improves functional outcomes for clients with first-episode psychosis, compare the effectiveness of CR delivery methods, and explore whether cognitive improvement is associated with improvement in functioning.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable schizophrenia
Started Jun 2019
Longer than P75 for not_applicable schizophrenia
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2019
CompletedFirst Posted
Study publicly available on registry
April 29, 2019
CompletedStudy Start
First participant enrolled
June 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
ExpectedOctober 7, 2025
October 1, 2025
4.4 years
April 5, 2019
October 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in occupational functioning
Change in occupational functioning will be measured with the MIRECC Global Assessment of Functioning (GAF) Occupational Functioning scale. A clinician rates occupational functioning according to the client's primary role (worker, student, or not in labor force/homemaker) on a scale of 1-100 where a higher rating indicates better functioning.
At study enrollment and every 3 months through study end, range of time frame 3-12 months
Change in social functioning
Change in social functioning will be measured with the MIRECC Global Assessment of Functioning (GAF) Social Functioning scale. A clinician rates the client's average social functioning during the past month on a scale of 1-100 where higher scores indicate better functioning.
At study enrollment and every 3 months through study end, range of time frame 3-12 months
Change in psychiatric symptoms
Change in symptoms will be measured with the MIRECC Global Assessment of Functioning (GAF) Symptoms scale. A clinician rates psychiatric symptom severity on a scale of 1-100 where a higher rating indicates fewer or less severe psychiatric symptoms.
At study enrollment and every 3 months through study end, range of time frame 3-12 months
Secondary Outcomes (1)
Change in Average Neurocognition
Before and after completion of cognitive remediation, an average of 3 months
Study Arms (3)
Treatment as Usual
NO INTERVENTIONThis is the standard coordinated specialty care treatment (without cognitive remediation) that is provided to OnTrackNY clients. This treatment involves psychiatric treatment, employment and educational support, substance abuse treatment, family education and support, CBT-informed individual psychotherapy, and cognitive health support services as needed.
Clinic-Based Cognitive Remediation
EXPERIMENTALClinic-based cognitive remediation consists of twice weekly group-based and clinician-led sessions.
Partial-Remote Cognitive Remediation
EXPERIMENTALPartial-Remote cognitive remediation consists of one weekly group-based, clinician-led session plus independent cognitive practice.
Interventions
Computer-based exercises targeting impairments in cognitive domains (sensory processing, processing speed, attention, working memory, executive functions) are paired with verbal discussions and group-based activities to strengthen metacognition and bridge newly learned cognitive skills to everyday life. Sessions are led twice weekly by a clinician in small groups.
Computer-based exercises targeting impairments in cognitive domains (sensory processing, processing speed, attention, working memory, executive functions) are paired with verbal discussions and group-based activities to strengthen metacognition and bridge newly learned cognitive skills to everyday life. Sessions are led once weekly by a clinician in small groups and clients gain additional practice by accessing clinician-assigned computer-based exercises independently.
Eligibility Criteria
You may qualify if:
- Enrolled in a participating OTNY cognitive remediation program
You may not qualify if:
- Not eligible to be enrolled in a participating OTNY cognitive remediation program
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- New York State Psychiatric Institutelead
- Columbia Universitycollaborator
- National Institute of Mental Health (NIMH)collaborator
Study Sites (9)
Kings County Hospital Center
Brooklyn, New York, 11203, United States
Services for the Underserved
Brooklyn, New York, 11238, United States
Bellevue Hospital Center
New York, New York, 10016, United States
Washington Heights Community Service
New York, New York, 10032, United States
Elmhurst Hospital Center
Queens, New York, 11373, United States
Rochester Psychiatric Center
Rochester, New York, 14610, United States
Staten Island University Hospital
Staten Island, New York, 10309, United States
The Institute for Family Health
The Bronx, New York, 10032, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alice Medalia, PhD
New York State Psychiatric Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medical Psychology (in Psychiatry) at CUMC
Study Record Dates
First Submitted
April 5, 2019
First Posted
April 29, 2019
Study Start
June 1, 2019
Primary Completion
October 31, 2023
Study Completion (Estimated)
August 31, 2026
Last Updated
October 7, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- A list of all data expected to be collected in the project will be submitted to the NDCT 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.
- Access Criteria
- Data in NIH repositories may be accessed through the NIH Data Access Committee which reviews data access and submission requests.
All materials necessary to replicate the adapted cognitive remediation (CR) intervention will be prepared for public sharing. This includes the menu of web-based cognitive exercises employed by CR clinicians and treatment manual for bridging group verbal discussions. De-identified program evaluation 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). De-identified data will include demographic data, and raw data derived from occupational, social, symptom, and cognitive measures.