NCT03930251Suspended
Cognitive Remediation for Coordinated Specialty Care
Does the Addition of Cognitive Remediation to Coordinated Specialty Care Services Improve Functional Outcome
Source: ClinicalTrials.gov · Last updated 7 Oct 2025
Reason given: 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.
Brief summary (registry, in English)
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.
- Status (registry)
- Suspended
- Study type
- Interventional
- Enrollment
- 117 (actual)
- First submitted
- 5 Apr 2019
- Start date
- 1 Jun 2019
- Primary completion date
- 31 Oct 2023
- Lead sponsor
- New York State Psychiatric Institute
- Diseases
- Schizophrenia
- NCT number
- NCT03930251
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Not eligible to be enrolled in a participating OTNY cognitive remediation program
Who the study is looking for
- Enrolled in a participating OTNY cognitive remediation program
Age in the registry: 18 years to 30 years · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kings County Hospital Center | Brooklyn | United States | Unknown status |
| Services for the Underserved | Brooklyn | United States | Unknown status |
| Washington Heights Community Service | New York | United States | Unknown status |
| Bellevue Hospital Center | New York | United States | Unknown status |
| Elmhurst Hospital Center | Queens | United States | Unknown status |
| Rochester Psychiatric Center | Rochester | United States | Unknown status |
| Staten Island University Hospital | Staten Island | United States | Unknown status |
| Montefiore Medical Center | The Bronx | United States | Unknown status |
| The Institute for Family Health | The Bronx | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.