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 (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.

At the time of first-episode, most people with schizophrenia have cognitive impairments that significantly contribute to poor functioning. Early intervention with cognitive remediation (CR), an evidence-based skills intervention that targets cognitive processes, is designed to enhance cognition and functional recovery in people identified as having cognitive health needs. Evidence suggests that provision of CR to those in the early stage of schizophrenia, and in the context of rehabilitation services, results in greater cognitive and functional gains.

OnTrackNY (OTNY) is a New York-based Coordinated Specialty Care (CSC) program that provides early psychosis treatment to young people, between 16 and 30 years of age, who have experienced the onset of non-affective psychosis within two years of beginning treatment. CSC programs provide a significant benefit over usual care, but on average 50% of patients remain disabled after two years. OTNY, like many other CSC programs, provides cognitive health evaluation and supportive treatment but does not routinely offer CR. However, evidence suggests that when cognitive disability is promptly addressed, people show increased self-esteem, engagement in the community and sense of well-being. Therefore, the addition of CR to OTNY may allow treatment to proceed at a faster rate, promote more rapid engagement and mitigate challenges experienced by clients in school or work.

This study aims to:

1. Adapt a 12-week long CR intervention to 2 delivery methods using the input of experts, OnTrackNY mental health clinicians, and clients to improve the acceptability of the intervention content.
2. Examine whether CR can enhance the cognitive and functional outcomes for people with first episode psychosis (FEP) receiving treatment in a CSC program and identified as having cognitive health needs.
3. Compare the effectiveness of "in clinic/clinician-led" and "partial-remote/independent" CR delivery approaches.

This study will occur in phases. In Phase 1, CR content and delivery will be adapted using the input of experts, and training manuals will be created for two intervention approaches. Phase 2 will involve training of mental health clinicians at two OnTrackNY programs to add a formal battery of cognitive assessments and adapted CR. One program will be assigned to deliver CR exclusively "in-clinic" with the aid of a clinician and the other "partial-remote/independent" (one in-clinic session per week with independent cognitive practice). Following quality improvement/program evaluation procedures, the investigators will refine CR based on feedback from providers and clients. Phase 3 will involve nine OnTrackNY programs where clinicians will be trained by researchers to conduct the formal cognitive assessment battery and CR, if applicable. Three programs will be randomly assigned to provide treatment as usual (TAU) and six will be assigned to TAU and CR (either "in-clinic/clinician-led" or "partial-remote/independent").

Referral for cognitive health services will follow routine clinical practice through which clients and their clinicians document cognitive health needs and decide what intervention suits their needs. Clients will be given the option of enrolling in the program's CR intervention. Client characteristics, CR enrollment and outcomes will be made available for quality improvement monitoring and program evaluation in de-identified form. The investigators will examine outcomes for clients identified as having cognitive health needs. To address whether adding CR improves functional outcomes in CSC programs, the investigators will compare measures of community functioning and psychiatric symptom severity across groups. Functional outcome measures will be examined for the time most proximal to CR enrollment and every three months thereafter until study end (range 3-12 months of follow-up depending upon rolling enrollment). Cognition will be measured before and after completion of CR (an average of 3 months) to compare the effectiveness of the two CR delivery approaches and examine whether cognitive improvement is associated with improvement in functioning.

Inclusion Criteria:

• Enrolled in a participating OTNY cognitive remediation program

Exclusion Criteria:

• Not eligible to be enrolled in a participating OTNY cognitive remediation program

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.

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.

Data in NIH repositories may be accessed through the NIH Data Access Committee which reviews data access and submission requests.