Cognitive Remediation for Coordinated Specialty Care

Schizophrenia Clinical Trial

Official title:

Does the Addition of Cognitive Remediation to Coordinated Specialty Care Services Improve Functional Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03930251
• Other study ID #: 7700
• Secondary ID: 1R34MH118318-01
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: December 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Enrolled in a participating OTNY cognitive remediation program

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Behavioral:
• Clinic-Based Cognitive Remediation
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.
• Partial-Remote Cognitive Remediation
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.

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York
United States	The Institute for Family Health	Bronx	New York
United States	Kings County Hospital Center	Brooklyn	New York
United States	Services for the Underserved	Brooklyn	New York
United States	Bellevue Hospital Center	New York	New York
United States	Washington Heights Community Service	New York	New York
United States	Elmhurst Hospital Center	Queens	New York
United States	Rochester Psychiatric Center	Rochester	New York
United States	Staten Island University Hospital	Staten Island	New York

Sponsors (3)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	Columbia University, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Change in Average Neurocognition	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) for attention/vigilance. All scores will be converted to standardized T scores and averaged together to formulate one measure, Average Neurocognition. The secondary outcome measure will be change in Average Neurocognition from pre to post treatment such that a higher value represents a better outcome.	Before and after completion of cognitive remediation, an average of 3 months