跳至主要内容
临床试验/NCT03930251
NCT03930251暂停不适用

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

New York State Psychiatric Institute18 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
入组人数
117
试验地点
18
主要终点
Change in occupational functioning

研究概览

简要总结

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.

详细描述

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").

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Enrolled in a participating OTNY cognitive remediation program

排除标准

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

结局指标

主要结局

Change in occupational functioning

时间窗: At study enrollment and every 3 months through study end, range of time frame 3-12 months

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.

Change in social functioning

时间窗: At study enrollment and every 3 months through study end, range of time frame 3-12 months

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.

Change in psychiatric symptoms

时间窗: At study enrollment and every 3 months through study end, range of time frame 3-12 months

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.

次要结局

  • Change in Average Neurocognition(Before and after completion of cognitive remediation, an average of 3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alice Medalia

Professor of Medical Psychology (in Psychiatry) at CUMC

New York State Psychiatric Institute

研究点 (18)

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