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

在协调的专业护理服务中添加认知矫正是否可以改善功能结果？

• 批准号: 10480373
• 负责人: Alice Medalia
• 金额: $ 6.4万
• 依托单位: NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-12-03 至 2022-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10480373
• 关键词: Adult; Behavioral; Clinic; Cognition; Cognitive; Cognitive deficits; Cognitive remediation; Communities; Consultations; Coordinated Specialty Care; Data; Development; Early Intervention; Effectiveness; Exercise; Goals; Impaired cognition; Intervention; Intervention Studies; Knowledge; Life; Methods; Modeling; Outcome; Persons; Phase; Population; Psychoses; Public Health; Quality of life; Randomized; Recovery; Rehabilitation therapy; Research; Schizophrenia; Schools; Services; Structure; Testing; Work; care systems; cognitive process; early psychosis; efficacy trial; evidence base; feasibility testing; feasibility trial; first episode psychosis; functional gain; functional outcomes; improved; improved outcome; poor communities; programs; remote delivery; severe mental illness; skills; social; treatment adherence; treatment as usual

Cognitive impairment is evident at first episode in most people with schizophrenia and is a key driver of poor community functioning. Early intervention to reduce cognitive deficit has the potential to impact recovery and quality of life. Cognitive remediation (CR) is an evidence-based behavioral skills intervention that directly targets the cognitive processes underlying functioning in everyday life. Efficacy trials suggest that provision of CR during an early stage of schizophrenia, and in the context of a rehabilitation program, results in greater cognitive and functional gains than when it is provided later in the course of the illness and independent of a recovery program. What is less clear is whether CR for first episode psychosis can enhance the outcomes of coordinated specialty care (CSC), an evidence-based rehabilitation approach for people with recent onset psychosis. Across CSC programs, about half of early psychosis consumers do not achieve vocational, educational and/or social recovery. Adding CR to the menu of services could potentially improve these outcomes but mechanism of CR delivery needs to be studied. It is unclear whether delivery of CR needs to be done exclusively in the clinic with a clinician, or if some of the cognitive exercises can be done remotely and independently. In this pilot research we aim to adapt an efficacious model of CR which is implemented in a statewide system of care for adults with chronic mental illness, so as to optimize its feasibility and effectiveness for people with early psychosis in CSC treatment settings. The hypotheses are that (1) adding CR to CSC treatment as usual (TAU) will improve cognitive and functional outcomes, (2) delivering CR exclusively in-clinic will yield better retention than delivering part of CR remotely, and (3) cognitive improvement is associated with improvement in functional outcome. In Phase 1 (months 1-5), consultation with CSC experts will guide CR adaptations to be developmentally and programmatically appropriate for use in CSCs treating an early psychosis population. In Phase 2 (months 6-15), we will conduct an open feasibility trial (N=16) of the adapted interventions in two CSC programs, one randomized to deliver CR exclusively in-clinic and the other randomized to partial-remote delivery. Using data on acceptability, tolerability, treatment adherence, treatment fidelity, and target engagement (i.e. change in cognition), we will make final adjustments to the intervention content and structure. In Phase 3 (months 16-36), we will conduct a cluster randomized pilot feasibility trial of the adapted CR interventions with 3 CSC programs providing TAU, and six programs providing TAU+CR, either in-clinic (3 programs) or partial-remote (3 programs). The goal of this phase is to test the feasibility of the adapted CR interventions and impact on functional outcome, compare impact of CR delivery methods on treatment retention and effectiveness, and examine whether cognitive gains are associated with improvements in functional outcome (e.g. work, school) for those receiving CR. These data will serve as a prerequisite to a later, larger-scale intervention study of adding CR to the current array of CSC services for early psychosis.

大多数精神分裂症患者在首次发作时就会出现明显的认知障碍，并且是导致精神分裂症的关键驱动因素。 社区功能较差。减少认知缺陷的早期干预有可能影响康复 和生活质量。认知矫正（CR）是一种基于证据的行为技能干预措施，可直接 针对日常生活中功能的认知过程。功效试验表明，提供 CR 在精神分裂症的早期阶段以及在康复计划的背景下，会产生更大的效果 与在病程后期提供且独立于疾病的情况相比，认知和功能方面的增益 恢复计划。尚不清楚的是首次发作精神病的 CR 是否可以提高治疗结果 协调专业护理 (CSC)，一种针对近期发病患者的循证康复方法 精神病。在 CSC 项目中，大约一半的早期精神病消费者没有获得职业、 教育和/或社会恢复。将 CR 添加到服务菜单中可能会改善这些 结果但需要研究 CR 传递的机制。目前尚不清楚是否需要交付 CR 专门在诊所与临床医生一起完成，或者如果某些认知练习可以远程完成 独立。在这项试点研究中，我们的目标是采用一种有效的 CR 模型，该模型在 全州成人慢性精神疾病护理系统，以优化其可行性和有效性 适用于 CSC 治疗环境中患有早期精神病的人。假设 (1) 将 CR 添加到 CSC 照常治疗 (TAU) 将改善认知和功能结果，(2) 仅在诊所提供 CR 比远程提供部分 CR 会产生更好的保留率，并且 (3) 认知改善与 功能结果的改善。在第一阶段（第 1-5 个月），与 CSC 专家的协商将指导 CR 适应发展和程序上适合用于治疗早期疾病的 CSC 精神病人群。在第 2 阶段（第 6-15 个月），我们将对改编后的方案进行公开可行性试验（N=16） 两个 CSC 项目的干预措施，一个是随机在临床上专门提供 CR，另一个是 随机分配至部分远程交付。使用关于可接受性、耐受性、治疗依从性、治疗的数据 保真度和目标参与度（即认知的改变），我们将对干预进行最终调整 内容和结构。在第 3 阶段（第 16-36 个月），我们将进行整群随机试点可行性试验 适应的 CR 干预措施包括 3 个提供 TAU 的 CSC 计划和 6 个提供 TAU+CR 的计划， 诊所内（3 个程序）或部分远程（3 个程序）。此阶段的目标是测试该方案的可行性 调整 CR 干预措施及其对功能结果的影响，比较 CR 实施方法对功能结果的影响 治疗保留率和有效性，并检查认知增益是否与改善相关 接受 CR 的人的功能结果（例如工作、学校）。这些数据将作为 后来，进行了更大规模的干预研究，将 CR 添加到当前针对早期精神病的 CSC 服务中。