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

认知障碍在大多数精神分裂症患者中首发明显，是导致 社区功能不佳。减少认知缺陷的早期干预可能会影响康复 和生活质量。认知补救(CR)是一种基于证据的行为技能干预，直接 目标是日常生活中潜在的认知过程。疗效试验表明，提供 在精神分裂症的早期阶段以及在康复计划的背景下，CR会导致更大的 认知和功能方面的进步，而不是在病程较晚时提供，而不依赖于 恢复计划。不太清楚的是，治疗首发精神病的CR是否可以提高预后 协调专科护理(CSC)--一种针对新发患者的循证康复方法 精神错乱。在CSC项目中，大约一半的早期精神病患者没有达到职业， 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 但CR的结果和机制尚需研究。目前尚不清楚CR的交付是否需要 仅在诊所与临床医生一起进行，或者如果一些认知练习可以远程进行 独立的。在这项试点研究中，我们的目标是采用一个有效的CR模型，该模型在一个 全州范围内的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治疗环境中的早期精神病患者。假设如下：(1)在CSC中加入CR 照常治疗(TAU)将改善认知和功能结果，(2)仅在临床上提供CR 将产生比远程提供部分CR更好的保留，以及(3)认知改善与 功能结果的改善。在第一阶段(1-5个月)，咨询CSC专家将指导CR 适应在发展和编程上适合用于CSCS治疗早期 精神病患者。在第二阶段(6-15个月)，我们将进行一项公开的可行性试验(N=16) 对两个CSC项目的干预，一个随机提供CR，另一个只在诊所提供CR 随机化到部分远程交付。使用可接受性、耐受性、治疗依从性、治疗 保真度和目标参与度(即认知变化)，我们将对干预做出最后调整 内容和结构。在第三阶段(16-36个月)，我们将进行一项整群随机试点可行性试验 调整后的CR干预措施，其中3个CSC项目提供TAU，6个项目提供TAU CR， 门诊(3个方案)或部分远程(3个方案)。这一阶段的目标是测试 适应的CR干预和对功能结局的影响，比较CR分娩方法对 治疗保留和有效性，并检查认知能力的提高是否与改善有关 对于那些接受CR的人来说，在功能结果(例如，工作、学校)方面。这些数据将作为 后来，更大规模的干预研究将CR添加到目前治疗早期精神病的CSC服务阵列中。

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.