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

在大多数精神分裂症患者中，认知障碍在首次发作时是明显的，并且是精神分裂症的关键驱动因素。 社区功能差。减少认知缺陷的早期干预可能会影响恢复 和生活质量。认知补救（CR）是一种基于证据的行为技能干预， 目标是日常生活中潜在的认知过程。疗效试验表明， 在精神分裂症的早期阶段，在康复计划的背景下，CR导致更大的 认知和功能的增益比当它是在疾病的过程中后期提供，独立于一个 恢复计划。目前尚不清楚的是，首次发作精神病的CR是否可以提高治疗的结果。 协调专科护理（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患者没有达到职业， 教育和/或社会康复。将CR添加到服务菜单中可以潜在地改善这些 结果，但CR交付机制需要研究。目前尚不清楚是否需要交付CR 完全在诊所与临床医生一起完成，或者如果一些认知练习可以远程完成， 独立地。在这项试点研究中，我们的目标是适应一个有效的CR模型，该模型在一个 为患有慢性精神疾病的成年人提供全州范围的护理系统，以优化其可行性和有效性 早期精神病患者的治疗方案。假设：（1）在CSC中加入CR 常规治疗（TAU）将改善认知和功能结局，（2）仅在诊所内提供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 功能结果改善。在第1阶段（1-5个月），咨询CSC专家将指导CR 适应是发展和编程上适合用于治疗早期癌症的CSC。 精神病人群。在第2阶段（6-15个月），我们将进行一项适应性开放可行性试验（N=16）。 两个CSC项目中的干预，一个随机分配，仅在诊所内提供CR，另一个 随机分配至部分远程递送。使用可接受性、耐受性、治疗依从性、治疗 忠诚度和目标参与（即认知的变化），我们将对干预措施进行最终调整 内容和结构。在第3阶段（16-36个月），我们将进行一项分组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， 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 调整CR干预措施和对功能结局的影响，比较CR输送方法对 治疗保留率和有效性，并检查认知增益是否与改善有关 在功能成果（如工作，学校）为那些接受CR。这些数据将作为 后来，更大规模的干预研究，增加CR到目前的一系列CSC服务的早期精神病。

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.