1/2-Integration of Illness Management and Recovery Within ACT

我们的多站点、关联R34提案的目标是开发和评估一种新的社会心理方法的可行性，以改善严重精神疾病患者的心理健康，同时获得计划后续R01研究申请所需的初步试点数据，以进一步评估这种干预措施。具体来说，我们计划调整和试点一种方法，将两种基于证据的方法整合到患有严重精神疾病的成年人身上：疾病管理和康复（IMR）和自信的社区治疗（ACT）。该R34研究项目将实现三个具体目标：(1)制定、调整和标准化治疗方案，以便将IMR纳入ACT团队；(2)在小型开放式临床试验中评估IMR+ACT干预的实施可行性和可接受性；(3)使用随机临床试验（RCT）设计进行初步结果和过程评估，随机化发生在ACT团队水平。我们假设结合IMR+ACT的协议将是可行的，并为消费者和提供者所接受。综合IMR+ACT规划有可能减少持续性症状，增强功能，并促进接受ACT服务的严重精神疾病患者的康复。研究和发展活动将分三个阶段进行。在第一阶段，我们将扩大应用前试点活动，进一步开发、调整和完善IMR+ACT治疗方案。新方案将包括一份新的治疗手册、培训材料和保真度量表，所有这些都将具体说明在联合疗法中调整和整合药物综合治疗。在第二阶段，我们将对IMR+ACT进行小规模的公开试验，以收集有关实施该计划的可行性、可接受性以及ACT员工对该模型的忠诚度的数据。在第三阶段，我们将使用随机对照试验设计对IMR+ACT干预进行结果和过程评估。具体而言，我们将随机分配8个团队，在两个州实施IMR+ACT项目或继续仅提供ACT（每种情况4个团队），并在总共96名消费者（每个ACT团队12名）中评估临床、功能和恢复变量的结果。研究结果将提供重要的信息，包括随机分配ACT团队是否提供IMR的可行性、团队内部差异的估计，以及在ACT服务中添加IMR的临床影响的初步数据，这将为规划更大规模的IMR+ACT有效性的R01研究提供信息。

The goals of our multi-site, linked R34 proposals are to develop and evaluate the feasibility of a novel psychosocial approach for improving the mental health of people with severe mental illness while obtaining preliminary pilot data needed to plan a subsequent R01 research application to further evaluate this intervention. Specifically, we plan to adapt and pilot an approach for integrating two evidence-based practices for adults with serious mental illness: Illness Management and Recovery (IMR) and Assertive Community Treatment (ACT). This R34 research project will accomplish three specific aims: (1) develop, adapt, and standardize the treatment protocol for integrating IMR into ACT teams; (2) assess the implementation feasibility and acceptability of the IMR+ACT intervention in a small, open clinical trial; and (3) conduct a preliminary outcome and process evaluation using a pilot randomized clinical trial (RCT) design, with randomization occurring at the ACT team level. We hypothesize that the protocol for combining IMR+ACT will be feasible to implement and acceptable to consumers and providers. The integrated IMR+ACT program has the potential to reduce persistent symptoms, enhance functioning, and facilitate the recovery of people with severe mental illness who are receiving ACT services. The research and development activities will be conducted in three stages. In Stage 1 we will expand our pre-application pilot activities to further develop, adapt, and refine the IMR+ACT treatment protocol. The new protocol will include a new treatment manual, training materials, and a fidelity scale, all of which will specify the adaptation and integration of IMR within ACT. During Stage 2, we will conduct a small open trial of IMR+ACT in order to collect data on the feasibility of implementing the program, its acceptability, and the fidelity of ACT staff to the model. In Stage 3, we will conduct an outcome and process evaluation of the IMR+ACT intervention using an RCT design. Specifically, we will randomize eight teams to implement either the IMR+ACT program or continue to provide ACT Only (four teams per condition) in two states, and assess outcomes across a battery of clinical, functional, and recovery variables in a total of 96 consumers (12 per ACT team). The findings will yield important information about the feasibility of randomizing ACT teams to provide IMR or not, estimates of within team variances, and preliminary data on the clinical impact of adding IMR to ACT services, which will inform the planning of a larger-scale R01 study of IMR+ACT effectiveness.