Optimizing a self-directed mobile mindfulness intervention for improving

随着2005年每年管理的200万心肺衰竭患者的生存率提高， 美国重症监护病房（ICU），很明显，这些患者患有严重的， 持续的出院后心理困扰症状，包括抑郁、焦虑和出院后 创伤性应激障碍（PTSD）。然而，很少有针对性的干预措施， 患者的经验，并适应他们的许多身体，社会和经济障碍， 个性化护理。为了填补这一空白，我们开发了一种创新的基于应用程序的移动的正念训练 该计划旨在促进自动化护理服务和与疾病相关的痛苦的自我管理。 随后，我们进行了一项名为LIFT研究（R34）的试点随机临床试验（RCT AT 00819），将移动的正念与标准的电话正念程序进行了比较， 心肺衰竭幸存者的ICU教育控制。我们发现移动的 正念是可行的，可接受的，可用的，并有更大的临床影响， 比任何一个比较者的心理痛苦。该试验还强调了改善 干预的影响与其目标人群、内容交付和系统技术有关。 为了解决这些差距，我们提出了一个为期5年的项目，其概念是优化 多阶段优化研究（MOST）框架的阶段。我们将优化移动的正念 有四个具体目标：（1）优化移动的正念的关键技术元素的可用性; (2)使用析因实验设计，确定哪些干预成分贡献最大 有意义的可行性，可用性和对心理困扰的影响;（3）探索障碍， 促进干预措施的实施;（4）使用混合方法的方法和数据， 目标2和3，完善，更新和操作最终的mMT干预系统。结束时 这个U 01涉及320名心肺衰竭幸存者，我们将提供一个移动的正念系统， 全面优化了可用性、效率、可扩展性和临床影响， 下一步的确定性随机对照试验，并可以作为一个模型，以距离为基础的身心干预。 我们的U 01提案的创新元素包括其范式转换自动阶梯式治疗 方法及其易于传播的移动的应用程序交付系统的属性，可以允许 无缝，廉价的人群水平的mMT和其他身心疗法的规模。本研究 解决了痛苦症状，个性化精准医疗和自我的研究重点， 美国国立卫生研究院和许多专业协会概述的管理。我们 一个经过验证的研究网络拥有开展U 01项目的经验，可以推动该领域的发展 个性化治疗填补了不断增长的人口的重要临床护理空白。

As survival has improved for the 2 million people with cardiorespiratory failure managed annually in US intensive care units (ICUs), it has become apparent that these patients suffer from severe and persistent post-discharge symptoms of psychological distress including depression, anxiety, and post- traumatic stress disorder (PTSD). However, few targeted interventions exist that are relevant to patients' experiences and that accommodate their many physical, social, and financial barriers to personalized care. To fill this gap, we developed an innovative app-based mobile mindfulness training program that promotes automated care delivery and self-management of symptom-related distress. Subsequently, we conducted a pilot randomized clinical trial (RCT) called the LIFT study (R34 AT00819) that compared mobile mindfulness to both a standard telephone mindfulness program and an ICU education control among survivors of cardiorespiratory failure. We found that mobile mindfulness was feasibly delivered, acceptable, usable, and had a greater clinical impact on psychological distress than either comparator. This trial also highlighted opportunities to improve the intervention's impact related to its targeted population, content delivery, and system technology. To address these gaps, we propose a 5-year project that is conceptualized as the Optimization Phase of a multiphase optimization study (MOST) framework. We will optimize mobile mindfulness with four specific aims: (1) Optimize the usability of key technological elements of mobile mindfulness; (2) Using a factorial experimental design, identify which intervention components contribute most meaningfully to feasibility, usability, and impact on psychological distress; (3) Explore barriers and facilitators to intervention implementation; and (4) Using a mixed methods approach and data from Aims 2 & 3, refine, update, and operationalize the final mMT intervention system. At the conclusion of this U01 involving 320 cardiorespiratory failure survivors, we will deliver a mobile mindfulness system fully optimized for usability, efficiency, scalability, and clinical impact that will be off-the-shelf ready for a next-step definitive RCT—and can serve as a model for distance-based mind and body interventions. Innovative elements of our U01 proposal include its paradigm-shifting automated stepped therapy approach and its easily disseminatable mobile app delivery system—attributes that could allow seamless, inexpensive population-level scaling of mMT and other mind-body therapies. This study addresses research priorities on distress symptoms, personalized precision medicine, and self- management outlined by the National Institutes of Health and numerous professional societies. Our proven research network has the experience to conduct this U01 project that could advance the field with a personalizable therapy that fills an important clinical care gap for a growing population.