Optimizing a self-directed mobile mindfulness intervention for improving

由于每年接受治疗的200万心肺衰竭患者的存活率有所提高， 美国重症监护病房(ICU)，很明显，这些患者患有严重和 持续的出院后心理困扰症状，包括抑郁、焦虑和 创伤应激障碍(PTSD)。然而，与以下方面相关的针对性干预措施很少 患者的经历，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，我们开发了一款创新的基于应用程序的移动正念训练 促进自动化护理提供和症状相关痛苦自我管理的计划。 随后，我们进行了一项试验性随机临床试验(RCT)，称为LIFT研究(R34 AT00819)，将移动正念与标准的电话正念程序和 心肺功能衰竭存活者的ICU教育控制。我们发现了那部手机 正念是可行的，可接受的，可用的，并对临床有更大的影响 比两个参照者的心理痛苦都要大。这项试验还突显了改善 干预措施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，将其概念化为 多阶段优化研究(MOST)框架的阶段。我们将优化移动正念 有四个具体目标：(1)优化移动正念关键技术元素的可用性； (2)采用析因实验设计，确定哪些干预成分的贡献最大 对心理困扰的可行性、可用性和影响有意义；(3)探索障碍和 促进干预实施；以及(4)使用混合方法方法和来自 目标2和3，改进、更新和运行最终的MMT干预系统。在……结束时 今年的U01涉及320名心肺衰竭幸存者，我们将提供一个移动正念系统 针对可用性、效率、可扩展性和临床影响进行了全面优化，将为 下一步明确的随机对照试验--可作为基于距离的心理和身体干预的模型。 我们的U01方案的创新元素包括其范式转换自动阶梯疗法 方法及其易于传播的移动应用交付系统-这些属性可以 无缝、廉价的MMT和其他心身疗法的人群水平扩展。本研究 解决痛苦症状、个性化精准医学和自我保护方面的研究重点 国家卫生研究院和许多专业协会概述的管理。我们的 经过验证的研究网络拥有实施U01项目的经验，这可能会推动该领域的发展 通过个性化治疗，填补了不断增长的人口的重要临床护理缺口。

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.