Optimizing a self-directed mobile mindfulness intervention for improving

优化自我导向的移动正念干预以提高

• 批准号: 10477411
• 负责人: Christopher Ethan Cox
• 金额: $ 66.62万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10477411
• 关键词: Address; Adherence; Anxiety; Clinical; Collaborations; Computer software; Critical Illness; Data; Development; Dissemination and Implementation; Distress; Dose; Education; Educational Intervention; Elements; Enrollment; Ensure; Evaluation; Experimental Designs; Failure; Goals; Guidelines; Health Services Accessibility; Home; Hospitals; Intensive Care Units; Intervention; Interview; Mental Depression; Methods; Mind-Body Intervention; Mindfulness Training; Modeling; National Center for Complementary and Integrative Health; Outcome; Outcome Study; Participant; Patients; Pattern; Persons; Phase; Population; Post-Traumatic Stress Disorders; Professional Organizations; Randomized; Randomized Clinical Trials; Recording of previous events; Research; Research Design; Research Methodology; Research Personnel; Research Priority; Sampling; Self Management; Self-Direction; Structure; Survivors; Symptoms; System; Target Populations; Technology; Telephone; Testing; Training Programs; United States National Institutes of Health; Update; Work; barrier to care; base; care delivery; clinical care; depressive symptoms; effective therapy; experience; implementation intervention; improved; innovation; innovative technologies; intervention delivery; mindfulness; mindfulness intervention; mobile application; multidisciplinary; multiphase optimization strategy; patient oriented; persistent symptom; personalized care; personalized medicine; precision medicine; programs; psychological distress; psychological symptom; responders and non-responders; response; screening; social; success; symptom self management; usability

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.

随着每年 200 万心肺衰竭患者的生存率得到改善 在美国重症监护病房 (ICU) 中，这些患者显然患有严重且 出院后持续出现的心理困扰症状，包括抑郁、焦虑和出院后症状 创伤性应激障碍（PTSD）。然而，很少有与此相关的有针对性的干预措施 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，我们开发了一种基于应用程序的创新移动正念训练 促进自动化护理服务和症状相关困扰的自我管理的计划。 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) AT00819）将移动正念与标准电话正念计划进行了比较 对心肺衰竭幸存者进行 ICU 教育控制。我们发现手机 正念的传递是可行的、可接受的、可用的，并且对以下方面产生了更大的临床影响： 心理困扰程度高于任何一个比较者。该试验还强调了改进的机会 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，其概念为优化 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) 使用析因实验设计，确定哪些干预成分贡献最大 对可行性、可用性和对心理困扰的影响有意义； (3)探索障碍和 干预实施的促进者； (4) 使用混合方法和数据 目标 2 和 3 完善、更新并实施最终的 mMT 干预系统。结束时 这个U01涉及320名心肺衰竭幸存者，我们将提供移动正念系统 针对可用性、效率、可扩展性和临床影响进行了全面优化，现成可用 下一步明确的随机对照试验——可以作为基于距离的身心干预的模型。 我们 U01 提案的创新元素包括其范式转变的自动阶梯疗法 方法及其易于传播的移动应用程序交付系统——可以允许 mMT 和其他身心疗法的无缝、廉价的人群水平扩展。这项研究 解决了关于痛苦症状、个性化精准医疗和自我治疗的研究重点 美国国立卫生研究院和众多专业协会概述的管理。我们的 成熟的研究网络拥有开展 U01 项目的经验，该项目可以推动该领域的发展 个性化治疗可以填补不断增长的人口的重要临床护理空白。