Mobile Mindfulness to Improve Psychological Distress after Critical Illness

 描述（由申请人提供）：在重症监护室（ICU）需要生命支持的> 100万人中，大多数人现在都能存活下来。然而，随着生存率的提高，越来越多的人不仅遭受随后的身体残疾，而且还遭受抑郁、焦虑和创伤后应激障碍（PTSD）的持续症状。很少有干预措施解决ICU幸存者的心理困扰。更少的是解决物理，地理和后勤障碍，接受出院后的支持，医疗生病的人口遇到。因此，这一群体的公共卫生需求得不到满足。正念是一种适应性强的自我调节练习，它使用各种冥想技巧来缓解心理困扰症状，通常面对面教授数月。作为标准正念练习的延伸，我们开发了一个电话/网络交付的移动的正念训练（mMBT）系统，该系统由ICU幸存者的输入提供信息，可以解决医学疾病患者的交付障碍。我们最近的试点研究表明，早期支持mMBT的可行性和可接受性，现在与增强的内容和电子患者报告的结果的能力。我们对mMBT的早期研究虽然很有希望，但确定了在人群定位方面的关键知识差距，与研究设计相关的心理困扰估计的合理范围，以及在进行确定性临床试验之前必须解决的可接受性保证。因此，我们提出了一项针对NCCAM PAR-14-182的为期2年的试点研究，其中70名ICU幸存者被随机分配到6个每周一次的mMBT或教育对照电话会议。我们的具体目标将使用定量和定性方法：（1）评估mMBT的可行性，可接受性和可用性以及（2）更好地估计mMBT对心理困扰症状的影响。在探索性目标中，我们将在一项由目标1和2告知的20人非对照研究中探索自我导向mMBT的影响。我们提案的创新要素包括使用ICU幸存者作为研究有护理障碍的医学疾病患者的模型，移动的健康提供系统，关注出院后治疗的常见障碍，可广泛传播，和探索潜在的范式转移自动化阶梯疗法的元素，可以改善身心疗法的获得和提高大规模心灵的可行性，涉及严重疾病的人体临床试验。总的来说，这个R34项目是必要的，也足以为未来提供信息。 RCT可以通过个性化治疗推进重症监护领域，使患者能够参与自己的康复。

 DESCRIPTION (provided by applicant): A majority of the >1 million people who require life support in an intensive care unit (ICU) now survive. As survival has improved however, growing numbers suffer not only from subsequent physical disability, but also persistent symptoms of depression, anxiety, and post-traumatic stress disorder (PTSD). Few interventions address ICU survivors' psychological distress. Fewer still address the physical, geographical, and logistical barriers to receiving post-discharge support that medically ill populations encounter. Consequently, this population suffers with an unmet need of great public health importance. Mindfulness is an adaptable self-regulation practice that alleviates psychological distress symptoms using a variety of meditative techniques, typically taught face-to face over months. As an extension of standard mindfulness practices, we developed a telephone-/web-delivered mobile mindfulness-based training (mMBT) system informed by ICU survivors' input that could address medically ill patients' delivery barriers. Our recent pilot study demonstrated early support for mMBT's feasibility and acceptability, now with enhanced content and electronic patient-reported outcomes capability. Our early work on mMBT, while promising, identified key knowledge gaps in population targeting, plausible ranges of psychological distress estimates relevant to study design, and assurance of acceptability that must be addressed before a definitive clinical trial is conducted. Therefore, we propose a 2-year pilot study targeting NCCAM PAR-14-182 in which 70 ICU survivors are randomized to 6 weekly telephone sessions of either mMBT or an education control. Our specific aims will use quantitative and qualitative methods to: (1) evaluate mMBT feasibility, acceptability, and usability as well as (2) better estimate mMBT's effect on psychological distress symptoms. In an exploratory aim, we will explore the impact of self-directed mMBT in a 20-person uncontrolled study informed by Aims 1 & 2. Innovative elements of our proposal include a using ICU survivors as a model for studying medically ill patients with barriers to care, a mobile health delivery system, focus on common barriers to post- discharge therapy, amenability to wide dissemination, and exploration of potentially paradigm-shifting automated stepped therapy-elements that could improve access to mind-body therapies and enhance the feasibility of large-scale mind-body clinical trials involving serious illness. Overall, this R34 project is necessary and sufficient to inform a future RCT that could advance the field of critical care with a personalizable therapy that empowers patients to participate in their own recovery.