Optimizing a self-directed mobile copying skills training intervention for improving cardiorespiratory failture survivors' psychological distress: a pilot randomized clinical trial

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），研究已经澄清了这些幸存者如何遭受严重和 心理困扰的持续症状-抑郁、焦虑和创伤后应激障碍 （PTSD）-出院后。然而，很少有干预措施与患者的经历相关 并且还适应了他们在个性化护理方面的许多身体、社会和经济障碍。到 为了填补这一空白，我们开发了一个基于电话和网络的应对技能培训（CST）计划。 CST是一种以适应性应对为目标的心理社会干预措施， 减少心理困扰和提高生活质量的技能。我们进行了一项多中心 一项名为CSTEP的随机临床试验（RCT）将CST与教育计划（EP）进行了比较， ICU幸存者接受机械通气治疗心肺衰竭的一般样本。CST 在预先指定的亚组中，6个月时抑郁症状减轻，生活质量改善， 基线遇险升高。该随机对照试验还确定了有关识别的最佳实践的关键问题， 使那些高度痛苦但身体疾病可控的患者，以及 以更方便和可扩展的方式进行干预。在最近的一项随机对照试验中， 在LIFT干预（LIFT）中，我们发现自我导向的移动的应用程序方法增加了剂量，依从性和 潴留然而，许多患者报告对基于冥想的干预热情不高。 在进行第二次多中心RCT之前，需要将有希望的CST内容应用于LIFT， 灵感的移动的应用程序为基础的交付系统，然后在目标患者人群中进行测试， 响应的高可能性（即，高基线心理困扰）。因此，我们建议两年 R34混合方法项目涉及110名心肺衰竭幸存者。我们的具体目标是：（1） 优化自我导向移动的应用程序（mCST）和自动出院后痛苦的可用性 筛选系统;（2）在一项试验性3臂RCT中测试两种有希望的mCST迭代与常规治疗， 个月随访，以及（3）探索mCST实施的促进因素和障碍，使用这些数据， 通知mCST应用程序的任何必要的最终修订。 我们的团队拥有经过验证的专业知识来进行这项R34，这是必要的，也是足够的， 通知下一步以疗效为中心的多中心RCT，该RCT可以通过个性化的 但可扩展的治疗。创新包括mCST的自动筛选范式转换方法， 治疗和结果评估。总体而言，mCST可以显着改善获得心理社会 治疗，并加强任何医院或诊所为基础的干预。最后，这款R34解决了当前 美国国立卫生研究院、国家医学科学院和专业学会概述的研究优先事项。

As survival has improved for the 2 million people with cardiorespiratory failure managed annually in US intensive care units (ICUs), research has clarified how these survivors suffer from severe and persistent symptoms of psychological distress—depression, anxiety, and post-traumatic stress disorder (PTSD)—after discharge. However, few interventions exist that are relevant to patients' experiences and that also accommodate their many physical, social, and financial barriers to personalized care. To fill this gap, we developed a telephone- and web-based coping skills training (CST) program. CST is an empirically-supported psychosocial intervention that targets the use of the adaptive coping skills to decrease psychological distress and improve quality of life. We conducted a multicenter randomized clinical trial (RCT) called CSTEP that compared CST to an education program (EP) among a general sample of ICU survivors who received mechanical ventilation for cardiorespiratory failure. CST reduced depression symptoms and improved quality of life at 6 months in a pre-specified subgroup with elevated baseline distress. This RCT also identified key questions regarding best practices for identi- fying patients who are highly distressed yet whose physical illness is manageable, as well as delivering the intervention in a more convenient, and scalable manner. In a recent RCT testing a mindfulness intervention (LIFT), we found that a self-directed mobile app approach increased dose, adherence, and retention. However, many patients reported low enthusiasm for a meditation-based intervention. What is needed before a second multicenter RCT is to apply the promising CST content to a LIFT- inspired mobile app-based delivery system, and then to test it within a targeted patient population with a high likelihood of response (i.e., high baseline psychological distress). Therefore, we propose a 2-year R34 mixed-methods project involving 110 cardiorespiratory failure survivors. Our specific aims will: (1) Optimize the usability of a self-directed mobile app (mCST) and an automated post-discharge distress screening system; (2) Test two promising iterations of mCST vs. usual care in a pilot 3-arm RCT with 3- month follow up, and (3) Explore facilitators and barriers to mCST implementation, using these data to inform any necessary final revisions to the mCST app. Our team has the proven expertise to conduct this R34, which is both necessary and sufficient to inform a next-step efficacy-focused multicenter RCT that could advance the field with a personalizable yet scalable therapy. Innovations include mCST’s paradigm-shifting approach to automated screening, therapy, and outcomes assessment. Overall, mCST could significantly improve access to psychosocial therapies and augment any hospital- or clinic-based intervention. Last, this R34 addresses current research priorities outlined by the NIH, the National Academy of Medicine, and professional societies.