Optimizing a self-directed mobile mindfulness intervention for improving cardiorespiratory failure survivors' psychological distress (LIFT2): Design and rationale of a randomized factorial experimental clinical trial.
Optimizing a self-directed mobile mindfulness intervention for improving cardiorespiratory failure survivors' psychological distress (LIFT2): Design and rationale of a randomized factorial experimental clinical trial.
复制标题
优化自我导向移动正念干预以改善心肺衰竭幸存者的心理困扰（LIFT2）：随机析因实验临床试验的设计和原理。
DOI：
10.1016/j.cct.2020.106119
复制
发表时间：
2020
影响因子：
2.2
通讯作者：
Hough,CatherineL
中科院分区：
文献类型：
--
作者：
Cox,ChristopherE;Olsen,MarenK;Gallis,JohnA;Porter,LauraS;Greeson,JeffreyM;Gremore,Tina;Frear,Allie;Ungar,Anna;McKeehan,Jeffrey;McDowell,Brittany;McDaniel,Hannah;Moss,Marc;Hough,CatherineL
尽管每年200万重症监护病房(ICU)幸存者中有75%的人经历了持续数月至数年的心理困扰症状，但针对他们的症状并满足他们独特需求的治疗方法很少。作为回应，我们开发了Lift，这是一款基于移动应用程序的正念干预。在一项先导性随机临床试验(LIFT1)中，LIFT2研究比基于电话的正念程序或教育控制更能减少痛苦症状。目的描述正在进行的因素实验临床试验(LIFT2)的方法，以帮助开发和实施LIFT干预版本，该版本在效果、可行性、可扩展性和成本方面进行了优化。方法和分析LIFT2研究是一项优化试验，概念上是一个更大的多阶段优化策略(MOST)项目的组成部分。LIFT2的目标是使用一项涉及152名患者的2×3×2×2因子实验试验，以确定针对ICU幸存者的Lift移动正念计划的理想组成部分，这些因素包括(1)由治疗师Call进行的研究介绍与仅限APP，(2)治疗师与仅APP对持续或恶化症状的反应，以及(3)高剂量与低剂量。主要试验结果是由PHQ-9仪器测量的随机化后1个月抑郁症状的变化。次要结果包括焦虑、创伤后应激障碍和身体症状；可行性、可接受性和可用性的衡量标准；以及在后续研究完成后对研究参与者进行的半结构化访谈的定性分析所评估的主题。我们将使用一般线性模型来比较各因素的主要影响和相互作用的结果。
IntroductionAlthough as many as 75% of the >2 million annual intensive care unit (ICU) survivors experience symptoms of psychological distress that persist for months to years, few therapies exist that target their symptoms and accommodate their unique needs. In response, we developed LIFT, a mobile app-based mindfulness intervention. LIFT reduced distress symptoms more than either a telephone-based mindfulness program or education control in a pilot randomized clinical trial (LIFT1).ObjectiveTo describe the methods of a factorial experimental clinical trial (LIFT2) being conducted to aid in the development and implementation of the version of the LIFT intervention that is optimized across domains of effect, feasibility, scalability, and costs.Methods and analysisThe LIFT2 study is an optimization trial conceptualized as a component of a larger multiphase optimization strategy (MOST) project. The goal of LIFT2 is to use a 2 × 2 × 2 factorial experimental trial involving 152 patients to determine the ideal components of the LIFT mobile mindfulness program for ICU survivors across factors including (1) study introduction by call from a therapist vs. app only, (2) response to persistent or worsening symptoms over time by therapist vs. app only, and (3) high dose vs. low dose. The primary trial outcome is change in depression symptoms 1 month from randomization measured by the PHQ-9 instrument. Secondary outcomes include anxiety, post-traumatic stress disorder, and physical symptoms; measures of feasibility, acceptability, and usability; as well as themes assessed through qualitative analysis of semi-structured interviews with study participants conducted after follow up completion. We will use general linear models to compare outcomes across the main effects and interactions of the factors.