基于移动应用程序的正念干预，用于解决 COVID-19 感染住院幸存者的心理压力

CHEST critical care Pub Date : 2024-03-04 DOI:10.1016/j.chstcc.2024.100063

Christopher E. Cox MD, MPH , John A. Gallis ScM , Maren K. Olsen PhD , Laura S. Porter PhD , Tina M. Gremore PhD , Theodore J. Iwashyna MD, PhD , Ellen S. Caldwell MS , Jeffrey M. Greeson PhD , Marc Moss MD , Catherine L. Hough MD

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引用次数: 0

摘要

研究问题能否在临床试验网络中可行且快速地实施一种由手机应用提供的自我引导正念干预，以减少痛苦症状？研究设计与方法2021年1月至2022年5月期间，在美国29个地点开展了一项随机临床试验，研究对象包括因COVID-19相关疾病住院且出院时抑郁症状升高的幸存者。参与者被随机分为干预组和常规护理对照组。干预包括四个主题周的每日音频、视频和文本内容。所有研究程序都是虚拟的。主要结果是在 3 个月时使用患者健康问卷 9 评估抑郁症状。次要结果包括焦虑（广泛性焦虑症 7 项量表）、生活质量（EQ-5D）和依从性。我们使用一般线性模型来估计治疗臂随时间变化的结果差异。结果56名随机参与者（平均年龄± SD，51.0± 13.2岁；38名女性[67.9%]；14名黑人参与者[25%]）中，45人（干预组：n = 23 [79%]；对照组：n = 22 [81%]）在6个月时仍在接受治疗。干预组和对照组参与者在 3 个月时的患者健康问卷 9（-0.5 vs 0.1）、广泛性焦虑症 7 项量表（-0.3 vs 0.1）或 EQ-5D （-0.03 vs 0.02）评分的平均改善幅度分别为-0.5 vs 0.1、-0.3 vs 0.1、-0.03 vs 0.02；6 个月的结果相似。只有 15 名参与者（51.7%）开始接受干预，而完成的 56 项规定干预活动的平均数量（± SD）为 12.0 ± 15.2。在COVID-19住院治疗的幸存者中，心理困扰症状较重的患者对基于手机应用的自主正念干预的依从性较差。未来广泛动员的心理困扰干预措施应将重点放在患者参与和简化监管上，以提高成功率。试验注册ClinicalTrials.gov; 编号: NCT04581200; URL: www.clinicaltrials.gov

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Mobile App-Based Mindfulness Intervention for Addressing Psychological Distress Among Survivors of Hospitalization for COVID-19 Infection

Background

Psychological distress symptoms are present and persistent among many patients who survive a critical illness like COVID-19.

Research Question

Could a self-directed mobile app-delivered mindfulness intervention be feasibly and rapidly implemented within a clinical trials network to reduce distress symptoms?

Study Design and Methods

A randomized clinical trial was conducted between January 2021 and May 2022 at 29 US sites and included survivors of hospitalization due to COVID-19-related illness with elevated symptoms of depression at discharge. Participants were randomized to intervention or usual care control. The intervention consisted of four themed weeks of daily audio, video, and text content. All study procedures were virtual. The primary outcome was depression symptoms assessed with the Patient Health Questionnaire 9 at 3 months. Secondary outcomes included anxiety (Generalized Anxiety Disorder 7-item scale), quality of life (EQ-5D), and adherence. We used general linear models to estimate treatment arm differences in outcomes over time.

Results

Among 56 randomized participants (mean age ± SD, 51.0 ± 13.2 years; 38 female [67.9%]; 14 Black participants [25%]), 45 (intervention: n = 23 [79%]; control: n = 22 [81%]) were retained at 6 months. There was no difference in mean improvement between intervention and control participants at 3 months in Patient Health Questionnaire 9 (−0.5 vs 0.1), Generalized Anxiety Disorder 7-item scale (−0.3 vs 0.1), or EQ-5D (−0.03 vs 0.02) scores, respectively; 6-month results were similar. Only 15 participants (51.7%) initiated the intervention, whereas the mean number ± SD of the 56 prescribed intervention activities completed was 12.0 ± 15.2. Regulatory approvals delayed trial initiation by nearly a year.

Interpretation

Among survivors of COVID-19 hospitalization with elevated psychological distress symptoms, a self-directed mobile app-based mindfulness intervention had poor adherence. Future psychological distress interventions mobilized at broad scale should focus efforts on patient engagement and regulatory simplification to enhance success.