Addressing Psychological Distress Symptoms Among Serious Illness Survivors of a Viral Pandemic With a Completely Self-directed, Symptom-responsive Mobile Mindfulness Intervention: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 8
- 主要终点
- Change in Patient Health Questionnaire-9 Item Scale (PHQ-9) Over 3 Months Post-discharge
研究概览
简要总结
This is a randomized clinical trial (RCT) nested within the NIH PETAL Network's COVID cohort study (BLUE CORAL [Biology and Longitudinal Epidemiology: COVID Observational Study]) of patients hospitalized for COVID-19-related illness. COVID-19 patients enrolled in BLUE CORAL with elevated distress symptoms 1 month post-discharge will be randomized to either the Lift mobile app intervention or a usual care control.
详细描述
The novel coronavirus (COVID-19) pandemic has changed access to and the delivery of medical care across the world rapidly and radically as increasingly large waves of patients fill clinics, hospital wards, and intensive care units (ICUs). Patients with comparable illnesses have high rates of persistent psychological distress symptoms including depression, anxiety, and PTSD. Currently there are few easily accessible therapies available for this distress in this time of deep fear and worry, social distancing, cancelled clinics, isolation and quarantine practices, and understaffed hospitals.
Lift, a novel mobile app-based mindfulness intervention, may be able to address COVID-19 patients' distress and access to care issues. Lift was piloted successfully in the intensive care unit (ICU; R34 AT00819) and is currently in the midst of a multicenter factorial experimental clinical trial designed to determine which of 8 versions is optimized for symptom relief, cost, and scalability (parent U01 AT009974).
This 2-arm, parallel group randomized clinical trial seeks to expand the scope of the parent U01 project to test the clinical impact of a psychological distress intervention rapidly deployed during a pandemic. This trial will include 300 patients who were hospitalized due to COVID-19; collect data at 1, 3, and 6 months post-discharge; and address 3 specific aims: (1) Compare the clinical impact of Lift vs. usual care control and (2) Compare long-term (6-month) outcomes of RCT patients both by treatment arm as well to the entire BLUE CORAL cohort, and (3) Explore participant-reported barriers and facilitators to intervention deployment, uptake, and engagement in a pandemic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Outcomes assessor will be blinded to group assignment, as will the investigators
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BLUE CORAL eligibility (the parent cohort study from which RCT participants will be recruited)
- •Inclusion criteria:
- •Adult hospitalized within 14 days of a positive PCR test for COVID-19
- •Evidence of acute COVID-19, with fever or respiratory manifestations, as characterized by signs and symptoms such as cough, dyspnea, tachypnea, hypoxemia, and infiltrates on chest imaging.
排除标准
- •Lack of informed consent
- •More than 72 hours of continuous hospitalization.
- •Comfort care orders in place at the time of enrollment and/or unexpected to survive for 24 hours
- •Previous enrollment in BLUE CORAL
- •LIFT COVID RCT eligibility
- •Inclusion criteria:
- •Enrolled in BLUE CORAL
- •Survival to time of BLUE CORAL 1-month post-discharge interview
- •English-speaking
- •Domiciled with access to a working telephone and smartphone, tablet, or computer with wifi or internet connection
- •Absence of severe dementia or cognitive dysfunction either before hospitalization or at time of 1 month post-discharge interview
- •Exclusion criteria:
- •PHQ-9 <5 at time of interview 1 month post-discharge
- •Suicidal ideation at time of interview 1 month post-discharge
结局指标
主要结局
Change in Patient Health Questionnaire-9 Item Scale (PHQ-9) Over 3 Months Post-discharge
时间窗: T1 (time of randomization [i.e., 1 month post-hospital discharge), T2 (2 months post-randomization [i.e., 3 months post-hospital discharge)
Depression symptoms. Scores range from 0 (better) to 27 (worse)
次要结局
- Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) at 6 Months Post-discharge(T1 (time of randomization [i.e., 1 month post-hospital discharge), T3 (5 months post-randomization [i.e., 6 months post-hospital discharge))
- Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) at 3 Months Post-discharge(T1 (time of randomization [i.e., 1 month post-hospital discharge), T2 (2 months post-randomization [i.e., 3 months post-hospital discharge))
- Change in EuroQOL-5DL (Quality of Life) Scale at 3 Months Post-discharge(T1 (time of randomization [i.e., 1 month post-hospital discharge), T2 (2 months post-randomization [i.e., 3 months post-hospital discharge))
- Change in EuroQOL-5DL (Quality of Life) Scale at 6 Months Post-discharge(T1 (time of randomization [i.e., 1 month post-hospital discharge), T3 (5 months post-randomization [i.e., 6 months post-hospital discharge))
- Change in Patient Health Questionnaire-9 Item Scale (PHQ-9) Over 6 Months Post-discharge(T1 (time of randomization [i.e., 1 month post-hospital discharge), T3 (5 months post-randomization [i.e., 6 months post-hospital discharge))
- Number of Participants With Cardiopulmonary Symptoms at 3 Months Post-discharge(T1 (time of randomization [i.e., 1 month post-hospital discharge), T2 (2 months post-randomization [i.e., 3 months post-hospital discharge))
- Number of Participants With Cardiopulmonary Symptoms at 6 Months Post-discharge(T1 (time of randomization [i.e., 1 month post-hospital discharge), T3 (5 months post-randomization [i.e., 6 months post-hospital discharge))