A Self-directed Mobile Mindfulness Intervention to Address Distress and Burnout in Frontline Healthcare Workers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Sessions Completed
研究概览
简要总结
This is a pilot randomized waitlist control trial assessing if the feasibility of using a mobile mindfulness app to treat emotional distress and burnout amongst nurses taking care of COVID-19 patients. This trial will help inform the study team if dissemination the intervention to a large number of nurses in a short time period is feasible, and if the intervention has evidence of a clinical impact.
详细描述
Emotional distress and burnout are common among health care workers, particularly among nurses. These burdens have been worsened due to the COVID-19 pandemic's imposition of substantial physical and psychological stressors as well as persistent worry about personal health. There are few effective therapies for healthcare workers' symptoms of distress, fewer still that can be easily scaled, and most require face-to-face contact which is discouraged during a pandemic.
Mindfulness is a type of mind-body therapy that promotes a practice of non-judgmental awareness that can alleviate distress by uncoupling emotional reactions and habitual behavior from unpleasant symptoms, thoughts, and emotions. LIFT is a mobile mindfulness app which can assess levels of emotional distress via survey, and subsequently offer mindfulness content.
The LIFT-Healthcare Worker pilot randomized control trial (RCT) seeks to address those unmet needs. The trial will explore the feasibility and impact of the LIFT mobile app in relieving symptoms of emotional distress among nurses directly caring for COVID-19 patients in the Duke University Health System.
Target enrollment is for up to 200 participants. After signing consent, participants will be randomized via the LIFT app in a 2:1 (intervention:control) fashion into two arms:
- Arm 1: Intervention group (access to LIFT mindfulness app)
- Arm 2: Control waitlist group (delayed access to LIFT app)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Adult ≥ 18 years of age
- •Currently working as a nurse in an adult COVID unit at Duke University Hospital
- •English Fluency
排除标准
- •Lack of access to either reliable smartphone with cellular data plan or home internet access.
- •Anticipation of leaving current position in ≤30 days.
结局指标
主要结局
Sessions Completed
时间窗: 30 days post-randomization
Number of daily mindfulness sessions completed by participants in intervention arm, a measure of feasibility.
Intervention Completion
时间窗: 30 days post randomization
The percentage of participants who complete all 4 weeks of the intervention, a measure of feasibility.
Survey Completion at Baseline
时间窗: Baseline
The percentage of patients who complete surveys at baseline, a measure of feasibility.
Survey Completion at 1 Month
时间窗: 30 days post randomization
The percentage of patients who complete surveys at 1 month, a measure of feasibility.
次要结局
- Change in Perceived Stress Scale (PSS-4)(Baseline to 30 days post-randomization)
- Change in Maslach Burnout Index (MBI) - Emotional Exhaustion(Baseline to 30 days post-randomization)
- Change in Patient Health Questionnaire-9 Item Scale (PHQ-9)(Baseline to 30 days post-randomization)
- Change in Generalized Anxiety Disorder 7-item Scale (GAD-7)(Baseline to 30 days post-randomization)
- Change in Maslach Burnout Index (MBI) - Depersonalization(Baseline to 30 days post-randomization)
- Change in Maslach Burnout Index (MBI) - Personal Accomplishment(Baseline to 30 days post-randomization)