A Self-directed Mobile Mindfulness Intervention to Address Distress and Burnout in Frontline Healthcare Workers

Study Overview
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Brief Summary
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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.

Detailed Description
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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) AIM 1, which is to determine the feasibility of using the LIFT app among nurses directly caring for COVID-19 patients, will be assessed via the app which tracks user fidelity and adherence, and the use of an interactive dashboard for administrative users (i.e., study team) to track individual participant use. An open ended narrative question at 1 month will also help provide guidance for improving usability in future studies, as will directed telephone interviews with participants with high and low app. AIM 2, which is to assess evidence of clinical impact of LIFT compared to control among nurses directly caring for COVID-19 patients at 1 month, will be assessed by comparing changes in the Patient Health Questionnaire-9 (PHQ-9), General Anxiety Disorder -7 (GAD-7) questionnaire, the Maslach Burnout Index (MBI), and Perceived Stress Scale 4 (PSS-4) over the study duration (1 month) between intervention and usual care groups.

Official Title
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A Self-directed Mobile Mindfulness Intervention to Address Distress and Burnout in Frontline Healthcare Workers

Conditions
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Emotional Distress, Burnout, Professional, Stress, Job, Anxiety, Depressive Symptoms

Intervention / Treatment
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* Behavioral: LIFT Mindfulness


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult ≥ 18 years of age Currently working as a nurse in an adult COVID unit at Duke University Hospital English Fluency Exclusion Criteria: Lack of access to either reliable smartphone with cellular data plan or home internet access. Anticipation of leaving current position in ≤30 days.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single site, pilot randomized waitlist control trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1: Intervention group (access to LIFT mindfulness app)<br>Participants randomized to the intervention arm will be provided access to LIFT app's daily mobile mindfulness therapy for 30 days. | Behavioral: LIFT Mindfulness<br>* 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 that has previously been used in ICU patients, where it was shown to reduce symptoms of depression, anxiety, and PTSD.<br>|
| No Intervention: Arm 2: Control waitlist group (delayed access to LIFT mindfulness app)<br>Control participants will not receive access to the LIFT app daily mobile mindfulness therapy during study period. They may have access to LIFT app daily mobile mindfulness therapy after completion of the study period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention completion | The percentage of participants who complete all 4 weeks of the intervention, a measure of feasibility. | Between baseline and 30 days post randomization | 
| Sessions completed | Number of daily mindfulness sessions completed by participants in intervention arm, a measure of feasibility. | Between baseline and 30 days post-randomization | 
| Survey completion | The percentage of patients who complete surveys at baseline 1 month, a measure of feasibility. | Between baseline and 30 days post-randomization. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Health Questionnaire-9 Item scale (PHQ-9) | Depression symptoms. Scores range from 0 (better) to 27 (worse) | Between baseline and 30 days post-randomization | 
| Change in Generalized Anxiety Disorder 7-item scale (GAD-7) | Anxiety symptoms. Scores range from 0 (better) to 21 (worse) | Between Baseline and 30 days post-randomization | 
| Change in Perceived Stress Scale (PSS-4) | Stress symptoms. Scores range from 0 (better) to 16 (worse) | Between Baseline and 30 days post-randomization | 
| Change in Maslach Burnout Index (MBI) | Burnout Symptoms. Score range 0-132, based on three components: emotional exhaustion, depersonalization, and personal accomplishment. High scores in emotional exhaustion and depersonalization and low scores in personal accomplishment are indicative of burnout, but there are not set threshold values. | Between Baseline and 30 days post-randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emotional distress, COVID-19, Burnout