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

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.

Study Overview

• Status: Completed
• Conditions: Burnout, Professional; Anxiety; Depressive Symptoms; Emotional Distress; Stress, Job
• Intervention / Treatment: Behavioral: LIFT Mindfulness

Detailed Description

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:

1. Arm 1: Intervention group (access to LIFT mindfulness app)
2. 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.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult ≥ 18 years of age
2. Currently working as a nurse in an adult COVID unit at Duke University Hospital
3. English Fluency

Exclusion Criteria:

1. Lack of access to either reliable smartphone with cellular data plan or home internet access.
2. Anticipation of leaving current position in ≤30 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1: Intervention group (access to LIFT mindfulness app); Participants randomized to the intervention arm will be provided access to LIFT app's daily mobile mindfulness therapy for 30 days.	Behavioral: LIFT Mindfulness; 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.
No Intervention: Arm 2: Control waitlist group (delayed access to LIFT mindfulness app); 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?

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.	30 days post randomization
Sessions Completed	Number of daily mindfulness sessions completed by participants in intervention arm, a measure of feasibility.	30 days post-randomization
Survey Completion at Baseline	The percentage of patients who complete surveys at baseline, a measure of feasibility.	Baseline
Survey Completion at 1 Month	The percentage of patients who complete surveys at 1 month, a measure of feasibility.	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).	Baseline to 30 days post-randomization
Change in Generalized Anxiety Disorder 7-item Scale (GAD-7)	Anxiety symptoms. Scores range from 0 (better) to 21 (worse).	Baseline to 30 days post-randomization
Change in Perceived Stress Scale (PSS-4)	Stress symptoms. Scores range from 0 (better) to 16 (worse).	Baseline to 30 days post-randomization
Change in Maslach Burnout Index (MBI) - Emotional Exhaustion	All MBI items are scored using a 7 level frequency ratings from "never" to "daily." The MBI has three component scales: emotional exhaustion (9 items), depersonalization (5 items) and personal achievement (8 items). Each scale measures its own unique dimension of burnout. Reported here is the emotional exhaustion component, which has a score range of 0-54, where a higher score indicates greater emotional exhaustion (indicative of burnout).	Baseline to 30 days post-randomization
Change in Maslach Burnout Index (MBI) - Depersonalization	All MBI items are scored using a 7 level frequency ratings from "never" to "daily." The MBI has three component scales: emotional exhaustion (9 items), depersonalization (5 items) and personal achievement (8 items). Each scale measures its own unique dimension of burnout. Reported here is the depersonalization component, which has a score range of 0-30, where a higher score indicates greater depersonalization (indicative of burnout).	Baseline to 30 days post-randomization
Change in Maslach Burnout Index (MBI) - Personal Accomplishment	All MBI items are scored using a 7 level frequency ratings from "never" to "daily." The MBI has three component scales: emotional exhaustion (9 items), depersonalization (5 items) and personal achievement (8 items). Each scale measures its own unique dimension of burnout. Reported here is the personal achievement component, which has a score range of 0-30, where a lower score indicates less sense of personal achievement (indicative of burnout).	Baseline to 30 days post-randomization

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Christopher Cox, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2021
• Primary Completion (Actual): January 30, 2022
• Study Completion (Actual): February 4, 2022

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 24, 2021
• First Posted (Actual): March 25, 2021

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: COVID-19; Burnout; Emotional distress
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Occupational Diseases; Depression; Burnout, Professional; Burnout, Psychological; Occupational Stress
• Other Study ID Numbers: Pro00107657

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No