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Completed

NCT Number: NCT04816708

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

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.

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Key information

Conditions

Emotional Distress Anxiety Anxiety Disorders Behavior Behavioral Symptoms Burnout, Professional Burnout, Psychological COVID-19 Coronaviridae Infections Coronavirus Infections Depression Depressive Symptoms Infections Lung Diseases Mental Disorders Nidovirales Infections Occupational Diseases Occupational Stress Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Stress, Job Stress, Psychological Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LIFT Mindfulness

Behavioral

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.

Primary outcomes

  1. Intervention Completion

    Time frame: 30 days post randomization

    The percentage of participants who complete all 4 weeks of the intervention, a measure of feasibility.

  2. Sessions Completed

    Time frame: 30 days post-randomization

    Number of daily mindfulness sessions completed by participants in intervention arm, a measure of feasibility.

  3. Survey Completion at Baseline

    Time frame: Baseline

    The percentage of patients who complete surveys at baseline, a measure of feasibility.

  4. Survey Completion at 1 Month

    Time frame: 30 days post randomization

    The percentage of patients who complete surveys at 1 month, a measure of feasibility.

Secondary outcomes

  1. Change in Patient Health Questionnaire-9 Item Scale (PHQ-9)

    Time frame: Baseline to 30 days post-randomization

    Depression symptoms. Scores range from 0 (better) to 27 (worse).

  2. Change in Generalized Anxiety Disorder 7-item Scale (GAD-7)

    Time frame: Baseline to 30 days post-randomization

    Anxiety symptoms. Scores range from 0 (better) to 21 (worse).

  3. Change in Perceived Stress Scale (PSS-4)

    Time frame: Baseline to 30 days post-randomization

    Stress symptoms. Scores range from 0 (better) to 16 (worse).

  4. Change in Maslach Burnout Index (MBI) - Emotional Exhaustion

    Time frame: Baseline to 30 days post-randomization

    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).

  5. Change in Maslach Burnout Index (MBI) - Depersonalization

    Time frame: Baseline to 30 days post-randomization

    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).

  6. Change in Maslach Burnout Index (MBI) - Personal Accomplishment

    Time frame: Baseline to 30 days post-randomization

    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).

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Acronym: LIFT-HCW

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 25, 2021
Registry last updated
Feb 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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