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

Primary Purpose

Emotional Distress, Burnout, Professional, Stress, Job

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LIFT Mindfulness
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emotional Distress focused on measuring Emotional distress, COVID-19, Burnout

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

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

Arm 2: Control waitlist group (delayed access to LIFT mindfulness app)

Arm Description

Participants randomized to the intervention arm will be provided access to LIFT app's daily mobile mindfulness therapy for 30 days.

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.

Outcomes

Primary Outcome Measures

Intervention completion
The percentage of participants who complete all 4 weeks of the intervention, a measure of feasibility.
Sessions completed
Number of daily mindfulness sessions completed by participants in intervention arm, a measure of feasibility.
Survey completion
The percentage of patients who complete surveys at baseline 1 month, a measure of feasibility.

Secondary Outcome Measures

Change in Patient Health Questionnaire-9 Item scale (PHQ-9)
Depression symptoms. Scores range from 0 (better) to 27 (worse)
Change in Generalized Anxiety Disorder 7-item scale (GAD-7)
Anxiety symptoms. Scores range from 0 (better) to 21 (worse)
Change in Perceived Stress Scale (PSS-4)
Stress symptoms. Scores range from 0 (better) to 16 (worse)
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.

Full Information

First Posted
March 23, 2021
Last Updated
February 8, 2022
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT04816708
Brief Title
A Self-directed Mobile Mindfulness Intervention to Address Distress and Burnout in Frontline Healthcare Workers
Acronym
LIFT-HCW
Official Title
A Self-directed Mobile Mindfulness Intervention to Address Distress and Burnout in Frontline Healthcare Workers
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
May 19, 2021 (Actual)
Primary Completion Date
January 30, 2022 (Actual)
Study Completion Date
February 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emotional Distress, Burnout, Professional, Stress, Job, Anxiety, Depressive Symptoms
Keywords
Emotional distress, COVID-19, Burnout

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single site, pilot randomized waitlist control trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Intervention group (access to LIFT mindfulness app)
Arm Type
Active Comparator
Arm Description
Participants randomized to the intervention arm will be provided access to LIFT app's daily mobile mindfulness therapy for 30 days.
Arm Title
Arm 2: Control waitlist group (delayed access to LIFT mindfulness app)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
LIFT Mindfulness
Intervention Description
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 Outcome Measure Information:
Title
Intervention completion
Description
The percentage of participants who complete all 4 weeks of the intervention, a measure of feasibility.
Time Frame
Between baseline and 30 days post randomization
Title
Sessions completed
Description
Number of daily mindfulness sessions completed by participants in intervention arm, a measure of feasibility.
Time Frame
Between baseline and 30 days post-randomization
Title
Survey completion
Description
The percentage of patients who complete surveys at baseline 1 month, a measure of feasibility.
Time Frame
Between baseline and 30 days post-randomization.
Secondary Outcome Measure Information:
Title
Change in Patient Health Questionnaire-9 Item scale (PHQ-9)
Description
Depression symptoms. Scores range from 0 (better) to 27 (worse)
Time Frame
Between baseline and 30 days post-randomization
Title
Change in Generalized Anxiety Disorder 7-item scale (GAD-7)
Description
Anxiety symptoms. Scores range from 0 (better) to 21 (worse)
Time Frame
Between Baseline and 30 days post-randomization
Title
Change in Perceived Stress Scale (PSS-4)
Description
Stress symptoms. Scores range from 0 (better) to 16 (worse)
Time Frame
Between Baseline and 30 days post-randomization
Title
Change in Maslach Burnout Index (MBI)
Description
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.
Time Frame
Between Baseline and 30 days post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Cox, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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