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

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ClinicalTrials.gov Identifier: NCT04816708
Recruitment Status : Recruiting
First Posted : March 25, 2021
Last Update Posted : May 27, 2021
Sponsor:
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Emotional Distress Burnout, Professional Stress, Job Anxiety Depressive Symptoms Behavioral: LIFT Mindfulness Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single site, pilot randomized waitlist control trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Self-directed Mobile Mindfulness Intervention to Address Distress and Burnout in Frontline Healthcare Workers
Actual Study Start Date : May 19, 2021
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2022

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.



Primary Outcome Measures :
  1. Intervention completion [ Time Frame: Between baseline and 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: Between baseline and 30 days post-randomization ]
    Number of daily mindfulness sessions completed by participants in intervention arm, a measure of feasibility.

  3. Survey completion [ Time Frame: Between baseline and 30 days post-randomization. ]
    The percentage of patients who complete surveys at baseline 1 month, a measure of feasibility.


Secondary Outcome Measures :
  1. Change in Patient Health Questionnaire-9 Item scale (PHQ-9) [ Time Frame: Between baseline and 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: Between Baseline and 30 days post-randomization ]
    Anxiety symptoms. Scores range from 0 (better) to 21 (worse)

  3. Change in Perceived Stress Scale (PSS-4) [ Time Frame: Between Baseline and 30 days post-randomization ]
    Stress symptoms. Scores range from 0 (better) to 16 (worse)

  4. Change in Maslach Burnout Index (MBI) [ Time Frame: Between Baseline and 30 days post-randomization ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04816708


Contacts
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Contact: Christopher Cox, MD 919-681-7232 christopher.cox@duke.edu
Contact: Elias Pratt, MD 919-684-8111 elias.pratt@duke.edu

Locations
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United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Elias H Pratt, MD       elias.pratt@duke.edu   
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Christopher Cox, MD Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04816708    
Other Study ID Numbers: Pro00107657
First Posted: March 25, 2021    Key Record Dates
Last Update Posted: May 27, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
Emotional distress
COVID-19
Burnout
Additional relevant MeSH terms:
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Burnout, Professional
Depression
Burnout, Psychological
Behavioral Symptoms
Stress, Psychological
Occupational Stress
Occupational Diseases