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

NCT ID: NCT04816708

Last Updated: 2024-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-19
• Study Completion Date: 2022-02-04

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:

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

LIFT Mindfulness

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Cox, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

References

Pratt EH, Hall L, Jennings C, Olsen MK, Jan A, Parish A, Porter LS, Cox CE. Mobile Mindfulness for Psychological Distress and Burnout among Frontline COVID-19 Nurses: A Pilot Randomized Trial. Ann Am Thorac Soc. 2023 Oct;20(10):1475-1482. doi: 10.1513/AnnalsATS.202301-025OC.

Reference Type: DERIVED

PMID: 37289650 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00107657

Identifier Type: -

Identifier Source: org_study_id