Clinical trial NCT04816708: A Self-directed Mobile Mindfulness Intervention to Address Distress and Burnout in Frontline Healthcare Workers
Official title: A Self-directed Mobile Mindfulness Intervention to Address Distress and Burnout in Frontline Healthcare Workers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotional Distress
Burnout, Professional
Stress, Job
Anxiety
Depressive Symptoms
Keywords: Emotional distress
COVID-19
Burnout
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2021-03-25
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single site, pilot randomized waitlist control trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Intervention Completion
timeFrame: 30 days post randomization
measure: Sessions Completed
timeFrame: 30 days post-randomization
measure: Survey Completion at Baseline
timeFrame: Baseline
measure: Survey Completion at 1 Month
timeFrame: 30 days post randomization
Secondary outcomes:
measure: Change in Patient Health Questionnaire-9 Item Scale (PHQ-9)
timeFrame: Baseline to 30 days post-randomization
measure: Change in Generalized Anxiety Disorder 7-item Scale (GAD-7)
timeFrame: Baseline to 30 days post-randomization
measure: Change in Perceived Stress Scale (PSS-4)
timeFrame: Baseline to 30 days post-randomization
measure: Change in Maslach Burnout Index (MBI) - Emotional Exhaustion
timeFrame: Baseline to 30 days post-randomization
measure: Change in Maslach Burnout Index (MBI) - Depersonalization
timeFrame: Baseline to 30 days post-randomization
measure: Change in Maslach Burnout Index (MBI) - Personal Accomplishment
timeFrame: Baseline to 30 days post-randomization
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Christopher Cox, MD
role: PRINCIPAL_INVESTIGATOR
References: