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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04816708

Acronym

LIFT-HCW

Enrollment

102

Registered

2021-03-25

Start date

2021-05-19

Completion date

2022-02-04

Last updated

2024-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Emotional distress, COVID-19, Burnout

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.

Interventions

BEHAVIORALLIFT 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Single site, pilot randomized waitlist control trial

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Intervention Completion	30 days post randomization	The percentage of participants who complete all 4 weeks of the intervention, a measure of feasibility.
Sessions Completed	30 days post-randomization	Number of daily mindfulness sessions completed by participants in intervention arm, a measure of feasibility.
Survey Completion at Baseline	Baseline	The percentage of patients who complete surveys at baseline, a measure of feasibility.
Survey Completion at 1 Month	30 days post randomization	The percentage of patients who complete surveys at 1 month, a measure of feasibility.

Secondary

Measure	Time frame	Description
Change in Maslach Burnout Index (MBI) - Depersonalization	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).
Change in Generalized Anxiety Disorder 7-item Scale (GAD-7)	Baseline to 30 days post-randomization	Anxiety symptoms. Scores range from 0 (better) to 21 (worse).
Change in Maslach Burnout Index (MBI) - Personal Accomplishment	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).
Change in Perceived Stress Scale (PSS-4)	Baseline to 30 days post-randomization	Stress symptoms. Scores range from 0 (better) to 16 (worse).
Change in Patient Health Questionnaire-9 Item Scale (PHQ-9)	Baseline to 30 days post-randomization	Depression symptoms. Scores range from 0 (better) to 27 (worse).
Change in Maslach Burnout Index (MBI) - Emotional Exhaustion	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).

Countries

United States

Participant flow

Recruitment details

Participants were recruited from May 19, 2021 - December 15, 2021 via flyer and/or email which contained QR code and/or URL to download app. Flyers were distributed in eligible hospital units, and emails were sent to listservs for nurses working in eligible units.

Participants by arm

Arm	Count
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. 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.	69
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.	33
Total	102

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	10	4

Baseline characteristics

Characteristic	Arm 1: Intervention Group (Access to LIFT Mindfulness App)	Total	Arm 2: Control Waitlist Group (Delayed Access to LIFT Mindfulness App)
Age, Continuous	27 years	26.5 years	25 years
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants	8 Participants	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	62 Participants	94 Participants	32 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) Asian	3 Participants	7 Participants	4 Participants
Race (NIH/OMB) Black or African American	2 Participants	4 Participants	2 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants	3 Participants	0 Participants
Race (NIH/OMB) White	60 Participants	87 Participants	27 Participants
Region of Enrollment United States	69 Participants	102 Participants	33 Participants
Sex: Female, Male Female	65 Participants	96 Participants	31 Participants
Sex: Female, Male Male	4 Participants	6 Participants	2 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 59	0 / 29
other Total, other adverse events	1 / 59	0 / 29
serious Total, serious adverse events	0 / 59	0 / 29

Outcome results

Primary

Intervention Completion

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

Time frame: 30 days post randomization

Population: Not applicable to the control group.

Arm	Measure	Value (NUMBER)
Arm 1: Intervention Group (Access to LIFT Mindfulness App)	Intervention Completion	28 percentage of participants

Primary

Sessions Completed

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

Time frame: 30 days post-randomization

Population: Not applicable to the control group.

Arm	Measure	Value (MEDIAN)
Arm 1: Intervention Group (Access to LIFT Mindfulness App)	Sessions Completed	3 sessions per day

Primary

Survey Completion at 1 Month

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

Time frame: 30 days post randomization

Arm	Measure	Value (NUMBER)
Arm 1: Intervention Group (Access to LIFT Mindfulness App)	Survey Completion at 1 Month	86 percentage of participants
Arm 2: Control Waitlist Group (Delayed Access to LIFT Mindfulness App)	Survey Completion at 1 Month	88 percentage of participants

Primary

Survey Completion at Baseline

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

Time frame: Baseline

Arm	Measure	Value (NUMBER)
Arm 1: Intervention Group (Access to LIFT Mindfulness App)	Survey Completion at Baseline	100 percentage of participants
Arm 2: Control Waitlist Group (Delayed Access to LIFT Mindfulness App)	Survey Completion at Baseline	100 percentage of participants

Secondary