Emotional DistressLIFT-HCWNCT04816708
A Self-directed Mobile Mindfulness Intervention to Address Distress and Burnout in Frontline Healthcare Workers
A study testing LIFT Mindfulness in people with Emotional Distress and Burnout, Professional, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emotional Distress, Burnout, Professional, Stress, Job
- What is being tested?
- LIFT Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2021to 4 Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult ≥ 18 years of age
- Currently working as a nurse in an adult COVID unit at Duke University Hospital
- English Fluency
Who cannot join
- Lack of access to either reliable smartphone with cellular data plan or home internet access.
- Anticipation of leaving current position in ≤30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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.
Read the 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.
- Being tested
- LIFT Mindfulness
- Keywords
- Emotional distress, COVID-19, Burnout
- Medical subject headings
- Burnout, Professional, Occupational Stress, Anxiety Disorders, Depression, COVID-19, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIFT MindfulnessBehavioural
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 group | Role | What they receive |
|---|---|---|
| Arm 1: Intervention group (access to LIFT mindfulness app) | Active comparator | Participants randomized to the intervention arm will be provided access to LIFT app's daily mobile mindfulness therapy for 30 days. Receives: Behavioral: LIFT Mindfulness |
| Arm 2: Control waitlist group (delayed access to LIFT mindfulness app) | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Completion
The percentage of participants who complete all 4 weeks of the intervention, a measure of feasibility.
Measured: 30 days post randomization
Sessions Completed
Number of daily mindfulness sessions completed by participants in intervention arm, a measure of feasibility.
Measured: 30 days post-randomization
Survey Completion at Baseline
The percentage of patients who complete surveys at baseline, a measure of feasibility.
Measured: Baseline
Survey Completion at 1 Month
The percentage of patients who complete surveys at 1 month, a measure of feasibility.
Measured: 30 days post randomization
Secondary outcomes (6)
Change in Patient Health Questionnaire-9 Item Scale (PHQ-9)
Depression symptoms. Scores range from 0 (better) to 27 (worse).
Measured: Baseline to 30 days post-randomization
Change in Generalized Anxiety Disorder 7-item Scale (GAD-7)
Anxiety symptoms. Scores range from 0 (better) to 21 (worse).
Measured: Baseline to 30 days post-randomization
Change in Perceived Stress Scale (PSS-4)
Stress symptoms. Scores range from 0 (better) to 16 (worse).
Measured: Baseline to 30 days post-randomization
Change in Maslach Burnout Index (MBI) - Emotional Exhaustion
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).
Measured: Baseline to 30 days post-randomization
Change in Maslach Burnout Index (MBI) - Depersonalization
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).
Measured: Baseline to 30 days post-randomization
Change in Maslach Burnout Index (MBI) - Personal Accomplishment
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).
Measured: Baseline to 30 days post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start19 May 2021
- Primary completion30 Jan 2022
- Study completion4 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emotional DistressStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single site, pilot randomized waitlist control trial
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Cox, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816708
- Sponsor's protocol ID
- Pro00107657
- Acronym
- LIFT-HCW
- Status last verified
- Feb 2024
- First submitted
- 23 Mar 2021
- Last updated
- 22 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37289650
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Self-directed Mobile Mindfulness Intervention to Address Distress and Burnout in Frontline Healthcare Workers
- ClinicalTrials.gov ID
- NCT04816708
- Acronym / sponsor ID
- LIFT-HCW / Pro00107657
- Keywords
- Emotional distress, COVID-19, Burnout
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 19 May 2021 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 4 Feb 2022 (actual)
- First posted
- 25 Mar 2021 (actual)
- Results
- Posted 22 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single site, pilot randomized waitlist control trial
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Intervention group (access to LIFT mindfulness app) | Active comparator | Behavioral: LIFT MindfulnessParticipants randomized to the intervention arm will be provided access to LIFT app's daily mobile mindfulness therapy for 30 days. |
| Arm 2: Control waitlist group (delayed access to LIFT mindfulness app) | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult ≥ 18 years of age
- Currently working as a nurse in an adult COVID unit at Duke University Hospital
- English Fluency
Key exclusion criteria (2 listed)
- Lack of access to either reliable smartphone with cellular data plan or home internet access.
- Anticipation of leaving current position in ≤30 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LIFT MindfulnessMindfulness 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. | Behavioural | Arm 1: Intervention group (access to LIFT mindfulness app) |
Primary outcome
Intervention Completion
Time frame: 30 days post randomization
The percentage of participants who complete all 4 weeks of the intervention, a measure of feasibility.
Sessions Completed
Time frame: 30 days post-randomization
Number of daily mindfulness sessions completed by participants in intervention arm, a measure of feasibility.
Survey Completion at Baseline
Time frame: Baseline
The percentage of patients who complete surveys at baseline, a measure of feasibility.
Survey Completion at 1 Month
Time frame: 30 days post randomization
The percentage of patients who complete surveys at 1 month, a measure of feasibility.
6 secondary outcomes
Change in Patient Health Questionnaire-9 Item Scale (PHQ-9)
Time frame: Baseline to 30 days post-randomization
Change in Generalized Anxiety Disorder 7-item Scale (GAD-7)
Time frame: Baseline to 30 days post-randomization
Change in Perceived Stress Scale (PSS-4)
Time frame: Baseline to 30 days post-randomization
Change in Maslach Burnout Index (MBI) - Emotional Exhaustion
Time frame: Baseline to 30 days post-randomization
Change in Maslach Burnout Index (MBI) - Depersonalization
Time frame: Baseline to 30 days post-randomization
Change in Maslach Burnout Index (MBI) - Personal Accomplishment
Time frame: Baseline to 30 days post-randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37289650Pratt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Cox, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LIFT Mindfulness in people with Emotional Distress and Burnout, Professional, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Completion (time frame: 30 days post randomization). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04816708, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.