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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.
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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LIFT Mindfulness | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Completion | The percentage of participants who complete all 4 weeks of the intervention, a measure of feasibility. | 30 days post randomization |
| Sessions Completed | Number of daily mindfulness sessions completed by participants in intervention arm, a measure of feasibility. | 30 days post-randomization |
| Survey Completion at Baseline | The percentage of patients who complete surveys at baseline, a measure of feasibility. | Baseline |
| Survey Completion at 1 Month | The percentage of patients who complete surveys at 1 month, a measure of feasibility. | 30 days post randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient Health Questionnaire-9 Item Scale (PHQ-9) | Depression symptoms. Scores range from 0 (better) to 27 (worse). | Baseline to 30 days post-randomization |
| Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Cox, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37289650 | Derived | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intervention Completion | The percentage of participants who complete all 4 weeks of the intervention, a measure of feasibility. | Not applicable to the control group. | Posted | Number | percentage of participants | 30 days post randomization |
|
Up to 30 days post-randomization
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal Ideation | Psychiatric disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher E. Cox, MD | Duke University | 919-681-7232 | christopher.cox@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 31, 2021 | Mar 8, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002055 | Burnout, Professional |
| D000073397 | Occupational Stress |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D000086382 | COVID-19 |
| D000077062 | Burnout, Psychological |
| ID | Term |
|---|---|
| D009784 | Occupational Diseases |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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Single site, pilot randomized waitlist control trial
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Anxiety symptoms. Scores range from 0 (better) to 21 (worse).
| Baseline to 30 days post-randomization |
| Change in Perceived Stress Scale (PSS-4) | Stress symptoms. Scores range from 0 (better) to 16 (worse). | 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). | 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). | 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). | Baseline to 30 days post-randomization |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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 | Sessions Completed | Number of daily mindfulness sessions completed by participants in intervention arm, a measure of feasibility. | Not applicable to the control group. | Posted | Median | Inter-Quartile Range | sessions per day | 30 days post-randomization |
|
|
|
| Primary | Survey Completion at Baseline | The percentage of patients who complete surveys at baseline, a measure of feasibility. | Posted | Number | percentage of participants | Baseline |
|
|
|
| Primary | Survey Completion at 1 Month | The percentage of patients who complete surveys at 1 month, a measure of feasibility. | Posted | Number | percentage of participants | 30 days post randomization |
|
|
|
| Secondary | Change in Patient Health Questionnaire-9 Item Scale (PHQ-9) | Depression symptoms. Scores range from 0 (better) to 27 (worse). | Data not collected on 14 participants. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to 30 days post-randomization |
|
|
|
| Secondary | Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) | Anxiety symptoms. Scores range from 0 (better) to 21 (worse). | Data not collected on 14 participants. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to 30 days post-randomization |
|
|
|
| Secondary | Change in Perceived Stress Scale (PSS-4) | Stress symptoms. Scores range from 0 (better) to 16 (worse). | Data not collected on 14 participants. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to 30 days post-randomization |
|
|
|
| Secondary | 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). | Data not collected on 14 participants. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to 30 days post-randomization |
|
|
|
| Secondary | 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). | Data not collected on 14 participants. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to 30 days post-randomization |
|
|
|
| Secondary | 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). | Data not collected on 14 participants. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to 30 days post-randomization |
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| 0 |
| 59 |
| 0 |
| 59 |
| 1 |
| 59 |
| EG001 | 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. | 0 | 29 | 0 | 29 | 0 | 29 |
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| D001523 |
| Mental Disorders |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |