Trial Outcomes & Findings for A Self-directed Mobile Mindfulness Intervention to Address Distress and Burnout in Frontline Healthcare Workers (NCT NCT04816708)
NCT ID: NCT04816708
Last Updated: 2024-02-22
Results Overview
The percentage of participants who complete all 4 weeks of the intervention, a measure of feasibility.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
102 participants
Primary outcome timeframe
30 days post randomization
Results posted on
2024-02-22
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
69
|
33
|
|
Overall Study
COMPLETED
|
59
|
29
|
|
Overall Study
NOT COMPLETED
|
10
|
4
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
10
|
4
|
Baseline Characteristics
A Self-directed Mobile Mindfulness Intervention to Address Distress and Burnout in Frontline Healthcare Workers
Baseline characteristics by cohort
| Measure |
Arm 1: Intervention Group (Access to LIFT Mindfulness App)
n=69 Participants
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.
|
Arm 2: Control Waitlist Group (Delayed Access to LIFT Mindfulness App)
n=33 Participants
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.
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27 years
n=5 Participants
|
25 years
n=7 Participants
|
26.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
62 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
60 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
69 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days post randomizationPopulation: Not applicable to the control group.
The percentage of participants who complete all 4 weeks of the intervention, a measure of feasibility.
Outcome measures
| Measure |
Arm 1: Intervention Group (Access to LIFT Mindfulness App)
n=69 Participants
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.
|
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.
|
|---|---|---|
|
Intervention Completion
|
28 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: 30 days post-randomizationPopulation: Not applicable to the control group.
Number of daily mindfulness sessions completed by participants in intervention arm, a measure of feasibility.
Outcome measures
| Measure |
Arm 1: Intervention Group (Access to LIFT Mindfulness App)
n=69 Participants
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.
|
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.
|
|---|---|---|
|
Sessions Completed
|
3 sessions per day
Interval 1.0 to 17.0
|
—
|
PRIMARY outcome
Timeframe: BaselineThe percentage of patients who complete surveys at baseline, a measure of feasibility.
Outcome measures
| Measure |
Arm 1: Intervention Group (Access to LIFT Mindfulness App)
n=69 Participants
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.
|
Arm 2: Control Waitlist Group (Delayed Access to LIFT Mindfulness App)
n=33 Participants
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.
|
|---|---|---|
|
Survey Completion at Baseline
|
100 percentage of participants
|
100 percentage of participants
|
PRIMARY outcome
Timeframe: 30 days post randomizationThe percentage of patients who complete surveys at 1 month, a measure of feasibility.
Outcome measures
| Measure |
Arm 1: Intervention Group (Access to LIFT Mindfulness App)
n=69 Participants
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.
|
Arm 2: Control Waitlist Group (Delayed Access to LIFT Mindfulness App)
n=33 Participants
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.
|
|---|---|---|
|
Survey Completion at 1 Month
|
86 percentage of participants
|
88 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to 30 days post-randomizationPopulation: Data not collected on 14 participants.
Depression symptoms. Scores range from 0 (better) to 27 (worse).
Outcome measures
| Measure |
Arm 1: Intervention Group (Access to LIFT Mindfulness App)
n=59 Participants
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.
|
Arm 2: Control Waitlist Group (Delayed Access to LIFT Mindfulness App)
n=29 Participants
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.
|
|---|---|---|
|
Change in Patient Health Questionnaire-9 Item Scale (PHQ-9)
|
-2.94 score on a scale
Interval -4.07 to -1.82
|
-0.74 score on a scale
Interval -2.27 to 0.8
|
SECONDARY outcome
Timeframe: Baseline to 30 days post-randomizationPopulation: Data not collected on 14 participants.
Anxiety symptoms. Scores range from 0 (better) to 21 (worse).
Outcome measures
| Measure |
Arm 1: Intervention Group (Access to LIFT Mindfulness App)
n=59 Participants
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.
|
Arm 2: Control Waitlist Group (Delayed Access to LIFT Mindfulness App)
n=29 Participants
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.
|
|---|---|---|
|
Change in Generalized Anxiety Disorder 7-item Scale (GAD-7)
|
-2.91 score on a scale
Interval -3.31 to -1.07
|
-0.79 score on a scale
Interval -2.29 to 0.71
|
SECONDARY outcome
Timeframe: Baseline to 30 days post-randomizationPopulation: Data not collected on 14 participants.
Stress symptoms. Scores range from 0 (better) to 16 (worse).
Outcome measures
| Measure |
Arm 1: Intervention Group (Access to LIFT Mindfulness App)
n=59 Participants
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.
|
Arm 2: Control Waitlist Group (Delayed Access to LIFT Mindfulness App)
n=29 Participants
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.
|
|---|---|---|
|
Change in Perceived Stress Scale (PSS-4)
|
-0.65 score on a scale
Interval -1.27 to -0.02
|
-0.97 score on a scale
Interval -1.8 to -0.15
|
SECONDARY outcome
Timeframe: Baseline to 30 days post-randomizationPopulation: Data not collected on 14 participants.
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).
Outcome measures
| Measure |
Arm 1: Intervention Group (Access to LIFT Mindfulness App)
n=59 Participants
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.
|
Arm 2: Control Waitlist Group (Delayed Access to LIFT Mindfulness App)
n=29 Participants
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.
|
|---|---|---|
|
Change in Maslach Burnout Index (MBI) - Emotional Exhaustion
|
-3.51 score on a scale
Interval -5.64 to -1.39
|
-2.19 score on a scale
Interval -5.14 to 0.75
|
SECONDARY outcome
Timeframe: Baseline to 30 days post-randomizationPopulation: Data not collected on 14 participants.
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).
Outcome measures
| Measure |
Arm 1: Intervention Group (Access to LIFT Mindfulness App)
n=59 Participants
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.
|
Arm 2: Control Waitlist Group (Delayed Access to LIFT Mindfulness App)
n=29 Participants
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.
|
|---|---|---|
|
Change in Maslach Burnout Index (MBI) - Depersonalization
|
-0.29 score on a scale
Interval -1.19 to 0.61
|
-1.89 score on a scale
Interval -3.11 to -0.66
|
SECONDARY outcome
Timeframe: Baseline to 30 days post-randomizationPopulation: Data not collected on 14 participants.
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).
Outcome measures
| Measure |
Arm 1: Intervention Group (Access to LIFT Mindfulness App)
n=59 Participants
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.
|
Arm 2: Control Waitlist Group (Delayed Access to LIFT Mindfulness App)
n=29 Participants
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.
|
|---|---|---|
|
Change in Maslach Burnout Index (MBI) - Personal Accomplishment
|
0.23 score on a scale
Interval -1.11 to 1.57
|
-0.63 score on a scale
Interval -2.49 to 1.22
|
Adverse Events
Arm 1: Intervention Group (Access to LIFT Mindfulness App)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm 2: Control Waitlist Group (Delayed Access to LIFT Mindfulness App)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1: Intervention Group (Access to LIFT Mindfulness App)
n=59 participants at risk
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.
|
Arm 2: Control Waitlist Group (Delayed Access to LIFT Mindfulness App)
n=29 participants at risk
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.
|
|---|---|---|
|
Psychiatric disorders
Suicidal Ideation
|
1.7%
1/59 • Up to 30 days post-randomization
|
0.00%
0/29 • Up to 30 days post-randomization
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place