Trial Outcomes & Findings for Lift Mobile Mindfulness for COVID-19 Distress Symptoms (NCT NCT04581200)
NCT ID: NCT04581200
Last Updated: 2023-11-07
Results Overview
Depression symptoms. Scores range from 0 (better) to 27 (worse)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
56 participants
Primary outcome timeframe
T1 (time of randomization [i.e., 1 month post-hospital discharge), T2 (2 months post-randomization [i.e., 3 months post-hospital discharge)
Results posted on
2023-11-07
Participant Flow
Participant milestones
| Measure |
Lift Mobile Mindfulness Program
Will receive standard Lift mobile mindfulness program intervention content, app-based response to elevated symptoms, and no introductory call from a therapist. This program lasts 1 month and includes 4 unique weeks' worth of audio, video, and text content.
Lift: The intervention is a mobile app-based mindfulness training program designed to be used over a 1-month period.
|
Usual Care Control
Usual care.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
27
|
|
Overall Study
COMPLETED
|
23
|
22
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
| Measure |
Lift Mobile Mindfulness Program
Will receive standard Lift mobile mindfulness program intervention content, app-based response to elevated symptoms, and no introductory call from a therapist. This program lasts 1 month and includes 4 unique weeks' worth of audio, video, and text content.
Lift: The intervention is a mobile app-based mindfulness training program designed to be used over a 1-month period.
|
Usual Care Control
Usual care.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
5
|
Baseline Characteristics
Lift Mobile Mindfulness for COVID-19 Distress Symptoms
Baseline characteristics by cohort
| Measure |
Lift Mobile Mindfulness Program
n=29 Participants
Will receive standard Lift mobile mindfulness program intervention content, app-based response to elevated symptoms, and no introductory call from a therapist. This program lasts 1 month and includes 4 unique weeks' worth of audio, video, and text content.
Lift: The intervention is a mobile app-based mindfulness training program designed to be used over a 1-month period.
|
Usual Care Control
n=27 Participants
Usual care.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.0 years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
53.1 years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
51.0 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: T1 (time of randomization [i.e., 1 month post-hospital discharge), T2 (2 months post-randomization [i.e., 3 months post-hospital discharge)Population: Participants who completed the study.
Depression symptoms. Scores range from 0 (better) to 27 (worse)
Outcome measures
| Measure |
Lift Mobile Mindfulness Program
n=23 Participants
Will receive standard dose Lift mobile mindfulness program intervention content, app-based response to elevated symptoms, and no introductory call from a therapist. This program lasts 1 month and includes 4 unique weeks' worth of audio, video, and text content.
Lift: The intervention is a mobile app-based mindfulness training program designed to be used over a 1-month period.
|
Usual Care Control
n=22 Participants
Usual care.
|
|---|---|---|
|
Change in Patient Health Questionnaire-9 Item Scale (PHQ-9) Over 3 Months Post-discharge
|
0.09 score on a scale
Standard Deviation 3.22
|
-0.50 score on a scale
Standard Deviation 4.31
|
SECONDARY outcome
Timeframe: T1 (time of randomization [i.e., 1 month post-hospital discharge), T3 (5 months post-randomization [i.e., 6 months post-hospital discharge)Population: Data not collected on 4 participants.
Depression symptoms. Scores range from 0 (better) to 27 (worse)
Outcome measures
| Measure |
Lift Mobile Mindfulness Program
n=27 Participants
Will receive standard dose Lift mobile mindfulness program intervention content, app-based response to elevated symptoms, and no introductory call from a therapist. This program lasts 1 month and includes 4 unique weeks' worth of audio, video, and text content.
Lift: The intervention is a mobile app-based mindfulness training program designed to be used over a 1-month period.
|
Usual Care Control
n=25 Participants
Usual care.
|
|---|---|---|
|
Change in Patient Health Questionnaire-9 Item Scale (PHQ-9) Over 6 Months Post-discharge
|
-0.63 score on a scale
Standard Deviation 5.76
|
-0.84 score on a scale
Standard Deviation 4.71
|
SECONDARY outcome
Timeframe: T1 (time of randomization [i.e., 1 month post-hospital discharge), T2 (2 months post-randomization [i.e., 3 months post-hospital discharge)Population: Participants who completed the study.
Anxiety symptoms. Scores range from 0 (better) to 21 (worse).
Outcome measures
| Measure |
Lift Mobile Mindfulness Program
n=23 Participants
Will receive standard dose Lift mobile mindfulness program intervention content, app-based response to elevated symptoms, and no introductory call from a therapist. This program lasts 1 month and includes 4 unique weeks' worth of audio, video, and text content.
Lift: The intervention is a mobile app-based mindfulness training program designed to be used over a 1-month period.
|
Usual Care Control
n=22 Participants
Usual care.
|
|---|---|---|
|
Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) at 3 Months Post-discharge
|
0.09 score on a scale
Standard Deviation 4.76
|
-0.27 score on a scale
Standard Deviation 5.29
|
SECONDARY outcome
Timeframe: T1 (time of randomization [i.e., 1 month post-hospital discharge), T3 (5 months post-randomization [i.e., 6 months post-hospital discharge)Population: Data not collected on 4 participants.
Anxiety symptoms. Scores range from 0 (better) to 21 (worse).
Outcome measures
| Measure |
Lift Mobile Mindfulness Program
n=27 Participants
Will receive standard dose Lift mobile mindfulness program intervention content, app-based response to elevated symptoms, and no introductory call from a therapist. This program lasts 1 month and includes 4 unique weeks' worth of audio, video, and text content.
Lift: The intervention is a mobile app-based mindfulness training program designed to be used over a 1-month period.
|
Usual Care Control
n=25 Participants
Usual care.
|
|---|---|---|
|
Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) at 6 Months Post-discharge
|
0.26 score on a scale
Standard Deviation 4.83
|
0.68 score on a scale
Standard Deviation 4.57
|
SECONDARY outcome
Timeframe: T1 (time of randomization [i.e., 1 month post-hospital discharge), T2 (2 months post-randomization [i.e., 3 months post-hospital discharge)Population: Participants who completed the study.
EuroQOL-5DL health states can be represented by a single summary number (index value), which reflects how good or bad a health state is according to the preferences of the general population of a country/region. An EQ-5D summary index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension. The index is calculated by deducting the appropriate weights from 1, the value for full health. A higher index value indicates a greater health state; an increase in index value indicates an improvement in health state. The summary item can range from 0 (worst quality of life) to 100 (best quality of life).
Outcome measures
| Measure |
Lift Mobile Mindfulness Program
n=23 Participants
Will receive standard dose Lift mobile mindfulness program intervention content, app-based response to elevated symptoms, and no introductory call from a therapist. This program lasts 1 month and includes 4 unique weeks' worth of audio, video, and text content.
Lift: The intervention is a mobile app-based mindfulness training program designed to be used over a 1-month period.
|
Usual Care Control
n=22 Participants
Usual care.
|
|---|---|---|
|
Change in EuroQOL-5DL (Quality of Life) Scale at 3 Months Post-discharge
|
0.02 index value
Standard Deviation 0.19
|
-0.03 index value
Standard Deviation 0.25
|
SECONDARY outcome
Timeframe: T1 (time of randomization [i.e., 1 month post-hospital discharge), T3 (5 months post-randomization [i.e., 6 months post-hospital discharge)Population: Participants who completed the study.
EuroQOL-5DL health states can be represented by a single summary number (index value), which reflects how good or bad a health state is according to the preferences of the general population of a country/region. An EQ-5D summary index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension. The index is calculated by deducting the appropriate weights from 1, the value for full health. A higher index value indicates a greater health state; an increase in index value indicates an improvement in health state. The summary item can range from 0 (worst quality of life) to 100 (best quality of life).
Outcome measures
| Measure |
Lift Mobile Mindfulness Program
n=23 Participants
Will receive standard dose Lift mobile mindfulness program intervention content, app-based response to elevated symptoms, and no introductory call from a therapist. This program lasts 1 month and includes 4 unique weeks' worth of audio, video, and text content.
Lift: The intervention is a mobile app-based mindfulness training program designed to be used over a 1-month period.
|
Usual Care Control
n=22 Participants
Usual care.
|
|---|---|---|
|
Change in EuroQOL-5DL (Quality of Life) Scale at 6 Months Post-discharge
|
0.6 index value
Standard Deviation 0.36
|
0.66 index value
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: T1 (time of randomization [i.e., 1 month post-hospital discharge), T2 (2 months post-randomization [i.e., 3 months post-hospital discharge)Population: Participants who completed the study.
Cardiopulmonary symptoms such as breathlessness, fatigue, oxygen use
Outcome measures
| Measure |
Lift Mobile Mindfulness Program
n=23 Participants
Will receive standard dose Lift mobile mindfulness program intervention content, app-based response to elevated symptoms, and no introductory call from a therapist. This program lasts 1 month and includes 4 unique weeks' worth of audio, video, and text content.
Lift: The intervention is a mobile app-based mindfulness training program designed to be used over a 1-month period.
|
Usual Care Control
n=22 Participants
Usual care.
|
|---|---|---|
|
Number of Participants With Cardiopulmonary Symptoms at 3 Months Post-discharge
|
10 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: T1 (time of randomization [i.e., 1 month post-hospital discharge), T3 (5 months post-randomization [i.e., 6 months post-hospital discharge)Population: Participants who completed the study.
Cardiopulmonary symptoms such as breathlessness, fatigue, oxygen use
Outcome measures
| Measure |
Lift Mobile Mindfulness Program
n=23 Participants
Will receive standard dose Lift mobile mindfulness program intervention content, app-based response to elevated symptoms, and no introductory call from a therapist. This program lasts 1 month and includes 4 unique weeks' worth of audio, video, and text content.
Lift: The intervention is a mobile app-based mindfulness training program designed to be used over a 1-month period.
|
Usual Care Control
n=22 Participants
Usual care.
|
|---|---|---|
|
Number of Participants With Cardiopulmonary Symptoms at 6 Months Post-discharge
|
8 Participants
|
9 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: T1 (time of randomization [i.e., 1 month post-hospital discharge), T2 (2 months post-randomization [i.e., 3 months post-hospital discharge), T3 (5 months post-randomization [i.e., 6 months post-hospital discharge)Population: Data not collected.
Hospital readmissions and clinic visits during follow up
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: T3 (5 months post-randomization [i.e., 6 months post-hospital discharge)Population: Not applicable to the usual care arm.
Tasks include intervention sessions, weekly surveys, and intervention elements (e.g., videos, audio).
Outcome measures
| Measure |
Lift Mobile Mindfulness Program
n=23 Participants
Will receive standard dose Lift mobile mindfulness program intervention content, app-based response to elevated symptoms, and no introductory call from a therapist. This program lasts 1 month and includes 4 unique weeks' worth of audio, video, and text content.
Lift: The intervention is a mobile app-based mindfulness training program designed to be used over a 1-month period.
|
Usual Care Control
Usual care.
|
|---|---|---|
|
Intervention Adherence as Measured by Percentage of Tasks Completed
|
23.0 percentage of tasks completed
Standard Deviation 29.3
|
—
|
Adverse Events
Lift Mobile Mindfulness Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place