Trial Outcomes & Findings for Optimizing a Mobile Mindfulness Intervention for ICU Survivors (NCT NCT04038567)
NCT ID: NCT04038567
Last Updated: 2024-08-15
Results Overview
Absolute values, not change scores. Depression symptoms. Scores range from 0 (better) to 27 (worse)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
247 participants
Primary outcome timeframe
1 month post-randomization
Results posted on
2024-08-15
Participant Flow
Note that this is a factorial experimental trial in which 3 factors were examined, each at 2 levels (i.e., a 2\^3 design). In this trial the 3 factors and 2 levels are as follows: 1. Introduction to intervention (app introduction vs. therapist introduction) 2. Dose (standard vs. high) 3. Response to depression symptoms that increase during the intervention period (app response vs. therapist response)
Participant milestones
| Measure |
App Introduction to Intervention, High Dose, and Therapist Response
Introduction to intervention via the mobile app itself. High dose of meditation time (twice a day). Therapist call in response to elevated psychological distress symptoms during intervention period.
|
Therapist Introduction to Intervention, High Dose, and Therapist Response
Introduction to intervention via a call from the study therapist. High dose of meditation time (twice a day). Therapist call in response to elevated psychological distress symptoms during intervention period.
|
App Introduction to Intervention, Standard Dose, and Therapist Response
Introduction to intervention via the mobile app itself. Standard dose of meditation time (once a day). Therapist call in response to elevated psychological distress symptoms during intervention period.
|
Therapist Introduction to Intervention, Standard Dose, and Therapist Response
Introduction to intervention via a call from the study therapist. Standard dose of meditation time (once a day). Therapist call in response to elevated psychological distress symptoms during intervention period.
|
App Introduction to Intervention, High Dose, and App Response
Introduction to intervention via the mobile app itself. High dose of meditation time (twice a day). Mobile app response to elevated psychological distress symptoms during intervention period.
|
Therapist Introduction to Intervention, High Dose, and App Response
Introduction to intervention via a call from the study therapist. High dose of meditation time (twice a day). Mobile app response to elevated psychological distress symptoms during intervention period.
|
App Introduction to Intervention, Standard Dose, and App Response
Introduction to intervention via the mobile app itself. Standard dose of meditation time (once a day). Mobile app response to elevated psychological distress symptoms during intervention period.
|
Therapist Introduction to Intervention, Standard Dose, and App Response
Introduction to intervention via a call from the study therapist. Standard dose of meditation time (once a day). Mobile app response to elevated psychological distress symptoms during intervention period.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
31
|
31
|
32
|
32
|
31
|
30
|
30
|
|
Overall Study
COMPLETED
|
21
|
23
|
23
|
25
|
19
|
24
|
22
|
25
|
|
Overall Study
NOT COMPLETED
|
9
|
8
|
8
|
7
|
13
|
7
|
8
|
5
|
Reasons for withdrawal
| Measure |
App Introduction to Intervention, High Dose, and Therapist Response
Introduction to intervention via the mobile app itself. High dose of meditation time (twice a day). Therapist call in response to elevated psychological distress symptoms during intervention period.
|
Therapist Introduction to Intervention, High Dose, and Therapist Response
Introduction to intervention via a call from the study therapist. High dose of meditation time (twice a day). Therapist call in response to elevated psychological distress symptoms during intervention period.
|
App Introduction to Intervention, Standard Dose, and Therapist Response
Introduction to intervention via the mobile app itself. Standard dose of meditation time (once a day). Therapist call in response to elevated psychological distress symptoms during intervention period.
|
Therapist Introduction to Intervention, Standard Dose, and Therapist Response
Introduction to intervention via a call from the study therapist. Standard dose of meditation time (once a day). Therapist call in response to elevated psychological distress symptoms during intervention period.
|
App Introduction to Intervention, High Dose, and App Response
Introduction to intervention via the mobile app itself. High dose of meditation time (twice a day). Mobile app response to elevated psychological distress symptoms during intervention period.
|
Therapist Introduction to Intervention, High Dose, and App Response
Introduction to intervention via a call from the study therapist. High dose of meditation time (twice a day). Mobile app response to elevated psychological distress symptoms during intervention period.
|
App Introduction to Intervention, Standard Dose, and App Response
Introduction to intervention via the mobile app itself. Standard dose of meditation time (once a day). Mobile app response to elevated psychological distress symptoms during intervention period.
|
Therapist Introduction to Intervention, Standard Dose, and App Response
Introduction to intervention via a call from the study therapist. Standard dose of meditation time (once a day). Mobile app response to elevated psychological distress symptoms during intervention period.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
4
|
5
|
4
|
6
|
4
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
1
|
1
|
4
|
1
|
1
|
1
|
|
Overall Study
missed survey window
|
1
|
2
|
0
|
0
|
1
|
1
|
2
|
2
|
|
Overall Study
technical issues
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Medical issues (i.e., illness)
|
0
|
1
|
2
|
1
|
1
|
1
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
1
|
Baseline Characteristics
Optimizing a Mobile Mindfulness Intervention for ICU Survivors
Baseline characteristics by cohort
| Measure |
App Introduction to Intervention, High Dose, and Therapist Response
n=30 Participants
Introduction to intervention via the mobile app itself. High dose of meditation time (twice a day). Therapist call in response to elevated psychological distress symptoms during intervention period.
|
Therapist Introduction to Intervention, High Dose, and Therapist Response
n=31 Participants
Introduction to intervention via a call from the study therapist. High dose of meditation time (twice a day). Therapist call in response to elevated psychological distress symptoms during intervention period.
|
App Introduction to Intervention, Standard Dose, and Therapist Response
n=31 Participants
Introduction to intervention via the mobile app itself. Standard dose of meditation time (once a day). Therapist call in response to elevated psychological distress symptoms during intervention period.
|
Therapist Introduction to Intervention, Standard Dose, and Therapist Response
n=32 Participants
Introduction to intervention via a call from the study therapist. Standard dose of meditation time (once a day). Therapist call in response to elevated psychological distress symptoms during intervention period.
|
App Introduction to Intervention, High Dose, and App Response
n=32 Participants
Introduction to intervention via the mobile app itself. High dose of meditation time (twice a day). Mobile app response to elevated psychological distress symptoms during intervention period.
|
Therapist Introduction to Intervention, High Dose, and App Response
n=31 Participants
Introduction to intervention via a call from the study therapist. High dose of meditation time (twice a day). Mobile app response to elevated psychological distress symptoms during intervention period.
|
App Introduction to Intervention, Standard Dose, and App Response
n=30 Participants
Introduction to intervention via the mobile app itself. Standard dose of meditation time (once a day). Mobile app response to elevated psychological distress symptoms during intervention period.
|
Therapist Introduction to Intervention, Standard Dose, and App Response
n=30 Participants
Introduction to intervention via a call from the study therapist. Standard dose of meditation time (once a day). Mobile app response to elevated psychological distress symptoms during intervention period.
|
Total
n=247 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
55.3 years
STANDARD_DEVIATION 15.0 • n=5 Participants
|
51.6 years
STANDARD_DEVIATION 14.6 • n=7 Participants
|
48.2 years
STANDARD_DEVIATION 15.7 • n=5 Participants
|
48.8 years
STANDARD_DEVIATION 14.8 • n=4 Participants
|
47.4 years
STANDARD_DEVIATION 16.4 • n=21 Participants
|
49.4 years
STANDARD_DEVIATION 17.1 • n=8 Participants
|
51.3 years
STANDARD_DEVIATION 14.4 • n=8 Participants
|
49.4 years
STANDARD_DEVIATION 15.2 • n=24 Participants
|
50.22 years
STANDARD_DEVIATION 15.38 • n=42 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
11 Participants
n=24 Participants
|
104 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
14 Participants
n=8 Participants
|
19 Participants
n=24 Participants
|
143 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
24 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
24 Participants
n=8 Participants
|
26 Participants
n=24 Participants
|
217 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
35 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
24 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
23 Participants
n=24 Participants
|
179 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
12 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
10 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
31 participants
n=7 Participants
|
31 participants
n=5 Participants
|
32 participants
n=4 Participants
|
32 participants
n=21 Participants
|
31 participants
n=8 Participants
|
30 participants
n=8 Participants
|
30 participants
n=24 Participants
|
247 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 1 month post-randomizationPopulation: Participants who had data collected at both time points.
Absolute values, not change scores. Depression symptoms. Scores range from 0 (better) to 27 (worse)
Outcome measures
| Measure |
Standard Dose
n=97 Participants
Standard dose of meditation time (once a day).
|
High Dose
n=94 Participants
High dose of meditation time (twice a day).
|
App Response
n=92 Participants
Mobile app response to elevated psychological distress symptoms during intervention period.
|
Therapist Response
n=99 Participants
Therapist call in response to elevated psychological distress symptoms during intervention period.
|
App Introduction to Intervention
n=91 Participants
Introduction to intervention via the mobile app itself.
|
Therapist Introduction to Intervention
n=100 Participants
Introduction to intervention via a call from the study therapist.
|
|---|---|---|---|---|---|---|
|
Patient Health Questionnaire-9 Item Scale (PHQ-9)
|
7.0 units on a scale
Standard Deviation 5.2
|
5.6 units on a scale
Standard Deviation 4.2
|
6.2 units on a scale
Standard Deviation 5.3
|
6.4 units on a scale
Standard Deviation 4.3
|
6.2 units on a scale
Standard Deviation 4.7
|
6.4 units on a scale
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: Between baseline 1 month post-randomizationPopulation: Participants who had data collected at both time points.
Absolute values, not change scores. Anxiety symptoms. Scores range from 0 (better) to 21 (worse)
Outcome measures
| Measure |
Standard Dose
n=95 Participants
Standard dose of meditation time (once a day).
|
High Dose
n=87 Participants
High dose of meditation time (twice a day).
|
App Response
n=88 Participants
Mobile app response to elevated psychological distress symptoms during intervention period.
|
Therapist Response
n=94 Participants
Therapist call in response to elevated psychological distress symptoms during intervention period.
|
App Introduction to Intervention
n=87 Participants
Introduction to intervention via the mobile app itself.
|
Therapist Introduction to Intervention
n=95 Participants
Introduction to intervention via a call from the study therapist.
|
|---|---|---|---|---|---|---|
|
Generalized Anxiety Disorder 7-item Scale (GAD-7)
|
6.2 units on a scale
Standard Deviation 5.3
|
4.2 units on a scale
Standard Deviation 4.3
|
5.1 units on a scale
Standard Deviation 4.7
|
5.3 units on a scale
Standard Deviation 5.1
|
5.5 units on a scale
Standard Deviation 5.4
|
4.9 units on a scale
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: Between baseline 3 months post-randomizationPopulation: Participants who had data collected at both time points.
Absolute values, not change scores. Depression symptoms. Scores range from 0 (better) to 27 (worse)
Outcome measures
| Measure |
Standard Dose
n=95 Participants
Standard dose of meditation time (once a day).
|
High Dose
n=87 Participants
High dose of meditation time (twice a day).
|
App Response
n=88 Participants
Mobile app response to elevated psychological distress symptoms during intervention period.
|
Therapist Response
n=94 Participants
Therapist call in response to elevated psychological distress symptoms during intervention period.
|
App Introduction to Intervention
n=87 Participants
Introduction to intervention via the mobile app itself.
|
Therapist Introduction to Intervention
n=95 Participants
Introduction to intervention via a call from the study therapist.
|
|---|---|---|---|---|---|---|
|
Patient Health Questionnaire-9 Item Scale (PHQ-9)
|
8.12 units on a scale
Standard Deviation 6.23
|
6.10 units on a scale
Standard Deviation 4.65
|
6.73 units on a scale
Standard Deviation 5.69
|
7.55 units on a scale
Standard Deviation 5.53
|
7.28 units on a scale
Standard Deviation 5.76
|
7.04 units on a scale
Standard Deviation 5.50
|
SECONDARY outcome
Timeframe: Between baseline 3 months post-randomizationPopulation: Participants who had data collected at both time points.
Absolute values, not change scores. Anxiety symptoms. Scores range from 0 (better) to 21 (worse)
Outcome measures
| Measure |
Standard Dose
n=95 Participants
Standard dose of meditation time (once a day).
|
High Dose
n=87 Participants
High dose of meditation time (twice a day).
|
App Response
n=88 Participants
Mobile app response to elevated psychological distress symptoms during intervention period.
|
Therapist Response
n=94 Participants
Therapist call in response to elevated psychological distress symptoms during intervention period.
|
App Introduction to Intervention
n=87 Participants
Introduction to intervention via the mobile app itself.
|
Therapist Introduction to Intervention
n=95 Participants
Introduction to intervention via a call from the study therapist.
|
|---|---|---|---|---|---|---|
|
Generalized Anxiety Disorder 7-item Scale (GAD-7)
|
6.83 units on a scale
Standard Deviation 5.74
|
4.38 units on a scale
Standard Deviation 4.12
|
6.25 units on a scale
Standard Deviation 5.45
|
5.11 units on a scale
Standard Deviation 4.86
|
5.62 units on a scale
Standard Deviation 5.07
|
5.69 units on a scale
Standard Deviation 5.28
|
SECONDARY outcome
Timeframe: Between baseline 3 months post-randomizationPopulation: Participants who had data collected at both time points.
Absolute values, not change scores. PTSD symptoms. Scores can range from 10 (best) to 70 (worst).
Outcome measures
| Measure |
Standard Dose
n=95 Participants
Standard dose of meditation time (once a day).
|
High Dose
n=87 Participants
High dose of meditation time (twice a day).
|
App Response
n=88 Participants
Mobile app response to elevated psychological distress symptoms during intervention period.
|
Therapist Response
n=94 Participants
Therapist call in response to elevated psychological distress symptoms during intervention period.
|
App Introduction to Intervention
n=87 Participants
Introduction to intervention via the mobile app itself.
|
Therapist Introduction to Intervention
n=95 Participants
Introduction to intervention via a call from the study therapist.
|
|---|---|---|---|---|---|---|
|
Post-Traumatic Stress Symptom Inventory (PTSS)
|
31.75 units on a scale
Standard Deviation 24.05
|
25.67 units on a scale
Standard Deviation 13.05
|
29.75 units on a scale
Standard Deviation 23.95
|
27.99 units on a scale
Standard Deviation 14.89
|
29.94 units on a scale
Standard Deviation 23.88
|
27.83 units on a scale
Standard Deviation 15.10
|
SECONDARY outcome
Timeframe: 1 month post-randomizationQuantified by number with activity (or not) in app during final week (4) of intervention
Outcome measures
| Measure |
Standard Dose
n=124 Participants
Standard dose of meditation time (once a day).
|
High Dose
n=120 Participants
High dose of meditation time (twice a day).
|
App Response
n=123 Participants
Mobile app response to elevated psychological distress symptoms during intervention period.
|
Therapist Response
n=124 Participants
Therapist call in response to elevated psychological distress symptoms during intervention period.
|
App Introduction to Intervention
n=125 Participants
Introduction to intervention via the mobile app itself.
|
Therapist Introduction to Intervention
n=122 Participants
Introduction to intervention via a call from the study therapist.
|
|---|---|---|---|---|---|---|
|
Intervention Adherence: Activity in App During Final Week of Intervention
|
112 Participants
|
104 Participants
|
105 Participants
|
111 Participants
|
105 Participants
|
108 Participants
|
SECONDARY outcome
Timeframe: 1 month post-randomizationQuantified by mean (SD) number of intervention content (audio, video, text) views
Outcome measures
| Measure |
Standard Dose
n=124 Participants
Standard dose of meditation time (once a day).
|
High Dose
n=120 Participants
High dose of meditation time (twice a day).
|
App Response
n=123 Participants
Mobile app response to elevated psychological distress symptoms during intervention period.
|
Therapist Response
n=124 Participants
Therapist call in response to elevated psychological distress symptoms during intervention period.
|
App Introduction to Intervention
n=125 Participants
Introduction to intervention via the mobile app itself.
|
Therapist Introduction to Intervention
n=122 Participants
Introduction to intervention via a call from the study therapist.
|
|---|---|---|---|---|---|---|
|
Intervention Adherence: Number of Views of Content
|
34.88 mobile app content views
Standard Deviation 35.81
|
39.38 mobile app content views
Standard Deviation 31.38
|
40.53 mobile app content views
Standard Deviation 38.31
|
33.70 mobile app content views
Standard Deviation 28.14
|
34.24 mobile app content views
Standard Deviation 31.37
|
40.03 mobile app content views
Standard Deviation 35.82
|
SECONDARY outcome
Timeframe: 3 months post-randomizationPopulation: Data not collected.
A measure of acceptability. Scores can range from 8 (worst) to 32 (best)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 months post-randomizationPopulation: Data not collected.
A measure of intervention usability. Each of 10 items is scored from 1 to 5. For each of the odd numbered questions, subtract 1 from the score. For each of the even numbered questions, subtract their value from 5. Take these new values and add up the total score. Then multiply this by 2.5.Scores can range from 0 (worst) to 100 (best)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Between baseline and 1 month post-randomizationPopulation: Participants who had data collected at both time points.
This is the absolute value, not change score. A measure of mindfulness qualities. Scores can range from 5 (worst) to 30 (best).
Outcome measures
| Measure |
Standard Dose
n=97 Participants
Standard dose of meditation time (once a day).
|
High Dose
n=94 Participants
High dose of meditation time (twice a day).
|
App Response
n=92 Participants
Mobile app response to elevated psychological distress symptoms during intervention period.
|
Therapist Response
n=99 Participants
Therapist call in response to elevated psychological distress symptoms during intervention period.
|
App Introduction to Intervention
n=91 Participants
Introduction to intervention via the mobile app itself.
|
Therapist Introduction to Intervention
n=100 Participants
Introduction to intervention via a call from the study therapist.
|
|---|---|---|---|---|---|---|
|
Mindful Attention Awareness Scale (MAAS)
|
22.86 units on a scale
Standard Deviation 5.06
|
24.04 units on a scale
Standard Deviation 5.71
|
23.31 units on a scale
Standard Deviation 5.67
|
23.59 units on a scale
Standard Deviation 5.18
|
23.41 units on a scale
Standard Deviation 5.22
|
23.49 units on a scale
Standard Deviation 5.61
|
SECONDARY outcome
Timeframe: Between baseline 3 months post-randomizationPopulation: Participants who had data collected at both time points.
These are absolute values, not change scores. A measure of mindfulness qualities. Scores can range from 5 (worst) to 30 (best).
Outcome measures
| Measure |
Standard Dose
n=95 Participants
Standard dose of meditation time (once a day).
|
High Dose
n=87 Participants
High dose of meditation time (twice a day).
|
App Response
n=88 Participants
Mobile app response to elevated psychological distress symptoms during intervention period.
|
Therapist Response
n=94 Participants
Therapist call in response to elevated psychological distress symptoms during intervention period.
|
App Introduction to Intervention
n=87 Participants
Introduction to intervention via the mobile app itself.
|
Therapist Introduction to Intervention
n=95 Participants
Introduction to intervention via a call from the study therapist.
|
|---|---|---|---|---|---|---|
|
Mindful Attention Awareness Scale (MAAS)
|
22.43 units on a scale
Standard Deviation 5.79
|
23.08 units on a scale
Standard Deviation 5.94
|
22.57 units on a scale
Standard Deviation 6.23
|
22.90 units on a scale
Standard Deviation 5.51
|
22.43 units on a scale
Standard Deviation 5.51
|
23.03 units on a scale
Standard Deviation 6.17
|
SECONDARY outcome
Timeframe: Between baseline and 1 month post-randomizationPopulation: Participants who had data collected at both time points.
These are absolute values, not change scores. An adapted version of the PHQ-15; a measure of physical symptoms. Scores can range from 10 (best) to 20 (worst).
Outcome measures
| Measure |
Standard Dose
n=97 Participants
Standard dose of meditation time (once a day).
|
High Dose
n=94 Participants
High dose of meditation time (twice a day).
|
App Response
n=92 Participants
Mobile app response to elevated psychological distress symptoms during intervention period.
|
Therapist Response
n=99 Participants
Therapist call in response to elevated psychological distress symptoms during intervention period.
|
App Introduction to Intervention
n=91 Participants
Introduction to intervention via the mobile app itself.
|
Therapist Introduction to Intervention
n=100 Participants
Introduction to intervention via a call from the study therapist.
|
|---|---|---|---|---|---|---|
|
Patient Health Questionnaire 10-item Scale (PHQ-10)
|
6.66 units on a scale
Standard Deviation 3.44
|
6.02 units on a scale
Standard Deviation 3.16
|
6.31 units on a scale
Standard Deviation 3.32
|
6.37 units on a scale
Standard Deviation 3.32
|
6.50 units on a scale
Standard Deviation 3.16
|
6.19 units on a scale
Standard Deviation 3.45
|
SECONDARY outcome
Timeframe: Between baseline 3 months post-randomizationPopulation: Participants who had data collected at both time points.
This is an absolute value, not a change score. An adapted version of the PHQ-15; a measure of physical symptoms. Scores can range from 10 (best) to 20 (worst).
Outcome measures
| Measure |
Standard Dose
n=87 Participants
Standard dose of meditation time (once a day).
|
High Dose
n=95 Participants
High dose of meditation time (twice a day).
|
App Response
n=88 Participants
Mobile app response to elevated psychological distress symptoms during intervention period.
|
Therapist Response
n=94 Participants
Therapist call in response to elevated psychological distress symptoms during intervention period.
|
App Introduction to Intervention
n=95 Participants
Introduction to intervention via the mobile app itself.
|
Therapist Introduction to Intervention
n=87 Participants
Introduction to intervention via a call from the study therapist.
|
|---|---|---|---|---|---|---|
|
Patient Health Questionnaire 10-item Scale (PHQ-10)
|
6.15 units on a scale
Standard Deviation 3.86
|
5.64 units on a scale
Standard Deviation 3.28
|
5.85 units on a scale
Standard Deviation 3.58
|
5.96 units on a scale
Standard Deviation 3.62
|
6.21 units on a scale
Standard Deviation 3.44
|
5.63 units on a scale
Standard Deviation 3.72
|
SECONDARY outcome
Timeframe: Between baseline and 1 month post-randomizationPopulation: Participants who had data collected at both time points.
This is an absolute, not change, value. the EuroQOL is a measure of quality of life. Scores can range from 0 (worst) to 100 (best)
Outcome measures
| Measure |
Standard Dose
n=97 Participants
Standard dose of meditation time (once a day).
|
High Dose
n=94 Participants
High dose of meditation time (twice a day).
|
App Response
n=92 Participants
Mobile app response to elevated psychological distress symptoms during intervention period.
|
Therapist Response
n=99 Participants
Therapist call in response to elevated psychological distress symptoms during intervention period.
|
App Introduction to Intervention
n=91 Participants
Introduction to intervention via the mobile app itself.
|
Therapist Introduction to Intervention
n=100 Participants
Introduction to intervention via a call from the study therapist.
|
|---|---|---|---|---|---|---|
|
EuroQOL Scale
|
58.87 units on a scale
Standard Deviation 21.98
|
66.56 units on a scale
Standard Deviation 21.64
|
63.91 units on a scale
Standard Deviation 21.43
|
61.43 units on a scale
Standard Deviation 22.75
|
61.56 units on a scale
Standard Deviation 23.07
|
63.60 units on a scale
Standard Deviation 21.25
|
SECONDARY outcome
Timeframe: Between baseline 3 months post-randomizationPopulation: Participants who had data collected at both time points.
A measure of quality of life. Scores can range from 0 (worst) to 100 (best)
Outcome measures
| Measure |
Standard Dose
n=97 Participants
Standard dose of meditation time (once a day).
|
High Dose
n=94 Participants
High dose of meditation time (twice a day).
|
App Response
n=92 Participants
Mobile app response to elevated psychological distress symptoms during intervention period.
|
Therapist Response
n=99 Participants
Therapist call in response to elevated psychological distress symptoms during intervention period.
|
App Introduction to Intervention
n=91 Participants
Introduction to intervention via the mobile app itself.
|
Therapist Introduction to Intervention
n=100 Participants
Introduction to intervention via a call from the study therapist.
|
|---|---|---|---|---|---|---|
|
Change in EuroQOL Scale
|
61.68 units on a scale
Standard Deviation 24.15
|
66.21 units on a scale
Standard Deviation 22.48
|
65.02 units on a scale
Standard Deviation 24.87
|
62.74 units on a scale
Standard Deviation 22.03
|
62.07 units on a scale
Standard Deviation 22.23
|
65.47 units on a scale
Standard Deviation 24.44
|
SECONDARY outcome
Timeframe: Between baseline and 1 month post-randomization; THIS WAS NOT RECORDEDPopulation: Data were not collected
A visual analog scale appended to the PHQ-9 which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the PHQ-9. Scores range from 0 (best) to 100 (worst)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 1 month post-randomizationA visual analog scale appended to the PHQ-9 which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the PHQ-9. Scores range from 0 (best) to 100 (worst)
Outcome measures
| Measure |
Standard Dose
n=97 Participants
Standard dose of meditation time (once a day).
|
High Dose
n=94 Participants
High dose of meditation time (twice a day).
|
App Response
n=92 Participants
Mobile app response to elevated psychological distress symptoms during intervention period.
|
Therapist Response
n=99 Participants
Therapist call in response to elevated psychological distress symptoms during intervention period.
|
App Introduction to Intervention
n=91 Participants
Introduction to intervention via the mobile app itself.
|
Therapist Introduction to Intervention
n=100 Participants
Introduction to intervention via a call from the study therapist.
|
|---|---|---|---|---|---|---|
|
Distress Associated With Depression Symptom Frequency
|
44.26 units on a scale
Standard Deviation 28.96
|
34.02 units on a scale
Standard Deviation 25.14
|
41.34 units on a scale
Standard Deviation 28.36
|
37.25 units on a scale
Standard Deviation 26.78
|
41.22 units on a scale
Standard Deviation 28.53
|
37.40 units on a scale
Standard Deviation 26.65
|
SECONDARY outcome
Timeframe: At 1 month post-randomizationA visual analog scale appended to the GAD-7 which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the GAD-7. Scores range from 0 (best) to 100 (worst)
Outcome measures
| Measure |
Standard Dose
n=124 Participants
Standard dose of meditation time (once a day).
|
High Dose
n=123 Participants
High dose of meditation time (twice a day).
|
App Response
n=123 Participants
Mobile app response to elevated psychological distress symptoms during intervention period.
|
Therapist Response
n=124 Participants
Therapist call in response to elevated psychological distress symptoms during intervention period.
|
App Introduction to Intervention
n=125 Participants
Introduction to intervention via the mobile app itself.
|
Therapist Introduction to Intervention
n=122 Participants
Introduction to intervention via a call from the study therapist.
|
|---|---|---|---|---|---|---|
|
Distress Associated With Anxiety Symptom Frequency
|
50.11 units on a scale
Standard Deviation 26.07
|
44.67 units on a scale
Standard Deviation 25.38
|
48.57 units on a scale
Standard Deviation 24.47
|
46.24 units on a scale
Standard Deviation 27.15
|
45.31 units on a scale
Standard Deviation 26.50
|
49.54 units on a scale
Standard Deviation 25.04
|
SECONDARY outcome
Timeframe: Between baseline 3 months post-randomizationPopulation: Data were not collected
A visual analog scale appended to the GAD-7 which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the GAD-7. Scores range from 0 (best) to 100 (worst)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 1 month post-randomizationA visual analog scale appended to the PTSS which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the PTSS. Scores range from 0 (best) to 100 (worst)
Outcome measures
| Measure |
Standard Dose
n=124 Participants
Standard dose of meditation time (once a day).
|
High Dose
n=123 Participants
High dose of meditation time (twice a day).
|
App Response
n=123 Participants
Mobile app response to elevated psychological distress symptoms during intervention period.
|
Therapist Response
n=124 Participants
Therapist call in response to elevated psychological distress symptoms during intervention period.
|
App Introduction to Intervention
n=125 Participants
Introduction to intervention via the mobile app itself.
|
Therapist Introduction to Intervention
n=122 Participants
Introduction to intervention via a call from the study therapist.
|
|---|---|---|---|---|---|---|
|
Distress Associated With PTSD Symptom Frequency
|
49.56 units on a scale
Standard Deviation 28.59
|
42.02 units on a scale
Standard Deviation 30.54
|
47.69 units on a scale
Standard Deviation 28.63
|
43.94 units on a scale
Standard Deviation 30.84
|
44.60 units on a scale
Standard Deviation 30.52
|
47.04 units on a scale
Standard Deviation 29.04
|
SECONDARY outcome
Timeframe: At 3 months post-randomizationPopulation: Data were not collected
Absolute values, not change scores. A visual analog scale appended to the PTSS which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the PTSS. Scores range from 0 (best) to 100 (worst)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Between baseline and 1 month post-randomizationPopulation: Participants who had data collected at both time points.
Absolute values, not change scores. Post-traumatic stress disorder symptoms. Scores can range from 10 (best) to 70 (worst).
Outcome measures
| Measure |
Standard Dose
n=97 Participants
Standard dose of meditation time (once a day).
|
High Dose
n=94 Participants
High dose of meditation time (twice a day).
|
App Response
n=92 Participants
Mobile app response to elevated psychological distress symptoms during intervention period.
|
Therapist Response
n=99 Participants
Therapist call in response to elevated psychological distress symptoms during intervention period.
|
App Introduction to Intervention
n=91 Participants
Introduction to intervention via the mobile app itself.
|
Therapist Introduction to Intervention
n=100 Participants
Introduction to intervention via a call from the study therapist.
|
|---|---|---|---|---|---|---|
|
Post-Traumatic Stress Symptom Inventory (PTSS)
|
31.53 units on a scale
Standard Deviation 28.04
|
23.65 units on a scale
Standard Deviation 11.04
|
29.53 units on a scale
Standard Deviation 27.81
|
25.77 units on a scale
Standard Deviation 13.36
|
28.91 units on a scale
Standard Deviation 28.14
|
26.38 units on a scale
Standard Deviation 13.08
|
SECONDARY outcome
Timeframe: 1 month post-randomizationA measure of acceptability. Scores can range from 8 (worst) to 32 (best)
Outcome measures
| Measure |
Standard Dose
n=97 Participants
Standard dose of meditation time (once a day).
|
High Dose
n=94 Participants
High dose of meditation time (twice a day).
|
App Response
n=92 Participants
Mobile app response to elevated psychological distress symptoms during intervention period.
|
Therapist Response
n=99 Participants
Therapist call in response to elevated psychological distress symptoms during intervention period.
|
App Introduction to Intervention
n=91 Participants
Introduction to intervention via the mobile app itself.
|
Therapist Introduction to Intervention
n=100 Participants
Introduction to intervention via a call from the study therapist.
|
|---|---|---|---|---|---|---|
|
Client Satisfaction Questionnaire (CSQ)
|
24.86 units on a scale
Standard Deviation 5.11
|
25.71 units on a scale
Standard Deviation 4.10
|
25.81 units on a scale
Standard Deviation 4.58
|
24.79 units on a scale
Standard Deviation 4.67
|
25.27 units on a scale
Standard Deviation 4.46
|
25.31 units on a scale
Standard Deviation 4.82
|
SECONDARY outcome
Timeframe: 1 month post-randomizationPopulation: Data not collected.
A measure of intervention usability. Each of 10 items is scored from 1 to 5. For each of the odd numbered questions, subtract 1 from the score. For each of the even numbered questions, subtract their value from 5. Take these new values and add up the total score. Then multiply this by 2.5.Scores can range from 0 (worst) to 100 (best)
Outcome measures
Outcome data not reported
Adverse Events
App Introduction to Intervention, High Dose, and Therapist Response
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Therapist Introduction to Intervention, High Dose, and Therapist Response
Serious events: 4 serious events
Other events: 1 other events
Deaths: 0 deaths
App Introduction to Intervention, Standard Dose, and Therapist Response
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Therapist Introduction to Intervention, Standard Dose, and Therapist Response
Serious events: 2 serious events
Other events: 1 other events
Deaths: 1 deaths
App Introduction to Intervention, High Dose, and App Response
Serious events: 3 serious events
Other events: 1 other events
Deaths: 1 deaths
Therapist Introduction to Intervention, High Dose, and App Response
Serious events: 5 serious events
Other events: 1 other events
Deaths: 0 deaths
App Introduction to Intervention, Standard Dose, and App Response
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Therapist Introduction to Intervention, Standard Dose, and App Response
Serious events: 2 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
App Introduction to Intervention, High Dose, and Therapist Response
n=30 participants at risk
Introduction to intervention via the mobile app itself. High dose of meditation time (twice a day). Therapist call in response to elevated psychological distress symptoms during intervention period.
|
Therapist Introduction to Intervention, High Dose, and Therapist Response
n=31 participants at risk
Introduction to intervention via a call from the study therapist. High dose of meditation time (twice a day). Therapist call in response to elevated psychological distress symptoms during intervention period.
|
App Introduction to Intervention, Standard Dose, and Therapist Response
n=31 participants at risk
Introduction to intervention via the mobile app itself. Standard dose of meditation time (once a day). Therapist call in response to elevated psychological distress symptoms during intervention period.
|
Therapist Introduction to Intervention, Standard Dose, and Therapist Response
n=32 participants at risk
Introduction to intervention via a call from the study therapist. Standard dose of meditation time (once a day). Therapist call in response to elevated psychological distress symptoms during intervention period.
|
App Introduction to Intervention, High Dose, and App Response
n=32 participants at risk
Introduction to intervention via the mobile app itself. High dose of meditation time (twice a day). Mobile app response to elevated psychological distress symptoms during intervention period.
|
Therapist Introduction to Intervention, High Dose, and App Response
n=31 participants at risk
Introduction to intervention via a call from the study therapist. High dose of meditation time (twice a day). Mobile app response to elevated psychological distress symptoms during intervention period.
|
App Introduction to Intervention, Standard Dose, and App Response
n=30 participants at risk
Introduction to intervention via the mobile app itself. Standard dose of meditation time (once a day). Mobile app response to elevated psychological distress symptoms during intervention period.
|
Therapist Introduction to Intervention, Standard Dose, and App Response
n=30 participants at risk
Introduction to intervention via a call from the study therapist. Standard dose of meditation time (once a day). Mobile app response to elevated psychological distress symptoms during intervention period.
|
|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization
|
20.0%
6/30 • Number of events 6 • 3 months
Adverse events: 1. death 2. hospitalization for any reason 3. Suicidal ideation as indicated by a response on the PHQ-9 item 9 as any response other than 0 ('never')
|
12.9%
4/31 • Number of events 4 • 3 months
Adverse events: 1. death 2. hospitalization for any reason 3. Suicidal ideation as indicated by a response on the PHQ-9 item 9 as any response other than 0 ('never')
|
3.2%
1/31 • Number of events 8 • 3 months
Adverse events: 1. death 2. hospitalization for any reason 3. Suicidal ideation as indicated by a response on the PHQ-9 item 9 as any response other than 0 ('never')
|
6.2%
2/32 • Number of events 2 • 3 months
Adverse events: 1. death 2. hospitalization for any reason 3. Suicidal ideation as indicated by a response on the PHQ-9 item 9 as any response other than 0 ('never')
|
9.4%
3/32 • Number of events 3 • 3 months
Adverse events: 1. death 2. hospitalization for any reason 3. Suicidal ideation as indicated by a response on the PHQ-9 item 9 as any response other than 0 ('never')
|
16.1%
5/31 • Number of events 5 • 3 months
Adverse events: 1. death 2. hospitalization for any reason 3. Suicidal ideation as indicated by a response on the PHQ-9 item 9 as any response other than 0 ('never')
|
6.7%
2/30 • Number of events 2 • 3 months
Adverse events: 1. death 2. hospitalization for any reason 3. Suicidal ideation as indicated by a response on the PHQ-9 item 9 as any response other than 0 ('never')
|
6.7%
2/30 • Number of events 2 • 3 months
Adverse events: 1. death 2. hospitalization for any reason 3. Suicidal ideation as indicated by a response on the PHQ-9 item 9 as any response other than 0 ('never')
|
Other adverse events
| Measure |
App Introduction to Intervention, High Dose, and Therapist Response
n=30 participants at risk
Introduction to intervention via the mobile app itself. High dose of meditation time (twice a day). Therapist call in response to elevated psychological distress symptoms during intervention period.
|
Therapist Introduction to Intervention, High Dose, and Therapist Response
n=31 participants at risk
Introduction to intervention via a call from the study therapist. High dose of meditation time (twice a day). Therapist call in response to elevated psychological distress symptoms during intervention period.
|
App Introduction to Intervention, Standard Dose, and Therapist Response
n=31 participants at risk
Introduction to intervention via the mobile app itself. Standard dose of meditation time (once a day). Therapist call in response to elevated psychological distress symptoms during intervention period.
|
Therapist Introduction to Intervention, Standard Dose, and Therapist Response
n=32 participants at risk
Introduction to intervention via a call from the study therapist. Standard dose of meditation time (once a day). Therapist call in response to elevated psychological distress symptoms during intervention period.
|
App Introduction to Intervention, High Dose, and App Response
n=32 participants at risk
Introduction to intervention via the mobile app itself. High dose of meditation time (twice a day). Mobile app response to elevated psychological distress symptoms during intervention period.
|
Therapist Introduction to Intervention, High Dose, and App Response
n=31 participants at risk
Introduction to intervention via a call from the study therapist. High dose of meditation time (twice a day). Mobile app response to elevated psychological distress symptoms during intervention period.
|
App Introduction to Intervention, Standard Dose, and App Response
n=30 participants at risk
Introduction to intervention via the mobile app itself. Standard dose of meditation time (once a day). Mobile app response to elevated psychological distress symptoms during intervention period.
|
Therapist Introduction to Intervention, Standard Dose, and App Response
n=30 participants at risk
Introduction to intervention via a call from the study therapist. Standard dose of meditation time (once a day). Mobile app response to elevated psychological distress symptoms during intervention period.
|
|---|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Suicidal ideation (per PHQ-9 item 9)
|
0.00%
0/30 • 3 months
Adverse events: 1. death 2. hospitalization for any reason 3. Suicidal ideation as indicated by a response on the PHQ-9 item 9 as any response other than 0 ('never')
|
3.2%
1/31 • Number of events 1 • 3 months
Adverse events: 1. death 2. hospitalization for any reason 3. Suicidal ideation as indicated by a response on the PHQ-9 item 9 as any response other than 0 ('never')
|
3.2%
1/31 • Number of events 1 • 3 months
Adverse events: 1. death 2. hospitalization for any reason 3. Suicidal ideation as indicated by a response on the PHQ-9 item 9 as any response other than 0 ('never')
|
3.1%
1/32 • Number of events 1 • 3 months
Adverse events: 1. death 2. hospitalization for any reason 3. Suicidal ideation as indicated by a response on the PHQ-9 item 9 as any response other than 0 ('never')
|
3.1%
1/32 • Number of events 1 • 3 months
Adverse events: 1. death 2. hospitalization for any reason 3. Suicidal ideation as indicated by a response on the PHQ-9 item 9 as any response other than 0 ('never')
|
3.2%
1/31 • Number of events 1 • 3 months
Adverse events: 1. death 2. hospitalization for any reason 3. Suicidal ideation as indicated by a response on the PHQ-9 item 9 as any response other than 0 ('never')
|
3.3%
1/30 • Number of events 1 • 3 months
Adverse events: 1. death 2. hospitalization for any reason 3. Suicidal ideation as indicated by a response on the PHQ-9 item 9 as any response other than 0 ('never')
|
6.7%
2/30 • Number of events 2 • 3 months
Adverse events: 1. death 2. hospitalization for any reason 3. Suicidal ideation as indicated by a response on the PHQ-9 item 9 as any response other than 0 ('never')
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place