Trial Outcomes & Findings for Mindful Hearts Study: Mindfulness to Reduce Stress (NCT NCT01784796)
NCT ID: NCT01784796
Last Updated: 2021-09-16
Results Overview
Psychological stress measured with the Perceived Stress Scale (PSS). Total scores on the PSS range from 0 to 40 with higher scores indicating higher levels of perceived stress. Scores between 0 to 13 suggest low stress, scores between 14 and 26 suggest moderate stress, and scores between 27 and 40 indicate high perceived stress.
COMPLETED
NA
164 participants
8 week
2021-09-16
Participant Flow
We had powered the study for a total of 110 participants (55 in each group). To account for attrition, we planned on recruiting a total of 138 participants (69 in each group). We enrolled 164 participants and 136 of these completed baseline data.
Participant milestones
| Measure |
Mindfulness Based Stress Reduction
8 week Mindfulness Based Stress Reduction program
|
Health Education Program
8 week Health Education program
Health Education Program: 8 week Health Education Program
|
|---|---|---|
|
Overall Study
STARTED
|
87
|
77
|
|
Overall Study
Baseline Data Collected
|
75
|
61
|
|
Overall Study
4 Week Data Collection
|
48
|
41
|
|
Overall Study
8 wk Data Collection
|
50
|
46
|
|
Overall Study
COMPLETED
|
39
|
34
|
|
Overall Study
NOT COMPLETED
|
48
|
43
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mindful Hearts Study: Mindfulness to Reduce Stress
Baseline characteristics by cohort
| Measure |
Mindfulness Based Stress Reduction
n=75 Participants
8 week Mindfulness Based Stress Reduction program
Mindfulness Based Stress Reduction: 8 week Mindfulness Based Stress Reduction Program
|
Health Education Program
n=61 Participants
8 week Health Education program
Health Education Program: 8 week Health Education Program
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
71 Participants
n=93 Participants
|
59 Participants
n=4 Participants
|
130 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Age, Continuous
|
50.83 years
n=93 Participants
|
50.51 years
n=4 Participants
|
50.75 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=93 Participants
|
61 Participants
n=4 Participants
|
136 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=93 Participants
|
07 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
64 Participants
n=93 Participants
|
54 Participants
n=4 Participants
|
118 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
55 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
72 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
75 Participants
n=93 Participants
|
61 Participants
n=4 Participants
|
136 Participants
n=27 Participants
|
|
Center for Epidemiological Studies Depression Scale
|
22.78 units on a scale
STANDARD_DEVIATION 13.76 • n=93 Participants
|
19.22 units on a scale
STANDARD_DEVIATION 11.67 • n=4 Participants
|
21.17 units on a scale
STANDARD_DEVIATION 13.00 • n=27 Participants
|
|
Perceived Stress Scale
|
19.64 units on a scale
STANDARD_DEVIATION 8.21 • n=93 Participants
|
17.50 units on a scale
STANDARD_DEVIATION 7.52 • n=4 Participants
|
18.70 units on a scale
STANDARD_DEVIATION 8.00 • n=27 Participants
|
|
Quality of Life Index
|
17.96 units on a scale
STANDARD_DEVIATION 6.29 • n=93 Participants
|
19.16 units on a scale
STANDARD_DEVIATION 5.39 • n=4 Participants
|
18.70 units on a scale
STANDARD_DEVIATION 6.30 • n=27 Participants
|
PRIMARY outcome
Timeframe: 8 weekPopulation: Baseline data was compared to 8 week data (completion of program) for both the MBSR and HEP groups.
Psychological stress measured with the Perceived Stress Scale (PSS). Total scores on the PSS range from 0 to 40 with higher scores indicating higher levels of perceived stress. Scores between 0 to 13 suggest low stress, scores between 14 and 26 suggest moderate stress, and scores between 27 and 40 indicate high perceived stress.
Outcome measures
| Measure |
Mindfulness Based Stress Reduction
n=50 Participants
8 week Mindfulness Based Stress Reduction program
Mindfulness Based Stress Reduction: 8 week Mindfulness Based Stress Reduction Program
|
Health Education Program
n=46 Participants
8 week Health Education program
Health Education Program: 8 week Health Education Program
|
|---|---|---|
|
Perceived Stress
|
15.94 score on a scale
Standard Deviation 8.53
|
15.50 score on a scale
Standard Deviation 7.33
|
PRIMARY outcome
Timeframe: 8 weekDepressive symptoms were measured with the CES-D Total scores for the CES-D range from 0 to 60 with higher scores indicating greater depressive symptoms.
Outcome measures
| Measure |
Mindfulness Based Stress Reduction
n=50 Participants
8 week Mindfulness Based Stress Reduction program
Mindfulness Based Stress Reduction: 8 week Mindfulness Based Stress Reduction Program
|
Health Education Program
n=46 Participants
8 week Health Education program
Health Education Program: 8 week Health Education Program
|
|---|---|---|
|
Depressive Symptoms
|
18.38 score on a scale
Standard Deviation 13.26
|
14.46 score on a scale
Standard Deviation 11.03
|
PRIMARY outcome
Timeframe: 8 weekMeasured with Quality of Life Index-III Generic (QLI) Total scores for the QLI range from 0 to 30 with higher scores indicating better quality of life.
Outcome measures
| Measure |
Mindfulness Based Stress Reduction
n=50 Participants
8 week Mindfulness Based Stress Reduction program
Mindfulness Based Stress Reduction: 8 week Mindfulness Based Stress Reduction Program
|
Health Education Program
n=46 Participants
8 week Health Education program
Health Education Program: 8 week Health Education Program
|
|---|---|---|
|
Quality of Life (QOL)
|
19.77 score on a scale
Standard Deviation 5.81
|
19.46 score on a scale
Standard Deviation 5.00
|
SECONDARY outcome
Timeframe: 6 monthsCardiovascular risk as measured by Reynolds Risk Score. The Reynolds Cardiovascular Risk score predicts the percent risk of having a heart attack, stroke or other major heart disease in the next 10 years. Scores range from 0 to 100% with higher scores representing greater risk of developing cardiovascular disease in 10 years.
Outcome measures
| Measure |
Mindfulness Based Stress Reduction
n=39 Participants
8 week Mindfulness Based Stress Reduction program
Mindfulness Based Stress Reduction: 8 week Mindfulness Based Stress Reduction Program
|
Health Education Program
n=34 Participants
8 week Health Education program
Health Education Program: 8 week Health Education Program
|
|---|---|---|
|
Cardiovascular Risk
|
4.77 score on a scale
Standard Deviation 3.16
|
5.80 score on a scale
Standard Deviation 4.83
|
Adverse Events
Mindfulness Based Stress Reduction
Health Education Program
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mindfulness Based Stress Reduction
n=75 participants at risk
8 week Mindfulness Based Stress Reduction program
Mindfulness Based Stress Reduction: 8 week Mindfulness Based Stress Reduction Program
|
Health Education Program
n=61 participants at risk
8 week Health Education program
Health Education Program: 8 week Health Education Program
|
|---|---|---|
|
Gastrointestinal disorders
Hospitalization
|
1.3%
1/75 • Number of events 1 • Duration of study and follow up - which was 6 months
|
0.00%
0/61 • Duration of study and follow up - which was 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place