Trial Outcomes & Findings for Brief Mindfulness Meditation Course to Reduce Stress in Healthcare Professionals (NCT NCT03781336)
NCT ID: NCT03781336
Last Updated: 2021-05-12
Results Overview
The Perceived Stress Scale (PSS) is used to assess self-reported perceived stress. It is a 10-item scale, with a total range from 0 (no symptoms) to 40 (highest severity).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
82 participants
Primary outcome timeframe
Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)
Results posted on
2021-05-12
Participant Flow
Participant milestones
| Measure |
Mindfulness-based Self-care
Mindfulness-based self-care (5 weeks)
Mindfulness-based self care: Experimental: an abridged mindfulness-based program that is incorporated into the work day, which consists of five weekly 1.5 hour sessions.
|
Life as Usual Control
Life as usual control (5 weeks)
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
37
|
|
Overall Study
COMPLETED
|
43
|
35
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Mindfulness-based Self-care
Mindfulness-based self-care (5 weeks)
Mindfulness-based self care: Experimental: an abridged mindfulness-based program that is incorporated into the work day, which consists of five weekly 1.5 hour sessions.
|
Life as Usual Control
Life as usual control (5 weeks)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
Brief Mindfulness Meditation Course to Reduce Stress in Healthcare Professionals
Baseline characteristics by cohort
| Measure |
Mindfulness-based Self-care
n=43 Participants
Mindfulness-based self-care (5 weeks)
Mindfulness-based self care: Experimental: an abridged mindfulness-based program that is incorporated into the work day, which consists of five weekly 1.5 hour sessions.
|
Life as Usual Control
n=35 Participants
Life as usual control (5 weeks)
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.7 years
STANDARD_DEVIATION 15.4 • n=99 Participants
|
36.4 years
STANDARD_DEVIATION 13.0 • n=107 Participants
|
36.0 years
STANDARD_DEVIATION 14.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Marital status
Single
|
28 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Marital status
Married
|
8 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Marital status
Divorced or separated
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Marital status
Widowed or other
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Religion
Agnostic
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Religion
Atheism
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Religion
Buddhism
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Religion
Christianity
|
18 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Religion
Hinduism
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Religion
Islam
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Religion
Judaism
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Religion
Not affiliated or other
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Current position
Administrator
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Current position
Nurse
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Current position
PhD Scientist
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Current position
Physician
|
7 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Current position
Social Worker
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Current position
Training Fellow
|
19 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Education level
Some college
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Education level
Completed college
|
22 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Education level
Graduate school or Advance degree
|
20 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Preexisting condition
Medical condition
|
16 participants
n=99 Participants
|
9 participants
n=107 Participants
|
25 participants
n=206 Participants
|
|
Preexisting condition
Psychiatric condition
|
16 participants
n=99 Participants
|
14 participants
n=107 Participants
|
30 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)The Perceived Stress Scale (PSS) is used to assess self-reported perceived stress. It is a 10-item scale, with a total range from 0 (no symptoms) to 40 (highest severity).
Outcome measures
| Measure |
Mindfulness-based Self-care
n=43 Participants
Mindfulness-based self-care (5 weeks)
Mindfulness-based self care: Experimental: an abridged mindfulness-based program that is incorporated into the work day, which consists of five weekly 1.5 hour sessions.
|
Life as Usual Control
n=35 Participants
Life as usual control (5 weeks)
|
|---|---|---|
|
Perceived Stress Scale (PSS)
Baseline
|
19.63 score on a scale
Standard Deviation 6.26
|
18.80 score on a scale
Standard Deviation 6.36
|
|
Perceived Stress Scale (PSS)
Postintervention
|
17.29 score on a scale
Standard Deviation 5.84
|
18.54 score on a scale
Standard Deviation 6.30
|
|
Perceived Stress Scale (PSS)
Follow-up
|
13.80 score on a scale
Standard Deviation 6.45
|
NA score on a scale
Standard Deviation NA
Follow-up data not collected from the life as usual control subjects.
|
SECONDARY outcome
Timeframe: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)The Mindful Attention Awareness Scale-Trait Version (MAAS-T) is used to assess self-reported trait mindfulness. It is a 15-item scale, with a total range from 0 (low mindfulness) to 90 (high mindfulness).
Outcome measures
| Measure |
Mindfulness-based Self-care
n=43 Participants
Mindfulness-based self-care (5 weeks)
Mindfulness-based self care: Experimental: an abridged mindfulness-based program that is incorporated into the work day, which consists of five weekly 1.5 hour sessions.
|
Life as Usual Control
n=35 Participants
Life as usual control (5 weeks)
|
|---|---|---|
|
Mindful Attention Awareness Scale (MAAS) - Trait Version
Baseline
|
3.74 score on a scale
Standard Deviation 0.99
|
3.61 score on a scale
Standard Deviation 0.89
|
|
Mindful Attention Awareness Scale (MAAS) - Trait Version
Postintervention
|
3.95 score on a scale
Standard Deviation 0.83
|
3.70 score on a scale
Standard Deviation 0.96
|
|
Mindful Attention Awareness Scale (MAAS) - Trait Version
Follow-up
|
4.33 score on a scale
Standard Deviation 0.85
|
NA score on a scale
Standard Deviation NA
Follow-up data not collected from the life as usual control subjects.
|
SECONDARY outcome
Timeframe: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)The Mindful Attention Awareness Scale-State Version (MAAS-S) is used to assess self-reported state mindfulness. It is a 5-item scale, with a total range from 0 (high mindfulness) to 30 (low mindfulness).
Outcome measures
| Measure |
Mindfulness-based Self-care
n=43 Participants
Mindfulness-based self-care (5 weeks)
Mindfulness-based self care: Experimental: an abridged mindfulness-based program that is incorporated into the work day, which consists of five weekly 1.5 hour sessions.
|
Life as Usual Control
n=35 Participants
Life as usual control (5 weeks)
|
|---|---|---|
|
Mindful Attention Awareness Scale (MAAS) - State Version
Baseline
|
2.23 score on a scale
Standard Deviation 1.24
|
2.48 score on a scale
Standard Deviation 1.08
|
|
Mindful Attention Awareness Scale (MAAS) - State Version
Postintervention
|
3.74 score on a scale
Standard Deviation 1.18
|
2.78 score on a scale
Standard Deviation 1.16
|
|
Mindful Attention Awareness Scale (MAAS) - State Version
Follow-up
|
4.08 score on a scale
Standard Deviation 1.04
|
NA score on a scale
Standard Deviation NA
Follow-up data not collected from the life as usual control subjects.
|
SECONDARY outcome
Timeframe: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)The Positive And Negative Affect Scale (PANAS) is used to assess self-reported positive and negative affect. It is a two dimension scale, with total ranges for each scale from 0 (low positive/negative affect) to 50 (high positive/negative affect). These are the Positive Affect Scores
Outcome measures
| Measure |
Mindfulness-based Self-care
n=43 Participants
Mindfulness-based self-care (5 weeks)
Mindfulness-based self care: Experimental: an abridged mindfulness-based program that is incorporated into the work day, which consists of five weekly 1.5 hour sessions.
|
Life as Usual Control
n=35 Participants
Life as usual control (5 weeks)
|
|---|---|---|
|
Positive Affect Scores (PANAS)
Baseline
|
32.85 units on a scale
Standard Deviation 7.73
|
33.67 units on a scale
Standard Deviation 5.95
|
|
Positive Affect Scores (PANAS)
Postintervention
|
35.69 units on a scale
Standard Deviation 7.12
|
31.42 units on a scale
Standard Deviation 7.27
|
|
Positive Affect Scores (PANAS)
Follow-up
|
36.13 units on a scale
Standard Deviation 8.43
|
NA units on a scale
Standard Deviation NA
Follow-up data not collected from the life as usual control subjects.
|
SECONDARY outcome
Timeframe: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)Visual Analog Scale-Anxiety (VAS-A) is used to assess self-reported anxiety. It is a 1-item scale, with a total range from 1 (low anxiety) to 10 (high anxiety).
Outcome measures
| Measure |
Mindfulness-based Self-care
n=43 Participants
Mindfulness-based self-care (5 weeks)
Mindfulness-based self care: Experimental: an abridged mindfulness-based program that is incorporated into the work day, which consists of five weekly 1.5 hour sessions.
|
Life as Usual Control
n=35 Participants
Life as usual control (5 weeks)
|
|---|---|---|
|
Visual Analog Scale-Anxiety (VAS-A)
Baseline
|
4.72 score on a scale
Standard Deviation 1.62
|
4.57 score on a scale
Standard Deviation 1.69
|
|
Visual Analog Scale-Anxiety (VAS-A)
Postintervention
|
2.58 score on a scale
Standard Deviation 1.52
|
4.23 score on a scale
Standard Deviation 1.73
|
|
Visual Analog Scale-Anxiety (VAS-A)
Follow-up
|
3.29 score on a scale
Standard Deviation 1.47
|
NA score on a scale
Standard Deviation NA
Follow-up data not collected from the life as usual control subjects.
|
SECONDARY outcome
Timeframe: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)Mindful Self Care Scale-General (MSCS-G) is used to assess self-reported mindful self care. It is a 3-item scale, with a total range from 0 (low self care) to 12 (high self care).
Outcome measures
| Measure |
Mindfulness-based Self-care
n=43 Participants
Mindfulness-based self-care (5 weeks)
Mindfulness-based self care: Experimental: an abridged mindfulness-based program that is incorporated into the work day, which consists of five weekly 1.5 hour sessions.
|
Life as Usual Control
n=35 Participants
Life as usual control (5 weeks)
|
|---|---|---|
|
Mindful Self Care Scale-General (MSCS-G)
Baseline
|
5.60 score on a scale
Standard Deviation 2.75
|
6.00 score on a scale
Standard Deviation 2.88
|
|
Mindful Self Care Scale-General (MSCS-G)
Postintervention
|
7.29 score on a scale
Standard Deviation 2.44
|
5.54 score on a scale
Standard Deviation 2.77
|
|
Mindful Self Care Scale-General (MSCS-G)
Follow-up
|
6.37 score on a scale
Standard Deviation 2.76
|
NA score on a scale
Standard Deviation NA
Follow-up data not collected from the life as usual control subjects.
|
SECONDARY outcome
Timeframe: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)The Maslach Burnout Inventory (MBI 2-Item) is used to assess self-reported burnout. The 2-Item inventory assesses emotional exhaustion (Item-1) and depersonalization (Item-2) separately from 1 (no symptoms) to 7 (highest severity).
Outcome measures
| Measure |
Mindfulness-based Self-care
n=43 Participants
Mindfulness-based self-care (5 weeks)
Mindfulness-based self care: Experimental: an abridged mindfulness-based program that is incorporated into the work day, which consists of five weekly 1.5 hour sessions.
|
Life as Usual Control
n=35 Participants
Life as usual control (5 weeks)
|
|---|---|---|
|
Maslach Burnout Inventory (MBI)
Baseline-item 1
|
2.95 score on a scale
Standard Deviation 1.56
|
3.29 score on a scale
Standard Deviation 1.45
|
|
Maslach Burnout Inventory (MBI)
Postintervention-item 1
|
2.89 score on a scale
Standard Deviation 1.63
|
2.74 score on a scale
Standard Deviation 1.62
|
|
Maslach Burnout Inventory (MBI)
Follow-up-item 1
|
2.31 score on a scale
Standard Deviation 1.64
|
NA score on a scale
Standard Deviation NA
Follow-up data not collected from the life as usual control subjects.
|
|
Maslach Burnout Inventory (MBI)
Baseline-item 2
|
1.76 score on a scale
Standard Deviation 1.32
|
1.6 score on a scale
Standard Deviation 1.42
|
|
Maslach Burnout Inventory (MBI)
Postintervention-item 2
|
1.22 score on a scale
Standard Deviation 1.13
|
1.57 score on a scale
Standard Deviation 1.36
|
|
Maslach Burnout Inventory (MBI)
Follow-up-item 2
|
1.34 score on a scale
Standard Deviation 1.21
|
NA score on a scale
Standard Deviation NA
Follow-up data not collected from the life as usual control subjects.
|
SECONDARY outcome
Timeframe: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)The Positive And Negative Affect Scale (PANAS) is used to assess self-reported positive and negative affect. It is a two dimension scale, with total ranges for each scale from 0 (low positive/negative affect) to 50 (high positive/negative affect). These are the Negative Affect Scores
Outcome measures
| Measure |
Mindfulness-based Self-care
n=43 Participants
Mindfulness-based self-care (5 weeks)
Mindfulness-based self care: Experimental: an abridged mindfulness-based program that is incorporated into the work day, which consists of five weekly 1.5 hour sessions.
|
Life as Usual Control
n=35 Participants
Life as usual control (5 weeks)
|
|---|---|---|
|
Negative Affect Scores (PANAS)
Baseline
|
21.44 units on a scale
Standard Deviation 7.38
|
21.21 units on a scale
Standard Deviation 7.27
|
|
Negative Affect Scores (PANAS)
Postintervention
|
20.73 units on a scale
Standard Deviation 6.24
|
19.09 units on a scale
Standard Deviation 7.60
|
|
Negative Affect Scores (PANAS)
Follow-up
|
18.22 units on a scale
Standard Deviation 6.01
|
NA units on a scale
Standard Deviation NA
Follow-up data not collected from the life as usual control subjects.
|
Adverse Events
Mindfulness-based Self-care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Life as Usual 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