Trial Outcomes & Findings for Development and Feasibility of Mindfulness Based Pain Reduction (NCT NCT04980612)
NCT ID: NCT04980612
Last Updated: 2025-04-10
Results Overview
Change in average pain intensity in past week on Numeric Rating Scale \[0 to 10\] will be assessed by internet-based questionnaire using REDCap negative values indicate improvement.
ACTIVE_NOT_RECRUITING
NA
52 participants
baseline, post 8-week intervention
2025-04-10
Participant Flow
Participant milestones
| Measure |
MBPR
Mindfulness-Based Pain Reduction
|
MBSR
Mindfulness-Based Stress Reduction
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
11
|
|
Overall Study
COMPLETED
|
34
|
6
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
Reasons for withdrawal
| Measure |
MBPR
Mindfulness-Based Pain Reduction
|
MBSR
Mindfulness-Based Stress Reduction
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
5
|
Baseline Characteristics
Development and Feasibility of Mindfulness Based Pain Reduction
Baseline characteristics by cohort
| Measure |
MBPR
n=41 Participants
Mindfulness-Based Pain Reduction
|
MBSR
n=11 Participants
Mindfulness-Based Stress Reduction
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.0 years
STANDARD_DEVIATION 12.1 • n=99 Participants
|
58.4 years
STANDARD_DEVIATION 6.1 • n=107 Participants
|
50.3 years
STANDARD_DEVIATION 12.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 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
|
9 Participants
n=99 Participants
|
4 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
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
PEG score
|
14.2 units on a scale
STANDARD_DEVIATION 5.5 • n=99 Participants
|
16.6 units on a scale
STANDARD_DEVIATION 4.9 • n=107 Participants
|
14.8 units on a scale
STANDARD_DEVIATION 5.6 • n=206 Participants
|
PRIMARY outcome
Timeframe: baseline, post 8-week interventionChange in average pain intensity in past week on Numeric Rating Scale \[0 to 10\] will be assessed by internet-based questionnaire using REDCap negative values indicate improvement.
Outcome measures
| Measure |
MBPR
n=34 Participants
Mindfulness-Based Pain Reduction
|
MBSR
n=6 Participants
Mindfulness-Based Stress Reduction
|
|---|---|---|
|
Pain Intensity
|
-2.30 score on a scale
Standard Deviation 2.50
|
-1.83 score on a scale
Standard Deviation 1.94
|
SECONDARY outcome
Timeframe: baseline, post 8-week interventionChange in average of the scores for the 3 Pain Interference items on PROMIS-29 \[5-point Likert scale from 1 "Not at all" to 5 "Very much"\] average for past week will be assessed by internet-based questionnaire using REDCap \[range 3 - 15, higher values more interference\] negative numbers indicate improvement in pain interference
Outcome measures
| Measure |
MBPR
n=34 Participants
Mindfulness-Based Pain Reduction
|
MBSR
n=6 Participants
Mindfulness-Based Stress Reduction
|
|---|---|---|
|
Pain Interference
|
-6.23 score on a scale
Standard Deviation 7.36
|
-6.08 score on a scale
Standard Deviation 3.22
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, post 8-week interventionchange in scores for the 8 scales of the Multidimensional Assessment of Interoceptive Awareness (MAIA-2) \[6-point 0-5 Likert scale Never to Always\] will be assessed by internet-based questionnaire using REDCap. Each scale range from 0-5, total score over all 8 scales is the mean of the score of the 8 scales, also ranges 0-5. Higher values indicate higher interoceptive awareness. positive values indicate improvement.
Outcome measures
| Measure |
MBPR
n=34 Participants
Mindfulness-Based Pain Reduction
|
MBSR
n=6 Participants
Mindfulness-Based Stress Reduction
|
|---|---|---|
|
Interoceptive Awareness
|
0.76 score on a scale
Standard Deviation 0.61
|
0.61 score on a scale
Standard Deviation 0.69
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, post 8-week intervention.using fMRI, insula cortex activation and connectivity in brain fMRI; awaiting separate analysis
Outcome measures
Outcome data not reported
Adverse Events
MBPR
MBSR
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MBPR
n=34 participants at risk
Mindfulness-Based Pain Reduction
|
MBSR
n=6 participants at risk
Mindfulness-Based Stress Reduction
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
pain increase
|
2.9%
1/34 • Number of events 1 • 6 months
minimal risk
|
0.00%
0/6 • 6 months
minimal risk
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place