Trial Outcomes & Findings for Mindful Action for Pain (NCT NCT03800654)
NCT ID: NCT03800654
Last Updated: 2026-02-17
Results Overview
The BPI Pain Interference subscale consists of 7-items rated on a 0 - 10 scale that measures the degree to which pain interferes with various aspects of life, including mobility, social activities, and mood. Scores are averaged with a range from 0 to 10. Higher scores indicate higher levels of pain interference (i.e., worse outcome).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
126 participants
Primary outcome timeframe
Baseline and week 9
Results posted on
2026-02-17
Participant Flow
126 participants completed the informed consent procedure. However, 9 of these participants either declined or were excluded prior to assigning them to an intervention and 1 participant did not complete the baseline assessment (violating are intent-to-treat criterion). Thus, only 116 (Phase 1: n=29; Phase 2: n=87) were assigned to an intervention and completed the baseline assessment.
Participant milestones
| Measure |
Mindful Action for Pain (MAP) Development (Years 1-2)
In the first arm, MAP will be fully developed.
Mindful Action for Pain: MAP integrates formal mindfulness meditation with methods from Acceptance and Commitment Therapy and Dialectical Behavior Therapy.
|
MAP (Years 3-5)
Mindful Action for Pain: MAP integrates formal mindfulness meditation with methods from Acceptance and Commitment Therapy and Dialectical Behavior Therapy.
|
CBT (Years 3-5)
Cognitive Behavioral Therapy for Chronic Pain: CBT-CP is the current gold standard psychosocial intervention for chronic pain and will be compared to MAP in the second arm of the study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
29
|
46
|
41
|
|
Overall Study
COMPLETED
|
23
|
39
|
31
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
10
|
Reasons for withdrawal
| Measure |
Mindful Action for Pain (MAP) Development (Years 1-2)
In the first arm, MAP will be fully developed.
Mindful Action for Pain: MAP integrates formal mindfulness meditation with methods from Acceptance and Commitment Therapy and Dialectical Behavior Therapy.
|
MAP (Years 3-5)
Mindful Action for Pain: MAP integrates formal mindfulness meditation with methods from Acceptance and Commitment Therapy and Dialectical Behavior Therapy.
|
CBT (Years 3-5)
Cognitive Behavioral Therapy for Chronic Pain: CBT-CP is the current gold standard psychosocial intervention for chronic pain and will be compared to MAP in the second arm of the study.
|
|---|---|---|---|
|
Overall Study
Time constraints
|
3
|
3
|
3
|
|
Overall Study
Did Not Meet Inclusion Criteria
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
6
|
|
Overall Study
Medical Health Issue
|
0
|
0
|
1
|
|
Overall Study
Personal Issues
|
0
|
2
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
Baseline Characteristics
2 phases of project
Baseline characteristics by cohort
| Measure |
Mindful Action for Pain (MAP) Development (Years 1-2)
n=29 Participants
In the first arm, MAP will be fully developed.
Mindful Action for Pain: MAP integrates formal mindfulness meditation with methods from Acceptance and Commitment Therapy .
|
MAP (Years 3-5)
n=46 Participants
Mindful Action for Pain: MAP integrates formal mindfulness meditation with methods from Acceptance and Commitment Therapy .
|
CBT (Years 3-5)
n=41 Participants
Cognitive Behavioral Therapy for Chronic Pain: CBT-CP is the current gold standard psychosocial intervention for chronic pain and will be compared to MAP in the second arm of the study.
|
Total
n=116 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.28 Years
STANDARD_DEVIATION 13.92 • n=25 Participants • 2 phases of project
|
50.83 Years
STANDARD_DEVIATION 12.21 • n=20 Participants • 2 phases of project
|
47.88 Years
STANDARD_DEVIATION 12.62 • n=45 Participants • 2 phases of project
|
51.40 Years
STANDARD_DEVIATION 13.20 • n=76 Participants • 2 phases of project
|
|
Sex: Female, Male
Female
|
6 Participants
n=25 Participants
|
10 Participants
n=20 Participants
|
10 Participants
n=45 Participants
|
26 Participants
n=76 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=25 Participants
|
36 Participants
n=20 Participants
|
31 Participants
n=45 Participants
|
90 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=25 Participants
|
10 Participants
n=20 Participants
|
10 Participants
n=45 Participants
|
27 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=25 Participants
|
35 Participants
n=20 Participants
|
31 Participants
n=45 Participants
|
88 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
1 Participants
n=76 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=45 Participants
|
2 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=25 Participants
|
5 Participants
n=20 Participants
|
3 Participants
n=45 Participants
|
9 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=45 Participants
|
1 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=25 Participants
|
13 Participants
n=20 Participants
|
13 Participants
n=45 Participants
|
34 Participants
n=76 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=25 Participants
|
18 Participants
n=20 Participants
|
18 Participants
n=45 Participants
|
45 Participants
n=76 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=25 Participants
|
3 Participants
n=20 Participants
|
1 Participants
n=45 Participants
|
5 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=25 Participants
|
6 Participants
n=20 Participants
|
4 Participants
n=45 Participants
|
20 Participants
n=76 Participants
|
|
Region of Enrollment
United States
|
29 Participants
n=25 Participants
|
46 Participants
n=20 Participants
|
41 Participants
n=45 Participants
|
116 Participants
n=76 Participants
|
|
Brief Pain Inventory - Pain Interference
|
6.77 units on a scale
STANDARD_DEVIATION 1.66 • n=25 Participants
|
7.31 units on a scale
STANDARD_DEVIATION 1.76 • n=20 Participants
|
7.38 units on a scale
STANDARD_DEVIATION 1.95 • n=45 Participants
|
7.20 units on a scale
STANDARD_DEVIATION 1.81 • n=76 Participants
|
PRIMARY outcome
Timeframe: Baseline and week 9Population: Veterans with heterogenous chronic pain
The BPI Pain Interference subscale consists of 7-items rated on a 0 - 10 scale that measures the degree to which pain interferes with various aspects of life, including mobility, social activities, and mood. Scores are averaged with a range from 0 to 10. Higher scores indicate higher levels of pain interference (i.e., worse outcome).
Outcome measures
| Measure |
Mindful Action for Pain (MAP) Development (Years 1-2)
n=29 Participants
In the first arm, MAP will be fully developed.
Mindful Action for Pain: MAP integrates formal mindfulness meditation with methods from Acceptance and Commitment Therapy.
|
MAP Group (Years 3-5)
n=46 Participants
In Years 3-5, MAP will be compared to CBT-CP to establish feasibility of a larger, future trial.
Mindful Action for Pain: MAP integrates formal mindfulness meditation with methods from Acceptance and Commitment Therapy.
|
CBT Group (Years 3-5)
n=41 Participants
In Years 3-5, MAP will be compared to CBT-CP to establish feasibility of a larger, future trial.
Cognitive Behavioral Therapy for Chronic Pain: CBT-CP is the current gold standard psychosocial intervention for chronic pain and will be compared to MAP in the second arm of the study.
|
|---|---|---|---|
|
Brief Pain Inventory (BPI) Pain Interference Subscale Change
Baseline
|
6.77 units on a scale
Standard Deviation 1.66
|
7.31 units on a scale
Standard Deviation 1.76
|
7.38 units on a scale
Standard Deviation 1.95
|
|
Brief Pain Inventory (BPI) Pain Interference Subscale Change
Post-treatment
|
5.40 units on a scale
Standard Deviation 2.32
|
6.19 units on a scale
Standard Deviation 2.04
|
5.63 units on a scale
Standard Deviation 2.20
|
SECONDARY outcome
Timeframe: Baseline and week 9Population: Veterans with heterogenous chronic pain
The CPAQ consists of 20-items rated on a 0 - 6 scale that measures the degree that patients have adjusted to pain as part of their identity and lifestyle. Scores range from 0 to 120. Higher scores indicate higher levels of pain acceptance (i.e., better outcome).
Outcome measures
| Measure |
Mindful Action for Pain (MAP) Development (Years 1-2)
n=29 Participants
In the first arm, MAP will be fully developed.
Mindful Action for Pain: MAP integrates formal mindfulness meditation with methods from Acceptance and Commitment Therapy.
|
MAP Group (Years 3-5)
n=46 Participants
In Years 3-5, MAP will be compared to CBT-CP to establish feasibility of a larger, future trial.
Mindful Action for Pain: MAP integrates formal mindfulness meditation with methods from Acceptance and Commitment Therapy.
|
CBT Group (Years 3-5)
n=41 Participants
In Years 3-5, MAP will be compared to CBT-CP to establish feasibility of a larger, future trial.
Cognitive Behavioral Therapy for Chronic Pain: CBT-CP is the current gold standard psychosocial intervention for chronic pain and will be compared to MAP in the second arm of the study.
|
|---|---|---|---|
|
Chronic Pain Acceptance Questionnaire (CPAQ)
Baseline
|
65.55 units on scale
Standard Deviation 11.54
|
63.50 units on scale
Standard Deviation 10.80
|
62.78 units on scale
Standard Deviation 9.72
|
|
Chronic Pain Acceptance Questionnaire (CPAQ)
Posttreatment
|
72.78 units on scale
Standard Deviation 7.90
|
65.23 units on scale
Standard Deviation 14.02
|
67.03 units on scale
Standard Deviation 8.99
|
SECONDARY outcome
Timeframe: Baseline and week 9Population: Veterans with heterogenous chronic pain
The MAAS consists of 15-items assessing present-moment attention and awareness of everyday experiences. Scores range from 1-6 with higher scores reflecting greater mindfulness (i.e., better outcome).
Outcome measures
| Measure |
Mindful Action for Pain (MAP) Development (Years 1-2)
n=29 Participants
In the first arm, MAP will be fully developed.
Mindful Action for Pain: MAP integrates formal mindfulness meditation with methods from Acceptance and Commitment Therapy.
|
MAP Group (Years 3-5)
n=46 Participants
In Years 3-5, MAP will be compared to CBT-CP to establish feasibility of a larger, future trial.
Mindful Action for Pain: MAP integrates formal mindfulness meditation with methods from Acceptance and Commitment Therapy.
|
CBT Group (Years 3-5)
n=41 Participants
In Years 3-5, MAP will be compared to CBT-CP to establish feasibility of a larger, future trial.
Cognitive Behavioral Therapy for Chronic Pain: CBT-CP is the current gold standard psychosocial intervention for chronic pain and will be compared to MAP in the second arm of the study.
|
|---|---|---|---|
|
Mindfulness Attention Awareness Scale (MAAS)
Baseline
|
3.62 units on scale
Standard Deviation 1.00
|
3.87 units on scale
Standard Deviation 1.07
|
3.55 units on scale
Standard Deviation 1.00
|
|
Mindfulness Attention Awareness Scale (MAAS)
Posttreatment
|
3.93 units on scale
Standard Deviation .80
|
3.97 units on scale
Standard Deviation 1.01
|
3.63 units on scale
Standard Deviation 1.18
|
SECONDARY outcome
Timeframe: Baseline and week 9Population: Veterans with heterogenous chronic pain
The PCS consists of 13 items rated on 0 - 4 scale that measures the degree to which people experience an aversive orientation towards pain. Scores range from 0 - 52). Higher scores indicate higher levels of pain catastrophizing (i.e., worse outcome).
Outcome measures
| Measure |
Mindful Action for Pain (MAP) Development (Years 1-2)
n=28 Participants
In the first arm, MAP will be fully developed.
Mindful Action for Pain: MAP integrates formal mindfulness meditation with methods from Acceptance and Commitment Therapy.
|
MAP Group (Years 3-5)
n=45 Participants
In Years 3-5, MAP will be compared to CBT-CP to establish feasibility of a larger, future trial.
Mindful Action for Pain: MAP integrates formal mindfulness meditation with methods from Acceptance and Commitment Therapy.
|
CBT Group (Years 3-5)
n=41 Participants
In Years 3-5, MAP will be compared to CBT-CP to establish feasibility of a larger, future trial.
Cognitive Behavioral Therapy for Chronic Pain: CBT-CP is the current gold standard psychosocial intervention for chronic pain and will be compared to MAP in the second arm of the study.
|
|---|---|---|---|
|
Pain Catastrophizing Scale (PCS)
Posttreatment
|
21.74 units on scale
Standard Deviation 10.66
|
22.72 units on scale
Standard Deviation 11.88
|
21.52 units on scale
Standard Deviation 12.49
|
|
Pain Catastrophizing Scale (PCS)
Baseline
|
26.86 units on scale
Standard Deviation 12.29
|
28.98 units on scale
Standard Deviation 11.31
|
27.80 units on scale
Standard Deviation 12.25
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Collected daily during the 8-week interventionPopulation: Data not collected for participants in the CBT (Years 3-5) Arm.
On these diaries, participants report the duration of daily meditation practice via a smartphone application. The investigators then aggregated the total amount of meditation minutes completed at home during the 8-week intervention.
Outcome measures
| Measure |
Mindful Action for Pain (MAP) Development (Years 1-2)
n=23 Participants
In the first arm, MAP will be fully developed.
Mindful Action for Pain: MAP integrates formal mindfulness meditation with methods from Acceptance and Commitment Therapy.
|
MAP Group (Years 3-5)
n=46 Participants
In Years 3-5, MAP will be compared to CBT-CP to establish feasibility of a larger, future trial.
Mindful Action for Pain: MAP integrates formal mindfulness meditation with methods from Acceptance and Commitment Therapy.
|
CBT Group (Years 3-5)
In Years 3-5, MAP will be compared to CBT-CP to establish feasibility of a larger, future trial.
Cognitive Behavioral Therapy for Chronic Pain: CBT-CP is the current gold standard psychosocial intervention for chronic pain and will be compared to MAP in the second arm of the study.
|
|---|---|---|---|
|
Meditation Diaries
|
12.11 Hours
Standard Deviation 5.49
|
11.14 Hours
Standard Deviation 6.02
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and week 9Population: Data from MAP Development years 1-2 not included because there was no randomization.
Participants in Phase 2 MAP and CBT groups wore actiwatches for two 7-day periods at baseline and week 9 to measure average physical activity counts.
Outcome measures
| Measure |
Mindful Action for Pain (MAP) Development (Years 1-2)
n=31 Participants
In the first arm, MAP will be fully developed.
Mindful Action for Pain: MAP integrates formal mindfulness meditation with methods from Acceptance and Commitment Therapy.
|
MAP Group (Years 3-5)
n=34 Participants
In Years 3-5, MAP will be compared to CBT-CP to establish feasibility of a larger, future trial.
Mindful Action for Pain: MAP integrates formal mindfulness meditation with methods from Acceptance and Commitment Therapy.
|
CBT Group (Years 3-5)
In Years 3-5, MAP will be compared to CBT-CP to establish feasibility of a larger, future trial.
Cognitive Behavioral Therapy for Chronic Pain: CBT-CP is the current gold standard psychosocial intervention for chronic pain and will be compared to MAP in the second arm of the study.
|
|---|---|---|---|
|
Actigraphy
Activity counts post-treatment
|
220.01 Activity counts
Standard Deviation 127.49
|
227.46 Activity counts
Standard Deviation 136.96
|
—
|
|
Actigraphy
Activity counts baseline
|
220.09 Activity counts
Standard Deviation 133.36
|
210.93 Activity counts
Standard Deviation 136.43
|
—
|
Adverse Events
Mindful Action for Pain (MAP) Development (Years 1-2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MAP (Years 3-5)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CBT (Years 3-5)
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