Trial Outcomes & Findings for Compassion Meditation vs. Health Education for Veterans (NCT NCT04651296)
NCT ID: NCT04651296
Last Updated: 2026-09-01
Results Overview
Self-report questionnaire; pain interference subscale includes 7 items measuring the degree to which pain interferes with various aspects of life, including mobility, social activities, and mood. Subscale scores range from 0 to 70 with higher scores indicative of greater pain disability.
COMPLETED
PHASE2
142 participants
Change from baseline to 3-month follow-up
2026-09-01
Participant Flow
Participant milestones
| Measure |
Compassion Meditation
10 week, group-based manualized compassion meditation training
|
Health Education
10 week, group-based manualized health education protocol
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
67
|
|
Overall Study
COMPLETED
|
48
|
51
|
|
Overall Study
NOT COMPLETED
|
27
|
16
|
Reasons for withdrawal
| Measure |
Compassion Meditation
10 week, group-based manualized compassion meditation training
|
Health Education
10 week, group-based manualized health education protocol
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
14
|
8
|
|
Overall Study
Lost to Follow-up
|
13
|
6
|
|
Overall Study
discontinued due to low enrollment
|
0
|
2
|
Baseline Characteristics
n = 2 did not report years of education
Baseline characteristics by cohort
| Measure |
Compassion Meditation
n=75 Participants
10 week, group-based manualized compassion meditation training
|
Health Education
n=67 Participants
10 week, group-based manualized health education protocol
|
Total
n=142 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
22 Participants
n=75 Participants
|
17 Participants
n=67 Participants
|
39 Participants
n=142 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=75 Participants
|
50 Participants
n=67 Participants
|
103 Participants
n=142 Participants
|
|
Age, Continuous
|
47.34 years
STANDARD_DEVIATION 14.07 • n=75 Participants
|
48.04 years
STANDARD_DEVIATION 13.34 • n=67 Participants
|
47.67 years
STANDARD_DEVIATION 13.69 • n=142 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=75 Participants
|
2 Participants
n=67 Participants
|
2 Participants
n=142 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=75 Participants
|
3 Participants
n=67 Participants
|
6 Participants
n=142 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=75 Participants
|
1 Participants
n=67 Participants
|
2 Participants
n=142 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=75 Participants
|
15 Participants
n=67 Participants
|
40 Participants
n=142 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=75 Participants
|
34 Participants
n=67 Participants
|
69 Participants
n=142 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=75 Participants
|
1 Participants
n=67 Participants
|
5 Participants
n=142 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=75 Participants
|
11 Participants
n=67 Participants
|
18 Participants
n=142 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=75 Participants
|
17 Participants
n=67 Participants
|
33 Participants
n=142 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=75 Participants
|
49 Participants
n=67 Participants
|
106 Participants
n=142 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=75 Participants
|
1 Participants
n=67 Participants
|
3 Participants
n=142 Participants
|
|
Education
|
13.93 years
STANDARD_DEVIATION 1.88 • n=75 Participants • n = 2 did not report years of education
|
13.66 years
STANDARD_DEVIATION 1.86 • n=65 Participants • n = 2 did not report years of education
|
13.81 years
STANDARD_DEVIATION 1.87 • n=140 Participants • n = 2 did not report years of education
|
PRIMARY outcome
Timeframe: Change from baseline to 3-month follow-upPopulation: All participants that completed baseline and posttreatment assessment are included in overall analysis population. Rows may differ from the total population due to missing data.
Self-report questionnaire; pain interference subscale includes 7 items measuring the degree to which pain interferes with various aspects of life, including mobility, social activities, and mood. Subscale scores range from 0 to 70 with higher scores indicative of greater pain disability.
Outcome measures
| Measure |
Compassion Meditation
n=48 Participants
10 week, group-based manualized compassion meditation training
|
Health Education
n=51 Participants
10 week, group-based manualized health education protocol
|
|---|---|---|
|
Brief Pain Inventory (BPI) Pain Interference Subscale
Baseline pain interference
|
6.64 score on a scale
Standard Deviation 1.66
|
7.07 score on a scale
Standard Deviation 2.04
|
|
Brief Pain Inventory (BPI) Pain Interference Subscale
Posttreatment pain interference
|
5.93 score on a scale
Standard Deviation 2.14
|
6.35 score on a scale
Standard Deviation 2.63
|
|
Brief Pain Inventory (BPI) Pain Interference Subscale
3-Month Follow-up pain interference
|
6.19 score on a scale
Standard Deviation 1.99
|
6.09 score on a scale
Standard Deviation 2.82
|
PRIMARY outcome
Timeframe: Change from baseline to 3-month follow-upPopulation: All participants that completed baseline and posttreatment assessment are included in overall analysis population. Rows may differ from the total population due to missing data.
The Clinical Global Impressions scale (CGI) consists of two clinician-rated one-item measures assessing 1) the severity of psychopathology from minimum of 1 (normal, not at all ill) to maximum of 7 (among the most extremely ill patients), CGI-Severity (CGI-S), and 2) the improvement in functioning since baseline assessment from 1 (very much improved since the initiation of treatment) to 7 (very much worse since the initiation of treatment), CGI-Improvement (CGI-I). The items are not combined. Total score 1 - 7, where higher CGI-S scores indicate greater severity of psychopathology (worse outcome). Higher CGI-I scores indicate less improvement since previous assessment (worse outcome). The primary outcome measure reported is the CGI-Severity. The CGI-S is a well-established measure of psychological symptom severity and is applicable across psychological conditions.
Outcome measures
| Measure |
Compassion Meditation
n=48 Participants
10 week, group-based manualized compassion meditation training
|
Health Education
n=51 Participants
10 week, group-based manualized health education protocol
|
|---|---|---|
|
Clinical Global Impression Scale (CGI)
Baseline CGI-S
|
4.71 score on a scale
Standard Deviation .74
|
4.69 score on a scale
Standard Deviation .79
|
|
Clinical Global Impression Scale (CGI)
Posttreatment CGI-S
|
4.35 score on a scale
Standard Deviation .93
|
4.51 score on a scale
Standard Deviation .86
|
|
Clinical Global Impression Scale (CGI)
3-Month Follow-up CGI-S
|
4.16 score on a scale
Standard Deviation .89
|
4.13 score on a scale
Standard Deviation 1.11
|
SECONDARY outcome
Timeframe: Change from baseline to 3-month follow-upPopulation: All participants that completed baseline and posttreatment assessment are included in overall analysis population. Rows may differ from the total population due to missing data.
Self-report questionnaire; 5 items assessing global life satisfaction. Total scores range from 5 to 35, with higher scores indicating greater satisfaction with life.
Outcome measures
| Measure |
Compassion Meditation
n=48 Participants
10 week, group-based manualized compassion meditation training
|
Health Education
n=51 Participants
10 week, group-based manualized health education protocol
|
|---|---|---|
|
Satisfaction With Life Scale (SWLS)
Baseline SWLS
|
15.90 points on likert like scale
Standard Deviation 6.66
|
13.80 points on likert like scale
Standard Deviation 5.97
|
|
Satisfaction With Life Scale (SWLS)
Posttreatment SWLS
|
18.98 points on likert like scale
Standard Deviation 6.93
|
14.29 points on likert like scale
Standard Deviation 6.15
|
|
Satisfaction With Life Scale (SWLS)
3-Month Follow-up SWLS
|
18.60 points on likert like scale
Standard Deviation 6.8
|
16.21 points on likert like scale
Standard Deviation 7.05
|
SECONDARY outcome
Timeframe: Change from baseline to 3-month follow-upPopulation: All participants that completed baseline and posttreatment assessment are included in overall analysis population. Rows may differ from the total population due to missing data.
The physical component summary (PCS) measures physical health-related quality of life and is one of the summary scores derived from the Veterans SF-36. The PCS is a standardized T-score with an average of 50 and a standard deviation of 10 points. Higher PCS scores indicate better quality of life, and PCS scores of \< 50 indicate health quality of life below national norms.
Outcome measures
| Measure |
Compassion Meditation
n=48 Participants
10 week, group-based manualized compassion meditation training
|
Health Education
n=51 Participants
10 week, group-based manualized health education protocol
|
|---|---|---|
|
Veterans SF-36 PCS
3-Month Follow-up VR-36 PCS
|
23.71 T-Score
Standard Deviation 13.67
|
20.99 T-Score
Standard Deviation 14.88
|
|
Veterans SF-36 PCS
Baseline VR-36 PCS
|
22.05 T-Score
Standard Deviation 15.68
|
19.71 T-Score
Standard Deviation 11.93
|
|
Veterans SF-36 PCS
Posttreatment VR-36 PCS
|
24.18 T-Score
Standard Deviation 15.30
|
21.55 T-Score
Standard Deviation 13.45
|
SECONDARY outcome
Timeframe: Change from baseline to 3-month follow-upPopulation: All participants that completed baseline and posttreatment assessment are included in overall analysis population. Rows may differ from the total population due to missing data.
The mental component summary (MCS) measures mental health-related quality of life and is one of the summary scores derived from the Veterans SF-36. The MCS is a standardized T-score with an average of 50 and a standard deviation of 10 points. Higher MCS scores indicate better quality of life, and MCS scores of \< 50 indicate health quality of life below national norms.
Outcome measures
| Measure |
Compassion Meditation
n=48 Participants
10 week, group-based manualized compassion meditation training
|
Health Education
n=51 Participants
10 week, group-based manualized health education protocol
|
|---|---|---|
|
Veterans SF-36 MCS
Baseline VR-36 MCS
|
33.35 T-Score
Standard Deviation 8.38
|
34.31 T-Score
Standard Deviation 9.24
|
|
Veterans SF-36 MCS
Posttreatment VR-36 MCS
|
37.91 T-Score
Standard Deviation 8.73
|
35.27 T-Score
Standard Deviation 8.60
|
|
Veterans SF-36 MCS
3-Month Follow-up VR-36 MCS
|
37.85 T-Score
Standard Deviation 8.88
|
35.44 T-Score
Standard Deviation 11.05
|
Adverse Events
Compassion Meditation
Health Education
Serious adverse events
| Measure |
Compassion Meditation
n=75 participants at risk
10 week, group-based manualized compassion meditation training
|
Health Education
n=67 participants at risk
10 week, group-based manualized health education protocol
|
|---|---|---|
|
Psychiatric disorders
psychiatric disorders
|
1.3%
1/75 • from enrollment until end of follow-up, approximately nine months
|
0.00%
0/67 • from enrollment until end of follow-up, approximately nine months
|
|
General disorders
general disorders that affect more than one system
|
2.7%
2/75 • from enrollment until end of follow-up, approximately nine months
|
0.00%
0/67 • from enrollment until end of follow-up, approximately nine months
|
Other adverse events
| Measure |
Compassion Meditation
n=75 participants at risk
10 week, group-based manualized compassion meditation training
|
Health Education
n=67 participants at risk
10 week, group-based manualized health education protocol
|
|---|---|---|
|
Infections and infestations
Symptoms of illness, including cold, flu and COVID-19
|
9.3%
7/75 • from enrollment until end of follow-up, approximately nine months
|
6.0%
4/67 • from enrollment until end of follow-up, approximately nine months
|
|
Psychiatric disorders
emotional distress
|
5.3%
4/75 • from enrollment until end of follow-up, approximately nine months
|
10.4%
7/67 • from enrollment until end of follow-up, approximately nine months
|
|
Musculoskeletal and connective tissue disorders
joint pain
|
6.7%
5/75 • from enrollment until end of follow-up, approximately nine months
|
1.5%
1/67 • from enrollment until end of follow-up, approximately nine months
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
4.0%
3/75 • from enrollment until end of follow-up, approximately nine months
|
9.0%
6/67 • from enrollment until end of follow-up, approximately nine months
|
|
General disorders
pain
|
5.3%
4/75 • from enrollment until end of follow-up, approximately nine months
|
9.0%
6/67 • from enrollment until end of follow-up, approximately nine months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place