Trial Outcomes & Findings for An Evaluation of MBSR and CBT for Veterans With Chronic Pain (NCT NCT04486066)
NCT ID: NCT04486066
Last Updated: 2025-06-25
Results Overview
The primary outcome is the Brief Pain Inventory Short Form Interference subscale (BPI). This is a 7-item scale that assesses the extent to which pain interferes with activities in daily life, such as general activity, mood, walking ability, work, relations with other people, sleep, and enjoyment of life. Scores range from 0 to 10 with higher scores indicating greater pain interference.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
217 participants
Primary outcome timeframe
Baseline, Immediate post-treatment, 6 months after completing treatment
Results posted on
2025-06-25
Participant Flow
Participant milestones
| Measure |
Mindfulness-Based Stress Reduction (MBSR)
In MBSR, participants meet for 2 hours per week for 8 weeks in a video group format and receive instruction in mindfulness meditation according to a standardized curriculum, are given daily homework, participate in group discussions, and can ask questions.
Mindfulness-Based Stress Reduction: In MBSR, participants meet by video for 2 hours per week for 8 weeks in a group format and receive instruction in mindfulness meditation according to a standardized curriculum, are given daily homework, participate in group discussions, and can ask questions.
|
Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)
Cognitive Behavioral Therapy (CBT) is the most widely used non-pharmacologic intervention for chronic pain and a version of CBT specifically addressing chronic pain (CBT-CP) has been developed for use in VA with Veterans. Fundamentally, CBT is an approach that seeks to ameliorate dysfunctional relationships between an individual's thoughts, feelings, and behaviors to improve functioning and quality of life. At our site, the CBT-CP format has been adapted for clinical use (i.e., as part of usual clinical care) to 8 sessions in a video group format, while retaining all essential elements.
Cognitive Behavioral Therapy for Chronic Pain: Cognitive Behavioral Therapy (CBT) is the most widely used non-pharmacologic intervention for chronic pain and a version of CBT specifically addressing chronic pain (CBT-CP) has been developed for use in VA with Veterans. Fundamentally, CBT is an approach that seeks to ameliorate dysfunctional relationships between an individual's thoughts, feelings, and behaviors to improve functioning and quality of life. At our site, the CBT-CP format has been adapted for clinical use (i.e., as part of usual clinical care) to 8 video sessions in a group format, while retaining all essential elements.
|
Usual Care
Veterans randomized to usual care will continue to be followed by their usual care providers for all medical and mental health care. This can include continued use of medications, specialty referrals and other usual elements of care. They will be asked to not enroll in the specific MBSR or CBT-CP interventions during the 8-month study period, but can attend other groups interventions, such as CBT-Insomnia, Acceptance and Commitment Therapy for Chronic Pain, and other groups for chronic pain and PTSD as directed by their treating providers. They can also enroll in MBSR or CBT-CP at the completion of the study.
Usual Care: Veterans randomized to usual care will continue to be followed by their usual care providers for all medical and mental health care. This can include continued use of medications, specialty referrals and other usual elements of care. They will be asked to not enroll in the specific MBSR or CBT-CP interventions during the 8-month study period, but can attend other groups interventions, such as CBT-Insomnia, Acceptance and Commitment Therapy for Chronic Pain, and other groups for chronic pain and PTSD as directed by their treating providers. They can also enroll in MBSR or CBT-CP at the completion of the study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
75
|
71
|
71
|
|
Overall Study
Completed Treatment
|
48
|
55
|
0
|
|
Overall Study
Post-treatment Assessment
|
68
|
68
|
70
|
|
Overall Study
COMPLETED
|
66
|
65
|
69
|
|
Overall Study
NOT COMPLETED
|
9
|
6
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Evaluation of MBSR and CBT for Veterans With Chronic Pain
Baseline characteristics by cohort
| Measure |
Mindfulness-Based Stress Reduction (MBSR)
n=75 Participants
In MBSR, participants meet for 2 hours per week for 8 weeks in a video group format and receive instruction in mindfulness meditation according to a standardized curriculum, are given daily homework, participate in group discussions, and can ask questions.
Mindfulness-Based Stress Reduction: In MBSR, participants meet by video for 2 hours per week for 8 weeks in a group format and receive instruction in mindfulness meditation according to a standardized curriculum, are given daily homework, participate in group discussions, and can ask questions.
|
Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)
n=71 Participants
Cognitive Behavioral Therapy (CBT) is the most widely used non-pharmacologic intervention for chronic pain and a version of CBT specifically addressing chronic pain (CBT-CP) has been developed for use in VA with Veterans. Fundamentally, CBT is an approach that seeks to ameliorate dysfunctional relationships between an individual's thoughts, feelings, and behaviors to improve functioning and quality of life. At our site, the CBT-CP format has been adapted for clinical use (i.e., as part of usual clinical care) to 8 sessions in a video group format, while retaining all essential elements.
Cognitive Behavioral Therapy for Chronic Pain: Cognitive Behavioral Therapy (CBT) is the most widely used non-pharmacologic intervention for chronic pain and a version of CBT specifically addressing chronic pain (CBT-CP) has been developed for use in VA with Veterans. Fundamentally, CBT is an approach that seeks to ameliorate dysfunctional relationships between an individual's thoughts, feelings, and behaviors to improve functioning and quality of life. At our site, the CBT-CP format has been adapted for clinical use (i.e., as part of usual clinical care) to 8 video sessions in a group format, while retaining all essential elements.
|
Usual Care
n=71 Participants
Veterans randomized to usual care will continue to be followed by their usual care providers for all medical and mental health care. This can include continued use of medications, specialty referrals and other usual elements of care. They will be asked to not enroll in the specific MBSR or CBT-CP interventions during the 8-month study period, but can attend other groups interventions, such as CBT-Insomnia, Acceptance and Commitment Therapy for Chronic Pain, and other groups for chronic pain and PTSD as directed by their treating providers. They can also enroll in MBSR or CBT-CP at the completion of the study.
Usual Care: Veterans randomized to usual care will continue to be followed by their usual care providers for all medical and mental health care. This can include continued use of medications, specialty referrals and other usual elements of care. They will be asked to not enroll in the specific MBSR or CBT-CP interventions during the 8-month study period, but can attend other groups interventions, such as CBT-Insomnia, Acceptance and Commitment Therapy for Chronic Pain, and other groups for chronic pain and PTSD as directed by their treating providers. They can also enroll in MBSR or CBT-CP at the completion of the study.
|
Total
n=217 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
116 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
37 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
101 Participants
n=4 Participants
|
|
Age, Continuous
|
61.3 years
STANDARD_DEVIATION 14.9 • n=5 Participants
|
60.8 years
STANDARD_DEVIATION 13.9 • n=7 Participants
|
61.0 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
61.0 years
STANDARD_DEVIATION 13.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
177 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
71 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
197 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
142 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Immediate post-treatment, 6 months after completing treatmentPopulation: Some participants did not complete the post-treatment and 6-month follow-up assessments. The main analyses that will be shared in publication are intent-to-treat but the means below reflect only those with complete data.
The primary outcome is the Brief Pain Inventory Short Form Interference subscale (BPI). This is a 7-item scale that assesses the extent to which pain interferes with activities in daily life, such as general activity, mood, walking ability, work, relations with other people, sleep, and enjoyment of life. Scores range from 0 to 10 with higher scores indicating greater pain interference.
Outcome measures
| Measure |
Mindfulness-Based Stress Reduction (MBSR)
n=75 Participants
In MBSR, participants meet for 2 hours per week for 8 weeks in a video group format and receive instruction in mindfulness meditation according to a standardized curriculum, are given daily homework, participate in group discussions, and can ask questions.
Mindfulness-Based Stress Reduction: In MBSR, participants meet by video for 2 hours per week for 8 weeks in a group format and receive instruction in mindfulness meditation according to a standardized curriculum, are given daily homework, participate in group discussions, and can ask questions.
|
Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)
n=71 Participants
Cognitive Behavioral Therapy (CBT) is the most widely used non-pharmacologic intervention for chronic pain and a version of CBT specifically addressing chronic pain (CBT-CP) has been developed for use in VA with Veterans. Fundamentally, CBT is an approach that seeks to ameliorate dysfunctional relationships between an individual's thoughts, feelings, and behaviors to improve functioning and quality of life. At our site, the CBT-CP format has been adapted for clinical use (i.e., as part of usual clinical care) to 8 sessions in a video group format, while retaining all essential elements.
Cognitive Behavioral Therapy for Chronic Pain: Cognitive Behavioral Therapy (CBT) is the most widely used non-pharmacologic intervention for chronic pain and a version of CBT specifically addressing chronic pain (CBT-CP) has been developed for use in VA with Veterans. Fundamentally, CBT is an approach that seeks to ameliorate dysfunctional relationships between an individual's thoughts, feelings, and behaviors to improve functioning and quality of life. At our site, the CBT-CP format has been adapted for clinical use (i.e., as part of usual clinical care) to 8 video sessions in a group format, while retaining all essential elements.
|
Usual Care
n=71 Participants
Veterans randomized to usual care will continue to be followed by their usual care providers for all medical and mental health care. This can include continued use of medications, specialty referrals and other usual elements of care. They will be asked to not enroll in the specific MBSR or CBT-CP interventions during the 8-month study period, but can attend other groups interventions, such as CBT-Insomnia, Acceptance and Commitment Therapy for Chronic Pain, and other groups for chronic pain and PTSD as directed by their treating providers. They can also enroll in MBSR or CBT-CP at the completion of the study.
Usual Care: Veterans randomized to usual care will continue to be followed by their usual care providers for all medical and mental health care. This can include continued use of medications, specialty referrals and other usual elements of care. They will be asked to not enroll in the specific MBSR or CBT-CP interventions during the 8-month study period, but can attend other groups interventions, such as CBT-Insomnia, Acceptance and Commitment Therapy for Chronic Pain, and other groups for chronic pain and PTSD as directed by their treating providers. They can also enroll in MBSR or CBT-CP at the completion of the study.
|
|---|---|---|---|
|
Pain Interference Subscale of Brief Pain Inventory (BPI)
Baseline
|
4.7 score on a scale
Standard Deviation 2.2
|
4.8 score on a scale
Standard Deviation 2.2
|
4.9 score on a scale
Standard Deviation 2.2
|
|
Pain Interference Subscale of Brief Pain Inventory (BPI)
Post-treatment
|
4.4 score on a scale
Standard Deviation 2.3
|
3.7 score on a scale
Standard Deviation 2.0
|
4.8 score on a scale
Standard Deviation 2.2
|
|
Pain Interference Subscale of Brief Pain Inventory (BPI)
6-month follow-up
|
4.4 score on a scale
Standard Deviation 2.6
|
3.8 score on a scale
Standard Deviation 2.2
|
4.9 score on a scale
Standard Deviation 2.5
|
Adverse Events
Mindfulness-Based Stress Reduction (MBSR)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mindfulness-Based Stress Reduction (MBSR)
n=75 participants at risk
In MBSR, participants meet for 2 hours per week for 8 weeks in a video group format and receive instruction in mindfulness meditation according to a standardized curriculum, are given daily homework, participate in group discussions, and can ask questions.
Mindfulness-Based Stress Reduction: In MBSR, participants meet by video for 2 hours per week for 8 weeks in a group format and receive instruction in mindfulness meditation according to a standardized curriculum, are given daily homework, participate in group discussions, and can ask questions.
|
Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)
n=71 participants at risk
Cognitive Behavioral Therapy (CBT) is the most widely used non-pharmacologic intervention for chronic pain and a version of CBT specifically addressing chronic pain (CBT-CP) has been developed for use in VA with Veterans. Fundamentally, CBT is an approach that seeks to ameliorate dysfunctional relationships between an individual's thoughts, feelings, and behaviors to improve functioning and quality of life. At our site, the CBT-CP format has been adapted for clinical use (i.e., as part of usual clinical care) to 8 sessions in a video group format, while retaining all essential elements.
Cognitive Behavioral Therapy for Chronic Pain: Cognitive Behavioral Therapy (CBT) is the most widely used non-pharmacologic intervention for chronic pain and a version of CBT specifically addressing chronic pain (CBT-CP) has been developed for use in VA with Veterans. Fundamentally, CBT is an approach that seeks to ameliorate dysfunctional relationships between an individual's thoughts, feelings, and behaviors to improve functioning and quality of life. At our site, the CBT-CP format has been adapted for clinical use (i.e., as part of usual clinical care) to 8 video sessions in a group format, while retaining all essential elements.
|
Usual Care
n=71 participants at risk
Veterans randomized to usual care will continue to be followed by their usual care providers for all medical and mental health care. This can include continued use of medications, specialty referrals and other usual elements of care. They will be asked to not enroll in the specific MBSR or CBT-CP interventions during the 8-month study period, but can attend other groups interventions, such as CBT-Insomnia, Acceptance and Commitment Therapy for Chronic Pain, and other groups for chronic pain and PTSD as directed by their treating providers. They can also enroll in MBSR or CBT-CP at the completion of the study.
Usual Care: Veterans randomized to usual care will continue to be followed by their usual care providers for all medical and mental health care. This can include continued use of medications, specialty referrals and other usual elements of care. They will be asked to not enroll in the specific MBSR or CBT-CP interventions during the 8-month study period, but can attend other groups interventions, such as CBT-Insomnia, Acceptance and Commitment Therapy for Chronic Pain, and other groups for chronic pain and PTSD as directed by their treating providers. They can also enroll in MBSR or CBT-CP at the completion of the study.
|
|---|---|---|---|
|
Infections and infestations
Hospitalization (not study related)
|
0.00%
0/75 • 9 months (baseline to 6-months post-treatment assessment)
Study definition conforms to clinicaltrials.gov definition
|
1.4%
1/71 • Number of events 1 • 9 months (baseline to 6-months post-treatment assessment)
Study definition conforms to clinicaltrials.gov definition
|
0.00%
0/71 • 9 months (baseline to 6-months post-treatment assessment)
Study definition conforms to clinicaltrials.gov definition
|
|
Cardiac disorders
Hospitalization (not study related)
|
1.3%
1/75 • Number of events 1 • 9 months (baseline to 6-months post-treatment assessment)
Study definition conforms to clinicaltrials.gov definition
|
0.00%
0/71 • 9 months (baseline to 6-months post-treatment assessment)
Study definition conforms to clinicaltrials.gov definition
|
0.00%
0/71 • 9 months (baseline to 6-months post-treatment assessment)
Study definition conforms to clinicaltrials.gov definition
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place