Trial Outcomes & Findings for Mindfulness for Pain and Suicide (NCT NCT05286112)
NCT ID: NCT05286112
Last Updated: 2026-08-25
Results Overview
Pain interference was measured using the Brief Pain Inventory. Scores range from 0 to 10 with higher scores indicating greater pain-related interference in activities. Data are from the 6-month follow-up assessment.
COMPLETED
NA
76 participants
baseline to 6 months post-treatment follow-up
2026-08-25
Participant Flow
Potential participants were recruited through a case finding procedure of VHA medical records.
Potential participants were screened for eligibility, consented (if eligible and interested), and completed a baseline assessment.
Participant milestones
| Measure |
Mindfulness-Based Cognitive Therapy (MBCT)
MBCT delivered over the course of 10, \~60 minute weekly sessions
|
Health Education
Health education sessions delivered over the course of 10, \~60 minute weekly sessions
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
38
|
|
Overall Study
COMPLETED
|
26
|
25
|
|
Overall Study
NOT COMPLETED
|
12
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mindfulness for Pain and Suicide
Baseline characteristics by cohort
| Measure |
Mindfulness-Based Cognitive Therapy (MBCT)
n=38 Participants
MBCT delivered over the course of 10, \~60 minute weekly sessions
|
Health Education
n=38 Participants
Health education sessions delivered over the course of 10, \~60 minute weekly sessions
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.4 years
STANDARD_DEVIATION 14.3 • n=31 Participants
|
51.2 years
STANDARD_DEVIATION 14.4 • n=49 Participants
|
53.3 years
STANDARD_DEVIATION 14.4 • n=80 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=31 Participants
|
14 Participants
n=49 Participants
|
30 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=31 Participants
|
24 Participants
n=49 Participants
|
46 Participants
n=80 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=31 Participants
|
1 Participants
n=49 Participants
|
1 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=31 Participants
|
5 Participants
n=49 Participants
|
10 Participants
n=80 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=31 Participants
|
30 Participants
n=49 Participants
|
58 Participants
n=80 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=31 Participants
|
1 Participants
n=49 Participants
|
1 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=31 Participants
|
1 Participants
n=49 Participants
|
6 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=31 Participants
|
3 Participants
n=49 Participants
|
5 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=31 Participants
|
35 Participants
n=49 Participants
|
71 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Suicidal ideation intensity
|
1.61 score on a scale
STANDARD_DEVIATION 1.1 • n=31 Participants
|
2.22 score on a scale
STANDARD_DEVIATION 1.34 • n=49 Participants
|
1.91 score on a scale
STANDARD_DEVIATION 1.25 • n=80 Participants
|
|
Depression
|
19.7 scores on a scale
STANDARD_DEVIATION 7.5 • n=31 Participants
|
20.5 scores on a scale
STANDARD_DEVIATION 6.7 • n=49 Participants
|
20.1 scores on a scale
STANDARD_DEVIATION 7.1 • n=80 Participants
|
|
Interpersonal needs
|
41.6 scores on a scale
STANDARD_DEVIATION 14.9 • n=31 Participants
|
50.8 scores on a scale
STANDARD_DEVIATION 14.0 • n=49 Participants
|
46.1 scores on a scale
STANDARD_DEVIATION 15.1 • n=80 Participants
|
|
Pain interference
|
6.5 scores on a scale
STANDARD_DEVIATION 2.0 • n=31 Participants
|
7.1 scores on a scale
STANDARD_DEVIATION 1.8 • n=49 Participants
|
6.8 scores on a scale
STANDARD_DEVIATION 1.9 • n=80 Participants
|
|
Physical health-related quality of life
|
29.1 scores on a scale
STANDARD_DEVIATION 12.4 • n=31 Participants
|
26.7 scores on a scale
STANDARD_DEVIATION 10.8 • n=49 Participants
|
27.9 scores on a scale
STANDARD_DEVIATION 11.6 • n=80 Participants
|
|
Mental health-related quality of life
|
28.9 scores on a scale
STANDARD_DEVIATION 10.8 • n=31 Participants
|
27.3 scores on a scale
STANDARD_DEVIATION 12.5 • n=49 Participants
|
28.1 scores on a scale
STANDARD_DEVIATION 11.6 • n=80 Participants
|
|
Pain intensity
|
5.6 scores on a scale
STANDARD_DEVIATION 1.3 • n=31 Participants
|
6.0 scores on a scale
STANDARD_DEVIATION 1.4 • n=49 Participants
|
5.8 scores on a scale
STANDARD_DEVIATION 1.3 • n=80 Participants
|
|
Mindfulness
|
108.3 scores on a scale
STANDARD_DEVIATION 16.5 • n=31 Participants
|
116.0 scores on a scale
STANDARD_DEVIATION 14.9 • n=49 Participants
|
112.1 scores on a scale
STANDARD_DEVIATION 16.1 • n=80 Participants
|
|
Pain acceptance
|
21.8 Scores on a scale
STANDARD_DEVIATION 11.5 • n=31 Participants
|
21.1 Scores on a scale
STANDARD_DEVIATION 9.6 • n=49 Participants
|
21.4 Scores on a scale
STANDARD_DEVIATION 10.5 • n=80 Participants
|
|
Pain catastrophizing
|
30.6 Scores on a scale
STANDARD_DEVIATION 11.1 • n=31 Participants
|
33.4 Scores on a scale
STANDARD_DEVIATION 9.7 • n=49 Participants
|
32.0 Scores on a scale
STANDARD_DEVIATION 10.4 • n=80 Participants
|
|
Fear of movement
|
44.7 Scores on a scale
STANDARD_DEVIATION 6.8 • n=31 Participants
|
44.8 Scores on a scale
STANDARD_DEVIATION 6.7 • n=49 Participants
|
44.8 Scores on a scale
STANDARD_DEVIATION 6.7 • n=80 Participants
|
PRIMARY outcome
Timeframe: 1-month post-treatmentPopulation: Data collected at 1-month follow-up when there was more missing data than at study completion.
The Abbreviated Acceptability Rating Profile assesses the extent to which participants agree with 8 statements about the intervention. Scores range from 1 to 6 with higher scores indicating higher acceptability. Data are from the 1-month follow-up assessment.
Outcome measures
| Measure |
Mindfulness-Based Cognitive Therapy (MBCT)
n=21 Participants
MBCT delivered over the course of 10, \~60 minute sessions
|
Health Education
n=22 Participants
Health education sessions delivered over the course of 10, \~60 minute sessions
|
|---|---|---|
|
Treatment Acceptability
|
4.7 scores on a scale
Standard Deviation 1.4
|
4.3 scores on a scale
Standard Deviation 1.6
|
PRIMARY outcome
Timeframe: 6-month post treatment follow-upSuicide ideation intensity will be assessed using the Columbia Suicide Severity Rating Scale Ideation intensity subscale. Scores range from 2 to 25 with higher scores indicating greater intensity of ideation. Data are from the 6-month follow-up assessment.
Outcome measures
| Measure |
Mindfulness-Based Cognitive Therapy (MBCT)
n=26 Participants
MBCT delivered over the course of 10, \~60 minute sessions
|
Health Education
n=25 Participants
Health education sessions delivered over the course of 10, \~60 minute sessions
|
|---|---|---|
|
Suicidal Ideation Intensity
|
8.93 scores on a scale
Standard Deviation 9.27
|
9.92 scores on a scale
Standard Deviation 6.05
|
PRIMARY outcome
Timeframe: 6 months post-treatment follow-upPopulation: 1 additional participant did not complete the PHQ-9 in the Health Education condition.
The Patient Health Questionnaire-9 was used to assess depression symptoms. Scores range from 0 to 27 with higher scores indicating greater severity of depression. Data are from the 6-month follow-up assessment.
Outcome measures
| Measure |
Mindfulness-Based Cognitive Therapy (MBCT)
n=26 Participants
MBCT delivered over the course of 10, \~60 minute sessions
|
Health Education
n=24 Participants
Health education sessions delivered over the course of 10, \~60 minute sessions
|
|---|---|---|
|
Depression
|
14.6 scores on a scale
Standard Deviation 6.9
|
18.5 scores on a scale
Standard Deviation 8.6
|
PRIMARY outcome
Timeframe: 6-months post-treatment follow-upPopulation: 2 additional participants with missing data in the Health Education condition.
The Interpersonal Needs Questionnaire was used to assessed interpersonal needs. Scores range from 12 to 84 with higher scores indicating greater conflict with interpersonal needs. Data are from the 6-month follow-up assessment.
Outcome measures
| Measure |
Mindfulness-Based Cognitive Therapy (MBCT)
n=26 Participants
MBCT delivered over the course of 10, \~60 minute sessions
|
Health Education
n=23 Participants
Health education sessions delivered over the course of 10, \~60 minute sessions
|
|---|---|---|
|
Interpersonal Needs
|
35.81 scores on a scale
Standard Deviation 17.0
|
36.2 scores on a scale
Standard Deviation 17.0
|
PRIMARY outcome
Timeframe: baseline to 6 months post-treatment follow-upPain interference was measured using the Brief Pain Inventory. Scores range from 0 to 10 with higher scores indicating greater pain-related interference in activities. Data are from the 6-month follow-up assessment.
Outcome measures
| Measure |
Mindfulness-Based Cognitive Therapy (MBCT)
n=26 Participants
MBCT delivered over the course of 10, \~60 minute sessions
|
Health Education
n=25 Participants
Health education sessions delivered over the course of 10, \~60 minute sessions
|
|---|---|---|
|
Pain Interference
|
5.4 scores on a scale
Standard Deviation 2.2
|
6.2 scores on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: 6 months post-treatment follow-upPopulation: 1 additional participant with missing data from the Health Education condition.
The Veterans Rand (VR)-12 was used to assess physical health-related quality of life. Scores fall between 20 and 60 in clinical populations with higher scores indicating higher physical health-related quality of life. Data are from the 6-month follow-up assessment.
Outcome measures
| Measure |
Mindfulness-Based Cognitive Therapy (MBCT)
n=26 Participants
MBCT delivered over the course of 10, \~60 minute sessions
|
Health Education
n=24 Participants
Health education sessions delivered over the course of 10, \~60 minute sessions
|
|---|---|---|
|
Physical Health-related Quality of Life
|
28.6 scores on a scale
Standard Deviation 10.9
|
28.7 scores on a scale
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: baseline to 6 months post-treatment follow-upPopulation: On additional participant with missing data from the MBCT condition.
Pain intensity was assessed using the Brief Pain Inventory Pain Severity subscale. Scores range from 0 to 10 with higher scores indicating more severe pain intensity. Data are from the 6-month follow-up assessment.
Outcome measures
| Measure |
Mindfulness-Based Cognitive Therapy (MBCT)
n=25 Participants
MBCT delivered over the course of 10, \~60 minute sessions
|
Health Education
n=25 Participants
Health education sessions delivered over the course of 10, \~60 minute sessions
|
|---|---|---|
|
Pain Intensity
|
5.4 scores on a scale
Standard Deviation 1.6
|
5.8 scores on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 6-months post treatment assessmentPopulation: One additional participant with missing data from the Health Education condition
The Veterans Rand (VR)-12 was used to assess mental health-related quality of life. Scores fall between 20 and 60 in clinical populations with higher scores indicating higher mental health-related quality of life. Data are from the 6-month follow-up assessment.
Outcome measures
| Measure |
Mindfulness-Based Cognitive Therapy (MBCT)
n=26 Participants
MBCT delivered over the course of 10, \~60 minute sessions
|
Health Education
n=24 Participants
Health education sessions delivered over the course of 10, \~60 minute sessions
|
|---|---|---|
|
Mental Health-related Quality of Life
|
37.4 scores on a scale
Standard Deviation 11.7
|
30.7 scores on a scale
Standard Deviation 11.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months post-treatment follow-upPopulation: One additional participant in the Health Education condition had missing data.
We used the Five Facet Mindfulness Questionnaire (FFMQ) to assess mindfulness. Scores range from 39 to 195 with higher scores indicating higher mindfulness. Data are from the 6-month follow-up assessment.
Outcome measures
| Measure |
Mindfulness-Based Cognitive Therapy (MBCT)
n=26 Participants
MBCT delivered over the course of 10, \~60 minute sessions
|
Health Education
n=24 Participants
Health education sessions delivered over the course of 10, \~60 minute sessions
|
|---|---|---|
|
Mindfulness
|
125 scores on a scale
Standard Deviation 21.0
|
112.3 scores on a scale
Standard Deviation 15.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months post-treatment follow-upPopulation: One additional participant with missing data from the Health Education condition
Pain acceptance was assessed using the Chronic Pain Acceptance Questionnaire (CPAQ) scores range from 0 to 120 with higher scores indicating greater acceptance of pain with higher scores indicating greater pain acceptance.
Outcome measures
| Measure |
Mindfulness-Based Cognitive Therapy (MBCT)
n=26 Participants
MBCT delivered over the course of 10, \~60 minute sessions
|
Health Education
n=24 Participants
Health education sessions delivered over the course of 10, \~60 minute sessions
|
|---|---|---|
|
Pain Acceptance
|
25.8 scores on a scale
Standard Deviation 10.7
|
23.08 scores on a scale
Standard Deviation 9.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline to 6 months post-treatment follow-upPopulation: One additional participant with missing data in the Health Education condition.
Pain catastrophizing was assessed using the Pain Catastrophizing Scale (PCS). Scores range from 0 to 52 with higher scores indicate greater pain catastrophizing. Data are from the 6-month follow-up assessment.
Outcome measures
| Measure |
Mindfulness-Based Cognitive Therapy (MBCT)
n=26 Participants
MBCT delivered over the course of 10, \~60 minute sessions
|
Health Education
n=24 Participants
Health education sessions delivered over the course of 10, \~60 minute sessions
|
|---|---|---|
|
Pain Catastrophizing
|
25.6 scores on a scale
Standard Deviation 8.6
|
30.6 scores on a scale
Standard Deviation 9.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline to 6 months post-treatment follow-upPopulation: 6 additional participants had missing data, 2 from the MBCT condition and 4 from Health Education.
Fear of movement due to pain will be measured using the Tampa Scale of Kinesiophobia. The scores range from 17-68 with higher scores indicating indicating greater fear of movement. Data are from the 6-month follow-up assessment.
Outcome measures
| Measure |
Mindfulness-Based Cognitive Therapy (MBCT)
n=24 Participants
MBCT delivered over the course of 10, \~60 minute sessions
|
Health Education
n=21 Participants
Health education sessions delivered over the course of 10, \~60 minute sessions
|
|---|---|---|
|
Fear of Movement
|
43.9 scores on a scale
Standard Deviation 6.3
|
45.9 scores on a scale
Standard Deviation 6.8
|
Adverse Events
Mindfulness-Based Cognitive Therapy (MBCT)
Health Education
Serious adverse events
| Measure |
Mindfulness-Based Cognitive Therapy (MBCT)
n=38 participants at risk
MBCT delivered over the course of 10, \~60 minute weekly sessions
|
Health Education
n=38 participants at risk
Health education sessions delivered over the course of 10, \~60 minute weekly sessions
|
|---|---|---|
|
Psychiatric disorders
Hospitalization associated with significant psychiatric distress
|
5.3%
2/38 • Number of events 2 • Baseline until end of follow-up, up to 6 months post-treatment
|
5.3%
2/38 • Number of events 2 • Baseline until end of follow-up, up to 6 months post-treatment
|
|
Cardiac disorders
Cardiac related hospitalization
|
7.9%
3/38 • Number of events 3 • Baseline until end of follow-up, up to 6 months post-treatment
|
2.6%
1/38 • Number of events 1 • Baseline until end of follow-up, up to 6 months post-treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization related to respiratory system
|
2.6%
1/38 • Number of events 2 • Baseline until end of follow-up, up to 6 months post-treatment
|
0.00%
0/38 • Baseline until end of follow-up, up to 6 months post-treatment
|
|
Gastrointestinal disorders
Hospitalization associated with digestive system
|
2.6%
1/38 • Number of events 1 • Baseline until end of follow-up, up to 6 months post-treatment
|
2.6%
1/38 • Number of events 1 • Baseline until end of follow-up, up to 6 months post-treatment
|
|
Metabolism and nutrition disorders
Hospitalization related to metabolism disorder
|
0.00%
0/38 • Baseline until end of follow-up, up to 6 months post-treatment
|
5.3%
2/38 • Number of events 3 • Baseline until end of follow-up, up to 6 months post-treatment
|
|
Injury, poisoning and procedural complications
Hospitalization from an injury
|
0.00%
0/38 • Baseline until end of follow-up, up to 6 months post-treatment
|
2.6%
1/38 • Number of events 1 • Baseline until end of follow-up, up to 6 months post-treatment
|
|
Blood and lymphatic system disorders
Hospitalization due to blood clots
|
0.00%
0/38 • Baseline until end of follow-up, up to 6 months post-treatment
|
2.6%
1/38 • Number of events 1 • Baseline until end of follow-up, up to 6 months post-treatment
|
Other adverse events
| Measure |
Mindfulness-Based Cognitive Therapy (MBCT)
n=38 participants at risk
MBCT delivered over the course of 10, \~60 minute weekly sessions
|
Health Education
n=38 participants at risk
Health education sessions delivered over the course of 10, \~60 minute weekly sessions
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory related emergency department visit
|
10.5%
4/38 • Number of events 4 • Baseline until end of follow-up, up to 6 months post-treatment
|
5.3%
2/38 • Number of events 3 • Baseline until end of follow-up, up to 6 months post-treatment
|
|
Eye disorders
emergency dept visit associated with visual problems
|
2.6%
1/38 • Number of events 1 • Baseline until end of follow-up, up to 6 months post-treatment
|
0.00%
0/38 • Baseline until end of follow-up, up to 6 months post-treatment
|
|
Psychiatric disorders
Increased psychiatric distress
|
15.8%
6/38 • Number of events 10 • Baseline until end of follow-up, up to 6 months post-treatment
|
18.4%
7/38 • Number of events 7 • Baseline until end of follow-up, up to 6 months post-treatment
|
|
Nervous system disorders
Migraines
|
2.6%
1/38 • Number of events 1 • Baseline until end of follow-up, up to 6 months post-treatment
|
0.00%
0/38 • Baseline until end of follow-up, up to 6 months post-treatment
|
|
Injury, poisoning and procedural complications
Injury
|
2.6%
1/38 • Number of events 1 • Baseline until end of follow-up, up to 6 months post-treatment
|
10.5%
4/38 • Number of events 5 • Baseline until end of follow-up, up to 6 months post-treatment
|
|
Musculoskeletal and connective tissue disorders
Increased musculoskeletal pain
|
2.6%
1/38 • Number of events 1 • Baseline until end of follow-up, up to 6 months post-treatment
|
5.3%
2/38 • Number of events 2 • Baseline until end of follow-up, up to 6 months post-treatment
|
|
Cardiac disorders
Cardiac related emergency department visit
|
5.3%
2/38 • Number of events 2 • Baseline until end of follow-up, up to 6 months post-treatment
|
2.6%
1/38 • Number of events 1 • Baseline until end of follow-up, up to 6 months post-treatment
|
|
Renal and urinary disorders
Urinary issues leading to emergency department visit
|
0.00%
0/38 • Baseline until end of follow-up, up to 6 months post-treatment
|
2.6%
1/38 • Number of events 1 • Baseline until end of follow-up, up to 6 months post-treatment
|
|
Gastrointestinal disorders
Gastrointestinal problems leading to emergency dept
|
0.00%
0/38 • Baseline until end of follow-up, up to 6 months post-treatment
|
13.2%
5/38 • Number of events 5 • Baseline until end of follow-up, up to 6 months post-treatment
|
|
Infections and infestations
Infection leading to emergency department visit
|
0.00%
0/38 • Baseline until end of follow-up, up to 6 months post-treatment
|
5.3%
2/38 • Number of events 3 • Baseline until end of follow-up, up to 6 months post-treatment
|
|
Blood and lymphatic system disorders
Blood or lymphatic issues leading to an emergency department visit
|
0.00%
0/38 • Baseline until end of follow-up, up to 6 months post-treatment
|
5.3%
2/38 • Number of events 3 • Baseline until end of follow-up, up to 6 months post-treatment
|
|
Skin and subcutaneous tissue disorders
Skin-related emergency department visit
|
0.00%
0/38 • Baseline until end of follow-up, up to 6 months post-treatment
|
5.3%
2/38 • Number of events 2 • Baseline until end of follow-up, up to 6 months post-treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/38 • Baseline until end of follow-up, up to 6 months post-treatment
|
2.6%
1/38 • Number of events 1 • Baseline until end of follow-up, up to 6 months post-treatment
|
Additional Information
Lisham Ashrafioun
VA Center of Excellence for Suicide Prevention
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place