An interventional study of Mindfulness-Based Cognitive Therapy (MBCT) and Health Education in Chronic Pain, Suicidal Ideation and Suicide, Attempted, sponsored by Canandaigua VA Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Canandaigua VA Medical Center · Not applicable, Interventional, and Treatment
The proposed study will assess the feasibility and acceptability of a mindfulness-based intervention to reduce functional impairment from chronic pain and risk of suicide.
The investigators are seeking to develop a combined intervention, MBCT-S/P, to focus on both improving functioning and mitigating suicide risk in veterans with chronic pain. The investigators plan to test the new manual's feasibility and acceptability in a sample of veterans experiencing chronic pain and suicidal ideation. Participants will be randomized to either the MBCT-S/P condition (n=38) or the Education control condition (n=38) to assess additional aspects of study feasibility. The investigators also plan to assess a variety of clinical outcomes including suicidal ideation, pain interference in activities, and opioid use. Participants will complete questionnaires pre-treatment, and 1-, 3-, and 6-months post-treatment.
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
This study's enrollment of 76 is above the median of 60 across 2,388 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Canandaigua VA Medical Center is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MBCT delivered over the course of 10, \~60 minute sessions
Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)
Health education sessions delivered over the course of 10, \~60 minute sessions
Behavioral: Health Education
10 sessions focused on increasing mindfulness awareness to address thoughts, emotions, and behaviors that maintain functional impairment and risk of suicide.
Health education provides information on the importance and benefits of and guidelines for living a healthy lifestyle.
Treatment Acceptability
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.
Time frame: 1-month post-treatment
Suicidal Ideation Intensity
Suicide 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.
Time frame: 6-month post treatment follow-up
Depression
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.
Time frame: 6 months post-treatment follow-up
Interpersonal Needs
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.
Time frame: 6-months post-treatment follow-up
Pain Interference
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.
Time frame: baseline to 6 months post-treatment follow-up
Physical Health-related Quality of Life
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.
Time frame: 6 months post-treatment follow-up
Pain Intensity
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.
Time frame: baseline to 6 months post-treatment follow-up
Mental Health-related Quality of Life
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.
Time frame: 6-months post treatment assessment
Mindfulness
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.
Time frame: 6 months post-treatment follow-up
Pain Acceptance
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.
Time frame: 6 months post-treatment follow-up
Pain Catastrophizing
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.
Time frame: baseline to 6 months post-treatment follow-up
Fear of Movement
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.
Time frame: baseline to 6 months post-treatment follow-up
Potential participants were recruited through a case finding procedure of VHA medical records.
| Milestone | Mindfulness-Based Cognitive Therapy (MBCT) | Health Education |
|---|---|---|
| Started | 38 | 38 |
| Completed | 26 | 25 |
| Not completed | 12 | 13 |
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.
| scores on a scale | Mindfulness-Based Cognitive Therapy (MBCT) | Health Education |
|---|---|---|
| Treatment Acceptability | 4.7 ± 1.4 | 4.3 ± 1.6 |
Suicide 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.
| scores on a scale | Mindfulness-Based Cognitive Therapy (MBCT) | Health Education |
|---|---|---|
| Suicidal Ideation Intensity | 8.93 ± 9.27 | 9.92 ± 6.05 |
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.
| scores on a scale | Mindfulness-Based Cognitive Therapy (MBCT) | Health Education |
|---|---|---|
| Depression | 14.6 ± 6.9 | 18.5 ± 8.6 |
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.
| scores on a scale | Mindfulness-Based Cognitive Therapy (MBCT) | Health Education |
|---|---|---|
| Interpersonal Needs | 35.81 ± 17.0 | 36.2 ± 17.0 |
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.
| scores on a scale | Mindfulness-Based Cognitive Therapy (MBCT) | Health Education |
|---|---|---|
| Pain Interference | 5.4 ± 2.2 | 6.2 ± 2.4 |
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.
| scores on a scale | Mindfulness-Based Cognitive Therapy (MBCT) | Health Education |
|---|---|---|
| Physical Health-related Quality of Life | 28.6 ± 10.9 | 28.7 ± 11.6 |
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.
| scores on a scale | Mindfulness-Based Cognitive Therapy (MBCT) | Health Education |
|---|---|---|
| Mindfulness | 125 ± 21.0 | 112.3 ± 15.3 |
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.
| scores on a scale | Mindfulness-Based Cognitive Therapy (MBCT) | Health Education |
|---|---|---|
| Pain Acceptance | 25.8 ± 10.7 | 23.08 ± 9.6 |
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.
| scores on a scale | Mindfulness-Based Cognitive Therapy (MBCT) | Health Education |
|---|---|---|
| Pain Catastrophizing | 25.6 ± 8.6 | 30.6 ± 9.9 |
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.
| scores on a scale | Mindfulness-Based Cognitive Therapy (MBCT) | Health Education |
|---|---|---|
| Pain Intensity | 5.4 ± 1.6 | 5.8 ± 1.2 |
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.
| scores on a scale | Mindfulness-Based Cognitive Therapy (MBCT) | Health Education |
|---|---|---|
| Fear of Movement | 43.9 ± 6.3 | 45.9 ± 6.8 |
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.
| scores on a scale | Mindfulness-Based Cognitive Therapy (MBCT) | Health Education |
|---|---|---|
| Mental Health-related Quality of Life | 37.4 ± 11.7 | 30.7 ± 11.8 |
Collected over Baseline until end of follow-up, up to 6 months post-treatment. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mindfulness-Based Cognitive Therapy (MBCT) | 0/38 (0%) | 7/38 (18.4%) | 13/38 (34.2%) |
| Health Education | 0/38 (0%) | 6/38 (15.8%) | 19/38 (50%) |
| Event | Mindfulness-Based Cognitive Therapy (MBCT) | Health Education |
|---|---|---|
| Cardiac related hospitalizationCardiac disorders | 3/38 | 1/38 |
| Hospitalization associated with significant psychiatric distressPsychiatric disorders | 2/38 | 2/38 |
| Hospitalization related to metabolism disorderMetabolism and nutrition disorders | 0/38 | 2/38 |
| Hospitalization related to respiratory systemRespiratory, thoracic and mediastinal disorders | 1/38 | 0/38 |
| Hospitalization associated with digestive systemGastrointestinal disorders | 1/38 | 1/38 |
| Hospitalization from an injuryInjury, poisoning and procedural complications | 0/38 | 1/38 |
| Hospitalization due to blood clotsBlood and lymphatic system disorders | 0/38 | 1/38 |
| Event | Mindfulness-Based Cognitive Therapy (MBCT) | Health Education |
|---|---|---|
| Increased psychiatric distressPsychiatric disorders | 6/38 | 7/38 |
| Gastrointestinal problems leading to emergency deptGastrointestinal disorders | 0/38 | 5/38 |
| Respiratory related emergency department visitRespiratory, thoracic and mediastinal disorders | 4/38 | 2/38 |
| InjuryInjury, poisoning and procedural complications | 1/38 | 4/38 |
| Increased musculoskeletal painMusculoskeletal and connective tissue disorders | 1/38 | 2/38 |
| Cardiac related emergency department visitCardiac disorders | 2/38 | 1/38 |
| Infection leading to emergency department visitInfections and infestations | 0/38 | 2/38 |
| Blood or lymphatic issues leading to an emergency department visitBlood and lymphatic system disorders | 0/38 | 2/38 |
| Skin-related emergency department visitSkin and subcutaneous tissue disorders | 0/38 | 2/38 |
| MigrainesNervous system disorders | 1/38 | 0/38 |
| Age, Continuous(years) | Mindfulness-Based Cognitive Therapy (MBCT) | Health Education | Total |
|---|---|---|---|
| Mean | 55.4 ± 14.3 | 51.2 ± 14.4 | 53.3 ± 14.4 |
| Sex: Female, Male(Participants) | Mindfulness-Based Cognitive Therapy (MBCT) | Health Education | Total |
|---|---|---|---|
| Female | 16 | 14 | 30 |
| Male | 22 | 24 | 46 |
| Race (NIH/OMB)(Participants) | Mindfulness-Based Cognitive Therapy (MBCT) | Health Education | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 5 | 10 |
| White | 28 | 30 | 58 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 5 | 1 | 6 |
| Ethnicity (NIH/OMB)(Participants) | Mindfulness-Based Cognitive Therapy (MBCT) | Health Education | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 3 | 5 |
| Not Hispanic or Latino | 36 | 35 | 71 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Suicidal ideation intensity(score on a scale) | Mindfulness-Based Cognitive Therapy (MBCT) | Health Education | Total |
|---|---|---|---|
| Mean | 1.61 ± 1.1 | 2.22 ± 1.34 | 1.91 ± 1.25 |
| Depression(scores on a scale) | Mindfulness-Based Cognitive Therapy (MBCT) | Health Education | Total |
|---|---|---|---|
| Mean | 19.7 ± 7.5 | 20.5 ± 6.7 | 20.1 ± 7.1 |
| Interpersonal needs(scores on a scale) | Mindfulness-Based Cognitive Therapy (MBCT) | Health Education | Total |
|---|---|---|---|
| Mean | 41.6 ± 14.9 | 50.8 ± 14.0 | 46.1 ± 15.1 |
| Pain interference(scores on a scale) | Mindfulness-Based Cognitive Therapy (MBCT) | Health Education | Total |
|---|---|---|---|
| Mean | 6.5 ± 2.0 | 7.1 ± 1.8 | 6.8 ± 1.9 |
7 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Participant data is available upon request as part of scientific collaboration.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Canandaigua VA Medical Center