Chronic PainPhase 2NCT04651296
Compassion Meditation vs. Health Education for Veterans
A Phase 2 study testing compassion meditation and health education in people with Chronic Pain and Stress Disorders, Posttraumatic, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Chronic pain (CP) is a major health problem for military Veterans, and CP is often associated with comorbid mental health problems, including posttraumatic stress disorder (PTSD) and depression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Stress Disorders, Posttraumatic, Depression
- What is being tested?
- compassion meditation and health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2022to 4 Feb 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Criteria for inclusion include
- Veteran status
- age 18 or greater
- able to consent
- pain most days (> 3 days/week) for at least 6 months
- probable diagnosis of depression and/or PTSD
Who cannot join
- serious suicidality or homicidality that has required urgent or emergent evaluation or treatment within the past three months or a suicide attempt within the past year
- a known, untreated substance abuse or dependence problem (inclusion is possible if there is evidence that the individual has been afforded and is complying with treatment for the substance problem)
- untreated/unstable serious mental disorders, such as psychotic disorders or bipolar disorder, or serious dissociative symptoms
- cognitive impairment that would interfere with treatment, and
- concurrent enrollment in any other treatment specifically targeting chronic pain, anxiety, depression, or PTSD symptoms or social functioning (e.g., couples therapy) or any meditative or mind-body intervention (e.g., mindfulness, yoga)
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
About this study
Official title: Efficacy of Mind-Body Approaches for the Treatment of Chronic Pain With Psychological Comorbidity
Chronic pain (CP) is a major health problem for military Veterans, and CP is often associated with comorbid mental health problems, including posttraumatic stress disorder (PTSD) and depression. CP with psychological comorbidity is associated with increased healthcare costs, medication use, risk of suicide and rates of disability and reduced quality of life. Current empirically supported treatments do not always lead to substantial improvements (up to 50% of patients drop out or are do not respond to treatment). This project was designed to evaluate the efficacy of a novel intervention for addressing these challenges. Compassion meditation (CM), a meditative practice that focuses on the wish to remove suffering, is a contemplative practice that has promise for the amelioration of physical and mental health problems as well as promoting positive affect and improving quality of life. This study will evaluate the efficacy of Cognitively-Based Compassion Training for Chronic Pain with Psychological Comorbidity (CBCT-CP+) compared to Health Education while Living with Pain (H.E.L.P.) control condition, in a sample of among Veterans with CP conditions and psychological comorbidity.
Read the detailed description
Chronic pain (CP), defined as persistent (>6 months), non-malignant, musculoskeletal or generalized pain, is a prevalent and costly public health problem. CP is highly prevalent among Veterans; 30-40% of Veterans have moderate to severe CP. CP has a significant negative impact on mental health and quality of life. CP is associated with declines in physical and social functioning, decreased activity levels, anxiety, negative mood, and depression. Approximately 1.6 million Veterans Health Administration (VHA) enrolled Veterans have CP and psychological distress associated with mental health comorbidities, including posttraumatic stress disorder (PTSD; ~50%), depression (~25%), and anxiety disorder(s) (~25%). Despite this urgent clinical need and extraordinary economic and societal costs, there are currently no evidence-based psychosocial interventions that simultaneously target comorbid mental health symptoms and CP interference in Veterans.
The Veterans Health Administration and National Center for Complementary and Integrative Health have similarly prioritized the use of complementary and integrative health approaches for the treatment of complex physical and mental health conditions. Currently, forty percent of Veterans with CP report using these approaches, and 70% of non-users would use these approaches if they were offered at the VA.
Compassion meditation (CM), a meditative practice that focuses on the wish to remove suffering, is a contemplative practice that has promise for the amelioration of physical and mental health problems as well as promoting positive affect and improving quality of life. CM has been shown to decrease anxiety and depressive symptoms in clinical populations, and is associated with reductions in pain severity, pain disability, pain catastrophizing, psychological distress, pain-related anxiety and depression, and pain-related anger in civilians with CP. CBCT (Cognitively-Based Compassion Training), a manualized CM protocol, is associated with reduced stress-related immune responses, improved negative affect, and reduced suicidality and depression in civilians. CBCT has also been shown to increase social connectedness and positive affect, and reduce depressive and PTSD symptoms in Veterans.
With this randomized controlled trial (RCT), the investigators will evaluate the efficacy of Cognitively-Based Compassion Training for Chronic Pain with Psychological Comorbidity (CBCT-CP+). The trial will compare CBCT-CP+ to Health Education while Living with Pain (H.E.L.P.) control condition, in a sample of 126 Veterans with CP conditions and psychological comorbidities. The rationale for the proposed study of compassion meditation for CP with psychological comorbidity is motivated by (1) a pressing clinical need, (2) a clear theoretical model, and (3) initial evidence of its safety, feasibility and potential positive clinical effect for improving psychiatric conditions among Veterans.
Findings from this study could inform clinical practice and policy by investigating whether a compassion-based intervention targeting both CP and psychological comorbidities will improve treatment outcomes for Veterans. Further, results of the trial will lay the groundwork for multi-site studies that would attempt to determine efficacy of CBCT-CP+ across VA clinics and formally investigate putative mechanisms of treatment effects. This work could ultimately lead to better care for Veterans, greater patient and therapist satisfaction, and lower healthcare and societal costs.
- Conditions
- Chronic Pain, Stress Disorders, Posttraumatic, Depression
- Being tested
- compassion meditation, health education
- Keywords
- meditation
- Medical subject headings
- Chronic Pain, Stress Disorders, Post-Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
compassion meditationBehavioural
Also called cognitively-based compassion meditation for chronic pain with psychological comorbidity
manualized compassion meditation training
health educationBehavioural
Also called health education while living with pain
manualized health education group
| Study group | Role | What they receive |
|---|---|---|
| compassion meditation | Experimental | 10 week, group-based manualized compassion meditation training Receives: Behavioral: compassion meditation |
| health education | Active comparator | 10 week, group-based manualized health education protocol Receives: Behavioral: health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Inventory (BPI) Pain Interference Subscale
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.
Measured: Change from baseline to 3-month follow-up
Clinical Global Impression Scale (CGI)
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.
Measured: Change from baseline to 3-month follow-up
Secondary outcomes (3)
Satisfaction With Life Scale (SWLS)
Self-report questionnaire; 5 items assessing global life satisfaction. Total scores range from 5 to 35, with higher scores indicating greater satisfaction with life.
Measured: Change from baseline to 3-month follow-up
Veterans SF-36 PCS
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.
Measured: Change from baseline to 3-month follow-up
Veterans SF-36 MCS
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.
Measured: Change from baseline to 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start4 Jan 2022
- Primary completion21 Aug 2025
- Study completion4 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental condition: manualized compassion meditation protocol, a 10-session group-based meditation training class led by a trained instructor Control condition: manualized health education protocol, a 10-session group-based health education and discussion led by a trained instructor
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Anne L Malaktaris, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651296
- Sponsor's protocol ID
- MHBC-010-20S
- Other IDs
- CX002041-01A2
- Status last verified
- Aug 2026
- First submitted
- 24 Nov 2020
- Last updated
- 1 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Specific parameters of sharing are not yet established
Publications
Malaktaris A, Afari N, Casmar P, Herbert MS, Raver R, Kangas J, Liu L, Zeidan F, Lang AJ. Efficacy of Cognitively-based compassion training for Veterans with chronic pain with psychological Comorbidity: Protocol for a randomized clinical trial. Contemp Clin Trials Commun. 2026 May 7;51:101646. doi: 10.1016/j.conctc.2026.101646. eCollection 2026 Jun.
PubMed 42179864
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Mind-Body Approaches for the Treatment of Chronic Pain With Psychological Comorbidity
- ClinicalTrials.gov ID
- NCT04651296
- Acronym / sponsor ID
- MHBC-010-20S
- Conditions
- Chronic Pain, Stress Disorders, Posttraumatic, Depression
- Keywords
- meditation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 21 Aug 2025 (actual)
- Study completion
- 4 Feb 2026 (actual)
- First posted
- 3 Dec 2020 (actual)
- Results
- Posted 1 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic pain (CP) is a major health problem for military Veterans, and CP is often associated with comorbid mental health problems, including posttraumatic stress disorder (PTSD) and depression. CP with psychological comorbidity is associated with increased healthcare costs, medication use, risk of suicide and rates of disability and reduced quality of life. Current empirically supported treatments do not always lead to substantial improvements (up to 50% of patients drop out or are do not respond to treatment). This project was designed to evaluate the efficacy of a novel intervention for addressing these challenges. Compassion meditation (CM), a meditative practice that focuses on the wish to remove suffering, is a contemplative practice that has promise for the amelioration of physical and mental health problems as well as promoting positive affect and improving quality of life. This study will evaluate the efficacy of Cognitively-Based Compassion Training for Chronic Pain with Psychological Comorbidity (CBCT-CP+) compared to Health Education while Living with Pain (H.E.L.P.) control condition, in a sample of among Veterans with CP conditions and psychological comorbidity.
Detailed description
Chronic pain (CP), defined as persistent (>6 months), non-malignant, musculoskeletal or generalized pain, is a prevalent and costly public health problem. CP is highly prevalent among Veterans; 30-40% of Veterans have moderate to severe CP. CP has a significant negative impact on mental health and quality of life. CP is associated with declines in physical and social functioning, decreased activity levels, anxiety, negative mood, and depression. Approximately 1.6 million Veterans Health Administration (VHA) enrolled Veterans have CP and psychological distress associated with mental health comorbidities, including posttraumatic stress disorder (PTSD; ~50%), depression (~25%), and anxiety disorder(s) (~25%). Despite this urgent clinical need and extraordinary economic and societal costs, there are currently no evidence-based psychosocial interventions that simultaneously target comorbid mental health symptoms and CP interference in Veterans.
The Veterans Health Administration and National Center for Complementary and Integrative Health have similarly prioritized the use of complementary and integrative health approaches for the treatment of complex physical and mental health conditions. Currently, forty percent of Veterans with CP report using these approaches, and 70% of non-users would use these approaches if they were offered at the VA.
Compassion meditation (CM), a meditative practice that focuses on the wish to remove suffering, is a contemplative practice that has promise for the amelioration of physical and mental health problems as well as promoting positive affect and improving quality of life. CM has been shown to decrease anxiety and depressive symptoms in clinical populations, and is associated with reductions in pain severity, pain disability, pain catastrophizing, psychological distress, pain-related anxiety and depression, and pain-related anger in civilians with CP. CBCT (Cognitively-Based Compassion Training), a manualized CM protocol, is associated with reduced stress-related immune responses, improved negative affect, and reduced suicidality and depression in civilians. CBCT has also been shown to increase social connectedness and positive affect, and reduce depressive and PTSD symptoms in Veterans.
With this randomized controlled trial (RCT), the investigators will evaluate the efficacy of Cognitively-Based Compassion Training for Chronic Pain with Psychological Comorbidity (CBCT-CP+). The trial will compare CBCT-CP+ to Health Education while Living with Pain (H.E.L.P.) control condition, in a sample of 126 Veterans with CP conditions and psychological comorbidities. The rationale for the proposed study of compassion meditation for CP with psychological comorbidity is motivated by (1) a pressing clinical need, (2) a clear theoretical model, and (3) initial evidence of its safety, feasibility and potential positive clinical effect for improving psychiatric conditions among Veterans.
Findings from this study could inform clinical practice and policy by investigating whether a compassion-based intervention targeting both CP and psychological comorbidities will improve treatment outcomes for Veterans. Further, results of the trial will lay the groundwork for multi-site studies that would attempt to determine efficacy of CBCT-CP+ across VA clinics and formally investigate putative mechanisms of treatment effects. This work could ultimately lead to better care for Veterans, greater patient and therapist satisfaction, and lower healthcare and societal costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental condition: manualized compassion meditation protocol, a 10-session group-based meditation training class led by a trained instructor Control condition: manualized health education protocol, a 10-session group-based health education and discussion led by a trained instructor
| Arm | Type | Receives |
|---|---|---|
| compassion meditation | Experimental | Behavioral: compassion meditation10 week, group-based manualized compassion meditation training |
| health education | Active comparator | Behavioral: health education10 week, group-based manualized health education protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Criteria for inclusion include
- Veteran status
- age 18 or greater
- able to consent
- pain most days (> 3 days/week) for at least 6 months
Key exclusion criteria (5 listed)
- serious suicidality or homicidality that has required urgent or emergent evaluation or treatment within the past three months or a suicide attempt within the past year
- a known, untreated substance abuse or dependence problem (inclusion is possible if there is evidence that the individual has been afforded and is complying with treatment for the substance problem)
- untreated/unstable serious mental disorders, such as psychotic disorders or bipolar disorder, or serious dissociative symptoms
- cognitive impairment that would interfere with treatment, and
- concurrent enrollment in any other treatment specifically targeting chronic pain, anxiety, depression, or PTSD symptoms or social functioning (e.g., couples therapy) or any meditative or mind-body intervention (e.g., mindfulness, yoga)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| compassion meditationAlso: cognitively-based compassion meditation for chronic pain with psychological comorbiditymanualized compassion meditation training | Behavioural | compassion meditation |
| health educationAlso: health education while living with painmanualized health education group | Behavioural | health education |
Primary outcome
Brief Pain Inventory (BPI) Pain Interference Subscale
Time frame: Change from baseline to 3-month follow-up
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.
Clinical Global Impression Scale (CGI)
Time frame: Change from baseline to 3-month follow-up
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.
3 secondary outcomes
Satisfaction With Life Scale (SWLS)
Time frame: Change from baseline to 3-month follow-up
Veterans SF-36 PCS
Time frame: Change from baseline to 3-month follow-up
Veterans SF-36 MCS
Time frame: Change from baseline to 3-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42179864Malaktaris A, Afari N, Casmar P, Herbert MS, Raver R, Kangas J, Liu L, Zeidan F, Lang AJ. Efficacy of Cognitively-based compassion training for Veterans with chronic pain with psychological Comorbidity: Protocol for a randomized clinical trial. Contemp Clin Trials Commun. 2026 May 7;51:101646. doi: 10.1016/j.conctc.2026.101646. eCollection 2026 Jun.
- Individual participant dataSharing planned: No. Specific parameters of sharing are not yet established
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne L Malaktaris principal investigator
VA San Diego Healthcare System, San Diego, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing compassion meditation and health education in people with Chronic Pain and Stress Disorders, Posttraumatic, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory (BPI) Pain Interference Subscale (time frame: Change from baseline to 3-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04651296, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.