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Compassion Meditation vs. Health Education for Veterans

Efficacy of Mind-Body Approaches for the Treatment of Chronic Pain With Psychological Comorbidity

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04651296
Enrollment
142
Registered
2020-12-03
Start date
2022-01-04
Completion date
2026-02-04
Last updated
2026-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Depression, Stress Disorders, Posttraumatic

Keywords

meditation

Brief 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. 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.

Interventions

manualized compassion meditation training

BEHAVIORALhealth education

manualized health education group

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The outcome evaluator is blind to experimental condition

Intervention 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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* 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)

Design outcomes

Primary

MeasureTime frameDescription
Brief Pain Inventory (BPI) Pain Interference SubscaleChange from baseline to 3-month follow-upSelf-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)Change from baseline to 3-month follow-upThe 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.

Secondary

MeasureTime frameDescription
Satisfaction With Life Scale (SWLS)Change from baseline to 3-month follow-upSelf-report questionnaire; 5 items assessing global life satisfaction. Total scores range from 5 to 35, with higher scores indicating greater satisfaction with life.
Veterans SF-36 PCSChange from baseline to 3-month follow-upThe 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.
Veterans SF-36 MCSChange from baseline to 3-month follow-upThe 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAnne L Malaktaris

VA San Diego Healthcare System, San Diego, CA

Baseline characteristics

Characteristic
Age, Continuous47.34 years
STANDARD_DEVIATION 14.07
Education13.93 years
STANDARD_DEVIATION 1.88
Ethnicity (NIH/OMB)
Hispanic or Latino
16 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
49 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants
Race (NIH/OMB)
Asian
6 Participants
Race (NIH/OMB)
Black or African American
40 Participants
Race (NIH/OMB)
More than one race
5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
Race (NIH/OMB)
Unknown or Not Reported
18 Participants
Race (NIH/OMB)
White
35 Participants
Sex: Female, Male
Female
17 Participants
Sex: Female, Male
Male
53 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 750 / 67
other
Total, other adverse events
23 / 7524 / 67
serious
Total, serious adverse events
3 / 750 / 67

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 2, 2026