Compassion Meditation vs. Health Education for Veterans

NCT04651296 | Completed Phase 2 DMC

• 2 other identifiers: MHBC-010-20SCX002041-01A2
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Chronic Pain; Stress Disorders, Posttraumatic

Keywords

meditation

Outcome Measures

Primary Outcomes (2)

• 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.

  Change from baseline to 3-month follow-up

• Clinical Global Impression scale (CGI)

  The CGI consists of two clinician-rated one-item measures assessing 1) the severity of psychopathology from 1 (normal, not at all ill) to 7 (among the most extremely ill patients), 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-I. The CGI is a well-established measure of psychological symptom severity and is applicable across psychological conditions.

  Change from baseline to 3-month follow-up

Secondary Outcomes (2)

• Satisfaction with Life Scale (SWLS)

  Change from baseline to 3-month follow-up

• Veterans SF-36

  Change from baseline to 3-month follow-up

Study Arms (2)

compassion meditation

EXPERIMENTAL

10 week, group-based manualized compassion meditation training

Behavioral: compassion meditation

health education

ACTIVE COMPARATOR

10 week, group-based manualized health education protocol

Behavioral: health education

Interventions

health education BEHAVIORAL

manualized health education group

Also known as: health education while living with pain

health education

compassion meditation BEHAVIORAL

manualized compassion meditation training

Also known as: cognitively-based compassion meditation for chronic pain with psychological comorbidity

compassion meditation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

Location

MeSH Terms

Conditions

Chronic Pain; Stress Disorders, Post-Traumatic; Depression

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Anne L Malaktaris

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome evaluator is blind to experimental condition
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 3, 2020
• Study Start: January 4, 2022
• Primary Completion: August 21, 2025
• Study Completion: February 4, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)