Compassion Meditation vs. Health Education for Veterans

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Not yet recruiting
CT.gov ID
NCT04651296
Collaborator
(none)
126
Enrollment
1
Location
2
Arms
49.1
Anticipated Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: compassion meditation
  • Behavioral: health education
Phase 2

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

Study Type:
Interventional
Anticipated Enrollment :
126 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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 instructorExperimental 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 (Outcomes Assessor)
Masking Description:
The outcome evaluator is blind to experimental condition
Primary Purpose:
Treatment
Official Title:
Efficacy of Mind-Body Approaches for the Treatment of Chronic Pain With Psychological Comorbidity
Anticipated Study Start Date :
Nov 29, 2021
Anticipated Primary Completion Date :
Jun 30, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

ArmIntervention/Treatment
Experimental: compassion meditation

10 week, group-based manualized compassion meditation training

Behavioral: compassion meditation
manualized compassion meditation training
Other Names:
  • cognitively-based compassion meditation for chronic pain with psychological comorbidity
  • Active Comparator: health education

    10 week, group-based manualized health education protocol

    Behavioral: health education
    manualized health education group
    Other Names:
  • health education while living with pain
  • Outcome Measures

    Primary Outcome Measures

    1. Brief Pain Inventory (BPI) Pain Interference subscale [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.

    2. Clinical Global Impression scale (CGI) [Change from baseline to 3-month follow-up]

      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.

    Secondary Outcome Measures

    1. Satisfaction with Life Scale (SWLS) [Change from baseline to 3-month follow-up]

      Self-report questionnaire; 5 items assessing global life satisfaction. Total scores range from 5 to 35, with higher scores indicating greater satisfaction with life.

    2. Veterans SF-36 [Change from baseline to 3-month follow-up]

      Self-report questionnaire with 36 items that assesses health-related quality of life; yields a physical component summary (PCS) and a mental component summary (MCS).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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)

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1VA San Diego Healthcare System, San Diego, CASan DiegoCaliforniaUnited States92161

    Sponsors and Collaborators

    • VA Office of Research and Development

    Investigators

    • Principal Investigator: Anne L Malaktaris, VA San Diego Healthcare System, San Diego, CA

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    VA Office of Research and Development
    ClinicalTrials.gov Identifier:
    NCT04651296
    Other Study ID Numbers:
    • MHBC-010-20S
    • CX002041-01A2
    First Posted:
    Dec 3, 2020
    Last Update Posted:
    Nov 17, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by VA Office of Research and Development
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 17, 2021