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Compassion Meditation vs. Health Education for Veterans

Primary Purpose

Chronic Pain, Stress Disorders, Posttraumatic, Depression

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
compassion meditation
health education
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring meditation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • VA San Diego Healthcare System, San Diego, CARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

compassion meditation

health education

Arm Description

10 week, group-based manualized compassion meditation training

10 week, group-based manualized health education protocol

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
Veterans SF-36
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).

Full Information

First Posted
November 24, 2020
Last Updated
December 9, 2022
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT04651296
Brief Title
Compassion Meditation vs. Health Education for Veterans
Official Title
Efficacy of Mind-Body Approaches for the Treatment of Chronic Pain With Psychological Comorbidity
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 4, 2022 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
February 28, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Stress Disorders, Posttraumatic, Depression
Keywords
meditation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
The outcome evaluator is blind to experimental condition
Allocation
Randomized
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
compassion meditation
Arm Type
Experimental
Arm Description
10 week, group-based manualized compassion meditation training
Arm Title
health education
Arm Type
Active Comparator
Arm Description
10 week, group-based manualized health education protocol
Intervention Type
Behavioral
Intervention Name(s)
compassion meditation
Other Intervention Name(s)
cognitively-based compassion meditation for chronic pain with psychological comorbidity
Intervention Description
manualized compassion meditation training
Intervention Type
Behavioral
Intervention Name(s)
health education
Other Intervention Name(s)
health education while living with pain
Intervention Description
manualized health education group
Primary Outcome Measure Information:
Title
Brief Pain Inventory (BPI) Pain Interference subscale
Description
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.
Time Frame
Change from baseline to 3-month follow-up
Title
Clinical Global Impression scale (CGI)
Description
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.
Time Frame
Change from baseline to 3-month follow-up
Secondary Outcome Measure Information:
Title
Satisfaction with Life Scale (SWLS)
Description
Self-report questionnaire; 5 items assessing global life satisfaction. Total scores range from 5 to 35, with higher scores indicating greater satisfaction with life.
Time Frame
Change from baseline to 3-month follow-up
Title
Veterans SF-36
Description
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).
Time Frame
Change from baseline to 3-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne L Malaktaris
Phone
(858) 642-3794
Email
anne.malaktaris@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Edith Bonilla, MSW
Phone
(858) 552-8585
Ext
2965
Email
edith.bonilla@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne L Malaktaris
Organizational Affiliation
VA San Diego Healthcare System, San Diego, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System, San Diego, CA
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne L Malaktaris
Phone
858-642-3794
Email
anne.malaktaris@va.gov
First Name & Middle Initial & Last Name & Degree
Anne L Malaktaris

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Specific parameters of sharing are not yet established

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Compassion Meditation vs. Health Education for Veterans

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