Clinical trial NCT04651296: 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
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Pain
Stress Disorders, Posttraumatic
Depression
Keywords: meditation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-12-03
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Brief Pain Inventory (BPI) Pain Interference subscale
timeFrame: Change from baseline to 3-month follow-up
measure: Clinical Global Impression scale (CGI)
timeFrame: Change from baseline to 3-month follow-up
Secondary outcomes:
measure: Satisfaction with Life Scale (SWLS)
timeFrame: Change from baseline to 3-month follow-up
measure: Veterans SF-36
timeFrame: Change from baseline to 3-month follow-up
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego, CA
name: Anne L Malaktaris
role: PRINCIPAL_INVESTIGATOR
References: