Compassion Meditation for Chronic Pain

Overseen By Edith Bonilla, MSW

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: VA Office of Research and Development

Disqualifiers: Substance abuse, Psychotic disorders, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

142 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you cannot be enrolled in any other treatment specifically targeting chronic pain, anxiety, depression, or PTSD symptoms.

What data supports the effectiveness of the treatment Compassion Meditation for Chronic Pain?

Research suggests that compassion-focused therapies, like Compassion Meditation, can help people manage chronic pain by improving emotional processing and reducing negativity. Although more high-quality studies are needed, these therapies may help people accept and cope with their pain better. ^{1 2 3 4 5}

Is Compassion Meditation safe for humans?

Compassion meditation, including practices like Cognitively-Based Compassion Training (CBCT), is generally considered safe for humans, as it involves mental exercises aimed at increasing compassion and does not involve any physical interventions. ^{2 5 6 7 8}

How is Compassion Meditation different from other treatments for chronic pain?

Compassion Meditation, or Cognitively-Based Compassion Training (CBCT), is unique because it focuses on cultivating compassion to manage chronic pain, potentially addressing emotional factors like anger that can influence pain perception. Unlike traditional pain management programs that often rely on cognitive behavioral therapy (CBT), this approach encourages acceptance and emotional processing, which may help reduce negativity and improve pain outcomes. ^{2 3 4 6 9}

What is the purpose of this trial?

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.

Research Team

Anne L Malaktaris

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Eligibility Criteria

This trial is for Veterans aged 18 or older with chronic pain most days and a probable diagnosis of depression or PTSD. They must be able to consent and not currently enrolled in other treatments targeting their conditions or mind-body interventions. Excluded are those with recent serious suicidality, untreated substance issues, unstable mental disorders, or cognitive impairments.

Inclusion Criteria

Veteran status

I have experienced pain on most days for at least 6 months.

I have been diagnosed with depression or PTSD.

Exclusion Criteria

You have had serious thoughts about hurting yourself or others recently, or have tried to hurt yourself in the past year.

You have a substance abuse problem that is not being treated.

I am not currently enrolled in any treatments for chronic pain, mental health issues, or mind-body interventions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 10-week group-based manualized compassion meditation training or health education protocol

10 weeks

Weekly group sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• Compassion Meditation
• Health Education

Trial Overview The study compares Compassion Meditation (CM), which focuses on alleviating suffering, against Health Education for managing chronic pain and psychological comorbidities like PTSD and depression among Veterans. The efficacy of CM will be measured against the control group receiving standard health education.

Participant Groups

Group I: compassion meditation Experimental Treatment 1 Intervention

10 week, group-based manualized compassion meditation training

Group II: health education Active Control 1 Intervention

10 week, group-based manualized health education protocol

Compassion Meditation is already approved in United States for the following indications:

Approved in United States as Compassion Meditation for:

• Chronic Pain
• Posttraumatic Stress Disorder (PTSD)
• Depression

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

A short-term online version of Compassionate Mind Training (CMT) significantly increased compassion levels in both Sri Lankan and UK participants, demonstrating its effectiveness across cultures.

The study, which included 211 participants in total, showed that the benefits of CMT in reducing distress and enhancing well-being were maintained even two weeks after the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the Cross-cultural Applicability of a Brief Compassionate Mind Training: a Study Comparing Sri Lankan and UK People. Kariyawasam, L., Ononaiye, M., Irons, C., et al.[2023]

The review analyzed 16 studies involving a total of 1,683 participants with chronic pain, focusing on compassion-based psychological interventions and self-compassion's relationship with pain outcomes.

Due to high variability in study quality and results, no definitive conclusions could be made about the effectiveness of compassion-based interventions or the impact of self-compassion on pain management, highlighting the need for more rigorous research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Self-Compassion in Chronic Pain: From Correlation to Efficacy. Lanzaro, C., Carvalho, SA., Lapa, TA., et al.[2021]

A 12-week Compassion-Focused Therapy (CFT) group for individuals with persistent pain showed positive outcomes, helping participants reduce feelings of isolation and improve self-reassurance and coping strategies.

Participants reported a growing acceptance of their pain limitations, suggesting that CFT can be an effective complementary approach to traditional pain management programs that often rely on cognitive behavioral therapy principles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'All these things don't take the pain away but they do help you to accept it': making the case for compassion-focused therapy in the management of persistent pain. Gooding, H., Stedmon, J., Crix, D.[2023]

A 9-week group compassion cultivation intervention for 12 chronic pain patients led to significant reductions in pain severity and anger, as well as increased pain acceptance, indicating its potential effectiveness as a treatment.

Observer ratings from patients' significant others supported these findings, highlighting observable emotional and behavioral improvements in patients after the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study of a compassion meditation intervention in chronic pain. Chapin, HL., Darnall, BD., Seppala, EM., et al.[2022]

Cognitively Based Compassion Training (CBCT®) significantly increased self-compassion and reduced perceived stress among participants, with a notable improvement in emotional well-being measured over three time points in a study involving 65 individuals.

The training not only enhanced individual emotional health but also fostered greater community engagement, suggesting that CBCT® can be an effective intervention for promoting social well-being in vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Cognitively Based Compassion Training in the outskirts: A mixed study. Kolchraiber, FC., Tanaka, LH., Negi, LT., et al.[2023]

A pilot study involving 20 participants with chronic low back pain showed that self-compassion meditation training led to reduced clinical pain intensity and disability, along with increased self-compassion and interoceptive awareness after just two weeks of practice.

Functional MRI results indicated that self-compassion training altered brain responses to pain, specifically reducing pain processing in the right temporo-parietal junction and enhancing anticipation responses in the right dorsolateral prefrontal cortex, suggesting a potential mechanism for pain regulation through self-compassion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Self-Compassion Training Alters Neural Responses to Evoked Pain for Chronic Low Back Pain: A Pilot Study. Berry, MP., Lutz, J., Schuman-Olivier, Z., et al.[2021]

A study involving 278 patients with chronic back pain found that an AI-driven cognitive behavioral therapy for chronic pain (AI-CBT-CP) was noninferior to standard telephone CBT-CP, showing similar effectiveness in reducing disability and pain over 6 months.

AI-CBT-CP not only achieved better clinical outcomes for patients but also required less than half the therapist time compared to traditional CBT-CP, suggesting it could improve access to treatment for more patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools: A Randomized Comparative Effectiveness Trial. Piette, JD., Newman, S., Krein, SL., et al.[2023]

Long-term meditation practitioners experienced a significant reduction in the unpleasantness of pain during Open Monitoring meditation, suggesting that this technique enhances emotional regulation in response to pain.

Focused Attention meditation did not show any significant effects on pain perception, indicating that Open Monitoring may be a more effective approach for managing negative emotional responses to painful stimuli.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differential effects on pain intensity and unpleasantness of two meditation practices. Perlman, DM., Salomons, TV., Davidson, RJ., et al.[2022]

Mindfulness-based meditation has been shown to effectively reduce chronic pain, making it a valuable option for patients who do not respond well to traditional medications or surgeries.

Research indicates that mindfulness interventions may work through specific neural mechanisms, providing both immediate and long-lasting pain relief for individuals suffering from chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness Meditation in the Treatment of Chronic Pain. Brandel, MG., Lin, C., Hennel, D., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Exploring the Cross-cultural Applicability of a Brief Compassionate Mind Training: a Study Comparing Sri Lankan and UK People. [2023]

2. England pubmed.ncbi.nlm.nih.gov

A Systematic Review of Self-Compassion in Chronic Pain: From Correlation to Efficacy. [2021]

3. England pubmed.ncbi.nlm.nih.gov

'All these things don't take the pain away but they do help you to accept it': making the case for compassion-focused therapy in the management of persistent pain. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Pilot study of a compassion meditation intervention in chronic pain. [2022]

5. Brazil pubmed.ncbi.nlm.nih.gov

Effects of Cognitively Based Compassion Training in the outskirts: A mixed study. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Brief Self-Compassion Training Alters Neural Responses to Evoked Pain for Chronic Low Back Pain: A Pilot Study. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools: A Randomized Comparative Effectiveness Trial. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Differential effects on pain intensity and unpleasantness of two meditation practices. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Mindfulness Meditation in the Treatment of Chronic Pain. [2022]