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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether compassion meditation, known as Cognitively-Based Compassion Training (CBCT), can assist Veterans with chronic pain and related mental health issues, such as PTSD (post-traumatic stress disorder) and depression. Participants will either practice compassion meditation or engage in health education sessions to determine which approach better enhances their quality of life. Veterans who experience pain most days for at least six months and have symptoms of depression or PTSD may be suitable candidates. The trial aims to discover more effective methods for managing chronic pain and its mental health effects. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to potentially groundbreaking pain management solutions.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that compassion meditation is generally safe for people with chronic pain. In an initial study, participants experienced less pain and anger after practicing compassion meditation and became more accepting of their pain. These benefits occurred without serious side effects, indicating that the practice is well-tolerated.

Further research on compassion meditation suggests it can lower stress and reduce inflammation, offering potential health benefits without major risks. While specific safety data for this trial phase is not available, other studies suggest that compassion meditation is well-tolerated.

Overall, compassion meditation appears to be a safe option for managing chronic pain and emotional challenges. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for chronic pain?

Unlike the standard treatments for chronic pain, like medications and physical therapies, compassion meditation offers a unique approach by emphasizing mental and emotional well-being. This technique helps individuals develop empathy and kindness toward themselves and others, which can potentially reduce the perception of pain. Researchers are excited about this meditation technique because it might provide a non-drug option that addresses pain through emotional resilience, offering relief without the side effects commonly associated with medications.

What evidence suggests that this trial's treatments could be effective for chronic pain?

Research has shown that compassion meditation, which participants in this trial may receive, can help with chronic pain. In a small study, participants reported feeling less pain and anger after practicing it and found it easier to accept their pain. Compassion meditation, such as Cognitively-Based Compassion Training (CBCT-CP+), aims to reduce suffering, potentially improving both physical and mental health. These early results suggest that compassion meditation might help manage chronic pain and related mental health issues. Another group in this trial will receive health education, serving as an active comparator. ^{1 2 3 4 6}

Who Is on the Research Team?

Anne L Malaktaris

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04651296

Compassion Meditation vs. Health Education for Veterans This study will evaluate the efficacy of Cognitively-Based Compassion Training for Chronic Pain with Psychological Comorbidity (CBCT-CP+) compared to Health ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4972045/

Pilot study of a compassion meditation intervention in ... In this predominantly female sample, patients had significantly reduced pain severity and anger and increased pain acceptance at post-treatment compared to ...

3. withpower.com withpower.com/trial/phase-3-stress-disorders-post-traumatic-9-2021-19098

Compassion Meditation for Chronic Pain · Info for Participants This study will evaluate the efficacy of Cognitively-Based Compassion Training for Chronic Pain with Psychological Comorbidity (CBCT-CP+) compared to Health ...

4. researchgate.net researchgate.net/publication/275650512_Pilot_study_of_a_compassion_meditation_intervention_in_chronic_pain

Pilot study of a compassion meditation intervention in ... In this predominantly female sample, patients had significantly reduced pain severity and anger and increased pain acceptance at post-treatment ...

5. tandfonline.com tandfonline.com/doi/abs/10.1080/15360288.2022.2141944

Outcome Expectancies, Effects, and Mechanisms of Brief ... This study investigated the analgesic effects of a single session of mindfulness meditation (MM) and loving-kindness meditation (LKM) relative to a control.

6. compassion.emory.edu compassion.emory.edu/cbct-compassion-training/index.html

CBCT® | Cognitively-Based Compassion Training CBCT® is one of the most researched compassion training programs, with the following outcomes: Significant decrease in: stress biomarkers and inflammatory ...