Compassion Meditation for PTSD

Recruiting at 1 trial location

Overseen By Haley Suit, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Veterans Medical Research Foundation

Disqualifiers: Serious suicidality, Untreated substance use, others

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

Compensation: Varies

Number of Visits: 10

Duration: 10 weeks

144 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 other PTSD treatments or meditation-based practices while participating.

What data supports the effectiveness of the treatment Compassion Meditation for PTSD?

Research shows that compassion meditation and loving-kindness meditation can help reduce PTSD symptoms and depression, as seen in studies with veterans. These practices increase self-compassion and mindfulness, which are linked to improvements in mental health. ^{1 2 3 4 5}

Is compassion meditation safe for humans?

Research on compassion meditation, including studies with veterans with PTSD and health professionals, suggests it is generally safe and well-tolerated. Participants in these studies reported improvements in symptoms and well-being without significant adverse effects. ^{2 3 6 7 8}

How does compassion meditation treatment differ from other PTSD treatments?

Compassion meditation for PTSD is unique because it focuses on cultivating compassion for oneself and others, which can help reduce symptoms by enhancing self-compassion and mindfulness. Unlike traditional PTSD treatments, it involves meditation practices like loving-kindness meditation and Cognitively-Based Compassion Training (CBCT®), which are designed to stabilize attention and develop present-moment awareness. ^{2 3 5 7 9}

What is the purpose of this trial?

Compassion meditation (CM) is a contemplative practice that builds compassion for and connectedness with others. CM has shown promise as a way of enhancing recovery for Veterans with Posttraumatic Stress Disorder (PTSD). The proposed project will examine the feasibility of a clinical trial by assessing our ability to deliver CM and a control intervention consistently with a diverse groups of Veterans from different parts of the country and optimizing the way in which outcomes are determined.

Eligibility Criteria

This trial is for Veterans who can consent and have PTSD or similar symptoms causing distress. They must not be in another PTSD treatment or meditation practice, have untreated serious mental illness, cognitive issues that affect participation, untreated substance problems, or severe suicidal/homicidal thoughts.

Inclusion Criteria

Able/willing to consent

Veteran status

I am experiencing PTSD or symptoms of PTSD that affect my daily life.

Exclusion Criteria

My thinking or memory problems do not interfere with daily activities.

I am currently participating in another PTSD treatment or meditation practice.

I do not have an untreated or unstable serious mental illness.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Compassion Meditation or Applied Relaxation interventions over 10 weeks

10 weeks

10 sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Applied relaxation
• Compassion meditation

Trial Overview The study tests Compassion Meditation (CM) against Applied Relaxation to see if CM helps Veterans with PTSD recover better. It's a test run to see if the methods work well across different locations and how best to measure their effects.

Participant Groups

Group I: Compassion meditation Experimental Treatment 1 Intervention

Compassion meditation is a contemplative meditation practice that fosters compassion through contemplation of common humanity.

Group II: Applied relaxation Active Control 1 Intervention

Veteran.calm is an applied relaxation program that exposes participants to a variety of relaxation strategies and their application.

Applied relaxation is already approved in United States for the following indications:

Approved in United States as Compassion Meditation for:

• Posttraumatic Stress Disorder (PTSD)
• Depression

Who Is Running the Clinical Trial?

Veterans Medical Research Foundation

Lead Sponsor

Trials

46

Recruited

5,100+

Veterans Health Research Institute of CNY

Collaborator

Trials

1

Recruited

140+

Institute for Medical Research, Inc.

Industry Sponsor

Trials

2

Recruited

260+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Bedford Research Corporation, Inc.

Collaborator

Trials

4

Recruited

1,600+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Findings from Research

An abbreviated Mindfulness-Based Stress Reduction (MBSR) program consisting of 6 weekly 75-minute sessions can effectively be implemented during staff lunch breaks, making it a practical training option for healthcare providers and clinic staff.

This adapted MBSR program is not only feasible but also well-accepted, suggesting it could enhance the well-being of healthcare workers in a workplace setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Stress Reduction for Health Care Staff: Expanding Holistic Nursing Paradigms to the Whole System. Hazlett-Stevens, H.[2021]

A pilot study involving 28 veterans showed that compassion meditation (CM) significantly reduced PTSD symptoms more than a psychoeducation and relaxation program (Veteran.calm), with a substantial effect size (d = -0.85).

Both CM and Veteran.calm had similar levels of treatment credibility, attendance, and participant satisfaction, indicating that CM is a feasible and promising intervention for veterans with PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compassion Meditation for Posttraumatic Stress Disorder in Veterans: A Randomized Proof of Concept Study. Lang, AJ., Malaktaris, AL., Casmar, P., et al.[2020]

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 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 loving-kindness meditation program for veterans with PTSD showed significant improvements, with a large effect size in reducing PTSD symptoms (d = -0.89) and a medium effect size in reducing depression (d = -0.49) at the 3-month follow-up.

The study found that increased self-compassion played a key role in mediating the reductions in PTSD and depression symptoms, suggesting that loving-kindness meditation is a safe and effective intervention for enhancing mental health in veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Loving-kindness meditation for posttraumatic stress disorder: a pilot study. Kearney, DJ., Malte, CA., McManus, C., et al.[2022]

This pilot trial is investigating the acceptability and preliminary efficacy of Cognitively-Based Compassion Training (CBCT) for improving health-related quality of life (HRQOL) in cancer survivors and their caregivers, with 40 dyads participating in an 8-week intervention.

CBCT aims to enhance self-compassion and empathy, potentially addressing depressive symptoms and other HRQOL domains, while also measuring biomarkers of inflammation and cortisol levels to assess overall wellness and healthcare utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitively-Based Compassion Training versus cancer health education to improve health-related quality of life in survivors of solid tumor cancers and their informal caregivers: study protocol for a randomized controlled pilot trial. Pace, TWW., Dodds, SE., Sikorskii, A., et al.[2020]

A new compassion meditation protocol, Cognitively Based Compassion Training (CBCT-Vet), was developed and evaluated with 36 Veterans suffering from PTSD over 8-10 sessions, showing it was well-received and acceptable to participants.

Participation in the CBCT-Vet program was associated with significant reductions in PTSD and depression symptoms, suggesting potential benefits for Veterans, although further research is needed to establish causality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compassion Meditation for Veterans with Posttraumatic Stress Disorder (PTSD): a Nonrandomized Study. Lang, AJ., Casmar, P., Hurst, S., et al.[2022]

A study involving 177 health professionals showed that brief online training in mind-body practices significantly improved their gratitude, well-being, self-compassion, and confidence in providing compassionate care, with all measures showing statistically significant changes (P < .001).

The training modules focused on Gratitude, Positive Word, and Loving-kindness/Compassion meditation, demonstrating that such practices are feasible and beneficial for enhancing the emotional well-being of diverse healthcare practitioners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online Training in Specific Meditation Practices Improves Gratitude, Well-Being, Self-Compassion, and Confidence in Providing Compassionate Care Among Health Professionals. Rao, N., Kemper, KJ.[2022]

Meditation-based approaches, including mindfulness, mantra, and compassion meditation, are increasingly sought after for managing PTSD, despite limited rigorous research on their effectiveness.

While empirical evidence for the efficacy of meditation in treating PTSD is scarce, the existing studies suggest potential benefits, indicating that further evaluation of these treatments is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The theoretical and empirical basis for meditation as an intervention for PTSD. Lang, AJ., Strauss, JL., Bomyea, J., et al.[2021]

References

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

Mindfulness-Based Stress Reduction for Health Care Staff: Expanding Holistic Nursing Paradigms to the Whole System. [2021]

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

Compassion Meditation for Posttraumatic Stress Disorder in Veterans: A Randomized Proof of Concept Study. [2020]

3. Brazil pubmed.ncbi.nlm.nih.gov

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

4. 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]

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

Loving-kindness meditation for posttraumatic stress disorder: a pilot study. [2022]

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

Cognitively-Based Compassion Training versus cancer health education to improve health-related quality of life in survivors of solid tumor cancers and their informal caregivers: study protocol for a randomized controlled pilot trial. [2020]

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

Compassion Meditation for Veterans with Posttraumatic Stress Disorder (PTSD): a Nonrandomized Study. [2022]

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

Online Training in Specific Meditation Practices Improves Gratitude, Well-Being, Self-Compassion, and Confidence in Providing Compassionate Care Among Health Professionals. [2022]

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

The theoretical and empirical basis for meditation as an intervention for PTSD. [2021]