Mindfulness for Coronary Artery Disease

Overseen By Michael T Osborne, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Anti-inflammatories, Psychiatric medications

Disqualifiers: Neurological disease, Substance abuse, others

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

Compensation: Varies

Number of Visits: 11

Duration: 8 weeks

36 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aims to evaluate the effect of 8 weeks of a stress reduction intervention on atherosclerotic plaque inflammation in adults with stable coronary artery disease, as quantified by positron emission tomography (PET) with 18F-fluorodeoxyglucose (FDG) in individuals with increased psychosocial stress.

Will I have to stop taking my current medications?

The trial requires that you have been on a stable medication regimen for at least 90 days before joining, but it doesn't specify if you need to stop any current medications. It seems you can continue your current medications as long as they meet the trial's criteria.

What data supports the effectiveness of the treatment Mindfulness-Based Stress Reduction (MBSR) for patients with coronary artery disease?

Research shows that Mindfulness-Based Stress Reduction (MBSR) can help reduce anxiety, depression, and stress in patients with heart conditions, including those who have undergone procedures like percutaneous coronary intervention (PCI). Studies also indicate that MBSR can improve psychological well-being and depressive symptoms in coronary artery disease patients, suggesting it may be a beneficial treatment for managing stress and emotional health in these individuals. ^{1 2 3 4 5}

Is mindfulness-based stress reduction (MBSR) safe for humans?

Mindfulness-based stress reduction (MBSR) is generally considered safe for humans and has been used to help with stress, anxiety, depression, and various chronic illnesses. It is a meditation program that has been adapted for different settings and populations, including patients with heart conditions and healthcare staff, without significant safety concerns reported. ^{1 4 6 7 8}

How does the treatment Mindfulness-Based Stress Reduction (MBSR) differ from other treatments for coronary artery disease?

Mindfulness-Based Stress Reduction (MBSR) is unique because it focuses on reducing psychological distress through mindfulness meditation, which can improve mental well-being and potentially enhance heart health. Unlike traditional treatments that may focus on physical aspects, MBSR addresses the emotional and psychological needs of patients, offering a holistic approach to managing coronary artery disease. ^{1 3 4 5 7}

Research Team

Michael Osborne, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adults with stable coronary artery disease who have had a heart issue like a heart attack or surgery over 6 months ago. They should feel stressed, not be in cardiac rehab or stress reduction programs, and must commit to the course and imaging sessions. Participants can't join if they're pregnant, very overweight, have metal implants, uncontrolled diabetes, serious mental health issues or substance abuse problems.

Inclusion Criteria

I haven't used tobacco, abused substances, or had psychiatric meds in the last 6 months.

I had heart surgery or a heart attack more than 6 months ago.

You need to feel stressed or have a stress score higher than 13.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Imaging and Randomization

Participants undergo baseline FDG-PET and MRI imaging followed by randomization into intervention or control groups

1 week

1 visit (in-person)

Treatment

Participants in the experimental group undergo an 8-week stress reduction intervention focusing on mindfulness and relaxation techniques

8 weeks

8 sessions (in-person or virtual)

Follow-up

Participants return for follow-up imaging and evaluation to assess changes in arterial inflammation and other biomarkers

12 weeks

1 visit (in-person)

Treatment Details

Interventions

• Stress Reduction

Trial Overview The study tests whether an 8-week stress reduction program can lower inflammation in blood vessels of the heart as seen on special PET scans using FDG in people with stable coronary artery disease who are also experiencing high levels of stress.

Participant Groups

Group I: Stress reduction Experimental Treatment 1 Intervention

Optimally tolerated medical therapy and stress reduction course for 8 weeks

Group II: Usual care Active Control 1 Intervention

Optimally tolerated medical therapy

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Findings from Research

A brief, one-on-one, telephone-adapted mindfulness-based stress reduction (MBSR) intervention significantly reduced psychological distress in patients who underwent percutaneous coronary intervention (PCI), as evidenced by lower scores on the Hospital Anxiety and Depression Scale (HADS) and Perceived Stress Scale (PSS).

The study involved 70 PCI patients, with 62 completing the trial, and showed that the improvements in psychological symptoms were linked to increased mindfulness, highlighting the effectiveness of this accessible intervention format.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief, one-on-one, telephone-adapted mindfulness-based stress reduction for patients undergoing percutaneous coronary intervention: a randomized controlled trial. Hou, Y., Zhao, X., Lu, M., et al.[2020]

Mindfulness-based stress reduction (MBSR) significantly lowered systolic blood pressure, perceived stress, and anger in 60 cardiac patients after eight 2.5-hour sessions, compared to a control group that received no therapy.

While MBSR showed effectiveness in reducing systolic blood pressure and stress-related measures, it did not have a significant impact on diastolic blood pressure, indicating a targeted effect on certain cardiovascular parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of mindfulness-based stress reduction on cardiac patients' blood pressure, perceived stress, and anger: a single-blind randomized controlled trial. Momeni, J., Omidi, A., Raygan, F., et al.[2022]

A pilot randomized controlled trial involving 47 cardiac patients showed that an 8-week mindfulness-based stress reduction (MBSR) program significantly improved depression and anxiety levels compared to usual care, with effects observed at 3 months post-intervention.

MBSR was found to be a safe and well-received strategy, particularly benefiting patients with mild depression, and it also showed positive trends in cardiovascular risk factors, suggesting its potential as a valuable addition to cardiac rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Trial of Mindfulness-Based Stress Reduction in Cardiac Patients Eligible for Cardiac Rehabilitation. Nijjar, PS., Connett, JE., Lindquist, R., et al.[2023]

In a study of 34 female patients with microvascular angina, an 8-week mindfulness-based stress reduction (MBSR) program significantly improved left ventricular function, as indicated by an increase in global longitudinal strain (GLS).

MBSR also enhanced endothelial function, demonstrated by improved flow-mediated dilatation (FMD), while reducing stress levels, suggesting that mindfulness practices can positively affect heart health in this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Mindfulness Based Stress Reduction Therapy on Myocardial Function and Endothelial Dysfunction in Female Patients with Microvascular Angina. Kim, BJ., Cho, IS., Cho, KI.[2022]

Mindfulness-based stress reduction (MBSR) was found to be a feasible intervention for coronary artery disease (CAD) patients with depressive symptoms, with 20% of participants completing the 8-week course.

Participants who completed MBSR showed a significant decrease in depressive symptoms immediately after the course and maintained this improvement after 12 months, unlike a reference group of CAD patients who did not experience any significant changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Stress Reduction for Coronary Artery Disease Patients: Potential Improvements in Mastery and Depressive Symptoms. Lundgren, O., Garvin, P., Nilsson, L., et al.[2023]

Mindfulness-based stress reduction (MBSR) has been shown to improve mental health and reduce symptoms of stress, anxiety, and depression across 31 randomized studies involving both clinical and non-clinical populations.

The implementation of MBSR in the healthcare system is recommended to be gradual, ensuring that MBSR teachers in Denmark receive adequate training and education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of mindfulness on symptoms of stress, anxiety and depression]. Fjorback, LO., Rasmussen, BH., Preuss, T.[2019]

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 systematic review of 18 studies found that Mindfulness Based Stress Reduction (MBSR) therapy significantly improves the conditions of patients with chronic illnesses such as cancer, hypertension, and diabetes.

MBSR offers a promising alternative treatment method that helps patients manage their diseases more effectively, although more research is needed to fully understand its mechanisms and potential adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction: a non-pharmacological approach for chronic illnesses. Niazi, AK., Niazi, SK.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Brief, one-on-one, telephone-adapted mindfulness-based stress reduction for patients undergoing percutaneous coronary intervention: a randomized controlled trial. [2020]

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

The effects of mindfulness-based stress reduction on cardiac patients' blood pressure, perceived stress, and anger: a single-blind randomized controlled trial. [2022]

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

Randomized Trial of Mindfulness-Based Stress Reduction in Cardiac Patients Eligible for Cardiac Rehabilitation. [2023]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Impact of Mindfulness Based Stress Reduction Therapy on Myocardial Function and Endothelial Dysfunction in Female Patients with Microvascular Angina. [2022]

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

Mindfulness-Based Stress Reduction for Coronary Artery Disease Patients: Potential Improvements in Mastery and Depressive Symptoms. [2023]

6. Denmark pubmed.ncbi.nlm.nih.gov

[Effect of mindfulness on symptoms of stress, anxiety and depression]. [2019]

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

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

8. India pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction: a non-pharmacological approach for chronic illnesses. [2022]