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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how an 8-week stress reduction course, Mindfulness-Based Stress Reduction (MBSR), affects heart plaque inflammation in individuals with stable coronary artery disease. Researchers aim to determine if reducing stress can improve well-being and heart health in those with heart conditions. Participants will either continue their usual medical care or add the stress reduction program to their routine. This trial suits individuals who received heart disease treatments over six months ago, feel stressed, and are open to trying a new stress-reduction course. As an unphased trial, it offers participants the chance to explore innovative stress-reduction techniques that could enhance overall well-being.

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 prior data suggests that this stress reduction intervention is safe for individuals with coronary artery disease?

Research has shown that mindfulness-based stress reduction (MBSR) is generally safe for people. Studies have found that MBSR can enhance well-being in heart patients without causing major side effects. For example, one study found that MBSR improved mental health and reduced stress in heart patients during their first year of treatment. Another study suggested that MBSR might help lower blood pressure in individuals with hypertension. Overall, these findings suggest that MBSR is well-tolerated and usually does not lead to harmful effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using stress reduction techniques for coronary artery disease because they offer a non-pharmacological approach to managing the condition. Unlike standard treatments that often focus on medications like beta-blockers, statins, and antiplatelet agents, stress reduction involves mindfulness practices that can help reduce stress and potentially improve heart health. This method targets the psychological factors contributing to coronary artery disease, offering a holistic complement to conventional therapies. By integrating stress management with medical care, this approach could enhance overall patient well-being and provide benefits that medication alone might not achieve.

What evidence suggests that stress reduction is effective for coronary artery disease?

Research has shown that mindfulness-based stress reduction (MBSR), which participants in this trial may receive, can benefit individuals with coronary artery disease (CAD). Studies have found that MBSR lowers anxiety, depression, and stress in heart disease patients. It may also improve blood pressure and body mass index (BMI), both crucial for heart health. Additionally, MBSR can boost confidence in managing health and enhance overall quality of life. These findings suggest that reducing stress might lower inflammation in the heart's arteries for those experiencing high stress levels. ^{1 3 6 7 8}

Who Is on the Research Team?

Michael Osborne, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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) 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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9399009/

Mindfulness-Based Stress Reduction for Coronary Artery ... In summary, mindfulness seems to be a good candidate treatment that rests on a foundational resilience framework to reduce stress and distress among patients ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3734636/

Mindfulness-based stress reduction program in coronary ... Conclusion: The MBSR program is effective in reducing symptoms of anxiety and depression, perceived stress, BP and BMI in patients with CHD.

3. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2024.1435243/full

Effect of mindfulness-based interventions on anxiety, ... This review concludes that MBIs have a higher efficacy in improving the psychological outcomes of anxiety and depression among patients with CAD ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2352906718301763

Effectiveness of mindfulness-based stress reduction ... This study was to investigate the effectiveness of a mindfulness-based stress reduction (MBSR) program on self-efficacy and quality of life in patients with ...

5. nature.com nature.com/articles/s41598-019-54932-2

Randomized Trial of Mindfulness-Based Stress Reduction ... This pilot RCT provides preliminary evidence of MBSR's potential to improve short term psychosocial well-being in cardiac patients during their first year of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11367009/

The Utilization and Potential of Mindfulness-Based Stress ... This article primarily focuses on applying mindfulness-based stress reduction in PCI patients with coronary heart disease and its future prospects.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT00106275

Mindfulness-Based Stress Reduction Program as an ... MBSR will be proven to be a reliable and efficacious treatment for fibromyalgia as reflected in an improvement in patient reported health variables.

8. ahajournals.org ahajournals.org/doi/10.1161/HYPERTENSIONAHA.120.16160

Effect and Acceptability of Mindfulness-Based Stress ... The mindfulness-based stress reduction program (MBSR) may reduce blood pressure (BP) in patients with hypertension or elevated BP.