Stress Reduction for Heart Disease

Overseen By Ahmed Tawakol, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: PSS score <6

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

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how an 8-week stress reduction program might reduce inflammation in heart disease. It focuses on people with high stress levels, as stress can affect heart health. Participants will either undergo the stress reduction program or join a group that receives no intervention. Those who often feel stressed and are interested in joining might find this trial a good fit. As an unphased trial, it offers a unique opportunity to contribute to understanding the impact of stress reduction on heart health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this stress reduction intervention is safe?

Research has shown that mindfulness-based stress reduction (MBSR) is generally safe for most people. In one study, 87% of participants completed the MBSR program, and over 95% remained in the study until it ended, indicating that most found the program manageable. Another study found that MBSR helped reduce feelings of anxiety, depression, and stress. These results suggest that the stress reduction techniques used in the trial are well-tolerated and have been successfully used by people with heart conditions. Overall, evidence indicates that individuals can safely participate in stress reduction programs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about stress reduction techniques for heart disease because they offer a non-invasive and holistic approach to managing the condition. Unlike traditional treatments like medications or surgical interventions, stress reduction focuses on lifestyle changes that can empower patients to take control of their health. This method targets the root cause of stress, which is a significant risk factor for heart disease, potentially offering long-term benefits without the side effects associated with medication. By reducing stress, patients may see improvements in heart health, mood, and overall well-being.

What evidence suggests that stress reduction might be an effective treatment for heart disease?

Research has shown that stress reduction techniques, such as mindfulness-based stress reduction (MBSR), can benefit people with heart disease. Studies have found that MBSR eases anxiety and depression, lowers blood pressure, and improves the overall quality of life for those with heart conditions. In one study, 87% of participants completed the MBSR program, and the benefits persisted over time. Another study suggested that MBSR might help manage risk factors for heart disease, such as high blood pressure and diabetes. This trial will evaluate the effectiveness of an 8-week stress reduction course, provided to participants in the experimental arm, in addressing heart-related issues. ^{1 3 6 7 8}

Who Is on the Research Team?

Ahmed Tawakol, MD

Principal Investigator

MGH

Are You a Good Fit for This Trial?

This trial is for adults aged 30-65 who feel stressed out or have a stress score over 5. It's not for those with lower stress levels.

Inclusion Criteria

I feel very stressed and am interested in joining.

I am between 30 and 65 years old.

Exclusion Criteria

Your Perceived Stress Scale (PSS) score is less than 6.

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

Participants undergo baseline Fluorodeoxyglucose-Positron emission tomography / magnetic resonance imaging

1 week

1 visit (in-person)

Treatment

Participants receive an 8-week stress reduction intervention focusing on mindfulness and relaxation techniques

8 weeks

Weekly sessions (in-person or virtual)

Follow-up

Participants return for follow-up imaging and evaluation to assess the intervention's impact

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Stress Reduction

Trial Overview The study tests if an 8-week program to reduce stress can decrease inflammation in blood vessels, measured by a special heart scan using PET and FDG.

How Is the Trial Designed?

Group I: Stress Reduction Experimental Treatment 1 Intervention

8 week stress reduction course

Group II: Control Active Control 1 Intervention

No intervention

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

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]

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) programs have shown potential in reducing stress and improving health outcomes, based on an integrative review of 21 clinical studies.

However, there is a need for more controlled, randomized studies and qualitative research to better understand the effectiveness and implementation of MBSR interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating mindfulness-based stress reduction. Proulx, K.[2019]

Mindfulness-Based Stress Reduction (MBSR) significantly decreased anxiety levels in healthcare graduate students after 8 weeks of training, with improvements maintained at 3 weeks post-course.

MBSR also increased empathy among students at the end of the program, although this effect did not persist at the 3-week follow-up, and no significant changes in burnout were observed between the intervention and control groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction training is associated with greater empathy and reduced anxiety for graduate healthcare students. Barbosa, P., Raymond, G., Zlotnick, C., et al.[2013]

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]

Mindfulness-based stress reduction (MBSR) is increasingly recommended by healthcare providers for its benefits in managing conditions like anxiety, depression, chronic pain, and insomnia.

Incorporating MBSR techniques into daily medical practice can help physicians reduce their own stress and prevent burnout, promoting overall wellness in both patients and providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Demystifying mindfulness. Lawson, K.[2011]

The Journeys to Wellness trial successfully adapted the standard 8-week mindfulness-based stress reduction (MBSR) program into a workshop and teleconference format (tMBSR) for 63 kidney transplant candidates, showing high attendance and satisfaction rates among participants.

Participants in the tMBSR group reported significantly higher expectations of the intervention's usefulness for managing their health (83%) compared to the tSupport group (43%), indicating a positive reception and potential efficacy of the mindfulness training for improving quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone-adapted mindfulness-based stress reduction (tMBSR) for patients awaiting kidney transplantation: Trial design, rationale and feasibility. Reilly-Spong, M., Reibel, D., Pearson, T., et al.[2022]

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]

The mindfulness-based stress reduction (MBSR) program significantly helped mental health professionals reduce their work stress and improve their self-care, which in turn enhanced patient care.

Participants in the MBSR program reported increased patient satisfaction and a reduction in patient safety events, indicating a positive impact on both staff well-being and patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of mindfulness meditation in promoting a culture of safety on an acute psychiatric unit. Brady, S., O'Connor, N., Burgermeister, D., et al.[2012]

An 8-week mindfulness-based stress reduction (MBSR) program significantly improved pain perception, quality of life, coping with pain, anxiety, and depression in 58 female fibromyalgia patients, with effect sizes ranging from 0.40 to 1.10.

A 3-year follow-up of 26 participants showed that the benefits of MBSR were sustained over time, with effect sizes between 0.50 and 0.65, indicating its potential for long-term positive impact on well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness training as an intervention for fibromyalgia: evidence of postintervention and 3-year follow-up benefits in well-being. Grossman, P., Tiefenthaler-Gilmer, U., Raysz, A., et al.[2019]

Mindfulness-based stress reduction (MBSR) showed positive effects on patients, helping them feel more rested and in better control of their pain, although no specific sociodemographic factors were found to predict who would benefit most from the program.

The only notable predictor of a better outcome was older age, suggesting that patients who accept their pain as part of life and are in stable conditions may be more likely to engage effectively with mindfulness techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness--What Works for Whom? Referral, Feasibility, and User Perspectives Regarding Patients with Mixed Chronic Pain. Petersen, M., la Cour, P.[2016]

Citations

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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.

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

Effectiveness of mindfulness-based stress reduction ... The MBSR program led to a stable improvement of the scores of self-efficacy and quality of life of cardiovascular patients. Abstract. Introduction.

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Women, Stress and Heart Health: Mindfulness-Based ... In cardiovascular disease, MBSR may be helpful for controlling several risk factors for coronary heart disease such as hypertension, type 2 diabetes mellitus, ...

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

Randomized Trial of Mindfulness-Based Stress Reduction ... 87% of MBSR patients completed the intervention; study retention was >95% at each follow-up visit. At 3 months, compared to controls, MBSR ...

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

Effect of mindfulness-based interventions on anxiety, ... This study aims to quantify the effect of mindfulness-based interventions (MBIs) on anxiety, depression and stress in CAD patients.

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

Effect and Acceptability of Mindfulness-Based Stress ... Our meta-analyses did not find a significant reduction in out-of-office BP after MBSR. MBSR reduced depressive, anxiety, and stress symptoms.

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2769761

Effect of a Brief Mindfulness-Based Program on Stress in ... This randomized clinical trial found that a brief course of mindfulness training during work hours was feasible and effective in reducing stress ...