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

Trial Summary

What is the purpose of this trial?

The plot study aims to evaluate the effect of 8 weeks of stress reducing intervention on atherosclerotic plaque inflammation in adults, as quantified by positron emission tomography (PET) with fluorine-2-deoxy-D-glucose (FDG) in individuals with increased psychosocial stress.

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 data supports the effectiveness of the treatment Stress Reduction, Mindfulness-Based Stress Reduction, MBSR, Stress Management Training for heart disease?

Research shows that Mindfulness-Based Stress Reduction (MBSR) can help lower blood pressure and reduce stress and anger in heart patients, which are important factors in managing heart disease. ^{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, as it is a non-drug therapy used to help with stress, anxiety, depression, and other conditions. It has been used in various settings, including for patients with chronic illnesses and healthcare staff, without significant safety concerns reported. ^{6 7 8 9 10}

How is the Stress Reduction treatment different from other treatments for heart disease?

Stress Reduction, specifically Mindfulness-Based Stress Reduction (MBSR), is unique because it uses mindfulness meditation to help reduce stress, which can improve heart function and lower blood pressure. Unlike medications, it involves attending group sessions and practicing mindfulness techniques, making it a non-drug approach to managing heart disease. ^{1 6 8 11 12}

Research Team

Ahmed Tawakol, MD

Principal Investigator

MGH

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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) 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]

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]

References

1. 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]

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

The impact of mindfulness meditation in promoting a culture of safety on an acute psychiatric unit. [2012]

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

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

4. India pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction training is associated with greater empathy and reduced anxiety for graduate healthcare students. [2013]

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

Demystifying mindfulness. [2011]

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

Telephone-adapted mindfulness-based stress reduction (tMBSR) for patients awaiting kidney transplantation: Trial design, rationale and feasibility. [2022]

7. Denmark pubmed.ncbi.nlm.nih.gov

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

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

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

9. India pubmed.ncbi.nlm.nih.gov

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

10. Switzerland pubmed.ncbi.nlm.nih.gov

Mindfulness training as an intervention for fibromyalgia: evidence of postintervention and 3-year follow-up benefits in well-being. [2019]

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

Integrating mindfulness-based stress reduction. [2019]

12. 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]