Mindfulness for Coronary Artery Disease
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Massachusetts General Hospital
Must not be taking: Anti-inflammatories, Psychiatric medications
Disqualifiers: Neurological disease, Substance abuse, others
No Placebo Group
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.
12345Is 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.
14678How 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.
13457Eligibility 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.
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Trial 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)
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Stress reductionExperimental Treatment1 Intervention
Optimally tolerated medical therapy and stress reduction course for 8 weeks
Group II: Usual careActive Control1 Intervention
Optimally tolerated medical therapy
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Massachusetts General HospitalBoston, MA
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Who Is Running the Clinical Trial?
Massachusetts General HospitalLead Sponsor
References
Brief, one-on-one, telephone-adapted mindfulness-based stress reduction for patients undergoing percutaneous coronary intervention: a randomized controlled trial. [2020]Psychological distress and negative conditions are highly frequent in patients with percutaneous coronary intervention (PCI). Mindfulness-based stress reduction (MBSR) has been shown to be effective in reducing psychological symptoms in patients with chronic diseases. The available evidence has supported the potential benefit of MBSR for PCI patients. However, the traditional group classroom format and long exercise times of MBSR were deemed as barriers to access for these patients. The aim of this study was to examine the short-term effectiveness of a brief, one-on-one, telephone-adapted MBSR on psychological distress of PCI patients. A randomized controlled trial was conducted. Seventy consecutive PCI patients who met the inclusion criteria were randomized to a three-session mindfulness intervention group (N = 35) or a waitlist control group (N = 35). The Hospital Anxiety and Depression Scale (HADS), Perceived Stress Scale (PSS), and short form of the Freiburg Mindfulness Inventory (FMI-s) were used to assess anxiety and depression, stress, and mindfulness before and after the intervention. Sixty-two patients completed the study. Compared with the waitlist group, the MBSR group showed greater decreases in HADS (p = .006) and PSS (p = .035) scores. The intention-to-treat (ITT) analysis also demonstrated that HADS (p = .018) and PSS (p = .037) scores decreased significantly in the MBSR group compared with those in the waitlist group at Week 6. These effects were mediated by an increase in mindfulness. The brief, one-on-one, telephone-adapted mindfulness intervention can improve psychological symptoms in PCI patients.
The effects of mindfulness-based stress reduction on cardiac patients' blood pressure, perceived stress, and anger: a single-blind randomized controlled trial. [2022]This study aimed at assessing the effects of mindfulness-based stress reduction (MBSR) on cardiac patients' blood pressure (BP), perceived stress, and anger. In total, 60 cardiac patients were recruited between April and June 2015 from a specialized private cardiac clinic located in Kashan, Iran. Patients were allocated to the intervention and control groups. Patients in the experimental group received MBSR in eight 2.5-hour sessions, while patients in the control group received no psychological therapy. The main outcomes were BP, perceived stress, and anger. Analysis of covariance revealed a significant difference between the study groups regarding the posttest values of systolic BP, perceived stress, and anger (P
Randomized Trial of Mindfulness-Based Stress Reduction in Cardiac Patients Eligible for Cardiac Rehabilitation. [2023]Currently, exercise-based cardiac rehabilitation (CR) is the only recommended secondary prevention strategy for cardiac patients that attempts to tackle stress and psychosocial wellbeing, but it is under-utilized and lacks a comprehensive curriculum for this purpose; hence there is a critical gap to address psychosocial needs of cardiac patients after an event. Mindfulness-based stress reduction (MBSR) has shown benefits in the general population but its role in cardiac patients is not clear. We conducted a pilot randomized controlled trial (RCT) of MBSR in CR-eligible cardiac patients during their initial year of recovery. Patients were allocated 2:1 (intervention:control) to an 8-week MBSR group intervention or usual care. Standard measures of depression, anxiety, perceived stress, health related quality of life (HRQOL), blood pressure, biomarkers (lipids, HbA1c, CRP) and 24-hour Holter monitoring were obtained at baseline, 3- and 9-months post-randomization. Sub-group analyses were performed for participants with at least mild depression (PHQ-9 ≥ 5). 47 patients [mean age 58.6 years; 38% female; 77% white] were enrolled in 2 cohorts. 87% of MBSR patients completed the intervention; study retention was >95% at each follow-up visit. At 3 months, compared to controls, MBSR patients showed improvements in depression [p = 0.01] and anxiety [p = 0.04] with a similar trend in HRQOL [p = 0.06]. The MBSR group showed greater improvement or less worsening of most CV risk factors, with an attenuation of treatment effects at 9 months. Participants with at PHQ-9 scores ≥5 at baseline showed greater improvement in psychosocial and CV outcomes, that persisted at 9 months. MBSR is a safe and well received secondary prevention strategy. 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 recovery.
Impact of Mindfulness Based Stress Reduction Therapy on Myocardial Function and Endothelial Dysfunction in Female Patients with Microvascular Angina. [2022]Mindfulness-based stress reduction (MBSR) is a structured group program that employs mindfulness meditation to alleviate suffering associated with physical, psychosomatic, and psychiatric disorders. In this study, we investigate the impact of MBSR on left ventricular (LV) and endothelial function in female patients with microvascular angina.
Mindfulness-Based Stress Reduction for Coronary Artery Disease Patients: Potential Improvements in Mastery and Depressive Symptoms. [2023]Depressive symptoms after coronary events are associated with a worse prognosis. When changing the focus from psychopathology towards a resilience framework, treatments such as mindfulness meditation could offer novel ways to address psychological distress among coronary artery disease (CAD) patients. We studied the feasibility of mindfulness-based stress reduction (MBSR) for CAD patients with depressive symptoms. Seventy-nine CAD patients with elevated depressive symptoms were invited to an 8-week MBSR course. Twenty-four patients (30%) accepted and 16 (20%) completed MBSR. Depressive symptoms decreased immediately after the course (p = .006). After 12 months, this improvement remained, and Mastery scores increased (p = .005). A reference group of 108 CAD patients did not show any significant changes in depressive symptoms or Mastery between 1 and 12 months after a coronary event. MBSR thus appears to be a feasible alternative for CAD patients with elevated depressive symptoms. Future studies are warranted to study if MBSR can improve psychological functioning in CAD patients.Clinicaltrials.gov (Registration Number: NCT03340948).
[Effect of mindfulness on symptoms of stress, anxiety and depression]. [2019]Mindfulness-based stress reduction (MBSR) is a manualised group intervention using mindfulness training as a means of reducing the suffering associated with physical, psychosomatic and psychiatric illness. A review of the literature includes 31 randomised studies. Results indicate that MBSR may improve mental health and reduce symptoms of stress, anxiety and depression in both clinical and non-clinical populations. Implementation in the health-care system is recommended to take place over time to secure sufficient education of MBSR teachers in Denmark.
Mindfulness-Based Stress Reduction for Health Care Staff: Expanding Holistic Nursing Paradigms to the Whole System. [2021]Mindfulness-based stress reduction (MBSR) is a well-known mindfulness meditation program for patients that also may benefit health care providers and clinic staff themselves. An abbreviated MBSR program adapted into 6 weekly 75-minute sessions held during staff lunch breaks provided a feasible and acceptable staff training approach within the workplace setting.
Mindfulness-based stress reduction: a non-pharmacological approach for chronic illnesses. [2022]Mindfulness Based Stress Reduction (MBSR) therapy is a meditation therapy, though originally designed for stress management, it is being used for treating a variety of illnesses such as depression, anxiety, chronic pain, cancer, diabetes mellitus, hypertension, skin and immune disorders.