Mindfulness & Stress Management Study for Cardiac Patients

Completed · Not applicable

Conditions studied: Heart Diseases, Heart Failure, Myocardial Infarction, Chronic Stable Angina, Coronary Artery Bypass, Angioplasty

In brief

The guideline-recommended standard of care for patients who have experienced a heart attack, heart failure, or other coronary event or procedure is exercise-based cardiac rehabilitation (CR). Despite proven benefits, traditional CR is severely underutilized. Moreover, what is typically lacking from traditional CR programs is effective psychosocial risk management. This represents a critical gap in care given the well-documented psychosocial needs of this patient population.The objective of this feasibility study is to conduct a pilot randomized controlled trial (RCT) of Mindfulness-Based Stress Reduction (MBSR) versus usual care in CR-eligible cardiac patients. Randomization will be stratified within two strata based on participation in CR (yes/no) among CR-eligible patients. The primary goals of this pilot study are to: 1) obtain estimates of treatment effects and variability; 2) evaluate recruitment and retention strategies; and 3) examine the safety of the MBSR protocol in CR-eligible patients.

Key facts

Study ID

NCT02722213

Run by

University of Minnesota

People needed

47

Starts

2016-05-01

Expected to finish

2017-08-01

Last updated by the study team

2019-11-01

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women age 21 and older that are medically eligible and been referred for traditional exercise-based CR (heart attack within the past 12 months, open heart surgery such as coronary bypass/valve/heart transplant, coronary angioplasty or stent placement, current stable angina, or heart failure)
• Willing to participate in all assessments and be randomized to either study condition
• Able to give informed consent.

You may not qualify if…

• Has a cardiac pacemaker and is pacemaker-dependent or has an untreated atrial arrhythmia;
• Previously completed an MBSR course;
• Unable to read and write in English

Where it is running

• University of Minnesota Medical Center — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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