Mindfulness & Stress Management Study for Cardiac Patients
CompletedNot applicableNCT02722213
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Mindfulness-Based Stress Reduction as an Adjunct Intervention to Cardiac Rehabilitation: A Pilot Study
- Conditions
- Heart Diseases
- Heart Failure
- Myocardial Infarction
- Chronic Stable Angina
- Coronary Artery Bypass
- Angioplasty
- Interventions
- Behavioral: Mindfulness-Based Stress Reduction (MBSR).
- Sponsor
- University of Minnesota
- Collaborators
- Fairview Health Services
- Start date
- 2016-05
- Primary completion
- 2017-08
- Sex
- All
- Age range
- from 21 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02722213