Mindfulness & Stress Management Study for Cardiac Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02722213|
Recruitment Status : Completed
First Posted : March 29, 2016
Last Update Posted : November 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Heart Diseases Heart Failure Myocardial Infarction Chronic Stable Angina Coronary Artery Bypass Angioplasty||Behavioral: Mindfulness-Based Stress Reduction (MBSR).||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mindfulness-Based Stress Reduction as an Adjunct Intervention to Cardiac Rehabilitation: A Pilot Study|
|Study Start Date :||May 2016|
|Actual Primary Completion Date :||August 2017|
|Actual Study Completion Date :||August 2017|
Experimental: Mindfulness-Based Stress Reduction
The intervention is an 8-week Mindfulness-Based Stress Reduction (MBSR) course, with 8 weekly 2.5-hour group sessions, and 1 all-day (6.5 hours) retreat, taught per standard protocol in a group setting. The course includes instruction and practice of meditation, breathing techniques, gentle yoga and Tai Chi poses, with shared discussion, brief readings and home practice between sessions. Participants will continue with usual care and receive standard educational materials on healthy lifestyles and stress management.
Note: This study will recruit patients eligible for exercise-based cardiac rehabilitation (CR). Randomization to either MBSR or control (no MBSR) condition will occur within two strata (CR; no CR) will occur based on current enrollment in CR at time of study enrollment.
Behavioral: Mindfulness-Based Stress Reduction (MBSR).
MBSR is a combination of mindfulness meditation, breathing practices, gentle yoga, and other relaxation techniques; it is taught in a manualized 8-week program, does not require special equipment, and can be practiced safely by people of all abilities
No Intervention: Control (No MBSR)
Those randomized to the control condition will continue with usual care and receive standard educational materials on healthy lifestyles and stress management. At the end of the study control participants will receive a compact disc and workbook on MBSR.
Note: This study will recruit patients who are eligible for traditional exercise-based cardiac rehabilitation (CR). Randomization will be stratified based on whether or not patients are actively enrolled in CR at the time of the study. Within each stratum, participants will be randomized to either the intervention (MBSR) or control (no MBSR) condition.
- Change (improvement) in heart rate variability (HRV). [ Time Frame: 0-9 months ]Time domain and frequency domain variables will be assessed via 24-hour Holter monitoring at baseline, 3-month follow-up and 9-month follow-up. HRV is a well-established method to assess the autonomic nervous system, and has been shown to be a predictor of hard outcomes in cardiac patients. Given the deranged autonomic milieu in these patients, HRV is an appropriate surrogate end point for improved outcomes in this cohort.
- Psychosocial function [ Time Frame: 0-9 months ]Depressive symptoms, anxiety, stress, and health-related quality of life measures will be used to assess psychosocial function at baseline and changes in psychosocial function over the course of the study.
- Cardiovascular risk factors: C-reactive protein (CRP), lipids, hemoglobin A1c (HgA1c) [ Time Frame: 0-9 months ]Measures of lipids, inflammation (CRP) and glucose metabolism (HgA1c) will be obtained at 3 time points (baseline; 3-month follow-up; 9-month follow-up) to determine changes over the course of the study in these important cardiovascular risk factors.
- Physical functioning [ Time Frame: 0-9 months ]The Short Physical Performance Battery (SPPB) will be administered at baseline, 3-month follow-up and 9-month follow-up and will allow study investigators to evaluate changes in participants' physical function over time.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02722213
|United States, Minnesota|
|University of Minnesota Medical Center|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Susan A Everson-Rose, PhD||University of Minnesota|