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Mindfulness & Stress Management Study for Cardiac Patients

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ClinicalTrials.gov Identifier: NCT02722213
Recruitment Status : Completed
First Posted : March 29, 2016
Last Update Posted : May 7, 2019
Sponsor:
Collaborator:
Fairview Health Services
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
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.

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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Minnesota
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Fairview Health Services
Investigators
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Principal Investigator: Susan A Everson-Rose, PhD University of Minnesota - Clinical and Translational Science Institute
  Study Documents (Full-Text)

Documents provided by University of Minnesota - Clinical and Translational Science Institute:

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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02722213     History of Changes
Other Study ID Numbers: #MED-2015-24043
First Posted: March 29, 2016    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Heart Failure
Infarction
Heart Diseases
Myocardial Infarction
Angina, Stable
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms