Mindfulness & Stress Management Study for Cardiac Patients

Objectives:

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.

Design and Outcomes:

The study design is a randomized controlled trial with randomization in two strata. The
primary outcome will be a change (improvement) in heart rate variability (HRV) as assessed
by a 24-hour Holter monitor worn by patients three times throughout the study (pre- and
post-intervention and 9-month follow-up). Both time domain (SDNN and RMSSD) and frequency
domain (Total power, Low Frequency power, High Frequency power) variables will be assessed.
HRV is a well-established method to assess the autonomic nervous system. Secondary outcomes
will include changes in stress, depression, anxiety, quality of life, physical functioning
and cardiovascular risk factors. All participants will undergo a baseline assessment,
followed by randomization to the treatment or control condition, and three follow-up
assessments, at 3, 6, and 9 months after randomization. The 3-month follow-up will occur
immediately post-intervention. The baseline, 3-month and 9-month (final) follow-up
assessments will be in-person and will include questionnaires on stress and emotions,
quality of life, a short physical performance battery, a blood draw to assess lipids, high
sensitivity C-Reactive Protein and hemoglobin A1c as well as the 24-hour Holter monitor to
assess HRV. The 6-month follow-up assessment will be by telephone only and include brief
assessments of moods, stress, and symptoms. The investigators anticipate the pilot study
will be completed in 18 months.

Interventions and Duration:

Upon enrollment, participants will be randomized into two groups, the intervention group
(MBSR) or the control group (no MBSR). Randomization will occur separately for those
enrolled in CR and those not enrolled in CR. For those in the stratum that attends CR, the
control condition will consist of CR only and usual care, whereas for participants in the
stratum that does not attend CR, the control condition will consist of usual care. All
participants in both strata will received standard printed materials on healthy lifestyles
and stress management. The intervention lasts for 8 weeks and will occur within the first 12
weeks (3 months) after randomization. The standard outpatient Phase II CR program offered
within the Fairview Hospital system is a traditional exercise-based program that includes an
intake visit and up to 24 1-hour monitored exercise sessions (1-3 times per week for 8-24
weeks, individualized to patient needs and therapy goals) and up to 8 or 9 1-hour
educational sessions. Patients participating in CR who are randomized to the intervention
group will participate in the same standard outpatient Phase II CR as those individuals
randomized to the control condition within this stratum, plus an 8-week MBSR course. The
MBSR course is taught per a standard protocol in a group setting and consists of eight
2.5-hour weekly sessions and one 6.5-hour retreat; the MBSR course will be led by trained
facilitators from the University of Minnesota Center for Spirituality and Healing.

Sample Size and Population:

The targeted enrollment is 72 participants, with 36 randomized to participate in MBSR across
the two strata and 36 randomized to the control condition (no MBSR) who will receive usual
care (this includes CR for those who have opted to enroll in CR). The investigators will
recruit CR-eligible cardiac patients from three sites within the Fairview Hospital system
that offer CR (Ridges in Burnsville, Southdale in Edina, and University of Minnesota
Riverside Campus in Minneapolis), as well as through electronic health records, clinic
visits with health care providers, advertisement and flyers located at clinics and the CR
locations, and inclusion of the study on www.studyfinder.umn.edu.

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