Heart Failure Clinical Trial
Official title:
Mindfulness-Based Stress Reduction as an Adjunct Intervention to Cardiac Rehabilitation: A Pilot Study
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.
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). Time domain variables SDNN (the standard deviation
of R-to-R intervals and RMSSD (the root mean square of successive differences in adjacent
R-to-R intervals will be assessed. Time 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. Secondary outcomes will include psychosocial
measures (depressive symptoms, mentally unhealthy days, stress, and anxiety) as well as
cardiovascular risk factors (systolic blood pressure, body mass index, high density
lipoprotein cholesterol, triglycerides, hemoglobin A1C, and c-reactive protein). 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 and the 9-month
follow up will occur 6-months 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 48 participants, with 32 randomized to participate in MBSR across
the two strata and 16 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.
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