Mindfulness & Stress Management Study for Cardiac Patients

NCT02722213 | Completed DMC

• 1 other identifier: 1603M85502
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Diseases; Heart Failure; Myocardial Infarction; Chronic Stable Angina; Coronary Artery Bypass; Angioplasty

Outcome Measures

Primary Outcomes (1)

• Change (improvement) in heart rate variability (HRV).

  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.

  0-9 months

Secondary Outcomes (3)

• Psychosocial function

  0-9 months

• Cardiovascular risk factors: C-reactive protein (CRP), lipids, hemoglobin A1c (HgA1c)

  0-9 months

• Physical functioning

  0-9 months

Study Arms (2)

Mindfulness-Based Stress Reduction

EXPERIMENTAL

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).

Control (No MBSR)

NO INTERVENTION

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.

Interventions

Mindfulness-Based Stress Reduction (MBSR). BEHAVIORAL

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

Mindfulness-Based Stress Reduction

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• Fairview Health Services: collaborator

Study Sites (1)

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Heart Diseases; Heart Failure; Myocardial Infarction; Angina, Stable

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Susan A Everson-Rose, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: March 29, 2016
• Study Start: May 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: November 1, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)