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Mindfulness & Stress Management Study for Cardiac Patients

NCT02722213 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2019-11-01

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Susan A Everson-Rose, PhD · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02722213 on ClinicalTrials.gov