NCT03826836

Mind Our Heart Study

Effectiveness of Mindfulness-based Stress Reduction for Improving Quality of Life in Patients With Cardiovascular Disease: a Randomised Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Catharina Ziekenhuis Eindhoven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with atherosclerotic cardiovascular disease (i.e. peripheral artery disease, ischemic heart failure, myocardial infarction) are randomised to (1) treatment as usual (i.e. best medical care) or (2) treatment as usual (i.e. best medical care) in combination with an eight-week mindfulness-based stress reduction programme.

Detailed description

Rationale: Distress, including depression, anxiety, and chronic stress, is common among patients with cardiovascular disease. This reduces their quality of life and worsens their prognosis. A structured mindfulness training programme, such as the 8-week mindfulness-based stress reduction (MBSR) course, may reduce distress, improve quality of life, support a healthy lifestyle and modify cardiovascular risks. The aim of this randomised controlled trial is to determine whether MBSR improves the quality of life in patients with atherosclerotic cardiovascular disease. Objective: The primary objective is the effect of MBSR on quality of life. Secondary objectives are the effects of MBSR on mental health, mindfulness, and cardiovascular risk factors, and the cost-effectiveness of MBSR. Study design: Multicenter Torgerson preference randomised controlled trial. Complemented with qualitative research in a maximum of 12 patients in the intervention arm. Study population: Patients with atherosclerotic cardiovascular disease (i.e. coronary artery disease, ischemic heart failure, and peripheral artery disease). Intervention: The intervention group will receive an 8-week MBSR programme in addition to treatment as usual (TAU+MBSR), while the control group will receive only treatment as usual (TAU). Main study parameters: The primary outcome is the change of scores on the SF-36 scale, which is an instrument for measuring quality of life. Secondary outcomes are depression and anxiety (HADS questionnaire), stress (PSS-10 questionnaire), mindfulness (FFMQ-SF questionnaire), smoking, BMI, blood pressure, heart rate, plasma lipids and HbA1c, hair cortisol, quality of life measured by EQ-5D-5L questionnaire, health care costs, and non-health care costs. Nature and extent of the burden and risks: Participation in this trial is not associated with additional risks compared to treatment as usual. MBSR is proven to be safe and is widely accepted for patients with a variety of conditions as well as for healthy persons. The burden of participation (i.e. time investment and extra examinations) will be compensated by the possible benefits. MBSR is already successfully used for the treatment of a variety of physical and mental conditions, including chronic pain, cancer, anxiety, depression and burnout. As a substantial number of patients with cardiovascular disease experience distress, mindfulness could be an effective intervention for this population as well. The American Heart Association recently stated that meditation, as it is a low-cost and low-risk intervention, may be considered as an adjunct to current cardiovascular management. However, further research on the effects of mindfulness is warranted and should preferably consist of randomised, adequately powered studies with use of a control group.

Conditions

• Peripheral Arterial Disease
• Heart Failure
• Myocardial Infarction
• Atherosclerotic Cardiovascular Disease

Interventions

Type	Name	Description
BEHAVIORAL	Mindfulness-based stress reduction	Mindfulness-based stress reduction (MBSR) is a structured programme of 8 weekly sessions of 2-2,5 hours in groups of 8-16 participants organized at the hospital sites. Additionally, participants are encouraged to practice each day for 30-45 minutes using audio-recordings of the guided exercises. The programme is provided by experienced mindfulness teachers according to the standard MBSR protocol, except for the all-day session.

Timeline

• Start date: 2019-01-01
• Primary completion: 2021-12-01
• Completion: 2025-12-01
• First posted: 2019-02-01
• Last updated: 2019-02-01

Locations

2 sites across 1 country: Netherlands