Clinical trial NCT03826836: Mind Our Heart Study
Official title: Effectiveness of Mindfulness-based Stress Reduction for Improving Quality of Life in Patients With Cardiovascular Disease: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Peripheral Arterial Disease
Heart Failure
Myocardial Infarction
Atherosclerotic Cardiovascular Disease
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
Collaborators: name: Dutch Heart Foundation
name: Erasmus Medical Center
name: Maxima Medical Center
First posted: 2019-02-01
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Adult (i.e. older than 18 years)
* Established ASCVD (i.e. coronary artery disease, ischemic heart failure, or peripheral artery disease)

Exclusion Criteria:

1. Current acute cardiovascular event (myocardial infarction, major stroke, acute limb ischemia in prior 2 weeks)
2. Critical limb ischemia
3. Terminal illness
4. History of psychosis
5. Current severe psychiatric disorder
6. Current psychotherapy
7. Non-Dutch speaking
8. Cognitive impairment
9. Behavioural problems that distort group therapy
10. Active mindfulness/meditation or yoga practice within the past year
11. Current participation in another clinical trial that interferes with this study's intervention or primary outcome

Primary outcomes:
measure: Health Related Quality of Life
timeFrame: Baseline, 3, 6, 12, 24, and 60 months.
Secondary outcomes:
measure: Depression
timeFrame: Baseline, 3, 6, 12, 24, and 60 months.
measure: Anxiety
timeFrame: Baseline, 3, 6, 12, 24, and 60 months.
measure: Perception of stress
timeFrame: Baseline, 3, 6, 12, 24, and 60 months.
measure: Hair cortisol levels
timeFrame: Baseline, 3, 6 and 12 months.
measure: Five facets of mindfulness
timeFrame: Baseline, 3, 6, 12, 24, and 60 months.
measure: Smoking status
timeFrame: Baseline, 3, and 12 months.
measure: Alcohol use
timeFrame: Baseline, 3, and 12 months.
measure: Body Mass Index (BMI)
timeFrame: Baseline, 3, and 12 months.
measure: Blood pressure
timeFrame: Baseline, 3, and 12 months.
measure: Heart rate
timeFrame: Baseline, 3, and 12 months.
measure: Serum lipids
timeFrame: Baseline, 3, and 12 months.
measure: Glycated hemoglobin (HbA1c)
timeFrame: Baseline, 3, and 12 months.
measure: Cost-effectiveness
timeFrame: 12 months
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
city: Veldhoven
country: Netherlands
facility: Máxima Medical Center
Study officials:
affiliation: Erasmus Medical Center
name: Ellen Rouwet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Catharina Ziekenhuis Eindhoven
name: Joep Teijink, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: