Peripheral Arterial DiseaseNCT03826836
Mind Our Heart Study
A study testing Mindfulness-based stress reduction in people with Peripheral Arterial Disease and Heart Failure, run by Catharina Ziekenhuis Eindhoven at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Heart Failure, Myocardial Infarction
- What is being tested?
- Mindfulness-based stress reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesNetherlands
- Study dates
- Jan 2019to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (i.e. older than 18 years)
- Established ASCVD (i.e. coronary artery disease, ischemic heart failure, or peripheral artery disease)
Who cannot join
- Current acute cardiovascular event (myocardial infarction, major stroke, acute limb ischemia in prior 2 weeks)
- Critical limb ischemia
- Terminal illness
- History of psychosis
- Current severe psychiatric disorder
- Current psychotherapy
Show all 11Show fewer
- Non-Dutch speaking
- Cognitive impairment
- Behavioural problems that distort group therapy
- Active mindfulness/meditation or yoga practice within the past year
- Current participation in another clinical trial that interferes with this study's intervention or primary outcome
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Catharina Hospital
Eindhoven
Joep Teijink, MD,PhD, +31402397150, joep.teijink@catharinaziekenhuis.nl
Joep Teijink, MD,PhD
Máxima Medical Center
Veldhoven
Marc Scheltinga, MD,PhD, +3140 - 888 85 50, m.scheltinga@mmc.nl
Marc Scheltinga, MD, PhD
About this study
Official title: Effectiveness of Mindfulness-based Stress Reduction for Improving Quality of Life in Patients With Cardiovascular Disease: a Randomised Controlled Trial
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.
Read the 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
- Being tested
- Mindfulness-based stress reduction
- Medical subject headings
- Peripheral Arterial Disease, Heart Failure, Myocardial Infarction, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based stress reductionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Treatment as usual (i.e. best medical treatment). |
| Mindfulness-based stress reduction | Experimental | Treatment as usual (i.e. best medical treatment) in combination with an eight-week mindfulness-based stress reduction programme. Receives: Behavioral: Mindfulness-based stress reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Related Quality of Life
Health related quality of life (HRQOL) will be measured with the SF-36 (Short Form) questionnaire, which contains 36 questions. The total score is based on a 100-point scale, with a higher score indicating a higher quality of life.
Physical health summary scores are derived using four scales (physical functioning, role functioning due to physical problems, bodily pain and general health perceptions), while mental health summary scores are derived using four other scales (mental health, role limitations due to emotional problems, social functioning and vitality).
The change of scores over time for all time points will be reported.
Measured: Baseline, 3, 6, 12, 24, and 60 months.
Secondary outcomes (13)
Depression
Depression will be measured with the Hospital Anxiety and Depression Scale (HADS), which is a 14-item self-report screening scale which is used to indicate the possible presence of anxiety and/or depressive symptoms. The scale includes 7 items on anxiety and 7 items on depression, both with a score ranging from 0 to 21. The total score is classified into no anxiety or depression disorder (≤7), possible disorder (8-10), and probable disorder (≥11).
Measured: Baseline, 3, 6, 12, 24, and 60 months.
Anxiety
Anxiety will be measured with the Hospital Anxiety and Depression Scale (HADS), which is a 14-item self-report screening scale which is used to indicate the possible presence of anxiety and/or depressive symptoms. The scale includes 7 items on anxiety and 7 items on depression, both with a score ranging from 0 to 21. The total score is classified into no anxiety or depression disorder (≤7), possible disorder (8-10), and probable disorder (≥11).
Measured: Baseline, 3, 6, 12, 24, and 60 months.
Perception of stress
Stress will be measured with the Perceived Stress Scale 10, which is the most widely used psychological instrument for measuring the perception of stress and consists of 10 items. It is a measure of the degree to which situations in one's life are appraised as stressful. Items are designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. Scores can range from 0 to 40 with higher scores indicating higher perceived stress.
Measured: Baseline, 3, 6, 12, 24, and 60 months.
Hair cortisol levels
Measurement of cortisol levels in hair
Measured: Baseline, 3, 6 and 12 months.
Five facets of mindfulness
Mindfulness will be measured with the Five Facet Mindfulness Questionnaire Short-Form (FFMQ-SF), and a single question about daily mindfulness practice (daily, weekly or not regularly).
The FFMQ-SF is a 24-items self-report screening scale which is used to measure five facets of mindfulness. These five facets are observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Facet scores range from 5 to 25 (for the 'observing' facet 4 to 20), with higher scores indicating more mindfulness.
Measured: Baseline, 3, 6, 12, 24, and 60 months.
Smoking status
Smoking status will be measured as dichotomous outcome (yes or no). If yes, the amount of cigarettes smoked per day will be recorded.
Measured: Baseline, 3, and 12 months.
Alcohol use
Alcohol use will be measured as dichotomous outcome (yes or no). If yes, the number of glasses of alcohol per week will be recorded.
Measured: Baseline, 3, and 12 months.
Body Mass Index (BMI)
BMI will be reported as kg/m².
Measured: Baseline, 3, and 12 months.
Blood pressure
Systolic and diastolic blood pressure will be measured using an automatic monitor. The mean of three measurements will be recorded.
Measured: Baseline, 3, and 12 months.
Heart rate
Heart rate will be measured using an automatic monitor. The mean of three measurements will be recorded.
Measured: Baseline, 3, and 12 months.
Serum lipids
Serum levels of total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides will be reported in units of mmol/L.
Measured: Baseline, 3, and 12 months.
Glycated hemoglobin (HbA1c)
Glycated hemoglobin (HbA1c) will be reported in units of mmol/L.
Measured: Baseline, 3, and 12 months.
Cost-effectiveness
The EQ-5D-5L questionnaire will be used for estimating preference weight for health status, which is combined with time in order to compute quality-adjusted life years (QALYs). The cost-effectiveness analysis includes health-care and non-health-care costs and is performed on an intention-to-treat basis. Outcomes are the total costs and QALYs. From these costs and QALYs incremental cost-effectiveness ratios (ICERs) are calculated.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study startJan 2019 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Heart Foundation, Erasmus Medical Center, Maxima Medical Center
- Responsible party
- Principal investigator, Joep Teijink, Catharina Ziekenhuis Eindhoven
- Investigators
- Ellen Rouwet, MD, PhD, Principal investigator, Erasmus Medical CenterJoep Teijink, MD, PhD, Principal investigator, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03826836
- Sponsor's protocol ID
- CZE-2018.24
- Status last verified
- Jan 2019
- First submitted
- 29 Jan 2019
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mindfulness-based Stress Reduction for Improving Quality of Life in Patients With Cardiovascular Disease: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03826836
- Acronym / sponsor ID
- CZE-2018.24
- Conditions
- Peripheral Arterial Disease, Heart Failure, Myocardial Infarction, Atherosclerotic Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Collaborators
- Dutch Heart Foundation, Erasmus Medical Center, Maxima Medical Center
- Study start
- Jan 2019 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 1 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Treatment as usual (i.e. best medical treatment). |
| Mindfulness-based stress reduction | Experimental | Behavioral: Mindfulness-based stress reductionTreatment as usual (i.e. best medical treatment) in combination with an eight-week mindfulness-based stress reduction programme. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult (i.e. older than 18 years)
- Established ASCVD (i.e. coronary artery disease, ischemic heart failure, or peripheral artery disease)
Key exclusion criteria (11 listed)
- Current acute cardiovascular event (myocardial infarction, major stroke, acute limb ischemia in prior 2 weeks)
- Critical limb ischemia
- Terminal illness
- History of psychosis
- Current severe psychiatric disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based stress reductionMindfulness-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. | Behavioural | Mindfulness-based stress reduction |
Primary outcome
Health Related Quality of Life
Time frame: Baseline, 3, 6, 12, 24, and 60 months.
Health related quality of life (HRQOL) will be measured with the SF-36 (Short Form) questionnaire, which contains 36 questions. The total score is based on a 100-point scale, with a higher score indicating a higher quality of life. Physical health summary scores are derived using four scales (physical functioning, role functioning due to physical problems, bodily pain and general health perceptions), while mental health summary scores are derived using four other scales (mental health, role limitations due to emotional problems, social functioning and vitality). The change of scores over time for all time points will be reported.
13 secondary outcomes
Depression
Time frame: Baseline, 3, 6, 12, 24, and 60 months.
Anxiety
Time frame: Baseline, 3, 6, 12, 24, and 60 months.
Perception of stress
Time frame: Baseline, 3, 6, 12, 24, and 60 months.
Hair cortisol levels
Time frame: Baseline, 3, 6 and 12 months.
Five facets of mindfulness
Time frame: Baseline, 3, 6, 12, 24, and 60 months.
Smoking status
Time frame: Baseline, 3, and 12 months.
Alcohol use
Time frame: Baseline, 3, and 12 months.
Body Mass Index (BMI)
Time frame: Baseline, 3, and 12 months.
Blood pressure
Time frame: Baseline, 3, and 12 months.
Heart rate
Time frame: Baseline, 3, and 12 months.
Serum lipids
Time frame: Baseline, 3, and 12 months.
Glycated hemoglobin (HbA1c)
Time frame: Baseline, 3, and 12 months.
Cost-effectiveness
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen Rouwet, MD, PhD principal investigator
Erasmus Medical Center
Joep Teijink, MD, PhD principal investigator
Catharina Ziekenhuis Eindhoven
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based stress reduction in people with Peripheral Arterial Disease and Heart Failure, run by Catharina Ziekenhuis Eindhoven at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandra Jansen, MD (+3140-2396347, info@mindourheartstudy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Related Quality of Life (time frame: Baseline, 3, 6, 12, 24, and 60 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2019.