<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03826836</url>
  </required_header>
  <id_info>
    <org_study_id>CZE-2018.24</org_study_id>
    <nct_id>NCT03826836</nct_id>
  </id_info>
  <brief_title>Mind Our Heart Study</brief_title>
  <official_title>Effectiveness of Mindfulness-based Stress Reduction for Improving Quality of Life in Patients With Cardiovascular Disease: a Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Catharina Ziekenhuis Eindhoven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dutch Heart Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Erasmus Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Maxima Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Catharina Ziekenhuis Eindhoven</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with atherosclerotic cardiovascular disease (i.e. peripheral artery disease,&#xD;
      ischemic heart failure, myocardial infarction) are randomised to (1) treatment as usual (i.e.&#xD;
      best medical care) or (2) treatment as usual (i.e. best medical care) in combination with an&#xD;
      eight-week mindfulness-based stress reduction programme.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale: Distress, including depression, anxiety, and chronic stress, is common among&#xD;
      patients with cardiovascular disease. This reduces their quality of life and worsens their&#xD;
      prognosis. A structured mindfulness training programme, such as the 8-week mindfulness-based&#xD;
      stress reduction (MBSR) course, may reduce distress, improve quality of life, support a&#xD;
      healthy lifestyle and modify cardiovascular risks. The aim of this randomised controlled&#xD;
      trial is to determine whether MBSR improves the quality of life in patients with&#xD;
      atherosclerotic cardiovascular disease.&#xD;
&#xD;
      Objective: The primary objective is the effect of MBSR on quality of life. Secondary&#xD;
      objectives are the effects of MBSR on mental health, mindfulness, and cardiovascular risk&#xD;
      factors, and the cost-effectiveness of MBSR.&#xD;
&#xD;
      Study design: Multicenter Torgerson preference randomised controlled trial. Complemented with&#xD;
      qualitative research in a maximum of 12 patients in the intervention arm.&#xD;
&#xD;
      Study population: Patients with atherosclerotic cardiovascular disease (i.e. coronary artery&#xD;
      disease, ischemic heart failure, and peripheral artery disease).&#xD;
&#xD;
      Intervention: The intervention group will receive an 8-week MBSR programme in addition to&#xD;
      treatment as usual (TAU+MBSR), while the control group will receive only treatment as usual&#xD;
      (TAU).&#xD;
&#xD;
      Main study parameters: The primary outcome is the change of scores on the SF-36 scale, which&#xD;
      is an instrument for measuring quality of life. Secondary outcomes are depression and anxiety&#xD;
      (HADS questionnaire), stress (PSS-10 questionnaire), mindfulness (FFMQ-SF questionnaire),&#xD;
      smoking, BMI, blood pressure, heart rate, plasma lipids and HbA1c, hair cortisol, quality of&#xD;
      life measured by EQ-5D-5L questionnaire, health care costs, and non-health care costs.&#xD;
&#xD;
      Nature and extent of the burden and risks: Participation in this trial is not associated with&#xD;
      additional risks compared to treatment as usual. MBSR is proven to be safe and is widely&#xD;
      accepted for patients with a variety of conditions as well as for healthy persons. The burden&#xD;
      of participation (i.e. time investment and extra examinations) will be compensated by the&#xD;
      possible benefits. MBSR is already successfully used for the treatment of a variety of&#xD;
      physical and mental conditions, including chronic pain, cancer, anxiety, depression and&#xD;
      burnout. As a substantial number of patients with cardiovascular disease experience distress,&#xD;
      mindfulness could be an effective intervention for this population as well. The American&#xD;
      Heart Association recently stated that meditation, as it is a low-cost and low-risk&#xD;
      intervention, may be considered as an adjunct to current cardiovascular management. However,&#xD;
      further research on the effects of mindfulness is warranted and should preferably consist of&#xD;
      randomised, adequately powered studies with use of a control group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">January 2019</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized controlled trial</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Health Related Quality of Life</measure>
    <time_frame>Baseline, 3, 6, 12, 24, and 60 months.</time_frame>
    <description>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.&#xD;
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).&#xD;
The change of scores over time for all time points will be reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>Baseline, 3, 6, 12, 24, and 60 months.</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>Baseline, 3, 6, 12, 24, and 60 months.</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perception of stress</measure>
    <time_frame>Baseline, 3, 6, 12, 24, and 60 months.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hair cortisol levels</measure>
    <time_frame>Baseline, 3, 6 and 12 months.</time_frame>
    <description>Measurement of cortisol levels in hair</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Five facets of mindfulness</measure>
    <time_frame>Baseline, 3, 6, 12, 24, and 60 months.</time_frame>
    <description>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).&#xD;
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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Smoking status</measure>
    <time_frame>Baseline, 3, and 12 months.</time_frame>
    <description>Smoking status will be measured as dichotomous outcome (yes or no). If yes, the amount of cigarettes smoked per day will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol use</measure>
    <time_frame>Baseline, 3, and 12 months.</time_frame>
    <description>Alcohol use will be measured as dichotomous outcome (yes or no). If yes, the number of glasses of alcohol per week will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index (BMI)</measure>
    <time_frame>Baseline, 3, and 12 months.</time_frame>
    <description>BMI will be reported as kg/m².</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>Baseline, 3, and 12 months.</time_frame>
    <description>Systolic and diastolic blood pressure will be measured using an automatic monitor. The mean of three measurements will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>Baseline, 3, and 12 months.</time_frame>
    <description>Heart rate will be measured using an automatic monitor. The mean of three measurements will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum lipids</measure>
    <time_frame>Baseline, 3, and 12 months.</time_frame>
    <description>Serum levels of total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides will be reported in units of mmol/L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycated hemoglobin (HbA1c)</measure>
    <time_frame>Baseline, 3, and 12 months.</time_frame>
    <description>Glycated hemoglobin (HbA1c) will be reported in units of mmol/L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness</measure>
    <time_frame>12 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Peripheral Arterial Disease</condition>
  <condition>Heart Failure</condition>
  <condition>Myocardial Infarction</condition>
  <condition>Atherosclerotic Cardiovascular Disease</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Treatment as usual (i.e. best medical treatment).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mindfulness-based stress reduction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment as usual (i.e. best medical treatment) in combination with an eight-week mindfulness-based stress reduction programme.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness-based stress reduction</intervention_name>
    <description>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.</description>
    <arm_group_label>Mindfulness-based stress reduction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult (i.e. older than 18 years)&#xD;
&#xD;
          -  Established ASCVD (i.e. coronary artery disease, ischemic heart failure, or peripheral&#xD;
             artery disease)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current acute cardiovascular event (myocardial infarction, major stroke, acute limb&#xD;
             ischemia in prior 2 weeks)&#xD;
&#xD;
          2. Critical limb ischemia&#xD;
&#xD;
          3. Terminal illness&#xD;
&#xD;
          4. History of psychosis&#xD;
&#xD;
          5. Current severe psychiatric disorder&#xD;
&#xD;
          6. Current psychotherapy&#xD;
&#xD;
          7. Non-Dutch speaking&#xD;
&#xD;
          8. Cognitive impairment&#xD;
&#xD;
          9. Behavioural problems that distort group therapy&#xD;
&#xD;
         10. Active mindfulness/meditation or yoga practice within the past year&#xD;
&#xD;
         11. Current participation in another clinical trial that interferes with this study's&#xD;
             intervention or primary outcome&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ellen Rouwet, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Erasmus Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Joep Teijink, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Catharina Ziekenhuis Eindhoven</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sandra Jansen, MD</last_name>
    <phone>+3140-2396347</phone>
    <email>info@mindourheartstudy.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Catharina Hospital</name>
      <address>
        <city>Eindhoven</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <contact>
      <last_name>Joep Teijink, MD,PhD</last_name>
      <phone>+31402397150</phone>
      <email>joep.teijink@catharinaziekenhuis.nl</email>
    </contact>
    <investigator>
      <last_name>Joep Teijink, MD,PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Máxima Medical Center</name>
      <address>
        <city>Veldhoven</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <contact>
      <last_name>Marc Scheltinga, MD,PhD</last_name>
      <phone>+3140 - 888 85 50</phone>
      <email>m.scheltinga@mmc.nl</email>
    </contact>
    <investigator>
      <last_name>Marc Scheltinga, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Catharina Ziekenhuis Eindhoven</investigator_affiliation>
    <investigator_full_name>Joep Teijink</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Peripheral Arterial Disease</mesh_term>
    <mesh_term>Peripheral Vascular Diseases</mesh_term>
    <mesh_term>Atherosclerosis</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03826836
org study id: CZE-2018.24
nct id: NCT03826836
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled trial
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Health Related Quality of Life
time frame: Baseline, 3, 6, 12, 24, and 60 months.
description: 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.
measure: Depression
time frame: Baseline, 3, 6, 12, 24, and 60 months.
description: 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).
measure: Anxiety
time frame: Baseline, 3, 6, 12, 24, and 60 months.
description: 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).
measure: Perception of stress
time frame: Baseline, 3, 6, 12, 24, and 60 months.
description: 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.
measure: Hair cortisol levels
time frame: Baseline, 3, 6 and 12 months.
description: Measurement of cortisol levels in hair
measure: Five facets of mindfulness
time frame: Baseline, 3, 6, 12, 24, and 60 months.
description: 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.
measure: Smoking status
time frame: Baseline, 3, and 12 months.
description: Smoking status will be measured as dichotomous outcome (yes or no). If yes, the amount of cigarettes smoked per day will be recorded.
measure: Alcohol use
time frame: Baseline, 3, and 12 months.
description: Alcohol use will be measured as dichotomous outcome (yes or no). If yes, the number of glasses of alcohol per week will be recorded.
measure: Body Mass Index (BMI)
time frame: Baseline, 3, and 12 months.
description: BMI will be reported as kg/m².
measure: Blood pressure
time frame: Baseline, 3, and 12 months.
description: Systolic and diastolic blood pressure will be measured using an automatic monitor. The mean of three measurements will be recorded.
measure: Heart rate
time frame: Baseline, 3, and 12 months.
description: Heart rate will be measured using an automatic monitor. The mean of three measurements will be recorded.
measure: Serum lipids
time frame: Baseline, 3, and 12 months.
description: Serum levels of total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides will be reported in units of mmol/L.
measure: Glycated hemoglobin (HbA1c)
time frame: Baseline, 3, and 12 months.
description: Glycated hemoglobin (HbA1c) will be reported in units of mmol/L.
measure: Cost-effectiveness
time frame: 12 months
description: 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.
arm group label: Control Group
arm group type: No Intervention
description: Treatment as usual (i.e. best medical treatment).
arm group label: Mindfulness-based stress reduction
arm group type: Experimental
description: Treatment as usual (i.e. best medical treatment) in combination with an eight-week mindfulness-based stress reduction programme.
intervention type: Behavioral
intervention name: Mindfulness-based stress reduction
description: 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.
arm group label: Mindfulness-based stress reduction
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ellen Rouwet, MD, PhD
role: Principal Investigator
affiliation: Erasmus Medical Center
last name: Joep Teijink, MD, PhD
role: Principal Investigator
affiliation: Catharina Ziekenhuis Eindhoven
last name: Sandra Jansen, MD
phone: +3140-2396347
email: info@mindourheartstudy.com
facility: 
contact: 
investigator: 
facility: 
contact: 
investigator: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Catharina Ziekenhuis Eindhoven
investigator full name: Joep Teijink
investigator title: Principal Investigator
mesh term: Cardiovascular Diseases
mesh term: Myocardial Infarction
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases
mesh term: Atherosclerosis
mesh term: Infarction
sharing ipd: No