Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
240 participants
INTERVENTIONAL
2019-01-31
2025-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Control Group
Treatment as usual (i.e. best medical treatment).
No interventions assigned to this group
Mindfulness-based stress reduction
Treatment as usual (i.e. best medical treatment) in combination with an eight-week mindfulness-based stress reduction programme.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Established ASCVD (i.e. coronary artery disease, ischemic heart failure, or peripheral artery disease)
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Dutch Heart Foundation
OTHER
Erasmus Medical Center
OTHER
Maxima Medical Center
OTHER
Catharina Ziekenhuis Eindhoven
OTHER
Responsible Party
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Joep Teijink
Principal Investigator
Principal Investigators
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Ellen Rouwet, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Joep Teijink, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Catharina Ziekenhuis Eindhoven
Locations
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Catharina Hospital
Eindhoven, , Netherlands
Máxima Medical Center
Veldhoven, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CZE-2018.24
Identifier Type: -
Identifier Source: org_study_id
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