Status:
UNKNOWN
Mind Our Heart Study
Lead Sponsor:
Catharina Ziekenhuis Eindhoven
Collaborating Sponsors:
Dutch Heart Foundation
Erasmus Medical Center
Conditions:
Peripheral Arterial Disease
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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) o...
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 structur...
Eligibility Criteria
Inclusion
- Adult (i.e. older than 18 years)
- Established ASCVD (i.e. coronary artery disease, ischemic heart failure, or peripheral artery disease)
Exclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT03826836
Start Date
January 1 2019
End Date
December 1 2025
Last Update
February 1 2019
Active Locations (2)
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1
Catharina Hospital
Eindhoven, Netherlands
2
Máxima Medical Center
Veldhoven, Netherlands