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Mind Our Heart Study

NCT03826836 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2019-02-01

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

  • Dutch Heart Foundation

    collaborator OTHER

  • Erasmus Medical Center

    collaborator OTHER

  • Maxima Medical Center

    collaborator OTHER

  • Catharina Ziekenhuis Eindhoven

    lead OTHER

Principal Investigators

  • Ellen Rouwet, MD, PhD · Erasmus Medical Center

  • Joep Teijink, MD, PhD · Catharina Ziekenhuis Eindhoven

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-31
Primary Completion
2021-12-31
Completion
2025-12-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03826836 on ClinicalTrials.gov