Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06438159

Impact of Mindfulness-Based Stress Reduction Meditation Practice on Patients After Cardiac Rehabilitation.

Led by Elsan · Updated on 2025-01-22

74

Participants Needed

1

Research Sites

104 weeks

Total Duration

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AI-Summary

What this Trial Is About

Cardiac rehabilitation is a major component of treatment for patients suffering from coronary pathology revealed by myocardial infarction or acute coronary syndrome warranting transluminal coronary angioplasty, as well as in the aftermath of cardiac surgery. A significant proportion of patients in this situation (40%) suffer from varying degrees of anxiety and depression, which are difficult to treat. These impair their quality of life and can make it more difficult for them to take part in the rehabilitation program, compromising the results that can be expected. Finally, they are often associated with lax compliance with medical treatment, less control of risk factors and less regular exercise. Cardiac rehabilitation teams are well aware of this anxiety-depressive picture, and various therapies such as sophrology, relaxation and yoga have been proposed as alternatives to conventional medical treatments to help patients through this period. Among these alternatives is the concept of "Mindfulness-Based Meditation", based on the Mindfulness-Based Stress Reduction (MBSR) protocol described by Dr. JKabat Zinn. It has been the subject of several prospective randomized studies, which have demonstrated that it is suitable for the management of patients in this situation, and that it has measurable beneficial effects on their sense of well-being. To our knowledge, the MBSR program used in cardiac rehabilitation has never been the subject of a randomized comparative study in France to assess its effectiveness on medium- and long-term anxiety-depressive disorders. This is the objective of this study.

CONDITIONS

Official Title

Impact of Mindfulness-Based Stress Reduction Meditation Practice on Patients After Cardiac Rehabilitation.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Cardiac patients eligible for cardiac rehabilitation
  • Hospital Anxiety and Depression Scale (HADS) anxiety score >7 or depression score >7
  • Age 18 years or older
  • Affiliated with or beneficiary of a social security scheme
  • Signed free and informed consent form
Not Eligible

You will not qualify if you...

  • Currently treated for severe psychiatric disorders such as major depression, psychosis, or schizophrenia
  • Unable to follow the 8-week MBSR program
  • Minor or adult under legal protection (guardianship, curatorship), or deprived of liberty by judicial or administrative decision
  • Medical conditions interfering with study participation or investigator judgment
  • Pregnant or breastfeeding
  • Refusal or inability to comply with study protocol for any reason

AI-Screening

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Trial Site Locations

Total: 1 location

1

Clinique d'Aressy

Aressy, France, 64320

Actively Recruiting

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Research Team

B

Bernard Truong, MD

CONTACT

B

Bernard Truong, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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