Impact of Mindfulness-Based Stress Reduction Meditation Practice on Patients After Cardiac Rehabilitation. (CARDIO-MBSR)

Elsan

Status: Not yet enrolling

Conditions: Cardiac Disease

Treatments: Other: Conventional cardiac rehabilitation; Other: Cardiac rehabilitation with Mindfulness-Based Stress Reduction (MBSR)

Study type: Interventional

Funder types: Other

Identifiers

NCT06438159

CARDIO-MBSR

Details and patient eligibility

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.

Enrollment: 74 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Cardiac patients eligible for cardiac rehabilitation,
2. Patient with a Hospital Anxiety and Depression Scale (HADS) score for the anxiety dimension (HADS-A) >7 or a score for the depression dimension (HADS-D) > 7
3. Age ≥ 18 years
4. Affiliated with a social security scheme or beneficiary of such a scheme
5. Patient signed free and informed consent form

Exclusion criteria

1. Patients already treated for severe psychiatric disorders (major depression, psychosis, schizophrenia)
2. Inability to follow the 8-week MBSR program
3. Protected patient: minor, adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
4. Medical conditions which may interfere with the conduct of the study and the investigator's judgment, and which may render the patient unfit to participate in the study.
5. Pregnant or breast-feeding patient
6. Refusal to participate in the study or inability to comply with the study protocol for any reason whatsoever

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Cardiac rehabilitation with Mindfulness-Based Stress Reduction (MBSR)

Experimental group

Description:

Conventional cardiac rehabilitation over 4 weeks with the introduction of MBSR over 8 weeks

Treatment:

Other: Cardiac rehabilitation with Mindfulness-Based Stress Reduction (MBSR)

Conventional cardiac rehabilitation

Active Comparator group

Description:

Conventional cardiac rehabilitation over 4 weeks

Treatment:

Other: Conventional cardiac rehabilitation