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

NCT ID: NCT06438159

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-12
• Study Completion Date: 2026-11-12

Brief Summary

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

Cardiac Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Cardiac rehabilitation with Mindfulness-Based Stress Reduction (MBSR)

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

Group Type: EXPERIMENTAL

Cardiac rehabilitation with Mindfulness-Based Stress Reduction (MBSR)

Intervention Type: OTHER

The MBSR program is as follows:

• 8 weekly group sessions of 2h30 led by the mindfulness instructor,
• Sessions of around 45 minutes a day to be carried out by the patient, at home, for personal training,
• An intensive day between the 6th and 7th sessions to explore certain practices more intensively, in order to support participants in effectively integrating mindfulness meditation into various life situations.

Conventional cardiac rehabilitation

Conventional cardiac rehabilitation over 4 weeks

Group Type: ACTIVE_COMPARATOR

Conventional cardiac rehabilitation

Intervention Type: OTHER

The usual cardiac rehabilitation program combines exercise training and therapeutic education workshops, with a daily session for four weeks.

Interventions

Cardiac rehabilitation with Mindfulness-Based Stress Reduction (MBSR)

The MBSR program is as follows:

• 8 weekly group sessions of 2h30 led by the mindfulness instructor,
• Sessions of around 45 minutes a day to be carried out by the patient, at home, for personal training,
• An intensive day between the 6th and 7th sessions to explore certain practices more intensively, in order to support participants in effectively integrating mindfulness meditation into various life situations.

Intervention Type: OTHER

Conventional cardiac rehabilitation

The usual cardiac rehabilitation program combines exercise training and therapeutic education workshops, with a daily session for four weeks.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Elsan

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinique d'Aressy

Aressy, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Bernard Truong, MD

Role: CONTACT

recherche.na@elsan.care

0556003048

Bernard Truong, MD

Role: CONTACT

Facility Contacts

Bernard Truong, MD

Role: primary

recherche.na@elsan.care

0556003048

Other Identifiers

CARDIO-MBSR

Identifier Type: -

Identifier Source: org_study_id