Clinical trial NCT06438159: Impact of Mindfulness-Based Stress Reduction Meditation Practice on Patients After Cardiac Rehabilitation.
Official title: Impact of Mindfulness-Based Stress Reduction Meditation Practice on Medium- and Long-term Follow-up of Cardiac Patients After Cardiac Rehabilitation.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Disease
Keywords: cardiac rehabilitation
MBSR
Lead sponsor: Elsan
Sponsor class: OTHER
First posted: 2024-05-31
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Change from baseline of HADS anxiety and depression scores
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: To assess the quality of life
timeFrame: Baseline, 1 month, 6 months and 12 months
measure: Medical treatment compliance
timeFrame: Baseline, 1 month, 6 months and 12 months
measure: Changes from baseline of cardiac risk factor "fasting blood glucose"
timeFrame: Baseline, 1 month, 6 months and 12 months
measure: Changes from baseline of cardiac risk factor "glycosylated hemoglobin"
timeFrame: Baseline, 1 month, 6 months and 12 months
measure: Changes from baseline of cardiac risk factor "Lipid profile LDLc"
timeFrame: Baseline, 1 month, 6 months and 12 months
measure: Changes from baseline of cardiac risk factor "Lipid profile HDLc"
timeFrame: Baseline, 1 month, 6 months and 12 months
measure: Changes from baseline of cardiac risk factor "BMI"
timeFrame: Baseline, 1 month, 6 months and 12 months
measure: Changes from baseline of cardiac risk factor "effort"
timeFrame: Baseline, 1 month, 6 months and 12 months
measure: Changes from baseline of cardiac risk factor "activity"
timeFrame: Baseline, 1 month, 6 months and 12 months
measure: Changes from baseline of cardiac risk factor "Tobacco consumption"
timeFrame: Baseline, 1 month, 6 months and 12 months
measure: Changes from baseline of cardiac risk factor "Blood pressure measurement"
timeFrame: Baseline, 1 month, 6 months and 12 months
measure: To assess the patient's anxiety
timeFrame: Baseline, 1 months and 6 months
measure: To assess the patient's depression
timeFrame: Baseline, 1 months and 6 months
measure: To evaluate the continuation of formal and informal mindfulness meditation practices in patients who have benefited from the MBSR program.
timeFrame: 3 months, 6 months and 12 months
measure: To evaluate the patient's "mindfulness" and its impact on vital aspects in patients who have benefited from the MBSR program.
timeFrame: 3 months, 6 months and 12 months
Other outcomes:
Locations:
city: Aressy
country: France
facility: Clinique d'Aressy
Study officials:
References: