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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
74
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.
The usual cardiac rehabilitation program combines exercise training and therapeutic education workshops, with a daily session for four weeks.
Clinique d'Aressy
Aressy, France
Change from baseline of HADS anxiety and depression scores
HADS (Hospital Anxiety and Depression Scale) is a self questionnaire including 14 items which identifies and quantifies the depression and anxiety from which a person suffers.
Time frame: Baseline and 12 months
To assess the quality of life
The patients' quality of life will be measured by the MQOL-R questionnaire, which is a 14-point tool forming 4 subscales: physical, psychological, existential and social.
Time frame: Baseline, 1 month, 6 months and 12 months
Medical treatment compliance
The patients' compliance to their medical treatment will be measured by the GIRERD self-questionnaire including 6 questions, to assess compliance, i.e. whether treatment is taken regularly and as prescribed.
Time frame: Baseline, 1 month, 6 months and 12 months
Changes from baseline of cardiac risk factor "fasting blood glucose"
fasting blood glucose (in g/L)
Time frame: Baseline, 1 month, 6 months and 12 months
Changes from baseline of cardiac risk factor "glycosylated hemoglobin"
glycosylated hemoglobin (% of total hemoglobin)
Time frame: Baseline, 1 month, 6 months and 12 months
Changes from baseline of cardiac risk factor "Lipid profile LDLc"
Low Density Lipoprotein cholesterol (g/l) * Tobacco consumption (in packs.year) * BMI * Ricci Gagnon scale and 6-minute walk test
Time frame: Baseline, 1 month, 6 months and 12 months
Changes from baseline of cardiac risk factor "Lipid profile HDLc"
High Density Lipoprotein cholesterol (g/l)
Time frame: Baseline, 1 month, 6 months and 12 months
Changes from baseline of cardiac risk factor "BMI"
BMI ( weight and height will be combined to report BMI in kg/m2)
Time frame: Baseline, 1 month, 6 months and 12 months
Changes from baseline of cardiac risk factor "effort"
6-minute walk test
Time frame: Baseline, 1 month, 6 months and 12 months
Changes from baseline of cardiac risk factor "activity"
Ricci Gagnon scale: self questionnaire including 9 questions to evaluate if the subject has an inactive, active or very active profile
Time frame: Baseline, 1 month, 6 months and 12 months
Changes from baseline of cardiac risk factor "Tobacco consumption"
Tobacco consumption (in packs.year)
Time frame: Baseline, 1 month, 6 months and 12 months
Changes from baseline of cardiac risk factor "Blood pressure measurement"
Blood pressure
Time frame: Baseline, 1 month, 6 months and 12 months
To assess the patient's anxiety
HADS anxiety score
Time frame: Baseline, 1 months and 6 months
To assess the patient's depression
HADS depression score
Time frame: Baseline, 1 months and 6 months
To evaluate the continuation of formal and informal mindfulness meditation practices in patients who have benefited from the MBSR program.
Patients of the MBSR group will be asked two questions : "Do you still do formal meditation practices?" "Do you still do informal meditation practices?"
Time frame: 3 months, 6 months and 12 months
To evaluate the patient's "mindfulness" and its impact on vital aspects in patients who have benefited from the MBSR program.
FFMQ (Five Facets Mindfulness Questionnaire) questionnaire, which includes 39 questions, which assess the 5 facets which constitute mindfulness as a construct: * Describe the experience: talk about the experience in words. * Acting mindfully: performing actions with active attention to each step. * Non-judgment: absence of positive or negative comments on the thoughts and emotions experienced. * Non-reactivity to private events: allowing thoughts and emotions to exist without responding to them automatically. * Observation: remaining aware and focused on the experience, even when it is aversive or painful.
Time frame: 3 months, 6 months and 12 months
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