Impact of Mindfulness-Based Stress Reduction Meditation Practice on Patients After Cardiac Rehabilitation.
- Conditions
- Cardiac Disease
- Interventions
- Other: Conventional cardiac rehabilitationOther: Cardiac rehabilitation with Mindfulness-Based Stress Reduction (MBSR)
- Registration Number
- NCT06438159
- Lead Sponsor
- Elsan
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 74
- Cardiac patients eligible for cardiac rehabilitation,
- 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
- Age ≥ 18 years
- Affiliated with a social security scheme or beneficiary of such a scheme
- Patient signed free and informed consent form
- Patients already treated for severe psychiatric disorders (major depression, psychosis, schizophrenia)
- Inability to follow the 8-week MBSR program
- Protected patient: minor, adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
- 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.
- Pregnant or breast-feeding patient
- Refusal to participate in the study or inability to comply with the study protocol for any reason whatsoever
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional cardiac rehabilitation Conventional cardiac rehabilitation Conventional cardiac rehabilitation over 4 weeks Cardiac rehabilitation with Mindfulness-Based Stress Reduction (MBSR) Cardiac rehabilitation with Mindfulness-Based Stress Reduction (MBSR) Conventional cardiac rehabilitation over 4 weeks with the introduction of MBSR over 8 weeks
- Primary Outcome Measures
Name Time Method Change from baseline of HADS anxiety and depression scores Baseline and 12 months 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.
- Secondary Outcome Measures
Name Time Method To assess the quality of life Baseline, 1 month, 6 months and 12 months 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.
Medical treatment compliance Baseline, 1 month, 6 months and 12 months 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.
Changes from baseline of cardiac risk factor "activity" Baseline, 1 month, 6 months and 12 months Ricci Gagnon scale: self questionnaire including 9 questions to evaluate if the subject has an inactive, active or very active profile
Changes from baseline of cardiac risk factor "Tobacco consumption" Baseline, 1 month, 6 months and 12 months Tobacco consumption (in packs.year)
To assess the patient's depression Baseline, 1 months and 6 months HADS depression score
Changes from baseline of cardiac risk factor "fasting blood glucose" Baseline, 1 month, 6 months and 12 months fasting blood glucose (in g/L)
Changes from baseline of cardiac risk factor "glycosylated hemoglobin" Baseline, 1 month, 6 months and 12 months glycosylated hemoglobin (% of total hemoglobin)
Changes from baseline of cardiac risk factor "Lipid profile HDLc" Baseline, 1 month, 6 months and 12 months High Density Lipoprotein cholesterol (g/l)
Changes from baseline of cardiac risk factor "BMI" Baseline, 1 month, 6 months and 12 months BMI ( weight and height will be combined to report BMI in kg/m2)
Changes from baseline of cardiac risk factor "effort" Baseline, 1 month, 6 months and 12 months 6-minute walk test
To assess the patient's anxiety Baseline, 1 months and 6 months HADS anxiety score
Changes from baseline of cardiac risk factor "Lipid profile LDLc" Baseline, 1 month, 6 months and 12 months Low Density Lipoprotein cholesterol (g/l)
* Tobacco consumption (in packs.year)
* BMI
* Ricci Gagnon scale and 6-minute walk testTo evaluate the patient's "mindfulness" and its impact on vital aspects in patients who have benefited from the MBSR program. 3 months, 6 months and 12 months 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.Changes from baseline of cardiac risk factor "Blood pressure measurement" Baseline, 1 month, 6 months and 12 months Blood pressure
To evaluate the continuation of formal and informal mindfulness meditation practices in patients who have benefited from the MBSR program. 3 months, 6 months and 12 months Patients of the MBSR group will be asked two questions :
"Do you still do formal meditation practices?" "Do you still do informal meditation practices?"
Trial Locations
- Locations (1)
Clinique d'Aressy
🇫🇷Aressy, France