Cardiac DiseaseCARDIO-MBSRNCT06438159
Impact of Mindfulness-Based Stress Reduction Meditation Practice on Patients After Cardiac Rehabilitation.
A study testing Cardiac rehabilitation with Mindfulness-Based Stress Reduction (MBSR) and Conventional cardiac rehabilitation in people with Cardiac Disease, run by Elsan at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- Cardiac rehabilitation with Mindfulness-Based Stress Reduction (MBSR) and Conventional cardiac rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteFrance
- Study dates
- 12 Nov 2024to 12 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Mindfulness-Based Stress Reduction Meditation Practice on Medium- and Long-term Follow-up of Cardiac Patients After Cardiac Rehabilitation.
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.
Read more
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
- Being tested
- Cardiac rehabilitation with Mindfulness-Based Stress Reduction (MBSR), Conventional cardiac rehabilitation
- Keywords
- cardiac rehabilitation, MBSR
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac rehabilitation with Mindfulness-Based Stress Reduction (MBSR)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 rehabilitationOther
The usual cardiac rehabilitation program combines exercise training and therapeutic education workshops, with a daily session for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac rehabilitation with Mindfulness-Based Stress Reduction (MBSR) | Experimental | Conventional cardiac rehabilitation over 4 weeks with the introduction of MBSR over 8 weeks Receives: Other: Cardiac rehabilitation with Mindfulness-Based Stress Reduction (MBSR) |
| Conventional cardiac rehabilitation | Active comparator | Conventional cardiac rehabilitation over 4 weeks Receives: Other: Conventional cardiac rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 months
Secondary outcomes (15)
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.
Measured: 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.
Measured: Baseline, 1 month, 6 months and 12 months
Changes from baseline of cardiac risk factor "fasting blood glucose"
fasting blood glucose (in g/L)
Measured: Baseline, 1 month, 6 months and 12 months
Changes from baseline of cardiac risk factor "glycosylated hemoglobin"
glycosylated hemoglobin (% of total hemoglobin)
Measured: 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
Measured: Baseline, 1 month, 6 months and 12 months
Changes from baseline of cardiac risk factor "Lipid profile HDLc"
High Density Lipoprotein cholesterol (g/l)
Measured: 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)
Measured: Baseline, 1 month, 6 months and 12 months
Changes from baseline of cardiac risk factor "effort"
6-minute walk test
Measured: 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
Measured: Baseline, 1 month, 6 months and 12 months
Changes from baseline of cardiac risk factor "Tobacco consumption"
Tobacco consumption (in packs.year)
Measured: Baseline, 1 month, 6 months and 12 months
Changes from baseline of cardiac risk factor "Blood pressure measurement"
Blood pressure
Measured: Baseline, 1 month, 6 months and 12 months
To assess the patient's anxiety
HADS anxiety score
Measured: Baseline, 1 months and 6 months
To assess the patient's depression
HADS depression score
Measured: 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?"
Measured: 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.
Measured: 3 months, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start12 Nov 2024
- Primary completion12 Nov 2026 (estimated)
- Study completion12 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06438159
- Sponsor's protocol ID
- CARDIO-MBSR
- Acronym
- CARDIO-MBSR
- Status last verified
- Jun 2026
- First submitted
- 23 May 2024
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Mindfulness-Based Stress Reduction Meditation Practice on Medium- and Long-term Follow-up of Cardiac Patients After Cardiac Rehabilitation.
- ClinicalTrials.gov ID
- NCT06438159
- Acronym / sponsor ID
- CARDIO-MBSR / CARDIO-MBSR
- Conditions
- Cardiac Disease
- Keywords
- cardiac rehabilitation, MBSR
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 74 participants (actual)
- Lead sponsor
- ElsanUniversity, hospital or other
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 12 Nov 2026 (estimated)
- Study completion
- 12 Nov 2026 (estimated)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiac rehabilitation with Mindfulness-Based Stress Reduction (MBSR) | Experimental | Other: Cardiac rehabilitation with Mindfulness-Based Stress Reduction (MBSR)Conventional cardiac rehabilitation over 4 weeks with the introduction of MBSR over 8 weeks |
| Conventional cardiac rehabilitation | Active comparator | Other: Conventional cardiac rehabilitationConventional cardiac rehabilitation over 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Cardiac rehabilitation with Mindfulness-Based Stress Reduction (MBSR) |
| Conventional cardiac rehabilitationThe usual cardiac rehabilitation program combines exercise training and therapeutic education workshops, with a daily session for four weeks. | Other | Conventional cardiac rehabilitation |
Primary outcome
Change from baseline of HADS anxiety and depression scores
Time frame: 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.
15 secondary outcomes
To assess the quality of life
Time frame: Baseline, 1 month, 6 months and 12 months
Medical treatment compliance
Time frame: Baseline, 1 month, 6 months and 12 months
Changes from baseline of cardiac risk factor "fasting blood glucose"
Time frame: Baseline, 1 month, 6 months and 12 months
Changes from baseline of cardiac risk factor "glycosylated hemoglobin"
Time frame: Baseline, 1 month, 6 months and 12 months
Changes from baseline of cardiac risk factor "Lipid profile LDLc"
Time frame: Baseline, 1 month, 6 months and 12 months
Changes from baseline of cardiac risk factor "Lipid profile HDLc"
Time frame: Baseline, 1 month, 6 months and 12 months
Changes from baseline of cardiac risk factor "BMI"
Time frame: Baseline, 1 month, 6 months and 12 months
Changes from baseline of cardiac risk factor "effort"
Time frame: Baseline, 1 month, 6 months and 12 months
Changes from baseline of cardiac risk factor "activity"
Time frame: Baseline, 1 month, 6 months and 12 months
Changes from baseline of cardiac risk factor "Tobacco consumption"
Time frame: Baseline, 1 month, 6 months and 12 months
Changes from baseline of cardiac risk factor "Blood pressure measurement"
Time frame: Baseline, 1 month, 6 months and 12 months
To assess the patient's anxiety
Time frame: Baseline, 1 months and 6 months
To assess the patient's depression
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.
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.
Time frame: 3 months, 6 months and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac rehabilitation with Mindfulness-Based Stress Reduction (MBSR) and Conventional cardiac rehabilitation in people with Cardiac Disease, run by Elsan at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of HADS anxiety and depression scores (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.