## Protocol Section
### Identification Module
**NCT ID:** NCT06438159

**Acronym:** CARDIO-MBSR

**Brief Title:** 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.

#### Organization Study ID Info
**ID:** CARDIO-MBSR
#### Organization
**Class:** OTHER
**Full Name:** Elsan
### Status Module
#### Completion Date
**Date:** 2026-09-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-29

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-09-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-09-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Elsan

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Cardiac Disease

**Keywords:**

- cardiac rehabilitation

- MBSR

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 74

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: Cardiac rehabilitation with Mindfulness-Based Stress Reduction (MBSR)

**Label:** Cardiac rehabilitation with Mindfulness-Based Stress Reduction (MBSR)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Conventional cardiac rehabilitation over 4 weeks

**Intervention Names:**

- Other: Conventional cardiac rehabilitation

**Label:** Conventional cardiac rehabilitation

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Cardiac rehabilitation with Mindfulness-Based Stress Reduction (MBSR)

**Description:** 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.

**Name:** Cardiac rehabilitation with Mindfulness-Based Stress Reduction (MBSR)

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Conventional cardiac rehabilitation

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

**Name:** Conventional cardiac rehabilitation

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Change from baseline of HADS anxiety and depression scores

**Time Frame:** Baseline and 12 months

#### Secondary Outcomes

**Description:** 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.

**Measure:** To assess the quality of life

**Time Frame:** Baseline, 1 month, 6 months and 12 months

**Description:** 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.

**Measure:** Medical treatment compliance

**Time Frame:** Baseline, 1 month, 6 months and 12 months

**Description:** fasting blood glucose (in g/L)

**Measure:** Changes from baseline of cardiac risk factor "fasting blood glucose"

**Time Frame:** Baseline, 1 month, 6 months and 12 months

**Description:** glycosylated hemoglobin (% of total hemoglobin)

**Measure:** Changes from baseline of cardiac risk factor "glycosylated hemoglobin"

**Time Frame:** Baseline, 1 month, 6 months and 12 months

**Description:** Low Density Lipoprotein cholesterol (g/l)

* Tobacco consumption (in packs.year)
* BMI
* Ricci Gagnon scale and 6-minute walk test

**Measure:** Changes from baseline of cardiac risk factor "Lipid profile LDLc"

**Time Frame:** Baseline, 1 month, 6 months and 12 months

**Description:** High Density Lipoprotein cholesterol (g/l)

**Measure:** Changes from baseline of cardiac risk factor "Lipid profile HDLc"

**Time Frame:** Baseline, 1 month, 6 months and 12 months

**Description:** BMI ( weight and height will be combined to report BMI in kg/m2)

**Measure:** Changes from baseline of cardiac risk factor "BMI"

**Time Frame:** Baseline, 1 month, 6 months and 12 months

**Description:** 6-minute walk test

**Measure:** Changes from baseline of cardiac risk factor "effort"

**Time Frame:** Baseline, 1 month, 6 months and 12 months

**Description:** Ricci Gagnon scale: self questionnaire including 9 questions to evaluate if the subject has an inactive, active or very active profile

**Measure:** Changes from baseline of cardiac risk factor "activity"

**Time Frame:** Baseline, 1 month, 6 months and 12 months

**Description:** Tobacco consumption (in packs.year)

**Measure:** Changes from baseline of cardiac risk factor "Tobacco consumption"

**Time Frame:** Baseline, 1 month, 6 months and 12 months

**Description:** Blood pressure

**Measure:** Changes from baseline of cardiac risk factor "Blood pressure measurement"

**Time Frame:** Baseline, 1 month, 6 months and 12 months

**Description:** HADS anxiety score

**Measure:** To assess the patient's anxiety

**Time Frame:** Baseline, 1 months and 6 months

**Description:** HADS depression score

**Measure:** To assess the patient's depression

**Time Frame:** Baseline, 1 months and 6 months

**Description:** Patients of the MBSR group will be asked two questions :

"Do you still do formal meditation practices?" "Do you still do informal meditation practices?"

**Measure:** 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

**Description:** 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.

**Measure:** 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

### Eligibility Module

**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 Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** cardiotmkb@me.com

**Name:** Bernard Truong, MD

**Phone:** +33622079508

**Role:** CONTACT

**Contact 2:**

**Name:** Bernard Truong, MD

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Aressy

**Contacts:**

***Contact 1:***

- **Email:** cardiotmk@me.com

- **Name:** Bernard Truong, MD

- **Phone:** +33622079508

- **Role:** CONTACT

***Contact 2:***

- **Name:** Bernard Truong, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** France

**Facility:** Clinique d'Aressy

**Zip:** 64320

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M9419

- Name: Heart Diseases

- Relevance: HIGH

- As Found: Cardiac Disease

### Condition Browse Module - Meshes

- ID: D000006331

- Term: Heart Diseases

### Misc Info Module

- Version Holder: 2024-05-31
