Impact of Mindfulness-Based Stress Reduction Meditation Practice on Patients After Cardiac Rehabilitation.

NCT06438159 | Recruiting

• 1 other identifier: CARDIO-MBSR
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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

Cardiac Disease

Keywords

cardiac rehabilitation; MBSR

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 12 months

Secondary Outcomes (15)

• To assess the quality of life

  Baseline, 1 month, 6 months and 12 months

• Medical treatment compliance

  Baseline, 1 month, 6 months and 12 months

• Changes from baseline of cardiac risk factor "fasting blood glucose"

  Baseline, 1 month, 6 months and 12 months

• Changes from baseline of cardiac risk factor "glycosylated hemoglobin"

  Baseline, 1 month, 6 months and 12 months

• Changes from baseline of cardiac risk factor "Lipid profile LDLc"

  Baseline, 1 month, 6 months and 12 months

Study Arms (2)

Cardiac rehabilitation with Mindfulness-Based Stress Reduction (MBSR)

EXPERIMENTAL

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

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

Conventional cardiac rehabilitation

ACTIVE COMPARATOR

Conventional cardiac rehabilitation over 4 weeks

Other: Conventional cardiac rehabilitation

Interventions

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.

Cardiac rehabilitation with Mindfulness-Based Stress Reduction (MBSR)

Conventional cardiac rehabilitation OTHER

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

Conventional cardiac rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Elsan: lead

Study Sites (1)

Clinique d'Aressy

Aressy, 64320, France

RECRUITING

MeSH Terms

Conditions

Heart Diseases

Interventions

Cardiac Rehabilitation; Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Bernard Truong, MD

CONTACT

0556003048; recherche.na@elsan.care

Bernard Truong, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: May 31, 2024
• Study Start: November 12, 2024
• Primary Completion (Estimated): November 12, 2026
• Study Completion (Estimated): November 12, 2026
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)