The Mindfulness Intervention as Myocardial Infarction Rehabilitation Additive (MIMIRA) Study

Study Overview
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Brief Summary
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The Mindfulness Intervention as Myocardial Infarction Rehabilitation Additive (MIMIRA) study aimed at studying the feasibility and acceptability of Mindfulness Based Stress Reduction - an 8 week course in meditation and yoga - in patients with a recent coronary artery event and elevated depressive symptoms. To address these questions patients with elevated scores on a depression scale were invited to participate in MBSR, and there evaluation of the course as well as a panel of psychological risk factors and resources was measured.

Detailed Description
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Depressive symptomatology in patients with coronary artery disease (CAD) has prognostic importance. Yet, psychological interventions in clinical practice are scarce. Here, we explored the feasibility and acceptability of mindfulness-based stress reduction (MBSR) in patients with depressive symptoms after a recent coronary event. A second aim was to investigate psychological risk factors and resources among participants. To address the research questions, depressive symptoms were first measured in a reference population, at 1 and 12 months after a coronary event (myocardial infarction or unstable angina pectoris), and a cut-off for elevated depressive symptoms were obtained from the median in this group. Thereafter, similar CAD patients with elevated depressive symptoms (above median in the reference group), from the same outpatient clinic, were consecutively invited to an 8-week MBSR program. Serious physical or psychiatric illness that would be an obstacle to participation were exclusion criteria. Patients who completed the MBSR-course were asked to evaluate its various facets, and completion rate and attendance were feasibility outcomes. Psychological variables were measured before, after the course as well as 12 months later.

Official Title
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The Mindfulness Intervention as Myocardial Infarction Rehabilitation Additive (MIMIRA) Study

Conditions
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Coronary Artery Disease, Depressive Symptoms

Intervention / Treatment
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* Behavioral: Mindfulness Based Stress Reduction (MBSR)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recent (within 12 month) first time coronary artery event; defined as a diagnosis of myocardial infarction or unstable angina pectoris addressed with either percutaneous coronary intervention (PCI) or coronary artery by-pass graft surgery (CABG). Depressive symptoms above a score of 8 on the questionnaire centre for epidemiological studies depression scale (CES-D). Interest for participation in MBSR. Exclusion Criteria: Major depression or other serious psychiatric illness (such as psychosis or ongoing life crisis). Severe comorbidities, such as cancer, severe cognitive impairment and alcohol or drug abuse. Practical hindrances for participation in MBSR.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Pilot and feasibility study of one cohort.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBSR participation<br>Participation in the 8 week Mindfulness Based Stress Reduction (MBSR) course. | Behavioral: Mindfulness Based Stress Reduction (MBSR)<br>* An 8-week course in mindfulness meditation, yoga training and weekly group support in the form of weekly 2,5 hour meetings at the hospital.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility | Patient evaluation questionnaire | Immediately after the 8-week intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive Symptoms | Centre for Epidemiological Studies Scale Depression (CES-D) questionnaire (Radloff) | Before, immediately after and 12 months post intervention. | 
| Anxiety | Generalized Anxiety Disorder Scale - 7 (GAD-7) questionnaire (Spitzer) | Before, immediately after and 12 months post intervention. | 
| Mindfulness | Five Facets of Mindfulness Questionnaire (FFMQ) (Baer) | Before, immediately after and 12 months post intervention. | 
| Acceptance | Acceptance and Action Questionnaire II (AAQII) (Block) | Before, immediately after and 12 months post intervention. | 
| Mastery | Mastery questionnaire (Pearlin & Shooler) | Before, immediately after and 12 months post intervention. | 
| Self-esteem | Self-esteem questionnaire (Rosenberg) | Before, immediately after and 12 months post intervention. | 
| Patients experiences of mindfulness training | Written journal entries (linguistic content) | Continuously during the 8 week course. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness Based Stress Reduction, Depressive symptoms, Coronary Artery Disease, Mastery