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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Depressive Symptoms
• Intervention / Treatment: Behavioral: Mindfulness Based Stress Reduction (MBSR)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Linköping, Sweden, 581 83
    • Linköping University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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).
2. Depressive symptoms above a score of 8 on the questionnaire centre for epidemiological studies depression scale (CES-D).
3. Interest for participation in MBSR.

Exclusion Criteria:

1. Major depression or other serious psychiatric illness (such as psychosis or ongoing life crisis).
2. Severe comorbidities, such as cancer, severe cognitive impairment and alcohol or drug abuse.
3. Practical hindrances for participation in MBSR.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MBSR participation; Participation in the 8 week Mindfulness Based Stress Reduction (MBSR) course.	Behavioral: Mindfulness Based Stress Reduction (MBSR); 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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Linkoeping University
• Investigators: Principal Investigator: Lena LJ Jonasson, M.D. Ph.D., Division of Cardiovascular Medicine, Department of Medical and Health Sciences, Linköping University

Publications and helpful links

General Publications

• Lundgren O, Garvin P, Nilsson L, Tornerefelt V, Andersson G, Kristenson M, Jonasson L. Mindfulness-Based Stress Reduction for Coronary Artery Disease Patients: Potential Improvements in Mastery and Depressive Symptoms. J Clin Psychol Med Settings. 2022 Sep;29(3):489-497. doi: 10.1007/s10880-021-09822-z. Epub 2021 Sep 28.
• Lundgren O, Garvin P, Kristenson M, Jonasson L, Thylen I. A journey through chaos and calmness: experiences of mindfulness training in patients with depressive symptoms after a recent coronary event - a qualitative diary content analysis. BMC Psychol. 2018 Sep 13;6(1):46. doi: 10.1186/s40359-018-0252-1.

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2012
• Primary Completion (Actual): November 18, 2014
• Study Completion (Actual): November 30, 2014

Study Registration Dates

• First Submitted: November 6, 2017
• First Submitted That Met QC Criteria: November 8, 2017
• First Posted (Actual): November 14, 2017

Study Record Updates

• Last Update Posted (Actual): November 14, 2017
• Last Update Submitted That Met QC Criteria: November 8, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Mastery; Coronary Artery Disease; Mindfulness Based Stress Reduction; Depressive symptoms
• Additional Relevant MeSH Terms: Behavioral Symptoms; Ischemia; Pathologic Processes; Necrosis; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Myocardial Infarction; Infarction; Depression; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 2013/17/31

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data will be available on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No