Clinical trial NCT03340948: The Mindfulness Intervention as Myocardial Infarction Rehabilitation Additive (MIMIRA) Study
Official title: The Mindfulness Intervention as Myocardial Infarction Rehabilitation Additive (MIMIRA) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Depressive Symptoms
Keywords: Mindfulness Based Stress Reduction
Depressive symptoms
Coronary Artery Disease
Mastery
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2017-11-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot and feasibility study of one cohort.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility
timeFrame: Immediately after the 8-week intervention.
Secondary outcomes:
measure: Depressive Symptoms
timeFrame: Before, immediately after and 12 months post intervention.
measure: Anxiety
timeFrame: Before, immediately after and 12 months post intervention.
measure: Mindfulness
timeFrame: Before, immediately after and 12 months post intervention.
measure: Acceptance
timeFrame: Before, immediately after and 12 months post intervention.
measure: Mastery
timeFrame: Before, immediately after and 12 months post intervention.
measure: Self-esteem
timeFrame: Before, immediately after and 12 months post intervention.
measure: Patients experiences of mindfulness training
timeFrame: Continuously during the 8 week course.
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Linköping University
Study officials:
affiliation: Division of Cardiovascular Medicine, Department of Medical and Health Sciences, Linköping University
name: Lena LJ Jonasson, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.