| Registry | NCT03340948, acronym MIMIRA |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, supportive care |
| Enrollment | 24 (Actual) |
| Sponsor | Linkoeping University (Other gov) |
| Conditions | Coronary Artery Disease, Depressive Symptoms |
| Interventions | Mindfulness Based Stress Reduction (MBSR) (Behavioral) |
| Dates | start 2012-01-31, primary completion 2014-11-18, completion 2014-11-30, first posted 2017-11-14, last updated 2017-11-14 |
| Locations | 1 site in Sweden |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| MBSR participation | Experimental | Behavioral: Mindfulness Based Stress Reduction (MBSR) | Participation in the 8 week Mindfulness Based Stress Reduction (MBSR) course. |
Sex: All, ages: 18 Years to 70 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Linköping University | Linköping | Sweden |