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

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Depressive Symptoms
• Interventions: Behavioral: Mindfulness Based Stress Reduction (MBSR)

• Registration Number: NCT03340948
• Lead Sponsor: Linkoeping University

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.

Study Timeline

• Study Start: 2012-01-31
• Primary Completion: 2014-11-18
• Study Completion: 2014-11-30
• Status Verified: 2017-11
• Study First Submitted: 2017-11-06
• Study First Submitted QC: 2017-11-08
• Last Update Submitted: 2017-11-08
• Study First Posted: 2017-11-14
• Last Update Posted: 2017-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MBSR participation	Mindfulness Based Stress Reduction (MBSR)	Participation in the 8 week Mindfulness Based Stress Reduction (MBSR) course.

Primary Outcome Measures

Name	Time	Method
Feasibility	Immediately after the 8-week intervention.	Patient evaluation questionnaire

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Linköping University; 🇸🇪 Linköping, Sweden