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

Coronary Artery Disease Clinical Trial

— MIMIRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03340948
• Other study ID #: 2013/17/31
• Status: Completed
• Phase: N/A
• First received: November 6, 2017
• Last updated: November 8, 2017
• Start date: January 31, 2012
• Est. completion date: November 30, 2014

Study information

• Verified date: November 2017
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 30, 2014
• Est. primary completion date: November 18, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Depression
• Depressive Symptoms
• Infarction
• Myocardial Infarction
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
Sweden	Linköping University	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome

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