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

NCT ID: NCT03340948

Last Updated: 2017-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Coronary Artery Disease Depressive Symptoms

Keywords

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Mindfulness Based Stress Reduction Depressive symptoms Coronary Artery Disease Mastery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pilot and feasibility study of one cohort.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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MBSR participation

Participation in the 8 week Mindfulness Based Stress Reduction (MBSR) course.

Group Type EXPERIMENTAL

Mindfulness Based Stress Reduction (MBSR)

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Linkoeping University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Oskar Lundgren

PhD Candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lena LJ Jonasson, M.D. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Division of Cardiovascular Medicine, Department of Medical and Health Sciences, Linköping University

Locations

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Linköping University

Linköping, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 34585329 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30213276 (View on PubMed)

Other Identifiers

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2013/17/31

Identifier Type: -

Identifier Source: org_study_id