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Completed

NCT Number: NCT03340948

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Linköping University

Linköping, 581 83, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).
  • Depressive symptoms above a score of 8 on the questionnaire centre for epidemiological studies depression scale (CES-D).
  • Interest for participation in MBSR.

Exclusion criteria

  • Major depression or other serious psychiatric illness (such as psychosis or ongoing life crisis).
  • Severe comorbidities, such as cancer, severe cognitive impairment and alcohol or drug abuse.
  • Practical hindrances for participation in MBSR.

Treatment and study plan

mindfulness based stress reduction (MBSR)

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.

Primary outcomes

  1. Feasibility

    Time frame: Immediately after the 8-week intervention.

    Patient evaluation questionnaire

Secondary outcomes

  1. Depressive Symptoms

    Time frame: Before, immediately after and 12 months post intervention.

    Centre for Epidemiological Studies Scale Depression (CES-D) questionnaire (Radloff)

  2. Anxiety

    Time frame: Before, immediately after and 12 months post intervention.

    Generalized Anxiety Disorder Scale - 7 (GAD-7) questionnaire (Spitzer)

  3. Mindfulness

    Time frame: Before, immediately after and 12 months post intervention.

    Five Facets of Mindfulness Questionnaire (FFMQ) (Baer)

  4. Acceptance

    Time frame: Before, immediately after and 12 months post intervention.

    Acceptance and Action Questionnaire II (AAQII) (Block)

  5. Mastery

    Time frame: Before, immediately after and 12 months post intervention.

    Mastery questionnaire (Pearlin & Shooler)

  6. Self-esteem

    Time frame: Before, immediately after and 12 months post intervention.

    Self-esteem questionnaire (Rosenberg)

  7. Patients experiences of mindfulness training

    Time frame: Continuously during the 8 week course.

    Written journal entries (linguistic content)

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Registry information

Acronym: MIMIRA

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 14, 2017
Registry last updated
Nov 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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