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

• ClinicalTrials.gov Identifier: NCT03340948
• Recruitment Status: Completed
• First Posted: November 14, 2017
• Last Update Posted: November 14, 2017
• Sponsor: Linkoeping University
• Information provided by (Responsible Party): Oskar Lundgren, Linkoeping University

Tracking Information

• First Submitted Date: November 6, 2017
• First Posted Date: November 14, 2017
• Last Update Posted Date: November 14, 2017
• Actual Study Start Date: January 31, 2012
• Actual Primary Completion Date: November 18, 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 8, 2017)

Feasibility [ Time Frame: Immediately after the 8-week intervention. ]

Patient evaluation questionnaire

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: November 8, 2017)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Mindfulness Intervention as Myocardial Infarction Rehabilitation Additive (MIMIRA) Study
• Official Title: The Mindfulness Intervention as Myocardial Infarction Rehabilitation Additive (MIMIRA) Study
• 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Pilot and feasibility study of one cohort.

Masking: None (Open Label)
Primary Purpose: Supportive Care

Condition

• Coronary Artery Disease
• Depressive Symptoms

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.

Study Arms

Experimental: MBSR participation

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

Intervention: Behavioral: Mindfulness Based Stress Reduction (MBSR)

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 8, 2017): 24
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: November 30, 2014
• Actual Primary Completion Date: November 18, 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Sweden

Administrative Information

• NCT Number: NCT03340948
• Other Study ID Numbers: 2013/17/31
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided
• Plan Description: Individual participant data will be available on reasonable request.

• Current Responsible Party: Oskar Lundgren, Linkoeping University
• Original Responsible Party: Same as current
• Current Study Sponsor: Linkoeping University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Lena LJ Jonasson, M.D. Ph.D.; Division of Cardiovascular Medicine, Department of Medical and Health Sciences, Linköping University

• PRS Account: Linkoeping University
• Verification Date: November 2017