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

Primary Purpose

Coronary Artery Disease, Depressive Symptoms

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Mindfulness Based Stress Reduction (MBSR)
Sponsored by
Linkoeping University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Coronary Artery Disease focused on measuring Mindfulness Based Stress Reduction, Depressive symptoms, Coronary Artery Disease, Mastery

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Linköping University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MBSR participation

Arm Description

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

Outcomes

Primary Outcome Measures

Feasibility
Patient evaluation questionnaire

Secondary Outcome Measures

Depressive Symptoms
Centre for Epidemiological Studies Scale Depression (CES-D) questionnaire (Radloff)
Anxiety
Generalized Anxiety Disorder Scale - 7 (GAD-7) questionnaire (Spitzer)
Mindfulness
Five Facets of Mindfulness Questionnaire (FFMQ) (Baer)
Acceptance
Acceptance and Action Questionnaire II (AAQII) (Block)
Mastery
Mastery questionnaire (Pearlin & Shooler)
Self-esteem
Self-esteem questionnaire (Rosenberg)
Patients experiences of mindfulness training
Written journal entries (linguistic content)

Full Information

First Posted
November 6, 2017
Last Updated
November 8, 2017
Sponsor
Linkoeping University
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1. Study Identification

Unique Protocol Identification Number
NCT03340948
Brief Title
The Mindfulness Intervention as Myocardial Infarction Rehabilitation Additive (MIMIRA) Study
Acronym
MIMIRA
Official Title
The Mindfulness Intervention as Myocardial Infarction Rehabilitation Additive (MIMIRA) Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
January 31, 2012 (Actual)
Primary Completion Date
November 18, 2014 (Actual)
Study Completion Date
November 30, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Depressive Symptoms
Keywords
Mindfulness Based Stress Reduction, Depressive symptoms, Coronary Artery Disease, Mastery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pilot and feasibility study of one cohort.
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MBSR participation
Arm Type
Experimental
Arm Description
Participation in the 8 week Mindfulness Based Stress Reduction (MBSR) course.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Stress Reduction (MBSR)
Intervention Description
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 Outcome Measure Information:
Title
Feasibility
Description
Patient evaluation questionnaire
Time Frame
Immediately after the 8-week intervention.
Secondary Outcome Measure Information:
Title
Depressive Symptoms
Description
Centre for Epidemiological Studies Scale Depression (CES-D) questionnaire (Radloff)
Time Frame
Before, immediately after and 12 months post intervention.
Title
Anxiety
Description
Generalized Anxiety Disorder Scale - 7 (GAD-7) questionnaire (Spitzer)
Time Frame
Before, immediately after and 12 months post intervention.
Title
Mindfulness
Description
Five Facets of Mindfulness Questionnaire (FFMQ) (Baer)
Time Frame
Before, immediately after and 12 months post intervention.
Title
Acceptance
Description
Acceptance and Action Questionnaire II (AAQII) (Block)
Time Frame
Before, immediately after and 12 months post intervention.
Title
Mastery
Description
Mastery questionnaire (Pearlin & Shooler)
Time Frame
Before, immediately after and 12 months post intervention.
Title
Self-esteem
Description
Self-esteem questionnaire (Rosenberg)
Time Frame
Before, immediately after and 12 months post intervention.
Title
Patients experiences of mindfulness training
Description
Written journal entries (linguistic content)
Time Frame
Continuously during the 8 week course.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lena LJ Jonasson, M.D. Ph.D.
Organizational Affiliation
Division of Cardiovascular Medicine, Department of Medical and Health Sciences, Linköping University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Linköping University
City
Linköping
ZIP/Postal Code
581 83
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Individual participant data will be available on reasonable request.
Citations:
PubMed Identifier
34585329
Citation
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.
Results Reference
derived
PubMed Identifier
30213276
Citation
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.
Results Reference
derived

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

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