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

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

Tracking Information
First Submitted Date  ICMJE November 6, 2017
First Posted Date  ICMJE November 14, 2017
Last Update Posted Date November 14, 2017
Actual Study Start Date  ICMJE January 31, 2012
Actual Primary Completion Date November 18, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2017)
Feasibility [ Time Frame: Immediately after the 8-week intervention. ]
Patient evaluation questionnaire
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Mindfulness Intervention as Myocardial Infarction Rehabilitation Additive (MIMIRA) Study
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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  ICMJE
  • Coronary Artery Disease
  • Depressive Symptoms
Intervention  ICMJE 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  ICMJE 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, Kristenson M, Jonasson L, Thylén 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 8, 2017)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 30, 2014
Actual Primary Completion Date November 18, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03340948
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: Undecided
Plan Description: Individual participant data will be available on reasonable request.
Responsible Party Oskar Lundgren, Linkoeping University
Study Sponsor  ICMJE Linkoeping University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP