NCT03340948

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2014

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2014

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 14, 2017

Completed
Last Updated

November 14, 2017

Status Verified

November 1, 2017

Enrollment Period

2.8 years

First QC Date

November 6, 2017

Last Update Submit

November 8, 2017

Conditions

Coronary Artery DiseaseDepressive Symptoms

Keywords

Mindfulness Based Stress ReductionDepressive symptomsCoronary Artery DiseaseMastery

Outcome Measures

Primary Outcomes (1)

  • Feasibility

    Patient evaluation questionnaire

    Immediately after the 8-week intervention.

Secondary Outcomes (7)

  • Depressive Symptoms

    Before, immediately after and 12 months post intervention.

  • Anxiety

    Before, immediately after and 12 months post intervention.

  • Mindfulness

    Before, immediately after and 12 months post intervention.

  • Acceptance

    Before, immediately after and 12 months post intervention.

  • Mastery

    Before, immediately after and 12 months post intervention.

  • +2 more secondary outcomes

Study Arms (1)

MBSR participation

EXPERIMENTAL

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

Behavioral: Mindfulness Based Stress Reduction (MBSR)

Interventions

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.

MBSR participation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linköping University

Linköping, 581 83, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 34585329DERIVED

  • 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.

    PMID: 30213276DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseDepression

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Lena LJ Jonasson, M.D. Ph.D.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Pilot and feasibility study of one cohort.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

November 6, 2017

First Posted

November 14, 2017

Study Start

January 31, 2012

Primary Completion

November 18, 2014

Study Completion

November 30, 2014

Last Updated

November 14, 2017

Record last verified: 2017-11

Locations

SE(1)