Coronary Artery DiseaseMIMIRANCT03340948
The Mindfulness Intervention as Myocardial Infarction Rehabilitation Additive (MIMIRA) Study
A study testing Mindfulness Based Stress Reduction (MBSR) in people with Coronary Artery Disease and Depressive Symptoms, run by Linkoeping University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Coronary Artery Disease, Depressive Symptoms
- What is being tested?
- Mindfulness Based Stress Reduction (MBSR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSweden
- Study dates
- 31 Jan 2012to 30 Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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.
- Conditions
- Coronary Artery Disease, Depressive Symptoms
- Being tested
- Mindfulness Based Stress Reduction (MBSR)
- Keywords
- Mindfulness Based Stress Reduction, Depressive symptoms, Coronary Artery Disease, Mastery
- Medical subject headings
- Coronary Artery Disease, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Stress Reduction (MBSR)Behavioural
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 group | Role | What they receive |
|---|---|---|
| MBSR participation | Experimental | Participation in the 8 week Mindfulness Based Stress Reduction (MBSR) course. Receives: Behavioral: Mindfulness Based Stress Reduction (MBSR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Patient evaluation questionnaire
Measured: Immediately after the 8-week intervention.
Secondary outcomes (7)
Depressive Symptoms
Centre for Epidemiological Studies Scale Depression (CES-D) questionnaire (Radloff)
Measured: Before, immediately after and 12 months post intervention.
Anxiety
Generalized Anxiety Disorder Scale - 7 (GAD-7) questionnaire (Spitzer)
Measured: Before, immediately after and 12 months post intervention.
Mindfulness
Five Facets of Mindfulness Questionnaire (FFMQ) (Baer)
Measured: Before, immediately after and 12 months post intervention.
Acceptance
Acceptance and Action Questionnaire II (AAQII) (Block)
Measured: Before, immediately after and 12 months post intervention.
Mastery
Mastery questionnaire (Pearlin \& Shooler)
Measured: Before, immediately after and 12 months post intervention.
Self-esteem
Self-esteem questionnaire (Rosenberg)
Measured: Before, immediately after and 12 months post intervention.
Patients experiences of mindfulness training
Written journal entries (linguistic content)
Measured: Continuously during the 8 week course.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start31 Jan 2012
- Primary completion18 Nov 2014
- Study completion30 Nov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot and feasibility study of one cohort.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Oskar Lundgren, Linkoeping University
- Investigators
- Lena LJ Jonasson, M.D. Ph.D., Principal investigator, Division of Cardiovascular Medicine, Department of Medical and Health Sciences, Linköping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340948
- Sponsor's protocol ID
- 2013/17/31
- Acronym
- MIMIRA
- Status last verified
- Nov 2017
- First submitted
- 6 Nov 2017
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data will be available on reasonable request.
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.
PubMed 34585329Lundgren 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.
PubMed 30213276
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mindfulness Intervention as Myocardial Infarction Rehabilitation Additive (MIMIRA) Study
- ClinicalTrials.gov ID
- NCT03340948
- Acronym / sponsor ID
- MIMIRA / 2013/17/31
- Conditions
- Coronary Artery Disease, Depressive Symptoms
- Keywords
- Mindfulness Based Stress Reduction, Depressive symptoms, Coronary Artery Disease, Mastery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 31 Jan 2012 (actual)
- Primary completion
- 18 Nov 2014 (actual)
- Study completion
- 30 Nov 2014 (actual)
- First posted
- 14 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot and feasibility study of one cohort.
| Arm | Type | Receives |
|---|---|---|
| MBSR participation | Experimental | Behavioral: Mindfulness Based Stress Reduction (MBSR)Participation in the 8 week Mindfulness Based Stress Reduction (MBSR) course. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | MBSR participation |
Primary outcome
Feasibility
Time frame: Immediately after the 8-week intervention.
Patient evaluation questionnaire
7 secondary outcomes
Depressive Symptoms
Time frame: Before, immediately after and 12 months post intervention.
Anxiety
Time frame: Before, immediately after and 12 months post intervention.
Mindfulness
Time frame: Before, immediately after and 12 months post intervention.
Acceptance
Time frame: Before, immediately after and 12 months post intervention.
Mastery
Time frame: Before, immediately after and 12 months post intervention.
Self-esteem
Time frame: Before, immediately after and 12 months post intervention.
Patients experiences of mindfulness training
Time frame: Continuously during the 8 week course.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
- Derived from this study: PubMed 34585329Lundgren 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.
- Derived from this study: PubMed 30213276Lundgren 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.
- Individual participant dataSharing planned: Undecided. Individual participant data will be available on reasonable request.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lena LJ Jonasson, M.D. Ph.D. principal investigator
Division of Cardiovascular Medicine, Department of Medical and Health Sciences, Linköping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Stress Reduction (MBSR) in people with Coronary Artery Disease and Depressive Symptoms, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: Immediately after the 8-week intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03340948, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2017.