Myocardial InfarctionMI-CBTNCT04649307
Cognitive Behavioral Therapy Following Myocardial Infarction
A study testing MI-CBT in people with Myocardial Infarction, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Myocardial infarction (MI) is one of the leading cause s of health loss globally, representing a large proportion of general disability. Anxiety and depression occur in 20-30 percent of patients following MI and have been identified as risk factors for recurrent adverse cardiac event. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- MI-CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSweden
- Study dates
- 29 Dec 2020to 1 Dec 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ( - )MI ≥ 6 months before assessment (type 1 STEMI/NSTEMI) ( - )Age 18-69 years endorsed cardiac anxiety that leads to significant distress or interferes with daily life (Cardiac Anxiety Questionnaire (CAQ); score ≥20) ( - ) On optimal medical treatment ( - )Able to read and write in Swedish.
Who cannot join
- ( - ) heart failure with severe systolic dysfunction (ejection fraction ≤ 35%) ( - ) significant valvular disease ( - ) planned coronary artery bypass surgery or other invasive therapy ( - ) other severe medical illness ( - )any medical restriction to physical exercise ( - )severe psychiatric disorder, severe depression, or risk of suicide ( - )alcohol dependency.
Trial locations and contacts
1 site in 1 country.
About this study
Myocardial infarction (MI) is one of the leading cause s of health loss globally, representing a large proportion of general disability. Anxiety and depression occur in 20-30 percent of patients following MI and have been identified as risk factors for recurrent adverse cardiac event. The purpose of our this study is to develop and evaluate a disease specific cognitive behavioral therapy (C BT) protocol to reduce cardia anxiety, depression, increase physical inactivity and quality of life (Q oL) in patients following MI.
Read the detailed description
The study will include 20 patients. The MI-specific CBT lasts for 8 weeks and is delivered face-to-face via a secure digital video solution (to minimize cancelled sessions because of the COVID-19 pandemic) or at the Karolinska Universitetssjukhuset cardiac research unit, by licensed psychologists with expertise in CBT for cardiac disease. During treatment, the psychologists will have direct access to a cardiologist assigned to the project and treatments are conducted in close interdisciplinary collaboration to ensure patient safety.
- Conditions
- Myocardial Infarction
- Being tested
- MI-CBT
- Keywords
- CBT, Cardiac anxiety, Quality of Life, Physical activity
- Medical subject headings
- Myocardial Infarction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MI-CBTBehavioural
Education, Interoceptive exposure, Exposure in-vivo, Behavioral activation, Relapse prevention
| Study group | Role | What they receive |
|---|---|---|
| MI-CBT | Other | The treatment will be based on the AF treatment developed by the research group and further be developed and adapted during the course the study, based on the clinical presentation of the MI patients and their response to the CBT interventions detailed below. The MI-specific CBT will consist of 8 weekly face-to face digital video sessions with home assignments that can be reviewed and reported in the research groups secure platform. CBT for MI primarily targets two processes of disability; cardiac anxiety, and depressive inactivity Receives: Behavioral: MI-CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac anxiety questionnaire
Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
Measured: baseline
Cardiac anxiety questionnaire
Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
Measured: 2 months from baseline
Cardiac anxiety questionnaire
Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
Measured: 8 months from baseline
Secondary outcomes (21)
12-Item Short-Form Health Survey (SF-12)
General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life.
Measured: Baseline
12-Item Short-Form Health Survey (SF-12)
General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life.
Measured: 2 months from baseline
12-Item Short-Form Health Survey (SF-12)
General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life.
Measured: 8 months from baseline
Body Sensation Questionnaire
Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
Measured: Baseline
Body Sensation Questionnaire
Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
Measured: 2 months from baseline
Body Sensation Questionnaire
Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
Measured: 8 months from baseline
Patient Health Questionnaire-9
Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression.
Measured: Baseline
Patient Health Questionnaire-9
Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression.
Measured: 2 months from Baseline
Patient Health Questionnaire-9
Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression.
Measured: 8 months from Baseline
Generalized Anxiety Disorder 7-item
General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
Measured: Baseline
Generalized Anxiety Disorder 7-item
General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
Measured: 2 months from baseline
Generalized Anxiety Disorder 7-item
General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
Measured: 8 months from baseline
The Godin Leisure-time Exercise
Level of physical activity. The participant rate numbers of time per week that they engage in physical activity. The numb ers are the categorized in to low, moderate, and high levels of physical activity.
Measured: Baseline
The Godin Leisure-time Exercise
Level of physical activity. The participant rate numbers of time per week that they engage in physical activity. The numb ers are the categorized in to low, moderate, and high levels of physical activity.
Measured: 2 months from Baseline
The Godin Leisure-time Exercise
Level of physical activity. The participant rate numbers of time per week that they engage in physical activity. The numb ers are the categorized in to low, moderate, and high levels of physical activity.
Measured: 8 months from Baseline
Tampas Scale for Kinesophobia-Heart version
Fear of physical activity. The total score varies between 17 and 68, with higher values indicating more severe kinesiophobia.
Measured: Baseline
Tampas Scale for Kinesophobia-Heart version
Fear of physical activity. The total score varies between 17 and 68, with higher values indicating more severe kinesiophobia.
Measured: 2 months from Baseline
Tampas Scale for Kinesophobia-Heart version
Fear of physical activity. The total score varies between 17 and 68, with higher values indicating more severe kinesiophobia.
Measured: 8 months form Baseline
Client satisfaction Questionnaire
Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment.
Measured: 2 months from Baseline
Adverse events
Potential adverse reactions to the treatment. Participants will be asked to report and rate the short- and long term discomfort of the adverse event on a scale from 0 ('did not affect me at all') and 3 ('affected me very negatively').
Measured: 2 months from baseline
Adverse events
Potential adverse reactions to the treatment. Participants will be asked to report and rate the short- and long term discomfort of the adverse event on a scale from 0 ('did not affect me at all') and 3 ('affected me very negatively').
Measured: 8 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start29 Dec 2020
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brjann Ljotsson, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649307
- Sponsor's protocol ID
- MI-CBT
- Acronym
- MI-CBT
- Status last verified
- May 2022
- First submitted
- 24 Nov 2020
- Last updated
- 24 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy Following Myocardial Infarction
- ClinicalTrials.gov ID
- NCT04649307
- Acronym / sponsor ID
- MI-CBT / MI-CBT
- Conditions
- Myocardial Infarction
- Keywords
- CBT, Cardiac anxiety, Quality of Life, Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 29 Dec 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 2 Dec 2020 (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.
Myocardial infarction (MI) is one of the leading cause s of health loss globally, representing a large proportion of general disability. Anxiety and depression occur in 20-30 percent of patients following MI and have been identified as risk factors for recurrent adverse cardiac event. The purpose of our this study is to develop and evaluate a disease specific cognitive behavioral therapy (C BT) protocol to reduce cardia anxiety, depression, increase physical inactivity and quality of life (Q oL) in patients following MI.
Detailed description
The study will include 20 patients. The MI-specific CBT lasts for 8 weeks and is delivered face-to-face via a secure digital video solution (to minimize cancelled sessions because of the COVID-19 pandemic) or at the Karolinska Universitetssjukhuset cardiac research unit, by licensed psychologists with expertise in CBT for cardiac disease. During treatment, the psychologists will have direct access to a cardiologist assigned to the project and treatments are conducted in close interdisciplinary collaboration to ensure patient safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MI-CBT | Other | Behavioral: MI-CBTThe treatment will be based on the AF treatment developed by the research group and further be developed and adapted during the course the study, based on the clinical presentation of the MI patients and their response to the CBT interventions detailed below. The MI-specific CBT will consist of 8 weekly face-to face digital video sessions with home assignments that can be reviewed and reported in the research groups secure platform. CBT for MI primarily targets two processes of disability; cardiac anxiety, and depressive inactivity |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ( - )MI ≥ 6 months before assessment (type 1 STEMI/NSTEMI) ( - )Age 18-69 years endorsed cardiac anxiety that leads to significant distress or interferes with daily life (Cardiac Anxiety Questionnaire (CAQ); score ≥20) ( - ) On optimal medical treatment ( - )Able to read and write in Swedish.
Key exclusion criteria (1 listed)
- ( - ) heart failure with severe systolic dysfunction (ejection fraction ≤ 35%) ( - ) significant valvular disease ( - ) planned coronary artery bypass surgery or other invasive therapy ( - ) other severe medical illness ( - )any medical restriction to physical exercise ( - )severe psychiatric disorder, severe depression, or risk of suicide ( - )alcohol dependency.
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 |
|---|---|---|
| MI-CBTEducation, Interoceptive exposure, Exposure in-vivo, Behavioral activation, Relapse prevention | Behavioural | MI-CBT |
Primary outcome
Cardiac anxiety questionnaire
Time frame: baseline
Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
Cardiac anxiety questionnaire
Time frame: 2 months from baseline
Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
Cardiac anxiety questionnaire
Time frame: 8 months from baseline
Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
21 secondary outcomes
12-Item Short-Form Health Survey (SF-12)
Time frame: Baseline
12-Item Short-Form Health Survey (SF-12)
Time frame: 2 months from baseline
12-Item Short-Form Health Survey (SF-12)
Time frame: 8 months from baseline
Body Sensation Questionnaire
Time frame: Baseline
Body Sensation Questionnaire
Time frame: 2 months from baseline
Body Sensation Questionnaire
Time frame: 8 months from baseline
Patient Health Questionnaire-9
Time frame: Baseline
Patient Health Questionnaire-9
Time frame: 2 months from Baseline
Patient Health Questionnaire-9
Time frame: 8 months from Baseline
Generalized Anxiety Disorder 7-item
Time frame: Baseline
Generalized Anxiety Disorder 7-item
Time frame: 2 months from baseline
Generalized Anxiety Disorder 7-item
Time frame: 8 months from baseline
The Godin Leisure-time Exercise
Time frame: Baseline
The Godin Leisure-time Exercise
Time frame: 2 months from Baseline
The Godin Leisure-time Exercise
Time frame: 8 months from Baseline
Tampas Scale for Kinesophobia-Heart version
Time frame: Baseline
Tampas Scale for Kinesophobia-Heart version
Time frame: 2 months from Baseline
Tampas Scale for Kinesophobia-Heart version
Time frame: 8 months form Baseline
Client satisfaction Questionnaire
Time frame: 2 months from Baseline
Adverse events
Time frame: 2 months from baseline
Adverse events
Time frame: 8 months from baseline
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 24 May 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MI-CBT in people with Myocardial Infarction, run by Karolinska Institutet 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 1 inclusion and 1 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 24 May 2022. 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?
Cardiac anxiety questionnaire (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 May 2022.