Online CBT Targeting Cardiac AnxietyMI-CBTNCT05580718
Online Cognitive Behavioral Therapy Targeting Cardiac Anxiety
A study testing MI-CBT in people with Online CBT Targeting Cardiac Anxiety, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of the present study is to evaluate an internet-delivered exposure-based cognitive behavioral therapy (CBT) protocol tailored for patients following myocardial infaction (MI) to increase Quality of Life (Qol) and physical activity by reducing cardiac anxiety. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Online CBT Targeting Cardiac Anxiety
- 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
- 96 participants
- Where
- 1 siteSweden
- Study dates
- 17 Oct 2022to 14 Mar 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Myocardial infarction ≥ 6 months before assessment (type 1 STEMI/NSTEMI)
- Age 18-80 years;
- Clinically significant cardiac anxiety that leads to severe distress and/or interferes with daily life
- On adequate medical treatment(21); (E) 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 percutaneous interventions
- Any medical restriction to physical exercise
- Severe medical illness
- Grade 3 hypertension (i.e., blood pressure ≥ 180 systolic and/or 110 diastolic)
Show all 9Show fewer
- Severe psychiatric disorder or risk of suicide
- Alcohol dependency
- Ongoing psychological treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Online Cognitive Behavioral Therapy Targeting Cardiac Anxiety Following Myocardial Infarction: A Randomized Controlled Trial
The purpose of the present study is to evaluate an internet-delivered exposure-based cognitive behavioral therapy (CBT) protocol tailored for patients following myocardial infaction (MI) to increase Quality of Life (Qol) and physical activity by reducing cardiac anxiety.
Read the detailed description
In the present research project, the investigators have tailored a CBT protocol to target the hypothesized mechanisms of how cardiac anxiety affects the clinical course of MI; by using exposure therapy to reduce fear, hypervigilance, and misinterpretations of cardiac symptoms to reduce MI-related avoidance and increasing physical activity.
Participants (estimated N=100) are randomized to internet-delivered CBT for 8 weeks or to a waitlist offered treatment as usual. Patients in the control arm will be crossed over to CBT treatment 3 months after the experimental group has completed treatment. Assessments will be conducted pre-treatment, post-treatment, 3 months (primary endpoint), 1-, 2 - and 5 years after treatment. These measurement points will also include the control group as it is crossed over to CBT after the 3-month follow-up
- Conditions
- Online CBT Targeting Cardiac Anxiety
- Being tested
- MI-CBT
- Keywords
- Myocardial infarction, Cardiac Anxiety, internet-CBT, Secondary prevention
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MI-CBTBehavioural
- Education Common reactions following MI and general lifestyle advice on e.g., physical activity. The role of cardiac anxiety and avoidance behavior on quality of life and physical health. Brief training in self-observation.
- Goal setting Identifying life areas impaired by MI-related disability or symptom fear. Set health behavioral goals i.e., increased physical activity and gradually take steps towards them.
- Exposure therapy Exposure to physical sensations (e.g., palpitations due to physical activity) to reduce fear of these symptoms. Gradual exposure to avoided situations, activities and increase in physical activity.
- Relapse prevention Prevention of relapse into avoidance behaviors by identifying risk situations and conduct a plan forward on maintaining a healthy physically and active lifestyle.
| Study group | Role | What they receive |
|---|---|---|
| Online CBT targeting cardiac anxiety | Experimental | CBT for MI primarily targets two processes of MI-related disability: fear of cardiac-related symptoms avoidance behavior and physical inactivity. The CBT is therapist-guided and lasts for 8 weeks. Receives: Behavioral: MI-CBT |
| Waitlist control | No intervention | Participants randomised to waitlist can have no other concurrent psychological treatment but are free to use any medical treatment as usual. Participants on the waitlist also complete pre- and post-treatment, the follow-up measurement as well as weekly instruments (with exception of the treatment process measures Credibility scale and WAI). After the 3-month follow-up assessments, participants will receive internet-CBT for MI over 8 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seattle Angina Questionnaire
A measure of coronary artery disease on five scales: physical limitation scale, anginal stability scale, anginal frequency scale, treatment satisfaction scale, and the disease. perception scale with a score ranging from 0 to 100. A higher score indicating a better quality of life.
Measured: From baseline to 5 months
Secondary outcomes (66)
Seattle Angina Questionnaire
A measure of coronary artery disease on five scales: physical limitation scale, anginal stability scale, anginal frequency scale, treatment satisfaction scale, and the disease perception scale. With a score ranging from 0 to 100. A higher score indicating a better quality of life.
Measured: From baseline to 8 weeks
Seattle Angina Questionnaire
A measure of coronary artery disease on five scales: physical limitation scale, anginal stability scale, anginal frequency scale, treatment satisfaction scale, and the disease perception scale. With a score ranging from 0 to 100. A higher score indicating a better quality of life.
Measured: Change over 8 measurement points measured from baseline and weekly for 8 weeks during treatment
Seattle Angina Questionnaire
A measure of coronary artery disease on five scales: physical limitation scale, anginal stability scale, anginal frequency scale, treatment satisfaction scale, and the disease perception scale. With a score ranging from 0 to 100. A higher score indicating a better quality of life.
Measured: From baseline to 1 year and 2 months
Seattle Angina Questionnaire
A measure of coronary artery disease on five scales: physical limitation scale, anginal stability scale, anginal frequency scale, treatment satisfaction scale, and the disease perception scale. With a score ranging from 0 to 100. A higher score indicating a better quality of life
Measured: From baseline to 2 years and 2 months
Seattle Angina Questionnaire
A measure of coronary artery disease on five scales: physical limitation scale, anginal stability scale, anginal frequency scale, treatment satisfaction scale, and the disease perception scale. With a score ranging from 0 to 100. A higher score indicating a better quality of life.
Measured: From baseline to 5 years and 2 months
12-Item Short-Form Health Survey
General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life
Measured: From baseline to 8 weeks
12-Item Short-Form Health Survey
General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life
Measured: From baseline to 5 months
12-Item Short-Form Health Survey
General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life
Measured: From baseline to 1 year and 2 months
12-Item Short-Form Health Survey
General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life
Measured: From baseline to 2 year and 2 months
12-Item Short-Form Health Survey
General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life
Measured: From baseline to 5 year and 2 months
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: From baseline to 8 weeks
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: Change over 8 measurement points measured from baseline and weekly for 8 weeks during treatment
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: From baseline to 5 months
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: From baseline to 1 year and 2 months
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: From baseline to 2 year and 2 months
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: From baseline to 5 year and 2 months
Myocardial infarction behavior questionnaire
MI-related avoidance questionnaire behaviors developed by the research group
Measured: From baseline to 8 weeks
Myocardial infarction behavior questionnaire
MI-related avoidance questionnaire behaviors developed by the research group
Measured: From baseline to 5 months
Myocardial infarction behavior questionnaire
MI-related avoidance questionnaire behaviors developed by the research group. score ranging from 0 to 68 . Higher scores indicate more avoidance behavior.
Measured: From baseline to 1 year and 2 months
Myocardial infarction behavior questionnaire
MI-related avoidance questionnaire behaviors developed by the research group. score ranging from 0 to 68 . Higher scores indicate more avoidance behavior.
Measured: From baseline to 2 years and 2 months
Myocardial infarction behavior questionnaire
MI-related avoidance questionnaire behaviors developed by the research group. score ranging from 0 to 68 . Higher scores indicate more avoidance behavior.
Measured: From baseline to 5 years and 2 months
Body Sensation Questionnaire
Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
Measured: From baseline to 8 weeks
Body Sensation Questionnaire
Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
Measured: From baseline to 5 months
Body Sensation Questionnaire
Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
Measured: From baseline to 1 year and 2 months
Body Sensation Questionnaire
Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
Measured: From baseline to 2 years and 2 months
Body Sensation Questionnaire
Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
Measured: From baseline to 5 years and 2 months
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
Cardiac-related symptoms in two sub scales A) frequency: score ranging from 0-48, with higher score indicating higher frequency of symptoms, B) severity of experienced symptom: score ranging from 0- 48, with a higher score indicating more severe symptoms
Measured: From baseline to 8 weeks
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
Cardiac-related symptoms in two sub scales A) frequency: score ranging from 0-48, with higher score indicating higher frequency of symptoms, B) severity of experienced symptom: score ranging from 0- 48, with a higher score indicating more severe symptoms
Measured: From baseline to 5 months
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
Cardiac-related symptoms in two sub scales A) frequency: score ranging from 0-48, with higher score indicating higher frequency of symptoms, B) severity of experienced symptom: score ranging from 0- 48, with a higher score indicating more severe symptoms
Measured: From baseline to 1 year and 2 months
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
Cardiac-related symptoms in two sub scales A) frequency: score ranging from 0-48, with higher score indicating higher frequency of symptoms, B) severity of experienced symptom: score ranging from 0- 48, with a higher score indicating more severe symptoms
Measured: From baseline to 2 years and 2 months
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
Cardiac-related symptoms in two sub scales A) frequency: score ranging from 0-48, with higher score indicating higher frequency of symptoms, B) severity of experienced symptom: score ranging from 0- 48, with a higher score indicating more severe symptoms
Measured: From baseline to 5 years and 2 months
Patient Health Questionnaire-9
Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression
Measured: From Baseline to 8 weeks
Patient Health Questionnaire-9
Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression
Measured: From Baseline to 5 months
Patient Health Questionnaire-9
Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression
Measured: From Baseline to 1 year and 2 months
Patient Health Questionnaire-9
Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression
Measured: From Baseline to 2 years and 2 months
Patient Health Questionnaire-9
Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression
Measured: From Baseline to 5 years and 2 months
Generalized Anxiety Disorder 7-item
General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
Measured: From Baseline to 8 weeks
Generalized Anxiety Disorder 7-item
General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
Measured: From Baseline to 5 months
Generalized Anxiety Disorder 7-item
General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
Measured: From Baseline to 1 year and 2 months
Generalized Anxiety Disorder 7-item
General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
Measured: From Baseline to 2 years and 2 months
Generalized Anxiety Disorder 7-item
General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
Measured: From Baseline to 5 years and 2 months
Perceived stress scale 4-item
Stress reactivity. A greater score indicate more perceived stress.
Measured: Baseline to 8 weeks
Perceived stress scale 4-item
Stress reactivity. Score ranges 0-16 and a greater score indicate more perceived stress.
Measured: Baseline to 5 months
Perceived stress scale 4-item
Stress reactivity. Score ranges 0-16 and a greater score indicate more perceived stress.
Measured: Baseline to 1 year and 2 months
Perceived stress scale 4-item
Stress reactivity. Score ranges 0-16 and a greater score indicate more perceived stress.
Measured: Baseline to 2 years and 2 months
Perceived stress scale 4-item
Stress reactivity. Score ranges 0-16 and a greater score indicate more perceived stress.
Measured: Baseline to 5 years and 2 months
The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
Level of physical activity and inactivity: On the Godin leisure-time excercise: 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. And from International Physical Activity Questionnaire we will use 1 item on inactivity
Measured: Baseline to 8 weeks
The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
Level of physical activity and inactivity: On the Godin leisure-time excercise: 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. And from International Physical Activity Questionnaire we will use 1 item on inactivity
Measured: Baseline to 5 months
The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
Level of physical activity and inactivity: On the Godin leisure-time excercise: 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. And from International Physical Activity Questionnaire we will use 1 item on inactivity
Measured: Baseline to 1 year and 2 months
The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
Level of physical activity and inactivity: On the Godin leisure-time excercise: 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. And from International Physical Activity Questionnaire we will use 1 item on inactivity
Measured: Baseline to 2 years and 2 months
The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
Level of physical activity and inactivity: On the Godin leisure-time excercise: 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. And from International Physical Activity Questionnaire we will use 1 item on inactivity
Measured: Baseline to 5 years and 2 months
Lifestyle factors: The national Board of health and Welfare questionnaire
Questionnaire regarding diet (5 item), tobacco (2 item) and alcohol (3 item) diet (5 item), tobacco (2 item) and alcohol (3 item) and BMI.
Measured: Baseline to 8 weeks
Lifestyle factors: The national Board of health and Welfare questionnaire
Questionnaire regarding diet (5 item), tobacco (2 item) and alcohol (3 item) diet (5 item), tobacco (2 item) and alcohol (3 item) and BMI.
Measured: Baseline to 5 months
Lifestyle factors: The national Board of health and Welfare questionnaire
Questionnaire regarding diet (5 item), tobacco (2 item) and alcohol (3 item) diet (5 item), tobacco (2 item) and alcohol (3 item) and BMI.
Measured: Baseline to 1 year and 2 months
Lifestyle factors: The national Board of health and Welfare questionnaire
Questionnaire regarding diet (5 item), tobacco (2 item) and alcohol (3 item) diet (5 item), tobacco (2 item) and alcohol (3 item) and BMI.
Measured: Baseline to 2 years and 2 months
Lifestyle factors: The national Board of health and Welfare questionnaire
Questionnaire regarding diet (5 item), tobacco (2 item) and alcohol (3 item) diet (5 item), tobacco (2 item) and alcohol (3 item) and BMI.
Measured: Baseline to 5 years and 2 months
Healthcare consumption and work loss:Tic-P
The Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry assesses societal cost during the last month. These costs include the participant's health care consumption (direct medical costs), time spent in other health promoting activities (direct non-medical costs), and sick leave, unemployment, and reduced work capacity at work and in the domestic realm (indirect non-medical costs).
Measured: From baseline to 8 weeks
Healthcare consumption and work loss:Tic-P
The Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry assesses societal cost during the last month. These costs include the participant's health care consumption (direct medical costs), time spent in other health promoting activities (direct non-medical costs), and sick leave, unemployment, and reduced work capacity at work and in the domestic realm (indirect non-medical costs).
Measured: From baseline to 5 months
Healthcare consumption and work loss:Tic-P
The Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry assesses societal cost during the last month. These costs include the participant's health care consumption (direct medical costs), time spent in other health promoting activities (direct non-medical costs), and sick leave, unemployment, and reduced work capacity at work and in the domestic realm (indirect non-medical costs).
Measured: From baseline to 1 year and 2 months
Healthcare consumption and work loss:Tic-P
The Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry assesses societal cost during the last month. These costs include the participant's health care consumption (direct medical costs), time spent in other health promoting activities (direct non-medical costs), and sick leave, unemployment, and reduced work capacity at work and in the domestic realm (indirect non-medical costs).
Measured: From baseline to 2 years and 2 months
Healthcare consumption and work loss:Tic-P
The Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry assesses societal cost during the last month. These costs include the participant's health care consumption (direct medical costs), time spent in other health promoting activities (direct non-medical costs), and sick leave, unemployment, and reduced work capacity at work and in the domestic realm (indirect non-medical costs).
Measured: From baseline to 5 years and 2 months
University of Toronto Atrial fibrillation Severity Scale (AFSS)
3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption.
Measured: From Baseline to 8 weeks
University of Toronto Atrial fibrillation Severity Scale (AFSS)
3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption.
Measured: From Baseline to 5 months
University of Toronto Atrial fibrillation Severity Scale (AFSS)
3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption.
Measured: From Baseline to 1 year and 2 months
University of Toronto Atrial fibrillation Severity Scale (AFSS)
3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption.
Measured: From Baseline to 2 years and 2 months
University of Toronto Atrial fibrillation Severity Scale (AFSS)
3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption.
Measured: From Baseline to 5 years and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start17 Oct 2022
- Primary completion14 Mar 2025 (estimated)
- Study completion14 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Online CBT Targeting Cardiac AnxietyStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Heart Lung Foundation, The Swedish Research Council, Sahlgrenska University Hospital
- Responsible party
- Principal investigator, Josefin Särnholm, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05580718
- Sponsor's protocol ID
- MI-RCT1
- Acronym
- MI-CBT
- Status last verified
- Aug 2024
- First submitted
- 7 Oct 2022
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Johnsson A, Ljotsson B, Liliequist BE, Lidin M, Lof M, Maurex L, Olafsdottir E, Rautio E, Sandborg J, Braunschweig F, Mellbin LG, Sarnholm J. Digital Cognitive Behavioral Therapy for Cardiac Anxiety After Myocardial Infarction: Effects on Disease-Specific Health Status-Detailed Methods and Protocol. JACC Adv. 2026 Apr;5(4):102669. doi: 10.1016/j.jacadv.2026.102669. Epub 2026 Mar 25.
PubMed 41879569
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Cognitive Behavioral Therapy Targeting Cardiac Anxiety Following Myocardial Infarction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05580718
- Acronym / sponsor ID
- MI-CBT / MI-RCT1
- Conditions
- Online CBT Targeting Cardiac Anxiety
- Keywords
- Myocardial infarction, Cardiac Anxiety, internet-CBT, Secondary prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Swedish Heart Lung Foundation, The Swedish Research Council, Sahlgrenska University Hospital
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 14 Mar 2025 (estimated)
- Study completion
- 14 Mar 2025 (estimated)
- First posted
- 14 Oct 2022 (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 purpose of the present study is to evaluate an internet-delivered exposure-based cognitive behavioral therapy (CBT) protocol tailored for patients following myocardial infaction (MI) to increase Quality of Life (Qol) and physical activity by reducing cardiac anxiety.
Detailed description
In the present research project, the investigators have tailored a CBT protocol to target the hypothesized mechanisms of how cardiac anxiety affects the clinical course of MI; by using exposure therapy to reduce fear, hypervigilance, and misinterpretations of cardiac symptoms to reduce MI-related avoidance and increasing physical activity.
Participants (estimated N=100) are randomized to internet-delivered CBT for 8 weeks or to a waitlist offered treatment as usual. Patients in the control arm will be crossed over to CBT treatment 3 months after the experimental group has completed treatment. Assessments will be conducted pre-treatment, post-treatment, 3 months (primary endpoint), 1-, 2 - and 5 years after treatment. These measurement points will also include the control group as it is crossed over to CBT after the 3-month follow-up
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online CBT targeting cardiac anxiety | Experimental | Behavioral: MI-CBTCBT for MI primarily targets two processes of MI-related disability: fear of cardiac-related symptoms avoidance behavior and physical inactivity. The CBT is therapist-guided and lasts for 8 weeks. |
| Waitlist control | No intervention | –Participants randomised to waitlist can have no other concurrent psychological treatment but are free to use any medical treatment as usual. Participants on the waitlist also complete pre- and post-treatment, the follow-up measurement as well as weekly instruments (with exception of the treatment process measures Credibility scale and WAI). After the 3-month follow-up assessments, participants will receive internet-CBT for MI over 8 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Myocardial infarction ≥ 6 months before assessment (type 1 STEMI/NSTEMI)
- Age 18-80 years;
- Clinically significant cardiac anxiety that leads to severe distress and/or interferes with daily life
- On adequate medical treatment(21); (E) Able to read and write in Swedish.
Key exclusion criteria (9 listed)
- heart failure with severe systolic dysfunction (ejection fraction ≤ 35%)
- Significant valvular disease
- Planned coronary artery bypass surgery or percutaneous interventions
- Any medical restriction to physical exercise
- Severe medical illness
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-CBT* Education Common reactions following MI and general lifestyle advice on e.g., physical activity. The role of cardiac anxiety and avoidance behavior on quality of life and physical health. Brief training in self-observation. * Goal setting Identifying life areas impaired by MI-related disability or symptom fear. Set health behavioral goals i.e., increased physical activity and gradually take steps towards them. * Exposure therapy Exposure to physical sensations (e.g., palpitations due to physical activity) to reduce fear of these symptoms. Gradual exposure to avoided situations, activities and increase in physical activity. * Relapse prevention Prevention of relapse into avoidance behaviors by identifying risk situations and conduct a plan forward on maintaining a healthy physically and active lifestyle. | Behavioural | Online CBT targeting cardiac anxiety |
Primary outcome
Seattle Angina Questionnaire
Time frame: From baseline to 5 months
A measure of coronary artery disease on five scales: physical limitation scale, anginal stability scale, anginal frequency scale, treatment satisfaction scale, and the disease. perception scale with a score ranging from 0 to 100. A higher score indicating a better quality of life.
66 secondary outcomes
Seattle Angina Questionnaire
Time frame: From baseline to 8 weeks
Seattle Angina Questionnaire
Time frame: Change over 8 measurement points measured from baseline and weekly for 8 weeks during treatment
Seattle Angina Questionnaire
Time frame: From baseline to 1 year and 2 months
Seattle Angina Questionnaire
Time frame: From baseline to 2 years and 2 months
Seattle Angina Questionnaire
Time frame: From baseline to 5 years and 2 months
12-Item Short-Form Health Survey
Time frame: From baseline to 8 weeks
12-Item Short-Form Health Survey
Time frame: From baseline to 5 months
12-Item Short-Form Health Survey
Time frame: From baseline to 1 year and 2 months
12-Item Short-Form Health Survey
Time frame: From baseline to 2 year and 2 months
12-Item Short-Form Health Survey
Time frame: From baseline to 5 year and 2 months
Cardiac anxiety questionnaire
Time frame: From baseline to 8 weeks
Cardiac anxiety questionnaire
Time frame: Change over 8 measurement points measured from baseline and weekly for 8 weeks during treatment
Cardiac anxiety questionnaire
Time frame: From baseline to 5 months
Cardiac anxiety questionnaire
Time frame: From baseline to 1 year and 2 months
Cardiac anxiety questionnaire
Time frame: From baseline to 2 year and 2 months
Cardiac anxiety questionnaire
Time frame: From baseline to 5 year and 2 months
Myocardial infarction behavior questionnaire
Time frame: From baseline to 8 weeks
Myocardial infarction behavior questionnaire
Time frame: From baseline to 5 months
Myocardial infarction behavior questionnaire
Time frame: From baseline to 1 year and 2 months
Myocardial infarction behavior questionnaire
Time frame: From baseline to 2 years and 2 months
Myocardial infarction behavior questionnaire
Time frame: From baseline to 5 years and 2 months
Body Sensation Questionnaire
Time frame: From baseline to 8 weeks
Body Sensation Questionnaire
Time frame: From baseline to 5 months
Body Sensation Questionnaire
Time frame: From baseline to 1 year and 2 months
Body Sensation Questionnaire
Time frame: From baseline to 2 years and 2 months
Body Sensation Questionnaire
Time frame: From baseline to 5 years and 2 months
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
Time frame: From baseline to 8 weeks
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
Time frame: From baseline to 5 months
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
Time frame: From baseline to 1 year and 2 months
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
Time frame: From baseline to 2 years and 2 months
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
Time frame: From baseline to 5 years and 2 months
Patient Health Questionnaire-9
Time frame: From Baseline to 8 weeks
Patient Health Questionnaire-9
Time frame: From Baseline to 5 months
Patient Health Questionnaire-9
Time frame: From Baseline to 1 year and 2 months
Patient Health Questionnaire-9
Time frame: From Baseline to 2 years and 2 months
Patient Health Questionnaire-9
Time frame: From Baseline to 5 years and 2 months
Generalized Anxiety Disorder 7-item
Time frame: From Baseline to 8 weeks
Generalized Anxiety Disorder 7-item
Time frame: From Baseline to 5 months
Generalized Anxiety Disorder 7-item
Time frame: From Baseline to 1 year and 2 months
Generalized Anxiety Disorder 7-item
Time frame: From Baseline to 2 years and 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Derived from this study: PubMed 41879569Johnsson A, Ljotsson B, Liliequist BE, Lidin M, Lof M, Maurex L, Olafsdottir E, Rautio E, Sandborg J, Braunschweig F, Mellbin LG, Sarnholm J. Digital Cognitive Behavioral Therapy for Cardiac Anxiety After Myocardial Infarction: Effects on Disease-Specific Health Status-Detailed Methods and Protocol. JACC Adv. 2026 Apr;5(4):102669. doi: 10.1016/j.jacadv.2026.102669. Epub 2026 Mar 25.
- 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 Online CBT Targeting Cardiac Anxiety, 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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 27 Aug 2024. 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?
Results are not available in the source record.
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?
Seattle Angina Questionnaire (time frame: From baseline to 5 months). 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 NCT05580718, which also lists 1 linked publication.
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 27 Aug 2024.