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| Name | Class |
|---|---|
| Swedish Heart Lung Foundation | OTHER |
| The Swedish Research Council | OTHER_GOV |
| Sahlgrenska University Hospital | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MI-CBT | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Abnormal Laboratory Values | Venous blood will be collected for local analyses of fasting plasma glucose, HbA1c, plasma total cholesterol, LDL, HDL, triglycerides, hsCRP, creatinine, stress-related hormones such as cortisol, copeptin and vasopressin | From Baseline to 8 weeks |
| Number of Participants With Abnormal Laboratory Values |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Stockholm | 11635 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41879569 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 18, 2024 | Jun 20, 2024 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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|
| 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. |
| 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. | 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 | 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. | 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 | 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 | 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 | 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 | 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 | 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. | 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. | 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. | 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. | 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. | 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. | From baseline to 5 year and 2 months |
| Myocardial infarction behavior questionnaire | MI-related avoidance questionnaire behaviors developed by the research group | From baseline to 8 weeks |
| Myocardial infarction behavior questionnaire | MI-related avoidance questionnaire behaviors developed by the research group | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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. | 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. | 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. | 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. | From Baseline to 5 years and 2 months |
| Perceived stress scale 4-item | Stress reactivity. A greater score indicate more perceived stress. | Baseline to 8 weeks |
| Perceived stress scale 4-item | Stress reactivity. Score ranges 0-16 and a greater score indicate more perceived stress. | Baseline to 5 months |
| Perceived stress scale 4-item | Stress reactivity. Score ranges 0-16 and a greater score indicate more perceived stress. | 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. | 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. | 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 | 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 | 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 | 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 | 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 | 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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). | 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). | 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). | 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. | 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. | 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. | 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. | 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. | From Baseline to 5 years and 2 months |
Venous blood will be collected for local analyses of fasting plasma glucose, HbA1c, plasma total cholesterol, LDL, HDL, triglycerides, hsCRP, creatinine, stress-related hormones such as cortisol, copeptin and vasopressin |
| From Baseline to 5 months |
| Algometry (Somedic AB, Hörby, Sweden) | A pain sensitivity measurement with algometry (Somedic AB, Hörby, Sweden); consisting of a handle with a 1 cm rubber plate at the end will be used. Algometers are used to measure pressure pain thresholds, the exact pressure (kPa) is registered in the algometer and thus a measure of a person's pain threshold can be assessed. | From Baseline to 8 weeks |
| Algometry (Somedic AB, Hörby, Sweden) | A pain sensitivity measurement with algometry (Somedic AB, Hörby, Sweden); consisting of a handle with a 1 cm rubber plate at the end will be used. Algometers are used to measure pressure pain thresholds, the exact pressure (kPa) is registered in the algometer and thus a measure of a person's pain threshold can be assessed. | From Baseline to 5 months |
| Accelerometer (Actigraf®) | An Accelerometer (Actigraf®) will be carried on the wrist over to measure physical activity over 1 week | Baseline to 8 weeks |
| Accelerometer (Actigraf®) | An Accelerometer (Actigraf®) will be carried on the wrist over to measure physical activity over 1 week week at each assessment | Baseline to 5 months |
| 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'). | From Baseline to 8 weeks |
| 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'). | 8 measurement points measured from baseline and weekly for 8 weeks during treatment |
| 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'). | From Baseline to 5 months |
| 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'). | From Baseline to 1 year and 2 months |
| 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'). | From Baseline to 2 years and 2 months |
| 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'). | From Baseline to 5 years and 2 months |
| Client satisfaction Questionnaire | Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment. | Baseline to 8 weeks |
| Treatment Credibility Scale | Measures treatment credibility | 1-2 weeks from baseline |
| Working Alliance Inventory | Measures therapeutic alliance with the psychologist | 1-2 weeks from baseline |
| Follow-up questions on health changes | We will ask participant to describe if they have experienced any psychosocial stressors, changes in physical health, such as invasive therapy and changes of medication | Baseline to 8 weeks |
| Follow-up questions on health changes | We will ask participant to describe if they have experienced any psychosocial stressors, changes in physical health, such as invasive therapy and changes of medication | Baseline to 5 months |
| Follow-up questions on health changes | We will ask participant to describe if they have experienced any psychosocial stressors, changes in physical health, such as invasive therapy and changes of medication | Baseline to 1 year and 2 months |
| Follow-up questions on health changes | We will ask participant to describe if they have experienced any psychosocial stressors, changes in physical health, such as invasive therapy and changes of medication | Baseline to 2 years and 2 months |
| Follow-up questions on health changes | We will ask participant to describe if they have experienced any psychosocial stressors, changes in physical health, such as invasive therapy and changes of medication | Baseline to 5 years and 2 months |
| AFFS/SCL-4 | 4 items derived from the Symptoms Checklist (SCL) and the Atrial Fibrillation Severity Scale (AFSS) measuring disabling cardiac symptoms | Change over 8 measurement points measured from baseline and weekly for 8 weeks during treatment |
| MI-behavior Questionnaire | 5 items measuring avoidance behavior from the MI-related avoidance questionnaire behaviors developed by the research group | Change over 8 measurement points measured from baseline and weekly for 8 weeks during treatment |
| Perceived stress scale 4-item | Measure of perceived stress and stress reactivity. Score ranging 0 -16 with a higher score indicating more perceived stress. | Change over 8 measurement points measured from baseline and weekly for 8 weeks during treatment |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |