Online Cognitive Behavioral Therapy Targeting Cardiac Anxiety

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Online Cognitive Behavioral Therapy Targeting Cardiac Anxiety Following Myocardial Infarction: A Randomized Controlled Trial

Conditions
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Online CBT Targeting Cardiac Anxiety

Intervention / Treatment
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* Behavioral: MI-CBT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria: 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. Exclusion Criteria: 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) Severe psychiatric disorder or risk of suicide Alcohol dependency Ongoing psychological treatment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Online CBT targeting cardiac anxiety<br>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. | Behavioral: MI-CBT<br>* 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.<br>|
| No Intervention: Waitlist control<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial infarction, Cardiac Anxiety, internet-CBT, Secondary prevention