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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
* 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.
Karolinska University Hospital
Stockholm, Sweden
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.
Time frame: From baseline to 5 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
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Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From baseline to 5 year and 2 months
Myocardial infarction behavior questionnaire
MI-related avoidance questionnaire behaviors developed by the research group
Time frame: From baseline to 8 weeks
Myocardial infarction behavior questionnaire
MI-related avoidance questionnaire behaviors developed by the research group
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From Baseline to 5 years and 2 months
Perceived stress scale 4-item
Stress reactivity. A greater score indicate more perceived stress.
Time frame: Baseline to 8 weeks
Perceived stress scale 4-item
Stress reactivity. Score ranges 0-16 and a greater score indicate more perceived stress.
Time frame: Baseline to 5 months
Perceived stress scale 4-item
Stress reactivity. Score ranges 0-16 and a greater score indicate more perceived stress.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From Baseline to 5 years and 2 months