The aim of this study is to evaluate if an online Cognitive Behavioral Therapy (CBT) protocol customized for patients following Acute Coronary Syndrome (ACS), reduce cardiac anxiety, enhance Quality of Life (QoL), and promote increased physical activity while controlling for caregiver attention, utilizing an active control group receiving internet-based cardiac lifestyle intervention.
ACS is a leading global cause of mortality and health-related losses. Following ACS, many individuals exhibit symptoms of anxiety and depression, recognized risk factors for recurrent cardiovascular events. Specifically, anxiety related to cardiac symptoms and avoidance behavior, known as cardiac anxiety, has been shown to increase the long-term risk of adverse cardiac events. The purpose of the present interdisciplinary research project is to develop and evaluate an online CBT protocol tailored for ACS patients. This project comprises a series of clinical studies aimed at accumulating knowledge about the most effective ways to treat ACS patients with CBT over the internet. The aim of this study is to assess whether internet-based CBT, following ACS, reduces cardiac anxiety and improves QoL, while controlling for caregiver attention and expectancy of improvement using an active control group. Method: A randomized controlled trial is conducted where participants are randomly assigned to either internet-based CBT (N= 88) or internet-based cardiac lifestyle intervention (internet-CL) (N= 88). The active control group receives internet-CL, focusing on lifestyle modification and health-promoting behaviors. Weekly therapist support through online written communication is provided to participants in both groups. Both treatment are conducted over 8-weeks and are comparable in terms of the number of treatment modules, intensity, and attention from the treating psychologist.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
176
* Common reactions following ACS. The role of cardiac anxiety and avoidance behavior on quality of life and physical health. Brief training in self-observation, i.e., labeling. General lifestyle advice on e.g., physical activity, diet. * Identifying life areas impaired by ACS-related disability or symptom fear. Set health behavioral goals i.e., increased physical activity and gradually take steps towards them. * Gradual 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. * Prevention of relapse into avoidance behaviors by identifying risk situations and conduct a plan forward on maintaining a healthy physically and active lifestyle.
* Education on ACS, risk factors, its treatments and medication. * Education and advice promoting healthy habits regarding diet, alcohol and tobacco. * Education and advice regarding physical activity and the beneficial effects on health. * Education regarding common emotional reactions following ACS. * Prevention of relapse and plan forward to maintain a healthy lifestyle.
Karolinska University Hospital
Stockholm, Sweden
RECRUITINGCardiac anxiety questionnaire modified for weekly assessment
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 9 measurement points measured from baseline and weekly for 8 weeks during treatment [PRIMARY ENDPOINT]
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 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
HeartQoL Health-related Quality of Life Questionnaire modified for weekly assessment
The HeartQoL questionnaire, comprising 14 items, includes a Global scale of 14 items, further divided into Physical (10 items) and Emotional (4 items) subscales. Scores range from 0 to 3, with 3 indicating the highest level and 0 the lowest.
Time frame: Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment
HeartQoL Health-related Quality of Life Questionnaire
The HeartQoL questionnaire, comprising 14 items, includes a Global scale of 14 items, further divided into Physical (10 items) and Emotional (4 items) subscales. Scores range from 0 to 3, with 3 indicating the highest level and 0 the lowest.
Time frame: From baseline to 8 months
HeartQoL Health-related Quality of Life Questionnaire
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The HeartQoL questionnaire, comprising 14 items, includes a Global scale of 14 items, further divided into Physical (10 items) and Emotional (4 items) subscales. Scores range from 0 to 3, with 3 indicating the highest level and 0 the lowest.
Time frame: From baseline to 1 year and 2 months
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease) modified for weekly assessment
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 8 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
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: 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 8 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
Behaviors following cardiac event questionnaire (BCEQ)
MI-related avoidance questionnaire behaviors developed by the research group
Time frame: From baseline to 8 weeks
Behaviors following cardiac event questionnaire (BCEQ)
MI-related avoidance questionnaire behaviors developed by the research group
Time frame: From baseline to 8 months
Behaviors following cardiac event questionnaire (BCEQ)
MI-related avoidance questionnaire behaviors developed by the research group
Time frame: From baseline to 1 year and 2 months
DOSE Non-Adherence questionnaire
3 items from this two domain scale measuring medical adherence designed to assess missed doses and reasons for missed doses.
Time frame: From baseline to 8 weeks
DOSE Non-Adherence questionnaire
3 items from this two domain scale measuring medical adherence designed to assess missed doses and reasons for missed doses.
Time frame: From baseline to 8 months
DOSE Non-Adherence questionnaire
3 items from this two domain scale measuring medical adherence designed to assess missed doses and reasons for missed doses.
Time frame: From baseline to 1 year 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. A greater score indicate more perceived stress.
Time frame: Baseline to 8 months
Perceived stress scale 4-item
Stress reactivity. A greater score indicate more perceived stress.
Time frame: Baseline to 1 year and 2 months
Short Fatigue questionnaire
4-item scale measuring fatigue.
Time frame: From baseline to 8 weeks
Short Fatigue questionnaire
4-item scale measuring fatigue.
Time frame: Baseline to 8 months
Short Fatigue questionnaire
4-item scale measuring fatigue.
Time frame: 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 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 8 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
Insomnia Severity Index
Measurement of the degree of sleep difficulties. The total score can range from 0 to 28 points. Higher scores indicate more severe sleep difficulties.
Time frame: From Baseline to 8 weeks
Insomnia Severity Index
Measurement of the degree of sleep difficulties. The total score can range from 0 to 28 points. Higher scores indicate more severe sleep difficulties.
Time frame: From Baseline to 8 months
Insomnia Severity Index
Measurement of the degree of sleep difficulties. The total score can range from 0 to 28 points. Higher scores indicate more severe sleep difficulties.
Time frame: From Baseline to 1 year and 2 months
Perceived stress scale 4-item
Stress reactivity. A greater score indicate more perceived stress.
Time frame: Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment
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 8 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
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 8 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
Aversive cognition to medication
: A 3-item subset of questions with regards to psychological distress associated with cardiac medication
Time frame: Baseline to 8 weeks
Adversive cognition to medication
: A 3-item subset of questions with regards to psychological distress associated with cardiac medication
Time frame: Baseline to 8 months
Adversive cognition to medication
: A 3-item subset of questions with regards to psychological distress associated with cardiac medication
Time frame: Baseline to 1 year and 2 months