Online Cognitive Behavioral Therapy Targeting Cardiac Anxiety
- Conditions
- Online CBT Targeting Cardiac Anxiety
- Interventions
- Behavioral: MI-CBT
- Registration Number
- NCT05580718
- Lead Sponsor
- Karolinska Institutet
- Brief 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.
- 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 96
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Online CBT targeting cardiac anxiety MI-CBT 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.
- Primary Outcome Measures
Name Time Method Seattle Angina Questionnaire 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.
- Secondary Outcome Measures
Name Time Method Body Sensation Questionnaire From baseline to 5 years and 2 months Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
Cardiac anxiety questionnaire From baseline to 5 year and 2 months Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease) From baseline to 5 years and 2 months 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
Perceived stress scale 4-item Baseline to 5 years and 2 months Stress reactivity. Score ranges 0-16 and a greater score indicate more perceived stress.
Seattle Angina Questionnaire From baseline to 5 years and 2 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.
Generalized Anxiety Disorder 7-item From Baseline to 5 years and 2 months General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
12-Item Short-Form Health Survey From baseline to 5 year and 2 months General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life
Myocardial infarction behavior questionnaire From baseline to 5 years and 2 months MI-related avoidance questionnaire behaviors developed by the research group. score ranging from 0 to 68 . Higher scores indicate more avoidance behavior.
Lifestyle factors: The national Board of health and Welfare questionnaire Baseline to 5 years and 2 months Questionnaire regarding diet (5 item), tobacco (2 item) and alcohol (3 item) diet (5 item), tobacco (2 item) and alcohol (3 item) and BMI.
Healthcare consumption and work loss:Tic-P From baseline to 5 years and 2 months 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).
Patient Health Questionnaire-9 From Baseline to 5 years and 2 months Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression
The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity Baseline to 5 years and 2 months 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
University of Toronto Atrial fibrillation Severity Scale (AFSS) From Baseline to 5 years and 2 months 3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption.
Trial Locations
- Locations (1)
Karolinska University Hospital
🇸🇪Stockholm, Sweden