Internet-based Behavioral Intervention Following ACS
- Conditions
- Acute Coronary SyndromeOnline CBT Targeting Cardiac Anxiety
- Interventions
- Behavioral: Internet-CLBehavioral: Internet-CBT
- Registration Number
- NCT06298864
- Lead Sponsor
- Karolinska Institutet
- Brief Summary
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.
- Detailed Description
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=130) or internet-based cardiac lifestyle intervention (internet-CL) (N=130). 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 260
- ACS ≥ 6 months before assessment (type 1 MI STEMI/NSTEMI or unstable angina [UA])
- Age 18 and older
- Clinically significant cardiac anxiety that leads to distress and/or interferes with daily life (Cardiac Anxiety Questionnaire; CAQ: ≥18
- Able to read and write in Swedish
- Heart failure New York heart Association class IV or ejection fraction ≤ 30%
- Significant valvular disease
- Planned coronary artery bypass surgery or percutaneous interventions
- Any medical restriction to physical exercise
- Severe medical illness or an acute health threatening disease (e.g., cancer)
- Grade 3 hypertension (i.e., blood pressure ≥ 180 systolic and/or 110 diastolic)
- Severe mental illness requiring urgent psychiatric hospitalization or intervention, or risk of suicide
- Alcohol or substance use disorder that would impede ability to complete study protocol
- Ongoing psychological treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Internet-based Cardiac Lifestyle intervention (Internet-CL) Internet-CL Internet-CL is based on strategies for behavioral change and guidelines on health promoting lifestyle modifications following ACS. The Internet-CL is therapist-guided and lasts for 8 weeks. Internet-based Cognitive Behavioral Therapy (Internet-CBT) Internet-CBT Internet-CBT following ACS is exposure-based, centering on exposure to cardiac related symptoms and situations. The CBT is therapist-guided and lasts for 8 weeks.
- Primary Outcome Measures
Name Time Method Cardiac anxiety questionnaire modified for weekly assessment Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment [PRIMARY ENDPOINT] Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
- Secondary Outcome Measures
Name Time Method DOSE Non-Adherence questionnaire From baseline to 1 year and 2 months 3 items from this two domain scale measuring medical adherence designed to assess missed doses and reasons for missed doses.
Insomnia Severity Index From Baseline to 1 year and 2 months Measurement of the degree of sleep difficulties. The total score can range from 0 to 28 points. Higher scores indicate more severe sleep difficulties.
Lifestyle factors: The national Board of health and Welfare questionnaire Baseline to 1 year 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.
Aversive cognition to medication Baseline to 8 weeks : A 3-item subset of questions with regards to psychological distress associated with cardiac medication
Cardiac anxiety questionnaire From baseline to 1 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.
HeartQoL Health-related Quality of Life Questionnaire modified for weekly assessment Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment 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.
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease) modified for weekly assessment From baseline to 8 weeks 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
Myocardial infarction behavior questionnaire From baseline to 1 year and 2 months MI-related avoidance questionnaire behaviors developed by the research group
HeartQoL Health-related Quality of Life Questionnaire From baseline to 1 year and 2 months 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.
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease) From baseline to 1 year 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
University of Toronto Atrial fibrillation Severity Scale (AFSS) From baseline to 1 year and 2 months 3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption
Perceived stress scale 4-item Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment Stress reactivity. A greater score indicate more perceived stress.
Short Fatigue questionnaire Baseline to 1 year and 2 months 4-item scale measuring fatigue.
Patient Health Questionnaire-9 From Baseline to 1 year 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 1 year 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
Adversive cognition to medication Baseline to 1 year and 2 months : A 3-item subset of questions with regards to psychological distress associated with cardiac medication
Trial Locations
- Locations (1)
Karolinska University Hospital
🇸🇪Stockholm, Sweden