Internet-based Behavioral Intervention Following ACS

NCT06298864 · tracked via the Priya Life Science Sweden tracker

Sponsor

Karolinska Institutet

Phase

Not applicable

Started

2024-03-07

Last updated

2025-09-16

Condition(s) studied

Acute Coronary SyndromeOnline CBT Targeting Cardiac Anxiety

Investigational drug(s) / intervention(s)

Internet-CBTInternet-CL

Internet-CBT: * 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.

Internet-CL: * 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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

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.

Trial sites (1)

Facility	City	Region	Status
Karolinska University Hospital	Stockholm	Sweden	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06298864 on ClinicalTrials.gov ↗ ← All trials in Sweden