RecruitingNot ApplicableNCT06298864

Internet-based Behavioral Intervention Following ACS

Digital Cognitive Behavioral Therapy for Cardiac Anxiety Following Acute Coronary Syndrome: a Randomized Controlled Trial Comparing CBT to a Digital Lifestyle Intervention


Sponsor

Karolinska Institutet

Enrollment

176 participants

Start Date

Mar 7, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests an internet-based behavioral program designed to help people who experience significant anxiety about their heart health after a heart attack (called cardiac anxiety). The program is aimed at reducing anxiety and improving daily function. **You may be eligible if...** - You had a heart attack or unstable angina at least 6 months ago - You are 18 or older and experience ongoing heart-related anxiety that is distressing or interferes with daily life - You can read and write in Swedish **You may NOT be eligible if...** - You have severe heart failure or very low heart pumping function (ejection fraction under 30%) - You have significant heart valve disease or are awaiting heart surgery - You have a medical restriction to physical exercise - You have severe mental illness requiring urgent care, or are at risk of suicide - You have an alcohol or substance use disorder that would interfere with study participation - You are currently in another psychological treatment program - You have high blood pressure that is dangerously elevated (Grade 3) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALInternet-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.

BEHAVIORALInternet-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.


Locations(1)

Karolinska University Hospital

Stockholm, Sweden

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NCT06298864


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