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

Acute Coronary Syndrome Online CBT Targeting Cardiac Anxiety

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

Inclusion Criteria4

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 Criteria9

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

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.