NCT06298864Recruiting
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
Source: ClinicalTrials.gov · Last updated 16 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 176 (estimated)
- First submitted
- 26 Feb 2024
- Start date
- 7 Mar 2024
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- Karolinska Institutet
- Diseases
- Coronary artery disease
- NCT number
- NCT06298864
What you commit to
- Study type: Interventional
- Planned participants: 176
- From 7 Mar 2024 to the primary completion date, 31 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Planned coronary artery bypass surgery or percutaneous interventions
Other illness
- Significant valvular disease
- 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
Lab values
- Heart failure New York heart Association class IV or ejection fraction ≤ 30%
Other
- Any medical restriction to physical exercise
- Ongoing psychological treatment
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Karolinska University Hospital Coordinator of this site? Confirm its status | Stockholm | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.