Online therapy for anxiety after heart issues
Digital Cognitive Behavioral Therapy for Cardiac Anxiety Following Acute Coronary Syndrome: a Randomized Controlled Trial Comparing CBT to a Digital Lifestyle Intervention
This study is testing an online therapy program to see if it can help people recovering from heart issues feel less anxious and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 176 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT06298864 on ClinicalTrials.gov |
What this trial studies
This study evaluates an online Cognitive Behavioral Therapy (CBT) program designed for patients recovering from Acute Coronary Syndrome (ACS) to reduce cardiac anxiety, improve quality of life, and encourage physical activity. Participants will be randomly assigned to either the internet-based CBT group or an active control group receiving internet-based cardiac lifestyle intervention. Both groups will receive weekly therapist support through online communication over an 8-week period. The study aims to determine the effectiveness of the online CBT protocol in alleviating anxiety and enhancing overall well-being in ACS patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have experienced ACS at least 6 months prior and are experiencing clinically significant cardiac anxiety.
Not a fit: Patients with severe heart failure, significant valvular disease, or ongoing psychological treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce cardiac anxiety and improve the quality of life for patients recovering from ACS.
How similar studies have performed: Previous studies have shown promise in using online CBT for anxiety management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Stockholm
- Karolinska University Hospital — Stockholm, Sweden (Recruiting)
Study contacts
- Study coordinator: Josefin Särnholm, Lic psychologist, PhD
- Email: josefin.sarnholm@ki.se
- Phone: + 46 852483258
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.