NCT05607992

Brief Internet-delivered CBT After ACS

Brief Internet-delivered Exposure-based Therapy to Reduce Post-traumatic Stress Symptoms and Cardiac Anxiety After Acute Coronary Syndrome: a Pilot Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the present pilot study is to evaluate the feasibility and potential efficacy of a brief, internet-delivered CBT protocol provided early after acute coronary syndrome (ACS).

Detailed description

Acute coronary syndrome (ACS; myocardial infarction (MI) or unstable angina (UA)) is one of the leading causes of mortality and health loss globally. ACS is a stressful and potentially life-threatening cardiovascular event, and many patients develop symptoms of post-traumatic stress (PTSS) and cardiac anxiety post ACS, which have been shown to negatively affect patients' long-term cardiovascular prognosis.The aim of the proposed pilot study is to develop and evaluate a brief internet-delivered exposure-based CBT intervention provided early following ACS to reduce ACS-related PTSS, cardiac anxiety. and increase physical activity and quality of life. Patients with recent ACS (≥ 4 weeks to 6 months) and with elevated PTSS and anxiety will be eligible. After informed consent, patients will be randomized to internet-delivered CBT (N=15) or to a wait-list control group (N=15). The treatment is a 5 week, therapist-guided, internet-delivered intervention which includes imaginal exposure, interoceptive exposure, and exposure in-vivo. Assessments will be conducted at baseline, immediate post-treatment, and 2- and 6- months after treatment. The wait-list will be crossed over to CBT after completion of the 2 month follow-up.

Conditions

• Psychological Trauma
• Acute Coronary Syndrome

Interventions

Type	Name	Description
BEHAVIORAL	Brief exposure-based CBT	The 5-week intervention is psychologist-guided and delivered via text-based interactive online treatment modules, where patients complete weekly homework assignments and have regular online contact with psychologists with training in CBT for cardiac disease. Key components include imaginal exposure of the ACS event, interoceptive exposure through at home physical activity that stimulats the CV system, exposure in-vivo to reduce avoided situations, and activities to enhance physical activity wellbeing. Labeling (i.e., describing cardiac-related symptoms, thoughts, and feelings) will be used continuously during treatment to enhance the effect of exposure.

Timeline

• Start date: 2023-05-18
• Primary completion: 2024-08-21
• Completion: 2024-08-21
• First posted: 2022-11-07
• Last updated: 2024-08-27

Locations

2 sites across 1 country: Sweden