NCT05580718

Online Cognitive Behavioral Therapy Targeting Cardiac Anxiety

Online Cognitive Behavioral Therapy Targeting Cardiac Anxiety Following Myocardial Infarction: A Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the present study is to evaluate an internet-delivered exposure-based cognitive behavioral therapy (CBT) protocol tailored for patients following myocardial infaction (MI) to increase Quality of Life (Qol) and physical activity by reducing cardiac anxiety.

Detailed description

In the present research project, the investigators have tailored a CBT protocol to target the hypothesized mechanisms of how cardiac anxiety affects the clinical course of MI; by using exposure therapy to reduce fear, hypervigilance, and misinterpretations of cardiac symptoms to reduce MI-related avoidance and increasing physical activity. Participants (estimated N=100) are randomized to internet-delivered CBT for 8 weeks or to a waitlist offered treatment as usual. Patients in the control arm will be crossed over to CBT treatment 3 months after the experimental group has completed treatment. Assessments will be conducted pre-treatment, post-treatment, 3 months (primary endpoint), 1-, 2 - and 5 years after treatment. These measurement points will also include the control group as it is crossed over to CBT after the 3-month follow-up

Conditions

• Online CBT Targeting Cardiac Anxiety

Interventions

Type	Name	Description
BEHAVIORAL	MI-CBT	* Education Common reactions following MI and general lifestyle advice on e.g., physical activity. The role of cardiac anxiety and avoidance behavior on quality of life and physical health. Brief training in self-observation. * Goal setting Identifying life areas impaired by MI-related disability or symptom fear. Set health behavioral goals i.e., increased physical activity and gradually take steps towards them. * Exposure therapy 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. * Relapse prevention Prevention of relapse into avoidance behaviors by identifying risk situations and conduct a plan forward on maintaining a healthy physically and active lifestyle.

Timeline

• Start date: 2022-10-17
• Primary completion: 2025-03-14
• Completion: 2025-03-14
• First posted: 2022-10-14
• Last updated: 2024-08-27

Locations

1 site across 1 country: Sweden