Clinical Trial

A Precision Medicine Approach to the Prevention of Depression in Patients With Atrial Fibrillation

Study acronym: HOPE-AF
Completed
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Summary
The purpose of the proposed project is to test a new therapist-assisted, eHealth intervention (HOPE-AF) targeted to prevent depression in patients with atrial fibrillation (AF). AF is the most common sustained cardiac arrhythmia. Age is the most common risk factor for AF, and given the ageing of the population, the prevalence of AF has increased threefold during the last 50 years. AF is now considered a major public health challenge. AF is not only associated with increased risk of stroke and heart failure but patients with AF also tend to continuously focus on the body's signals and have difficulties accepting the disease. This is often paired with psychological reactions, such as excessive worry and anxiety, increasing the risk of withdrawal from social activities, which often leads to depression. Patients with AF and comorbid depression are at greater risk of a poor prognosis. The project is a feasibility study to examine acceptability, adherence and limited efficacy, as well as barriers and facilitators for implementation of the intervention in clinical practice. The project is multi-disciplinary and embedded within the rehabilitation setting in the hospitals, enhancing the chance of later implementation.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-09-10.
Trial Details
NCT Number NCT07178691
Lead Sponsor University of Southern Denmark
Collaborators: Aalborg University Hospital, Esbjerg Hospital - University Hospital of Southern Denmark, Zealand University Hospital
Conditions Atrial Fibrillation (AF), Depression - Major Depressive Disorder, Anxiety
Enrollment 28 participants
Start Date 2024-04-19
Primary Completion 2025-03-17 (estimated)
Study Completion 2025-03-17 (estimated)
Updated on ClinicalTrials.gov 2026-04-29