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

NCT07178691 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-04-29

No results posted yet for this study

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.

Conditions

  • Atrial Fibrillation (AF)
  • Depression - Major Depressive Disorder
  • Anxiety

Interventions

OTHER

Online psychological intervention

The HOPE-AF intervention is an online psychological intervention to prevent depression in patients with atrial fibrillation. The intervention combines verbal psychological sessions over phone or video with online text messages and a tailored 4-12 weeks online intervention with new modules each week including psychological exercises in writing and as sound exercises (e.g., breathing exercises and relaxations exercises etc.) and videos.

Sponsors & Collaborators

  • Aalborg University Hospital

    collaborator OTHER

  • Esbjerg Hospital - University Hospital of Southern Denmark

    collaborator OTHER

  • Zealand University Hospital

    collaborator OTHER

  • University of Southern Denmark

    lead OTHER

Principal Investigators

  • Susanne s Pedersen, Professor · University of Southern Denmark, Department of Psychology

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-19
Primary Completion
2025-03-17
Completion
2025-03-17

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07178691 on ClinicalTrials.gov