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

NCT07178691 | Completed

• 2 other identifiers: 12.048S-20230078
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

Brief 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

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

Keywords

atrial fibrillation; prevention of depression; Psychological intervention; online intervention

Outcome Measures

Primary Outcomes (1)

• Drop out rate

  Drop out rate. What is the rate of drop out during the intervention from the 28 included patients. Drop out is defined as patients who want to stop the intervention or patients who stop responding to messages and phone/video calls. A drop-out rate \<25% was considered acceptable.

  From start of the intervention to completion of intervention, i.e., from 0 to 12 weeks.

Secondary Outcomes (7)

• Adherence

  From start of the intervention to completion of intervention, i.e., from 0 to 12 weeks.

• Symptoms of depression

  From completion of baseline questionnaire (after enrollment and prior to intervention start) to completion of follow up questionniare (sent to patients 13 weeks after intervention start).

• Anxiety related to cardiac disease

  From completion of baseline questionnaire (after enrollment and prior to intervention start) to completion of follow up questionniare (sent to patients 13 weeks after intervention start).

• Symptoms of anxiety

  From completion of baseline questionnaire (after enrollment and prior to intervention start) to completion of follow up questionniare (sent to patients 13 weeks after intervention start).

• Atrial fibrillation related quality of life

  From completion of baseline questionnaire (after enrollment and prior to intervention start) to completion of follow up questionniare (sent to patients 13 weeks after intervention start).

Study Arms (1)

online psychological intervention

EXPERIMENTAL

The participants will receive the HOPE-AF online psychological intervention. The intervention is designed to prevent depression in patients with atrial fibrillation

Other: Online psychological intervention

Interventions

Online psychological intervention OTHER

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.

online psychological intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Diagnosis of paroxysmal or persistent AF \[if persistent AF, duration \< 2 years\]
• Able to use and access a computer or tablet/iPad to adhere to the intervention - Proficient in the Danish language (reading and writing)
• Ability to provide informed written consent.

You may not qualify if:

• Depression \[Hospital Anxiety and Depression Scale: HADS-D ≥11 (moderate symptoms)
• Anxiety \[Hospital Anxiety and Depression Scale: HADS-A ≥11 (moderate symptoms)
• Severe psychiatric or neurological disorder (e.g., schizophrenia or dementia)
• In need of psychiatric help due to comprehensive psychiatric issues, diagnosed or not
• Seeing a psychologist or mental health professional for the treatment of depression and anxiety
• Experiencing significant life stressors that hinder adherence to the HOPE-AF treatment
• Participating in another research project involving intervention for depression
• Not being able or willing to spend 1-2 hours on the intervention each week

Sponsors & Collaborators

• University of Southern Denmark: lead
• Aalborg University Hospital: collaborator
• Esbjerg Hospital - University Hospital of Southern Denmark: collaborator
• Zealand University Hospital: collaborator

Study Sites (3)

Aalborg University Hospital

Aalborg, 9100, Denmark

Location

University Hospital Esbjerg and Grindsted, University of Southern Denmark

Esbjerg, 6700, Denmark

Location

Zealand University Hospital, Roskilde, Department of Cardiology

Roskilde, 4000, Denmark

Location

MeSH Terms

Conditions

Atrial Fibrillation; Anxiety Disorders

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Susanne s Pedersen, Professor

  University of Southern Denmark, Department of Psychology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 17, 2025
• Study Start: April 19, 2024
• Primary Completion: March 17, 2025
• Study Completion: March 17, 2025
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)