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Can a digital therapy stop depression before it starts in heart patients?

NCT ID NCT07178691

Prevention Sponsor: University of Southern Denmark Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested an online psychological program designed to prevent depression in people with atrial fibrillation (AF), a common heart rhythm problem. The program combined phone or video sessions with online modules and exercises over 4-12 weeks. The trial included 28 adults with AF who did not already have depression or anxiety. The main goal was to see if the program was acceptable and practical, not yet to prove it works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
online psychological intervention (therapist-assisted eHealth program with sessions, modules, and exercises)
What this could lead to
If this approach works, it could offer a way to prevent depression in people with atrial fibrillation, improving their quality of life and heart health outcomes.
What could go wrong
This was a very small feasibility study with only 28 participants and no control group. Larger, more rigorous trials are needed to know if it truly prevents depression.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

28 people

The number who actually took part.

Started

Apr 2024

Finished

Mar 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

anxiety anxiety disorder atrial fibrillation major depressive disorder depressive disorder prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anxiety Atrial fibrillation (AF) Depression - major depressive disorder

Contacts and locations

Locations

  • Aalborg University Hospital

    Aalborg, 9100, Denmark

  • University Hospital Esbjerg and Grindsted, University of Southern Denmark

    Esbjerg, 6700, Denmark

  • Zealand University Hospital, Roskilde, Department of Cardiology

    Roskilde, 4000, Denmark

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