Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07113548

PERSONAE - a Personalized Online Treatment of Depression

Led by Region of Southern Denmark · Updated on 2025-08-15

175

Participants Needed

1

Research Sites

85 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this clinical trial is to determine whether a personalized online treatment for depression, delivered via an app (PERSONAE), is effective in treating mild to moderate depression in adults. The study will also assess the safety of the Monsenso app. The main questions it aims to answer are: Does the PERSONAE intervention reduce depression scores compared to standard internet-based treatment for depression? What challenges do participants experience when using the PERSONAE intervention? Researchers will compare PERSONAE to Treatment As Usual (a standard, one-size-fits-all treatment) to evaluate whether PERSONAE is more effective in treating mild to moderate depression. Participants will: Complete a 12-week online treatment program based on cognitive behavioral therapy (CBT). Undergo an intake assessment and complete weekly questionnaires. Receive guidance from a clinical psychologist tailored to their individual needs

CONDITIONS

Official Title

PERSONAE - a Personalized Online Treatment of Depression

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older
  • Patient Health Questionnaire-9 (PHQ-9) score greater than 4 and less than 22
  • Any gender
  • Diagnosed with major depressive disorder according to the International Classification of Diseases 10th edition
Not Eligible

You will not qualify if you...

  • Unable to speak or read Danish
  • No access to a smartphone
  • Pregnant or breastfeeding
  • Heightened suicide risk based on PHQ-9 item 9 and Quick Inventory of Depressive Symptoms item 12
  • Diagnosed substance dependence, bipolar disorder, psychotic illness, or obsessive-compulsive disorder
  • Currently receiving therapeutic treatment for anxiety or depression

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Center for Digital Psychiatry

Odense, Denmark, 5000

Actively Recruiting

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Research Team

T

Trine TH Sainte-Marie, ph.d. student

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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