PERSONAE - a Personalized Online Treatment of Depression

Recruiting now · Not applicable

Conditions studied: Depression - Major Depressive Disorder

In brief

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

Key facts

Study ID

NCT07113548

Run by

Region of Southern Denmark

People needed

175

Starts

2025-06-10

Expected to finish

2027-02-01

Last updated by the study team

2025-08-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years or older.
• Patient Health Questionnaire-9 items (PHQ-9) >4 AND <22.
• Any gender.
• Meeting the diagnostic criteria of the International Classification of Diseases and Related Health Problems 10th edition for major depressive disorder

You may not qualify if…

• Unable to speak and/or read Danish.
• No access to a smartphone.
• Pregnant or breastfeeding.
• Heightened suicide risk as per the PHQ-9 (item 9 >1) and Quick Inventory of Depressive Symptoms (QIDS) item 12.
• Comorbid disorders: Diagnosed substance dependence, bipolar affective disorder, psychotic illness, or obsessive-compulsive disorder.
• Not currently in therapeutic treatment for anxiety or depression.

Where it is running

• Center for Digital Psychiatry — Odense, Denmark (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.