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PERSONAE - a Personalized Online Treatment of Depression

RECRUITINGN/ASponsored by Region of Southern Denmark
Actively Recruiting
PhaseN/A
SponsorRegion of Southern Denmark
Started2025-06-10
Est. completion2026-10
Eligibility
Age18 Years+
Healthy vol.Accepted

Summary

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

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Conditions2

DepressionDepression - Major Depressive Disorder

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