NCT07113548 PERSONAE - a Personalized Online Treatment of Depression
| NCT ID | NCT07113548 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Region of Southern Denmark |
| Condition | Depression - Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 175 participants |
| Start Date | 2025-06-10 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 175 participants in total. It began in 2025-06-10 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Kim Mathiasen, Ph.d.
PRINCIPAL INVESTIGATOR
University of Southern Denmark & Aarhus University
Frequently Asked Questions
Who can join the NCT07113548 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Depression - Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07113548 currently recruiting?
Yes, NCT07113548 is actively recruiting participants. Contact the research team at trine.theresa.holmberg@rsyd.dk for enrollment information.
Where is the NCT07113548 trial being conducted?
This trial is being conducted at Odense, Denmark.
Who is sponsoring the NCT07113548 clinical trial?
NCT07113548 is sponsored by Region of Southern Denmark. The principal investigator is Kim Mathiasen, Ph.d. at University of Southern Denmark & Aarhus University. The trial plans to enroll 175 participants.
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