NCT07113548Recruiting
PERSONAE - a Personalized Online Treatment of Depression
PERSONAE: a Personalized Adaptation of Stepped Care Internet-based Cognitive Behavioral Therapy for Depression - A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 15 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 175 (estimated)
- First submitted
- 12 Jun 2025
- Start date
- 10 Jun 2025
- Primary completion date
- Oct 2026
- Lead sponsor
- Region of Southern Denmark
- Diseases
- Depression
- NCT number
- NCT07113548
What you commit to
- Study type: Interventional
- Planned participants: 175
- From 10 Jun 2025 to the primary completion date, Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Comorbid disorders: Diagnosed substance dependence, bipolar affective disorder, psychotic illness, or obsessive-compulsive disorder.
Other
- 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.
- Not currently in therapeutic treatment for anxiety or depression.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Center for Digital Psychiatry Coordinator of this site? Confirm its status | Odense | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.