Tests a personalized online treatment for depression delivered by app
Tests a personalized online therapy app for adults with mild to moderate depression.
Plain-language title generated from the registry record
Registry title: PERSONAE - a Personalized Online Treatment of Depression
Key facts
- Where
- Odense, DenmarkSee the site
Where in Denmark
- Center for Digital PsychiatryOdense, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Region of Southern Denmark
- Trial code
- NCT07113548
- Record updated
- 15 August 2025
- Original description
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:Read full original descriptionShow less
PERSONAE: a Personalized Adaptation of Stepped Care Internet-based Cognitive Behavioral Therapy for Depression - A Randomized Controlled Trial
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
Inclusion: 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: Comorbid disorders: Diagnosed substance dependence, bipolar affective disorder, psychotic illness, or obsessive-compulsive disorder; 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.