PERSONAE: personalized online treatment for depression
Official title: PERSONAE: a Personalized Adaptation of Stepped Care Internet-based Cognitive Behavioral Therapy for Depression - A Randomized Controlled Trial
Run by Region of Southern Denmark · NCT07113548 · Data updated 2026-11-12
This project will test whether PERSONAE, a 12-week personalized app-based CBT program with psychologist guidance, helps adults with mild to moderate depression more than a standard internet CBT program.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 175 (estimated) |
| Sponsor | Region of Southern Denmark Academic / other |
| Locations | 1 site (Odense) |
| Status | Recruiting |
| Started | June 10, 2025 |
| Main results expected | October 2026 |
| Study ends | February 2027 |
| Registry record updated | August 15, 2025 |
| Trial ID | NCT07113548 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with mild to moderate major depressive disorder (PHQ-9 >4 and <22), who can read Danish, have a smartphone, are not pregnant or breastfeeding, and are not currently in psychotherapy are the intended participants.
✕Probably not a fit
People with high suicide risk, bipolar disorder, psychosis, substance dependence, OCD, those currently in psychotherapy, pregnant or breastfeeding individuals, or those without Danish language ability or a smartphone are excluded and unlikely to benefit from this program.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized interventional trial compares a personalized internet-delivered cognitive behavioral therapy (iCBT) program delivered via the PERSONAE app to a standard, one-size-fits-all iCBT program over 12 weeks. Adults with major depressive disorder and PHQ-9 scores between 5 and 21 enroll, complete an intake assessment, and answer weekly questionnaires while receiving tailored guidance from a clinical psychologist. The protocol excludes people with high suicide risk, certain comorbid psychiatric diagnoses, pregnancy/breastfeeding, or current psychotherapy, and requires Danish language and smartphone access. Safety monitoring includes regular symptom checks and procedures for elevated suicide risk.
Why it matters
Potential benefit: If successful, PERSONAE could offer a more effective, accessible, and lower-cost personalized online CBT option that reduces depressive symptoms and improves engagement.
How similar studies have gone: Standard internet-based CBT has established efficacy for mild to moderate depression, while personalized and stepped-care digital CBT approaches show promise but have been less extensively tested.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Center for Digital Psychiatry
Odense, Denmark Recruiting
Study contacts
- Principal investigator: Kim Mathiasen, Ph.d. — University of Southern Denmark & Aarhus University
- Study coordinator: Trine TH Sainte-Marie, ph.d. student
- Email: trine.theresa.holmberg@rsyd.dk
- Phone: + 42209922
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Understanding how the orbitofrontal cortex guides approach vs. avoidance in depression
This study tests how different parts of the orbitofrontal cortex influence whether people pursue rewards or risk loss, and whether this pattern is altered in Major Depressive Disorder.
-
Health education program to help depression in older adults and caregivers in Ho Chi Minh City
A community-based education program for people 60+ and their caregivers is being tested to see if it can lower depression and improve quality of life compared with standard care.
-
Prucalopride for low mood: testing a 5-HT4 receptor activator for cognition and sleep
This study tests whether prucalopride, a 5-HT4 receptor drug, can improve thinking and sleep in adults with low mood or major depressive disorder compared to a placebo.
-
Pre-visit Companion Brief: a primary care AI-assisted check for depression and anxiety
This pilot tests an AI-powered pre-visit assessment that creates a concise Companion Brief for clinicians to help identify depression and anxiety during routine primary care.
-
Medically tailored groceries to help depression in people with food insecurity
This trial tests whether giving medically tailored groceries for six months can reduce depressive symptoms in adults who have depression and struggle with access to food.
-
Health and Work Ability After Inpatient Treatment for Stress-Related Disorders: Follow-Up of the HARMODI Cohort
This study follows people who had inpatient treatment for stress-related disorders to see how their health and ability to work change over the next three years and what factors help them return to work.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.