PERSONAE: personalized online treatment for depression
PERSONAE: a Personalized Adaptation of Stepped Care Internet-based Cognitive Behavioral Therapy for Depression - A Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 175 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Region of Southern Denmark Academic / other |
| Locations | 1 site (Odense) |
| Trial ID | NCT07113548 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Odense
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.