Recruiting

PERSONAE - a Personalized Online Treatment of Depression

ClinicalTrials.gov IDNCT07113548

PhaseNA

Enrollment175

SponsorRegion of Southern Denmark

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Depression - Major Depressive Disorder

About this study

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

Interventions

Behavioral: Personalized iCBT for depression — Participants receive 12 sessions of personalized treatment in an online iCBT program. The treatment includes the option for weekly written feedback from a psychologist, or video-based interventions depending on the participant's current status. The content of the 12-week program is tailored to the participant's individual symptom profile. The treatment incorporates elements from standard Cognitive Behavioral Therapy (CBT), Acceptance and Commitment Therapy (ACT), Compassion-Focused Therapy (CFT), and Positive Activity Interventions (PAT). The program consists of nine modules, each targeting a specific area: Rumination, Anhedonia, Tearfulness and emotional regulation, Sleep problems, Difficulty concentrating, Eating issues, Low energy, Social withdrawal, Self-critical thinking, The treatment concludes with support aimed at preventing relapse.
Behavioral: Standard iCBT — Standard iCBT consisting of a "one size fits all"" progression of cognitive behavioral therapy over 12 weeks. This includes: Introduction to Online Cognitive Behavioral Therapy Start of Treatment Rumination Activity Monitoring Activity Planning Cognitive Restructuring Behavioral Experiment I Behavioral Experiment II Core Beliefs I Core Beliefs II Relapse Prevention

Primary outcomes

Change from baseline in the mean depression score on the 9-item Patient Health Questionnaire (PHQ-9). (From enrollment to 12 weeks of treatment, plus follow up at 3, 6, and 12 months)

Eligibility information

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.

Study locations

Center for Digital Psychiatry, Odense, 5000 Denmark

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-28.