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PERSONAE - a Personalized Online Treatment of Depression
Sponsor: Region of Southern Denmark
Summary
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
Official title: PERSONAE: a Personalized Adaptation of Stepped Care Internet-based Cognitive Behavioral Therapy for Depression - A Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
175
Start Date
2025-06-10
Completion Date
2027-02
Last Updated
2025-08-15
Healthy Volunteers
No
Conditions
Interventions
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.
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
Locations (1)
Center for Digital Psychiatry
Odense, Denmark