PERSONAE - a Personalized Online Treatment of Depression

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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

Eligibility

Primary outcome measure(s)

• 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
  The Patient Health Questionnaire-9 (PHQ-9) has a total score range of 0-27, with higher scores indicating more severe depressive symptoms. The questionnaire will be administered via automated REDCap surveys at baseline, post-treatment, and at 3-, 6-, and 12-month follow-ups, as well as during treatment through the Minddistrict (TAU) and Monsenso (PERSONAE) programs. The PHQ-9 evaluates nine core symptoms of depression.

Trial sites (1)

More Region of Southern Denmark trials in Denmark

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