Efficacy of a Personalized, Response-based Transdiagnostic Intervention for Emotional Disorders Delivered Via the Internet: A Protocol for an Adaptive Randomized Controlled Trial

This adaptive randomized controlled trial evaluates the efficacy of a transdiagnostic, internet-delivered psychological intervention for emotional disorders, tailored to patient´s early clinical response. 366 adults with clinically significant symptoms of depression and/or anxiety will begin a 12 module self-applied program. Based on sympton reduction after the first three modules, participants will be classified as early or late responders and randomized into different experimental arms. The main hypothesis is that a hybrid format (self-applied modules plus synchronous sessions with a therapist) will yield better outcomes for late responders. Outcomes include symptom reduction, emotional regulation and internet based therapheutic alliance.

NCT Number	NCT07051148
Lead Sponsor	Universitat Jaume I
Conditions	Emotional Disorders, Anxiety, Depression, Unipolar
Enrollment	366 participants
Start Date	2027-05-01
Primary Completion	2029-12 (estimated)
Study Completion	2030-07 (estimated)
Updated on ClinicalTrials.gov	2026-05-27