Stepped Versus Stratified Care for Anxiety Disorders in Youth

The goal of this clinical trial is to compare stepped care to stratified care as overall healthcare models for children and adolescents aged 8-17 with anxiety disorders. It addresses one main question: • Is stepped care non-inferior to stratified care in supporting participants to achieve a treatment response? Researchers will compare two care models: * Stepped care, where all participants begin with 14 weeks of internet-delivered cognitive behavioral therapy (ICBT) and receive an additional 14 weeks of personalized in-person CBT if needed. * Stratified care, where participants are assigned to either 14 weeks of ICBT or 14 weeks of in-person CBT based on clinical complexity, and may also receive additional 14 weeks of in-person CBT if necessary. Participants will: * Be randomly assigned to one of the two care models. * Complete a wide range of assessments at baseline, during treatment, and at 4, 8, 12, and 24 months, with the 8-month point as the primary endpoint. * Receive either ICBT, in-person CBT, or both, depending on their care model and response to treatment. * Participate in ancillary studies involving DNA sampling, cognitive testing, and national registry linkages to help predict treatment response and long-term outcomes.

NCT Number	NCT06942429
Lead Sponsor	Region Skane Collaborators: Lund University
Conditions	Social Anxiety Disorder, Separation Anxiety Disorder, Specific Phobia, Panic Disorder, Generalized Anxiety Disorder, Agoraphobia
Enrollment	556 participants
Start Date	2025-06-19
Primary Completion	2029-11-05 (estimated)
Study Completion	2031-03-05 (estimated)
Updated on ClinicalTrials.gov	2026-02-27