Stepped Versus Stratified Care for Anxiety Disorders in Youth

NARecruitingINTERVENTIONAL
Enrollment

556

Participants

Timeline

Start Date

June 19, 2025

Primary Completion Date

November 5, 2029

Study Completion Date

March 5, 2031

Conditions
Social Anxiety DisorderSeparation Anxiety DisorderSpecific PhobiaPanic DisorderGeneralized Anxiety DisorderAgoraphobia
Interventions
BEHAVIORAL

Internet-delivered cognitive-behavioral therapy

Internet-delivered cognitive behavioral therapy (ICBT) is a 12-module intervention delivered over a maximum of 14 weeks. Two age-specific versions are available: \[1\] for children aged 8-12 years and \[2\] for adolescents aged 13-17 years. Both versions share the same core content, but the texts, illustrations, videos, and exercises are adapted to be developmentally appropriate. Each version focuses on exposure, along with psychoeducation, coping strategies, and relapse prevention. Caregivers have access to a parallel program that mirrors the structure of the youth program. Both patients and caregivers engage with a therapist through a secure digital platform, communicating via text messages similar to emails. Two scheduled telephone or videoconference calls are conducted approximately 3-4 and 7-8 weeks into treatment, respectively, to follow up on adherence and address questions related to the intervention. Additional telephone support will be available on demand.

BEHAVIORAL

Personalized in-person cognitive-behavioral therapy

Personalized in-person cognitive-behavioral therapy (CBT) follows a manual drawing on previously published protocols and meta-analyses on effective components of CBT for pediatric anxiety disorders and results from our pilot study. It consists of 12 weekly one-hour sessions delivered over a maximum of 14 weeks. It follows a disorder-specific CBT approach, with a strong emphasis on therapist-led exposure tailored to the patient's principal anxiety disorder. Participants receive workbooks containing information on anxiety disorders, the treatment rationale, and the rationale for exposure therapy. The intervention has three phases: \[1\] 1-2 sessions of psychoeducation and symptom identification, \[2\] 8-10 sessions of therapist-led exposure with homework, and \[3\] 1-2 sessions of relapse prevention planning. Caregiver involvement is tailored to the individual needs of each participant, with a maximum of 2 additional hours allocated for caregivers beyond the standard treatment time.

Trial Locations (1)

22185

RECRUITING

Forskningsmottagning Barn och ungdomspsykiatri Lund, Lund

All Listed Sponsors
collaborator

Lund University

OTHER

lead

Region Skane

OTHER

NCT06942429 - Stepped Versus Stratified Care for Anxiety Disorders in Youth | Biotech Hunter | Biotech Hunter