Stepped Versus Stratified Care for Anxiety Disorders in Youth

NCT06942429 | Recruiting DMC

• 1 other identifier: Dnr 2025-01014-01
• Study Type: interventional
• Target: 556
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Specific Phobia; Panic Disorder; Generalized Anxiety Disorder; Agoraphobia; Social Anxiety Disorder; Separation Anxiety Disorder

Keywords

anxiety disorders; children; adolescents; cognitive behavioral therapy; non-inferiority; care models; stepped care; stratified care

Outcome Measures

Primary Outcomes (1)

• Clinical Global Impressions - Improvement Scale

  The Clinical Global Impressions - Improvement (CGI-I) Scale is a 1-item measure where a trained interviewer uses all available information about the patient to rate improvement on a 7-point scale: 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse. In this study, improvement on the CGI-I is assessed by comparing the current status of the participant to their baseline condition. In line with previous studies, a score of 1 or 2 on the CGI-I is classified as a treatment response and scores of 3 to 7 as non-response. This binary variable is the primary outcome of the trial.

  4 months (17-20 weeks post-randomization); 8 months (35-40 weeks post-randomization, primary endpoint); 12 months (53-60 weeks post-randomization, observational follow-up); 24 months (105-116 weeks post-randomization, observational follow-up)

Secondary Outcomes (8)

• Pediatric Anxiety Rating Scale

  Baseline; 4 months (17-20 weeks post-randomization); 8 months (35-40 weeks post-randomization, primary endpoint); 12 months (53-60 weeks post-randomization, observational follow-up); 24 months (105-116 weeks post-randomization, observational follow-up)

• Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders - Child and Adolescent Version

  Baseline; 4 months (17-20 weeks post-randomization); 8 months (35-40 weeks post-randomization, primary endpoint); 12 months (53-60 weeks post-randomization, observational follow-up); 24 months (105-116 weeks post-randomization, observational follow-up)

• Clinical Global Impressions Scale-Severity

  Baseline; 4 months (17-20 weeks post-randomization); 8 months (35-40 weeks post-randomization, primary endpoint); 12 months (53-60 weeks post-randomization, observational follow-up); 24 months (105-116 weeks post-randomization, observational follow-up)

• Children's Global Assessment Scale

  Baseline; 4 months (17-20 weeks post-randomization); 8 months (35-40 weeks post-randomization, primary endpoint); 12 months (53-60 weeks post-randomization, observational follow-up); 24 months (105-116 weeks post-randomization, observational follow-up)

• Revised Children's Anxiety and Depression Scale

  Baseline; 4 months (17-20 weeks post-randomization); 8 months (35-40 weeks post-randomization, primary endpoint); 12 months (53-60 weeks post-randomization, observational follow-up); 24 months (105-116 weeks post-randomization, observational follow-up)

Other Outcomes (1)

• Health economic outcomes

  Baseline; 4 months (17-20 weeks post-randomization); 8 months (35-40 weeks post-randomization, primary endpoint); 12 months (53-60 weeks post-randomization, observational follow-up); 24 months (105-116 weeks post-randomization, observational follow-up)

Study Arms (2)

Stepped Care

EXPERIMENTAL

All participants in stepped care will receive internet-delivered cognitive-behavioral therapy (ICBT) in the first Treatment course (A). Participants who have not responded to treatment or continue to exhibit clinical levels of anxiety severity will be offered personalized in-person CBT in the second Treatment course (B).

Behavioral: Internet-delivered cognitive-behavioral therapy; Behavioral: Personalized in-person cognitive-behavioral therapy

Stratified Care

ACTIVE COMPARATOR

In stratified care, Treatment course A aims to allocate approximately half of the participants to internet-delivered cognitive-behavioral therapy (ICBT) and the other half to personalized in-person CBT, based on their algorithm-generated clinical complexity score. Identical to stepped care, those who have not responded to treatment or continue to exhibit clinical levels of anxiety severity after Treatment course A will be offered personalized in-person CBT in Treatment course B.

Behavioral: Internet-delivered cognitive-behavioral therapy; Behavioral: Personalized in-person cognitive-behavioral therapy

Interventions

Internet-delivered cognitive-behavioral therapy BEHAVIORAL

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.

Stepped Care; Stratified Care

Personalized in-person cognitive-behavioral therapy BEHAVIORAL

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.

Stepped Care; Stratified Care

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged 8.0 to 17.5 years. Confirmed by the child and/or caregiver.
• Principal DSM-5-TR anxiety disorder of social anxiety disorder, generalized anxiety disorder, panic disorder, separation anxiety disorder, specific phobia, or agoraphobia. Confirmed by the structured diagnostic interview (DIAMOND-KID). "Principal" indicates that the anxiety disorder is judged by the clinician to be in most urgent need of treatment (among potential co-occurring disorders).
• Available caregiver who can support the child in treatment. Confirmed by the caregiver.
• Child and at least one caregiver can read, write, and communicate in Swedish. Confirmed by the child and/or caregiver.
• Child (≥13 years) and caregiver have access to a Swedish electronic identification (BankID or Freja eID).
• Access to the internet. Confirmed by the child and/or caregiver.
• Ability to attend in-person CBT sessions at the clinic. Confirmed by the child and/or caregiver.

You may not qualify if:

• Principal DSM-5-TR anxiety disorder of specific phobia concerning the domain of blood-injection-injury (due to the ICBT program not including relevant information on applied-tension techniques to avoid fainting during exposure exercises). Confirmed by a specific phobia of this sort being classified as the most functionally impairing anxiety disorder during the structured diagnostic interview (DIAMOND-KID).
• Ongoing psychological treatment for an anxiety disorder. Confirmed by the child and/or caregiver.
• Social/familial/educational difficulties in more immediate need of management than an anxiety disorder. Confirmed by the assessor through information from the child and/or caregiver and/or other available sources.
• Immediate risk to self or others that require urgent attention, such as suicidality. Confirmed by the assessor through information from the child and/or caregiver and other available sources.
• The potential participant has a relative (e.g., sibling, cousin) included in the study. Confirmed by the assessor through information from the caregiver and other available sources.

Sponsors & Collaborators

• Region Skane: lead
• Lund University: collaborator

Study Sites (1)

Forskningsmottagning Barn och ungdomspsykiatri Lund

Lund, 22185, Sweden

RECRUITING

Related Links

• All versions of the study protocol are shared on the Open Science Framework platform. The trial includes an ancillary study, fully described in the study protocol, designed to identify predictive markers of treatment response and long-term outcomes.

MeSH Terms

Conditions

Phobia, Social; Anxiety, Separation; Phobia, Specific; Panic Disorder; Generalized Anxiety Disorder; Agoraphobia; Anxiety Disorders

Condition Hierarchy (Ancestors)

Phobic Disorders; Mental Disorders; Neurodevelopmental Disorders

Study Officials

• Matti Cervin, PhD

  Lund University & CAMHS Skåne

  PRINCIPAL INVESTIGATOR

• Eva Serlachius, MD, PhD

  Lund University & CAMHS Skåne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matti Cervin, PhD

CONTACT

0046(0)737199700; matti.cervin@med.lu.se

Eva Serlachius, MD, PhD

CONTACT

0046(0)707155232; eva.serlachius@med.lu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Statistical analyst
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Senior Clinical Psychologist

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 24, 2025
• Study Start: June 19, 2025
• Primary Completion (Estimated): November 5, 2029
• Study Completion (Estimated): March 5, 2031
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

SE (1)