NCT06942429 Stepped Versus Stratified Care for Anxiety Disorders in Youth
| NCT ID | NCT06942429 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Region Skane |
| Condition | Social Anxiety Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 556 participants |
| Start Date | 2025-06-19 |
| Primary Completion | 2029-11-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 556 participants in total. It began in 2025-06-19 with a primary completion date of 2029-11-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Aged 8.0 to 17.5 years. Confirmed by the child and/or caregiver. 2. 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). 3. Available caregiver who can support the child in treatment. Confirmed by the caregiver. 4. Child and at least one caregiver can read, write, and communicate in Swedish. Confirmed by the child and/or caregiver. 5. Child (≥13 years) and caregiver have access to a Swedish electronic identification (BankID or Freja eID). 6. Access to the internet. Confirmed by the child and/or caregiver. 7. Ability to attend in-person CBT sessions at the clinic. Confirmed by the child and/or caregiver. Exclusion Criteria: 1. 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). 2. Ongoing psychological treatment for an anxiety disorder. Confirmed by the child and/or caregiver. 3. 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. 4. 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. 5. 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.
Contact & Investigator
Matti Cervin, PhD
PRINCIPAL INVESTIGATOR
Lund University & CAMHS Skåne
Frequently Asked Questions
Who can join the NCT06942429 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 17 Years, studying Social Anxiety Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06942429 currently recruiting?
Yes, NCT06942429 is actively recruiting participants. Contact the research team at matti.cervin@med.lu.se for enrollment information.
Where is the NCT06942429 trial being conducted?
This trial is being conducted at Lund, Sweden.
Who is sponsoring the NCT06942429 clinical trial?
NCT06942429 is sponsored by Region Skane. The principal investigator is Matti Cervin, PhD at Lund University & CAMHS Skåne. The trial plans to enroll 556 participants.
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