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NCT06942429 | NOT YET RECRUITING | Social Anxiety Disorder

Stepped Versus Stratified Care for Anxiety Disorders in Youth
Sponsor:

Region Skane

Information provided by (Responsible Party):

Matti Cervin

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.

Condition or disease

Social Anxiety Disorder

Separation Anxiety Disorder

Specific Phobia

Panic Disorder

Generalized Anxiety Disorder

Agoraphobia

Intervention/treatment

Internet-delivered cognitive-behavioral therapy

Personalized in-person cognitive-behavioral therapy

Phase

NA

Detailed Description:

A detailed description is available in the full study protocol. All study protocol versions can be accessed at the Open Science Framework (https://osf.io/a9qhw/).

Study Type : INTERVENTIONAL
Estimated Enrollment : 556 participants
Masking : DOUBLE
Masking Description : Statistical analyst
Primary Purpose : TREATMENT
Official Title : Stepped Versus Stratified Care for Anxiety Disorders in Youth: A Pragmatic Non-Inferiority Randomized Controlled Trial
Actual Study Start Date : 2025-05-05
Estimated Primary Completion Date : 2029-11-05
Estimated Study Completion Date : 2031-03-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 8 Years to 17 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1) 8 to \<18 years of age.
  • * 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.
Stepped Versus Stratified Care for Anxiety Disorders in Youth

Location Details

NCT06942429

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Sweden,

Research Reception Children and Youth Psychiatry Lund

Lund, Sweden, 22185