Stepped Versus Stratified Care for Anxiety Disorders in Youth

Region Skane

Status: Not yet enrolling

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06942429

Dnr 2025-01014-01

Details and patient eligibility

About

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.

Full 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/).

Enrollment: 556 estimated patients

Sex: All

Ages: 8 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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556 participants in 2 patient groups

Stepped Care

Experimental group

Description:

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).

Treatment:

Behavioral: Internet-delivered cognitive-behavioral therapy

Behavioral: Personalized in-person cognitive-behavioral therapy

Stratified Care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Internet-delivered cognitive-behavioral therapy

Behavioral: Personalized in-person cognitive-behavioral therapy