Stepped Versus Stratified Care for Anxiety Disorders in Youth

Official title

Stepped Versus Stratified Care for Anxiety Disorders in Youth: A Pragmatic Non-Inferiority Randomized Controlled Trial

Overview

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.

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/).

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 h
• 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 containi

Primary outcome measures

• Clinical Global Impressions - Improvement Scale [Time frame: 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 outcome measures (8)

• Pediatric Anxiety Rating Scale [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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)]
• Child Anxiety Life Interference Scale-Revised [Time frame: Baseline; 4 months (17 to 20 weeks post-randomization); 8 months (35 to 40 weeks post-randomization, primary endpoint); 12 months; 24 months]
• Proportion of participants who do not adhere to the assigned treatment/s [Time frame: 4 months (17-20 weeks post-randomization); 8 months (35-40 weeks post-randomization, primary endpoint)]
• Adverse events [Time frame: 4 months (17-20 weeks post-randomization); 8 months (35-40 weeks post-randomization, primary endpoint)]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Sweden · 1 center

• Forskningsmottagning Barn och ungdomspsykiatri Lund — Lund

Identifiers

NCT: NCT06942429 · Dnr 2025-01014-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗