Stepped vs Stratified Care for Pediatric Anxiety Disorders (PMAX)

Region Skane

Status: Completed

Conditions: Anxiety Disorders

Treatments: Behavioral: In-person cognitive behavioral therapy (CBT); Behavioral: Internet-delivered cognitive behavioral therapy (ICBT)

Study type: Interventional

Funder types: Other

Identifiers

NCT06016907

2022-07219-01

Details and patient eligibility

About

The purpose of this trial is to evaluate the feasibility, acceptability, and safety of two care pathways (including internet-delivered cognitive behavioral therapy [CBT] and/or in-person CBT) for children and adolescents with anxiety disorders.

Full description

Introduction: Anxiety disorders are a major contributor to disability in children and adolescents. Cognitive behavioral therapy (CBT), delivered both in-person and by the internet (ICBT), is efficacious, but how to best organize the care pathway to increase access and benefit is unclear.

Methods: With the aim to conduct a fully powered randomized controlled trial, the present study is a randomized controlled, single-blind, pilot study where 50 youth with anxiety disorders and their caregivers will be randomized (1:1) to stepped care or stratified care. Stepped and stratified care are two competing service delivery models which include evidence-based interventions but differ regarding the timing and staging of interventions.

In the stepped care arm, all participants will begin with 12 modules of ICBT delivered over 12 weeks. Participants with an insufficient response will then be offered 12-weeks of personalized in-person CBT. In the stratified care arm, the investigators aim to offer about half of the participants ICBT and the other half in-person CBT, with this selection being based on a risk score algorithm that integrates known predictors of non-response to treatment.

Mirroring the structure in stepped care, all non-responders in stratified care (both those who started with ICBT and in-person CBT) will be offered an additional 12-week course of in-person CBT. The ICBT and in-person CBT interventions will be identical in treatment length, but will differ in the delivery of treatment, utilizing the possibility of increased personalization and therapist-involvement in in-person CBT.

The objectives of the pilot study are to examine feasibility, acceptability, and safety of study procedures, precision of the risk score algorithm, and statistical properties of outcome measures. The feasibility, acceptability, and safety objectives are operationalized in detail in the full study protocol published at the Open Science Framework (OSF; see link in the References-section at the bottom of this record).

Data will be collected at baseline, post-allocation (week 1), weekly during treatment course A (week 2-13), after treatment course A (POST-1; time window for data collection between week 14-17), weekly during treatment course B (if applicable, week 18-29), and after treatment course B (POST-2; time window for data collection between week 30-33). POST-2 is the primary endpoint of the study.

Enrollment: 51 patients

Sex: All

Ages: 8 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 8 to <18 years of age.
2. A principal Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) anxiety disorder of social anxiety disorder, generalized anxiety disorder, panic disorder, separation anxiety disorder, specific phobia, or agoraphobia.
3. A Clinical Global Impression Scale - Severity (CGI-S) score >3 in relation to severity of all anxiety symptoms.
4. Child and caregiver able to read, write and communicate in Swedish.
5. An available caregiver who can support the child in treatment.
6. Access to the internet.
7. Ability to attend treatment sessions at the clinic.

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).
2. Established or suspected intellectual disability.
3. Another mental disorder in more immediate need of management than an anxiety disorder (e.g., schizophrenia spectrum and other psychotic disorders, bipolar disorder, anorexia nervosa, substance use disorders).
4. Social/familial/educational difficulties in more immediate need of management than an anxiety disorder.
5. Ongoing psychological treatment for an anxiety disorder.
6. Initiation or adjustment of any psychotropic medication for anxiety (i.e., selective serotonin reuptake inhibitors, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitor or antipsychotics) within 8 weeks prior to assessment.
7. Immediate risk to self or others that require urgent attention, such as suicidality.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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51 participants in 2 patient groups

Stepped care

Other group

Description:

Participants will receive up to two courses of treatment. All participants in stepped care will receive internet-delivered cognitive behavioral therapy (ICBT) in the first course (A). Participants with an insufficient treatment response will then be offered in-person cognitive behavioral therapy (CBT) in the second course (B). Even if participants are offered treatment in course B, participants are free to decline this offer, and will instead only be invited to the remaining outcome assessments.

Treatment:

Behavioral: In-person cognitive behavioral therapy (CBT)

Behavioral: Internet-delivered cognitive behavioral therapy (ICBT)

Stratified care

Other group

Description:

Participants will receive up to two courses of treatment. In stratified care, in treatment course A, the investigators aim to offer around half of the participants ICBT and the other half in-person CBT (based on their risk of non-response). All participants in stratified care who do not sufficiently respond to treatment in course A will be offered personalized in-person CBT in course B. Even if participants are offered treatment in course B, participants are free to decline this offer, and will instead only be invited to the remaining outcome assessments.

Treatment:

Behavioral: In-person cognitive behavioral therapy (CBT)

Behavioral: Internet-delivered cognitive behavioral therapy (ICBT)