Status:
COMPLETED
Stepped vs Stratified Care for Pediatric Anxiety Disorders
Lead Sponsor:
Region Skane
Collaborating Sponsors:
Lund University
Conditions:
Anxiety Disorders
Eligibility:
All Genders
8-17 years
Phase:
NA
Brief Summary
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 ch...
Detailed 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 efficacio...
Eligibility Criteria
Inclusion
- 8 to \<18 years of age.
- 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.
- A Clinical Global Impression Scale - Severity (CGI-S) score \>3 in relation to severity of all anxiety symptoms.
- Child and caregiver able to read, write and communicate in Swedish.
- An available caregiver who can support the child in treatment.
- Access to the internet.
- Ability to attend treatment sessions at the clinic.
Exclusion
- 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).
- Established or suspected intellectual disability.
- 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).
- Social/familial/educational difficulties in more immediate need of management than an anxiety disorder.
- Ongoing psychological treatment for an anxiety disorder.
- 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.
- Immediate risk to self or others that require urgent attention, such as suicidality.
Key Trial Info
Start Date :
October 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2024
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT06016907
Start Date
October 2 2023
End Date
November 14 2024
Last Update
November 27 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Child and Adolescent Mental Health Services, Region Skane
Lund, Skåne County, Sweden, 22185