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RECRUITING

NCT06661460

Internet-Delivered Cognitive Behavioral Intervention for Youths With Anxiety Disorders

Sponsor: Lund University

View on ClinicalTrials.gov

Summary

The goal of this study is to develop a new internet-delivered cognitive behavioral therapy (ICBT) intervention for youths with anxiety disorders based on the best current knowledge about effective cognitive behavioral therapy for the target group, refine the intervention in collaboration with patient and public representatives, and conduct a preliminary evaluation of the treatment effects in an open clinical trial. The primary objective of the study is: 1\. To evaluate the preliminary efficacy of a newly developed ICBT intervention for children and adolescents with anxiety disorders in reducing anxiety severity, as measured by the Pediatric Anxiety Rating Scale (PARS). Secondary objectives of the study are: 1. To examine the preliminary efficacy (PARS) of the ICBT intervention at 3 months post-treatment. 2. To examine how youths with anxiety disorders, their caregivers, therapists, and healthcare leadership experience the ICBT intervention. 3. To examine factors (e.g., age, type of anxiety disorder, presence of depressive symptoms, experiences of ICBT) that predict treatment outcome. 4. To examine how the ICBT intervention can be improved (e.g., treatment content and technical delivery) for future use. Participants will: * Undergo ICBT treatment for anxiety disorders during 12 weeks * Complete questionnaires at multiple time points throughout the study * Participate in follow-ups post-treatment and 3 months post-treatment * A selection of participants will also be invited to focus group interviews with the aim to generate ideas on how the intervention may be improved for future use

Official title: Development and Preliminary Evaluation of a New Internet-Delivered Cognitive Behavioral Intervention for Youths With Anxiety Disorders

Key Details

Gender

All

Age Range

8 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-12-12

Completion Date

2027-06-01

Last Updated

2026-02-20

Healthy Volunteers

Conditions

ANXIETY DISORDERS (or Anxiety and Phobic Neuroses)Specific Phobia Social Anxiety Disorder Separation Anxiety Disorder Generalized Anxiety Disorder Panic Disorder Agoraphobia

Interventions

BEHAVIORAL

Internet-Delivered Cognitive Behavioral Therapy

The intervention is a therapist-guided, internet-delivered cognitive behavioral therapy (ICBT) program primarily based on exposure therapy, involving the gradual confrontation of feared situations and/or stimuli. Treatment is accessed through a smartphone, tablet or laptop/desktop device. The 12-week intervention is available in two different versions depending on the participant's age: one for 8-12-year-olds and one for 13-17-year-olds. Each version consists of separate logins to 12 modules (chapters) for the child/adolescent and 12 modules for the caregivers. Both the child/adolescent and caregiver have individual contact with a trained therapist over the internet platform. The therapist provides feedback, responds to questions and sends reminders to complete the next module if required. Communication is carried out via text messages in the platform, via telephone (if deemed justified) and through a scheduled telephone or videoconference call approximately 4-5 weeks into treatment.

Inclusion Criteria: 1\) 8 to \<18 years of age. * Confirmed by the child/caregiver and subsequently by the medical record system. 2) A principal DSM-5-TR anxiety disorder of specific phobia, separation anxiety disorder, social anxiety disorder, generalized anxiety disorder, panic disorder or agoraphobia. * Confirmed by the Diagnostic Interview for Anxiety, Mood, and OCD and related Neuropsychiatric Disorders - Child and Adolescent Version (DIAMOND-KID). 3\) Child and caregiver able to read, write and communicate in Swedish. * Confirmed by the child/caregiver. 4) An available caregiver who can support the child in treatment. * Confirmed by the caregiver. 5) Access to a smartphone, tablet, or laptop/desktop device, and the internet. * Confirmed by the child/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 blood-injection-injury phobia being classified as the principal anxiety disorder as assessed by the DIAMOND-KID. 2\) Established or suspected intellectual disability. * Confirmed by the caregiver (through previous diagnosis) and/or by attending a special needs school for learning difficulties. 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). * According to the DIAMOND-KID and/or other available sources. 4) Social/familial/educational difficulties in more immediate need of management than an anxiety disorder. * Confirmed by the assessor through information from the child/caregiver and/or other available sources. 5\) Immediate risk to self or others that require urgent attention, such as acute suicidality. * Confirmed by the assessor through information from the child/caregiver and other available sources. 6\) Previous CBT for an anxiety disorder, defined as five or more sessions with a certified CBT therapist within the 12 months prior to assessment. * Confirmed by the child/caregiver or the medical record system. 7) Ongoing psychological treatment for an anxiety disorder. * Confirmed by the child/caregiver or the medical record system. 8) 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. * Confirmed by the child/caregiver or the medical record system. 9) Participation in user involvement sessions in the present study. * Confirmed by the researcher.

Locations (1)

Barn- och ungdomshälsan, Länssjukhuset

Kalmar, Region Kalmar Län, Sweden