Internet-Delivered Cognitive Behavioral Intervention for Youths With Anxiety Disorders

NCT06661460 | Recruiting

• 1 other identifier: 2024-04296-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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:

• 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

Conditions

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

Keywords

Anxiety disorders; Children; Adolescents; Cognitive Behavioral Therapy; Remote delivery; Internet; Internet-delivered cognitive behavioral therapy

Outcome Measures

Primary Outcomes (1)

• Pediatric Anxiety Rating Scale (PARS)

  Used to assess anxiety severity. Clinician-rated. The scale yields a score of 0 to 35, with higher scores indicating more severe anxiety.

  Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).

Secondary Outcomes (31)

• Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders - Child and Adolescent Version (DIAMOND-KID)

  Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).

• Clinical Global Impression Scale - Severity (CGI-S)

  Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).

• Clinical Global Impression Scale - Improvement (CGI-I)

  Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).

• Children's Global Assessment Scale (CGAS)

  Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).

• Therapist time

  Consecutively throughout the 12 week treatment period.

Study Arms (1)

Internet-Delivered Cognitive-Behavioral Therapy

EXPERIMENTAL

Includes the intervention Internet-Delivered Cognitive-Behavioral Therapy.

Behavioral: Internet-Delivered Cognitive Behavioral Therapy

Interventions

Internet-Delivered Cognitive Behavioral Therapy BEHAVIORAL

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.

Internet-Delivered Cognitive-Behavioral Therapy

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \) 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).
• \) 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.

You may not qualify if:

• \) 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.
• \) Established or suspected intellectual disability.
• Confirmed by the caregiver (through previous diagnosis) and/or by attending a special needs school for learning difficulties.
• \) 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.
• \) 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.
• \) 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.

Sponsors & Collaborators

• Lund University: lead

Study Sites (1)

Barn- och ungdomshälsan, Länssjukhuset

Kalmar, Region Kalmar Län, 391 85, Sweden

RECRUITING

Related Links

• All full study protocol versions are published at the Open Science Framework (OSF).

MeSH Terms

Conditions

Anxiety Disorders; Phobic Disorders; Phobia, Specific; Phobia, Social; Anxiety, Separation; Generalized Anxiety Disorder; Panic Disorder; Agoraphobia

Condition Hierarchy (Ancestors)

Mental Disorders; Neurodevelopmental Disorders

Study Officials

• Per Andrén, PhD

  Department of Clinical Sciences, Lund, Lund University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Per Andrén, PhD

CONTACT

+46 70-435 17 40; per.andren@med.lu.se

Eva Serlachius, PhD

CONTACT

+46 70-715 52 32; eva.serlachius@med.lu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 28, 2024
• Study Start: December 12, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

SE (1)