Internet-Delivered Cognitive Behavioral Intervention for Youths With Anxiety Disorders

NCT ID: NCT06661460

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2027-04-01

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:

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

Detailed Description

A detailed description is available in the full study protocol. All full study protocol versions may be accessed at the Open Science Framework (https://osf.io/fdnga/).

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Internet-Delivered Cognitive-Behavioral Therapy

Includes the intervention Internet-Delivered Cognitive-Behavioral Therapy.

Group Type: EXPERIMENTAL

Internet-Delivered Cognitive Behavioral Therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lund University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Per Andrén, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Sciences, Lund, Lund University

Locations

Barn- och ungdomshälsan, Länssjukhuset

Kalmar, Region Kalmar Län, Sweden

Countries

Sweden

Central Contacts

Per Andrén, PhD

Role: CONTACT

per.andren@med.lu.se

+46 70-435 17 40

Eva Serlachius, PhD

Role: CONTACT

eva.serlachius@med.lu.se

+46 70-715 52 32

Facility Contacts

Sandra Andrekson, Lic. psychologist

Role: primary

sandra.andrekson@med.lu.se

+46 73-595 38 31

Related Links

https://osf.io/fdnga/

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

Other Identifiers

2024-04296-01

Identifier Type: -

Identifier Source: org_study_id