Internet-Delivered Cognitive Behavioral Intervention for Youths With Anxiety Disorders (NCT06661460) | Clinical Trial Compass
RecruitingNot Applicable
Internet-Delivered Cognitive Behavioral Intervention for Youths With Anxiety Disorders
Sweden48 participantsStarted 2025-12-12
Plain-language 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
Who can participate
Age range
8 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 psyc…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pediatric Anxiety Rating Scale (PARS)
Timeframe: Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).