Online cognitive behavioral therapy for children and adolescents with anxiety
Development and Preliminary Evaluation of a New Internet-Delivered Cognitive Behavioral Intervention for Youths With Anxiety Disorders
This project will test whether an internet-delivered CBT program can help children and teens with anxiety feel less anxious.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 8 Years to 17 Years |
| Sex | All |
| Sponsor | Lund University Academic / other |
| Locations | 1 site (Kalmar, Region Kalmar Län) |
| Trial ID | NCT06661460 on ClinicalTrials.gov |
What this trial studies
Researchers developed a new internet-delivered cognitive behavioral therapy (ICBT) program for youths using current best practices and refined it together with patient and public representatives. They will run an open clinical trial to get initial data on whether the program reduces anxiety severity measured by the Pediatric Anxiety Rating Scale (PARS) immediately after treatment and at three months. The trial will also collect qualitative feedback from youths, caregivers, therapists, and healthcare leaders about their experiences with the intervention. Participants must be 8 to under 18, speak Swedish, have caregiver support, and have access to an internet-capable device.
Who should consider this trial
Good fit: Children and adolescents aged 8 to <18 with a principal DSM-5 anxiety disorder (excluding blood-injection-injury specific phobia), who speak Swedish, have an available caregiver to support treatment, and have internet-enabled device access.
Not a fit: Patients whose main phobia is blood-injection-injury, those who do not speak Swedish, lack caregiver support, or lack reliable internet/device access are unlikely to benefit from this ICBT program.
Why it matters
Potential benefit: If successful, this program could expand access to evidence-based CBT and reduce anxiety symptoms for children and adolescents who cannot easily attend in-person therapy.
How similar studies have performed: Previous internet-delivered CBT programs for youth have generally produced symptom reductions in prior trials, although results vary by program, age group, and setting.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Kalmar, Region Kalmar Län
- Barn- och ungdomshälsan, Länssjukhuset — Kalmar, Region Kalmar Län, Sweden (Recruiting)
Study contacts
- Principal investigator: Per Andrén, PhD — Department of Clinical Sciences, Lund, Lund University
- Study coordinator: Per Andrén, PhD
- Email: per.andren@med.lu.se
- Phone: +46 70-435 17 40
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.