Internet-Delivered Cognitive Behavioral Intervention for Youths With Anxiety Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Internet-Delivered Cognitive Behavioral Therapy.
- Who it may be relevant to
- Registry conditions: ANXIETY DISORDERS (or Anxiety and Phobic Neuroses), Specific Phobia, Social Anxiety Disorder, Separation Anxiety Disorder. Basic parameters: 8 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Development and Preliminary Evaluation of a New Internet-Delivered Cognitive Behavioral Intervention for Youths With Anxiety Disorders
Overview
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/).
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 (ch
Primary outcome measures
- Pediatric Anxiety Rating Scale (PARS) [Time frame: Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).]
Secondary outcome measures (12)
- Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders - Child and Adolescent Version (DIAMOND-KID) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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 [Time frame: Consecutively throughout the 12 week treatment period.]
- Module completion [Time frame: Consecutively throughout the 12 week treatment period.]
- Number of participants with concomitant interventions [Time frame: Post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).]
- Revised Child Anxiety and Depression Scale - Child version (RCADS-C) [Time frame: Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).]
- Child Anxiety Life Interference Scale - Revised - Child version (CALIS-R-C) [Time frame: Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).]
- Patient Health Questionnaire-2 (PHQ-2) [Time frame: Baseline; 3, 6, and 9 weeks into treatment; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).]
- Generalized Anxiety Disorder-2 (GAD-2) [Time frame: Baseline; 3, 6, and 9 weeks into treatment; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).]
- Well-being [Time frame: Baseline; 3, 6, and 9 weeks into treatment; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Barn- och ungdomshälsan, Länssjukhuset — Kalmar
Identifiers
NCT: NCT06661460 · 2024-04296-01