An interventional study of Internet-delivered cognitive-behavioral therapy and Personalized in-person cognitive-behavioral therapy in Social Anxiety Disorder, Separation Anxiety Disorder and Specific Phobia, sponsored by Region Skane. Recruiting at 1 site in Sweden. Open to participants aged 8 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Region Skane · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to compare stepped care to stratified care as overall healthcare models for children and adolescents aged 8-17 with anxiety disorders. It addresses one main question:
Researchers will compare two care models:
Participants will:
A detailed description is available in the full study protocol. All study protocol versions can be accessed at the Open Science Framework (https://osf.io/a9qhw/).
367 studies on the registry are indexed under Phobia, Social; 58 are open to participants now.
This study's planned enrollment of 556 is above the median of 76 across 338 interventional studies indexed under Phobia, Social.
Browse Phobia, Social studies →Region Skane is the lead sponsor of 386 studies on the registry; 122 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants in stepped care will receive internet-delivered cognitive-behavioral therapy (ICBT) in the first Treatment course (A). Participants who have not responded to treatment or continue to exhibit clinical levels of anxiety severity will be offered personalized in-person CBT in the second Treatment course (B).
Behavioral: Internet-delivered cognitive-behavioral therapy · Behavioral: Personalized in-person cognitive-behavioral therapy
In stratified care, Treatment course A aims to allocate approximately half of the participants to internet-delivered cognitive-behavioral therapy (ICBT) and the other half to personalized in-person CBT, based on their algorithm-generated clinical complexity score. Identical to stepped care, those who have not responded to treatment or continue to exhibit clinical levels of anxiety severity after Treatment course A will be offered personalized in-person CBT in Treatment course B.
Behavioral: Internet-delivered cognitive-behavioral therapy · Behavioral: Personalized in-person cognitive-behavioral therapy
Internet-delivered cognitive behavioral therapy (ICBT) is a 12-module intervention delivered over a maximum of 14 weeks. Two age-specific versions are available: \[1\] for children aged 8-12 years and \[2\] for adolescents aged 13-17 years. Both versions share the same core content, but the texts, illustrations, videos, and exercises are adapted to be developmentally appropriate. Each version focuses on exposure, along with psychoeducation, coping strategies, and relapse prevention. Caregivers have access to a parallel program that mirrors the structure of the youth program. Both patients and caregivers engage with a therapist through a secure digital platform, communicating via text messages similar to emails. Two scheduled telephone or videoconference calls are conducted approximately 3-4 and 7-8 weeks into treatment, respectively, to follow up on adherence and address questions related to the intervention. Additional telephone support will be available on demand.
Personalized in-person cognitive-behavioral therapy (CBT) follows a manual drawing on previously published protocols and meta-analyses on effective components of CBT for pediatric anxiety disorders and results from our pilot study. It consists of 12 weekly one-hour sessions delivered over a maximum of 14 weeks. It follows a disorder-specific CBT approach, with a strong emphasis on therapist-led exposure tailored to the patient's principal anxiety disorder. Participants receive workbooks containing information on anxiety disorders, the treatment rationale, and the rationale for exposure therapy. The intervention has three phases: \[1\] 1-2 sessions of psychoeducation and symptom identification, \[2\] 8-10 sessions of therapist-led exposure with homework, and \[3\] 1-2 sessions of relapse prevention planning. Caregiver involvement is tailored to the individual needs of each participant, with a maximum of 2 additional hours allocated for caregivers beyond the standard treatment time.
Clinical Global Impressions - Improvement Scale
The Clinical Global Impressions - Improvement (CGI-I) Scale is a 1-item measure where a trained interviewer uses all available information about the patient to rate improvement on a 7-point scale: 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse. In this study, improvement on the CGI-I is assessed by comparing the current status of the participant to their baseline condition. In line with previous studies, a score of 1 or 2 on the CGI-I is classified as a treatment response and scores of 3 to 7 as non-response. This binary variable is the primary outcome of the trial.
Time frame: 4 months (17-20 weeks post-randomization); 8 months (35-40 weeks post-randomization, primary endpoint); 12 months (53-60 weeks post-randomization, observational follow-up); 24 months (105-116 weeks post-randomization, observational follow-up)
Pediatric Anxiety Rating Scale
The Pediatric Anxiety Rating Scale (PARS) is a clinician-rated measure of overall anxiety severity. It includes seven items assessing the number of anxiety symptoms, their frequency, anxiety-related avoidance, anxiety-related distress, physical symptoms of anxiety, family interference, and social interference. In the current study, in accordance with other trials for youth anxiety disorders, the 6-item version of PARS is used which excludes the item assessing number of symptoms. The resulting 6-item scale yields a score of 0 to 30, with higher scores indicating more severe anxiety.
Time frame: Baseline; 4 months (17-20 weeks post-randomization); 8 months (35-40 weeks post-randomization, primary endpoint); 12 months (53-60 weeks post-randomization, observational follow-up); 24 months (105-116 weeks post-randomization, observational follow-up)
Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders - Child and Adolescent Version
The Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders - Child and Adolescent Version (DIAMOND-KID) is a semi-structured interview that assesses the most common mental disorders in children and adolescents, including all the anxiety disorders used for inclusion in the present study. The full interview is conducted at baseline and at the 12- and 24-month post-randomization assessments. A shortened version that includes anxiety disorders and major depression is conducted at the 4- and 8-month post-randomization assessments. Data from the DIAMOND-KID will be used to evaluate the proportion who no longer meet diagnostic criteria for \[1\] their principal baseline anxiety disorder and \[2\] any anxiety disorder.
Time frame: Baseline; 4 months (17-20 weeks post-randomization); 8 months (35-40 weeks post-randomization, primary endpoint); 12 months (53-60 weeks post-randomization, observational follow-up); 24 months (105-116 weeks post-randomization, observational follow-up)
Clinical Global Impressions Scale-Severity
The Clinical Global Impressions Scale-Severity (CGI-S) is a single-item measure where a trained assessor makes an overall severity rating of a specific disorder accounting for all available information about the patient, including but not limited to current symptoms, impairment, and general functioning. In this study, in line with previous trials of youth anxiety disorders, the CGI-S is used to rate the overall severity of the patient's anxiety symptoms, irrespective of their association with a specific anxiety disorder.
Time frame: Baseline; 4 months (17-20 weeks post-randomization); 8 months (35-40 weeks post-randomization, primary endpoint); 12 months (53-60 weeks post-randomization, observational follow-up); 24 months (105-116 weeks post-randomization, observational follow-up)
Children's Global Assessment Scale
The Children's Global Assessment Scale (CGAS) is a clinician-rated one-item scale of psychosocial functioning/impairment, ranging from 1 to 100 with higher scores indicating better functioning.
Time frame: Baseline; 4 months (17-20 weeks post-randomization); 8 months (35-40 weeks post-randomization, primary endpoint); 12 months (53-60 weeks post-randomization, observational follow-up); 24 months (105-116 weeks post-randomization, observational follow-up)
Revised Children's Anxiety and Depression Scale
The Revised Children's Anxiety and Depression Scale (RCADS) is a patient- and caregiver-reported questionnaire assessing specific anxiety symptoms and their frequency. The original version includes 47 items. In the present study, we use the 30-item version, which maintains the factor structure of the original version and demonstrates conserved psychometric properties. The RCADS has shown adequate psychometric properties in several studies, including in Swedish youth, and is an internationally recommended measure for the assessment of internalizing symptoms in children and adolescents. Both patient- and caregiver-reported versions are used in the study. We will use the subscale that sums all the anxiety symptoms, which ranges from 0 to 60, with higher scores indicating more frequent anxiety symptoms.
Time frame: Baseline; 4 months (17-20 weeks post-randomization); 8 months (35-40 weeks post-randomization, primary endpoint); 12 months (53-60 weeks post-randomization, observational follow-up); 24 months (105-116 weeks post-randomization, observational follow-up)
Child Anxiety Life Interference Scale-Revised
The Child Anxiety Life Interference Scale-Revised (CALIS-R) is a patient- and caregiver-reported measure of interference associated with youth anxiety. The measure is an internationally recommended tool for the assessment of interference stemming from anxiety in children and adolescents. The patient-reported version consists of 9 items, each rated on a 0-4 response scale, resulting in a total score of 0 to 36, with higher overall scores indicating more interference. The caregiver-reported version consists of two sub-scales, where one sub-scale assesses interference for the child (9 items; range: 0 to 36) and the other interference for the family (8 items; range: 0 to 32), with higher scores indicating more interference. For the caregiver-reported version, the two sub-scales will be reported separately.
Time frame: Baseline; 4 months (17 to 20 weeks post-randomization); 8 months (35 to 40 weeks post-randomization, primary endpoint); 12 months; 24 months
Proportion of participants who do not adhere to the assigned treatment/s
Non-adherence to treatment is defined as completing fewer than six modules of ICBT, attending fewer than six sessions of personalized in-person CBT, or discontinuing/refusing treatment despite clinical judgment indicating it is warranted. An exception to the six-module/session rule is made if treatment is discontinued due to substantial symptom improvement to non-clinical levels, with therapist agreement that further treatment is unnecessary. At 4 months, non-adherence is assessed based on the first course of treatment. At 8 months, it is assessed based on overall adherence across both treatment courses: \[0\] complete adherence (adhering to all assigned treatments), \[1\] partial adherence (adhering to one but not all assigned treatments), or \[2\] full non-adherence (adhering to no assigned treatment).
Time frame: 4 months (17-20 weeks post-randomization); 8 months (35-40 weeks post-randomization, primary endpoint)
Adverse events
Adverse events are continuously screened, recorded, and monitored by study personnel and through the patient- and caregiver-reported Adverse Events Questionnaire, which includes 22 predefined events and an open-ended option. Events will be reported as the total number of documented events, ranging from 0 with no defined upper limit.
Time frame: 4 months (17-20 weeks post-randomization); 8 months (35-40 weeks post-randomization, primary endpoint)
Health economic outcomes
Health economic evaluations, including the calculation of Incremental Cost-Effectiveness Ratios (ICER) and assessment of willingness-to-accept thresholds, will be performed. The details will be specified in a separate Health Economic Analysis Plan (HEAP) and the planned approach is available in the full study protocol at Open Science Framework (https://osf.io/a9qhw/). These measures will not be used to make inference about the non-inferiority RCT regarding anxiety outcomes.
Time frame: Baseline; 4 months (17-20 weeks post-randomization); 8 months (35-40 weeks post-randomization, primary endpoint); 12 months (53-60 weeks post-randomization, observational follow-up); 24 months (105-116 weeks post-randomization, observational follow-up)
Plan to share: Undecided — The data are pseudonymized according to national (Swedish) and European Union legislation and cannot be anonymized and published in an open repository. Participants in the study consent for their data to be shared with other international researchers for research purposes. The data can be made available upon reasonable request on a case-by-case basis according to the current legislation and ethical permits.
Started Jun 2025 (actual). Primary completion is estimated for Nov 2029, 52 months after the start.
Of 142 non-industry interventional studies with no phase under Phobia, Social, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 44. This study's planned 52 months is above that.
Counting every sponsor, half of 148 studies reached it within 28 months; a quarter within 14 and three quarters within 43.
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