Social Anxiety DisorderNCT06942429
Stepped Versus Stratified Care for Anxiety Disorders in Youth
A study testing Internet-delivered cognitive-behavioral therapy and Personalized in-person cognitive-behavioral therapy in people with Social Anxiety Disorder and Separation Anxiety Disorder, run by Region Skane at 1 site in Sweden.
Trial summary
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: Is stepped care non-inferior to stratified care in supporting participants to achieve a treatment response?… Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Social Anxiety Disorder, Separation Anxiety Disorder, Specific Phobia
- What is being tested?
- Internet-delivered cognitive-behavioral therapy and Personalized in-person cognitive-behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 556 participants
- Where
- 1 siteSweden
- Study dates
- 19 Jun 2025to 5 Mar 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 8.0 to 17.5 years. Confirmed by the child and/or caregiver.
- Principal DSM-5-TR anxiety disorder of social anxiety disorder, generalized anxiety disorder, panic disorder, separation anxiety disorder, specific phobia, or agoraphobia. Confirmed by the structured diagnostic interview (DIAMOND-KID). "Principal" indicates that the anxiety disorder is judged by the clinician to be in most urgent need of treatment (among potential co-occurring disorders).
- Available caregiver who can support the child in treatment. Confirmed by the caregiver.
- Child and at least one caregiver can read, write, and communicate in Swedish. Confirmed by the child and/or caregiver.
- Child (≥13 years) and caregiver have access to a Swedish electronic identification (BankID or Freja eID).
- Access to the internet. Confirmed by the child and/or caregiver.
- Ability to attend in-person CBT sessions at the clinic. Confirmed by the child and/or caregiver.
Who cannot join
- 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 specific phobia of this sort being classified as the most functionally impairing anxiety disorder during the structured diagnostic interview (DIAMOND-KID).
- Ongoing psychological treatment for an anxiety disorder. Confirmed by the child and/or caregiver.
- Social/familial/educational difficulties in more immediate need of management than an anxiety disorder. Confirmed by the assessor through information from the child and/or caregiver and/or other available sources.
- Immediate risk to self or others that require urgent attention, such as suicidality. Confirmed by the assessor through information from the child and/or caregiver and other available sources.
- The potential participant has a relative (e.g., sibling, cousin) included in the study. Confirmed by the assessor through information from the caregiver and other available sources.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Forskningsmottagning Barn och ungdomspsykiatri Lund
Lund, 22185
Matti Cervin, PhD, 0046(0)737199700, matti.cervin@med.lu.se
About this study
Official title: Stepped Versus Stratified Care for Anxiety Disorders in Youth: A Pragmatic Non-Inferiority Randomized Controlled Trial
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:
- Is stepped care non-inferior to stratified care in supporting participants to achieve a treatment response?
Read more
Researchers will compare two care models:
- Stepped care, where all participants begin with 14 weeks of internet-delivered cognitive behavioral therapy (ICBT) and receive an additional 14 weeks of personalized in-person CBT if needed.
- Stratified care, where participants are assigned to either 14 weeks of ICBT or 14 weeks of in-person CBT based on clinical complexity, and may also receive additional 14 weeks of in-person CBT if necessary.
Participants will:
- Be randomly assigned to one of the two care models.
- Complete a wide range of assessments at baseline, during treatment, and at 4, 8, 12, and 24 months, with the 8-month point as the primary endpoint.
- Receive either ICBT, in-person CBT, or both, depending on their care model and response to treatment.
- Participate in ancillary studies involving DNA sampling, cognitive testing, and national registry linkages to help predict treatment response and long-term outcomes.
Read the detailed description
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/).
- Conditions
- Social Anxiety Disorder, Separation Anxiety Disorder, Specific Phobia, Panic Disorder, Generalized Anxiety Disorder, Agoraphobia
- Being tested
- Internet-delivered cognitive-behavioral therapy, Personalized in-person cognitive-behavioral therapy
- Keywords
- anxiety disorders, children, adolescents, cognitive behavioral therapy, non-inferiority, care models, stepped care, stratified care
- Medical subject headings
- Phobia, Social, Anxiety, Separation, Phobia, Specific, Panic Disorder, Generalized Anxiety Disorder, Agoraphobia, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered cognitive-behavioral therapyBehavioural
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 therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Stepped Care | Experimental | 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). Receives: Behavioral: Internet-delivered cognitive-behavioral therapy; Behavioral: Personalized in-person cognitive-behavioral therapy |
| Stratified Care | Active comparator | 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. Receives: Behavioral: Internet-delivered cognitive-behavioral therapy; Behavioral: Personalized in-person cognitive-behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 4 months (17-20 weeks post-randomization); 8 months (35-40 weeks post-randomization, primary endpoint)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start19 Jun 2025
- Primary completion5 Nov 2029 (estimated)
- Study completion5 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 556 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Principal investigator, Matti Cervin, Region Skane
- Investigators
- Matti Cervin, PhD, Principal investigator, Lund University & CAMHS SkåneEva Serlachius, MD, PhD, Principal investigator, Lund University & CAMHS Skåne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942429
- Sponsor's protocol ID
- Dnr 2025-01014-01
- Status last verified
- Feb 2026
- First submitted
- 9 Apr 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepped Versus Stratified Care for Anxiety Disorders in Youth: A Pragmatic Non-Inferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06942429
- Acronym / sponsor ID
- Dnr 2025-01014-01
- Conditions
- Social Anxiety Disorder, Separation Anxiety Disorder, Specific Phobia, Panic Disorder, Generalized Anxiety Disorder, Agoraphobia
- Keywords
- anxiety disorders, children, adolescents, cognitive behavioral therapy, non-inferiority, care models, stepped care, stratified care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 556 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- 19 Jun 2025 (actual)
- Primary completion
- 5 Nov 2029 (estimated)
- Study completion
- 5 Mar 2031 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is stepped care non-inferior to stratified care in supporting participants to achieve a treatment response?
Researchers will compare two care models:
- Stepped care, where all participants begin with 14 weeks of internet-delivered cognitive behavioral therapy (ICBT) and receive an additional 14 weeks of personalized in-person CBT if needed.
- Stratified care, where participants are assigned to either 14 weeks of ICBT or 14 weeks of in-person CBT based on clinical complexity, and may also receive additional 14 weeks of in-person CBT if necessary.
Participants will:
- Be randomly assigned to one of the two care models.
- Complete a wide range of assessments at baseline, during treatment, and at 4, 8, 12, and 24 months, with the 8-month point as the primary endpoint.
- Receive either ICBT, in-person CBT, or both, depending on their care model and response to treatment.
- Participate in ancillary studies involving DNA sampling, cognitive testing, and national registry linkages to help predict treatment response and long-term outcomes.
Detailed description
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/).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stepped Care | Experimental | Behavioral: Internet-delivered cognitive-behavioral therapy, Behavioral: Personalized in-person cognitive-behavioral therapyAll 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). |
| Stratified Care | Active comparator | Behavioral: Internet-delivered cognitive-behavioral therapy, Behavioral: Personalized in-person cognitive-behavioral therapyIn 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. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Aged 8.0 to 17.5 years. Confirmed by the child and/or caregiver.
- Principal DSM-5-TR anxiety disorder of social anxiety disorder, generalized anxiety disorder, panic disorder, separation anxiety disorder, specific phobia, or agoraphobia. Confirmed by the structured diagnostic interview (DIAMOND-KID). "Principal" indicates that the anxiety disorder is judged by the clinician to be in most urgent need of treatment (among potential co-occurring disorders).
- Available caregiver who can support the child in treatment. Confirmed by the caregiver.
- Child and at least one caregiver can read, write, and communicate in Swedish. Confirmed by the child and/or caregiver.
- Child (≥13 years) and caregiver have access to a Swedish electronic identification (BankID or Freja eID).
Key exclusion criteria (5 listed)
- 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 specific phobia of this sort being classified as the most functionally impairing anxiety disorder during the structured diagnostic interview (DIAMOND-KID).
- Ongoing psychological treatment for an anxiety disorder. Confirmed by the child and/or caregiver.
- Social/familial/educational difficulties in more immediate need of management than an anxiety disorder. Confirmed by the assessor through information from the child and/or caregiver and/or other available sources.
- Immediate risk to self or others that require urgent attention, such as suicidality. Confirmed by the assessor through information from the child and/or caregiver and other available sources.
- The potential participant has a relative (e.g., sibling, cousin) included in the study. Confirmed by the assessor through information from the caregiver and other available sources.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-delivered cognitive-behavioral therapyInternet-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. | Behavioural | Stepped Care, Stratified Care |
| Personalized in-person cognitive-behavioral therapyPersonalized 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. | Behavioural | Stepped Care, Stratified Care |
Primary outcome
Clinical Global Impressions - Improvement Scale
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)
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.
8 secondary outcomes
Pediatric Anxiety Rating Scale
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
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
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
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
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
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
Time frame: 4 months (17-20 weeks post-randomization); 8 months (35-40 weeks post-randomization, primary endpoint)
Adverse events
Time frame: 4 months (17-20 weeks post-randomization); 8 months (35-40 weeks post-randomization, primary endpoint)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- All versions of the study protocol are shared on the Open Science Framework platform. The trial includes an ancillary study, fully described in the study protocol, designed to identify predictive markers of treatment response and long-term outcomes.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
Related trials for Social Anxiety Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Bonding Before Birth: A mHealth Intervention for First-time Expectant Couples
Anxiety, Pregnancy
Recruiting
Comprehensive Assessment of Rehabilitation Experience Using the SAFE Scale
Caregiver Anxiety, Acquired Brain Injury
Not yet recruiting
Online Study on the Impact of a Self-Help Tool for Social Anxiety
Social Anxiety
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matti Cervin, PhD principal investigator
Lund University & CAMHS Skåne
Eva Serlachius, MD, PhD principal investigator
Lund University & CAMHS Skåne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-delivered cognitive-behavioral therapy and Personalized in-person cognitive-behavioral therapy in people with Social Anxiety Disorder and Separation Anxiety Disorder, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matti Cervin, PhD (0046(0)737199700, matti.cervin@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Global Impressions - Improvement Scale (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.