New stepped care approach aims to tackle childhood anxiety in primary care
NCT ID NCT05686512
First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 2 times
Summary
This study tests a stepped care cognitive behavioural therapy (CBT) program for children aged 7-12 with mild to moderate anxiety, delivered in primary care settings. All children start with a brief group intervention, and those needing more support receive additional individual CBT sessions. The trial aims to see if this approach is feasible and acceptable, with 30 participants enrolled across several primary care units in Sweden.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cognitive behavioural therapy (CBT) delivered in a stepped care format (group sessions plus individual sessions)
- What this could lead to
- If successful, this could provide an effective, accessible treatment for childhood anxiety in primary care, reducing wait times and specialist referrals.
- What could go wrong
- This is a small feasibility study with only 30 participants, so results may not apply broadly. The intervention may not be effective or acceptable in real-world primary care settings.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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30 people
The number who actually took part.
- Started
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Feb 2023
- Expected to finish
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Dec 2025
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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7 to 12 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * The child is 7-12 years old. Confirmed by the caregiver and subsequently by the medical records. * The child suffers from mild to moderate anxiety. The term "mild to moderate anxiety" has not been explicitly defined but is a term aimed to specify a demarcation between the FLMH and the psychiatric specialist services. Adequate level of care for the patient is decided based on an overall clinical assessment. The Children Global Assessment Scale (CGAS) is often used to guide the decision on level of care, where a CGAS value above 60 clearly indicates primary care services, a value below 50 clearly indicates specialist services. For values between 50 and 60 the overall clinical evaluation of symptom severity and impaired function guide the decision on level of care. Confirmed by the assessor at the FLMH-unit Exclusion Criteria: * Other psychiatric or developmental disorders than anxiety, or social issues that primarily require other interventions (i.e., where an intervention targeting mild to moderate anxiety is not adequate). Confirmed by assessor at the FLMH-unit. * The child has another ongoing psychological intervention. An ongoing psychological treatment for any other psychiatric disorder. Confirmed by the caregiver.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Center for epidemiology and community medicine (CES), Stockholm Region
Stockholm, 10435, Sweden
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