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NCT06748833: SMILE
An App Responding to Behaviour of People to Promote Mental Wellbeing in Anxious Youth
NA trial testing SMILE Intervention App in Anxiety in 101 participants. Completed in 3 December 2024.
24 September 2024
Quick facts
| Lead sponsor | Dalhousie University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 101 |
| Start date | 19 September 2023 |
| Primary completion | 24 September 2024 |
| Estimated completion | 3 December 2024 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- SMILE Intervention App
Conditions studied
- Anxiety — all drugs for Anxiety →
- Sleep Problems — all drugs for Sleep Problems →
Sponsor
Dalhousie University
Who can join
Adults 12 to 21, any sex, with Anxiety or Sleep Problems. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical trial is to utilize mobile-sensing techniques to produce and test a simplified and personalized treatment app, Smile for Life (SMILE), for youth diagnosed with an anxiety disorder. The main questions it aims to answer are: 1. What specific areas of difficulty (e.g., social interactions, physical activity/mobility, and sleep quality) are most impacted in youth with anxiety disorders, and how can a novel treatment app address these challenges? 2. Does the use of the novel treatment app lead to a measurable reduction in anxiety symptoms among youth, as assessed by the Screen for Child Anxiety Related Disorders (SCARED) survey, compared to a control group? Researchers will compare the intervention to a control group (a group not given the SMILE app) to see if the intervention works to improve psychological functioning. Participants will: * Complete an online survey on emotional well-being and personality traits at the beginning and end of the one-month study, as well as at the 3-month follow-up. Participants will receive daily notifications asking participants to rate their social-emotional functioning. The app will then recommend a treatment plan and also ask participants to rate how helpful treatments were. Three months after the end of the study, participants will be asked to complete a follow-up assessment rating the app's usability. * Participants in the intervention group will use a mobile app to practice cognitive behavioural therapy (CBT) treatment for their social-emotional issues.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
An app responding to behavior of people to promote mental wellbeing in anxious youth.
Hagalwadi J, Sutherland D, Dolek S, Marin-Dragu S, et al · · 2026 · PMID 41759674 · DOI 10.1016/j.jad.2026.121503
Verify or expand the search:
- PubMed search for NCT06748833
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06748833 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Dalhousie University
- Last refreshed: 3 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06748833.
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