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NCT06748833: SMILE

An App Responding to Behaviour of People to Promote Mental Wellbeing in Anxious Youth

Completed NA Last updated 3 January 2025
What this trial tests

NA trial testing SMILE Intervention App in Anxiety in 101 participants. Completed in 3 December 2024.

Timeline
19 September 2023
Primary endpoint
24 September 2024
3 December 2024

Quick facts

Lead sponsorDalhousie University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment101
Start date19 September 2023
Primary completion24 September 2024
Estimated completion3 December 2024
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

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):

  1. 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:

Other recruiting trials for Anxiety

Currently open trials in the same condition.

Other Dalhousie University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing