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

NCT06748833 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2025-01-03

No results posted yet for this study

Summary

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.

Conditions

Interventions

BEHAVIORAL

SMILE Intervention App

The SMILE app, an iOS and Android compatible smartphone app, is based on effective CBT-based treatment features to help patients manage anxiety symptomology. Access requires a unique login. The SMILE app utilizes three relaxation features: calm breathing, mindfulness meditation, and deep muscle relaxation; one cognitive feature, thought journaling and the challenging of thoughts; one self-monitoring technique; a positive imagery game; and a feature aimed to reduce avoidance behaviour through exposure. The app will be self-guided, with no additional human involvement needed. Participants will be instructed to actively engage with at least one of the app's major functions for a minimum of 3 minutes per day.

Sponsors & Collaborators

  • Dalhousie University

    lead OTHER

Principal Investigators

  • Sandra M Meier, PhD · Dalhousie University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-19
Primary Completion
2024-09-24
Completion
2024-12-03

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06748833 on ClinicalTrials.gov