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

NCT06748833 | Completed

• 1 other identifier: 1026748_SMILE
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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:

• 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

Anxiety; Sleep Problems

Keywords

anxiety; sleep problems; youths; mobile apps; mobile sensing; eHealth

Outcome Measures

Primary Outcomes (1)

• Anxiety and sleep problems

  Anxiety symptoms will be assessed using the 41-item SCARED questionnaire, where participants rate symptoms as not/hardly ever true (1), somewhat/sometimes true (2), or very/often true (3). Sleep problems will be assessed with the 7-item ISI, measuring difficulty falling/staying asleep and waking too early on a 5-point scale (0 = none, 4 = very severe). The ISI also evaluates sleep satisfaction, the noticeability of sleep issues, worry/distress about sleep, and their impact on daily functioning. Both tools will be administered pre- and post-intervention and at a three-month follow-up, providing comprehensive data on changes in anxiety and sleep problems over time. These measures will help determine the intervention's effectiveness in reducing anxiety and improving sleep quality.

  One month

Study Arms (2)

SMILE Intervention Group

EXPERIMENTAL

The intervention group used the SMILE App, and the Predicting Risk and Outcomes of Social InTerActions (PROSIT) app, which is a mobile sensing app.

Behavioral: SMILE Intervention App

Control Non-SMILE Intervention Group

NO INTERVENTION

Participants in the control group downloaded and used only the PROSIT app, they did not use the SMILE App.

Interventions

SMILE Intervention App BEHAVIORAL

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.

SMILE Intervention Group

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Ability to read, write, and speak English
• Aged 12-21
• Regular access to and usage of a smartphone
• Score \>25 on SCARED (25) (i.e., youth with anxiety disorders)

You may not qualify if:

• Other psychotherapy-based intervention
• Major medical illnesses which might impact participation (e.g., long periods of hospitalization)
• Youth who cannot provide informed consent (as this is a self-directed treatment program).

Sponsors & Collaborators

• Dalhousie University: lead

Study Sites (1)

Dalhousie University

Halifax, Nova Scotia, B3H 4R2, Canada

Location

MeSH Terms

Conditions

Anxiety Disorders; Parasomnias

Condition Hierarchy (Ancestors)

Mental Disorders; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Sandra M Meier, PhD

  Dalhousie University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 27, 2024
• Study Start: September 19, 2023
• Primary Completion: September 24, 2024
• Study Completion: December 3, 2024
• Last Updated: January 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)