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

January 2, 2025 updated by: Sandra Meier, Dalhousie University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background: The landscape of mental health treatment is expected to change due to the widespread use and availability of the Internet and mobile devices, as well as their increased capacity to deliver quality interventions. The development of treatment apps, such as the one investigated in the proposed study, will help to dismantle some of the barriers that prohibit youth from seeking or accessing treatment under the current health care model.

Smartphone interventions are particularly promising due to their ability to provide treatment exercises and monitor symptoms in situ (i.e., in real-time), immediately after or before pivotal events. A recent systematic review pointed out that some studies utilizing these digital interventions have high attrition rates; in some cases, rising as high as 70%. This is likely due to the fact that youth do not enjoy using digital health care systems that they perceive as impersonal and confusing to navigate.

Objective: Thus, the present study aims to determine which mobile-sensed daily life behaviours are indicative of anxiety problems by comparing the mobile- sensing profiles of youth with and without anxiety disorders as well as to evaluate the effectiveness of the novel treatment app on youth with anxiety disorders. The SMILE app incorporates Cognitive Behavioral Therapy (CBT) based treatment functions to help patients improve their mental health.

Method: Participants will be recruited and randomly allocated into the intervention and the control group. The study will measure anxiety, depression, drug and alcohol problems, and sleep problems before and after the one-month intervention period as psychological variables. Additionally, a 3-month follow-up will be the defining response of success for the SMILE app as participants will be asked to rate the app's ease of use, helpfulness, understandability, and if they would recommend the app to a friend.

Implications: If the intervention demonstrates effectiveness in reducing anxiety symptoms, it will undergo further testing to confirm its reliability and generalizability across diverse youth populations. Following these evaluations, the intervention will be integrated into the clinical care of youth with anxiety disorders, serving as both a stand-alone treatment option and a supplemental tool to complement existing therapeutic approaches, such as cognitive-behavioral therapy (CBT). This dual application will enable its use in various care settings, enhancing accessibility and providing tailored support to address the unique needs of individuals. Ultimately, the intervention aims to improve treatment outcomes, empower youth in managing their anxiety, and reduce the overall burden of anxiety disorders on mental health services.

The study will examine if a significant reduction of anxiety symptoms can be achieved in youth using the novel treatment app. We intend to recruit 120 participants with anxiety disorders between the ages of 12 and 21.

It is hypothesized that:

  1. Youth with anxiety disorders will have fewer social interactions, be less physically active/mobile, and sleep worse, indicating areas in which these youth experience problems that the novel treatment app will need to focus on addressing using its features.
  2. The effects of the novel treatment app will reduce youths' anxiety problems as measured by the SCARED survey compared to those in the control group.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
101

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 4R2
        • Dalhousie University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SMILE Intervention Group
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
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.
No Intervention: Control Non-SMILE Intervention Group
Participants in the control group downloaded and used only the PROSIT app, they did not use the SMILE App.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Anxiety and sleep problems
Time Frame: One month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dalhousie University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sandra M Meier, PhD, Dalhousie University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 19, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 24, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 3, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1026748_SMILE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Participant data will be made available upon reasonable request to Dr. Sandra Meier (PI).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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