AnxietySMILENCT06748833
An App Responding to Behaviour of People to Promote Mental Wellbeing in Anxious Youth
A study testing SMILE Intervention App in people with Anxiety and Sleep Problems, run by Dalhousie University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Sleep Problems
- What is being tested?
- SMILE Intervention App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteCanada
- Study dates
- 19 Sep 2023to 3 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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?
- 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.
Read the 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:
- 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.
- 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.
- Conditions
- Anxiety, Sleep Problems
- Being tested
- SMILE Intervention App
- Keywords
- anxiety, sleep problems, youths, mobile apps, mobile sensing, eHealth
- Medical subject headings
- Anxiety Disorders, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMILE Intervention AppBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start19 Sep 2023
- Primary completion24 Sep 2024
- Study completion3 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalhousie University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Meier, Dalhousie University
- Investigators
- Sandra M Meier, PhD, Principal investigator, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748833
- Sponsor's protocol ID
- 1026748_SMILE
- Acronym
- SMILE
- Status last verified
- Jan 2025
- First submitted
- 19 Dec 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will be made available upon reasonable request to Dr. Sandra Meier (PI).
Publications
Hagalwadi J, Sutherland D, Dolek S, Marin-Dragu S, Bagnell A, Wozney L, Orji R, Meier S. An app responding to behavior of people to promote mental wellbeing in anxious youth. J Affect Disord. 2026 Jul 1;404:121503. doi: 10.1016/j.jad.2026.121503. Epub 2026 Feb 25.
PubMed 41759674
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An App Responding to Behaviour of People to Promote Mental Wellbeing in Anxious Youth
- ClinicalTrials.gov ID
- NCT06748833
- Acronym / sponsor ID
- SMILE / 1026748_SMILE
- Conditions
- Anxiety, Sleep Problems
- Keywords
- anxiety, sleep problems, youths, mobile apps, mobile sensing, eHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Dalhousie UniversityUniversity, hospital or other
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- 24 Sep 2024 (actual)
- Study completion
- 3 Dec 2024 (actual)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- 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.
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:
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMILE Intervention Group | Experimental | Behavioral: SMILE Intervention AppThe intervention group used the SMILE App, and the Predicting Risk and Outcomes of Social InTerActions (PROSIT) app, which is a mobile sensing 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. |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMILE Intervention AppThe 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. | Behavioural | SMILE Intervention Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Derived from this study: PubMed 41759674Hagalwadi J, Sutherland D, Dolek S, Marin-Dragu S, Bagnell A, Wozney L, Orji R, Meier S. An app responding to behavior of people to promote mental wellbeing in anxious youth. J Affect Disord. 2026 Jul 1;404:121503. doi: 10.1016/j.jad.2026.121503. Epub 2026 Feb 25.
- Individual participant dataSharing planned: No. Participant data will be made available upon reasonable request to Dr. Sandra Meier (PI).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra M Meier, PhD principal investigator
Dalhousie University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMILE Intervention App in people with Anxiety and Sleep Problems, run by Dalhousie University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety and sleep problems (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06748833, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.