SMILE: Supporting mental health in young people: integrated methodology for clinical decisions and evidence-based interventions
| ISRCTN | ISRCTN32523126 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32523126 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 24-25CLPS015 |
| Sponsor | University of Edinburgh |
| Funder | HORIZON EUROPE European Research Council |
- Submission date
- 25/04/2025
- Registration date
- 29/04/2025
- Last edited
- 29/04/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Adolescence is a time when many young people experience mental health challenges. They might turn to social media for support, but this can sometimes make things worse. The SMILE project aims to help young people build resilience by using a gamified platform with digital cognitive behavioural interventions.
Who can participate?
Young people aged 10-24 years old are invited to participate in the study.
What does the study involve?
Participants will use the SMILE tools for 6 weeks. They will play a serious game and answer questions about their mood and wellbeing. Some participants will receive feedback based on their game performance and wellbeing metrics.
What are the possible benefits and risks of participating?
Participants might benefit from improved mental health and resilience. However, there is a risk that some might not find the interventions helpful or could feel uncomfortable with the feedback.
Where is the study run from?
The study will be conducted in seven countries: Cyprus, Germany, Italy, Poland, Slovenia, Spain, and the UK.
When is the study starting and how long is it expected to run for?
February 2025 to July 2026
Who is funding the study?
The study is funded by the European Union’s Horizon Europe research and innovation programme.
Who is the main contact?
Matthias Schwannauer, m.schwannauer@ed.ac.uk
Contact information
Public, Scientific, Principal investigator
The University of Edinburgh
School of Health in Social Science
Teviot Place
Edinburgh
EH8 9AG
United Kingdom
 ORCID ID |
0000-0002-4683-2596 |
|---|---|
| Phone | +44 1316513954 |
| m.schwannauer@ed.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Cluster randomized multi-site multi-arm adaptive trial design |
| Secondary study design | Cluster randomised trial |
| Study type | Participant information sheet |
| Scientific title | SMILE: Supporting Mental Health in Young People: Integrated Methodology for cLinical dEcisions and evidence-based interventions |
| Study acronym | SMILE Trial |
| Study objectives | Primary hypothesis: It is hypothesized that, compared with the control period, anxiety and depression scores (primary outcomes) will be lower in the experimental conditions (i.e., with and without feedback) post-test. Secondary hypotheses 1: It is hypothesized that, compared with the control period, the secondary outcomes (well-being, resilience, emotion regulation and self-efficacy) will be higher and social anxiety lower in the experimental conditions (i.e., with and without feedback) post-test. Secondary hypothesis 2: It is hypothesized that feedback will be positively associated with the feasibility, acceptability, and preliminary effectiveness of the SMILE tools. To meet objective 2, we will test the following hypotheses: Secondary hypothesis 3: Compared with the control period and the experimental condition without feedback, well-being and resilience will be higher in the experimental condition with feedback post-test. |
| Ethics approval(s) |
Approved 12/02/2025, The University of Edinburgh, School of Health in Social Science, Research Ethics Committee (Medical School, Teviot Place, Edinburgh, EH8 9AG, United Kingdom; +44 1316513954; ethics.hiss@ed.ac.uk), ref: 24-25CLPS015 |
| Health condition(s) or problem(s) studied | Depression and anxiety in children and young people |
| Intervention | During the SMILE study, participants will be asked to participate in a digital psychosocial intervention in the form of a serious game app and a companion app. Participants will be invited to play a serious game, designed to increase skills like cognitive flexibility, self-efficacy, critical thinking, self-regulation, and self-confidence, and by this prevent symptoms of depression and anxiety. The game will consist of a range of scenarios, divided into five modules, with goal-oriented and story-driven game activities. Throughout the 6 weeks of their participation, young people will also be asked to participate in a companion app. The companion app contains self-report measures, Experience Sampling Methodology (ESM) and invitations to record weekly brief video diary entries. In clusters allocated to the feedback condition, participants will receive visualisations generated based on these measures and their in-game behaviours. Through interacting with this feedback, they will be invited to reflect on their data. Participants in clusters allocated to the no feedback condition will be asked to participate in the game and companion app, but they will not receive graphical feedback based on their input. Randomisation will be conducted in blocks (using block randomisation) at the consortium level using REDCap software by a statistician who is not involved in the study. A total of 24 clusters (8 clusters per sequence) will be randomised into two conditions, feedback and no feedback; these will be allocated pragmatically between sites and adjusted in size and distribution if indicated by the interim analyses. There is no randomisation at the individual level. Clusters will be blinded as to which of the two interventions they will receive, i.e., with or without feedback. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
1. Depression is measured using the Patient Health Questionnaire for Adolescents (PHQ-A) at Weeks 2, 4 and 6 |
| Key secondary outcome measure(s) |
1. Well-being is measured using the Warwick-Edinburgh Mental Well-being Scale (WEMWBS) at Weeks 1, 3 and 5 |
| Completion date | 31/07/2026 |
Eligibility
| Participant type(s) | Healthy volunteer, Learner/student |
|---|---|
| Age group | Mixed |
| Lower age limit | 10 Years |
| Upper age limit | 24 Years |
| Sex | All |
| Target sample size at registration | 1438 |
| Key inclusion criteria | 1. Adolescents and young adults aged 10-24 years 2. Participants under 16 require consent from a parent or guardian, as well as their own agreement to participate. Informed Consent Forms and their digital equivalents will be tailored to be age-appropriate, ensuring both guardians and participants can make informed decisions. If either the parent or the participant does not agree, the participant will not be included in the study 3. Must complete measures of primary outcome 4. Must have normal or corrected to normal vision |
| Key exclusion criteria | 1. Unable to consent to participation 2. Have a current confirmed diagnosis or treatment episode for: 2.1. severe mental disorder (schizophrenia, bipolar disorder, severe depression), 2.2. substance use disorder, 2.3. epileptic disorders, 2.4. gaming addiction |
| Date of first enrolment | 01/05/2025 |
| Date of final enrolment | 30/06/2026 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
- Germany
- Italy
- Poland
- Slovakia
- Spain
Study participating centres
Im Neuenheimer Feld 130.3 (room 06.322)
69120 Heidelberg
Heidelberg
69120
Germany
Faculty of Electrical Engineering and Computer Science
Koroška cesta 46, 2000 Maribor, Slovenija
Maribor
2000
Slovakia
Medical School | Teviot Place | EH8 9AG
Edinburgh
EH8 9AG
United Kingdom
Chodakowska 19/31, 03-815 Warsaw
Warsaw
03815
Poland
Bologna, Italy
Bologna
40138
Italy
47016 Valladolid
Valladolid
47016
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in publicly available repository |
| IPD sharing plan | The data collected in the study will be anonymised and then used to develop a decision support system (DSS) for researchers in order to carry out an exploratory analysis to 1) recognize and map key factors associated with mood changes, 2) develop transparent algorithms to visualize patterns in mood-change prediction, and 3) support end-user self-monitoring and self-assessment in serious-games. The DSS will be developed within a GDPR compliant software environment. Participants' personal information will be used to create synthetic data – artificial information that statistically resembles real data without containing any actual personal details. This process helps the research team develop and test systems while completely protecting individuals' privacy. The synthetic data maintains the patterns and relationships found in the original information but cannot be traced back to any specific person. This approach allows researchers to gain valuable insights while ensuring the highest standards of confidentiality and data protection. Additionally, this methodology helps decrease bias in the resulting algorithms, creating more equitable systems that better represent and serve all populations. Since the information is completely anonymous, this data can be shared among different researchers, even outside the SMILE consortium, without exposing the participants, the owners of the original data, to any risks of re-identification or identification exposure. The datasets generated during and/or analysed during the current study will be stored in a publicly available repository. With participants’ consent, anonymised data used in the final analysis will be uploaded to an open science repository after the study in completed in October 2026. The repository name/weblink to this curated dataset are currently unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 2.5 | 18/04/2025 | 29/04/2025 | No | No |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- 47236 SMILE Pilot Protocol v2.5 180425.pdf
- Protocol file
Editorial Notes
28/04/2025: Trial's existence confirmed by University of Edinburgh
