RecruitingInterventional

SMILE: Supporting mental health in young people: integrated methodology for clinical decisions and evidence-based interventions

The SMILE study is looking into new ways to help young people aged 10 to 24 who are experiencing anxiety or depression. Many young people turn to social media for support, which isn't always helpful. This study uses a fun, game-like online platform with activities designed to build strength and coping skills (resilience). Participants will use these tools for six weeks, playing games and answering questions about their mood. Some will get personalised feedback based on their progress. The aim is to see if this digital approach can improve their mental well-being. The study will take place in the UK and six other countries, starting in February 2025 and finishing in July 2026.

At a glance

Status

Recruiting

Sponsor

University of Edinburgh

Enrolment target

1,438

Start

01 May 2025

Estimated completion

30 Jun 2026

Depression and anxiety in children and young people

What is this study about?

Growing up can be tough, and many young people experience feelings of anxiety or depression. Sometimes they look for help online, which might not always be the best solution. The SMILE project is here to explore a new way to support young people aged 10 to 24 during these times.

The study aims to help young people become stronger and better at handling life's challenges. It does this by using a special online program that feels like playing a game. This program includes activities that teach helpful ways of thinking and coping, known as cognitive behavioural therapy, in a digital format.

The idea behind SMILE is to offer a supportive tool that could lead to better mental health for young people. It's a research study funded by the European Union, which means it's part of a bigger effort to find new and effective ways to help people across different countries.

Key takeaways

A study for young people (10-24) with anxiety or depression.
Uses an online game to teach coping skills and build resilience.
Participation involves using online tools for 6 weeks.
Aims to improve mental health and well-being.
Runs from February 2025 to July 2026 in the UK and other countries.

Who may be eligible?

This study is for young people aged between 10 and 24 years old. If you're under 16, you'll need your parent or guardian to agree for you to take part, and you'll also need to agree yourself. We want to make sure everyone involved is happy and understands what they're signing up for.

To join, you should be able to see clearly, either naturally or with glasses/contact lenses. We also need to be sure you can fully understand and agree to take part. For your safety, there are some reasons why you wouldn't be able to join. For example, if you have a current diagnosis or treatment for certain severe mental health conditions like schizophrenia or severe depression, drug addiction, epilepsy, or a gaming addiction, this study wouldn't be suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 10 and 24 years old?
If under 16, are your parents/guardians willing to agree, and are you willing to agree yourself?
Can you see clearly (with or without glasses/lenses)?
Do you not currently have a diagnosis like severe depression, schizophrenia, or a gaming addiction?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the SMILE study, you'll be asked to use the online tools for six weeks. This involves playing a special 'serious game' and regularly answering questions about how you're feeling and your overall well-being. Some participants will also receive personalised feedback based on how they play the game and their mood reports. There are no face-to-face visits, and you won't be given any medication as part of this study. The whole process, including follow-up questions, will happen online over this six-week period.

Potential risks and benefits

Taking part in the SMILE study might help improve your mental health and make you feel more resilient, which means better able to bounce back from difficult situations. However, it's possible that you might not find the online tools helpful, or you might feel uncomfortable with some of the feedback you receive. You have the right to stop participating in the study at any time, for any reason, without it affecting your medical care or relationship with the study team.

Locations (6)

Universitaet Heidelberg
Approximate
Heidelberg, Germany
University of Maribor
Unverified
Maribor, Slovakia
The University of Edinburgh
Approximate
Edinburgh, United Kingdom
SWPS University
Approximate
Warsaw, Poland
IRCCS-AOUBO Policlinico Sant'Orsola
City only
Bologna, Italy
Clínica de Memoria de Valladolid
City only
Valladolid, Spain

Common questions

What kind of game will I play?

You'll play a 'serious game' designed to teach you coping skills and improve your well-being, rather than just for entertainment.

How long do I need to use the online tools?

You will use the SMILE online tools for a total of six weeks.

Do I need to go to a clinic?

No, all the study activities, including using the online tools and answering questions, will be done remotely.

Who is running this study?

The study is funded by the European Union and is being run across seven countries, including the UK, with the main contact being Matthias Schwannauer.

Can my parents get involved?

If you are under 16, your parents or guardians will need to give their permission for you to participate, alongside your own agreement.

How to find out more

Matthias Schwannauer

m.schwannauer@ed.ac.uk +44 1316513954 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.