Helping young people to adapt their internet use and promote mental well-being in a rapidly changing world

ISRCTN	ISRCTN55100480
DOI	https://doi.org/10.1186/ISRCTN55100480
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	359738
Protocol serial number	CPMS 69008
Sponsor	University of Hertfordshire
Funders	HORIZON EUROPE Framework Programme, Innovate UK, Staatssekretariat für Bildung, Forschung und Innovation

Submission date: 21/10/2025
Registration date: 23/10/2025
Last edited: 07/11/2025

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Young people are particularly susceptible to digital technology overuse, including in response to the COVID pandemic, and are therefore vulnerable to its potential harmful effects on mental health. Problematic usage of the internet (PUI) is thought to disrupt a person’s life, with major consequences for that person, and wider consequences for societal health and well-being. The BootStRaP study brings together a group of researchers from 12 countries, and by working together, they are aiming to change the way that people and governments understand problematic usage of the internet, and by engaging in this study, to reduce the harm that digital devices like phones have on the mental health of young people.

Who can participate?
Students from schools involved in the study, aged between 12 and 16 years, with routine access to a mobile phone.

What does the study involve?
The BootStRaP study involves young people taking part in a digital programme designed to help them reflect on their internet use and build skills to manage it in healthier ways. The study is delivered entirely through two smartphone apps: BootstrApp, which guides participants through tasks and questionnaires, and Dragon Game, which includes fun cognitive games. Before starting, participants complete a 2-week baseline assessment. This includes answering questions about their internet habits, emotional well-being, and personality traits. It also involves some interactive tasks and passive data collection (like screen time and app usage), but no personal content (like messages or photos) is accessed.

After the baseline, participants are randomly assigned to one of three groups:
Emotional Regulation Intervention: This helps young people understand and manage their emotions. It includes games, videos, and exercises that teach emotional awareness, coping strategies, and how emotions influence behaviour.
Inhibitory Control Intervention: This focuses on helping young people manage impulsive behaviours, such as compulsive scrolling or gaming. It teaches self-control strategies, attention-shifting techniques, and ways to resist urges.
Control Group: This group receives general information about internet use and mental health, but no interactive activities.

Each intervention lasts 4 weeks, with tasks delivered every couple of days via push notifications. These tasks are short and engaging, and participants can complete them at school or at home. Some examples include:
Rating their mood and receiving personalised feedback.
Watching short videos about emotions or impulsivity.
Playing games that help them practise emotional or behavioural skills.
Reflecting on their internet use and setting goals for change.

Participants at higher risk of problematic internet use receive extra support modules, which include more in-depth exercises and personalised feedback.
After the 4-week intervention, participants complete a follow-up assessment to see how things have changed. Depending on the study phase, this happens either 3 months or 6 months later. Throughout the study, participants are supported by school-based ambassadors (teachers and students) and can access mental health resources through the app if needed. They can also choose to receive feedback on their progress, such as screen time summaries or mood tracking.

What are the possible benefits and risks of participating?
Benefits
Learn practical skills to manage emotions and impulses.
Reflect on internet habits and improve digital well-being.
Receive personalised feedback and support.
Help researchers develop better tools for young people.

Risks
The study is non-clinical and considered low risk.
Some questions may feel personal, but participants can skip any they don’t want to answer.
Support links are provided in the app if participants feel distressed.
Participants can withdraw at any time.

Where is the study run from?
The study will be conducted online via the BootstrApp across 9 European countries (UK, France, Germany, Hungary, Lithuania, Netherlands, Portugal, Spain and Switzerland). The study is led by researchers at the University of Hertfordshire in the UK, with researchers from 12 other countries.

When is the study starting and how long is it expected to run for?
These studies are the 2nd phase of a larger project, which started on the 1st July 2023 and will run for 5 years. Phase two of the study will run for 2 years and finish in July 2027.

Who is funding the study?
1. The European Union, European Health and Digital Executive Agency (HADEA)
2. The Innovate UK program (UKRI)
3. The Swiss Confederation, State Secretariat for Education, Research and Innovation (SERI)

Who is the main contact?
1. Prof. Naomi Fineberg, bootstrap@herts.ac.uk
2. Prof. Jose Menchon, jmenchon@bellvitgehospital.cat
3. Mrs Natalie Hall, n.hall4@herts.ac.uk

Contact information

Mrs Natalie Hall
Public, Scientific

University of Hertfordshire, Innovation Centre, College Lane
Hatfield
AL10 9AB
United Kingdom

ORCID ID	0000-0002-3635-7699
Phone	+44 (0)7394 361218
Email	n.hall4@herts.ac.uk

Prof Naomi Fineberg
Principal investigator

HPFT, Rosanne House, Parkway
Welwyn Garden City
AL86HG
United Kingdom

ORCID ID	0000-0003-1158-6900
Email	bootstrap@herts.ac.uk

Study information

Primary study design	Interventional
Study design	Multi-centre controlled individually randomized observer-blind parallel-group three-arm trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Boosting societal adaptation and mental health in a rapidly digitalising, post-pandemic Europe (BootStRaP Phase 2)
Study acronym	BootStRaP
Study objectives	Extensive use of the internet has given rise to problematic patterns of use, involving loss of control of time spent online, that have adverse effects on the health and well-being of individuals, especially teenagers. Problematic use of the Internet (PUI) is an umbrella term describing a broad range of potentially harmful forms of online behaviour, such as excessive gambling, gaming, and social media use. The EU-funded Bootstrap project aims to mitigate the risks. It will carry out research across Europe to closely monitor the internet usage patterns of young people, to identify patterns of PUI behaviours that result in harm, and devise strategies to tackle these issues. The aim of this phase of the study, which incorporates both a pilot study (cohort 2) and an RCT (cohort 3), is to investigate two promising theory-informed candidate preventative interventions, targeting A: emotional regulation and B: inhibitory control, for Problematic Use of the Internet (PUI). For the Pilot study: The primary objective is to use participants’ individual characteristics to build models for predicting outcomes for both novel preventative interventions when compared to a control condition (non-interactive provision of information on PUI). The secondary objective is to explore the effectiveness of each preventative intervention compared to a control condition when allocated at random. For the RCT: The primary objective is to evaluate the effectiveness of the predictive models derived from the pilot. We achieve this by comparing the effectiveness of each intervention (i.e., targeting emotional regulation or inhibitory control) when allocated either according to an algorithm derived from individual baseline outcome predictors (tailored arm), or when allocated at random (random arm) versus a control condition (non-interactive provision of information on PUI). The secondary objective is to evaluate and compare the cost-effectiveness and cost-utility of both allocation methods (tailored, random), investigating feasibility for large-scale implementation.
Ethics approval(s)	1. Approved 01/10/2025, Health, Science, Engineering and Technology ECDA (University of Hertfordshire, Governance Services, College Lane, Hatfield, AL10 9AB, United Kingdom; +44 (0)1707 281010; hsetecda@herts.ac.uk), ref: 0635 2025 Jul HSET 2. Approved 28/08/2025, Ethics Committee of the Faculty of Behavioral and Empirical Cultural Sciences at the Ruprecht-Karls-University Heidelberg (Ethikkommission der Fakultät für Verhaltens- und Empirische Kulturwissenschaften) (Postfach 10 57 60 69047 Heidelberg, Heidelberg, 69047, Germany; +49 6221 54-2894; dekanat@verkult.uni-heidelberg.de), ref: AZ Lind 2025 1/1 3. Approved 07/10/2025, Cantonal Ethics Committee Zurich (Postfach 121, Zurich, 8090, Switzerland; +41 432597970; admin.kek@kek.zh.ch), ref: 2025-01758 4. Submitted 30/07/2025, Research Ethics Committee with Medicines (CEIm) (Comité De Ética De La Investigación Con Medicamentos (CEIm)) (Técnica CEIm HGU Gregorio Anexo al Pabellón de psiquiatría, Madrid, 28007, Spain; +34 91 586 7007; ceim.hgugm@salud.madrid.org), ref: TBC 5. Submitted 01/09/2025, Ethics Committee of the Faculty of Psychology and Educational Sciences of the University of Porto (Rua Alfredo Allen, s/n 4200-135, Porto, 4200-135, Portugal; +351 226 079 700; comissao_etica@fpce.up.pt), ref: TBC 6. Submitted 05/09/2025, CPP Sud-Méditerranéen 1 (Hôpital Sainte Marguerite Pavillon 9, 270, bld Sainte Marguerite, Marseille, 13274, France; +33 4 91 74 42 56; cppsudmed1@gmail.com), ref: TBC 7. Submitted 08/09/2025, University of Lithuanian Health Sciences Center of Bioetics (Lietuvos Sveikatos Mokslų Universitetas Bioetikos Centras) (TilZ.es st. 18, Kaunas, LT-47181, Lithuania; +370 (8 37) 327233; bioetika@lmsu.lt), ref: TBC 8. Submitted 13/09/2025, Research Ethics Committee of the Faculty of Education and Psychology of ELTE Eötvös Loránd University (Kazinczy u. 23-27, Budapest, 1075, Hungary; + 36-1 461-4500 / 3885; keb@ppk.elte.hu), ref: TBC
Health condition(s) or problem(s) studied	Problematic usage of the internet in adolescents
Intervention	The two digital interventions developed and refined during the pilot study will be implemented in both the pilot and the RCT. These interventions are underpinned by behavioural change theory. Designed to reduce problematic usage of the internet (PUI) in adolescents, the interventions integrate evidence-based techniques to support emotional regulation and inhibitory control through interactive, personalised, and engaging digital content. 1. Emotional Regulation Intervention This intervention helps young people understand and manage their emotions better. It starts by encouraging them to reflect on their internet use and emotional habits. Then, it teaches practical skills for handling emotions through interactive games and exercises. The goal is to build emotional awareness and reduce unhealthy behaviours linked to internet use. 2. Inhibitory Control Intervention This intervention focuses on helping young people manage impulsive and compulsive behaviours. It begins with self-reflection and confidence-building activities, then teaches strategies to strengthen self-control. Interactive challenges and games help participants practise these skills in everyday life. Both interventions are personalised based on the level of risk: those at higher risk get more in-depth support, while others receive general guidance. 3. Control Group Participants in the control group receive a digital educational programme that covers general topics like internet habits and emotional wellbeing. However, it does not include interactive or skill-building activities, components necessary for meaningful behavioural change.
Intervention type	Behavioural
Primary outcome measure(s)	Problematic use of the internet (PUI) will be measured using the Problematic Internet Use Questionnaire in its short version (PIUQ-SF-9) at baseline, post-intervention, and 3-month follow-up
Key secondary outcome measure(s)	1. PUI as measured using The Internet Severity and Activities Addiction Questionnaire versions ISAAQ-part b, and ISAAQ-ED; A short version of the Assessment of Criteria for Specific Internet-use Disorders (ACSID-11) at baseline, post-intervention, and 3-month follow-up In addition, participants are asked about their Browser Activity: “What do you usually do when you're on the internet using your browser?” in an open-text question format. 2. Depression and anxiety are measured using the 21 Item version (DASS-21) at baseline, post-intervention, and 3-month follow-up 3. Self-stigma is measured using the Paediatric Self-Stigmatization Scale (PaedS) at baseline, post-intervention, and 3-month follow-up 4. Obsessive-compulsive disorder symptoms are measured using the Short Obsessive Compulsive Disorder Screener (SOCS) at baseline, post-intervention, and 3-month follow-up 5. Emotional and behavioural difficulties are measured using the Strengths and Difficulties Questionnaire (SDQ) at baseline, post-intervention, and 3-month follow-up 6. Quality of life is measured using the Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) at baseline, post-intervention, and 3-month follow-up 7. General health status is measured using the EQ-5D-Y and World Health Organisation Disability Assessment Schedule (WHODAS 2.0)(adapted for internet use), at baseline, post-intervention, and 3-month follow-up 8. Cognitive Variables (Affect regulation and Inhibitory executive control) measured using The BrainPAC (Project - The BrainPark Assessment of Cognition (BrainPAC) Project \| BrainPark, n.d.) enhanced value-modulated attentional capture (VMAC) task and enhanced Stop Signal task (SST), at baseline, post-intervention, and 3-month follow-up 9. Impulsive behaviour is measured using the Urgency –Premeditation - Perseverance - Sensation Seeking - Positive Urgency (UPPS-P), at baseline, post-intervention, and 3-month follow-up 10. Compulsivity is measured using the Cambridge–Chicago Compulsivity Trait Scale (CHI-T), at baseline, post-intervention, and 3-month follow-up 11. Height (in cm), Weight (in kg) and body mass index (BMI) will be recorded at baseline and 3-month follow-up 12. Favorite sports or exercise activities will be recorded at baseline and 3-month follow-up 13. Consequential expectancies of internet usage will be measured using the Internet Use Expectancies Scale (IUES), at baseline, post-intervention, and 3-month follow-up 14. Misinformation will be measured using a Visual Analog Scale (VAS) asking how much of the information on the internet they believe to be true (0% to 100%) at baseline and 3-month follow-up 15. Gratification and compensation are measured using the Experience of Gratification and Compensation Scale (EGS/ECS), at baseline, post-intervention, and 3-month follow-up 16. Fear of missing out is measured using the Fear of Missing Out Scale, at baseline, post-intervention, and 3-month follow-up 17. School performance is measured using the mean marks from the previous year recorded at baseline and 3-month follow-up 18. Family relationship quality and communication are measured using a 5-point Likert scale at baseline and 3-month follow-up 14. Socioeconomic status is measured using 3 items of the Family Affluence Scale III (FAS), at baseline and 3-month follow-up 15. Vaccine Hesitancy is measured using an adapted version of the Vaccine Hesitancy Scale (VHS), at baseline and 3-month follow-up 16. Habitual nature will be measured using the Self-Report Habit Index (SRHI), at baseline, post-intervention, and 3-month follow-up 17. Phone usage is monitored using mobile sensing data collected through the app throughout the 5 months. Data collected includes: Device sessions (Timestamps, Duration), Contact list (Number of contacts), Calls (Timestamps per Call, Duration, incoming, outgoing, missed), SMS (Timestamps per SMS, Text length, incoming/outgoing), Installed apps (Number of apps), App Sessions (Timestamps per session, duration), App Statistics (Count and Usage time per app), Encrypted GPS / Locations (Timestamps, Anonymized position), Accelerometer (Timestamps and axis data), Rotation Rate (Timestamps and axis data), Pedometer (Count of steps per day), Visits (Like GPS but aggregated). Device information will also be collected through the app and includes: Screen size, Operating system (OS), OS version, country, language, device, BootstrApp version
Completion date	30/07/2027

Eligibility

Participant type(s)	Learner/student
Age group	Child
Lower age limit	12 Years
Upper age limit	16 Years
Sex	All
Target sample size at registration	5871
Key inclusion criteria	1. Age between 12 and 16 years 2. Routine access to a mobile device 3. Student at a school involved in the study
Key exclusion criteria	1. No exclusive access to a mobile phone 2. Phone operating systems older than 15.6 for iOS or 10 for Android
Date of first enrolment	20/11/2025
Date of final enrolment	30/03/2027

Locations

Countries of recruitment

United Kingdom
England
France
Germany
Hungary
Lithuania
Netherlands
Portugal
Spain
Switzerland

Study participating centres

University of Hertfordshire

College Lane
Hatfield
AL10 9AB
United Kingdom

Eotvos Lorand Tudomanyegyetem

EGYETEM TER 1-3
Budapest
1053
Hungary

Universidade Do Porto

PRACA GOMES TEIXEIRA
Porto
4099-002
Portugal

Lietuvos Sveikatos Mokslu Universitetas

A MICKEVICIAUS GATVE 9
Kaunas
44307
Lithuania

Stichting Vu

DE BOELELAAN 1105
Amsterdam
1081 HV
Netherlands

Fundacion Para La Investigacion Biomedica Del Hospital Gregorio Maranon

CALLE DOCTOR ESQUERDO 46
Madrid
28007
Spain

Centre Hospitalier Universitaire Montpellier

AVENUE DU DOYEN GASTON GIRAUD 191
Montpellier
34000
France

Heidelberg University

Grabengasse 1
Heidelberg
69117
Germany

Universitat Zurich

RAMISTRASSE 71 null
Zurich
8006
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The data-sharing plans for the current study are 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 2.0	01/10/2025	07/11/2025	No	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Additional files

ISRCTN55100480_Protocol [Cohort 2 and 3]_v2.0_01Oct2025.pdf: Protocol file

Editorial Notes

07/11/2025: Protocol [Cohort 2 and 3] version 2.0 added.
2. The scientific title was changed from "Boosting societal adaptation and mental health in a rapidly digitalising, post-pandemic Europe (BootStRaP)" to "Boosting societal adaptation and mental health in a rapidly digitalising, post-pandemic Europe (BootStRaP Phase 2)".
21/10/2025: Study's existence confirmed by the Ethics Committee of the Faculty of Behavioral and Empirical Cultural Sciences at the Ruprecht-Karls-University Heidelberg (Ethikkommission der Fakultät für Verhaltens- und Empirische Kulturwissenschaften), Germany.