How effective are walk-in mental health centers for young people with psychological distress in Europe and Australia?

ISRCTN ISRCTN13725260
DOI https://doi.org/10.1186/ISRCTN13725260
EU Horizon project YOUTHreach Grant number 101156514
Protocol serial number 2025-01-YEAH
Sponsor Maastricht University
Funder HORIZON EUROPE Framework Programme
Submission date
27/11/2025
Registration date
09/12/2025
Last edited
28/11/2025
Recruitment status
Not yet recruiting
Overall study status
Ongoing
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Mental health problems often start in teenage years and early adulthood. They can cause a lot of distress and have become worse during the COVID-19 pandemic. Despite this, young people often face barriers to getting timely help, such as long waiting lists, privacy concerns, and difficulties moving from child to adult services.
To help, youth mental health support centres (YEAHs) have been set up in several countries, inspired by Australia’s headspace model. These centres provide mental, physical, sexual health, substance use, and vocational support in one place. They aim to make care easier to access, provide youth-friendly services, involve families, and focus on prevention and early intervention.
However, it is unclear how well these principles work in practice and whether they improve mental health, are accepted by young people, or are cost-effective. Previous studies suggest YEAHs improve access to care and reduce distress, but these studies often had short follow-ups and limited safety or economic data.
This study aims to test YEAH centres in seven European countries and Australia. It will evaluate their effectiveness, safety, reach, adoption, implementation, and maintenance, using surveys, interviews, and economic analysis.

Who can participate?
The study is open to young people aged 12 to 25 years with clinically relevant psychological distress. Participants can have questions or concerns about their mental or physical health, sexuality, school, work, or finances.

What does the study involve?
Participants will join one of two groups:
1. YEAH + Care as Usual (YEAH+CAU) – participants use YEAH services along with usual care.
2. Care as Usual (CAU) – participants continue with regular services without YEAH support.
About 610 participants will be in each group. Groups are not randomly assigned for ethical reasons; instead, participants in the control group will be matched based on location and characteristics.
Data will be collected at four time points: baseline, 3 months, 6 months, and 12 months. Most outcomes are self-reported, including mental health, well-being, quality of life, and self-esteem. The study will also examine how the centres are implemented and the factors that help or hinder their success using interviews, workshops, and observations.

What are the possible benefits and risks of participating?
Benefits:
- Access to integrated youth health services through YEAH.
- Improved mental health, including well-being, quality of life, self-efficacy, and self-esteem over time compared to usual care.
- Participants receive reimbursement for completing surveys, e.g., gift vouchers .
Risks:
- Thinking about mental health issues may temporarily worsen symptoms or trigger suicidal thoughts.
Participants will be given information on support services and emergency contacts. In case of serious medical or mental health crises, local emergency or psychiatric care will be contacted immediately.

Where is the study run from?
The study is sponsored by Maastricht University and conducted jointly with Charité – Universitätsmedizin Berlin. Related work packages on the design, implementation, and analysis phase are led by Central Institute of Mental Health and Servicio Madrileno de Salud. The following study centers are involved in recruiting participants:
- Charité – Universitätsmedizin Berlin
- Maastricht University
- University of Birmingham
- Provincia Lombardo Veneta – Ordine Ospedaliero di San Giovanni di Dio – Fatebenefratelli
- University of Galway
- Mittetulundusuhing Peaasjad
- Hospital General Universitario Gregorio Marañón
- University of Melbourne

When is the study starting and how long is it expected to run for?
- Preparation started: 1 January 2025
- Recruitment: 1 January 2026 – 31 December 2027
- Final assessments: until 31 December 2028
- Study end: 31 December 2029

Who is funding the study?
The European Union funds the study as part of the Horizon Europe project YOUTHreach (Grant number: 101156514). The views expressed in the study are those of the authors and not necessarily those of the EU or its agencies.

Who is the main contact?
Andreas Bechdolf, Chief Investigator (Andreas.bechdolf@charite.de)
Sophie Leijdesdorff, Co-Chief Investigator (sophie.leijdesdorff@maastrichtuniversity.nl)

Contact information

Prof Andreas Bechdolf
Principal investigator

Charité - Universitätsmedizin Berlin
Department of Psychiatry and Neurosciences, CCM
Charitéplatz 1
Berlin
10117
Germany

ORCiD logoORCID ID 0000-0003-4796-3392
Phone +49 (0)15114552161
Email andreas.bechdolf@charite.de
Dr Sophie Leijdesdorff
Principal investigator

University Maastricht
Faculty Of Health, Medicine And Life Sciences And Its School For Mental Health And Neuroscience
Minderbroedersberg 4
Maastricht
6200 MD
Netherlands

ORCiD logoORCID ID 0000-0001-9930-3391
Phone +31 (0)433883543
Email Sophie.Leijdesdorff@maastrichtuniversity.nl
Ms Jule Leickert
Public

Charité - Universitätsmedizin Berlin
Department of Psychiatry and Neurosciences, CCM
Charitéplatz 1
Berlin
10117
Germany

ORCiD logoORCID ID 0009-0002-1415-3836
Phone +49 (0)15114552161
Email jule.leickert@charite.de
Prof Ulrich Reininghaus
Scientific

Department of Public Mental Health
Central Institute of Mental Health
J5
Mannheim
68159
Germany

ORCiD logoORCID ID 0000-0002-9227-5436
Phone +49 (0)621 1703-1930
Email ulrich.reininghaus@zi-mannheim.de

Study information

Primary study designObservational
Observational study designLongitudinal study
Scientific titleEffectiveness and public health impact of walk-in Youth mEntal heAltH support centres: a hybrid (cost-)effectiveness-implementation study in seven European countries and Australia
Study acronymYEAH
Study objectivesThe primary objective of this multi-country cohort study is to evaluate the effectiveness and public health impact of the YEAH intervention for youth mental health across seven European countries and Australia. Using an adapted EUnetHTA framework alongside the RE-AIM framework, the study aims to assess Safety, Reach, Effectiveness, Adoption, Implementation, and Maintenance of YEAH through a participatory implementation study, a quasi-experimental design, economic evaluation, and process evaluation.

1. Primary hypothesis: It is hypothesized that, compared with the control condition (care as usual (CAU)), psychological distress, assessed with the CORE10, will, on average, be lower in the experimental condition (YEAH+CAU) than in the control condition at 6-month follow-up (t2) (primary outcome), after propensity score matching and controlling for covariates.

2. Secondary hypotheses: It is hypothesized that, compared with the control condition (CAU), the experimental condition (YEAH+CAU) while controlling for respective secondary outcomes at baseline will, on average after propensity score matching and controlling for covariates, demonstrate:
a) higher subjective quality of life and well-being at 3-month (t1), 6-month (t2), and 12-month (t3) follow-up,
b) lower psychological distress at 3-month (t1) and 12-month (t3) follow-up.
Ethics approval(s)

Approved 12/11/2025, Ethik-Kommission der Charité – Universitätsmedizin Berlin (Charitéplatz 1, Berlin, 10117, Germany; +49 (0)30 450 517 222; ethikkommission@charite.de), ref: EA2/203/25

Health condition(s) or problem(s) studiedPrevention and early intervention of mental disorders in youth with psychological distress
InterventionThe YEAH study is a hybrid effectiveness-implementation design conducted as a prospective, multi-country, quasi-experimental cohort study with non-equivalent groups. Study participants will be recruited either for the experimental condition receiving YEAH plus Care as Usual (YEAH+CAU) or a control condition solely receiving Care as Usual (CAU) (n=610 YEAH+CAU vs. n=610 CAU). Due to ethical considerations, randomization is not employed; Controls will be recruited from corresponding catchment areas and statistically matched. Outcome data will be collected at four time points: baseline (t0), 3-months (t1), 6-months (t2), and 12-months (t3) follow-up. The primary and most secondary outcomes rely on self-reported measures.

The implementation at a new site will follow a participatory approach by including stakeholder groups as well as ethical and regulatory requirements. The process evaluation exploring contextual and mechanistic factors influencing implementation as well as the ethical research employs qualitative methods (interviews, workshops, observations) guided by i.e., Theory of Change and Realist Evaluation.

Control condition (CAU): Participants in the control condition will be provided with CAU (i.e., continue to receive and have access to all public mental health services they received prior to the start of the study). CAU will include all public mental health care delivered according to local and national service guidelines and protocols by general practitioners (primary care doctors), psychiatrists, clinical psychologists, school psychologists, social workers, psychological counsellors, and other public mental health practitioners available in the catchment areas of YEAH. The comparator for the current trial is purposefully selected to reflect CAU, broadly defined, to mirror the naturalistic service landscape and practice to which beneficial effects ought to generalise.

Experimental condition (YEAH + CAU): The YEAH are easy-access (i.e., soft-entry, stigma-free, and free of charge) walk-in youth mental health support service systems. Although these services are embedded in their respective national healthcare systems, these services share fundamental principles providing youth aged 12-25 with the possibility to discuss mental health as well as physical, sexual, financial, educational, vocational and social problems. These services have been set up in co-creation with young people. Some of them also offer of peer-to-peer counselling by trained and professionally supervised peers and experience experts. Beside peer support, most YEAH offer brief therapeutic, mostly cognitive behavioural based interventions, on average up to 8 sessions, family engagement, and access to social work or supported education and supported employment. Although in some centres many users only have one session, treatment can last several weeks and around 20% of the users are referred to secondary mental health services, treatment at YEAH is not specifically time limited. In contrast to traditional mental health services that have a more diagnosis/treatment-focused working method, these youth mental health initiatives have a common mission aiming at reaching young people as early as possible to increase resilience and promote mental well-being, and consequently the chance of a healthy development.
The naturalistic intervention is delivered by the multidisciplinary teams regularly working in the YEAH. The multidisciplinary teams include clinical specialists (e.g., psychiatrists, psychologists, mental health nurses) and other clinical/non-clinical staff (e.g., counsellors, social workers, nurses, general practitioners, alcohol and drug workers and vocational workers). Some of the centres (e.g., @ease in The Netherlands) are designed as a volunteer peer-to-peer model, i.e., counselling services are provided by trained volunteer young-adult peers and professionally supervised. These young-adult peers are over 18 and generally under 30 years old. They are supervised by on-site healthcare or youth professionals, including psychologists, psychiatry residents, behavioural scientists, social workers, youth workers and specialized nurses. In summary, the intervention consists of various support services, such as, diagnostics, brief therapy, social counselling, job coaching and drug prescriptions which are delivered in different ways: in-person, online or over the phone.
Intervention typeOther
Primary outcome measure(s)

Clinical effectiveness defined as psychological distress measured using the CORE-10 at 6-month follow-up (t2)

Key secondary outcome measure(s)

Clinical effectiveness:
1. Psychological distress measured with the CORE-10 at 3- (t1) and 12-month follow-up (t3)
2. Quality of life and wellbeing measured with MyLifeTracker at 3- (t1), 6- (t2), and 12-month (t3) follow-up
3. User satisfaction using adapted items from the Jigsaw satisfaction survey at 3- (t1), 6- (t2), and 12-month (t3) follow-up

Health economic evaluation:
1. Cost effectiveness: cost per unit decrease in psychological distress, measured using the CORE-10
2. Cost-utility analysis (cost per quality adjusted life years (QALYs) measured using the EQ-5D-5L except in the UK and Ireland where the EQ-5D-3L will be used
3. Costs of interventions measured using a Resource Use Measurement tailored to reflect the structure of the health system in each country

Completion date31/12/2029

Eligibility

Participant type(s)Patient
Age groupMixed
Lower age limit12 Years
Upper age limit25 Years
SexAll
Target sample size at registration1220
Key inclusion criteria1. Age 12-25 years
2. Experimental condition only: First presentation to YEAH (earlier or consecutive counselling or mental health service use is allowed)
3. Presence of clinically meaningful psychological distress operationalized as a score of >10 on the CORE-10
4. Willingness to participate,
5. Ability to give informed consent
6. Parental consent for minors, if applicable
Key exclusion criteria1. Insufficient command of the local study language(s) to provide valid answers to self-report questionnaires (Estonian, German, Italian, English, Spanish, or Dutch)
2. Acute suicidality or acute threat to others
Date of first enrolment01/01/2026
Date of final enrolment31/12/2027

Locations

Countries of recruitment

  • United Kingdom
  • England
  • Australia
  • Estonia
  • Germany
  • Ireland
  • Italy
  • Netherlands
  • Spain

Study participating centres

University of Birmingham
Edgbaston Campus
Birmingham
B15 2TT
England
Charité-Universitätsmedizin Berlin
Department of Psychiatry and Neurosciences, CCM
Universitätsplatz 1
Berlin
10117
Germany
University Maastricht
Faculty Of Health, Medicine And Life Sciences (FHML) And Its School For Mental Health And Neuroscience (Mhens), Minderbroedersberg 4-6
Maastricht
6211
Netherlands
Provincia Lombardo Veneta - Ordine Ospedaliero Di San Giovanni Di Dio- Fatebenefratelli
Via Pilastroni 4
Brescia
25121
Italy
University of Galway
University Road
Galway
H91 TK33
Ireland
Mittetulundusuhing Peaasjad
Maneeži street 3
Tallinn
10117
Estonia
Servicio Madrileño de Salud- Hospital General Universitario Gregorio Marañón
Instituto de Psiquiatría y Salud Mental Hospital Gregorio Marañón
Calle Ibiza 43
Madrid
28009
Spain
University of Melbourne
Faculty of Medicine, Dentistry and Health Sciences, Victoria
Melbourne
3010
Australia

Results and Publications

Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
IPD sharing planThe datasets generated during and/or analysed during the current study will be available upon request from Dominiek Smit (dominiek.smit@maastrichtuniversity.nl), who is responsible for data curation and data management.

Editorial Notes

27/11/2025: Trial's existence confirmed by European Health and Digital Executive Agency (HADEA).