The European Alliance Against Depression four-level depression and suicide prevention and wellbeing promotion community intervention focused on vulnerable groups: a study protocol for a prospective, controlled, cross-country design (MentBest)
| ISRCTN | ISRCTN10521127 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10521127 |
| EU Horizon grant no. | 101080651 |
| Sponsor | European Alliance Against Depression |
| Funder | European Health and Digital Executive Agency |
- Submission date
- 14/11/2025
- Registration date
- 26/02/2026
- Last edited
- 26/02/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Depression is one of the leading causes of disability worldwide and is closely linked to suicide. Social changes such as economic crises, migration, ageing, and pandemics have increased stress and mental health risks, especially for vulnerable groups like young people, older adults, migrants, the long-term unemployed, and people with previous mental health problems. This study is part of the EU-funded MENTBEST project and aims to prevent and reduce depression and suicide across Europe. It uses a four-level community approach developed by the European Alliance Against Depression (EAAD), which combines healthcare training, public awareness campaigns, community support, and online tools.
Who can participate?
Adults aged 18 and over can take part in the general population surveys. People aged 15 and above can use the iFightDepression® online tool. Participation is voluntary.
What does the study involve?
Participants in the general population survey will be asked to complete questionnaires about wellbeing, anxiety and depression symptoms, and attitudes towards depression. These surveys will take place before and after the 24-month intervention. People using the iFightDepression® tool will complete short questionnaires when they register and six weeks later.
What are the possible benefits and risks of participating?
There are no known risks from taking part. Benefits may include increased awareness of mental health, reduced stigma, better access to care, and possible improvement in depressive symptoms.
Where is the study run from?
The study is coordinated by the European Alliance Against Depression (EAAD) and carried out by partner institutions in Albania, Estonia, Greece, Ireland, and Spain.
When is the study starting and how long is it expected to run for?
October 2024 to January 2027
Who is funding the study?
The study is funded by the European Union’s Horizon Europe Programme.
Who is the main contact?
Prof. Ulrich Hegerl, EAAD (info@eaad.net)
Contact information
Public, Scientific
Centre Fòrum Research Unit, C/ Llull 410
Barcelona
08019
Spain
 ORCID ID |
0000-0002-2405-0593 |
|---|---|
| Phone | +34 933 26 85 00 |
| bhogg@researchmar.net |
Principal investigator
Goerdelerring 9
Leipzig
04109
Germany
| ORCID ID |
0000-0002-3039-7470 |
|---|---|
| Phone | +49 69630186344 |
| ulrich.hegerl@deutsche-depressionshilfe.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective controlled cross-country community intervention cluster randomized study |
| Secondary study design | Cluster randomised trial |
| Scientific title | The European Alliance Against Depression four-level community intervention for depression and suicide prevention and wellbeing promotion focused on vulnerable groups: a study protocol for a prospective, controlled, cross-country design comparing intervention and control regions to reduce suicide attempts, deaths by suicide, and depressive symptoms, and to improve wellbeing (MentBest) |
| Study acronym | MENTBEST |
| Study objectives | 1. Outcome evaluation: to assess the effectiveness of the expanded 4-level intervention using a controlled, cross-country design, focusing on clinical outcomes. 2. Process evaluation: to investigate the implementation process of the intervention in a comprehensive manner. 3. Economic evaluation: to examine the cost-effectiveness of the intervention, expressed as the estimated incremental cost per suicide attempt avoided and per percentage point improvement on selected health outcomes measured through a general population survey. |
| Ethics approval(s) |
1. Approved 06/11/2024, Ethics Committee for Clinical Investigation (CEIm), Hospital del Mar Barcelona (C/ Dr. Aiguader 88, Barcelona, 08003, Spain; +34 933160679; ceic-psmar@researchmar.net), ref: 2024/11534/I 2. Approved 16/07/2024, Ethics Research Committe of the Psychology department of the University of York Europe Campus. (Proxenou Koromila 24, Thessaloniki, 54622, Greece; +30 2310 224421; arladas@york.citycollege.eu), ref: 1078 3. Approved 10/09/2024, Ethics Committee, Ministry of Health and Social Welfare (Rr. Kavajes, Tirana, 1001, Albania; -; gentaqirjako@gmail.com), ref: - 4. Approved 19/09/2024, Tervise Arengu Instituudi inimuuringute eetikakomitee (TAIEK) (Paldiski mnt 80, Tallinn, 10617, Estonia; +372 659 3924; eetikakomitee@tai.ee), ref: Otsus nr 1372 [reference: Project 2578 - MENTBEST] 5. Approved 27/02/2025, Social Research Ethics Committee (SREC) (Office of Vice President for Research & Innovation, 4th Floor, Block E, Food Science Building University College Cork, Cork, T12 K8AF, Ireland; +353 (0)21 4903501; srec@ucc.ie), ref: SREC Log No: 2024-227 (population survey) and SREC Log No: 2025-015 (Training evaluation) 6. Submitted 13/11/2025, Research Ethics, Faculty of Education and Health Sciences, University of Limerick (Faculty Office, Faculty of Education and Health Sciences, University of Limerick, Limerick, V94 T283, Ireland; +353-61-213081; ehsresearchethics@ul.ie), ref: - |
| Health condition(s) or problem(s) studied | Prevention of suicidal behaviour and depression and promotion of wellbeing in the community (general population and vulnerable groups.) |
| Intervention | Communities in the intervention arm will receive the four-level European Alliance Against Depression (EAAD) community intervention (MentBest), with added components to improve wellbeing and reach vulnerable groups. Level 1 involves training healthcare professionals to recognize and treat depression and suicidal behaviour. Level 2 consists of public awareness campaigns to improve knowledge about depression, reduce stigma, and promote help-seeking. Level 3 provides training for community facilitators (teachers, school counsellors, police, clergy, pharmacists, social workers) to offer early support, crisis intervention, referral, and stigma reduction. Level 4 includes the iFightDepression® guided tool for patients with mild to moderate depressoin, and support activities for patients and high-risk groups, such as self-help groups, crisis hotlines, and information about local mental health services. Additional components include the iFight4Wellbeing website and tailored materials for five vulnerable groups (young people, older adults, migrants/refugees, long-term unemployed, and people with past or current mental health conditions). The intervention lasts 24 months, starting with an opening ceremony. Implementation will be continuously monitored via trackers and stakeholder surveys, and a general population survey (500 adults per region) will assess wellbeing and mental health at baseline and after 24 months. The intervention aims to reduce depression and suicidal behavior, including suicide attempts and deaths. Intervention and control regions were selected using a pragmatic approach, aiming to match areas with similar characteristics in each country. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
1. Rate of completed suicides measured using official mortality data from national authorities and suicide registers following WHO ICD-10/11 classifications at baseline (pre-intervention) and 24 months |
| Key secondary outcome measure(s) |
1. Knowledge and attitudes about depression measured using the Personal Stigma Subscale of the Depression Stigma Scale (DSS; Griffiths et al., 2004) and attitudes towards help-seeking using the the Attitudes Towards Seeking Professional Psychological Help-Short Form (ATSPPH-SF; Fischer & Farina, 1995) at baseline (pre-intervention) and 24 months |
| Completion date | 31/01/2027 |
Eligibility
| Participant type(s) | Health professional, Healthy volunteer, Patient, Population, Resident, Service user |
|---|---|
| Age group | Mixed |
| Lower age limit | 15 Years |
| Upper age limit | 120 Years |
| Sex | All |
| Target sample size at registration | 4700 |
| Key inclusion criteria | Participants must belong to one of the four study levels: Level 1: Healthcare professionals involved in depression care. Level 2: General population, including the five vulnerable groups: Young people: 15–24 years; Older people: 65+ years, Long-term unemployed, Migrants/refugees and people with an existing mental disorder. Level 3: Community gatekeepers Level 4: People with mild to moderate depression using the iFightDepression® tool. Participants in Level 2 (general population survey) must be 18 years or older. Participants in Level 4 (iFightDepression® tool users) must be 15 years or older. |
| Key exclusion criteria | 1. Individuals under 18 years of age for the general population survey. 2. Individuals under 15 years of age for using the iFightDepression® tool. |
| Date of first enrolment | 28/10/2024 |
| Date of final enrolment | 31/01/2027 |
Locations
Countries of recruitment
- Albania
- Estonia
- Greece
- Ireland
- Spain
Study participating centres
Barcelona
08003
Spain
Thessaloníki
54622
Greece
Tirana
1001
Albania
Cork
T12 K8AF
Ireland
Tallinn
11615
Estonia
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in publicly available repository |
| IPD sharing plan | Data will be analysed by the team in KU Leuven. The datasets generated during and/or analyzed during the current study will be stored in a publicly available repository. These will be made available following publication of the study results. Any research data on which scientific publications are based and that the project creates itself will be anonymised and freely shared for research purposes on an open-access repository (e.g., the German Elixir node or Zenodo) following publication of the main project results. All project-created data will be enriched with appropriate CDISC and/or SNOMED metadata and ontologies, to maximise FAIR findability, accessibility, integration and re-use. All participants are required to provide informed consent. |
Editorial Notes
14/11/2025: Trial's existence confirmed by European Health and Digital Executive Agency.
