# Advancing innovative interventions for mental, behavioural and neurodevelopmental disorders
EUACC page: https://www.euacc.ai/calls/HORIZON-HLTH-2025-03-DISEASE-02-two-stage
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## Public content

**topic id:** HORIZON-HLTH-2025-03-DISEASE-02-two-stage
**call id:** HORIZON-HLTH-2025-03-two-stage
**title:** Advancing innovative interventions for mental, behavioural and neurodevelopmental disorders
**programme:** Horizon Europe
**cluster:** HLTH
**status:** closed
**deadline date:** 2026-04-16T00:00:00+00:00
**deadline model:** two-stage
**start date:** 2025-05-22T00:00:00+00:00
**url:** https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/topic-details/HORIZON-HLTH-2025-03-DISEASE-02-two-stage
**description:** Expected Outcome:
This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination “Tackling diseases and reducing disease burden”. To that end, proposals under this topic should aim to deliver results that are directed, tailored towards and contributing to all the following expected outcomes:
• The scientific and clinical communities make effective use of state-of-the-art knowledge, data, technologies, tools, methods, best practices, and trainings to underpin and complement the development of innovative interventions[1] aimed at achieving a lasting benefit.
• The scientific and clinical communities benefit from the exchange of data, knowledge and best practices, thereby strengthening their collaboration in the EU, the Associated Countries and beyond.
• The scientific and clinical communities make wide use of relevant databases and/or integrate them with existing infrastructures for storage and sharing of collected data according to FAIR[2] principles, thereby encouraging further use of the data.
• Policymakers, funders, scientific and clinical communities, patient organisations, regulators, and other relevant bodies are informed of the research advances made and the requirements for a widespread implementation of the innovative therapeutic interventions and complementary approaches.
• Patients and caregivers are constructively engaged with the research, ensuring that their needs are catered for, with the aim of tangibly benefitting from the interventions.
 Scope:
Mental, behavioural and neurodevelopmental disorders, that include for example severe depression, anxiety, schizophrenia, psychosis, post-traumatic stress disorder (PTSD), addictive behaviours (drugs[3], alcohol, gaming and others), obsessive-compulsive disorder, eating disorders and autism spectrum disorder are a high burden for patients, health systems and society, and remain unmet medical needs. More innovative, safer and more effective therapeutic and relapse-preventing solutions based on active substances are required, as for example for mental disorders many available treatments show modest efficacy, non-negligible side effects, discontinuation problems and high relapse rates. Additionally, other non-invasive multidisciplinary and/or transdiagnostic approaches (e.g. neurostimulation, neuroimaging, digital, non-pharmaceutical, psychotherapy, psychosocial) should be further developed to complement the therapeutic and relapse prevention solutions. These approaches aim to further improve health outcomes, self-determination, autonomy and quality of life in the long-term.
The disorders within the scope of this topic fall under Chapter 6 of the International Classification of Diseases[4]. Rare diseases are excluded[5].
Proposals should address most of the following aspects:
• Perform rigorous clinical studies into the safety and efficacy of the innovative interventions and their mode of administration, ensuring adequate cohorts/sample sizes with adequate representation of the patient population, including in terms of age, sex and ethnicity.
• Through the clinical studies, gain further insight into the mechanism(s) of action of the innovative therapies and complementary approaches. This could entail analyses of imaging (e.g. MRI, ultrasound, nuclear imaging), as well as physiological, molecular, biochemical or omics signatures revealing potential perturbations prior to the intervention and recovery thereafter, and it could lead to the development of surrogate endpoints. This insight should open the path to more personalised interventions and approaches.
• Use and/or develop technologies, including digital ones (e.g., (generative) Artificial Intelligence - AI[6], wearable technologies) to help implement and monitor the long-term efficacy of the intervention(s), as well as manage the disorder and/or monitor their progression (e.g. with unobtrusive technologies suitable for patient monitoring at home and in real-world conditions), whilst also ensuring they are bias-free, inclusive, and ethically sound.
• Exploit existing data, biobanks, registries and/or cohorts, together with the generation of new data that should be managed in line with the FAIR principles.
• Engage all relevant stakeholders (especially patients and patients’ representatives for the disorder, caregivers, clinicians, counsellors, regulators, etc.) to design end-user optimised interventions, applying gender-sensitive and intersectional approaches.
• Advance research by leveraging already existing and emerging state-of-the-art research infrastructures (e.g. ECRIN[7], EATRIS[8], EBRAINS[9], BBMRI[10], EuroBioImaging[11], European Genomic Data Infrastructure[12], etc.), as well as results stemming from EU-supported research projects, where applicable.
• Engage with national public health authorities and regulators to ensure a robust development pathway and further uptake of the intervention.
 The participation of start-ups, micro, small and medium-sized enterprises (SMEs)[13] is encouraged with the aim of strengthening their scientific and technological foundations, enhancing their innovation potential, and exploring possibilities for commercial exploitation.
Funded projects should liaise with the European Partnership for Brain Health (covered by topic HORIZON-HLTH-2025-02-DISEASE-01) once launched.
The topic requires the effective contribution of social sciences and humanities (SSH) disciplines and the involvement of SSH experts, institutions as well as the inclusion of relevant SSH expertise, in order to produce meaningful and significant effects enhancing the societal impact of the related research activities.
All projects funded under this topic are strongly encouraged to participate in networking and joint activities, as appropriate. Therefore, proposals should include a budget for the attendance to regular joint meetings and may consider covering the costs of any other potential joint activities without the prerequisite to detail concrete joint activities at this stage. The details of these joint activities will be defined during the grant agreement preparation phase.
Applicants invited to the second stage should provide details of their clinical studies[14] in the dedicated annex using the template provided in the submission system. As proposals under this topic are expected to include clinical studies, the use of the template is strongly encouraged.
[1] Innovative interventions should be based on new and/or alternative approaches that are aimed at achieving a lasting therapeutic benefit. The innovative intervention should be a combination of a product based on an active substance that is complemented by another multidisciplinary approach.
[2] See definition of FAIR data in the introduction to this work programme part.
[3] If proposals concern drug addiction, they are encouraged to liaise with the EU Drugs Agency.
[4] International Classification of Diseases 11th Revision (ICD-11), developed by the World Health Organization (WHO); Chapter 6: ‘Mental, behavioural or neurodevelopmental disorders’.
[5] Rare diseases, as defined by the European Union Regulation on Orphan Medicinal Products (1999), being a disease that affects not more than 1 person per 2000 in the European population (https://www.orpha.net/).
[6] Generative AI is a type of AI technology that can generate various forms of new content such as text, images, sounds, and even code, such as for programming or gene sequencing (https://ec.europa.eu/newsroom/dae/redirection/document/101621).
[7] https://ecrin.org
[8] https://eatris.eu
[9] https://www.ebrains.eu
[10] https://www.bbmri-eric.eu
[11] https://www.eurobioimaging.eu
[12] https://gdi.onemilliongenomes.eu
[13] https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32003H0361
[14] Please note that the definition of clinical studies (see introduction to this work programme part) is broad and it is recommended that you review it thoroughly before submitting your application.
**conditions:** General conditions
1. Admissibility Conditions, Proposal page limit and layout
Applicants submitting a proposal under the blind evaluation pilot (see General Annex F) must not disclose their organisation names, acronyms, logos nor names of personnel in the proposal abstract and Part B of their first-stage application (see General Annex E).

Admissibility Conditions are described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes.
Proposal page limits and layout are described in Part B of the Application Form available in the Submission System.

2. Eligible Countries
Eligible Countries are described in Annex B of the Work Programme General Annexes.
A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects. See the information in the Horizon Europe Programme Guide.

3. Other Eligible Conditions
In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding.

If projects use satellite-based earth observation, positioning, navigation and/or related timing data and services, beneficiaries must make use of Copernicus and/or Galileo/EGNOS (other data and services may additionally be used).

The following exceptions apply: subject to restrictions for the protection of European communication networks.

Other Eligible Conditions are described in Annex B of the Work Programme General Annexes.

4. Financial and operational capacity and exclusion
Financial and operational capacity and exclusion are described in Annex C of the Work Programme General Annexes.

5a. Evaluation and award: Award criteria, scoring and thresholds
This topic is part of the blind evaluation pilot under which first stage proposals will be evaluated blindly.

Evaluation and award: Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes.

5b. Evaluation and award: Submission and evaluation processes
For the first stage, the thresholds for each criterion will be 4 (Excellence) and 4 (Impact). The overall threshold applying to the sum of the two individual scores will be set at a level that ensures the total requested budget of proposals admitted to stage 2 is as close as possible to four times the available budget, and not less than three and a half times the available budget.

For the second stage, the thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 4 (Implementation). The cumulative threshold will be 12.

Evaluation and award: Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual.

5c. Evaluation and award: Indicative timeline for evaluation and grant agreement
Evaluation and award: Indicative timeline for evaluation and grant agreement are described in Annex F of the Work Programme General Annexes.

6. Legal and financial set-up of the grants
Eligible costs will take the form of a lump sum as defined in the Decision of 7 July 2021 authorising the use of lump sum contributions under the Horizon Europe Programme – the Framework Programme for Research and Innovation (2021-2027) – and in actions under the Research and Training Programme of the European Atomic Energy Community (2021-2025) [[This decision is available on the Funding and Tenders Portal, in the reference documents section for Horizon Europe, under ‘Simplified costs decisions’ or through this link: https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/guidance/ls-decision_he_en.pdf]].

Legal and financial set-up of the grants are described in Annex G of the Work Programme General Annexes.

Specific conditions
 Specific conditions are described in the specific topic of the Work Programme.

Application and evaluation forms and additional documents:
 Application and evaluation form templates
Standard application form (HE RIA IA Stage 1) - the application form specific to this call is available in the Submission System
Standard application form (HE RIA, IA) - the application form specific to this call is available in the Submission System
Standard evaluation form (HE RIA, IA and CSA Stage 1) - will be used with the necessary adaptations
Standard evaluation form (HE RIA, IA) - will be used with the necessary adaptations
Guidance
HE Programme Guide
Model Grant Agreement (MGA)
Lump Sum MGA
Call-specific instructions
Information on clinical studies (HE)
Detailed budget table (HE LS)
Guidance: "Lump sums - what do I need to know?"

Additional documents1
 HE Main Work Programme 2025 – 1. General Introduction
HE Main Work Programme 2025 – 4. Health
HE Main Work Programme 2025 – 14. General Annexes
HE Programme Guide
HE Framework Programme 2021/695
HE Specific Programme Decision 2021/764
EU Financial Regulation 2024/2509
Decision authorising the use of lump sum contributions under the Horizon Europe Programme
Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment
EU Grants AGA — Annotated Model Grant Agreement 
Funding & Tenders Portal Online Manual 
Funding & Tenders Portal Terms and Conditions 
Funding & Tenders Portal Privacy Statement
**action type:** HORIZON  Research and Innovation Actions
**budget:** 
  **budget Years Columns:** 
    - 2025
  **budget Topic Action Map:** 
    **110789:** 
      -         **action:** HORIZON-HLTH-2025-03-ENVHLTH-02-two-stage - HORIZON-RIA HORIZON  Research and Innovation Actions
        **budget Year Map:** 
          **2025:** 40000000
        **deadline Dates:** 
          - 2025-09-16
          - 2026-04-16
        **deadline Model:** two-stage
        **expected Grants:** 5
        **max Contribution:** 8000000
        **min Contribution:** 7000000
        **planned Opening Date:** 2025-05-22
    **110790:** 
      -         **action:** HORIZON-HLTH-2025-03-ENVHLTH-01-two-stage - HORIZON-RIA HORIZON  Research and Innovation Actions
        **budget Year Map:** 
          **2025:** 40000000
        **deadline Dates:** 
          - 2025-09-16
          - 2026-04-16
        **deadline Model:** two-stage
        **expected Grants:** 6
        **max Contribution:** 7000000
        **min Contribution:** 6000000
        **planned Opening Date:** 2025-05-22
    **110791:** 
      -         **action:** HORIZON-HLTH-2025-03-DISEASE-02-two-stage - HORIZON-RIA HORIZON  Research and Innovation Actions
        **budget Year Map:** 
          **2025:** 50000000
        **deadline Dates:** 
          - 2025-09-16
          - 2026-04-16
        **deadline Model:** two-stage
        **expected Grants:** 7
        **max Contribution:** 8000000
        **min Contribution:** 6000000
        **planned Opening Date:** 2025-05-22
    **110792:** 
      -         **action:** HORIZON-HLTH-2025-03-STAYHLTH-01-two-stage - HORIZON-RIA HORIZON  Research and Innovation Actions
        **budget Year Map:** 
          **2025:** 40000000
        **deadline Dates:** 
          - 2025-09-16
          - 2026-04-16
        **deadline Model:** two-stage
        **expected Grants:** 5
        **max Contribution:** 8000000
        **min Contribution:** 6000000
        **planned Opening Date:** 2025-05-22
    **110793:** 
      -         **action:** HORIZON-HLTH-2025-03-IND-03-two-stage - HORIZON-RIA HORIZON  Research and Innovation Actions
        **budget Year Map:** 
          **2025:** 40000000
        **deadline Dates:** 
          - 2025-09-16
          - 2026-04-16
        **deadline Model:** two-stage
        **expected Grants:** 5
        **max Contribution:** 8000000
        **min Contribution:** 6000000
        **planned Opening Date:** 2025-05-22
**keywords:** HORIZON-HLTH-2025-03-DISEASE-02-two-stage, HORIZON-HLTH-2025-03-two-stage, Behavioural neuroscience (e.g. sleep, consciousness, handedness), Brain research, Clinical neurology, Clinical research, Clinical trials, Developmental neurobiology, Mental disorders, Mental health, Neurobiology, Neurochemistry and neuropharmacology, Neurosciences (including psychophysiology), Psychiatric disorders, Psychiatric disorders (e.g. schizophrenia, autism, Tourette's syndrome, obsessive compulsive disorder, depression, bipolar disorder, attention deficit hyperactivity disorder), Psychiatry, Public health, Substance abuse
**last synced at:** 2026-11-09T17:23:17.403+00:00

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