Wellcome Mental Health Award: Transforming early intervention for anxiety, depression and psychosis in young people

Wellcome Mental Health Award: Transforming early intervention for anxiety, depression and psychosis in young people is sponsored by Wellcome Trust. Funding for projects that robustly test the real-world effectiveness and assess implementation strategies of scalable transformative early interventions for anxiety, depression and psychosis in young people.

Lead applicant career stage:Administering organisation location: Anywhere in the world (apart from mainland China) £200,000 for the Foundation Phase and £5 million to £8 million for the Impact Phase 12 months for the Foundation Phase and up to 5 years for the Impact Phase ## This award is structured in two phases: ### Foundation Phase (open to applications week commencing 28 July 2025) This first phase of the funding call will provide teams with £200,000 to build their teams and develop their detailed proposal for their research study over 12 months.

We expect to make around 20 awards in the highly competitive Foundation phase of this funding call. This research proposal must be for a definitive effectiveness study and assessment of strategies for implementation and scaling of a psychological and/or a social intervention. The research must take place in the UK or a low- and middle-income country (LMIC).

The proposal must capture multiple outcomes that are relevant to people with lived experience and implementing partners, including mental health outcomes, functional outcomes and full economic evaluation.

Projects will be chosen for the Foundation Phase based on: * the existing evidence of efficacy for the intervention * potential for being taken to scale, with the cost of the intervention low enough to be sustainable in the proposed context * potential for sustainable partnerships between research teams and implementing partners * outline plans for real-world testing of the effectiveness and implementation of the intervention Teams taking part in the Foundation Phase will be invited to be part of a community of practice to participate and share learning in key areas relevant to developing, implementing and scaling psychological and/or social interventions.

Wellcome will provide support to teams during the Foundation Phase as they develop their research proposals. ### Impact Phase (open to applications February 2027) In the second phase of the funding call, all funded teams from the Foundation Phase will be invited to apply for the Impact Phase. We expect the award amount for the Impact Phase to be between £5 million and £8 million and the duration to be up to 5 years.

The upper limits will be confirmed during the Foundation Phase. * Include the necessary research expertise, technical skills and organisational support to deliver the proposed research.

Team expertise should be diverse and interdisciplinary for: * supporting the generation of evidence for real-world effectiveness * conducting a full economic evaluation * assessing implementation and scaling strategies of interventions * Be led by an experienced researcher due to the size of the Impact Phase award.

We are committed to ensuring the involvement and development of early-career researchers as part of these awards and require one early-career researcher be named as a coapplicant. Early-career researchers must have completed a PhD or equivalent research degree, or if a researcher in the humanities or social sciences have at least four years' equivalent research experience.

They should have no more than three years of postdoctoral experience. The rest of the team can include researchers at any stage of their career. * Include implementation partners.

At least one implementation partner must be included as a coapplicant. Implementation partners are key stakeholders who enable the implementation of the intervention in the intended context. They are individuals with the authority to impact or make decisions regarding implementation and scaling.

This could be either inside or outside of health systems. This is not an exhaustive list and more than one implementation partner may be essential for your project.

Implementation partners can include individuals from: * national or local government agencies * private sector providers * non-government organisations * international organisations * Include either a lead applicant or coapplicant based in each country where the research will take place. * Be an appropriate size for the proposed project.

Teams must consist of at least three applicants (lead applicant and two coapplicants) and must not exceed twelve applicants (lead applicant and eleven coapplicants). There is no limit on the number of collaborators. * Include people with lived experience of mental health problems as part of the project team.

This may include, but is not limited to: * Must include the skills needed within the overall team to effectively involve and collaborate with lived experience experts. * Have the experience needed to lead the development of a collaborative, large scale research project of an intervention, ensuring the necessary support structures are in place for this.

* Have experience of, or demonstrate commitment to, effectively leading a team that embeds lived experience expertise, as relevant to the research project. * Have a permanent, open-ended or long-term rolling contract, or the guarantee of one, for the duration of the Foundation Phase and Impact Phase awards. The contract should not be conditional on receiving this award.

Lead applicants with less than three years remaining on their contract at the point of application must have secured their next position at an eligible organisation and provide a letter of support from them. * Be able to demonstrate why they are the best person to lead the research.

We will only consider lead applicants based outside the country where of the proposed research is taking place if there is a clear justification for their leadership. * Be able to contribute at least 20% of their research time to this project. If the applicant does not have protected research time, they must be able to contribute 20% of their time to this award.

Coapplicants can be based at the same or different organisations as other applicants, including in different countries. Researchers can be at any career stage and come from any relevant discipline, but at least one coapplicant must be an early-career researcher. At least one coapplicant must be an implementation partner.

* Be essential for the delivery of the project and make a significant contribution. For example, in designing the proposed research or leading a specific component of the project. * Have a guarantee of space from their administering organisation for the duration of their commitment to the project.

They do not need to have a permanent, open-ended or long-term rolling contract. * Be able to contribute at least 10% of their research time. Coapplicants who do not have protected research time and implementation partners who are coapplicants must be able to contribute at least 10% of their time to this award.

Collaborators are distinct from coapplicants. Collaborators support the delivery of the project but don't lead on a specific component of the project.

For example, collaborators could support by: * providing access to resources, such as datasets and clinical records sharing subject-specific knowledge and guidance * providing feedback through the research process based on their specific expertise Collaborators are not paid for their input but you can request costs for their expenses.

Collaborators are not assessed for eligibility and they are not required to give a minimum time commitment to the award. Read about the different applicant roles at Wellcome. ### If you’ve spent time away from research #### Career breaks, parental leave, sick leave You can apply for this award if you have spent time away from research (for example, for a career break, parental leave or long-term sick leave).

We will take this into consideration during the review of your application. Lead and coapplicants can be part-time. Part-time applicants should still be able to contribute at least 20% of their research time to the project if a lead applicant and 10% if a coapplicant .

Applicants who do not have protected research time and implementation partners must be able to contribute at least 20% of their time to the award if a lead applicant and 10% if a coapplicant. Their part-time work should be compatible with delivering the project successfully. You cannot apply for this call if: * You intend to carry out activities which involve the transfer of funds into mainland China.

* You cannot demonstrate that you can dedicate enough time and resources to the project, if funded. * You are already an applicant on two applications for this funding call: * You can only be a lead applicant on one application and a coapplicant on another one. * You can be a coapplicant on two applications.

* You must demonstrate that you have sufficient capacity for both projects if funded. The applications should be for different projects with no overlap of activities. * You already have applied for, or hold, the maximum number of Wellcome awards for your career stage.

Find out how many Wellcome awards you can apply for, or hold, at one time depending on your career stage. * Your proposed research does not fit the aims of this award. Check if your research is right for this call.

## Is your organisation right for this call? The administering organisation can be based anywhere in the world apart from mainland China. However, the research must take place in the United Kingdom and/or low- or middle-income countries (LMICs).

At the Foundation Phase, the administering organisation must be one of the following: * higher education institution * healthcare organisation * not-for-profit or non-governmental organisation Multilateral organisations can apply. Please contact usto discuss further. Proposals must meet all funding call requirements.

Commercial organisations cannot be the administering organisation. We recognise the important role commercial partners may play in developing and scaling interventions and welcome them as coapplicants and collaborators.

If you are funded through the Foundation Phase and there is a strong rationale for a commercial organisation to be the administering organisation at the Impact Phase, you will have an opportunity to inform us of this at the next phase.

#### Collaboration agreements If the application involves a collaboration or partnership between multiple organisations, the partners must enter into a suitable collaboration agreement, including provisions that cover: * access to background intellectual property * ownership of foreground intellectual property * arrangements for the protection, management and exploitation of foreground intellectual property The lead applicant’s administering organisation is required under our grant conditions to own all the foreground intellectual property arising from the project and to take the lead in any commercialisation activity.

For guidance, read Wellcome's intellectual property policy. ### Your research environment Wellcome believes that a diversity of people and expertise leads to richer understanding and more impactful discoveries. Excellent research happens in environments where people from all backgrounds are treated with respect, are supported and enabled to thrive.

Our definition of a research environment is not limited to the quality of the infrastructure, but also considers the culture and behaviours that create excellent research practice. This includes research that is inclusive in design and practice, ethical and engaged with relevant community stakeholders, as well as open and transparent.

This is an important requirement for Wellcome funding, and it will be assessed at the Impact Phase but not the Foundation Phase. Read guidance on how to talk about research environment in your application. ## Is your research right for this call?

There are hundreds of millions of people being held back by mental health challenges across the globe. The majority of mental health problems start in adolescence or early adulthood. We are looking for interventions that can reach large numbers of people in a low-cost and sustainable way.

### What your proposal must include Your Foundation Phase project proposal must: * be a **psychological and/or social intervention** * focus on early intervention for **anxiety, depression and/or psychosis** * be targeted at**young people**, between the ages of 10 and 30 * have one or more clear **active ingredients** identified for how the main components of the intervention produce a therapeutic effect * have **existing robust evidence for efficacy** in the same broad age group, the same condition and the same mode of delivery that is being proposed for this funding call * have an outlined pathway to **implementation at scale** #### **Psychological and/or social interventions** This funding is focused on psychological and/or social interventions only.

We define these terms broadly and consider in scope any intervention targeting improvements in a person’s mental health by changing their cognitions, emotions or behaviours by influencing psychological processes and/or interventions targeting social connections or social determinants of mental health.

Psychological and/or social interventions can be delivered: * through any mode, including face-to-face, telehealth, mobile apps and online platforms * using any method, such as individual therapy, group therapy, community-based and peer support or a policy initiative * delivered in any setting, for example, within a school, community, healthcare service #### **Mental health conditions in scope** This funding call invites proposals targeting early intervention for anxiety, depression and psychotic disorders.

This includes: * all types of anxiety (including obsessive-compulsive disorder and post-traumatic stress disorder) * all types of depressive disorders (including post-natal depression) * all forms of psychotic disorders (including schizophrenia, postpartum psychosis and bipolar disorder) We recognise the flaws, complexity and overlap inherent in current diagnostic categories.

Therefore, proposals may focus on specific symptoms, including transdiagnostic symptoms that cut across traditional diagnostic boundaries and are shared by multiple disorders. This approach allows for innovative pathways to understanding and treating mental health conditions.

While we do not prescribe any specific diagnostic or classification system, applicants are expected to employ a framework and measurement approach aligned with their research aims. A clear rationale for the chosen approach should be provided. #### **Age range in scope** We will consider interventions focused on people aged between 10 and 30, however our priority is to support intervening as early as possible in this age group.

We are particularly interested to fund projects with interventions targeted at people under 18. We are including a larger age range to account for the later onset of psychosis and recognising that there are often delays in identifying and diagnosing mental health problems, particularly in low- and middle- income countries. #### **Active ingredients** Research proposals must identify the **active ingredient(s)** of the intervention.

If it is a complex, multi component intervention, the active ingredient of each component must be identified. An active ingredient refers to the specific element or component within the intervention that is responsible for its intended effects.

It is the part of the intervention that directly contributes to achieving the desired outcome or change, such as a specific therapy technique, a particular educational strategy, or a behavioural or social modification method. This builds on Wellcome’s active ingredients commission which was focussed on youth anxiety and depression.

The active ingredient can either have been empirically demonstrated or have a strong theoretical foundation. You must include a logic model with your application that identifies the active ingredient. This should be uploaded as additional information to support your application.

#### **Evidence for efficacy** This funding call is not designed to develop new interventions. We want to fund the robust evaluation and scaling of existing interventions where efficacy has already been shown. We define efficacy as the ability of an intervention to produce its intended effects under controlled and ideal conditions.

As a minimum, interventions must already have demonstrated efficacy, characterised by: * Success in two or more randomised controlled trials or other rigorous study design suitable for social interventions such as quasi-experimental studies or comprehensive observational research.

These must include: * efficacy data in the same broad age group and mental health condition * at least one study to demonstrate efficacy of the intervention using the same mode (for example, including face-to-face, telehealth, mobile apps and online platforms) and delivery method (for example, individual therapy, group therapy, community-based and peer support) as the current application.

* Evidence that changes in standardised mental health or functional outcomes are attributable to the intervention, supported by careful design and analysis to minimise external variable influence. Proposals can be based on adapting the intervention to a different geographical or contextual setting, a different dose or be delivered by a different workforce to the existing efficacy data.

Proposals will also be considered if the intervention has already been demonstrated to be efficacious in a real-world setting. The efficacy data must demonstrate a quantifiable impact of the intervention on a validated mental health or functional outcome. This should be both statistically significant and clinically meaningful in line with the priorities of those with lived experience.

Evidence may come from both quantitative and qualitative research. #### **Pathway to implementation and scale** The cost of the proposed intervention must be low enough to be scalable and sustainable in the proposed context.

Proposals must demonstrate how an intervention that has been shown to be effective on a small scale and/or under controlled or well-supported research conditions, will be scaled up and implemented effectively, while maintaining the active ingredient(s) of the intervention. This must include considerations of feasibility related to costs, workforce, time and infrastructure.

You must outline how the intervention will be scaled to reach a greater number of eligible people in more than one setting or type of setting, while retaining its effectiveness. A setting is broadly defined and could be, for example, a school, a healthcare organisation, a community, a city, a town, a village or a country. Implementation partners are key to enable sustainable implementation of the intervention in the intended context.

They are individuals with the authority to impact or make decisions regarding implementation and scaling. This could be either inside or outside of health systems.

Some examples of implementation partners may include (this list is not exhaustive): * national or local government agencies * private sector providers * non-government organisations * international organisations Implementation partners should be engaged throughout the project lifecycle, including developing the research questions and designing the implementation strategies.

Co-development of the project with implementation partners ensures that the research is relevant to their needs and priorities, making it more likely that the intervention will be taken up and scaled. The project proposal must identify how the Foundation Phase will be used to consolidate and further develop relationships between research teams and implementation partners, to build and maintain long-term sustainable partnerships.

It must detail the team’s plans for co-designing a robust project plan for the Impact Phase. Where there are gaps in team skills and expertise relevant to the project delivery, the funding proposal must outline how the Foundation Phase funding will be used to address them. Sustainable partnerships are built on shared goals, mutual respect, and genuine commitment to achieving a common vision.

The nesta partnership toolkit provides guidance on building sustainable partnerships. We expect fairness and equity to be considered in all partnerships and we use the UKCDR definition of an equitable partnership, “partnerships in which there is mutual participation, mutual trust and respect, mutual benefit and equal value placed on each partners’ contribution at all stages of the research process”.

These resources provide guidance on how to approach equitable partnerships in different aspects of a research project: * the UKCDR & ESSENCE Equitable Partnerships Resource Hub * A Global Code of Conduct for Equitable Research Partnerships * consensus statement on measures to promote equitable authorship in the publication of research from international partnerships The Foundation Phase can include: * sustainable partnership building and engagement activities with researchers and implementation partners * training and skills development (including research skills and formal qualifications/credit bearing courses if relevant) * developing meaningful lived experience involvement plans * landscaping activities that assess the local context to understand the social, economic, and cultural environment and map available resources * theory of change workshops for intervention implementation and scaling * co-design of the project plan for real-world testing of the intervention * co-development of the intervention’s pathway to implementation and scaling * networking and knowledge exchange activities Proposals at the Foundation Phase must include an outline for a definitive effectiveness study.

We recognise that measuring both clinical symptoms and functioning are crucial to assessing the effectiveness of an intervention. You must therefore incorporate at least one measure of functioning such as (but not limited to) work, school or relationships into your project plan. The measure must be relevant to people with lived experience and implementing partners.

This work must also comply with our policy on research involving human participants. Randomised Controlled Trials (RCTs) are considered gold standard. However, there may be practical and ethical reasons why an RCT is not the best method to test the effectiveness of an intervention under real-world conditions.

Other robust methods that measure trends over time may be more suitable in some circumstances.

Examples of acceptable evidence for effectiveness and implementation include: * RCTs (hybrid effectiveness-implementation trials, stepped wedge design, cluster randomised trial, adaptive design) * strong comparison group designs * regression discontinuity * difference in difference * mendelian randomisation Projects must include an outline plan for a full economic evaluation of the intervention with justification given for the proposed method.

Full economic evaluations compare the costs of at least two competing options (for instance, a new intervention versus the existing standard of care) to determine the additional cost of one intervention over another or the existing standard of care and the gains to society of that additional cost.

Gains to society might include: * better healthcare outcomes * improved quality of life * increased productivity in the workforce * better educational outcomes * reduced healthcare costs The 12-month Foundation Phase funding should be used to further develop research plans in collaboration with implementation partners.

Proposals must involve people with lived experience of anxiety, depression and/or psychosis, relevant to your research topic. There are a range of ways that research teams can involve and collaborate with lived experience experts.

This may include, but is not limited to: Lived experience experts should be engaged as colleagues who use their knowledge and expertise to inform the strategic direction, governance, design and delivery of the research. Lived Experience experts should be based out of or be familiar with the local context where the research is taking place.

They must be involved in appropriate and ethical ways to inform multiple aspects and stages of the research project. Their contribution should not be limited to recruitment and retention strategies. You should budget for and compensate people who provide lived experience expertise appropriately to their role and the scale of the project.

### Type of research that is not right for this call Research proposals that are **not** right for this call: 1. Include conducting significant primary research during the Foundation Phase. The major primary research component should be reserved for completion during the Impact Phase.

2. Primarily target neurodevelopmental conditions, neurodegenerative diseases, or mental health disorders and symptoms outside of the broad categories of anxiety, depression, and/or psychosis. For example, proposals with eating disorders or substance abuse as the primary focus of the research are not in scope.

3. Include research that takes place in countries outside of the United Kingdom or low- or middle- income countries. 4.

Focus solely on general well-being rather than validated mental health outcomes or symptoms of anxiety, depression and psychosis. 5. Focus solely on exploratory or curiosity-driven mechanistic research that is not directly relevant to the scope of the call.

6. Include an intervention that: * Is not primarily a psychological and/or social intervention. * Lacks theory and some understanding of its active ingredients.

* Does not have efficacy data provided by at least two studies. * Is intended for universal/primary prevention. * Is not focused on reducing symptom severity and/or functional impairment.

* Solely focuses on diagnosis, prognosis or monitoring of symptoms. These may be an additional focus where the primary focus of the intervention is treatment. * Does not demonstrate the potential for scalability.

* Relies entirely on artificial intelligence systems to make predictions and provide recommendations, without transparent insight into how those predictions are made. * Is solely for tracking and/or supporting self-management of symptoms of mental health conditions with no other psychological or social interventional component. Read about what research we fund in mental health.

## How applications are assessed Proposals submitted at the Foundation Phase must include an outline plan for the Impact Phase comprising: * plan for assessment of the effectiveness of the intervention * completion of a full economic evaluation * testing of strategies for implementation and scaling Funding proposals must detail how the 12-month Foundation Phase funding will be used to build sustainable partnerships and co-develop a full project plan for the Impact Phase.

Nine months after the start of the Foundation Phase, funded teams will be invited to submit a research proposal with details of the work packages that will be carried out during the Impact Phase. Where relevant, Impact Phase applications should also indicate if initial plans and team have changed or evolved based on the outcomes of the Foundation Phase.

Teams will have approximately 3 months to submit their applications for the Impact Phase and more detailed guidance will be provided to assist them in this process. All applications for the Foundation Phase will be evaluated using the weighted assessment criteria. Applications will be reviewed by a panel of experts, including lived experience experts and an international youth panel.

### Essential criteria and weightings There are five weighted assessment criteria for applications to the Foundation Phase: 1. #### strength, scalability and sustainability of the intervention (30%) 2. #### suitability of the proposed methodology (20%) 3.

#### suitability and expertise of the team (20%) 4. #### lived experience involvement (20%) 5. #### review by a youth panel (10%) #### 1.

Strength, scalability and sustainability of the intervention (30%) * Strong justification that the intervention can be taken to scale, with the cost of delivery of the intervention low enough to be sustainable in the proposed context and evidence of acceptability to end users (including young people). * Evidence for efficacy of the intervention is rigorous and well-described.

There is a demonstrated quantifiable impact of the intervention on a validated measure of mental health or functioning. This will be both statistically significant and clinically meaningful in line with the priorities of those with lived experience.

* Strong evidence demonstrating the active ingredient(s) of the intervention, the quality of the intervention logic model and articulation of how these will be maintained when delivering the intervention at scale #### 2. Suitability of the proposed methodology (20%) * Clear strategies for developing sustainable partnerships with implementation partners ensuring effective co-production of the research and the pathway to impact.

A clear rationale is provided for the activities and assurance that they can be delivered effectively within the available resources and timeframe during the Foundation Phase.

* For the proposed research in the Impact Phase, the plans include outlines of the methodology for: * assessing the intervention’s real-world effectiveness with outcomes that are relevant to people with lived experience and implementation partners, including mental health outcomes and functional outcomes * evaluating implementation and scaling strategies, using a validated theoretical or conceptual framework, encompassing robust study design and implementation outcomes.

* a full economic evaluation of the intervention #### 3. Suitability and expertise of the team (20%) The project features an integrated, collaborative plan of work, developed by a team that includes those with the appropriate research expertise as well as implementation partners. * Has clearly identified implementation partners, at least one of whom is a coapplicant, with a rationale and plan for the role of implementation partner(s).

* Is composed of individuals with the necessary expertise and technical skills, alongside a diversity of disciplines and perspectives. Plans are in place to obtain any missing expertise during the Foundation Phase, where relevant. * Provides evidence of existing implementation partner relationships through letters of support, with plans to strengthen, expand and include new partners where relevant.

* Has appropriate management plans in place, describing the equitable organisation and day-to-day management of the collaboration. * Includes lived experience experts or possesses the skills to effectively involve and collaborate with people with lived experience of mental health problems.

* Includes at least one early-career researcher as a coapplicant on the award * Possesses the necessary experience to deliver both the Foundation and Impact Phases of the project.

This will include: * the ability to build sustainable, meaningful collaborations across multiple partners * evidence of capability to lead a large-scale, collaborative research project, within budget and within time * the necessary support structures in place to enable them to have the time and support to deliver the project * hold(s) the expertise, time and resources essential to make significant contributions to the project #### 4.

Lived Experience Involvement (20%) * People with lived experience are meaningfully involved at multiple stages, including the conception, planning, design, delivery and dissemination of the proposal. There is a clear rationale for their inclusion (or exclusion) at each stage.

* Where necessary, the project includes a comprehensive strategy to equip people with lived experience with the essential knowledge and skills needed for meaningful participation. * Lived experience perspectives are represented across the proposal, including in the team’s leadership and governance roles.

* Lived experience experts have relevant experience and expertise applicable to the research, including being representative of the research location. * People with lived experience are compensated appropriately for their time and labour. #### 5.

Review by a youth panel (10%) The final 10% of the weighted assessment will come from an international panel of young people. As the call is focused on interventions for young people, it is important that their perspectives are included in decision making. Young people will be asked to review the plain language summary of the intervention that must be uploaded with your application.

Young people will be asked to share their assessment of: * the clarity of the intervention and its underlying mechanisms * acceptability of the intervention to young people * barriers that would significantly hinder youth participation in the intervention and how these will be addressed ## Research costs we’ll cover Each successful team will receive a grant of £200,000.

Please complete the application budget section outlining how you would allocate these funds across the activities proposed. The total must add up to £200,000 (or equivalent if applying in a different currency). You must contribute at least 20% of your research time to