Mental Health Award: Accelerating scalable digital mental health interventions

Mental Health Award: Accelerating scalable digital mental health interventions is sponsored by Wellcome Trust. This funding call from Wellcome aims to accelerate the development and evaluation of scalable digital interventions for early intervention in depression, anxiety, and psychosis.

### This scheme is now closed Administering organisation location: Anywhere in the world (apart from mainland China) £3 to 7 million per project ## Upcoming application stage Calculating next key date… Application process timeline This is a funding call for team awards. Applications must include a lead applicant and coapplicants.

The award will be held by a lead applicant from an eligible administering organisation, on behalf of a team of coapplicants. Wellcome cannot make awards to teams with co-lead applicants. The team (lead and coapplicants) must include: * The research expertise required to drive the proposed research, as lead and/or coapplicants.

* At least one individual from an organisation that can take the intervention to scale (company or not-for-profit) listed as an applicant (lead or coapplicant). The organisation must be able to demonstrate that they have the expertise and ability to take the intervention to scale.

Indicators include but are not limited to: * previous track record of the organisation or of key personnel including successful fundraising appropriate to the aims, stage and size of the organisation (this does not need to be in the field of mental health) * business plan (should include a sustainability plan for the product) * demonstrated links to suitable development partners and relevant networks (for example, letters of support or evidence of previous collaborations) * People with lived experience of mental health problems.

This can be as lead applicants, coapplicants and/or team members. The overall team should also include the skills needed to effectively involve and collaborate with lived experience experts. * Justification for the inclusion of each applicant on the proposal.

* The necessary expertise, technical skills and organisational support to deliver the proposed research. This should be multidisciplinary where appropriate, for example, expertise in mental health, lived experience, data science, implementation science, ethics, social science or clinical trials. * Coapplicants based in each country where the research will take place.

If the proposed research is planned to take place only in a low- or middle-income country, the lead applicant must be affiliated with an eligible organisation based in that country. * An appropriate number of team members to deliver the proposal within the timeframe. This will depend on the proposed research.

Teams must consist of at least two applicants (including the lead applicant) and will typically not exceed eight applicants (excluding collaborators). There is no limit to the size of overall team (for example, including staff, sub-contractors or collaborators). The team (lead and coapplicants) can include multiple researchers as required for the proposed research.

Researchers may be embedded in a company, not-for-profit or a separate entity such as a higher education institution. We encourage lead applicants to put together diverse teams that include coapplicants at any stage of their career, including those who are new to the field of mental health science.

We do not require applications to include a UK or other high-income country partner and do not prioritise such applications over those that only include low- or middle-income country (LMICs) partners. * Have experience in people and research management, as appropriate for their career stage.

* Have the experience needed to lead and drive a collaborative, large-scale research proposal and/or the necessary support structures in place to enable this. * Have experience of, or demonstrate commitment to, effectively leading a team that embeds lived experience expertise, as relevant to the research proposal. * Have a permanent, open-ended or long-term rolling contract (or the guarantee of one) for the duration of the award.

The contract should not be conditional on receiving this award. * Be able to contribute at least 20% of their research time over the course of the award. If the lead applicant does not have protected research time, they must be able to contribute 20% of their time to the award.

The lead applicant’s administering organisation is required under Wellcome's grant conditions to own all the foreground intellectual property arising from the project and to take the lead in any commercialisation activity. For guidance, applicants are advised to read Wellcome's intellectual property policy.

* Be essential for the delivery of the proposal and make a significant contribution, for example, in designing the proposed research and leading a specific component of the proposal. The specific involvement of coapplicants should be justified in the application. * Demonstrate the team’s commitment to effectively embed lived experience expertise, as relevant to the proposed research.

* Have a guarantee of workspace from their administering organisation for the duration of their commitment to the proposal, but do not need to have a permanent, open-ended or long-term rolling contract. * Be able to contribute at least 20% of their research time over the course of the award. If the coapplicant does not have protected research time, they must be able to contribute 20% of their time to the award.

* Be based at an eligible organisation such as a higher education institution, not-for-profit organisation or company (which can include a sole trader or self-employed person's business). * based in the same or in different organisations Collaborators are distinct from coapplicants as they will support the delivery of the proposed research but will not lead on a specific component of the research.

For example, collaborators could provide technical, clinical or subject-matter expertise. They could also provide access to tools or resources, such as datasets, clinical records, or organisations led by or collaborating with lived experience experts. 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 work (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.

If you have retired, you must have a guarantee of workspace from your administering organisation and you must contact us before applying. Lead and coapplicants can be employed part-time. There is no formal minimum, but part-time applicants should still be able to contribute at least 20% of their time to the proposed research and their part-time work should be compatible with delivering this successfully.

You should not apply for this call if: * Your team does not include the research expertise required and an individual from a company or not-for-profit in the applicant team (as lead or coapplicants). * Your team does not include lived experience experts as lead applicant, coapplicants or team members. * You intend to carry out activities that involve the transfer of funds into mainland China.

* You cannot demonstrate that you can dedicate enough time and resources to the proposed research throughout the award. * You are already an applicant on two applications to this funding call. You cannot be an applicant on more than two applications.

* You can only be a lead applicant on one application. You could then be a coapplicant on a second application. * If you are not a lead applicant, you can be a coapplicant on two applications.

* If you are an applicant on two applications, you must demonstrate that you have sufficient capacity for both awards if both are funded. * 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 what kinds of research aren’t right for this call. ## Is your organisation right for this call?

An administering organisation is an eligible organisation that formally submits the application to Wellcome and is responsible for administering funding if the proposal is awarded. This is the organisation where the lead applicant is based. ### Where your administering organisation is based The administering organisation can be based anywhere in the world except mainland China and can be a: * Higher education institution.

* Non-academic healthcare organisation. * Not-for-profit or non-governmental research organisation. * Company or not-for-profit organisation.

Organisations must be legally incorporated. If your application is successful and your organisation has not previously received funding from Wellcome, a further financial assessment may be required. Wellcome will not pay for working capital costs of commercial organisations.

When we fund companies, we may fund through a Programme-Related Investment (PRI). Funding may need to occur through a convertible loan or revenue sharing agreement to ensure public benefit. Wellcome will communicate this to successful applicants.

We do not prioritise any type of organisation over another for our funding. We use the assessment criteria on this page to identify the most competitive proposals. ### What the administering organisation must do The administering organisation is required under our grant conditions to own all the foreground intellectual property (IP) arising from the project and to take the lead in any commercialisation activity.

Wellcome does not directly own or co-own IP arising from its research funding. For guidance, applicants are advised to read Wellcome's intellectual property policy. The administering organisation must: * Give the applicant the workspace and resources they’ll need for the duration of the award.

* If based in the UK, meet the responsibilities required by the Concordat to Support the Career Development of Researchers. If based outside the UK, at a minimum the organisation must follow the principles of the Concordat.

* Give you, and any staff employed on the grant, ten days a year (pro-rata if part-time) to undertake training and continuing professional development (CPD) in line with the Concordat to Support the Career Development of Researchers. * Provide a system of onboarding, embedding and planning for when the applicant and team member(s) join the organisation and/or start the award.

* Provide you with the status and benefits of other staff of similar seniority.

#### Collaboration agreements When entering 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 outputs arising from the award including foreground intellectual property * arrangements for protecting, managing and exploiting outputs including foreground intellectual property ### Your research environment #### What is a research environment?

Wellcome believes that involvement of 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, supported and enabled to thrive.

Our definition of a research environment is not restricted 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. ## Is your research right for this call?

1. **evaluate and further develop new or improved digital mental health interventions** which are designed for large-scale implementation for early intervention in anxiety, depression or psychosis and 2.

**create or further develop collaborative partnerships** between researchers, lived experience experts and organisations that can take the interventions to scale (whether a company or not-for-profit) ### Interventions this funding will support This funding call will support the evaluation and further development of software and/or artificial intelligence intended to be used for the treatment of symptoms of anxiety, depression or psychosis or for the reduction of functional impairment.

This includes but is not limited to web-based programmes, mobile applications, applications of generative AI, chatbots, extended reality, wearable devices or video games. In scope are interventions which: * Are designed to lead to reductions in symptom(s) and/or functional impairments. * Can be new or improved.

“Improved” examples include, but are not limited to, an intervention that has been adapted (for example, language or cultural) to improve reach or accessibility; can be better targeted (due to better understanding of mechanism or aetiology); is more sustainable; is more cost-effective; and/or has fewer side effects.

* May range from provider-administered used with intermittent/regular practitioner guidance, self-guided with human support to self-guided and fully automated. * Are standalone or integrated (blended) with other treatments (such as with psychological or pharmacological therapy). * Have the individual with mental health problems as the end user.

* Are intended to be implemented in healthcare settings, workplaces, schools, homes or other settings. * Are designed for large scale delivery. * May be designed for children, adolescents and/or adults.

Interventions may also target at-risk groups including but not limited to clinical-high-risk for psychosis or perinatal populations * Offer a competitive advantage in relation to existing options or developments in the field.

We define “early intervention” as an intervention designed to be used as early as possible in the treatment of mental health problems, in a way that reflects the priorities and needs of those who experience these problems. We recognise that ‘as early as possible’ will be context specific.

It may be at the first presentation of symptoms or, in some contexts, especially inlow- and middle-income countries (LMICs), people may be at the earliest point of accessing care so there is no age cut-off. ### Mental health conditions that proposals can address This funding call is focused on proposals that target symptoms of anxiety, depression and psychotic disorders.

This includes: * all types of anxiety and depressive disorders (including obsessive-compulsive disorder and post-traumatic stress disorder) * all forms of psychotic disorders (including schizophrenia, postpartum psychosis and bipolar disorder) We recognise that the current diagnostic categories are imperfect but removing all categories or creating new ones also presents difficulties.

Whilst we do not specify any particular diagnostic or classification system, we expect applicants to use a framework and measurement approach that fits their research aim and to provide a clear rationale for doing so. ### What your research proposal must include Your research proposal must include: **1.

Collaboration between researchers and a company or not-for-profit organisation** Proposals must comprise a team with the research expertise required to drive the proposed research, an organisation which can take the intervention to scale (whether a company or not-for-profit) and lived experience experts.

This is to accelerate the development of scalable evidence-based digital mental health interventions, including in low-resource settings, with a focus on implementation from the start of the project. A researcher is someone with the expertise to develop and evaluate the intervention. The collaboration between researchers and the company or not-for-profit may be new or existing.

We are open to different collaboration models but expect: * Researchers to serve as the analytical leads and have the necessary expertise to design and deliver robust evaluations of the interventions.

* Researchers may be embedded within the company or not-for-profit organisation they are collaborating with, or a separate entity such as a higher education institution, research institute, non-academic healthcare organisation, not-for-profit or non-governmental research organisation. * Intellectual property ownership and sharing plans to be agreed upon at the outset and be in line with the terms of the grant conditions.

* The company or not-for-profit organisation to serve as the downstream or implementation lead, at least initially. If this is not the case, then clear plans for engaging with downstream or implementation partners should be outlined as part of the proposal.

Teams can propose to evaluate interventions which have been developed in any setting including a higher education institution, research institute, non-academic healthcare organisation, not-for-profit or non-governmental research organisation, or company. **2.

****Ability to scale and be sustainable** In this call, we refer to scalability as the potential or ability of an intervention, which has been shown to work on a small scale or under controlled conditions, to be expanded to reach a greater proportion of the eligible population while retaining effectiveness. This will be assessed relative to the stage of development the intervention is currently at.

Proposals should demonstrate or plan to advance the potential for the intervention to be delivered at scale by (as appropriate): * Considering scalability factors and assessing implementation outcomes such as acceptability, adoption, affordability, costs, engagement, integration with existing infrastructure, feasibility and sustainability (even for pilot studies).

* Having evidence of or plans to assess the feasibility of scalability of the intervention based on costs, workforce requirements, time required and infrastructure requirements. Interventions should be tested as close to routine operating conditions and resource constraints to the setting in which the intervention will be scaled up.

* Outlining the regulatory classification, regulatory status and path to approval for the context in which they intend to scale up (at least initially).

* Having already engaged, or a plan to engage, with key stakeholders such as policy makers, technical experts, service providers, national and commercial health providers/systems, school systems, clinicians, community organisations, patient or consumer advocacy groups and faith-based organisations. * Outlining whether the intervention is consistent with national, state or regional policy directions.

* Outlining whether the intervention has the potential to be applicable and acceptable in settings beyond the context of the research. * Considering the necessary technical resources or infrastructure (for example, compute power or cloud computing) required during the research, during scale up and during post-market suveillance.

Proposals should demonstrate or plan to advance the potential for the intervention to be delivered sustainably by (as appropriate): * demonstrating the competitive advantage of the intervention in relation to existing options or developments, particularly in the context in which the intervention is being tested * outlining the subsequent development steps required before the technology could be submitted to regulatory bodies * considering any known clinical, manufacturing, technical regulatory or marketing issues that may affect the ability to deliver the product to market * developing a proposed implementation strategy, including delivery and market penetration, required partners and proposed financial commitment * considering equitable access plans for the assets developed through this research **3.

A minimum viable product and feasibility data** Proposals should propose to progress the development of the intervention to the next translational stage, such as: generating safety, efficacy, effectiveness or real-world evidence data, generating evidence for regulation, or adapting existing interventions (for example, language or cultural adaptation) for new settings or populations.

We expect teams to have both a minimum viable product and feasibility data before applying. The feasibility data should extend beyond data solely focused on how to optimise the digital tool (for example, user experience testing). The feasibility data should be relevant to, and inform, how the proposed research will be undertaken.

We expect the feasibility data to be from the intervention you plan to evaluate on the same condition, symptom(s) and population you are proposing as part of your research. For low- and middle-income country (LMIC) based research we will accept feasibility data generated in a different setting (but must be from the same intervention, condition and symptoms).

Research feasibility data includes but is not limited to: * exploring the feasibility and acceptability of the intervention * feasibility and acceptability of the recruitment and retention process or randomisation of the intervention * the suitability of the outcome measures and patients’ experiences * the calculation of appropriate sample sizes * testing of the intervention in small sample sizes If feasibility data are unpublished, they should be briefly outlined in the proposal.

If you are unclear about whether your feasibility data is sufficient or fits this award, please get in touch with us through the scope check. **4. Plans for evaluating the intervention** Proposals must plan rigorous evaluations of the interventions.

The potential for the research to have a significant and measurable impact on early intervention for anxiety, depression or psychosis must be made clear.

You may employ a range of designs, including but not limited to: * clinical trials (for example, randomised controlled trials, pragmatic trials, cluster randomised trials, stepped wedge designs, factorial trials, adaptive or just in time interventions) * quasi-experimental designs * real-world evidence generation studies * hybrid effectiveness-implementation studies We will fund proposals where the mechanism(s) of action has been identified or a plan to investigate this is proposed.

These may be biological, social, psychological or other. The proposal must include the appropriate measures to assess changes in the mechanism(s) of action (for example, pre- and post-intervention). Proposals must consider appropriate comparators for the translational stage of the intervention and the study design employed.

A clear justification for and description of the comparator arm should be provided, including in the cases where no comparator arm or a placebo arm is proposed. The justification should take into consideration the context in which the intervention will be implemented and the treatments available to end users within that context.

Your proposed research is encouraged to include diverse and underrepresented populations and to employ a mixed-methods approach. **5. Involvement of people with lived experience** Proposals must involve lived experience expertise.

We recognise that there is a range of ways that research teams can involve and collaborate with lived experience experts. This may include, but is not limited to: You should budget for and compensate people who provide lived experience expertise. The budget should reflect the scale and ambition of the proposed research.

**6. Inclusive and safe interventions** We want to fund proposals testing user-centred, ethical and safe interventions where the benefits of the intervention outweigh any risks. The intervention and research design should address (as appropriate): * Data privacy and confidentiality.

* Appropriate safeguards, with clear plans for how safety will be monitored and addressed, including how adverse events such as suicide risk and symptom increases will be identified, managed and reported. This applies to both the proposed research and once the tool is implemented at scale.

* Wherever possible, acknowledging in-built biases with respect to AI and detailing any mitigation strategies, including how they will be communicated to participants. * Ethical considerations, such as accessibility of the intervention to different groups. * Possible unintended consequences of the intervention.

* Plans for how engagement with the intervention will be measured and reported (for example, uptake, usage, adherence, completion and satisfaction). Plans for measuring challenges with sustained engagement should also be included, including an assessment of reasons for lack of engagement or dropout.

* How to build trust between the end user and digital tool in a responsible and inclusive manner throughout the development and evaluation of the intervention. **7.

One or more of our recommended common measures** ### Kinds of research that are not right for this call Research that is not right for this call includes proposals that: * Have a primary focus on symptoms of neurodevelopmental conditions, neurodegenerative diseases, or mental health problems outside of the broad categories of anxiety, depression and/or psychosis (for example, eating disorders or substance abuse).

* Involve participants without mental health problems as the sole focus of the proposal. * Lack a hypothesised mechanistic understanding/mechanism of action. * Are not focused on reducing symptom severity and/or functional impairments.

* Involve teletherapy as the sole focus of the intervention. * The sole focus of the intervention is on diagnosis, prognosis or monitoring of symptoms. These may be an additional focus where the primary focus of the intervention is treatment.

* Consist of one-way information-sharing interventions. * Do not demonstrate the potential for scalability. * Are intended for prevention whether universal/primary prevention.

* Are descriptive studies, including epidemiological. * Involve health systems research around the distribution and uptake of interventions as the sole focus of the proposal. * Focus on direct service provision or support for access to current services (for instance, the delivery of existing services rather than the generation of evidence).

* Are related to healthcare reorganisation. * Have implementation science research as the sole focus of the proposal. * Concentrate on exploratory or curiosity-driven mechanistic research that is not directly relevant to the scope of the call.

* Only include qualitative work. * Do not comply with Wellcome’s research environment principles of open science and relevant diverse inputs. * Do not propose inclusive and safe interventions.

Digital interventions offer immense potential for mental health. They can provide scalable and accessible solutions to mental health problems, offering personalised and convenient care while widening access to treatments. However, availability of evidence-based digital mental health interventions at scale are still limited.

In preparation for this funding call, Wellcome commissioned a series of scoping activities to explore the landscape of digital mental health interventions and how we can help to advance progress in this field. These scoping activities identified several barriers which might contribute to the lack of interventions delivered at scale.

* **Limited collaboration**: There is a lack of collaboration between researchers and organisations who can take interventions to scale such as companies and not-for-profit organisations. Bringing these stakeholders together is necessary to: * Deliver evidence-based scalable interventions by bringing together the necessary expertise and skills that each party possesses.

This includes robust scientific development and evaluation by researchers and consideration of sustainable uptake and commercialisation by scale-up partners. * Find a sustainable business model: The pathway to market for a digital mental health intervention is unclear, with few solutions overcoming regulatory hurdles and achieving wide-scale delivery.

Market uncertainties including fluctuating investment levels, economic conditions and technological advancements further hinder the development and reach of interventions. These challenges are even greater in low-resource settings, where intermittent access to digital technologies, stigma and affordability lead to an even more fragmented ecosystem for developers.

Read our report on how to create better research environments to drive progress in digital mental health.

* Support uptake and implementation within healthcare or other systems: Understanding the needs of the relevant systems and how a solution will meet these needs, navigating procurement processes integrating solutions with existing care and IT systems and ensuring uptake by healthcare professionals and end-users poses significant challenges.

Read our report on how to create better research environments to drive progress in digital mental health. * **Insufficient involvement of lived experience:** Many interventions lack meaningful engagement with individuals with lived experience, resulting in reduced acceptability and uptake of their interventions. Read our report on involving lived experience in the research and development of digital mental health interventions.

* **Limited development of tools in****low- and middle-income countries (LMICs)****:** Despite the opportunity that digital technology presents to provide care in low-resource contexts, there is a scarcity of digital tools being developed and implemented in low- and middle-income countries (LMICs). Most tools in these contexts are still in the early stages of development (for example, pilot or feasibility trials).

Read our landscaping report on digital mental health in low- and middle-income countries (LMICs). To overcome these barriers and advance progress towards evidence-based, scalable digital interventions, collaboration between stakeholders across the ecosystem is crucial.

With this funding call, Wellcome aims to: * facilitate long-term collaboration between researchers, organisations (companies and not-for-profits) that can bring these products to scale and lived experience experts * support more widespread involvement of individuals with lived experience in the evaluation of mental health interventions * foster the development of scalable interventions, including those suitable for low-resource settings or populations with reduced, shared or intermittent access to digital technologies * support robust evaluations to build a stronger evidence base of effective interventions * assist developers and researchers in establishing the necessary relationships for wide-scale implementation, navigating regulatory pathways and creating sustainability plans for their interventions ## Research costs we'll cover You can ask Wellcome to pay for: If you are based in the UK or Republic of Ireland at a higher education institute (HEI), research institute or non-academic healthcare organisation, you cannot ask for your salary.

If you are based at a charity, non-governmental organisation (NGO), social enterprise, not-for-profit or a company, you can ask for a contribution to your salary, equal to the time you will spend on the award.

If you are based outside of the UK or Republic of Ireland, you can ask for a contribution to your salary if you hold a permanent, open-ended or long-term rolling contract that states that you have to get your salary from external grant funding. The amount we pay will be proportionate to the time you contribute to the award, for example if you contribute 30% of your time to the award we will fund 30% of your salary.

You will have to contribute at least 20% of your research time to this award. Your administering organisation must confirm: * that your employment contract states you must get salary recovery from external grant funding * that they will underwrite the salary and post for the period of time that you will be working on the grant Coapplicants must contribute at least 20% of their research time to this programme.

If any coapplicant employed on your grant holds a permanent, open-ended or long-term rolling contract that states that they have to get their salary from external grant funding, you can ask us for a contribution to their salary in your application. The amount we pay will be proportionate to the time they contribute to the award, for example if they contribute 30% of their time to the award we will fund 30% of their salary.

Your host organisation must confirm: * that the coapplicant’s employment contract states they must get salary recovery from external grant funding * that they will underwrite the post, including any salary costs not covered by Wellcome, for the period of time that the person will be working on the grant Coapplicants can also ask for salary where they: * Are employed by a charity, non-governmental organisation (NGO), not-for-profit social enterprise or commercial organisation.

The amount they request must be proportionate to the time they will spend on the grant. * Don’t have a permanent, open ended or long-term rolling contract and they: * Will spend 80% of their time on this grant. In this case, they can ask for their full salary.

Their post does not need to be underwritten and can be contingent on the application being successful. * Will spend less than 80% of their time on the grant. In this case, they can request salary proportionate to the