As a member of the Common Measures Board for Mental Health Science, Wellcome is committed to identify and adopt common measures so that, in time, data can be combined and compared across studies to answer crucial research questions. Teams planning to conduct research projects with human participants and to collect data on anxiety and/or depression must use (as a minimum) one or more of the following recommended measures:

• PHQ-9 (adults)
• GAD-7 (adults)
• RCADS-25 (children and adolescents)

In exceptional circumstances when these measures are not feasible (for example, due to length), we may agree to the use of shorter versions (for example, PHQ-2, GAD-2, RCADS-10), however, the reasoning for this must be clearly justified.

Please note that we do not currently have an agreed measure for psychosis, therefore, applicants should use the measure(s) that is most appropriate to address their research question.

Applications must demonstrate the involvement of lived experience expertise in the planning, design, and delivery of the research. We recognise that there are a range of ways that research teams can involve and collaborate with people with lived experience. For example, this may include, but not be limited to, expert advisors, coapplicants, collaborators, or advisory group members. We are open to any methods of involvement that teams choose but expect lived experience experts to be involved in the most appropriate ways to inform multiple aspects and stages of the research project. It is key for us is that this is not tokenistic or a tick box exercise.

For further information on what we mean by ‘people with lived experience’, including guidance for meaningful involvement, see the guidance provided.

For translational research, we expect the following to be considered, as is relevant to the proposal:

• the subsequent development steps required leading to regulatory approval
• the key desired attributes of your healthcare innovation
• any clinical, manufacturing, regulatory or marketing issues known that may affect the ability to deliver the product to market
• a downstream partner
• the future implementation strategy, including delivery and market penetration.

Research must consider potential uptake from the outset. For example:

• applicants may engage with potential end users of research, including people experiencing anxiety, depression or psychosis, caregivers/families, clinicians and service managers for future implementation and impact for policy
• applicants may engage with stakeholders, such as policymakers, health care professionals, regulatory bodies and downstream partners, as appropriate, during the research process to ensure results are implementable, scalable, suitable for commercialisation and in line with policy and end users’ needs
• applicants may employ a mixed methods approach and include social science and health economics expertise (as appropriate) to ensure that the interventions are appropriate, acceptable and feasible and that any potential social, cultural or economic barriers to implementation are examined
• proposed research may consider and include measures such as (but not limited to) acceptability, adoption, appropriateness, affordability, costs, feasibility, fidelity, penetrance and sustainability, as relevant.

Below we provide additional guidance to completing various sections in the full application. Please follow these as appropriate for your individual project.

The proposal 

Provide your answer to this question as a PDF attachment. The uploaded document must be no longer than 4000 words* in length, in 11-point Arial font and portrait format.

This document should include:

1. Aims and key deliverables

•  Please include a vision statement that specifies what you are looking to achieve with the funding requested and what you want to achieve in the longer term.
• The specific aims and objectives of the proposed project.

2. Background and justification 

The unmet need and strength of the research question.

• The scientific background to the project.
• The justification for the proposed research, which may include (but is not limited to): your focus on anxiety depression and/or psychosis, the specific population involved and how the research meets the needs of end users.
• Description of how the proposed research will advance knowledge in relation to at least one of the following:
  • Mechanistic underpinning of the bi-directional role of sleep and circadian disruptions in the development and resolution of anxiety, depression and/or psychosis.
  • Identification and/or validation of sleep and circadian markers that enable early stratification of people with anxiety, depression and/or psychosis.
  •  Development of early interventions for anxiety, depression and/or psychosis that target sleep and/or circadian processes and the competitive advantage of such interventions.
• The supporting hypothesis and underpinning mechanism or plan to investigate it.
• Support from existing evidence (for example, existing literature, systematic reviews/meta-analyses, proof of concept data or pilot data as relevant).

The potential for impact. 

• The potential for the research to have a significant and measurable impact on early intervention in anxiety, depression and/or psychosis.
• The potential for different geographical, societal and cultural contexts to impact on the research.
• Please also address:
  • How you will consider the potential uptake of the research from the outset.
  • The potential for the research to have applicability and acceptability in settings beyond the specific context of the research.

3. Details of the planned activities

• An overview of the proposed workplan, clarifying how it will address the research question(s).
• The proposed methodology under each work package.
• Where relevant, please include details on interventions, research design (including trial design), target populations, sample size and power, community and patient group involvement (this can also be included under ‘Additional Information’).
• The outcomes to be measured and the specific sleep, circadian rhythm, mental health, functional and/or quality of life measures and analyses to be used, plus justification. Please indicate if these measures have been validated in the proposed settings or how you propose to validate these.
• The key risk-reducing steps to be addressed and overcome.
• For intervention development, please include a description of the pathway to impact beyond this funding, considering:
  • What subsequent development steps are required?
  • Who the downstream partner could be (which may include further development by the applicant)?
  • Are there any clinical, manufacturing, regulatory or marketing issues known that may affect the ability to deliver the product to market?
  • What would the implementation strategy be, including delivery and market penetration?
  • If you have outlined any regulatory considerations or risks above, show evidence that you are accounting for regulatory requirements in the product development pathway.
  • For projects that do not include a clinical trial you should still outline the likely clinical pathway.
  • Include the target product profile or key desired attributes of your healthcare innovation.
  • How you will consider equitable access to the assets developed through this research.

4. Details of how you will involve people with lived experience

Please include information on how people with lived experience of anxiety, depression and/or psychosis (ideally with the sleep and circadian issues relevant to the research topic) will be involved in multiple stages of the design, delivery, and dissemination of the project. As part of this please explain:

• Your approaches to involvement at each stage of the project in detail.
• How you plan to identify and recruit people with lived experience with the relevant skills to work on the project. As part of this please also clearly state the relevant skills and expertise you are looking for from the people with lived experience you plan to work with.
• How the proposed research is feasible from the perspective of lived experience expertise (for example, recruitment plans are feasible and appropriate, intervention protocol is appropriate, plans for participant retention are suitable, protocol or methodology proposed is inclusive towards under-served groups).

People with lived experience should be appropriately compensated or paid for their time. This information should be included under the “Costs requested and Justification” section, along with any additional costs needed to ensure your lived experience involvement plans are appropriately budgeted for. Please see our guidance on involving people with lived experience for further information on how to involve people with lived experience in your research.

5. Research location and environment

• Describe how the research location(s) can provide the necessary research infrastructure and resources to support the research goal.
• Describe how the research environment will support and develop your research capabilities and management/leadership skills.

6. Timetable and milestones (as appropriate)

*This PDF upload will not count as part of your three pages of optional additional information (see below). You should embed figures, graphs, and tables, if essential to the proposal, in the text. You may upload other essential information separately, for example: references, unpublished data, letters of support. The additional information should not be an extension of the proposal. You must provide all information pertinent to your proposal within the application form (it is not acceptable to refer to additional unpublished information on personal websites). If more than one organisation will be involved in the project, indicate what work will be undertaken at each organisation. You must cite any references in full, including all authors, the full title of each publication, journal title, year, volume, and pages. Citations to preprints should state ‘Preprint’, the repository name, and the article persistent identifier (for example, DOI). You may shorten references with more than 10 authors to et al, but please ensure that your position as author (if applicable) remains clear.

Additional information

You may provide up to three A4 pages of additional information, such as Gantt charts, figures, graphs, or additional unpublished data. Please embed it within the text of your upload for your proposal or upload it separately under ‘Additional information’. If the additional information exceeds the equivalent of three pages of A4 we will return your application to you to reduce the amount of information.

Team composition and management

Describe the roles of all applicants and how the project will be managed and led. (500 words max.)

Please indicate how the team is uniquely positioned to deliver this project and realise your long-term vision.

• Comment on whether the proposed team has worked together in the past and, if so, describe any key outcomes or achievements from these collaborations.
• If you are collaborating for the first time, comment on how and why you have chosen to work with the people and/or organisations listed.

For completeness and for applicants’ planning purposes we provide below the full assessment criteria and weightings that will be used at the full application stage. At the shortlisting stage, a simplified rubric will be used.

Assessment criteria for full applications 

There are four weighted criteria:

1. The research question, the proposed methodology and the potential for impact (40%)
2. Suitability and expertise of the team (20%)
3. Lived experience involvement (20%)
4. Suitability of research location, research environment, and research culture (20%)

1. The research question, the proposed methodology and the potential for impact (40%) 

Rationale and potential for impact:

• The research has sufficient scope and ambition, such that the findings  have the potential to have a significant and measurable impact on early intervention (for example, early symptom presentation, including early relapses, or the earliest point of contact with a healthcare system) for people with anxiety, depression and/or psychosis.
• The proposed research project will lead to insights into the interdependent roles of sleep and circadian rhythm disruption in the development and resolution of anxiety, depression and/or psychosis or vice versa.
• The proposed research is hypothesis driven and includes an underpinning mechanism or the project includes plans to investigate this mechanism.
• The proposed research is well justified, involves characterisation of changes in sleep and circadian rhythms in relation to anxiety, depression and/or psychosis and will advance knowledge in relation to at least one of the following:
  • Mechanistic underpinning of the bi-directional role of sleep and circadian disruptions in development and resolution of anxiety, depression and/or psychosis.
  • Identification and/or validation of sleep and circadian markers that enable early stratification in anxiety, depression and/or psychosis.
  • Development of early interventions for anxiety, depression and/or psychosis that target sleep and/or circadian processes, with demonstrated competitive advantage.
• The proposed research project includes a clearly defined population and has considered how it meets the needs of end users.
• Where appropriate:
  • The proposed research has considered how the research may be impacted by different contexts and whether there is potential for the research to have applicability and acceptability in settings beyond the specific context of the research.
  • Uptake of research has been considered from the outset.

Strength of evidence: 

• The proposal includes evidence that supports its feasibility and potential for impact.
• The proposal includes information on the competitive advantage of the intervention under development relative to anything that’s already available or being developed.

Strength of methodology: 

• There is a clear project plan that addresses the hypothesis/research question.
• The proposed methodological approach is appropriate, well-designed, feasible, and supported by relevant evidence or expertise (for example, the choice of model system is justified, the sample is adequately powered, for human studies a recruitment plan is in place, participant heterogeneity is being harnessed and/or considered in the study design).
• The study incorporates both sleep and circadian measures and considers measurement during wakefulness as well as sleep.The use of measures is justified.
• The study incorporates measures of anxiety, depression and/or psychosis and functional outcomes or measures of quality of life, which are justified.
• The project is achievable in the timelines proposed.​
• The resources requested are appropriate and well justified.​

2. Suitability and expertise of the team (20%)  

Lead applicant:

• Has research experience relevant to the project, as evidenced through research outputs and/or preliminary data (as appropriate for their career stage).
• Has the experience needed to drive and lead a collaborative research programme.
• Has experience of people and research management and training, as appropriate for their career stage.
• Can contribute at least 20% of their research time to this project.

Coapplicants:

• The expertise of the coapplicants is essential for the delivery of the project and their contribution to the project is justified.
• The coapplicants have the appropriate time (can contribute a minimum of 10% of their research time) and necessary resources available to deliver the project.

Team:

• The team has the necessary expertise and technical skills to deliver the proposed research project.
• There is a justified team approach whereby all applicants are necessary to deliver the proposed research and there is evidence that the proposed collaboration would be feasible and fruitful (for example, the team has appropriate management plans in place, describing how the collaboration will be organised and run day-to-day).
• The team has the necessary expertise to effectively involve and collaborate with people with lived experience of anxiety, depression and/or psychosis in the proposed project.
• Where research occurs in more than one location, applications include coapplicants based in each country where the research will take place.
• Applicants have contributed and are committed to fostering a positive and inclusive research culture.

3. Lived experience involvement (20%) 

• People with lived experience of anxiety, depression and/or psychosis (ideally with the sleep and circadian issues relevant to the research topic) are involved in multiple stages of the design, delivery, and dissemination of the project.
• Approaches to involvement (or lack of involvement) at each stage of the project should be explained in detail.
• The proposed research is feasible from the perspective of lived experience expertise.
• People with lived experience are appropriately compensated or paid for their time.
• An appropriate number of people with lived experience are involved in the application.
• Plans to involve people with lived experience in the project are appropriately costed and budgeted.

4. Suitability of research location, research environment, and research culture (20%) 

Assessment of this criteria should take into consideration the context for example, geographical location and local context or commercial environment.

Research location and environment:

• The research environment is suitable to support and develop the applicants and their proposed research.
• The research environment(s) is supportive of the research project, has plans to promote a diverse and inclusive environment and will help the applicant to develop their research capabilities, and leadership and management skills.
• The applicants have access to the necessary research infrastructure.

Research culture:

• Detailed description of how the applicants will contribute to and develop a positive and inclusive research culture. This may (but is not limited to) include:
  • Project management plans, including how project priorities and decisions will be determined.
  • Equitable plans for collaborating with researchers in low resource settings.
  • Plans for how contributions to research outputs will be credited as appropriate.
  • Plans for leadership and people management or development, supporting collaborations, research integrity and contributions to the wider research community.

Outputs management plans:

• Detailed description of a suitable outputs management plan (for example, depositing, sharing, and storing data, open access publishing).
• Applicants manage their research outputs in a way that will achieve the greatest health benefit.

• Duration of award: projects of any duration up to 5 years.
• Level of funding: projects of any budget up to £3 million.

You should ask for a level and duration of funding that is justifiable for your proposed research. You must justify all costs within the costs section of your application.

If your proposal is likely to exceed the proposed level or duration of funding, please get in touch with us.