Grants for Integrating Mental Health Care into Health Care Systems in LMICs

Grants for Integrating Mental Health Care into Health Care Systems in LMICs is sponsored by National Institutes of Health (NIH). This opportunity supports mission-aligned projects and measurable outcomes.

Expired RFA-MH-22-130: Integrating Mental Health Care into Health Care Systems in Low- and Middle-Income Countries (R01 Clinical Trial Optional) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute of Mental Health ( NIMH ) National Cancer Institute ( NCI ) Funding Opportunity Title Integrating Mental Health Care into Health Care Systems in Low- and Middle-Income Countries (R01 Clinical Trial Optional) R01 Research Project Grant November 8, 2024 - This RFA has been reissued as PAR-25-201 March 10, 2022 - Notice of Correction to Letters of Support Expectations for RFA-MH-22-130, "Integrating Mental Health Care into Health Care Systems in Low- and Middle-Income Countries (R01 Clinical Trial Optional)".

See Notice NOT-MH-22-185 Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity See Section III. 3. Additional Information on Eligibility .

Assistance Listing Number(s) Funding Opportunity Purpose This Funding Opportunity Announcement (FOA) invites implementation research applications to develop, optimize, and test innovative theory-based strategies to integrate mental and physical health care within health care systems in low-and middle-income countries (LMICs).

This FOA aims to support innovative research for implementing, scaling up, and financially sustaining integrated mental health care models to ultimately increase demand and utilization, quality, access, and availability of mental health care.

This FOA is also expected to contribute to the long-term goals of strengthening the sustainable research capacity in LMICs and enhancing the potential for multidirectional knowledge and the exchange of research advancements. NIMH encourages partnerships between institutions in LMICs and high-income-countries (HICs).

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to the application due date Renewal / Resubmission / Revision (as allowed) All applications are due by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide , except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information Part 2. Full Text of Announcement Section I.

Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Part 2. Full Text of Announcement Section I.

Funding Opportunity Description Globally, more than 75% of people who need treatment, do not receive treatment for mental, neurological, and substance use disorders. Mental illnesses occur more commonly in people with other physical and chronic health conditions such as cardiovascular disease, diabetes, alcohol and substance use disorders, HIV, and more recently, people infected with COVID-19.

Individuals with comorbidities have lower treatment adherence, poorer clinical outcomes, and a higher risk of disability and mortality. The relationship between mental illness and other chronic diseases is complex, bidirectional, and integrates multiple mechanisms, including biological, psychosocial, environmental, and economic factors.

Understanding the potential mechanisms and interactions could help identify more efficacious strategies, interventions, and models of care to simultaneously address mental and co-occurring chronic illnesses. Integrating mental health care into health care systems is a promising strategy to help expand access to mental health care and co-treat coexisting conditions.

Integrated care may also increase accessibility, enhance continuity of care, and reduce cost. In addition, integrated care may produce efficiencies in health care delivery by providing care for multiple conditions.

While there is evidence that some integrated care models significantly improve depression, anxiety, and other behavioral health conditions, it is unclear whether integrating mental health care into physical care can also improve other physical conditions.

The service delivery infrastructure and other community care platforms such as primary care settings, community care centers, and platforms for chronic disease management also offer an opportunity to investigate models for integrating mental health care into health care systems in low-and middle-income countries (LMICs).

Different integrated care models have been used in the outpatient management of mental disorders and other physical illnesses in high-income countries. Some integration models, such as the Collaborative Care Model and Stepped Care Model, have significantly improved mental health outcomes.

However, while a variety of integrated care models have been tested in LMICs, considerably less is known about the optimal structure and implementation strategies necessary to scale up and sustain models of integration in LMICs.

Research Scope and Objectives This FOA aims to support innovative implementation research to develop, optimize, and test innovative strategies for overcoming barriers to the adoption, adaptation, integration, scale-up, and financially sustaining integrated mental health care models to ultimately increase demand and utilization, quality, access, and availability of mental health care.

This FOA is also expected to contribute to the long-term goals of strengthening the sustainable research capacity in LMICs and enhancing the potential for multidirectional knowledge and research advancements exchange. Applications may propose new studies or secondary data analyses.

All projects must describe the extent of researchers' significant involvement in LMIC settings and propose a research project element and a research capacity element.

It will be essential for the proposed researchers to describe how the proposed research is relevant to the local context and aligns with NIMH's scientific priorities of transforming the prevention and treatment of mental illnesses and translating evidence into practice and policy. The potential for reciprocal learning will be considered an added value.

All applicants will be expected to substantially involve key personnel in the setting where the study will be conducted. For applications proposing a single PD/PI, the PD/PI will be required to have a primary academic appointment in an LMIC institution. Applications proposing MPIs will be required to include at least one PD/PI who has a primary academic appointment in an LMIC institution where the projects occur.

The other PI(s) on the project can have an appointment at an LMIC-based institution or at a HIC-based institution. Research projects must be conducted in the LMIC in which the single PD/PI or at least one PD/PI has a primary appointment.

Applications to conduct secondary analyses must demonstrate the sufficiency of existing data sets in both quantity and quality to test hypothesized mediational pathways or to generate new hypotheses using computational and/or data science analytic approaches.

Applications that propose primary data collection must specify the models, variables, and measures used to identify and test potential pathways and mechanisms that may account for changes in key outcomes. Proposed studies should be consistent with the NIMH experimental therapeutics approach . Valid and reliable measures will provide useful Information about pathways and mechanisms that may account for intervention effects.

Accordingly, applicants should plan to use the most direct and objective measures possible in the study setting, including validated measures of mental and psychical health beyond self-reports and other subjective measures, where possible, and include measures that span more than one level of assessment if possible and appropriate.

NIMH encourages applicants to consider RDoC or RDoC-like constructs when defining intervention targets and outcomes, as feasible in the setting (see the RDoC webpage for more details) For researchers proposing a new study, NIMH strongly encourages the employment of person-centric, multidisciplinary, and multilevel approaches, as well as multi-component interventions that potentially impact mental and physical health outcomes and quality of life.

Of specific interest is research that uses task-sharing, innovative digital health technologies, and syndemic frameworks, where appropriate. The use of competency-based training approaches and competency assessments is strongly encouraged in order to improve the quality of care and reach (accurate detection).

For applications proposing a syndemic approach to implement integrated health care, applicants should operationalize the framework proposed based on appropriate methodological techniques to develop (e.g., epidemiological data, mixed methods, qualitative and ethnographic research) and evaluate (e.g., appropriated statistic methods) the impact of the syndemic model to improve mental and other clinical health outcomes.

For applications proposing multi-component interventions or applying a syndemic approach, applicants should examine how different components contribute to and/or interact synergistically to produce the observed mental and other clinical health outcomes.

This may involve advanced data analytic approaches, modeling; structuring, harmonizing, and extracting meaningful features from multiple data streams; and advanced computational and statistical approaches.

Applications with data collection plans that involve multiple respondent groups (e.g., clients/patients, therapists/providers, supervisors, administrators) should address provisions for human subject protections and consenting procedures for all participant groups, accordingly.

Research capacity element Researchers are expected to describe a plan and activities between the partner country institutions and/or between the LMICs institutions, to strengthen research capacity at local and regional levels in LMICs and enhance the potential for multidirectional knowledge and research advancements exchange.

Activities may include but are not limited to: Sharing education platforms to strengthen and develop expertise across research team members in different institutions and countries. Engaging students and early investigators from the partner country institutions in bilateral training and exchanging knowledge on topics relevant to the research project.

Providing opportunities for obtaining relevant qualifications and expertise in research (e.g., Master’s and Ph. D. degrees).

Developing and disseminating implementation science programs to support the development of future studies. Training in writing and submitting grants to NIH, written and publishing manuscripts. Professional development in grants administration to foster proficiency in the management of scientific and administrative aspects of the grant.

Contributing to inform and disseminate common measures/data elements, evidence-based treatment, prevention, and health system policies where the study is taking place.

Making efficient use of local/regional oversight bodies such as International Review Boards (IRB) and Data and Safety Monitoring Boards (DSMBs) Examples of relevant research topics include but are not limited to: This FOA aims to support innovative implementation research to develop, optimize, and test innovative strategies for implementing, scaling up and financially sustaining integrated mental health care models in LMICs.

The general scope of the research includes, but is not limited to: Identify and implement an optimal integration model to ensure scalability and sustainability. Identify the necessary core elements of integrated mental health care models (e.g., routine screening, training/hiring case manager and consulting, disease registry)to enable the model’s implementation, scale-up, and sustainability.

Develop and test implementation strategies and innovative health technologies to improve health system-, patient-, and family-level outcomes and ensure the quality of integration. Develop and test models and strategies for training, supervising, and supporting providers, including identifying the optimal functions, roles, and composition of integrated care teams to deliver integrated care with fidelity and high quality.

Test mechanisms of actions/ target mediators of implementation strategies for overcoming barriers to the adoption, adaptation, integration, scale-up, and sustainability of integrated care models. Develop and test models and strategies for linking integrated care with other community-based services.

Develop and test behavioral economic strategies, financing models (payment mechanisms), and health policies that influence the success of scaling up and sustaining the provision of integrated care; by including an integrated care model on the universal health system and a cost-effective bundle of service.

Determine how an integrated care model can best engage local communities to enhance service user participation (e.g., demand and utilization).

Examine the independent and complementary or synergistic effects on the mental and physical health outcome of integrated care models with multilevel interventions targeting modifiable conditions (e.g., the structure of the health system, health policies, and other social drivers of mental illness).

Test strategies that target health system arrangements, such as incentives, regulations, and policies, which may facilitate or deter the availability (supply), accessibility, scalability, and sustainability of integrated care model and test relevant approaches to measure and extract existing data regarding these arrangements.

For applications involving clinical trials : Consistent with the NIMH experimental therapeutics approach , this FOA is intended to support research trials that not only test the intervention effects on outcomes of interest but also explicitly inform understanding regarding whether the intervention engages associated change mechanisms that were previously identified under more controlled, efficacy conditions, thereby reconfirming the intervention targets and testing whether previously identified change mechanisms are operative in the effectiveness context (see NIMH webpage on Clinical Trials ).

In this manner, the effectiveness trial results will advance knowledge regarding therapeutic change mechanisms and have utility regardless of trial outcomes (e.g., in the event of negative results, Information about whether the intervention was successful at engaging its targets can facilitate interpretation).

NIMH encourages projects to test the effectiveness of preventive, therapeutic, or services interventions designed as hybrid effectiveness-implementation trials, as appropriate, depending on the level of pre-existing effectiveness evidence and implementation readiness. This FOA encourages effectiveness research that simultaneously tests strategies to promote successful implementation (i.e., as Hybrid Type II trials).

Likewise, studies primarily aimed at testing an implementation or dissemination strategy should also be designed to assess the outcomes and effectiveness of the intervention/approach that is being implemented, as appropriate and feasible (i.e., as Hybrid Type III trials).

NIMH encourages studies that test intervention and service delivery strategies that incorporate features specifically designed to prevent threats to intervention fidelity and implementation strategy fidelity, as appropriate.

Strategies that might be used to enhance scalability and sustained implementation include but are not limited to consumer-facing technology (e.g., self-administered content) and provider-facing technology (e.g., technology to support provider training and sustained implementation fidelity); expert consultation via existing resources or other sustainable means (e.g., telehealth, collaborative care approaches); or other robust design features that promote provider competence and sustained implementation fidelity.

National Cancer Institute (NCI) The National Cancer Institute seeks implementation science projects integrating mental health services across the cancer care continuum including during cancer prevention, detection, diagnosis, treatment including palliative care, and survivorship.

Examples include (but are not limited to) studies that seek to understand and evaluate sustainable approaches to integrating mental health services into cancer diagnosis and treatment; optimizing mental health care for survivors seeing oncology and non-oncology providers; and adapting or developing and testing mental health care interventions to settings with underdeveloped infrastructure.

Applications Not Responsive to this FOA (all applications) The following will be considered nonresponsive to this FOA and will not be reviewed: Applications that propose research to be conducted primarily in HICs, including but not limited to the US. Research focused on including services for chronic conditions care into specialized mental health programs. Studies examining the efficacy and effectiveness of new pharmacologic therapies.

Studies limited to descriptive analyses of disease prevalence and health systems. Studies conducted exclusively in academic research laboratories as opposed to effectiveness studies in community practice clinics/settings (e.g., studies in research clinics that involve research therapists or other features that are not representative of typical practice settings and substantially impact generalizability).

For the purposes of this FOA, use the following definitions: LMICs: are defined according to the fiscal year 2022 World Bank designations of low- and middle-income countries (LMICs) (see World Bank Data Helpdesk webpage ). Reciprocal learning : in the field of global mental health, reciprocal learning is a multidirectional exchange of research advancements requiring sharing of ideas and collaboration.

This process expands the benefit of research innovations to diverse contexts, communities, and populations, equitably improving mental health and shaping future research worldwide. Chronic conditions : refer to non-communicable and communicable conditions that last at least three months, remitting and recurring symptoms, and often slow progression.

Person-centric approach: the management and delivery of health services so that clients receive a continuum of preventive and curative services, according to their needs over time and across different levels of the health system (WHO) Syndemic: is the aggregation of two or more concurrent or sequential disease clusters, interacting synergistically at both the population and individual levels, contributing to excess burden of disease and prognosis.

Implementation research: is defined as the scientific study of strategies to adopt and integrate evidence-based health interventions into clinical and community settings to improve individual outcomes and benefit population health. Dissemination research: is defined as the scientific study of the targeted distribution of information and intervention materials to a specific public health or clinical practice audience.

The intent is to understand how best to communicate and integrate knowledge and the associated evidence-based interventions. Technical Assistance Teleconference A Technical Assistance teleconference will be held via Zoom (Webinar ID 161 812 3252) for potential applicants on March 16, 2022 at 9:00 AM ET. Click here to register.

Please check the NIMH Center for Global Mental Health website for webinar updates. The NIMH has published updated policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring ( NOT-MH-19-027 ). The application’s PHS Human Subjects and Clinical Trials Information, including the Data and Safety Monitoring Plan, should reflect the policies and guidance in this notice.

Plans for the protection of research participants and data and safety monitoring will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations. See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Only those application types listed here are allowed for this FOA. Optional: Accepting applications that either propose or do not propose clinical trial(s). Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards NIMH and NCI intend to commit $3M in FY 2023 to fund 6-7 awards. Application budgets are not limited but need to reflect the actual needs of the proposed project. .

The scope of the proposed project should determine the project period. The maximum project period is 5 years. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award.

All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM. gov registration process.

SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application. Dun and Bradstreet Universal Numbering System (DUNS) Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM.

By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, after obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.

eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants. gov registrations; all registrations must be in place by time of submission.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants. gov Applicants must have an active SAM registration in order to complete the Grants.

gov registration. Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.

If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

For institutions/organizations proposing a single PD/PI will be required to have a primary academic appointment in an LMIC institution. Applications proposing MPIs will be required to include at least one PD/PI who has a primary academic appointment in an LMIC institution where the projects occur. Applications proposing MPIs can have a contact PI in either institution.

NIMH encourages partnerships between institutions in LMICs and HICs. Research projects must be conducted in the LMIC in which the single PD/PI or at least one PD/PI has a primary appointment. LMICs are defined according to the fiscal year 2022 World Bank designations of low- and middle-income countries (LMICs) (see World Bank Data Helpdesk webpage ).

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement. 3. Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2. 3. 7.

4 Submission of Resubmission Application . This means that the NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application. A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see 2. 3. 9.

4 Similar, Essentially Identical, or Identical Applications ) Section IV. Application and Submission Information 1. Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants.

gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants. gov Workspace are available in Part 1 of this FOA.

See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2. Content and Form of Application Submission It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise.

Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1.

Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information: Descriptive title of proposed activity Name(s), address(es), and telephone number(s) of the PD(s)/PI(s) Names of other key personnel Participating institution(s) Number and title of this funding opportunity The letter of intent should be sent to: All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA. All instructions in the SF424 (R&R) Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information All instructions in the SF424 (R&R) Application Guide must be followed. SF424(R&R) Senior/Key Person Profile All instructions in the SF424 (R&R) Application Guide must be followed. Describe the extent of involvement of researchers in LMICs.

Describe the team's expertise and knowledge of the social and cultural contexts of the LMIC setting with appropriate participation and leadership by LMIC investigators, key personnel, and stakeholders. All instructions in the SF424 (R&R) Application Guide must be followed.

The PD/PI is encouraged to budget travel costs to present the research results at high-caliber technical meetings, at least one of which is devoted directly to global health research. A portion of the budget could include costs for external members of the advisory committee to meet, if possible by teleconference and or in-person. All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Address the degree to which the proposed integrated model is relevant to the local context and could be disseminated into practice and policy given: (i) the current health system function (e.g., current available financial and non-financial resources); (ii) service delivery arrangements or payment mechanisms; (iii) typical service structures (e.g., health policies) and use patterns; and (iv) public health impact.

Detail how the proposed research will lead to new knowledge about an optimal and effective integration model to ensure scalability and sustainability. For studies that involve clinical trials: Justify the practical effect of the integrated model in terms of the estimated hypothesized effect size (e.g., in terms of mental and physical health outcomes, and implementation outcomes).

Address the potential impact of the integrated model in terms of: the empirical basis for the anticipated effect size (e.g., citing data regarding the magnitude of the association between the target and the clinical endpoint of interest and/or effect sizes obtained in prior efficacy studies), the clinical meaningfulness of the anticipated increment in effects compared to existing approaches, and As relevant and appropriate, describe how application of digital technologies, big data, or other innovative approaches or frameworks are leveraged to implement, scale up, and sustain accessible and effective integrated mental health care models to ultimately increase demand and utilization, quality, access, and availability of mental health care.

Projects must propose a research project and a research capacity element in collaboration between multiple investigators/institutions. Provide evidence that outcome measures are valid and reliable for the proposed population(s). Detail the procedures that will be used to identify and systematically quantify the resources necessary to implement and scale-up the intervention.

As relevant, address how the study contributes to advancing the personalization of mental health care and describe the collection of clinical and biological variables (e.g., blood for genetic analysis, other potential biomarkers) that might be used to examine moderators or inform/test algorithms for more prescriptive approaches.

Address plans to examine moderators and/or the potential to contribute information regarding potential moderators to larger databases. Describe plans to establish or develop research partnerships with local decision-makers such as representatives from government agencies, non-government organizations, provider organizations where the study will take place, such as Ministry/Department of Health, Education, Social Welfare, and Finance.

Partnerships with global health organizations and /or developmental agencies (e.g., WHO, USAID, World Bank) are encouraged. Applications that will involve the acquisition of new data must: Propose implementation research that applies implementation science theories, models, and frameworks to inform research design and utilize a broader range of implementation outcomes.

Propose integration of mental health services into existing health care systems or other existing platforms of care for physical conditions such as primary care settings, community care centers, platforms for chronic disease management, and those used to support mobile populations to improve care coordination and patient-family and fitness system-level outcomes. Describe plans