Opportunity Information: Apply for RFA MH 20 510
Laboratories to Optimize Digital Health (R01 Clinical Trial Required) is a discretionary NIH grant opportunity from the Department of Health and Human Services, specifically the National Institute of Mental Health (NIMH), listed under Funding Opportunity Number RFA-MH-20-510 (CFDA 93.242). The central goal is to fund innovative research projects that can measurably improve digital mental health interventions by expanding who they reach, improving how efficiently they can be delivered, strengthening their clinical effectiveness, and raising the overall quality of these tools when used in real-world settings.
A defining feature of this opportunity is its emphasis on building and using "digital health test beds." In practical terms, NIMH is looking for applicants to create research environments that rely on well-established digital mental health platforms (for example, mature apps, web-based programs, messaging platforms, or other proven digital delivery systems) so that investigators can rapidly refine and optimize interventions that already have an evidence base. Rather than starting from scratch with a brand-new platform or a purely exploratory prototype, the intent is to leverage existing, credible digital infrastructure to speed up iteration, evaluation, and deployment-relevant learning. The expectation is that these test beds will support continuous improvement and rigorous testing workflows, allowing research teams to evaluate strategies that make digital interventions more scalable and impactful.
The funding announcement also requires clinical trials, and it places particular weight on trials that are statistically powered to deliver a definitive answer about whether a digital mental health intervention works. That means the research design should be strong enough, and the sample size large enough, to test effectiveness with confidence rather than producing only preliminary or suggestive findings. The overall direction is toward higher-certainty evidence that can guide practice, implementation, and future dissemination, including understanding what changes or optimization strategies actually improve outcomes.
Eligible applicants are broad and include many types of organizations that can support large-scale, rigorous health research. This includes state, county, city, township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; Native American tribal organizations that are not federally recognized as governments; public housing authorities and Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (as long as they are not institutions of higher education under those categories); for-profit organizations other than small businesses; small businesses; and additional entities as clarified in the funding announcement's eligibility details. This wide eligibility reflects the reality that digital mental health research and implementation often involve cross-sector partnerships, such as collaborations among universities, health systems, community organizations, schools, and technology partners.
From an administrative perspective, the opportunity was created on November 25, 2019, and the original closing date was November 2, 2020. NIMH anticipated making about three awards under this announcement. The listed award ceiling is shown as 0, which typically signals that a specific maximum dollar cap is not provided in the summary field and that applicants should refer to the full announcement and NIH budget policy guidance for allowable costs, scope-appropriate budgeting, and any institute-specific expectations.
Overall, this FOA is best understood as an effort by NIMH to accelerate the maturation of digital mental health care by funding robust, platform-based research laboratories that can quickly optimize existing evidence-based interventions and then validate their impact through well-powered clinical trials. The focus is not just on whether a digital program can work in ideal conditions, but on developing scalable approaches that increase reach, improve delivery efficiency, and produce reliable effectiveness results that can inform real-world mental health service improvements.Apply for RFA MH 20 510
- The Department of Health and Human Services, National Institutes of Health in the health sector is offering a public funding opportunity titled "Laboratories to Optimize Digital Health (R01 Clinical Trial Required)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242.
- This funding opportunity was created on Nov 25, 2019.
- Applicants must submit their applications by Nov 02, 2020. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The number of recipients for this funding is limited to 3 candidate(s).
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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Frequently Asked Questions (FAQs)
What is the Laboratories to Optimize Digital Health (R01 Clinical Trial Required) funding opportunity?
This is a discretionary NIH grant opportunity sponsored by the U.S. Department of Health and Human Services, through the National Institute of Mental Health (NIMH). It is listed under Funding Opportunity Number (FON) RFA-MH-20-510 and CFDA 93.242, and it supports R01 research projects that include clinical trials.
What is the main goal of this FOA?
The central goal is to fund innovative research projects that measurably improve digital mental health interventions. The FOA emphasizes improvements that expand who these interventions reach, increase delivery efficiency, strengthen clinical effectiveness, and raise overall quality in real-world settings.
What kinds of improvements are applicants expected to target?
Based on the FOA description, projects should focus on measurable improvements such as:
- Expanding reach (getting digital interventions to more people or underserved groups)
- Improving delivery efficiency (making interventions easier, faster, or less resource-intensive to deliver)
- Strengthening clinical effectiveness (improving mental health outcomes)
- Improving real-world quality (making tools work better in routine, practical settings)
What is a "digital health test bed" in the context of this opportunity?
In this FOA, a digital health test bed is a research environment built around well-established digital mental health platforms. The test bed is meant to support rapid refinement, optimization, and rigorous evaluation of interventions that already have an evidence base, using continuous improvement and testing workflows.
Does this opportunity support building brand-new digital platforms from scratch?
The emphasis is not on starting from scratch with a brand-new platform or a purely exploratory prototype. Instead, the intent is to leverage existing, credible digital infrastructure (such as mature apps, web-based programs, messaging platforms, or other proven digital delivery systems) to speed iteration and generate deployment-relevant learning.
What types of digital platforms can serve as the foundation for a test bed?
The FOA describes examples such as mature apps, web-based programs, messaging platforms, and other proven digital delivery systems, as long as the platform is well-established and supports rapid refinement and rigorous testing of evidence-based digital mental health interventions.
Are clinical trials required under this FOA?
Yes. The funding opportunity explicitly requires clinical trials.
What level of clinical trial rigor does NIMH expect?
The FOA places particular weight on clinical trials that are statistically powered to provide a definitive answer about whether a digital mental health intervention works. That implies a strong design and a sample size large enough to test effectiveness with confidence, rather than producing only preliminary or suggestive findings.
Is the FOA focused on efficacy under ideal conditions or effectiveness in real-world settings?
The FOA emphasizes real-world impact. It is described as focusing not only on whether a digital program can work in ideal conditions, but also on developing scalable approaches and producing reliable effectiveness results that can inform real-world mental health service improvements.
What does "optimization" mean for this program?
Within this opportunity, optimization refers to rapidly refining and improving digital mental health interventions that already have an evidence base, using established platforms and test-bed workflows to learn what changes meaningfully improve outcomes, scalability, reach, efficiency, and quality.
Who is the sponsoring agency for this opportunity?
The sponsoring agency is the Department of Health and Human Services, specifically the National Institutes of Health (NIH), through the National Institute of Mental Health (NIMH).
What is the Funding Opportunity Number (FON) and CFDA number?
The Funding Opportunity Number is RFA-MH-20-510 and the CFDA number is 93.242.
What award mechanism is used?
The FOA is described as an R01 opportunity, and it is labeled "Clinical Trial Required."
How many awards did NIMH anticipate making?
NIMH anticipated making about three awards under this funding announcement.
When was this funding opportunity created and when did it close?
The opportunity was created on November 25, 2019. The original closing date was November 2, 2020.
Is there a maximum award amount (ceiling) listed?
The summary shows an award ceiling of 0, which typically indicates that a specific maximum dollar cap is not provided in the summary field. Applicants are expected to rely on the full funding announcement and NIH budget policy guidance for allowable costs and scope-appropriate budgeting.
What types of organizations are eligible to apply?
Eligibility is broad and includes a wide range of organization types that can support large-scale, rigorous health research, including:
- State governments
- County governments
- City or township governments
- Special district governments
- Independent school districts
- Public and state-controlled institutions of higher education
- Private institutions of higher education
- Federally recognized Native American tribal governments
- Native American tribal organizations that are not federally recognized as governments
- Public housing authorities and Indian housing authorities
- Nonprofits with or without 501(c)(3) status (as long as they are not institutions of higher education under those categories)
- For-profit organizations other than small businesses
- Small businesses
- Additional entities as clarified in the funding announcement eligibility details
Are partnerships across sectors consistent with the intent of this FOA?
Yes. The FOA description notes that digital mental health research and implementation often involve cross-sector partnerships, such as collaborations among universities, health systems, community organizations, schools, and technology partners.
What makes this FOA different from exploratory digital mental health research?
A defining feature is the emphasis on using well-established digital mental health platforms as test beds to rapidly refine and optimize interventions with an evidence base, combined with rigorous, well-powered clinical trials intended to yield definitive effectiveness answers.
What kinds of outcomes is NIMH trying to enable through this program?
The FOA is oriented toward producing higher-certainty evidence that can guide practice, implementation, and future dissemination. It also emphasizes learning which optimization strategies actually improve clinical outcomes, reach, delivery efficiency, scalability, and overall quality in real-world settings.
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