Individually Measured Phenotypes to Advance Computational Translation in Mental Health (IMPACT-MH) (U01 Clinical Trial Optional) | RFA MH 25 195

Opportunity Information: Apply for RFA MH 25 195

The funding opportunity titled "Individually Measured Phenotypes to Advance Computational Translation in Mental Health (IMPACT-MH)" is an NIH discretionary grant program offered as a U01 cooperative agreement (clinical trial optional) under Funding Opportunity Number RFA-MH-25-195 (CFDA 93.242). It is designed to push mental health research toward more precise, individualized clinical decision-making by developing and validating novel behavioral measures and pairing them with a modern data infrastructure that can support computational modeling. In practical terms, the program is aiming to move beyond broad diagnostic categories alone and instead build "clinical signatures" grounded in measurable behavioral performance that can improve how clinicians assess patients, estimate prognosis, and select or tailor treatments.

A central emphasis of the NOFO is the use of behavioral tasks that can capture stable and meaningful individual differences, not just group averages. The first core objective is to develop new tasks or optimize existing tasks so they better quantify person-specific behavioral phenotypes relevant to mental disorders. These tasks are expected to demonstrate real-world value by adding predictive utility on top of standard clinical diagnosis, meaning the behavioral measures should improve prediction of clinically important outcomes when combined with usual diagnostic and clinical information. The intention is that these behavioral phenotypes will be suitable for translational use, supporting precision assessment and potentially guiding treatment selection, monitoring, or outcome forecasting.

The second objective is to create or strengthen a data infrastructure that enables computational approaches to turn these behavioral measures into decision-support tools. This implies a focus not only on collecting high-quality behavioral and clinical data, but also on structuring, standardizing, and sharing data in ways that make it usable for advanced analytics, including computational modeling and prediction. The desired endpoint is an ecosystem where well-characterized behavioral phenotypes can be aggregated and analyzed to build clinically meaningful predictive tools, rather than isolated datasets that cannot be integrated or reused. While the opportunity summary does not specify particular platforms or standards, the stated goal strongly signals expectations around interoperability, data governance, and readiness for computational translation.

Because this is a U01 cooperative agreement, awardees should anticipate substantial NIH scientific/programmatic involvement during the project period compared with a typical investigator-initiated grant. Cooperative agreements generally include collaborative oversight, milestone-driven progress, and coordination across sites or teams when relevant, which fits the NOFOs emphasis on infrastructure and translational deliverables. The "clinical trial optional" designation indicates that applicants may propose studies that do or do not meet the NIH definition of a clinical trial, depending on what is needed to validate the behavioral measures and demonstrate clinical prediction value.

In terms of eligibility, the NOFO is broadly open across public, private, nonprofit, and for-profit sectors (excluding small business-focused mechanisms, though small businesses are listed as eligible). Eligible applicants include state, county, and local 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 other than federally recognized tribal governments; public housing authorities/Indian housing authorities; and nonprofit organizations both with and without 501(c)(3) status (as long as they are not institutions of higher education in those nonprofit categories). For-profit organizations other than small businesses, as well as small businesses themselves, are also eligible. The opportunity also highlights additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), along with faith-based or community-based organizations, eligible federal agencies, regional organizations, non-domestic (non-U.S.) entities/foreign organizations, U.S. territories or possessions, and Indian/Native American tribal governments that are not federally recognized.

Key administrative details included in the listing are an original closing date of October 18, 2024, an award ceiling of $2,500,000, and an NIH posting/creation date of June 26, 2024. While the expected number of awards is not specified in the provided text, the ceiling suggests support for relatively substantial, multi-component projects that can cover both measurement development/optimization and the associated data infrastructure and computational translation work.

Overall, IMPACT-MH is structured to accelerate a shift in mental health research from primarily symptom-based classification toward measurable, individually informative behavioral phenotypes that can be computationally modeled and translated into practical clinical tools. The program is essentially betting that better behavioral measurement, combined with scalable data systems and modern computational methods, can produce stronger prediction and more precise treatment decision-making than diagnosis alone.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Individually Measured Phenotypes to Advance Computational Translation in Mental Health (IMPACT-MH) (U01 Clinical Trial Optional)" 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 2024-06-26.
• Applicants must submit their applications by 2024-10-18. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $2,500,000.00 in funding.
• 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.

Apply for RFA MH 25 195

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