Laboratories to Optimize Digital Health (R01 Clinical Trial Required) | PAR 22 154

Opportunity Information: Apply for PAR 22 154

Laboratories to Optimize Digital Health (R01 Clinical Trial Required) is a National Institute of Mental Health (NIMH) funding opportunity that supports full-scale, definitive clinical trials of digital mental health interventions, paired with infrastructure and methods that let research teams improve and evaluate those interventions quickly and rigorously. The central idea is to build or use "digital health test beds" based on well-established digital mental health platforms so that investigators can iteratively refine evidence-based tools and then test them in statistically powered studies that can provide a clear answer about whether the intervention works. In practice, this means the program is looking for projects that go beyond early feasibility or small pilot testing and instead focus on strategies that measurably increase the reach (who can access and use the intervention), efficiency (cost, time, scalability, workflow burden), effectiveness (clinical outcomes), and quality (fidelity, safety, user experience, reliability) of digital mental health care.

This opportunity uses the NIH R01 grant mechanism and explicitly requires a clinical trial, signaling that funded projects must include prospective assignment to an intervention and an evaluation of health-related outcomes in human participants. NIMH is emphasizing interventions that are already evidence-based and delivered through established digital platforms, with the goal of making optimization faster and more systematic than the traditional slow cycle of redesigning tools and running separate studies. A strong fit for this FOA would be a project that uses a mature digital platform (for example, a widely deployed app, web-based program, or integrated digital service) as a test environment to refine an intervention component, adapt it for real-world use, improve engagement and adherence, or enhance clinical impact, and then confirm effectiveness through a well-powered trial design. The emphasis on "statistically powered to provide a definitive answer" indicates that applicants are expected to propose sample sizes, outcomes, and analysis plans that can credibly detect clinically meaningful effects, rather than exploratory signals.

The opportunity is offered by the National Institutes of Health (NIH), with NIMH as the sponsoring institute, and it falls under the health funding activity area (CFDA 93.242). The funding instrument is a discretionary grant, and the specific funding opportunity number is PAR-22-154. While the source text does not list an award ceiling or the expected number of awards, the structure and language align with standard R01 expectations: multi-year research projects with substantial scope, clear milestones, and strong methodological rigor appropriate for effectiveness testing in clinical populations.

Eligibility is broad and intentionally inclusive, spanning public and private institutions as well as community and governmental entities that can support clinical trial research in digital mental health. Eligible applicants include state, county, and city or township governments; special district governments; independent school districts; public housing authorities and Indian housing authorities; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; other Native American tribal organizations; nonprofits with or without 501(c)(3) status (other than higher education institutions); for-profit organizations (other than small businesses); small businesses; and additional organizations captured under NIH eligibility rules. The FOA also calls out additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and even non-U.S. (foreign) entities. This wide eligibility reflects NIMH's interest in research that can be conducted in diverse settings, including community-based contexts and systems that serve populations often underrepresented in clinical research.

Overall, the program is geared toward accelerating the translation of digital mental health tools into real-world impact by funding projects that combine rapid optimization with definitive clinical testing. Successful applications are likely to present a clear plan for using an existing digital platform as a scalable test bed, specify how the intervention will be refined to improve reach and outcomes, and execute a robust, well-powered clinical trial that can settle the question of effectiveness with high confidence.

• The 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 2022-04-05.
• Applicants must submit their applications by 2023-01-06. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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 PAR 22 154

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: