Opportunity Information: Apply for PAR 23 096
Laboratories to Optimize Digital Health (R01 Clinical Trial Required), funding opportunity number PAR 23 096, is a National Institutes of Health (NIH) discretionary grant administered through the National Institute of Mental Health (NIMH). The core purpose of this program is to fund innovative research projects that can measurably improve digital mental health interventions by increasing their reach (who can access them and how broadly they can be deployed), efficiency (how quickly and cost-effectively they can be delivered and improved), effectiveness (how well they work in real-world conditions), and overall quality (usability, reliability, engagement, and clinical value). It is positioned as a practical, test-and-learn program focused on generating strong evidence, not just building new apps or running small pilots.
A defining feature of the opportunity is its emphasis on creating or using "digital health test beds." In plain terms, these are research environments built on well-established digital mental health platforms that are already capable of delivering interventions at scale and capturing meaningful data. Rather than starting from scratch, applicants are expected to leverage mature, proven platforms to rapidly refine and optimize existing evidence-based digital mental health interventions. The intent is to shorten the cycle from idea to improved intervention by enabling iterative testing, optimization, and deployment in a controlled but realistic setting. This also signals a preference for projects that can move quickly because they are built on infrastructure that already works.
Another central requirement is that the funded work must include clinical trials, and those trials should be statistically powered to deliver a definitive answer about whether the intervention works. That means NIMH is looking for studies designed with adequate sample size and rigorous methods so the results are conclusive, not merely suggestive. The program is therefore aimed at later-stage evaluation and optimization efforts where the intervention is sufficiently mature to be tested in a robust trial, and where improvements can be made in a structured way using the test bed approach.
The funding instrument is an R01 research project grant, under the health funding activity category (CFDA number 93.242). The opportunity was created on 2023-01-06, with an original closing date listed as 2025-03-05. An award ceiling is not specified in the provided source data, and the expected number of awards is also not listed, which typically means applicants should rely on the full FOA for budget guidance, scope expectations, and any institute-specific limitations.
Eligibility is broad and includes a wide range of U.S. entities: state, county, and 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; tribal organizations that are not federally recognized tribal governments; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status (outside of higher education); for-profit organizations (other than small businesses); and small businesses. In addition, the FOA explicitly calls out other eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, regional organizations, and even non-U.S. entities (foreign organizations). This breadth suggests NIMH is encouraging participation from diverse organizational types and settings, including community-based and under-resourced contexts where digital mental health tools may help close access gaps.
Overall, this opportunity supports rigorous, clinically tested digital mental health work that is ready to be optimized and validated at scale. The projects NIMH is trying to catalyze are those that use robust platforms as test beds, refine evidence-based digital interventions quickly and intelligently, and then confirm effectiveness through well-powered clinical trials that can guide real-world adoption and implementation decisions.Apply for PAR 23 096
- 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 2023-01-06.
- Applicants must submit their applications by 2025-03-05. (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.
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Frequently Asked Questions (FAQs)
What is the Laboratories to Optimize Digital Health (R01 Clinical Trial Required) opportunity?
Laboratories to Optimize Digital Health (R01 Clinical Trial Required) is a National Institutes of Health (NIH) discretionary grant opportunity administered by the National Institute of Mental Health (NIMH). It supports research projects that measurably improve digital mental health interventions, with an emphasis on generating strong evidence through rigorous, well-powered clinical trials.
What is the funding opportunity number?
The funding opportunity number is PAR 23 096.
Which agency administers this program?
This is an NIH grant administered through the National Institute of Mental Health (NIMH).
What type of grant mechanism is used?
The program uses the R01 research project grant mechanism.
Is a clinical trial required?
Yes. A defining requirement of this opportunity is that the funded work must include clinical trials.
How rigorous do the clinical trials need to be?
The clinical trials are expected to be statistically powered to deliver a definitive answer about whether the intervention works. This means the study design and sample size should be sufficient for conclusive results rather than exploratory or suggestive findings.
What is the core purpose of the program?
The core purpose is to fund innovative research that measurably improves digital mental health interventions by increasing reach, efficiency, effectiveness, and overall quality. Quality is described in practical terms such as usability, reliability, engagement, and clinical value.
Does this program focus on building brand-new mental health apps?
Based on the description provided, the program is positioned as a practical, test-and-learn effort focused on evidence generation, not simply building new apps or running small pilots. It emphasizes optimizing and refining interventions using established platforms.
What does NIMH mean by "digital health test beds" in this program?
"Digital health test beds" are research environments built on well-established digital mental health platforms that are already capable of delivering interventions at scale and capturing meaningful data. Applicants are expected to leverage mature platforms rather than start from scratch.
Why does the opportunity emphasize using mature platforms and test beds?
The intent is to shorten the cycle from idea to improved intervention by enabling iterative testing, optimization, and deployment in a controlled but realistic setting. This also implies a preference for projects that can move quickly because they are built on infrastructure that already works.
What kinds of improvements is NIMH looking for in digital mental health interventions?
NIMH is looking for measurable improvements in:
- Reach: who can access the intervention and how broadly it can be deployed
- Efficiency: how quickly and cost-effectively it can be delivered and improved
- Effectiveness: how well it works in real-world conditions
- Overall quality: usability, reliability, engagement, and clinical value
Is this opportunity more appropriate for early-stage or later-stage digital interventions?
Based on the requirements described, this opportunity is aimed at later-stage evaluation and optimization efforts where the intervention is sufficiently mature to be tested in a robust clinical trial and improved using an iterative test bed approach.
What is the CFDA number and funding activity category?
The funding activity category is listed as health, and the CFDA number provided is 93.242.
When was this funding opportunity created?
The opportunity was created on 2023-01-06.
What is the closing date listed in the provided information?
The original closing date listed in the provided source data is 2025-03-05.
Is there an award ceiling listed?
No award ceiling is specified in the provided source data.
Is the expected number of awards listed?
No. The expected number of awards is not listed in the provided source data.
What should applicants do if budget limits or award counts are not shown?
Because the award ceiling and expected number of awards are not provided in the source data, applicants are typically expected to rely on the full Funding Opportunity Announcement (FOA) for budget guidance, scope expectations, and any institute-specific limitations.
Who is eligible to apply?
Eligibility is broad and includes many U.S. entity types, including:
- State, county, and 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
- Tribal organizations that are not federally recognized tribal governments
- Public housing authorities and Indian housing authorities
- Nonprofits with and without 501(c)(3) status (outside of higher education)
- For-profit organizations (other than small businesses)
- Small businesses
Are certain types of institutions explicitly encouraged or called out as eligible?
Yes. The FOA explicitly calls out additional eligible applicants, including:
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISISs)
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Faith-based or community-based organizations
- Eligible federal agencies
- U.S. territories or possessions
- Regional organizations
- Non-U.S. entities (foreign organizations)
Can for-profit organizations apply?
Yes. The eligibility list includes for-profit organizations (other than small businesses) and also separately includes small businesses.
Can non-U.S. (foreign) organizations apply?
Yes. The eligibility section explicitly includes non-U.S. entities (foreign organizations).
Does this opportunity support work intended for real-world adoption?
Yes. The program emphasizes improving how digital mental health interventions work in real-world conditions and generating strong evidence that can guide real-world adoption and implementation decisions.
What is the overall theme or approach of the program?
The overall approach is a practical, iterative "test-and-learn" model: use robust digital platforms as test beds, rapidly refine and optimize evidence-based digital mental health interventions, and then confirm effectiveness through well-powered clinical trials.
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