Opportunity Information: Apply for PAR 25 206
The National Institute of Mental Health (NIMH), part of the National Institutes of Health (NIH), is soliciting applications for PAR 25-206, an R01 funding opportunity that requires a clinical trial. The focus is on pilot effectiveness trials for post-acute interventions and services aimed at improving longer-term outcomes for people with mental health conditions after they have completed an initial, acute phase of treatment. In practical terms, this program is about what happens next: how to consolidate early gains, manage lingering symptoms or functional impairment, prevent relapse, support adherence, and help people use services appropriately once the most intensive stage of care has ended.
The core emphasis is on developing and testing interventions that are matched to the stage of illness in both purpose and intensity. NIMH is looking for approaches that make sense for the post-acute phase, meaning they should be designed to maintain or extend benefits from prior treatment without imposing unnecessary burden. Examples of the kinds of post-acute goals highlighted include maintaining improvement achieved in acute treatment, addressing residual symptoms or day-to-day functioning problems that remain, reducing risk of relapse or recurrence, supporting continued engagement with care when appropriate, and improving how individuals navigate and use services over time.
This NOFO is specifically for pilot-phase effectiveness research, not fully powered definitive trials. Applicants are expected to run a clinical trial that can answer early, practical questions about whether the intervention is workable in real-world settings and for the intended population. The trial design should generate evidence on feasibility (can the study and intervention actually be delivered as intended), tolerability (is the burden manageable), acceptability (do participants and settings find it usable and worthwhile), and safety. In addition, it should provide preliminary signals of effectiveness, meaning early outcome patterns that suggest the intervention could improve post-acute outcomes enough to justify a larger, more definitive study.
A key expectation is that the pilot trial does more than just measure outcomes; it should also test whether the intervention engages the target(s) or mechanism(s) that are presumed to drive its effects. In other words, NIMH wants applicants to articulate what the intervention is supposed to change (a clinical, behavioral, service-use, or other mechanism) and then collect data that show whether that change is actually happening. The point is to reduce uncertainty before scaling up: the pilot should yield the kind of information needed to plan a larger comparative effectiveness study or practical trial, including estimates and operational details that inform design decisions.
This funding opportunity is positioned as a stepping stone to a later, fully powered effectiveness trial. NIMH explicitly notes that support for definitive, fully powered effectiveness studies focused on post-acute phase interventions is provided through a separate R01 mechanism identified as TEMP-24813. That separation matters because it signals how reviewers will likely judge applications: success here is not defined by definitive proof of effectiveness, but by a strong pilot trial that demonstrates the intervention can be implemented, is acceptable and safe, engages its intended targets, and produces preliminary outcome data that justify and shape the next-stage trial.
In terms of logistics and eligibility, this is a discretionary grant (R01) under the NIH umbrella, in the health funding activity category, associated with CFDA number 93.242. The opportunity was created on October 31, 2024, with an original closing date listed as January 7, 2028. A wide range of applicant organizations are eligible, including state, county, city/township, and special district governments; public and state-controlled institutions of higher education; private institutions of higher education; independent school districts; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; Native American tribal organizations that are not federally recognized governments; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. The announcement also highlights additional eligible groups 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), eligible federal agencies, faith-based and community-based organizations, regional organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations).
Overall, PAR 25-206 is aimed at advancing the post-acute phase of mental health care by funding pilot clinical trials that are pragmatic enough to reflect real service settings while still being rigorous about what the intervention is targeting and how it might work. The deliverable is not a final answer about effectiveness, but a well-justified, well-executed pilot trial that de-risks a future definitive effectiveness study and strengthens the field of post-acute mental health intervention research.Apply for PAR 25 206
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Pilot Effectiveness Trials for Post-Acute Interventions and Services to Optimize Longer-term Outcomes (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 2024-10-31.
- Applicants must submit their applications by 2028-01-07.
- 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): NIMH/NIH PAR 25-206 (R01 Clinical Trial Required)
1) What is PAR 25-206?
PAR 25-206 is a National Institute of Mental Health (NIMH) funding opportunity under the National Institutes of Health (NIH) that solicits applications for an R01 research grant. It specifically requires a clinical trial and focuses on pilot effectiveness trials of post-acute interventions and services for people with mental health conditions.
2) Which agency is offering this opportunity?
The opportunity is offered by the National Institute of Mental Health (NIMH), which is part of the National Institutes of Health (NIH).
3) What type of grant mechanism is this?
This is an NIH R01 discretionary grant.
4) Is a clinical trial required under this NOFO?
Yes. PAR 25-206 is an R01 funding opportunity that requires a clinical trial.
5) What is the main focus of the research supported by PAR 25-206?
The focus is on pilot effectiveness trials for post-acute interventions and services intended to improve longer-term outcomes after an individual completes an initial, acute phase of mental health treatment. The program emphasizes what happens next after acute care: maintaining gains, managing residual symptoms or functional impairment, preventing relapse, supporting adherence and engagement as appropriate, and helping people navigate services over time.
6) What does "post-acute" mean in the context of this opportunity?
"Post-acute" refers to the phase after a person has completed an initial, acute (most intensive) stage of treatment. The interventions supported here are meant to consolidate or extend benefits from acute care without adding unnecessary burden.
7) What kinds of post-acute goals does NIMH highlight for this program?
Examples of highlighted post-acute goals include: maintaining improvements achieved during acute treatment; addressing residual symptoms and day-to-day functional problems; reducing risk of relapse or recurrence; supporting continued engagement with care when appropriate; supporting adherence; and improving how individuals navigate and use services appropriately over time.
8) What does it mean that interventions should be "matched to the stage of illness"?
NIMH is looking for approaches designed specifically for the post-acute phase, with purpose and intensity that fit that stage. The intent is to maintain or extend earlier treatment benefits while avoiding unnecessary burden or intensity that may not be justified after acute care.
9) Are applications expected to propose a fully powered, definitive effectiveness trial?
No. This NOFO is specifically for pilot-phase effectiveness research, not fully powered definitive trials. Review expectations are aligned with pilot aims such as feasibility and acceptability, along with preliminary signals of effectiveness.
10) What is the primary expectation for the study design in PAR 25-206?
Applicants are expected to run a pilot effectiveness clinical trial that answers early, practical questions about whether the intervention is workable in real-world settings and for the intended population.
11) What pilot outcomes or indicators is NIMH expecting applicants to evaluate?
The pilot trial is expected to generate evidence on feasibility (whether the study and intervention can be delivered as intended), tolerability (whether burden is manageable), acceptability (whether participants and settings find it usable and worthwhile), and safety. It should also provide preliminary signals of effectiveness (early outcome patterns suggesting potential benefit).
12) What does NIMH mean by "preliminary signals of effectiveness"?
It refers to early outcome patterns observed in the pilot trial that suggest the intervention may improve post-acute outcomes enough to justify a larger, more definitive study. It is not the same as proving effectiveness definitively.
13) Does the pilot trial need to measure more than clinical or functional outcomes?
Yes. NIMH emphasizes that the pilot trial should also test whether the intervention engages the target(s) or mechanism(s) presumed to drive its effects, not just whether outcomes change.
14) What is meant by "targets" or "mechanisms" in this NOFO?
In this context, a target or mechanism is what the intervention is supposed to change (for example, a clinical, behavioral, service-use, or other mechanism). Applicants are expected to articulate what should change and collect data showing whether that change is actually occurring.
15) Why is target/mechanism engagement important for PAR 25-206?
The intent is to reduce uncertainty before scaling up. Showing that the intervention engages its intended targets helps justify a future, larger trial and strengthens planning decisions for next-stage comparative effectiveness or practical trials.
16) What is the intended role of PAR 25-206 in the overall research pipeline?
PAR 25-206 is positioned as a stepping stone to a later, fully powered effectiveness trial. Success is defined by a strong pilot trial that demonstrates implementability, acceptability, safety, target engagement, and preliminary outcome patterns that justify and shape a definitive trial.
17) Where does NIMH indicate support for definitive, fully powered effectiveness trials?
NIMH notes that support for definitive, fully powered effectiveness studies focused on post-acute phase interventions is provided through a separate R01 mechanism identified as TEMP-24813.
18) How might the existence of a separate mechanism (TEMP-24813) affect how PAR 25-206 applications are judged?
It signals that reviewers will likely evaluate PAR 25-206 applications as pilot trials rather than expecting definitive proof of effectiveness. The emphasis is on de-risking and informing a later, fully powered trial.
19) What kinds of settings are emphasized for these pilot effectiveness trials?
The opportunity emphasizes trials that are pragmatic enough to reflect real service settings while remaining rigorous about the intervention targets and how the intervention might work.
20) What is the CFDA number associated with this opportunity?
The associated CFDA number is 93.242.
21) What is the funding activity category?
The opportunity is listed in the health funding activity category.
22) When was this opportunity created?
The opportunity was created on October 31, 2024.
23) What is the original closing date listed for PAR 25-206?
The original closing date is listed as January 7, 2028.
24) What types of organizations are eligible to apply?
A wide range of organizations are eligible, including: state governments; county governments; city/township governments; special district governments; public and state-controlled institutions of higher education; private institutions of higher education; independent school districts; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; Native American tribal organizations that are not federally recognized governments; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses.
25) Are specific institution types and community-based groups highlighted as eligible?
Yes. The announcement highlights eligibility for groups 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), eligible federal agencies, faith-based and community-based organizations, regional organizations, and U.S. territories or possessions.
26) Are non-U.S. (foreign) organizations eligible to apply?
Yes. Non-U.S. entities (foreign organizations) are listed among eligible applicants.
27) What is the key deliverable NIMH is looking for from awards under PAR 25-206?
The key deliverable is a well-justified, well-executed pilot clinical trial that demonstrates the intervention can be implemented, is acceptable and safe, engages its intended targets, and produces preliminary outcome data that justify and inform a future definitive effectiveness study.
28) What is not considered the main deliverable for this opportunity?
This opportunity is not aimed at delivering a final, definitive answer about effectiveness. It is designed to produce pilot-stage evidence that de-risks and guides a later fully powered effectiveness trial.
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