Opportunity Information: Apply for PAR 21 132
The National Institute of Mental Health (NIMH), under the National Institutes of Health (NIH), is soliciting applications for PAR-21-132, titled "Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01 Clinical Trial Required)." This funding opportunity is a reissue of the earlier RFA-MH-18-707 and sits within NIMH's clinical trials pipeline. The central purpose is to support well-powered, confirmatory efficacy clinical trials of non-pharmacological interventions that aim to treat or prevent mental disorders in both adults and children. The emphasis is on interventions that address unmet therapeutic needs, meaning applicants should be proposing approaches that fill meaningful gaps where existing options are insufficient, inaccessible, or not effective for key populations.
A defining feature of this opportunity is its alignment with NIMH's experimental therapeutics approach. In practical terms, NIMH is not only looking for trials that test whether an intervention works, but also for trials designed to clarify how it works. Applications are expected to articulate a credible target or mechanism tied to underlying disease processes and to incorporate measures that can demonstrate whether the intervention engages that target and whether changes in that target relate to clinical improvement. The intent is to move beyond simple outcome comparisons and produce interpretable evidence linking intervention effects to hypothesized mechanisms of therapeutic change. This makes the trial design more than a standard efficacy test; it becomes a structured test of a theory of change, grounded in measurable processes.
The award mechanism is the NIH R01 grant, and a clinical trial is required, signaling that proposed work must include a prospective study assigning human participants to one or more interventions to evaluate effects on health-related outcomes. The interventions must be non-pharmacological, which commonly includes areas like psychotherapy and behavioral interventions, device-based or neuromodulation approaches, digital therapeutics, cognitive training, family-based interventions, school-based prevention programs, and other non-drug therapeutic or preventive strategies. While the notice does not list specific allowable modalities, the framing makes clear that the intervention should be therapeutic or preventive in intent and aimed at mental disorders, with rigorous confirmatory testing rather than early exploratory development.
Eligibility is broad and includes many types of domestic and non-domestic organizations. 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; and tribal organizations that are not federally recognized. The opportunity also welcomes public housing authorities/Indian housing authorities, nonprofits with and without 501(c)(3) status (excluding institutions of higher education in those categories), for-profit organizations (including those other than small businesses), and small businesses. The announcement explicitly notes additional eligible applicants 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, regional organizations, U.S. territories or possessions, eligible federal agencies, and foreign (non-U.S.) entities. This broad eligibility signals NIMH's openness to partnerships and trial sites that can reach diverse populations and real-world service settings.
From an administrative standpoint, the opportunity is categorized as a discretionary grant within the health funding activity category and is associated with CFDA (Assistance Listing) number 93.242. The original closing date listed is 2024-10-15. The source information does not specify an award ceiling or expected number of awards, so applicants typically need to rely on NIH R01 budgeting conventions and justify costs based on the scope, sample size, intervention delivery, measurement strategy, and trial operations needed for a confirmatory efficacy study.
Overall, this announcement is aimed at applicants ready to run a definitive test of a non-pharmacological mental health intervention, with the added expectation that the trial will directly probe a hypothesized mechanism tied to mental disorder processes. Competitive applications, by design, would be expected to present a strong scientific rationale for the intervention, a clear statement of the target/mechanism, rigorous and feasible trial methods, and measurement plans capable of showing both clinical benefit and interpretable links between mechanism engagement and outcomes.Apply for PAR 21 132
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (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 2021-03-02.
- Applicants must submit their applications by 2024-10-15. (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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FAQs: PAR-21-132 - Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01 Clinical Trial Required)
What is PAR-21-132?
PAR-21-132 is a National Institute of Mental Health (NIMH) funding opportunity under the National Institutes of Health (NIH) titled "Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01 Clinical Trial Required)." It solicits applications to conduct well-powered, confirmatory efficacy clinical trials of non-pharmacological interventions intended to treat or prevent mental disorders.
Which NIH Institute is offering this opportunity?
This opportunity is offered by the National Institute of Mental Health (NIMH), which is part of the National Institutes of Health (NIH).
Is this a new funding opportunity or related to an earlier one?
This announcement is described as a reissue of an earlier opportunity, RFA-MH-18-707, and it sits within NIMH's clinical trials pipeline.
What is the main purpose of this grant?
The main purpose is to support definitive, confirmatory efficacy trials of non-pharmacological interventions aimed at treating or preventing mental disorders in adults and children. The trials are expected to be well-powered and designed to provide clear, interpretable evidence.
What types of interventions are supported?
The interventions must be non-pharmacological (non-drug). Examples commonly associated with this scope include psychotherapy and behavioral interventions, device-based or neuromodulation approaches, digital therapeutics, cognitive training, family-based interventions, school-based prevention programs, and other non-drug therapeutic or preventive strategies aimed at mental disorders.
Does the announcement list specific intervention modalities that are allowed?
No specific list of allowable modalities is provided in the source information. The key requirement is that the intervention is non-pharmacological, intended to be therapeutic or preventive, and aimed at mental disorders, with confirmatory (not early exploratory) testing.
Is a clinical trial required?
Yes. The opportunity is explicitly labeled "Clinical Trial Required," meaning the proposed project must include a prospective study in which human participants are assigned to one or more interventions to evaluate effects on health-related outcomes.
What does "confirmatory efficacy clinical trial" mean in this context?
Based on the description, NIMH is seeking definitive, well-powered trials designed to test whether an intervention works (efficacy) rather than early-stage, exploratory development. The expectation is rigorous design and adequate power to support clear conclusions.
Who is the target population for the interventions?
The opportunity supports trials that address mental disorders in both adults and children.
What does it mean that the intervention should address "unmet therapeutic needs"?
It means applicants should propose approaches that fill meaningful gaps where existing options are insufficient, inaccessible, or not effective for key populations.
What is NIMH's "experimental therapeutics approach" and why does it matter here?
NIMH emphasizes trials that clarify not only whether an intervention works, but how it works. Applications are expected to identify a credible target or mechanism related to underlying disease processes, include measures to show the intervention engages that target, and test whether changes in the target relate to clinical improvement.
What kind of mechanism information is NIMH expecting in the application?
The application is expected to articulate a credible target or mechanism tied to underlying disease processes, and to incorporate measurements that can demonstrate (1) target engagement and (2) whether target change relates to clinical improvement. The goal is interpretable evidence linking outcomes to a hypothesized mechanism of therapeutic change.
Is it enough to compare outcomes between groups without measuring mechanisms?
No. The source description indicates NIMH intends to move beyond simple outcome comparisons and expects trials to produce interpretable evidence that links intervention effects to hypothesized mechanisms through measurable processes.
What award mechanism is used for this opportunity?
The award mechanism is the NIH R01 grant.
What kind of organizations are eligible to apply?
Eligibility is broad and includes domestic and non-domestic organizations. 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; and tribal organizations that are not federally recognized.
Are nonprofits eligible?
Yes. The opportunity includes nonprofits with and without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories as stated in the source information).
Are for-profit organizations eligible?
Yes. For-profit organizations are eligible, including those other than small businesses.
Are small businesses eligible?
Yes. Small businesses are listed among eligible applicants.
Are school districts and education-focused entities eligible?
Yes. Independent school districts and multiple categories of higher education institutions are included among eligible applicants.
Are tribal governments and tribal organizations eligible?
Yes. Federally recognized Native American tribal governments are eligible, and tribal organizations that are not federally recognized are also included as eligible applicants.
Are U.S. territories eligible?
Yes. U.S. territories or possessions are explicitly noted among eligible applicants.
Are foreign (non-U.S.) entities eligible to apply?
Yes. Foreign (non-U.S.) entities are explicitly listed as eligible applicants.
Are faith-based or community-based organizations eligible?
Yes. The announcement explicitly notes faith-based or community-based organizations among eligible applicants.
Are housing authorities eligible?
Yes. Public housing authorities/Indian housing authorities are listed as eligible applicants.
Are federal agencies eligible to apply?
Yes. Eligible federal agencies are included in the eligibility list provided in the source information.
Does the opportunity encourage partnerships or diverse trial sites?
The broad eligibility, including community-based organizations, schools, governments, higher education, tribal entities, and foreign organizations, signals openness to partnerships and trial sites capable of reaching diverse populations and real-world service settings.
What is the Assistance Listing (CFDA) number for this opportunity?
The opportunity is associated with Assistance Listing (CFDA) number 93.242.
How is this opportunity categorized in terms of funding type and activity?
It is categorized as a discretionary grant within the health funding activity category.
What is the closing date listed for the opportunity?
The original closing date listed in the provided information is 2024-10-15.
Is there an award ceiling or a stated number of expected awards?
The provided information does not specify an award ceiling or an expected number of awards.
How should applicants think about budgeting given the lack of a stated award ceiling?
The source information suggests applicants typically rely on NIH R01 budgeting conventions and justify costs based on the scope of work, including sample size, intervention delivery, measurement strategy, and trial operations needed for a confirmatory efficacy study.
What elements would likely make an application competitive based on the description?
Based on the information provided, competitive applications would be expected to include a strong scientific rationale for the intervention, a clear statement of the target/mechanism, rigorous and feasible confirmatory trial methods, and measurement plans capable of showing clinical benefit and interpretable links between mechanism engagement and outcomes.
Is this opportunity focused on early-stage intervention development?
No. The framing emphasizes rigorous confirmatory testing rather than early exploratory development.
What kinds of outcomes is the trial expected to evaluate?
The trial must evaluate effects on health-related outcomes in human participants, consistent with the definition of a clinical trial described in the source information. In addition, the design is expected to evaluate target engagement and the relationship between target change and clinical improvement.
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