Opportunity Information: Apply for PAR 21 135
The National Institute of Mental Health (NIMH), under the National Institutes of Health (NIH), is soliciting applications for a phased grant opportunity titled Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R61/R33 Clinical Trial Required), funding opportunity number PAR-21-135. This announcement is a reissue of an earlier NIMH request (RFA-MH-18-704) and sits within NIMH's broader clinical trials pipeline. The overall goal is to accelerate the creation and early testing of new psychosocial interventions, or new intervention targets, that could prevent mental disorders or improve treatment outcomes. The emphasis is not simply on showing that an intervention "works," but on building interventions in a way that clearly tests mechanisms of change, consistent with NIMH's experimental therapeutics approach.
A central feature of this opportunity is its focus on translating advances from basic and applied science into real-world preventive or therapeutic strategies. The FOA encourages investigators to draw from developments in behavioral science, cognitive science, affective science, and neuropsychological research to identify promising targets (for example, a specific cognitive bias, emotion regulation process, social learning mechanism, or other modifiable process linked to symptoms or functioning). Applicants are expected to design psychosocial interventions that can engage those targets in measurable ways, and then connect that target engagement to clinically meaningful improvement. In practical terms, the work is meant to move beyond broad intervention packages and toward interventions that can demonstrate, with data, that they are affecting the intended mechanism and that this mechanistic change is tied to changes in clinical outcomes.
The grant uses a two-phase R61/R33 structure. The R61 phase supports early, milestone-driven work for up to two years. This first phase is intended for piloting, refining, and parameter-setting, with a strong focus on evaluating whether the intervention actually engages the proposed target and on establishing key intervention parameters (such as dose, intensity, delivery format, feasibility benchmarks, fidelity procedures, and measures sensitive to change). If the project meets its prespecified milestones, it can transition into the R33 phase, which can provide up to three additional years. The R33 phase is designed to replicate target engagement findings from earlier work and to more directly test whether target engagement is associated with improvement in one or more clinical outcomes. Across both phases, clinical trials are required, meaning the project must involve prospective assignment to an intervention condition and evaluation of outcomes in a way that meets NIH's definition of a clinical trial.
The opportunity is categorized as a discretionary grant within the health funding activity area, associated with CFDA number 93.242. While the notice does not specify an award ceiling or expected number of awards in the provided excerpt, it does indicate an original closing date of October 15, 2024, and a creation date of March 2, 2021. Because the mechanism is milestone-driven, applicants should expect that clear, objective go/no-go criteria and rigorous measurement plans will be important to competitiveness, particularly around how target engagement will be assessed and how links between mechanistic change and clinical endpoints will be evaluated.
Eligibility is broad and includes many types of domestic applicants such as state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; and federally recognized Native American tribal governments. Eligible organizational applicants also include public housing authorities and Indian housing authorities; Native American tribal organizations that are not federally recognized tribal governments; nonprofit organizations with or without 501(c)(3) status (excluding institutions of higher education when specified in the eligibility listing); for-profit organizations other than small businesses; and small businesses. In addition, the FOA explicitly highlights other 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, eligible federal government agencies, regional organizations, U.S. territories or possessions, and even non-U.S. entities (foreign organizations). This wide eligibility scope signals NIMH's interest in supporting diverse research teams and settings, including community-linked organizations that may be well positioned to develop and test interventions in populations with unmet needs.
In summary, PAR-21-135 is aimed at early-stage, mechanism-focused development of psychosocial preventive and therapeutic interventions for mental disorders, using a structured R61/R33 pathway to move from initial target engagement testing and intervention optimization to replication of target engagement and evaluation of how mechanistic change relates to clinical improvement. The defining expectation is a rigorous experimental therapeutics framework: identify a plausible, measurable target; show that the intervention engages it; and demonstrate that engaging it matters for clinical outcomes.Apply for PAR 21 135
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R61/R33 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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Frequently Asked Questions (FAQs)
What is the name of this funding opportunity?
The opportunity is titled Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R61/R33 Clinical Trial Required).
What is the funding opportunity number?
The funding opportunity number is PAR-21-135.
Which agency is offering this grant?
This opportunity is offered by the National Institute of Mental Health (NIMH), which is part of the National Institutes of Health (NIH).
What is the overall goal of PAR-21-135?
The goal is to accelerate the creation and early testing of new psychosocial interventions (or new intervention targets) that could prevent mental disorders or improve treatment outcomes, with a strong emphasis on showing how and why an intervention works through measurable mechanisms of change.
What kinds of interventions does this FOA focus on?
The FOA focuses on psychosocial therapeutic and preventive interventions for mental disorders. It is aimed at developing interventions that are built to test specific mechanisms of change rather than only evaluating broad treatment packages.
Is this opportunity focused on effectiveness (does it work) or mechanisms (how it works)?
The emphasis is on mechanisms. The FOA highlights NIMH's experimental therapeutics approach, where applicants are expected to identify a plausible target, show the intervention engages that target, and link that engagement to clinically meaningful outcomes.
What does "experimental therapeutics approach" mean in this FOA?
In this context, it means the project should (1) identify a measurable, modifiable target tied to symptoms or functioning, (2) design an intervention that engages that target in measurable ways, and (3) evaluate whether changes in that target are connected to improvements in clinical outcomes.
What are examples of intervention targets mentioned or implied by the FOA?
The FOA encourages targets informed by behavioral and brain-related sciences, such as a cognitive bias, an emotion regulation process, a social learning mechanism, or other modifiable processes linked to symptoms or functioning.
What fields of science does the FOA encourage applicants to draw from?
The FOA encourages translation from advances in behavioral science, cognitive science, affective science, and neuropsychological research into preventive or therapeutic strategies.
What grant mechanism is used?
This opportunity uses a two-phase R61/R33 grant structure.
How long is the R61 phase?
The R61 phase supports early, milestone-driven work for up to two years.
What is the purpose of the R61 phase?
The R61 phase is intended for piloting, refining, and parameter-setting, with a strong focus on determining whether the intervention engages the proposed target and establishing key parameters such as dose, intensity, delivery format, feasibility benchmarks, fidelity procedures, and measures sensitive to change.
How long is the R33 phase?
The R33 phase can provide up to three additional years after R61.
What is the purpose of the R33 phase?
The R33 phase is designed to replicate target engagement findings from earlier work and to more directly test whether target engagement is associated with improvement in one or more clinical outcomes.
Does a project automatically move from R61 to R33?
No. Transition to the R33 phase depends on whether the project meets its prespecified milestones (objective go/no-go criteria) established for the R61 phase.
Why are milestones so important in this FOA?
Because the mechanism is milestone-driven, applicants should expect that competitiveness will depend heavily on clear, objective milestones and rigorous plans for measuring target engagement and linking mechanistic change to clinical outcomes.
Are clinical trials required?
Yes. This FOA is labeled Clinical Trial Required, and it states that clinical trials are required across both phases.
What does "clinical trial required" mean here?
It means the project must involve prospective assignment to an intervention condition and evaluation of outcomes in a manner that meets NIH's definition of a clinical trial.
What type of research pipeline is this FOA part of?
This announcement sits within NIMH's broader clinical trials pipeline, with an emphasis on early-stage development and testing of mechanistically informed psychosocial interventions.
Is this FOA a reissue of a prior announcement?
Yes. It is a reissue of an earlier NIMH request, RFA-MH-18-704.
What is the activity area and type of grant?
The opportunity is categorized as a discretionary grant within the health funding activity area.
What is the CFDA number associated with this opportunity?
The associated CFDA number is 93.242.
What is the original closing date mentioned in the provided information?
The excerpt indicates an original closing date of October 15, 2024.
What is the creation date listed for this opportunity?
The provided information lists a creation date of March 2, 2021.
Does the provided excerpt specify an award ceiling or the expected number of awards?
No. The excerpt notes that an award ceiling and expected number of awards are not specified in the provided information.
Who is eligible to apply?
Eligibility is broad and includes many domestic applicant types such as state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; and federally recognized Native American tribal governments.
Are nonprofit organizations eligible?
Yes. Eligible organizations include nonprofit organizations with or without 501(c)(3) status (with the eligibility listing noting exclusions related to institutions of higher education when specified).
Are for-profit organizations eligible?
Yes. The eligibility list includes for-profit organizations other than small businesses as well as small businesses.
Are tribal organizations eligible?
Yes. The FOA includes federally recognized Native American tribal governments and also Native American tribal organizations that are not federally recognized tribal governments.
Are U.S. territories or possessions eligible?
Yes. The FOA explicitly includes U.S. territories or possessions as eligible applicants.
Are foreign (non-U.S.) organizations eligible to apply?
Yes. The FOA explicitly states that non-U.S. entities (foreign organizations) are eligible.
Are community-based or faith-based organizations eligible?
Yes. The FOA highlights faith-based or community-based organizations as among the eligible applicants.
Are certain institution types explicitly highlighted as eligible?
Yes. The FOA explicitly highlights eligibility for institutions such as 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).
Are public housing authorities eligible?
Yes. The eligibility list includes public housing authorities and Indian housing authorities.
Are eligible federal government agencies included?
Yes. The FOA includes eligible federal government agencies.
What kinds of studies are expected during intervention development?
Across the two phases, the FOA emphasizes studies that (1) test whether the intervention engages the target, (2) refine and optimize intervention parameters (dose, intensity, format, feasibility, fidelity), and (3) evaluate whether mechanistic change is tied to clinical outcomes.
What are examples of intervention parameters the FOA expects applicants to establish?
The FOA mentions parameters such as dose, intensity, delivery format, feasibility benchmarks, fidelity procedures, and measures sensitive to change.
What is meant by "target engagement" in this FOA?
Target engagement refers to demonstrating with data that the intervention is actually affecting the intended mechanism (the proposed cognitive, emotional, behavioral, or social process) in measurable ways.
What is meant by linking target engagement to clinical outcomes?
It means evaluating whether measured changes in the target are associated with improvement in one or more clinically meaningful outcomes (for example, symptom change or functional improvement), consistent with the experimental therapeutics framework described in the FOA.
What is the defining expectation of a competitive application based on the excerpt?
The defining expectation is a rigorous experimental therapeutics plan: identify a plausible, measurable target; show the intervention engages it; and demonstrate that engaging it matters for clinical outcomes, supported by clear milestones and rigorous measurement strategies.
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