Opportunity Information: Apply for RFA MH 18 704
The National Institutes of Health (NIH) funding opportunity titled "Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R61/R33 - Clinical Trial Required)" is designed to accelerate the early-stage development of new psychosocial treatments and prevention approaches for mental disorders across the lifespan, including both adults and children. The central goal is to fund efficient, milestone-driven clinical trials that test whether a novel intervention meaningfully affects a clearly defined target that is believed to play a role in the risk for, cause of, or maintenance of a mental disorder. The announcement uses an "experimental therapeutics" framework, meaning the study is not just about whether symptoms improve, but whether the intervention engages a specific mechanism or process in a measurable way. A key expectation is that the trial will produce results that remain scientifically valuable even if the intervention does not work as hoped, because the findings should still help the field decide whether the intervention should move forward, be revised, or be discontinued.
This FOA focuses on innovation in either (1) the intervention target or (2) the intervention strategy. Targets can include modifiable behavioral, cognitive, affective, or interpersonal processes, as well as neural circuits, patterns of neural activity tied to specific behaviors or cognitive functions, or other neurobiological mechanisms linked to mental disorders. In other words, applicants are expected to ground their intervention in contemporary basic science about how mental disorders emerge and persist, then translate that science into an intervention that can be tested in a structured way. The intervention itself can be delivered in person, through technology (such as digital tools or telehealth-enabled approaches), or via other formats, as long as what is being tested is genuinely novel in its target and/or strategy. The FOA also allows these psychosocial interventions to be tested either as stand-alone treatments (monotherapies) or as additions that augment standard care, as long as the study design can isolate and evaluate the proposed mechanism and its relationship to outcomes.
The award mechanism is a phased R61/R33 grant, which is meant to support fast, evidence-based decisions about whether further investment is justified. The first phase (R61) provides up to two years of support for preliminary, milestone-driven testing, with an emphasis on demonstrating target engagement. Target engagement here means showing that the intervention measurably changes the proposed mechanism or process it is designed to affect, not simply that participants report feeling better. This early phase is built around explicit "go/no-go" milestones, so the project should be structured with clear decision points and measurable criteria that determine whether it is ready to advance. If the project meets those milestones, the second phase (R33) can provide up to three additional years of funding. In the R33 phase, the work typically expands to replicate the target engagement finding and, critically, to test whether changes in the target/mechanism are linked to meaningful clinical benefit, such as symptom reduction, improved functioning, or reduced risk of developing a disorder for prevention-focused projects.
A defining feature of this opportunity is its insistence on high-utility results. Applicants are expected to design trials so that, regardless of whether the intervention produces the desired clinical outcomes, the study still provides strong evidence about whether the hypothesized mechanism was engaged and whether engaging it appears to matter for clinical change. This emphasis helps avoid ambiguous trials that only measure symptom shifts without clarifying why they occurred, and it supports faster scientific learning by making it easier to decide what to refine, what to scale, and what to abandon. Overall, the program is intended to shorten the path from basic mechanistic discoveries (for example, findings about specific cognitive biases, interpersonal dynamics, affect regulation processes, or neurobiological pathways) to interventions that can restore functioning, reduce symptoms, or prevent the onset of mental disorders among people at risk.
From an eligibility and administrative standpoint, this is a discretionary NIH grant in the health funding category (CFDA 93.242), listed under Funding Opportunity Number RFA-MH-18-704. A wide range of applicants can apply, including state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (other than small businesses); and small businesses. The FOA also explicitly highlights additional eligible applicant types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and even non-U.S. entities (foreign organizations), reflecting an intent to broaden participation and encourage diverse research settings and partnerships.
Finally, this opportunity is explicitly a clinical trial required announcement, meaning applicants must be proposing a clinical trial that tests the psychosocial intervention in human participants. The original posting indicates a creation date of November 13, 2017, with an original closing date of February 18, 2021. Even though those dates describe that specific listing, the core structure and intent of the FOA are clear: fund early, rigorous, mechanism-focused psychosocial intervention studies with built-in decision rules, and use that disciplined approach to speed the development of next-generation treatments and prevention strategies for mental disorders.Apply for RFA MH 18 704
- 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 2017-11-13.
- Applicants must submit their applications by 2021-02-18. (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 title of this NIH funding opportunity?
The funding opportunity is titled "Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R61/R33 - Clinical Trial Required)."
What is the main purpose of this opportunity?
The purpose is to accelerate early-stage development of new psychosocial treatments and prevention approaches for mental disorders across the lifespan by funding efficient, milestone-driven clinical trials that test whether a novel intervention meaningfully affects a clearly defined target believed to contribute to the risk for, cause of, or maintenance of a mental disorder.
Which NIH framework guides the research approach for this FOA?
The FOA uses an "experimental therapeutics" framework. This means projects are expected to test not only whether clinical outcomes change (such as symptoms), but also whether the intervention measurably engages a specific hypothesized mechanism or process.
What does "experimental therapeutics" mean in practical terms for the trial design?
In practical terms, the trial should be designed to measure whether the intervention changes a specific target/mechanism (target engagement) and to evaluate whether engaging that target is related to meaningful clinical benefit. The study is expected to remain scientifically informative even if clinical outcomes do not improve as hoped, because it should still clarify whether the mechanism was engaged and whether that engagement appears to matter.
What kinds of interventions does this FOA support?
This FOA supports psychosocial therapeutic and preventive interventions for mental disorders. The intervention can be delivered in person, via technology (including digital tools and telehealth-enabled approaches), or other formats, as long as what is being tested is genuinely novel in its target and/or strategy.
Is the opportunity focused on treatment only, or does it include prevention?
It includes both treatment and prevention. The FOA is intended to support interventions that can reduce symptoms and restore functioning as well as approaches aimed at reducing risk or preventing the onset of mental disorders among people at risk.
What populations are included?
The FOA addresses mental disorders across the lifespan, including both adults and children.
What is meant by innovation in the "intervention target" versus the "intervention strategy"?
The FOA emphasizes innovation in either (1) the intervention target (the mechanism/process the intervention is designed to change) or (2) the intervention strategy (the way the intervention is designed or delivered). Applicants are expected to justify novelty in at least one of these areas.
What types of targets/mechanisms are considered appropriate?
Targets can include modifiable behavioral, cognitive, affective, or interpersonal processes, as well as neural circuits, patterns of neural activity tied to specific behaviors or cognitive functions, or other neurobiological mechanisms linked to mental disorders.
Does the FOA require grounding the intervention in basic science?
Yes. Applicants are expected to ground the intervention in contemporary basic science about how mental disorders emerge and persist, and then translate that mechanistic understanding into an intervention that can be tested in a structured way.
Can the psychosocial intervention be tested as a stand-alone treatment?
Yes. The FOA allows psychosocial interventions to be tested as stand-alone treatments (monotherapies).
Can the intervention be tested as an add-on to standard care?
Yes. Interventions may be tested as additions that augment standard care, as long as the study design can isolate and evaluate the proposed mechanism and its relationship to outcomes.
What grant mechanism is used for this opportunity?
The opportunity uses a phased R61/R33 award mechanism.
How does the R61/R33 phased structure work?
The R61 phase provides up to two years of support for preliminary, milestone-driven testing with an emphasis on demonstrating target engagement. If explicit go/no-go milestones are met, the project can transition to the R33 phase, which can provide up to three additional years to expand the work (typically to replicate target engagement and test whether target change is linked to meaningful clinical benefit).
How long can the R61 phase last?
Up to two years.
How long can the R33 phase last?
Up to three additional years, contingent on meeting R61 milestones and transition criteria.
What are "go/no-go" milestones in this FOA?
They are explicit, measurable decision points built into the R61 phase that determine whether the project should advance to the R33 phase. The project is expected to include clear criteria and decision rules that support fast, evidence-based decisions about whether further investment is justified.
What does "target engagement" mean in this program?
Target engagement means showing that the intervention measurably changes the proposed mechanism or process it is designed to affect. It is not limited to participants reporting symptom improvement; it requires evidence that the hypothesized target itself has been affected.
What is expected in the R33 phase beyond target engagement?
The R33 phase typically expands to replicate the target engagement finding and to test whether changes in the target/mechanism are linked to meaningful clinical benefit (for example, symptom reduction, improved functioning, or reduced risk of developing a disorder for prevention-focused projects).
Why does the FOA emphasize "high-utility" results?
The FOA prioritizes trials that deliver clear, decision-relevant evidence. The intent is that, even if the intervention does not produce the desired clinical outcomes, the study still provides strong evidence about whether the mechanism was engaged and whether engaging it appears to matter. This supports faster learning about what to refine, scale, or discontinue.
Does this FOA require a clinical trial?
Yes. This is explicitly a "Clinical Trial Required" announcement, meaning applicants must propose a clinical trial testing the psychosocial intervention in human participants.
What is the Funding Opportunity Number for this FOA?
The Funding Opportunity Number is RFA-MH-18-704.
What is the CFDA number and funding category?
It is listed under CFDA 93.242 and is in the health funding category.
What kinds of organizations are eligible to apply?
A wide range of applicants are eligible, including state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (other than small businesses); and small businesses.
Are minority-serving institutions and community-based organizations explicitly included as eligible applicants?
Yes. The FOA explicitly highlights eligibility for organizations such as HBCUs, Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), and faith-based or community-based organizations, among others.
Are U.S. territories and non-U.S. entities eligible?
Yes. The FOA highlights eligibility that includes U.S. territories or possessions and non-U.S. entities (foreign organizations).
When was the original posting created, and what was the original closing date?
The original posting indicates a creation date of November 13, 2017, with an original closing date of February 18, 2021.
What kind of outcomes are considered "meaningful clinical benefit" in this FOA?
Examples described include symptom reduction, improved functioning, and (for prevention-focused projects) reduced risk of developing a disorder. The FOA emphasizes linking these outcomes to changes in the hypothesized target/mechanism.
What is the core scientific expectation even if the intervention does not work as intended?
The trial should still produce scientifically valuable results by clearly testing whether the hypothesized mechanism was engaged and whether engaging it appears related to clinical change. The findings should help determine whether the intervention should move forward, be revised, or be discontinued.
What is the overall program goal beyond a single trial?
The broader goal is to shorten the path from basic mechanistic discoveries (for example, findings about cognitive biases, interpersonal dynamics, affect regulation processes, or neurobiological pathways) to interventions that can restore functioning, reduce symptoms, or prevent the onset of mental disorders.
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