Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01- Clinical Trial Required) | RFA MH 18 707

Opportunity Information: Apply for RFA MH 18 707

This funding opportunity, titled "Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01 - Clinical Trial Required)" (RFA-MH-18-707), is a National Institutes of Health (NIH) discretionary grant program focused on running well-designed, confirmatory efficacy clinical trials for non-drug interventions aimed at preventing or treating mental disorders in both adults and children. It sits within the NIH health research mission (CFDA 93.242) and uses the R01 grant mechanism, with the important requirement that applicants propose an actual clinical trial.

The central goal is to support trials that do more than test whether an intervention "works" in a general sense. The FOA requires an experimental therapeutics approach, meaning the study needs to explicitly test a hypothesized mechanism of action and show whether the intervention meaningfully engages and changes that mechanism. Just as important, the trial must evaluate how changes in that mechanism relate to changes in clinical outcomes or real-world functioning. In practical terms, the funder is looking for studies that can explain not only if outcomes improve, but also why they improve, based on measurable biological, psychological, behavioral, or other mechanistic targets.

A defining feature of this opportunity is its emphasis on decision-quality evidence. Trials must be designed so that the results are highly informative regardless of whether they are positive or negative. The expectation is that the findings will directly support clear "go/no-go" decisions about what should happen next: further development, larger effectiveness testing in real-world settings, or broader dissemination and implementation. This pushes applicants to propose rigorous designs, meaningful outcome measures, and adequate statistical power so that the results can credibly guide next steps in the intervention pipeline.

The interventions eligible under this FOA are strictly non-pharmacological and can include a wide range of therapeutic and preventive approaches. Examples include behavioral interventions, cognitive and cognitive-behavioral strategies, interpersonal therapies, and device-based interventions. Device approaches may be invasive or surgically implanted, as well as noninvasive, including transcranial methods. Combination interventions are also allowed when scientifically justified. What matters most is that the intervention has a solid scientific foundation and is far enough along that confirmatory efficacy testing is appropriate.

To be considered appropriate for this confirmatory stage, the intervention is expected to meet several readiness criteria. It should be grounded in a compelling scientific rationale, with prior evidence that it engages the proposed mechanism of action (not just theoretical arguments). It should also show a preliminary efficacy signal, indicating that earlier studies have suggested potential clinical benefit. Finally, it must address an unmet therapeutic need, reinforcing that the work has meaningful potential impact for populations where current options are limited, ineffective, difficult to access, or otherwise insufficient.

The FOA supports a sufficiently powered efficacy trial, meaning applicants are expected to propose a study large and rigorous enough to detect clinically meaningful effects and to evaluate the mechanistic pathway. This generally implies careful attention to sample size justification, participant selection, trial design features that reduce bias, and outcomes that reflect clinically and functionally relevant change. Mechanism measurement is not optional; it is a core requirement, along with analysis of the relationship between mechanistic change and clinical or functional improvement.

Eligibility is broad and includes many types of U.S. and non-U.S. organizations. Eligible applicants include state, county, city or township governments, special district governments, and independent school districts, as well as public and state-controlled institutions of higher education and private institutions of higher education. Tribal entities are eligible, including federally recognized Native American tribal governments and other Native American tribal organizations. The opportunity is also open to public housing authorities and Indian housing authorities, nonprofits with and without 501(c)(3) status, for-profit organizations (other than small businesses), and small businesses. Additional explicitly listed eligible groups include 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 agencies, regional organizations, non-domestic (non-U.S.) entities, and U.S. territories or possessions.

Key administrative details provided in the source include the NIH as the sponsoring agency, the funding instrument type as a grant, and the activity category as health. The original closing date listed is February 18, 2021, and the FOA creation date is November 14, 2017. The award ceiling and expected number of awards are not specified in the provided data, which typically means applicants would need to consult the full announcement or NIH budget guidance to understand any practical funding limits or anticipated award volume.

Overall, this FOA is aimed at mature, well-justified non-pharmacological interventions that are ready for a definitive efficacy test, with mechanistic measurement built in, and with a study design strong enough to produce results that can confidently drive next-stage development or determine that further investment is not warranted.

• 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 2017-11-14.
• 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.

Apply for RFA MH 18 707

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: