Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01) | RFA MH 17 614

Opportunity Information: Apply for RFA MH 17 614

This grant opportunity, titled "Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01)" (Funding Opportunity Number RFA-MH-17-614), is a National Institutes of Health (NIH) funding announcement in the health area (CFDA 93.242) focused on running rigorous clinical trials that test whether a non-drug intervention truly works for mental disorders in adults and children. The central aim is confirmatory efficacy testing, meaning the trials should be large and well-controlled enough to give a clear answer about clinical benefit under research conditions, rather than early-stage feasibility or broad real-world implementation. A defining feature is that these studies must be built to generate results with high scientific value even if the intervention does not outperform a control, so that the field can make informed "go/no-go" decisions about whether to move the intervention forward into larger effectiveness trials, further development, or dissemination efforts.

A key expectation is the use of an experimental therapeutics approach. In practice, that means applicants are not only asked to test outcomes, but also to directly measure the intervention's hypothesized mechanism of action and demonstrate how changes in that mechanism relate to changes in clinical symptoms or functional outcomes. The trial is expected to evaluate whether the intervention engages its intended target (for example, a cognitive process, neural circuit, behavioral pattern, social-interpersonal mechanism, or physiological marker) and whether engagement of that target helps explain improvements that matter to patients, such as symptom reduction, functional gains, or prevention of disorder onset or relapse. This emphasis is meant to ensure the trial produces interpretable evidence about how and why an intervention works (or does not), which strengthens future decision-making and reduces the risk of investing in approaches that cannot be meaningfully advanced.

The FOA supports non-pharmacological interventions broadly defined. Examples explicitly encouraged include behavioral, cognitive, and interpersonal therapies, as well as device-based approaches. Device-based methods can be invasive or surgically implanted, or noninvasive approaches such as transcranial or other neuromodulation techniques, and combinations of approaches are also within scope. Importantly, the intervention proposed for confirmatory efficacy testing is expected to rest on a strong scientific rationale and prior evidence. The announcement highlights that appropriate candidates should already have (1) a compelling theoretical or empirical basis, (2) prior demonstration that the intervention engages and alters the proposed mechanism of action, and (3) a preliminary efficacy signal suggesting the approach may improve clinical or functional outcomes. In addition, the intervention should address an unmet therapeutic need, which generally implies it targets populations, outcomes, or conditions where current options are insufficient, ineffective, poorly tolerated, inaccessible, or otherwise lacking.

From a study design standpoint, the FOA is aimed at sufficiently powered efficacy trials, meaning the sample size and analytic plan should be capable of detecting clinically meaningful effects and supporting strong conclusions. The intention is not a small pilot or proof-of-concept study, but a more definitive test that can guide next steps. Because the goal includes actionable "go/no-go" decisions, applicants are implicitly encouraged to propose designs that are tight on internal validity, incorporate appropriate comparison conditions, and include robust measurement of both the mechanistic target and the clinical or functional endpoints. The desired outcome is a clear determination of the intervention's potential for significant clinical benefit, along with mechanistic evidence that clarifies whether the hypothesized pathway is actually responsible for any observed change.

Eligibility is broad and includes many types of organizations that commonly participate in NIH-funded clinical research. Eligible applicants include state, county, city, township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations with or without 501(c)(3) status (excluding higher education institutions where specified); public housing authorities/Indian housing authorities; federally recognized Native American tribal governments; and Native American tribal organizations other than federally recognized tribal governments. The FOA also allows applications from for-profit organizations (other than small businesses) and small businesses, and it lists additional eligible categories 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 agencies, regional organizations, U.S. territories or possessions, and even non-U.S. entities (foreign organizations). This wide eligibility reflects an interest in drawing on diverse research settings and expertise, including community-based and culturally specific institutions, as long as the proposed trial meets the scientific and methodological expectations.

Administratively, the opportunity is an NIH discretionary grant using the R01 mechanism, which typically supports mature, multi-year research projects with well-developed methods and leadership structures. The posting indicates a creation date of 2016-12-13 and an original closing date of 2017-11-14 (meaning this specific announcement window is historical as provided in the source data). While an award ceiling and expected number of awards are not specified in the provided details, the overall framing makes clear that the program is intended to fund well-designed, adequately powered confirmatory trials rather than smaller exploratory studies. In short, this FOA is best understood as support for decisive, mechanism-informed clinical efficacy trials of non-pharmacological interventions for mental disorders, designed to produce highly informative results that can guide whether an intervention should advance toward broader testing and eventual dissemination.

• 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)" 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 2016-12-13.
• Applicants must submit their applications by 2017-11-14. (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 17 614

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