Opportunity Information: Apply for RFA MH 16 425
Apply for RFA MH 16 425
- 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 Mental Health Research Grants.
- This funding opportunity was created on Mar 30, 2015 and posted on Mar 30, 2015.
- Applicants must submit their applications by Oct 14, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $4,000,000.00 to eligible and selected applicants.
- The number of recipients for this funding is limited to 4 candidate(s).
- Eligible applicants include: City or township governments County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Special district governments Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Private institutions of higher education Public and State controlled institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) State governments Independent school districts.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
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Opportunity Summary:
The Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01) funding opportunity (RFA-MH-16-425) was a National Institutes of Health (NIH) grant program designed to pay for rigorous, confirmatory clinical trials that test whether a non-drug intervention truly works for preventing or treating mental disorders in children or adults. The emphasis is on an experimental therapeutics approach, meaning the study cannot just ask "does it help?"; it also needs to test whether the intervention engages a specific, hypothesized mechanism of action and whether changes in that mechanism are meaningfully tied to changes in clinical symptoms or functional outcomes. In practice, the NIH is looking for trials where the scientific payoff is high no matter what the results show, so that the field can make a clear go/no-go decision about whether the intervention should move forward into larger effectiveness studies, broader implementation and dissemination efforts, or be revised or discontinued.
A central expectation of this FOA is that the intervention is non-pharmacological and aimed at mental disorders, with examples explicitly including behavioral, cognitive, interpersonal, and device-based approaches, as well as combinations of these modalities. The intervention being proposed should not be early-stage or speculative. Instead, it should be supported by a compelling scientific rationale, prior evidence that it can engage and alter the proposed mechanism (for example, a neural, cognitive, behavioral, physiological, or social-process target that the treatment is intended to change), and at least some preliminary signal suggesting efficacy. Another key requirement is that the project addresses an unmet therapeutic need, which generally means the intervention aims to fill a gap where existing treatments are insufficient, inaccessible, poorly tolerated, or ineffective for an important group of patients or settings.
The trial itself is expected to be confirmatory and sufficiently powered, which implies a design with enough participants and methodological rigor to produce reliable estimates of efficacy rather than exploratory hints. Importantly, the FOA stresses measurement: applicants are expected to build in assessments of the hypothesized mechanism of action and to analyze the relationship between mechanism change and clinical or functional improvement. This is meant to strengthen interpretation of outcomes. If the trial is positive, it helps show not only that the intervention works, but also that it works through the intended pathway, increasing confidence that it is a robust and generalizable treatment. If the trial is negative, the study should still produce decisive information, such as whether the mechanism was not successfully engaged (suggesting the intervention may need redesign) or whether the mechanism changed without clinical benefit (suggesting the underlying theory may be wrong or incomplete). This focus is intended to reduce wasted effort and help the field move forward based on clear evidence.
Administratively, this was a discretionary NIH grant using the R01 funding mechanism, categorized under health research, with an estimated total funding level of about $4,000,000 and an expected four awards. It fell under CFDA 93.242 (Mental Health Research Grants) and did not require cost sharing or matching. The opportunity was posted March 30, 2015, with an original and current closing date listed as October 14, 2016, and it was archived November 14, 2016. While it is no longer open, the details are still useful as a template for how NIH, and especially NIMH-related programs, often structure clinical trial funding around mechanism-based, decision-oriented efficacy testing.
Eligibility was broad and included many types of organizations that might conduct clinical trials: state, county, city, and special district governments; public housing authorities; independent school districts; public and private institutions of higher education; nonprofits with or without 501(c)(3) status; for-profit organizations (including small businesses); and tribal governments and tribal organizations. The additional eligibility language also extended to a wide range of institution types and community-serving entities, including HBCUs, Hispanic-serving institutions, AANAPISIs, tribally controlled colleges and universities, faith-based or community-based organizations, U.S. territories or possessions, regional organizations, eligible federal agencies, and even non-U.S. (foreign) entities. This wide eligibility reflects the reality that impactful mental health intervention research can be developed and tested in academic medical centers, community clinics, schools, tribal and territorial health systems, and other real-world settings, as long as the research team can deliver a rigorous, mechanism-informed clinical trial.
In short, the FOA funded well-justified, mechanism-testing, adequately powered efficacy trials of non-drug interventions for mental disorders, with the explicit goal of generating clear, high-utility evidence that supports confident next-step decisions about whether an intervention merits broader testing, scaling, or dissemination.
Frequently Asked Questions (FAQs)
What is the purpose of the Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01) opportunity (RFA-MH-16-425)?
This NIH funding opportunity was designed to support rigorous, confirmatory clinical trials that test whether a non-pharmacological (non-drug) intervention truly works to prevent or treat mental disorders in children or adults. A key goal was to generate clear, decision-ready evidence so the field can make a confident go/no-go determination about whether an intervention should move forward, be revised, or be discontinued.
Is this funding opportunity still open?
No. The opportunity is archived and no longer accepting applications. It listed an original and current closing date of October 14, 2016, and it was archived on November 14, 2016.
What funding mechanism was used?
This was a discretionary NIH grant using the R01 funding mechanism.
Which NIH program area did this opportunity fall under?
It was categorized under health research and aligned with mental health research funding. The CFDA listing provided was 93.242 (Mental Health Research Grants).
What types of interventions were supported?
The FOA focused on non-pharmacological interventions for mental disorders. Examples explicitly included behavioral, cognitive, interpersonal, and device-based approaches, as well as combinations of these modalities.
What does "non-pharmacological" mean in this FOA?
In this context, non-pharmacological means the intervention is not a drug treatment. The emphasis is on interventions like behavioral therapies, cognitive approaches, interpersonal treatments, devices, or combinations of these, aimed at preventing or treating mental disorders.
What is meant by a "confirmatory" efficacy clinical trial?
A confirmatory trial, as described here, is expected to be adequately powered and methodologically rigorous so it can produce reliable estimates of efficacy rather than exploratory or preliminary hints. The intention is to yield results that support clear next-step decisions.
What does "sufficiently powered" imply for trial design?
It implies enrolling enough participants and using enough methodological rigor to generate reliable, credible estimates of efficacy, rather than an underpowered study that can only suggest trends.
What is the "experimental therapeutics" approach referenced in the opportunity?
The experimental therapeutics approach means the study cannot only ask whether an intervention helps. It must also test whether the intervention engages a specific, hypothesized mechanism of action, and whether changes in that mechanism are meaningfully tied to changes in clinical symptoms or functional outcomes.
What is a "mechanism of action" in this FOA?
A mechanism of action is the specific, hypothesized process the intervention is intended to change. The FOA gave examples of targets such as neural, cognitive, behavioral, physiological, or social-process mechanisms.
What kind of measurements were expected in the trial?
The FOA emphasized measurement of the hypothesized mechanism of action and analysis of the relationship between mechanism change and clinical or functional improvement. This measurement-focused design is meant to strengthen how results are interpreted.
Why does the FOA require testing the link between mechanism change and clinical outcomes?
Because the NIH goal here was not just to see if an intervention works, but to understand whether it works through the intended pathway. This helps increase confidence in positive findings and makes negative findings more informative by clarifying what failed (mechanism engagement, the theory, or the clinical impact).
What kinds of outcomes were considered important?
The FOA highlights clinical symptoms and functional outcomes, and expects applicants to evaluate whether changes in the hypothesized mechanism relate meaningfully to improvement in those outcomes.
What level of prior evidence was expected for an intervention?
The intervention should not be early-stage or speculative. It was expected to be supported by a compelling scientific rationale, prior evidence that it can engage and alter the proposed mechanism, and at least some preliminary signal suggesting efficacy.
Does this opportunity support early-stage or speculative interventions?
No. The FOA indicated the proposed intervention should not be early-stage or speculative; it should already have a strong rationale and evidence supporting mechanism engagement and preliminary efficacy.
What is an "unmet therapeutic need" in the context of this FOA?
It generally means the intervention addresses a gap where existing treatments are insufficient, inaccessible, poorly tolerated, or ineffective for an important patient group or setting.
Why did the FOA emphasize "high scientific payoff" regardless of results?
The NIH sought trials designed to be informative whether outcomes were positive or negative. A positive trial would support moving forward; a negative trial should still clarify whether the intervention failed to engage the mechanism (suggesting redesign) or whether the mechanism changed without clinical benefit (suggesting the underlying theory may be wrong or incomplete).
How would a positive trial be interpreted under this FOA?
A positive trial would ideally show both that the intervention improves clinical or functional outcomes and that it does so through the intended mechanism, supporting confidence that the treatment is robust and potentially generalizable.
How would a negative trial still be considered useful?
The FOA aimed for decisive information. A negative outcome could reveal that the mechanism was not engaged (suggesting the intervention needs revision) or that the mechanism changed without clinical benefit (suggesting the theory behind the intervention may be incomplete or incorrect).
Who was eligible to apply?
Eligibility was broad and included many organization types capable of conducting clinical trials, including state, county, city, and special district governments; public housing authorities; independent school districts; public and private institutions of higher education; nonprofits with or without 501(c)(3) status; for-profit organizations (including small businesses); tribal governments and tribal organizations; and additional institution types such as HBCUs, Hispanic-serving institutions, AANAPISIs, tribally controlled colleges and universities, faith-based or community-based organizations, U.S. territories or possessions, regional organizations, eligible federal agencies, and non-U.S. (foreign) entities.
Could for-profit organizations apply?
Yes. The eligibility list included for-profit organizations, including small businesses.
Could tribal governments or tribal organizations apply?
Yes. Tribal governments and tribal organizations were included in the eligibility description.
Could schools or school districts apply?
Yes. Independent school districts were included, reflecting that mental health intervention research may be tested in school settings when a rigorous trial is feasible.
Could community-based or faith-based organizations apply?
Yes. The additional eligibility language included faith-based and community-based organizations.
Were non-U.S. (foreign) entities eligible?
Yes. The eligibility language explicitly included non-U.S. (foreign) entities.
Did the FOA require cost sharing or matching funds?
No. The opportunity indicated that cost sharing or matching was not required.
How much funding was available and how many awards were expected?
The estimated total funding level was about $4,000,000, with an expected four awards.
When was the opportunity posted and when did it close?
It was posted on March 30, 2015. The original and current closing date listed was October 14, 2016.
What was the overall decision-making goal of the funded trials?
The trials were intended to support clear next steps, such as moving an intervention into larger effectiveness studies, broader implementation and dissemination efforts, revising the intervention, or discontinuing it based on decisive evidence.
Can the details of this archived FOA still be useful?
Yes. Even though it is no longer open, the description can serve as a template for how NIH (including NIMH-related programs) often structures clinical trial funding around mechanism-based, decision-oriented efficacy testing.
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