Opportunity Information: Apply for RFA MH 15 340
Apply for RFA MH 15 340
- 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 Jan 27, 2015 and posted on May 14, 2014.
- Applicants must submit their applications by Feb 19, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $5,000,000.00 to eligible and selected applicants.
- The number of recipients for this funding is limited to 5 candidate(s).
- Eligible applicants include: County governments 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 Independent school districts Private institutions of higher education City or township governments For profit organizations other than small businesses Public housing authorities/Indian housing authorities State governments Special district governments Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Public and State controlled institutions of higher education Native American tribal governments (Federally recognized).
- 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 Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The NIH funding opportunity RFA-MH-15-340, titled "Confirmatory Efficacy Clinical Trials of Non Pharmacological Interventions for Mental Disorders (R01)," was designed to fund well powered, confirmatory efficacy clinical trials of non pharmacological interventions aimed at preventing or treating mental disorders in both children and adults. The emphasis is on moving beyond early stage or purely exploratory work and instead running rigorous trials that can clearly answer whether an intervention is ready to move forward toward broader development, scaling, or later stage effectiveness testing. A central expectation is that the study will generate results that are scientifically useful regardless of whether the intervention ultimately works; in other words, even negative findings should be interpretable and capable of informing a clear go/no go decision about next steps.
A defining feature of this FOA is its requirement for an experimental therapeutics approach. That means applicants are expected to specify a hypothesized mechanism of action for the intervention and then build the trial around testing not only clinical outcomes, but also whether the intervention actually engages that mechanism. The trial should include measurement of the proposed target or mechanism and evaluate the relationship between changes in that mechanism and changes in clinical symptoms and/or functional outcomes. This is meant to strengthen the science behind intervention development by clarifying why an intervention works (or does not), not simply whether participants improve on average.
The interventions envisioned under this announcement are non pharmacological and can include behavioral, cognitive, interpersonal, or combined approaches, among others. The FOA is geared toward interventions that are already sufficiently developed to justify confirmatory efficacy testing. To be considered appropriate, an intervention should be supported by a compelling scientific rationale, evidence from prior work that it engages and alters the proposed mechanism, and at least a preliminary efficacy signal suggesting potential benefit. Another key requirement is that the intervention addresses an unmet therapeutic need, reinforcing the program goal of supporting work that could fill meaningful gaps in current mental health prevention or treatment options.
In practical terms, NIH intended these grants to support adequately powered efficacy trials, meaning sample sizes and designs should be strong enough to detect clinically meaningful effects and support confident interpretation. The focus on confirmatory testing implies attention to strong methodology, clear outcome definitions, appropriate control or comparison conditions, and analytic plans that can link mechanism change to clinical or functional change. The end goal is to determine whether the intervention has real potential for significant clinical benefit and whether it is ready to justify further investment in larger scale testing or implementation oriented research.
Administratively, this was a discretionary NIH grant opportunity using the R01 mechanism within the health category, associated with CFDA 93.242 (Mental Health Research Grants). NIH estimated about $5,000,000 in total funding and expected to make around five awards. There was no cost sharing or matching requirement. The opportunity was posted May 14, 2014, with closing dates in February 2015 (original closing date February 18, 2015; current closing date February 19, 2015), and it was archived March 21, 2015.
Eligibility was broad and included many organization types such as state, county, city, township, and special district governments; public and private institutions of higher education; public and state controlled universities; nonprofits with or without 501(c)(3) status; for profit organizations (other than small businesses, though small businesses were also listed as eligible); independent school districts; public housing authorities/Indian housing authorities; and various tribal entities. The FOA also explicitly allowed applications from non U.S. entities and foreign institutions, as well as foreign components of U.S. organizations, consistent with NIH policy. Additional categories mentioned include faith based and community based organizations, HBCUs, Hispanic serving institutions, AANAPISISs, Alaska Native and Native Hawaiian Serving Institutions, TCCUs, U.S. territories or possessions, and eligible federal agencies.
For applicants seeking the full requirements, detailed application instructions, and NIH expectations for trial design and reporting, NIH provided the official announcement link at http://grants.nih.gov/grants/guide/rfa-files/RFA-MH-15-340.html. For access or technical issues, the contact listed was the NIH Office of Extramural Research webmaster (FBOWebmaster@OD.NIH.GOV).
FAQs: NIH RFA-MH-15-340 (R01) - Confirmatory Efficacy Clinical Trials of Non Pharmacological Interventions for Mental Disorders
What is the title and identifier of this NIH funding opportunity?
This funding opportunity is NIH RFA-MH-15-340, titled "Confirmatory Efficacy Clinical Trials of Non Pharmacological Interventions for Mental Disorders (R01)."
What is the main purpose of RFA-MH-15-340?
The purpose is to fund well powered, confirmatory efficacy clinical trials of non pharmacological interventions aimed at preventing or treating mental disorders in children and adults, using rigorous methods to answer whether an intervention is ready to move forward to broader development, scaling, or later stage effectiveness testing.
What type of studies does this FOA emphasize?
It emphasizes adequately powered, confirmatory efficacy clinical trials rather than early stage or purely exploratory studies.
Who is the intended population for interventions studied under this FOA?
Interventions may target both children and adults, and may focus on prevention or treatment of mental disorders.
What does "confirmatory efficacy" mean in the context of this announcement?
It means the trial should be designed to provide a clear, rigorous answer about whether the intervention produces clinically meaningful benefit, with methodology strong enough to support confident interpretation and next step decisions.
What is the expected scientific value of the trial results?
The FOA expects results to be scientifically useful regardless of whether the intervention works. Even negative findings should be interpretable and capable of supporting a clear go/no go decision about next steps.
What is the "experimental therapeutics approach" requirement?
A defining requirement is that applicants specify a hypothesized mechanism of action (a proposed target) for the intervention and design the trial to test not only clinical outcomes, but also whether the intervention engages that mechanism.
What does the FOA require related to mechanism or target measurement?
The trial should include measurement of the proposed target or mechanism and evaluate the relationship between changes in that mechanism and changes in clinical symptoms and/or functional outcomes.
Why does NIH require testing of mechanism engagement in addition to clinical outcomes?
The goal is to strengthen intervention development science by clarifying why an intervention works (or does not), rather than only reporting whether participants improve on average.
What kinds of interventions are eligible under this FOA?
The interventions are non pharmacological and can include behavioral, cognitive, interpersonal, or combined approaches, among others.
Does this FOA support early stage intervention development?
No. It is geared toward interventions that are already sufficiently developed to justify confirmatory efficacy testing, rather than early stage or purely exploratory work.
What evidence should support an intervention to be considered appropriate for this FOA?
An intervention should have a compelling scientific rationale, evidence from prior work that it engages and alters the proposed mechanism, and at least a preliminary efficacy signal suggesting potential benefit.
Does the intervention need to address a specific programmatic need?
Yes. A key requirement is that the intervention addresses an unmet therapeutic need, reflecting the goal of filling meaningful gaps in prevention or treatment options for mental disorders.
What does "adequately powered" mean for the proposed efficacy trials?
It means the sample size and design should be strong enough to detect clinically meaningful effects and enable confident interpretation of outcomes.
What design and analysis features are implied by the confirmatory focus?
The FOA implies strong methodology, clear outcome definitions, appropriate control or comparison conditions, and analytic plans capable of linking mechanism change to clinical or functional change.
What is the end goal of research funded under this FOA?
The end goal is to determine whether the intervention has real potential for significant clinical benefit and whether it is ready to justify further investment in larger scale testing or implementation oriented research.
What NIH grant mechanism is used for this opportunity?
This opportunity uses the R01 mechanism.
What is the category and CFDA number associated with this program?
It is within the health category and is associated with CFDA 93.242 (Mental Health Research Grants).
How much total funding did NIH estimate for this FOA, and how many awards were expected?
NIH estimated about $5,000,000 in total funding and expected to make around five awards.
Is cost sharing or matching required?
No. There was no cost sharing or matching requirement.
When was the opportunity posted?
The opportunity was posted May 14, 2014.
What were the application closing dates?
The closing dates were in February 2015, with an original closing date of February 18, 2015 and a current closing date of February 19, 2015.
Is this funding opportunity still active?
No. It was archived March 21, 2015.
What types of organizations were eligible to apply?
Eligibility was broad and included state, county, city, township, and special district governments; public and private institutions of higher education; public and state controlled universities; nonprofits with or without 501(c)(3) status; for profit organizations; small businesses (also listed as eligible); independent school districts; public housing authorities/Indian housing authorities; and various tribal entities.
Were community based or faith based organizations eligible?
Yes. Faith based and community based organizations were explicitly included among the eligible categories.
Were minority serving institutions included in the eligibility list?
Yes. The eligibility list included HBCUs, Hispanic serving institutions, AANAPISISs, Alaska Native and Native Hawaiian Serving Institutions, and TCCUs.
Could non U.S. organizations apply?
Yes. The FOA explicitly allowed applications from non U.S. entities and foreign institutions, as well as foreign components of U.S. organizations, consistent with NIH policy.
Were U.S. territories or possessions included as eligible applicants?
Yes. U.S. territories or possessions were mentioned among eligible categories.
Where can applicants find the official FOA announcement and full requirements?
The official announcement link provided by NIH is http://grants.nih.gov/grants/guide/rfa-files/RFA-MH-15-340.html.
Who was listed as the contact for access or technical issues?
The contact listed was the NIH Office of Extramural Research webmaster at FBOWebmaster@OD.NIH.GOV.
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