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Full-Scale Hybrid Effectiveness-Implementation Trials for Mental Health Interventions (R01 - Clinical Trial Required)

Federal funding opportunity PAR-25-177 from National Institutes of Health (Department of Health and Human Services).

Apply on Grants.gov →Application closes October 15, 2027

Posted: November 26, 2024
Closes: October 15, 2027
Cost sharing: No
Instrument: Grant
Assistance listing: 93.242
Category: Health
Archives: November 20, 2027

Program funding history

Awards made under Assistance Listing 93.242 across FY2025–FY2027, from public federal spending records.

FY2025 obligated: $1.8B
FY2026 obligated: $1.8B
FY2027 (to date) obligated: $0
Awards in window: 6,272

Top recipients: Yale Univ, University of Pittsburgh - of the Commonwealth System of Higher Education, Icahn School of Medicine at Mount Sinai, Trustees of the University of Pennsylvania, the, Washington University, the

Source: USAspending.gov · refreshed October 2026 · Program page: awards, recipients and the opportunities under this listing →

Synopsis

Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (R01 Clinical Trial Required). This NOFO is a key element of NIMHs set of NOFOs to support clinical trials research across the intervention development and testing pipeline. The NOFO supports (1) clinical trials to test the effectiveness of optimized therapeutic and preventive interventions for use in community and practice settings; and (2) clinical trials to evaluate the effectiveness of patient-, provider-, organizational-, or systems-level services interventions to improve access, continuity, quality, equity, and/or value of mental health services. This NOFO is intended to support trials that: address a significant problem, such that the findings have potential to inform practice; are adequately powered to definitively answer the primary research question(s), with well-justified hypotheses supported by pilot data; and are designed to examine questions regarding mediators and moderators of effects. Consistent with the NIMH experimental therapeutics approach, this NOFO is intended to support effectiveness trials that explicitly address whether the intervention engages the target(s)/mechanism(s) presumed to underlie the intervention effects (i.e., the mechanism(s) that accounts for changes in clinical/functional outcomes, changes in provider behavior, improved access or continuity of services, etc.). The collaborative R01 mechanism provides support for multisite trials when two or more sites are necessary for completion of the trial (e.g., to increase sample size, accelerate recruitment, or increase sample diversity and representation).

Who can apply

Special district governments
Public and State controlled institutions of higher education
County governments
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
City or township governments
Native American tribal governments (Federally recognized)
Private institutions of higher education
Public housing authorities/Indian housing authorities
Native American tribal organizations (other than Federally recognized tribal governments)
Small businesses
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
For profit organizations other than small businesses
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.

How to apply

Applications go through the official government listing. Grants Radar links you straight to the source — applying is free.

View on Grants.gov Full announcement

Agency contact: National Institutes of Health · [email protected] · 301-402-2541

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