Pilot Hybrid Effectiveness-Implementation Trials for Mental Health Interventions (R01 Clinical Trial Required)
Can you apply?
This grant is for researchers conducting pilot effectiveness-implementation hybrid trials testing mental health interventions. Eligible applicants include nonprofit organizations, academic institutions, research centers, and hospitals with research capacity. Applicants must have institutional research infrastructure and IRB-approved protocols. Clinical trial requirements mandate rigorous study design with defined endpoints and appropriate populations.
Activities supported include designing and testing mental health interventions, conducting effectiveness-implementation hybrid research, and generating pilot data. Preference goes to work addressing implementation barriers in real-world clinical settings. Funding supports research staff, equipment, and direct project costs related to trial conduct and analysis.
This grant is for researchers conducting pilot effectiveness-implementation hybrid trials testing mental health interventions. Eligible applicants include nonprofit organizations, academic institutions, research centers, and hospitals with research capacity. Applicants must have institutional research infrastructure and IRB-approved protocols. Clinical trial requirements mandate rigorous study design with defined endpoints and appropriate populations.
Activities supported include designing and testing mental health interventions, conducting effectiveness-implementation hybrid research, and generating pilot data. Preference goes to work addressing implementation barriers in real-world clinical settings. Funding supports research staff, equipment, and direct project costs related to trial conduct and analysis.
Program description
Pilot Effectiveness Trials for Treatment, Preventive and Services Interventions (R01 Clinical Trial Required). As part of NIMH’s clinical trials pipeline NOFOs, this announcement encourages pilot effectiveness studies focused on 1) optimizing the effectiveness of preventive and therapeutic interventions with previously demonstrated efficacy, for use with broader target populations or for use in community practice settings, and 2) developing and preliminary testing innovative services interventions. Consistent with the NIMH experimental therapeutics approach, this NOFO is intended to support pilot studies of intervention effectiveness or service delivery approaches 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.).
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- County Government
- Hospital
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Small Business (SBA-defined)
- Special District
- State Government
- Tribal Nation
- Tribal Organization
Details
This grant is for researchers conducting pilot effectiveness-implementation hybrid trials testing mental health interventions. Eligible applicants include nonprofit organizations, academic institutions, research centers, and hospitals with research capacity. Applicants must have institutional research infrastructure and IRB-approved protocols. Clinical trial requirements mandate rigorous study design with defined endpoints and appropriate populations.
Activities supported include designing and testing mental health interventions, conducting effectiveness-implementation hybrid research, and generating pilot data. Preference goes to work addressing implementation barriers in real-world clinical settings. Funding supports research staff, equipment, and direct project costs related to trial conduct and analysis.
How to apply
Application links
Required documents
- SF-424 and SF-424 (R&R)
- Project Narrative (specific aims, research strategy, significance)
- Detailed Budget and Budget Justification
- Biographical Sketches of all senior personnel
- Institutional Resources and Environment
- Letters of Support from collaborating sites
- Data Safety Monitoring Plan (if human subjects involved)
- IRB Approval or IRB protocol documentation
- Preliminary Data section
- Biographical Sketch (NIH format)
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.242 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$75,056,208
-
$74,756,329
-
$72,845,834
-
$64,705,159
-
$63,991,707
-
$54,214,022
-
$38,895,082
-
$38,475,557
-
$34,635,977
-
$34,475,710
Top States by Funding
- CA 15 awards $408.1M
- MA 9 awards $230.3M
- NY 6 awards $184.2M
- WA 4 awards $174.9M
- CT 3 awards $138.9M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.242). How funding has trended year over year.
| 2024 | $1,722,300,004 | |
| 2025 | $1,726,864,191 | |
| 2026 est. | $99,221,272 |
FAQ
Who can apply for this R01 Clinical Trial grant?
Nonprofit research institutions, universities, hospitals, and federally recognized organizations with established research capacity. Individual researchers must have institutional affiliation and research infrastructure.
What is a hybrid effectiveness-implementation trial?
Studies that simultaneously test intervention effectiveness while examining implementation strategies in real-world settings. The design bridges traditional efficacy research with practical deployment questions.
What types of mental health interventions qualify?
Behavioral, psychological, and clinical interventions with preliminary evidence. Interventions must address identified mental health needs and have clear mechanisms.
When are typical application deadlines?
NIH R01s typically have 2-3 submission dates annually. Check NIH.gov for all open dates and allow 3-4 months for preparation.
How competitive is this funding?
Very competitive. Success rates for NIH R01s typically range 15-25%. Strong preliminary data and clear implementation focus improve competitiveness.
💡 Tips for applicants
- Build a strong multidisciplinary team including clinical experts, implementation scientists, and biostatisticians.
- Ground your intervention in existing evidence; pilot data strengthens applications significantly.
- Address implementation barriers explicitly; explain how you'll test real-world deployment.
- Develop realistic timelines and budgets; overambitious scope causes rejections.
- Use your specific aims section to clearly separate effectiveness and implementation research questions.
⚠️ Common mistakes
Underestimating implementation complexity or glossing over real-world barriers. Weak preliminary data or insufficient justification for the proposed intervention. Vague or overly broad specific aims that confuse reviewers about actual deliverables.
Similar grants
- OPEN 27-0343-10 FFY27 Local Agency General Non-Enforcement — Illinois Department of Transportation
- ROLLING Annual Agency Threshold Application Applicants for Funding Start Here — Texas City of Austin - Austin Public Health
- CLOSED Virginia’s Black Indigenous and People of Color (BIPOC) Grant – FY26 — Virginia The Virginia Department of Historic Resources
- ROLLING RTAP Grant Program (Rolling) — Virginia Department of Rail and Public Transportation
- ROLLING Rail Industrial Access Grant (RIA) — Virginia Department of Rail and Public Transportation