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

National Institutes of Health

NIMH solicits clinical trial applications through a series of notice of funding opportunities (NOFOs) that cover the intervention development pipeline, from first-in-human, early testing of new interventions, confirmatory efficacy trials, through to effectiveness trials.

This NOFO seeks to support well-powered clinical trials consistent with NIMH's priorities for: 1) optimizing preventive and therapeutic interventions with previously demonstrated efficacy for use with broader target populations or for delivery routine care, school, community, or online settings, and 2) research on implementation strategies that support the delivery and sustainability of optimized interventions in accessible settings. Applications responsive to this NOFO are hybrid effectiveness implementation trials that examine the effectiveness and clinical impact of interventions to prevent or treat mental illness, implementation challenges and strategies within the intervention setting, and at least one mechanism of action associated with an intervention and/or implementation strategy. The research covered under this announcement addresses practice-relevant questions and must be conducted within accessible intervention settings where the typical consumer can be identified as in need of care and be readily connected to an intervention.

Applicants pursuing other stages of the clinical trial pipeline should consider one of the companion NOFOs listed above.

Deadlines:

Letter of Intent: 30 days before the application due date
Application: Feb 14, 2025; June 17, 2025; Oct 15, 2025; Feb 13, 2026; June 15, 2026; Oct 15, 2026; Feb 17, 2027; June 15, 2027; Oct 15, 2027

PAR-25-177 Expiration Date October 16, 2027

Specialties

Mental Health

Others

Eligibility Requirements

Higher Education Institutions

Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions
Historically Black Colleges and Universities (HBCUs)
Tribally Controlled Colleges and Universities (TCCUs)
Alaska Native and Native Hawaiian Serving Institutions
Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

Small Businesses
For-Profit Organizations (Other than Small Businesses)

Local Governments

State Governments
County Governments
City or Township Governments
Special District Governments
Indian/Native American Tribal Governments (Federally Recognized)
Indian/Native American Tribal Governments (Other than Federally Recognized).

Federal Governments

Eligible Agencies of the Federal Government
U.S. Territory or Possession

Other

Independent School Districts
Public Housing Authorities/Indian Housing Authorities
Native American Tribal Organizations (other than Federally recognized tribal governments)
Faith-based or Community-based Organizations
Regional Organizations
Non-domestic (non-U.S.) Entities (Foreign Organizations)

Foreign Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Sponsor Details

Sponsor Institute/Organizations: National Institutes of Health

Address: National Institutes of Health; 31 Center Drive; MSC 2220; Bethesda; MD 20892-2220; USA

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