← Back to contracts

Effectiveness Trials to Test Mental Health System Interventions (R61/R33 Clinical Trial Required)

US National Institutes of Health (NIH) grant open #PAR-25-285
Response due Oct 15, 2027 · 00:00 UTC

Summary

This NIH funding opportunity (PAR-25-285) solicits R61/R33 phased clinical trial applications to test effectiveness of mental health system interventions. The R61 phase typically covers milestone-driven feasibility/pilot work, while the R33 phase supports the full-scale effectiveness trial. The opportunity is open from November 2024 through October 2027, allowing multiple submission cycles. It is issued by the National Institutes of Health under the Department of Health and Human Services.

What they want

Applicants must design and conduct effectiveness trials that test interventions operating at the mental health system level (e.g., care delivery models, service system redesign, implementation strategies). The R61 phase requires achievement of predefined milestones before transitioning to the R33 effectiveness trial phase. A clinical trial is required per the funding opportunity announcement designation.
Deliverables
  • R61 phase milestone achievement report demonstrating readiness for R33
  • Full-scale R33 effectiveness trial
  • Clinical trial registration
  • Research findings and publications per NIH data-sharing and reporting requirements
Technical requirements
  • Clinical trial required as a condition of the award mechanism
  • R61 phase must include predefined milestones for go/no-go progression to R33 phase
  • Intervention must operate at the mental health system level

How they evaluate

Submission: Grants.gov federal grants portal (electronic submission)

Risks & flags

  • Long open window (Nov 2024 – Oct 2027) with multiple submission cycles is standard for NIH Program Announcements — not a single-bidder indicator
  • No dollar values, page limits, or specific eligibility restrictions surfaced in the provided text — full FOA should be reviewed for any restrictive eligibility criteria

Market context

inferred from NAICS
Professional, Scientific & Technical Services
NAICS 541711
US market size
$2.0T
Typical award
$25K – $50M
Typical buyers
All federal civilianDoDStates
Commonly required
8(a)WOSBSDVOSBPE/PMP

Sector-level estimate — full code lookup not yet in catalog.

Effectiveness Trials to Test Mental Health…
Due Oct 15
Onboard ↗