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Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R61/R33 Clinical Trial Required)

US · MD · Bethesda National Institutes of Health (NIH) grant open #PAR-25-182
Response due Oct 15, 2027 · 00:00 UTC

Summary

This NIH funding opportunity (PAR-25-182) solicits research applications for the development of psychosocial therapeutic and preventive interventions targeting mental disorders. The R61/R33 phased award mechanism requires a clinical trial component. The R61 phase typically supports early-stage milestone-driven development and feasibility work, while the R33 phase supports expanded efficacy or effectiveness testing. The opportunity is open from November 2024 through October 2027, indicating a rolling submission cycle with multiple due dates.

What they want

Applicants must propose research to develop and test psychosocial (non-pharmacological) interventions — either therapeutic or preventive — aimed at mental disorders. The phased R61/R33 mechanism requires: (1) an R61 phase establishing feasibility, refining the intervention, and meeting pre-specified milestones before progression; and (2) an R33 phase conducting a clinical trial to evaluate the intervention's efficacy, effectiveness, or preventive impact. A clinical trial is explicitly required at the R33 stage.
Deliverables
  • R61 phase: feasibility data, refined intervention protocol, milestone achievement documentation
  • R33 phase: clinical trial results evaluating intervention efficacy, effectiveness, or preventive impact
  • Research publications and data sharing per NIH requirements
Technical requirements
  • Clinical trial must be included as required component
  • Phased R61/R33 award mechanism — R61 milestones must be met before R33 activation
  • Interventions must be psychosocial (non-pharmacological) in nature
  • Target population must be individuals at risk for or diagnosed with mental disorders

How they evaluate

  • Scientific and technical merit (peer review by NIH study section)
  • Significance and innovation of proposed intervention
  • Approach rigor and feasibility
  • Qualifications of investigator(s) and team
  • Adequacy of environment and resources
  • Clinical trial design quality
Submission: Electronic submission via Grants.gov and NIH ASSIST or institutional submission systems

Eligibility & certifications

SAM registration (System for Award Management)Institutional assurances for human subjects research (IRB approval pathway)NIH human subjects protections complianceGood Clinical Practice (GCP) training for clinical trial staff

Risks & flags

  • Rolling close date through 2027 with multiple submission cycles — verify specific AIDS/standard due dates on NIH website
  • No dollar value stated — award sizes vary widely by institute and program; applicants should check companion FOA details
  • R61/R33 phased mechanism introduces milestone gate that can terminate funding before R33 — unusual risk for applicants

Market context

inferred from NAICS
R&D in Physical, Engineering, Life Sciences (except Nanotech & Biotech)
NAICS 541715
US market size
$95B
Typical award
$100K – $50M+
Typical buyers
DoDNSFNIHNASADOE
Commonly required
DCAA-compliant accountingITARCMMC L2
Development of Psychosocial Therapeutic an…
Due Oct 15
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