Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R61/R33 Clinical Trial Required) | PAR 25 182

Frequently Asked Questions (FAQs)

What is this funding opportunity?

Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R61/R33 Clinical Trial Required) is a National Institute of Mental Health (NIMH), National Institutes of Health (NIH) funding opportunity (PAR 25-182; CFDA 93.242). It supports early-stage, clinically grounded work to create and refine new psychosocial interventions and prevention strategies for mental disorders, with a required clinical trial component.

What is the overall purpose of this program?

The purpose is to move promising findings from basic and translational research (behavioral, cognitive, affective, and neuropsychological sciences) into psychosocial interventions that can be tested in humans through a structured clinical trials pipeline. The program emphasizes understanding how and why an intervention works by measuring whether it engages a defined target and how that relates to clinical outcomes.

What kinds of projects are a good fit?

Projects are a fit when they propose a new psychosocial therapy or preventive program and clearly specify the intervention target (the process or mechanism the intervention is designed to change). Competitive projects are expected to include data showing the intervention can engage that target in ways that matter, and to follow a phased clinical trials approach from early development to replication and outcome linkage.

What is meant by a "psychosocial" intervention in this opportunity?

Based on the description provided, psychosocial interventions are approaches grounded in behavioral, cognitive, affective, and related psychological sciences that aim to modify processes relevant to mental disorders (for example, behavior, cognition, emotion regulation, learning, stress responsivity, or social processing). The focus is on interventions and prevention strategies that can be tested in humans.

What is the NIMH "experimental therapeutics" approach?

The experimental therapeutics approach means success is not defined only by symptom improvement. Applicants are expected to define a measurable target and demonstrate target engagement, then connect that engagement to downstream clinical outcomes. This steers projects toward hypothesis-driven testing of mechanisms (how and why the intervention works) rather than treating the intervention as a black box.

What is an "intervention target" in this context?

An intervention target is the process or mechanism the intervention is designed to change. Examples mentioned in the opportunity description include behavior, cognition, emotion regulation, learning, stress responsivity, and social processing. The target should be clearly defined and measurable.

What does "target engagement" mean for applicants?

Target engagement means demonstrating, with data, that the intervention measurably changes the proposed target. The program expects teams to show that the intervention can engage the target and later test whether changes in the target are associated with improvements in clinical outcomes.

Is a clinical trial required?

Yes. The notice explicitly requires a clinical trial, and both phases of the R61/R33 mechanism involve clinical trial activity as described in the opportunity summary.

What is the R61/R33 funding mechanism?

This is a two-phase award that supports progression from early pilot development work (R61) to a more confirmatory stage (R33). The structure is designed to move projects forward through a clinical trials pipeline, starting with refining the intervention and demonstrating target engagement, and then replicating target engagement and linking it to clinical outcomes.

How long can the R61 phase last, and what is it for?

The R61 phase can provide up to two years of support. It is intended for evaluation of target engagement and establishing key intervention parameters. Typical R61 activities include refining intervention content and delivery, assessing feasibility and acceptability in the intended population, optimizing dosing or intensity (such as number of sessions, duration, modality, and level of support), and demonstrating that the intervention measurably engages the proposed target.

How long can the R33 phase last, and what is it for?

The R33 phase can provide up to three additional years of support. It is intended to replicate target engagement findings and to test whether changes in the target are associated with changes in clinical outcomes (such as symptom change, functioning, or other clinical endpoints relevant to the disorder and population).

What does the program mean by "intervention parameters"?

Intervention parameters refer to key design and delivery features that may need to be established or optimized early on. The opportunity description gives examples such as dosing or intensity, including number of sessions, duration, modality, and level of support.

What types of outcomes are expected to be studied?

The program emphasizes two linked outcome types: (1) measurable engagement of the defined target and (2) downstream clinical outcomes. Clinical outcomes may include symptom change, functioning, or other clinical endpoints depending on the disorder and population, with an expectation in the later phase to test the relationship between target change and clinical improvement.

Who is eligible to apply?

Eligibility is broad. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public housing authorities/Indian housing authorities; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; other Native American tribal organizations; nonprofits (with or without 501(c)(3) status); for-profit organizations other than small businesses; small businesses; and other entities.

Are minority-serving institutions and community-based organizations included in eligibility?

Yes. The opportunity highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), and faith-based or community-based organizations.

Can federal agencies or regional organizations apply?

Yes. The opportunity description lists eligible federal agencies and regional organizations among additional eligible applicants.

Are U.S. territories included?

Yes. U.S. territories or possessions are specifically noted among additional eligible applicants.

Are non-U.S. (foreign) organizations eligible?

Yes. The opportunity description states that non-U.S. entities (foreign organizations) are included among eligible applicants.

Which NIH institute is sponsoring this opportunity?

This opportunity is offered by the National Institute of Mental Health (NIMH), within the National Institutes of Health (NIH).

What is the opportunity number and CFDA listing?

The opportunity is PAR 25-182, and the CFDA listing provided is 93.242.

What kind of grant is this administratively?

It is described as a discretionary grant opportunity from NIH/NIMH.

What are the key themes reviewers are likely to focus on based on the description?

Based on the provided description, key themes include: clearly defined and measurable intervention targets; data demonstrating target engagement; careful parameter setting and optimization early in development; and, in the later phase, replication plus a direct test of whether target engagement relates to improvement in clinical outcomes.

What is the original closing date and when was the listing created?

The listing provides an original closing date of 2027-10-15 and a creation date of 2024-11-26.

Is the award ceiling or expected number of awards provided here?

No. The provided source data does not state a specific award ceiling or expected number of awards. Applicants would typically rely on the full NOFO and NIH budget guidance for budget and cost expectations.

Does the description indicate what kinds of partnerships might be helpful?

Yes. It notes that intervention development often benefits from partnerships across universities, healthcare systems, community providers, schools, and culturally specific organizations, reflecting the broad eligibility and practical setting needs for psychosocial intervention testing.