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

Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R61/R33) is sponsored by NIMH. Supports the development of psychosocial therapeutic and preventive interventions for mental disorders.

Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R61/R33 Clinical Trial Required) | Research Funding National Institutes of Health Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R61/R33 Clinical Trial Required) The purpose of this NOFO is to encourage pilot research developing and testing innovative psychosocial intervention approaches in which the target and/or intervention strategy is novel.

Consistent with NIMH’s experimental therapeutics approach, this NOFO is intended to speed the translation of emergent research on mechanisms and processes underlying mental disorders into promising novel psychosocial preventative or therapeutic interventions.

Targets may include, but are not limited to, potentially modifiable behavioral, cognitive, affective, and/or interpersonal factors or processes, neural circuits or neural activity subserving specific behaviors or cognitive processes, and/or other neurobiological mechanisms.

Novel psychosocial interventions may be standalone interventions or novel augmentations to efficacious interventions for which there is an empirical rationale by which the augmentation (and corresponding target) is expected to substantially enhance outcomes.

Support will be provided for up to two years (R61 phase) for preliminary milestone-driven testing of a novel intervention's impact on a target process or mechanism associated with mental disorder risk, causation, or maintenance (target engagement). Up to 3 years of additional support (R33 phase) will be provided for studies with findings that meet the "go/no-go" milestones embedded in the R61 phase.

The R33 phase is intended to support the replication of target engagement and to test whether engaging the intervention target/mechanism mediates changes in clinical outcomes. Ultimately, trials must be designed so that results, whether positive or negative, will provide information of high scientific utility and will support "go/no-go" decisions about further development and/or testing of the intervention.

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

Letter of Intent Due Date(s): 30 days before the application due date Application Due Date(s): 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-25-182 Expiration Date October 16, 2027 The scope of the proposed project should determine the project period.

The maximum period of the combined R61 and R33 phases is 5 years, with up to 2 years for the R61 phase and up to 3 years for the R33 phase. Applications with a project period less than 5 years are encouraged where feasible. Medical - Clinical Science