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

The purpose of this Funding Opportunity Announcement (FOA) is to support the efficient pilot testing of novel psychosocial therapeutic and preventive interventions for mental disorders in adults and children, using an experimental therapeutics approach. Under this FOA, 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 or testing of the intervention. This FOA supports the development and testing of innovative psychosocial intervention approaches where the target and/or the intervention strategy is novel. Targets might 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 associated with risk for, causation of, or maintenance of a mental disorder. Eligible psychosocial intervention strategies might include in-person or technology-assisted delivery, provided the target and/or the intervention strategy is novel. This FOA supports the development and testing of novel psychosocial interventions, as defined above, as monotherapies or as augmentations to standard treatment. Support will be provided for up to two years (R61 phase) for preliminary milestone-driven testing of the intervention's impact on a target (a process or mechanism associated with risk for, causation, or maintenance of a clinical condition), that is, its target engagement. Contingent on meeting "go/no-go" milestones in the R61 phase, up to 3 years of additional support (R33 phase) may be provided for studies to replicate target engagement and relate change in the intervention target/mechanism to clinical benefit. Ultimately, this R61/R33 FOA is intended to speed the translation of emerging basic science findings of mechanisms and processes underlying mental disorders into novel interventions that can be efficiently tested for their promise in restoring function and reducing symptoms for those living with mental disorders, or for preventing mental disorders among those at risk.