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Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R33 Clinical Trial Required) - PAR-25-181

Funder
National Institutes of Health
LOI Deadline
LOI Required
Recommended, but not required
Application Deadline
Maximum Project Duration
3 years
Research Focus Areas
Prevention
Psychosocial Intervention
Mental Health Treatments/Interventions
Research Methods
Randomized Control Trials (RCT)
Description
NIMH solicits clinical trial applications through a series of notice of funding opportunities (NOFOs) that cover the intervention development pipeline, from first-in-human, early testing of new interventions, confirmatory efficacy trials, through to effectiveness trials. 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. The R33 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.