Reviews applications concerned with clinical research of pharmacotherapeutic, psychotherapeutic, somatic and combination treatments as applied to a range of disorders occurring in adults. Clinical research may be conducted across a spectrum of settings from laboratories to community-based clinics, including research where the intervention is a platform for investigating mediators and moderators of treatment effects. Study populations include adults age 21 years and older (may include participants ages 18 and 20). Identification of biomarkers of treatment efficacy, investigations of treatment effectiveness, and novel combinations of treatments are typical. Studies will cover the evaluation of efficacy and/or effectiveness.
Specific Areas Covered by ITVA:
- Effectiveness and efficacy trials of pharmacological, somatic, psychosocial, computerized, or combination treatments, as well as maintenance trials (preserving wellness, preventing relapse), rehabilitation trials for mental or behavioral disorders, pilot effectiveness and efficacy trials for mental disorders, and treatment protocol (algorithmic) development
- Treatment trials which include personalization as a goal in order to optimize effect sizes, including those studies which explore mediators and moderators, including basic biological or behavioral mechanisms, in order to understand factors that underlie treatment optimization
- Translational clinical trials that are designed to have an expected impact on clinical practice. Translational studies might include, but are not limited to, those involving imaging technologies, genotyping and other biomarker identifiers that may be related to treatment response
- Treatment trials that examine efficacy/effectiveness that are also aimed at defining the mechanisms of the intervention, including neurocircuitry or other cross-cutting pathophysiological changes
- Treatment research in community based practice settings, such as primary care, specialty medical care, community mental health or community health centers
- Follow-up studies from treatment trials, involving longitudinal follow-up of a sample that has previously participated in a mental health intervention trial
ITVA has the following shared interests within the NIMH IRG:
With Interventions Committee for Mental Disorders involving Children and their Families (ITVC): While ITVA and ITVC both review applications concerned with clinical trials of pharmacotherapeutic, somatic and psychotherapeutic and combination treatments as applied to the full range of mental disorders conducted across an array of settings from laboratories to community-based clinics, the study populations differ with ITVA focusing on adults (>21 years of age) and ITVC focusing on children (0-21 years of age). Applications involving studies population 18 years and older may be reviewed in ITVA if the primary focus is on the adult.
With Mental Health Services Research Committee (SERV): ITVA reviews applications concerned with clinical trials and treatments as applied to a broad range of mental health disorders in children, while SERV reviews applications of clinical services and service systems to affect the delivery of treatment for mental illness.
(* These descriptions should to be used as guidelines when determining the appropriate review locus for your application. In many instances, applications involve areas of science and/or methodologies that cross between study sections. In those instances, it is the staff within the NIMH Scientific Review Branch who, in consultation with the applicant if he/she requested a specific section, ultimately determines where an application will be reviewed.)