Notice Number: NOT-MH-15-013
Release Date: April 16, 2015
National Institute of Mental Health (NIMH)
NIMH is issuing this Notice to highlight priority areas for research related to women's mental health during pregnancy and the postpartum period. NIMH encourages applications via the parent R21 and R01 funding announcements as well as the NIMH clinical trials funding opportunity announcements.
NIMH has a long-standing commitment to perinatal mental health research, meaning research focused on women’s mental health before, during, and immediately following pregnancy. In addition to perinatal depression and postpartum psychosis, this Notice encourages research on anxiety disorders, obsessive compulsive disorder, post-traumatic stress disorder, eating disorders and such serious mental illnesses as bipolar disorder and schizophrenia that can have profound effects on the health of the mother and child. A subset of women enters the perinatal period with medical conditions that can contribute to neuropsychiatric disorders, such as human immunodeficiency virus (HIV) infection and hepatitis C virus (HCV) infection. These conditions and other comorbid medical conditions need to be further explored at the level of basic, epidemiological, diagnostic, clinical, and intervention research in relation to perinatal mental health. Reduction of the public health burden of mental disorders during the perinatal period will improve the health and well-being of new mothers, their children, and families.
Basic and Clinical Neuroscience
Advances in our understanding of perinatal mood and other mental disorders are likely to come from several areas of research, including mechanistic studies of hormone-sensitive brain circuits implicated in mood, cognition or social behavior; neurotransmitter systems; and the development of appropriate peripartum model systems. Model systems could be used to examine combined genetic and environmental influences on postpartum hormonal status and/or maternal behavior to investigate the mechanisms during the peripartum period that contribute to the emergence of mental disorders in the mother. Finally, new tools are needed to advance the understanding of neuroendocrine control of mood, cognition and affiliative social behaviors in humans, non-human primates, and other species.
Examples of basic, translational, and clinical research encouraged by NIMH include, but are not limited to, the following:
Clinical Course, Epidemiological and Risk Factors Research
Meeting the goal of personalized medical treatment requires understanding how pregnancy interacts with risk for various mental disorders. Clinical and epidemiological studies can be of optimal value when they seek to identify biomarkers that can help identify risk and when they seek to identify mechanisms that help explain factors that confer risk or protection. Mechanisms are defined as the cascades of social, behavioral, and/or neurobiological processes through which risk and protective factors operate to produce depression, anxiety, and other disorders. NIMH investigators are encouraged to study these mechanisms when appropriate, within the Research Domain Criteria (RDoC) framework.
Examples of clinical course, epidemiological, and risk factors research encouraged by NIMH include, but are not limited to, the following:
Establishing an evidence base for effective interventions for diverse groups of pregnant or postpartum women requires inclusion of adequate numbers of members of racial/ethnic and other underrepresented groups in clinical trials. Secondary analysis of existing data sources that will deepen the evidence base for intervention effectiveness in diverse groups of perinatal women is encouraged. Scientific areas of interest for NIMH include, but are not limited to subgroup analyses of treatment outcomes in intervention studies and analyses of potential mediators of treatment efficacy and effectiveness within or across racial/ethnic, sex, socioeconomic, or geographically diverse groups.
It is important to provide empirically supported and/or theoretically robust arguments to justify the adaptation of extant interventions for specified subgroups, including adaptations specifically to address the needs of pregnant/postpartum women belonging to various racial and ethnic minority groups, age groups, or income levels; pregnant/postpartum women with various comorbid conditions or risk factors (e.g., post-traumatic stress disorder, interpersonal violence); or pregnant/postpartum women receiving care in specified settings (e.g., obstetric practices, home visitation, and pediatric practices). Adaptation or extension of proven interventions should only be undertaken if there is a compelling rationale, supported by empirical evidence, that can be justified in terms of: (a) theoretical and empirical support for the adaptation target (e.g., changes a factor that has been associated with non-response, partial response, patient non-engagement, or relapse); (b) clear explication of the mechanism by which that moderator variable functions to disadvantage or advantage a subgroup (ideally, with behavioral and/or biological data that support the mechanism hypothesis); and (c) evidence to suggest that the adapted intervention will result in a substantial improvement in response rate, speed of response, an aspect of care, or uptake in community/practice settings when compared to existing intervention approaches.
NIMH encourages research approaches that are efficient in cost and design; are designed to inform or test prescriptive, personalized intervention approaches, comparative effectiveness, and stepped-care models; and that answer questions about the mediators, moderators and mechanisms of interventions, ultimately leading to more cost-effective, personalized interventions. In order to advance knowledge more rapidly and cost effectively, use of consortia, existing practice-based research networks, large available data sets and other types of research infrastructure are encouraged. Similarly, opportunities for sharing data are encouraged by incorporating standard measures that can be shared across studies, such as those described in NOT-MH-15-009.
NIMH requires a higher level of rigor in studies of mental health-related interventions and has recently issued a set of funding opportunity announcements for clinical trials research that involves an experimental medicine based approach to intervention development and testing. Please note, applicants considering clinical trials should review the NIMH policy NOT-MH-14-007 and the NIMH clinical trials website and contact NIMH Program Officials regarding the match between a potential application and current priorities.
The following are examples of intervention studies encouraged by NIMH:
Screening and Services Research
NIMH places a high priority on services research that improves the identification of otherwise undetected perinatal mental disorders and connects women who are diagnosed with these disorders with accessible and appropriate evidence-based treatment. Treatment delivery models should take into consideration the many potential barriers to accessing treatment for women with perinatal mental disorders, as well as challenges to treatment engagement, especially for women with low incomes and multiple life stressors. Women’s mental health care preferences, including a preference for care in non-specialty settings, such as OB/GYN, primary care, and other non-traditional settings, should be taken into account. The feasibility of proposed treatment delivery models for the targeted setting, in terms of workforce requirements, training, provider and patient acceptability, and available payment mechanisms, should be carefully considered. Service delivery interventions to improve perinatal mental disorder detection and care at multiple levels – patient, practitioner, organizational, community, and systems – are encouraged.
As noted above in the section on Interventions Research, NIMH employs an experimental medicine model for all clinical trials research. Investigators should review the policy NOT-MH-14-007 and funding announcements at the Clinical Trials Funding Opportunity Announcements website (http://www.nimh.nih.gov/funding/opportunities-announcements/clinical-trials-foas/index.shtml).
The following are examples of services research encouraged by NIMH:
Funding Opportunity Announcements that can be used to pursue these and other research activities include, but are not limited to:
Please note that investigators interested in pursuing clinical trials research should review the NIMH Clinical Trials Funding Opportunity Announcements website (http://www.nimh.nih.gov/funding/opportunities-announcements/clinical-trials-foas/index.shtml )
and policy for submitting applications containing clinical trials (NOT-MH-14-007). These sites announce that, beginning with applications submitted for the June 5, 2014 submission date, and all subsequent applicable deadlines, NIMH will not accept R01, R21 or R03 applications that include clinical trials of potential therapies for mental disorders under the NIH parent grant Funding Opportunity Announcement (FOA) PA-13-302, NIH parent R21 FOA PA-13-303 and NIH parent R03 FOA PA-13-304. Specific guidance on application submission procedures are described in NOT-MH-14-007 as well as on the NIMH clinical Trials FOA-Applicant FAQs. Applicants considering such an application are strongly encouraged to consult with NIMH program officials prior to submission.
Please direct all inquiries to:
Tamara Lewis Johnson, MPH, MBA
National Institute of Mental Health (NIMH)