June 23, 2021
NOT-MH-15-013 - Notice of Information: NIMH High-Priority Areas for Research on Women's Mental Health During Pregnancy and the Postpartum Period - RESCINDED
National Institute of Mental Health (NIMH)
The purpose of this notice is to outline high priority areas of research related to women's mental health during the perinatal period. NIMH is interested in receiving applications that will provide new knowledge in perinatal mental disorders and that will test strategies for translating this knowledge into improved diagnostics, therapies, and services to improve women’s mental health during the perinatal period. This Notice of Information applies broadly to most but not all Funding Opportunity Announcements (FOAs) that are aligned with NIMH research priorities.
NIMH has a long-standing commitment to research focused on mental disorders that occur during pregnancy and the postpartum period, up to one year following parturition (childbirth). This notice encourages research on perinatal depression, postpartum psychosis, suicidal ideation and behavior, anxiety disorders, obsessive compulsive disorder, post-traumatic stress disorder, eating disorders, attention deficit hyperactivity disorder and serious mental illnesses including bipolar and schizophrenia spectrum disorders that can have profound effects on perinatal mental health. Intervention studies that propose adaptation of effective prevention or treatment interventions for perinatal women should only be undertaken if there is a compelling rationale supported by empirical evidence indicating a need for adaptation. This notice encourages research that will lead to the reduction of the public health burden of perinatal mental disorders by improving the health and well-being of perinatal women in the United States and in low- to middle-income countries (LMICs).
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 often defined as a cascade of social, behavioral, and/or neurobiological processes through which risk and protective factors operate to produce suicidal thoughts, depression, anxiety, and other mental disorders. NIMH investigators are encouraged to study these mechanisms where 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:
NIMH supports intervention research to examine the effectiveness of prevention and treatment intervention approaches (i.e., the utility of research-based approaches in community practice settings) and research to optimize, sequence, and personalize intervention approaches for improved response rates, more complete and rapid remission, and improved functional outcomes for diverse groups. Efficacy studies using highly innovative intervention approaches that address an unmet therapeutic need or otherwise have the potential for substantially improving outcomes for pregnant and postpartum women with mental disorders are also encouraged.
Studies that propose to adapt extant interventions to meet specific needs of population subgroups 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. This applies to adaptations designed to address the needs of pregnant/postpartum women in general and pregnant/postpartum women belonging to various racial and ethnic minority groups, age groups, or income levels; those with various comorbid conditions or risk factors (e.g., post-traumatic stress disorder, interpersonal violence); or those receiving care in specified settings (e.g., obstetric practices, home visitation, community settings, prisons, and pediatric practices).
Establishing an evidence base for effective interventions for diverse groups of pregnant and/or postpartum women requires inclusion of adequate numbers of members of racial/ethnic and other underrepresented women in clinical trials. Secondary analysis of existing data sources, including those that combine samples and/or expand existing cohorts, that will deepen the evidence base for intervention effectiveness in diverse subgroups of perinatal women is encouraged. Scientific areas of interest for NIMH include, but are not limited to, subgroup analyses of prevention and treatment outcomes in intervention studies and analyses of potential mediators of treatment efficacy and effectiveness within or across racial/ethnic, gender, socioeconomic, or geographically diverse groups.
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.
NIMH requires a higher level of rigor in studies of mental health-related interventions and has issued a set of FOAs for clinical trials research that involves an experimental therapeutics-based approach to intervention development and testing, including FOAs that are intended to support the translation of emerging basic science findings of mechanisms and processes underlying mental disorders into novel psychosocial interventions. Please note, applicants considering clinical trials should review 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, connects women who are diagnosed with these disorders with accessible and appropriate evidence-based treatment and engages women in this care. Service delivery interventions to improve perinatal mental disorder detection and care at multiple levels – patient, practitioner, organizational, community, and systems – are encouraged. The involvement of perspectives from a broad range of care stakeholders—including patients, clinicians, health system leaders, state policy leaders, and other healthcare decision makers—at every stage of the research project is encouraged in order to yield service delivery strategies that are relevant and can be rapidly integrated into practice.
NIMH employs an experimental therapeutics approach for all clinical trials research, including clinical trials to test mental health screening and services interventions. Investigators should review the NIMH clinical trials website and contact NIMH Program Officials regarding the match between a potential application and current priorities. For screening and services research studies not involving clinical trials, applicants are encouraged to contact NIMH program officials regarding the match between the potential application and current priorities.
The following are examples of services research encouraged by NIMH:
Investigators planning to submit an application related to the topics outlined above are strongly encouraged to discuss their proposed research with the scientific contact listed below well in advance of the application due date.
Tamara Lewis Johnson, MPH, MBA
National Institute of Mental Health (NIMH)
Telephone: (301) 594-7963