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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NIMH High-Priority Areas for Research on Women's Mental Health During Pregnancy and the Postpartum Period - RESCINDED

Issued by

National Institute of Mental Health (NIMH)

Purpose

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).

Research Priorities

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:

• Studies of functional changes in brain neurochemistry that occur in conjunction with perinatal hormonal transitions in healthy and/or mentally ill populations of women.
• Studies that identify risk factors that predict the occurrence or recurrence of perinatal mental disorders or susceptibility to hormonally modulated risk for psychopathology.
• Studies of genetic architecture to identify markers of risk and resilience for women living at increased risk for perinatal mental disorders.
• Studies that examine the combined environmental and genetic influences on maternal/paternal protective factors or risk factors that may either prevent or increase vulnerability to disordered mood, cognition, and social behavior during the perinatal period.
• Studies that examine the neurobiological bases of cognitive resilience during the postpartum period.
• Studies that support the development of novel visualization tools to facilitate research on peripartum changes in brain circuits and signaling cascades regulating mood, cognition, and social behavior.
• Studies to develop and apply novel approaches to assess the neurophysiological impact of perinatal hormonal transitions in healthy and/or affected populations with an emphasis on approaches that assess activity changes across brain networks with high spatial and temporal resolution.

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:

• Studies of the mechanisms of health disparities in perinatal mental disorders and in co-occurring HIV infection.
• Studies to better understand the impact of mental disorders on the health of women living with HIV and their infants during the perinatal period, in particular, and the effects of mental disorders on women’s ability to engage in HIV care and adhere to their antiretroviral regimen during and after pregnancy.
• Studies to identify novel biomarkers for perinatal suicidal thoughts and behaviors, mood and anxiety disorders, and serious mental illness such as bipolar or schizophrenia spectrum disorders especially those associated with different clinical histories and trajectories (e.g., reproductive-related mood changes or disorder severity).
• Studies that empirically evaluate whether perinatal depression is a distinct subtype of depression with a different pathophysiology, suggesting the need for unique interventions.
• Studies that use the RDoC framework to examine mechanisms that give rise to mental disorders during pregnancy, for example, studies that clarify the underlying causes of disorders during pregnancy with efforts towards integrating genetic, neurobiological, imaging, behavioral, and clinical data.
• Studies that explore dimensions of functioning with identifiable subtypes within broad clinical phenotype.
• Studies that examine the course of mental disorders which are diagnosed prior to pregnancy and the predictors of the trajectory of the mental illness over the course of the perinatal period.

Interventions Research
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:

• Maintenance studies of non-pharmacological interventions to prevent postpartum relapse.
• Studies of pharmacological maintenance treatments during the perinatal period for women with serious mental illness, such as psychosis and bipolar disorder, and studies of pharmacological prophylaxis strategies for these conditions in women at increased risk for a recurrence of psychotic perinatal conditions.
• Studies of innovative and highly scalable non-pharmacological interventions for identifying, preventing, and treating perinatal mental disorders.
• Development and testing of interventions, both pharmacological and non-pharmacological, to address mental disorders among mothers living with HIV during and after pregnancy, including the impact of these interventions on HIV-related outcomes among the mothers and their infants.
• Studies of the efficacy, safety, pharmacokinetics, and pharmacodynamics of pharmacotherapies for treatment of perinatal mental disorders, especially those occurring during pregnancy and lactation, as well as their interactions with treatments for co-occurring HIV.
• Studies of the safety, effectiveness, and durability of rapid-acting interventions (e.g., brexanolone) for racially, ethnically, and geographically diverse samples of perinatal women along with adjunctive or subsequent interventions that improve and maintain response.
• Studies that make use of large data sets to examine the noninferiority of established evidence-based interventions (e.g., cognitive behavioral therapy) or differential responses to such treatment for perinatal mental disorders.
• Studies that use dismantling or factorial designs to isolate core components of preventive interventions and optimize interventions to be more efficient.
• Studies that use optimized preventive interventions in pragmatic trials and take advantage of electronic health records for assessing outcomes.
• Studies that use approaches that address well documented logistical barriers that may interfere with engagement and adherence, and barriers to care in implementing preventive interventions.
• Studies that aggregate prevention trial data sets to better understand impact of interventions on diverse groups of perinatal women and low base rate behaviors such as death by suicide.
• Studies that use novel mixed methods approaches to examine stigma as a barrier to seeking help for perinatal mental disorders and to develop interventions to improve access to treatment.
• Studies that examine the risk and protective factors of including race and/or ethnicity in the development and testing of interventions to address disparities in perinatal mental health outcomes.
• Research in perinatal women living with HIV to determine whether evidence-based perinatal mental health interventions lead to improvements in HIV care continuum outcomes.
• Studies that develop technologies or tools to quantitatively predict or indicate an increased risk for perinatal mental disorders.

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:

• Studies that address the limitations of existing, or develop novel, perinatal mental health assessment tools, including those designed to monitor progress on prevention of screening, and treatment for perinatal mental disorders.
• Studies involving service delivery interventions for the prevention or care of perinatal mental disorders that leverage technology to improve access to care and mental health and functional outcomes.
• Research that identifies mutable factors that impact access, continuity, utilization, quality, value, and outcomes for perinatal mental health care, including disparities in treatments, outcomes, or scalability of perinatal mental health services, which may serve as targets in future perinatal mental health care service delivery intervention development.
• Research that integrates and analyzes large data sets to understand factors affecting perinatal mental health services outcomes using sophisticated computational and predictive analytic approaches.
• Studies that test implementation strategies of evidence-based interventions to address health disparities in mental health services for perinatal mental disorders.
• Research that examines and addresses structural factors that limit access to perinatal mental health services by leveraging technology to promote greater health equity for racial, ethnic, and gender diverse women during the reproductive years.
• Research that investigates the coordination of perinatal mental health services between clinicians (e.g., obstetricians, midwives, pediatricians, HIV care providers) and mental health providers to address continuity of mental health care for women and to ensure feasibility within extant public and employer based financing of perinatal mental health services.
• Studies involving service delivery interventions that utilize paraprofessionals in the detection and care of women with perinatal mental health disorders, as well as those utilizing staff already employed in the service setting, and support task-sharing/shifting in LMICs.
• Studies examining the factors involved in care decision-making by women with perinatal mental disorders in choosing treatment and services, and in clinical decision-making by health care providers in caring for patients with perinatal mental disorders.
• Research on the impact of various public and employer-based financing arrangements on the detection, assessment, referral and treatment of perinatal mental health disorders, and research to examine the value of practice patterns of different health providers and systems in addressing such disorders.
• Research on perinatal mental health disorders in relation to engagement in medical care, treatment adherence, and clinical outcomes for comorbid conditions such as HIV in global and domestic settings.
• Studies that identify variations in care that affect mental health and functional outcomes.
• Research that incorporates cultural preferences, gender, social systems, and social networks to increase appropriate help-seeking, use and provision of services, and effectiveness, quality, and outcomes of services to improve perinatal mental health outcomes.
• Studies that address necessary features for rapid dissemination, adoption, and implementation of new perinatal mental health screening and service delivery approaches in clinical and community settings.
• Studies that address maternal mental health barriers that are unique to LMIC settings, including studies that examine and optimize respectful perinatal care.
• Studies that develop sustainable models for mental health and perinatal care integration in LMIC settings.

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.

Inquiries

Please direct all inquiries to:

Tamara Lewis Johnson, MPH, MBA
National Institute of Mental Health (NIMH)
Telephone: (301) 594-7963
Email: [email protected]