Related Announcements

PA-20-141 Formative and Pilot Intervention Research for Prevention and Treatment of HIV/AIDS (R34 Clinical Trial Optional)

PA-20-144 Innovations in HIV Prevention, Testing, Adherence, and Retention to Optimize HIV Prevention and Care Continuum Outcomes (R01 Clinical Trial Optional)

PA-20-145 Innovations in HIV Prevention, Testing, Adherence, and Retention to Optimize HIV Prevention and Care Continuum Outcomes (R21 Clinical Trial Optional)

PA-20-184  Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)

PA-20-185  NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)

PA-20-194 NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)

PA-20-195 NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)

PA-20-196 NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required)

PA-21-235 NIMH Exploratory/Developmental Research Grant (R21 Clinical Trial Not Allowed) 

PAR-19-189 Pilot Services Research Grants Not Involving Clinical Trials (R34 Clinical Trial Not Allowed)

PAR-21-130 Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (R01 Clinical Trial Required)

PAR-21-131 Pilot Effectiveness Trials for Treatment, Preventive and Services Interventions (R34 Clinical Trial Required)

PAR-21-132 Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01 Clinical Trial Required)

PAR-21-316 Innovative Mental Health Services Research Not Involving Clinical Trials (R01 Clinical Trials Not Allowed)

NOT-20-105 Consolidated Notice on NIMH Clinical Trials Policies

Issued by

National Institute of Mental Health (NIMH)

Purpose

NIMH is issuing this Notice of Special Interest (NOSI) to highlight interest in basic, translational, intervention and services research relevant to the COVID-19 pandemic. NIMH is especially interested in research to provide an evidence base to understand how mental illness contributes to COVID-19 risk and mortality, how incident mental illness develops with COVID-19, and the development of scalable interventions to meet the public mental health needs during and resulting from the pandemic both specifically related to the virus but also at a broader population level that is impacted by stress, disruptions, and loss of lives in the pandemic. Research addressing the intersection of COVID-19, mental health, and HIV treatment and prevention are also of interest to NIMH. Research is anticipated to focus on particularly vulnerable populations based on existing evidence of increased mental health symptoms and illness and preexisting and worsening health disparities.

Background 

The importance of expanding research on the impact of the COVID-19 pandemic on mental health is prioritized by the substantial funding proposed in the Fiscal Year 2022 budgets from both the House and Senate. Although funds have not yet been appropriated and NIMH operates under a Continuing Resolution which maintains funding at the previous year’s level, NIMH acknowledges the contribution that new research could make to understand, prevent, and treat mental illness in the context of the pandemic. Mental illness increases risk for SARS-CoV-2 infection, is associated with higher mortality from COVID-19, and is among the incident illnesses that may emerge following infection. Further, the widespread impact of the pandemic even among those not infected has resulted in substantially increased reports of symptoms and illness across the lifespan. Researchers responded quickly to the emergence of COVID-19 to provide this initial body of knowledge. Substantial resources have been devoted to the development of large cohorts and longitudinal studies to support research on the long-term effects of COVID-19 (see RECOVER Initiative). These efforts are invaluable but are unlikely to provide the depth of mental health research that is needed. Similarly, NIMH has supported initial research to investigate interventions with deployment-focused models of services design and testing. These projects are anticipated to accelerate new interventions, but few have focused on the early development and late life stages and do not cover all areas of anticipated need.  

Preexisting health disparities related to mental health are worsened by the pandemic. Racial and ethnic minority populations have experienced higher rates of infection and loss of life, acute adverse employment and economic impacts, and disproportionate representation among essential workers experiencing increased risk of the virus, and the burden of stress to meet demands of workplaces. The disproportionate mental health burden impacting these communities is consistent and evident in surveillance reports of mental health symptoms. Other groups including sexual and gender minorities have similarly reported disproportionate impacts of the COVID-19 pandemic on mental health as have socioeconomically disadvantaged and rural populations. Addressing mental health disparities, including those associated with the COVID-19 pandemic, is a priority of NIMH. 

Research Objectives 

In order to significantly improve our understanding of the risks, mechanisms, and treatment in response to COVID-19 among individuals at risk for, or experiencing mental disorders across the lifespan, NIMH is encouraging the submission of applications to address the following areas of scientific interest: 

Basic Research

• Research establishing experimental systems to model SARS-CoV-2 CNS infection.  
• Studies of SARS-CoV-2-specific maternal immune responses, eg. TH17 signaling in CNS development and function in offspring. 
• Studies to clarify the role of SARS-CoV-2-infected brain endothelial cells and brain lymphatics responsible for triggering cognitive and emotional deficits, including the impact of stress, hormonal influences as well as sex effects in experimental systems.
• Studies to understand the impact of SARS-CoV-2 on the neuro-immune milieu and the resulting disruption of neuronal circuits, function, or behavior relevant to mental health.

Translational Research

• Studies to identify mechanisms by which people with mental illness are at increased risk of SARS-CoV-2 infection and death.  
• Mechanistic clinical trials (see NOT-MH-20-105) to probe the relevance of therapeutic targets uniquely or robustly implicated specific to COVID-19 and mental illness.   
• Research to identify potential intervention targets for modifying social connectedness, isolation, and/or loneliness via social media and/or electronic communication to prevent the development of clinically significant mental health symptoms. 
• Research that leverages existing cohorts/datasets to examine the impact of mitigation approaches (including distance learning, physical distancing, and workplace changes) on mental health and the factors that alleviate or exacerbate the impact of school disruptions on outcomes (e.g., individual, school, or policy level factors) to inform future policy or interventions. 
• Research accessing and leveraging public and/or commercial educational, surveillance, and mental health data and/or private EHR data to identify populations at high mental health risk due to the pandemic (e.g., care disruptions, changes in primary instruction settings, other social vulnerabilities).  
• Studies to develop scalable mental health interventions, particularly for populations who may have less familiarity with or access to technologically-mediated means of social connection (e.g., older adults, individuals in rural communities). 
• Studies of existing mental health research data from across multiple labs nationwide (e.g. see NIMH Data Archive) to understand how the pandemic impacted the rigor of data collection and how adaptations to research in the pandemic may have impacted task reliability/validity. 

Services and Intervention Research

• Research to address vaccine hesitancy, uptake, and implementation among mental health populations. 
• Research on the effects of pandemic-related changes to mental health care delivery and systems on mental health care patients (e.g. impact on the quality of patient care and mental health outcomes and functioning) and providers (e.g. preventing and mitigating burnout, and the quality of patient care).   
• Research on whether implementation of preventive interventions prior to the pandemic reduce risk for mental health difficulties across different stages of development. 
• Research to evaluate whether evidence-based prevention interventions in middle- and high-school settings decreases risk for mental health problems. 
• Projects to develop and test tools that would enable health and social service workers to have real-time access to resources for case management and referral to medical/psychiatric treatment, as well as social support services, to meet the complex needs of persons with mental illness. 
• Research to determine the feasibility and utility of technology-enabled screening to identify/triage those in immediate need of in-patient behavioral health, medications, and opioid replacement therapy. Higher priority research would include evaluation of participant follow through and outcomes related to point-of-care triage and referral to services (e.g., web-based or other self-care, and/or telephone counseling that supports individual brief CBT for distress, online group interventions, etc.). 
• Development and testing of technology to leverage/build on the available response workforce to enable practical, scalable, and sustainable mental health screening, triage, and prevention/treatment interventions along a continuum of intensity for mental disorders across the lifespan, particularly for high risk populations both within and outside healthcare settings (i.e. school or workplace screening is also of interest). Interventions appropriate for mass trauma response are of interest (e.g., Psychological First Aid [PFA]; enhanced PFA; self-guided and professionally assisted skills based interventions, internet-based interventions for managing common posttraumatic symptoms and stress related symptoms and conditions; brief CBT-based approaches for distress, and Collaborative Care programs) as are those to improve de-escalation of suicidal crises, reduce suicide attempt risk, and/or improve post-acute recovery for youth at elevated risk for self-injurious thoughts and behaviors treated in acute care settings). 
• Research to understand and improve engagement and continuity of care including approaches to facilitate (re)connection to care for persons with serious mental disorders who experience disruption in services. 

HIV/AIDS Research 

• Develop and test interventions to promote HIV self-testing and COVID-19 self-testing including use of digital technologies, supports, or innovative strategies (e.g., secondary distribution, or communications-based) to promote return of results, confirmatory or regular testing, contact tracing and linkage to ongoing HIV and COVID-19 prevention or treatment services. 
• Development and testing of communication strategies to address HIV and COVID-19 testing hesitancy, COVID-19 vaccine hesitancy and enhance COVID-19 vaccination series completion and booster follow-up as recommended for people living with HIV or high-incidence populations. 
• Research on interventions such as those conducted through telemedicine that may promote continuity of HIV prevention and care services, including mental health services, during the COVID-19 pandemic particularly for populations experiencing health disparities. 
• Epidemiologic, clinical, and basic studies of the incidence and prevalence of PASC (Post-acute sequelae of COVID) in people living with HIV (PLWH) compared to participants without HIV with a focus on mental health, neurologic, and behavioral sequelae and relating to immunologic, viral and treatment factors as well as other factors during the acute and post-acute SARS-CoV-2 infection.  
• Understand the pathophysiology of acute and post-acute SARS-CoV2 CNS complications in people living with HIV including the role of immune dysfunction on neuronal function and reactivation of HIV from latent reservoirs. 

Global Mental Health Research 

• Research focused on digital health and systems interventions in low- and middle-income countries (LMICs) to improve de-escalation of suicidal crises, reduce the risk of suicide attempts , and/or improve recovery for populations at elevated risk for self-injurious thoughts and behaviors as a result of the COVID-19 pandemic. 
• Research focused on digital health and systems interventions in LMICs to screen and manage common mental disorders (e.g., depression, anxiety) for populations at elevated risk (including mobile populations) of worsening morbidity because of the COVID-19 pandemic 
• Research focused on integrating and increasing screening of mental health and substance use symptoms in populations accessing primary care as a result of the COVID-19 pandemic  
• Research to examine the impact of pandemic-related changes in social determinants of health (e.g. school closures, employment loss, food insecurity, housing insecurity) on mental health outcomes and functioning in LMICs.

Additional areas of research relevant to COVID-19 and mental illness should be discussed with scientific program staff for technical assistance with NIMH priorities and potential overlap with existing research efforts and other potential funding mechanisms. 

Application and Submission Information

This notice applies to due dates on or after February 15, 2022 and subsequent receipt dates through January 8, 2025. 

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice.

• PA-20-141 Formative and Pilot Intervention Research for Prevention and Treatment of HIV/AIDS (R34 Clinical Trial Optional)
• PA-20-144 Innovations in HIV Prevention, Testing, Adherence, and Retention to Optimize HIV Prevention and Care Continuum Outcomes (R01 Clinical Trial Optional)
• PA-20-145 Innovations in HIV Prevention, Testing, Adherence, and Retention to Optimize HIV Prevention and Care Continuum Outcomes (R21 Clinical Trial Optional)
• PA-20-184  Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)
• PA-20-185  NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
• PA-20-194 NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)
• PA-20-195 NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)
• PA-20-196 NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required)
• PA-21-235 NIMH Exploratory/Developmental Research Grant (R21 Clinical Trial Not Allowed)
• PAR-19-189 Pilot Services Research Grants Not Involving Clinical Trials (R34 Clinical Trial Not Allowed)
• PAR-21-130 Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (R01 Clinical Trial Required)
• PAR-21-131 Pilot Effectiveness Trials for Treatment, Preventive and Services Interventions (R34 Clinical Trial Required)
• PAR-21-132 Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01 Clinical Trial Required)
• PAR-21-316 Innovative Mental Health Services Research Not Involving Clinical Trials (R01 Clinical Trials Not Allowed)

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

• For funding consideration, applicants must include “NOT-MH-22-100” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Applications nonresponsive to terms of this NOSI will be withdrawn from consideration for this initiative.

Inquiries

Scientific/Research Contact(s)

Division of AIDS Research  

Pim Brouwers, Ph.D. 
National Institute of Mental Health (NIMH) 
Telephone: 240-627-3863 
Email: [email protected] 

Division of Neuroscience and Basic Behavioral Science 

Susan Koester, Ph.D. 
National Institute of Mental Health (NIMH) 
Telephone: 301-443-3563 
Email: [email protected] 

Division of Services and Intervention Research  

Adam Haim, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-435-3593
Email: [email protected]

Division of Translational Research

Susan Borja, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-1252
Email: [email protected]

Center for Global Mental Health Research 

Leonardo Cubillos, MD, MPH 
National Institute of Mental Health (NIMH) 
Telephone: 301-827-9095 
Email: [email protected] 

Financial/Grants Management Contact(s)

Terri Jarosik
National Institute of Mental Health (NIMH)
Telephone: 301-443-3858
Email: [email protected]