DEPARTMENT OF DEFENSE - CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAMS

NEWS RELEASE

Released: March 3, 2023

Department of Defense
Congressionally Directed Medical Research Programs (CDMRP)
Traumatic Brain Injury and Psychological Health Research Program
Anticipated Funding Opportunities for Fiscal Year 2023 (FY23)

The FY23 Defense Appropriations Act provides funding for Traumatic Brain Injury and Psychological Health Research Program (TBIPHRP) to support research into the treatment, prevention, and detection of traumatic brain injury (TBI) and improved psychological health. The managing agent for the anticipated program announcements/funding opportunities is the CDMRP at the U.S. Army Medical Research and Development Command (USAMRDC).

The TBIPHRP is providing the information in this pre-announcement to allow investigators time to plan and develop ideas for submission to the anticipated FY23 funding opportunities. This pre-announcement should not be construed as an obligation by the government. The FY23 TBIPHRP funding opportunity announcements and General Application instructions/General Submission Instructions for the following award mechanisms will be posted on the Grants.gov website. Pre-application and application deadlines will be available when the announcements are released.

Applications submitted to the FY23 TBIPHRP must address one or more of the following Focus Areas, not all of which will be applicable to every award mechanism:

Understand:

  1. Understand: Research will address knowledge gaps in, epidemiology, and etiology of psychological health conditions and/or TBIs.
    1. Understanding of risk, protective, and biological factors contributing to an individual’s vulnerability to, response to, and long-term outcomes of psychological health conditions and/or TBI. Studies with an objective biomarker component are allowed. Research of interest includes, but is not limited to:
      • Understanding psychological health trajectories associated with trauma (e.g. acute stress reactions [ASRs], adjustment disorders, posttraumatic stress disorder [PTSD]) and suicidality that incorporate internal and external factors. For example, factors could include time course, demographic characteristics, career progression, history of trauma exposure, and community and cultural factors.
      • Understanding how the approach to psychiatric diagnosis (e.g., ASRs, adjustment disorders, PTSD) in the military relates to occupational impairment and/or military separation.
      • Understanding the contribution of pre- and post-injury patient, family, and caregiver education, as well as cultural, demographic, stigma, and bias factors that may relate to treatment-seeking and adherence.
      • Development and analysis of modeling from clinical data and other human data (e.g., electronic health records, exposure, training, and/or occupational data) to forecast the long-term and/or late effects of brain exposures, such as TBI, and co-occurring conditions.
      • Development and analysis of communication and tools/technology adoption that would facilitate clinical translation and identification of risk factors, educational barriers, social determinates of health, and other factors that may impede clinical translation.
    2. Understanding sexual harassment and assault prevention, perpetration, victimization, and response. Methodologies that ensure anonymity for participants are strongly encouraged. Research of interest includes, but is not limited to:
      • Understanding processes of shame, stigma, and institutional betrayal among sexual assault victims and their units/teams and evaluation of approaches to mitigate these experiences. Experiences of marginalized groups, male victims, and victims of intimate partner and family1 violence are of particular interest.
      • Understanding how interpersonal and individual conditions, choices, behaviors, and psychological health are influenced by organizational-level factors relate to sexual assault and harassment prevention, perpetration, and response. Measurement and analysis of organizational-level factors, such as culture, climate, and training, beyond aggregating individual perceptions, are encouraged. Research could include the progression from sexual harassment to sexual assault and factors influencing sexual harassment.
      • Understanding barriers to reporting sexual assault and factors that contribute to retaliation within units/teams and evaluation of approaches to mitigate barriers, prevent retaliation, and improve psychological health outcomes of victims. Research could include data from influencers, bystanders, and perpetrators, as well as environmental, structural, and demographic factors (e.g., workplace culture, climate, senior leader diversity, age, gender).
      • Understanding the psychological health consequences of intimate partner and family violence.

Prevent and Assess:

  1. Prevent and Assess: Research will address the prevention or progression of psychological health conditions and/or TBI through population, selective, and indicated prevention approaches. Efforts that focus on primary prevention (including protection), screening, diagnosis, and prognosis are within scope.
    1. Identification and validation of biomarkers or other objective markers for diagnosis, prognosis, or monitoring of psychological health conditions and/or TBI, repetitive exposures, and associated sequelae (e.g., chronic migraine, dizziness, neurocognitive symptoms, sleep, post-traumatic headache, secondary complications).
    2. Approaches or tools to prevent or reduce risk of psychological health conditions and/or TBI. Research of interest includes, but is not limited to:
      • Evaluation of environmental sensor data in aspects related to brain health and risk from brain blast and impact exposures.
      • Development of innovative materials and technologies that can prevent or reduce risk of TBI.
      • Generation of physiological evidence regarding the safety, efficacy, and utility of candidate neuroprotective measures. Animal models, if used, should be validated and well justified within the literature and should demonstrate clear alignment to clinical populations.
      • Validation of objective tools/methods for assessing and real-time health status monitoring of psychological health conditions and/or TBI.
      • Development of clinical decision-making frameworks or tools that incorporate objective assessments and long-term outcomes to return to activity/duty decisions.
    3. Development of injury thresholds and exposure standards for TBI.
    4. Development, evaluation, and implementation of crosscutting prevention approaches targeting upstream factors or leveraging communities and peers to address multiple adverse outcomes such as suicide, multiple forms of violence, and alcohol and substance use disorders. Examples of upstream factors could include social connectedness, inclusiveness, culture, problem-solving, emotional regulation, communication, underlying health disparities, financial stability, geographical isolation, rural challenges, and environmental extremes. Research of interest may include, but is not limited to:
      • Optimized messaging for successful dissemination and implementation.
      • Inclusion of families1 and evaluation of family impact.
      • Culturally acceptable approaches to reducing access to lethal means and promoting means safety for suicide and violence prevention.
    5. Development of solutions to increase readiness and psychological resilience in individuals, small teams, families,1 and communities to ameliorate the potential negative impacts of specific military and life stressors. Research of interest includes, but is not limited to:
      • Effective pharmacologic or non-pharmacologic prevention interventions. Solutions for prevention of ASRs and PTSD or adjustment disorders may be proposed.
      • Preparation of Service Members and units for missions and to help reset and improve resilience between deployments.
      • Effective solutions to support relationships and parenting, prepare families for potential secondary trauma exposure, and empower families to access tailored support and resources.
    6. Development of solutions to address aspects of workplace culture and climate (e.g., leadership attitudes, group characteristics, group identification factors) that are associated with increases in harmful behaviors. Research of interest includes, but is not limited to, solutions to provide and incentivize positive options and substitutes for alcohol and substance use and promote pro-social behavioral norms.

Treat:

  1. Treat: Research will address immediate and long-term treatments and improvements in systems of care, including access to and delivery of health care services. Treatment topics may include novel treatments and interventions, personalized medicine approaches, length and durability of treatment, rehabilitation, relapse, and relapse prevention.
    1. Interventions that promote sustained functional recovery, including interventions administered acutely, during the post-acute phase, or during the chronic phase of injury. Research of interest includes, but is not limited to:
      • Rapid assessments and treatments for psychological health conditions. Interventions addressing adjustment disorders, ASRs, and PTSD may be proposed.
      • Interventions focused on sensory and motor dysfunction after brain injury.
      • Interventions that address neurodegenerative processes associated with TBI.
      • Interventions that restore cognitive reserve and functioning.
      • Novel therapeutic candidates based on evolving changes of pathophysiology and/or theoretical mechanisms of psychological health conditions and/or TBI.
      • Interventions and/or the delivery of health care services to improve the ability to treat co-occurring TBI and psychological health conditions.
      • Personalized medicine approaches to treatment that may include tailoring treatment to the biological and endophenotypic elements present. Treatment approaches may consider how TBI, PTSD, depression, or other psychological health conditions are interrelated.
      • Considerations for sequencing and optimal combinations of pharmacologic and non-pharmacologic interventions.
      • Effective, early interventions for delivery in rural or other resource-limited environments (e.g., far-forward military environments), and/or by non-clinicians (e.g., peers, teams, first responders/medics).
    2. Validated methods for reducing barriers to care for psychological health conditions and/or TBI challenges (e.g., PTSD, suicidal ideation or behaviors, alcohol and substance use, anxiety, depression) and informing processes that lead to increases in help-seeking behavior.
      • Research of interest includes, but is not limited to, individual, peer/unit/team, leader, family, caregivers, community, and enterprise level methods.
    3. Implementation, follow-up, and services research to increase provider adoption and availability of evidence-based treatments, as well as treatment engagement, follow-up care, and understanding of long-term outcomes. Research of interest includes, but is not limited to:
      • Clinical effectiveness studies comparing new/novel capabilities to existing evidence-based treatments and/or the standard of care.
      • Identification and evaluation of methods for successful dissemination and implementation of interventions.
    4. Effective postvention strategies to address social connectedness during reintegration of individuals into workplace or community environments following a sexual assault, suicide event, or other severe trauma. Proposed research should also consider preventing subsequent suicides or other counterproductive behaviors among individuals and community members.

1 “Family” should be broadly defined to include not just spouses, but also parents, significant others/fiancés/partners, children, caregivers, or close friends.



Award Mechanism Eligibility Key Mechanism Elements Funding
Clinical Trial Award Extramural applicants only

Investigators at the level of Assistant Professor and above (or equivalent)

  • Supports clinical trials for pharmacological (e.g., biologics, drugs) and non-pharmacological (e.g., devices, psychotherapy) interventions.
  • Different funding levels, based on the scope of research, are available. It is the responsibility of the Principal Investigator (PI) to select the funding level that is most appropriate for the research proposed. The funding level should be selected based on the scope of the research project, rather than the amount of the budget.

The following are general descriptions, although not all-inclusive, of the scope of the research projects that would be appropriate to propose under each funding level:

  • Funding Level 1: Proof-of-principle pilot trials, correlative studies, and other innovative, exploratory clinical trials.
  • Funding Level 2: Clinical trials for promising treatments or interventions that have already demonstrated acceptable safety in human subjects.
  • Funding Level 3: Large-scale clinical trials to demonstrate efficacy in relevant patient populations.
  • Submission of a preproposal is required; application submission is by invitation only
Funding Level 1
  • Maximum funding of $500,000 for direct costs (plus indirect costs).
  • Maximum period of performance is years.
Funding Level 2
  • Maximum funding of $2,000,000 for direct costs (plus indirect costs).
  • Maximum period of performance is years.
Funding Level 3
  • Maximum funding of $4,000,000 for direct costs (plus indirect costs).
  • Maximum period of performance is 4 years.
Focused Program Award Extramural applicants only

Investigators at the level of Full Professor and above (or equivalent)

  • Supports a synergistic, multidisciplinary research program of at least four distinct but complementary projects addressing an overarching goal.
  • Projects should work together to answer critical questions, resolve differing hypotheses, and translate laboratory findings to clinical applications.
  • Projects may range from exploratory to hypothesis-developing through small-scale clinical trials that together address the overarching goal/question.
  • Research team of highly qualified, multidisciplinary project leaders should be led by a PI with demonstrated success in directing large, focused projects.
  • Submission of a preproposal is required; application submission is by invitation only.
  • Maximum funding of $5,000,000 for direct costs (plus indirect costs)
  • Maximum period of performance is 4 years.
Investigator-Initiated Research Award Investigators at the level of Assistant Professor and above (or equivalent)
  • Supports research with the ability to make an original and important contribution to research and/or patient care.
  • Partnering PI Option is available.
  • Clinical trials will not be supported.
  • Submission of a Letter of Intent is required prior to full application submission.
  • Maximum funding of $500,000 for direct costs (plus indirect costs).
  • Maximum period of performance is 3 years.
Translational Research Award Investigators at the level of Assistant Professor and above (or equivalent)
  • Supports the translation of promising research into clinical application (i.e., preclinical to clinical translation).
  • May support small-scale pilot clinical trial when necessary to inform the next step in clinical development.
  • Partnering PI Option is available.
  • Submission of a Letter of Intent is required prior to full application submission.
  • Maximum funding of $1,000,000 for direct costs (plus indirect costs).
  • Maximum period of performance is 4 years.
Health Services Research Award
(Formerly known as the Patient-Centered Research Award)
Investigators at the level of Assistant Professor and above (or equivalent)
  • Bridges the gap between research, practice, and policy by building a knowledge base on how interventions and clinical practices/guidelines and policies can be deployed to targeted populations at the appropriate time at the point of need.
  • Clinical trials are allowed as long as they meet the intent of the mechanism.
  • Submission of a Letter of Intent is required prior to full application submission.
  • Maximum funding of $1,500,000 for direct costs (plus indirect costs)
  • Maximum period of performance is 4 years.

A pre-application is required and must be submitted through the Biomedical Research Application Portal (eBRAP) prior to the pre-application deadline. All applications must conform to the final funding opportunity announcements that will be available for downloading from the Grants.gov website. The application package containing the required forms for each award mechanism will also be found on Grants.gov. A listing of all CDMRP and other USAMRDC extramural funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420.

Submission deadlines are not available until the funding opportunity announcements are released. For email notification when announcements are released, subscribe to program-specific news and updates under “Email Subscriptions” on the eBRAP homepage. For more information about the TBIPHRP or other CDMRP-administered programs, please visit the CDMRP website (https://cdmrp.health.mil).


Point of Contact:

CDMRP Public Affairs
301-619-9783
usarmy.detrick.medcom-cdmrp.mbx.cdmrp-public-affairs@health.mil


Last updated Friday, March 3, 2023