Promoting Research on Music and Health: Phased Innovation Award for Music Interventions (R61/R33 Clinical Trial Optional)

Promoting Research on Music and Health: Phased Innovation Award for Music Interventions (R61/R33 Clinical Trial Optional) is sponsored by National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH). This funding opportunity aims to increase understanding of how music affects the brain when used therapeutically and to use that knowledge to develop evidence-based music interventions to enhance health or treat specific diseases and disorders.

Expired PAR-20-266: Promoting Research on Music and Health: Phased Innovation Award for Music Interventions (R61/R33 Clinical Trial Optional) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) National Endowment for the Arts ( NEA ) Components of Participating Organizations National Center for Complementary and Integrative Health ( NCCIH ) National Institute on Alcohol Abuse and Alcoholism ( NIAAA ) Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) National Institute of Mental Health ( NIMH ) National Cancer Institute ( NCI ) All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers.

The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Behavioral and Social Sciences Research ( OBSSR ) Funding Opportunity Title Promoting Research on Music and Health: Phased Innovation Award for Music Interventions (R61/R33 Clinical Trial Optional) R61 / R33 Exploratory/Developmental Phased Award Reissue of RFA-AT-19-001 , Promoting Research on Music and Health: Phased Innovation Award for Music Interventions (R61/R33, Clinical Trial Optional) Notices of Special Interest associated with this funding opportunity NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022 August 18, 2022 - Notice of Clarification of Research Examples for PAR-20-266: Promoting Research on Music and Health: Phased Innovation Award for Music Interventions (R61/R33 Clinical Trial Optional) .

See Notice NOT-AT-22-028 October 28, 2021 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available. See Notice NOT-OD-22-018 . September 13, 2021 - Updates to the Non-Discrimination Legal Requirements for NIH Recipients.

See Notice August 5, 2021 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022. August 5, 2021 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements. See Notice NOT-OD-21-170 April 20, 2021 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel.

See Notice NOT-OD-21-109 March 25, 2021 - Notice of NICHD Participation in PAR-20-266. See Notice NOT-HD-21-021 . August 19, 2020 - Notice of Intent to Publish a Funding Opportunity Announcement for Music and Health: Understanding And Developing Music Medicine (R21).

See Notice NOT-NS-20-100 . August 19, 2020 - Notice of Intent to Publish Funding Opportunity Announcements for Music and Health: Understanding And Developing Music Medicine (R01). See Notice NOT-NS-20-096 .

Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity PAR-21-100 , R01 Research Project Grant See Section III. 3. Additional Information on Eligibility .

Catalog of Federal Domestic Assistance (CFDA) Number(s) 93. 213, 93. 866, 93.

273; 93. 393; 93. 242, 93.

865 Funding Opportunity Purpose The purpose of this Funding Opportunity Announcement (FOA) is to promote innovative research on music and health with an emphasis on developing music interventions aimed at understanding their mechanisms of action and clinical applications for the treatment of many diseases, disorders, and conditions. Given the emphasis on innovation, little or no preliminary data are needed to apply under this FOA.

Because of the need for a multidisciplinary approach, collaborations among basic researchers, translational science researchers, music intervention experts, other clinical researchers, music health professionals, and technology development researchers are encouraged. The FOA utilizes a phased R61/R33 funding mechanism to support mechanistic research and to evaluate the clinical relevance of music interventions.

The R61 phase will provide funding to either investigate the biological mechanisms or behavioral processes underlying music interventions in relevant animal models, healthy human subjects, and/or clinical populations, or can be used to develop innovative technology or approaches to enhance music intervention research.

The second R33 phase will provide support for further mechanistic investigations in human subjects or animal models, intervention development, or pilot clinical studies. The pilot clinical studies may focus on intervention optimization/refinement, feasibility, adherence, and/or identification of appropriate outcome measures to inform future clinical research.

Transition from the R61 to the R33 phase of the award will depend on successful completion of pre-specified milestones established in the R61.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) New : October 02, 2020; June 02, 2021; October 04, 2021; June 02, 2022; October 03, 2022; June 02, 2023 Resubmissions: October 19, 2020; June 17, 2021; October 19, 2021; June 17, 2022; October 19, 2022; June 19, 2023 All applications are due by 5:00 PM local time of applicant organization.

All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s). Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s) October 19,2020; June 17, 2021; October 19, 2021; June 17, 2022; October 19, 2022; June 19, 2023 All applications are due by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on the listed date(s).

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

February 2021; October 2021; February 2022; October 2022; February 2023; October 2023 May 2021; January 2022; May 2022; January 2023; May 2023; January 2024 July 2021; April 2022; July 2022; April 2023; July 2023; April 2024 Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide ,except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review. Part 1. Overview Information Part 2.

Full Text of Announcement Section I. Funding Opportunity Description Section II. Award Information Section III.

Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Part 2.

Full Text of Announcement Section I. Funding Opportunity Description The purpose of this FOA is to promote innovative research on music and health with an emphasis on developing music interventions aimed at understanding their mechanisms of action and clinical applications for the treatment of many diseases, disorders, and conditions. Given the emphasis on innovation, little or no preliminary data are needed to apply under this FOA.

with. Because of the need for a multidisciplinary approach, collaborations among basic researchers, translational science researchers, music intervention experts, other clinical researchers, music health professionals, and technology development researchers are encouraged. The FOA utilizes a phased R61/R33 funding mechanism to support mechanistic research and/or to evaluate the clinical relevance of music interventions.

The R61 phase may either investigate the biological mechanisms or behavioral processes underlying music interventions in relevant animal models, healthy human subjects, and/or clinical populations, or be used to develop innovative technology or approaches to enhance music intervention research.

The second R33 phase will provide support for further mechanistic investigations in human subjects or animal models, intervention development, or pilot clinical studies. The pilot clinical studies may focus on intervention optimization/refinement, feasibility, adherence, and/or identification of appropriate outcome measures to inform future clinical research.

Transition from the R61 to the R33 phase of the award will depend on successful completion of pre-specified milestones established in the R61. Music has the remarkable ability to enhance child development, improve adult function and well-being, and optimize the quality of life during aging. Many studies have shown that music can also ameliorate the symptoms of a broad range of diseases and disorders that occur throughout the lifespan.

Recent scientific breakthroughs, including the development of new technologies, are providing the community with opportunities to understand the mechanisms through which music acts, and to develop new music interventions for a variety of diseases, disorders, and conditions.

To capitalize on these opportunities, NIH has issued initiatives intended to: i) promote our understanding of the basic mechanisms through which music is processed by the brain and body; ii) explore how music impacts normal health and development; and iii) facilitate rigorous studies of music interventions to treat disease symptoms. In 2016, NIH, John F.

Kennedy Center for the Performing Arts (KC), and National Endowment for the Arts (NEA) formed a collaborative partnership ( Sound Health ) and organized a workshop to evaluate the state of basic and applied music research ( Music and the Brain ).

In this meeting, a diverse panel of experts discussed three overlapping periods of life (childhood, adulthood, and aging) and made recommendations for enhancing research in each of these domains ( NIH report ). The group developed a set of recommendations intended to highlight research opportunities and promote rigorous research.

These recommendations centered around four broad areas: 1) Basic and Mechanistic Research, 2) Translational and Clinical Research, 3) Methods and Outcomes, and 4) Capacity Building and Infrastructure. In 2017, a trans-NIH Music and Health working group was formed to capitalize on these recommendations and promote their implementation.

To achieve this goal, NIH issued three related funding opportunity announcements (FOAs) in 2019 that fall into two categories. The first two FOAs ( RFA-NS-19-008 , R01 and RFA-NS-19-009 , R21 ) supported R01 and R21 awards, respectively, that were intended to broadly support any research areas related to the fundamentals and application of music in health.

The third FOA ( RFA-AT-19-001 , R61 / R33 ) utilized a phased R61/R33 mechanism to support research on music and health geared toward music intervention. This FOA has similar objectives to that of a prior FOA, RFA-AT-19-001 (R61/R33), to support phased innovation research on music interventions in human subjects or appropriate animal models.

While no preliminary data are required for the R61 phase, transition to the R33 phase is contingent on successful completion of agreed-upon Go/No-Go milestones. Investigators are expected to participate in an annual meeting convened by the NIH to review progress of the funded research and highlight advances on the science of music and health and should therefore budget accordingly.

Current research findings suggest that the auditory cortex in the brain is the key region to process many of the unique sound features of music, such as pitch, rhythm, and harmonic structures, although much more remains to be investigated to fully understand the neural correlates of music listening and music performance.

Preliminary evidence has emerged to suggest that brain regions involved in emotional regulation, reward, cognitive and motor function, and other sensory functions such as pain, as well as regulation of many internal bodily functions and activities, may be coactivated with the auditory cortex during music listening or music performance.

As these brain regions have been implicated in a broad range of organ dysfunctions and nervous system disorders, these preliminary studies provide a theoretical premise to investigate the potential of music interventions for relevant diseases, disorders, and conditions.

Research Objectives and Specific Requirements The primary objective of the R61 phase supported under this FOA is to promote innovative basic/mechanistic research on music interventions. The R61 phase can be a basic, mechanistic, or technology development study in relevant animal models, human subjects, or both. Preliminary data are not required for a R61 phase application.

However, applicants may include preliminary data if they are available.

Examples of topics of high interests for the R61 phase include, but are not limited to: Assessing feasibility to enroll and retain study population, deliver and/or implement proposed music-based inventions, collect data, etc, and/or assess acceptability using qualitative or quantitative measuress, that may determine reasons for dropouts, such as preference ratings, assessmets of participant burden, and perceived credibility/value of the interventions.

The mechanisms of music interventions for pain, opioid misuse, management of other symptoms, or palliative care The mechanisms of music interventions for visual impairments, hearing restoration; voice, speech, language rehabilitation; or spatial orientation The mechanisms of music interventions for obesity treatment and appetite control or parasympathetic neural stimulation for stress relief for patients or caregivers The mechanisms of music interventions on promoting well-being or behaviors associated with health and well-being, such as exercise; or improving the emotional/behavioral status of individuals with dementia (e.g. Alzheimer’s disease (AD) or Alzheimer’s disease related dementias (ADRD)) The mechanisms of music interventions for motor disorders across the lifespan, including stroke and Parkinson’s disease The mechanisms of music interventions for general brain disorders or memory improvement Individual differences in the mechanisms and outcome effects of music interventions Development and testing of new technology for music intervention delivery Applicants are expected to develop a detailed description of the music intervention they propose to use in the study.

For mechanistic studies, in animal models or human subjects, investigators are encouraged to properly define the distinct components of a complex music intervention or provide adequate description and justification of focusing on a specific component (e.g., rhythm, melody, harmonic structure, pitch, or other individual motor or components) of complex music interventions.

The proposed mechanism(s) or process(es), when appropriate, are expected to be assessed using objective, quantifiable, and reproducible measures. Applicants are also expected to provide detailed descriptions of the measures and a strong rationale for choosing such measures. If the R61 phase includes a mechanistic clinical trial, applicants are encouraged to refer to https://www.

ClinicalTrials. gov for a review of the registered trials already under way or completed to help determine whether: 1) the results of ongoing trials can inform the design of the proposed study, and 2) the proposed study is innovative. In addition, a randomized intervention design is encouraged for this phase of study with human subjects.

An intended clinical or functional outcome for the proposed intervention is not required for the R61 phase but may be included to give a preliminary assessment of the relevance of the putative mechanism to the intended influence on a functional or clinical outcome.

While more than one mechanism or process may be proposed for and examined under the R61 phase, investigators are encouraged to focus on one or two primary measures for the mechanism(s) of action or process(es), with other potential mechanisms as either alternatives or secondary. The effect of the intervention on the primary mechanisms should be adequately powered statistically in animal model or human subject studies.

The primary objective of the R33 phase is to support the development and implementation of rigorous, evidence-based proof-of-concept studies of music interventions in healthy human subjects or appropriate clinical populations, or innovative in-depth mechanistic studies in relevant animal models to investigate how components of music interventions may work.

Examples of R33 phase projects include, but are not limited to: Mechanistic studies examing music-based interventions in research participants, if the R61 phase focuses on feasibility and/or acceptability of the planned (R33) randomized mechanistic clinical trial.

Further mechanistic studies of music interventions in human subjects or in-depth analysis in animal models, if the R61 phase focuses on a basic mechanistic study in animal models.

For instance, the R61 phase may examine whether specific musical structures (e.g., pitch, rhythm, harmonic structures, and/or chord) may activate discrete neural correlates in a relevant animal model, while the R33 phase would explore the mechanistic effects of such musical structures in modulating parallel brain activities in a relevant clinical population.

Optimization or in-depth studies of mechanistic effects of music interventions, if the R61 phase focuses on a preliminary mechanistic study in human subjects.

For instance, the R61 phase may examine whether active music engagement coactivates auditory and motor cortices in a clinical population, while the R33 phase may study whether additional brain stimulation of the cortical connections may enhance or impair the auditory/motor connectivity as well as the associated clinical effects.

Pilot feasibility studies of music interventions, if the R61 phase focuses on novel technology development or basic research.

For instance, if the R61 phase develops an app-delivered music intervention, the R33 phase could involve a randomized trial of the music intervention app versus a comparator app in the target population to assess feasibility (e.g., recruitment and retention rates, fidelity of implementation, participant adherence rates, data collection procedures, etc.) and acceptability (e.g., qualitative assessments, reasons for dropouts, preference ratings, participant burden, credibility).

Pilot clinical studies of music interventions including proof of principle, if the R61 phase focuses on a basic mechanistic study in human models.

For instance, if the R61 phase examines whether a music intervention is associated with basal ganglia activity, the R33 phase could involve a randomized trial of the music intervention vs. a standard care comparator among Parkinson’s disease patients to assess feasibility and acceptability parameters, examine within-group pre-post changes in clinically relevant measures, and/or examine correlations between changes in basal ganglia activity and clinically relevant measures as proof-of-principle.

In the R33 phase, human mechanistic studies are encouraged to be statistically powered for the hypothesized mechanisms or processes.

Pilot feasibility studies are not expected to be powered for the proposed mechanistic or clinical outcomes; instead they should be primarily focused on examining important questions about feasibility and acceptability that will directly inform the design and conduct of a future, fully-powered clinical efficacy or effectiveness study.

Examination of within group pre-post changes in clinical outcomes or the correlation of mechanistic outcomes with clinical outcomes may be included in pilot clinical studies as indication of proof-of-principle of the proposed music intervention on hypothesized clinical outcomes. Pilot clinical studies are not meant to be definitive trials and should not propose to examine clinical efficacy or effectiveness in an underpowered sample.

In many cases, including feasibility work, a randomized clinical trial design may be appropriate for the R33 phase, with the choice of the control group determined by the needs for testing the specific outcomes or by the research question to be answered in a future fully powered efficacy trial. Masking of subjects and objective methods of assessment using masked raters should be employed whenever possible.

Masking procedures should be clearly specified for the study participants/patients, instructors/practitioners, outcome assessors, data analysts/statisticians, and principal investigators.

R61/R33 Transition Milestones and Processes In the R61 phase application, investigators are expected to describe a set of Go/No-Go milestones that will allow for a definitive assessment of whether the R61 phase provides sufficient evidence to support the subsequent R33 phase study as proposed in the grant application.

Because the R61 phase fundamentally serves as the phase to collect key preliminary data for the proposed R33 phase study, the proposed R61/R33 transition milestones should specify the quantifiable metrics that would determine the successful completion of such key preliminary data, preferably with a timeline. Progress under the R61 phase will be administratively reviewed by NIH program officials.

Funding for and transition to the R33 phase is contingent on the following: 1) meeting the Go/No-Go milestones articulated in the R61 phase, 2) the availability of funds, and 3) regulatory approval of the planned R33 activities by the administrating NIH Institute or Center.

If the R61 phase study is not able to complete the milestones as defined at the initial award stage, then the investigators will not be able to transition to the R33 phase. To transform knowledge and practice in music and health research programs, collaboration across fields was recommended by the participants in the NIH/KC/NEA workshop to evaluate the state of basic and applied music research ( Music and the Brain ).

This FOA strongly encourages applications that assemble an interdisciplinary, collaborative team of creative, independent investigators to address the complex and important research questions relevant to the science of music interventions. The team should be able to provide an integrative plan for working together to effectively address the complex challenge at hand.

The team science approach encouraged by this FOA will inform discovery-based or hypothesis-generative approaches, to advance the science of music interventions and its impact on health.

Examples of collaborative teams for this FOA include, but are not limited to: Basic research scientist, music health professional, intervention expert Clinical researcher, music therapist, neurologist or other medical profession expert Biomedical, behavioral, and/or social scientist, intervention expert, musician, music therapist Technology development researcher (e.g., mhealth, novel delivery system), neuroscientist, music health professional Scope and Specific Areas of Research Interest This FOA supports a broad range of research on music interventions and health.

In addition, specific Areas of Research Interest from the participating NIH ICs of this FOA are listed below. Applicants are strongly encouraged to contact the Scientific/Research Contacts from various NIH ICs listed in Section VII prior to submission to discuss IC program relevance.

National Center for Complementary and Integrative Health ( NCCIH ) NCCIH is broadly interested in supporting research aimed at understanding the mechanisms by which music interventions may influence symptom management with high-priority interest in pain, stress-related disorders, and sleep disorders, as well as opioid misuse and enhancement of emotional well-being.

NCCIH is also interested in supporting early-phase clinical studies for intervention optimization and refinement, feasibility, and acceptability testing, to prepare for future large-scale definitive efficacy studies of music interventions related to pain, management of other symptoms, or enhancement of emotional well-being.

While the early-phase clinical studies supported in the R33 phase of this FOA may include evaluation of within group, pre-post changes in clinical outcomes or the correlation of mechanistic outcomes with clinical outcomes as useful proof-of-principle information, NCCIH will not support research proposing to examine preliminary efficacy or effectiveness in an underpowered sample via this FOA.

National Cancer Institute ( NCI ) NCI is interested in supporting research within the mission of NCI. The following are example research areas of interest: Identify the biological mechanisms or behavioral processes to understand how music interventions improve tolerance to or increase effectiveness of various cancer therapy modalities (e.g., through modulation of immune tone).

Identify biological mechanisms or behavioral processes to understand how music interventions prevent or ameliorate cancer related symptoms and toxicities. Develop novel music-based interventions including in combination with other integrative medicine modalities to improve tolerance or increase effectiveness of various cancer therapy modalities.

Develop novel music-based interventions to improve symptom management in patients through the cancer control continuum (i.e., those receiving active treatment, during survivorship, or those receiving palliative or end-of-life care). Symptoms include but are not limited to anxiety, depression, altered sleep, fatigue, pain, generalized coping with cancer and its treatment, and other symptoms that can decrease quality of life.

Develop strategies to promote music-based cancer therapy augmentation to improve tolerance and increase effectiveness of various cancer therapy modalities for low resource settings.

National Institute on Aging ( NIA ) NIA supports research to improve the health and well-being of older adults and is interested in studies that integrate basic research on music to inform the development of efficacious interventions for individuals as they age and on intervention development research which attempt to understand the basic behavioral, affective, cognitive, social and biological mechanisms of behavior change.

The purpose of the interventions to be developed may be, for example, to promote health and well-being, promote behaviors associated with health and well-being (e.g., exercise), cope with stress (e.g., dementia caregivers), improve the emotional/behavioral status and/or physical function of individuals with neurodegenerative disorders such as Alzheimer’s disease and Alzheimer’s disease related dementias (AD/ADRD) and Parkinson’s disease, or help older individuals with declining memory improve their memory.

Applicants are encouraged to review the NIH Stage Model for intervention development ( https://www. nia. nih.

gov/research/dbsr/stage-model-behavioral-intervention-development ) and the NIH Science of Behavior Change (SOBC) experimental medicine methodology ( https://commonfund. nih. gov/behaviorchange ) as they prepare their applications.

National Institute on Alcohol Abuse and Alcoholism ( NIAAA ) NIAAA is interested in supporting research within the mission of NIAAA. Example research areas of interest to NIAAA include 1) How does music modulate negative emotion states associated with the alcohol use disorder (AUD)? What are the biological and neurological underpinnings of the modulation?

2) How does alcohol exposure across the life span, during early development, adolescent stage, adult, and aging, impact music processing? 3) Can music facilitate cognitive recovery following heavy chronic alcohol use, and what are the underlying neurocircuit mechanisms? 4) How does music impact recovery from AUD?

Which types of music might promote sustained abstinence? National Institute of Mental Health ( NIMH ) NIMH supports research to discover the causes of mental illness and to develop more effective and safer interventions. Under this FOA , NIMH will accept applications that propose mechanistic clinical trials ( see NOT-MH-19-006) but not applications proposing tests of clinical efficacy and/or safety of novel interventions.

According to NIMH’s definition, a mechanistic clinical trial is a study that uses clinical trial methodology in order to test hypotheses about biological or behavioral processes, pathophysiology of a disease, or the mechanism of action of an established intervention.

Regarding mechanistic clinical trials, NIMH is interested in applications proposing two types of studies, including 1) mechanistic clinical trials using an intervention of known efficacy to investigate the pathophysiology, and/or psychopathology of mental disorders or the mechanisms of therapeutic responses; and to advance biomarkers of basic neurobiological processes, and 2) mechanistic clinical trials utilizing an experimental manipulation focused on understanding brain function in healthy individuals or those with disorders, by measuring responses to the experimental manipulation.

Additionally, for the R33 phase NIMH will accept applications proposing innovative in-depth mechanistic studies or further mechanistic investigations in relevant animal models to investigate how components of music interventions may work.

Applications that propose a clinical trial for the purpose of testing the safety and/clinical efficacy of novel interventions are outside of the scope of NIMH research interests for this FOA and will not be referred for review.

Applicants interested in evaluating treatments for clinical efficacy should apply through one of the FOAs listed at the NIMH clinical trials website , which includes links to the NIMH clinical trials RFAs and a list of frequently asked questions (FAQs ). NIMH strongly encourages applicants to consult with NIMH Program Officials when developing plans for an application.

This early contact will provide an opportunity to clarify NIMH policies and guidelines and identify whether the proposed project is consistent with NIMH program priorities, and to determine which available FOA would best support the proposed research.

This is particularly important if there is doubt as to whether or not the submission is determined to be an NIH-defined clinical trial, and if found to be a clinical trial, whether it is a mechanistic clinical trial as defined by NIMH.

Examples of research areas of interest to NIMH : Mechanistic studies to address the question of how listening to or performing music promotes brain health through the rhythmic entrainment of neural activity in the brain and, importantly, how rhythmic entrainment may have ancillary benefits for neural systems supporting cognition, learning, mood, and social/affiliative behavior.

Investigations of the neural networks that might underlie atypical music processing (e.g., pitch discrimination, pitch memory, memory for tone/picture) in subgroups of individuals with neuropsychiatric disorders. Where there is preliminary evidence of atypical music processing in subgroups of individuals with neuropsychiatric disorders, further evaluation of networks relevant to music processing is of interest.

These studies must be supported by empirical evidence that the networks under study are relevant to music processing and to the neuropsychiatric condition(s) under study. Mechanistic studies to address the question of how listening to or performing music promotes brain health through mood induction (for example inducing anxiolytic effects) or physical exercise.

To support the goal of advancing research through widespread data sharing among researchers, investigators funded under this FOA by NIMH are expected to share those data via the National Institute of Mental Health Data Archive (NDA) . NDA is a secure informatics platform for scientific collaboration and data sharing that enables the effective communication of detailed research data, tools, and supporting documentation.

A cost estimation tool for data sharing is available on NDA’s webpage (see Cost Estimation ) and can be used when preparing budgets for applications. NIMH requires reporting of recruitment milestones for participants in all NIMH extramural-funded clinical research studies proposing to enroll 150 or more subjects per study, and all clinical trials, regardless of size (see NOT-MH-19-027 ) .

All NIMH funded mechanistic clinical trials funded under this FOA must report recruitment milestones, including those with fewer than 150 subjects. This requirement will be stated in the notice of grant award.

Office of Behavioral and Social Sciences Research ( OBSSR ) OBSSR is broadly interested behavioral neuroscience and social science research that investigates the mechanisms that underlie music-based interventions for the improvement and/or maintenance of health and well-being, or the prevention and/or treatment of behavioral and/or neurological/psychiatric disorders.

OBSSR does not accept assignment of applications or manage awards that are funded. Please contact one of the ICs listed for inquiries regarding the suitability of the proposed project for the FOA and the IC’s research portfolio. See Section VIII.

Other Information for award authorities and regulations. Section II. Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed Resubmission of RFA-AT-19-001 or this FOA The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA. Optional: Accepting applications that either propose or do not propose clinical trial(s) Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Application budgets for the R61 and R33 phases must reflect the actual needs of the proposed project. The R61 phase cannot exceed $350,000 in direct costs in any given