Investigator Initiated Clinical Trials of Complementary and Integrative Interventions Delivered Remotely or via mHealth (R01 Clinical Trial Required)
ID: 357303Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Grant

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/357303

Additional Information

http://grants.nih.gov/grants/guide/pa-files/PAR-25-268.html
Timeline
    Description

    The National Institutes of Health (NIH) is offering a funding opportunity for investigator-initiated clinical trials focused on complementary and integrative health interventions delivered remotely or via mobile health (mHealth) technologies. Applicants are required to design fully powered clinical trials that do not involve in-person contact between research staff and participants, providing preliminary data on the feasibility, safety, and potential clinical benefits of their proposed interventions. This initiative aligns with the NIH's commitment to addressing public health challenges and expanding access to integrative health approaches, particularly in areas of high research priority identified by the National Center for Complementary and Integrative Health (NCCIH). Interested applicants should note that the submission period opens on January 20, 2025, and must include a Plan for Enhancing Diverse Perspectives (PEDP) as part of their application; for further inquiries, they can contact NIH Grants Information at grantsinfo@nih.gov.

    Point(s) of Contact
    grantsinfo@nih.gov
    Files
    Title
    Posted
    PAR-25-268-Full-Announcement.html
    PAR-25-268.html
    The National Center for Complementary and Integrative Health (NCCIH) is seeking applications for investigator-initiated clinical trials that deliver complementary and integrative health interventions remotely or via mobile health (mHealth) technologies. The funding opportunity, designated as PAR-25-268, emphasizes the need for trials that assess the efficacy or effectiveness of such interventions without in-person interactions between research staff and participants. Successful applications must provide preliminary data supporting the feasibility, safety, and potential clinical benefits of the interventions proposed. Integral to the application process is the requirement for a Plan for Enhancing Diverse Perspectives (PEDP) to foster inclusivity among research participants, especially from diverse and underrepresented backgrounds. Key details include the funding’s alignment with NCCIH's strategic priorities, including research on mind and body interventions, health behavior promotion, and reducing health disparities. Applications are expected to be robust, well-justified designs with rigorous methodology for remote engagement. The timeline indicates open submission beginning January 20, 2025, but applicants are urged to initiate early communications with NCCIH scientific contacts to ensure readiness. This funding opportunity reflects NCCIH's commitment to expanding access to integrative health approaches and addressing public health challenges through innovative research practices.
    Similar Opportunities
    Investigator Initiated Clinical Trials of Complementary and Integrative Interventions Delivered Remotely or via mHealth (R01 Clinical Trial Required)
    National Institutes of Health
    The National Institutes of Health (NIH) is inviting applications for the funding opportunity titled "Investigator Initiated Clinical Trials of Complementary and Integrative Interventions Delivered Remotely or via mHealth." This initiative encourages the submission of proposals for fully remotely conducted clinical trials aimed at assessing the efficacy of complementary and integrative health interventions, particularly in areas designated as high research priorities by the National Center for Complementary and Integrative Health (NCCIH). The trials must involve no in-person contact between research staff and participants, utilizing mobile health technologies, and applicants are required to provide preliminary data demonstrating the feasibility and safety of their proposed approaches, along with a Plan for Enhancing Diverse Perspectives (PEDP) that will be evaluated during the review process. The application period opens on January 20, 2024, with a submission deadline of February 20, 2026. Interested applicants can find more information and guidance at the NIH website or contact NIH Grants Information at grantsinfo@nih.gov for further inquiries.
    NCCIH Multi-Site Feasibility Clinical Trials of Mind and Body Interventions (R01 Clinical Trial Required)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity for multi-site feasibility clinical trials of mind and body interventions through the National Center for Complementary and Integrative Health (NCCIH). This R01 research grant invites applications focused on investigating complementary health approaches that utilize physical or psychological therapies, with an emphasis on demonstrating prior feasibility data to support the multi-site approach. The initiative aims to enhance understanding of integrative health interventions, particularly their efficacy and impact on diverse populations and health disparities. Interested applicants can apply for a maximum project budget of $350,000 annually over a period not exceeding three years, with a submission deadline of January 20, 2024. For further inquiries, applicants may contact NIH Grants Information at grantsinfo@nih.gov.
    NCCIH Multi-Site Feasibility Clinical Trials of Mind and Body Interventions (R01 Clinical Trial Required)
    National Institutes of Health
    The National Institutes of Health (NIH), through the National Center for Complementary and Integrative Health (NCCIH), has announced a funding opportunity for multi-site feasibility clinical trials focused on mind and body interventions under the R01 grant mechanism. This initiative aims to support studies that gather essential data necessary for planning larger efficacy trials, with specific objectives including assessing recruitment feasibility, intervention fidelity, and participant adherence across multiple sites. The funding is crucial for advancing research in complementary and integrative health, addressing public health challenges, and fostering innovative healthcare approaches. Eligible applicants can request up to $350,000 in direct costs per year, with applications due by November 17, 2026. For further details, interested parties can contact NIH Grants Information at grantsinfo@nih.gov or visit the official announcement at https://grants.nih.gov/grants/guide/pa-files/PAR-25-267.html.
    Feasibility Clinical Trials of Mind and Body Interventions for NCCIH High Priority Research Topics (R34 Clinical Trial Required)
    National Institutes of Health
    The National Institutes of Health (NIH), through the National Center for Complementary and Integrative Health (NCCIH), is offering a funding opportunity for feasibility clinical trials focused on mind and body interventions addressing high-priority research topics. The objective is to support R34 planning grants that gather essential data necessary for the design and planning of future full-scale efficacy studies, specifically examining aspects such as intervention acceptability, recruitment strategies, and data collection procedures. This initiative is crucial for advancing research in nonpharmacological approaches to symptom management, particularly relevant in the context of increasing healthcare demands. Interested applicants can apply for grants of up to $450,000 over three years, with a submission deadline of November 13, 2026. For further inquiries, applicants may contact NIH Grants Information at grantsinfo@nih.gov or visit the additional information link at https://grants.nih.gov/grants/guide/pa-files/PAR-24-084.html.
    Feasibility Clinical Trials of Mind and Body Interventions for NCCIH High Priority Research Topics (R34 Clinical Trial Required)
    National Institutes of Health
    The National Institutes of Health (NIH), through the National Center for Complementary and Integrative Health (NCCIH), is inviting applications for the R34 Planning Grant aimed at conducting feasibility clinical trials of mind and body interventions for high-priority research topics. The primary objective of this funding opportunity is to gather essential data necessary for planning future full-scale clinical efficacy or effectiveness studies, with a strong emphasis on addressing gaps in existing knowledge and enhancing public health outcomes, particularly for underserved populations. Eligible applicants include a diverse range of organizations such as higher education institutions, nonprofits, and community-based organizations, with a funding limit of $450,000 over a maximum project period of three years. Interested parties should submit their applications by November 17, 2026, and are encouraged to contact NIH Grants Information at grantsinfo@nih.gov for further inquiries.
    Mobile Health: Technology and Outcomes in Low and Middle Income Countries (R21/R33 - Clinical Trial Optional)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "Mobile Health: Technology and Outcomes in Low and Middle Income Countries (R21/R33 - Clinical Trial Optional)" aimed at encouraging exploratory research on mobile health (mHealth) interventions tailored for low- and middle-income countries (LMICs). The initiative seeks to develop, validate, and assess innovative mHealth technologies that can improve health outcomes in these regions, fostering partnerships between U.S. institutions and LMIC entities to enhance research capabilities and address global health challenges. Funding of up to $125,000 is available for R21 projects over two years, with the potential for an additional $200,000 per year in the R33 phase, contingent upon milestone completion. Applications will be accepted starting February 21, 2025, with a closing date of March 20, 2026. For further inquiries, interested applicants can contact NIH Grants Information at grantsinfo@nih.gov.
    Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative UG3/UH3 Clinical Trial Required)
    National Institutes of Health
    The National Institutes of Health (NIH), through the National Center for Complementary and Integrative Health (NCCIH), is offering a funding opportunity for the establishment of a Clinical Coordinating Center (CCC) to support multi-site investigator-initiated clinical trials focused on mind and body interventions. Applicants are required to develop comprehensive plans that include project management, participant recruitment, and data analysis, while collaborating with a corresponding Data Coordinating Center (DCC) to ensure the trials are scientifically robust and aligned with NCCIH's research priorities. This initiative aims to explore the efficacy and effectiveness of complementary health approaches, emphasizing the inclusion of diverse populations and the necessity for a detailed plan to enhance diversity in research teams and subjects. Interested applicants must submit their proposals by January 20, 2025, and can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries. For more details, please refer to the full announcement available at https://grants.nih.gov/grants/guide/pa-files/PAR-24-275.html.
    Data Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative U24 Clinical Trial Required)
    National Institutes of Health
    The National Institutes of Health (NIH), through the National Center for Complementary and Integrative Health (NCCIH), is inviting applications for a Data Coordinating Center (DCC) to support multi-site, investigator-initiated clinical trials focused on mind and body interventions. The DCC will be responsible for project coordination, administrative support, data management, and biostatistical analysis for Phase III clinical trials, and must be submitted alongside a Clinical Coordinating Center (CCC) proposal. This initiative is crucial for advancing research in complementary and integrative health strategies that address public health challenges, emphasizing participant diversity and data integrity. Interested applicants should note that the application deadline is January 20, 2025, with a funding period of up to 7 years, and can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries.
    Laboratories to Optimize Digital Health (R01 Clinical Trial Required)
    National Institutes of Health
    The National Institutes of Health (NIH) is inviting applications for the "Laboratories to Optimize Digital Health" grant, aimed at enhancing the reach and effectiveness of digital mental health interventions. This initiative focuses on innovative research projects that leverage established digital health platforms to conduct clinical trials, ultimately seeking to address health disparities and improve mental health outcomes. The funding opportunity encourages collaboration and the development of scalable, technology-driven solutions, with no budget limits and a maximum project period of four years. Interested applicants can find more information and submit inquiries via email at grantsinfo@nih.gov, with applications due by March 5, 2025.
    NCCIH Natural Product Early Phase Clinical Trial Phased Innovation Award (R61/R33 Clinical Trial Required)
    National Institutes of Health
    The National Institutes of Health (NIH), through the National Center for Complementary and Integrative Health (NCCIH), invites applications for the NCCIH Natural Product Early Phase Clinical Trial Phased Innovation Award (R61/R33), aimed at supporting early-phase clinical trials of natural products such as botanicals and dietary supplements. This funding opportunity encourages research that evaluates the pharmacokinetics, safety, and efficacy of these natural products, with a focus on advancing promising interventions backed by prior scientific evidence. The program is designed to foster innovative clinical research that enhances understanding of the beneficial impacts of natural products on health conditions, while ensuring inclusivity through a Plan for Enhancing Diverse Perspectives (PEDP). Applicants may request up to $350,000 per year, with a project duration of up to six years contingent upon successful milestone completion, and the application deadline is November 13, 2026. For further inquiries, interested parties can contact NIH Grants Information at grantsinfo@nih.gov.