Key Dates

Related Announcements

• November 29, 2023- Notice of Special Interest (NOSI): SBIR/STTR Program Priorities to Bridge Gaps in Advancing the NIMH Mission.See Notice NOT-MH-24-110
• July 18, 2023 - Notice of Special Interest (NOSI): Innovative Technologies to develop novel tools to prevent and treat HIV in underserved populations. See Notice NOT-MH-23-200
• July 12, 2023 - PHS 2023-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required). See NOFO PA-23-231
• July 12, 2023 - PHS 2023-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed). See NOFO PA-23-230
• July 12, 2023 - PHS 2023-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed). See NOFO PA-23-232
• July 12, 2023 - PHS 2023-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required). See NOFO PA-23-233

Issued by

National Institute of Mental Health (NIMH)

Purpose

The National Institute of Mental Health (NIMH) is issuing this Notice of Special Interest (NOSI) to encourage Small Business Concerns (SBCs) to submit Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grant applications that propose to develop, refine, and evaluate digital mental health technologies. Digital health technology includes mobile health (mHealth) (smartphones, wearable sensors, tablets or other devices) and health information technology (internet platforms, and electronic health records) that collect or use biological, social, and behavioral data. These technologies hold promise for enriching clinical research and clinical trials data in psychiatry as well as augmenting clinical care. Note that diversity is encouraged, See Notice of NIH’s Interest in Diversity for more details.

Background

The NIMH SBIR and STTR Programs support Small Business Concerns (SBCs) to develop innovative technologies that have the potential to succeed commercially and provide societal benefits aligned with the NIMH mission. The NIMH National Advisory Mental Health Council (NAMHC) report, Opportunities and Challenges of Developing Information Technologies on Behavioral and Social Science Clinical Research summarizes opportunities and challenges of developing new digital health technologies and provides an overview of NIMH priorities and recommendations. These recommendations should guide SBCs developing applications responsive to this NOSI.

Objectives

Rigorous research is needed to test the efficacy, effectiveness, or implementation of innovative digital mental health interventions or service delivery tools. Novel technologies are also needed to understand the trajectory and etiology of mental disorders, to predict and prevent mental illness, and to support basic or clinical mental health research and clinical trial design/implementation.

Technologies that would help to reduce mental health disparities and promote equity in access, quality, and effectiveness of mental health care among racial and ethnic minorities, sexual and gender minorities, socioeconomically disadvantaged populations, or underserved rural populations are strongly encouraged.

Responsive Areas of Research

Examples of high priority SBIR/STTR digital health research areas for NIMH include, but are not limited to:

Assessment. Technology-assisted data collection presents opportunities for accurate, efficient, real-time assessment and automated collection of behavior in natural environments, clinical settings or clinical trials. Priorities include research to support commercially viable and accessible technology or computational approaches to understand developmental disease trajectories, infer subjective mental states or risk for self-harm or suicide from observable behaviors (e.g., sensor data, voice/speech samples, text-based samples for Natural Language Processing [NLP], facial movement, locomotion, Global Positioning System [GPS], social sensing, device or electronic media use patterns), evaluate treatment response, establish more homogeneous subgroups of patients, or examine interventions that leverage these digital profiles. New data science methods and workflows are needed for building robust and interpretable predictive models based on multi-component biomarker and clinical data in prodromal phases of illness. Attention should be made to the stability, replicability, and reproducibility of the digital data.

Intervention Refinement and Testing. Digital health technologies may enhance the reach or effectiveness of interventions across mental health conditions and illness phases. Commercial products might include technologies to deliver adaptive interventions based on empirically supported strategies for treatment tailoring or stepped care, just-in-time interventions that respond to information about an individual’s current state, or interventions that leverage technology to improve intervention delivery, adherence, or engagement using evidence-based behavioral strategies or novel digital platforms.

Service Interventions and Service Delivery. Technologies may facilitate service delivery via patient-facing, clinician-facing, or systems-level applications that are designed to improve service access, engagement/continuity, quality, efficiency, equity, and value.?Such technology could include products supporting measurement-based care, decision aides to match individuals to appropriate interventions and services based on severity and need, products to facilitate dissemination and implementation within healthcare systems, provider training technologies, or digital tools to monitor and ensure sustained treatment fidelity or improved service use outcomes.

Across these topic areas, careful attention should be given to privacy and safety concerns including: (1) data privacy and plans for ethical collection, storage, and use of personal health data, (2) safeguards with respect to use of artificial intelligence (AI) such as addressing biases and inequity in underlying data and protecting end-users from unhelpful or harmful interactions (e.g., managing and constraining data sources used by unsupervised AI), and (3) an appropriate match between the level of clinical need and the level of support delivered, including plans for stepped care or intervention if severe symptoms, self-harm or suicide risk are identified in the context of technology use or during research participation.

SBIR/STTR applicants are encouraged to review the Food and Drug Administration (FDA) policies on regulation of digital health products. If appropriate, applications should discuss the possible regulatory status of their product and describe any plans for premarket submissions to FDA. Applicants may consider including Technical and Business Assistance (TABA) funding in their budget to support development of regulatory plans.

Research strategies to evaluate the technology might include case-control, cross-sectional, and longitudinal designs as well as randomized controlled trials, quasi-experimental designs with non-randomized comparison groups, time series designs, and other designs of equivalent rigor and relevance. Applicants are strongly encouraged to establish study teams with appropriate technical, data science, user experience, safety, and mental health or health systems subject-matter expertise.

Product development could be strengthened by proposing engagement or iterative design with appropriate end-users and relevant advisors such as persons with lived experience of mental illness and their families, clinicians and other service providers, health systems/administrators, state and local public health or housing agencies, school systems, criminal justice systems, patient or consumer advocacy groups, community-based organizations, and faith-based organizations.

Examples of studies that would not be considered high priority?include the following:

• Plans to convert an established face-to-face intervention to a technology-based intervention without a strong rationale for how technology would improve intervention reach or effectiveness.
• Products that consist of solely one-way text messages or reminders.
• Applications that take interventions or products developed for adults and propose to test them among youth without considering developmental differences.
• Applications that propose complex, provider-intensive approaches or interventions that do not incorporate features to enhance scalability and sustained delivery with fidelity.

Digital mental health technologies appropriate for this NOSI may request project durations of up to two years for Phase I and up to three years for Phase II. Generally, budgets of up to $450,000 total cost per year for Phase I awards, $750,000 total cost per year for Phase II awards, and $1,000,000 total cost per year for Phase IIB awards may be requested. All budget requests need to be well justified. Please reach out to program staff to discuss proposed budgets prior to submitting an application.

Application and Submission Information

This notice applies to due dates on or after January 5, 2024, and subsequent receipt dates through January 6, 2027.

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

• PA-23-230 - PHS 2023-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed).
• PA-23-231 - PHS 2023-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required).
• PA-23-232 - PHS 2023-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed).
• PA-23-233 - PHS 2023-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required).

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

• For funding consideration, applicants must include NOT-MH-24-120 (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 not be considered for the NOSI initiative.

Inquiries

Please direct all inquiries to the Scientific/Research, Peer Review, and Financial/Grants Management contacts in Section VII of the listed notice of funding opportunity.

Scientific/Research Contact(s)

Adam Haim, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-435-3593
Email: Haima@mail.nih.gov

Margaret C. Grabb, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-7123
Email: mgrabb@mail.nih.gov

Vasudev R Rao, MBBS, MS.
National Institute of Mental Health (NIMH)
Telephone: 301-825-3259
Email: vasudev.rao@nih.gov

Financial/Grants Management Contact(s)

Jane Lin
National Institute of Mental Health (NIMH)
Telephone: 301-443-2229
Email: linja@mail.nih.gov