Behavioral Intervention Development Funding Opportunity

The Translational Research Institute on Pain in Later Life (TRIPLL) announces a behavioral intervention development grant program, designed to support social and behavioral clinical trials that will test non-pharmacological pain and pain management interventions in later life. TRIPLL will award up to $210,000 direct costs per year for up to 2 years.

Final proposal due (if selected):  January 15, 2025

Earliest start date, pending NIA review:  July 1, 2025

TRIPLL sponsors clinical trials that apply the NIH Stage Model for Behavioral Intervention Development. TRIPLL is particularly interested in receiving applications to support Stage II-III clinical trials that engage participants from medically underserved, racially and ethnically diverse older adults. We will also consider applications of Stage 1b or Stage IV trials and hybrid pragmatic trials. TRIPLL will also consider applications requesting supplemental funding for already funded clinical trials that seek to increase sample size, add pain outcomes, or add new sites or populations of older adults.

TRIPLL is funded by a 5-year grant from the National Institute on Aging (National Institutes of Health).

Projects that could be funded by TRIPLL include, but are not limited to:

• A Stage II efficacy trial of a mobile health application to increase patient positive affect as a means to mitigate the impact of pain

• A Stage III multi-site effectiveness trial of a program that encourages physical activity, testing behavioral mechanisms such as increased self-efficacy for pain management

• A Stage III multi-site effectiveness trial that provides novel psychological therapy to shift beliefs about the causes of pain.

• A Stage II or III intervention directed at health care providers to increase referral of patients to non-pharmacological treatments and therapies to help manage pain.

• Stage IV testing of a public health/raising awareness intervention designed to increase physical activity among older office workers

• Conducting a pragmatic effectiveness–implementation hybrid trial of low-cost pain medication management strategies through Visiting Nuse Services

To compete successfully for funding, applicants must propose clinical trials based on the NIH Stage Model for Behavioral Intervention Development, focus on mechanisms of behavioral change, and demonstrate potential for future funding and implementation. TRIPLL welcomes projects that partner with community agencies serving older adults.

PhD and MD level Investigators from all US institutions are eligible to apply. Multidisciplinary teams are highly encouraged.

Letter of intent (LOI)

A letter of intent to apply for funding is required. The letter of intent is due December 1, 2024. Letters of intent will be reviewed and ranked by TRIPLL investigators and advisory board members. TRIPLL will extend invitations for the submission of pre-proposals that will be due January 15, 2025.

The letter of intent should be 1-2 pages in length. Please describe the trial to be conducted and the evidence upon which the proposed trial is based. Letters of intent should state: 1) NIH Stage of the trial (or type of hybrid effectiveness); and 2) Behavioral mechanism of change targeted in the trial. The letter of intent should be accompanied by current NIH standard biosketches for all study investigators.

Application Process

To be considered for funding, investigators must submit a 6-page proposal by January 15, 2025, to Patricia Kim at pak2020@med.cornell.edu. TRIPLL’s Review Panel will meet in January 2025 to review/rank the final proposals and select the most meritorious applications.

The 6-page pre-proposal (single-spaced) should include: 1) Significance and Background; 2) Innovation; 3) Research Approach (the Approach must include a power analysis); 4) If applicable, information on the collaborating agency/ies and how the collaborative process will take place; and finally; 5) Description of any current funding and timetable for applying for additional funding after the trial is completed. If the project includes collaboration with a community agency, the application must be accompanied by a signed letter of agreement from the director of the agency. A one-page Specific Aims must also be included, as well as references (but are not counted in the 6 page limit). As appendices, applicants must include current NIH biosketches for project investigators and a letter of commitment from the agency partner (if applicable). Partnering agencies must have 501(c)3 status.

Allowable expenses include research-related costs, research assistant salaries with fringe benefits, communications and supplies, respondent incentives, travel related to the research, data and resource sharing expenses, and equipment purchases less than $1500. Salary support for the Principal Investigator is permitted but must be thoroughly justified how such salary support is critical to performing the proposed research tasks. Additionally, if the investigator plans to work with a community agency (or agencies), it is generally expected that a fund for the collaborating agencies will be provided to cover expenses they may incur.

How will projects be selected for funding?

The TRIPLL review panel will evaluate grant proposals, respectively. Funding decisions will be announced on February 15, 2025. Reviewers will evaluate projects based on the timeliness of the proposed project, immediate relevance, and application to developing feasible non-pharmacological interventions appropriate for older people with chronic pain, scientific merit, the feasibility of completion in the time requested, probability of attracting outside funding, and qualifications and commitment of the investigator to the project. Proposal reviewers will examine an applicant’s record of scholarly productivity and proposal submission activity when making funding decisions.

If you are awarded a TRIPLL grant:

1. Your project will be reviewed by the National Institute on Aging before funding is released. 

2. By March 15, 2025 you must complete a checklist of items required for the NIA review. Behavioral Intervention Core Director Elaine Wethington (ew20@cornell.edu) will provide you with a copy of the checklist for submission to TRIPLL. Instructions are included with the checklist. TRIPLL must submit the completed checklist to NIA no later than April 1, 2025. This deadline is firm and cannot be extended.

3. Study investigators are expected to make two presentations about study progress to the TRIPLL Executive Committee during the year, and investigators must meet at least quarterly with the TRIPLL investigators to report on the project’s progress.

4. Investigators may be asked to present their projects and project findings at online meetings convened by the Roybal Centers Coordinating Center.

Questions? Email TRIPLL’s Program Manager, Patty Kim at pak2020@med.cornell.edu

Click here to see full funding announcement

Notice of Funding Opportunity: Testing Mechanisms of Benefit in Tailored Home and Community-Based Dementia Care Interventions

The Establishing Mechanisms of Benefit to Reinforce the Alzheimer’s Care Experience (EMBRACE) AD/ADRD Roybal Center (RFA-AG-24-007) will support trials that test mechanism driven, tailored interventions in home- and community-based contexts. Our Center is particularly interested in dementia care interventions that:

1. Tailor their intervention components to the needs of individuals living with AD/ADRD, their care partners, or others);

2. Target one or more levels of influence (e.g., individuals living with AD/ADRD; the living environment; the family/social network/provider; and/or the neighborhood and community); and

3. Identify, measure, and test mechanisms of action (i.e., causal drivers that specify why an intervention works, such as constructs representing self-regulation, stress resilience, or social/interpersonal processes that influence a desired behavior change).

EMBRACE requests applications to support a 1- to 2-year award for a clinical trial that tests mechanisms of action for tailored home- and community-based dementia care interventions. Proposed trials should demonstrate high potential to advance to later stages of the NIH Stage Model for Behavioral Intervention Development for further testing, dissemination, and/or implementation. EMBRACE will support one trial in the upcoming year of funding with a maximum total cost of $200,000 per year. Pending approval from the National Institute on Aging (NIA), EMBRACE trials will begin on June 1, 2025.

Eligibility

Per RFA-AG-24-007, “Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PI(s) for Roybal clinical trials is invited to work with his/her organization to develop an application for support. The eligible PIs for Roybal clinical trials include, but are not limited to, junior investigators, investigators from diverse backgrounds including those from underrepresented groups, and established investigators at the Center institutions or at outside institutions, or in association with academic and/or corporate partners.”

As stated in RFA-AG-24-007, EMBRACE will support preliminary clinical trials in any stage of the NIH Stage Model for Behavioral Intervention Development. Supported trials may: “1) leverage a Stage 0 basic research finding to create a potent implementable intervention, defined by its principles; 2) examine the principles, or mechanism of action underlying a behavioral intervention, in all Stages of research); 3) create and/or modify, and conduct preliminary testing of real-world-friendly training procedures (Stage I) and further test these procedures (Stage III), as appropriate, before progressing to Stage IV; and 4) create and/or modify and pilot test and test methods to maximize real-world fidelity (Stage I and III) to maximize successful later-Stage real-world clinical trials.”

An important consideration for any funded EMBRACE trial is the presence of adequate statistical power to test the proposed mechanism of action and/or efficacy of the dementia care intervention. EMBRACE values trials that are inclusive; trials “may involve creating, adapting, and/or testing interventions that are designed to be feasible and acceptable across multiple races and ethnicities; conducting studies that seek to determine the mechanisms through which an intervention may have efficacy for one group of individuals, but not for another, where the elucidation of mechanisms informs the development of precision interventions targeting the specific processes requiring modification” (RFA-AG-24-007).

Evaluation Criteria

We will apply the following criteria when considering EMBRACE trial applications: a) significance/innovation of idea; b) clearly identified and measurable mechanism of action (e.g., Science of Behavior Change mechanisms such as self-regulation; stress resilience; and/or interpersonal/social processes); c) clearly-specified intervention target level (individual living with dementia; caregiver; living environment; and/or neighborhood community); d) inclusion of a tailored intervention delivered within home and/or community settings; e) potential of the trial to yield high-quality data leading to future extramural funding at a subsequent stage of the NIH Stage Model; f) scientific merit and feasibility of design/analysis; and g) a focus on diverse samples.

Application Process

The first step in applying for EMBRACE funding is to complete our Letter of Intent (LOI) form, available here.

A traditional LOI is not required. Please provide the following information via the LOI form:

• Principal Investigator (PI)/Multiple Principal Investigator (MPI) name(s), institution(s), and background information

• Title of proposed project

• The dementia care/caregiving challenge addressed

• Intervention proposed and hypothesis

• Mechanism of action targeted

• Level of influence targeted

• A Specific Aims page

• An NIH-formatted biosketch for PI. For formatting guidelines and examples, please see here.

The EMBRACE Behavioral and Intervention Development Core would be happy to discuss proposal ideas or answer related questions from potential applicants. Please email embrace@umn.edu to schedule a time to do so. Completed Letters of Intent (again, via the LOI form here) are due on November 20, 2024, at 5 PM CST. Applicants with highly promising LOIs will be invited to submit a full EMBRACE trial application no later than December 15, 2024.

While the LOI deadline has passed, please visit the EMBRACE website to see other funding opportunities.

Click here to visit the EMBRACE website

These select applicants will have the opportunity to consult with the EMBRACE Behavioral and Intervention Development Core to review design, innovation, and alignment before submitting a full application, which is due February 1, 2025.

EMBRACE trials will be selected no later than March 1, 2025, with an anticipated start date of June 1, 2025, contingent on NIA approval.

EMBRACE LOI Announcement.pdf

Download PDF • 216KB

Embrace Info Sheet.pdf

Download PDF • 398KB

Notice of Funding Opportunity: Behavioral Intervention Trials

The Brigham and Women's Hospital Roybal Center for Therapeutic Optimization Using Behavioral Science (funded through NIA RFA-AG-24-006) seeks to develop and test principle-driven, potent, practical, scalable, and sustainable behavioral interventions to enhance the appropriate prescribing of and adherence to evidence-based medications with the goal of improving the lives of midlife and older people. We are pleased to issue a call for proposals for randomized clinical trials that test behavioral interventions aimed at improving evidence-based medication use. These trials should measure clinically-relevant outcomes and should aim to generate strong preliminary data for follow-on funding. For the upcoming year, we will support 2- 3 projects with a maximum annual direct cost of $200,000. Most projects will be funded for a 12-month period, starting June 1, 2025 (pending NIA approval), although projects of up to 24-months will also be considered.

Eligibility

Eligible investigators include, but are not limited to, Early Stage Investigators (ESIs) and established investigators from academic, non-profit or corporate institutions. Applicants who are underrepresented minorities and applicants who have not previously received funding through the BWH Roybal Center for Therapeutic Optimization Using Behavioral Science are particularly encouraged to apply. Eligibility for investigators outside of the US is based on NIH policies listed in the NIA Roybal RFA and as further detailed in the NIH Grants Policy Statement. Collaboration with individuals who have experience successfully conducting pragmatic clinical trials of behavioral interventions, including with Center affiliated faculty, is strongly recommended for all applications.

Evaluation Criteria

Applications will be evaluated using criteria: (1) the significance of the medication use problem being addressed including its potential to promote healthy aging; (2) the strength and novelty of the principle-driven behavioral intervention being evaluated including the rigor of supporting preliminary data; (3) the scientific approach including the appropriateness of the study outcomes, how mechanisms of actions will be evaluated and whether novel analytic methods and technological approaches are used to gain a deeper understanding of mechanisms of behavior and to facilitate the creation of interventions that are personalized but applicable to population health improvement; (4) the feasibility that the study can be carried out; (5) the quality, diversity and complementarity of the investigative team, including experience in conducting trials; and (6) the potential to lead to follow-on funding, such as an R01. Examples of successfully funded projects can be found here.

Application Process

For the first phase of the trial review process, please submit a, letter of intent (LOI) containing:

1. General Information

a) Descriptive title of proposed activity

b) Name(s), address(es), and telephone number(s) of the PI(s)

c) Names of other key personnel and participating institution(s)

d) Estimated budget (total direct and indirect) 2 Center for Healthcare Delivery Sciences │1620 Tremont Street, Boston, Ma 02120

2. Research Strategy (maximum 2-pages, single-spaced pages with one-inch margins) containing the following information:

a) Description and significance of the medication-use problem being addressed

b) Proposed behavioral intervention, its theoretical underpinnings and hypothesized mechanism of behavior change for the problem being

c) Brief description of research design including study design, subject eligibility criteria, intervention description, primary outcomes and method to evaluate mechanism of behavior change

d) Proposed study setting and timelines

e) Summary of qualifications of the investigative team

3. NIH Biosketch:

An NIH format biographical sketch must be submitted for the PI(s) and all Co-Is. Please follow this link for biosketch instructions and samples.

We would be pleased to meet with prospective applicants interested in discussing proposal ideas. Please email us at c4hds@bwh.harvard.edu to request a consultation. The LOI should submitted via email to c4hds@bwh.harvard.edu by November 1, 2024, 5pm ET. Highly-ranked LOIs will be notified that they have been invited to submit a full application by the first week of December 2024. Full application will be due January 6, 2025. Prior to this date, those invited to the full proposal stage will be required to meet with the BWH Roybal Center Behavioral Intervention Development (BID) Core to discuss their study design and plans for the conduct of the proposed trials

Awarded pilot projects are anticipated to begin June 1, 2025, pending NIA approval.