Behavioral RCT Funding Announcement

Each year, millions of Americans who experience serious health events such as heart attacks, strokes, or cancer diagnoses develop severe anxiety, depression, and even PTSD, and all too often, these individuals do not follow recommendations for health behaviors such as exercise, diet, or taking medications even though they are essential to recovery and prognosis.

The Columbia Roybal Center for Fearless Behavior Change, funded through the National Institute on Aging (NIA), is dedicated to advancing behavioral interventions that reduce psychological distress and improve health behaviors in these patients, with the ultimate goal of advancing effective behavioral interventions with the potential to be routinely implemented into clinical practice.

We are excited to announce our new call for proposals to fund randomized clinical trials (RCTs) that test behavioral interventions. These trials should seek to test interventions that are designed to reduce psychological distress and/or improve health behaviors in diverse midlife and older adults who have suffered serious health events. Studies that test implementation strategies for increasing the uptake of effective behavioral interventions into practice will also be eligible. Interventions should be designed with consideration of mechanisms of behavior change and health equity. Relevant study populations include, but are not limited to, patients with stroke, myocardial infarction, cardiac arrest, COPD, heart failure, respiratory failure, or recent diagnosis of cancer or end-stage renal disease. Relevant behavioral outcomes include, but are not limited to, measures of quality of life or psychological distress such as depression, anxiety, or PTSD and of health behaviors such as medication adherence, physical activity, or sleep.

Applicants must demonstrate how they will follow the mechanism-driven approach to intervention development promoted by the Science of Behavior Change. This involves testing the effect of the intervention not only on the target health behavior (e.g., medication adherence or physical activity), but also on the proximal mechanism that explains how the intervention works (e.g., reducing fear of recurrent cardiovascular events). Applicants are also expected to explain how the current trial will help advance the intervention along the NIH Stage Model and what the next step in intervention development will be if they are successful. (See NIH Stage Model for nomenclature onstage of behavioral intervention development).

Early-stage studies that are limited to assessing the feasibility of behavioral interventions (i.e., Stage I on the NIH Stage Model) are not eligible.

Award Amount

Up to $300,000 in total costs over a two-year period, contingent on institutional IC rates. The second year of funding will be dependent on achieving milestones from Year 1.  

Investigators will also receive support from the Columbia Roybal Center with finalizing the study protocol including selecting robust measures of behavioral mechanisms and health behaviors (e.g., actigraphy, electronic pill bottles); consultations on data management and analysis; planning for data and safety monitoring; and advice on integrating implementation outcomes into their research plan. Investigators will also gain mentorship from experienced behavioral trialists involved in the Columbia Roybal Center as well as opportunities for disseminating their study findings. Applicants are also encouraged to inquire about the possibility of applying for co-funding from other Centers in the Roybal Network.

Duration

Up to 2 years, with an anticipated project period June 01, 2025 – May 31, 2027.

Number of Awards

Up to 1 award per year.

Eligibility

Applicants can be post-doctoral research fellows or faculty of any rank but must show evidence of being able to complete the trial within two years. Applicants from groups that are underrepresented in behavioral medicine research are particularly encouraged to apply. Applicants are not required to be affiliated with Columbia University; however, all applicants must be directly affiliated with a domestic, US-based institution. This project does not currently support foreign/international components or foreign/international institutions.

Deadline

Applications are now being accepted. Applications must be submitted by Monday, December 16, 2024.

Trial Selection

Applicants will be notified of the outcome of their application by Monday, January 20, 2025. All submissions will receive feedback from the review committee. Applications that are not selected may resubmit their application the following year. Selected projects will then coordinate with the Roybal research team to formally submit a proposal for broader NIH approval, with an anticipated project period of June 01, 2025 – May 31, 2027, pending NIA and IRB approval.

Application Process Overview

Applicants will be required to submit a 3-page research strategy describing the significance, innovation, approach, and expertise of the study team, statistical analysis plan, preliminary budget, and biosketches of all co-investigators.

Review Process

Reviewers, including patient stakeholders, will score proposals from 1-9 for overall impact, broadly mirroring the NIH approach to grant review. Reviewers will judge each application on the basis of significance, innovation, expertise of the applicant and formation of diverse multidisciplinary teams inclusive of patient stakeholders, rigor of the scientific approach including its consideration of mechanisms of behavior change, likelihood that study activities can be completed on time, potential impact on health equity, potential to lead to subsequent funding, and alignment with goals of the Columbia Roybal Center. Early-stage investigator status will be viewed favorably when prioritizing applications for funding.

At least two independent reviews will be obtained for each proposal. A “study section” will be convened in December 2024 at which the top ranked proposals will be discussed. One proposal will be selected for funding in the upcoming year.

Applicants are encouraged, but not required, to attend pre-application office hours with our Center’s directors to ask questions about how to be responsive to the RFP.

Interested applicants may choose to write a brief letter of intent (no more than one page) to Co-Directors, Dr. Ian Kronish, ik2293@cumc.columbia.edu, and Dr. Nathalie Moise, nm2562@cumc.columbia.edu, if they wish to schedule a consultation. 

Contact

For any questions about the scientific content, contact: Dr. Ian Kronish and Dr. Nathalie Moise, Directors, Columbia Roybal Center, ik2293@columbia.edu (212) 342-1335 and nm2562@cumc.columbia.edu

For any questions about the application process and format, contact: Robin Cumella, rmc2203@cumc.columbia.edu. 

Click here to see full funding announcement

Behavioral Intervention Trials

ASU Roybal Center seeks applications to conduct NIH Stage I-III randomized clinical trials that will develop and test mechanisms of behavioral change (MoBC)-driven and technology-enabled behavioral and lifestyle interventions for older adults living alone with cognitive decline.

These trials should test the ASU Roybal Center’s Conceptual Framework (Exhibit 1) with rigorous design to secure future funding (e.g.,NIH R01) to advance to the next Stage. We will award two trials at $150,000

total (direct + indirect) each year for two years, starting June 1, 2025 (pending NIA approval). Applicants

are strongly encouraged to seek IDCwaivers from their own institutions to maximize the direct costs for trials.

One-year no-cost extension may be considered.

Eligibility

The awards are for Early Stage Investigators (ESIs) as defined by the NIH, mid-career and established investigators across the U.S. Collaboration with experts in behavioral and lifestyle interventions, including with Center faculty, is encouraged but not required. The award selection process will adhere to the ASU Advancing Inclusion and Culture (AIC) guidelines. 

Evaluation criteria

Applications will be evaluated on six criteria:

1. significance of the problem for older adults living alone with cognitive decline

2. ability to test ASU Roybal Center’s Conceptual Framework

3. methodological rigor

4. strength and novelty of the intervention

5. potential to advance to the next Stage and future funding

6. qualifications of the investigator team

   
   

Application Process

Step 1: Submit a Letter of Intent (LOI) to ASURoybalCenter@asu.edu by 11:59pm PST on 2/18/2025 in one PDF document containing the following in order:

1. General Information Form

   1. Cover page with project title

   2. Name of Principal Investigator and project team

   3. Contact information including mailing address, email, and telephone

2. Research Strategy (maximum 2 single-spaced pages with one-inch margins) describing: 

   1. significance of the problem as it relates to older adults living alone with cognitive decline

   2. Test of an operationalized model of ASU Roybal Center’s Conceptual Framework (see Figure 1)

   3. Enablement of behavior and lifestyle intervention by technology 

   4. Methods including design, setting, sample and sample size, control (if applicable), outcome(s), and timeline

   5. Plan to advance to next Stage research and its NIH funding mechanism(s)

   6. Qualifications of the investigator team

3. NIH Biosketch for the PI(s) and all Co-Is. Please follow biosketch instructions and examples.

Step 2: Consult with ASU Roybal Center Behavioral Intervention Development (BID) Core.

Step 3: Submit full application (1-page Specific Aims & 6-page Research Strategy). PIs who are invited to submit will receive notification by Friday, February 28 with instructions for full application submission which is due by 11:59pm PST on 3/31/2025.

Click here to see full funding announcement

Call for Applications: Interventions for Elder Mistreatment

The Roybal Center for Elder Mistreatment Intervention Research is pleased to announce a call for applications for projects aimed at advancing research on interventions for elder mistreatment (EM), including (a) interventions to prevent EM and (b) interventions to prevent the negative health and mental health consequences of EM. The Center is designed to overcome crucial barriers that have historically prevented significant, impactful progression of EM intervention development research, and to assist investigators in building sustainable EM research programs.

Application due:  February 12, 2025

Background

EM, including financial exploitation, neglect, self-neglect, and various forms of abuse, affects a significant portion of older adults living in the community (over 15%) and an even greater number of persons living with Alzheimer’s Disease and Related Dementias (over 50%). Despite the negative outcomes associated with EM, evidence-based guidelines for prevention and management are lacking. The UTHealth Roybal Center for Elder Mistreatment Intervention Research aims to address this lack of available interventions by supporting innovative projects that advance the field of EM research through mechanisms-focused interventions.

Eligibility

We invite proposals from new and new-to-the-field investigators who intend to develop or adapt evidence-based interventions from related fields that target known EM risk factors or outcomes through a clearly defined mechanism. Interventions can target either the caregivers at risk for engaging in EM or the older adults at risk for experiencing EM. Eligible applicants must be independent researchers with faculty appointments at the time the award will be made. Applicants must also include a letter of support from their department chair confirming their availability of release time if funded.

Proposals must focus on stages 0-2 of the NIH Stage Model of Behavioral Intervention Development and must be supported by a clearly defined mechanism. All proposed projects must be a clinical trial with adequate statistical power to test mechanisms of behavior change and/or the efficacy of the intervention. We understand that not all scientists get extensive training in trial design and power analysis, which can be a barrier to submitting a proposal. However, we don’t want this to be a barrier for you. We can connect you with experts who can assist you with these elements of your proposal. 

Research Focus  

We encourage applications that address:

• Adaptation of evidence-based interventions to target known EM risk factors or outcomes.

• Development and initial testing of behavioral intervention mechanisms.

• Innovative approaches to real-world testing and collaboration with service providers.

Applicants will be judged as non-responsive if:

• They do not have a primary focus on behavioral and/or social intervention development.

• They are not focused on supporting community-dwelling older adults or their caregivers in the prevention or reduction of EM and its outcomes. Proposals focused on long-term care settings are outside the scope of this solicitation.

• They do not address stage 0-2 of the NIH Stage Model of Behavioral Intervention Development.

• Applications that do not state and propose to test, within their Specific Aims, hypotheses regarding the mechanism of behavior change of interventions for each of the clinical trials proposed.

Funding Details

• Amount: The Center intends to commit $300,000 in total costs each year to fund 1-3 awards.

• Duration: The Center will consider projects that are up to 2 years in length.

• Indirect costs: All project budgets should be inclusive of indirect costs. We strongly encourage applicants to seek IDC waivers to maximize the direct costs available to projects.

• Format: Proposals must adhere to the R03 grant format guidelines.

• Support Requirements: If your project involves university cores, services, or external recruitment sites (e.g., bioinformatics support for electronic health record data), please include appropriate letters of support.

  
  

Mentorship and Support

To ensure the progression of successful interventions, the selected project proposals will benefit from guidance provided by the UTH Roybal Cores, the Evaluation Committee, and the External Advisory Committee. This will include help working with service providers such as Adult Protective Services, securing testing sites, and navigating IRB requirements. A formal mentor or training plan is not required.

Submission Instructions

Please submit a one-page specific aims page directly to Drs. Acierno and Cannell (contact information below or at right) before submitting a full application.

Applications should be submitted electronically to the School of Nursing grants management office. Proposals must adhere to the R03 format guidelines and include all necessary letters of support.

Click here to see full funding announcement

Funding-Announcement.pdf

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