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.