Application Instructions

The Columbia Roybal Center of Fearless Behavior Change will accept and consider all applications; however, early investigators will receive special consideration. Pilot projects will receive up to $50,000 for a one-year duration, inclusive of direct and indirect costs. Affiliation with Columbia University is not required to apply. Prior successful applications are available upon request.

Pilot Application Template

Please provide us with the following information:

Title Page (1 page)

1. Provide the pilot study title
2. Provide contact information, including name, academic credentials, role on the proposal, address, email, and phone number, for the Principal Investigator and any co-investigators, collaborators and/or consultants
3. Stage of Intervention Development (Stage 0 to Stage V, according to NIH Stage of Behavioral Intervention Development https://www.nia.nih.gov/research/dbsr/nih-stage-model-behavioral-intervention-development)
4. State the target patient population (e.g., survivors of acute myocardial infarction)
5. State the target behavioral mechanism (e.g., fear of recurrent heart attack)
6. State the targeted health behavior(s) (e.g., cardiac medication adherence)
7. Provide a brief synopsis of the proposal (250 words or less)

Specific Aims & Research Design (3 pages maximum)

This section should not exceed three (3) single-spaced, typed pages (provide at least one-half inch margins (½") - top, bottom, left, and right - for all pages; 11- or 12- point font required; excluding references. It should include:

1. Description of the public health problem that the intervention will address (.5 page)
2. Rationale for the intervention to be tested. The rationale should include a brief review of the evidence in support of the behavioral mechanism that the intervention is designed to target. (1 page)
3. Description of the study design including eligibility, recruitment, consent, randomization (if applicable), description of intervention and control (if applicable), and key measures. The description of the study design should include an explanation for the stage of intervention development (1 page)
4. Long-term goals, including plans for future publication and funding (.5 page)

Statistical Design and Power (2 pages)

1. State the statistical hypotheses of the proposal. If the study is a feasibility pilot, then hypotheses should be relevant to feasibility outcomes (e.g., feasibility of recruitment and retention, fidelity to study protocol)
2. State the primary and secondary outcomes
3. Describe the analysis plans for the primary and secondary endpoints as well as any exploratory or descriptive analyses, including whether there will be any interim analyses or subgroup analyses
4. Describe the rationale for the targeted sample size and power estimates. Of note, pilot and feasibility studies are not expected to be powered to test the efficacy of behavioral interventions.

References (No page limit)

Budget (.5 page)

1. Budget justification with itemized list of expenses and total amounts.

Note: The maximal award is in the sum of $50,000, inclusive of indirect costs. Your detailed budget should directly support your protocol. Each item must be justified in the budget justification section of the application form. This pilot can fund faculty salary. Other expenses may include technologist/staff salary, fringe, supplies or research-related services. Please contact David Hiti at dth2110@cumc.columbia.edu with any budgetary questions. Please calculate any salaries using your institution’s fringe rate.

NIH Biosketches (5 page maximum per biosketch)

Please include an NIH-style biosketch for each investigator, including collaborators and/or consultants, with personal statements tailored to the application. Importantly, please ensure biosketches adhere to the new format required after 1/25/2022. Updated Biosketch resources, including FAQs and sample Biosketch format pages can be found here: https://grants.nih.gov/grants/forms/biosketch.htm

Other Requirements

1. A member of the research team must commit to attending the annual Columbia Roybal Center Retreat and the bi-weekly pilot study work-in-progress meetings.

Submit Your Application

To submit your application, please attach all documents as PDF files and email to Darlene Straussman at ds3900@cumc.columbia.edu using the subject line: Roybal Pilot Application Submission.

Please Note: All awarded projects are conditionally selected until appropriate approvals are received including, at minimum, IRB approval. IRB approval is not required at the time of application but is required to receive NIA prior approval. Submission to the IRB must be completed within thirty (30) days of notification of potential pilot funding. Once IRB approval is received, documentation must be submitted to David Lopez Veneros at dl2698@cumc.columbia.edu immediately.