Application Instructions

1. Provide the RCT 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, stakeholders, and/or consultants
3. State the Stage of Intervention Development according to NIH Stage of Behavioral Intervention Development
4. State the target patient population (e.g., survivors of acute myocardial infarction)
5. State the target behavioral mechanism and the measure used to measure this mechanism (e.g., fear of recurrent heart attack)
6. State the targeted outcome(s) (e.g., depression, PTSD, cardiac medication adherence)
7. Provide a brief synopsis of the proposal (250 words or less)
8. Please limit to 1 page

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). Stage V trials should include the generalizable evidence to practice gap, summary of barriers and facilitators, theory-informed strategy development, and mechanisms by which the strategy may be targeting outcomes. 
3. Description of the study design including eligibility, recruitment, consent, randomization (if applicable), description of intervention and control (if applicable), and key measures including of the proposed behavioral mechanism(s) of action. 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 the next stage of intervention development depending on study outcomes and possible funding opportunities to support the next step (.5 page)

This section should include a timeline for achieving milestones for submitting IRB, accruing first patient, 50% of the sample, 100% of the sample, completing follow-up assessments, and analyzing data relevant to the primary outcome(s). Please limit to 1 page.

1. Description of plans to engage diverse scientists and stakeholders with lived experience in the design, conduct, or dissemination of the trial
2. Articulate plans to recruit and retain a representative sample of individuals impacted by this health event.
3. Please limit to .5 page.

1. State the statistical hypotheses of the proposal.
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, studies are expected to be powered to test the efficacy of behavioral interventions.
5. Describe the statistical plan for assessing the influence of the intervention on the proposed mechanism(s) of behavior change
6. Please limit to 2 pages.

No page limit.

Budget justification with itemized list of expenses and total amounts. Please limit to 0.5 page. 

Note: The maximal award is in the sum of $300,000, total costs, contingent on institutional IC rates, over 2 years. Your detailed budget should directly support your protocol. Each item must be justified in the budget justification section of the application form. This trial can fund faculty salary. Other expenses may include technologist/staff salary, fringe, supplies or research-related services. Please contact Tyla Yurgel at ty2267@cumc.columbia.edu with any budgetary questions. Please calculate any salaries using your institution’s fringe rate.

Please include an NIH-style biosketch for each investigator (no more than 5 pages per biosketch), 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. Please ensure you have an eRA commons ID listed on your biosketch. Updated Biosketch resources, including FAQs and sample Biosketch format pages can be found here: https://grants.nih.gov/grants/forms/biosketch.htm

1. A member of the research team must commit to attending the annual Columbia Roybal Center Retreat and the study progress meetings with the Roybal team (typically once every 2 weeks).
2. A member of the research team must commit to submitting current enrollment and screening data in CROMS* on the 15^th of every month the trial is active as required by the NIA.
3. A member of the research team must commit to maintaining an accurate and up-to-date ClinicalTrials.gov entry for the trial, including submission of results no more than 365 days after the trial’s primary completion date. 

*CROMS is the National Institute on Aging (NIA)’s Clinical Research Operations Management System, designed to provide NIA staff and grantees with real-time tracking, reporting, and management of clinical research enrollment data, study documents, and activities.