Wednesday, May 18, 2022
5/18/2022
Addie Weaver (PI); K01MH110605 NOT-MH-21-120: K01 Supplement Due to COVID-19 Disruption Abstract This Administrative Supplement due to COVID-19 Disruption seeks to provide five months of additional salary support to the Principal Investigator in completing her Mentored Research Scientist Career Development Award focused on developing and testing a technology-assisted cognitive behavioral therapy for depression, tailored for the rural context and for delivery by clergy. The proposed mentored research, informed by the the Replicating Effective Programs framework (REP) and CBPR, aims to (1) adapt and package group CBT for depression for delivery by clergy, and conduct an open pilot test of the adapted intervention; (2) conduct a pilot randomized controlled trial (pRCT) to assess the intervention’s preliminary effect on depression and explore the relationship between potential mechanisms of change and expected outcomes; and (3) explore intervention acceptability and feasibility using mixed methods to assess multiple stakeholders perceptions of the intervention and its implementation. The Principal Investigator made substantial progress in completing these aims. She developed the intervention, Raising Our Spirits Together, and successfully piloted it with extremely promising results. The randomized controlled trial (RCT) is underway, with 28 participants, or 33.3% of the required sample, enrolled in the study. However, the COVID-19 pandemic resulted in substantial delays to the project, given the stoppage of in-person research activities in March 2020. As a result, the Principal Investigator adapted this important research for completely virtual engagement with participants. This required significant time and effort to assess the feasibility of virtual delivery, adapt all study protocols and procedures, and obtain Institutional Review Board approval for all changes. Additionally, virtual recruitment efforts resulted in slower recruitment flow than anticipated in our targeted rural communities, delaying recruitment milestones originally expected for the RCT. The Principal Investigator has obtained approval to conduct in-person recruitment following safety protocols in order to facilitate engagement with rural residents in the study’s target communities. The newly approved in-person recruitment efforts resulted in recruiting six participants in a one- month period. This Administrative Supplement will provide support for the Principal Investigator to maintain a consistent level of effort needed to finish recruiting the 56 additional participants needed to complete her RCT and continue her role leading all aspects of this research project. Additionally, the Administrative Supplement will support the Principal Investigator in engaging in career development activities and receiving critical mentorship related to closing out a mental health intervention project of this scope. Finally, the Administrative Supplement will ensure the return on investment for this important research, as completing the RCT is essential for understanding the effectiveness and acceptability of this innovative mental health intervention delivery model that has great promise for improving access to evidence-supported depression treatment in underserved rural communities.
HHS’ Tracking Accountability in Government Grants System (TAGGS) website provides access to detailed descriptions of grants, loans, aggregated direct payments and other types of financial assistance awarded by the HHS Operating Divisions (OPDIVs) and the Office of the Secretary Staff Divisions (STAFFDIVs).
