Increasing the Health Equity and Population-Level Impact of A Digital Therapeutic for Smokers with Psychiatric Illness

NIDA, K02DA054304

4/1/2022 – 3/31/2027

Roger Vilardaga, PhD (Wake Forest University)

Caitlyn Arnold, Clinical Research Coordinator II

The goal of this Independent Scientist Award (K02) is to seek five years of training and protected time to enable and expand the work of a newly established independent investigator. The candidate’s laboratory, the Access to Behavioral Health for All (ABHA) Lab, is supported by a recent R01 (Parent Study; DA037276; March 2020-2025) that will evaluate the efficacy of a novel digital therapeutic (DTx) for smoking cessation tailored to patients with serious mental illness. The candidate’s research to date has focused on the development of DTx using user-centered design research, and the subsequent testing of their efficacy using clinical trials methodology. However, efficacy trials do not always translate into real-world practice, nor are tested treatments always adopted by racial and ethnic minorities. This gap is well documented in the implementation science literature. A recent longitudinal epidemiological survey (N=40,181) showed that while the smoking rates of Non-Hispanic Whites with serious psychological distress significantly declined over the last decade, no significant declines occurred among their Black and Latino counterparts. This data accentuates the critical need to develop DTx that have an equitable population health impact. Therefore, the five years of protected time provided by this Independent Scientist Award will fundamentally enhance the candidate’s current program of research by providing formal training and contact with expert collaborators in the following key areas: (1) health equity and participatory research, (2) implementation science, and (3) DTx’s oversight, marketing, and dissemination.

The award will also support a convergent mixed-methods Ancillary Study based on the RE-AIM framework, that will examine health equity and implementation science outcomes in the Parent Study. This Independent Scientist Award will provide the necessary research experience and network of collaborators to scale up widespread dissemination of DTx addressing the systemic challenges of racial/ethnic minorities with tobacco use disorder and serious mental illness. Along with the planned collaborations with national experts in each of the key training domains, this award will establish the conditions to pursue and maintain this program of research in the future by protecting the candidate’s time from clinical responsibilities. In the short term, the award will generate preliminary data to inform the design of a large pragmatic trial that will evaluate equitable dissemination of DTx for smoking cessation in patients with serious mental illness. In the long term the award will generate a new body of research rigorously examining racial and ethnic inequities in DTx for addiction treatment, a new model for the equitable implementation and technology transfer of DTx among racial/ethnic minorities, and mentoring opportunities for diverse junior scientists that will extend the impact of this work beyond the candidate’s own program of research.

Tobacco use disorder disproportionally affects patients with serious mental illness. Our research shows that over the last decade, racial and ethnic minorities with serious psychological distress sustained high rates of smoking — in sharp contrast to Whites, who experienced a significant decline. This Independent Scientist Award will provide training and protected time to focus on a program of research that develops and implements treatments addressing this important health inequity.