The long term goal of this Pathway to Independence Award (PIA) is to develop a program of research focused on increasing the effectiveness and reach of smoking cessation interventions for adults with serious mental illness (SMI) using mobile health technology. This long term goal will be achieved via a 5-year training and research plan that will launch Dr. Roger Vilardaga?s independent program of research and academic career. The career objectives of this award are to: (1) become an expert in the science of behavioral smoking cessation interventions; (2) master the development, testing and implementation of mobile health interventions; (3) become an expert in the implementation of clinical trials in people with SMI. These career objectives will be achieved via formal coursework, trainings, seminars, national conferences, mentorship and research experience. The knowledge derived from this training plan will equip the PI to pursue the following aims.
The first aim, guided by an expert panel, is to develop an Acceptance and Commitment Therapy smartphone application for smoking cessation for people with SMI, and a smartphone coaching guide for staff.
The second aim i s to conduct iterative usability testing of the resulting app and coaching guide in a sample of 10 people with SMI. Finally, the third aim is to conduct a two-arm feasibility randomized trial that compares the novel app to an app based on best-practice smoking cessation guidelines (QuitGuide) in a sample of 90 people with SMI from a community-based setting. Both arms will include a low cost pharmacological intervention (nicotine replacement therapy). The primary feasibility outcomes in this trial (e.g., recruitment and retention rates) will determine a reliable methodological approach to conduct a fully-powered R01 trial. Drs. Richard Ries will serve as the primary mentor on this PIA, providing support as Dr. Vilardaga receives his training and establishes himself as an independent investigator in a new institution. The mentoring and consulting team of experts in SMI, smoking cessation, computer science and methods/statistics (Drs. Ries, McClernon, Ziedonis, Saxon, Kientz and Atkins), will ensure that the PI receives the necessary support to successfully complete the proposed research. The K99 will take place at the University of Washington and the Fred Hutchinson Cancer Research Center in Seattle. The R00 will take place at Duke University. These cutting-edge research institutions will provide an excellent environment for completion of the PI?s objectives. This study meets NIDA?s major programmatic priorities of using innovative technologies and integrating behavioral and pharmacological interventions to improve substance use treatment and outcomes (NOT-DA-10-019). The study addresses a serious problem ?high smoking rates in people with SMI?, and it proposes the delivery of a promising behavioral intervention for smoking cessation in a ?real-world? setting using a wider reaching technology. This PIA will forge the PI?s pathway to independence by laying the foundation for a career in mobile health interventions for smoking cessation in people with SMI.
Smoking tobacco shortens the lifespan of adults with serious mental illness by 25 years and contributes to $317 billion healthcare expenditures and indirect loss of earnings and disability benefits. A new model to deliver more effective and wider reaching smoking cessation interventions in individuals with serious mental illness is highly needed. This project proposes to develop such model and test its initial feasibility.
