Contemporary Clinical Trials Communications (Dec 2021)
Stress, depression, sleep problems and unmet social needs: Baseline characteristics of low-income smokers in a randomized cessation trial
Abstract
Background: Low-income Americans smoke cigarettes at higher rates and quit less than other groups. Methods: To increase their engagement in and success using evidence-based cessation methods, we tested two interventions using a 2x2 randomized factorial design: (1) telephone navigation to reduce financial strain and address social needs such as food, rent and utility payment; and (2) a specialized tobacco quitline designed for low-income smokers. From June 2017 to November 2020, we enrolled 1,944 low-income smokers in Missouri, USA, recruited through the Missouri 2-1-1 helpline, into the trial. This paper describes recruitment, key characteristics and life circumstances of this high-risk population. Results: After eligibility screening, 1,944 participants completed baseline and were randomized. Participants were racially diverse (58% African American), poor (51% < $10,000 annual pre-tax household income) and many reported less than high school education (30%). They reported a mean of 2.5 unmet social needs, especially childcare and paying bills, had high rates of stress, depressive symptoms and sleep problems, and most were in fair or poor health. There were few differences between these variables, and no differences between tobacco use and cessation variables, across the four study groups and between participants recruited pre and during the COVID-19 pandemic. Conclusions: Trial recruitment through the 2-1-1 helpline is feasible for reaching a population of low-income smokers. Low-income smokers face myriad daily challenges beyond quitting smoking. Cessation interventions need to account for and address these life circumstances. Trial registration: Clinicaltrials.gov NCT03194958.