Reducing racial/ethnic tobacco cessation disparities via cognitive behavioral therapy: Design of a dualsite randomized controlled trial

Racial/ethnic disparities in tobacco cessation are such that U.S. minorities have greater difficulty quitting compared to White non-Hispanics. Group differences in distress (i.e., perceived stress and depressive symptoms) may contribute to cessation disparities. The allostasis model of health suggests that the toll of chronic stress experienced by racial/ethnic minorities may lead to dysregulation of the physiological stress system and drug use. Previous research suggests that group cognitive behavioral therapy (CBT) for tobacco cessation addresses distress as a modifiable mechanism and has the potential to reduce/eliminate disparities. The present study is a dualsite randomized controlled trial aimed at evaluating the efficacy of group CBT in eliminating racial/ethnic differences in smoking cessation and distress. The study utilizes a [2 (intervention: group CBT or group general health education [GHE]) × 3 (race/ethnicity: African American/Black, Hispanic, White)] factorial design by randomizing 225 adult smokers from the community. Both interventions provide eight counseling sessions and eight weeks of nicotine patch therapy. Assessments occur at the end-of-therapy, and at 3-, 6-, and 12-months. Generalized longitudinal mixed modeling will be used to test our primary abstinence outcome, biochemically-confirmed 7-day point prevalence abstinence at 12-months. We hypothesize that group CBT will reduce or eliminate racial/ethnic differences in perceived stress, depressive symptoms, and smoking cessation compared to group GHE. We also hypothesize that reductions in physiological distress, assessed by salivary cortisol, will mediate racial/ethnic group differences in smoking cessation, particularly among racial/ethnic minorities. This study has implications for eliminating disparities in psychosocial factors related to tobacco use and cessation. Trial registration: Clinicaltrials.gov NCT02511236 . Registered on July 27, 2015.