Culturally specific versus standard group cognitive behavioral therapy for smoking cessation among African Americans: an RCT protocol

BACKGROUND: African American smokers experience disproportionately higher rates of tobacco-related illnesses compared to Caucasians. It has been suggested that interventions targeted to specific racial/ethnic groups (i.e., culturally specific) are needed; however, the literature examining the efficacy of culturally specific interventions is equivocal. Moreover, there are few descriptions of methods used to create these interventions. The main aim of this study is to test the efficacy of a culturally specific smoking cessation intervention among African Americans. METHODS/DESIGN: A 2-arm randomized controlled trial (RCT) will be conducted to assess the efficacy of a culturally specific group cognitive behavioral therapy (CBT), compared to standard group CBT among treatment-seeking smokers from the community. Participants in both conditions receive the transdermal nicotine patch (TNP) for 8-weeks. We intend to randomize at least 247 adult smokers who self-identify as African American into the trial. Enrolled participants are block randomized into one of two groups: Standard group CBT (control) or a culturally specific group CBT (CS-CBT). Groups are matched for time and attention, and consist of eight sessions. The primary outcome variable is 7-day point prevalence abstinence (7-day ppa). Smoking status is assessed at the end-of-counseling (EOC), and 3, 6, and 12-month follow-ups, with self-reported abstinence verified by saliva cotinine. We hypothesize that the CS-CBT condition will produce significantly greater smoking cessation rates compared to the control condition. We also expect that this effect will be moderated by acculturation and ethnic identity, such that the CS-CBT will show the greatest effect on cessation among participants who are less acculturated and have greater ethnic identity. DISCUSSION: Answering the fundamental question of whether culturally specific interventions lead to incremental efficacy over established, evidence-based approaches is of utmost importance. This study will have implications for the development and implementation of smoking cessation interventions among African Americans and other racial/ethnic minority groups. TRIAL REGISTRATION: NCT01811758