Evaluating the effectiveness of the BeHealthyR study: A group-randomized controlled trial using an integrated approach to improve smoking cessation behavior among disadvantaged smokers

Abstract

Abstract Background Smokers with a low socioeconomic position (SEP) often experience heightened stress due to increased exposure to daily hassles and multiple environmental, social, and smoking-specific stressors. In turn, these stressors may deplete mental bandwidth and trigger unhealthy behavioral responses, such as smoking. This study aimed to evaluate the effectiveness of an integrated multicomponent intervention developed to concurrently target stress- and smoking-related behaviors among socioeconomically disadvantaged smokers. Methods A 3-group randomized controlled trial was conducted between February 2018 and July 2019. Adult low-SEP smokers experiencing stress complaints were recruited from disadvantaged neighborhoods in Rotterdam. Groups of participants were randomly assigned to a stress management course (SM, n = 62), stress management with a buddy component (SMb, n = 66) or a waitlist (n = 90). The SM and SMb groups received psychoeducation topics linked to cognitive and behavioral technique activities. SMb additionally provided emotional and instrumental support. The waitlist group received the intervention after the study. Groups were randomized using a computer-generated random allocation. Participants were blinded to the study hypotheses, while the research team was unblinded to allocation. Primary outcomes were assessed at baseline (T0), at week four of the intervention (T1) and at 12 weeks (T2), and included total stress scores, nicotine dependence scores, self-reported and expired carbon monoxide (eCO)-validated smoking abstinence at T1 and T2. The analyses were intention-to-treat and adjusted for covariates measured at baseline. Intervention effectiveness was examined using mixed-effects models. Results Of 209 participants (mean age, 47.1 (SD = 11.3, range 21–78 years), 176 completed the intervention (retention rate 84%). A significant reduction in stress levels was found in the SM at one month and in the SMb at three months compared to the waitlist. At one month and three months, nicotine dependence scores were significantly lower in the SM and SMb groups than in the waitlist group. No significant changes were observed in expired carbon monoxide levels. Conclusions These findings show that a multicomponent intervention aimed at relieving stress complaints may be a solution to improve smoking-related outcomes among socioeconomically disadvantaged smokers. These findings have implications and merit further evaluation. Trial registration: www.clinicaltrials.gov; identifier: NCT03553979; date of registration: 01/01/2018