Protocol for a randomized controlled trial of a cognitive-behavioral therapy–based smoking cessation intervention in incarcerated individuals: The PRISANTABAC Study

Smoking prevalence in French prisons exceeds 70%, far higher than in the general population. Few rigorous smoking cessation interventions have been evaluated in correctional settings, and existing studies show substantial heterogeneity and high risk of bias. Cognitive-behavioural therapy (CBT) is effective in the general population but has rarely been adapted to prison contexts. The PRISANTABAC trial addresses this gap by evaluating a brief group-based CBT intervention for smoking cessation in a French prison. To evaluate the effectiveness of group CBT, compared with a health education intervention and a wait-list control, on smoking abstinence at 1-month (M1) and 3-month (M3) follow-ups, and to explore individual predictors of abstinence. PRISANTABAC is a three-arm randomized controlled trial conducted in a French correctional facility. Participants are randomized (1:1:1) to a three-session CBT group, a health education group, or a wait-list control. The primary outcome is biochemically validated 7-day point prevalence abstinence at M3 (0 cigarettes/day; expired CO < 8 ppm); abstinence at M1 is a key secondary outcome. Secondary outcomes include nicotine dependence, craving, motivation to quit, self-efficacy, and cigarettes smoked per day. Abstinence will be analysed using logistic regression, and repeated continuous outcomes using linear mixed-effects models. Analyses will follow the intention-to-treat principle. This trial will provide the first rigorously designed evaluation of a brief group-based CBT smoking cessation intervention in a French prison setting and is expected to inform the development of evidence-based cessation interventions adapted to correctional environments. • A three-arm randomized controlled trial of smoking cessation in a prison setting • Evaluation of a brief group-based CBT intervention adapted to incarceration • Comparison with health education and wait-list control conditions • Biochemically validated abstinence assessed at 1- and 3-month follow-ups • Exploratory identification of psychological predictors of smoking cessation in prison