Abstract
BACKGROUND: Tobacco use is a leading risk factor for premature mortality. Individuals with mental disorders exhibit a smoking prevalence twice that of the general population and engage in higher levels of tobacco consumption, thereby elevating their risk for tobacco-related health complications. Unlike with other substance use disorders, clinical practice in Germany neglects tobacco dependence as a risk factor prior to the initiation of psychotherapy, despite a clear need for intervention: Prolonged cigarette smoking exacerbates mental health symptoms and influences processes central to psychotherapy, such as implicit cognitive processes and emotion regulation. Moreover, short-term nicotine withdrawal associated with tobacco dependence can undermine motivation, reduce positive reinforcement, and cause emotional instability, potentially hindering efforts to improve mental health or the effectiveness of psychotherapeutic interventions. These factors underscore the importance of integrating smoking cessation strategies prior to formal psychotherapy to optimize the therapeutic process and patient outcomes. This study investigates the effects of initiating an intensified smoking cessation program prior to starting psychotherapy. Main measure outcomes of interest are the degree of tobacco dependence, smoking behavior, and mental health outcomes in smokers with mental disorders. By addressing smoking behavior prior to therapy, this trial seeks to establish a more solid foundation for therapeutic work, potentially improving mental health outcomes and promoting a comprehensive approach to mental health care. METHODS: A single-center randomized controlled trial in an outpatient psychotherapeutic clinic will examine the effects of an intensified smoking cessation intervention versus a waiting control condition. The primary outcome measures include smokers' nicotine dependence, smoking behavior, and mental health symptoms related to their primary mental disorder, analyzed using variance analysis methods. The smoking intervention consists of a common guideline-based cognitive-behavioral program supplemented by a digital health application. Secondary outcomes include changes in self-reported self-efficacy and implicit cognitive biases. In addition, motivational measures, self-efficacy, implicit approach tendencies, and attitudes toward online interventions will be assessed as secondary measures and examined as potential predictors, moderators, or mediators in exploratory analyses. Attitudes toward online interventions will be measured once at baseline, while all other measures will be assessed before the intervention, post-treatment, and at 6-week and 6-month follow-up sessions. DISCUSSION: Addressing smoking behavior before psychotherapy holds potential to significantly enhance mental health outcomes. This study investigates the integration of smoking cessation strategies prior to psychotherapeutic care for cigarette-smoking individuals with mental disorders. By aligning tobacco dependence treatment with approaches used for other substance use disorders, we aim to establish and discuss a comprehensive and guideline-conformant method. This strategy seeks to improve patient outcomes and a cohesive, integrated method for treating smokers with comorbid mental health disorders. TRIAL REGISTRATION: Prospectively registered on ISCRTN on 01.05.2024, reference number ISRCTN12859609.