Sünkel Esra Teresa, Neubert Marie, Machulska Alla, Klucken Tim
Department of Clinical Psychology and Psychotherapy, University of Siegen, Obergraben 23, Siegen, 57072, Germany.
Trials. 2025 Jul 1;26(1):231. doi: 10.1186/s13063-025-08917-4.
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.
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.
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.
Prospectively registered on ISCRTN on 01.05.2024, reference number ISRCTN12859609.
烟草使用是过早死亡的主要风险因素。患有精神障碍的个体吸烟率是普通人群的两倍，且烟草消费量更高，从而增加了他们出现与烟草相关健康并发症的风险。与其他物质使用障碍不同，德国的临床实践在心理治疗开始前忽视了烟草依赖这一风险因素，尽管显然有干预的必要：长期吸烟会加剧心理健康症状，并影响心理治疗的核心过程，如内隐认知过程和情绪调节。此外，与烟草依赖相关的短期尼古丁戒断会削弱动机、减少积极强化，并导致情绪不稳定，可能会阻碍改善心理健康的努力或心理治疗干预的效果。这些因素凸显了在正式心理治疗前整合戒烟策略以优化治疗过程和患者预后的重要性。本研究调查在开始心理治疗前启动强化戒烟计划的效果。主要关注的测量结果是患有精神障碍的吸烟者的烟草依赖程度、吸烟行为和心理健康结果。通过在治疗前解决吸烟行为问题，本试验旨在为治疗工作建立更坚实的基础，可能改善心理健康结果，并促进心理健康护理的综合方法。
在一家门诊心理治疗诊所进行的单中心随机对照试验将研究强化戒烟干预与等待对照条件的效果。主要结局指标包括吸烟者的尼古丁依赖、吸烟行为以及与其原发性精神障碍相关的心理健康症状，使用方差分析方法进行分析。吸烟干预包括一个基于常见指南的认知行为项目，并辅以数字健康应用程序。次要结局包括自我报告的自我效能感和内隐认知偏差的变化。此外，动机测量、自我效能感、内隐趋近倾向以及对在线干预的态度将作为次要测量指标进行评估，并在探索性分析中作为潜在的预测因素、调节因素或中介因素进行检验。对在线干预的态度将在基线时测量一次，而所有其他测量指标将在干预前、治疗后以及6周和6个月的随访时进行评估。
在心理治疗前解决吸烟行为问题有可能显著改善心理健康结果。本研究调查了对患有精神障碍的吸烟个体在心理治疗前整合戒烟策略的情况。通过将烟草依赖治疗与用于其他物质使用障碍的方法相结合，我们旨在建立并讨论一种全面且符合指南的方法。这一策略旨在改善患者预后，并为治疗合并心理健康障碍的吸烟者建立一种连贯、综合的方法。
于2024年5月1日在ISCRTN上进行前瞻性注册，注册号为ISRCTN12859609。
