Evaluation of Tobacco Treatment Strategies for Inpatient Psychiatry

描述（由申请人提供）：本研究的总体目标是确定治疗严重精神疾病住院成年吸烟者烟草依赖的有效策略。尼古丁依赖是精神病患者中最普遍的药物滥用障碍，这一群体占美国烟草市场的44%至46%，令人震惊16,17。按花费的美元计算，这相当于每年390亿美元的烟草销售额。虽然许多试验已经证实了对住院病人进行戒烟干预的有效性，但针对急性精神病住院病人的研究却很少。美国精神病学协会的烟草治疗指南将精神病住院治疗确定为促进戒烟的理想机会。与一般人群相比，患有精神疾病的人戒烟率较低，而且在不久的将来戒烟的积极性和准备程度可能更低。因此，需要采取足够有力的、多成分的干预措施来解决尼古丁依赖的生理和行为方面的问题，并在戒烟过程的各个阶段帮助吸烟者。采用三组加性设计，提出的随机临床试验（N=1100）旨在评估急性精神病住院患者中不同强度的戒烟治疗。该应用程序建立在Prochaska博士的K23指导职业发展奖的基础上，并试图确定：(i)是否可以在从社区医院招募的更大、更多样化的患者群体中复制学术性精神病院的初步成功；（ii）如果更广泛和密集的临床治疗可以超越我们目前的最佳做法。这三组分别是：(1)常规护理（N=150），包括在住院期间提供简短的戒烟建议、戒烟指南和尼古丁替代；(2)简短治疗（N=475）增加了基于阶段的手册、计算机提供的针对阶段的个性化反馈和简短的戒烟咨询会议，在住院期间和在第3个月和第6个月重复，并在住院后获得12周的尼古丁替代；(3)延长治疗（N=475）在我们目前的简短治疗的基础上，提供额外12周的尼古丁替代（总共24周），包括个性化的、咨询师提供的动机和手动认知行为停止治疗。我们假设，延长治疗的效果将优于短期治疗，而且两组治疗在产生戒烟尝试和最终戒掉香烟方面都将比常规治疗更有效。次要目标将模拟治疗条件的成本效益；检查治疗结果的调节因子和调节因子；并前瞻性地研究吸烟、心理健康功能和其他物质使用之间随时间变化的关系。公共卫生相关性声明：在美国，患有精神疾病的人平均过早死亡25年，与烟草有关的心血管疾病、肺部疾病和癌症被确定为主要原因24。尽管吸烟率高，戒烟率低，而且对健康有毁灭性的影响，但对患有精神疾病的吸烟者的临床治疗研究仍然有限。本研究旨在通过一项随机对照试验，评估在社区医院急性精神科住院的吸烟者不同强度的烟草治疗。

DESCRIPTION (provided by applicant): The overall goal of this research is to identify efficacious strategies for treating tobacco dependence among adult smokers hospitalized with severe mental illness. Nicotine dependence is the most prevalent substance abuse disorder among psychiatric patients, a group that accounts for a staggering 44% to 46% of the US tobacco market16, 17. In terms of dollars spent, this equates to $39 billion in annual tobacco sales18. While numerous trials have established the effectiveness of smoking cessation interventions for hospitalized medical patients, little research has targeted the acute psychiatric inpatient setting19. The American Psychiatric Association's tobacco treatment guidelines identify psychiatric hospitalization as an ideal opportunity for promoting smoking cessation1. Individuals with mental illness have lower quit rates and may be less motivated and prepared to quit in the near future than the general population20-22. Thus, sufficiently intense, multi- component interventions are needed that address both the physiological and behavioral aspects of nicotine dependence and assist smokers at all stages of readiness through the quitting process23. Using a three group additive design, the proposed randomized clinical trial (N=1100) aims to evaluate tobacco cessation treatments of varying intensities initiated in the acute psychiatric inpatient setting. The application builds upon Dr. Prochaska's K23 mentored career development award and seeks to determine: (i) whether the initial successes seen in an academic-based psychiatric hospital can be replicated in a larger and more diverse patient population recruited from a community hospital; and (ii) if more extended and intensive clinician-delivered treatment can outperform our current best practices. The three groups are: (1) Usual Care (N=150) consisting of brief cessation advice, a quit smoking guide, and nicotine replacement provided during hospitalization; (2) Brief Treatment (N=475) adds a stage-based manual, computer-delivered stage-tailored individualized feedback and brief cessation counseling sessions during hospitalization and repeated at months 3 and 6, and access to 12 weeks of nicotine replacement following hospitalization; (3) Extended Treatment (N=475) builds upon our current brief treatment and provides 12 additional weeks of nicotine replacement (24 weeks total) with individualized, counselor-delivered motivational and manualized cognitive behavioral cessation treatment. We hypothesize that the extended treatment will outperform the brief treatment, and that both treatment groups will be more effective than usual care in producing quit attempts and ultimately abstinence from cigarettes. Secondary aims will model the cost-effectiveness of the treatment conditions; examine moderators and mediators of treatment outcomes; and prospectively examine the relation between changes in smoking, mental health functioning, and use of other substances over time. Public Health Relevance Statement: Individuals with mental illness in the US are dying, on average, 25 years prematurely, with tobacco-related illnesses of cardiovascular and lung disease and cancer identified as chief causes24. Despite the high prevalence of smoking, low rates of quitting, and devastating health effects, clinical treatment research with smokers with mental illness remains limited. This study aims to evaluate, in a randomized controlled trial, tobacco treatments of varying intensities for smokers hospitalized on acute psychiatric inpatient units in a community hospital.