Trial of Integrated Smoking Cessation, Exercise, and Weight Management in SMI

描述（由申请人提供）：患有严重精神疾病（SMI）的人的死亡率是没有严重精神疾病（SMI）的人的三倍，主要是由于心血管疾病（CVD）。吸烟是重度精神障碍患者心血管疾病的最大单一因素。即使在全国吸烟率下降的同时，尼古丁成瘾对至少一半的重度精神分裂症成年人来说是一个根深蒂固的问题，而且符合指南的戒烟治疗的比例很小。绝大多数重度精神障碍患者表示他们想戒烟。联合药物治疗和行为治疗在重度精神分裂症的试验中增加了戒断率，但尚未在社区环境中进行测试或广泛应用。此外，已经观察到体重增加与戒烟有关，肥胖在重度精神病人中已经很普遍。在戒烟过程中，运动可以改善尼古丁戒断症状，减少体重增加，但在重度精神分裂症患者中，还没有研究将运动与戒烟治疗结合起来。所有心血管疾病风险行为的负担都非常高：吸烟；缺乏身体活动;不健康的饮食;在这一弱势群体中，特别是那些吸烟的人群，迫切需要联合健康行为改变干预措施。本R-01申请的目的是开发和测试一种创新的，可扩展的干预措施，可以广泛采用，以促进重度精神分裂症患者长期戒烟，改善身体活动和体重控制。我们的多学科研究团队在重度精神障碍患者的健康行为改变方面具有独特的资质，结合了戒烟、减肥和运动干预方面的领先专家，以及在测试短信技术以维持和支持行为改变方面的知识。我们建议进行TRIUMPH试验，这是一项以社区心理健康组织为基础的两组试验，该试验将检验这样一种假设，即在实现长期戒烟、身体健康和体重维持方面，一个为期18个月的综合、实用的戒烟计划，结合运动和体重咨询，将优于常规治疗（TAU）控制。我们将招募220名患有重度精神障碍的成年人参加马里兰州两个社区精神卫生组织中的一个，他们目前是吸烟者，表示有兴趣戒烟。我们将根据准备程度进行分层，在1或6个月内设定戒烟日期，并随机分配参与者接受：1)转介到戒烟热线的TAU或2)18个月的干预，其中包括：i)由健康教练根据参与者的戒烟准备程度量身定制的团体和个人戒烟和体重咨询；Ii)在社区诊所使用伐尼克兰或安非他酮+尼古丁替代疗法进行药物治疗；Iii)团体锻炼和健身房；㈣支持改变健康行为的短信。主要结局是在18个月时戒烟7天；次要结果包括体重、6分钟步行测试、饮食和10年心血管事件风险。改善所有心血管疾病风险行为对于降低重度精神疾病患者的过早死亡率至关重要，需要在社区环境中采取创新的综合干预措施。TRIUMPH试验将对这种方法进行测试，该方法可广泛应用于重度精神障碍吸烟者，并且实施起来切实可行。

DESCRIPTION (provided by applicant): Persons with serious mental illness (SMI) have three times higher mortality rates than those without SMI, primarily due to cardiovascular disease (CVD). Tobacco smoking is the single largest contributor to CVD in SMI. Even while nationally smoking rates are dropping, nicotine addiction is an entrenched problem for at least half of SMI adults, and rates of guideline-concordant cessation treatment are minimal. The vast majority with SMI state they would like to quit. Combination pharmacotherapy and behavioral treatment increases abstinence rates in trials in SMI, but has not been tested or widely used in community settings. Moreover, weight gain has been observed with smoking abstinence, and obesity is already widespread in SMI. Exercise may improve nicotine withdrawal symptoms and reduce weight gain during a quit attempt, but no studies of exercise added to smoking cessation treatment have been done in SMI. With extraordinarily high burden of all the CVD risk behaviors: smoking; physical inactivity; unhealthy diet; and obesity, combined health behavior change interventions are urgently needed in this vulnerable population, especially in those who smoke. The objective of this R-01 application is to develop and test an innovative, scalable intervention that could be widely adopted to promote long-term smoking abstinence, improved physical activity and weight control in SMI. Our multidisciplinary research team is uniquely qualified in health behavior change in persons with SMI, combining leading experts in smoking cessation, weight loss and exercise interventions and knowledgeable in testing text messaging technology to sustain and support behavior change. We propose the TRIUMPH Trial, a community mental health organization-based, two-arm trial that will test the hypothesis that an 18-month comprehensive, practical tobacco smoking cessation program integrating exercise and weight counseling will be superior to a treatment as usual (TAU) control in achieving prolonged smoking abstinence, physical fitness and weight maintenance. We will enroll 220 adults with SMI attending one of two community mental health organizations in Maryland, who are current smokers expressing interest in quitting. We will stratify by readiness to set a quit date within 1 or 6 months and randomly assign participants to receive: 1) TAU with referral to a quit line or 2) the 18-month intervention that will include: i) group and individual smoking cessation and weight counseling by a health coach and tailored to participants' readiness to quit; ii) pharmacotherapy with either varenicline, or bupropion + nicotine replacement therapy, prescribed in the community clinic; iii) group exercise and gym access; and iv) text messaging supporting health behavior change. The primary outcome will be 7-day point- prevalence smoking abstinence at 18 months; secondary outcomes will include weight, 6-minute walk test, diet and 10-year risk of CVD events. Improving all CVD risk behaviors is critical to decrease premature mortality in SMI, and will require innovative, integrated interventions in community settings. The TRIUMPH Trial will test such an approach that reaches a broad range of smokers with SMI and is practical to implement.