Mobile contingency management for smoking cessation in returning US Veterans

描述(由申请人提供)：尽管最近努力将戒烟治疗方案的覆盖范围扩大到以临床为基础的护理之外，但包括使用戒烟辅助设备在内的戒烟治疗仍然远远没有得到充分利用。如果戒烟计划要在人群层面上对改变健康行为产生重大影响(影响=达到X效果)，就有必要开发新的创新战略，以增加治疗强度、获得机会和参与度。强化行为疗法的使用，如应急管理(CM)，在难以治疗的人群中证明了减少吸烟的有效性，但由于需要通过临床监测每天多次核实戒烟情况，其覆盖范围有限。移动健康(MHealth)平台的开发使密集的健康管理方法的使用变得可移植和可行。目前这项研究的主要目标是评估一种积极主动的远程健康干预的有效性，该干预将基于证据的戒烟治疗与基于智能手机的便携式吸烟率应急管理相结合。中心假设是，通过增加移动CM来增加可用的远程健康吸烟方法的强度，将是降低从伊拉克/阿富汗战争归来的退伍军人吸烟率的有效方式。在强有力的初步数据的指导下，这一假说将在一项两组设计的比较有效性试验中得到检验，在该设计中，260名资深吸烟者将被随机分为两组，一组接受结合基于证据的认知行为电话咨询(TC)的“MCM”干预，一组接受远程医学诊所，以获得尼古丁替代(NRT)，或者接受通过智能手机实施的MCM，或者接受控制治疗师、药物、时间和注意力影响的对照条件。具体目的是评估(1)在随机化后3个月、6个月和12个月的生物验证、自我报告的长期戒烟随访中，MCM对戒烟率的影响；(2)MCM干预在质量调整生命年(QALY)中的相对成本效益；(3)潜在的治疗中介，包括自我效能和治疗过程机制。这种方法是创新的，因为它建立在mHealth技术进步的基础上，并将首次评估基于智能手机的移动CM与其他针对OEF/OIF/OND退伍军人的循证戒烟治疗。令人惊讶的是，缺乏旨在评估多组分戒烟干预措施的研究，这些干预措施将CM与基于证据的认知行为治疗和戒烟辅助手段(如NRT)相结合。吸烟仍然是美国最致命的物质使用障碍，退伍军人吸烟相关的发病率和死亡率尤其高。在相对年轻和有风险的返乡退伍军人群体中确定减少烟草使用的成本效益办法的意义可能是巨大的，因为这将防止严重的发病率和死亡率。

DESCRIPTION (provided by applicant): Despite recent efforts to expand reach of smoking cessation treatment options beyond clinic based care, smoking cessation treatment including the use of smoking cessation aids remain greatly underutilized. If cessation programs are to have significant impact (Impact = Reach X Efficacy) on changing health behavior at the population level, there is a fundamental need to develop new and innovative strategies to increase treatment intensity, access, and participation. The use of intensive behavioral therapies, such as contingency management (CM), have demonstrated efficacy for reducing smoking in difficult-to-treat populations, but have had limited reach given the need to verify abstinence multiple times daily via clinic based monitoring. The development of a mobile health (mHealth) platform to provide CM has made the use of intensive CM approaches portable and feasible. The primary goal of the current study is to evaluate the effectiveness of a proactive tele-health intervention that combines evidenced based treatment for smoking cessation with smart- phone based, portable contingency management on smoking rates. The central hypothesis is that increasing the intensity of available tele-health smoking approaches through the addition of mobile CM will be an effective way to reduce smoking rates in Veterans returning from the Iraq/Afghanistan wars. Guided by strong preliminary data, this hypothesis will be tested in a comparative effectiveness trial with a two-group design in which 260 Veteran smokers will be randomized to receive either a "mCM" intervention which combines evidenced based cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for access to nicotine replacement (NRT), and mCM administered through a smart phone or to a control condition that will provide controls for therapist, medication, time and attention effects. Specific aims are to evaluate (1) the impact of mCM on rates of abstinence from cigarettes as measured by bio-verified, self-reported prolonged abstinence at 3-month, 6-month, and 12 month post-randomization follow-up, (2) the relative cost-effectiveness of the mCM intervention in quality adjusted life years (QALY), and (3) potential treatment mediators including self-efficacy and treatment process mechanisms. The approach is innovative because it builds upon advances in mHealth technology and will be the first evaluation of smart phone based mobile CM in conjunction with other evidence- based smoking cessation treatment for OEF/OIF/OND Veterans. There is a surprising lack of research aimed at evaluating multi-component smoking cessation interventions that integrate CM with evidence-based cognitive-behavioral treatment and smoking cessation aids such as NRT. Cigarette smoking remains the most lethal substance use disorder in the United States and military veterans are at particular high risk for smoking related morbidity and mortality. The significance of identifying cost-effective approaches to decreasing tobacco use in the relatively young and at-risk cohort of returning Veterans could be tremendous as it will prevent significant morbidity and mortality.