Telephone-Delivered Acceptance and Commitment Therapy for Smoking Cessation

描述(由申请人提供)：戒烟电话戒烟专线(QLS)，在所有50个州可用；现在每年为超过500,000名吸烟者提供服务。平均而言，即使在传统认知行为疗法(CBT)和药物疗法(通常是尼古丁替代疗法；NRT)的帮助下，QL呼叫者在12个月的随访中也只有14%(范围：8%至20%)戒烟。QLS的低戒烟率扼杀了它们对公共健康的巨大潜在影响。为了解决戒烟率低的问题，从而启动一种新的研究范式，专注于创新的生活质量行为干预内容，我们建议测试一种新的咨询方法，称为接受与承诺疗法(ACT)，作为电话传递的戒烟干预。我们最近完成了一项小规模(N=121)NIDA R21试点随机QL试验，研究对象是由于R21预算限制而动力不足的州QL呼叫者主动交付的ACT和CBT。结果表明：(1)ACT在状态QL情境下实施和评估是可行的；(2)参与者的参与度和满意度高于CBT；(3)CBT比CBT更容易接受戒烟渴望；(4)随机化后6个月戒烟率高于CBT(尽管不显著)。在这些充满希望和非决定性结果的基础上，现在需要一项具有大样本和全功率样本(N=1168)和较长期随访(即12个月)的比较有效性随机试验来最终确定电话递送的ACT：(1)提供比CBT更高的戒烟率，(2)根据其基于理论的机制运作，以及(3)比CBT更具成本效益。因此，我们建议在国家戒烟专线呼叫者中进行一项电话提供的ACT咨询+NRT(n=584)与电话提供的传统CBT咨询+NRT(n=584)的随机比较有效性试验，以证明电话提供的ACT：(1)在随机化后12个月，电话提供的ACT的30天点戒烟率显著高于电话提供的传统CBT；(2)戒烟结果受到三个心理过程的显著调节，这三个心理过程是支持ACT的理论模型的核心：接受内部(A)感觉，(B)情绪，和(C)提示吸烟的想法；(3)以每个额外戒毒者的成本、增量成本效益(ICER)和每个质量调整生命年的增量成本(QALY)来衡量，成本效益将显著高于电话交付的CBT。这项研究受到初步结果的良好推动，显示出令人兴奋的前景，将提高戒烟线的成功率，从而降低医疗成本，减少与烟草相关的过早死亡。如果ACT被证明是有效和具有成本效益的，它将为科学界提供一个新的QL干预概念模型，并为戒烟LINES提供一种新的治疗方法，每年可帮助(50万人中)更多的45000人戒烟，从而节省医疗费用和延长生命。

DESCRIPTION (provided by applicant): Smoking cessation telephone quit lines (QLs), available in all 50 states; now serve over 500,000 smokers each year. On average, only 14% (range: 8% to 20%) of QL callers stop smoking by the 12 month follow-up even with the aid of traditional Cognitive Behavioral Therapy (CBT) combined with pharmacotherapy (typically nicotine replacement therapy; NRT). The low quit rates of QLs stifle their great potential public health impact. To address the low quit rate problem, and thereby start a new research paradigm focused on innovative QL behavioral intervention content, we propose to test a novel counseling approach, called Acceptance & Commitment Therapy (ACT), as a telephone-delivered quit smoking intervention. We recently completed a small (N = 121) NIDA R21 pilot randomized QL trial of proactively-delivered ACT vs. CBT in state QL callers that was underpowered due to R21 budget limits. Results showed that ACT: (1) was feasible to implement and evaluate in a state QL context, (2) had higher participant engagement and satisfaction than CBT, (3) had higher levels of acceptance of cravings than CBT, which in turn predicted quitting smoking, and (4) had higher (albeit non-significant) 6-month post randomization quit rates than CBT. Building on these promising and non- definitive results, a comparative effectiveness randomized trial with a large and fully-powered sample size (N = 1168) and longer term follow-up (i.e., 12 months) is now needed to definitively determine whether telephone- delivered ACT: (1) provides higher quit rates than CBT, (2) operates according to its theory-based mechanisms, and (3) is more cost-effective than CBT. Accordingly, we propose to conduct a randomized comparative effectiveness trial of telephone-delivered ACT counseling plus NRT (n=584) versus telephone-delivered traditional CBT counseling plus NRT (n=584) in state quit line callers, in order to demonstrate that telephone-delivered ACT: (1) has significantly higher 30-day point prevalence abstinence at 12 months post-randomization than telephone-delivered traditional CBT; (2) has smoking cessation outcomes significantly mediated by three psychological processes central to the theoretical model underlying ACT: acceptance of internal (a) sensations, (b) emotions, and (c) thoughts that cue smoking; (3) Will be significantly more cost-effective than telephone-delivered CBT, as measured by cost per additional quitter, incremental cost-effectiveness (ICER), and incremental cost per quality-adjusted life year (QALY). The study, well-motivated by preliminary results, shows exciting promise for improving the success rates of quit lines and thereby lowering healthcare costs and reducing premature tobacco-related deaths. If shown to be efficacious and cost-effective, ACT would provide the scientific field a new conceptual model of QL intervention and quit lines a new treatment approach that could help 45,000 more (of the 500,000) quit line callers to stop smoking each year, thereby saving in medical costs and prolonging lives.