Telephone-Delivered Acceptance and Commitment Therapy for Smoking Cessation

描述（由申请人提供）：戒烟电话戒烟热线（QLs），在所有50个州提供；现在每年为超过50万烟民提供服务。平均而言，在12个月的随访中，即使使用传统的认知行为疗法（CBT）和药物治疗（典型的尼古丁替代疗法；NRT）的帮助下，只有14%（范围：8%到20%）的QL打电话者戒烟。ql的低戒烟率扼杀了它们潜在的巨大公共卫生影响。为了解决低戒烟率问题，从而开始一个新的研究范式，专注于创新的QL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），作为一种电话传递的戒烟干预。我们最近完成了一项小型（N = 121） NIDA R21试点随机QL试验，在由于R21预算限制而动力不足的州QL调用者中，主动提供ACT与CBT。结果表明ACT:(1)在状态QL环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)对渴望的接受程度高于CBT，这反过来预测了戒烟，(4)随机化后6个月的戒烟率高于CBT（尽管不显著）。在这些有希望但不确定的结果的基础上，现在需要进行一项比较有效的随机试验，采用大样本和全动力样本（N = 1168）和长期随访（即12个月），以明确确定电话递送ACT是否：(1)比CBT提供更高的戒烟率，(2)根据其基于理论的机制运作，(3)比CBT更具成本效益。因此，我们建议对电话提供的ACT咨询加NRT （n=584）与电话提供的传统CBT咨询加NRT （n=584）的状态戒除热线来电者进行随机比较效果试验，以证明电话提供的ACT:(1)在随机化后12个月的30天点患病率戒除率显著高于电话提供的传统CBT；(2)戒烟结果是否受到ACT理论模型核心的三个心理过程的显著调节：接受内部(a)感觉，(b)情绪和(c)暗示吸烟的想法；(3)通过每个额外戒烟者的成本、增量成本效益（ICER）和每个质量调整生命年（QALY）的增量成本来衡量，将明显比电话交付的CBT更具成本效益。在初步结果的推动下，这项研究显示出提高戒烟成功率、从而降低医疗成本和减少与烟草有关的过早死亡的令人兴奋的前景。如果证明有效和具有成本效益，ACT将为科学领域提供QL干预和戒烟热线的新概念模型，一种新的治疗方法，可以帮助每年（50万）戒烟热线电话中的45,000多人戒烟，从而节省医疗费用并延长生命。

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.