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50多万吸烟者提供服务。平均而言，只有14%（范围：8%至20%）的QL呼叫者在12个月随访时停止吸烟，即使在传统认知行为疗法（CBT）联合药物治疗（通常为尼古丁替代疗法; NRT）的帮助下。QLs的低退出率扼杀了他们巨大的潜在公共卫生影响。为了解决低戒烟率的问题，从而开始一个新的研究范式，专注于创新的QL行为干预的内容，我们建议测试一种新的咨询方法，称为接受与承诺疗法（ACT），作为一个电话提供戒烟干预。我们最近完成了一项小型（N = 121）NIDA R21试点随机QL试验，在州QL呼叫者中主动提供ACT与CBT，由于R21预算限制，该试验动力不足。结果显示，ACT：（1）在州QL背景下实施和评估是可行的，（2）参与者参与度和满意度高于CBT，（3）接受渴望的程度高于CBT，这反过来又预测了戒烟，（4）随机化后6个月的戒烟率高于CBT（尽管不显著）。基于这些有希望的和非确定性的结果，一项具有较大和完全把握度的样本量（N = 1168）和长期随访（即，12个月），现在需要明确确定是否电话交付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，（3）比CBT更具成本效益。因此，我们建议在州戒烟热线呼叫者中进行一项电话传递ACT咨询加NRT（n=584）与电话传递传统CBT咨询加NRT（n=584）的随机比较有效性试验，以证明电话传递ACT：（1）在随机化后12个月时，30天时点戒烟率显著高于电话传递传统CBT;（2）戒烟结果显著受ACT理论模型核心的三个心理过程介导：接受内部（a）感觉，（B）情绪和（c）提示吸烟的想法;（3）将比电话提供的CBT更具成本效益，如每个额外戒烟者的成本，增量成本效益（ICER），每质量调整生命年（QALY）的增量成本。这项研究受到初步结果的充分激励，显示出令人兴奋的提高戒烟成功率的前景，从而降低医疗成本并减少与烟草相关的过早死亡。如果被证明是有效的和具有成本效益的，ACT将为科学领域提供一个新的QL干预概念模型，戒烟热线是一种新的治疗方法，每年可以帮助45，000多名（500，000名）戒烟热线呼叫者戒烟，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.