Improving Smoking Cessation Quitlines: Pilot Study of Acceptance Therapy

描述（由申请人提供）：戒烟电话戒烟热线是美国烟草控制计划的一个组成部分。但是，非常需要增加它们的成功。即使使用戒烟热线的传统认知行为疗法与药物疗法（通常是尼古丁替代疗法; NRT）相结合的标准干预，平均86%的使用戒烟热线的吸烟者会复发吸烟（即，14%的人退出）。目前还没有新的、有效的咨询方法来提高戒烟热线的戒烟成功率。我们通过试点测试一种有前途的方法来解决这一关键需求，这种方法称为接受与承诺疗法（ACT），作为电话提供的戒烟干预措施。我们最近完成了一项针对社区招募参与者的小型（n =14）单臂可行性研究，该研究表明，通过电话提供ACT戒烟是可行的，参与者接受干预。在治疗后12个月（93%保留），意向治疗延长戒断率为29%。虽然结果很有希望，但没有对照组，样本量只有14人，参与者不是退出热线的呼叫者，也没有提供NRT。为了建立在这些结果的基础上，现在需要一项试点随机对照试验，包括更大的样本量，从戒烟热线呼叫者中招募，并提供NRT，以告知全规模R 01随机试验的设计。因此，本提案的目的是进行一项试点随机试验，比较电话提供的ACT咨询加NRT与电话提供的CBT咨询加NRT，以便：（1）证明ACT的实施结果至少与传统CBT一样好;（2）证明ACT与CBT相比，具有更高的戒烟率和相关行为改变率的趋势;（3）证明ACT（而不是传统的CBT）的戒烟结果是由两个心理测量介导的，这两个心理测量是ACT理论模型的核心：（a）接受吸烟的内部线索（感觉，情绪和思想）和（B）承诺戒烟。关键的创新是一个新的概念模型戒烟咨询。该研究将这种新模型应用于戒烟这一非常重要的公共卫生问题，并在戒烟热线的广泛传播背景下测试该模型。这项研究提出了一个研究范式的转变，越来越多的创新戒烟咨询内容。该提案显示出令人兴奋的希望，可以提高戒烟热线的成功率，从而降低医疗成本，减少与烟草相关的过早死亡。 公共卫生相关性：这项为期两年的R21随机试验将试点测试一种新出现的咨询方法，称为接受和承诺疗法（ACT），作为电话提供的戒烟干预。如果ACT后来在全面试验中被证明是有效的，并传播到50%到100%的美国戒烟热线，那么每年可能会有31，000到61，000多名吸烟者戒烟。

DESCRIPTION (provided by applicant): Smoking cessation telephone quitlines are an integral component in the US tobacco control program. But increasing their success is greatly needed. Even with quitlines' standard intervention of traditional Cognitive Behavioral Therapy combined with pharmacotherapy (typically nicotine replacement therapy; NRT), an average of 86% of smokers using quitlines will relapse to smoking (i.e., 14% stay quit). There are no new, proven-effective counseling approaches to improve the smoking cessation success rates of quitlines. We address this critical need by pilot testing a promising approach, called Acceptance & Commitment Therapy (ACT), as a telephone-delivered smoking cessation intervention. We recently completed a small (n =14) single- arm feasibility study of community-recruited participants which demonstrated that ACT for smoking cessation was feasibly-delivered by telephone and that participants were receptive to the intervention. At 12 months post- treatment (93% retention), the intent-to-treat prolonged abstinence rate was 29%. While results were promising, there was no control group, the sample size was only 14, participants were not quitline callers, and no NRT was provided. To build on these results, a pilot randomized controlled trial that includes a larger sample size, recruitment from quitline callers, and NRT provision is now needed to inform the design of a full- scale R01 randomized trial. Accordingly, the aims of this proposal are to conduct a pilot randomized trial comparing telephone-delivered ACT counseling plus NRT to telephone-delivered CBT counseling plus NRT, in order to: (1) Demonstrate that ACT's implementation outcomes are at least as good as those of traditional CBT; (2) Demonstrate that ACT, as compared to CBT, has a trend toward higher smoking cessation and related behavior change rates; (3) Demonstrate that the smoking cessation outcomes of ACT, but not traditional CBT, are mediated by two psychological measures that are central to the theoretical model underlying ACT: (a) acceptance of internal cues to smoke (sensations, emotions, and thoughts) and (b) commitment to quitting smoking. The key innovation is a new conceptual model for quitline counseling. The study applies this new model to the highly important public health problem of smoking cessation and tests the model in the widely disseminable context of a quitline. The study proposes a research paradigm shift toward increasing innovations in quitline counseling content. The proposal shows exciting promise for improving the success rates of quitlines and thereby lowering healthcare costs and reducing premature tobacco-related deaths. PUBLIC HEALTH RELEVANCE: This two-year R21 randomized trial will pilot test a newly emerging counseling approach, called Acceptance & Commitment Therapy (ACT), as a telephone-delivered smoking cessation intervention. If ACT is later proven effective in a full-scale trial and disseminated to 50% to 100% of US quitlines, it is possible that 31,000 to 61,000 more smokers could quit each year.