Randomized Trial of Web-Delivered Acceptance Therapy for Smoking Cessation

描述（由申请人提供）：戒烟干预网站现在每天24小时接触数百万成年人。不幸的是，目前可用的戒烟网站的有效性很低。他们的平均戒烟率是7%到10%。现在是时候测试一种新的干预模式，这种模式有可能提高戒烟网站的戒烟率。为了启动一个新的研究范式，专注于创新的基于网络的干预内容，目前的研究将测试一种有前途的治疗方法，称为接受和承诺疗法（ACT）。我们最近开发了第一个ACT戒烟网站，并在一项随机对照试验中进行了初步测试，将其与遵循美国临床实践指南（Smokefree.gov）的国家级当前标准网站进行比较。试验设计被证明是可行的，成功的国家招募（N = 222）和均衡的随机化。ACT干预是可行的，与Smokefree.gov相比，参与者的利用率和满意度更高。ACT干预在短期随访中显示出对戒烟过程和结果的有希望的结果（即，3个月）。在这些结果的基础上，一项更大样本的随机试验 尺寸（N = 2554）和长期随访（即，12个月），现在需要明确确定ACT网站是否提供比目前可用的戒烟网站更强大的戒烟率。因此，我们建议进行一项随机对照试验，将ACT戒烟网站与www.example.com进行比较Smokefree.gov，以便：（1）证明基于网络的ACT戒烟率明显高于国家级当前标准网站（Smokefree.gov）。主要结局：随机分组后12个月时的30天时点戒烟率;（2）证明基于网络的ACT（而不是Smokefree.gov）戒烟结局由三个心理过程介导，这三个心理过程是ACT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。这项研究，以及有前途的试点结果的动机，将提供一个基于网络的ACT戒烟计划及其潜在的中介过程的明确测试。积极的结果可以为目前标准的基于网络的干预提供一种新的干预模式，并在低成本的公共卫生干预中显着提高吸烟者的长期戒烟率。

DESCRIPTION (provided by applicant): Smoking cessation intervention websites are now reaching millions of adults 24 hours a day. Unfortunately, currently available smoking cessation websites have low effectiveness. Their average quit rates are 7 to 10%. Now is the time to test a new intervention model with potential to boost quit rates of smoking cessation websites. To start a new research paradigm focusing on innovative web-based intervention content, the current study will test a promising treatment approach called Acceptance & Commitment Therapy (ACT). We recently developed the first ACT smoking cessation website and pilot tested it in a randomized controlled trial comparing it with a national-level current standard website following US Clinical Practice Guidelines (Smokefree.gov). The trial design was proven feasible, with successful national recruitment (N = 222) and balanced randomization. The ACT intervention was feasible, with higher participant utilization and satisfaction, as compared to Smokefree.gov. The ACT intervention showed promising results on cessation processes and outcomes at short term follow-up (i.e., 3 months). Building on these results, a randomized trial with a larger sample size (N = 2554) and longer term follow-up (i.e., 12 months) is now needed to definitively determine whether the ACT website provides more robust quit rates than currently available smoking cessation websites. Accordingly, we propose to conduct a randomized controlled trial comparing the ACT smoking cessation website with Smokefree.gov, in order to: (1) Demonstrate that web-based ACT has significantly higher smoking cessation rates than a national-level current standard website (Smokefree.gov). Primary outcome: 30-day point prevalence abstinence at 12 months post randomization; (2) Demonstrate that the web-based ACT (but not Smokefree.gov) smoking cessation outcomes are mediated by three psychological processes that are central to the theoretical model underlying ACT: acceptance of internal (a) sensations, (b) emotions, and (c) thoughts that cue smoking. This study, well-motivated by promising pilot results, will provide a definitive test of the web-based ACT for smoking cessation program and its underlying mediational processes. Positive results could provide current standard web-based interventions a new intervention paradigm and significantly improve long term cessation rates for smokers in a low cost public health intervention.