Web-Delivered Acceptance & Commitment Therapy for Smokers with Bipolar Disorder

 描述（由申请人提供）：高达70%的双相情感障碍成年人吸烟，而普通人群中只有20%吸烟，导致烟草相关疾病和死亡率不成比例地高。患有双相情感障碍的吸烟者的戒烟率不到没有精神疾病的吸烟者的一半（17%对43%）。提高这一群体戒烟率的主要障碍是：（1）双相情感障碍吸烟者戒烟的独特挑战，这些挑战在标准戒烟咨询中没有得到解决，例如普遍认为吸烟有助于控制疾病症状，以及（2）在精神卫生保健系统中获得烟草治疗的机会有限。迫切需要新的方法来解决这两个障碍。基于网络的接受和承诺疗法（ACT）是一种新的戒烟治疗模式，与美国政府Smokefree.gov网站的现行标准相比，其戒烟率增加了一倍多（3个月随访时为23%对10%）。增加尼古丁替代疗法（NRT）--一种有效且可获得的药物疗法--并针对这种干预措施来解决双相情感障碍吸烟者戒烟的主要障碍，可以显着改善极低的戒烟率。拟议的项目涉及开发和试点测试的有针对性的，基于网络的ACT干预吸烟者与双相情感障碍（WebQuit Plus），这是建立在我们有前途的试点数据显示40%的戒烟率和90%的可接受性，为这种干预时，提供面对面的，个人治疗。研究将分两个阶段进行。第一阶段将包括干预开发和网站可用性测试（n=12）。第二阶段将是一项试点随机对照试验，在国家抑郁症中心网络（NNDC）的三个站点进行，比较WebQuit Plus（n=30）和Smokefree.gov（n=30）。这两种干预措施将与尼古丁贴片联合使用。本研究的主要目的是确定在NNDC内进行更大规模、多中心疗效试验的可行程序，主要可行性结局包括：（1）招募（即，接触、筛选、合格和同意的数量;不合格或拒绝的原因），（2）干预完成和（3）结局数据保留。另一个主要目的是比较WebQuit Plus与Smokefree.gov在治疗满意度和利用率、ACT基于理论的戒烟结果改变机制以及10周治疗期结束时和治疗后1个月随访时的双相情感障碍症状。这项研究在两个关键方面具有重要意义和创新性：（1）它应用了一种有前途的新治疗（ACT），具有戒烟的新作用机制（即，接受）的问题，戒烟率低的问题，吸烟者与双相情感障碍，和（2）干预是基于网络的，使其访问，潜在的成本效益，并容易传播到精神卫生保健设置。如果在更大的试验中发现有效 从这个试点试验中可以看出，WebQuit Plus可以对双相情感障碍成年人中吸烟和吸烟相关疾病的高患病率产生持久的积极影响。

 DESCRIPTION (provided by applicant): Up to 70% of adults with bipolar disorder smoke, compared with only 20% of the general population, leading to disproportionately high rates of tobacco-related disease and mortality. Quit rates for smokers with bipolar disorder are less than half that of smokers without psychiatric disorders (17% vs. 43%). Key barriers to improving quit rates in this group are: (1) unique challenges of quitting for smokers with bipolar disorder that are not addressed in standard cessation counseling, such as the commonly held belief that smoking helps to manage symptoms of the disorder, and (2) limited access to tobacco treatment within the mental health care system. New approaches are greatly needed to address both of these barriers. Web-based Acceptance and Commitment Therapy (ACT) is a new model of smoking cessation treatment that more than doubled quit rates compared to the current standard, the US government's Smokefree.gov site (23% vs. 10% at 3-month follow- up). Adding nicotine replacement therapy (NRT)--an effective and accessible pharmacotherapy-and targeting this intervention to address the major barriers to quitting for smokers with bipolar disorder could significantly improve the extremely low quit rates. The proposed project involves development and pilot testing of a targeted, web-based ACT intervention for smokers with bipolar disorder (WebQuit Plus), which builds on our promising pilot data showing 40% quit rate and 90% acceptability for this intervention when delivered as face- to-face, individual therapy. The study will be conducted in two phases. The first phase will consist of intervention development and web site usability testing (n=12). The second phase will be a pilot randomized, controlled trial at three sites within the National Network of Depression Centers (NNDC), comparing WebQuit Plus (n=30) to Smokefree.gov (n=30). Both interventions will be delivered in combination with the nicotine patch. A primary aim of the study is to determine feasible procedures for conducting a larger, multi-site efficacy trial within the NNDC, with primary feasibility outcomes including: (1) recruitment (i.e., number approached, screened, eligible, and consented; reasons for ineligibility or refusal), (2) completion of the intervention and (3) outcom data retention. Another primary aim is to compare WebQuit Plus to Smokefree.gov on treatment satisfaction and utilization, ACT's theory-based mechanism of change smoking cessation outcomes, and bipolar disorder symptoms at the end of the 10-week treatment period and at 1-month post-treatment follow- up. This study is significant and innovative in two key respects: (1) it applies a promising new treatment (ACT) with a novel mechanism of action for smoking cessation (i.e., acceptance) to the problem of low quit rates among smokers with bipolar disorder, and (2) the intervention is web-based, making it accessible, potentially cost-effective, and easily disseminated to mental healthcare settings. If found to be effective in the larger trial that would be informed by this pilot trial, WebQuit Plus could have an enduring, positive impact on the high prevalence of smoking-and smoking-related illnesses-among adults with bipolar disorder.