Stage II Trial of Novel Behavioral Activation Intervention for Smoking Cessation

摘要 在美国，吸烟是导致死亡和残疾的主要原因。此外，抑郁症-- 相关的脆弱性与吸烟行为高度共存，并显著降低戒烟率 在社区和临床样本中。以前的研究已经检验了整合的有效性 将抑郁症的认知行为治疗纳入标准戒烟治疗重点 过去有严重抑郁障碍(MDD)病史的个人。然而，成功仅限于 关注MDD历史。通过针对患有当前疾病的个人可以实现更广泛的健康影响 抑郁症状增加，因为它们与戒烟失败有关。此外，它的复杂性 治疗抑郁症的认知行为方法可能会损害它们与戒烟的有效整合 协议。因此，目前吸烟水平升高的吸烟者需要新的戒烟方法 抑郁症状。我们最近完成了一项初步的随机对照试验，比较了 综合新型行为激活戒烟疗法(BATS)与标准戒烟疗法 吸烟者的治疗(ST)[两种情况下都接受8周的尼古丁透皮贴片(TNP)] 抑郁症状加重。初步研究结果表明，在戒烟后的第一周， 接受BATS(n=26)的参与者戒酒(P&lt；.05)的可能性是ST(n=16)的2.7倍 参与者。BATS参与者的禁酒率也明显高于(P=0.02)ST 参与者在戒烟后26周的随访期内。初步结果令人鼓舞， 支持规模更大的II期随机对照试验，以便更好地将BATS确立为有效的 对患有抑郁症易感性的吸烟者的治疗。更重要的是，这项研究的参与者 主要是低收入的少数族裔个人。考虑到相当多的记录障碍，这一点很重要 对于这一高危人群来说，戒烟和较低的戒毒率是可行的。因此，本提案的目标是 对我们之前的I期治疗开发努力和小规模随机对照试验的后续研究 (随机对照试验)，在200名以低收入为主的类似样本中，进行第二阶段随机对照试验，比较BAT和ST 以及抑郁症状加重的少数族裔吸烟者。参与者的治疗将等同于 治疗师联系时间。参与者将在戒烟后52周内接受跟踪调查，样本量较大者将 允许对戒烟结果背后的机制进行更复杂的分析。我们预计这是一种 这个项目的结果，我们将为一个明确的，新颖的行为的有效性提供证据 激活吸烟治疗，对有显著复发风险的吸烟者效果良好。

Abstract Cigarette smoking is the leading cause of death and disability in the United States. Moreover, depression- related vulnerabilities are highly comorbid with smoking behavior and dramatically reduce cessation rates among both community and clinical samples. Previous research has examined the efficacy of integrating cognitive-behavioral treatment for depression into standard smoking cessation treatment focusing on individuals who have a past history of major depressive disorder (MDD). However, success has been limited in focusing on MDD history. A broader health impact can be achieved by targeting individuals with current elevated depressive symptoms given their association with cessation failure. Furthermore, the complexity of cognitive behavioral approaches for depression may impair their effective integration into smoking cessation protocols. As a result, new approaches to smoking cessation are needed for smokers with currently elevated depressive symptoms. We have recently completed an initial randomized controlled trial comparing an integrated novel behavioral activation smoking cessation treatment (BATS) versus standard smoking cessation treatment (ST) [with both conditions receiving 8 weeks of transdermal nicotine patch (TNP)] among smokers with elevated depressive symptoms. Preliminary findings indicate that in the first week post quit date, participants receiving BATS (n = 26) were 2.7 times more likely to be abstinent (p < .05) than ST (n = 16) participants. BATS participants also evidenced significantly higher (p = .02) abstinence rates than ST participants throughout the 26 week post-quit follow-up period. Preliminary results are encouraging and support a larger Stage II randomized controlled trial in order to better establish BATS as an efficacious treatment for smokers with depression-relevant vulnerabilities. Of further relevance, participants in this study were predominantly low income, minority individuals. This is important given considerable documented barriers to cessation and lower cessation rates for this at-risk group. Thus, the objective of the present proposal is to follow-up on our previous Stage I treatment development efforts and small scale randomized controlled trial (RCT) with a Stage II RCT comparing BATS to ST among a similar sample of 200 predominantly low income and minority smokers with elevated depressive symptoms. Treatments will be equated for participant and therapist contact time. Participants will be followed over 52 weeks post-quit date and the larger sample size will allow for more complex analyses of the mechanisms underlying cessation outcomes. We expect that as a result of this project, we will have provided evidence for the efficacy of a well-specified, novel behavioral activation smoking treatment that works well with smokers at significant risk for relapse.