Busch Andrew M, Tooley Erin M, Dunsiger Shira, Chattillion Elizabeth A, Srour John Fani, Pagoto Sherry L, Kahler Christopher W, Borrelli Belinda
The Miriam Hospital, Providence, RI, USA.
Warren Alpert Medical School of Brown University, Providence, RI, USA.
BMC Public Health. 2017 Apr 17;17(1):323. doi: 10.1186/s12889-017-4250-7.
Smoking cessation following hospitalization for Acute Coronary Syndrome (ACS) significantly reduces subsequent mortality. Depressed mood is a major barrier to cessation post-ACS. Although existing counseling treatments address smoking and depression independently in ACS patients, no integrated treatment addresses both. We developed an integrated treatment combining gold standard cessation counseling with behavioral activation-based mood management; Behavioral Activation Treatment for Cardiac Smokers (BAT-CS). The purpose of this pilot randomized controlled trial was to test feasibility, acceptability, and preliminary efficacy of BAT-CS vs. Standard of Care (SC).
Participants were recruited during hospitalization for ACS and were randomly assigned to BAT-CS or SC. The nicotine patch was offered in both conditions. Smoking, mood, and stress outcomes were collected at end-of-treatment and 24-week follow-up.
Fifty-nine participants (28 BAT-CS, 31 SC) were recruited over 42 weeks, and assessment completion was above 80% in both conditions. Treatment acceptability and fidelity were high. At 24 week follow-up adjusted odds ratios favoring BAT-CS were 1.27 (95% CI: 0.41-3.93) for 7-day point prevalence abstinence and 1.27 (95% CI: 0.42-3.82) for continuous abstinence. Time to first smoking lapse was significantly longer in BAT-CS (62.4 vs. 31.8 days, p = 0.03). At 24-weeks, effect sizes for mood and stress outcomes ranged from η of.07-.11, with significant between treatment effects for positive affect, negative affect, and stress.
The design of this study proved feasible and acceptable. Results provide preliminary evidence that combining behavioral activation with standard smoking cessation counseling could be efficacious for this high risk population. A larger trial with longer follow-up is warranted.
NCT01964898 . First received by clinicaltrials.gov October 15, 2013.
急性冠状动脉综合征(ACS)住院后戒烟可显著降低后续死亡率。情绪低落是ACS后戒烟的主要障碍。尽管现有的咨询治疗分别针对ACS患者的吸烟和抑郁问题,但尚无综合治疗方案同时解决这两个问题。我们开发了一种综合治疗方法,将金标准戒烟咨询与基于行为激活的情绪管理相结合;即针对心脏病吸烟者的行为激活治疗(BAT-CS)。这项初步随机对照试验的目的是测试BAT-CS与标准护理(SC)相比的可行性、可接受性和初步疗效。
在ACS住院期间招募参与者,并将其随机分配到BAT-CS组或SC组。两组均提供尼古丁贴片。在治疗结束时和24周随访时收集吸烟、情绪和压力结果。
在42周内招募了59名参与者(28名BAT-CS组,31名SC组),两组的评估完成率均高于80%。治疗的可接受性和保真度很高。在24周随访时,倾向于BAT-CS组的调整后优势比在7天点流行率戒烟方面为1.27(95%CI:0.41-3.93),在持续戒烟方面为1.27(95%CI:0.42-3.82)。BAT-CS组首次吸烟复吸的时间显著更长(62.4天对31.8天,p=0.03)。在24周时,情绪和压力结果的效应大小范围为η=0.07-0.11,在积极情绪、消极情绪和压力方面治疗组间存在显著差异。
本研究的设计证明是可行和可接受的。结果提供了初步证据,表明将行为激活与标准戒烟咨询相结合可能对这一高危人群有效。有必要进行一项随访时间更长的更大规模试验。
NCT01964898。于2013年10月15日首次被clinicaltrials.gov收录。