Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.
Edith Nourse Rogers Memorial VA Medical Center, Bedford, MA.
Nicotine Tob Res. 2020 Aug 24;22(9):1543-1552. doi: 10.1093/ntr/ntz242.
Smokers with bipolar disorder (BD) are less successful at quitting than the general population. In this study, we evaluated in a pilot randomized controlled trial a novel, targeted, web-based intervention for smokers with BD based on acceptance and commitment therapy (ACT) and designed for reach and disseminability.
Daily smokers (n = 51) with bipolar I or II disorder were recruited from four US sites and randomly assigned to one of two web-based smoking cessation interventions-ACT-based WebQuit Plus (n = 25) or Smokefree.gov (n = 26) over a 10-week treatment period. All participants received nicotine patch for 8 weeks. Key outcomes were trial design feasibility, intervention acceptability, and cessation at end of treatment and 1-month follow-up.
We screened 119 to enroll 51 participants (target sample size = 60) over 24 months. The most common reason for ineligibility was the inability to attend study appointments. Retention was 73% at end of treatment and 80% at follow-up, with no differences by arm. The mean number of logins was twice as high for WebQuit Plus (10.3 vs. 5.3). The usefulness of program skills was rated higher for WebQuit Plus (75% vs. 29%). Biochemically confirmed, 7-day abstinence at end of treatment was 12% in WebQuit Plus versus 8% in Smokefree.gov (odds ratio = 1.46, 95% confidence interval = 0.21 to 9.97). At follow-up, abstinence rates were 8% in both arms.
Trial design produced favorable retention rates, although alternative recruitment methods will be needed for a larger trial. At end of treatment, acceptability and estimated effect size of WebQuit Plus relative to Smokefree.gov were promising and support continued program refinement and evaluation.
In this first randomized controlled trial of a targeted intervention for smokers with BD, we found that the ACT-based WebQuit Plus intervention, delivered in combination with the nicotine patch, had promising acceptability and cessation outcomes relative to Smokefree.gov. The observed signals for acceptability and cessation suggest that the WebQuit Plus program should be refined based on participant feedback and evaluated in a larger trial. Feasibility findings from this study also provide direction for refining trial procedures to enhance the recruitment of smokers with BD.
与一般人群相比，患有双相情感障碍（BD）的吸烟者戒烟成功率较低。在这项研究中，我们评估了一项基于接受和承诺疗法（ACT）的针对 BD 吸烟者的新型、靶向、基于网络的干预措施，该措施旨在提高可及性和可传播性。
从美国的四个地点招募了每日吸烟的 BD I 或 II 型患者（n = 51），并将他们随机分配到两种基于网络的戒烟干预措施之一——基于 ACT 的 WebQuit Plus（n = 25）或 Smokefree.gov（n = 26），治疗期为 10 周。所有参与者均接受了 8 周的尼古丁贴片治疗。主要结果是试验设计的可行性、干预措施的可接受性以及治疗结束时和 1 个月随访时的戒烟情况。
我们筛查了 119 名患者，以在 24 个月内招募 51 名患者（目标样本量为 60 名）。最常见的不合格原因是无法参加研究预约。治疗结束时的保留率为 73%，随访时为 80%，两组之间无差异。WebQuit Plus 的平均登录次数是 Smokefree.gov 的两倍（10.3 次对 5.3 次）。WebQuit Plus 的程序技能有用性评分更高（75%对 29%）。治疗结束时，WebQuit Plus 组的生物化学确认 7 天戒烟率为 12%，Smokefree.gov 组为 8%（比值比=1.46，95%置信区间=0.21 至 9.97）。随访时，两个组的戒烟率均为 8%。
尽管需要采用替代的招募方法才能进行更大规模的试验，但试验设计产生了有利的保留率。在治疗结束时，WebQuit Plus 相对于 Smokefree.gov 的可接受性和估计效果大小具有很大的希望，支持进一步完善和评估该方案。
在这项针对 BD 吸烟者的靶向干预措施的首次随机对照试验中，我们发现，在尼古丁贴片的基础上，基于 ACT 的 WebQuit Plus 干预措施具有良好的可接受性和戒烟效果，优于 Smokefree.gov。可接受性和戒烟方面的观察信号表明，应根据参与者的反馈对 WebQuit Plus 计划进行改进，并在更大规模的试验中进行评估。本研究的可行性发现也为改进试验程序以提高 BD 吸烟者的招募提供了方向。
