Kale Dimitra, Beard Emma, Marshall Anna-Marie, Pervin Jodi, Wu Qi, Ratschen Elena, Shahab Lion
Department of Behavioural Science and Health, University College London, London, 1-19 Torrington Place, WC1E 7HB, UK.
Helen McArdle Nursing and Care Research Institute, University of Sunderland, Sunderland, UK.
BMC Psychiatry. 2025 Jan 3;25(1):13. doi: 10.1186/s12888-024-06387-7.
Smoking rates in the UK have declined steadily over the past decades, masking considerable inequalities, as little change has been observed among people with a mental health condition. This trial sought to assess the feasibility and acceptability of supplying an electronic cigarette (e-cigarette) starter kit for smoking cessation as an adjunct to usual care for smoking cessation, to smokers with a mental health condition treated in the community, to inform a future effectiveness trial.
This randomised controlled feasibility trial, conducted March-December 2022, compared the intervention (e-cigarette starter kit with a corresponding information leaflet and demonstration with Very Brief Advice) with a 'usual care' control at 1-month follow-up. Participants were ≥ 18 years, receiving treatment for any mental health condition in primary or secondary care in three Mental Health Trusts in Yorkshire and one in London, UK. They were also willing to address their smoking through either cessation or reduction of cigarette consumption. The agreed primary outcome measure was feasibility (consent ~ 15% of eligible participants; attrition rate < 30%). Acceptability, validated sustained abstinence and ≥ 50% cigarette consumption reduction at 1-month, were also evaluated and qualitative interviews conducted to further explore acceptability in this population.
Feasibility targets were partially met; of 201 eligible participants, 43 (mean age = 45.2, SD = 12.7; 39.5% female) were recruited (21.4%) and randomised (intervention:48.8%, n = 21; control:51.2%, n = 22). Attrition rate was 37.2% at 1-month follow-up and was higher (45.5%) in the control group. At follow-up (n = 27), 93.3% (n = 14) in the intervention group and 25.0% (n = 3) in the control group reported e-cigarette use. The intervention was well received with minimal negative effects. In intention-to-treat analysis, validated sustained abstinence at 1-month was 2/21 (9.5%) and 0/22 (0%) and at least 50% reduction in cigarette consumption 13/21 (61.9%) and 3/22 (13.6%), for the intervention and control group, respectively. Qualitative analysis of participant interviews (N = 5) showed the intervention was broadly acceptable, but they also highlighted areas of improvements for the intervention and trial delivery.
Offering an e-cigarette starter kit to smokers with a mental health condition treated in the community was acceptable and largely feasible, with harm reduction outcomes (i.e. switching from cigarette smoking to e-cigarette use and substantial reduction in cigarette consumption) favouring the intervention. The findings of the study will be used to help inform the design of a main trial.
Registry: ISRCTN.
ISRCTN17691451. Date of registration: 30/09/2021.
在过去几十年中，英国的吸烟率稳步下降，但掩盖了相当大的不平等现象，因为在有心理健康问题的人群中几乎没有观察到变化。本试验旨在评估为社区中接受治疗的有心理健康问题的吸烟者提供电子烟启动套件作为戒烟常规护理辅助手段的可行性和可接受性，为未来的有效性试验提供信息。
这项随机对照可行性试验于2022年3月至12月进行，在1个月的随访中，将干预措施（带有相应信息手册的电子烟启动套件以及非常简短建议的示范）与“常规护理”对照进行比较。参与者年龄≥18岁，在英国约克郡的三个心理健康信托机构和伦敦的一个机构接受初级或二级护理中的任何心理健康问题治疗。他们也愿意通过戒烟或减少香烟消费来解决吸烟问题。商定的主要结局指标是可行性（同意参与的人数约占 eligible participants 的15%；失访率<30%）。还评估了可接受性、经过验证的持续戒烟以及1个月时香烟消费量减少≥50%的情况，并进行了定性访谈以进一步探讨该人群的可接受性。
部分实现了可行性目标；在201名 eligible participants 中，43人（平均年龄 = 45.2，标准差 = 12.7；39.5%为女性）被招募（占21.4%）并随机分组（干预组：48.8%，n = 21；对照组：51.2%，n = 22）。1个月随访时的失访率为37.2%，对照组更高（45.5%）。在随访时（n = 27），干预组93.3%（n = 14）和对照组25.0%（n = 3）报告使用了电子烟。该干预措施受到好评，负面影响最小。在意向性分析中，干预组和对照组1个月时经过验证的持续戒烟率分别为2/21（9.5%）和0/22（0%），香烟消费量至少减少50%的比例分别为13/21（61.9%）和3/22（13.6%）。对参与者访谈（N = 5）的定性分析表明，该干预措施总体上是可接受的，但他们也强调了干预措施和试验实施方面需要改进的领域。
为社区中接受治疗的有心理健康问题的吸烟者提供电子烟启动套件是可接受的，并且在很大程度上是可行的，减少危害的结果（即从吸烟转向使用电子烟以及大幅减少香烟消费）有利于干预措施。该研究结果将用于为主要试验的设计提供信息。
注册机构：ISRCTN。
ISRCTN17691451。注册日期：2021年9月30日。
