Taylor Gemma, Aveyard Paul, Bartlem Kate, Shaw Alison, Player Jeremy, Metcalfe Chris, Kessler David, Munafò Marcus
1Addiction and Mental Health Group (AIM), Department of Psychology, University of Bath, 10 West, Bath, BA2 7AY UK.
2Nuffield Department of Primary Care Health Sciences, UK Centre for Tobacco and Alcohol Studies, University of Oxford, Radcliffe Primary Care Building, Radcliffe Observatory Quarter Woodstock Road, Oxford, OX2 6GG UK.
Pilot Feasibility Stud. 2019 Jan 22;5:16. doi: 10.1186/s40814-018-0385-2. eCollection 2019.
People with depression/anxiety are twice as likely to smoke and are less responsive to standard tobacco treatments, leading to a reduced life expectancy of up to 13.6 years compared to people without depression/anxiety. However, this group of smokers is motivated to quit, and as a result of quitting smoking, their depression/anxiety is likely to improve. In England, people with depression/anxiety are referred to a primary care-based psychological therapies service known as 'Improving Access to Psychological Therapies' (IAPT), which could offer smoking cessation treatment as part of usual care but currently does not. In this study, we aim (1) to establish the feasibility and acceptability of delivering a smoking cessation treatment alongside IAPT usual care and (2) to establish the feasibility of a multi-centre randomised trial to compare the combined smoking cessation and IAPT treatment to usual IAPT treatment alone.
A randomised and controlled, multi-centre trial to test the acceptability, feasibility and implementation of smoking cessation treatment as offered alongside usual IAPT care, compared to usual care alone, with nested qualitative methods. We will include adult daily smokers with depression/anxiety, who would like help to quit smoking and are about to start IAPT treatment. Follow-up will be conducted at 3-months after baseline. The main outcome will be retention in the smoking cessation treatment. Secondary outcomes are smoking-related (biochemically-verified 7-day point prevalence smoking cessation, number of cigarettes smoked per day, Heaviness of Smoking Index), mental health-related (PHQ-9), service-related (number of 'Did Not Attends', number of planned and completed IAPT sessions), acceptability and feasibility (participant and clinician acceptability and satisfaction of intervention as assessed by questionnaires and qualitative interviews, interviews will also explore acceptability and feasibility of data collection procedures and impact of smoking cessation treatment on usual care and mental health recovery) and implementation-related (intervention delivery checklist, qualitative analysis of intervention delivery).
If the intervention is shown to be acceptable, feasible and suitably implemented, we can conduct a randomised controlled trial. In a future trial, we would examine whether adding smoking cessation treatment increases smoking abstinence and improves depression and anxiety more than usual care, which would lead to long-term health improvement.
ISRCTN99531779.
患有抑郁症/焦虑症的人吸烟的可能性是其他人的两倍,并且对标准烟草治疗的反应较差,与没有抑郁症/焦虑症的人相比,预期寿命缩短多达13.6年。然而,这组吸烟者有戒烟的动机,并且由于戒烟,他们的抑郁症/焦虑症可能会改善。在英国,患有抑郁症/焦虑症的人会被转介到一项基于初级保健的心理治疗服务,即“改善心理治疗可及性”(IAPT),该服务可以在常规护理中提供戒烟治疗,但目前并未提供。在本研究中,我们旨在(1)确定在IAPT常规护理的同时提供戒烟治疗的可行性和可接受性,以及(2)确定进行一项多中心随机试验的可行性,以比较联合戒烟和IAPT治疗与单独的常规IAPT治疗。
一项随机对照多中心试验(采用嵌套定性方法),以测试在常规IAPT护理的同时提供戒烟治疗的可接受性、可行性和实施情况,并与单独的常规护理进行比较。我们将纳入患有抑郁症/焦虑症的成年每日吸烟者,他们希望获得戒烟帮助并且即将开始IAPT治疗。随访将在基线后3个月进行。主要结局将是在戒烟治疗中的留存率。次要结局包括与吸烟相关的(经生化验证的7天点患病率戒烟情况、每天吸烟的支数、吸烟指数)、与心理健康相关的(PHQ-9)、与服务相关的(“未就诊”次数、计划和完成的IAPT疗程数)、可接受性和可行性(通过问卷和定性访谈评估参与者和临床医生对干预的可接受性和满意度,访谈还将探讨数据收集程序的可接受性和可行性以及戒烟治疗对常规护理和心理健康恢复的影响)以及与实施相关的(干预实施清单、干预实施的定性分析)。
如果该干预措施被证明是可接受的、可行的并且得到适当实施,我们可以进行一项随机对照试验。在未来的试验中,我们将研究添加戒烟治疗是否比常规护理更能提高戒烟率并改善抑郁和焦虑症状,这将带来长期的健康改善。
ISRCTN99531779。