将戒烟治疗整合到常见精神疾病患者的常规在线心理护理中：一项在线随机可行性和试点研究方案（ESCAPE 数字）。

IntEgrating Smoking Cessation treAtment into usual online Psychological care for people with common mEntal illness: Protocol for an online randomised feasibility and pilot study (ESCAPE digital).

机构信息

Addiction and Mental Health Group, Department of Psychology, University of Bath, Bath BA2 7AY, UK.

Amwell, 1 Stephen St Upper, Dublin 8 D08 DR9P, Ireland.

出版信息

Contemp Clin Trials. 2024 Jun;141:107541. doi: 10.1016/j.cct.2024.107541. Epub 2024 Apr 21.

DOI:10.1016/j.cct.2024.107541

PMID:38643854

Abstract

BACKGROUND

In the UK, smoking prevalence in people with depression (34%) and anxiety (29%) is more than double that of the general population (13%). People who stop smoking improve their mental health with comparable effect sizes found for antidepressants. In England, online psychological therapy is a standard treatment for depression and anxiety. Online therapy is an acceptable setting for smoking cessation support; however, integrated smoking and mental health support is not available. This novel study aims to assess the acceptability and feasibility of an online smoking cessation intervention, and trial procedures, offered alongside online mental health treatment as it offers increased reach to people with common mental health difficulties who smoke.

METHODS

A two-armed; Intervention (Integrated SilverCloud smoking cessation support) and control group (SilverCloud usual care), pragmatic, randomised controlled feasibility trial. We aim to recruit 500 adult smokers eligible for online mental health treatment. Follow-up will be conducted at 3-months and 6-months. We will assess the acceptability and feasibility of the trial procedures (i.e., recruitment, data completeness, self-reported acceptability and satisfaction) and the intervention (i.e., self-reported quit attempt, engagement with the smoking cessation and mental health programs, smoking cessation medicine and e-cigarette use, self-reported acceptability and satisfaction) and pilot clinical outcomes (i.e., biologically validated smoking abstinence, anxiety, depression, quality of health).

CONCLUSION

If the Trial is successful, a randomised controlled effectiveness trial will follow to examine whether integrated smoking cessation and mental health treatment increases smoking abstinence and improves depression and anxiety compared to usual care.

TRIAL REGISTRATION

ISRCTN10612149 (https://doi.org/10.1186/ISRCTN10612149), 02/02/2023.

摘要

背景

在英国，患有抑郁症（34%）和焦虑症（29%）的人群中的吸烟率是普通人群（13%）的两倍多。戒烟的人可以改善心理健康，其效果与抗抑郁药相当。在英格兰，在线心理治疗是抑郁症和焦虑症的标准治疗方法。在线治疗是戒烟支持的可接受环境；然而，目前还没有提供综合的吸烟和心理健康支持。这项新的研究旨在评估一种在线戒烟干预措施及其试验程序的可接受性和可行性，该干预措施与在线心理健康治疗同时提供，为患有常见心理健康问题且吸烟的人群提供了更多的帮助。

方法

一项两臂、干预（综合 SilverCloud 戒烟支持）和对照组（SilverCloud 常规护理）、实用、随机对照可行性试验。我们旨在招募 500 名符合在线心理健康治疗条件的成年吸烟者。随访将在 3 个月和 6 个月时进行。我们将评估试验程序（即招募、数据完整性、自我报告的可接受性和满意度）和干预（即自我报告的戒烟尝试、对戒烟和心理健康计划的参与、戒烟药物和电子烟使用、自我报告的可接受性和满意度）以及试验的临床结局（即生物验证的戒烟率、焦虑、抑郁、健康质量）的可接受性和可行性。