Müssener Ulrika, Bendtsen Marcus, Karlsson Nadine, White Ian R, McCambridge Jim, Bendtsen Preben
Department of Medicine and Health Sciences, Linköping University, 581 83, Linköping, Sweden.
Department of Computer and Information Science, Linköping University, 581 83, Linköping, Sweden.
Trials. 2015 Apr 8;16:140. doi: 10.1186/s13063-015-0640-2.
Most smoking efforts targeting young people have so far been focused on prevention of initiation, whereas smoking cessation interventions have largely been targeted towards adult populations. Thus, there is limited evidence for effective smoking cessation interventions in young people, even though many young people want to quit smoking. Mobile communication technology has the potential to reach large numbers of young people and recent text-based smoking cessation interventions using phones have shown promising results.
METHODS/DESIGN: The study aims to evaluate a newly developed text-based smoking cessation intervention for students in colleges and universities in Sweden. The design is a randomised controlled trial (RCT) with a delayed/waiting list intervention control condition. The trial will be performed simultaneously in all colleges and universities served by 25 student health care centres in Sweden. Outcomes will be evaluated after 4 months, with 2 cessation primary outcomes and 4 secondary outcomes. After outcome evaluation the control group will be given access to the intervention.
The study will examine the effectiveness of a stand-alone SMS text-based intervention. The intervention starts with a motivational phase in which the participants are given an opportunity to set a quit date within 4 weeks of randomisation. This first phase and the subsequent core intervention phase of 12 weeks are totally automated in order to easily integrate the intervention into the daily routines of student and other health care settings. As well as providing data for the effectiveness of the intervention, the study will also provide data for methodological analyses addressing a number issues commonly challenging in Internet-based RCTs. For example, an extensive follow-up strategy will be used in order to evaluate the use of repeated attempts in the analysis, and in particular to explore the validity of a possible missing not at random assumption that the odds ratio between the primary outcome and response is the same at every attempt.
ISRCTN75766527, dated assigned 4 November 2014. Protocol version: Version 1, and date 7 November 2014.
迄今为止，大多数针对年轻人的控烟努力主要集中在预防开始吸烟方面，而戒烟干预措施大多针对成年人群体。因此，尽管许多年轻人想要戒烟，但针对年轻人的有效戒烟干预措施的证据有限。移动通信技术有潜力覆盖大量年轻人，最近基于短信的手机戒烟干预措施已显示出有希望的结果。
方法/设计：本研究旨在评估一种新开发的针对瑞典高校学生的基于短信的戒烟干预措施。设计为随机对照试验（RCT），采用延迟/等待列表干预对照条件。该试验将在瑞典25个学生医疗中心服务的所有高校同时进行。4个月后评估结果，有2个戒烟主要结局和4个次要结局。结局评估后，对照组将获得该干预措施。
本研究将检验一种独立的基于短信的干预措施的有效性。干预从一个动机激发阶段开始，在此阶段参与者有机会在随机分组后的4周内设定一个戒烟日期。为了便于将干预措施融入学生和其他医疗环境的日常活动中，这第一阶段和随后为期12周的核心干预阶段完全自动化。除了为干预措施的有效性提供数据外，本研究还将为解决基于互联网的随机对照试验中常见的一些问题的方法学分析提供数据。例如，将采用广泛的随访策略，以便在分析中评估重复尝试的使用情况，特别是探讨一个可能的非随机缺失假设的有效性，即每次尝试时主要结局与反应之间的比值比相同。
ISRCTN75766527，于2014年11月4日分配。方案版本：第1版，日期为2014年11月7日。
