Testing the Efficacy of a Lapse Management System in an Online Smoking Cessation
试验速览
- 阶段
- 不适用
- 入组人数
- 1,500
- 试验地点
- 2
- 主要终点
- 7 day point prevalence abstinence from cigarettes
研究概览
简要总结
The purpose of the trial is to test the adjunctive effect of adding a lapse management system to a best practices web- and mobile smoking cessation program.
详细描述
Background: Web- and mobile phone health behavior change interventions, including smoking cessation programs, offer great promise, but little is known about the components that may add to their effect.
Objectives: To assess tobacco abstinence associated with an adjunctive lapse management system combined with a best-practices web- and mobilephone based smoking cessation intervention. The investigators hypothesize that a program that includes the lapse management system will yield greater efficacy than a program that does not include such a component.
Methods: The investigators propose a 3-arm RCT with 1500 adult study participants that all receive a best practices web-based smoking cessation program designed for use on snart phones (web-app). Participants are randomized to either the web-app only, the web-app plus a web-based lapse management system, or web-app plus a SMS-based lapse management system.
The lapse management system will be based on the day-to-day logging of target behavior and providing just-in-time therapy to clients reporting a lapse. In the two versions of the lapse management system the logging of target behavior is done by asking a question about smoking status by web or SMS.
Measures: The primary outcome is 7-day point prevalence tobacco abstinence (as assessed at the 1- and 6-months follow-up). Potential predictors, moderators, and mediators of abstinence will also be examined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
The recruitment procedure and the treatment is fully automated and delivered by web, e-mail and SMS-textmessages - i.e., the participant is not contacted by any care providers, investigators or assessors during recruitment or treatment - and data are collected by means of web-based questionnaires. However, non-responders to the questionnaires will be contacted by phone for telephone interview.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 year or older
- •beeing a current smoker
- •determined to or considering to quit smoking
- •provide valid e-mail address
- •provide valid norwegian cell phone number
- •complete a baseline questionnaire
- •complete a ten day run-in period (preparation phase)
- •reporting an initial quit attempt ("yes, today I have quit smoking")
排除标准
- 未提供
研究组 & 干预措施
Web-based lapse management system
Endre: a digital smoking cessation counsellor + Lapse management system triggered from web-page
干预措施: Endre: a digital smoking cessation counsellor (Other)
Standard web-application
Endre: a digital smoking cessation counsellor
干预措施: Endre: a digital smoking cessation counsellor (Other)
Web-based lapse management system
Endre: a digital smoking cessation counsellor + Lapse management system triggered from web-page
干预措施: Lapse management system triggered from web-page (Other)
SMS & web-based lapse management system
Endre: a digital smoking cessation counsellor + Lapse management system triggered by SMS-textmessage
干预措施: Endre: a digital smoking cessation counsellor (Other)
SMS & web-based lapse management system
Endre: a digital smoking cessation counsellor + Lapse management system triggered by SMS-textmessage
干预措施: Lapse management system triggered by SMS-textmessage (Other)
结局指标
主要结局
7 day point prevalence abstinence from cigarettes
时间窗: measured at six months post cessation
no tobacco smoking during the last seven days
次要结局
- 7 day point prevalence abstinence from cigarettes(measured at one month post cessation)
- 7 day point prevalence abstinence from any nicotine products(measured at six months post cessation)
- 7 day point prevalence abstinence from any nicotine products(measured at one month post cessation)
研究者
Håvar Brendryen
Senior researcher
University of Oslo