Online Lapse Management Intervention
- Conditions
- Nicotine Dependence, Cigarettes
- Interventions
- Other: Lapse management system triggered from web-pageOther: Lapse management system triggered by SMS-textmessage
- Registration Number
- NCT03191825
- Lead Sponsor
- University of Oslo
- Brief Summary
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.
- Detailed Description
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.
Benefits: This protocol describes the first RCT that assesses the incremental efficacy of adding a lapse management system to an online smoking cessation intervention. These interventions constitute a cost-effective means to reach smokers who want to quit. By seeking to identify beneficial adjunctive mechanisms, their efficacy may be improved, which can make a substantial public health impact.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1500
- 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")
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Web-based lapse management system Lapse management system triggered from web-page Endre: a digital smoking cessation counsellor + Lapse management system triggered from web-page SMS & web-based lapse management system Lapse management system triggered by SMS-textmessage Endre: a digital smoking cessation counsellor + Lapse management system triggered by SMS-textmessage
- Primary Outcome Measures
Name Time Method 7 day point prevalence abstinence from cigarettes measured at six months post cessation no tobacco smoking during the last seven days
- Secondary Outcome Measures
Name Time Method 7 day point prevalence abstinence from cigarettes measured at one month post cessation no tobacco smoking during the last seven days
7 day point prevalence abstinence from any nicotine products measured at six months post cessation no use of products containing nicotine (smoking tobacco, snuff, e-cigarettes, nicotine replacement products etc) during the last seven days
Trial Locations
- Locations (2)
Department of Addictology, 1st Faculty of Medicine, Charles University
🇨🇿Praha, Czechia
The Norwegian Centre for Addiction Research
🇳🇴Oslo, Norway