Online Lapse Management Intervention

Study Overview
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Brief Summary
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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
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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.

Official Title
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Testing the Efficacy of a Lapse Management System in an Online Smoking Cessation

Conditions
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Nicotine Dependence, Cigarettes

Intervention / Treatment
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* Other: Endre: a digital smoking cessation counsellor
* Other: Lapse management system triggered from web-page
* Other: Lapse management system triggered by SMS-textmessage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All participants receive one out of three versions of a web-based smoking cessation program. Two of the versions includes a lapse management system that are based on a day-to-day logging of target behavior. In one version the logging is done on the web, while on the other version, logging is done by SMS-textmessages.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard web-application<br>Endre: a digital smoking cessation counsellor | Other: Endre: a digital smoking cessation counsellor<br>* A comprehensive 25-session intervention delivered by web, e-mail and SMS-text messages. Sessions are released one each day for 18 days, and then every second day for 14 days. Intervention content is tailored based on user input and individual usage pattern. The intervention is described in detail in Holter, Johansen & Brendryen (2016). How a fully automated eHealth program simulates three therapeutic processes: A case study. Journal of Medical Internet Research 18 (6).<br>|
| Experimental: Web-based lapse management system<br>Endre: a digital smoking cessation counsellor + Lapse management system triggered from web-page | Other: Endre: a digital smoking cessation counsellor<br>* A comprehensive 25-session intervention delivered by web, e-mail and SMS-text messages. Sessions are released one each day for 18 days, and then every second day for 14 days. Intervention content is tailored based on user input and individual usage pattern. The intervention is described in detail in Holter, Johansen & Brendryen (2016). How a fully automated eHealth program simulates three therapeutic processes: A case study. Journal of Medical Internet Research 18 (6).<br>Other: Lapse management system triggered from web-page<br>* The lapse management system is based on a day-to-day logging of the target behavior (smoking). This logging goes on for four weeks after an initial quit attempt. The current version of the system logs by asking the participant about their smoking status every time they log on to Endre (the digital smoking cessation counsellor). Participants that report a lapse is routed to a fully automated counselling session delivered by web.<br>|
| Experimental: SMS & web-based lapse management system<br>Endre: a digital smoking cessation counsellor + Lapse management system triggered by SMS-textmessage | Other: Endre: a digital smoking cessation counsellor<br>* A comprehensive 25-session intervention delivered by web, e-mail and SMS-text messages. Sessions are released one each day for 18 days, and then every second day for 14 days. Intervention content is tailored based on user input and individual usage pattern. The intervention is described in detail in Holter, Johansen & Brendryen (2016). How a fully automated eHealth program simulates three therapeutic processes: A case study. Journal of Medical Internet Research 18 (6).<br>Other: Lapse management system triggered by SMS-textmessage<br>* The lapse management system is based on a day-to-day logging of the target behavior (smoking). This logging goes on for four weeks after an initial quit attempt. The current version of the system logs by asking the participant about their smoking status in a textmessage (SMS) sent each evening. Participants that report a lapse, receives a new SMS with a link to a fully automated counselling session delivered by web.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7 day point prevalence abstinence from cigarettes | no tobacco smoking during the last seven days | measured at six months post cessation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7 day point prevalence abstinence from cigarettes | no tobacco smoking during the last seven days | measured at one month post cessation | 
| 7 day point prevalence abstinence from any nicotine products | no use of products containing nicotine (smoking tobacco, snuff, e-cigarettes, nicotine replacement products etc) during the last seven days | measured at one month post cessation | 
| 7 day point prevalence abstinence from any nicotine products | no use of products containing nicotine (smoking tobacco, snuff, e-cigarettes, nicotine replacement products etc) during the last seven days | measured at six months post cessation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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online intervention, mHealth m-Health, eHealth e-Health, smoking cessation, lapse management, relapse prevention