Study Results
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Basic Information
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UNKNOWN
NA
1500 participants
INTERVENTIONAL
2017-09-12
2022-10-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Standard web-application
Endre: a digital smoking cessation counsellor
Endre: a digital smoking cessation counsellor
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).
Web-based lapse management system
Endre: a digital smoking cessation counsellor + Lapse management system triggered from web-page
Endre: a digital smoking cessation counsellor
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).
Lapse management system triggered from web-page
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.
SMS & web-based lapse management system
Endre: a digital smoking cessation counsellor + Lapse management system triggered by SMS-textmessage
Endre: a digital smoking cessation counsellor
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).
Lapse management system triggered by SMS-textmessage
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.
Interventions
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Endre: a digital smoking cessation counsellor
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).
Lapse management system triggered from web-page
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.
Lapse management system triggered by SMS-textmessage
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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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The Research Council of Norway
OTHER
Charles University, Czech Republic
OTHER
University of Oslo
OTHER
Responsible Party
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Håvar Brendryen
Senior researcher
Principal Investigators
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Håvar Brendryen, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Oslo
Locations
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Department of Addictology, 1st Faculty of Medicine, Charles University
Prague, , Czechia
The Norwegian Centre for Addiction Research
Oslo, , Norway
Countries
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Central Contacts
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Facility Contacts
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References
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Holter MT, Johansen A, Brendryen H. How a Fully Automated eHealth Program Simulates Three Therapeutic Processes: A Case Study. J Med Internet Res. 2016 Jun 28;18(6):e176. doi: 10.2196/jmir.5415.
Related Links
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Official home page for PI at host institution
PIs Google Schoolar Profile
Other Identifiers
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NFR 228158/H10
Identifier Type: -
Identifier Source: org_study_id
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