Online Lapse Management Intervention

Nicotine Dependence, Cigarettes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03191825
• Other study ID #: NFR 228158/H10
• Status: Recruiting
• Phase: N/A
• Start date: September 12, 2017
• Est. completion date: October 1, 2022

Study information

• Verified date: September 2021
• Source: University of Oslo
• Contact: Håvar Brendryen, PhD
• Phone: +47 99 52 17 14
• Email: brendryen[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Nicotine Dependence, Cigarettes
• Tobacco Use Disorder

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Czechia	Department of Addictology, 1st Faculty of Medicine, Charles University	Praha
Norway	The Norwegian Centre for Addiction Research	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
University of Oslo	Charles University, Czech Republic, The Research Council of Norway

Countries where clinical trial is conducted

Czechia,  Norway, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	user engagement	number of completed sessions after initial quit attempt	during a one month timeframe after initial quit attempt
Other	number of lapse episodes after initial quit attempt	lapse episode = experiencing a temporary setback, i.e., smoking one or several cigarettes and then beeing abstinent again	assessed one month after cessation day
Primary	7 day point prevalence abstinence from cigarettes	no tobacco smoking during the last seven days	measured at six months post cessation
Secondary	7 day point prevalence abstinence from cigarettes	no tobacco smoking during the last seven days	measured at one month post cessation
Secondary	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
Secondary	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

External Links

•   Official home page for PI at host institution
•   PIs Google Schoolar Profile
•   The recruitment site