Clinical trial NCT03191825: Online Lapse Management Intervention
Official title: Testing the Efficacy of a Lapse Management System in an Online Smoking Cessation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nicotine Dependence, Cigarettes
Keywords: online intervention
mHealth m-Health
eHealth e-Health
smoking cessation
lapse management
relapse prevention
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
name: Charles University, Czech Republic
First posted: 2017-06-19
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: 7 day point prevalence abstinence from cigarettes
timeFrame: measured at six months post cessation
Secondary outcomes:
measure: 7 day point prevalence abstinence from cigarettes
timeFrame: measured at one month post cessation
measure: 7 day point prevalence abstinence from any nicotine products
timeFrame: measured at one month post cessation
measure: 7 day point prevalence abstinence from any nicotine products
timeFrame: measured at six months post cessation
Other outcomes:
measure: user engagement
timeFrame: during a one month timeframe after initial quit attempt
measure: number of lapse episodes after initial quit attempt
timeFrame: assessed one month after cessation day
Locations:
city: Praha
country: Czechia
facility: Department of Addictology, 1st Faculty of Medicine, Charles University
city: Oslo
country: Norway
facility: The Norwegian Centre for Addiction Research
Study officials:
affiliation: University of Oslo
name: Håvar Brendryen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.