Online Lapse Management Intervention

Not Applicable

• Conditions: Nicotine Dependence, Cigarettes

• 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.

Study Timeline

• Study First Submitted: 2017-06-14
• Study First Submitted QC: 2017-06-16
• Study First Posted: 2017-06-19
• Study Start: 2017-09-12
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-30
• Last Update Posted: 2021-10-08
• Primary Completion: 2022-10-01
• Study Completion: 2022-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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