Online Lapse Management Intervention

University of Oslo

Status: Unknown

Conditions: Nicotine Dependence, Cigarettes

Treatments: Other: Endre: a digital smoking cessation counsellor; Other: Lapse management system triggered by SMS-textmessage; Other: Lapse management system triggered from web-page

Study type: Interventional

Funder types: Other

Identifiers

NCT03191825

NFR 228158/H10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,500 participants in 3 patient groups

Standard web-application

Active Comparator group

Description:

Endre: a digital smoking cessation counsellor

Treatment:

Other: Endre: a digital smoking cessation counsellor

Web-based lapse management system

Experimental group

Description:

Endre: a digital smoking cessation counsellor + Lapse management system triggered from web-page

Treatment:

Other: Lapse management system triggered from web-page

Other: Endre: a digital smoking cessation counsellor

SMS & web-based lapse management system

Experimental group

Description:

Endre: a digital smoking cessation counsellor + Lapse management system triggered by SMS-textmessage

Treatment:

Other: Lapse management system triggered by SMS-textmessage

Other: Endre: a digital smoking cessation counsellor