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BEDREHELSE-Bedre helse og livskvalitet

Testing the efficacy of a lapse management system in an online smoking cessation intervention.

Awarded: NOK 7.9 mill.

Web applications as relapse prevention treatment for smoking cessation The relapse rate among persons trying to quit smoking is large. One week after quitting, approximately half have started smoking again, and only one in twenty is abstinent one year after. Even with the best pharmacological and psychosocial aids available for smoking cessation, quit rates in controlled studies rarely exceeds 20-30% at one year follow-up. Tobacco smoking is among the largest causes of morbidity and death globally, thus even small reductions in the relapse rate may result in significant improvements in public health. Online programs for smoking cessation are proven effective in several studies. However, there is huge variation in the content and design of such programs, and little is known about what sort of components can make such programs more effective. The primary objective of this research project is to assess the incremental efficacy of adding a lapse management system to a best practice online smoking cessation intervention. The lapse management system will be based on the day-to-day logging of target behavior and providing therapy just-in-time to clients reporting a lapse. By influencing the thoughts and emotions of the client in the critical phase after a lapse we hope to reduce the likelihood of the lapse to develop into a full-blown relapse. The lapse management system will be tested by randomizing clients into two groups. One group will get the program with and the other group will get the program without the lapse management system. During the first three years of the project the main activities was to develop an IT-plattform on which the smoking cessation program could be constructed, write the content of the program, pilot testing of a prototype, and interviewing test users of their experiences with the program. The program content will be delivered on e-mail, SMS textmessaging, and web-pages throughout the course of the program. The clinical rationale of the program was described in an article published in June 2016: It was based on motivational interviewing, and the main aims of the program is to strengthen (internal) motivation, establish a good working alliance, and relapse prevention. The central component is a lapse management system that is launched immediately after a user has reported having a lapse (by SMS). By influencing the thoughts and feelings during this critical phase after an initial lapse we hope to improve the treatment effect, that is, to prevent many initial lapses from escalating into a full-blown relapse. The development of the program is based on our previous experience with such programs, clinical experience from the national quitline, research literature, and formative research performed during the development phase (i.e., in depth interviews with users of a prototype of the program). The in-depth interviews will also form the basis for a qualitative paper that will be submitted for peer review during winter 2017/18. We are currently collecting data and recruiting participants to a large scale randomized trial testing the efficacy of the lapse management system. We estimate that recruitment will end spring 2019. During the winter 2015/16, the program was translated into Czech language, and researchers at the Charles University of Prague started pilot testing of the Czech version. From october 2018, we will also recruit Czech participants to the randomized trial. We have also been working close with senior researcher Brian Danaher and his team at the Oregon Research Institute and the University of Oregon. Danher was a guest researcher at the University of Oslo during may 2014 as part of his contributions to, and funded by, the current project. Project leader, Brendryen, was granted an overseas fellowship from the Research Council of Norway, and stayed in Eugene, Oregon, from January through August 2016 to work with Danaher and his team. Danaher and Brendryen have published together and are currently working on several manuscripts together.

Background: Online 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: We propose a controlled test assessing tobacco absti nence associated with an adjunctive lapse management system combined with a best-practices online smoking cessation intervention. We 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: We propose a 2-arm RCT with 1080 adult study participants randomized to either a lapse management intervention or a standard practice online intervention without the lapse management system. Because the central que stion is whether the lapse management system improves efficacy, both conditions use a very similar standard-practices core web-service that embodies many of the features found in the interventions tested in our prior online smoking cessation trials. The l apse 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. Measures: The primary outcome is 7-day point prevalence tobacco abstinence (i.e., not even a puff of smoke in the previous seven days, as assessed at the 2-, 6- and 12-months follow-up). Potential predictors, moderators, and mediators of abstinence will also be examined. Benefits: To the best of our knowledge, this application describes the first RCT that as sesses 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 mechanis ms, their efficacy may be improved, which can make a substantial public health impact.

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BEDREHELSE-Bedre helse og livskvalitet