Accepted for/Published in: JMIR Research Protocols
Date Submitted: Aug 19, 2020
Date Accepted: Nov 10, 2020
Effects of a text messaging smoking cessation intervention among online help seekers and primary healthcare visitors in Sweden: protocol for a randomized controlled trial using a Bayesian group sequential design
ABSTRACT
Background:
A steady decline of smoking prevalence in Sweden has been recorded over the past decade, however, people still continue to smoke and new smokers are added. There is a need for effective smoking cessation interventions that can scale to a national level and that are designed to reach individuals requiring smoking cessation support in the general population.
Objective:
Previous RCTs of smoking cessation interventions among high school and university students in Sweden have found consistent evidence that text messaging interventions are effective in helping students quit smoking. However, there are no studies which investigate the effects of text messaging interventions in a more general population. The objective of this study is to estimate the effects of a text messaging intervention on individuals seeking help to quit online and individuals visiting primary healthcare centres.
Methods:
A 2-arm, parallel groups (1:1), randomized controlled trial (RCT) will be employed to address the study objectives. The trial will follow a Bayesian group sequential design. Recruitment will be conducted online using search advertisement and through healthcare professionals at primary healthcare units. All participants will receive treatment as usual, however participants who are allocated to the intervention arm will also be given access to a 12-week text message smoking cessation intervention. Eight week prolonged abstinence and 4-week point prevalence will be primary outcomes, measured 3 and 6 months post randomization. Mediator variables will be measured to estimate causal mediation models.
Results:
Recruitment will commence in September 2020 and will not exceed 24 months. This means that a complete dataset will be available at the latest towards the end of 2022. We expect to publish the findings from this trial by June 2023.
Conclusions:
This trial will further our understanding on the effects of text messaging interventions among a more general population than has previously been studied. We also aim to learn about differential effects between those who seek support online and those who are given facilitated support at primary healthcare units. Trial recruitment is limited to the Swedish population, however a strength of this study is the pragmatic way in which participants are recruited. Through online advertisements, individuals who decided to look for support without interference by study procedures will be recruited. At primary healthcare units, individuals who were not necessarily looking for smoking cessation support are given information about the trial. This closely mimics the way the intervention would be disseminated in a real-world setting, and may therefore strengthen the argument of generalizability of findings. Clinical Trial: International Standard Randomized Controlled Trial Number (ISRCTN) 13455271; http://www.isrctn.com/ISRCTN13455271.
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