Comparing effectiveness of blended with face-to-face delivery modes of smoking cessation treatment: a randomized controlled non-inferiority trial (Preprint)

Abstract

Tobacco is a leading cause of death and disease, killing more than eight million people each year. Smoking cessation significantly reduces the risk of developing smoking-related diseases. Although combined treatment for addiction is promising, evidence of its effectiveness is still emerging. Currently, there is no published research on the effectiveness of blended smoking cessation treatments compared to face-to-face treatments, where web-based components replace 50% of the face-to-face components.

The primary objective of this two-arm randomized controlled non-inferiority trial was to determine whether a blended smoking cessation treatment is non-inferior to a face-to-face treatment with identical ingredients in achieving abstinence rates.

The study included 344 current smokers (at least one cigarette per day) attending an outpatient smoking cessation clinic in the Netherlands. Participants received either a blended 50% face-to-face and 50% web-based smoking cessation treatment (BSCT) or a face-to-face treatment (F2F) of similar ingredients and intensity. The primary outcome measure was cotinine-validated abstinence from all smoking products at three and 15 months after treatment initiation. Additional measures included CO-validated point-prevalence abstinence, self-reported point-prevalence abstinence, and self-reported continuous abstinence at three, six, nine, and 15 months after treatment initiation.

For none of the thirteen outcomes statistically confirmed non-inferiority of BSCT was found, whereas four outcomes showed significantly (P<.001) inferior abstinence rates of BSCT : Cotinine-validated point prevalence abstinence at three months (difference 12.7; 95% CI 6.2-19.4), self-reported point prevalence abstinence at six months (difference 19.3%; 95% CI 11.5-27.0) and at 15 months (difference of 11.7; 95% CI 5.8-17.9), and self-reported continuous abstinence at six months (difference 13.8; 95% CI 6.8-20.8). The remaining nine outcomes, including the cotinine-validated point prevalence abstinence at 15 months, were inconclusive.

In this high-intensity outpatient smoking cessation trial, the blended mode was predominantly less effective than the traditional face-to-face mode. The results contradict the widely assumed potential benefits of blended treatment and suggest that further research is needed to identify critical factors in the design of blended interventions.

Dutch Trial Register: Blended Smoking Cessation Treatment (published 24-03-2015; last update: 18-08-2022); https://clinicaltrialregister.nl/en/trial/27150

RR2-doi.org/10.1186/s12889-016-3851-x