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Randomized Controlled Trial
. 2014 Oct;16(10):1289-97.
doi: 10.1093/ntr/ntu066. Epub 2014 May 8.

Use of non-assigned interventions in a randomized trial of internet and telephone treatment for smoking cessation

Caroline O Cobb  1 , Amanda L Graham  2
Affiliations
Randomized Controlled Trial

Use of non-assigned interventions in a randomized trial of internet and telephone treatment for smoking cessation

Caroline O Cobb et al. Nicotine Tob Res. 2014 Oct.

Abstract

Introduction: A recent meta-analysis of Internet interventions for smoking cessation found mixed evidence regarding effectiveness. One explanation may be differential use of non-assigned cessation treatments-including other Internet programs-that either amplify or mask study intervention effects. We examined the impact of non-assigned treatment use on cessation outcomes in The iQUITT Study, a randomized trial of Internet and telephone treatment for smoking cessation.

Methods: Participants were randomized to a basic Internet (BI) comparison condition (N = 675), enhanced Internet (EI: N = 651), or EI plus telephone counseling (EI+P: N = 679). The primary outcome was 30-day point prevalence abstinence (ppa) at 3 and 6 months. Assigned intervention use was assessed with automated tracking data. Assessment of non-assigned treatments included pharmacotherapy, behavioral, alternative, and non-study Internet treatments. Univariate and multivariate logistic regression models examined whether non-assigned treatment use was associated with 30-day ppa.

Results: About 70% of participants used at least one non-assigned treatment. A higher rate of non-study Internet treatment among BI participants was the only treatment group difference at both 3 and 6 months. Multivariate models controlling for condition and baseline predictors of non-assigned treatment use showed that high-intensity non-study Internet treatment was positively associated with 30-day ppa at 3 and 6 months, and pharmacotherapy and behavioral treatment use was negatively associated with 30-day ppa at 6 months.

Conclusions: Non-assigned treatment use is an important factor to consider when evaluating Internet cessation interventions. Results highlight methodological issues in selecting a comparison condition. Researchers should report non-assigned treatment use alongside main trial outcomes.

Trial registration: ClinicalTrials.gov NCT00282009.

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Figures

Figure 1.
Figure 1.
Number and proportion of study participants reached at each follow-up reporting a quit attempt with complete non-assigned treatment utilization data.
See this image and copyright information in PMC

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