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Randomized Controlled Trial
. 2016 Jul;51(1):54-62.
doi: 10.1016/j.amepre.2015.12.016. Epub 2016 Feb 8.

Extended Self-Help for Smoking Cessation: A Randomized Controlled Trial

Thomas H Brandon  1 , Vani N Simmons  2 , Steven K Sutton  3 , Marina Unrod  2 , Paul T Harrell  4 , Cathy D Meade  2 , Benjamin M Craig  2 , Ji-Hyun Lee  5 , Lauren R Meltzer  2
Affiliations
Randomized Controlled Trial

Extended Self-Help for Smoking Cessation: A Randomized Controlled Trial

Thomas H Brandon et al. Am J Prev Med. 2016 Jul.

Abstract

Introduction: Far too few smokers receive recommended interventions at their healthcare visits, highlighting the importance of identifying effective, low-cost smoking interventions that can be readily delivered. Self-help interventions (e.g., written materials) would meet this need, but they have shown low efficacy. The purpose of this RCT was to determine the efficacy of a self-help intervention with increased duration and intensity.

Design: Randomized parallel trial design involving enrollment between April 2010 and August 2011 with follow-up data for 24 months.

Setting/participants: U.S. national sample of daily smokers (N=1,874).

Intervention: Participants were randomized to one of three arms of a parallel trial design: Traditional Self-Help (TSH, n=638), Standard Repeated Mailings (SRM, n=614), or Intensive Repeated Mailings (IRM, n=622). TSH received an existing self-help booklet for quitting smoking. SRM received eight different cessation booklets mailed over a 12-month period. IRM received monthly mailings of ten booklets and additional material designed to enhance social support over 18 months.

Main outcome measures: The primary outcome was 7-day point-prevalence abstinence collected at 6, 12, 18, and 24 months.

Results: Data were analyzed between 2013 and 2015. A dose-response effect was found across all four follow-up points. For example, by 24 months, IRM produced the highest abstinence rate (30.0%), followed by SRM (24.4%) and TSH (18.9%). The difference in 24-month abstinence rates between IRM and TSH was 11.0% (95% CI=5.7%, 16.3%). Cost analyses indicated that, compared with TSH, the incremental cost per quitter who received SRM and IRM was $560 and $361, respectively.

Conclusions: Self-help interventions with increased intensity and duration resulted in significantly improved abstinence rates that extended 6 months beyond the end of the intervention. Despite the greater intensity, the interventions were highly cost effective, suggesting that widespread dissemination in healthcare settings could greatly enhance quitting.

Trial registration: This study is registered at www.clinicaltrials.gov NCT01352195.

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Figures

Figure 1
Figure 1
CONSORT diagram.
Figure 2
Figure 2
Abstinence rates of the three intervention arms through 24-month assessment.
See this image and copyright information in PMC

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