Dataset Information

Self-help educational booklets for the prevention of smoking relapse following smoking cessation treatment: a randomized controlled trial.

ABSTRACT:

Aims

Most people who quit smoking for a short term will return to smoking again in 12 months. We tested whether self-help booklets can reduce relapse in short-term quitters after receiving behavioural and pharmacological cessation treatment.

Design

A parallel-arm, pragmatic individually randomized controlled trial.

Setting

Smoking cessation clinics in England. Participants People who stopped smoking for 4 weeks after receiving cessation treatment in stop smoking clinics.

Intervention

Participants in the experimental group (n=703) were mailed eight booklets, each of which taught readers how to resist urges to smoke. Participants in the control group (n=704) received a leaflet currently used in practice.

Measurements

The primary outcome was prolonged, carbon monoxide-verified abstinence from months 4 to 12. The secondary outcomes included 7-day self-reported abstinence at 3 and 12 months. Mixed-effects logistic regression was used to estimate treatment effects and to investigate possible effect modifying variables.

Findings

There were no statistically significant differences between the groups in prolonged abstinence from months 4 to 12 (36.9% versus 38.6%; odds ratio 0.93, 95% confidence interval 0.75-1.16; P=0.524). In addition, there were no significant differences between the groups in any secondary outcomes. However, people who reported knowing risky situations for relapse and using strategies to handle urges to smoke were less likely to relapse.

Conclusions

In people who stop smoking successfully with behavioural support, a comprehensive self-help educational programme to teach people skills to identify and respond to high-risk situations for return to smoking did not reduce relapse.

SUBMITTER: Maskrey V

PROVIDER: S-EPMC4832320 | biostudies-literature | 2015 Dec

REPOSITORIES: biostudies-literature

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Publications

Self-help educational booklets for the prevention of smoking relapse following smoking cessation treatment: a randomized controlled trial.

Maskrey Vivienne V Blyth Annie A Brown Tracey J TJ Barton Garry R GR Notley Caitlin C Aveyard Paul P Holland Richard R Bachmann Max O MO Sutton Stephen S Leonardi-Bee Jo J Brandon Thomas H TH Song Fujian F

Addiction (Abingdon, England) 20150918 12

<h4>Aims</h4>Most people who quit smoking for a short term will return to smoking again in 12 months. We tested whether self-help booklets can reduce relapse in short-term quitters after receiving behavioural and pharmacological cessation treatment.<h4>Design</h4>A parallel-arm, pragmatic individually randomized controlled trial.<h4>Setting</h4>Smoking cessation clinics in England. Participants People who stopped smoking for 4 weeks after receiving cessation treatment in stop smoking clinics.<h4 ...[more]

PMID: 26235659

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Project description: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.

Project description:BackgroundHispanic/Latinx smokers living in the United States face unique challenges in quitting smoking. This study evaluated the efficacy of a culturally relevant, Spanish-language, extended self-help smoking cessation intervention among Hispanic smokers.MethodsA 2-arm parallel randomized controlled trial was conducted with Hispanic/Latinx smokers living in the United States who preferred health information in Spanish and smoked 5 or more cigarettes per week. Participants were randomly allocated to receive Libre del Cigarrillo (LDC), which consisted of 11 booklets and 9 pamphlets mailed monthly over 18 months, or the usual care (UC), which was a single Spanish-language self-help booklet from the National Cancer Institute. The primary outcome was self-reported 7-day point prevalence smoking abstinence assessed 6, 12, 18, and 24 months after the baseline. Eight prespecified moderators of the intervention were evaluated. Cost-effectiveness was also evaluated. All statistical tests were 2-sided.ResultsData from all participants randomized to LDC (n = 714) or UC (n = 703) were used for analyses after multiple imputation to manage missing data. Generalized estimating equation analyses indicated that LDC abstinence rates were higher (P < .001) across all assessments. Logistic regression analyses revealed that at 24 months, the abstinence rate was greater for LDC (33.1%) than UC (24.3%; odds ratio, 1.54; 95% confidence interval, 1.18-2.02; P = .002). Men exhibited a strong intervention effect at all assessments (P values < .001), whereas the intervention effect for women was observed only at 6 and 12 months (P values < .018). In comparison with UC, the incremental cost per quitter in the LDC arm was $648.43 at 18 months and $683.93 at 24 months.ConclusionsA culturally relevant, Spanish-language intervention was efficacious and cost-effective for smoking cessation.Lay summaryResearch is needed to develop interventions for ethnic minority smokers. The aim of the current study was to test a Spanish-language adaptation of a validated and easily implemented self-help smoking cessation intervention in a nationwide randomized controlled trial. The findings demonstrated that the intervention produced greater smoking abstinence in comparison with a standard self-help booklet. Participants also were more satisfied with the intervention, and it was cost-effective. Efforts aimed at promoting tobacco abstinence in this underserved population could have significant public health implications, including potential reductions in cancer health disparities associated with tobacco smoking.

Project description:ObjectiveSmoking cessation and relapse prevention during and after pregnancy reduces the risk of adverse maternal and infant health outcomes, but the economic evaluations of such programs have not been systematically reviewed. This study aims to critically assess economic evaluations of smoking cessation and relapse prevention programs for pregnant women.MethodsAll relevant English-language articles were identified using PubMed (January 1966-2003), the British National Health Service Economic Evaluation Database, and reference lists of key articles. Economic evaluations of smoking cessation and relapse prevention among pregnant women were reviewed. Fifty-one articles were retrieved, and eight articles were included and evaluated. A single reviewer extracted methodological details, study designs, and outcomes into summary tables. All studies were reviewed, and study quality was judged using the criteria recommended by the Panel on Cost-Effectiveness in Health and Medicine and the British Medical Journal (BMJ) checklist for economic evaluations.ResultsThe search retrieved 51 studies. No incremental cost-effectiveness studies or cost-utility studies were found. A narrative synthesis was conducted on the eight studies thatmet the inclusion criteria. Roughly one-third employed cost-benefit analyses (CBA). Those conducting CBA have found favorable benefit-cost ratios of up to 3:1; for every dollar invested $3 are saved in downstream health-related costs.ConclusionsCBA suggests favorable cost-benefit ratios for smoking cessation among pregnant women, although currently available economic evaluations of smoking cessation and relapse prevention programs for pregnant women provide limited evidence on cost-effectiveness to determine optimal resource allocation strategies. Although none of these studies had been performed in accordance with Panel recommendations or BMJ guidelines, they are, however, embryonic elements of a more systematic framework. Existing analyses suggest that the return on investment will far outweigh the costs for this critical population. There is significant potential to improve the quality of economic evaluations of such programs; therefore, additional analyses are needed. The article concludes with ideas on how to design and conduct an economic evaluation of such programs in accordance with accepted quality standards.

Project description:IntroductionClose to half of women who were smokers prior to conception quit smoking in pregnancy, when endogenous progesterone levels are high. However, at least half resume pre-pregnancy smoking levels within weeks after delivery and when progesterone levels drop. The current pilot study tested the feasibility and preliminary efficacy of postpartum progesterone replacement in preventing relapse to smoking in postpartum women with a history of pre-pregnancy smoking.MethodsThis was an 8-week, double-blind, parallel, randomized, placebo-controlled pilot trial of 41 women with a history of pre-pregnancy smoking who achieved abstinence by 32 weeks of gestation. Immediately following delivery women were randomized to oral micronized progesterone (200mg twice daily) or placebo via computerized urn randomization program. The main outcome measures were descriptions of study feasibility: recruitment and retention. Secondary outcomes were 7-day point prevalence of abstinence at week 8, time to relapse and smoking cravings.ResultsThe trial was feasible with adequate randomization, 64% (41/64) of eligible women, and trial retention, 78% (32/41) completed the trial. Women taking progesterone were 1.8 times more likely to be abstinent during week 8 and took longer to relapse (10 vs. 4 weeks) compared to the placebo group, although these differences did not reach statistical significance. After adjusting for age and pre-quit smoking level, the number needed to treat was 7. There was a 10% greater decline per week in craving ratings in the progesterone group compared to placebo (β=-0.10, 95% CI: -0.15, -0.04, p<0.01). No serious adverse events occurred during the trial.ConclusionsThese preliminary findings support the promise of progesterone treatment in postpartum smokers and could constitute a therapeutic breakthrough.If these preliminary findings can be evaluated and replicated in a larger study with sufficient power, this may constitute an acceptable and safe smoking relapse prevention strategy for use during lactation.

Project description:There is a significant resumption of smoking following smoking cessation using varenicline. Both smoking cessation medications and counseling have been shown to increase smoking quit rates at one year. Thus, the combination of varenicline and interactive voice response (IVR) telephony followed by extended IVR may further improve smoking cessation rates at one and two years.101 participants were recruited from the community via newspaper advertisement. They attended a group counseling session and were given smoking information booklets from the Canadian Cancer Society. After 12 weeks of varenicline and 9 IVR calls, all participants who had quit smoking were randomized into 2 groups matched by levels of motivation and addiction as per baseline questionnaire score. The intervention group continued to receive bi-weekly IVR support for weeks 13-52. The control group no longer received IVR. The primary end-point was self-reported abstinence and exhaled carbon monoxide levels of less than 10 ppm for weeks 12, 52 and 2 years. Data were analyzed by Fisher's exact test or Wilcoxon rank-sum test.Of the 101 participants, 44 (43%) had stopped smoking after 12 weeks of varenicline and 9 IVR calls. Of these, 23 (52%) were randomized to receive IVR calls from weeks 13 to 52.At 52 weeks, 26 (59%) participants remained smoke-free. Of the 23 with IVR, 12 (52.2%) stopped smoking compared to 14 of 21 (66.7%) without IVR. At 2 years, 40 of the 44 (90.9%) randomized participants were contacted and 24 of the 44 (54.5%) came in for testing. Fourteen (13% of the original cohort, 30% who were abstinent at 12 weeks and 53% who were abstinent at 52 weeks) remained smoke-free. Five of the 23 (21.7%) randomized to IVR and 9 of the 21 (42.9%) randomized to no IVR remained smoke-free at 2 years.In this pilot study of an apparently healthy population, extended IVR did not affect abstinence rates. There was no relapse prevention benefit in offering 9 months of continued IVR to subjects who had stopped smoking after receiving 3 months of varenicline and IVR treatment.ClinicalTrial.gov: NCT00832806.

Dataset Information

Self-help educational booklets for the prevention of smoking relapse following smoking cessation treatment: a randomized controlled trial.

Aims

Design

Setting

Intervention

Measurements

Findings

Conclusions

Publications

Self-help educational booklets for the prevention of smoking relapse following smoking cessation treatment: a randomized controlled trial.

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