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Comparison of Allen Carr's Easyway programme with a specialist behavioural and pharmacological smoking cessation support service: a randomized controlled trial.

ABSTRACT: BACKGROUND AND AIMS:A combination of behavioural and pharmacological support is judged to be the optimal approach for assisting smoking cessation. Allen Carr's Easyway (ACE) is a single-session pharmacotherapy-free programme that has been in operation internationally for 38 years. We compared the effectiveness of ACE with specialist behavioural and pharmacological support delivered to the national standard in England. DESIGN:A two-arm, parallel-group, single-blind, randomized controlled trial. SETTING:London, UK, between February 2017 and May 2018. PARTICIPANTS:A total of 620 participants (310 in ACE and 310 in the combined behavioural and pharmacological support condition) were included in the analysis. Adult (? 18 years) smokers wanting to quit were randomized in a 1 : 1 ratio. Mean age for the total sample was 40.8 years, with 53.4% being male. Participant baseline characteristics (ethnicity, educational level, number of previous quit attempts, nicotine dependence) were evenly balanced between treatment groups. INTERVENTION AND COMPARATOR:The intervention was the ACE method of stopping smoking. This centres on a 4.5-6-hour session of group-based support, alongside subsequent text messages and top-up sessions if needed. It aims to make it easy to stop smoking by convincing smokers that smoking provides no benefits for them. The comparator was a specialist stop smoking service (SSS) providing behavioural and pharmacological support in accordance with national standards. MEASUREMENTS:The primary outcome was self-reported continuous abstinence for 26 weeks from the quit/quit re-set date verified by exhaled breath carbon monoxide measurement < 10 parts per million (p.p.m.). Primary analysis was by intention to treat. Secondary outcomes were: use of pharmacotherapy, adverse events and continuous abstinence up to 4 and 12 weeks. FINDINGS:A total of 468 participants attended treatment (255 ACE versus 213 SSS, P < 0.05). Of those who did attend treatment, 100 completed 6-month measures (23.7% ACE versus 20.7% SSS). Continuous abstinence to 26 weeks was 19.4% (60 of 310) in the ACE intervention and 14.8% (46 of 310) in the SSS intervention [risk difference for ACE versus SSS 4.5% (95% confidence interval (CI) = -1.4 to 10.4%, odds ratio (OR) = 1.38)]. The Bayes factor for superiority of the ACE condition was 1.24. CONCLUSION:There was no clear evidence of a difference in the efficacies of the Allen Carr's Easyway (ACE) and specialist smoking cessation support involving behavioural support and pharmacotherapy.

SUBMITTER: Frings D

PROVIDER: S-EPMC7186816 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Comparison of Allen Carr's Easyway programme with a specialist behavioural and pharmacological smoking cessation support service: a randomized controlled trial.

Frings Daniel D Albery Ian P IP Moss Antony C AC Brunger Helen H Burghelea Meda M White Sarah S Wood Kerry V KV

Addiction (Abingdon, England) 20200122 5

<h4>Background and aims</h4>A combination of behavioural and pharmacological support is judged to be the optimal approach for assisting smoking cessation. Allen Carr's Easyway (ACE) is a single-session pharmacotherapy-free programme that has been in operation internationally for 38 years. We compared the effectiveness of ACE with specialist behavioural and pharmacological support delivered to the national standard in England.<h4>Design</h4>A two-arm, parallel-group, single-blind, randomized cont ...[more]

PMID: 31968400

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Project description:BackgroundEffectiveness of evidence-based behaviour change interventions is likely to be undermined by failure to deliver interventions as planned. Behavioural support for smoking cessation can be a highly cost-effective, life-saving intervention. However, in practice, outcomes are highly variable. Part of this may be due to variability in fidelity of intervention implementation. To date, there have been no published studies on this. The present study aimed to: evaluate a method for assessing fidelity of behavioural support; assess fidelity of delivery in two English Stop-Smoking Services; and compare the extent of fidelity according to session types, duration, individual practitioners, and component behaviour change techniques (BCTs).MethodsTreatment manuals and transcripts of 34 audio-recorded behavioural support sessions were obtained from two Stop-Smoking Services and coded into component BCTs using a taxonomy of 43 BCTs. Inter-rater reliability was assessed using percentage agreement. Fidelity was assessed by examining the proportion of BCTs specified in the manuals that were delivered in individual sessions. This was assessed by session type (i.e., pre-quit, quit, post-quit), duration, individual practitioner, and BCT.ResultsInter-coder reliability was high (87.1%). On average, 66% of manual-specified BCTs were delivered per session (SD 15.3, range: 35% to 90%). In Service 1, average fidelity was highest for post-quit sessions (69%) and lowest for pre-quit (58%). In Service 2, fidelity was highest for quit-day (81%) and lowest for post-quit sessions (56%). Session duration was not significantly correlated with fidelity. Individual practitioner fidelity ranged from 55% to 78%. Individual manual-specified BCTs were delivered on average 63% of the time (SD 28.5, range: 0 to 100%).ConclusionsThe extent to which smoking cessation behavioural support is delivered as specified in treatment manuals can be reliably assessed using transcripts of audiotaped sessions. This allows the investigation of the implementation of evidence-based practice in relation to smoking cessation, a first step in designing interventions to improve it. There are grounds for believing that fidelity in the English Stop-Smoking Services may be low and that routine monitoring is warranted.

Project description:Smoking is a major cause of ill health and is associated with several diseases including cancer, coronary heart disease and stroke. Many psychological and pharmacological smoking cessation treatments are available and although they are undoubtedly the most cost-effective health interventions available, many people still fail to maintain cessation in the longer term. Recently, National Institute for Health and Care Excellence called for comparative studies to determine the short-term and long-term effectiveness of Allen Carr's Easyway (ACE) method of stopping smoking. This study will compare the efficacy of the ACE programme and a 1-1 counselling service available via the National Health Service.A two-arm, parallel-group, blinded, randomised controlled trial will be conducted with people who smoke tobacco cigarettes, are aged ?18 years and are motivated to quit. Exclusion criteria comprise self-reported mental health condition, pregnancy or respiratory disease such as chronic obstructive pulmonary disease or emphysema. The primary treatment outcome is smoking cessation 26 weeks after treatment. Participants will be analysed on an intention to treat basis at the point of randomisation. Before being randomised, the research team will not inform participants which two treatments are being compared. Once randomised researchers will be blinded to participant condition, and participants will be blinded to the condition they are not assigned to. Logistic regression will be used to estimate the effectiveness of the treatment condition on smoking cessation at 26 weeks. The following covariates will be included: baseline quit efficacy (at inclusion), age (at inclusion), gender and baseline nicotine dependency.Approval was granted by London-Fulham Research Ethics Committee (ref: 16/LO/1657). The study's findings will be published in peer-reviewed journals and disseminated at national and international conferences.ClinicalTrials.gov identifier number: NCT02855255. ISRCTN registration number: ISRCTN23584477; Pre-results.

Project description:BACKGROUND AND AIMS:Behavioural support increases smoking cessation in clinical settings, but effect sizes differ among providers, due possibly to variations in delivery. This study evaluates a measure ('fidelity index') intended to capture fidelity to delivery of content- and interaction-based items of a behavioural support (BS) for smoking cessation and the association of fidelity with quit rates. METHODS:A fidelity index for scoring the adherence and quality domains of a specific BS intervention, '5As for quit', was developed by classifying the intervention components using the taxonomy of behaviour change techniques. The index was applied to code 154 BS sessions audiotaped among 18 chest clinics in Pakistan to assess their fidelity and explore reliability of coding. The association between intervention fidelity and successful quit achieved by the same providers in a previous study was explored using regression analysis. RESULTS:The index represented two domains: adherence to delivery of content-based activities of 5As (37 items) and quality of interaction-based activities (eight items). The intercoder reliability was good for content-based (average Krippendorff's ? = 0.80) and moderate for interaction-based (average Krippendorff's ? = 0.66) items. Approximately 70% (intraclass correlation coefficient: adherence scores = 0.72, quality scores = 0.71) of variation in BS delivery was contributed by providers, which increased to 97% (g-coefficient: adherence scores = 0.973, quality scores = 0.974) after accounting for other sources of variation. Higher quit rates were positively associated with average quality scores [risk ratio = 2.15; 95% confidence interval (CI) = 1.43-3.24], but negatively associated with average adherence scores (risk ratio = 0.55; 95% CI = 0.40-0.77) within services. CONCLUSIONS:The fidelity index is a reliable measure for quantifying intervention fidelity of delivering smoking cessation behavioural support. Recommended revisions of the fidelity index include incorporation of additional interaction-based items, such as the relational techniques used in motivational interviewing.

Project description:BackgroundMany young people report they want to stop smoking and have tried to do so, but most of their quit attempts fail. For adult smokers, there is strong evidence that group behavioural support enhances quit rates. However, it is uncertain whether group behavioural support enhances abstinence in young smokers trying to quit.FindingsA cluster randomised trial for young people trying to stop smoking to compare the efficacy of a school-based 9 week intensive group behavioural support course versus a school-based 7 week brief advice only course. Participants were assessed for evidence of tobacco addiction and nicotine replacement therapy (NRT) was used if it was deemed appropriate by the therapist. Both types of course aimed to recruit approximately one hundred participants from approximately ten schools.The primary outcome was successful quitting at 4 weeks after quit day judged according to the Russell standard. Had the trial been completed, abstinence at 6 months after quit day and the relationships between successful quit attempts and 1) psychological assessments of dependence prior to quitting 2) salivary cotinine concentration prior to quitting and 3) sociodemographic characteristics would also have been assessed. The proportion of participants who stopped smoking in each arm of the trial were compared using Chi square tests.The trial was stopped shortly after it had started because funding to support the therapists running the stop smoking group behavioural support programme was withdrawn. Only three stop smoking courses were completed (two group support courses and one brief advice pharmacotherapy course). Seventeen participants in total entered the trial. At the end of the courses, one participant (10%) attending the group support programme had stopped smoking and no participant attending the brief advice programme had stopped smoking.DiscussionThe trial was stopped so we were unable to determine whether group support helped more young people to stop smoking than brief advice. Engagement and recruitment of participants proved much more difficult than had been anticipated. Fifteen of the seventeen participants reported that quitting smoking was either pretty important or very important to them. Thus, the stop smoking success rate could, nevertheless, be considered disappointing.Trial registrationCurrent Controlled Trials ISRCTN25181936.

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Comparison of Allen Carr's Easyway programme with a specialist behavioural and pharmacological smoking cessation support service: a randomized controlled trial.

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Comparison of Allen Carr's Easyway programme with a specialist behavioural and pharmacological smoking cessation support service: a randomized controlled trial.

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