Dependence on cigarettes is a deeply entrenched

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1 Behavioural support programmes for smoking cessation Needs and opportunities ROBERT WEST * Dependence on cigarettes involves a learned association between smoking behaviour and both brain reward circuitry and the relief of nicotine withdrawal symptoms. This process is overlaid by conditioning, beliefs and motives, which contribute towards keeping people smoking even when they want to stop. Nicotine replacement therapy (NRT), used to combat the craving and discomfort caused by nicotine withdrawal, goes a significant way towards helping smokers to recover from their dependence, but it is only part of the quitting process. Behavioural support programmes can be an effective aid to maintaining willpower and motivation. These programmes can range from intensive, face-to-face counselling and telephone counselling to self-help printed materials and videos. Low levels of access to, and demand for, intensive methods limit their reach, while generic self-help materials appear to have a small but significant impact in the absence of other interventions. There is some evidence that tailored support materials may be more effective than generic materials. The Committed Quitters programme offered by SmithKline Beecham is a set of highly tailored materials designed to supplement their NRT products. Evidence from clinical trials to date is encouraging and opens up the possibility of a new era in terms of getting cost-effective behavioural support to smokers on a large international scale. Keywords: smoking, smoking cessation, nicotine replacement therapy, behavioural treatment Dependence on cigarettes is a deeply entrenched behaviour that has been learned, on the one hand, by the association between the effects of nicotine on brain reward circuitry and the behaviour of smoking and, on the other hand, by the association between relief of nicotine withdrawal symptoms and smoking. Overlying this process is a complex edifice of conditioning, beliefs and motives, which contribute to keeping people smoking even when they want to stop. Nicotine replacement therapy (NRT) goes a significant way towards helping smokers to stop for good. It acts as a temporary buffer between smoking and total abstinence from nicotine, reducing the discomfort and cravings associated with smoking cessation. However, NRT does not provide a complete solution to the problem of cigarette dependence. Fortunately, smokers typically make many attempts to quit and if they use NRT on each occasion benefits become roughly cumulative. Behavioural support and guidance can also improve smokers' chances of stopping. 1 Even with NRT, smokers will experience powerful urges to smoke, lapses in motivation to remain abstinent and mood disturbance associated * Correspondence: Robert West PhD, Professor of Psychology, Department of Psychology, St George's Hospital Medical School, University of London, Cranmer Terrace, London SW17 ORE, UK, tel , fax , sgjt600@sghms.ac.uk Professor West has been reimbursed by SmithKline Beecham, Pharmacia and Upjohn, Glaxo Wellcome and other pharmaceutical companies for attending and presenting at symposia on nicotine replacement therapy. He has also received research funds and consultancy fees from these companies. with cigarette abstinence. This is where behavioural support programmes can help. These programmes exist in many different forms, ranging from intensive, face-to-face counselling and telephone counselling through to selfhelp behavioural support in the form of printed materials and videos. Despite the diversity in approaches to behavioural support, these all employ the same basic principles outlined below. WHAT BEHAVIOURAL SUPPORT PROGRAMMES OFFER Behavioural support programmes focus on three key objectives: maintaining or enhancing motivation to want to be smoke free; avoiding or minimising motivation to smoke and preventing motivation to smoke turning into action. These objectives can be achieved in a number of ways. For example, a smoker suffering serious withdrawal symptoms and receiving face-to-face counselling in a smoking cessation clinic can be reminded why he or she made the attempt to stop smoking, and can be offered support and encouragement at an individual level. It is also possible to provide advice to the smoker on how to minimise exposure to the tempting situations that may trigger a relapse. By identifying tempting situations it may be possible to help smokers avoid them, and if avoidance is not possible the smoker can be provided with hints and tips on how to manage their response to that situation. This can involve both behavioural coping, such as learning how to interact with people who are smoking, and mental coping (i.e. learning how to think about things in

2 EUROPEAN JOURNAL OF PUBLIC HEALTH VOL NO. 3 SUPPLEMENT a different way, or structuring the way that they think about certain situations). Additionally, behavioural support programmes can offer advice on the most effective use of NRT and help to manage patients' expectations about what NRT can and cannot do. ACCESS TO, AND DEMAND FOR, BEHAVIOURAL SUPPORT PROGRAMMES Behavioural support programmes can be of great benefit to the smoker wanting to quit, and the most effective format appears to be through intensive, face-to-face counselling, as received in a smoking cessation clinic. However, low levels of access to, and poor demand for, such treatment schemes severely limit their reach. Firstly, access to intensive behavioural support programmes is limited by the lack of facilities offering such services. At the time of writing, only a small proportion of the UK population has access to a specialist smoker's clinic run by the National Health Service. Such clinics are being established in the poorest areas of England with funds specially allocated for this purpose by the Government and it is hoped that in future years the coverage will become national. In most of the rest of Europe, access to specialist smoker's clinics is even more limited. Secondly, at present, only a small proportion of smokers appear to want help from a smoker's clinic. There may be difficulty with finding the time to attend the clinic sessions; smokers may not perceive that the clinic would provide much assistance for them or they may feel uncomfortable seeking help. Based on the utilisation of clinics where such facilities are available, it is estimated that about 1-2% of smokers would currently avail themselves of a clinic if it were on offer and reasonably close to where they live. Such services can offer a life saving approach, but the low level of uptake dictates that resources should be allocated to such services based on demand. SELF-HELP BEHAVIOURAL SUPPORT Evidence suggests that behavioural support in smoking cessation is effective, but there is clearly a need for some way of exposing a wider audience of smokers to the principles involved. Printed self-help material offers a potentially useful source of advice, guidance and support, and an abundance of leaflets and booklets have been available to smokers for many years. Traditionally, such materials have adopted a 'one size fits all' approach, giving essentially the same advice and information to all smokers. However, more recently there has been increasing interest in 'tailoring' materials to the individual needs of smokers. In principle, tailoring can go some way towards providing the benefits of individual treatment to a wide population. The personal interaction achieved in a clinic environment provides opportunities to find out more about the individual smoker (i.e. why he or she wants to quit and what are the perceived barriers to quitting). With this information, the support can be adjusted to suit the needs of that particular I smoker. This principle can also be applied to personally tailor self-help materials. In theory, a smoker could receive an encyclopaedic set of self-help materials that contained everything relevant to every smoker. However, in practice the smoker will probably not have the time or the inclination to select out the information and advice that is personally relevant to him or her. In addition, the mere recognition of materials as having been personally developed to meet the individual smoker's needs may enhance the effectiveness of the materials. IS SELF-HELP BEHAVIOURAL SUPPORT EFFECTIVE? To date, there are relatively few high-quality studies of the effectiveness of self-help materials on smoking cessation. The reviews published by the Cochrane Tobacco Addiction Group are a good source of review data on the effect of self-help materials, as well as for many other aspects of tobacco addiction, and form part of the Cochrane Library - a comprehensive database of reviews covering a broad spectrum of healthcare issues. As with other Cochrane reviews, those produced by the Tobacco Addiction Group are regularly updated systematic reviews of published research. Using strict quality criteria, these reviews largely cover randomised, controlled trials and use meta-analysis to statistically combine data. This can increase the power of findings from studies that are too small to produce reliable results on their own. A Cochrane review by Lancaster and Stead of trials investigating the benefits of self-help materials assessed only those trials with follow-up of 6 months or more 7 This included seven trials of self-help materials versus no support, ^ six trials of tailored versus untailored materials 5 ' " 15 and two trials of self-help materials versus nothing as an adjunct to NRT. ^' Looking at self-help material generally (figure I), a metaanalysis of the seven available studies shows a pooled beneficial effect over no intervention (odds ratio 1.23, 95% CI 1.01 to 1.51). Although small, this effect was statistically significant (p<0.05). However, the two trials investigating non-tailored self-help materials as an adjunct to NRT showed no benefit over the quit rates achieved with NRT alone. From a meta-analysis of the six trials investigating the use of tailored versus untailored self-help material (figure 2) there was evidence of a significant benefit of tailoring self-help material for the individual smoker's needs compared with untailored material (odds ratio 1.51, 95% CI 1.13 to 2.02; p<0.05). Of course, this begs the question of what kind of tailoring was adopted. In addition, it does not address the question of the effect of tailored versus untailored materials as an adjunct to NRT. APPLYING SELF-HELP BEHAVIOURAL SUPPORT TO THE SMOKING POPULATION Assuming that there are good grounds for wanting to use tailored materials to help smokers to stop, providing such materials to very large numbers of smokers is a major challenge. One method is to distribute tailored materials as part of an NRT programme. First launched in the United States, the Committed Quitters Stop Smoking

3 SUPPLEMENT Behavioural support programmes and smoking Odds ratio o o bo bo T r o "TO CO o T3 O 1.6 i No intervention Self-help materials 0 - Untailored self-help materials Tailored self-help materials Figure 1 Meta-analysis of seven randomised trials of smoking cessation with at least 6 months' follow-up. Self help is defined as structured programming for smokers trying to quit without intensive contact from a therapist. There was a small but statistically and clinically significant effect of self help materials over no intervention atall 4 (p<0.05). Figure 2 Meta-analysis of six randomised trials of smoking cessation with at least 6 months' follow-up. Self help is defined as structured programming for smokers trying to quit without intensive contact from a therapist. Using self-help material that was personally tailored for the individual smoker was significantly more effective than using general untailored material (p<0.05). Plan has been developed by SmithKline Beecham Consumer Healthcare in collaboration with experts in both smoking cessation and tailored communications. The programme forms an integral part of the company's smoking cessation products. A European template has now been developed, maintaining the principles of the US programme, but with adaptations to reflect the cultural differences of the European population. This template has been used to produce national programmes in the UK, Belgium and Sweden. Programmes in other European countries will follow. The Committed Quitters Stop Smoking Plan seeks to apply the general principles that underpin effective behavioural support. When a smoker purchases the NRT product he or she is invited to register with the programme by telephoning a Freephone number. This first contact is used to collect key information on the individual smoker (i.e. age, sex, number of cigarettes smoked per day, reasons for wanting to stop smoking, perceived barriers to stopping, smoking status of partner and the name of a person who can provide support). The answers obtained from this initial telephone call are then processed using a specially developed algorithm. The output is an individualised programme of printed materials, the contents of which have been selected based on the answers given, and drawn from a wide range of different advice, hints and tips to suit the situation of that particular smoker (table 1). There are many thousands of permutations, excluding trivial differences, so the programme should provide a strong sense of personalisation. It is intended that information and advice that is relevant to all smokers should be 'seamlessly' merged with the tailored advice to avoid giving a sense of artificiality. Each piece of material is also personalised with the smoker's name, smoking status, quit date and the person he or she has nominated to provide support. The risk of relapse to smoking is greatest early in the quit attempt. Therefore, to ensure that support is received as rapidly as possible after the initial phone call, the process of constructing the first piece of support material, printing it and sending it by post is completely automated. The first item received is a six-week diary which includes a daily planner that starts from the designated quit date. This format gives the opportunity to chart the progress of the quit attempt. Daily, personalised tips are also included. The next item, received after around 10 days, is a Table 1 Timeline for the Committed Quitters Stop Smoking Plan - a tailored behavioural support programme distributed with nicotine replacement therapy Timing Programme Objective On purchase of NRT 2-3 days 10 days 3 weeks 6 weeks 10 weeks Telephone registration and qm Six-week diary Tailored Tri-fold leaflet 1 Tailored Tri-fold leaflet 2 Tailored step-down booklet Congratulations letter (Or a relapse letter if required) To gather personal information to help tailor material To allow the quit attempt to be charted whilst offering personalised hints and tips To focus on issue of social support To reiterate earlier messages and address issues that will be relevant after 3 weeks smoke free To explain how to get through the process of stepping down nicotine To maintain motivation to stay smoke free To encourage another attempt in the near future

4 EUROPEAN JOURNAL OF PUBLIC HEALTH VOL NO. 3 SUPPLEMENT User guide CQP User guide CQP Figure 3 Results from a study of the effect of a computer-tailored, personalised smoking cessation programme on quit rate among smokers (average 26 cigarettes a day) as adjunct to nicotine gum. All smokers (n=3,627) received a generic user guide, while 44% (n=l,217) also received the materials of the Committed Quitters Programme (CQP). The CQP group demonstrated a significantly higher quit rate (p<0.05). Results shown are for all smokers. tri-fold leaflet focusing on the issue of social support. This leaflet explains the importance of support from family and friends, and explains how such support can be encouraged. At week three, the individual receives a further tri-fold leaflet to reinforce earlier messages. After 3 weeks without cigarettes the advice and support needs to cover different problems and situations from those experienced at the start of the quitting process. Tips on how to capitalise on a new healthier lifestyle through diet and exercise are included, and the benefits of remaining smoke free are reiterated. At this stage the individual is given a telephone number to call and register for the rest of the programme. Those who wish to continue with the programme receive a further booklet at week six. This coincides with the start of the second step in the NRT programme, whether it is switching to the lower dose patch or chewing fewer pieces of gum a day (in the US programme only), and prepares them for stepping down their daily nicotine dose. On completion of the ten-week NRT programme, the successful quitter receives a 'congratulations' letter containing additional advice on how to maintain abstinence. However, if the quit attempt fails, the individual receives a letter to acknowledge their relapse, and give encouragement and advice on making another attempt in the near future. DOES COMPUTER-TAILORED SUPPORT ACTUALLY MAKE A DIFFERENCE? There is preliminary evidence that tailoring written advice by this method can improve quit rates. There have been two clinical trials of the Committed Quitters Stop Smoking Plan in conjunction with either NRT gum 18 or patch. Both were randomised, open-label trials under- I taken in the US using the original US version of the Figure 4 Results from a study of the effect of a computer-tailored, personalised smoking cessation programme on quit rate among moderate smokers (average 30 cigarettes a day) as an adjunct to nicotine patch. All smokers (n=3,683) received a generic user guide, while 50% (n= 1,854) also received the materials of the Committed Quitters Programme (CQP). The CQP group demonstrated a significantly higher quit rate than the non-cqp group (p<0.05). Results shown are for those smokers that reported actually referring to the CQP or user guide (81% of total). 20 Committed Quitters Stop Smoking Plan. As a control, all smokers received the generic 'User Guide', a 24-page booklet supplied with the NRT packaging that contains hints and tips on how to give up and maintain abstinence from smoking. Approximately one-half of the smokers were randomised to follow the Committed Quitters Stop Smoking Plan in addition to receiving this user guide. As well as assessing abstinence from smoking, these trials also examined usage of the printed materials. The results of these trials are shown in figures 3 and 4- In the trial using NRT gum, when examining all smokers, irrespective of whether they looked at the materials or not, there was a significant improvement in self-reported abstinence rates at 6 and 12 weeks among those randomised to the tailored self-help support programme. As might be expected, this effect was more pronounced in the subgroup of participants who said they actually referred to the material, with six-week quit rates of 42% with the tailored material versus 29% with the generic support only (p<0.05). At 12 weeks the figures were 32% versus 19% (p<0.05). Similar results were seen in the trial using the NRT patch, although the increase in the quit rate reached statistical significance only when assessing the 81% of participants who said that they referred to the materials. It should be noted in this regard that the proportion who said that they referred to the materials was not less in the case of the Committed Quitters materials than the User Guide. Therefore, it is unlikely that either group was more highly self-selected to be motivated to stop. Limitations of both studies were the reliance on selfreport without biochemical validation (which was unavoidable because the participants were distributed over a very wide geographical area) and the relatively short follow-up period. Nevertheless, taken together, the results of these studies are encouraging.

5 SUPPLEMENT Behavioural support programmes and smoking ADAPTING THE PLAN FOR EUROPE A key objective when adapting the US plan for Europe was to maintain the basic sense, content and structure of the plan. Modifications to allow for national or cultural differences in language and taste were kept to a minimum. However, minor modifications, based on lessons learnt in the US, were made. The diary was modified to enable users to chart personal progress, and the overall design of all materials was updated and brought into a more European context. CONCLUSIONS The need for widely accessible behavioural support programmes in smoking cessation is clear. Using face-to-face counselling is limited both by availability and acceptability, and is therefore feasible in only a small proportion of situations. Standard pre-printed self-help support material is widely available, but as yet there is little to suggest that it is helpful when added to NRT. Tailoring self-help behavioural support materials offers an interesting and plausible new approach. Evidence to date is encouraging and opens up the possibility of a new era in terms of getting cost-effective behavioural support to smokers on a large international scale. 1 Raw M, McNeill A, West R. Smoking cessation guidelines for health professionals: a guide to effective smoking cessation interventions for the health care system. Thorax 1998;53(Suppl.5 Pt 1):S UK Government Department of Health. Smoking kills: a white paper on tobacco. Cm London: Stationery Office, Parrott S, Godfrey C, Raw M, West R, McNeill A. Guidance for commissioners on the cost effectiveness of smoking cessation interventions. Thorax 1998;53(Suppl.5):S1-S38. 4 Lancaster T, Stead LF. Self-help interventions for smoking cessation (Cochrane Review). The Cochrane Library. Issue 2. Oxford: Update Software Ledwith F. Immediate and delayed effects of postal advice on stopping smoking. Health Bull (Edinb) 1984;42(6): Cuckle HS, Van Vunakis H. The effectiveness of a postal smoking cessation 'kit'. Community Med 1984;6(3): Lando HA, Pirie PL, McGovern PG, Pechacek TF, Swim J, Loken B. A comparison of self-help approaches to smoking cessation. Addict Behav 1991;16(5): Gritz ER, Berman BA, Bastani R, Wu M. A randomized trial of a self-help smoking cessation intervention in a nonvolunteer female population: testing the limits of the public health model. Health Psychol 1992;11(5): Pallonen UE, Leskinen L, Prochaska JO, Willey CJ, Kaariainen R, Salonen JT. A 2-year self-help smoking cessation manual intervention among middle-aged Finnish men: an application of the transtheoretical model. Prev Med 1994;23(4): Curry SJ, McBride C, Grothaus LC, Louie D, Wagner EH. A randomized trial of self-help materials, personalized feedback, and telephone counseling with nonvolunteer smokers. J Consult Clin Psychol 1995;63(6): Humerfelt S, Eide GE, Kvale G, Aaro LE, Gulsvik A. Effectiveness of postal smoking cessation advice: a randomized controlled trial in young men with reduced FEV1 and asbestos exposure. Eur Respir J 1998;11(2): Owen N, Ewins AL, Lee C. Smoking cessation by mail: a comparison of standard and personalized correspondence course formats. Addict Behav 1989;14(4): Curry SJ, Wagner EH, Grothaus LC. Evaluation of intrinsic and extrinsic motivation interventions with a self-help smoking cessation program. J Consult Clin Psychol 1991;59(2): Prochaska JO, DiClemente CC, Velicer WF, Rossi JS. Standardized, individualized, interactive, and personalized self-help programs for smoking cessation. Health Psychol 1993;12(5): Burling TA, Marotta J, Gonzalez R, et al. Computerized smoking cessation program for the worksite: treatment outcome and feasibility. J Consult Clin Psychol 1989;57(5): Lando HA, Kalb EA, McGovern PG. Behavioral self-help materials as an adjunct to nicotine gum. Addict Behav 1988;13(2): Imperial Cancer Research Fund General Practice Research Group. Randomised trial of nicotine patches in general practice: results at one year. BMJ 1994,308(6942): Shiffman S, Paty J, Rohay J, Di Marino M, Gitchell J. The efficacy of computer-tailored smoking cessation material as a supplement to nicotine gum therapy. Arch Intern Med 2000;160: Shiffman S, Paty J, Rohay J, Di Marino M, Gitchell J. The efficacy of computer-tailored smoking cessation material as a supplement to nicotine patch therapy, (unpublished manuscript).

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