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clinmed/1999120009v1 (December 17, 1999)
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Randomised controlled trial of cognitive behavioural therapy for smokers living in a deprived area of London.

David F Marks, Catherine M Sykes

Correspodence to:

Professor David Marks, Health Research Centre, School of Health, Biological and Environmental Sciences, Middlesex University, London. Queensway, Enfield, Middx., EN3 4SF. E-mail: D.Marks{at}mdx.ac.uk

Summary

Background The overall smoking rates in the United Kingdom have fallen over the last few decades. However they have barely fallen for the least advantaged adults.1 This paper compares the efficacy of smoking cessation advice in the form of a health promotion booklet with that of psychological therapy for smokers living in a deprived area of London.

Methods 260 self- and GP-referred smokers took part in a randomised controlled trial with follow up at 12 months. Participants were randomly allocated to either one session of cognitive behavioural therapy (the Quit For Life Programme) or smoking cessation advice based on a Health Education Authority booklet (Stopping Smoking Made Easier).

Findings Twenty-three of 116 participants (19.8%) receiving therapy were abstinent and 10 (8.6%) had reduced cigarette consumption by at least 25% of pre-treatment level. Six (5.8%) of 104 participants in the control group were abstinent and none had reduced consumption.

Interpretation. Health professionals trained in Cognitive Behavioural Therapy are likely to have a bigger impact on reducing the number of people who smoke compared to those who only give advice on how to stop smoking.

Introduction

Consumed mainly as cigarettes, tobacco is responsible for three million deaths a year world-wide increasing to ten million by the year 2020 and is expected to kill half a billion of today’s global population.2 These deaths are avoidable but, in spite of the evidence concerning the damaging health effects of smoking, effective tobacco control still seems a long way off. In the European Region of the World Health Organisation in 1995 cigarettes were responsible for about 1.2 million deaths; in the USA, tobacco kills more than 400,000 people each year; in the UK the death rate is around 120,000 per annum, the cost to the hospital system in England at least 400 million per year, and industry loses over 50 million working days every year.3

The 40-year epidemiological study of male British doctors showed that stopping smoking by middle life (before age 45) produces almost the same life chances as never smoking at all.4 The study also showed that there is a dose-response relationship between mortality rates and tobacco consumption and that quitting or reducing smoking adds years to the lives of young or middle-aged smokers. There are also social and economic benefits which could be substantial when measured across the entire population.

A key group who have increased their smoking rates is low income adults.5 The prevalence of smoking is higher for people in manual than non-manual socio-economic groups (34% compared with 22% in 1996).2 The policy of discouraging smoking by increasing tobacco sales tax is failing to reduce smoking among the group of people who are least able to afford the habit and yet who become even more impoverished as a result of it.

The Smoking Kills White Paper states that ‘All health professionals working in hospital or community settings should assess habits and provide advice to smokers on giving up, whenever possible’(p36)1 . However it has been shown that GP’s advice on smoking cessation has an efficacy of 1-3% 6. The White Paper also recommends the use of Nicotine Replacement Therapy (NRT) to help deal with the cravings for nicotine when trying to stop. A free one-week course of NRT will be made available for those who are least able to afford it. The use of NRT however only has an efficacy of 2-6% in family practice settings and 7-16% in self-referred smokers.6

While the White Paper hints at the psychological nature of smoking (e.g. ‘smokers also need to be strongly motivated’ (p37), there is no clear strategy or recommendation on how to tackle the psychological addiction to nicotine. NRT is certainly unable to treat smokers’ psychological dependency on smoking. Psychological dependency, especially in the context of stressful events, is the major cause of continuing the habit in spite of having all of the necessary advice, health information and motivation to make the change. There is therefore a particular need for effective methods of smoking control among lower income groups who suffer from higher levels of anxiety, learned helplessness and relative deprivation.7

Without external intervention, the process of quitting or reducing depends upon individual perseverance and will-power. In spite of the fact that the majority of smokers say that they want to give up the habit (70% of men and 67% of women in 1996)2, relatively few are able to achieve long-term cessation or reduction without methods capable of reducing their psychological as well as their physical dependency. Cognitive-behavioural therapy (CBT) enables addictive behaviours to be changed by facilitating the control of the psychological processes responsible for, or associated with, the acquisition of the habit, e.g. conditioning, reinforcement, arousal, attention to cues, moods, feelings, suggestion, and imagery.8

The purpose of this paper is to describe a randomised controlled trial (RCT) of the efficacy of CBT for smokers, the QUIT FOR LIFE (QFL) Programme’,8 in comparison to a control treatment. The control treatment consisted of a health promotion intervention, ‘Stopping Smoking Made Easier’ (SSME), published by the Health Education Authority9 and commonly available in GP surgeries and health centres. This paper presents analyses of efficacy and cost-effectiveness and also data from a qualitative evaluation of QFL.

The QFL Programme uses a spectrum of thirty CBT and other relevant methods in a self-help package consisting of a handbook, reduction cards, a progress chart, and other necessary materials. A cassette tape of the handbook recorded by the BBC’s Nick Ross is also given to participants. This is useful for participants who do not like reading or are illiterate. The reverse side of the tape includes relaxation music. The self-help format requires attendance at one introductory session, a few days before the participants initiate a programme of systematic reduction. The methods are listed in Table 1. Revealing the truth behind tobacco advertising, especially informing participants that ‘low tar’ cigarettes actually contain exactly the same tobacco as ordinary high tar brands is particularly well received by the participants. The majority of the participants showed shock and disgust at being manipulated by the tobacco industry.

Table 1: List of procedures included in the QFL Programme.

 

METHOD

1

Rubber band around Pack

2

Record all smoking on Card

3

Program 1 (NURD)

4

Enter Daily Total on Chart

5

Program 2 (WESTD)

6

Keep list of Triggers

7

Program 3 (EASY)

8

Meditation

9

Imagery Rehearsal

10

Program 4 (NOGO)

11

The Eight Steps and Sensitization

12

Music Therapy (Slide 2, Cassette)

13

Win the Argument Game

14

List Personal Benefits of Quitting

15

Plan your D-Day

16

Try Different Ways of Relaxing

17

Rehearse Positive Programs

18

Increase Activity

19

Distraction

20

Help-line

21

Willpower

22

Learn Fail-Safe Procedure

23

Develop Eating Control Programme

24

Rules for Snacking

25

Develop Exercise Programme

26

Relapse Prevention

27

Assert Non Smokers’ Rights

28

Deconstruct Tobacco Advertising

29

Develop Time Management Skills

30

Prevent Stress and Strain

 

QFL aims at a gradual reduction of cigarette consumption over a period of 7-10 days. A set of targets guides the smoker towards a daily reduction of 50%. Of particular importance is the objective of increasing the smokers’ self-efficacy, a belief that they can and will be able to make the change from smoker to non-smoker. The therapy encourages smokers to be constantly vigilant concerning the process of rationalisation which gains more force as they approach complete cessation. This occurs on "D-Day", a planned 24-hour period when smoking is discontinued. The programme also trains participants to employ mental imagery, suggestion, relaxation and meditation.8

The QFL Programme is in two stages, reduction and relapse-prevention. The Programme is further sub-divided into ten sections spaced across a period of three months. The reduction stage begins on a Tuesday and finishes the following week with ‘D-Day’. Relapse-prevention starts on ‘D-Day’ and continues thereafter. In contrast to the control intervention, it is emphasised that will power is not needed in the QFL Programme. NRT is an optional adjunct during the initial period of 10-30 days immediately following D-Day. It is recommended that smokers use only the lowest dosage level gum or patch for this purpose. In practice NRT is used by a small minority of QFL participants owing to its high over-the-counter price.

The control intervention (SSME) is available in many GP surgeries throughout the UK and consists of a small booklet providing smoking cessation advice. SSME recommends a staged approach: preparing to stop, stopping, and staying stopped.9 The preparation stage consists of clarifying reasons for stopping, becoming ready to stop, and making an action plan. Smokers are recommended to stop suddenly, using their will power, rather than to gradually reduce their consumption. Smokers are advised to choose a day, obtain support from family and friends, review the action plan the day before, plan a suitably healthy reward for the end of the first day, and another for the end of the first week, and the first month, plan ahead, and to telephone the national ‘Quitline’, GP or health centre for further help. Once smokers have stopped they are exhorted to think positively, take care, not play games, keep busy, avoid alcohol, refuse or break up cigarettes offered by friends, learn to relax, and to ring the national ‘Quitline’. Normally the SSME does not include a group introductory session. Smokers are usually handed the SSME or sent it through the post.

Methods

The planned study population was adult smokers living in a deprived area of London who rang a smoking cessation clinic and booked to attend a smoking cessation trial. Posters and pamphlets advertising free quit smoking assistance were displayed in GP waiting rooms, pharmacies and a library noticeboard. The national Quitline was also informed about the trial. Dates and times of a one hour introductory session to the interventions were given to a receptionist. We then randomly allocated an intervention to a date. The reception was unaware of which intervention into which she was booking participants. When smokers telephoned the centre to volunteer for the free trial the receptionist gave the smokers a choice of dates and times and booked them into the first convenient introductory group session. There were no criteria for exclusion; all smokers who applied were admitted to the trial subject only to their informed consent. The primary outcome measure was point prevalence of smoking validated by a breath carbon monoxide readings.

131 individuals were allocated to the CBT programme and 129 to the control condition. Sessions were arranged by booking smokers into mixed groups of 3-12. Upon arrival at the clinic, participants were given an explanation about the trial and a consent form which informed them that two interventions were being evaluated and that they had been allocated to one of them by random selection. None refused to give informed consent.

Participants received either a 60-minute introduction to the CBT programme by or a 60-minute introduction to SSME by a health psychologist. Each session was run interactively, inviting questions and comments, and urging the smokers to comply with the instructions in the booklets provided. The two interventions were delivered with similar amounts of energy and enthusiasm. Every effort was made to motivate the smokers to follow the procedures recommended in the booklets provided. A breath CO reading was taken during the session using a Bedfont Smokerlyzer. At the conclusion of the session, the smokers were invited to call the clinic’s help-line if they had any further questions or problems. Finally, a 3-month follow-up meeting was arranged to monitor the participants progress.

At the 12 month follow up each participant’s smoking status was ascertained. If they failed to attend the follow up for a meeting, smoking status was ascertained by telephone or letter and arrangements were made to take a CO reading in cases where reduced or abstinence was reported. All participants were asked if they had used NRT in addition to CBT or the control treatment. Twenty-nine participants left the trial before the 12-month data-point: one died and twenty-eight became non-contactable by telephone or mail.

 

Results

The attendance rates for this trial were low; approximately one in four people who telephoned did not book into a session and one in two who booked into a session failed to appear. As smokers pass through a series of stages of change and are only inclined to enter treatment when they are in the action stage, this sample, as with all samples of smokers in cessation trials, is representative of smokers at the action stage.10

The SES distributions for the QFL and control groups were highly similar (Table 2). The sample contained a significant proportion of smokers on lower incomes including smokers from manual occupations (73/260 = 28%) and unemployed smokers (37/260 = 14%). The QFL sample contained 45 males and 86 females and reported an average cigarette consumption of 24.5 (SD,6.18) cigarettes per day at baseline. The control sample contained 49 males and 80 females and reported an average cigarette consumption of 25.5(SD,6.42) cigarettes per day at baseline.

 

Table 2. Socio-economic status of participants

 

SES

QFL

Control

Totals

I

0

0

0

II

20

23

43

IIIN

21

19

40

IIIM

14

14

28

IV

20

15

35

V

6

4

10

Unemployed

21

16

37

Retired

9

11

20

Students

10

7

17

Unknown

13

17

30

Totals

131

129

260

 

The participants who could be contacted at follow up totalled 228 at 12 months. A few participants reported using NRT as a complement to CBT (3) or SSME (8). Many reported that NRT was too expensive. They were unwilling to go without cigarettes to buy NRT. Because there were insufficient numbers to perform separate statistical analyses on these CBT + NRT and SSME + NRT groups, these participants were eliminated from further analysis. Smoking status at follow-up was classified into three categories: abstinence (zero cigarette consumption for at least one week), reduction (cigarette consumption at least 25% lower than baseline for at least four weeks), or no change. In the majority of cases (77/78 or 98.7%) participants' verbal reports of their smoking status were consistent with their breath carbon monoxide readings (Table 3). Only one participant (in the QFL condition) reported a smoking status (abstinence) inconsistent with her breath CO reading. This participant reported using NRT and so her data were removed from the analysis.

The observed frequencies of abstinence and reduction for the two groups are presented in Table 4. At 12 months twenty-three of 116 (19.8%; 95% CI: 13.0-28.3%) QFL participants were abstinent, compared to six of the 104 (5.8%; 95% CI: 2.1-12.1%) contactable control participants. Ten (8.6%; 95% CI: 4.2-15.3%) of the QFL group but none of the control group reported a reduced consumption (X2(2) = 20.48, p<0.0001). Approximately one in four (33/116 or 28.4%; 95% CI: 20.5-37.6%) of CBT participants were abstinent or had a significantly lower cigarette consumption 12 months after the treatment compared to one in seventeen (6/104 or 5.8%; 95% CI: 2.1-12.1%) of the controls (X2 (1) = 19.23, p<0.0001). The average daily cigarette consumption at 12 month follow up among the ten reducers in the CBT group was 10.23 (SD,5.64) as compared to a pre-treatment level of 26.08 (SD, 3.86). This is a reduction of 15.85 cigarettes per day or 61% of the baseline level.

Table 3: Distribution of breath carbon monoxide readings (parts per million) for participants reporting abstinence, reduced cigarette consumption, or no change.

 

CO level

(ppm)

Participants' reported smoking status

 

Abstinence

Reduced consumption

No change

Totals

<4

35

5

0

40

5-9

0

10

0

10

10+

1

5

22

28

Unavailable

11

9

11

31

Totals

47

29

33

109

 

 

Table 4: Numbers of participants reporting abstinence, reduction of at least

25 %, or no change twelve months after the intervention

 

  Smoking

status

QFL

Control

Abstinent

23

6

Reduction

10

0

No change

83

98

Totals

116

104

 

The data were analysed to investigate whether therapeutic outcomes were related to socio-economic status as indexed by occupation. Participants in SES categories I, II and IIIN and students were combined to form a high SES group; participants in categories IIIM, IV and V or who were unemployed were combined to form a low SES group. The 12 month follow up abstinence and reduction rates for these two sub-groups were analysed for each treatment condition but no statistically significant differences were obtained. Comparisons between male and female participants also revealed no significant differences in outcomes at 12 months.

Costs of delivering the two treatments differ because of differences in the costs of the supporting materials: the CBT materials cost 6.00; the control (SSME) booklets are available free of charge from the Health Education Authority or local health promotion units. The other costs for the two treatments are identical. These costs are estimated, assuming group sizes averaging five participants, as follows:

therapist’s fee: 30.00 (for one hour @ 25.00 per hour)

clerical/administration: 30.00 (for five hours @ 6.00 per hour)

room rental: free (NHS health centre or clinic)

heat & light 1.00

telephone: 5.00

CO monitor: 1.00

total: 67.00 for a group of five participants

or 13.40 per participant

The costs of the CBT and control treatments are 19.40 (adding 6.00 for the QFL pack) and 13.40 per person respectively. Cost-effectiveness is defined here as the cost of delivering each treatment to a sufficient number of self-referred smokers to produce one quitter or reducer. Since 28.4% (95% CI: 20.5-37.6%) of CBT participants are expected to be a quitter or reducer at 12 months; the cost per quitter/reducer is 68.30 (95% CI: 51.59-94.63). 5.8% (95% CI: 2.1-12.1%) of smokers receiving the control treatment are expected to be a quitter or reducer at 12 months; the cost per quitter/reducer is 231.03 (95% CI:110.74-638.09). These data suggest that CBT is 3.38 (95% CI: 1.17-12.4) times more cost-effective than the control treatment.

NRT costs approximately 180 per smoker to deliver a 10% chance of abstinence at one year post-treatment. In this case, CBT is 26 times more cost effective than NRT. Currently NRT is the treatment of choice recommended by the Department of Health’s Scientific Committee on Tobacco and Health.3 The American Agency for Health Care Policy and Research guidelines, on the other hand, suggested that both psychological and pharmacological treatments are effective components of smoking cessation interventions and that these two approaches should be combined.11

Acceptability among the smoking population is another important requirement for a smoking cessation intervention. This can best be determined using participants’ ratings of their satisfaction with the quality of the intervention. Thirty of the 128 QFL participants were selected at random to complete an evaluation questionnaire concerning five aspects of the programme (overall quality, quality of the book, quality of the audio-cassette, presentation, helpfulness of the therapist). The QFL therapy received high ratings for all five aspects of the programme with 138 of 150 ratings (92%) at the "Good", "V. Good" or "Excellent" levels. These data suggest that CBT presented in the QFL format is highly acceptable to smokers from a broad cross-section of the population as represented in this sample.

Discussion

The results of this randomised controlled trial suggest that CBT has high efficacy, cost-effectiveness and acceptability among smokers across a broad range of socio-economic backgrounds. The study found that one in five of smokers in the CBT group were fully abstinent at 12 months follow up; a 60% average reduction in cigarette consumption occurred in another one in twelve smokers. CBT was approximately five times more efficacious and three times more cost-effective than health education advice. Additionally, the efficacy of health education advice was probably increased in this study by adding the group introductory session to the advice. Stead and Lancaster systematically reviewed group programmes (with a minimum of two group meetings) for smoking cessation and found that there was an increase in cessation with the use of a group programme 12 .

It has been shown in this RCT that CBT is of high efficacy among a sample which included a high proportion of low income adults, a key group whose smoking rates have increased despite multiple health education campaigns and increases in price.2,5,7 Smokers need more than information; they need the skills and techniques to enable them to control the psychological processes underlying smoking . This study demonstrates that smokers from the complete range of socio-economic backgrounds are able to control the habit once given the appropriate methods. The reports of participants in this study also that many smokers on a low income are unwilling or unable to purchase NRT. The current policy of providing a one week’s free supply of patches is unlikely to succeed because smokers will be unable to afford to continue the treatment.

Further investigations are warranted to test the efficacy of QFL in combination with free NRT. Richmond, Kehoe & De Almeida Neto13 conducted a study in which hospital-based outpatients received 2 hours of CBT over 5 weeks with either NRT or a placebo patch. They reported a significantly significant difference in point prevalence abstinence rates between the 2 groups, with 28% of the CBT plus NRT and 12% of the CBT plus placebo patch abstaining at 12 months. If CBT can be added to the current provision of NRT it is likely that the quit rates could be doubled or trebled for minimum extra cost.

A few qualitative studies have looked at factors associated with smoking and smoking cessation in disadvantaged smokers. Two such studies, Stewart, Gilles, Brosky et al 14 and Gillies 15 , interviewed women of low SES status. The former study found that coping with stresses, powerlessness, low self-efficacy, social pressures and addiction were associated with smoking. The latter study identified a discourse of addiction. The author points out that smoking is often located within a disease model, perceiving it as a physical problem in need of treatment. Gillies suggests that this dominant construction of cigarette smoking as a physiological addiction is disempowering. The CBT described in this study tackles issues such as powerlessness and social pressures. It recognises that smoking is a pyschological addiction and stresses that participants do not require a huge amount of will-power to quit. In choosing from a range of psychological methods, smokers are empowered to quit.

Primary health care professionals can easily be trained to provide CBT for groups of smokers. This paper suggests that it would be efficacious and cost-effective for health professionals to include CBT techniques that tackle the psychological dependency of nicotine addiction in local smoking cessation services. If we are to make a really significant impact on the current prevalence of smoking, cognitive behaviour therapy needs to be offered as well as nicotine replacement therapy and stop smoking advice.

Acknowledgements

The assistance of Aroshini Wijetunge, Glenn Jarrett, and the late Rumina Dewshi in subject recruitment and data collection is acknowledged. The co-operation of the Health Education Authority who provided the booklets on "Stopping smoking made easier. The assistance of the National "Quitline" is also acknowledged.

Funding: No external funding.

Competing interest: None.

References

1 Smoking Kills. A White Paper on Tobacco. 1998

2 Statistical Bulletin. Statistics on smoking:England, 1976 to 1996. Department of Health 1998.

3 Poswillo, D. Report of the scientific committee on tobacco and health. London:The Stationery Office, 1998.

4 Doll, R., Peto, R., Wheatley, K. et al. Mortality in relation to smoking: 40 years’ observations on male British doctors. BMJ 1994; 309, 901-910.

5 Marsh, A. & McKay, S. Poor smokers. London: Policy Studies Institute, 1994.

6 Law, M. & Tang, J.L. An analysis of the effectiveness of interventions intended to help people stop smoking. Archives of Internal Medicine 1995; 155, 1933-1941.

7 Marks, D.F. Addiction, smoking and health: developing policy-based interventions. Psychology, Health and Medicine 1998; 3, 97-111.

8 Marks, D.F. The QUIT FOR LIFE Programme: An easier way to stop smoking and not start again. Leicester: British Psychological Society, 1993.

9 Health Education Authority. Stopping smoking made easier. Health Education Authority, London, 1992.

10 DiClemente, C.C., Prochaska, J.O. & Gilbertini, M. Self-efficacy and the stages of self-change of smoking. Cognitive Therapy and Research 1985; 9, 181-200.

11 US Department of Health & Human Services. Clinical practice guidelines 18: Smoking cessation. Washington, DC: US Government Printing Office, 1996. (Agency for health care policy and research; publication no 96-0692).

12 Stead, L.F. & Lancaster, T. Group behaviour therapy programmes for smoking cessation (Cochrane Review). The Cochrane Library, Issue 3, 1998. Oxford: Update Software.

13 Richmond, R.L., Kehoe,L. & De Almeida Neto, A.C. Effectiveness of a 24-hour transdermal nicotine patch in conjunction with a cognitive behavioural programme: one year outcome. Addiction 1997; 92, 27-31.

14 Stewart, M.J., Gillies, A., Brosky, G. et al. Smoking among disadvantages women: Causes and cessation. Canada Journal of Nursing Research, 1996, 28, 41-60

15 Gillies, V. An Analysis of the Discursive Positions of Women Smokers. In: Willig, C, ed. Applied Discourse Analysis,. Buckingham: Open University Press, 1999: 66-86.

 

 

 

 

 

 

 

 

 

 





This Article
Right arrow Abstract Freely available
Services
Right arrow Similar articles in this netprints
Right arrow Download to citation manager
Citing Articles
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Marks, D. F
Right arrow Articles by Sykes, C. M
Right arrow Search for Related Content
PubMed
Right arrow Articles by Marks, D. F
Right arrow Articles by Sykes, C. M
Related Collections
Right arrow Psychiatry:
Other Psychiatry

Right arrow Public Health:
Smoking

Right arrow Statistics and Research Methods:
Randomised Controlled Trials: examples

Right arrow Epidemiology:
Socioeconomic Determinants of Health


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