Addiction

A cluster randomised controlled trial of a brief tobacco cessation intervention for low income communities in India: Study Protocol

Journal:

Addiction ADD-13-0114 Trial Protocol 12-Feb-2013

Manuscript ID: Manuscript Type: Date Submitted by the Author:

Complete List of Authors:

SUBSTANCE: METHOD: FIELD OF STUDY: Keywords:

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tobacco

Sarkar, Bidyut; University College London, Epidemiology and Public health; Public Health Foundation of India, Future Faculty Shahab, Lion; University College London, Epidemiology and Public health Arora, Monika; Public Health Foundation of India, Centre for Tobacco control and Health Promotion Lorencatto, Fabiana; University College London, NCSCT Reddy, KSrinath; Public Health Foundation of India, West, Robert; University College London, Epidemiology and Public health

clinical trials epidemiology

tobacco cessation, intervention, trial, India, non-pharmacological

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Addiction

A cluster randomised controlled trial of a brief tobacco cessation intervention for low income communities in India: Study Protocol Bidyut K Sarkara,b, Lion Shahabb, Monika Aroraa, Fabiana Lorencattoc, K Srinath Reddya and Robert Westb
a

Public Health Foundation of India, New Delhi, India Department of Epidemiology and Public Health, University College London, London, UK NCSCT, University College London, London, U.K

Reprints and correspondence: Bidyut K Sarkar; Address: Public Health Foundation of India, New Delhi, India; E-mail: bidyutk.sarkar@gmail.com; Tel: +91 9818196320 Running head: Brief tobacco cessation intervention trial Word count: 3505

Declaration of Conflict of interest

BKS has a UKC-Wellcome trust capacity strengthening strategic award to PHFI and has no conflict of interest to declare. MA and KSR have no conflict of interest to declare. LS has received honoraria for talk and travel expenses from manufacturers of medications for smoking cessation to attend meetings and workshops. FL has received travel funds and hospitality from manufacturers of medications for smoking cessation. RW undertakes consultancy and research for and receives travel funds and hospitality from manufacturers of medications for smoking cessation.

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Abstract Background: India has 275 million adult tobacco users and tobacco use kills more than a million people in the country each year. There is an urgent need to develop and evaluate affordable and scalable interventions to promote cessation of tobacco use. Since tobacco use is so harmful, an increase of as little as one percentage point in long term quit success rates can have an important public health impact. Brief advice from a physician has been shown to have a small but meaningful effect on smoking cessation in developed countries. This study aims to evaluate the effectiveness of a brief scalable smoking cessation intervention from a trained health professional, to promote tobacco use cessation offered through outreach into poor urban communities in India. It is the first such trial in a low-middle income country. Methods/ Design: This is a pragmatic community based cluster randomised trial of tobacco users with two arms. The treatment arm is a brief intervention comprising brief advice including training in craving control using simple yogic breathing exercises (YBA) and the control arm is very brief advice (VBA). Out of a total of 32 clusters, 16 clusters will be allocated to the intervention arm and 16 clusters to the control arm. Each cluster will have 31 participants making a total of 992 participants. The primary outcome measure will follow the Russell Standard: self-report of sustained abstinence for at least 6 months following the intervention confirmed at the follow up by salivary cotinine. Secondary outcome measures will be: 1-week point prevalence abstinence at the 7-month follow-up point confirmed by saliva cotinine assessment; attempts to stop smoking between the intervention and the 1month follow up; 1-week self-reported point prevalence abstinence at the 1 month follow up. The study will involve checks on fidelity of delivery of the intervention. Discussion: This trial will inform national and international policy on delivery of a brief outreach intervention as a scalable and affordable intervention for tobacco use cessation.

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Trial registration: ISRCTN23362894

Acronym BABEX

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Introduction Background and objectives India has 275 million tobacco users including 164 million smokeless tobacco users, 69 million smokers and another 42 million using both combustible and smokeless forms of tobacco(1). Tobacco use is a risk factor for six out of the eight leading causes of death in the world(2). Tobacco use kills 5.4 million people globally each year (3) and an estimated one million people in India alone(4). Since tobacco use is so harmful, an increase of as little as one percentage point in long-term quit success rates can have an important public health impact (5).

Brief advice is a low cost intervention which can be delivered en masse by trained counsellors, nurses and physicians (6). Systematic reviews have reported that brief advice to quit has been shown to be better than no advice OR-1.66 (1.42-1.94), increasing 12 months quit rates by1-3% (7-10). A recent review of quit advice for smoking cessation which assessed brief interventions of less than 10 minutes without follow up counselling showed an increase in the frequency of quit attempts RR-1.24 (1.16-1.33), and that offering assistance generated more quit attempts RR-1.69 (1.24-2.31) than giving advice to quit on medical grounds (11). Further, providing brief advice to all smokers, irrespective of their interest to quit, has been reported to be more effective than offering assistance only to those who express an interest in doing so(11). However, whilst there is extensive evidence for the benefits of brief advice in the developed world, its effectiveness has yet to be evaluated in a randomised trial in low or middle income countries, and the effect size of this type of intervention in these settings is not known. Neither is it known whether such advice can reduce smokeless tobacco use.

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Unlike in developed countries such as the UK where behavioural therapy and/or pharmacotherapy is provided with no or little cost to patients in smoking cessation clinics, there is a very limited support service available for quitting tobacco use in India. England is at one extreme worldwide with complete coverage of the population with smoking cessation support through its National Health Service (12). By contrast, India had established just 19 Tobacco cessation clinics (TCCs) with WHO support by 2010 for a country with 275 million tobacco users, and even these few clinics were unable to provide free NRT or pharmacotherapy(13). Hence, there is an urgent need to identify and evaluate low cost, affordable, non-resource intensive, easily scalable interventions to promote cessation of tobacco use in India.

In the context of these considerations, and the high cost of pharmacotherapy, a promising, affordable and culturally appropriate option to enhance brief advice and aid smoking cessation in the Indian context is the use of breathing exercises, known as Pranayama within Yoga. Yoga originated in India as a traditional method of achieving good physical and mental health. Therefore, yogic breathing exercises are expected to have a high degree of acceptability as a tobacco cessation method. Although, relatively little research has been undertaken to test the hypothesis directly that yogic breathing exercises may improve quitting

rates, the research that exists, is promising.

McClernon et al (14) observed that controlled deep breathing significantly reduces smoking withdrawal symptoms, including craving for cigarettes and negative affect (being tense and irritable), while resulting in the maintenance of baseline arousal levels (being wide awake, able to concentrate). More recently, Shahab et al have reported a significant positive acute effect of yogic breathing exercises in yoga-nave smokers abstinent for at least 10 hours on withdrawal symptoms (15). Given that there is good evidence that the experience of severe cravings early on in quit attempts is an important mediator of relapse (16, 17), yogic

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breathing exercises may therefore increase smoking cessation rates. Indeed, Kochupillai et al (18) reported a positive impact of yogic breathing exercises on tobacco abstinence and found the 12 month abstinence rates of the yoga breathing exercises group to be similar to the pharmacological agent Bupropion. Given these promising findings and the need to adopt high-reach and less specialist based, affordable methods for tobacco cessation in India and in the concomitant absence of empirical data on the impact of brief interventions, such as quit advice, in low-to-middle income countries (19), this trial aims to evaluate the effectiveness of a single session of face to face quit advice with a single session training on yogic breathing exercises as a brief intervention on tobacco users in low income communities in India to promote tobacco use cessation. A cluster randomised design is adopted because of the risk of contamination between conditions given the close nature of the communities and the non-feasibility and ethical issues of individual randomisation within a community in a community based trial in

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these settings. Methods and design Study Design and timing

This is a two arm cluster randomized trial comparing two interventions: the treatment arm is a brief intervention consisting of a single face to face session of quit advice plus single session training on yogic breathing exercises (YBA) and the control arm of very brief advice alone (VBA). The participants will be followed up after one and seven months after the intervention to assess tobacco use status (the primary and secondary outcomes). The proposed study area has a total population of approx. 36,000 adults living in randomly selected administrative blocks of 32 large slum areas of low income residents spread over a

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wide geographical area in the city of Delhi, India. Each of these blocks will be considered as a cluster for randomisation in the study. Each of the selected low income administrative blocks can be one of two types of community: an authorised government rehabilitation known as resettlement colony with slightly better facilities and the other is an unauthorised settlement known as J.J. cluster. J.J. stands for Jhuggi-Jhopri meaning huts in local language. Equal numbers of both types of community were selected for inclusion in the study. Recruitment into the study started in January 2012 and it is currently ongoing. The study is anticipated to conclude in September 2013. Trial interventions and delivery

The intervention will be delivered at the individual level to participants in both arms. A written standard operating procedure (S.O.P) will be followed. The treatment arm is a single session of face to face quit advice including single session training in yogic breathing exercises (YBA) and the control arm is very brief advice (VBA). For both groups, the baseline interview will be conducted at the door step of the tobacco users residence and both YBA and VBA will be delivered face to face either individually or, for YBA, in very small groups of two to four participants using a standard script. All content is delivered in nontechnical and local language, i.e. Hindi. The scripts were translated in Hindi from English and the interview questionnaire prepared in both English and local Hindi. The consent form was translated from English to Hindi and also back translated to English. The yogic breathing arm (YBA), a brief intervention comprising advice to quit and breathing exercises will cover the following content:

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Explain the important groups of chemicals present and released on smoking and chewing tobacco and the specific diseases caused by tobacco use including cancer, respiratory and cardiovascular diseases.

Identify the personal health risks associated with the individuals specific form of tobacco use and also the economic burden and implications of tobacco use including cost of hospitalization and treatment of tobacco use related diseases.

Explain how quitting can reverse lot of the harm, and the benefits of early and complete abstinence.

Explain that the chances of success are higher with the use of some support as most persons experience temporary withdrawal symptoms as well as the importance of avoiding for a while places, situations and company which could precipitate relapse and advise to quit within the next month. Advice to seek support of family members and close friends in your quitting effort.

Explain the support options available for quitting including medications such as NRT, pharmacotherapy with cost implications and low cost non-pharmacological interventions like yogic breathing exercises.

Perform training in two yogic breathing exercises (Kapalbhati and Anulom-vilom) with the help of a standard training video of breathing exercises (see Table 1 for details on instructions).

Check receipt (comprehension) of the intervention by the participant by a brief practice session of breathing exercises by the tobacco user for 2-3 minutes. Ask to use these breathing exercises once in the morning (both exercises) and then (Anulom Vilom) whenever they experience cravings for tobacco during the day. Provide a

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blank calendar and request to tick mark the dates on which they use the breathing exercises to document enactment (adherence). Provide a handout of breathing exercise instructions in local language for reference. Inform will follow up after one month and again after 7 months.

For an assessment of the full effect of this brief intervention the control condition would ideally involve no advice on tobacco use, but this was considered unethical by relevant review boards. Therefore any effect size estimate produced by this trial is likely to be conservative. Very Brief Advice (VBA) will cover the following content: Explain that tobacco use is very harmful and causes major diseases such as cancer. Explain that quitting is the most important step they can take for their health. State that will follow up after one month and 7months.

Descriptions of the content of the intervention and control conditions were coded into component behaviour change techniques (BCTs) using the established taxonomy of smoking cessation BCTs (20). BCTs identified at least once within each condition are listed in Table 2. BCTs marked with an * have been shown to be significantly associated with improved four-week CO-validated quit outcomes, and are therefore considered to be evidence-based (21). Fidelity of intervention Fidelity will be promoted by following standard guidelines on checking delivery, participant receipt and enactment (22). The brief intervention will be delivered by using a standard checklist and script for advice to quit and use of a standard video for training in yogic breathing exercises. The delivery team will consist of one trained health professional and two

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field health workers trained and initially supervised by the same health professional. The first 10 episodes of quit advice will be tape recorded and the recording checked against the script by the trained health professional. If discrepancies are discovered at this stage, retraining will be undertaken to increase fidelity to the protocol and script. The participant receipt of the intervention will be checked by practice of breathing exercises by the participant in presence of the person delivering the intervention. Enactment of the intervention or adherence by the participant will be captured by requesting participants to tick mark on a blank calendar provided as a handout after the intervention and checked at the 4 week follow up.

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Randomisation

As low income blocks in the study area are stratified into two community types (J.J cluster and resettlement colony), an equal number of each are identified for inclusion prior to randomisation. Further, a list of all eligible tobacco user participants for recruitment is also finalized within each cluster prior to randomisation of clusters to the intervention or control

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arm.

The random sequence for allocation of clusters to the intervention and control arm is independently generated by computer using a random number generator in SPSS software with a uniform distribution and blocked so that an equal number of each community type are allocated to the intervention and control condition. Therefore 16 clusters (8 from each community type) will be randomly allocated to the yogic breathing exercises arm (YBA) and 16 clusters (8 from each community type) to the very brief advice (VBA) arm. Participant recruitment Following a census survey of each cluster, tobacco users identified will be invited for participation in this trial. Each cluster will be divided into three to four geographical parts

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(streets/ lanes/ outer/ inner) comprising an equal number of households from which an equal number of participants will be invited for participation. Those willing to provide consent will be checked for fulfilment of the inclusion criteria given below and formal consent taken. In case of multiple eligible participants in the same household, only one participant from each household will be recruited. Inclusion criteria: Any current self- reported daily user of any tobacco product Age of 23 years or more

Willing to provide consent to participate. Residing in the study community at the time of the trial

Exclusion criteria: Pregnancy

As a previous research study conducted in the same area undertook interventions for tobacco cessation in the age group 10-19 years - who would be 22 years old by the time recruitment for the current study, is completed - an older age cohort is the target for inclusion to avoid contamination with the previous research study. In addition, as the practice of yogic breathing exercises involves abdominal movements, the effect of which has not been evaluated in pregnant women, this group will not be advised to use them. Consent All participants are adults. Informed written consent will be taken from all participants. Those who cannot read or write will be read out the patient information sheet and will be requested to affix their thumb impression in the presence of a literate witness who will

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counter sign the consent form. Due to the nature of the intervention, blinding the participant to the intervention would not be feasible. However, since all the participants in a cluster will receive the same intervention, contamination is unlikely. Measures Baseline measures At the first visit, tobacco users will be asked to provide socio-demographic information (age, gender, occupation, education and income), information about their tobacco use history, any previous quit attempts, knowledge, attitudes and quitting intentions, nicotine dependence and screening for current depression. Nicotine dependence will be assessed with the Fagerstrom test for nicotine dependence (FTND)(23) modified for smokeless users as proposed by Karl Fagerstrom (24). Saliva samples will be collected for baseline salivary cotinine level assessment of various forms of tobacco use in India in a randomly selected 30 percent of

participants in both arms. Primary outcome measure

The primary outcome measure will follow the Russell Standard of self-reported abstinence: a maximum of 5 cigarettes/Bidis or 5 times use of chewing tobacco (or any other form of tobacco) in the 6 months preceding the follow up at 7 months after intervention delivery, validated by salivary cotinine level of less than 20ng/ml. Cotinine will be assessed by ELISA (25). As this tends to yield slightly higher levels than GC-MS because of inclusion of metabolites (26), the usual cut-off for GC-MS of 13ng/ml was increased by the ratio of the typical ELISA to GC-MS value. Secondary outcome measures

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The secondary outcome measures will be one week point prevalence abstinence assessed at 4 weeks and 7 months after intervention delivery. Attempts to stop tobacco use will also be documented. Further, immediately before and after the-intervention tobacco-related cognitions (intention to stop tobacco use and self-efficacy regarding tobacco use cessation) will be assessed using validated measures (27). Smokers will be asked to indicate their intention to stop tobacco use in the next month on two 7-point Likert-type response scales ranging from very likely to very unlikely or from definitely will not to definitely will. Self-efficacy (the belief that one can do something, e.g., change a given behaviour) will be assessed by asking participants on 7-point rating scales how confident they are to be able to stop tobacco use (from very confident to not at all confident). In addition, satisfaction with the yogic breathing exercises will be assessed immediately at the end of the delivery of intervention in the YBA group only. Participants will also be asked questions about the usefulness of yogic breathing and the frequency of use of these exercises

at the 4 week follow up. Sample Size

For a two group comparison of proportions of a binary outcome with a standard alpha of 0.05, 390 individuals per group, or a total of 780 individuals, would provide 90% power to detect a difference of 5% between the intervention (YBA) group (7%) and the control (VBA) group (2%) in two-tailed analysis (28). As this sample size is based on individual randomisation, this sample size has to be inflated for the design effect (Deff) of clustering. The sample size taking into account the clustering designated as mcluster is obtained by multiplying the individual randomisation sample size by the design effect. Therefore, the sample size required is calculated as mcluster = Deffx mindividual. The design effect is calculated as = 1 + (n* - 1) x ICC where n* = average cluster size and ICC = intra-cluster correlation co-

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efficient. The ICC is defined as the ratio of the between cluster variance to the total variance. Since there are no directly applicable values of ICC for our study, it is advised to calculate the sample size for a range of design effects. Intra-cluster correlation co-efficient values in the public health context are typically very small at around 0.001 (28). Given the fixed number of clusters and estimates from the uncorrected power analysis, the average cluster size is approximately 24.4 [=780/32], resulting in a design effect of 1.024 [=1+ (25-1) x0.001] or, using an ICC a magnitude larger at 0.01, in a design effect of 1.24. The required total sample size to detect an effect with 90% power is therefore 967 [=780x1.24], i.e. around 484 participants in each arm, or a minimum of 30.2 [=967/32] participants from each cluster, assuming equal cluster size. Rounding this off to the next whole number, it is proposed to recruit a total of 992 [=31x32] participants into this study. This sample size provides sufficient power at 90% to detect significant differences for an expected design effect of 1.24 and at 80% power for correspondingly higher design effects of up to 1.84 (or ICCs of up to 0.035). Data analysis and management

Case report forms (CRF) will be prepared. All data will be entered directly into the CRF; there will be no other source documents. Data entry will be into an SPSS database. Data will be cleaned to check for any data entry errors or inconsistencies prior to analysis. On completion, data will be analysed using the SPSS statistical package. The database will be prepared with English labels and variable names. Data analysis will be undertaken by the investigators and members of the study team as appropriate. Main analysis

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An intention to treat analysis will be conducted to account for any participants lost to follow up. The odds ratio and 95% confidence interval for tobacco cessation rates, provided by the primary and secondary outcome, in the intervention compared with control condition will be calculated with univariate logistic regression analysis using complex samples procedure to adjust for clustering. In sensitivity analysis, both groups will also be compared using a complex samples multivariate logistic regression model, adjusting for all baseline characteristics, in order to account for chance imbalances in the distribution of predictive baseline characteristics. Comparisons on other secondary outcomes will be by complex samples chi-square, logistic regression or analyses of variance depending on the scale of measurement.

Subgroup analyses

Planned subgroup analyses will involve separate estimation of effect sizes for users of smokeless and combustible tobacco products. Discussion

This study is set up to be a pivotal trial evaluating a low cost, easily scalable, nonpharmacological intervention for supporting adult tobacco users to quit tobacco use, specifically designed for application in low to middle income countries such as India. It attempts to follow the MRC guideline for developing and evaluating complex interventions which states that complex interventions may work best if tailored to local circumstances rather than being completely standardised (29). Ideally a no-intervention control arm would be included to test the full effect of the experimental intervention. However, in anticipation that this would be considered unethical, a very brief advice condition is used as the control. Thus the effect of the experimental intervention may be underestimated. Moreover, it is

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recognised that the design will not permit dissociation of the effect of the breathing exercises from quit advice. However, a three-arm trial would be too costly. Since the priority at this stage is to identify a cost-effective, scalable intervention that is maximally effective, this pragmatic study design was adopted. Quit advice has been proven to be slightly more effective if there are follow up sessions (9), but since follow up sessions would not be an easily scalable intervention, only a single quit advice session without any follow up visits was selected for evaluation. Following the same rationale, only a single session of training for simple beginner level, effective, yogic breathing exercises instead of multiple training sessions for yogic breathing exercises were adopted for this study.

If the intervention is found to be effective, it could inform tobacco cessation support policy at the national and international level by providing a low cost, non-physician dependent, easily scalable option for the government to deliver to the 275 million tobacco users in India and benefit millions of tobacco users in the country to quit.

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Governance and Ethical considerations The trial will conform to the UCL ethical procedures and subject to oversight by the UCL Ethics Committee, London, U.K. and PHFI Ethics Committee, New Delhi, India. UCL Ethics Registration ID: 3051/ 002; Data Protection Registration: Ref No Z6364106/ 2011/ 05/ 37. The study has received approval from UCL Research Ethics (3051/002 dated 20 Oct2011) and Institutional Ethics Committee, Public Health Foundation of India, New Delhi, India (TRC-IEC-122/11 dated 23 Feb2012). The protocol has also been registered at ISRCTN with trial registration No: ISRCTN23362894 and acronym BABEX. Funding

This work was supported by a Wellcome Trust Capacity Strengthening Strategic Award to Public Health Foundation of India & a consortium of U.K Universities (WTP grant reference no: 6936) with additional support from Cancer Research, U.K.

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References
1. Global Adult Tobacco Survey (GATS INDIA), 2009-2010. New Delhi: Ministry of Health and Family Welfare, Government of India2010. 2. Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Medicine. 2006;3(11):e442. 3. WHO Report on the Global Tobacco Epidemic, 2008: The MPOWER package. Geneva: World Health Organization2008. 4. Jha P, Jacob B, Gajalakhshmi V, Gupta PC, Dhingra N, Kumar R, et al. A Nationally representative Case-Control study of smoking and death in India. New England Journal of Medicine. 2008;358:1137-47. 5. West R. The clinical significance of small effects of smoking cessation treatments. Addiction. 2007;102(4):506-9. 6. Stead L.F BG, Lancaster T. Physician advice for smoking cessation. Cochrane Database Syst Rev. 2008(2):Art. No : CD000165. 7. Lancaster T, Stead L. Physician advice for smoking cessation. Cochrane database of systematic reviews (Online). 2004;4(CD000165.). 8. Lancaster T, . LS, . Individual behavioural counselling for smoking cessation. . Cochrane Database of Systematic Reviews. 2005;Art. No.: CD001292. (Issue 2). 9. Stead LF, Bergson G, Lancaster T. Physician advice for smoking cessation ( Review). Cochrane database of systematic reviews (Online). 2008;CD000165(2):1-55. 10. Stead L, T Lancaster. Group behaviour therapy programmes for smoking cessation- 2005. Cochrane Database of Systematic Reviews. 2009; Art. No.: CD001007( Issue 2). 11. Aveyard P, Begh R, Parsons A, Robert W. Brief opportunistic smoking cessation interventions: a systematic review and meta-analysis to compare advice to quit and offer of assistance. Addiction. [Review]. 2011;107:1066-73. 12. Fact sheet July 2012: ASH, UK2012 July 2012. 13. Murthy P, Saddichha S. Tobacco cessation services in India: Recent developments and the need for expansion. Indian Journal of Cancer. 2010;47(suppl 1). 14. McClernon FJ, Westman EC, Rose JE. The effects of controlled deep breathing on smoking withdrawal symptoms in dependent smokers. Addictive Behaviors. 2004;29(4):765-72. 15. Shahab L, Sarkar BK, West R. The acute effects of yogic breathing exercises on craving and withdrawal symptoms in abstaining smokers. Psychopharmacology (Berl). 2012 20 september 2012;online first. 16. West R, McNeill A, Raw M. Smoking cessation guidelines for health professionals: an update. Thorax. 2000;55(12):987-99. 17. Kober H, Kross EF, Mischel W, Hart CL, Ochsner KN. Regulation of craving by cognitive strategies in cigarette smokers. Drug and Alcohol Dependence. 2010;106(1):52-5. 18. Kochupillai V, Kumar P, Singh D, Aggarwal D, Bhardwaj N, Bhutani M, et al. Effect of Rhythmic Breathing (Sudarshan Kriya and Pranayam) on Immune Functions and Tobacco Addiction. Annals of the New York Academy of Sciences. 2005;1056(1):242-52. 19. Raw M, McNeill A, Rachael M. Case studies of tobacco dependence treatment in Brazil, England, India, South Africa and Uruguay. Addiction. 2010;105:1721-8. 20. Michie S, Hyder N, Walia A, West R. Development of a taxonomy of behavioural support for smoking cessation. Addictive Behaviors. 2011;36:315-9. 21. West R, Walia A, Hyder N, Shahab L, Michie S. Behaviour change techniques used by the English Stop Smoking Services and their association with short term outcomes. Nicotine & tobacco research advance access 2010. 22. Borrelli B. The assessment, monitoring, and enhancement of treatment fidelity in public health clinical trials. Journal of Public Health Dentistry. [Invited paper]. 2011;71:552-63. 23. Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. British journal of addiction. 1991 Sep;86(9):1119-27. 24. Ebbert JO, Patten CA, Schroeder DR. The Fagerstrom Test for Nicotine Dependence-Smokeless Tobacco (FTND-ST). Addictive Behaviors. [Randomized Controlled Trial Research Support, N.I.H., Extramural]. 2006 Sep;31(9):1716-21. 25. Watts RR, Langone JJ, Knight GJ, Lewtas J. Cotinine analytical workshop report: consideration of analytical methods for determining cotinine in human body fluids as a measure of passive exposure to tobacco smoke. Environ Health Perspect. [Review]. 1990 Mar;84:173-82.

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26. Alterman AI, Gariti P, Niedbala RS. Varying results for immunoassay screening kits for cotinine level. Psychol Addict Behav. [Evaluation Studies Research Support, U.S. Gov't, P.H.S.]. 2002 Sep;16(3):256-9. 27. Hall S, Bishop AJ, Marteau TM. Increasing readiness to stop smoking in women undergoing cervical screening: evaluation of two leaflets. Nicotine Tob Res. 2003 Dec;5(6):821-6. 28. Machin D, Campbell MJ, Tan SB, Tan SH. Sample Size Tables for Clinical Studies. with CD Rom. 3rd edition ed. Singapore: Wiley Blackwell; 2009. 29. Craig P, Dieppe P, Macintyre S, Mitchie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new MRC guidelines. British Medical Journal. 2008;337:a1655.

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Tables Table 1: Breathing exercise instructions^ KAPALBHATI Normal inhalation-forceful exhalation (1-2 minutes-on empty stomach once in morning) Start by breathing deeply: inhale slowly and deeply filling up your abdomen, then fill up your rib cage up to your collar bone and then exhale slowly, emptying your rib cage and then pull in your abdomen emptying it fully. Repeat a few times. Now, inhale your breath naturally and exhale forcefully (moderate force) with drawing in/ pulling in of the abdomen Do this natural inhale- forcefully exhale cycle repeatedly for a period of 1 minute and then rest by breathing normally. Do this for one minute at a time, rest by normal breathing in between to a total duration of 2 to 3 minutes for the first few days and then you can gradually increase the duration. Increase the duration to 5 minutes over a period of 2 months. Do not strain yourself and stop at any point time if you feel exhausted. Rest by breathing normally for half a minute before next exercise. ANULOM VILOM Alternate nostril inhalation-exhalation (3 minutes in morning and then for cravings during the day) Sit in a comfortable position with the back straight and upright Fold the fore and middle fingers of your hand into the palm and position your hand on the bridge of your nose to enable use of your thumb and the ring finger to close the nostrils alternatively. Close the right nostril with the thumb of your right hand and breathe in deeply inhaling through the left nostril, then close the left nostril with your ring finger and release the thumb from the right nostril and now exhale through the right nostril Then inhale through the right nostril, close the right nostril and exhale through the left nostril Now inhale through the left nostril, close the left nostril and exhale through right nostril.

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^ In this study a set of two simple, beginner level breathing exercises will be taught to participants. These breathing exercises are based on yogic pranayama recommended by Yoga Guru Swami Ramdev, Haridwar, India, for use for the general population. The participants will be shown a short video demonstration of the breathing exercises and will then be trained to undertake the exercises on their own for about 5 minutes.The breathing exercises should be done in an upright sitting position. This can then be repeated during the day based on need and feasibility.

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Table 2: BCT analysis of intervention and control conditions of the BABEX trial INTERVENTION CONDITION (Brief advice + yogic breathing) BM1- provide information on the consequences of smoking and smoking cessation BM5- Provide normative information on others behaviours and experiences BM9- Help identify reasons for wanting and not wanting to stop smoking *BS2- Relapse prevention and coping BS3- facilitate action planning/develop treatment plan BS6- prompt self-recording BM10- Emphasise the importance of abrupt cessation BS11- Advise on avoidance of cues for smoking BS14- Teach relaxation techniques *A1- Advise on stop smoking medications *A2- Advise on/facilitate use of social support RC4- Provide expectations regarding the treatment programme RC5- offer/direct towards appropriate written materials RC6- provide information on withdrawal symptoms *RC9- Summarise information/ confirm client decisions CONTROL (Very brief advice) BM1-provide information on the consequences of smoking and smoking cessation RC4- Provide expectations regarding the treatment programme

*Indicates BCT shown to be associated with improved four-week CO-validated quit outcomes in English Smoking Cessation services (21)

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