1.3.1. General Participant Information Sheet (1 of 3)
Participant Information Sheet Study title: Towards treatment stratification for successful smoking cessation: Harnessing predictive neurocognitive models. Thank you for expressing an interest in our research. It is being conducted in the Trinity College Institute of Neuroscience, Trinity College Dublin by Aoife Sweeney (MSc.) and various other researchers under the supervision of Prof. Robert Whelan and Dr. Nigel Vahey. What is this research about? Our research at Trinity College Dublin aims to use a harmless neuroimaging technique called electroencephalography (EEG) to improve how clinicians identify what smoking-cessation supports are best suited to each smoker's particular needs. By combining these brain activity measurements with the results of psychological tasks, we are seeking to identify what support techniques are most likely to help a given type of smoker to quit smoking. With this in mind, if you agree to participate you will be randomly assigned to receive one of three cutting-edge support packages designed to help you quit smoking in a caring and non-judgemental fashion. This will allow us to compare how well each of these three different types of support package work for the different types of smokers taking part in our research. For this reason we will ask you to refrain from using any other smoking-cessation supports during your participation in this study; and also to refrain from discussing your support package with anyone else who might be involved in our research. What are the benefits of taking part in this research study? You will dramatically improve your chances of successfully quitting smoking by engaging with the support package that we assign you as part of our research. You will also receive â‚Ź20 from us for each such visit (of which there will be a maximum of three) as a token of our appreciation for your involvement in our study. Moreover, you will receive up to â‚Ź10 in receipted travel expenses for each time you visit Trinity College Institute of Neuroscience as part of this study. Lastly and perhaps most importantly, your willingness to participate in our research represents an important contribution to the science of helping smokers to regain their freedom from smoking. Are there any risks involved in taking part in this research study? If you decide to participate, you will complete a range of computer-based tasks and questionnaires. It is possible that you may experience feelings of fatigue, frustration, anxiety or distress due to the length of each research session, which typically last between 2-3 hours. In order to minimize any such possibility we will encourage you to take multiple rest breaks during each research session. Also, the following free confidential listening services will help you cope with any such difficult feelings that might arise during your participation: Samaritans provide immediate support for anyone experiencing psychological distress. Freephone: 116 123. Website: www.samaritans.org 1
1.3.1. General Participant Information Sheet (2 of 3) Niteline is a listening, support and information service run by and for the students of UCD, TCD, DCU, NUIM, NCAD, and RCSI. It is open during term from 9pm-2:30am. Freephone: 1800 793 793. Online Listening: http://www.niteline.ie/onlinelistening.php Why have I been provided with information about this research? You have been provided with this information because you expressed an interest in abstaining from smoking and in taking part in this study. In order to participate in the study, you must (1) be aged 18-70 years, (2) have regularly smoked at least 5-10 cigarettes per day for at least the past 12 months; (4) have daily access to a smartphone that is compatible with apps downloaded from iTunes or Google Play, (5) have no history of hospitalization due to brain injury, and (6) be free from any serious psychiatric diagnoses (i.e. not including mild depression/anxiety). What is involved if I agree? All participants will be required to first complete a preliminary online questionnaire at home – this will usually take 40-60 minutes to complete. On the following day they will then be required to attend an initial ‘baseline’ assessment session in our offices in Trinity College lasting 2-3 hours during the day before they choose to quit smoking. After completing these tasks and questionnaires, you will receive details of the particular evidence-based smokingcessation support package that has been randomly assigned to you. It is absolutely essential that you do not discuss the details of these support packages with other (potential) participants in the current study – otherwise, it will not be possible for us to scientifically compare the effects of one support package to another without their effects being mixed up with each other. Then, as long as you remain abstinent from smoking, you will be required to also attend one 2.5 hour follow-up session 7 days after their baseline session, and another 2.5 hour follow-up session 4 weeks after their baseline session. Each of these three sessions will involve you completing a questionnaire assessing your demographics (e.g. age, gender, etc.), various aspects of your psychology, and of course details of your experience with nicotine and other drug use. In addition, you will also be required to complete a range of computer-based tasks while having your brain activity recorded using electroencephalography (EEG). EEG is a safe and non-invasive method of measuring electrical activity in the brain and poses no risk to you as a participant. In the event that you begin smoking again after your initial quit attempt then you should immediately notify the person coordinating your bookings via email/text (i.e. Psyched2Quit@gmail.com or 0851083260). Regardless of whether you remain abstinent from smoking or not, we will invite you to complete a brief online questionnaire at 2-, 6- and 12-months after your initial quit attempt (i.e. you can complete these questionnaires at home). Note that in order to verify your smoke-free status to the publishers of our research you will be required to provide a breath sample and a saliva sample at each the three EEG measurement sessions mentioned above. In addition, you will also be required to provide two breath samples at random during days 1-6 of your quit attempt at a place of your choosing (within the greater Dublin area) once it is within 12 hours of that sample being requested. Lastly, you will be required to give at least two randomly timed breath and saliva samples during weeks 2-4 of your abstinence. Failing to provide the above samples within 12 hours of being requested by phone text message will automatically classify you as having left the study. 2
1.3.1. General Participant Information Sheet (3 of 3) In the event that you begin smoking again after your initial quit attempt then you should contact us immediately (at Psyched2Quit@gmail.com or at 085-108 3260). This information is crucial to the core aims of our research -- so please do not feel hesitant about sharing it with us. Regardless of whether you remain abstinent from smoking or not, we will still invite you to complete a brief online questionnaire later on at home at three time points (i.e. 2-, 6- and 12-months after your initial quit attempt). How will my data be used? The data generated in this study will be used to learn more about effective interventions for quitting smoking. It will be made anonymous and stored indefinitely in the researcher’s personal archive to allow for re-analysis, ensuring that maximum benefit will be gained from the data. How will my privacy be protected? Information collected as part of the study will remain strictly confidential. Personal details (e.g. name, address) will be kept separate from all other data in a locked storage cabinet only accessible to the researcher and/or their supervisors. However, if the researcher strongly believes that there is a serious risk of harm or danger to either the participant or another individual, or if a serious crime has been committed, it may be necessary for them to reveal some of what you tell them to third parties even without your permission. Can I withdraw from the study? You have the right to withdraw from the study at any time during testing and also have the right to request a break. However, once your data has been collected you will no longer be able to withdraw your data from the study because the file connecting your name and the code assigned to you will be destroyed two weeks following data collection. Therefore, following this initial two-week period after you complete your participation, your data will be unidentifiable. How can I find out what findings and publications emerge from this research? If you would like to find out more about the results of this research, you can contact the researchers below. Contact Details: If you have any further questions or concerns about the study please contact its chief supervisor as follows: Prof. Robert Whelan Address: 1.27 Aras an Phiarsaigh School of Psychology Trinity College Dublin College Green Dublin 2 Email: Psyched2Quit@gmail.com Tel. No.: 085 108 3260
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