The ESCAPE study
THE ESSENTIALS
We want to develop better ways to help people with depression and anxiety to quit smoking.
We have collaboratively designed a smoking cessation intervention with service users, psychologists, and smoking cessation specialists. We are testing the feasibility of incorporating the smoking cessation treatment into routine psychological care for people with depression and anxiety.
This feasibility study will be used to inform a large randomised controlled trial of the intervention that will be tested in NHS psychological therapy services, known as Improving Access to Psychological Therapies (IAPT).
RESEARCH INFORMATION
Why are we doing this research?
Smoking is the world’s leading cause of preventable illness and death. In the UK, smoking rates have decreased from 46% during the 1970s to about 19% in recent years. However, smoking rates in people with mental illness have remained around 37%. People with depression/anxiety are twice as likely to smoke compared to people without depression/anxiety.
Importantly, research suggests that if you give up smoking, this could result in improvements in mental health. People with mental illness are more likely to quit smoking if they receive psychological support, as well as receiving smoking cessation medication.
For these reasons, in this research project we will offer mental health service users help to quit smoking alongside their routine psychological therapy. We want to see if quit smoking treatments are accepted by service users and psychologists, and are feasible and successfully implemented in this setting.
What are the aims of the research?
This research aims to offer service users treatment to quit smoking alongside psychological care. We want to answer these questions:
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Is smoking cessation treatment accepted by service users and psychologists in NHS psychological therapy settings?
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Can smoking cessation treatment be successfully implemented by psychologists in NHS psychological therapy settings?
How will the research findings be shared with the public and scientific community?
Results from this study will be peer-reviewed by service users, and will be:
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Submitted to peer-reviewed, open access journals and presented at conferences.
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Presented to collaborators and the NHS Trusts involved.
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Inform a protocol for a full-sized randomised controlled trial.
Who is running and funding the research?
The study is based in the Department of Psychology at the University of Bath and is funded by Cancer Research UK.
Dr Gemma Taylor, Prof Paul Aveyard, Dr David Kessler, and Prof Marcus Munafò are running the study.
They are part of the UK Centre for Tobacco and Alcohol Studies and the Medical Research Council’s Integrative Epidemiology Unit. Gemma is based at the University of Bath, David and Marcus are based at the University Bristol, and Paul is based at the University of Oxford.
Is the study ethically approved and registered?
The study received ethical approval from the NHS Health Research Authority Research Ethics Committee on March 19, 2018 (REC ID: 18/SW/0043, IRAS project ID: 239339).
The study has been registered with ISRCTN (International Standard Randomised Controlled Trial Number: ISRCTN99531779), which is a primary clinical trial registry recognised by the World Health Organisation.
INFORMATION FOR PARTICIPANTS
Why am I being asked to take part?
You are being asked to take part because you have been referred or self-referred to your local NHS psychological therapies service. We are looking to speak to people who are over (a) 18 years of age or over; (b) are about to attend an assessment at for psychological therapy; (c) have a diagnosis of depression or anxiety; (d) are regular daily smokers.
If you decide to take part, you are free to change your mind at any time without giving a reason. Saying no to the study, or taking part and later changing your mind, will not affect the services you receive from your psychologist or other health care providers.
What will I need to do if I take part?
A researcher will contact you by telephone at least 48-hours before your first psychology treatment appointment. During the phone call the researcher will talk to you about the study and will assess your eligibility to take part.
If you are eligible and happy to take part, you will be assigned to receive one of two smoking cessation treatments, both are proven methods to help people quit smoking. You will also receive a study welcome letter with information about the treatment and contact details for any questions you may have.
During the study your Psychological Wellbeing Practitioner will ask you for some information about your background, your smoking history, and mental health. Three months after you enrol in the study, one of our research team will contact you by telephone to ask you information about your smoking status, mental health, and how you got on with the treatment. If you are successful in quitting, and with your permission the researcher will visit you at your home, or a mutual location to check your carbon monoxide levels.
An optional part of the study will to be to take part in an interview so that we can learn about your experiences in the study. Another optional part of the study is to have your smoking treatment sessions recorded or listened to so that a researcher can determine how the smoking treatment is being delivered. This is to help us understand what we did well, and what we did not so well.
What are the treatments being offered?
Both treatments are very similar and involve behavioural, psychological support and medicine to help you quit. This difference between the treatments is that one will be delivered alongside your psychology therapy, and the other treatment will involve you being referred to your local stop smoking service at the end of your IAPT therapy.
If you were assigned to receive the smoking treatment alongside your psychology therapy, your Psychological Wellbeing Practitioner will talk to you about your smoking for up to 15 minutes during each therapy appointment. You will be guided through behavioural techniques to support you through the quit attempt. Your Psychological Wellbeing Practitioner will also talk about the psychology of quitting, and how quitting might improve your mental health. In addition, you would receive a smoking cessation medication of your choice to help with withdrawal symptoms.
And if you were assigned to receive smoking treatment after your psychology therapy is finished, you will receive a referral to your local stop smoking service. Your local stop smoking service will offer you very similar treatment as described above, and it will be based at their service.
Possible benefits and disadvantages of taking part
Quitting smoking is the best thing you can do for your physical health and your overall wellbeing. Your participation is voluntary, and by taking part you might increase your chances of quitting smoking. Also, the information we get from this study will help us to inform a large clinical trial examining the effectiveness of offering smoking cessation treatment in psychological therapy settings.
There are unlikely to be risks to your personal safety or health by taking part in this study, as all of the treatments offered are clinically proven to be safe. Due to the nature of mental health, you may find taking part overwhelming, and you are welcome to leave the session and withdraw your information at any time and can contact Dr Gemma Taylor to discuss this afterwards. Alternatively, you can contact Sane Mental Health Helpline on 0300 304 7000, or your health care provider.
Who is running and funding the study?
The study is based at the Tobacco and Alcohol Research Group at the University of Bristol and is funded by Cancer Research UK. We are part of the Medical Research Council’s Integrative Epidemiology Unit, and are working in collaboration with the University of Oxford.
Confidentiality and data storage
No identifiable participant data will be made public, and data will be stored in secured premises. Dr Gemma Taylor will have access to participant contact details for the duration of the study for making interview arrangements and if you wish Gemma can send you the study findings. Your contact details will be kept on an encrypted computer in an encrypted password protected spreadsheet, and your contact details will be destroyed when the study is finished (February 2020). If you disclose any information about plans to harm yourself or others, or any information about acts of terrorism the appropriate persons will be contacted.
We will ensure that study data are collected and stored carefully. Interview data collected from participants will be audio recorded, transcribed and anonymised, then transferred to the University of Bristol’s Research Data Storage Facility, a secured database designed for storage of sensitive data. Personal identifiable data will be stored using study identification numbers rather than your name, and will be stored on a password protected spreadsheet on the University of Bristol’s Secured Research Data Storage Facility (https://www.acrc.bris.ac.uk/storage.htm). Hard copies of data sheets linking participants' names to their ID number will be stored in locked filing cabinets in a locked office at the University of Bristol. All personal identifiable data and audio data will be destroyed at the end of the Research programme (February 28, 2020). Upon completion of the project, anonymised data will be uploaded to the University of Bristol’s Research Data Repository (https://data.bris.ac.uk/data/). All data will be anonymised, and data access will be restricted (https://data.bris.ac.uk/sensitive-research-data). Data is made available to approved bona-fide researchers, after they have signed a data access agreement, the person will be granted access to the University of Bristol’s Data Repository (https://data.bris.ac.uk) by the Research Data Services (https://data.blogs.ilrt.org/). Data stored in the repository will have a Data Object identifier (DOI) and will be mentioned during all dissemination of the project.
What if something goes wrong?
If you wish to complain or have any concerns about any aspect of the way you've been approached or treated during this study, please contact Dr Gemma Taylor at g.j.m.taylor@bath.ac.uk, Tel: 0122 38 3379, Mob: 0750 080 4534, or Gemma’s supervisor, Marcus Munafò at marcus.munafo@bristol.ac.uk, Tel: 0117 954 6841.
Will I receive any payment for taking part?
We unfortunately cannot pay you for your participation. But if you choose to take part in an interview after the study is completed – we will reimburse you for reasonable travel expenses to the interview venue.
CONTACT
If you're in Bristol:
Alexandra Hodges
Clinical Studies Officer
Telephone: 0117 919 5886
Email: Alexandra.Hodges@nhs.net
CONTACT
If you're in Bristol:
Alexandra Hodges
Clinical Studies Officer
Telephone: 0117 919 5886
Email: Alexandra.Hodges@nhs.net
CONTACT
If you're in Bristol:
Alexandra Hodges
Clinical Studies Officer
Telephone: 0117 919 5886
Email: Alexandra.Hodges@nhs.net
CONTACT
Chief Investigator
Dr Gemma Taylor
University of Bath, United Kingdom
Tel: 0122 38 3379
Mobile: 0750 080 4534
Email: G.M.J.Taylor@Bath.ac.uk
If you're in Bath:
Monalisa Bora-White
Research Coordinator
Email: monalisa.bora@nhs.net
If you're in North East London:
Ana Cardoso
Clinical Studies Officer
Telephone: 0300 555 1200 ext.53219
Email: ana.cardoso@nelft.nhs.uk
If you're in Oxford:
Talkingspace Plus
Telephone: 01865 901222
Email: talkingspaceplus@nhs.net
If you're in Dudley or Walsall:
Raj Baines
Research Nurse
Telephone: 0121 8031 318 (ext 3378)
Email: rajneet.bains@nhs.net
SMOKING & MENTAL HEALTH
One of the main reasons why smokers with depression or anxiety do not want to quit is because they feel that smoking helps them to cope with their mental health symptoms and other stress. These reasons are often confirmed by health care providers, and up until recently many people with mental health issues have been advised to treat their mental health first, and then try to quit smoking.
Studies show that quitting smoking may improve mental health similar to taking anti-depressants
Studies show that smokers with depression or anxiety can improve their chances of quitting while they are receiving support to cope with depression or anxiety. These improvements can occur as early as 6 weeks after quitting. Improvements in mental health might be a big as if you were to take anti-depressants.
Improvements in mental health can be explained by breaking addiction to tobacco
Nicotine levels reduce about 20 minutes after finishing a cigarette. Because of this, smokers start to experience withdrawal symptoms soon after having a cigarette, feeling low, or anxiety. Therefore, the smoker is in a constant state of withdrawal, with short periods of relief only when they are actively smoking and shortly after finishing a cigarette.
Smokers can mistake the ability of tobacco to relieve withdrawal symptoms to its ability to relieve stress and feeling low.
"Smoking and mental health" video
HOW TO COPE WITH WITHDRAWAL
Coping with tobacco withdrawal
The most important things to remember when quitting smoking, are:
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Withdrawal symptoms and urges to smoke will only last a few moments.
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Withdrawal symptoms will become weaker and less frequent as time goes on.
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Using your stop smoking medication will significantly help with your withdrawal symptoms.
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Most withdrawal symptoms stop 4-weeks after your last cigarette.
Common tobacco withdrawal symptoms
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Feeling low, restlessness, poor concentration, irritability / aggression (these usually last less than a month)
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Urges to smoke or cravings (usually get better over time if the client does not smoke, but can appear for a long time after quitting)
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Increased appetite and weight gain (can last for three months or longer)
Less common symptoms
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Light-headedness (usually lasts less than 48 hours)
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Waking at night (usually for less than a week)
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Mouth ulcers (can last over a month)
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Constipation (can last over a month)
“How-to-cope” video
HOW TO USE YOUR STOP SMOKING MEDICINE
HOW TO USE YOUR STOP SMOKING MEDICINE
Nicotine gum
It is important that you do not use nicotine gum like chewing gum
1. Chew twice, wait for tingle
2. Move between cheek and gums
3. Continue process for 30 minutes
Nicotine gum
It is important that you do not use nicotine gum like chewing gum
1. Chew twice, wait for tingle
2. Move between cheek and gums
3. Continue process for 30 minutes
Nicotine inhaler
1. Inhale into mouth, not lungs
2. It is up to you how many puffs you take, how many and for how long
3. A cartridge will last up to about 40 minutes of intense use
Nicotine mist
1. Unlock the nozzle (slide down the black nozzle, and push gently)
2. Point the nozzle into your open mouth
3. Press down to release mist into your mouth
4. Do not inhale
Nicotine patches
1. Always use a different area of skin to place the new patch
2. Do not use the same area of skin for at least 7-days
Nicotine mini-lozenge
1. Unlock the nozzle (slide down the black nozzle, and push gently)
2. Point the nozzle into your open mouth
3. Press down to release mist into your mouth
4. Do not inhale
E-CIGARETTES & VAPES
E-cigarettes
Some trial participants might choose to use e-cigarettes to aid quitting smoking. It's important to note that:
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Research so far shows that e-cigarettes are 95% less harmful than smoking. See report by Public Health England here.
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E-cigarettes do not contain tobacco, which causes the damage from smoking. They usually contain nicotine, which is addictive but doesn’t cause cancer.
Cancer Research UK animation about e-cigarettes