Plain English Summary
Background and study aims
Smoking continues to be a major health problem in the UK. Every year around 100,000 people in the UK die from smoking, with many more living with debilitating smoking-related illnesses. Smoking increases your risk of developing more than 50 serious health conditions, including cancer, heart disease and lung disease. It is important to understand the effectiveness of the various interventions designed to help people quit. The aim of this study is to compare the effectiveness of two stop smoking interventions amongst people living and working in the Lambeth and Southwark boroughs of London.
Who can participate?
Current smokers aged over 18 living and working in the Lambeth and Southwark boroughs of London.
What does the study involve?
Participants are randomly allocated to one of two groups. Participants in one group attend Allen Carr's Easyway to stop smoking programme, which consists of one 5/6-hour group session, plus one or two 3-hour booster sessions over the following 3 months for those who require them. Participants in the other group attend a 1-1 counselling service available via the NHS, consisting of one 30-minute session and four weekly follow-ups of 10-15 minutes. The effectiveness of both treatments is followed up at 4, 12 and 24 weeks after treatment. Participants’ success at stopping smoking is confirmed by breath testing. Participants’ continued use of nicotine-containing products (e.g. e-cigarettes, nicotine replacement products) and life satisfaction are also assessed.
What are the possible benefits and risks of participating?
The results of this study will add to the evidence around the use of the Allen Carr method. The Allen Carr method has yet to be NICE approved. We ensure that participants are aware of this and offer them NHS treatment before joining the study, and also offer them an NHS referral if they fail to quit during the study. Participants need to attend treatment and follow-up sessions, which may be an inconvenience. We ensure participants can schedule appointments at evenings and weekends, and are compensated for travel costs and time.
Where is the study run from?
London South Bank University (UK)
When is the study starting and how long is it expected to run for?
June 2016 to January 2018
Who is funding the study?
Allen Carr's Easyway (International) Ltd
Who is the main contact?
Dr Daniel Frings
Trial website
Contact information
Type
Scientific
Primary contact
Dr Daniel Frings
ORCID ID
http://orcid.org/0000-0002-0183-9516
Contact details
London South Bank University
103 Borough Road
London
SE1 0AA.
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT02855255
Protocol/serial number
RC7697
Study information
Scientific title
Comparing the 24-week efficacy of Allen Carr's Easyway to stop smoking and NHS 1-1 counselling provision amongst people living and working in the Lambeth and Southwark boroughs of London
Acronym
Study hypothesis
By comparing the Allen Carr's Easyway (ACE) method to a NHS-delivered treatment program, an estimate of the relative effectiveness of both methods (and associated costs) can be made. This will potentially inform future judgements about the use of this method by private and public healthcare providers.
Ethics approval
Submitted to Fulham Research Ethics Committee, London - pending
Study design
Single-centre, blinded between subjects, two-armed randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Smoking
Intervention
Participants are randomly allocated to either Allen Carr's Easyway to stop smoking programme or NHS 1-1 counselling service, using an adaptive randomisation programme to balance levels of prior smoking, number of prior quit attempts, age and gender.
1. Allen Carr's Easyway to stop smoking programme comprises one 5/6 hour group session (plus one or two 3 hour booster sessions over the following 3 months for those who require them)
2. The 1-1 counselling service available via the NHS comprises one 30-minute session and four weekly follow-ups of 10-15 minutes.
The efficacy of both treatments will be followed up at 4, 12 and 24 weeks after treatment. The evaluation will be compliant with the Russell 6 Standard (which requires, amongst other things, a double blind, randomised design, chemical verification of quit outcomes, and the inclusion of all participants who received treatment in the final analysis). The research team will also be blinded to participants' condition.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Cessation of smoking 24 weeks post treatment commencement, measured in line with the Russell 6 standard (i.e. fewer than 5 incidents of smoking from the quit date, including all participants lost to follow-up as failed treatment, and confirming all successful quits via breath carbon monoxide testing). The intention to treat principle will be followed and those lost to follow-up will be considered failed quit.
Secondary outcome measures
1. Self-reported maintenance of smoking cessation questions, measured at 4, 12, 24 weeks post treatment commencement; current cessation, number of slips, number of cigarettes in past week/month/since last session.
2. The Satisfaction with Life Scale (Diener, Emmons, Larsen, & Griffin, 1985), measured at baseline and 4, 12, 24 weeks post treatment commencement
3. Survey assessing use of nicotine replacement therapy/nicotine containing products, measured at 4, 12, 24 weeks post treatment commencement. Participants will be asked to answer Yes/No to the following: 'Since we last met, have you regularly used any of the following?' and 'Are you planning on using any of the following in the future?' E-cigarettes, nicotine patches, nicotine gum, other
4. Quit efficacy measured at baseline, 4, 12, 24 weeks post treatment commencement. Measured on a scale of 1-7 (strongly disagree - strongly agree), to the following items: 'I can achieve my aims to quit smoking', 'I can cope with the demands of quitting smoking', 'It is unlikely that I will do well at quitting smoking', 'I think I can perform well at quitting smoking'
5. Perceived value of being nicotine free measured at 4, 12, 24 weeks post treatment commencement. Measured on a scale of 1-7 (strongly disagree - strongly agree), to the following items: 'Being nicotine free is of value to me', 'I value being nicotine free', 'Having no nicotine in my system is/would be beneficial to me'
Overall trial start date
01/06/2016
Overall trial end date
31/07/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Current smoker aged over 18
2. Resident or work in Lambeth/Southwark areas
3. Prepared to be assigned randomly to one of two treatment conditions (NHS standard provision or Allen Carr's Easyway)
4. Intend to quit smoking cigarettes
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
620
Total final enrolment
620
Participant exclusion criteria
1. Individuals who would prefer an NHS-provided treatment
2. Currently in another RCT or similar research project
3. Have a mental health condition
4. Are pregnant
5. Have a respiratory disease (such as chronic obstructive pulmonary disease or emphysema)
6. Unable to reach the treatment locations (London South Bank Universities Southwark Campus or SW20)
Recruitment start date
01/01/2017
Recruitment end date
01/01/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
London South Bank University
103 Borough Road
London
SE1 0AA
United Kingdom
Sponsor information
Organisation
London South Bank University
Sponsor details
103 Borough Road
London
SE1 0AA
United Kingdom
+44 (0)20 7815 7815
fringsd@lsbu.ac.uk
Sponsor type
University/education
Website
Organisation
Allen Carr's Easyway (International) Ltd
Sponsor details
Park House
14 Pepys Road
Raynes Park
London
SW20 8NH
United Kingdom
Sponsor type
Industry
Website
Organisation
London South Bank University
Sponsor details
Sponsor type
Not defined
Website
Funders
Funder type
Industry
Funder name
Allen Carr's Easyway (International) Ltd
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
A study protocol is currently being prepared. At the end of the study, a non-technical summary of the results will be prepared for participants. Manuscripts will be prepared for publication in peer-reviewed journals and conference presentations prepared and delivered at relevant conferences.
Intention to publish date
31/08/2019
Participant level data
Stored in repository
Basic results (scientific)
Publication list
2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29247083
2020 results in https://www.ncbi.nlm.nih.gov/pubmed/31968400 (added 12/02/2020)