Condition category
Mental and Behavioural Disorders
Date applied
30/08/2016
Date assigned
28/09/2016
Last edited
23/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

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

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 measures

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

31/01/2018

Reason abandoned

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

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

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

31/01/2019

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes