Smoking CessationNCT02855255
Study Comparing Two Stop Smoking Intervention Efficacies
A study testing NHS 1-1 smoking cessation programme. and Group smoking cessation programme in people with Smoking Cessation, run by London South Bank University at 1 site in United Kingdom.
Trial summary
The proposed study will compare the efficacy of two psychological stop smoking interventions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- NHS 1-1 smoking cessation programme. and Group smoking cessation programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 620 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2017to 25 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current smoker Aged over 18 Prepared to be assigned randomly to one of two treatment conditions (NHS standard provision or Allen Carr's Easyway) Intend to quit smoking cigarettes.
Who cannot join
- Individuals who would prefer an NHS provided treatment Currently in another RCT or similar research project Have a mental health condition Are pregnant Have a respiratory disease (such as chronic obstructive pulmonary disease or emphysema).
- Unable to reach the treatment locations (London South Bank Universities Southwark Campus or SW20) .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the 26 Week Efficacy of Allen Carr's Easyway to Stop Smoking and NHS 1-1 Counselling Provision
The proposed study will compare the efficacy of two psychological stop smoking interventions.
Read the detailed description
The proposed study comprises a randomised controlled trial (n = 620) which will compare the efficacy of two psychological stop smoking interventions. Specifically, Allen Carr's Easyway smoking cessation programme comprising one 5/6 hour group session (plus one or two 3 hour booster sessions over the following 3 months for those who require them) and a 1-1 counselling service available via the NHS (comprising one 30 minute session and four weekly follow ups of 10-15 minutes) will be compared. The efficacy of both treatments will be followed up at 4, 12 and 26 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 findings will add to the evidence base around the use of the Allen Carr method, in particular by testing it in non-commercial settings.
- Conditions
- Smoking Cessation
- Being tested
- NHS 1-1 smoking cessation programme., Group smoking cessation programme
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NHS 1-1 smoking cessation programme.Behavioural
Smoking cessation using cognitive behavioural therapy/motivational interviewing
Group smoking cessation programmeBehavioural
Smoking cessation using Allen Carr's Easyway method being delivered in a spoken form.
| Study group | Role | What they receive |
|---|---|---|
| NHS smoking cessation | Active comparator | NHS 1-1 smoking cessation programme. One thirty minute session followed by up to five shorter sessions (approx.10/15minutes) comprising Cognitive Behavioural Therapy/Motivational Interviewing to assist with smoking cessation. Receives: Behavioral: NHS 1-1 smoking cessation programme. |
| Allen Carr's Easyway smoking cessation | Active comparator | Group smoking cessation programme. One 5/6 hour group session (plus one or two 3 hour booster sessions over the following 3 months for those who require them) comprising of Allen Carr's Easyway method being delivered in a spoken form. Receives: Behavioral: Group smoking cessation programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cessation of smoking
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.
Measured: 26 weeks post treatment commencement
Secondary outcomes (5)
Self-reported maintenance of smoking cessation questions
current cessation, number of slips, number of cigarettes in past week/month/since last session.
Measured: 4, 12, 26 weeks post treatment commencement
The Satisfaction with Life Scale (Diener, Emmons, Larsen, & Griffin, 1985).
A 5-item scale designed to measure global cognitive judgements of one's life satisfaction. Participants indicate how much they agree or disagree with each of the 5-items using a 7-point scale that ranges from 7 Strongly agree to 1 Strongly disagree.
Measured: Baseline and 4, 12, 26 weeks post treatment commencement
Survey assessing use of Nicotine replacement therapy/nicotine containing products
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.
Measured: 4, 12, 26 weeks post treatment commencement
Quit efficacy questionnaire
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'.
Measured: Baseline, 4, 12, 26 weeks post treatment commencement
Perceived value of being nicotine free - Questionnaire
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'.
Measured: 4, 12, 26 weeks post treatment commencement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study start1 Feb 2017
- Primary completion25 May 2018
- Study completion25 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 620 participants (actual)
Sponsor and investigators
- Lead sponsor
- London South Bank University
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lambeth, NHS Southwark CCG, Allen Carr Easyway
- Responsible party
- Sponsor
- Investigators
- Daniel Frings, PhD, Principal investigator, London South Bank University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02855255
- Sponsor's protocol ID
- 7697
- Status last verified
- Mar 2019
- First submitted
- 7 Jul 2016
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared at participant by participant level in an anonymous form via it being lodged with an appropriate data repository, alongside London South Bank University's own repository.
Publications
Wood KV, Albery IP, Moss AC, White S, Frings D. Study protocol for a randomised controlled trial of Allen Carr's Easyway programme versus Lambeth and Southwark NHS for smoking cessation. BMJ Open. 2017 Dec 14;7(12):e016867. doi: 10.1136/bmjopen-2017-016867.
PubMed 29247083
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the 26 Week Efficacy of Allen Carr's Easyway to Stop Smoking and NHS 1-1 Counselling Provision
- ClinicalTrials.gov ID
- NCT02855255
- Acronym / sponsor ID
- 7697
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 620 participants (actual)
- Lead sponsor
- London South Bank UniversityUniversity, hospital or other
- Collaborators
- NHS Lambeth, NHS Southwark CCG, Allen Carr Easyway
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 25 May 2018 (actual)
- Study completion
- 25 May 2018 (actual)
- First posted
- 4 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study will compare the efficacy of two psychological stop smoking interventions.
Detailed description
The proposed study comprises a randomised controlled trial (n = 620) which will compare the efficacy of two psychological stop smoking interventions. Specifically, Allen Carr's Easyway smoking cessation programme comprising one 5/6 hour group session (plus one or two 3 hour booster sessions over the following 3 months for those who require them) and a 1-1 counselling service available via the NHS (comprising one 30 minute session and four weekly follow ups of 10-15 minutes) will be compared. The efficacy of both treatments will be followed up at 4, 12 and 26 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 findings will add to the evidence base around the use of the Allen Carr method, in particular by testing it in non-commercial settings.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NHS smoking cessation | Active comparator | Behavioral: NHS 1-1 smoking cessation programme.NHS 1-1 smoking cessation programme. One thirty minute session followed by up to five shorter sessions (approx.10/15minutes) comprising Cognitive Behavioural Therapy/Motivational Interviewing to assist with smoking cessation. |
| Allen Carr's Easyway smoking cessation | Active comparator | Behavioral: Group smoking cessation programmeGroup smoking cessation programme. One 5/6 hour group session (plus one or two 3 hour booster sessions over the following 3 months for those who require them) comprising of Allen Carr's Easyway method being delivered in a spoken form. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Current smoker Aged over 18 Prepared to be assigned randomly to one of two treatment conditions (NHS standard provision or Allen Carr's Easyway) Intend to quit smoking cigarettes.
Key exclusion criteria (2 listed)
- Individuals who would prefer an NHS provided treatment Currently in another RCT or similar research project Have a mental health condition Are pregnant Have a respiratory disease (such as chronic obstructive pulmonary disease or emphysema).
- Unable to reach the treatment locations (London South Bank Universities Southwark Campus or SW20) .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NHS 1-1 smoking cessation programme.Smoking cessation using cognitive behavioural therapy/motivational interviewing | Behavioural | NHS smoking cessation |
| Group smoking cessation programmeSmoking cessation using Allen Carr's Easyway method being delivered in a spoken form. | Behavioural | Allen Carr's Easyway smoking cessation |
Primary outcome
Cessation of smoking
Time frame: 26 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.
5 secondary outcomes
Self-reported maintenance of smoking cessation questions
Time frame: 4, 12, 26 weeks post treatment commencement
The Satisfaction with Life Scale (Diener, Emmons, Larsen, & Griffin, 1985).
Time frame: Baseline and 4, 12, 26 weeks post treatment commencement
Survey assessing use of Nicotine replacement therapy/nicotine containing products
Time frame: 4, 12, 26 weeks post treatment commencement
Quit efficacy questionnaire
Time frame: Baseline, 4, 12, 26 weeks post treatment commencement
Perceived value of being nicotine free - Questionnaire
Time frame: 4, 12, 26 weeks post treatment commencement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
- Derived from this study: PubMed 29247083Wood KV, Albery IP, Moss AC, White S, Frings D. Study protocol for a randomised controlled trial of Allen Carr's Easyway programme versus Lambeth and Southwark NHS for smoking cessation. BMJ Open. 2017 Dec 14;7(12):e016867. doi: 10.1136/bmjopen-2017-016867.
- Individual participant dataSharing planned: Yes. Data will be shared at participant by participant level in an anonymous form via it being lodged with an appropriate data repository, alongside London South Bank University's own repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Frings, PhD principal investigator
London South Bank University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NHS 1-1 smoking cessation programme. and Group smoking cessation programme in people with Smoking Cessation, run by London South Bank University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cessation of smoking (time frame: 26 weeks post treatment commencement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02855255, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2019.