Study Comparing Two Stop Smoking Intervention Efficacies

Study Overview
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Brief Summary
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The proposed study will compare the efficacy of two psychological stop smoking interventions.

Detailed Description
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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.

Official Title
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Comparing the 26 Week Efficacy of Allen Carr's Easyway to Stop Smoking and NHS 1-1 Counselling Provision

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: NHS 1-1 smoking cessation programme.
* Behavioral: Group smoking cessation programme


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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) .

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NHS smoking cessation<br>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. | Behavioral: NHS 1-1 smoking cessation programme.<br>* Smoking cessation using cognitive behavioural therapy/motivational interviewing<br>|
| Active Comparator: Allen Carr's Easyway smoking cessation<br>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. | Behavioral: Group smoking cessation programme<br>* Smoking cessation using Allen Carr's Easyway method being delivered in a spoken form.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 26 weeks post treatment commencement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported maintenance of smoking cessation questions | current cessation, number of slips, number of cigarettes in past week/month/since last session. | 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. | 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. | 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'. | 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'. | 4, 12, 26 weeks post treatment commencement |