Smoking Cessation
Conditions
Brief summary
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.
Interventions
BEHAVIORALNHS 1-1 smoking cessation programme.
Smoking cessation using cognitive behavioural therapy/motivational interviewing
BEHAVIORALGroup smoking cessation programme
Smoking cessation using Allen Carr's Easyway method being delivered in a spoken form.
Sponsors
NHS Lambeth
NHS Southwark CCG
Allen Carr Easyway
London South Bank University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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) .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cessation of smoking | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported maintenance of smoking cessation questions | 4, 12, 26 weeks post treatment commencement | current cessation, number of slips, number of cigarettes in past week/month/since last session. |
| The Satisfaction with Life Scale (Diener, Emmons, Larsen, & Griffin, 1985). | Baseline and 4, 12, 26 weeks post treatment commencement | 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. |
| Survey assessing use of Nicotine replacement therapy/nicotine containing products | 4, 12, 26 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. |
| Quit efficacy questionnaire | Baseline, 4, 12, 26 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'. |
| Perceived value of being nicotine free - Questionnaire | 4, 12, 26 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'. |
Countries
United Kingdom
Outcome results
None listed