Study Comparing Two Stop Smoking Intervention Efficacies

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02855255
• Other study ID #: 7697
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: May 25, 2018

Study information

• Verified date: March 2019
• Source: London South Bank University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The proposed study will compare the efficacy of two psychological stop smoking interventions.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 620
• Est. completion date: May 25, 2018
• Est. primary completion date: May 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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) .

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• NHS 1-1 smoking cessation programme.
Smoking cessation using cognitive behavioural therapy/motivational interviewing
• Group smoking cessation programme
Smoking cessation using Allen Carr's Easyway method being delivered in a spoken form.

Locations

Country	Name	City	State
United Kingdom	London South Bank University	London

Sponsors (4)

Lead Sponsor	Collaborator
London South Bank University	Allen Carr Easyway, NHS Lambeth, NHS Southwark CCG

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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