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Study Comparing Two Stop Smoking Intervention Efficacies

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ClinicalTrials.gov Identifier: NCT02855255
Recruitment Status : Completed
First Posted : August 4, 2016
Last Update Posted : March 25, 2019
Sponsor:
Collaborators:
NHS Lambeth
NHS Southwark CCG
Allen Carr Easyway
Information provided by (Responsible Party):
London South Bank University

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

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: NHS 1-1 smoking cessation programme. Behavioral: Group smoking cessation programme Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 620 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Official Title: Comparing the 26 Week Efficacy of Allen Carr's Easyway to Stop Smoking and NHS 1-1 Counselling Provision
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : May 25, 2018
Actual Study Completion Date : May 25, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: NHS smoking cessation
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.
Smoking cessation using cognitive behavioural therapy/motivational interviewing
Active Comparator: Allen Carr's Easyway smoking cessation
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
Smoking cessation using Allen Carr's Easyway method being delivered in a spoken form.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Self-reported maintenance of smoking cessation questions [ Time Frame: 4, 12, 26 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). [ Time Frame: 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.

  3. Survey assessing use of Nicotine replacement therapy/nicotine containing products [ Time Frame: 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.

  4. Quit efficacy questionnaire [ Time Frame: 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'.

  5. Perceived value of being nicotine free - Questionnaire [ Time Frame: 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'.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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) .

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02855255


Locations
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United Kingdom
London South Bank University
London, United Kingdom, SE1 0AA
Sponsors and Collaborators
London South Bank University
NHS Lambeth
NHS Southwark CCG
Allen Carr Easyway
Investigators
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Principal Investigator: Daniel Frings, PhD London South Bank University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: London South Bank University
ClinicalTrials.gov Identifier: NCT02855255    
Other Study ID Numbers: 7697
First Posted: August 4, 2016    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No