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Completed

NCT Number: NCT02855255

Study Comparing Two Stop Smoking Intervention Efficacies

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

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London South Bank University

London, SE1 0AA, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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) .

Treatment and study plan

NHS 1-1 smoking cessation programme.

Behavioral

Smoking cessation using cognitive behavioural therapy/motivational interviewing

Group smoking cessation programme

Behavioral

Smoking cessation using Allen Carr's Easyway method being delivered in a spoken form.

Primary outcomes

  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 outcomes

  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'.

Sponsors and collaborators

Lead sponsor

London South Bank University

Other

Collaborators

  • Allen Carr Easyway
  • NHS Lambeth
  • NHS Southwark CCG

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 4, 2016
Registry last updated
Mar 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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