Study Comparing Two Stop Smoking Intervention Efficacies
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02855255|
Recruitment Status : Completed
First Posted : August 4, 2016
Last Update Posted : March 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation||Behavioral: NHS 1-1 smoking cessation programme. Behavioral: Group smoking cessation programme||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||620 participants|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- 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'.
- 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'.
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
|London South Bank University|
|London, United Kingdom, SE1 0AA|
|Principal Investigator:||Daniel Frings, PhD||London South Bank University|