Clinical trial NCT02855255: Study Comparing Two Stop Smoking Intervention Efficacies
Official title: Comparing the 26 Week Efficacy of Allen Carr's Easyway to Stop Smoking and NHS 1-1 Counselling Provision
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: London South Bank University
Sponsor class: OTHER
Collaborators: name: NHS Lambeth
name: NHS Southwark CCG
name: Allen Carr Easyway
First posted: 2016-08-04
Enrollment: 620
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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) .

Primary outcomes:
measure: Cessation of smoking
timeFrame: 26 weeks post treatment commencement
Secondary outcomes:
measure: Self-reported maintenance of smoking cessation questions
timeFrame: 4, 12, 26 weeks post treatment commencement
measure: The Satisfaction with Life Scale (Diener, Emmons, Larsen, & Griffin, 1985).
timeFrame: Baseline and 4, 12, 26 weeks post treatment commencement
measure: Survey assessing use of Nicotine replacement therapy/nicotine containing products
timeFrame: 4, 12, 26 weeks post treatment commencement
measure: Quit efficacy questionnaire
timeFrame: Baseline, 4, 12, 26 weeks post treatment commencement
measure: Perceived value of being nicotine free - Questionnaire
timeFrame: 4, 12, 26 weeks post treatment commencement
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: London South Bank University
Study officials:
affiliation: London South Bank University
name: Daniel Frings, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wood KV, Albery IP, Moss AC, White S, Frings D. Study protocol for a randomised controlled trial of Allen Carr's Easyway programme versus Lambeth and Southwark NHS for smoking cessation. BMJ Open. 2017 Dec 14;7(12):e016867. doi: 10.1136/bmjopen-2017-016867.