Study Comparing Two Stop Smoking Intervention Efficacies

NCT ID: NCT02855255

Last Updated: 2019-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

620 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2018-05-25

Brief Summary

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

Detailed Description

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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.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

NHS 1-1 smoking cessation programme.

Intervention Type BEHAVIORAL

Smoking cessation using cognitive behavioural therapy/motivational interviewing

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.

Group Type ACTIVE_COMPARATOR

Group smoking cessation programme

Intervention Type BEHAVIORAL

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

Interventions

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NHS 1-1 smoking cessation programme.

Smoking cessation using cognitive behavioural therapy/motivational interviewing

Intervention Type BEHAVIORAL

Group smoking cessation programme

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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) .
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NHS Lambeth

OTHER

Sponsor Role collaborator

NHS Southwark CCG

OTHER

Sponsor Role collaborator

Allen Carr Easyway

UNKNOWN

Sponsor Role collaborator

London South Bank University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Frings, PhD

Role: PRINCIPAL_INVESTIGATOR

London South Bank University

Locations

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London South Bank University

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 29247083 (View on PubMed)

Other Identifiers

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7697

Identifier Type: -

Identifier Source: org_study_id

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