NCT02855255

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
620

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2018

Completed
Last Updated

March 25, 2019

Status Verified

March 1, 2019

Enrollment Period

1.3 years

First QC Date

July 7, 2016

Last Update Submit

March 21, 2019

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

  • Cessation of smoking

    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.

    26 weeks post treatment commencement

Secondary Outcomes (5)

  • Self-reported maintenance of smoking cessation questions

    4, 12, 26 weeks post treatment commencement

  • The Satisfaction with Life Scale (Diener, Emmons, Larsen, & Griffin, 1985).

    Baseline and 4, 12, 26 weeks post treatment commencement

  • Survey assessing use of Nicotine replacement therapy/nicotine containing products

    4, 12, 26 weeks post treatment commencement

  • Quit efficacy questionnaire

    Baseline, 4, 12, 26 weeks post treatment commencement

  • Perceived value of being nicotine free - Questionnaire

    4, 12, 26 weeks post treatment commencement

Study Arms (2)

NHS smoking cessation

ACTIVE COMPARATOR

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.

Allen Carr's Easyway smoking cessation

ACTIVE COMPARATOR

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

Interventions

NHS 1-1 smoking cessation programme.BEHAVIORAL

Smoking cessation using cognitive behavioural therapy/motivational interviewing

NHS smoking cessation
Group smoking cessation programmeBEHAVIORAL

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

Allen Carr's Easyway smoking cessation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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) .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London South Bank University

London, SE1 0AA, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 29247083DERIVED

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Daniel Frings, PhD

    London South Bank University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2016

First Posted

August 4, 2016

Study Start

February 1, 2017

Primary Completion

May 25, 2018

Study Completion

May 25, 2018

Last Updated

March 25, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will share

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.

Locations

GB(1)