Condition category
Mental and Behavioural Disorders
Date applied
02/10/2014
Date assigned
27/11/2014
Last edited
20/07/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Smoking is the greatest cause of ill health with approximately 18% of deaths in England being associated with smoking. Providing people with incentives (e.g., money, vouchers) seems to be an effective way of helping people to quit smoking, but incentives administered by others may alter underlying motivation to quit and result in people starting up smoking again. Encouraging people to reward themselves (e.g., inviting friends round) could overcome these difficulties, yet people seem reluctant to do this. The aim of this study is to test if such “self-incentives” result in an increase in the number of people already attending community stop smoking services, and workplaces, quitting the habit. The study investigates whether an “if-when” plan (e.g., If I successfully abstain from smoking for a week, then I will reward myself by inviting friends around) can help people to stop smoking, what kind of self-incentives do lead people to stop smoking and the ideal rate of self-incentivising towards successfully quitting smoking.

Who can participate?
Any person aged 18 years or over who has approached one of the participating stop smoking services (or workplaces) and is smoking at the time of enrolment on to the program

What does the study involve?
Participants are randomly allocated into one of four groups. Those in group 1 (active control) are asked to form a plan to help them to quit smoking. Those in group 2 (active control) are asked to link suitable temptations to smoke with an appropriate response (using a list of 20 temptations and 20 responses through a planner known as the volitional help sheet). Those in group 3 (intervention) are asked to complete an 'if-then' plan which includes a self-incentive that can be used for each week that they have successfully quit smoking. Those in group 4 (intervention) are asked to complete an 'if-then' plan which includes a self-incentive that can be used for each month that they have successfully quit smoking. Participants are also asked about their smoking habits, nicotine dependence, thoughts, feelings and motivation towards the smoking quit attempts at the start of the trial, at the end of the trial (12 weeks later), and 6 months after the start of the trial. The repetition and agreement to self-incentivising are measured at the end of the trial and 6 months after the start of the trial.

What are the possible benefits and risks of participating?
Participants who complete an 'if-then' plan which includes a self-incentive may benefit from their participation by the intervention helping them to successfully quit smoking. There are no risks to taking part in the study.

Where is the study run from?
The stop smoking services in which participants are recruited are held in various health and community centres across North West England (UK). The workplaces in which participants are recruited are based in North West England (UK).

When is the study starting and how long is it expected to last?
October 2014 to September 2020

Who is funding the study?
University of Manchester (UK)

Who is the main contact?
Emma Brown
Emma.Brown@uea.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Chris Armitage

ORCID ID

Contact details

Manchester Centre for Health Psychology
School of Health Sciences
Division of Psychology and Mental Health
University of Manchester
Coupland Street
Oxford Road
Manchester
M13 9PL
United Kingdom
-
chris.armitage@manchester.ac.uk

Type

Public

Additional contact

Miss Emma Brown

ORCID ID

http://orcid.org/0000-0002-4753-3774

Contact details

School of Health Sciences
Faculty of Medicine and Health Sciences
University of East Anglia
Edith Cavell Building
Norwich
NR4 7UL
United Kingdom
-
Emma.Brown@uea.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The role of self-incentives in smoking cessation: a randomised controlled trial in community-based stop smoking services

Acronym

N/A

Study hypothesis

The main hypotheses are that:
1. Self-incentives will increase the number of participants who successfully quit smoking at follow-up.
2. Self-incentivising at the end of the week will be more effective at aiding smoking cessation than self-incentivising at the end of the month.
3. Providing smokers with self-incentives will be more effective at aiding smoking cessation than asking smokers to generate their own self-incentives.
4. Specific implementation intentions will be more effective at aiding smoking cessation than general implementation intentions.

Ethics approval

NRES Committee North West - Greater Manchester West, 05/09/2014, ref: 14/NW/1262

Study design

Multi-site parallel randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

A psychological health intervention within a smoking population

Intervention

Participants will be randomised to one of four groups:
1. To form a plan to help to quit smoking (active control)
2. To complete the volitional help sheet (active control)
3. To complete an 'if-then' plan which includes a self-incentive that can be used for each week that they have successfully quit smoking (intervention)
4. To complete an 'if-then' plan which includes a self-incentive that can be used for each month that they have successfully quit smoking (intervention)

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Increase in smoking quit status at six-months post baseline (self-reported)

Secondary outcome measures

1. Increase in smoking quit status at the end of the trial (12 weeks after baseline)
2. Changes in nicotine dependence (using the Fagerstrom Test for Nicotine Dependence) at the end of the trial and 6 months post baseline
3. Changes in smoking behaviour (using the Glover-Nilsson Smoking Behavior Questionnaire) at the end of the trial and 6 months post baseline
4. Changes in intention to quit smoking (using a three item scale taken from Armitage, 2008) at the end of the trial and 6 months post baseline
5. Changes in self-efficacy to quit smoking (using a three item scale taken from Armitage, 2008) at the end of the trial and 6 months post baseline
6. Changes in self-regulatory effort to quit smoking (using a six item scale taken from Armitage (2008) at the end of the trial and 6 months post baseline
7. Frequency of self-incentivising (using a measure adapted from Armitage, 2014) at the end of the trial and 6 months post baseline
8. Kinds of self-incentives used (using a measure adapted from Armitage, 2014) at the end of the trial and 6 months post baseline

Overall trial start date

15/10/2014

Overall trial end date

30/09/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 or over
2. Able to understand written and verbal English
3. Competent to provide informed consent
4. Attending one of the stop smoking services or workplaces currently involved in the trial

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

4140

Participant exclusion criteria

1. Under 18 years of age
2. Unable to understand written and verbal English
3. Not competent to provide informed consent
4. Attending a stop smoking service or workplace which isn't within those listed above

Recruitment start date

02/12/2014

Recruitment end date

30/09/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Manchester
Manchester
M13 9PL
United Kingdom

Sponsor information

Organisation

University of Manchester

Sponsor details

c/o Nalin Thakker
Oxford Road
Manchester
M13 9PL
United Kingdom
-
research-governance@manchester.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University of Manchester (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

20/07/2017: The overall trial end date was changed from 30/09/2016 to 30/09/2020.