Condition category
Mental and Behavioural Disorders
Date applied
17/03/2008
Date assigned
30/04/2008
Last edited
08/04/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Mairtin McDermott

ORCID ID

Contact details

Health Psychology Section
Department of Psychology
King's College London
5th Floor Bermondsey Wing
Guy's Campus
London
SE1 9RT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Evaluation of the effectiveness of acceptance of the negative reinforcement explanation for smoking in facilitating smoking cessation: A cluster-randomised controlled trial

Acronym

Study hypothesis

Primary hypothesis:
Successful communication of the negative reinforcement explanation for smoking reduces the urge to smoke (thereby facilitating smoking cessation) (Hypothesis I).

Secondary hypotheses:
Three possible mechanisms for this effect are hypothesised:

Acceptance of the negative reinforcement explanation for smoking reduces the urge to smoke via:
1. Decreased negative outcome expectations about remaining abstinent from smoking (Hypothesis II)
2. Increased positive outcome expectations about remaining abstinent from smoking (Hypothesis III)
3. Increased self-efficacy to abstain from smoking (Hypothesis IV)

Ethics approval

Application will be submitted to the East London and the City Research Ethics Committee 1 for their May 2008 meeting.

Study design

Single-centre two-group cluster-randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Smoking cessation

Intervention

Interventions:
Both experimental and control interventions will be delivered as the last part of the pre-quit group session (week two of a seven-week course). They will consist either of a 15-20 minute didactic presentation for the experimental intervention, or a 20 minute video for the control intervention. Both will be followed by ten minutes of discussion. One week later, again at the end of the standard group treatment session, this will be followed up by a 15-minute discussion of the previous week's session.

Experimental intervention:
The intervention communicates a set of ideas aimed at changing the way patients perceive the benefits of smoking and the post-quit withdrawal discomfort. It attempts to explain that in dependent smokers chronic smoking creates adaptation to nicotine. Withdrawal discomfort ensues in the absence of smoking. Smoking behaviour is largely driven by the desire to remove or avoid this unpleasant state. The apparently positive effects of smoking upon perceived stress, mood and concentration are primarily misattribution of the relief of withdrawal discomfort experienced immediately after smoking a cigarette. The withdrawal discomfort and urges to smoke which follow smoking cessation weaken after a few weeks. However, complete abstinence is necessary to achieve this, as even a single cigarette can reinstate the need to carry on smoking.

In a task to be completed as homework before the second treatment session, participants would be asked to monitor their urge to smoke over a three-hour period of abstinence and complete a task card to record the increase in urge to smoke relative to the increasing period of abstinence, and the abrupt alleviation of the resulting tension after smoking.

Control intervention:
Participants will view a 19-minute DVD entitled Smoking and Human Physiology (AIMS Multimedia). The DVD details the adverse health consequences of smoking and will be followed by a discussion. The video does not cover any aspect of the cognitive intervention.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Urges to smoke and withdrawal symptoms, assessed using the Mood & Physical Symptoms Scale (T2 and T3)

Timepoints:
T0: At baseline, immediately prior to the first intervention session
T1: Immediately following the first intervention session
T2: One week later, immediately following the second intervention session
T3: At follow-up one week following the second session

Secondary outcome measures

The following will be assessed by a 12-item questionnaire developed for the current research:
1. Participants' cognitions regarding the positive outcome expectations of smoking (T0, T1, T2, T3)
2. Expectations of the quitting process (T0, T1, T2, T3)
3. Self-efficacy (T0, T1, T2, T3)

Timepoints:
T0: At baseline, immediately prior to the first intervention session
T1: Immediately following the first intervention session
T2: One week later, immediately following the second intervention session
T3: At follow-up one week following the second session

Overall trial start date

02/06/2008

Overall trial end date

29/05/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Participants must be attending for treatment at the NHS specialist smoking cessation clinic (SSCC) at The Royal London Hospital in East London. All clinic clients who provide informed consent and are able to fill in the study forms in English will be eligible.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

140

Participant exclusion criteria

Unable to fill in the study forms in English.

Recruitment start date

02/06/2008

Recruitment end date

29/05/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

King's College London
London
SE1 9RT
United Kingdom

Sponsor information

Organisation

Institute of Psychiatry, King's College London (UK)

Sponsor details

DeCrespigny Park
Denmark Hill
London
SE5 8AF
United Kingdom

Sponsor type

University/education

Website

http://www.iop.kcl.ac.uk

Funders

Funder type

Charity

Funder name

Cancer Research UK PhD studentship (ref: C4770/A7173)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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