Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
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
Study setting(s)
Not specified
Study 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
Primary outcome measure
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 study start date
02/06/2008
Overall study end date
29/05/2009
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
140
Total final enrolment
145
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
England, United Kingdom
Study 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
England
United Kingdom
Sponsor type
University/education
Website
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 21/02/2012 | 17/04/2019 | Yes | No |