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07 August 2008
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| [ Print-friendly version ] |
| Can a brief cognitive intervention assist smokers in giving up? |
| ISRCTN | ISRCTN65854845 |
| ClinicalTrials.gov identifier | |
| Public title | Can a brief cognitive intervention assist smokers in giving up? |
| 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 | N/A |
| Serial number at source | N/A |
| 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. |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Smoking cessation |
| Participants - 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. |
| Participants - exclusion criteria | Unable to fill in the study forms in English. |
| Anticipated start date | 02/06/2008 |
| Anticipated end date | 29/05/2009 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | 140 |
| Interventions |
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. |
| Primary outcome measure(s) |
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 measure(s) |
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 |
| Sources of funding | Cancer Research UK PhD studentship (ref: C4770/A7173) |
| Trial website | |
| Publications | |
| Contact name | Mr Mairtin McDermott |
| Address |
Health Psychology Section
Department of Psychology King's College London 5th Floor Bermondsey Wing Guy's Campus |
| City/town | London |
| Zip/Postcode | SE1 9RT |
| Country | United Kingdom |
| Sponsor | Institute of Psychiatry, King's College London (UK) |
| Address |
DeCrespigny Park
Denmark Hill |
| City/town | London |
| Zip/Postcode | SE5 8AF |
| Country | United Kingdom |
| Sponsor website: | http://www.iop.kcl.ac.uk |
| Date applied | 17/03/2008 |
| Last edited | 30/04/2008 |
| Date ISRCTN assigned | 30/04/2008 |
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