Can a brief cognitive intervention assist smokers in giving up?
| ISRCTN | ISRCTN65854845 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65854845 |
| Secondary identifying numbers | N/A |
- Submission date
- 17/03/2008
- Registration date
- 30/04/2008
- Last edited
- 17/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Mairtin McDermott
Scientific
Scientific
Health Psychology Section
Department of Psychology
King's College London
5th Floor Bermondsey Wing
Guy's Campus
London
SE1 9RT
United Kingdom
Study information
| 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 |
| Scientific title | Evaluation of the effectiveness of acceptance of the negative reinforcement explanation for smoking in facilitating smoking cessation: A cluster-randomised controlled trial |
| Study objectives | 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. |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 29/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 140 |
| Total final enrolment | 145 |
| Key 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. |
| Key exclusion criteria | Unable to fill in the study forms in English. |
| Date of first enrolment | 02/06/2008 |
| Date of final enrolment | 29/05/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
King's College London
London
SE1 9RT
United Kingdom
SE1 9RT
United Kingdom
Sponsor information
Institute of Psychiatry, King's College London (UK)
University/education
University/education
DeCrespigny Park
Denmark Hill
London
SE5 8AF
England
United Kingdom
| Website | http://www.iop.kcl.ac.uk |
|---|---|
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Charity
Cancer Research UK PhD studentship (ref: C4770/A7173)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 21/02/2012 | 17/04/2019 | Yes | No |
Editorial Notes
17/04/2019: The following changes have been made:
1. Publication reference added.
2. The total final enrolment has been added.
04/07/2017: No publications found in PubMed, verifying study status with principal investigator.
