Smoking cessation for severe mental ill health trial
| ISRCTN | ISRCTN72955454 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72955454 |
| EudraCT/CTIS number | N/A |
| ClinicalTrials.gov number | N/A |
| Secondary identifying numbers | HTA 11/136/52 |
- Submission date
- 15/01/2015
- Registration date
- 16/01/2015
- Last edited
- 15/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Smoking is an important health issue, not just in the general public but also among people with severe mental ill health, and a large proportion of people who have experienced severe mental illnesses, such as schizophrenia or bipolar disorder, smoke. Not only are these people more likely to smoke, they smoke more heavily, are more addicted to nicotine and are less likely to receive help in quitting, compared to the general population. Smoking is a preventable health hazard, with proven associations with diseases such as cancer and heart disease. Smoking behaviour contributes to the poor physical health of people with severe mental ill health, increasing their risk of an early death. The introduction of public smoking bans and other government anti-smoking strategies have highlighted the smoking issue, prompting people to consider giving up smoking. Nicotine is the addictive component of smoking, causing smokers to have extreme difficulty in quitting. Various drugs and services are available to people wanting help to quit. However, these are targeted at the general public and it is not known if and how well these would work in people with severe mental ill health. People with mental health problems do express a desire to stop smoking, but they may require different strategies and greater support to help them quit smoking. To address this problem, we aim to evaluate a ‘bespoke smoking cessation’ (BSC) service specifically tailored to individual patients with severe mental ill health.
Who can participate?
People with a diagnosis of severe mental ill health who smoke and would like to stop or cut down on smoking.
What does the study involve?
Participants will be randomly allocated into one of two groups: a bespoke smoking cessation intervention or usual GP care. Those allocated to the bespoke smoking cessation intervention will be assigned a mental health nurse or allied health professional trained to deliver smoking cessation interventions. They will work with the patient and the patient’s GP or mental health specialist to advise on anti-smoking medication and provide behavioural support in the form of information, support and motivation sessions on cutting down to quit, setting quit dates and maintaining smoking abstinence. They will also regularly check the health and smoking status of the patient. This service is similar to that used in regular smoking cessation services, but with the specific adaptations of support, medication and tailoring support to the individual needs of patients with severe mental ill health.
What are the possible benefits and risks of participating?
Stopping smoking is the single most helpful thing people can do to improve their health. Stopping smoking also has the added benefit of saving a lot of money that would have spent on cigarettes. Stopping smoking can lead to withdrawal symptoms. These are normal symptoms which may be particularly strong when someone first quits, but should lessen over time.
Where is the study run from?
The main centre of the trial is York. We also expect to recruit participants from Manchester, Durham, Leeds, Sheffield, Leeds, London and Southampton.
When is the study starting and how long is it expected to run for?
The study will start recruiting in July 2015 and will recruit for 18 months. Participants will then be followed up for 12 months. An additional follow up will be carried out 3 years post randomisation. This follow up was not in the original protocol and the decision to include the additional follow up was made in 2018.
Who is funding the study?
The trial is funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme.
Who is the main contact?
Dr Emily Peckham
emily.peckham@york.ac.uk
Contact information
Scientific
Area 4, ARRC Building
Department of Health Sciences
University of York
Heslington
York
Y010 5DD
United Kingdom
 ORCID ID |
0000-0002-8236-6983 |
|---|---|
| Phone | +44 (0)1904 321370 |
| simon.gilbody@york.ac.uk |
Study information
| Study design | Multicentre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Smoking Cessation for Severe Mental Ill Health Trial (SCIMITAR+): a definitive randomised evaluation of a bespoke smoking cessation service |
| Study acronym | SCIMITAR+ |
| Study hypothesis | 1. A bespoke smoking cessation service for people with severe mental ill health is more clinically effective than usual GP care in helping people to stop smoking 2. A bespoke smoking cessation service for people with severe mental ill health is more cost effective than usual GP care in helping people to stop smoking |
| Ethics approval(s) | Current ethics approval as of 01/04/2019: REC approval for the 3 year follow up was given by NRES Committee Yorkshire & The Humber - Leeds East REC, 25/01/2019, ref: 18/YH/0499 Previous ethics approval: NRES Committee Yorkshire & The Humber - Leeds East REC, 19/03/2015, ref: 15/YH/0051 |
| Condition | Tobacco addiction in severe mental ill health |
| Intervention | Active intervention: bespoke smoking cessation tailored to the needs of people with severe mental ill health delivered by mental health nurse or other health professional trained in smoking cessation counselling. The nurse or other health professional will work in conjunction with the patient and patients' GP or mental health specialist to provide a smoking cessation service individually tailored to each patient. This service will be in line with current National Institute for Clinical Excellence (NICE) guidelines for smoking cessation services. Control intervention: usual care. The total duration for the treatment and follow-up combined will be 12 months post-recruitment. This applies for both active and control intervention arms of the trial. |
| Intervention type | Behavioural |
| Primary outcome measure | Self-reported smoking cessation at 12 months post-recruitment verified by carbon monoxide breath measurement |
| Secondary outcome measures | All secondary outcomes will be measured at the 6 and 12 month timepoints: 1. Reduction in the number of cigarettes smoked per day (self-report) 2. Dependence on smoking as assessed by the Fagerstrom Nicotine Dependence Questionnaire 3. Level of motivation as assessed by the Motivation to quit questionnaire 4. Patient Health Questionnaire 9 (PHQ-9) 5. Health Related Quality of Life (SF-12) 6. EuroQol EQ-5D Added 24/10/2016: 7. BMI 8. Health service use, collected via a bespoke questionnaire Added 28/08/2018: 9. Anxiety measured using GAD-7 at baseline, 6 and 12 months |
| Overall study start date | 01/01/2015 |
| Overall study end date | 01/07/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 400 |
| Total final enrolment | 526 |
| Participant inclusion criteria | As of 14/10/2016: Adults of all ages (either sex) with a documented diagnosis of severe and enduring mental illness (schizophrenia or delusional/psychotic illness or bipolar disorder) who currently smoke at least 5 tobacco cigarettes per day and are interested in cutting down or quitting smoking Initial: Adults of all ages (either sex) with severe and enduring mental illness who currently smoke and are interested in cutting down or quitting smoking |
| Participant exclusion criteria | 1. Patients with alcohol dependence 2. Patients with co-morbid drug addiction 3. Non-English speaking Added 14/10/2016: 1. Lack of capacity to consent 2. Pregnant or breastfeeding 3. Currently receiving advice from a stop smoking adviser |
| Recruitment start date | 01/07/2015 |
| Recruitment end date | 01/12/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Heslington
YO10 5DD
United Kingdom
Sponsor information
University/education
c/o Michael Barber
Heslington
York
YO10 5DD
England
United Kingdom
| Phone | +44 (0)1904 320000 |
|---|---|
| sue.final@york.ac.uk | |
"ROR" |
https://ror.org/04m01e293 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/04/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 26/01/2017 | 30/01/2017 | Yes | No |
| Results article | results | 19/01/2018 | 29/03/2019 | Yes | No |
| Results article | results | 01/05/2019 | 15/04/2019 | Yes | No |
| Results article | results | 01/09/2019 | 27/09/2019 | Yes | No |
| Results article | results | 15/10/2020 | 22/10/2020 | Yes | No |
| Results article | cross-sectional study results | 01/09/2020 | 17/05/2021 | Yes | No |
| Other publications | SWAT results | 20/11/2019 | 15/02/2023 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
15/02/2023: Publication reference added.
17/05/2021: Publication reference added.
22/10/2020: Publication reference added.
27/09/2019: Publication reference added.
15/04/2019: Publication reference and total final enrolment added.
02/04/2019: The ethics approval was updated.
01/04/2019: The plain English summary was updated.
29/03/2019: Publication reference added.
29/08/2018: IPD sharing statement added.
28/08/2018: The secondary outcome measures were updated and the publication and dissemination plan was added.
30/01/2017: Publication reference added.
