A Smoking Cessation Intervention for Severe Mental Ill Health Trial (SCIMITAR)
| ISRCTN | ISRCTN79497236 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79497236 |
| Protocol serial number | HTA 07/41/05 |
| Sponsor | University of York (UK) |
| Funder | Health Technology Assessment Programme |
- Submission date
- 29/06/2009
- Registration date
- 03/07/2009
- Last edited
- 14/09/2015
- 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
Prof Simon Gilbody
Scientific
Scientific
Area 4, Seebohm Rowntree Building
Department of Health Sciences
University of York
Heslington
York
YO10 5DD
United Kingdom
| Phone | +44 (0)1904 321370 |
|---|---|
| sg519@york.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pilot study and definitive fully randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A Smoking Cessation Intervention for Severe Mental Ill Health Trial: a pilot study and definitive randomised evaluation of a bespoke smoking cessation service |
| Study acronym | SCIMITAR |
| Study objectives | 1. Bespoke smoking cessation service for people with severe mental ill health is more acceptable than usual GP care 2. Bespoke smoking cessation service for people with mental ill health is more clinically effective than usual GP care in facilitating smoking cessation 3. Bespoke smoking cessation service for people with mental ill health is more cost effective than usual GP care in facilitating smoking cessation |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Tobacco addiction in severe mental illness |
| Intervention | Active intervention: mental health nurse trained in smoking cessation counselling 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 with mental ill health. This service will be in line with current National Institute for Clinical Excellence (NICE) guidelines for smoking cessation services and will include group support sessions for patients with mental ill health, pharmacotherapies to aid smoking cessation in addition to regular follow up by the smoking cessation officer. Control intervention: GP or mental health specialist following current NICE guidelines for smoking cessation services. This may include pharmacotherapies to aid smoking cessation, access to self-help materials and referral to local NHS stop smoking clinics. 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(s) |
Smoking cessation measured at 12 months post-recruitment (validated using carbon monoxide measurements). |
| Key secondary outcome measure(s) |
1. Self reported smoking cessation at 4, 6 and 12 months |
| Completion date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | Adults of all ages (either sex) with severe and enduring mental illness who currently smoke. |
| Key exclusion criteria | 1. Patients with alcohol dependence 2. Patients with co-morbid drug addiction |
| Date of first enrolment | 01/06/2010 |
| Date of final enrolment | 31/12/2012 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University of York
York
YO10 5DD
United Kingdom
YO10 5DD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2015 | Yes | No | |
| Results article | results | 01/05/2015 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
