A Smoking Cessation Intervention for Severe Mental Ill Health Trial (SCIMITAR)
| ISRCTN | ISRCTN79497236 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79497236 |
| Secondary identifying numbers | HTA 07/41/05 |
- 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
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
| Study design | Pilot study and definitive fully 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 the contact details below to request a patient 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 hypothesis | 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 |
| Condition | 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 | Smoking cessation measured at 12 months post-recruitment (validated using carbon monoxide measurements). |
| Secondary outcome measures | 1. Self reported smoking cessation at 4, 6 and 12 months 2. Health related quality of life (36-item short form health survey [SF-36]) 3. Health-state utility (EQ5D) at 4, 6 and 12 months |
| Overall study start date | 01/06/2010 |
| Overall study end date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Participant inclusion criteria | Adults of all ages (either sex) with severe and enduring mental illness who currently smoke. |
| Participant exclusion criteria | 1. Patients with alcohol dependence 2. Patients with co-morbid drug addiction |
| Recruitment start date | 01/06/2010 |
| Recruitment end date | 31/12/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of York
York
YO10 5DD
United Kingdom
YO10 5DD
United Kingdom
Sponsor information
University of York (UK)
University/education
University/education
Heslington
York
YO10 5DD
England
United Kingdom
| Phone | +44 (0)1904 430000 |
|---|---|
| mm714@york.ac.uk | |
| Website | http://www.york.ac.uk |
"ROR" |
https://ror.org/04m01e293 |
Funders
Funder type
Government
Health Technology Assessment Programme
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
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 | 01/03/2015 | Yes | No | |
| Results article | results | 01/05/2015 | Yes | No |
