Contact information
Type
Scientific
Contact name
Prof Simon Gilbody
ORCID ID
Contact details
Area 4
Seebohm Rowntree Building
Department of Health Sciences
University of York
Heslington
York
YO10 5DD
United Kingdom
+44 (0)1904 321370
sg519@york.ac.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
HTA 07/41/05
Study information
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
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
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
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
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
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Adults of all ages (either sex) with severe and enduring mental illness who currently smoke.
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
100
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
Sponsor information
Organisation
University of York (UK)
Sponsor details
Heslington
York
YO10 5DD
England
United Kingdom
+44 (0)1904 430000
mm714@york.ac.uk
Sponsor type
University/education
Website
ROR
Funders
Funder type
Government
Funder name
Health Technology Assessment Programme
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
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 |