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ISRCTN
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ISRCTN79497236
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ClinicalTrials.gov identifier
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Public title
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A Smoking Cessation Intervention for Severe Mental Ill Health Trial (SCIMITAR)
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Scientific title
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A Smoking Cessation Intervention for Severe Mental Ill Health Trial: a pilot study and definitive randomised evaluation of a bespoke smoking cessation service
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Acronym
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SCIMITAR
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Serial number at source
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HTA 07/41/05
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Study hypothesis
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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
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Ethics approval
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Not provided at time of registration
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Study design
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Pilot study and definitive fully randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Tobacco addiction in severe mental illness
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Participants - inclusion criteria
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Adults of all ages (either sex) with severe and enduring mental illness who currently smoke.
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Participants - exclusion criteria
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1. Patients with alcohol dependence
2. Patients with co-morbid drug addiction
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Anticipated start date
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01/06/2010
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Anticipated end date
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31/12/2012
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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100
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Interventions
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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.
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Primary outcome measure(s)
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Smoking cessation measured at 12 months post-recruitment (validated using carbon monoxide measurements).
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Secondary outcome measure(s)
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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
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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Contact name
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Prof
Simon
Gilbody
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Address
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Area 4, Seebohm Rowntree Building
Department of Health Sciences
University of York
Heslington
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City/town
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York
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Zip/Postcode
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YO10 5DD
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Country
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United Kingdom
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Tel
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+44 (0)1904 321370
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Email
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sg519@york.ac.uk
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Sponsor
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University of York (UK)
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Address
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Heslington
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City/town
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York
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Zip/Postcode
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YO10 5DD
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Country
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United Kingdom
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Tel
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+44 (0)1904 430000
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Email
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mm714@york.ac.uk
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Sponsor website:
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http://www.york.ac.uk
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Date applied
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29/06/2009
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Last edited
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03/07/2009
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Date ISRCTN assigned
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03/07/2009
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