Condition category
Mental and Behavioural Disorders
Date applied
29/06/2009
Date assigned
03/07/2009
Last edited
14/09/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 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

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

Trial setting

GP practices

Trial 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

Phase

Drug names

Primary outcome measures

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 trial start date

01/06/2010

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Adults of all ages (either sex) with severe and enduring mental illness who currently smoke.

Participant type

Patient

Age group

Adult

Gender

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

United Kingdom

Trial participating centre

University of York
York
YO10 5DD
United Kingdom

Sponsor information

Organisation

University of York (UK)

Sponsor details

Heslington
York
YO10 5DD
United Kingdom
+44 (0)1904 430000
mm714@york.ac.uk

Sponsor type

University/education

Website

http://www.york.ac.uk

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

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25827850
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26360283

Publication citations

Additional files

Editorial Notes