Condition category
Mental and Behavioural Disorders
Date applied
15/01/2015
Date assigned
16/01/2015
Last edited
24/10/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Smoking is an important health issue, not just in the general public but also among people with severe mental ill health, and a large proportion of people who have experienced severe mental illnesses, such as schizophrenia or bipolar disorder, smoke. Not only are these people more likely to smoke, they smoke more heavily, are more addicted to nicotine and are less likely to receive help in quitting, compared to the general population. Smoking is a preventable health hazard, with proven associations with diseases such as cancer and heart disease. Smoking behaviour contributes to the poor physical health of people with severe mental ill health, increasing their risk of an early death. The introduction of public smoking bans and other government anti-smoking strategies have highlighted the smoking issue, prompting people to consider giving up smoking. Nicotine is the addictive component of smoking, causing smokers to have extreme difficulty in quitting. Various drugs and services are available to people wanting help to quit. However, these are targeted at the general public and it is not known if and how well these would work in people with severe mental ill health. People with mental health problems do express a desire to stop smoking, but they may require different strategies and greater support to help them quit smoking. To address this problem, we aim to evaluate a ‘bespoke smoking cessation’ (BSC) service specifically tailored to individual patients with severe mental ill health.

Who can participate?
People with a diagnosis of severe mental ill health who smoke and would like to stop or cut down on smoking.

What does the study involve?
Participants will be randomly allocated into one of two groups: a bespoke smoking cessation intervention or usual GP care. Those allocated to the bespoke smoking cessation intervention will be assigned a mental health nurse or allied health professional trained to deliver smoking cessation interventions. They will work with the patient and the patient’s GP or mental health specialist to advise on anti-smoking medication and provide behavioural support in the form of information, support and motivation sessions on cutting down to quit, setting quit dates and maintaining smoking abstinence. They will also regularly check the health and smoking status of the patient. This service is similar to that used in regular smoking cessation services, but with the specific adaptations of support, medication and tailoring support to the individual needs of patients with severe mental ill health.

What are the possible benefits and risks of participating?
Stopping smoking is the single most helpful thing people can do to improve their health. Stopping smoking also has the added benefit of saving a lot of money that would have spent on cigarettes. Stopping smoking can lead to withdrawal symptoms. These are normal symptoms which may be particularly strong when someone first quits, but should lessen over time.

Where is the study run from?
The main centre of the trial is York. We also expect to recruit participants from Manchester, Durham, Leeds, Sheffield, Leeds, London and Southampton.

When is the study starting and how long is it expected to run for?
The study will start recruiting in July 2015 and will recruit for 18 months. Participants will then be followed up for 12 months.

Who is funding the study?
The trial is funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme.

Who is the main contact?
Dr Emily Peckham
emily.peckham@york.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Simon Gilbody

ORCID ID

http://orcid.org/0000-0002-8236-6983

Contact details

Area 4
ARRC Building
Department of Health Sciences
University of York
Heslington
York
Y010 5DD
United Kingdom
+44 (0)1904 321370
simon.gilbody@york.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 11/136/52

Study information

Scientific title

Smoking Cessation for Severe Mental Ill Health Trial (SCIMITAR+): a definitive randomised evaluation of a bespoke smoking cessation service

Acronym

SCIMITAR+

Study hypothesis

1. A bespoke smoking cessation service for people with severe mental ill health is more clinically effective than usual GP care in helping people to stop smoking
2. A bespoke smoking cessation service for people with severe mental ill health is more cost effective than usual GP care in helping people to stop smoking

More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/1113652
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0018/141507/PRO-11-136-52.pdf

Ethics approval

NRES Committee Yorkshire & The Humber - Leeds East REC, 19/03/2015, ref: 15/YH/0051

Study design

Multicentre 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 contact details to request a participant information sheet

Condition

Tobacco addiction in severe mental ill health

Intervention

Active intervention: bespoke smoking cessation tailored to the needs of people with severe mental ill health delivered by mental health nurse or other health professional trained in smoking cessation counselling. The nurse or other health professional 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. This service will be in line with current National Institute for Clinical Excellence (NICE) guidelines for smoking cessation services.

Control intervention: usual care.

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

Self-reported smoking cessation at 12 months post-recruitment verified by carbon monoxide breath measurement

Secondary outcome measures

All secondary outcomes will be measured at the 6 and 12 month timepoints:
1. Reduction in the number of cigarettes smoked per day (self-report)
2. Dependence on smoking as assessed by the Fagerstrom Nicotine Dependence Questionnaire
3. Level of motivation as assessed by the Motivation to quit questionnaire
4. Patient Health Questionnaire 9 (PHQ-9)
5. Health Related Quality of Life (SF-12)
6. EuroQol EQ-5D

Added 24/10/2016:
7. BMI
8. Health service use, collected via a bespoke questionnaire

Overall trial start date

01/01/2015

Overall trial end date

01/07/2018

Reason abandoned

Eligibility

Participant inclusion criteria

As of 14/10/2016:
Adults of all ages (either sex) with a documented diagnosis of severe and enduring mental illness (schizophrenia or delusional/psychotic illness or bipolar disorder) who currently smoke at least 5 tobacco cigarettes per day and are interested in cutting down or quitting smoking

Initial
Adults of all ages (either sex) with severe and enduring mental illness who currently smoke and are interested in cutting down or quitting smoking

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

1. Patients with alcohol dependence
2. Patients with co-morbid drug addiction
3. Non-English speaking

Added 14/10/2016:
1. Lack of capacity to consent
2. Pregnant or breastfeeding
3. Currently receiving advice from a stop smoking adviser

Recruitment start date

01/07/2015

Recruitment end date

01/12/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Health Sciences
University of York
Heslington
YO10 5DD
United Kingdom

Sponsor information

Organisation

University of York

Sponsor details

c/o Michael Barber
Heslington
York
YO10 5DD
United Kingdom
+44 (0)1904 320000
sue.final@york.ac.uk

Sponsor type

University/education

Website

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

To be confirmed at a later date

Intention to publish date

01/04/2019

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes