Smoking cessation for severe mental ill health trial

• Register: ISRCTN
• Last refreshed on: 27 February 2023
• Main ID: ISRCTN72955454
• Date of registration: 16/01/2015
• Prospective Registration: Yes
• Primary sponsor: University of York
• Public title: Smoking cessation for severe mental ill health trial
• Scientific title: Smoking Cessation for Severe Mental Ill Health Trial (SCIMITAR+): a definitive randomised evaluation of a bespoke smoking cessation service
• Date of first enrolment: 01/07/2015
• Target sample size: 400
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN72955454
• Study type: Interventional
• Study design: Multicentre randomised controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

England, United Kingdom

Contacts

• Name: Simon Gilbody

Key inclusion & exclusion criteria

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

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Tobacco addiction in severe mental ill health
Mental and Behavioural Disorders
Mental and behavioural disorders due to use of tobacco

Intervention(s)

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.

Primary Outcome(s)

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

Secondary Outcome(s)

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

Added 28/08/2018:
9. Anxiety measured using GAD-7 at baseline, 6 and 12 months

Secondary ID(s)

N/A

HTA 11/136/52

Source(s) of Monetary Support

Health Technology Assessment Programme

Ethics review

Status:
Approval date:
Contact:

Current ethics approval as of 01/04/2019: REC approval for the 3 year follow up was given by NRES Committee Yorkshire & The Humber - Leeds East REC, 25/01/2019, ref: 18/YH/0499 Previous ethics approval: NRES Committee Yorkshire & The Humber - Leeds East REC, 19/03/2015, ref: 15/YH/0051

Results

• Results available: Yes
• Date Completed: 01/07/2018