SCIMITAR+ extension version 1.0

  • Research type

    Research Study

  • Full title

    Smoking Cessation Intervention for Severe Mental Ill Health Trial (SCIMITAR): a definitive randomised evaluation of a bespoke smoking cessation service. Extended follow up.

  • IRAS ID

    258585

  • Contact name

    Simon Gilbody

  • Contact email

    simon.gilbody@york.ac.uk

  • Sponsor organisation

    University of York

  • ISRCTN Number

    ISRCTN72955454

  • Duration of Study in the UK

    1 years, 2 months, 1 days

  • Research summary

    Smoking significantly impacts the physical health of people with severe mental ill health (SMI) such as schizophrenia
    or bipolar disorder. Compared to the general population, a large proportion of SMI patients smoke and are likely to be heavy smokers with greater nicotine addiction. However these patients have greater difficulty in quitting and are less likely to receive help in quitting. Currently available smoking cessation services and drugs are aimed at the general public and whilst people with SMI do express a desire to stop smoking they may require different strategies and greater support to help them quit smoking.
    To address this problem the SCIMITAR pilot trial was conducted to evaluate the feasibility of delivering a ‘bespoke
    smoking cessation’ (BSC) service tailored to individual SMI patients and piloting the methods of recruitment, retention and follow up prior to conducting this full trial, the SCIMITAR Plus trial.
    In SCIMITAR Plus we aim to recruit 400 patients with SMI who will be randomly assigned to either BSC or usual care.
    Participants will be asked to complete follow up questionnaires and carry out a breath carbon monoxide test (to check smoking status) at 6 and 12 months. For those assigned to BSC a mental health nurse trained to deliver smoking cessation interventions will become the their mental health smoking cessation practitioner who will work with the patient’s GP or mental health specialist to advise on quit smoking strategies, provide information, support and motivation sessions on cutting down to quit, setting quit dates and maintaining smoking abstinence.
    SCIMITAR Plus will provide information on whether the BSC service is effective, and cost effective in helping people
    with SMI to stop smoking.
    In this extension to the SCIMITAR+ trial we will gather information on the longer term effectiveness of the BSC intervention by asking participants to complete a three year (post-randomisation) follow up.

  • REC name

    Yorkshire & The Humber - Leeds East Research Ethics Committee

  • REC reference

    18/YH/0499

  • Date of REC Opinion

    25 Jan 2019

  • REC opinion

    Further Information Favourable Opinion