Smoking Cessation Intervention for Severe Mental Ill Health Trial SCIMITAR : study protocol for a randomised controlled trialReport as inadecuate




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Trials

, 18:44

First Online: 26 January 2017Received: 25 October 2016Accepted: 06 January 2017DOI: 10.1186-s13063-017-1789-7

Cite this article as: Peckham, E., Arundel, C., Bailey, D. et al. Trials 2017 18: 44. doi:10.1186-s13063-017-1789-7

Abstract

BackgroundSmoking is highly prevalent among people who have experience of severe mental ill health, contributing to their poor physical health. Despite the ‘culture’ of smoking in mental health services, people with severe mental ill health often express a desire to quit smoking; however, the services currently available to aid quitting are those which are widely available to the general population and may not be suitable or effective for people with severe mental ill health. The aim of this study is to explore the effectiveness and cost-effectiveness of a bespoke smoking-cessation intervention specifically targeted at people with severe mental ill health.

Methods-designSCIMITAR+ is a multicentre, pragmatic, two-arm, parallel-group, individually randomised controlled trial.

We aim to recruit 400 participants aged 18 years and above with a documented diagnosis of bipolar disorder, schizophrenia or schizoaffective disorder who smoke. Potentially eligible participants identified in primary or secondary care will be screened, and baseline data collected. Eligible, consenting participants will be randomly allocated to one of two groups. In the intervention arm, the participant will be assigned a mental health professional trained to deliver smoking-cessation interventions who will work with the participant and participant’s GP or mental health specialist to provide an individually tailored smoking-cessation service. The comparator arm will be usual care – following current NICE guidelines for smoking cessation, in line with general guidance that is offered to all smokers, with no specific adaptation or enhancement in relation to severe mental ill health.

The primary outcome will be self-reported smoking cessation at 12 months verified by expired carbon monoxide CO measurement. Secondary outcome measures include Body Mass Index at 12 months, the Fagerström Test for Nicotine Dependence, Motivation to Quit questionnaire, SF-12, PHQ-9, GAD-7, EQ-5D-5 L, and health service utilisation at 6 and 12 months. The economic evaluation at 12 months will be conducted in the form of an incremental cost-effectiveness analysis.

DiscussionSCIMITAR+ trial is the largest trial to our knowledge to investigate the effectiveness of a bespoke smoking-cessation service for people with severe mental ill health.

Trial registrationInternational Standard Randomised Controlled Trials Number, ISRCTN72955454. Registered on 16 January 2015.

KeywordsSmoking cessation Nicotine replacement therapy Complex intervention Schizophrenia Bipolar disorder Severe mental ill health Randomised controlled trial AbbreviationsBMIBody Mass Index

CMHTCommunity Mental Health Team

COCarbon monoxide

DSMDiagnostic and Statistical Manual of Mental Disorders

EQ-5D-5LEuroQol 5 dimensions, 5 levels questionnaire

GADGeneral anxiety disorder

GPGeneral practitioner

ICDInternational Classification of Diseases

MH-SCPMental health smoking-cessation practitioner

NICENational Institute of health and Care Excellence

NRTNicotine replacement therapy

PHQPatient Health Questionnaire

SCIMITARSmoking Cessation Intervention for severe Mental Ill health Trial

SF-1212-item Short Form Health Survey

SMISevere mental ill health

Electronic supplementary materialThe online version of this article doi:10.1186-s13063-017-1789-7 contains supplementary material, which is available to authorized users.





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Source: https://link.springer.com/







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