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Smoking cessation for severe mental ill health trial

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN72955454
Enrollment
400
Registered
2015-01-16
Start date
2015-07-01
Completion date
Unknown
Last updated
2023-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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

Sponsors

University of York
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 11, 2026