Smoking cessation for severe mental ill health trial

Not Applicable

Completed

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

• Registration Number: ISRCTN72955454
• Lead Sponsor: niversity of York

Brief Summary

2017 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/28126031 protocol (added 30/01/2017) 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29351792 results (added 29/03/2019) 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30975539 results (added 15/04/2019) 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31549622 results (added 27/09/2019) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33054882/ results (added 22/10/2020) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32388396/ cross-sectional study results (added 17/05/2021) 2019 Other publications in https://pubmed.ncbi.nlm.nih.gov/32742637/ SWAT results (added 15/02/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-16
• Study Completion: 2018-07-01
• Last Update Posted: 27 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 526

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<br> All secondary outcomes will be measured at the 6 and 12 month timepoints:<br> 1. Reduction in the number of cigarettes smoked per day (self-report)<br> 2. Dependence on smoking as assessed by the Fagerstrom Nicotine Dependence Questionnaire<br> 3. Level of motivation as assessed by the Motivation to quit questionnaire<br> 4. Patient Health Questionnaire 9 (PHQ-9)<br> 5. Health Related Quality of Life (SF-12)<br> 6. EuroQol EQ-5D<br><br> Added 24/10/2016:<br> 7. BMI<br> 8. Health service use, collected via a bespoke questionnaire<br><br> Added 28/08/2018:<br> 9. Anxiety measured using GAD-7 at baseline, 6 and 12 months<br>