Smoking cessation in persons with mental health disorders Mental and Behavioural Disorders
Conditions
Interventions
Baseline data collection:
Once participant eligibility has been confirmed and consent has been obtained, a baseline visit will be completed to collect all baseline data. The following measures will be
smoking history and behaviour during inpatient stay (including number of cigarettes smoked per day, greatest length of time abstinent during stay, Heaviness of Smoking Index (HSI), Strength of urges t
Sponsors
Sheffield Health and Social Care NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 10/07/2024: 1. Adults (18 years+) who smoked prior to/during admission on acute NHS mental health wards and express an interest in maintaining abstinence or positively changing their smoking behaviour following discharge 2. Planned discharge within seven to fourteen days to address/accommodation within Trust’s catchment area 3. Able to understand and communicate in English 4. Access to a telephone or alternative digital advice to receive post-discharge support 5. Willing and able to provide informed consent Exclusion criteria: 6. Admitted under the care of older adult, learning disability, psychiatric intensive-care unit or forensic mental health services 7. Patients deemed not clinically appropriate to participate (at clinician discretion) Previous participant inclusion criteria: 1. Adults aged 18 years and older (no maximum age) 2. Current admission to an acute adult mental health inpatient setting 3. Planned discharge within seven to fourteen days to address/accommodation within the Trust’s catchment area 4. Tobacco smokers at time of admission or at any point after (as patients occasionally still commence smoking after admission) who express an interest in maintaining abstinence (if smokefree at time of assessment) or in positively changing their smoking behaviour following discharge (including cigarette reduction and e-cigarette approaches) 5. Able to understand and communicate in English 6. Access to a telephone or computer/alternative digital device to receive post-discharge support 7. Willing and able to provide informed consent
Exclusion criteria
Exclusion criteria: 1. Admitted under the care of older adult, learning disability, psychiatric intensive-care unit (PICU) or forensic mental health services. 2. Patients deemed not clinically appropriate to participate in study (at clinician discretion).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Recruitment and retention measured using screening data and retention rates captured throughout the duration of the study. 2. Compliance with the protocol measured using self-assessment checklists completed by the MTS's and reported protocol deviations throughout the duration of the study. 3. Level of contamination and suitability of randomisation approach measured using qualitative data collected at 3-months post randomisation and quantitative data collected at 3- and 6-months post randomisation from control participants who quit or reduce smoking. 4. Additional qualitative and quantitative measures of acceptability by undertaking semi-structured interviews with control and intervention group participants at 3 months post-randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured using self report (unless otherwise noted): 1. Self-reported 7-day point prevalence abstinence from tobacco validated by exhaled CO <10ppm at 3 and 6 months, 2. Self-reported relapse following discharge from hospital at 3 and 6 months, 3. 1, 2, and 3-month continuous abstinence at 3 months post randomisation, 4. 4, 5, and 6-month continuous abstinence at 6 months post randomisation 5. Tobacco consumption at baseline, 3- and 6-months post-randomisation, 6. Number of quit attempts at baseline, 3 and 6 months, 7. Motivation to quit at baseline 3 and 6 months, 8. Heaviness of Smoking Index at baseline, 3 and 6 months, 9. Use of NRT/e-cigarettes at baseline, 3 and 6 months, 10. Self-efficacy related to smoking cessation at baseline, 3 and 6 months, 11. Change in mental health PHQ-9 at baseline, 3 and 6 months, 12. Change in mental health GAD-7 at baseline, 3 and 6 months, 13. Change in mental health EQ-5D at baseline, 3 and 6 months, 14. Cost of delivering the SCEPTRE intervention and the control condition and feasibility of collecting health economic data measured using a bespoke health resource use questionnaire at 3 and 6 months post-randomisation. | — |
Countries
England, United Kingdom
Contacts
Public ContactLesley Sinclair
Outcome results
None listed