Smoking cessation using an e-cigarette in patients living in the community who have a mental illness Mental and Behavioural Disorders
Conditions
Interventions
The intervention allocation will be determined by block computer randomisation to ensure that each trial site has an equal proportion of intervention and control group participants. Randomisation wil
Sponsors
University of York
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Adults (aged >18 years) 2. Receiving treatment for a mental illness in primary or secondary care 3. Smokes regularly and have smoked combustible cigarettes in the past 7 days) 4. Must be willing to address their smoking behaviour, either by attempting to quit or by reducing their consumption 5. Must have the capacity to provide consent
Exclusion criteria
Exclusion criteria: 1. Patients must not have had an inpatient admission in the last 3 months 2. Smokers who are currently using e-cigarettes regularly (at least weekly) 3. Patients who are participating in other smoking cessation trials 4. Patients who are receiving treatment for drug or alcohol use 5. Patients who have a diagnosis of Alzheimer’s disease or dementia 6. Patients who are pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Self-reported 7-day point prevalence abstinencemeasured using a questionnaire (question written in-house) at 6 months 2. Co-verified quit (main outcome) measured using a CO monitor (smokylizer) at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. General smoking-related characteristics, abstinence, quit attempts and methods (including e-cigarettes), measured using a questionnaire (questions written in-house) at baseline, 1 month and 6 months 2. Nicotine dependence measured using the Fagerstrom Test for Nicotine Dependence at baseline, 1 month and 6 months 3. Strength of urges to smoke measured using the SUTS questionnaire at baseline, 1 month and 6 months 4. Motivation to quit measured using the Motivation To Stop Scale (MTSS) at baseline, 1 month and 6 months 5. Mental wellbeing measured using PHQ-9 and GAD-7 at baseline and 6 months 6. Alcohol use measured using AUDIT-C at baseline and 6 months 7. Health-related quality of life measured using EQ-5D-5L at baseline and 6 months 8. Attrition measured using a questionnaire (questions written in-house) at 1 month and 6 months 9. Adherence rate measured using a questionnaire (questions written in-house) at 1-month follow-up 10. Cost-effectiveness measured using a questionnaire (questions written in-house) at baseline, 1 month and 6 months 11. Adverse events measured using a questionnaire (questions written in-house) at 1 month and 6 months | — |
Countries
England, United Kingdom
Outcome results
None listed