The use of e-cigarettes for smoking cessation for people with mental illness. Other
Conditions
Interventions
The intervention consists of an e-cigarette starter kit containing a third generation e-cigarette (Aspire PockeX), a four-week supply of e-liquid (a choice of flavors and concentrations will be offere
Sponsors
University of York
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults (> 18 years) 2. Receiving treatment for a mental illness under the care of secondary care psychiatric community teams or community mental health teams (CMHTs) 3. Smoker (who smoke regularly and have smoked combustible cigarettes in the past 7 days) 4. Be willing to address their smoking behaviour, either by attempting to quit or by reducing their consumption and have the capacity to provide consent. 5. Have the capacity to consent (assessed by patient's care coordinator)
Exclusion criteria
Exclusion criteria: 1. Patients must not have had an inpatient admission in the last 3 months according to their health care record. 2. Smokers who are currently using e-cigarettes regularly (at least weekly) 3. Those who are participating in other smoking cessation trials 4. Those being treated for co-morbid drug or alcohol problems 5. Those who have a diagnosis of Alzheimer’s disease or dementia 6. Those who are are pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Feasibility and acceptability outcomes: The primary feasibility outcome measures in the feasibility trial will be consenting rate and recruitment frequency. 1.1. Consenting rate will be calculated from the number of eligible participants approached who consent to take part in the study. 1.2. Recruitment frequency will be calculated as the number of eligible patients at each site who agree to participate in the trial per month. 1.3. The attrition rate will be measured as the number of participants who fail to complete follow-up at 1 month. 2. Clinical (smoking-related) outcomes: 2.1. Continuous abstinence assessed at 1-month will be defined as not having smoked in the two weeks prior to follow-up, verified by a CO reading below 10 ppm, in keeping with the standard measure used in Stop Smoking Services. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Feasibility and acceptability outcomes: 1.1. Fidelity will be assessed by randomly sampling two intervention sessions per site with trained staff, audio-recording them and coding the use of behaviour change techniques during intervention deliver period 1.2. Characteristics of ‘usual care’ in different locations will be also noted, recording two interactions of patients with CMHTs or GPs at each site at baseline and using short pro-forma with control group participants at 1-month follow-up 1.3. Participant burden of data collection will be assessed via qualitative interviews conducted online or via telephone with participants to assess acceptability. 2. Clinical (smoking-related) outcomes: 2.1. Self-reported abstinence 2-4 weeks from enrollment or target quit date (whichever is later) will be recorded at 1-month follow-up. The change in cigarette consumption (and reduction in exhaled breath CO reading) from baseline to 1-month follow-up will be calculated in both intervention and control group participants. 3. Clinical (mental health-related) outcomes: General and mental health functioning will be assessed using most recent diagnosis (if available), antipsychotic medication use, and acute events (e.g. hospitalisation) in the last year. Mental health symptoms will be assessed with the PHQ-9 [Gilbody et al., 2007], GAD-7 [Spitzer et al., 2006] and SF-12 questionnaires [Ware et al., 1996] at 1 month follow-up. 4. Cost effectiveness: We will pilot service use questionnaires for health economic analysis and assess the health care utilisation data returned. We will calculate the costs of delivering the intervention and the control condition as the basis for the full RCT, for which a cost-effectiveness analysis is planned. Data will be collected at baseline and 1-month. 5. Serious Adverse Events (SAE): Adverse events (AE) will be recorded at 1-month follow-up as part of the follow-up questionnaires participants complete. | — |
Countries
England, United Kingdom
Contacts
Public ContactLion Shahab
Outcome results
None listed