Tobacco smoking in young people with ‘first-episode psychosis’ (FEP) Mental and Behavioural Disorders
Conditions
Interventions
The study aims to determine the acceptability and feasibility of using the ‘Smoke Free’ app in Early Intervention Services (EIS), for supporting smoking cessation in young adults with first-episode ps
Sponsors
University of Manchester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 18–35 years (inclusive) 2. A current service user of Early Intervention Services (defined as having a designated care coordinator within the service) 3. A self-reported regular smoker (defined as smoking =5 cigarettes per day) 4. Interested in reducing/quitting tobacco consumption using a smartphone app
Exclusion criteria
Exclusion criteria: 1. Currently prescribed clozapine 2. No access to a compatible iPhone or Android smartphone device 3. Inability to give informed consent (as assessed during recruitment) 4. Insufficient command of English language to engage with assessments/intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility measured using the following indicators: 1. Referral rates measured as the number of service users who are interested in using an app for quitting smoking, and thus referred to the study over the study period, at baseline 2. Recruitment rates measured as the proportion of referred individuals who successfully enroll in the study (having been willing and able to download the app and join the intervention) and those who did not meet eligibility criteria (and reasons for this), at baseline 3. Retention rates and therefore the feasibility of studying the impact of ‘Smoke-Free’ in the context of EIS, to gain sufficient outcome data, measured as the proportion of enrolled individuals who successfully complete the end-point assessments of the study at 6 weeks 4. Engagement levels measured from the automatically-recorded app usage metrics, including frequency of usage per week, sustenance of usage, and levels of engagement with the various app features collected continuously over the 6 week study period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Smoking Behaviour measured using the following: 1.1. Self-reported smoking measured using the Heaviness of Smoking Index (HSI) at baseline and 6 weeks 1.2. Abstinence from smoking measured using self-report assessments at baseline and 6 weeks, and also throughout the study via the app, which will also send participants a push notification one month after their set quit date. The app will ask the following question: ‘Have you smoked at all in the last month?’ Response options will be: ‘No, not a puff’; ‘1–5 cigarettes’; or ‘More than 5 cigarettes’. Those who respond ‘No, not a puff’ will be considered abstinent. 1.1. Attitudes towards smoking measured using standardised questions for ‘Readiness to quit smoking’ and ‘Confidence to quit smoking at baseline and 6 weeks’. Readiness will be assessed with the question “How ready are you to quit smoking within the next month (0?=?Not at all; 10?=?100% ready)?”, while Confidence is assessed by, “How confident are you that you will quit smoking within the next month (0?=?Not at all; 10?=?100% confident)?”. 2. Perceived health status measured using the following: 2.1. Quality of life measured using the Smoking Cessation Quality of Life (SCQoL) acute questionnaire at baseline and 6 weeks 2.2. Psychological wellbeing measured using the short form of the Depression, Anxiety, and Stress Scale (DASS 21) at baseline and 6 weeks 2.3. Adverse events reported by participants their care teams at any point over the course of the trial. Information on any adverse events experienced will be requested from participants at 6 weeks. 3. Subjective experience of ‘Smoke Free’ measured using one-to-one semi-structured interviews with participants perspectives on app-based smoking cessation generally at baseline and 6 weeks 4. Service user’s opinions on desirability and utility of smoking cessation apps | — |
Countries
England, United Kingdom
Outcome results
None listed