Smoking relapse prevention Mental and Behavioural Disorders Smoking relapse prevention
Conditions
Interventions
Participants will be randomised (stratified by country [and service within the UK] in permuted blocks of random size) to one of four study arms described in the Schedule of Intervention below. Randomi
practice replacement strateg
Sponsors
Queen Mary University of London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Users of the Stop Smoking Service in the UK who are abstinent in the last 2 weeks of treatment (treatment period is typically 4 weeks post quit date, QD) 2. Willing to use a smoking replacement product or online behavioural support tool if allocated to use 3. Aged 18 years and older 4. Own a mobile phone 5. Has Internet access 6. Able to read/write/understand English
Exclusion criteria
Exclusion criteria: 1. Enrolled in other smoking cessation/relapse prevention research 2. Currently using an electronic cigarette/oral NRT and planning to use for longer than 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Abstinence is measured by the follow up survey created for the purpose of the study at 3, 6 and 12 month post quit date, biochemically validated with a saliva sample. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Biochemically validated sustained abstinence is measured using the follow up survey created for the purpose of the study at 3, 6 and 12 month post quit date, biochemically validated with a saliva sample 2. Mechanisms of effect of strategies are measured using the Ecological Momemtary Assessment sub study data (at 8-12 weeks post quit date) and Qualitative sub study interview transcripts at 3, 6 and 12 month post quit date 3. Sustained reduction in cigarette consumption measured using the smoking status questions using the follow up survey created for the purpose of the study at 3, 6 and 12 months post quit date 4. Cost-effectiveness of the different strategies measured using the EuroQol five dimensions questionnaire (EQ5D) and smoking cessation and health service use questionnaires [provide specific questionnaire names/state if designed for this study – these are their names] at baseline, 6 and 12 months 5. Effects of strategies (e.g. on relapse rates, participant ratings etc.) on people from different socioeconomic and ethnic groups, of different gender, with different prior smoking habits, and those who stopped smoking using different forms of medication measured using demographic details from baseline survey created for the purpose of the study and smoking status/intervention ratings on follow up surveys created for the purpose of the study at 3, 6 and 12 months post quit date 6. Use and ratings of the strategies by participants, including reported engagement and negative aspects of the interventions measured using the use and ratings questions on the follow up surveys created for the purpose of the study at 3, 6 and 12 months post quit date | — |
Countries
Australia, England, United Kingdom
Outcome results
None listed