Tobacco use Mental and Behavioural Disorders Tobacco use
Conditions
Interventions
Randomisation: Participants are randomly assigned into the treatment and control arm at a 50:50 ratio.
Group 1 (Intervention): Participants in the intervention arm receive access to a
CBT) delivered through a mobile application. This consists of several sessions per week completed by the participant on their phone at their convenience, and without involvement of a healthcare profes
Sponsors
Digital Therapeutics Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 or older 2. Has been smoking at least five cigarettes a day for at least one year 3. Desires to quit in the next 30 days 4. Can attend appointments at one of several locations around London 5. Using Apple iPhone (5th generation or higher) or Android phone (version 18 or higher) 6. Working proficiency in English language
Exclusion criteria
Exclusion criteria: 1. Currently using any other form of support for smoking cessation (including Bupropion, Varenicline, behavioural support) or any other stop smoking applications 2. Has a serious health condition (as decided by the study team) 3. Currently pregnant 4. Has a diagnosed mental health condition for which medication is currently being prescribed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 24/07/2019: Self-reported 7-day point prevalence abstinence at 4-weeks post quit date Previous primary outcome measure: Abstinence at 4 weeks post agreed quit date confirmed as self-reported “no puff of smoke” (using a questionnaire) in the past 2 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 24/07/2019: 1. 7-day point prevalence abstinence at week 26 and 52 2. Number of quit attempts at week 4, 26, and 52 3. Client Satisfaction with the intervention at week 4 (treatment only) 4. Participant changes in confidence levels, knowledge, attitudes and perceptions related to smoking cessation at week 4 5. Participant changes in self-efficacy at week 4, 26, and 52 6. Participant changes in self-reported health and wellbeing at week 4, 26, and 52 7. Self-reported abstinence at 4-weeks post quit date confirmed by ‘no puff of smoke’ in the past two weeks 8. Sustained abstinence at 24 and 52 weeks, defined as a self-report of smoking no more than five cigarettes from 2 weeks after the target quit date Previous secondary outcome measures: All outcomes are assessed using questionnaires completed by the participant. 1. Successful quit attempt as defined in the primary outcome at 26 and 52 weeks 2. 7-day point prevalence abstinence at week 4, 26, and 52 3. Number of quit attempts at week 4, 26, and 52 4. Client Satisfaction with the intervention at week 4 (treatment only) 5. Participant changes in confidence levels, knowledge, attitudes and perceptions related to smoking cessation at week 4 6. Participant changes in self-efficacy at week 4, 26, and 52 7. Participant changes in self-reported health and wellbeing at week 4, 26, and 52 | — |
Countries
United Kingdom
Contacts
Public ContactSarrah Peerbux
Outcome results
None listed