Combining app-based behavioral therapy with electronic cigarettes for smoking cessation: a single-arm pilot trial
- Conditions
- Tobacco consumption (smoking)
- Registration Number
- DRKS00032652
- Lead Sponsor
- Institut für Integrative Gesundheitsversorgung und Gesundheitsförderung (IGVF)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 71
smoking cigarettes for at least 12 months, at least 5 cigarettes per day,
- motivation to stop smoking (Motivation To Stop Scale (MTSS; (41)) > 4 points),
- daily access to own smartphone (iOS 15/Android 11 or newer)
- resident in Germany,
- access to a personal email account,
- sufficient German language skills, written and spoken
- pregnancy/breastfeeding or intention to become pregnant during the study period,
- allergy to vegetable glycerol or propylene glycol,
- drug and/or alcohol dependence,
- severe psychiatric or physical illness or disease that is a contraindication to the use of e-cigarettes,
- taking medication that could affect the results of the study or is a contraindication to the use of e-cigarettes (bupropion/nortriptyline/varenicline/cytisine/clonidine/antidepressants),
- surgical procedure in the last 6 weeks (with anaesthesia),
- participation in another smoking cessation programme,
- use of e-cigarettes/tobacco heaters/alternative tobacco products/nicotine replacement therapy for more than 5 days in the last 30 days.
- no consent to participate
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Self-reported 7-day point prevalence abstinence (PPA) from cigarette smoking.<br>Measurement time points: Baseline (t0), after 4 weeks (t1), after 8 weeks (t2), after 12 weeks (t3), after 24 weeks (t4)
- Secondary Outcome Measures
Name Time Method - Percentage reduction in cigarettes smoked per day<br>- 30-days PPA<br>- Repeated PPA<br>- Continuous PPA (< 5 cigarettes since target quit date)<br>- Urges to smoke (VRS v4-1)<br>- Perceived stress (Perceived Stress Scale; PSS-10)<br>- Mindfulness (Freiburg Mindfulness Inventory short version; FFA)<br>- Smoking self-efficacy (How confident are you that you will be completely abstinent from smoking cigarettes in one year from now? (1 not confident at all” -10 very confident”), Smoking Self-Efficacy Questionnaire; SEQ-12)<br>- Subjective health (Short Form Health Survey; SF-12)<br>- Life satisfaction (L-1)<br><br>Measurement time points: Baseline (t0), after 4 weeks (t1), after 8 weeks (t2), after 12 weeks (t3), after 24 weeks (t4)