Randomised, multicentre, controlled, double-blind, prospective study to evaluate the superiority of the Smoke Free App compared to standard therapy in dependent smokers
Not Applicable
Recruiting
- Conditions
- F17Mental and behavioural disorders due to use of tobacco
- Registration Number
- DRKS00031140
- Lead Sponsor
- Smoke Free 23 GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1442
Inclusion Criteria
diagnosed tobacco dependence according to ICD-10 GM F17.2
- intention to stop smoking
- end device to use the app
- willingness to participate in the study
- resident (primary residence) in the Federal Republic of Germany
- valid private e-mail address, postal address and telephone number
- sufficient German language skills
Exclusion Criteria
- concurrent alcohol or drug dependence.
- acute symptomatic psychiatric disorder or suicide risk.
- severe cognitive impairment
- dementia
- acute concomitant illness at the time of the individual start of the study requiring hospitalisation
- insufficient German language skills
- living with a person who also uses the Smoke Free app
- use of another smartphone app for smoking cessation
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Self-reported 7-day point prevalence of smoking abstinence at 6-month follow-up.
- Secondary Outcome Measures
Name Time Method 1) Validated (cotinine test) 7-day point prevalence of smoking abstinence at 6-month follow-up.<br>2) Sustained abstinence over all measurement points