Primary prevention through smoking cessation Mental and Behavioural Disorders
Conditions
Interventions
Participants quit smoking after a smoke-free-programme provided by the addiction support Tirol
Quitting smoking is one of the most effective preventive health measures. This study aims to find out wh
Sponsors
Tirol Kliniken
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 to 75 years 2. Current smokers 3. Motivated to quit smoking 3. In possession of a smartphone and familiar with its use
Exclusion criteria
Exclusion criteria: 1. Active cancer (exception: non-melanocytic skin cancer) 2. Present and/or past severe psychiatric illnesses 3. Concurrent participation in another interventional study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness of the biofeedback method to sustain smoking cessation measured by comparing the number of ‘smoke-free’ participants in the groups with and without biofeedback until at least the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Achievement of the planned number of participants (n=200) in Tirol within 5 months measured using study records of recruitment at 6 months after recruitment initiation 2. Number of participants in the two groups (with and without biofeedback) who have completed the study (regardless of whether they continue smoking) measured using study records from baseline to 6 months of recruitment time 3. Epigenetic alterations as a result of smoking cessation evaluated using DNA methylation signatures associated with age, disease, or exposure, e.g. WID indices (WID-BC, WID-OC, WID-SMKand WID-age), epigenetic clocks, etc. and measured using microarray analysis (Illumina HumanMethylationEPIC) using of buccal and cervical/vaginal smears and blood at baseline and 2, 4, 6 and 8 months after study entry. Per-protocol and intention to treat analyses will be conducted and compared between the two groups at respective timepoints, and separately comparing changes from baseline in each group. 4. Clinical factors, including resting heart rate and blood pressure (measured using the device Boso Medicus X (Bosch + Sohn)) and vascular elasticity (measured using the device Vicorder®) at baseline and 2, 4, 6 and 8 months after study entry. Per-protocol and intention to treat analyses will be conducted and compared between the two groups at respective timepoints, and separately comparing changes from baseline in each group. 5. Quality of life (measured using the WHO quality of life questionnaire (WHOQOL)), quality and duration of sleep (measured using the Pittsburgh Sleep Quality Index (PSQI)) and stress level (measured using the Perceived Stress Scale (PSS-10)) at baseline and 2, 4, 6 and 8 months after study entry. Per-protocol and intention to treat analyses will be conducted and compared between the two groups at respective timepoints, and separately comparing changes from baseline in each group. 6. Blood values, including: 6.1. Blood count and differential blood count measured using flow | — |
Countries
Austria
Contacts
Public ContactSandra Plaikner
Outcome results
None listed