F17.2
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Age > 18 years smoking of at least 10 cigarettes per day motivation to stop smoking by participating in a group therapy analogous to "Nichtraucher in 6 Wochen"
Exclusion criteria
Exclusion criteria: Mental disorders that require treatment, alcohol consumption >2 beer or 1/2l wine per day (half the amount for women), substance abuse (anamnestic), insufficient German language skills, pregnancy, serious medical conditions that interfere with the ability to participate at the study, especially diseases with a life expectancy < 12 months. participation in programms for smoking cessation in the intervention period (incl. hypnosis, telefone consultation, acupuncture).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of constant tobacco abstinence after 6 and 12 months in both groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| 7-day point abstinence after 6 and 12 months (incl. cotinin-assessment for biovalidation), smoking status after completing the therapy, use of nicotine replacement therapies/medication, number and reasons for discontinuation of therapy, reasons for relapses, date of smoking the first cigarette, number of cigarettes and days smoking, number and duration of attempts to regain abstinence, change of the degree of smoking dependence with the FTND (Bleich et al., 2002) at relapse, self-efficacy expectation for tobacco abstinence (SER; Jäkle et al., 1999), motivation and volition for tobacco abstinence, according to the HAPA-Model (Schwarzer et al., 2008), cost-effectiveness analysis (QALYS by EQ-5D-5L; EuroQol Group, 2009), weight progression with a weighing protocol, side effects, adverse events (e.g. sleep disturbance, depression [PHQ-9, Löwe et al., 2002]) | — |
Countries
Germany
Contacts
Universitätsklinikum Freiburg