Tobacco Reduction
Conditions
Brief summary
The aim of this study is to evaluate a new cognitive behavioral smoking reduction program for ambulant patients in a three-armed study design. Study participants will be randomized to one of the following three study groups: experimental group: 5-week lasting cognitive behavioral reduction program (smoke\_less); active comparator: 15 minutes counseling interview; waiting group: no intervention. The three follow-up measures take place after the reduction program in week 6, 17 an 29. After the finalisation of the last follow-up, participants from the active comparator and waiting group get the chance to take part at the smoking reduction program at no charge.
Interventions
BEHAVIORALCognitive behavioral smoking reduction program Smoke_less
Duration: 5 weeks, 4 sessions over 2,5 hours and 2 phone calls
BEHAVIORAL15 minute counseling interview
Sponsors
Ludwig-Maximilians - University of Munich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 18-70 years * Result Fagerström-Test \>= 3 * Consumption of at least 10 Cig./day * carbon monoxide \>= 8 ppm * Wish, to reduce smoking but no intention to stop smoking within the next 4 weeks * Agreement, to resign to nicotine replacement therapy, other therapies for smoking reduction, e-cigarettes or non-smoking tobacco products during study time
Exclusion criteria
* severe psychiatric disorder * severe neurologic disease * alcohol, drug or medication abuse (acute or in anamnesis) * severe cardiovascular disease * severe cancer disease * severe internal disease * Consumption of psychopharmacological medication * acute suicidal tendency * pregnancy or lactation * consumption of medication therapy for smoking reduction in the last 3 month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in number of smoked cigarettes/day at 6, 17 and 29 weeks | 6, 17 and 29 weeks |
| Change from baseline in percentage of carbon monoxide in exhalation air at 6, 17 and 29 weeks | 6, 17 and 29 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Readiness to Change Questionnaire at 6, 17 and 29 weeks | 6, 17 and 29 weeks |
| Change from baseline in Process of Change Questionnaire at 6, 17 and 29 weeks | 6, 17 and 29 weeks |
| Change from baseline in Decisional Balance Questionnaire at 6, 17 and 29 weeks | 6, 17 and 29 weeks |
| Change from baseline in Fagerström Test for Nicotine Dependence at 6, 17 and 29 weeks | 6, 17 and 29 weeks |
| Change from baseline in knowledge and skills scale about smoking reduction at 6, 17 and 29 weeks | 6, 17 and 29 weeks |
| Change from baseline in stress scale at 6, 17 and 29 weeks | 6, 17 and 29 weeks |
| Change from baseline in health satisfaction satisfaction scale at 6, 17 and 29 weeks | 6, 17 and 29 weeks |
| Change from baseline in Self-Efficacy scale for smokers 6, 17 and 29 weeks | 6, 17 and 29 weeks |
| Change from baseline in Questionnaire of Smoking Urges at 6, 17 and 29 weeks | 6, 17 and 29 weeks |
Countries
Germany
Outcome results
None listed