Evaluation of a Cognitive Behavioral Smoking Reduction Program
Not Applicable
Completed
- Conditions
- Tobacco Reduction
- Registration Number
- NCT02337400
- Lead Sponsor
- Ludwig-Maximilians - University of Munich
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 155
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Change from baseline in health satisfaction satisfaction scale at 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 Change from baseline in Decisional Balance Questionnaire 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 Process of Change Questionnaire 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 Fagerström Test for Nicotine Dependence at 6, 17 and 29 weeks 6, 17 and 29 weeks Change from baseline in Readiness to Change Questionnaire at 6, 17 and 29 weeks 6, 17 and 29 weeks
Trial Locations
- Locations (1)
Dept. of Psychiatry
🇩🇪Munich, Germany
Dept. of Psychiatry🇩🇪Munich, Germany