Das Verhaltenstherapeutische Therapiemanual "Smoke_less" Zur Reduktion Des Tabakkonsums: Eine Evaluationsstudie Mit Ambulanten Patienten
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 2
- 主要终点
- Change from baseline in number of smoked cigarettes/day at 6, 17 and 29 weeks
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change from baseline in number of smoked cigarettes/day at 6, 17 and 29 weeks
时间窗: 6, 17 and 29 weeks
Change from baseline in percentage of carbon monoxide in exhalation air at 6, 17 and 29 weeks
时间窗: 6, 17 and 29 weeks
次要结局
- 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)
研究者
Oliver Pogarell
Prof. Dr. med.
Ludwig-Maximilians - University of Munich