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临床试验/NCT01589211
NCT01589211终止不适用

Brief Intervention Study for Quitting Smoking

Heidelberg University10 个研究点 分布在 1 个国家目标入组 347 人开始时间: 2011年12月16日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
347
试验地点
10
主要终点
Continuous abstinence rate

研究概览

简要总结

To investigate the effectiveness of a smoking cessation intervention of two sessions (120 min at a time) in a group setting on the basis of Motivational Interviewing (MI) and important elements of Cognitive Behavioural Therapy (CBT). According to national and international guidelines patients are advised to quit and pharmacologically supported with one of the established first line smoking cessation treatments.

详细描述

The study design is multicentric, prospective, randomized and controlled. The study is taking place in cooperation with smoking clinics of 5 centres in Germany (Heidelberg, Stuttgart, Munich, Chemnitz, Berlin). A total number of 800 smokers is calculated to participate in the study. After enrollment participants are randomized in one of the three intervention groups: (A) "Advice only", (B) "Brief intervention", (C) "Intensive therapy". The follow up includes a telephone interview 3 months after the last intervention, and two visits at the smoking clinics after 6 and 12 months with biochemical validation of the smoking status by measurement of the exhaled carbon monoxide and the concentration of cotinine in an urine sample respectively. The primary endpoint is the continuous abstinence rate after 12 months. Several secondary endpoints are determined amongst others the continuous abstinence rate after 6 months, point prevalence cessation rates after 6 and 12 months, life quality, weight gain, predictors of a successful cessation attempt.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18 years
  • Motivation to quit smoking

排除标准

  • severe somatic comorbidity or reduced life expectancy
  • severe episode of a psychiatric disease
  • reduced cognitive ability
  • abuse of alcohol or illicit drugs
  • other reasons at the discretion of responsible local study tutor

结局指标

主要结局

Continuous abstinence rate

时间窗: 12 months

Biochemical validation by measurement of urine cotinine levels

次要结局

  • Continuous abstinence rate(6 months)
  • Depression(0, 6 and 12 months)
  • Time point abstinence rate(6 and 12 months)
  • Quality of life (SF36 short form)(0, 6 and 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Felix JF Herth

Dr. med. Alexander Rupp

Heidelberg University

研究点 (10)

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