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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
347
Brief advice of about 10 min accompanied by self-help material
Compact cessation course on the basis of Motivational Interviewing (MI) and Cognitive Behavioural Therapy (CBT). Group setting. 2 x 120 min.
Cessation course over 6 dates. Group setting.
Thoraxklinik Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Pneumologische Praxis im Zentrum (former: Zentrum für Tabakentwöhnung Stuttgart)
Stuttgart, Baden-Wurttemberg, Germany
Klinikum der Universität München - Klinik für Psychiatrie und Psychotherapie
Munich, Bavaria, Germany
Technische Universität Chemnitz - Institut für Psychologie
Chemnitz, Saxony, Germany
Continuous abstinence rate
Biochemical validation by measurement of urine cotinine levels
Time frame: 12 months
Continuous abstinence rate
Time frame: 6 months
Time point abstinence rate
Time frame: 6 and 12 months
Quality of life (SF36 short form)
Quality of life
Time frame: 0, 6 and 12 months
Depression
Time frame: 0, 6 and 12 months
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Institut für Raucherberatung und Tabakentwöhnung am Gemeinsschaftskrankenhaus Havelhöhe
Berlin, Germany