Brief Intervention Study for Quitting Smoking

Not Applicable

Terminated

• Conditions: Smoking; Tobacco Use Cessation; Smoking Cessation
• Interventions: Behavioral: Brief advice; Behavioral: Compact cessation course; Behavioral: Standard cessation course

• Registration Number: NCT01589211
• Lead Sponsor: Heidelberg University

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2011-12-16
• Study First Submitted: 2012-04-27
• Study First Submitted QC: 2012-04-30
• Study First Posted: 2012-05-01
• Primary Completion: 2013-04-11
• Study Completion: 2013-04-11
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-31
• Last Update Posted: 2022-09-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 347

Inclusion Criteria

• Smoker
• Age > 18 years
• Motivation to quit smoking

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brief advice	Brief advice	A brief advice to stop smoking of about 10 min accompanied with self-help material
Compact cessation course	Compact cessation course	Cessation intervention of 2 x 120 min in a group setting
Standard cessation course	Standard cessation course	Cessation course in a group setting over 6 dates

Primary Outcome Measures

Name	Time	Method
Continuous abstinence rate	12 months	Biochemical validation by measurement of urine cotinine levels

Secondary Outcome Measures

Name	Time	Method
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	Quality of life

Trial Locations

Locations (5)

Pneumologische Praxis im Zentrum (former: Zentrum für Tabakentwöhnung Stuttgart); 🇩🇪 Stuttgart, Baden-Württemberg, Germany

Institut für Raucherberatung und Tabakentwöhnung am Gemeinsschaftskrankenhaus Havelhöhe; 🇩🇪 Berlin, Germany

Klinikum der Universität München - Klinik für Psychiatrie und Psychotherapie; 🇩🇪 Munich, Bavaria, Germany

Technische Universität Chemnitz - Institut für Psychologie; 🇩🇪 Chemnitz, Saxony, Germany

Thoraxklinik Heidelberg; 🇩🇪 Heidelberg, Baden-Württemberg, Germany