NCT01589211

Brief Intervention Study for Quitting Smoking

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 347 (actual)
• Sponsor: Heidelberg University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Smoking
• Tobacco Use Cessation
• Smoking Cessation

Interventions

Type	Name	Description
BEHAVIORAL	Brief advice	Brief advice of about 10 min accompanied by self-help material
BEHAVIORAL	Compact cessation course	Compact cessation course on the basis of Motivational Interviewing (MI) and Cognitive Behavioural Therapy (CBT). Group setting. 2 x 120 min.
BEHAVIORAL	Standard cessation course	Cessation course over 6 dates. Group setting.

Timeline

• Start date: 2011-12-16
• Primary completion: 2013-04-11
• Completion: 2013-04-11
• First posted: 2012-05-01
• Last updated: 2022-09-06

Locations

5 sites across 1 country: Germany