Brief Intervention Study for Quitting Smoking

Study Overview
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Brief Summary
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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
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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.

Official Title
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Brief Intervention Study for Quitting Smoking

Conditions
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Smoking, Tobacco Use Cessation, Smoking Cessation

Intervention / Treatment
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* Behavioral: Brief advice
* Behavioral: Compact cessation course
* Behavioral: Standard cessation course


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Brief advice<br>A brief advice to stop smoking of about 10 min accompanied with self-help material | Behavioral: Brief advice<br>* Brief advice of about 10 min accompanied by self-help material<br>|
| Experimental: Compact cessation course<br>Cessation intervention of 2 x 120 min in a group setting | Behavioral: Compact cessation course<br>* Compact cessation course on the basis of Motivational Interviewing (MI) and Cognitive Behavioural Therapy (CBT). Group setting. 2 x 120 min.<br>|
| Active Comparator: Standard cessation course<br>Cessation course in a group setting over 6 dates | Behavioral: Standard cessation course<br>* Cessation course over 6 dates. Group setting.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous abstinence rate | Biochemical validation by measurement of urine cotinine levels | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous abstinence rate |  | 6 months | 
| Time point abstinence rate |  | 6 and 12 months | 
| Quality of life (SF36 short form) | Quality of life | 0, 6 and 12 months | 
| Depression |  | 0, 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking, cessation, intervention, brief