Smoking, Smoking Cessation, Tobacco Use Cessation
Conditions
Keywords
smoking, cessation, intervention, brief
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.
Interventions
BEHAVIORALBrief advice
Brief advice of about 10 min accompanied by self-help material
BEHAVIORALCompact cessation course
Compact cessation course on the basis of Motivational Interviewing (MI) and Cognitive Behavioural Therapy (CBT). Group setting. 2 x 120 min.
BEHAVIORALStandard cessation course
Cessation course over 6 dates. Group setting.
Sponsors
Pfizer
Heidelberg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Continuous abstinence rate | 12 months | Biochemical validation by measurement of urine cotinine levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Continuous abstinence rate | 6 months | — |
| Time point abstinence rate | 6 and 12 months | — |
| Quality of life (SF36 short form) | 0, 6 and 12 months | Quality of life |
| Depression | 0, 6 and 12 months | — |
Countries
Germany
Outcome results
None listed