Clinical trial NCT01589211: Brief Intervention Study for Quitting Smoking
Official title: Brief Intervention Study for Quitting Smoking
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Smoking
Tobacco Use Cessation
Smoking Cessation
Keywords: smoking
cessation
intervention
brief
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2012-05-01
Enrollment: 347
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Continuous abstinence rate
timeFrame: 12 months
Secondary outcomes:
measure: Continuous abstinence rate
timeFrame: 6 months
measure: Time point abstinence rate
timeFrame: 6 and 12 months
measure: Quality of life (SF36 short form)
timeFrame: 0, 6 and 12 months
measure: Depression
timeFrame: 0, 6 and 12 months
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg
state: Baden-Württemberg
city: Stuttgart
country: Germany
facility: Pneumologische Praxis im Zentrum (former: Zentrum für Tabakentwöhnung Stuttgart)
state: Baden-Württemberg
city: Munich
country: Germany
facility: Klinikum der Universität München - Klinik für Psychiatrie und Psychotherapie
state: Bavaria
city: Chemnitz
country: Germany
facility: Technische Universität Chemnitz - Institut für Psychologie
state: Saxony
city: Berlin
country: Germany
facility: Institut für Raucherberatung und Tabakentwöhnung am Gemeinsschaftskrankenhaus Havelhöhe
Study officials:
affiliation: Heidelberg University
name: Alexander Rupp, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Heidelberg University
name: Michael Kreuter, PD Dr.
role: STUDY_CHAIR
affiliation: Heidelberg University
name: Felix JF Herth, Prof.
role: STUDY_DIRECTOR
References:
citation: Rupp A, Blank J, Ehmann M, Pousset R, Mühlig S, Sehl A, Fuchs S, Rüther T, Linhardt A, Grah C, Kreuter M. Basic data of the Brief Intervention Study for Quitting Smoking (BISQUITS). Pneumologie. 2014; 68 - P106 DOI: 10.1055/s-0034-1367889