Brief Intervention Study for Quitting Smoking

Smoking Cessation Clinical Trial

— BISQUITS  

Official title:

Brief Intervention Study for Quitting Smoking

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01589211
• Other study ID #: WS899101
• Status: Terminated
• Phase: N/A
• Start date: December 16, 2011
• Est. completion date: April 11, 2013

Study information

• Verified date: August 2022
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 347
• Est. completion date: April 11, 2013
• Est. primary completion date: April 11, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking
• Smoking Cessation
• Tobacco Use Cessation

Intervention

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

Locations

Country	Name	City	State
Germany	Institut für Raucherberatung und Tabakentwöhnung am Gemeinsschaftskrankenhaus Havelhöhe	Berlin
Germany	Technische Universität Chemnitz - Institut für Psychologie	Chemnitz	Saxony
Germany	Thoraxklinik Heidelberg	Heidelberg	Baden-Württemberg
Germany	Klinikum der Universität München - Klinik für Psychiatrie und Psychotherapie	Munich	Bavaria
Germany	Pneumologische Praxis im Zentrum (former: Zentrum für Tabakentwöhnung Stuttgart)	Stuttgart	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
Heidelberg University	Pfizer

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continuous abstinence rate	Biochemical validation by measurement of urine cotinine levels	12 months
Secondary	Continuous abstinence rate		6 months
Secondary	Time point abstinence rate		6 and 12 months
Secondary	Quality of life (SF36 short form)	Quality of life	0, 6 and 12 months
Secondary	Depression		0, 6 and 12 months