Brief Intervention Study for Quitting Smoking (BISQUITS)

August 31, 2022 updated by: Felix JF Herth, Heidelberg University
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

347

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 14089
        • Institut für Raucherberatung und Tabakentwöhnung am Gemeinsschaftskrankenhaus Havelhöhe
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69126
        • Thoraxklinik Heidelberg
      • Stuttgart, Baden-Württemberg, Germany, 70178
        • Pneumologische Praxis im Zentrum (former: Zentrum für Tabakentwöhnung Stuttgart)
    • Bavaria
      • Munich, Bavaria, Germany, 80331
        • Klinikum der Universität München - Klinik für Psychiatrie und Psychotherapie
    • Saxony
      • Chemnitz, Saxony, Germany, 09120
        • Technische Universität Chemnitz - Institut für Psychologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Brief advice
A brief advice to stop smoking of about 10 min accompanied with self-help material
Behavioral: Brief advice
Brief advice of about 10 min accompanied by self-help material
EXPERIMENTAL: Compact cessation course
Cessation intervention of 2 x 120 min in a group setting
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.
ACTIVE_COMPARATOR: Standard cessation course
Cessation course in a group setting over 6 dates
Behavioral: Standard cessation course
Cessation course over 6 dates. Group setting.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Collaborators

Pfizer

Investigators

  • Principal Investigator: Alexander Rupp, Dr., Heidelberg University
  • Study Chair: Michael Kreuter, PD Dr., Heidelberg University
  • Study Director: Felix JF Herth, Prof., Heidelberg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 16, 2011

Primary Completion (ACTUAL)

April 11, 2013

Study Completion (ACTUAL)

April 11, 2013

Study Registration Dates

First Submitted

April 27, 2012

First Submitted That Met QC Criteria

April 30, 2012

First Posted (ESTIMATE)

May 1, 2012

Study Record Updates

Last Update Posted (ACTUAL)

September 6, 2022

Last Update Submitted That Met QC Criteria

August 31, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • WS899101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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