NCT01589211

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
347

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2011

Geographic Reach
1 country

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 16, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 1, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2013

Completed
Last Updated

September 6, 2022

Status Verified

August 1, 2022

Enrollment Period

1.3 years

First QC Date

April 27, 2012

Last Update Submit

August 31, 2022

Conditions

SmokingTobacco Use CessationSmoking Cessation

Keywords

smokingcessationinterventionbrief

Outcome Measures

Primary Outcomes (1)

  • Continuous abstinence rate

    Biochemical validation by measurement of urine cotinine levels

    12 months

Secondary Outcomes (4)

  • Continuous abstinence rate

    6 months

  • Time point abstinence rate

    6 and 12 months

  • Quality of life (SF36 short form)

    0, 6 and 12 months

  • Depression

    0, 6 and 12 months

Study Arms (3)

Brief advice

ACTIVE COMPARATOR

A brief advice to stop smoking of about 10 min accompanied with self-help material

Behavioral: Brief advice

Compact cessation course

EXPERIMENTAL

Cessation intervention of 2 x 120 min in a group setting

Behavioral: Compact cessation course

Standard cessation course

ACTIVE COMPARATOR

Cessation course in a group setting over 6 dates

Behavioral: Standard cessation course

Interventions

Brief adviceBEHAVIORAL

Brief advice of about 10 min accompanied by self-help material

Brief advice
Compact cessation courseBEHAVIORAL

Compact cessation course on the basis of Motivational Interviewing (MI) and Cognitive Behavioural Therapy (CBT). Group setting. 2 x 120 min.

Compact cessation course
Standard cessation courseBEHAVIORAL

Cessation course over 6 dates. Group setting.

Standard cessation course

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Smoker
  • Age \> 18 years
  • Motivation to quit smoking

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Thoraxklinik Heidelberg

Heidelberg, Baden-Wurttemberg, 69126, Germany

Location

Pneumologische Praxis im Zentrum (former: Zentrum für Tabakentwöhnung Stuttgart)

Stuttgart, Baden-Wurttemberg, 70178, Germany

Location

Klinikum der Universität München - Klinik für Psychiatrie und Psychotherapie

Munich, Bavaria, 80331, Germany

Location

Technische Universität Chemnitz - Institut für Psychologie

Chemnitz, Saxony, 09120, Germany

Location

Institut für Raucherberatung und Tabakentwöhnung am Gemeinsschaftskrankenhaus Havelhöhe

Berlin, 14089, Germany

Location

Related 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

    BACKGROUND

MeSH Terms

Conditions

SmokingTobacco Use CessationSmoking Cessation

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Alexander Rupp, Dr.

    Heidelberg University

    PRINCIPAL INVESTIGATOR

  • Michael Kreuter, PD Dr.

    Heidelberg University

    STUDY CHAIR

  • Felix JF Herth, Prof.

    Heidelberg University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med. Alexander Rupp

Study Record Dates

First Submitted

April 27, 2012

First Posted

May 1, 2012

Study Start

December 16, 2011

Primary Completion

April 11, 2013

Study Completion

April 11, 2013

Last Updated

September 6, 2022

Record last verified: 2022-08

Locations

DE(5)