Evaluation of a Cognitive Behavioral Smoking Reduction Program

August 29, 2016 updated by: Oliver Pogarell, Ludwig-Maximilians - University of Munich

Das Verhaltenstherapeutische Therapiemanual "Smoke_less" Zur Reduktion Des Tabakkonsums: Eine Evaluationsstudie Mit Ambulanten Patienten

The aim of this study is to evaluate a new cognitive behavioral smoking reduction program for ambulant patients in a three-armed study design. Study participants will be randomized to one of the following three study groups: experimental group: 5-week lasting cognitive behavioral reduction program ("smoke_less"); active comparator: 15 minutes counseling interview; waiting group: no intervention.

The three follow-up measures take place after the reduction program in week 6, 17 an 29. After the finalisation of the last follow-up, participants from the active comparator and waiting group get the chance to take part at the smoking reduction program at no charge.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

155

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
      • Munich, Germany, D-80336
        • Dept. of Psychiatry

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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-70 years
  • Result Fagerström-Test >= 3
  • Consumption of at least 10 Cig./day
  • carbon monoxide >= 8 ppm
  • Wish, to reduce smoking but no intention to stop smoking within the next 4 weeks
  • Agreement, to resign to nicotine replacement therapy, other therapies for smoking reduction, e-cigarettes or non-smoking tobacco products during study time

Exclusion Criteria:

  • severe psychiatric disorder
  • severe neurologic disease
  • alcohol, drug or medication abuse (acute or in anamnesis)
  • severe cardiovascular disease
  • severe cancer disease
  • severe internal disease
  • Consumption of psychopharmacological medication
  • acute suicidal tendency
  • pregnancy or lactation
  • consumption of medication therapy for smoking reduction in the last 3 month

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Smoking Reduction Program
Cognitive behavioral smoking reduction program "Smoke_less" Duration: 5 weeks with 4 weekly sessions over 2,5 hours and two phone calls
Behavioral: Cognitive behavioral smoking reduction program "Smoke_less"
Duration: 5 weeks, 4 sessions over 2,5 hours and 2 phone calls
Active Comparator: Counseling Interview
15 minute counseling interview
Behavioral: 15 minute counseling interview
No Intervention: Waiting Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in number of smoked cigarettes/day at 6, 17 and 29 weeks
Time Frame: 6, 17 and 29 weeks
6, 17 and 29 weeks
Change from baseline in percentage of carbon monoxide in exhalation air at 6, 17 and 29 weeks
Time Frame: 6, 17 and 29 weeks
6, 17 and 29 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Fagerström Test for Nicotine Dependence at 6, 17 and 29 weeks
Time Frame: 6, 17 and 29 weeks
6, 17 and 29 weeks
Change from baseline in Questionnaire of Smoking Urges at 6, 17 and 29 weeks
Time Frame: 6, 17 and 29 weeks
6, 17 and 29 weeks
Change from baseline in Readiness to Change Questionnaire at 6, 17 and 29 weeks
Time Frame: 6, 17 and 29 weeks
6, 17 and 29 weeks
Change from baseline in Process of Change Questionnaire at 6, 17 and 29 weeks
Time Frame: 6, 17 and 29 weeks
6, 17 and 29 weeks
Change from baseline in Decisional Balance Questionnaire at 6, 17 and 29 weeks
Time Frame: 6, 17 and 29 weeks
6, 17 and 29 weeks
Change from baseline in Self-Efficacy scale for smokers 6, 17 and 29 weeks
Time Frame: 6, 17 and 29 weeks
6, 17 and 29 weeks
Change from baseline in knowledge and skills scale about smoking reduction at 6, 17 and 29 weeks
Time Frame: 6, 17 and 29 weeks
6, 17 and 29 weeks
Change from baseline in stress scale at 6, 17 and 29 weeks
Time Frame: 6, 17 and 29 weeks
6, 17 and 29 weeks
Change from baseline in health satisfaction satisfaction scale at 6, 17 and 29 weeks
Time Frame: 6, 17 and 29 weeks
6, 17 and 29 weeks

Collaborators and Investigators

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

Sponsor

Ludwig-Maximilians - University of Munich

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

Helpful Links

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

January 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

January 9, 2015

First Submitted That Met QC Criteria

January 9, 2015

First Posted (Estimate)

January 13, 2015

Study Record Updates

Last Update Posted (Estimate)

August 31, 2016

Last Update Submitted That Met QC Criteria

August 29, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • Eval_Smoke_less_LMU

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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