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Completed

NCT Number: NCT02337400

Evaluation of a Cognitive Behavioral Smoking Reduction Program

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.

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Key information

Conditions

Tobacco Reduction

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Psychiatry

Munich, D-80336, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive behavioral smoking reduction program "Smoke_less"

Behavioral

Duration: 5 weeks, 4 sessions over 2,5 hours and 2 phone calls

15 minute counseling interview

Behavioral

Primary outcomes

  1. Change from baseline in number of smoked cigarettes/day at 6, 17 and 29 weeks

    Time frame: 6, 17 and 29 weeks

  2. Change from baseline in percentage of carbon monoxide in exhalation air at 6, 17 and 29 weeks

    Time frame: 6, 17 and 29 weeks

Secondary outcomes

  1. Change from baseline in Fagerström Test for Nicotine Dependence at 6, 17 and 29 weeks

    Time frame: 6, 17 and 29 weeks

  2. Change from baseline in Questionnaire of Smoking Urges at 6, 17 and 29 weeks

    Time frame: 6, 17 and 29 weeks

  3. Change from baseline in Readiness to Change Questionnaire at 6, 17 and 29 weeks

    Time frame: 6, 17 and 29 weeks

  4. Change from baseline in Process of Change Questionnaire at 6, 17 and 29 weeks

    Time frame: 6, 17 and 29 weeks

  5. Change from baseline in Decisional Balance Questionnaire at 6, 17 and 29 weeks

    Time frame: 6, 17 and 29 weeks

  6. Change from baseline in Self-Efficacy scale for smokers 6, 17 and 29 weeks

    Time frame: 6, 17 and 29 weeks

  7. Change from baseline in knowledge and skills scale about smoking reduction at 6, 17 and 29 weeks

    Time frame: 6, 17 and 29 weeks

  8. Change from baseline in stress scale at 6, 17 and 29 weeks

    Time frame: 6, 17 and 29 weeks

  9. Change from baseline in health satisfaction satisfaction scale at 6, 17 and 29 weeks

    Time frame: 6, 17 and 29 weeks

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 13, 2015
Registry last updated
Aug 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.