Evaluation of a Cognitive Behavioral Smoking Reduction Program

Not Applicable

Completed

• Conditions: Tobacco Reduction
• Interventions: Behavioral: Cognitive behavioral smoking reduction program "Smoke_less"; Behavioral: 15 minute counseling interview

• Registration Number: NCT02337400
• Lead Sponsor: Ludwig-Maximilians - University of Munich

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-09
• Study First Submitted QC: 2015-01-09
• Study First Posted: 2015-01-13
• Primary Completion: 2016-02
• Study Completion: 2016-04
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-29
• Last Update Posted: 2016-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Smoking Reduction Program	Cognitive behavioral smoking reduction program "Smoke_less"	Cognitive behavioral smoking reduction program "Smoke_less" Duration: 5 weeks with 4 weekly sessions over 2,5 hours and two phone calls
Counseling Interview	15 minute counseling interview	15 minute counseling interview

Primary Outcome Measures

Name	Time	Method
Change from baseline in number of smoked cigarettes/day at 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	6, 17 and 29 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in health satisfaction satisfaction scale at 6, 17 and 29 weeks	6, 17 and 29 weeks
Change from baseline in Questionnaire of Smoking Urges at 6, 17 and 29 weeks	6, 17 and 29 weeks
Change from baseline in Decisional Balance Questionnaire at 6, 17 and 29 weeks	6, 17 and 29 weeks
Change from baseline in Self-Efficacy scale for smokers 6, 17 and 29 weeks	6, 17 and 29 weeks
Change from baseline in Process of Change Questionnaire at 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	6, 17 and 29 weeks
Change from baseline in stress scale at 6, 17 and 29 weeks	6, 17 and 29 weeks
Change from baseline in Fagerström Test for Nicotine Dependence at 6, 17 and 29 weeks	6, 17 and 29 weeks
Change from baseline in Readiness to Change Questionnaire at 6, 17 and 29 weeks	6, 17 and 29 weeks

Trial Locations

Locations (1)

Dept. of Psychiatry; 🇩🇪 Munich, Germany