Clinical trial NCT02337400: Evaluation of a Cognitive Behavioral Smoking Reduction Program
Official title: Das Verhaltenstherapeutische Therapiemanual "Smoke_less" Zur Reduktion Des Tabakkonsums: Eine Evaluationsstudie Mit Ambulanten Patienten
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Reduction
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2015-01-13
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in number of smoked cigarettes/day at 6, 17 and 29 weeks
timeFrame: 6, 17 and 29 weeks
measure: Change from baseline in percentage of carbon monoxide in exhalation air at 6, 17 and 29 weeks
timeFrame: 6, 17 and 29 weeks
Secondary outcomes:
measure: Change from baseline in Fagerström Test for Nicotine Dependence at 6, 17 and 29 weeks
timeFrame: 6, 17 and 29 weeks
measure: Change from baseline in Questionnaire of Smoking Urges at 6, 17 and 29 weeks
timeFrame: 6, 17 and 29 weeks
measure: Change from baseline in Readiness to Change Questionnaire at 6, 17 and 29 weeks
timeFrame: 6, 17 and 29 weeks
measure: Change from baseline in Process of Change Questionnaire at 6, 17 and 29 weeks
timeFrame: 6, 17 and 29 weeks
measure: Change from baseline in Decisional Balance Questionnaire at 6, 17 and 29 weeks
timeFrame: 6, 17 and 29 weeks
measure: Change from baseline in Self-Efficacy scale for smokers 6, 17 and 29 weeks
timeFrame: 6, 17 and 29 weeks
measure: Change from baseline in knowledge and skills scale about smoking reduction at 6, 17 and 29 weeks
timeFrame: 6, 17 and 29 weeks
measure: Change from baseline in stress scale at 6, 17 and 29 weeks
timeFrame: 6, 17 and 29 weeks
measure: Change from baseline in health satisfaction satisfaction scale at 6, 17 and 29 weeks
timeFrame: 6, 17 and 29 weeks
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Dept. of Psychiatry
Study officials:
References:
citation: Ruther T, Kiss A, Eberhardt K, Linhardt A, Kroger C, Pogarell O. Evaluation of the cognitive behavioral smoking reduction program "Smoke_less": a randomized controlled trial. Eur Arch Psychiatry Clin Neurosci. 2018 Apr;268(3):269-277. doi: 10.1007/s00406-017-0818-6. Epub 2017 Jun 14.