Evaluation of a Cognitive Behavioral Smoking Reduction Program

Study Overview
=================
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.

Official Title
-----------------
Das Verhaltenstherapeutische Therapiemanual Smoke_less Zur Reduktion Des Tabakkonsums: Eine Evaluationsstudie Mit Ambulanten Patienten

Conditions
-----------------
Tobacco Reduction

Intervention / Treatment
-----------------
* Behavioral: Cognitive behavioral smoking reduction program Smoke_less
* Behavioral: 15 minute counseling interview


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smoking Reduction Program<br>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<br>* Duration: 5 weeks, 4 sessions over 2,5 hours and 2 phone calls<br>|
| Active Comparator: Counseling Interview<br>15 minute counseling interview | Behavioral: 15 minute counseling interview<br> <br> |
| No Intervention: Waiting Control Group<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Fagerström Test for Nicotine Dependence 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 Readiness to Change Questionnaire at 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 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 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 health satisfaction satisfaction scale at 6, 17 and 29 weeks |  | 6, 17 and 29 weeks |