Evaluation of a Cognitive Behavioral Smoking Reduction Program

Ludwig Maximilian University of Munich

Status: Completed

Conditions: Tobacco Reduction

Treatments: Behavioral: Cognitive behavioral smoking reduction program "Smoke_less"; Behavioral: 15 minute counseling interview

Study type: Interventional

Funder types: Other

Identifiers

NCT02337400

Eval_Smoke_less_LMU

Details and patient eligibility

About

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.

Enrollment: 155 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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155 participants in 3 patient groups

Smoking Reduction Program

Experimental group

Description:

Cognitive behavioral smoking reduction program "Smoke_less" Duration: 5 weeks with 4 weekly sessions over 2,5 hours and two phone calls

Treatment:

Behavioral: Cognitive behavioral smoking reduction program "Smoke_less"

Counseling Interview

Active Comparator group

Description:

15 minute counseling interview

Treatment:

Behavioral: 15 minute counseling interview

Waiting Control Group

No Intervention group