Brief Intervention Study for Quitting Smoking

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

347 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-16

Study Completion Date

2013-04-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To investigate the effectiveness of a smoking cessation intervention of two sessions (120 min at a time) in a group setting on the basis of Motivational Interviewing (MI) and important elements of Cognitive Behavioural Therapy (CBT). According to national and international guidelines patients are advised to quit and pharmacologically supported with one of the established first line smoking cessation treatments.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of a Cognitive Behavioral Smoking Reduction Program

NCT02337400

Tobacco Reduction

COMPLETED NA

Internet-based Group Contingency Management to Promote Smoking Abstinence

NCT01181661

Cigarette Smoking

COMPLETED NA

Pain and Smoking Study

NCT02971137

Smoking Pain Smoking Cessation

COMPLETED NA

Smoking Pattern and Influencing Factors in Hospitalized Patients

NCT05959512

Smoking Behaviors

ACTIVE_NOT_RECRUITING

Intervention for Support Persons to Help Smokers Quit

NCT00379054

Smoking Cessation

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study design is multicentric, prospective, randomized and controlled. The study is taking place in cooperation with smoking clinics of 5 centres in Germany (Heidelberg, Stuttgart, Munich, Chemnitz, Berlin). A total number of 800 smokers is calculated to participate in the study. After enrollment participants are randomized in one of the three intervention groups: (A) "Advice only", (B) "Brief intervention", (C) "Intensive therapy". The follow up includes a telephone interview 3 months after the last intervention, and two visits at the smoking clinics after 6 and 12 months with biochemical validation of the smoking status by measurement of the exhaled carbon monoxide and the concentration of cotinine in an urine sample respectively. The primary endpoint is the continuous abstinence rate after 12 months. Several secondary endpoints are determined amongst others the continuous abstinence rate after 6 months, point prevalence cessation rates after 6 and 12 months, life quality, weight gain, predictors of a successful cessation attempt.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Smoking Tobacco Use Cessation Smoking Cessation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Brief advice

A brief advice to stop smoking of about 10 min accompanied with self-help material

Group Type ACTIVE_COMPARATOR

Brief advice

Intervention Type BEHAVIORAL

Brief advice of about 10 min accompanied by self-help material

Compact cessation course

Cessation intervention of 2 x 120 min in a group setting

Group Type EXPERIMENTAL

Compact cessation course

Intervention Type BEHAVIORAL

Compact cessation course on the basis of Motivational Interviewing (MI) and Cognitive Behavioural Therapy (CBT). Group setting. 2 x 120 min.

Standard cessation course

Cessation course in a group setting over 6 dates

Group Type ACTIVE_COMPARATOR

Standard cessation course

Intervention Type BEHAVIORAL

Cessation course over 6 dates. Group setting.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Brief advice

Brief advice of about 10 min accompanied by self-help material

Intervention Type BEHAVIORAL

Compact cessation course

Compact cessation course on the basis of Motivational Interviewing (MI) and Cognitive Behavioural Therapy (CBT). Group setting. 2 x 120 min.

Intervention Type BEHAVIORAL

Standard cessation course

Cessation course over 6 dates. Group setting.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Smoker
* Age \> 18 years
* Motivation to quit smoking

Exclusion Criteria

* severe somatic comorbidity or reduced life expectancy
* severe episode of a psychiatric disease
* reduced cognitive ability
* abuse of alcohol or illicit drugs
* other reasons at the discretion of responsible local study tutor

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No