title: Efficacy of confrontational counselling for smoking cessation in smokers with previously undiagnosed mild to moderate airflow limitation: study protocol of a randomized controlled trial.
abstract: BACKGROUND
  The use of spirometry for early detection of chronic obstructive pulmonary disease (COPD) is still an issue of debate, particularly because of a lack of convincing evidence that spirometry has an added positive effect on smoking cessation. We hypothesise that early detection of COPD and confrontation with spirometry for smoking cessation may be effective when applying an approach we have termed "confrontational counselling"; a patient-centred approach which involves specific communication skills and elements of cognitive therapy. An important aspect is to confront the smoker with his/her airflow limitation during the counselling sessions. The primary objective of this study is to test the efficacy of confrontational counselling in comparison to regular health education and promotion for smoking cessation delivered by specialized respiratory nurses in current smokers with previously undiagnosed mild to moderate airflow limitation.
  
  
  METHODS
  The study design is a randomized controlled trial comparing confrontational counselling delivered by a respiratory nurse combined with nortriptyline for smoking cessation (experimental group), health education and promotion delivered by a respiratory nurse combined with nortriptyline for smoking cessation (control group 1), and "care as usual" delivered by the GP (control group 2). Early detection of smokers with mild to moderate airflow limitation is achieved by means of a telephone interview in combination with spirometry. Due to a comparable baseline risk of airflow limitation and motivation to quit smoking, and because of the standardization of number, duration, and scheduling of counselling sessions between the experimental group and control group 1, the study enables to assess the "net" effect of confrontational counselling. The study has been ethically approved and registered.
  
  
  CONCLUSIONS
  Ethical as well as methodological considerations of the study are discussed in this protocol. A significant and relevant effect of confrontational counselling would provide an argument in favour of early detection of current smokers with airflow limitation. Successful treatment of tobacco dependence in respiratory patients requires repeated intensive interventions. The results of this study may also show that respiratory nurses are able to deliver this treatment and that intensive smoking cessation counselling is more feasible.
  
  
  BACKGROUND
  : Netherlands Trial Register (ISRCTN 64481813).
authors.affiliation: Department of General Practice, School for Public Health and Primary Care (CAPHRI), Maastricht University, Maastricht, The Netherlands. d.kotz@hag.unimaas.nl
authors.forename: Daniel
authors.initials: D
authors.lastname: Kotz
authors.forename: Geertjan
authors.initials: G
authors.lastname: Wesseling
authors.forename: Marcus J H
authors.initials: MJ
authors.lastname: Huibers
authors.forename: Onno C P
authors.initials: OC
authors.lastname: van Schayck
mesh_terms: D018759:Adrenergic Uptake Inhibitors / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D003376:Counseling / Q000379:methods*; D006801:Humans; D009661:Nortriptyline / Q000627:therapeutic use*; D010353:Patient Education as Topic; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis; D016540:Smoking Cessation / Q000379:methods*; D013147:Spirometry
chemical_list: D018759:Adrenergic Uptake Inhibitors; D009661:Nortriptyline