title: Study protocol for a non-inferiority trial of a blended smoking cessation treatment versus face-to-face treatment (LiveSmokefree-Study).
abstract: Smoking cessation can significantly reduce the risk of developing smoking-related diseases. Several face-to-face and web-based treatments have shown to be effective. Blending of web-based and face-to-face treatment is expected to improve smoking cessation treatment. The primary objective of this study is to compare the prolonged abstinence rate of the blended smoking cessation treatment with the face-to-face treatment. Secondary objectives are to assess the benefits of blended treatment in terms of cost effectiveness and patient satisfaction, and to identify mechanisms underlying successful smoking cessation.
  
  
  
  This study will be a single-center randomized controlled non-inferiority-trial with parallel group design. Patients (n = 344) will be randomly assigned to either the blended or the face-to-face group. Both treatments will consist of ten sessions with equal content held within 6 months. In the blended treatment five out of ten sessions will be delivered online. The treatments will cover the majority of behavior change techniques that are evidence-based within smoking cessation counseling. All face-to-face sessions in both treatments will take place at the outpatient smoking cessation clinic of a hospital. The primary outcome parameter will be biochemically validated prolonged abstinence at 15 months from the start of the smoking cessation treatment.
  
  
  
  This RCT will be the first study to examine the effectiveness of a blended smoking cessation treatment. It will also be the first study to explore patient satisfaction, adherence, cost-effectiveness, and the clinically relevant influencing factors of a blended smoking cessation treatment. The findings of this RCT are expected to substantially strengthen the base of evidence available to inform the development and delivery of smoking cessation treatment.
  
  
  
  Nederlands Trialregister NTR5113 . Registered 24 March 2015.
authors.affiliation: Research Group Technology, Health & Care, Saxion University of Applied Sciences, Postbus 70.000, 7500KB, Enschede, The Netherlands. l.siemer@saxion.nl.|Centre for eHealth and Well-being Research, University of Twente, Enschede, The Netherlands. l.siemer@saxion.nl.
authors.forename: Lutz
authors.identifier: 0000-0003-3019-9113
authors.initials: L
authors.lastname: Siemer
authors.affiliation: Centre for eHealth and Well-being Research, University of Twente, Enschede, The Netherlands.
authors.forename: Marcel E
authors.initials: ME
authors.lastname: Pieterse
authors.affiliation: Medisch Spectrum Twente, Enschede, The Netherlands.
authors.forename: Marjolein G J
authors.initials: MG
authors.lastname: Brusse-Keizer
authors.affiliation: Centre for eHealth and Well-being Research, University of Twente, Enschede, The Netherlands.|Tactus, Enschede, The Netherlands.
authors.forename: Marloes G
authors.initials: MG
authors.lastname: Postel
authors.affiliation: Research Group Technology, Health & Care, Saxion University of Applied Sciences, Postbus 70.000, 7500KB, Enschede, The Netherlands.
authors.forename: Somaya
authors.initials: S
authors.lastname: Ben Allouch
authors.affiliation: Centre for eHealth and Well-being Research, University of Twente, Enschede, The Netherlands.
authors.forename: Robbert
authors.initials: R
authors.lastname: Sanderman
mesh_terms: D000293:Adolescent; D000328:Adult; D005260:Female; D006801:Humans; D008297:Male; D055815:Young Adult; D002985:Clinical Protocols; D003131:Combined Modality Therapy; D003362:Cost-Benefit Analysis; D003376:Counseling / Q000379:methods; D020407:Internet; D017060:Patient Satisfaction; D012907:Smoking / Q000523:psychology / Q000628:therapy; D016540:Smoking Cessation / Q000379:methods / Q000523:psychology; D013997:Time Factors; D016896:Treatment Outcome; D000074099:Equivalence Trials as Topic
keywords: Blended care; Blended treatment; Health care sector; Internet-based-treatment; Online counseling; Randomized controlled trial; Smoking cessation; Tobacco use disorder; eHealth