title: Cost-effectiveness of i-Sleep, a guided online CBT intervention, for patients with insomnia in general practice: protocol of a pragmatic randomized controlled trial.
abstract: BACKGROUND
  Insomnia is a highly prevalent disorder causing clinically significant distress and impairment. Furthermore, insomnia is associated with high societal and individual costs. Although cognitive behavioural treatment for insomnia (CBT-I) is the preferred treatment, it is not used often. Offering CBT-I in an online format may increase access. Many studies have shown that online CBT for insomnia is effective. However, these studies have all been performed in general population samples recruited through media. This protocol article presents the design of a study aimed at establishing feasibility, effectiveness and cost-effectiveness of a guided online intervention (i-Sleep) for patients suffering from insomnia that seek help from their general practitioner as compared to care-as-usual.
  
  
  METHODS
  In a pragmatic randomized controlled trial, adult patients with insomnia disorder recruited through general practices are randomized to a 5-session guided online treatment, which is called "i-Sleep", or to care-as-usual. Patients in the care-as-usual condition will be offered i-Sleep 6 months after inclusion. An ancillary clinician, known as the psychological well-being practitioner who works in the GP practice (PWP; in Dutch: POH-GGZ), will offer online support after every session. Our aim is to recruit one hundred and sixty patients. Questionnaires, a sleep diary and wrist actigraphy will be administered at baseline, post intervention (at 8 weeks), and at 6 months and 12 months follow-up. Effectiveness will be established using insomnia severity as the main outcome. Cost-effectiveness and cost-utility (using costs per quality adjusted life year (QALY) as outcome) will be conducted from a societal perspective. Secondary measures are: sleep diary, daytime consequences, fatigue, work and social adjustment, anxiety, alcohol use, depression and quality of life.
  
  
  CONCLUSIONS
  The results of this trial will help establish whether online CBT-I is (cost-) effective and feasible in general practice as compared to care-as-usual. If it is, then quality of care might be increased because implementation of i-Sleep makes it easier to adhere to insomnia guidelines. Strengths and limitations are discussed.
  
  
  BACKGROUND
  Netherlands Trial register NTR 5202 (registered April 17(st) 2015).
authors.affiliation: Department of Clinical, Neuro, and Developmental Psychology, Section Clinical Psychology, Faculty of Behavioural and Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands. t.vander.zweerde@vu.nl.|EMGO institute for Health Care and Research, VU University Medical Centre, van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands. t.vander.zweerde@vu.nl.
authors.forename: Tanja
authors.identifier: http://orcid.org/0000-0001-9443-1757
authors.initials: T
authors.lastname: van der Zweerde
authors.affiliation: Department of Clinical Psychology, Faculty of Social and Behavioural Sciences, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: Jaap
authors.initials: J
authors.lastname: Lancee
authors.affiliation: EMGO institute for Health Care and Research, VU University Medical Centre, van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands.|Academic Network of Family Medicine (ANH), VU University Medical Center, van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands.
authors.forename: Pauline
authors.initials: P
authors.lastname: Slottje
authors.affiliation: Department of Health Sciences, Faculty of Earth and Life Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
authors.forename: Judith
authors.initials: J
authors.lastname: Bosmans
authors.affiliation: Department of Sleep and Cognition, Netherlands Institute for Neuroscience, an Institute of the Royal Netherlands Academy of Arts and Sciences, Amsterdam, The Netherlands.|Departments of Integrative Neurophysiology and Psychiatry, Centre for Neurogenomics and Cognitive Research, VU University Medical Centre, Amsterdam, The Netherlands.
authors.forename: Eus
authors.initials: E
authors.lastname: Van Someren
authors.affiliation: Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.
authors.forename: Charles
authors.initials: C
authors.lastname: Reynolds
authors.affiliation: Department of Clinical, Neuro, and Developmental Psychology, Section Clinical Psychology, Faculty of Behavioural and Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.|EMGO institute for Health Care and Research, VU University Medical Centre, van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands.
authors.forename: Pim
authors.initials: P
authors.lastname: Cuijpers
authors.affiliation: Department of Clinical, Neuro, and Developmental Psychology, Section Clinical Psychology, Faculty of Behavioural and Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.|EMGO institute for Health Care and Research, VU University Medical Centre, van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands.
authors.forename: Annemieke
authors.initials: A
authors.lastname: van Straten
mesh_terms: D000328:Adult; D015928:Cognitive Behavioral Therapy / Q000191:economics* / Q000379:methods*; D003362:Cost-Benefit Analysis / Q000191:economics / Q000379:methods / Q000706:statistics & numerical data*; D005194:Family Practice; D005260:Female; D006801:Humans; D020407:Internet; D008297:Male; D009426:Netherlands; D007319:Sleep Initiation and Maintenance Disorders / Q000191:economics / Q000628:therapy*
keywords: CBT-I; Cognitive behavioural therapy; Cost-effectiveness; General practice; Insomnia; Online treatment; Pragmatic randomized controlled trial