title: Effectiveness of internet-supported cognitive behavioral and chronobiological interventions and effect moderation by insomnia subtype: study protocol of a randomized controlled trial.
abstract: BACKGROUND
  DSM-V criteria for insomnia disorder are met by 6 to 10% of the adult population. Insomnia has severe consequences for health and society. One of the most common treatments provided by primary caregivers is pharmacological treatment, which is far from optimal and has not been recommended since a 2005 consensus report of the National Institutes of Health. The recommended treatment is Cognitive Behavioral Therapy for Insomnia. Effectiveness, however, is still limited. Only a few studies have evaluated the effectiveness of chronobiological treatments, including the timed application of bright light, physical activity and body warming. Another opportunity for optimization of treatment is based on the idea that the people suffering from insomnia most likely represent a heterogeneous mix of subtypes, with different underlying causes and expected treatment responses. The present study aims to evaluate the possibility for optimizing insomnia treatment along the principles of personalized and stratified medicine. It evaluates the following: 1. The relative effectiveness of internet-supported cognitive behavioral therapy, bright light, physical activity and body warming; 2. Whether the effectiveness of internet-supported cognitive behavioral therapy for insomnia can be augmented by simultaneous or prior application of bright light, physical activity and body warming; and 3. Whether the effectiveness of the interventions and their combination are moderated by the insomnia subtype.
  
  
  METHODS
  In a repeated measures, placebo-controlled, randomized clinical trial that included 160 people diagnosed with insomnia disorder, we are evaluating the relative effectiveness of 4 intervention weeks. Primary outcome is subjective sleep efficiency, quantified using a sleep diary. Secondary outcomes include other complaints of sleep and daytime functioning, health-related cost estimates and actigraphic objective sleep estimates. Compliance will be monitored both subjectively and objectively using activity, light and temperature sensors. Insomnia subtypes will be assessed using questionnaires. Mixed effect models will be used to evaluate intervention effects and moderation by insomnia subtype ratings.
  
  
  CONCLUSIONS
  The current study addresses multiple opportunities to optimize and personalize treatment of insomnia disorder.
  
  
  BACKGROUND
  Netherlands National Trial Register NTR4010, 4 June 2013.
authors.affiliation: Netherlands Institute for Neuroscience, An Institute of the Royal Netherlands Academy of Arts and Sciences, Meibergdreef 47, 1105 BA, Amsterdam, The Netherlands. k.dekker@nin.knaw.nl.
authors.forename: Kim
authors.initials: K
authors.lastname: Dekker
authors.affiliation: Department of Clinical and Health Psychology, Department of Experimental Psychology, Utrecht University, Heidelberglaan 1, 3584 CS, Utrecht, The Netherlands. j.s.benjamins@uu.nl.
authors.forename: Jeroen S
authors.initials: JS
authors.lastname: Benjamins
authors.affiliation: Department of Clinical Psychology, VU University Amsterdam & EMGO Institute for Health Care and Research, Van der Boechorststraat 1, 1081 BT, Amsterdam, The Netherlands. a.van.straten@vu.nl.
authors.forename: Annemieke
authors.initials: A
authors.lastname: Van Straten
authors.affiliation: Department of Psychology, Brain and Cognition group, University of Amsterdamy, Weesperplein 4, 1018 XA, Amsterdam, The Netherlands. w.f.hofman@uva.nl.|Personal Health Institute International, Lobo-Braakensiekstraat 94, 1065 HP, Amsterdam, The Netherlands. w.f.hofman@uva.nl.
authors.forename: Winni F
authors.initials: WF
authors.lastname: Hofman
authors.affiliation: Netherlands Institute for Neuroscience, An Institute of the Royal Netherlands Academy of Arts and Sciences, Meibergdreef 47, 1105 BA, Amsterdam, The Netherlands. e.van.someren@nin.knaw.nl.|Departments of Integrative Neurophysiology and Medical Psychology, Center for Neurogenomics and Cognitive Research (CNCR), Neuroscience Campus Amsterdam, VU University and Medical Center, De Boelelaan 1085, 1081 HV, Amsterdam, The Netherlands. e.van.someren@nin.knaw.nl.
authors.forename: Eus J W
authors.initials: EJ
authors.lastname: Van Someren
mesh_terms: D005260:Female; D006801:Humans; D008297:Male; D056044:Actigraphy / Q000295:instrumentation; D000204:Activity Cycles; D001833:Body Temperature Regulation; D019454:Chronotherapy / Q000379:methods; D015928:Cognitive Behavioral Therapy / Q000379:methods; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D020407:Internet; D008027:Light; D009043:Motor Activity; D009426:Netherlands; D011237:Predictive Value of Tests; D012107:Research Design; D012890:Sleep; D007319:Sleep Initiation and Maintenance Disorders / Q000145:classification / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy; D011795:Surveys and Questionnaires; D013813:Therapy, Computer-Assisted / Q000379:methods; D013817:Thermography / Q000295:instrumentation; D013997:Time Factors; D014159:Transducers; D016896:Treatment Outcome; D016032:Randomized Controlled Trials as Topic