title: Investigating neural mechanisms of change of cognitive behavioural therapy for chronic fatigue syndrome: a randomized controlled trial.
abstract: BACKGROUND
  Chronic fatigue syndrome (CFS) is characterized by profound and disabling fatigue with no known somatic explanation. Cognitive behavioral therapy (CBT) has proven to be a successful intervention leading to a reduction in fatigue and disability. Based on previous neuroimaging findings, it has been suggested that central neural mechanisms may underlie CFS symptoms and play a role in the change brought on by CBT. In this randomized controlled trial we aim to further investigate the neural mechanisms that underlie fatigue in CFS and their change by CBT.
  
  
  METHODS
  We will conduct a randomized controlled trial in which we collect anatomical and functional magnetic resonance imaging (MRI) measures from female CFS patients before and after CBT (N = 60) or waiting list (N = 30) and compare these with measures from age and education matched healthy controls (N = 30). By including a large treatment group we will also be able to compare patients that benefit from CBT with those that do not. In addition, to further investigate the role of endocrine and immune biomarkers in CFS, we will determine cortisol and cytokine concentrations in blood, hair and/or saliva.
  
  
  CONCLUSIONS
  This project creates an unique opportunity to enhance our understanding of CFS symptoms and its change by CBT in terms of neuroanatomical, neurofunctional, endocrinological and immunological mechanisms and can help to further improve future treatments strategies.
  
  
  BACKGROUND
  Dutch Trial Register #15852. Registered 9 December 2013 ( http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4311 ).
authors.affiliation: Radboud University Medical Center, Expert Centre for Chronic Fatigue, Nijmegen, The Netherlands. marieke.vanderschaaf@donders.ru.nl.|Donders Institute for Brain, Cognition, and Behaviour, Centre for Neuroimaging, Radboud University Nijmegen, Nijmegen, The Netherlands. marieke.vanderschaaf@donders.ru.nl.|Donders Institute, Centre for neuroimaging, Kapittelweg 29, P.O. Box 9101, NL-6500 HB, Nijmegen, The Netherlands. marieke.vanderschaaf@donders.ru.nl.
authors.forename: Marieke E
authors.initials: ME
authors.lastname: van Der Schaaf
authors.affiliation: Radboud University Medical Center, Expert Centre for Chronic Fatigue, Nijmegen, The Netherlands. iris.schmits@radboudumc.nl.
authors.forename: Iris C
authors.initials: IC
authors.lastname: Schmits
authors.affiliation: Department of Internal Medicine, Radboud University Medical Center, Nijmegen, The Netherlands. Megan.Roerink@radboudumc.nl.
authors.forename: Megan
authors.initials: M
authors.lastname: Roerink
authors.affiliation: Department of Psychiatry, Radboud University Medical Centre, Nijmegen, The Netherlands. dirk.e.m.geurts@gmail.com.
authors.forename: Dirk E M
authors.initials: DE
authors.lastname: Geurts
authors.affiliation: Donders Institute for Brain, Cognition, and Behaviour, Centre for Neuroimaging, Radboud University Nijmegen, Nijmegen, The Netherlands. ivan.toni@donders.ru.nl.
authors.forename: Ivan
authors.initials: I
authors.lastname: Toni
authors.affiliation: Behavioral Science Institute (BSI), Radboud University Nijmegen, Nijmegen, The Netherlands. k.roelofs@donders.ru.nl.
authors.forename: Karin
authors.initials: K
authors.lastname: Roelofs
authors.affiliation: Donders Institute for Brain, Cognition, and Behaviour, Centre for Neuroimaging, Radboud University Nijmegen, Nijmegen, The Netherlands. floris.delange@donders.ru.nl.
authors.forename: Floris P
authors.initials: FP
authors.lastname: De Lange
authors.affiliation: Department of Psychology, University of Marburg, Marburg, Germany. nater@uni-marburg.de.
authors.forename: Urs M
authors.initials: UM
authors.lastname: Nater
authors.affiliation: Department of Internal Medicine, Radboud University Medical Center, Nijmegen, The Netherlands. Jos.vanderMeer@radboudumc.nl.
authors.forename: Jos W M
authors.initials: JW
authors.lastname: van der Meer
authors.affiliation: Radboud University Medical Center, Expert Centre for Chronic Fatigue, Nijmegen, The Netherlands. hans.knoop@radboudumc.nl.
authors.forename: Hans
authors.initials: H
authors.lastname: Knoop
mesh_terms: D000328:Adult; D015415:Biomarkers / Q000032:analysis; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D015673:Fatigue Syndrome, Chronic / Q000175:diagnosis / Q000378:metabolism / Q000523:psychology / Q000628:therapy; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000379:methods; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000379:methods; D017063:Outcome Assessment, Health Care; D012107:Research Design
chemical_list: D015415:Biomarkers