Marieke E van Der Schaaf1,2,3, Iris C Schmits4, Megan Roerink5, Dirk E M Geurts6, Ivan Toni7, Karin Roelofs8, Floris P De Lange9, Urs M Nater10, Jos W M van der Meer11, Hans Knoop12. 1. Radboud University Medical Center, Expert Centre for Chronic Fatigue, Nijmegen, The Netherlands. marieke.vanderschaaf@donders.ru.nl. 2. Donders Institute for Brain, Cognition, and Behaviour, Centre for Neuroimaging, Radboud University Nijmegen, Nijmegen, The Netherlands. marieke.vanderschaaf@donders.ru.nl. 3. Donders Institute, Centre for neuroimaging, Kapittelweg 29, P.O. Box 9101, NL-6500 HB, Nijmegen, The Netherlands. marieke.vanderschaaf@donders.ru.nl. 4. Radboud University Medical Center, Expert Centre for Chronic Fatigue, Nijmegen, The Netherlands. iris.schmits@radboudumc.nl. 5. Department of Internal Medicine, Radboud University Medical Center, Nijmegen, The Netherlands. Megan.Roerink@radboudumc.nl. 6. Department of Psychiatry, Radboud University Medical Centre, Nijmegen, The Netherlands. dirk.e.m.geurts@gmail.com. 7. Donders Institute for Brain, Cognition, and Behaviour, Centre for Neuroimaging, Radboud University Nijmegen, Nijmegen, The Netherlands. ivan.toni@donders.ru.nl. 8. Behavioral Science Institute (BSI), Radboud University Nijmegen, Nijmegen, The Netherlands. k.roelofs@donders.ru.nl. 9. Donders Institute for Brain, Cognition, and Behaviour, Centre for Neuroimaging, Radboud University Nijmegen, Nijmegen, The Netherlands. floris.delange@donders.ru.nl. 10. Department of Psychology, University of Marburg, Marburg, Germany. nater@uni-marburg.de. 11. Department of Internal Medicine, Radboud University Medical Center, Nijmegen, The Netherlands. Jos.vanderMeer@radboudumc.nl. 12. Radboud University Medical Center, Expert Centre for Chronic Fatigue, Nijmegen, The Netherlands. hans.knoop@radboudumc.nl.
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/ DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: Dutch Trial Register #15852. Registered 9 December 2013 ( http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4311 ).
RCT Entities:
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/ DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: Dutch Trial Register #15852. Registered 9 December 2013 ( http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4311 ).
Authors: G Lange; J Steffener; D B Cook; B M Bly; C Christodoulou; W-C Liu; J Deluca; B H Natelson Journal: Neuroimage Date: 2005-04-07 Impact factor: 6.556
Authors: Floris P de Lange; Joke S Kalkman; Gijs Bleijenberg; Peter Hagoort; Sieberen P van der Werf; Jos W M van der Meer; Ivan Toni Journal: Brain Date: 2004-07-07 Impact factor: 13.501
Authors: Marieke F Gielissen; Hans Knoop; Petra Servaes; Joke S Kalkman; Marcus J Huibers; Stans Verhagen; Gijs Bleijenberg Journal: Health Qual Life Outcomes Date: 2007-07-02 Impact factor: 3.186