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Investigating neural mechanisms of change of cognitive behavioural therapy for chronic fatigue syndrome: a randomized controlled trial.

van Der Schaaf ME, Schmits IC, Roerink M, Geurts DE, Toni I, Roelofs K, De Lange FP, Nater UM, van der Meer JW, Knoop H - BMC Psychiatry (2015)

Bottom Line: 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.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.

View Article: PubMed Central - PubMed

Affiliation: Radboud University Medical Center, Expert Centre for Chronic Fatigue, Nijmegen, The Netherlands. marieke.vanderschaaf@donders.ru.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 ).

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Related in: MedlinePlus

Flowchart of inclusion. CFS = Chronic fatigue syndrome, CBT = Cognitive behavioural therapy
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Fig3: Flowchart of inclusion. CFS = Chronic fatigue syndrome, CBT = Cognitive behavioural therapy

Mentions: Power calculation is based on current standards in neuroimaging. For (f)MRI, the recommended number of subjects for between-group designs is 20 (Thirion et al., [92]). In addition, from previous studies we know that groups of 20 subjects per condition are sufficient to detect significant differences in (neuro) physiological parameters measured with fMRI [17, 18]. Similarly, a group of 22 subjects were sufficient to detect significant treatment effects measured with MRI [13]. Based on previous work at the ECCF (Knoop et al., [5]) it is assumed that approximately 50 % of the CFS patients in the CBT condition will show significant improvement (for definition: see above). Accordingly, to be able to compare successfully treated patients with non-successfully treated patients we will include twice as many patients in the CBT condition as in the waiting list condition. Assuming that 10 % of the measurements (from baseline as well as 2nd assessment) will yield technically insufficient data, 17 % of the patients will drop out from the study and a ratio of 2:1 (CBT: waiting list), we will include 30 healthy controls, 30 patients in the waiting list condition and 60 patients in the CBT condition (Fig. 3). Based on previous clinical work (Knoop et al., [74]; Wiborg et al., [9]), we expect a mean decline of–15.2 (±15.8) for patients in the CBT condition and–5.2 (±7.2) for patients in the waiting list condition. Accordingly, assuming an alfa of 0.05 and a power of 0.95 this will also yield enough power to replicate previous reported treatment effects on the primary clinical outcome measures. Note that technical failure of MRI measurements will not affect the collection of clinical measures.Fig. 3


Investigating neural mechanisms of change of cognitive behavioural therapy for chronic fatigue syndrome: a randomized controlled trial.

van Der Schaaf ME, Schmits IC, Roerink M, Geurts DE, Toni I, Roelofs K, De Lange FP, Nater UM, van der Meer JW, Knoop H - BMC Psychiatry (2015)

Flowchart of inclusion. CFS = Chronic fatigue syndrome, CBT = Cognitive behavioural therapy
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4489043&req=5

Fig3: Flowchart of inclusion. CFS = Chronic fatigue syndrome, CBT = Cognitive behavioural therapy
Mentions: Power calculation is based on current standards in neuroimaging. For (f)MRI, the recommended number of subjects for between-group designs is 20 (Thirion et al., [92]). In addition, from previous studies we know that groups of 20 subjects per condition are sufficient to detect significant differences in (neuro) physiological parameters measured with fMRI [17, 18]. Similarly, a group of 22 subjects were sufficient to detect significant treatment effects measured with MRI [13]. Based on previous work at the ECCF (Knoop et al., [5]) it is assumed that approximately 50 % of the CFS patients in the CBT condition will show significant improvement (for definition: see above). Accordingly, to be able to compare successfully treated patients with non-successfully treated patients we will include twice as many patients in the CBT condition as in the waiting list condition. Assuming that 10 % of the measurements (from baseline as well as 2nd assessment) will yield technically insufficient data, 17 % of the patients will drop out from the study and a ratio of 2:1 (CBT: waiting list), we will include 30 healthy controls, 30 patients in the waiting list condition and 60 patients in the CBT condition (Fig. 3). Based on previous clinical work (Knoop et al., [74]; Wiborg et al., [9]), we expect a mean decline of–15.2 (±15.8) for patients in the CBT condition and–5.2 (±7.2) for patients in the waiting list condition. Accordingly, assuming an alfa of 0.05 and a power of 0.95 this will also yield enough power to replicate previous reported treatment effects on the primary clinical outcome measures. Note that technical failure of MRI measurements will not affect the collection of clinical measures.Fig. 3

Bottom Line: 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.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.

View Article: PubMed Central - PubMed

Affiliation: Radboud University Medical Center, Expert Centre for Chronic Fatigue, Nijmegen, The Netherlands. marieke.vanderschaaf@donders.ru.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 ).

Show MeSH
Related in: MedlinePlus