No registrations found.
ID
Source
Brief title
Health condition
chronic fatigue syndrome
Sponsors and support
Expert Centre for Chronic fatigue, Radboud UMC Nijmegen
Intervention
Outcome measures
Primary outcome
- Blood Oxygenation Level Dependent (BOLD) signal as measured with functional Magnetic Resonance Imaging (fMRI)
- Cerebral tissue properties as measured with Magnetic Resonance Imaging (MRI), Diffusion Tensor Imaging (DTI) and MR-spectroscopy.
- Behavioural performance on computerized tasks
- Fatigue severity: checklist individual strength (CIS)
Secondary outcome
- Subjective measurements, e.g. self-report questionnaires, visual analogue scales
- NAA concentration as determined by MR-spectroscopy
- Cortisol and cytokine protein concentrations from hair, saliva and blood samples
Background summary
Chronic fatigue syndrome (CFS) is characterized by profound disabling fatigue with an unknown aetiology. CFS is currently treated with cognitive behavioural therapy (CBT), which has proven to be a successful intervention leading to a reduction in fatigue and disability. Consistent with cognitive behavioural models of CFS, recent clinical research has shown that mainly cognitive factors mediate successful therapy outcome. Accordingly, with support from neuroimaging studies, it has been suggested that central (cognitive) mechanisms play a role in CFS and its treatment. This project aims at identifying the neural correlates of central mechanisms that perpetuate CFS symptoms and underlie the mechanisms of change of CBT. Our hypotheses are derived from a neurobiological hierarchical Bayesian model of medically unexplained symptoms (Edwards et al., 2012) that emphasizes the influence of dysfunctional beliefs on perception. According to this model, somatoform symptoms arise from an inference failure between prior beliefs and sensory evidence. Thus, it is hypothesized that fatigue-related beliefs may bias perception towards experiencing fatigue. This project aims at investigating neural correlates associated with inference processes that are thought to underlie CFS symptoms. In addition, we will assess how these mechanisms change during cognitive behavioural therapy.
Study objective
The primary objectives of this project are:
- Identify neural correlates and behavioural measures that underlie cognitive processes that perpetuate CFS symptoms
- Identify neural mechanisms of change that mediate successful CBT.
Study design
CFS patients will be tested before and after cognitive behavioral therapy or waiting list (6 months apart) and compared with healthy controls.
Intervention
Cognitive behavioural therapy versus waitinglist
Marieke Schaaf, van der
[default]
The Netherlands
+31(0)24 3668236
marieke.vanderschaaf@donders.ru.nl
Marieke Schaaf, van der
[default]
The Netherlands
+31(0)24 3668236
marieke.vanderschaaf@donders.ru.nl
Inclusion criteria
• ≥ 18 years ≤ 65 years;
• Women;
• Able to speak read and write Dutch;
• Predominantly right handedness;
• Give written informed consent;
Patients:
• Meet the 1994 US centre for Disease Control and Prevention criteria for Chronic Fatigue Syndrome (revised
2003)
• Severely fatigued, i.e. scoring ≥ 40 on the subscale fatigue severity of the Checklist Individual Strength (CIS);
• Severely disabled; i.e scoring ≥ 700 in the Sickness Impact Profile r_08 (SIPr08) total score;
Healthy control:
• Scoring ≤ 35 on the subscale fatigue severity of the Checklist Individual Strength (CIS);
Exclusion criteria
• Any injury to the right hand that confounds hand grip performance;
• A maximal voluntary contraction (MVC) that exceeds the maximal dispersion of the hand grip device (>400
Newton)
• (History of) long term use of anti-depressants, anti-anxiety medications, beta-blockers benzodiazepines, psychostimulants
or sleep medication;
• Current major depressive or bipolar disorder
• (History of) Schizophrenia or delusional disorder.
• (History of) Anorexia nervosa or bulimia nervosa
• (History of) alcohol or substance abuse
• Severe obesity (BMI ≥ 40)
• Abnormal hearing or (uncorrected) vision;
MRI Contraindications:
• Irremovable metal objects in or around the body (e.g. braces, pacemaker, metal fragments, hearing devices);
• Claustrophobia;
• (History of) Epilepsy;
• Possible pregnancy or breastfeeding;
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4122 |
| NTR-old | NTR4311 |
| Other | CCMO Arnhem/Nijmegen : 2013/113 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |