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.
ID
Bron
Verkorte titel
Aandoening
chronic fatigue syndrome
Ondersteuning
Expert Centre for Chronic fatigue, Radboud UMC Nijmegen
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- Blood Oxygenation Level Dependent (BOLD) signal as measured with functional Magnetic Resonance Imaging (fMRI)<br>
- Cerebral tissue properties as measured with Magnetic Resonance Imaging (MRI), Diffusion Tensor Imaging (DTI) and MR-spectroscopy.<br>
- Behavioural performance on computerized tasks<br>
- Fatigue severity: checklist individual strength (CIS)<br>
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
CFS patients will be tested before and after cognitive behavioral therapy or waiting list (6 months apart) and compared with healthy controls.
Onderzoeksproduct en/of interventie
Cognitive behavioural therapy versus waitinglist
Publiek
Marieke Schaaf, van der
[default]
The Netherlands
+31(0)24 3668236
marieke.vanderschaaf@donders.ru.nl
Wetenschappelijk
Marieke Schaaf, van der
[default]
The Netherlands
+31(0)24 3668236
marieke.vanderschaaf@donders.ru.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• ≥ 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);
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• 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;
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4122 |
| NTR-old | NTR4311 |
| Ander register | CCMO Arnhem/Nijmegen : 2013/113 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |