chronic fatigue syndrome
Conditions
Interventions
Cognitive behavioural therapy versus waitinglist
Sponsors
Donders Institute for neuroimaging, Radboud University Nijmegen
Expert Centre for Chronic fatigue, Radboud UMC Nijmegen
Eligibility
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| - 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
| Measure | Time frame |
|---|---|
| - 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 | — |
Contacts
Public ContactMarieke Schaaf, van der
Donders Institute
Outcome results
None listed