NTR number

NTR3214

Date Registered NTR

14-dec-2011

Public Title

Behandeling van patiënten met chronisch vermoeidheidssyndroom met gedoseerde oefentherapie en/of cognitieve gedragstherapie.

Hypothesis

The hypothesis is that a combination of graded exercise training and cognitive behavioural therapy is more effective than each of these therapies alone.

Health Condition(s)

or Problem(s) studied

Chronic Fatigue Syndrome (CFS)

Inclusion criteria

1. Meet CDC-94 CFS criteria;

2. Age: 18-65 yr;

3. CIS-20 score > 35 on subscale fatigue.

Exclusion criteria

1. Not able to understand, speak, read or write Dutch sufficiently;

2. Severe mental disorder or severe physical co-morbidity, impeding physical exercise;

3. Patient is currently engaged in a legal procedure concerning disability-related financial bnefits;

4. Previously treated with GET or CBT for CFS.

Primary outcome

1. CIS-20 questionnaire (fatigue severity) at 6 months.

Secondary outcome

1. CIS-20 questionnaire (fatigue severity) at baseline and 3 months;

2. SCL-90-R questionnaire (psychiatric symptom) at baseline, 3 and 6 months;

3. RAND-36 questionnaire (functional impairment) at baseline, 3 and 6 months;

4. Maximal oxygen uptake capacity at baseline, 3 and 6 months;

5. EuroQol 5D (health outcome) at baseline, 3 and 6 months;

6. Healthcare consumption and economic costs questions at baseline, 3 and 6 months.