Adolescents aged 12-18 years with chronic fatigue syndrome were assigned to FITNET or usual care in a 1:1 ratio at one tertiary treatment centre in the Netherlands by use of a computer-generated blocked randomisation allocation schedule. The study was open label. Primary outcomes were school attendance, fatigue severity, and physical functioning, and were assessed at 6 months with computerised questionnaires. Analysis was by intention to treat. Thereafter, all patients were offered FITNET if needed. This trial is registered, number ISRCTN59878666.
68 of 135 adolescents were assigned to FITNET and 67 to usual care, and 67 and 64, respectively, were analysed. FITNET was significantly more effective than was usual care for all dichotomised primary outcomes at 6 months鈥攆ull school attendance (50 [75%] vs 10 [16%], relative risk 4路8, 95%CI 2路7-8路9; p<0路0001), absence of severe fatigue (57 [85%] vs 17 [27%], 3路2, 2路1-4路9; p<0路0001), and normal physical functioning (52 [78%] vs 13 [20%], 3路8, 2路3-6路3; p<0路0001). No serious adverse events were reported.
FITNET offers a readily accessible and highly effective treatment for adolescents with chronic fatigue syndrome. The results of this study justify implementation on a broader scale.
Netherlands Organisation for Health Research and Development.