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Design: Randomised controlled trial.
Allocation: Computer generated blocked allocation.
Blinding: Investigators and participants were not blinded.
Setting: Two outpatient clinics in Holland (paediatric hospital and treatment coordinating centre) receiving nationwide referrals.
Patients: 135 adolescents aged 12–18 years with chronic fatigue symptoms (Centers for Disease Control and prevention (CDC) definition).
Intervention: Adolescents were randomised to two groups to receive: newly developed computer-based FITNET programme (containing cognitive behavioural modules, e-consults and a separate parental programme) or standard care (combination of cognitive behavioural therapy, rehabilitation or graded exercise programmes).
Outcomes: Primary outcomes were school attendance, fatigue severity and physical functioning at 6 and 12 months, assessed via questionnaires and subscale ratings. Secondary outcome was self-rated improvement.
Follow-up period: Outcomes were assessed at 6 and 12 months.
Patient follow-up: At 6 and 12 months, 67/68 and 64/68 adolescents allocated to FITNET and 64/67 and 63/67 adolescents allocated to standard care were analysed respectively. Intention-to-treat analysis was performed.
FITNET was significantly more effective than standard care in all primary outcomes—full school attendance, absence of severe fatigue and normal physical functioning (see table 1). The FITNET group also reported better self-rated improvement.
Internet-based cognitive behavioural therapy (FITNET) was an effective treatment for adolescents with chronic fatigue syndrome.
Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) is relatively common (prevalence 1–2.4%1 ,2) and often disabling with up to 50% of children bedbound at some stage.3 New ways of providing treatment that allow teenagers with CFS/ME to access care is important.
In this well-conducted and innovative study, the web-based intervention was provided in two sections: a psychoeducational section and a cognitive behavioural section which consisted of 21 different modules for adolescents with support provided by e-consults from trained therapists. Perhaps uniquely parents followed a parallel programme which included the psychoeducation aspects but did not include the behavioural tools (patient diaries, etc). The results suggest that FITNET was remarkably effective compared to usual care in the Netherlands. 75% of children in the FITNET group were attending ‘full time school’ (>90% attendance) at 6 months compared to 16% in the usual care group. Both fatigue and physical function had improved more in those taking part in FITNET.
The authors were careful to ensure that all patients recruited had CFS/ME. All adolescents were assessed by a paediatrician who specialised in CFS/ME with a detailed history, examination and laboratory tests to exclude other causes of fatigue. All participants completed computerised self-reported questionnaires and those with abnormal scores had a clinical assessment by a psychologist to exclude primary depression or anxiety. The recruitment rate was extremely high for a trial (96%) suggesting that this approach is attractive to adolescents. The follow-up was also high (97%) at 12 months improving confidence in the validity of the results. Patients in the usual care arm who had not improved at 6 months were offered FITNET. This design ensured that all adolescents eventually had access to the intervention on offer. The results of patients in the usual care arm who crossed over to FITNET were similar to the original FITNET group at 12 months.
Is this approach transferable outside the Netherlands? Probably not without further study. It is unclear exactly what usual care in the Netherlands was, and how comparable it is to care in other countries. For example, 10% of children randomised to usual care were unable to receive any care because ‘treatment was not available within an acceptable travelling distance’. The remainder received a mixture of evidence based treatment including cognitive behavioural therapy and graded exercise therapy as well as non-evidence based treatments such as alternative treatment 16 (24%) and ‘rehabilitation treatment’, but the content, frequency, intensity and duration of such treatments is not known.
The cost-effectiveness of such a system is also uncertain: although FITNET did not require face to face consultations, it was resource intensive. The mean number of times patients and parents logged in was 255. The mean number of email consults by patients was 66.6 (SD 16.3) and by parents was 22.8 (10.3). The mean number of e-consults sent by the therapist was 28.7 (10.3) per patient and 19.5 (10.5) per parent. Further health economic analyses will help us know whether this approach is cost-effective or not.
Competing interests None.
Provenance and peer review Not commissioned; internally peer reviewed.