FITNET’s Internet-Based Cognitive Behavioural Therapy Is Ineffective and May Impede Natural Recovery in Adolescents with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. A Review

Abstract

The Dutch Fatigue In Teenagers on the interNET (FITNET) study claimed that after 6 months, internet based cognitive behaviour therapy in adolescents with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), led to a 63% recovery rate compared to 8% after usual care, and that this was maintained at long term follow up (LTFU). Our reanalysis shows that their post-hoc definition of recovery included the severely ill, the unblinded trial had no adequate control group and it used lax selection criteria as well as outcomes assessed via questionnaires rather than objective outcomes, further contributing to exaggerated recovery figures. Their decision not to publish the actometer results might suggest that these did not back their recovery claims. Despite these bias creating methodological faults, the trial still found no significant difference in recovery rates (“~60%”) at LTFU, the trial’s primary goal. This is similar to or worse than the documented 54–94% spontaneous recovery rates within 3–4 years, suggesting that both FITNET and usual care (consisting of cognitive behaviour and graded exercise therapies) are ineffective and might even impede natural recovery in adolescents with ME/CFS. This has implications for the upcoming costly NHS FITNET trial which is a blueprint of the Dutch study, exposing it to similar biases.

Cognitive behavioural therapy for myalgic encephalomyelitis/chronic fatigue syndrome is not effective. Re-analysis of a Cochrane review

“…'Indeed, it is difficult to imagine how such a large-scale investigation could have developed, proceeded and passed through the review process unless its scientific failings were actually characteristic of its field'. Analysis of the Dutch FITNET trial of Internet CBT for adolescents (Ghatineh and Vink, 2017), of the Dutch FatiGo trial of multidisciplinary rehabilitation treatment (Vink and Vink-Niese, 2018a) and of five Dutch hallmark CBT studies (Twisk and Corsius, 2017) supported this observation. A recent re-analysis of the Cochrane exercise review for CFS (Vink and Vink-Niese, 2018b) revealed a number of methodological concerns with many of the studies reviewed as part of the Cochrane review of GET for CFS and a lack of objective evidence for improvement in physical function.…”

The Draft Report by the Institute for Quality and Efficiency in Healthcare Does Not Provide Any Evidence That Graded Exercise Therapy and Cognitive Behavioral Therapy Are Safe and Effective Treatments for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

“…Moreover, another problem with outcomes assessed via questionnaires in a non-blinded trial is “response-shift bias”. This occurs when an intervention leads individuals to change their evaluation standard regarding the dimension measured, leading the therapist (and, often, also the patient) to conclude erroneously that the treatment has worked [ 29 , 33 ]. This form of bias is even more of a problem in CBT trials for ME/CFS, because this specific form of CBT aims to modify participants’ beliefs and perceptions of their symptoms [ 34 ].…”

The Importance of Accurate Diagnosis of ME/CFS in Children and Adolescents: A Commentary

“…This data is taken from a pediatric CBT trial of FITNET in the Netherlands (41). The Dutch trial has been criticized for over-stating benefits via post-hoc selection of recovery measures and for including young patients with general fatigue issues (42). Interestingly, at long-term follow up in the Dutch FITNET study (2 years+), recovery stood at 64% for CBT-GET participants, but 52.8% for usual care participants (43).…”