1) 🇪🇺 The controversial European project on Long Covid includes a randomized trial on amygdala retraining and online CBT. In a preliminary analysis, both fared no better than usual care.
2) This is a multinational consortium that received €6.5 million in funding from Horizon Europe (Grant ID: 101057553). It's led by Helsinki University Hospital but includes partners from Italy, Germany, Estonia, and the Netherlands. More info here:
cordis.europa.eu
3) The call it won (HORIZON-HLTH-2021-DISEASE-04-07) was issued in 2021 and focused on a mechanistic understanding of the interplay between virus and host such as deep immunological phenotyping and genetic patterns. Full description here: ec.europa.eu 4) The scope of the call focused on physiological mechanisms and molecular pathways. This makes it curious that a large behavioural trial was included. Even stranger is that the trial is for "patients with persistent somatic symptoms", so not just Long Covid. 5) The amygdala and insula retraining program is based on Ashok Gupta's theory. It assumes that "the amygdala can become chronically sensitized to bodily signals" and includes neurolinguistic programming which is considered a form of pseudo-science. 6) The other intervention is web-based acceptance and commitments therapy (ACT) and includes psychoeducation as well as exercises aimed at "relaxing the body and learning new ways of observing the symptoms." 7) The trial is still ongoing but last year a preliminary analysis was shared of the first 215 participants (the target was 360 participants). It showed no significant difference on 3 primary outcomes, with the treatment as usual group having slightly better results.
8 ) The authors write: "Preliminary analyses based on patient-reported outcome measures indicate no significant differences in effectiveness between the intervention arms." More data will be collected but "there is a low possibility that the results will change significantly." 9) Curious that these null results weren't mentioned in the French interview with L'Express. In it, the consortium leaders argued that biological studies only lead to null results and that a psychological approach ("Un cerveau bloqué en mode défense") is more promising. 10) Also strange that there seem to be no patient organizations involved in this entire project. Link to the trial protocol: Vangelova-Korpinen et al. Effectiveness of mindfulness-based online therapy or internet-delivered cognitive behavioral therapy...
journals.plos.org