Objective: This study aimed to evaluate the effectiveness of an online multicomponent intervention called FATIGUEWALK (FaW) compared to treatment as usual (TAU) in patients with chronic fatigue syndrome/ myalgic encephalomyelitis (CFS/ME). Method: FaW included pain neuroscience education, therapeutic exercise, cognitive restructuring, and mindfulness training. A total of 428 patients with CFS/ME were randomized into two study arms: online FaW plus TAU versus TAU alone. A single-blinded randomized controlled trial was conducted. Validated patient-reported outcome measures of fatigue, pain, anxiety, depression, and physical function were collected at baseline and posttreatment, following the FaW intervention, which lasted 12 weeks. Results: Statistically significant improvements (with small-to-moderate effect sizes) were observed in online FaW versus TAU alone with respect to multidimensional aspects of fatigue (Cohen's d ranging from 0.25 to 0.73) and most secondary outcomes (pain and fatigue intensity, depressive and anxious symptomatology, functional impairment, kinesiophobia, physical functioning). The absolute risk reduction in FaW versus TAU was 19%, 95% confidence interval (CI) [12.19, 25.80] with number needed to treat = 6, 95% CI [3.9, 8.2]. Overall, similar clinical improvements were observed in sensitivity analyses including a subgroup of patients without comorbidity with fibromyalgia (n = 70). Conclusions: This is the first study to assess the short-term effectiveness of an online multicomponent intervention added to TAU, compared to TAU alone, for the management of CFS/ME. Further trials, including active control groups with an equivalent treatment dose, and assessing the long-term effectiveness of the online FaW, are warranted.
Public Significance StatementThe FATIGUEWALK (FaW) program is a video-based multicomponent treatment for chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). This trial strongly suggests that FaW is an effective treatment for improving fatigue and psychological and physical comorbid impairment in CFS/ME patients, both with and without fibromyalgia. This study highlights the importance of online and multicomponent interventions for CFS/ME treatment. This article was published Online First December 21, 2023. Jaime Navarrete https://orcid.org/0000-0002-9482-4822 The authors have no known conflicts of interest to disclose. This study has not received specific funding. Jaime Navarrete has a research contract from the Institute of Health Carlos III (ISCIII; ICI20/00080). Albert Feliu-Soler has a Serra Hunter grant award (UAB-LE-8015). The authors are grateful to the CIBER of Epidemiology and Public Health (CIBERESP CB22/02/ 00052; ISCIII) for its support. ClinicalTrials.gov, Identifier: NCT04593225.Mayte Serrat and Jaime Navarrete are joint first coauthorship. Juan V. Luciano and Albert Feliu-Soler are joint senior coauthorship. Mayte Serrat contributed equally to funding acquisition, resources, software, supervision, validation, and visualization. Mayte Serrat and Albert Fe...