Testing non-inferiority of blended versus face-to-face cognitive behavioural therapy for severe fatigue in patients with multiple sclerosis and the effectiveness of blended booster sessions aimed at improving long-term outcome following both therapies: study protocol for two observer-blinded randomized clinical trials.

摘要: Cognitive behavioural therapy (CBT) has been found to be effective in reducing fatigue severity MS patients directly following treatment. However, long-term effects are inconsistent leaving room for improvement. In addition, individual face-to-face CBT draws heavily on limited treatment capacity, and the travel distance centre can burdensome patients. Therefore, we developed “MS Fit”, a blended MS-related fatigue, based protocol previous study, Stay internet-based booster sessions improve effectiveness of fatigue. This article presents two randomised clinical trials (RCTs) conducted within one study investigating (1) non-inferiority Fit compared with evidence-based (2) outcome no sessions. The first part this is an observer-blinded multicentre RCT, which 166 severely fatigued will randomly assigned (1:1 ratio, computer-generated sequence) either or (MS Fit) primary endpoint at 20 weeks after baseline. After post-treatment assessment, again computer generated consisting 2 4 months end second 52 weeks Primary measure both studies assessed subscale Checklist Individual Strength (CIS20r). Outcomes baseline (T0), (T20), 39 (T39 T52). If non-inferior CBT, it accessibility aims test whether possible Fit. Dutch Trial Register (NTR6966), registered 18 January 2018 https://www.trialregister.nl/trial/6782 All items from WHO Registration Data Set protocol.