Blended versus face-to-face cognitive behavioural therapy for severe fatigue in patients with multiple sclerosis: A non-inferiority RCT

Abstract

Background: Cognitive behavioural therapy (CBT) reduces multiple sclerosis (MS)-related fatigue. Implementation of face-to-face CBT is hindered by limited treatment capacity and traveling distances to treatment locations. Objective: Evaluate whether blended CBT (online treatment modules supported with guidance by a therapist) is non-inferior to face-to-face CBT in reducing fatigue severity in severely fatigued patients with MS. Method: A non-inferiority multicentre randomized clinical trial, in which 166 patients with MS were allocated to either face-to-face or blended CBT. Primary outcome was fatigue severity assessed with the Checklist Individual Strength fatigue subscale directly post-treatment (week 20). Mixed model analysis was used by a statistician blinded for allocation to determine between-group differences post-treatment. The upper limit of the 95% confidence interval (CI) was compared to a pre-specified non-inferiority margin of 5.32. Results: Blended CBT ( N = 82) was non-inferior to face-to-face CBT ( N = 84) (B = 1.70, 95% CI: −1.51 to 4.90). Blended CBT significantly reduced therapist time ( B = −187.1 minutes, 95% CI: 141.0–233.3). Post hoc analysis showed more improvement ( B = −5.35, 95% CI: −9.22 to −1.48) when patients received their preferred treatment. No harm related to treatment was reported. Discussion: Blended CBT is an efficient alternative to face-to-face CBT. Offering the preferred CBT format may optimize treatment outcome.

Effectiveness of a blended booster programme for the long-term outcome of cognitive behavioural therapy for MS-related fatigue: A randomized controlled trial

“…Congruence of treatment preference with the allocated initial treatment (face-to-face or blended CBT) did moderate treatment effect in the non-inferiority RCT. 11 We found no significant effect of treatment preference on boosters (data not shown).…”

“…Recruitment and inclusion of participants took place between April 2018 and December 2021. 11 Of the 166 participants in the non-inferiority RCT, 126 participants (77% female) with a mean age of 44.9 and a median disease duration of 7.0 years at baseline were subsequently randomized in the present study to either booster sessions or no booster programme. Reasons for exclusion were non-adherence to the initial treatment or lost to follow-up in the non-inferiority RCT and are displayed in the flow diagram ( Figure 1 ).…”

“…Blended CBT was non-inferior to faceto-face CBT with respect to its positive effect on fatigue severity. 11 Participants were randomized again post-treatment (at 20 weeks) to either a condition with boosters or a condition without boosters (see Figure 1). 12 item ⩾ 3), (d) current pregnancy or having given birth in the past 3 months, (e) pharmacological treatment for fatigue that was started in the past 3 months, (f) non-pharmacological therapies for fatigue in the past 3 months and (g) having received CBT for fatigue.…”

“…Blended CBT was non-inferior to face-to-face CBT with respect to its positive effect on fatigue severity. 11 Participants were randomized again post-treatment (at 20 weeks) to either a condition with boosters or a condition without boosters (see Figure 1 ). 12 Participants in the non-inferiority RCT met the following inclusion criteria: (a) definitive diagnosis of MS, (b) severely fatigued, checklist individual strength (CIS) fatigue ⩾35, (c) aged between 18 and 70 years, (d) ambulatory, Expanded Disability Status Scale (EDSS ⩽6), (e) no evident signs of an exacerbation and no corticosteroid treatment in the past 3 months and (f) no clinical indication of current infections, anaemia or thyroid dysfunction.…”