Long-term effectiveness of a cognitive behavioural therapy (CBT) in the management of fatigue in patients with relapsing remitting multiple sclerosis (RRMS): a multicentre, randomised, open-label, controlled trial versus standard care - Archive ouverte HAL
Article Dans Une Revue Journal of Neurology, Neurosurgery and Psychiatry Année : 2024

Long-term effectiveness of a cognitive behavioural therapy (CBT) in the management of fatigue in patients with relapsing remitting multiple sclerosis (RRMS): a multicentre, randomised, open-label, controlled trial versus standard care

Fanny Cassedanne
  • Fonction : Auteur
Frederic Barbot
  • Fonction : Auteur
Isabelle Vaugier
  • Fonction : Auteur
Sarah Thomas
  • Fonction : Auteur
Eric Manchon
  • Fonction : Auteur
Djamel Bensmail
  • Fonction : Auteur
Marie Blanchere
  • Fonction : Auteur
Olivier Heinzlef

Résumé

Background Fatigue is a disabling symptom of multiple sclerosis (MS). The lack of effective therapeutics has promoted the development of cognitive behavioural therapy (CBT)-based fatigue management programmes. However, their efficacy does not sustain over time. We proposed to test the long-term effectiveness of a 6-week fatigue programme supplemented with four booster sessions (‘FACETS+’) in patients with relapsing remitting MS (RRMS) and fatigue. Methods This multicentre, randomised, controlled, open-label, parallel-group trial versus standard care enrolled patients with RRMS and fatigue. Participants were randomised to either FACETS+ plus standard care or standard care alone. The primary outcome measure was fatigue impact (Modified Fatigue Impact Scale (MFIS) at 12 months) based on intention-to-treat analyses. Results From May 2017 to September 2020, 162 patients were screened; 105 were randomly assigned to FACETS+ (n=57) or standard care (n=48) and 88 completed the primary outcome assessment for the MFIS. At month 12, participants showed improved MFIS compared with baseline in the intervention group (mean difference (MD)=14.0 points; (95% CI 6.45 to 21.5)) and the control group (MD=6.1 points; (95% CI −0.30 to 12.5)) with a significant between-group difference in favour of the intervention group (adjusted MD=7.89 points; (95% CI 1.26 to 14.52), standardised effect size=0.52, p=0.021). No trial-related serious adverse events were reported. Conclusions A 6-week CBT-based programme with four booster sessions is superior to standard care alone to treat MS-related fatigue in the long term (12 months follow-up). The results support the use of the FACETS+ programme for the treatment of MS-related fatigue. Trial registration number NCT03758820 .

Dates et versions

hal-04768525 , version 1 (06-11-2024)

Identifiants

Citer

Marie Claire Gay, Fanny Cassedanne, Frederic Barbot, Isabelle Vaugier, Sarah Thomas, et al.. Long-term effectiveness of a cognitive behavioural therapy (CBT) in the management of fatigue in patients with relapsing remitting multiple sclerosis (RRMS): a multicentre, randomised, open-label, controlled trial versus standard care. Journal of Neurology, Neurosurgery and Psychiatry, 2024, 95 (2), pp.158-166. ⟨10.1136/jnnp-2023-331537⟩. ⟨hal-04768525⟩
9 Consultations
0 Téléchargements

Altmetric

Partager

More