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

Overview

Journal J Neurol Neurosurg Psychiatry

Publisher BMJ Publishing Group

Specialties Neurology
Neurosurgery
Psychiatry

Date 2023 Aug 30

PMID 37648439

Authors

Marie Claire Gay

Fanny Cassedanne

Frederic Barbot

Isabelle Vaugier

Sarah Thomas

Eric Manchon

Djamel Bensmail

Marie Blanchere

Olivier Heinzlef

Affiliations

Soon will be listed here.

Abstract

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.

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References

Thomas S, Thomas P, Nock A, Slingsby V, Galvin K, Baker R . Development and preliminary evaluation of a cognitive behavioural approach to fatigue management in people with multiple sclerosis. Patient Educ Couns. 2009; 78(2):240-9. DOI: 10.1016/j.pec.2009.07.001. View

Minden S, Frankel D, Hadden L, Perloffp J, Srinath K, Hoaglin D . The Sonya Slifka Longitudinal Multiple Sclerosis Study: methods and sample characteristics. Mult Scler. 2006; 12(1):24-38. DOI: 10.1191/135248506ms1262oa. View

Beck A . Cognitive therapy: past, present, and future. J Consult Clin Psychol. 1993; 61(2):194-8. DOI: 10.1037//0022-006x.61.2.194. View

Stankoff B, Waubant E, Confavreux C, Edan G, Debouverie M, Rumbach L . Modafinil for fatigue in MS: a randomized placebo-controlled double-blind study. Neurology. 2005; 64(7):1139-43. DOI: 10.1212/01.WNL.0000158272.27070.6A. View

Moss-Morris R, McCrone P, Yardley L, van Kessel K, Wills G, Dennison L . A pilot randomised controlled trial of an Internet-based cognitive behavioural therapy self-management programme (MS Invigor8) for multiple sclerosis fatigue. Behav Res Ther. 2012; 50(6):415-21. DOI: 10.1016/j.brat.2012.03.001. View

Moss-Morris R, Harrison A, Safari R, Norton S, van der Linden M, Picariello F . Which behavioural and exercise interventions targeting fatigue show the most promise in multiple sclerosis? A systematic review with narrative synthesis and meta-analysis. Behav Res Ther. 2019; 137:103464. DOI: 10.1016/j.brat.2019.103464. View

Strober L, Arnett P . An examination of four models predicting fatigue in multiple sclerosis. Arch Clin Neuropsychol. 2005; 20(5):631-46. DOI: 10.1016/j.acn.2005.04.002. View

Rooney S, McFadyen D, Wood D, Moffat D, Paul P . Minimally important difference of the fatigue severity scale and modified fatigue impact scale in people with multiple sclerosis. Mult Scler Relat Disord. 2019; 35:158-163. DOI: 10.1016/j.msard.2019.07.028. View

de Groot V, Beckerman H, Twisk J, Uitdehaag B, Hintzen R, Minneboo A . Vitality, perceived social support and disease activity determine the performance of social roles in recently diagnosed multiple sclerosis: a longitudinal analysis. J Rehabil Med. 2008; 40(2):151-7. DOI: 10.2340/16501977-0145. View

10.

Pottgen J, Moss-Morris R, Wendebourg J, Feddersen L, Lau S, Kopke S . Randomised controlled trial of a self-guided online fatigue intervention in multiple sclerosis. J Neurol Neurosurg Psychiatry. 2018; 89(9):970-976. DOI: 10.1136/jnnp-2017-317463. View

11.

Akker L, Beckerman H, Collette E, Twisk J, Bleijenberg G, Dekker J . Cognitive behavioral therapy positively affects fatigue in patients with multiple sclerosis: Results of a randomized controlled trial. Mult Scler. 2017; 23(11):1542-1553. DOI: 10.1177/1352458517709361. View

12.

Janse A, Nikolaus S, Wiborg J, Heins M, van der Meer J, Bleijenberg G . Long-term follow-up after cognitive behaviour therapy for chronic fatigue syndrome. J Psychosom Res. 2017; 97:45-51. DOI: 10.1016/j.jpsychores.2017.03.016. View

13.

Hemmett L, Holmes J, Barnes M, Russell N . What drives quality of life in multiple sclerosis?. QJM. 2004; 97(10):671-6. DOI: 10.1093/qjmed/hch105. View

14.

Blome C, Carlton J, Heesen C, Janssen M, Lloyd A, Otten M . How to measure fluctuating impairments in people with MS: development of an ambulatory assessment version of the EQ-5D-5L in an exploratory study. Qual Life Res. 2021; 30(7):2081-2096. PMC: 8233275. DOI: 10.1007/s11136-021-02802-8. View

15.

Linardon J . Meta-analysis of the effects of cognitive-behavioral therapy on the core eating disorder maintaining mechanisms: implications for mechanisms of therapeutic change. Cogn Behav Ther. 2018; 47(2):107-125. DOI: 10.1080/16506073.2018.1427785. View

16.

Hawton A, Goodwin E, Boddy K, Freeman J, Thomas S, Chataway J . Measuring the cost-effectiveness of treatments for people with multiple sclerosis: Beyond quality-adjusted life-years. Mult Scler. 2020; 28(3):346-351. PMC: 8894952. DOI: 10.1177/1352458520954172. View

17.

Penner I, Bechtel N, Raselli C, Stocklin M, Opwis K, Kappos L . Fatigue in multiple sclerosis: relation to depression, physical impairment, personality and action control. Mult Scler. 2007; 13(9):1161-7. DOI: 10.1177/1352458507079267. View

18.

Debouverie M, Pittion-Vouyovitch S, Guillemin F . [Reconsidering fatigue at the onset of multiple sclerosis]. Rev Neurol (Paris). 2009; 165 Suppl 4:S135-44. DOI: 10.1016/S0035-3787(09)72125-3. View

19.

Thomas P, Thomas S, Kersten P, Jones R, Slingsby V, Nock A . One year follow-up of a pragmatic multi-centre randomised controlled trial of a group-based fatigue management programme (FACETS) for people with multiple sclerosis. BMC Neurol. 2014; 14:109. PMC: 4046846. DOI: 10.1186/1471-2377-14-109. View

20.

Nourbakhsh B, Revirajan N, Morris B, Cordano C, Creasman J, Manguinao M . Safety and efficacy of amantadine, modafinil, and methylphenidate for fatigue in multiple sclerosis: a randomised, placebo-controlled, crossover, double-blind trial. Lancet Neurol. 2020; 20(1):38-48. PMC: 7772747. DOI: 10.1016/S1474-4422(20)30354-9. View