Behavior Cognitive Therapy on Fatigue Impact in MS Patients
Multicenter Study, Randomized, Parallel Group Controlled, Testing the Effectiveness of a Behavioral Cognitive Therapy (BCT) vs Usual Local Practice on the Fatigue of Patients With Relapsing Remittent Multiple Sclerosis (RRMS)
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Behavorial Cognitive Therapy (BCT)
What it measured
Main measures
Change assessment from Baseline measure of Fatigue Impact to month 6, 12 and 18
After 6 weeks and 6,12 and 18 months
Fatigue
Other measures (9)
Change assessment from Baseline of Anxiety and depression
After 12 months
Mood and sleepChange assessment from Baseline of Fatigue severity
After 6 weeks and 6 and 12 months
FatigueChange assessment from Baseline of Quality of sleep: Pittsburgh Sleep Quality scale
After 12 months
Mood and sleepChange assessment from Baseline of Quality of sleep: Epworth Sleepiness Scale
After 12 months
Mood and sleepChange assessment from Baseline of Cognitive disorders
After 12 months
Thinking and memoryChange assessment from Baseline of Quality of life: MSIS-29
After 6,12 and 18 months
Quality of life (reported by participants)Change assessment from Baseline of Quality of life: EQ5D-3L
After 6,12 and 18 months
Walking and mobilityPainMood and sleepQuality of life (reported by participants)Change assessment from Baseline of Medical care consumption and professional impact
After 6,12 and 18 months
Change assessment from Baseline of professional impact
After 6,12 and 18 months
Who could take part
Relapsing MS · 18 and over
Show the full criteria
Inclusion criteria
* RRMS * EDSS ≤ 5,5 * MFIS score > 45 * Outpatient treatment * Enable to follow the BCT sessions * French understanding * More than 18 years old * Inform consent signature * Membership in a social protection
Exclusion criteria
* Cognitive disorders avoiding patient participation * Relapse within last 3 months before baseline * Onset of DMT within 3 months * Onset of antidepressive treatment within 3 months * Onset of treatment for fatigue within 3 months * Psychiatric disorders
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Multiple sclerosis (MS) is a chronic inflammatory disease that leads to demyelination of the central nervous system. Fatigue is one of the most frequent and most disabling symptoms of MS. Up to 86% of individuals with MS experience fatigue at any one time; 65% consider it to be one of their three most troubling symptoms. Fatigue may limit or prevent participation in dayly activities and reduce psychological well-being (1, 2). Pharmacological and non-pharmacological treatments are available for MS-related fatigue, but evidence on effectiveness is mostly inconclusive or non-existent. The psychological approaches of fatigue management are interesting. To date, three RCTs using cognitive-behavioral group-based approaches in MS fatigue management programs have demonstrated their effectiveness (3-6). The results demonstrated a reduction in fatigue scores and better self-management of the disease in general. However, if these programs are effective at the time of their application and in the medium term, the issue of maintaining long-term therapeutic benefits is problematic. The aim of this research is to assess the effectiveness of the FACETS program (6), on a population of French patients with RRMS over a 18 month period. This program focuses on the management of fatigue and is based on a conceptual framework that incorporates elements of cognitive-behavioral, self-efficacy, self-management and energy effectiveness theories. It consists of six once-weekly sessions of 90 minutes, with homework activities between the sessions. It is designed for groups of 6 to 10 people. The investigators propose to add 4 booster sessions to the FACETS program, at week 6, 12, 18 et 36 after the end of the program, in order to activate and reinforce the cognitive and behavioral processes and enhance the benefits of FACETS in the longer term. This trial is randomized controlled comparative comparing a group receiving a FACETS program with a group receiving only a current local practice. Socio-demographic and medical data are measured as well as fatigue impact, fatigue severity, anxiety and depression, sleep disorder and quality of life. The expected results are a significantly greater decrease in fatigue severity and impact in the FACETS group than the control group post intervention and this difference will be maintained at 1 year.
Papers
Results
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.J Neurol Neurosurg Psychiatry · 2024
Results
Amato MP, Ponziani G, Siracusa G, Sorbi S. Cognitive dysfunction in early-onset multiple sclerosis: a reappraisal after 10 years. Arch Neurol. 2001 Oct;58(10):1602-6. doi: 10.1001/archneur.58.10.1602.Results
van Kessel K, Moss-Morris R, Willoughby E, Chalder T, Johnson MH, Robinson E. A randomized controlled trial of cognitive behavior therapy for multiple sclerosis fatigue. Psychosom Med. 2008 Feb;70(2):205-13. doi: 10.1097/PSY.0b013e3181643065. Epub 2008 Feb 6.Results
Thomas S, Thomas PW, Kersten P, Jones R, Green C, Nock A, Slingsby V, Smith AD, Baker R, Galvin KT, Hillier C. A pragmatic parallel arm multi-centre randomised controlled trial to assess the effectiveness and cost-effectiveness of a group-based fatigue management programme (FACETS) for people with multiple sclerosis. J Neurol Neurosurg Psychiatry. 2013 Oct;84(10):1092-9. doi: 10.1136/jnnp-2012-303Results
Compston A, Coles A. Multiple sclerosis. Lancet. 2002 Apr 6;359(9313):1221-31. doi: 10.1016/S0140-6736(02)08220-X.Results
Branas P, Jordan R, Fry-Smith A, Burls A, Hyde C. Treatments for fatigue in multiple sclerosis: a rapid and systematic review. Health Technol Assess. 2000;4(27):1-61.Results
Johansson S, Ytterberg C, Hillert J, Widen Holmqvist L, von Koch L. A longitudinal study of variations in and predictors of fatigue in multiple sclerosis. J Neurol Neurosurg Psychiatry. 2008 Apr;79(4):454-7. doi: 10.1136/jnnp.2007.121129.Results
Debouverie M, Pittion-Vouyovitch S, Guillemin F. [Reconsidering fatigue at the onset of multiple sclerosis]. Rev Neurol (Paris). 2009 Mar;165 Suppl 4:S135-44. doi: 10.1016/S0035-3787(09)72125-3. French.Results
Monks J. Experiencing symptoms in chronic illness: fatigue in multiple sclerosis. Int Disabil Stud. 1989 Apr-Jun;11(2):78-83. doi: 10.3109/03790798909166394.Results
Grima DT, Torrance GW, Francis G, Rice G, Rosner AJ, Lafortune L. Cost and health related quality of life consequences of multiple sclerosis. Mult Scler. 2000 Apr;6(2):91-8. doi: 10.1177/135245850000600207.
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History
Started
May 2017
Main results due
Oct 2020
Finished
Oct 2020