Behavior Cognitive Therapy on Fatigue Impact in MS Patients

NCT03758820 | Completed DMC

• 1 other identifier: FACCSEP
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Relapsing Remitting Multiple Sclerosis; Fatigue; Cognitive Therapy

Outcome Measures

Primary Outcomes (1)

• Change assessment from Baseline measure of Fatigue Impact to month 6, 12 and 18

  Fatigue impact evaluated by MFIS autoquestionnaire MFIS : Modified Fatigue Impact Scale, 5 response option (0 to 4), score of between 0 (better) and 84 (worse) : A score \> 45 means the patient is affected by fatigue.

  After 6 weeks and 6,12 and 18 months

Secondary Outcomes (10)

• Change assessment from Baseline of Anxiety and depression

  After 12 months

• Change assessment from Baseline of Fatigue severity

  After 6 weeks and 6 and 12 months

• Change assessment from Baseline of Quality of sleep: Pittsburgh Sleep Quality scale

  After 12 months

• Change assessment from Baseline of Quality of sleep: Epworth Sleepiness Scale

  After 12 months

• Change assessment from Baseline of Cognitive disorders

  After 12 months

Study Arms (2)

BCT group

EXPERIMENTAL

Intervention : Behavorial Cognitive Therapy (BCT) will be delivered by two psychologists at six once-weekly sessions of 90 minutes (with homework activities between the sessions) + 4 booster sessions at week 6, 12, 18 and 36 after the end of the programme. It was designed for groups of 8 to 10 people. The programme is standardised: PowerPoints presentations support each session and a detailed facilitator manual and companion patient workbook. accompany the programme.

Behavioral: Behavorial Cognitive Therapy (BCT)

Control group

NO INTERVENTION

Usual local practice

Interventions

Behavorial Cognitive Therapy (BCT) BEHAVIORAL

Check-in : review of the homewok Talk : Presentation of the aim of the session Group Activity : Relaxation and Execises Refreshment break Homework : exercises to practice at home and explanation about the forms to fill in. Passout : session handbook and supports for exercises.

BCT group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Réseau Sep Idf Ouest: lead

Study Sites (1)

Poissy St Germain Hospital

Poissy, 78300, France

Location

Related Publications (31)

• Edgley KJ. Sullivan M, Dehoux E. A survey of multiple sclerosis: II. Determinants of employment status. Can J Rehabil 4:127-132, 1991

  BACKGROUND

• Multiple Sclerosis Council. Fatigue and Multiple Sclerosis - Clinical Practice Guidelines, 1998.

  BACKGROUND

• Bowcher H, May M. Occupational Therapy for the Management of Fatigue in Multiple Sclerosis, Br J Occup Ther, 61(11):488-492, 1998.

  BACKGROUND

• Castell BD, Kazantzis N, Moss-Morris RE. Cognitive Behavioral Therapy and Graded Exercise for Chronic Fatigue Syndrome: A Meta-Analysis. Clin Psychol Sci Pract. 18(4):311-324, 2012.

  BACKGROUND

• 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.

  PMID: 11594918 RESULT

• 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.

  PMID: 18256342 RESULT

• 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-2012-303816. Epub 2013 May 21.

  PMID: 23695501 RESULT

• Compston A, Coles A. Multiple sclerosis. Lancet. 2002 Apr 6;359(9313):1221-31. doi: 10.1016/S0140-6736(02)08220-X.

  PMID: 11955556 RESULT

• 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.

  PMID: 11074395 RESULT

• 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.

  PMID: 18344396 RESULT

• 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.

  PMID: 19361678 RESULT

• 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.

  PMID: 2630556 RESULT

• 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.

  PMID: 10773854 RESULT

• Flensner G, Landtblom AM, Soderhamn O, Ek AC. Work capacity and health-related quality of life among individuals with multiple sclerosis reduced by fatigue: a cross-sectional study. BMC Public Health. 2013 Mar 15;13:224. doi: 10.1186/1471-2458-13-224.

  PMID: 23497281 RESULT

• White LJ, Castellano V. Exercise and brain health--implications for multiple sclerosis: Part 1--neuronal growth factors. Sports Med. 2008;38(2):91-100. doi: 10.2165/00007256-200838020-00001.

  PMID: 18201113 RESULT

• Ritvo PG, Fisk JD, Archibald CJ, Murray TJ, Field C. Psychosocial and neurological predictors of mental health in multiple sclerosis patients. J Clin Epidemiol. 1996 Apr;49(4):467-72. doi: 10.1016/0895-4356(95)00027-5. No abstract available.

  PMID: 8621999 RESULT

• Schwid SR, Covington M, Segal BM, Goodman AD. Fatigue in multiple sclerosis: current understanding and future directions. J Rehabil Res Dev. 2002 Mar-Apr;39(2):211-24.

  PMID: 12051465 RESULT

• Racke MK, Hawker K, Frohman EM. Fatigue in multiple sclerosis: is the picture getting simpler or more complex? Arch Neurol. 2004 Feb;61(2):176-7. doi: 10.1001/archneur.61.2.176. No abstract available.

  PMID: 14967763 RESULT

• Bakshi R. Fatigue associated with multiple sclerosis: diagnosis, impact and management. Mult Scler. 2003 Jun;9(3):219-27. doi: 10.1191/1352458503ms904oa.

  PMID: 12814166 RESULT

• Kos D, Kerckhofs E, Nagels G, D'hooghe MB, Ilsbroukx S. Origin of fatigue in multiple sclerosis: review of the literature. Neurorehabil Neural Repair. 2008 Jan-Feb;22(1):91-100. doi: 10.1177/1545968306298934. Epub 2007 Apr 4.

  PMID: 17409388 RESULT

• Tejani AM, Wasdell M, Spiwak R, Rowell G, Nathwani S. Carnitine for fatigue in multiple sclerosis. Cochrane Database Syst Rev. 2010 Feb 17;(2):CD007280. doi: 10.1002/14651858.CD007280.pub2.

  PMID: 20166093 RESULT

• Vanage SM, Gilbertson KK, Mathiowetz V. Effects of an energy conservation course on fatigue impact for persons with progressive multiple sclerosis. Am J Occup Ther. 2003 May-Jun;57(3):315-23. doi: 10.5014/ajot.57.3.315.

  PMID: 12785670 RESULT

• Mathiowetz VG, Finlayson ML, Matuska KM, Chen HY, Luo P. Randomized controlled trial of an energy conservation course for persons with multiple sclerosis. Mult Scler. 2005 Oct;11(5):592-601. doi: 10.1191/1352458505ms1198oa.

  PMID: 16193899 RESULT

• Lee MA, Smith S, Palace J, Matthews PM. Defining multiple sclerosis disease activity using MRI T2-weighted difference imaging. Brain. 1998 Nov;121 ( Pt 11):2095-102. doi: 10.1093/brain/121.11.2095.

  PMID: 9827769 RESULT

• Gay MC, Vrignaud P, Garitte C, Meunier C. Predictors of depression in multiple sclerosis patients. Acta Neurol Scand. 2010 Mar;121(3):161-70. doi: 10.1111/j.1600-0404.2009.01232.x. Epub 2010 Jan 12.

  PMID: 20070277 RESULT

• Feinstein A, Magalhaes S, Richard JF, Audet B, Moore C. The link between multiple sclerosis and depression. Nat Rev Neurol. 2014 Sep;10(9):507-17. doi: 10.1038/nrneurol.2014.139. Epub 2014 Aug 12.

  PMID: 25112509 RESULT

• Knoop H, van Kessel K, Moss-Morris R. Which cognitions and behaviours mediate the positive effect of cognitive behavioural therapy on fatigue in patients with multiple sclerosis? Psychol Med. 2012 Jan;42(1):205-13. doi: 10.1017/S0033291711000924. Epub 2011 Jun 15.

  PMID: 21672300 RESULT

• Gronwall DM. Paced auditory serial-addition task: a measure of recovery from concussion. Percept Mot Skills. 1977 Apr;44(2):367-73. doi: 10.2466/pms.1977.44.2.367.

  PMID: 866038 RESULT

• Ruet A, Deloire MS, Charre-Morin J, Hamel D, Brochet B. A new computerised cognitive test for the detection of information processing speed impairment in multiple sclerosis. Mult Scler. 2013 Oct;19(12):1665-72. doi: 10.1177/1352458513480251. Epub 2013 Mar 4.

  PMID: 23459569 RESULT

• Stankoff B, Waubant E, Confavreux C, Edan G, Debouverie M, Rumbach L, Moreau T, Pelletier J, Lubetzki C, Clanet M; French Modafinil Study Group. Modafinil for fatigue in MS: a randomized placebo-controlled double-blind study. Neurology. 2005 Apr 12;64(7):1139-43. doi: 10.1212/01.WNL.0000158272.27070.6A.

  PMID: 15824337 RESULT

• Gay MC, Cassedanne F, Barbot F, Vaugier I, Thomas S, Manchon E, Bensmail D, Blanchere M, Heinzlef O. 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 Jan 11;95(2):158-166. doi: 10.1136/jnnp-2023-331537.

  PMID: 37648439 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Fatigue

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Olivier HEINZLEF, MD

  Réseau Sep Idf Ouest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: randomization of patients
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: parallel group assignment

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: November 29, 2018
• Study Start: May 31, 2017
• Primary Completion: October 15, 2020
• Study Completion: October 15, 2020
• Last Updated: March 16, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)