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)

In spite of the fatigue impact is well known in MS, medical care of this symptom is not usual. Moreover, treatments of fatigue are available, but evidence for effectiveness is limited. This study will build upon the existing evidence base for the effectiveness of cognitive behavioral approaches, and particularly the recent FACETS trial published by co-applicants.

Scientific aim is to assess the effectiveness of the FACETS program plus 4 additional booster sessions on a population of French patients with RRMS over a 12 months period.

This study will provide evidence on whether the FACETS program plus booster sessions is effective in helping MS patients with their fatigue. The program is designed to facilitate use within health services. Thus, if the results from this trial are positive, there is potential for directly adding to the treatment options available to MS patients who have troublesome fatigue, and improving the central nervous system affecting approximately 2.5 million people (5). Fatigue is one of the most commonly reported and disabling symptoms of MS, often occurring daily (6) and with a variable course (7-8). 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 has been defined as a "subjective lack of physical and/or mental energy that is perceived by the individual or caregiver to interfere with usual or desired activities" (9).

Researchers have distinguished between primary and secondary fatigue (10). "Primary" fatigue relates to aspects of fatigue deemed to be directly related to the disease process such as lassitude or asthenia (an overwhelming sense of tiredness not directly related to participation in activity or exercise), "short-circuiting" fatigue (when muscular performance deteriorates during sustained activity but recovers after a short rest break) and heat sensitive fatigue (where fatigue is triggered or worsened by heat). "Secondary" fatigue refers to fatigue that is not unique to MS and is related to factors common to a range of chronic and disabling conditions (e.g. sleep disturbance, medication side effects, infection, physical exertion, depression, anxiety, stressful life events, characteristics of the local environment - such as lighting and temperature within a work setting). The relationship between these dimensions is complex; various symptoms of MS may act as predisposing factors for secondary fatigue.

Fatigue may limit or prevent participation in everyday activities, work, leisure and social pursuits, restrict role fulfilment and reduce psychological well-being (1-2) and is one of the key precipitants of early retirement (11-12). Its 'invisible' nature may lead to difficulties in personal and work relationships (13-14).