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)

CompletedNot a drug-phase studyRelapsing MSNCT03758820

What it found

Paper found, not read

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 sleep
  • Change assessment from Baseline of Fatigue severity

    After 6 weeks and 6 and 12 months

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

    After 12 months

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

    After 12 months

    Mood and sleep
  • Change assessment from Baseline of Cognitive disorders

    After 12 months

    Thinking and memory
  • Change 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

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History

    1. Started

      May 2017

    2. Main results due

      Oct 2020

    3. Finished

      Oct 2020

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