Améliorer l'Estime de Soi Des Patients Atteints de sclérose en Plaques : Test d'efficacité de la Technique d'Association Lexicale

RecruitingNot a drug-phase studyRelapsing and progressiveNCT07064291

What it found

Still running

No result yet.

What was tested

Treatment tested

  • The Lexical Association Technique (LAT)

Placebo

  • Placebo of the Lexical Association Technique

What it measured

Main measures

  • Effect of the therapeutic technique on patients' self-esteem assessed by comparing patients score at the RSES between the experimental and active control group after the procedure.

    The primary endpoint is defined as the difference in self-esteem scores measured on the day following the completion of the LAT or control procedure (post-test), that is, 14 days (±2 days) after the p

Other measures (7)

  • Durability of the effects on patients' self-esteem assessed by comparing patients score at the RSES between the experimental and active control group at distance from the end of the procedure.

    To assess durability, self-esteem will be measured 3, 7, and 14 days (±2) after the end of the LAT or control procedure. These follow-ups aim to determine whether the technique's effects persist beyon

  • Effects on quality of life assessed by comparing the evolution of scores on the Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) between the experimental and active control groups at distance from the end of the procedure.

    To assess whether self-esteem enhancement affects quality of life, MusiQoL scores will be collected at pre-test, post-test, then 7 and 14 days (±2) after the intervention, to analyze group trajectorie

    Bladder, bowel and sexual functionQuality of life (reported by participants)
  • Effects of the procedure on self-efficacy assessed by comparing the evolution of patients' scores on the General Self-Efficacy Scale (GSE) between the experimental and active control groups at distance from the end of the procedure.

    To explore effects on self-efficacy, GSE scores will be measured at pre-test, post-test, then 7 and 14 days (±2) after the LAT or control procedure. These follow-ups will help compare the progression

  • Effects on illness adaptation assessed by comparing the evolution of patients' scores on the Coping with Health Injuries and Problems questionnaire (CHIP) between the experimental and active control groups at distance from the end of the procedure.

    CHIP scores will be assessed at pre-test, post-test, then 7 and 14 days (±2) after the intervention to examine whether self-esteem enhancement improves illness adaptation and whether the groups differ

    Bladder, bowel and sexual function
  • Effects of the procedure on depressive symptoms assessed by comparing the evolution of patients' scores on the Center for Epidemiological Studies Depression Scale (CES-D) between the experimental and active control groups at distance from the end of the

    To explore potential effects on depressive symptoms, CES-D scores will be collected at pre-test, post-test, than 7 and 14 days (±2) after the LAT or control procedure, to assess whether symptom reduct

    Mood and sleep
  • Effects on trait anxiety assessed by comparing the evolution of patients' scores on the State-Trait Anxiety Inventory - Trait subscale (STAI-Y B) between the experimental and active control groups at distance from the end of the procedure.

    To test effects on trait anxiety, STAI-Y B scores will be measured at pre-test, post-test, then 7 and 14 days (±2) after the intervention. These time points will be used to compare changes between the

    Mood and sleep
  • Effects of the procedure on perceived stress assessed by comparing the evolution of patients' scores on the Perceived Stress Scale - 10 items (PSS-10) between the experimental and active control groups at distance from the end of the procedure.

    PSS-10 scores will be collected at pre-test, post-test, then 7 and 14 days (±2) after the LAT or control procedure, to evaluate whether perceived stress evolves differently between the experimental an

Who could take part

Relapsing and progressive · 18 and over

Show the full criteria

Inclusion criteria

* Native French speaker * Access to a computer and internet connection at home * Diagnosis of multiple sclerosis according to the revised criteria of Thompson et al. (2018), either relapsing-remitting or secondary progressive form, between 1 and 5 years since disease onset (RRMS or SPMS entry phase) * Currently receiving first- or second-line oral treatment (e.g., Teriflunomide, Dimethylfumarate, Fingolimod, Cladribine) * Adult participants (age ≥ 18) NON-INCLUSION CRITERIA * Participant currently excluded from another study * Individuals covered by Articles L1121-5 to L1121-8 of the French Public Health Code (CSP), i.e., legally protected persons: pregnant women, women in labor, breastfeeding mothers, individuals deprived of liberty by judicial or administrative decision, individuals under psychiatric care under Articles L.3212-1 and L.3213-1 not falling under Article L.1121-8, individuals admitted to healthcare or social institutions for reasons other than research, minors, individuals under legal protection or unable to provide informed consent * Staff members with a hierarchical link to the principal investigator SECONDARY EXCLUSION CRITERIA * Participants not presenting with low self-esteem, i.e., score >26 on the Self-Esteem Scale (EES; Vallières \& Vallerand, 1990) * Major life event significantly affecting well-being in the two weeks prior to study inclusion (e.g., bereavement, separation, childbirth, etc.) * Initiation of psychological, psychiatric, or pharmacological treatment (anxiolytics, antidepressants) within one month prior to study start

Exclusion criteria

Not separately supplied in the registry.

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

The goal of this clinical trial is to learn whether the Lexical Association Technique (LAT) can improve well-being in people recently diagnosed with multiple sclerosis (MS), either relapsing-remitting (RRMS) or secondary progressive (SPMS). The main questions it aims to answer are: * Does the LAT increase well-being more than a placebo technique ? * Does this technique help reduce psychological distress and improve quality of life ? Participants will: * Be randomly assigned to either the LAT group or the active control group * Complete short visualization exercises at home using a personal computer * Fill out questionnaires about self-esteem, stress, anxiety, depression, quality of life, and adjustment to illness * Take part in the study over several weeks, with assessments before, after, and 14 days after the intervention Researchers will compare results between the two groups (LAT group vs. Control group) to test the immediate and lasting effects of the LAT.

Papers

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History

    1. Started

      Jan 2026

    2. Main results due

      Jul 2027

    3. Finished

      Jul 2027

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