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Набор скоро начнётся NCT07064291

Enhancing Self-Esteem in Patients With Multiple Sclerosis: A Randomised Controlled Trial of the Lexical Association Technique

Без фазы С лечением Multiple Sclerosis Quality of Life (QOL)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: The Lexical Association Technique (LAT), Placebo of the Lexical Association Technique.
Кому может быть актуально
Состояния в реестре: Multiple Sclerosis, Quality of Life (QOL). Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

RATIONALE This research project aims to test the effectiveness of a therapeutic technique-the Lexical Association Technique (LAT) - to improve self-esteem in patients recently diagnosed with multiple sclerosis (MS), whether relapsing-remitting (RRMS) or secondary progressive (SPMS).

As with many chronic illnesses, self-esteem is significantly impacted by the diagnosis of multiple sclerosis. Patients tend to report markedly lower self-esteem compared to the general population (Sarısoy et al., 2013; M.-C. Gay et al., 2010; McCabe, 2005; Nosek et al., 2003; Walsh \& Walsh, 1989). Yet self-esteem has been identified as a resilience factor (Black \& Dorstyn, 2015) and has been associated with maintaining quality of life (Gil-González et al., 2020; Mikula et al., 2017), better treatment adherence (Wilski \& Tasiemski, 2016), and lower levels of perceived stress (Ifantopoulou et al., 2015). High self-esteem is also linked to various clinical benefits, such as reduced somatic symptoms, anxiety, insomnia, and social dysfunction (Mikula et al., 2021). Additionally, research has established links between low self-esteem and both anxiety and depressive symptoms (Sowislo \& Orth, 2013). Altogether, these findings support the relevance of incorporating therapeutic protocols that aim to enhance self-esteem into the care of people with MS.

The Lexical Association Technique (LAT), developed by Niveau, New, and Beaudoin in 2021, seeks to boost self-esteem by reinforcing associations between positive self-attributes and mental imagery that illustrate possession of those qualities. Its efficacy has already been demonstrated through three randomized clinical trials (Niveau et al., 2022; Niveau et al., 2023). Compared to other self-esteem enhancement techniques like CBT or reminiscence therapy, this protocol has several advantages: it requires minimal time and cognitive resources. Moreover, LAT exercises can be done at home on a personal computer, making it an accessible and low-cost tool for patients.

PRIMARY OBJECTIVE As this technique aims to enhance participants' self-esteem, we expect to replicate the findings of the two initial LAT studies, with higher self-esteem scores at the end of the therapeutic protocol in the experimental group compared to the active control group.

SECONDARY OBJECTIVES The secondary objective of this study is to assess potential clinical benefits that improved self-esteem may bring in terms of psychological well-being and prevention of psycho-social risks associated with the MS diagnosis. The protocol includes measures to evaluate how increased self-esteem might impact quality of life, perceived self-efficacy, adjustment to illness, perceived stress levels, and self-reported symptoms of anxiety and depression.

METHODOLOGY This is a therapeutic effectiveness study, monocentric, interventional, prospective, controlled, and randomized, conducted under double-blind conditions. The 160 participants will be allocated using a minimization protocol into one of two groups: an experimental group using LAT and an active control group performing similar visualizations with no direct connection to the self. Self-esteem will be measured at multiple time points (before, after, and up to 14 days after the intervention) to assess both immediate and lasting effects of the technique.

POPULATION The study will include two patient samples: one composed of patients recently diagnosed with RRMS, and another of patients recently diagnosed with SPMS. A total of 160 patients will be included in the study (80 with RRMS and 80 with SPMS).

EXPECTED OUTCOMES This project could help demonstrate the efficacy of a therapeutic tool that healthcare professionals could offer to patients in order to strengthen their psychological resources during critical periods when psycho-social disorders are likely to emerge and become entrenched.

Вмешательства

  • Другое The Lexical Association Technique (LAT)
    The Lexical Association Technique (LAT) was developed by Niveau, New, and Beaudoin in 2021 (Niveau et al., 2022). It is grounded in principles of memory functioning described in the cognitive psychology literature, particularly the theoretical framework of the Self-Memory System proposed by Conway (2000, 2005). The technique aims to enhance self-esteem by strengthening associative links between the self and positively valenced concepts stored in memory. To achieve this, it relies on the repeate
  • Другое Placebo of the Lexical Association Technique
    The active control condition is based on the same procedural structure as the Lexical Association Technique (LAT), but without the core therapeutic component - the self-referential content. Participants in the control group are exposed to a series of positive statements, similar in form and valence to those used in the LAT, but referring to others (e.g., generic social roles or entities such as teachers, pharmacists, or animals) rather than the self. Like in the LAT condition, participants are

Первичные конечные точки

  • 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. [Срок оценки: 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 participant's enrollment in the study.]
Вторичные конечные точки (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. [Срок оценки: 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 beyond the immediate post-test period.]
  • 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. [Срок оценки: 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 trajectories and detect delayed effects.]
  • 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. [Срок оценки: 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 across groups over time.]
  • 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. [Срок оценки: 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 in their coping trajectories.]
  • 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 [Срок оценки: 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 reduction differs by group.]
  • 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. [Срок оценки: 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 two groups.]
  • 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. [Срок оценки: 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 and control conditions.]

Критерии участия

Критерии включения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Поддерживающая терапия

Центры проведения

Франция · 1 центр
  • CHU Grenoble Alpes — Grenoble

Публикации

  • Endler, N. S., Parker, J. D. A., & Summerfeldt, L. J. (1998). Coping with health problems: Developing a reliable and valid multidimensional measure. Psychological Assessment, 10(3), 195-205. https://doi.org/10.1037/1040-3590.10.3.195
  • Simeoni M, Auquier P, Fernandez O, Flachenecker P, Stecchi S, Constantinescu C, Idiman E, Boyko A, Beiske A, Vollmer T, Triantafyllou N, O'Connor P, Barak Y, Biermann L, Cristiano E, Atweh S, Patrick D, Robitail S, Ammoury N, Beresniak A, Pelletier J; MusiQol study group. Validation of the Multiple Sclerosis International Quality of Life questionnaire. Mult Scler. 2008 Mar;14(2):219-30. doi: 10.11 PMID 17942521
  • Baumstarck-Barrau K, Pelletier J, Simeoni MC, Auquier P; MusiQol Study Group. [French validation of the Multiple Sclerosis International Quality of Life Questionnaire]. Rev Neurol (Paris). 2011 Jun-Jul;167(6-7):511-21. doi: 10.1016/j.neurol.2010.10.008. Epub 2011 Mar 21. French. PMID 21420136
  • Thompson AJ, Banwell BL, Barkhof F, Carroll WM, Coetzee T, Comi G, Correale J, Fazekas F, Filippi M, Freedman MS, Fujihara K, Galetta SL, Hartung HP, Kappos L, Lublin FD, Marrie RA, Miller AE, Miller DH, Montalban X, Mowry EM, Sorensen PS, Tintore M, Traboulsee AL, Trojano M, Uitdehaag BMJ, Vukusic S, Waubant E, Weinshenker BG, Reingold SC, Cohen JA. Diagnosis of multiple sclerosis: 2017 revisions PMID 29275977
  • Lesage FX, Berjot S, Deschamps F. Psychometric properties of the French versions of the Perceived Stress Scale. Int J Occup Med Environ Health. 2012 Jun;25(2):178-84. doi: 10.2478/S13382-012-0024-8. Epub 2012 Apr 19. PMID 22528542
  • Spielberger, C. D. (1983). State-Trait Anxiety Inventory for Adults (STAI-AD). APA PsycTests. https://doi.org/10.1037/t06496-000
  • Scholz U, Gutierrez-Dona BG, Sud S, Schwarzer R. Is General Self-Efficacy a universal construct? : Psychometric findings from 25 countries. European Journal of Psychological Assessment. 2002;18(3):242-51.
  • Dumont M, Schwarzer R, Jerusalem M. French Adaptation of the General Self-Efficacy Scale: Auto-efficacité Généralisée. Berlin, Allemagne, 2000.

Идентификаторы

NCT: NCT07064291 · 38RC25.0147 · France SEP-24 (SHS-ESTIME) · 2025-A00907-42

Первоисточники (государственные реестры)

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