Enhancing Self-Esteem in Patients With Multiple Sclerosis: A Randomised Controlled Trial of the Lexical Association Technique (SE-P-MS)

Grenoble Alpes University Hospital Center (CHU)

Status: Not yet enrolling

Conditions: Quality of Life (QOL); Multiple Sclerosis

Treatments: Other: The Lexical Association Technique (LAT); Other: Placebo of the Lexical Association Technique

Study type: Interventional

Funder types: Other

Identifiers

NCT07064291

38RC25.0147

2025-A00907-42 (Other Identifier)

France SEP-24 (SHS-ESTIME) (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 2 patient groups

Experimental Group (LAT)

Experimental group

Description:

Participants assigned to the experimental group will complete six LAT training sessions at home on a personal computer. Each session lasts approximately five minutes and involves episodic visualizations centered on the self. Repeated exposure across sessions is intended to strengthen memory associations between positive self-related traits and autobiographical experiences. During each session, a series of positive self-referential statements will be displayed on screen. For each statement, participants will be asked to visualize a specific event from their own life that illustrates the quality described. This exercise is designed to generate vivid, self-relevant mental imagery linked to various personal strengths and attributes.

Treatment:

Other: The Lexical Association Technique (LAT)

Active Control Group

Active Comparator group

Description:

Participants in the active control group will also complete six training sessions at home on a personal computer. The structure and timing of the sessions will be identical to those in the experimental condition. However, the statements presented will refer to others (e.g., pharmacists, teachers, animals...) rather than the self, while maintaining the same positive tone and format as the LAT items. As in the experimental group, participants will be asked to visualize a positive event corresponding to each statement. This control condition enables researchers to isolate the specific effect of self-referential content while preserving key task features such as episodic imagery, emotional valence, cognitive effort, duration, and computer-based delivery.

Treatment:

Other: Placebo of the Lexical Association Technique