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

NCT07064291 | Not Yet Recruiting

• 3 other identifiers: 38RC25.0147France SEP-24 (SHS-ESTIME)2025-A00907-42
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis; Quality of Life (QOL)

Keywords

Multiple Sclerosis; Psychological Well-Being; Lexical Association Technique; Randomized Controlled Trial; Quality of Life; Cognitive Intervention; Home-Based Therapy; Psychology; Mental Imagery; Self-esteem

Outcome Measures

Primary Outcomes (1)

• 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 outcome focuses on the effect of the Lexical Association Technique (LAT) on self-esteem following the procedure. The benefits will be assessed by comparing scores on the Rosenberg Self-Esteem Scale (RSES) between the experimental and active control groups at post-test. The RSES is a self-report measure of self-esteem, composed of 10 statements related to personal worth and self-acceptance (e.g., "I have a positive attitude toward myself"). Participants indicate their level of agreement using a four-point Likert scale ranging from 1 = Strongly Agree to 4 = Strongly Disagree, with total scores ranging from 10 to 40. The RSES is the most widely used and validated self-esteem questionnaire in psychological research, and has been adapted and validated in French (Self-Esteem Scale; Vallieres \& Vallerand, 1990).

  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.

Secondary Outcomes (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 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.

  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.

  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.

  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

  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.

Study Arms (2)

Experimental Group (LAT)

EXPERIMENTAL

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.

Other: The Lexical Association Technique (LAT)

Active Control Group

ACTIVE COMPARATOR

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.

Other: Placebo of the Lexical Association Technique

Interventions

The Lexical Association Technique (LAT) OTHER

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 repeated mental visualization of positive autobiographical episodes paired with positive self-referential linguistic statements. The effectiveness of this technique in increasing self-esteem has been demonstrated and replicated across three studies, conducted with distinct samples: two involving healthy participants and one involving a clinical sample of individuals with a chronic illness (Niveau et al., 2022, 2023).

Experimental Group (LAT)

Placebo of the Lexical Association Technique OTHER

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 asked to generate mental imagery based on each statement, visualizing a corresponding positive episodic event. This ensures that the control task involves the same cognitive mechanisms (episodic memory retrieval, positive visualization, and sustained attention), while excluding the specific associative link to the self that constitutes the active ingredient of the intervention. This control condition was designed to match the LAT in terms of structure, cognitive demand, and duration, and has be

Active Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• Participants not presenting with low self-esteem, i.e., score \>26 on the Self-Esteem Scale (EES; Vallières \& Vallerand, 1990)
• Initiation of psychological, psychiatric, or pharmacological treatment (anxiolytics, antidepressants) within one month prior to study start

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Laboratoire interuniversitaire de psychologie : personnalité, cognition et changement social - LIP-PC2S: collaborator
• Laboratoire de Psychologie et NeuroCognition: collaborator

Study Sites (1)

CHU Grenoble Alpes

Grenoble, Grenoble, 38043, France

Location

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MeSH Terms

Conditions

Multiple Sclerosis; Psychological Well-Being

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will employ a 2 × 2 mixed factorial design. The first independent variable is Group (Experimental vs. Control), treated as a between-subjects factor. The second independent variable is Time (with five levels: Pretest, Post-test, Retest at Day 3, Day 7, and Day 14 after the end of the protocol), treated as a within-subjects factor. This design allows for the examination of both the evolution of self-esteem over time and the differential effect of the intervention across groups. Note: At the end of the study, all participants - including those in the active control group - will receive access to the full version of the Lexical Association Technique, so that everyone can benefit from its maximum therapeutic effects.

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: July 14, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

FR (1)