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

NCT ID: NCT07064291

Last Updated: 2025-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2027-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Sclerosis Quality of Life (QOL)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental Group (LAT)

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.

Group Type EXPERIMENTAL

The Lexical Association Technique (LAT)

Intervention Type 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).

Active Control Group

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.

Group Type ACTIVE_COMPARATOR

Placebo of the Lexical Association Technique

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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 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).

Intervention Type OTHER

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 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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)


* 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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Laboratoire interuniversitaire de psychologie : personnalité, cognition et changement social - LIP-PC2S

UNKNOWN

Sponsor Role collaborator

Laboratoire de Psychologie et NeuroCognition

OTHER

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU Grenoble Alpes

Grenoble, Grenoble, France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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

Reference Type BACKGROUND

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: 10.1177/1352458507080733. Epub 2007 Oct 17.

Reference Type BACKGROUND
PMID: 17942521 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21420136 (View on PubMed)

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 of the McDonald criteria. Lancet Neurol. 2018 Feb;17(2):162-173. doi: 10.1016/S1474-4422(17)30470-2. Epub 2017 Dec 21.

Reference Type BACKGROUND
PMID: 29275977 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22528542 (View on PubMed)

Spielberger, C. D. (1983). State-Trait Anxiety Inventory for Adults (STAI-AD). APA PsycTests. https://doi.org/10.1037/t06496-000

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

Dumont M, Schwarzer R, Jerusalem M. French Adaptation of the General Self-Efficacy Scale: Auto-efficacité Généralisée. Berlin, Allemagne, 2000.

Reference Type BACKGROUND

Chantal Y, Vallerand RJ, Vallieres EF. Motivation and gambling involvement. J Soc Psychol. 1995 Dec;135(6):755-63. doi: 10.1080/00224545.1995.9713978.

Reference Type BACKGROUND
PMID: 8714442 (View on PubMed)

Rosenberg, M. (1965). Rosenberg Self-Esteem Scale (RSES). APA PsycTests. https://doi.org/10.1037/t01038-000

Reference Type BACKGROUND

Conway MA, Pleydell-Pearce CW. The construction of autobiographical memories in the self-memory system. Psychol Rev. 2000 Apr;107(2):261-88. doi: 10.1037/0033-295x.107.2.261.

Reference Type BACKGROUND
PMID: 10789197 (View on PubMed)

Conway, M. A. (2005). Memory and the self. Journal of Memory and Language, 53(4), 594-628. https://doi.org/10.1016/j.jml.2005.08.005

Reference Type BACKGROUND

Niveau N, Beaudoin M, De Cornulier J, New B. The Lexical Association Technique: A randomized controlled trial with breast cancer patients. Appl Psychol Health Well Being. 2023 Aug;15(3):846-864. doi: 10.1111/aphw.12412. Epub 2022 Nov 1.

Reference Type BACKGROUND
PMID: 36320165 (View on PubMed)

Sowislo JF, Orth U. Does low self-esteem predict depression and anxiety? A meta-analysis of longitudinal studies. Psychol Bull. 2013 Jan;139(1):213-240. doi: 10.1037/a0028931. Epub 2012 Jun 25.

Reference Type BACKGROUND
PMID: 22730921 (View on PubMed)

Mikula P, Timkova V, Fedicova M, Szilasiova J, Nagyova I. Self-management, self-esteem and their associations with psychological well-being in people with multiple sclerosis. Mult Scler Relat Disord. 2021 Aug;53:103069. doi: 10.1016/j.msard.2021.103069. Epub 2021 Jun 4.

Reference Type BACKGROUND
PMID: 34134016 (View on PubMed)

N Ifantopoulou P, K Artemiadis A, Triantafyllou N, Chrousos G, Papanastasiou I, Darviri C. Self-esteem is associated with perceived stress in multiple sclerosis patients. Neurol Res. 2015 Jul;37(7):588-92. doi: 10.1179/1743132815Y.0000000016. Epub 2015 Mar 3.

Reference Type BACKGROUND
PMID: 25736556 (View on PubMed)

Wilski M, Tasiemski T. Illness perception, treatment beliefs, self-esteem, and self-efficacy as correlates of self-management in multiple sclerosis. Acta Neurol Scand. 2016 May;133(5):338-45. doi: 10.1111/ane.12465. Epub 2015 Jul 20.

Reference Type BACKGROUND
PMID: 26190764 (View on PubMed)

Mikula P, Nagyova I, Krokavcova M, Vitkova M, Rosenberger J, Szilasiova J, Gdovinova Z, Stewart RE, Groothoff JW, van Dijk JP. Self-esteem, social participation, and quality of life in patients with multiple sclerosis. J Health Psychol. 2017 Jul;22(8):984-992. doi: 10.1177/1359105315621778. Epub 2016 Jan 12.

Reference Type BACKGROUND
PMID: 26764379 (View on PubMed)

Gil-Gonzalez I, Martin-Rodriguez A, Conrad R, Perez-San-Gregorio MA. Quality of life in adults with multiple sclerosis: a systematic review. BMJ Open. 2020 Nov 30;10(11):e041249. doi: 10.1136/bmjopen-2020-041249.

Reference Type BACKGROUND
PMID: 33257490 (View on PubMed)

Walsh A, Walsh PA. Love, self-esteem, and multiple sclerosis. Soc Sci Med. 1989;29(7):793-8. doi: 10.1016/0277-9536(89)90078-6.

Reference Type BACKGROUND
PMID: 2799422 (View on PubMed)

Black R, Dorstyn D. A biopsychosocial model of resilience for multiple sclerosis. J Health Psychol. 2015 Nov;20(11):1434-44. doi: 10.1177/1359105313512879. Epub 2013 Dec 9.

Reference Type BACKGROUND
PMID: 24323335 (View on PubMed)

Nosek MA, Hughes RB, Swedlund N, Taylor HB, Swank P. Self-esteem and women with disabilities. Soc Sci Med. 2003 Apr;56(8):1737-47. doi: 10.1016/s0277-9536(02)00169-7.

Reference Type BACKGROUND
PMID: 12639590 (View on PubMed)

McCabe MP. Mood and self-esteem of persons with multiple sclerosis following an exacerbation. J Psychosom Res. 2005 Sep;59(3):161-6. doi: 10.1016/j.jpsychores.2005.04.010.

Reference Type BACKGROUND
PMID: 16198189 (View on PubMed)

Gay MC, Vrignaud P, Garitte C, Meunier C. Predictors of depression in multiple sclerosis patients. Acta Neurol Scand. 2010 Mar;121(3):161-70. doi: 10.1111/j.1600-0404.2009.01232.x. Epub 2010 Jan 12.

Reference Type BACKGROUND
PMID: 20070277 (View on PubMed)

Sarisoy G, Terzi M, Gumus K, Pazvantoglu O. Psychiatric symptoms in patients with multiple sclerosis. Gen Hosp Psychiatry. 2013 Mar-Apr;35(2):134-40. doi: 10.1016/j.genhosppsych.2012.10.011. Epub 2012 Dec 21.

Reference Type BACKGROUND
PMID: 23260339 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

France SEP-24 (SHS-ESTIME)

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2025-A00907-42

Identifier Type: OTHER

Identifier Source: secondary_id

38RC25.0147

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Study of Empathy in MS
NCT05332951 COMPLETED
The MS-LINK™ Outcomes Study
NCT04735406 COMPLETED
Emotions in Multiple Sclerosis
NCT04804787 COMPLETED NA