Multiple SclerosisSE-P-MSNCT07064291
Enhancing Self-Esteem in Patients With Multiple Sclerosis: A Randomised Controlled Trial of the Lexical Association Technique
A study testing The Lexical Association Technique (LAT) in people with Multiple Sclerosis and Quality of Life (QOL), run by University Hospital, Grenoble at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Quality of Life (QOL)
- What is being tested?
- The Lexical Association Technique (LAT)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jan 2026to 27 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Grenoble Alpes
Grenoble, 38043
Mathieu VAILLANT, 33 (0)4 76 76 76 21, MVaillant@chu-grenoble.fr
Mathieu VAILLANT, PH
About this study
Official title: Améliorer l'Estime de Soi Des Patients Atteints de sclérose en Plaques : Test d'efficacité de la Technique d'Association Lexicale
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:
Read more
- 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.
Read the detailed 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.
- Conditions
- Multiple Sclerosis, Quality of Life (QOL)
- Being tested
- The Lexical Association Technique (LAT), Placebo of the Lexical Association Technique
- 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
- Medical subject headings
- Multiple Sclerosis, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
Placebo of the Lexical Association TechniqueOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo of the Lexical Association Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
The benefits will be assessed by comparing the evolution of scores on the Rosenberg Self-Esteem Scale (RSES) between the experimental and active control groups at temporal distance from the end of the end of the LAT or control protocol, using three additional time points : 3 days (±2 day) after the intervention (Retest Day 3), 7 days (±2 day) after the intervention (Retest Day 7), and 14 days (±2 days) after the intervention (Retest Day 14).
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).
Measured: 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.
The effects will be measured by comparing the evolution of scores on the French version of the Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL; Baumstarck-Barrau et al., 2011) between our experimental condition. This 31-item questionnaire assesses nine dimensions of quality of life: activities of daily living, psychological well-being, friendships, symptoms, family relationships, interactions with the healthcare system, sexual and sentimental life, coping, and rejection. Items are rated on Likert-type scales and a global normalized score is calculated, ranging from 0 (low quality of life) to 100 (high quality of life).The French version was validated in a population of patients with MS (primarily RRMS and SPMS), demonstrating good internal consistency, external validity, and reproducibility (Baumstarck-Barrau et al., 2011; Simeoni et al., 2008).
Measured: 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.
The effects will be measured by comparing the evolution of scores on the General Self-Efficacy Scale (GSE; Saleh et al., 2016; Dumont et al., 2000) between our experimental condition.
This 10-item scale, initially developed by Jerusalem \& Schwarzer (1995), measures the belief in one's own capacity to manage various life situations and overcome adversity in 10 items, each rated on a Likert scale. The total score ranges from 10 (low self-efficacy) to 40 (high self-efficacy). The French version (Dumont et al., 2000) has shown good psychometric properties, including internal consistency, external validity, and test-retest reliability (Saleh et al., 2016; Scholz et al., 2002).
Measured: 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.
The effects will be measured by comparing the evolution of scores on the Coping with Health Injuries and Problems questionnaire (CHIP; Montel \& Bungener, 2010) between our experimental condition.
The French version of this 24-item scale evaluates coping strategies specific to chronic illness across six dimensions: emotional regulation, well-being/self-care, distraction, information seeking, palliative coping, and avoidance. Each dimension is scored on a Likert scale, with normalized dimension scores ranging from 0 (low) to 100 (high). The French version was validated in populations with chronic illnesses (including MS), it shows good internal consistency and reliability (Montel \& Bungener, 2010; Endler et al., 1998).
Measured: 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
The effects will be measured by comparing the evolution of scores on the French version of the Center for Epidemiological Studies Depression Scale (CES-D; Fuhrer \& Rouillon, 1989) between our experimental condition.
The CES-D is a 20-item self-report measure assessing depressive symptom severity based on their frequency. Initially developed by Radloff (1977), it was translated and validated in French by Fuhrer \& Rouillon for both general and psychiatric populations. The total score ranges from 0 (low depressive symptoms) to 60 (high depressive symptoms). Psychometric evaluations have demonstrated strong internal and external validity as well as high internal consistency.
Measured: 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.
The effects will be measured by comparing the evolution of scores on the French version of the Trait subscale of the State-Trait Anxiety Inventory (STAI-Y B; Gauthier \& Bouchard, 1993) between our experimental condition.
This inventory contains two 20-item subscales: state anxiety (STAI-Y A) and trait anxiety (STAI-Y B). Each item is rated on a frequency-based Likert scale.
The total score ranges from 20 (low trait anxiety) to 80 (high trait anxiety). Only the trait form will be used in this study to assess chronic anxiety outside of situational stress. The French version, adapted from Spielberger's revised STAI-Y (1983), has shown strong internal and external validity as well as good sensitivity (Gauthier \& Bouchard, 1993).
Measured: 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.
The effects will be measured by comparing the evolution of scores on the French version of the Perceived Stress Scale - 10 items (PSS-10; Lesage et al., 2012) between our experimental condition.
Originally developed by Cohen et al. (1983), the PSS-10 assesses the degree to which individuals perceive their life as stressful. Each item is rated on a frequency-based Likert scale. The total score ranges from 10 (low perceived stress) to 40 (high perceived stress). The French version, validated by Lesage et al. (2012), demonstrated strong psychometric properties, including good internal consistency and construct validity.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start28 Jan 2026
- Primary completion27 Jul 2027 (estimated)
- Study completion27 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire interuniversitaire de psychologie : personnalité, cognition et changement social - LIP-PC2S, Laboratoire de Psychologie et NeuroCognition
- Responsible party
- Sponsor
- Investigators
- Mathieu VAILLANT, Principal investigator, CHU Grenoble Alpes, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07064291
- Sponsor's protocol ID
- 38RC25.0147
- Other IDs
- France SEP-24 (SHS-ESTIME), 2025-A00907-42
- Acronym
- SE-P-MS
- Status last verified
- Sep 2026
- First submitted
- 12 Jun 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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: 10.1177/1352458507080733. Epub 2007 Oct 17.
PubMed 17942521Baumstarck-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.
PubMed 21420136Thompson 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.
PubMed 29275977Lesage 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.
PubMed 22528542Spielberger, 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.
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.
PubMed 8714442Rosenberg, M. (1965). Rosenberg Self-Esteem Scale (RSES). APA PsycTests. https://doi.org/10.1037/t01038-000
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.
PubMed 10789197Conway, 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
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.
PubMed 36320165Sowislo 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.
PubMed 22730921Mikula 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.
PubMed 34134016
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Améliorer l'Estime de Soi Des Patients Atteints de sclérose en Plaques : Test d'efficacité de la Technique d'Association Lexicale
- ClinicalTrials.gov ID
- NCT07064291
- Acronym / sponsor ID
- SE-P-MS / 38RC25.0147
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Laboratoire interuniversitaire de psychologie : personnalité, cognition et changement social - LIP-PC2S, Laboratoire de Psychologie et NeuroCognition
- Study start
- 28 Jan 2026 (actual)
- Primary completion
- 27 Jul 2027 (estimated)
- Study completion
- 27 Jul 2027 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (LAT) | Experimental | Other: The Lexical Association Technique (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. |
| Active Control Group | Active comparator | Other: Placebo of the Lexical Association TechniqueParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Other | Experimental Group (LAT) |
| Placebo of the Lexical Association TechniqueThe 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 | Other | Active Control Group |
Primary outcome
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.
Time frame: 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.
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).
7 secondary outcomes
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- BackgroundEndler, 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
- Background: PubMed 17942521Simeoni 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.
- Background: PubMed 21420136Baumstarck-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.
- Background: PubMed 29275977Thompson 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.
- Background: PubMed 22528542Lesage 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.
- BackgroundSpielberger, C. D. (1983). State-Trait Anxiety Inventory for Adults (STAI-AD). APA PsycTests. https://doi.org/10.1037/t06496-000
- BackgroundScholz 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.
- BackgroundDumont M, Schwarzer R, Jerusalem M. French Adaptation of the General Self-Efficacy Scale: Auto-efficacité Généralisée. Berlin, Allemagne, 2000.
- Background: PubMed 8714442Chantal Y, Vallerand RJ, Vallieres EF. Motivation and gambling involvement. J Soc Psychol. 1995 Dec;135(6):755-63. doi: 10.1080/00224545.1995.9713978.
- BackgroundRosenberg, M. (1965). Rosenberg Self-Esteem Scale (RSES). APA PsycTests. https://doi.org/10.1037/t01038-000
- Background: PubMed 10789197Conway 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.
- BackgroundConway, 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
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mathieu VAILLANT principal investigator
CHU Grenoble Alpes, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Lexical Association Technique (LAT) in people with Multiple Sclerosis and Quality of Life (QOL), run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07064291, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.