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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Grenoble

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • The Lexical Association Technique (LAT)

    Other intervention

    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 Technique

    Other intervention

    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

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Experimental Group (LAT)Experimental treatment 1 intervention
Group B: Active Control GroupActive comparator 1 intervention

Trial outcomes

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).

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.

Secondary outcomes

1

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).

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.
2

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).

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.
3

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).

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.
4

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).

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Grenoble

Lead sponsor

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

Collaborator

Laboratoire de Psychologie et NeuroCognition

Collaborator