NCT05648292

Brief Summary

Personal identity is composed of multiple facets of the self that are constructed and nourished through memories of past experiences (i.e., autobiographical memory) and the imagination of events that may occur in the future (i.e., future thinking) . While our previous work has shown that people with relapsing-remitting multiple sclerosis (pwRRMS) have autobiographical memory and future thought disorders, their impact on personal identity has not yet been explored. Based on a cognitive and clinical neuropsychology approach, this research project aims to better understand the cognitive mechanisms involved in the relationship between identity, autobiographical memory and future thinking in pwRRMS. We will examine the extent to which pwRRMS manage to maintain and reshape their identity through life experiences, with a particular interest in the potential integration of the disease as a facet of their identity. In addition, we will explore the positive and/or negative consequences of disease-related identity changes on emotional well-being and quality of life, as well as their links with the duration and severity of the disease. Overall, this research project will contribute to identify new therapeutic levers that can be used for the development of adapted and personalized care.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

December 7, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 13, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2025

Completed
Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

2 years

First QC Date

December 5, 2022

Last Update Submit

September 5, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Relationships between personal identity, autobiographical memory and future thinking

    Scores obtained at the I AM and I WILL BE tasks assessing the access, qualitative properties of self-concepts, episodic richness and temporal organization of past and future events around self-concepts (between-group comparisons, pwRRMS versus control group)

    15 days

Secondary Outcomes (1)

  • Relationships between personal identity, psychological functioning and clinical characteristics

    15 days

Study Arms (2)

Clinical group

45 individuals with relapsing-remitting multiple sclerosis

Behavioral: Neuropsychological tests and psychological questionnaires

Control group

45 individuals with no chronic disease, matched in age, gender and level of education

Behavioral: Neuropsychological tests and psychological questionnaires

Interventions

* The clinical group will complete: * the BCcogSEP: a comprehensive neuropsychological examination * the IAM and I WILL BE tasks; experimental neuropsychological tasks to assess autobiographical memory, future thinking and personal identity * A series of questionnaires including the BRIEF COPE, the Connor Davidson Resilience Scale, the Satisfaction with Life Scale and the Hospital Anxiety and Depression Scale, which respectively assess coping strategies, resilience, life satisfaction and anxiety/depression * The control group will complete: * the IAM and I WILL BE tasks; experimental neuropsychological tasks to assess autobiographical memory, future thinking and personal identity * A series of questionnaires including the BRIEF COPE, the Connor Davidson Resilience Scale, the Satisfaction with Life Scale and the Hospital Anxiety and Depression Scale, which respectively assess coping strategies, resilience, life satisfaction and anxiety/depression

Clinical groupControl group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic

You may qualify if:

  • Diagnosis of relapsing-remitting MS according to the McDonald's revised diagnostic criteria
  • People aged between 18 and 55
  • French native speaker
  • Access to a computer or tablet, equipped with internet access, a camera and a microphone
  • Form of MS other than the relapsing-remitting form
  • Neurological history (other than MS for patients), history or current presence of psychiatric disorders (e.g., depression, anxiety disorders, schizophrenia), substance abuse (e.g., alcohol, cannabis; past or present)
  • Other diagnosed chronic pathology(ies) (other than MS for patients)
  • Severe cognitive impairment
  • Persons mentioned in Articles L1121-6 to L1121-8 in the French law (minors, persons deprived of liberty, adults subject to protective measures)
  • For the control group:
  • People aged between 18 and 55
  • Matched in age, gender and level in education
  • French native speaker
  • Access to a computer or tablet, equipped with internet access, a camera and a microphone
  • Neurological history (other than MS for patients), history or current presence of psychiatric disorders (e.g., depression, anxiety disorders, schizophrenia), substance abuse (e.g., alcohol, cannabis; past or present)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Raymond Poincaré Garches

Garches, Hauts De Seine, 92380, France

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • Alexandra ERNST, PhD

    Laboratoire DysCo - Université Paris 8

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra Ernst, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
15 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 5, 2022

First Posted

December 13, 2022

Study Start

December 7, 2022

Primary Completion

December 7, 2024

Study Completion

June 7, 2025

Last Updated

September 6, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations