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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05648292
Other study ID # 2022-A00495-38
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 7, 2022
Est. completion date June 7, 2025

Study information

Verified date September 2023
Source Centre d'Investigation Clinique et Technologique 805
Contact Alexandra Ernst, PhD
Phone +33628496210
Email aernst@univ-paris8.fr
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date June 7, 2025
Est. primary completion date December 7, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility For the clinical group: Inclusion Criteria: - 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 Non-inclusion Criteria: - MS relapse in the month prior to the inclusion - Treatment with corticosteroids during the month preceding the inclusion - 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: Inclusion Criteria: - 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 Non-inclusion Criteria: - 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)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Neuropsychological tests and psychological questionnaires
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

Locations

Country Name City State
France Hopital Raymond Poincaré Garches Garches Hauts De Seine

Sponsors (3)

Lead Sponsor Collaborator
Centre d'Investigation Clinique et Technologique 805 ARSEP foundation, University Paris 8 Vincennes Saint Denis

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Relationships between personal identity, psychological functioning and clinical characteristics Correlations between IAM and I WILL BE scores and scores obtained at the different questionnaires (BRIEF COPE, Connor Davidson Resilience Scale, Satisfaction with Life Scale, Hospital Anxiety and Depression Scale) Correlations between IAM and I WILL BE scores and level of functional disability (Expanded Disability Status Scale) Correlations between IAM and I WILL BE scores and disease duration 15 days
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