- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05648292
The Relationships Between Personal Identity, Autobiographical Memory and Future Thinking in People With Multiple Sclerosis (SELFSEP)
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Alexandra Ernst, PhD
- Phone Number: +33628496210
- Email: aernst@univ-paris8.fr
Study Locations
-
-
Hauts De Seine
-
Garches, Hauts De Seine, France, 92380
- Recruiting
- Hopital Raymond Poincaré Garches
-
Contact:
- Lucine Sonnet
- Phone Number: 01 47 10 46 14
- Email: lucine.sonnet@aphp.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Clinical group
45 individuals with relapsing-remitting multiple sclerosis
|
|
|
Control group
45 individuals with no chronic disease, matched in age, gender and level of education
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Relationships between personal identity, autobiographical memory and future thinking
Time Frame: 15 days
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Relationships between personal identity, psychological functioning and clinical characteristics
Time Frame: 15 days
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Alexandra ERNST, PhD, Laboratoire DysCo - Université Paris 8
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-A00495-38
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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