Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT06718920
Status:
RECRUITING
Last Update Posted:
2025-02-26
First Post:
2024-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adverse Childhood Experiences in Patients With MS: Impact on Quality of Life and on Coping Strategies Towards the Disease and Its Treatment
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Study Overview
Official Title:
Single-center Observational Study to Characterize Adverse Childhood Experiences (ACE) in Patients With Multiple Sclerosis and Their Impact on Quality of Life, Disease Coping Strategies, and Adherence to Disease Course-modifying Therapies
Status:
RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACE-MS
Brief Summary:
The goal of this observational study is to evaluate the presence of adverse childhood experiences (ACE) in patients with Multiple Sclerosis. The main questions it aims to answer are:
* Does the presence of ACE impact on quality of life of patients with multiple sclerosis?
* Does it influence how the patients cope with the disease and with disease course-modifying therapies? During follow up visits, planned as part of their regular medical care, participants will answer survey questions on a tablet .
* Does the presence of ACE impact on quality of life of patients with multiple sclerosis?
* Does it influence how the patients cope with the disease and with disease course-modifying therapies? During follow up visits, planned as part of their regular medical care, participants will answer survey questions on a tablet .
Detailed Description:
Multiple sclerosis is a chronic inflammatory, demyelinating, and neurodegenerative disease of the central nervous system, typically affecting young adults. Its etiopathogenesis is multifactorial, with the interaction of genetic susceptibility and environmental risk factors. Among these, childhood trauma and other forms of adverse childhood experiences (ACE) such as divorce or parental loss have been called out as possible risk factors in the development of MS and disease relapse.
Adverse Childhood Experiences are a heterogeneous group of negative experiences occurred during childhood, that may have an unfavorable impact on the later course of life in terms of physical and mental health. These effects may be related to changes in the prefrontal, limbic, and hypothalamic-pituitary-adrenal areas and may cause repercussions on the immune system, as documented on experimental models of autoimmune encephalitis. In addition to that, a history of ACE has been associated with the development of poor coping strategies during adulthood . Since multiple sclerosis represents a chronic and progressive disease, the kind of coping strategies developed from childhood may affect how the patient perceives the disease and may affect his or her adherence to treatment.
To date, data on the prevalence of traumatic events during childhood in patients with Multiple Sclerosis are limited to a few studies, while the impact of such events on how the patient copes with the diagnosis of disease and acceptance of therapy. has not yet been explored.
This study represents a preliminary analysis of the impact of ACE in a cohort of multiple sclerosis patients and aims to evaluate how early negative life experiences may affect patients' coping strategies towards the disease and their compliance to treatment.
Adverse Childhood Experiences are a heterogeneous group of negative experiences occurred during childhood, that may have an unfavorable impact on the later course of life in terms of physical and mental health. These effects may be related to changes in the prefrontal, limbic, and hypothalamic-pituitary-adrenal areas and may cause repercussions on the immune system, as documented on experimental models of autoimmune encephalitis. In addition to that, a history of ACE has been associated with the development of poor coping strategies during adulthood . Since multiple sclerosis represents a chronic and progressive disease, the kind of coping strategies developed from childhood may affect how the patient perceives the disease and may affect his or her adherence to treatment.
To date, data on the prevalence of traumatic events during childhood in patients with Multiple Sclerosis are limited to a few studies, while the impact of such events on how the patient copes with the diagnosis of disease and acceptance of therapy. has not yet been explored.
This study represents a preliminary analysis of the impact of ACE in a cohort of multiple sclerosis patients and aims to evaluate how early negative life experiences may affect patients' coping strategies towards the disease and their compliance to treatment.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: