Adverse Childhood Experiences in Patients with MS: Impact on Quality of Life and on Coping Strategies Towards the Disease and Its Treatment

Recruiting

• Conditions: Multiple Sclerosis

• Registration Number: NCT06718920
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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 .

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.

Study Timeline

• Study Start: 2024-01-13
• Status Verified: 2024-11
• Study First Submitted: 2024-11-21
• Study First Submitted QC: 2024-12-02
• Study First Posted: 2024-12-05
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-26
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Age older than 18 years;
• Diagnosis of relapsing-remitting multiple sclerosis according to McDonald criteria (2017 revisions) made between 2014 and 2024.
• Signature of informed consent

Exclusion Criteria

• Presence of language barrier
• Presence of conditions that prevent or limit understanding and proper completion of questionnaires

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the prevalence of ACE in a cohort of patients with relapsing-remitting multiple sclerosis	At enrollement	The patients will answer to questionnaires provided on an electronic tablet during regular follow up neurological visits.; The presence of dysfunctional parenting during childhood will be explored through the completion of the Measure of Parental Style (MOPS) questionnaire (score 0-28): higher scores mean higher probability to have experienced dysfunctional parenting, leading to ACE

Secondary Outcome Measures

Name	Time	Method
To correlate the impact of ACE on quality of life and general distress	1 year	Quality of life and general distress will be assessed through Brief Symptom Checklist (BSC): score 0-53, higher scores mean higher distress and worse quality of life
To correlate the impact of ACE on how the patient perceives and copes with the disease	1 year	Quality of life and physician-patient relationship satisfaction will be assessed through patient reported outcomes
To correlate the impact of ACE on treatment adherence	1 year	Treatment satisfaction and compliance will be assessed through patient reported otcomes
To correlate the impact of ACE on disease treatment	1 year	To explore treatment satisfaction through the analysis of the number of treatment switches for poor tolerability

Trial Locations

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Rome, RM, Italy