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

February 24, 2025 updated by: Mirabella Massimiliano, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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 .

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • RM
      • Rome, RM, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
        • Contact:
        • Contact:
          • Alessandra Cicia, Neurologist
        • Contact:
          • Assunta Bianco, Neurologist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

500 Multiple Sclerosis patients referred to the Multiple Sclerosis Center of the Agostino Gemelli IRCCS University Polyclinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients referred to the Multiple Sclerosis Center of the Agostino Gemelli IRCCS
Patients diagnosed with multiple sclerosis between 2014 and 2024, referring to the Multiple Sclerosis Center of the Agostino Gemelli IRCCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the prevalence of ACE in a cohort of patients with relapsing-remitting multiple sclerosis
Time Frame: At enrollement

The patients will answer to questionnaires provided on an electronic tablet during regular follow up neurological visits.

The presence of adverse childhood experiences will be explored through the completion of a specific questionnaire:

Childhood Trauma Questionnaire (CTQ): score 0-28 Higher scores mean higher probability to have experienced ACE
At enrollement
To assess the prevalence of ACE in a cohort of patients with relapsing-remitting multiple sclerosis
Time Frame: 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
At enrollement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To correlate the impact of ACE on quality of life and general distress
Time Frame: 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
1 year
To correlate the impact of ACE on how the patient perceives and copes with the disease
Time Frame: 1 year
Quality of life and physician-patient relationship satisfaction will be assessed through patient reported outcomes
1 year
To correlate the impact of ACE on treatment adherence
Time Frame: 1 year
Treatment satisfaction and compliance will be assessed through patient reported otcomes
1 year
To correlate the impact of ACE on disease treatment
Time Frame: 1 year
To explore treatment satisfaction through the analysis of the number of treatment switches for poor tolerability
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

November 21, 2024

First Submitted That Met QC Criteria

December 2, 2024

First Posted (Actual)

December 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 24, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6791

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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