Impact of Childhood Trauma on Quality of Life in Multiple Sclerosis Patients
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
This study looks at how childhood trauma affects the quality of life and coping strategies of people with Multiple Sclerosis to see if those early experiences impact their health and treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome, RM) |
| Trial ID | NCT06718920 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate how adverse childhood experiences (ACE) affect the quality of life and coping strategies of patients with Multiple Sclerosis (MS). Participants, diagnosed with relapsing-remitting MS, will complete surveys during their regular medical visits to assess the influence of childhood trauma on their disease management and treatment adherence. The study seeks to understand the relationship between early negative experiences and their long-term effects on health outcomes in MS patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have been diagnosed with relapsing-remitting Multiple Sclerosis.
Not a fit: Patients who have language barriers or conditions that hinder their understanding of the questionnaires may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how childhood trauma influences the management of Multiple Sclerosis, potentially leading to improved coping strategies and quality of life for patients.
How similar studies have performed: While there is limited data on the prevalence of ACE in MS patients, previous studies have suggested a potential link between childhood trauma and health outcomes, indicating that this area is underexplored but not entirely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Rome, RM
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome, Rm, Italy (Recruiting)
Study contacts
- Study coordinator: Massimiliano Mirabella, Neurology Associate Professor
- Email: massimiliano.mirabella@policlinicogemelli.it
- Phone: 0630155390
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.