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临床试验/NCT06718920
NCT06718920招募中不适用

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2024年1月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
1
主要终点
To assess the prevalence of ACE in a cohort of patients with relapsing-remitting multiple sclerosis

研究概览

简要总结

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 .

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

To assess the prevalence of ACE in a cohort of patients with relapsing-remitting multiple sclerosis

时间窗: 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

次要结局

  • To correlate the impact of ACE on quality of life and general distress(1 year)
  • To correlate the impact of ACE on how the patient perceives and copes with the disease(1 year)
  • To correlate the impact of ACE on treatment adherence(1 year)
  • To correlate the impact of ACE on disease treatment(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mirabella Massimiliano

Associate Professor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (1)

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