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

Официальное название

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

Обзор

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 .

Подробное описание

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.

Первичные конечные точки

• To assess the prevalence of ACE in a cohort of patients with relapsing-remitting multiple sclerosis [Срок оценки: At enrollement]
• To assess the prevalence of ACE in a cohort of patients with relapsing-remitting multiple sclerosis [Срок оценки: At enrollement]

Вторичные конечные точки (4)

• To correlate the impact of ACE on quality of life and general distress [Срок оценки: 1 year]
• To correlate the impact of ACE on how the patient perceives and copes with the disease [Срок оценки: 1 year]
• To correlate the impact of ACE on treatment adherence [Срок оценки: 1 year]
• To correlate the impact of ACE on disease treatment [Срок оценки: 1 year]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 1 центр

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome

Публикации

• Corallo F, Bonanno L, Di Cara M, Rifici C, Sessa E, D'Aleo G, Lo Buono V, Venuti G, Bramanti P, Marino S. Therapeutic adherence and coping strategies in patients with multiple sclerosis: An observational study. Medicine (Baltimore). 2019 Jul;98(29):e16532. doi: 10.1097/MD.0000000000016532. PMID 31335734
• Sheffler JL, Piazza JR, Quinn JM, Sachs-Ericsson NJ, Stanley IH. Adverse childhood experiences and coping strategies: identifying pathways to resiliency in adulthood. Anxiety Stress Coping. 2019 Sep;32(5):594-609. doi: 10.1080/10615806.2019.1638699. Epub 2019 Jul 9. PMID 31288568
• Nusslock R, Miller GE. Early-Life Adversity and Physical and Emotional Health Across the Lifespan: A Neuroimmune Network Hypothesis. Biol Psychiatry. 2016 Jul 1;80(1):23-32. doi: 10.1016/j.biopsych.2015.05.017. Epub 2015 Jun 4. PMID 26166230
• Khaw YM, Majid D, Oh S, Kang E, Inoue M. Early-life-trauma triggers interferon-beta resistance and neurodegeneration in a multiple sclerosis model via downregulated beta1-adrenergic signaling. Nat Commun. 2021 Jan 4;12(1):105. doi: 10.1038/s41467-020-20302-0. PMID 33397973
• McEwen BS. In pursuit of resilience: stress, epigenetics, and brain plasticity. Ann N Y Acad Sci. 2016 Jun;1373(1):56-64. doi: 10.1111/nyas.13020. Epub 2016 Feb 25. PMID 26919273
• Hepgul N, Pariante CM, Dipasquale S, DiForti M, Taylor H, Marques TR, Morgan C, Dazzan P, Murray RM, Mondelli V. Childhood maltreatment is associated with increased body mass index and increased C-reactive protein levels in first-episode psychosis patients. Psychol Med. 2012 Sep;42(9):1893-901. doi: 10.1017/S0033291711002947. Epub 2012 Jan 20. PMID 22260948
• Eid K, Bjork MH, Gilhus NE, Torkildsen O. Adverse Childhood Experiences and the Risk of Multiple Sclerosis Development: A Review of Potential Mechanisms. Int J Mol Sci. 2024 Jan 26;25(3):1520. doi: 10.3390/ijms25031520. PMID 38338799
• Spitzer C, Bouchain M, Winkler LY, Wingenfeld K, Gold SM, Grabe HJ, Barnow S, Otte C, Heesen C. Childhood trauma in multiple sclerosis: a case-control study. Psychosom Med. 2012 Apr;74(3):312-8. doi: 10.1097/PSY.0b013e31824c2013. Epub 2012 Mar 9. PMID 22408134

Идентификаторы

NCT: NCT06718920 · 6791

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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