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

NCT06718920 | Recruiting

• 1 other identifier: 6791
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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 .

Conditions

Multiple Sclerosis

Keywords

ACE; multiple sclerosis; treatment adherence; adverse childhood experiences; quality of life

Outcome Measures

Primary Outcomes (2)

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

  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

  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 Outcomes (4)

• 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

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, RM, 00168, Italy

RECRUITING

Related Publications (9)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Nikulina V, Widom CS. Child maltreatment and executive functioning in middle adulthood: a prospective examination. Neuropsychology. 2013 Jul;27(4):417-427. doi: 10.1037/a0032811.

  PMID: 23876115 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Health Behavior; Behavior

Central Study Contacts

Massimiliano Mirabella, Neurology Associate Professor

CONTACT

0630155390; massimiliano.mirabella@policlinicogemelli.it

Alessandra Cicia, Neurologist

CONTACT

0630155390; cicia.alessandra@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: December 5, 2024
• Study Start: January 13, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 26, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)