Resilience in Young Adults Newly Diagnosed With Multiple Sclerosis

NCT03825055 | Completed

• 1 other identifier: 2029CESC
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to fill the gap of knowledge on the biopsychosocial (BPS) characteristics and resilience of young adults newly diagnosed with Multiple Sclerosis, to evaluate the relationship among these variables, and to develop a BPS model of resilience.

Conditions

Multiple Sclerosis

Keywords

disease-specific variables; biopsychosocial characteristics; resilience; adjustment; quality of life; well-being; young adults

Outcome Measures

Primary Outcomes (1)

• Level of resilience

  Connor-Davidson Resilience Scale (CD-RISC; Connor \& Davidson, 2003), designed to assess resilience features in adolescents and adults. The CD-RISC is composed of 25 items and evaluated on a 5-point Likert scale (ranging from 0 "not true at all" to 4 "true nearly all of the time"), with higher scores reflecting higher levels of resilience.

  at study entry (i.e., within one month from informed consent)

Secondary Outcomes (1)

• Level of quality of life

  at study entry (i.e., within one month from informed consent)

Study Arms (1)

Young patients with MS

young adults (i.e., 18-45 years) newly diagnosed with MS (Case-Only)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Potentially eligible patients, diagnosed with MS in the 2 years prior to study inclusion, from the catchment area of the Multiple Sclerosis Regional Center of the Azienda Ospedaliera Universitaria Integrata of Verona will be identified during routine visits at the MS Centre of Borgo Roma Hospital Verona and asked to participate in the study.

You may qualify if:

• MRI of the brain in the 6 months prior to or within one month after screening visit according to a standardized protocol (including pre- and post-contrast volumetric T1-weighted, 3D Fluid Attenuated Inversion Recovery (FLAIR), and 3D Double Inversion Recovery (DIR) sequences for brain imaging, and sagittal and axial pre- and post-contrast volumetric T1-weighted, T2-weighted and short tau inversion recovery (STIR) sequences for spinal cord imaging)
• Italian speakers.

You may not qualify if:

• Clinically relevant cognitive deficits as evaluated by the treating neurologist

Sponsors & Collaborators

• Universita di Verona: lead
• Azienda Ospedaliera Universitaria Integrata Verona: collaborator
• Fondazione Italiana Sclerosi Multipla: collaborator
• Federico II University: collaborator

Study Sites (1)

Azienda Ospedaliera Universitaria Integrata Verona, Policlinico G.B. Rossi

Verona, Veneto, 37134, Italy

Location

Related Publications (9)

• Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113.

  PMID: 12964174 BACKGROUND

• Kern S, Schrempf W, Schneider H, Schultheiss T, Reichmann H, Ziemssen T. Neurological disability, psychological distress, and health-related quality of life in MS patients within the first three years after diagnosis. Mult Scler. 2009 Jun;15(6):752-8. doi: 10.1177/1352458509103300.

  PMID: 19482864 BACKGROUND

• Moss-Morris R, Dennison L, Landau S, Yardley L, Silber E, Chalder T. A randomized controlled trial of cognitive behavioral therapy (CBT) for adjusting to multiple sclerosis (the saMS trial): does CBT work and for whom does it work? J Consult Clin Psychol. 2013 Apr;81(2):251-62. doi: 10.1037/a0029132. Epub 2012 Jun 25.

  PMID: 22730954 BACKGROUND

• Pagnini F, Bosma CM, Phillips D, Langer E. Symptom changes in multiple sclerosis following psychological interventions: a systematic review. BMC Neurol. 2014 Nov 30;14:222. doi: 10.1186/s12883-014-0222-z.

  PMID: 25433519 BACKGROUND

• Solari A, Filippini G, Mendozzi L, Ghezzi A, Cifani S, Barbieri E, Baldini S, Salmaggi A, Mantia LL, Farinotti M, Caputo D, Mosconi P. Validation of Italian multiple sclerosis quality of life 54 questionnaire. J Neurol Neurosurg Psychiatry. 1999 Aug;67(2):158-62. doi: 10.1136/jnnp.67.2.158.

  PMID: 10406981 BACKGROUND

• Thompson AJ, Banwell BL, Barkhof F, Carroll WM, Coetzee T, Comi G, Correale J, Fazekas F, Filippi M, Freedman MS, Fujihara K, Galetta SL, Hartung HP, Kappos L, Lublin FD, Marrie RA, Miller AE, Miller DH, Montalban X, Mowry EM, Sorensen PS, Tintore M, Traboulsee AL, Trojano M, Uitdehaag BMJ, Vukusic S, Waubant E, Weinshenker BG, Reingold SC, Cohen JA. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol. 2018 Feb;17(2):162-173. doi: 10.1016/S1474-4422(17)30470-2. Epub 2017 Dec 21.

  PMID: 29275977 BACKGROUND

• Vickrey BG, Hays RD, Harooni R, Myers LW, Ellison GW. A health-related quality of life measure for multiple sclerosis. Qual Life Res. 1995 Jun;4(3):187-206. doi: 10.1007/BF02260859.

  PMID: 7613530 BACKGROUND

• Vickrey BG, Hays RD, Genovese BJ, Myers LW, Ellison GW. Comparison of a generic to disease-targeted health-related quality-of-life measures for multiple sclerosis. J Clin Epidemiol. 1997 May;50(5):557-69. doi: 10.1016/s0895-4356(97)00001-2.

  PMID: 9180648 BACKGROUND

• Gajofatto A, Donisi V, Busch IM, Gobbin F, Butturini E, Calabrese M, Carcereri de Prati A, Cesari P, Del Piccolo L, Donadelli M, Fabene P, Fochi S, Gomez-Lira M, Magliozzi R, Malerba G, Mariotti R, Mariotto S, Milanese C, Romanelli MG, Sbarbati A, Schena F, Mazzi MA, Rimondini M. Biopsychosocial model of resilience in young adults with multiple sclerosis (BPS-ARMS): an observational study protocol exploring psychological reactions early after diagnosis. BMJ Open. 2019 Aug 2;9(8):e030469. doi: 10.1136/bmjopen-2019-030469.

  PMID: 31377712 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

* blood sample (serum, whole blood) * sample of cerebrospinal fluid (CSF) * fecal sample

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Michela Rimondini, PhD

  Università di Verona

  PRINCIPAL INVESTIGATOR

• Alberto Gajofatto, MD, PhD

  Università di Verona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Clinical Psychology

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: January 31, 2019
• Study Start: February 26, 2019
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data can be made available upon reasonable request when data are published (6 months after publication).
• Access Criteria: Requestors will be required to sign a Data Access Agreement.

Locations

IT (1)