<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03825055</url>
  </required_header>
  <id_info>
    <org_study_id>2029CESC</org_study_id>
    <nct_id>NCT03825055</nct_id>
  </id_info>
  <brief_title>Resilience in Young Adults Newly Diagnosed With Multiple Sclerosis</brief_title>
  <acronym>BPS-ARMS</acronym>
  <official_title>Behaviour and Well-Being: A Bio-Psycho-Social Model of Resilience in Young Adults Newly Diagnosed With Multiple Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universita di Verona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Azienda Ospedaliera Universitaria Integrata Verona</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fondazione Italiana Sclerosi Multipla</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Federico II University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universita di Verona</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to fill the gap of knowledge on the biopsychosocial (BPS) characteristics and&#xD;
      resilience of young adults newly diagnosed with Multiple Sclerosis, to evaluate the&#xD;
      relationship among these variables, and to develop a BPS model of resilience.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Multiple sclerosis (MS) is the most common neurological disease causing disability in young&#xD;
      adults and is widely recognized as a major stress factor. Several studies have shown that the&#xD;
      first years after the diagnosis are distressing in terms of adjustment to the disease and&#xD;
      that MS negatively affects patients' psychological wellbeing, quality of life (QoL), and&#xD;
      social functioning (Kern et al., 2013; Moss-Morris et al., 2013; Pagnini et al., 2014).&#xD;
      Nevertheless, up to know, the link between disease-specific variables at diagnosis,&#xD;
      resilience, and psychological adjustment of MS patients remains largely unexplored,&#xD;
      especially in adolescents and young adults.&#xD;
&#xD;
      This study aims to fill the gap of knowledge on the biopsychosocial (BPS) characteristics and&#xD;
      resilience of young adults newly diagnosed with MS, to evaluate the relationship among these&#xD;
      variables, and to develop a BPS model of resilience.&#xD;
&#xD;
      Biological and clinical characteristics of young adults newly diagnosed with MS in the&#xD;
      University Hospital of Verona will be investigated by collecting clinical information,&#xD;
      performing neurological examinations, brain and cervical spinal cord magnet resonance imaging&#xD;
      (MRI), and analyzing cerebrospinal fluid and blood biomarkers (i.e. measures of inflammation,&#xD;
      axonal damage, oxidative stress and microRNAs (miRNAs) expression), body composition, gut&#xD;
      microbiota, and movement/perceptual markers. Psychosocial characteristics (e.g.,&#xD;
      psychological distress, illness perception, mindfulness trait, and coping strategies), QoL,&#xD;
      psychological wellbeing and resilience will be assessed by self-report questionnaires.&#xD;
      Comparative statistics (i.e., ANOVA or unpaired samples t-test, correlation and regression&#xD;
      analyses) will be applied to evaluate the relationship among biological, psychological and&#xD;
      social factors.&#xD;
&#xD;
      The results of this study are expected not only to allow a comprehensive and new&#xD;
      understanding of the determinants of resilience and adjustment in MS patients at this crucial&#xD;
      stage of life but also to inform resilience interventions, tailored to adolescents' and young&#xD;
      patients' specific needs, aiming to reduce the risk of maladaptive reactions to the disease&#xD;
      and to improve the psychological well-being and their quality of life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 26, 2019</start_date>
  <completion_date type="Actual">March 31, 2022</completion_date>
  <primary_completion_date type="Actual">March 31, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Level of resilience</measure>
    <time_frame>at study entry (i.e., within one month from informed consent)</time_frame>
    <description>Connor-Davidson Resilience Scale (CD-RISC; Connor &amp; Davidson, 2003), designed to assess resilience features in adolescents and adults.&#xD;
The CD-RISC is composed of 25 items and evaluated on a 5-point Likert scale (ranging from 0 &quot;not true at all&quot; to 4 &quot;true nearly all of the time&quot;), with higher scores reflecting higher levels of resilience.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Level of quality of life</measure>
    <time_frame>at study entry (i.e., within one month from informed consent)</time_frame>
    <description>Italian version of the MSQOL-54 (Solari et al., 1999). The MSQOL-54 is a multidimensional health-related Quality of Life measure that combines both generic and MS-specific items, such as fatigue and cognitive function (Vickrey et al, 1995, 1997; Solari et al., 1999). The instrument generates 12 scores (physical function, role limitations-physical, role limitations-emotion, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall QoL, and sexual function) along with two summary scores (i.e., physical health and mental health) derived from a weighted combination of scale scores. There are also two single-item measures: satisfaction with sexual function and change in health.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">51</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Young patients with MS</arm_group_label>
    <description>young adults (i.e., 18-45 years) newly diagnosed with MS (Case-Only)</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      -  blood sample (serum, whole blood)&#xD;
&#xD;
        -  sample of cerebrospinal fluid (CSF)&#xD;
&#xD;
        -  fecal sample&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Potentially eligible patients, diagnosed with MS in the 2 years prior to study inclusion,&#xD;
        from the catchment area of the Multiple Sclerosis Regional Center of the Azienda&#xD;
        Ospedaliera Universitaria Integrata of Verona will be identified during routine visits at&#xD;
        the MS Centre of Borgo Roma Hospital Verona and asked to participate in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  MS diagnosis in the 2 years prior to study inclusion, according to the revised&#xD;
             McDonald Criteria (Thompson et al., 2018);&#xD;
&#xD;
          -  MRI of the brain in the 6 months prior to or within one month after screening visit&#xD;
             according to a standardized protocol (including pre- and post-contrast volumetric&#xD;
             T1-weighted, 3D Fluid Attenuated Inversion Recovery (FLAIR), and 3D Double Inversion&#xD;
             Recovery (DIR) sequences for brain imaging, and sagittal and axial pre- and&#xD;
             post-contrast volumetric T1-weighted, T2-weighted and short tau inversion recovery&#xD;
             (STIR) sequences for spinal cord imaging)&#xD;
&#xD;
          -  Italian speakers.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically relevant cognitive deficits as evaluated by the treating neurologist&#xD;
&#xD;
          -  Treatment with any disease-modifying therapy (DMT) for MS at inclusion and by&#xD;
             completion of study procedures (maximum two months from consent); steroids&#xD;
             administration up to 30 days prior to inclusion is allowed.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michela Rimondini, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Università di Verona</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alberto Gajofatto, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Università di Verona</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Integrata Verona, Policlinico G.B. Rossi</name>
      <address>
        <city>Verona</city>
        <state>Veneto</state>
        <zip>37134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>12964174</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19482864</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22730954</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>25433519</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>10406981</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>29275977</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>7613530</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>9180648</PMID>
  </reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>November 12, 2022</last_update_submitted>
  <last_update_submitted_qc>November 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universita di Verona</investigator_affiliation>
    <investigator_full_name>Michela Rimondini</investigator_full_name>
    <investigator_title>Associate Professor in Clinical Psychology</investigator_title>
  </responsible_party>
  <keyword>disease-specific variables</keyword>
  <keyword>biopsychosocial characteristics</keyword>
  <keyword>resilience</keyword>
  <keyword>adjustment</keyword>
  <keyword>quality of life</keyword>
  <keyword>well-being</keyword>
  <keyword>young adults</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual participant data for the primary and secondary outcome measures (resilience, quality of life) will be made available upon reasonable request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data can be made available upon reasonable request when data are published (6 months after publication).</ipd_time_frame>
    <ipd_access_criteria>Requestors will be required to sign a Data Access Agreement.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03825055
org study id: 2029CESC
nct id: NCT03825055
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
Multiple sclerosis (MS) is the most common neurological disease causing disability in young
      adults and is widely recognized as a major stress factor. Several studies have shown that the
      first years after the diagnosis are distressing in terms of adjustment to the disease and
      that MS negatively affects patients' psychological wellbeing, quality of life (QoL), and
      social functioning (Kern et al., 2013; Moss-Morris et al., 2013; Pagnini et al., 2014).
      Nevertheless, up to know, the link between disease-specific variables at diagnosis,
      resilience, and psychological adjustment of MS patients remains largely unexplored,
      especially in adolescents and young adults.

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

      Biological and clinical characteristics of young adults newly diagnosed with MS in the
      University Hospital of Verona will be investigated by collecting clinical information,
      performing neurological examinations, brain and cervical spinal cord magnet resonance imaging
      (MRI), and analyzing cerebrospinal fluid and blood biomarkers (i.e. measures of inflammation,
      axonal damage, oxidative stress and microRNAs (miRNAs) expression), body composition, gut
      microbiota, and movement/perceptual markers. Psychosocial characteristics (e.g.,
      psychological distress, illness perception, mindfulness trait, and coping strategies), QoL,
      psychological wellbeing and resilience will be assessed by self-report questionnaires.
      Comparative statistics (i.e., ANOVA or unpaired samples t-test, correlation and regression
      analyses) will be applied to evaluate the relationship among biological, psychological and
      social factors.

      The results of this study are expected not only to allow a comprehensive and new
      understanding of the determinants of resilience and adjustment in MS patients at this crucial
      stage of life but also to inform resilience interventions, tailored to adolescents' and young
      patients' specific needs, aiming to reduce the risk of maladaptive reactions to the disease
      and to improve the psychological well-being and their quality of life.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Level of resilience
time frame: at study entry (i.e., within one month from informed consent)
description: 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.
measure: Level of quality of life
time frame: at study entry (i.e., within one month from informed consent)
description: Italian version of the MSQOL-54 (Solari et al., 1999). The MSQOL-54 is a multidimensional health-related Quality of Life measure that combines both generic and MS-specific items, such as fatigue and cognitive function (Vickrey et al, 1995, 1997; Solari et al., 1999). The instrument generates 12 scores (physical function, role limitations-physical, role limitations-emotion, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall QoL, and sexual function) along with two summary scores (i.e., physical health and mental health) derived from a weighted combination of scale scores. There are also two single-item measures: satisfaction with sexual function and change in health.
arm group label: Young patients with MS
description: young adults (i.e., 18-45 years) newly diagnosed with MS (Case-Only)
-  blood sample (serum, whole blood)

        -  sample of cerebrospinal fluid (CSF)

        -  fecal sample
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Michela Rimondini, PhD
role: Principal Investigator
affiliation: Università di Verona
last name: Alberto Gajofatto, MD, PhD
role: Principal Investigator
affiliation: Università di Verona
facility: 
country: Italy
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
responsible party type: Principal Investigator
investigator affiliation: Universita di Verona
investigator full name: Michela Rimondini
investigator title: Associate Professor in Clinical Psychology
mesh term: Multiple Sclerosis
mesh term: Sclerosis
sharing ipd: Yes
ipd description: De-identified individual participant data for the primary and secondary outcome measures (resilience, quality of life) will be made available upon reasonable request.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Analytic Code
ipd time frame: Data can be made available upon reasonable request when data are published (6 months after publication).
ipd access criteria: Requestors will be required to sign a Data Access Agreement.