Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intervention for Young Adults With Multiple Sclerosis (ESPRIMO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04431323
Recruitment Status : Recruiting
First Posted : June 16, 2020
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Azienda Ospedaliera Universitaria Integrata Verona

Brief Summary:

This study aims to develop - in collaboration with patients with multiple sclerosis (MS)- a psychosocial and physical activity intervention (i.e., ESPRIMO intervention) for young adults with MS targeted at improving patients' health-related quality of life (HRQoL). Further, the study seeks to preliminarily test the effect, feasibility, and acceptability of the ESPRIMO intervention using a pilot sample of young adults with MS.

Given that the ESPRIMO study will be conducted immediately after the COVID-19 emergency, it does not seem reasonable to start the co-creation of the intervention without taking into account the potential impact of this pandemic on the quality of life and well-being of patients with MS and on their management of care. Thus, the investigators seek to better understand the needs of the target population under these particular circumstances.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: ESPRIMO Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

ESPRIMO is a feasibility study using a participatory design.

It is composed of a pre-phase and three main consequential phases:

  • Pre-phase: Exploring the psychological impact of COVID-19 on young adults with MS using a cross-sectional web-based survey for patients with MS;
  • Phase 1 (Co-creation of the intervention): initial co-creation phase aiming to develop a biopsychosocial intervention (the so-called ESPRIMO intervention) targeted at young adults with MS, using cross-sectional web-based surveys for young adults with MS and healthcare providers as well as focus groups with patients;
  • Phase 2 (intervention): aiming to test preliminary effect, feasibility, and acceptability of the ESPRIMO intervention in a sample of young patients with MS; Phase 3 (Fine tuning of the intervention): evaluation of the results by the ESPRIMO Board (composed of four young adults with MS and three healthcare professionals) and subsequent fine-tuning of the ESPRIMO intervention.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ESPRIMO: A Bio-psycho-social Co-created Intervention for Young Adults With Multiple Sclerosis: Study Protocol for a Feasibility Study
Actual Study Start Date : May 13, 2020
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: biopsychosocial intervention

Young adults with MS will receive an intervention (group setting) composed of physical activities (duration: 10-12 weeks; either dancing or walking) and psychosocial interventions (6-8 encounters).

[The intervention will start as soon as 8-10 patients will have been enrolled. A waiting list will be then created and patients contacted when the subsequent group starts. This waiting list does not serve as control group.

One or more groups, respectively for the psychological intervention and the physical activities, may start at the same time but on different days, considering also the results of the co-creation phase.]

Behavioral: ESPRIMO

Participants will receive the intervention during Phase 2.

The intervention is based on the cognitive behavioral, the third-wave (mindfulness and acceptance and commitment therapy), and the positive psychology approach.

The frequency of the intervention and the specific content and aims of the psychological and physical intervention will be based on the results of the surveys and the focus group discussion (Pre-phase and Phase 1). In order to maximize the benefit of the integrated intervention, all the three components of the interventions (i.e., psychological, motor exercise and social components) will be administered in the same time period.

A preliminary theoretical framework of the intervention will be created prior to the survey phase according to the literature in the field. Specific aspects of this preliminary framework will be discussed during the co-creation phase and adapted after the analysis of the qualitative results.





Primary Outcome Measures :
  1. Change from Baseline Health-related Quality of Life up to 1 week post-intervention [ Time Frame: T0: baseline, T1: up to 1 week post-intervention ]

    Health-related Quality of Life at 1 day post-intervention will be Health-related quality of life will be measured by the Italian version of the "Coop/Wonca charts" [van Weel et al., 1993] at baseline and 1 day post-intervention assessing the changes between the two time points.

    The Coop/Wonca questionnaire is a self-reported single-item scale to explore HRQoL, including physical (fitness and daily activities), mental (emotions), social domains (social contacts) and above that general health and change in health status [Weel et al., 1995]. Each chart consists of a single question referring to the preceding two weeks and are scored on a 5-level ordinal scale ranging from 1 (no impact) to 5 (high impact), illustrated by a simple picture.


  2. Acceptance and Satisfaction with the Intervention assessed by an ad hoc questionnaire [ Time Frame: T1: up to 1 week post-intervention ]

    An ad hoc questionnaire (one of the two specific outcome measures evaluating the feasibility of the intervention) using closed (rated by Likert scales ranging from 1 (not at all) to 10 (very much, with higher scores reflecting higher levels of acceptance and satisfaction) and open questions will be administered to evaluate the acceptance and satisfaction of participants.

    Information on participants' experience will inform the intervention and its administration and will reduce barriers to participation for future patients.



Secondary Outcome Measures :
  1. Change from Baseline Resilience Features up to 1 week post-intervention [ Time Frame: T0: baseline, T1: up to 1 week post-intervention ]

    Resilience will be measured using the Italian version of the "Connor-Davidson Resilience Scale" [CD-RISC; Connor & Davidson, 2003] at baseline and 1 day post-intervention assessing the changes between the two time points.

    The CD-RISC is designed to assess resilience features in adolescents and adults and 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.


  2. Change from Baseline Well-being up to 1 week post-intervention [ Time Frame: T0: baseline, T1: up to 1 week post-intervention ]

    Well-being will be measured using the Italian version of the "Short Form 12 general health questionnaire" [SF12, Apolone et al., 2001] at baseline and 1 day post-intervention assessing the changes between the two time points.

    The SF12 is a validated 12-item questionnaire with Physical and Mental Component Summary (PCS and MCS, respectively) scores.

    The SF12 uses different types of scales (e.g., Yes/No questions, scales ranging from 1(always) to 6 (never)).


  3. Change from Baseline Mindfulness Traits up to 1 week post-intervention [ Time Frame: T0: baseline, T1: up to 1 week post-intervention ]

    Mindfulness traits will be assessed using the Italian version of the "Five Facet Mindfulness Questionnaire" [FFMQ; Baer et al., 2006; Giovannini et al., 2014] at baseline and 1 day post-intervention assessing the changes between the two time points.

    The FFMQ-SF is a 24-item self-report questionnaire measuring one general mindfulness factor and five secondary facets (i.e., Observe, Describe, Act with Awareness, Nonjudge, and Nonreact) on a 5-point Likert scale, ranging from 1 ("never or very rarely true") to 5 ("very often or always true"), with higher total scores reflecting a greater degree of mindfulness.


  4. Change from Baseline Self-efficacy in MS up to 1 week post-intervention assessed by the "Self-Efficacy in Multiple Sclerosis Scale" (SEMS) [ Time Frame: T0: baseline, T1: up to 1 week post-intervention ]

    Self-efficacy will be measured using the "Self-Efficacy in Multiple Sclerosis Scale" [SEMS; Bonino et al., 2016] at baseline and 1 day post-intervention assessing the changes between the two time points.

    It is a 15-item self-completion instrument using a 5-point Likert scale (from 0 = not at all confident to 4 = very confident). Items are conceptually allocated to two areas: "Goal setting" (9 items) and "Symptom management" (6 items).


  5. Change from Baseline Perceived Social Support up to 1 week post-intervention [ Time Frame: T0: baseline, T1: up to 1 week post-intervention ]

    Perceived social support will be measured using the "Multidimensional Scale of Perceived Social Support" [MSPSS; Prezza & Principato, 2002; Zimet et al., 1988] at baseline and 1 day post-intervention assessing the changes between the two time points.

    It is a 12-item self-report measure, assessing on a 7-point Likert scale (from 1 "strongly disagree" to 7 "strongly agree") the level of perceived social support of various sources: family, friends, and significant others.


  6. Change from Baseline Levels of Anxiety and Depression up to 1 week post-intervention [ Time Frame: T0: baseline, T1: up to 1 week post-intervention ]

    Levels of anxiety and depression will be measured using the "Hospital Anxiety and Depression Scale" [HADS; Zigmond & Snaith, 1983; Costantini et al., 1999] at baseline and 1 day post-intervention assessing the changes between the two time points.

    The HADS is a brief self-report questionnaire composed of 14 items describing on a 4-point scale from 0 to 3 the levels of anxiety a person is experiencing.

    HADS anxiety (HADS-A, 7 items) and depression (HADS-D, 7 items) subscale scores will be calculated, possibly ranging from 0 (no symptoms) to 21 (most severe symptoms). A HADS-A and HADS-D score of ≥8 indicates a high risk of anxiety and depressive disorder.


  7. Change from Baseline Illness Representations up to 1 week post-intervention [ Time Frame: T0: baseline, T1: up to 1 week post-intervention ]

    Illness perception will be measured using the "Brief Illness Perception Questionnaire" [Brief IPQ-R; Broadbent et al., 2006; Pain et al., 2006] at baseline and 1 day post-intervention assessing the changes between the two time points.

    It is a 9-item self-completion instrument using a 5-point Likert scale (from "strongly disagree" to "strongly agree") providing a quantitative measurement of the components of illness representations [Leventhal et al., 1984; Leventhal et al., 1997].


  8. Change from Baseline Committed Action up to 1 week post-intervention [ Time Frame: T0: baseline, T1: up to 1 week post-intervention ]

    The construct of committed action is measured applying the Italian version of the "The Committed Action Questionnaire-8" (CAQ-8) [McCracken et al., 2015] at baseline and 1 day post-intervention assessing the changes between the two time points.

    The CAQ-8, a short version of The Committed Action Questionnaire [McCracken, 2013], is an 8-item questionnaire using a 7-point Likert scale (from 0 = never true to 6 = always true).


  9. Change from Baseline Levels of (Motor and Cognitive) Fatigue up to 1 week post-intervention [ Time Frame: T0: baseline, T1: up to 1 week post-intervention ]

    Fatigue will be measured applying the "Fatigue Scale for Motor and Cognitive Functions" [FSMC; Penner et al., 2009; Elbers et al., 2012] at baseline and 1 day post-intervention assessing the changes between the two time points.

    It is a self-report fatigue questionnaires validated in patients with multiple sclerosis (MS) and useful to evaluate both motor and cognitive fatigue.

    It is composed by 20 items evaluated on a Likert scale, ranging from 1 (it never happens) to 5 (it always happens), with higher scores reflecting higher levels of motor and cognitive fatigue.


  10. Change from Baseline Perceived Autonomy Support up to 1 week post-intervention [ Time Frame: T0: baseline, T1: up to 1 week post-intervention ]

    Perceived autonomy support (as part of a set of variables reflecting attitudes towards physical activity and motivation to be physically active) will be measured with the "Perceived Autonomy Support Scale for Exercise Setting" (PASSES; Hagger et al., 2007) at baseline and 1 day post-intervention assessing the changes between the two time points.

    The 12 items are rated on a 7-point Likert scale ranging from 1(totally disagree) to 7 (totally agree), with higher scores reflecting greater perceptions of autonomy support.


  11. Change from Baseline Autonomous Motivation up to 1 week post-intervention [ Time Frame: T0: baseline, T1: up to 1 week post-intervention ]

    Autonomous motivation (as part of a set of variables reflecting attitudes towards physical activity and motivation to be physically active) will be measured with the "Behavioral Regulation in Exercise Questionnaire" [BREQ-3; Markland et al., 2014] at baseline and 1 day post-intervention assessing the changes between the two time points.

    The 24 items are rated on a 5-point Likert scale ranging from 1 (totally disagree) to 5 (totally agree).


  12. Change from Baseline Attitudes up to 1 week post-intervention [ Time Frame: T0: baseline, T1: up to 1 week post-intervention ]

    Attitudes (as part of a set of variables reflecting attitudes towards physical activity and motivation to be physically active) will be measured by a scale developed by Galli et al. [2018], following the recommendations of Ajzen [1991] at baseline and 1 day post-intervention assessing the changes between the two time points.

    The scale comprises 6 items with responses provided on seven-points scales (with contrasting adjectives (e.g.,"bad - good", "harmful-beneficial").


  13. Change from Baseline Subjective Norms up to 1 week post-intervention [ Time Frame: T0: baseline, T1: up to 1 week post-intervention ]

    Subjective norms (as part of a set of variables reflecting attitudes towards physical activity and motivation to be physically active) will be measured by a scale developed by Galli et al. [2018], following the recommendations of Ajzen [1991] at baseline and 1 day post-intervention assessing the changes between the two time points.

    The 3 items of the scale are rated on a 7-point Likert scale, ranging from 1 (strongly disagree) to 7 (strongly agree), with a greater single score (aggregated item scores) indicating greater normative social pressure toward the behavior.


  14. Change from Baseline Perceived Behavioral Control up to 1 week post-intervention [ Time Frame: T0: baseline, T1: up to 1 week post-intervention ]

    Perceived Behavioral Control (as part of a set of variables reflecting attitudes towards physical activity and motivation to be physically active) will be measured by a scale developed by Galli et al. [2018], following the recommendations of Ajzen [1991] at baseline and 1 day post-intervention assessing the changes between the two time points.

    The 3 items of the scale are rated on a 7-point Likert scale, with a greater single score (aggregated item scores) indicating greater perceived confidence toward the behavior.


  15. Change from baseline number of steps/day to 5 days post-intervention [ Time Frame: T0: baseline, T1: 5 days post-intervention ]
    A smartwatch will be used by each patient for 5 days at baseline (T0) and 5 days after the intervention (T1) in order to compare the number of steps/day.

  16. Change from baseline km traveled/day to 5 days post-intervention [ Time Frame: T0: baseline, T1: 5 days post-intervention ]
    A smartwatch will be used by each patient for 5 days at baseline (T0) and 5 days after the intervention (T1) in order to compare the number of km traveled/day.

  17. Change from baseline number of active hours/day to 5 days post-intervention [ Time Frame: T0: baseline, T1: 5 days post-intervention ]
    A smartwatch will be used by each patient for 5 days at baseline (T0) and 5 days after the intervention (T1) in order to compare the number of active hours/day.

  18. Change from baseline number of inactive hours/day to 5 days post-intervention [ Time Frame: T0: baseline, T1: 5 days post-intervention ]
    A smartwatch will be used by each patient for 5 days at baseline (T0) and 5 days after the intervention (T1) in order to compare the number of inactive hours/day.

  19. Change from Baseline number of hours of sleep/day to 5 days post-intervention [ Time Frame: T0: baseline, T1: 5 days post-intervention ]
    A smartwatch will be used by each patient for 5 days at baseline (T0) and 5 days after the intervention (T1) in order to compare the number of hours of sleep/day.

  20. Change from baseline heart rate to 5 days post-intervention [ Time Frame: T0: baseline, T1: 5 days post-intervention ]
    A smartwatch will be used by each patient for 5 days at baseline (T0) and 5 days after the intervention (T1) in order to compare the heart rate (HR).

  21. Change from baseline heart rate variability to 5 days post-intervention [ Time Frame: T0: baseline, T1: 5 days post-intervention ]
    A smartwatch will be used by each patient for 5 days at baseline (T0) and 5 days after the intervention (T1) in order to compare the heart rate variability (HRV).

  22. Change from estimated kilocalories consumed/day at baseline to 5 days post-intervention [ Time Frame: T0: baseline, T1: 5 days post-intervention ]
    A smartwatch will be used by each patient for 5 days at baseline (T0) and 5 days after the intervention (T1) in order to compare the estimated kilocalories consumed/day.

  23. Number of Drop Outs [ Time Frame: T1: up to 1 week post-intervention ]
    The number of drop outs is the second specific outcome measure evaluating the feasibility of the intervention.

  24. Exact Time of Dropping Out [ Time Frame: T1: up to 1 week post-intervention ]
    The exact time point of dropping out will also be assessed.

  25. Underlying Reasons for Dropping Out assessed by an ad hoc questionnaire with open questions [ Time Frame: T1: up to 1 week post-intervention ]
    Patients who drop out during the interventions will be contacted to assess the underlying reasons using an ad hoc questionnaire with open questions.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

As different samples of patients and healthcare professionals will be enrolled in the different phases of the studies, inclusion and exclusion criteria vary:

  1. Explorative pre-phase "Exploring the psychological impact of the COVID-19 emergency"

    Inclusion Criteria:

    • age range: 18-45 years;
    • MS Diagnosis;
    • Italian speakers;
    • electronic informed consent signed.

    Exclusion Criteria:

    • N/A
  2. Co-creation phase - Survey with young adults with MS

    Inclusion Criteria:

    • age range: 18-45 years;
    • MS diagnosis;
    • Italian speakers;
    • electronic informed consent signed.

    Exclusion Criteria:

    -N/A

  3. Co-creation phase - Survey with Healthcare Providers

    Inclusion Criteria:

    • being a healthcare professional working with MS patients;
    • Italian speakers;
    • electronic informed consent signed.

    Exclusion Criteria:

    -N/A

  4. Co-creation phase - Focus groups

    Inclusion Criteria:

    • age range: 18-45 years;
    • MS diagnosis;
    • Italian speakers;
    • signed informed consent.

    Exclusion Criteria:

    -N/A

  5. Intervention phase

Inclusion Criteria:

  • age range: 18-45 years;
  • Ms diagnosis according to the revised McDonald Criteria [Thompson et al., 2018];
  • Italian speakers;
  • Signed informed consent.

Exclusion Criteria:

  • clinically relevant cognitive deficits as evaluated by the treating neurologist which may represent obstacles in filling the questionnaires and participating in the intervention;
  • severe psychiatric disorders, such as psychosis, bipolar disorder, active substance abuse problems, dissociative disorders, or a current diagnosis of major depression as evaluated by the neurologist or the clinical psychologist;
  • clinically relevant physical impairments rendering impossible the physical activities included in the intervention, defined as an Expanded Disability Status Scale (EDSS) score higher than 3.5 [Bowen et al., 2001].

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04431323


Contacts
Layout table for location contacts
Contact: Michela Rimondini +39 045 8126412 michela.rimondini@univr.it
Contact: Alberto Gajofatto +39 045 812 4285 alberto.gajofatto@univr.it

Locations
Layout table for location information
Italy
Azienda Ospedaliera Universitaria Integrata Verona, Policlinico G.B. Rossi Recruiting
Verona, Veneto, Italy, 37134
Contact: Michela Rimondini, PhD    +39 045 8126412    michela.rimondini@univr.it   
Contact: Alberto Gajofatto, MD, PhD    +39 045 812 4285    alberto.gajofatto@univr.it   
Sub-Investigator: Valeria Donisi, PhD         
Sub-Investigator: Isolde M Busch, M.Sc.         
Sub-Investigator: Francesca Gobbin, MD         
Sub-Investigator: Maria Angela Mazzi, PhD         
Sub-Investigator: Annamaria Ghellere, M.Sc.         
Sub-Investigator: Francesca Vitali, PhD         
Sub-Investigator: Doriana Rudi         
Sub-Investigator: Alina Klonova         
Sub-Investigator: Lidia del Piccolo, PhD         
Sub-Investigator: Federico Schena, MD, PhD         
Sponsors and Collaborators
Azienda Ospedaliera Universitaria Integrata Verona
Investigators
Layout table for investigator information
Principal Investigator: Michela Rimondini Azienda Ospedaliera Universitaria Integrata Verona
Principal Investigator: Alberto Gajofatto Study Principal Investigator Azienda Ospedaliera Universitaria Integrata Verona
Publications:
Apolone G, Mosconi P, Quattrociocchi L, et al. Questionario sullo stato di salute SF-12. Versione italiana. Milano: Guerini e Associati, 2001.
Giovannini C, Giromini L, Bonalume L, et al. The Italian Five Facet Mindfulness Questionnaire: A Contribution to its Validity and Reliability. J Psychopathol Behav Assess 2014; 36.doi: 10.1007/s10862-013-9403-0.
Bonino S, Graziano F, Borghi M, et al. The Self-Efficacy in Multiple Sclerosis (SEMS) Scale: Development and Validation With Rasch Analysis. European Journal of Psychological Assessment. 2015; doi: 10.1027/1015-5759/a000350.
Pain D, Miglioretti M, Angelino, E. Development of Italian version of brief-IPQ (Illness perception questionnaire, short version), a method for assessing the illness representations. Psicologia della Salute. 2006. 81-89.
Leventhal H, Nerenz DR, Steele DS. Illness representations and coping with health threats. In: Baum, A. Taylor, S.E. and Singer, J.E. (Eds.), Handbook of psychology and health. Vol. IV. pp. 219-252. Hillsdale, NJ: Erlbaum, 1984.
Leventhal H, Benyamini Y, Brownlee S, et al. Illness representations: Theoretical foundations. In K. J. Petrie & J. A. Weinman (Ed.), Perceptions of health and illness: Current research and applications (p. 19-45). Reading, UK: Harwood Academic Publishers, 1997.
Prezza M, Principato MC. La rete e il sostegno sociale. In: Prezza M, Santinello M, eds. Conoscere la comunit . Bologna. Italy: Il Mulino, 2002: 193-233.
Zimet, G. D., Dahlem, N. W., Zimet, S. G., & Farley, G. K. (1988). The multidimensional scale of perceived social support. Journal of personality assessment, 52(1), 30-41.
Ajzen I. The theory of planned behavior. Organizational Behavior and Human Decision Processes. 1991;50:179- 211.

Layout table for additonal information
Responsible Party: Azienda Ospedaliera Universitaria Integrata Verona
ClinicalTrials.gov Identifier: NCT04431323    
Other Study ID Numbers: 2676CESC
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for the primary and secondary outcome measures will be made available upon reasonable request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Azienda Ospedaliera Universitaria Integrata Verona:
quality of life
young adults
biopsychosocial intervention
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases