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Completed

NCT Number: NCT04431323

Intervention for Young Adults With Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Verona, Veneto, 37134, Italy

About this study

Being the most common neurological disease causing disability in young adults, multiple sclerosis (MS) does not only impair physical functions but is also often associated with fatigue, symptoms of depression and anxiety as well as reduced health related quality of life (HRQoL). Especially the first years after the diagnosis can be emotionally challenging and psychological adjustment problematic. Since MS is generally detected between the ages of 20 and 40, a period of great significance for professional and personal development, the adaptation to this chronic disease may become even more challenging.

It is now well established that psychological interventions aiming to support people with MS (e.g., Cognitive Behavioural Therapy, mindfulness-based interventions) do not only have a positive effect on psychological aspects, such as resilience, but also on physiological outcomes (e.g., fatigue, physical vitality) and on the perception of general health.

According to the literature, psychological well-being and HRQoL can be also promoted by regular physical activity and exercise (e.g., walking, ballroom dancing), which present the additional advantage of reducing some physical symptoms of MS. Practicing physical activity in groups enables participants also to socialize and create interpersonal relationships, which in turn may significantly affect patients' psychological well-being and illness perception.

Despite the positive impact of interventions focusing on either physical, psychological or social/interpersonal dimensions, there has been little discussion about the development of comprehensive interventions based on the bio-psycho-social model of disease. Even less attention has been paid to the development of early interventions tailored to young adults' needs and to the engagement of patients in the creation of such programs despite the fact that patient engagement has become a central priority for researchers and policy makers in medicine.

Therefore, the investigators aim to develop - in collaboration with patients with MS - a psychosocial and motor intervention (i.e., ESPRIMO intervention) for young adults with MS targeted at improving patients' 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.

In the so-called co-creation phase, the primary aim is to create, together with patients, a bio-psycho-social intervention, following also the preferences and suggestions of healthcare professionals. In the intervention phase, the primary aim is to explore the feasibility of the intervention and its effect in improving their quality of life.

Secondary aims of the study are five-fold: 1) to collect patients' opinions and needs as well as healthcare professionals' perspectives on the preferred characteristics of a bio-psycho-social intervention; 2) to explore the effect of the bio-psycho-social intervention in improving bio-psycho-social aspects, such as quality of life, resilience, fatigue (see primary and secondary outcomes) 3) to investigate potential relationships between these psychological variables at baseline and post-intervention; 4) to assess the differences in effect, patient satisfaction and participation rates according to sociodemographic and clinical characteristics; 5) to examine the reasons for dropouts and possible barriers to participation.

Additionally, considering that the ESPRIMO Study will start shortly after the end of the COVID-19 emergency, the potential impact of this emergency on patients' well-being and quality of life must be taken into account when creating the intervention together with the patients.

Therefore, the investigators aim to explore in a pre-phase the potential impact of the COVID-19 emergency on the psychological status and management of disease and the potential positive resources used to deal with this highly challenging situation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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
  • 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

  • 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

  • Co-creation phase - Focus groups

Inclusion criteria

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

Exclusion criteria

-N/A

  • 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].

Treatment and study plan

ESPRIMO

Behavioral

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Other

Registry information

Official study title

ESPRIMO: A Bio-psycho-social Co-created Intervention for Young Adults With Multiple Sclerosis: Study Protocol for a Feasibility Study

Acronym: ESPRIMO

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 16, 2020
Registry last updated
Feb 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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