Multiple SclerosisESPRIMONCT04431323
Intervention for Young Adults With Multiple Sclerosis
A study testing ESPRIMO in people with Multiple Sclerosis, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- ESPRIMO
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteItaly
- Study dates
- 13 May 2020to 30 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age range: 18-45 years;
- MS Diagnosis;
- Italian speakers;
- electronic informed consent signed.
- age range: 18-45 years;
- MS diagnosis;
Show all 19Show fewer
- Italian speakers;
- electronic informed consent signed.
- being a healthcare professional working with MS patients;
- Italian speakers;
- electronic informed consent signed.
- age range: 18-45 years;
- MS diagnosis;
- Italian speakers;
- signed informed consent.
- age range: 18-45 years;
- Ms diagnosis according to the revised McDonald Criteria [Thompson et al., 2018];
- Italian speakers;
- Signed informed consent.
Who cannot join
- N/A
- Co-creation phase - Survey with young adults with MS
- -N/A
- Co-creation phase - Survey with Healthcare Providers
- -N/A
- Co-creation phase - Focus groups
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- -N/A
- Intervention phase
- 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].
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Ospedaliera Universitaria Integrata Verona, Policlinico G.B. Rossi
Verona, Veneto, 37134
About this study
Official title: ESPRIMO: A Bio-psycho-social Co-created Intervention for Young Adults With Multiple Sclerosis: Study Protocol for a Feasibility Study
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.
Read the detailed description
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.
- Conditions
- Multiple Sclerosis
- Being tested
- ESPRIMO
- Keywords
- quality of life, young adults, biopsychosocial intervention
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESPRIMOBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| biopsychosocial intervention | Experimental | 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.] Receives: Behavioral: ESPRIMO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Health-related Quality of Life 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.
Measured: T0: baseline, T1: up to 1 week post-intervention
Acceptance and Satisfaction with the Intervention assessed by an ad hoc questionnaire
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.
Measured: T1: up to 1 week post-intervention
Secondary outcomes (25)
Change from Baseline Resilience Features 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.
Measured: T0: baseline, T1: up to 1 week post-intervention
Change from Baseline Well-being 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)).
Measured: T0: baseline, T1: up to 1 week post-intervention
Change from Baseline Mindfulness Traits 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.
Measured: T0: baseline, T1: up to 1 week post-intervention
Change from Baseline Self-efficacy in MS up to 1 week post-intervention assessed by the "Self-Efficacy in Multiple Sclerosis Scale" (SEMS)
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).
Measured: T0: baseline, T1: up to 1 week post-intervention
Change from Baseline Perceived Social Support 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.
Measured: T0: baseline, T1: up to 1 week post-intervention
Change from Baseline Levels of Anxiety and Depression 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.
Measured: T0: baseline, T1: up to 1 week post-intervention
Change from Baseline Illness Representations 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].
Measured: T0: baseline, T1: up to 1 week post-intervention
Change from Baseline Committed Action 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).
Measured: T0: baseline, T1: up to 1 week post-intervention
Change from Baseline Levels of (Motor and Cognitive) Fatigue 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.
Measured: T0: baseline, T1: up to 1 week post-intervention
Change from Baseline Perceived Autonomy Support 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.
Measured: T0: baseline, T1: up to 1 week post-intervention
Change from Baseline Autonomous Motivation 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).
Measured: T0: baseline, T1: up to 1 week post-intervention
Change from Baseline Attitudes 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").
Measured: T0: baseline, T1: up to 1 week post-intervention
Change from Baseline Subjective Norms 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.
Measured: T0: baseline, T1: up to 1 week post-intervention
Change from Baseline Perceived Behavioral Control 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.
Measured: T0: baseline, T1: up to 1 week post-intervention
Change from baseline number of steps/day to 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.
Measured: T0: baseline, T1: 5 days post-intervention
Change from baseline km traveled/day to 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.
Measured: T0: baseline, T1: 5 days post-intervention
Change from baseline number of active hours/day to 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.
Measured: T0: baseline, T1: 5 days post-intervention
Change from baseline number of inactive hours/day to 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.
Measured: T0: baseline, T1: 5 days post-intervention
Change from Baseline number of hours of sleep/day to 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.
Measured: T0: baseline, T1: 5 days post-intervention
Change from baseline heart rate to 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).
Measured: T0: baseline, T1: 5 days post-intervention
Change from baseline heart rate variability to 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).
Measured: T0: baseline, T1: 5 days post-intervention
Change from estimated kilocalories consumed/day at baseline to 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.
Measured: T0: baseline, T1: 5 days post-intervention
Number of Drop Outs
The number of drop outs is the second specific outcome measure evaluating the feasibility of the intervention.
Measured: T1: up to 1 week post-intervention
Exact Time of Dropping Out
The exact time point of dropping out will also be assessed.
Measured: T1: up to 1 week post-intervention
Underlying Reasons for Dropping Out assessed by an ad hoc questionnaire with open questions
Patients who drop out during the interventions will be contacted to assess the underlying reasons using an ad hoc questionnaire with open questions.
Measured: T1: up to 1 week post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start13 May 2020
- Primary completion30 Jul 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michela Rimondini, Principal investigator, Azienda Ospedaliera Universitaria Integrata VeronaAlberto Gajofatto Study Principal Investigator, Principal investigator, Azienda Ospedaliera Universitaria Integrata Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04431323
- Sponsor's protocol ID
- 2676CESC
- Acronym
- ESPRIMO
- Status last verified
- Jan 2023
- First submitted
- 13 May 2020
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for the primary and secondary outcome measures will be made available upon reasonable request.
Publications
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.
PubMed 29275977Bowen J, Gibbons L, Gianas A, Kraft GH. Self-administered Expanded Disability Status Scale with functional system scores correlates well with a physician-administered test. Mult Scler. 2001 Jun;7(3):201-6. doi: 10.1177/135245850100700311.
PubMed 11475445Van Weel C. Functional status in primary care: COOP/WONCA charts. Disabil Rehabil. 1993 Apr-Jun;15(2):96-101. doi: 10.3109/09638289309165878.
PubMed 8513163Connor 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.
PubMed 12964174Apolone G, Mosconi P, Quattrociocchi L, et al. Questionario sullo stato di salute SF-12. Versione italiana. Milano: Guerini e Associati, 2001.
Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.
PubMed 16443717Giovannini 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.
Costantini M, Musso M, Viterbori P, Bonci F, Del Mastro L, Garrone O, Venturini M, Morasso G. Detecting psychological distress in cancer patients: validity of the Italian version of the Hospital Anxiety and Depression Scale. Support Care Cancer. 1999 May;7(3):121-7. doi: 10.1007/s005200050241.
PubMed 10335929Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
PubMed 6880820Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006 Jun;60(6):631-7. doi: 10.1016/j.jpsychores.2005.10.020.
PubMed 16731240Pain 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.
McCracken LM. Committed action: an application of the psychological flexibility model to activity patterns in chronic pain. J Pain. 2013 Aug;14(8):828-35. doi: 10.1016/j.jpain.2013.02.009. Epub 2013 May 4.
PubMed 23651881
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ESPRIMO: A Bio-psycho-social Co-created Intervention for Young Adults With Multiple Sclerosis: Study Protocol for a Feasibility Study
- ClinicalTrials.gov ID
- NCT04431323
- Acronym / sponsor ID
- ESPRIMO / 2676CESC
- Conditions
- Multiple Sclerosis
- Keywords
- quality of life, young adults, biopsychosocial intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Study start
- 13 May 2020 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| biopsychosocial intervention | Experimental | Behavioral: ESPRIMOYoung 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.] |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- age range: 18-45 years;
- Ms diagnosis according to the revised McDonald Criteria [Thompson et al., 2018];
- Italian speakers;
- Signed informed consent.
Key exclusion criteria (11 listed)
- Co-creation phase - Survey with young adults with MS
- -N/A
- Co-creation phase - Survey with Healthcare Providers
- -N/A
- Co-creation phase - Focus groups
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESPRIMOParticipants 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. | Behavioural | biopsychosocial intervention |
Primary outcome
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.
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.
25 secondary outcomes
Change from Baseline Resilience Features up to 1 week post-intervention
Time frame: T0: baseline, T1: up to 1 week post-intervention
Change from Baseline Well-being up to 1 week post-intervention
Time frame: T0: baseline, T1: up to 1 week post-intervention
Change from Baseline Mindfulness Traits up to 1 week post-intervention
Time frame: T0: baseline, T1: up to 1 week post-intervention
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
Change from Baseline Perceived Social Support up to 1 week post-intervention
Time frame: T0: baseline, T1: up to 1 week post-intervention
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
Change from Baseline Illness Representations up to 1 week post-intervention
Time frame: T0: baseline, T1: up to 1 week post-intervention
Change from Baseline Committed Action up to 1 week post-intervention
Time frame: T0: baseline, T1: up to 1 week post-intervention
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
Change from Baseline Perceived Autonomy Support up to 1 week post-intervention
Time frame: T0: baseline, T1: up to 1 week post-intervention
Change from Baseline Autonomous Motivation up to 1 week post-intervention
Time frame: T0: baseline, T1: up to 1 week post-intervention
Change from Baseline Attitudes up to 1 week post-intervention
Time frame: T0: baseline, T1: up to 1 week post-intervention
Change from Baseline Subjective Norms up to 1 week post-intervention
Time frame: T0: baseline, T1: up to 1 week post-intervention
Change from Baseline Perceived Behavioral Control up to 1 week post-intervention
Time frame: T0: baseline, T1: up to 1 week post-intervention
Change from baseline number of steps/day to 5 days post-intervention
Time frame: T0: baseline, T1: 5 days post-intervention
Change from baseline km traveled/day to 5 days post-intervention
Time frame: T0: baseline, T1: 5 days post-intervention
Change from baseline number of active hours/day to 5 days post-intervention
Time frame: T0: baseline, T1: 5 days post-intervention
Change from baseline number of inactive hours/day to 5 days post-intervention
Time frame: T0: baseline, T1: 5 days post-intervention
Change from Baseline number of hours of sleep/day to 5 days post-intervention
Time frame: T0: baseline, T1: 5 days post-intervention
Change from baseline heart rate to 5 days post-intervention
Time frame: T0: baseline, T1: 5 days post-intervention
Change from baseline heart rate variability to 5 days post-intervention
Time frame: T0: baseline, T1: 5 days post-intervention
Change from estimated kilocalories consumed/day at baseline to 5 days post-intervention
Time frame: T0: baseline, T1: 5 days post-intervention
Number of Drop Outs
Time frame: T1: up to 1 week post-intervention
Exact Time of Dropping Out
Time frame: T1: up to 1 week post-intervention
Underlying Reasons for Dropping Out assessed by an ad hoc questionnaire with open questions
Time frame: T1: up to 1 week post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Background: PubMed 29275977Thompson 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.
- Background: PubMed 11475445Bowen J, Gibbons L, Gianas A, Kraft GH. Self-administered Expanded Disability Status Scale with functional system scores correlates well with a physician-administered test. Mult Scler. 2001 Jun;7(3):201-6. doi: 10.1177/135245850100700311.
- Background: PubMed 8513163Van Weel C. Functional status in primary care: COOP/WONCA charts. Disabil Rehabil. 1993 Apr-Jun;15(2):96-101. doi: 10.3109/09638289309165878.
- Background: PubMed 12964174Connor 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.
- BackgroundApolone G, Mosconi P, Quattrociocchi L, et al. Questionario sullo stato di salute SF-12. Versione italiana. Milano: Guerini e Associati, 2001.
- Background: PubMed 16443717Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.
- BackgroundGiovannini 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.
- BackgroundBonino 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.
- Background: PubMed 10335929Costantini M, Musso M, Viterbori P, Bonci F, Del Mastro L, Garrone O, Venturini M, Morasso G. Detecting psychological distress in cancer patients: validity of the Italian version of the Hospital Anxiety and Depression Scale. Support Care Cancer. 1999 May;7(3):121-7. doi: 10.1007/s005200050241.
- Background: PubMed 6880820Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
- Background: PubMed 16731240Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006 Jun;60(6):631-7. doi: 10.1016/j.jpsychores.2005.10.020.
- BackgroundPain 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for the primary and secondary outcome measures will be made available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michela Rimondini principal investigator
Azienda Ospedaliera Universitaria Integrata Verona
Alberto Gajofatto Study Principal Investigator principal investigator
Azienda Ospedaliera Universitaria Integrata Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESPRIMO in people with Multiple Sclerosis, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04431323, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.