Study Results
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Basic Information
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COMPLETED
NA
53 participants
INTERVENTIONAL
2020-05-13
2022-10-30
Brief Summary
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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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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
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.
TREATMENT
NONE
Study Groups
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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).
\[The intervention will start as soon as 8-10 patients will have been enrolled. A waiting list will be then created and patients contacted when the subsequent group starts. This waiting list does not serve as control group.
One or more groups, respectively for the psychological intervention and the physical activities, may start at the same time but on different days, considering also the results of the co-creation phase.\]
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* MS Diagnosis;
* Italian speakers;
* electronic informed consent signed.
* age range: 18-45 years;
* MS diagnosis;
* 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.
Exclusion Criteria
* N/A
2. Co-creation phase - Survey with young adults with MS
-N/A
3. Co-creation phase - Survey with Healthcare Providers
-N/A
4. Co-creation phase - Focus groups
-N/A
5. 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 \[Bowen et al., 2001\].
18 Years
45 Years
ALL
No
Sponsors
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Azienda Ospedaliera Universitaria Integrata Verona
OTHER
Responsible Party
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Principal Investigators
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Michela Rimondini
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliera Universitaria Integrata Verona
Alberto Gajofatto Study Principal Investigator
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliera Universitaria Integrata Verona
Locations
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Azienda Ospedaliera Universitaria Integrata Verona, Policlinico G.B. Rossi
Verona, Veneto, Italy
Countries
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References
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Bowen 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.
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Other Identifiers
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2676CESC
Identifier Type: -
Identifier Source: org_study_id
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