Clinical trial NCT04431323: Intervention for Young Adults With Multiple Sclerosis
Official title: ESPRIMO: A Bio-psycho-social Co-created Intervention for Young Adults With Multiple Sclerosis: Study Protocol for a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: quality of life
young adults
biopsychosocial intervention
Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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 \[Bowen et al., 2001\].

Primary outcomes:
measure: Change from Baseline Health-related Quality of Life up to 1 week post-intervention
timeFrame: T0: baseline, T1: up to 1 week post-intervention
measure: Acceptance and Satisfaction with the Intervention assessed by an ad hoc questionnaire
timeFrame: T1: up to 1 week post-intervention
Secondary outcomes:
measure: Change from Baseline Resilience Features up to 1 week post-intervention
timeFrame: T0: baseline, T1: up to 1 week post-intervention
measure: Change from Baseline Well-being up to 1 week post-intervention
timeFrame: T0: baseline, T1: up to 1 week post-intervention
measure: Change from Baseline Mindfulness Traits up to 1 week post-intervention
timeFrame: T0: baseline, T1: up to 1 week post-intervention
measure: Change from Baseline Self-efficacy in MS up to 1 week post-intervention assessed by the "Self-Efficacy in Multiple Sclerosis Scale" (SEMS)
timeFrame: T0: baseline, T1: up to 1 week post-intervention
measure: Change from Baseline Perceived Social Support up to 1 week post-intervention
timeFrame: T0: baseline, T1: up to 1 week post-intervention
measure: Change from Baseline Levels of Anxiety and Depression up to 1 week post-intervention
timeFrame: T0: baseline, T1: up to 1 week post-intervention
measure: Change from Baseline Illness Representations up to 1 week post-intervention
timeFrame: T0: baseline, T1: up to 1 week post-intervention
measure: Change from Baseline Committed Action up to 1 week post-intervention
timeFrame: T0: baseline, T1: up to 1 week post-intervention
measure: Change from Baseline Levels of (Motor and Cognitive) Fatigue up to 1 week post-intervention
timeFrame: T0: baseline, T1: up to 1 week post-intervention
measure: Change from Baseline Perceived Autonomy Support up to 1 week post-intervention
timeFrame: T0: baseline, T1: up to 1 week post-intervention
measure: Change from Baseline Autonomous Motivation up to 1 week post-intervention
timeFrame: T0: baseline, T1: up to 1 week post-intervention
measure: Change from Baseline Attitudes up to 1 week post-intervention
timeFrame: T0: baseline, T1: up to 1 week post-intervention
measure: Change from Baseline Subjective Norms up to 1 week post-intervention
timeFrame: T0: baseline, T1: up to 1 week post-intervention
measure: Change from Baseline Perceived Behavioral Control up to 1 week post-intervention
timeFrame: T0: baseline, T1: up to 1 week post-intervention
measure: Change from baseline number of steps/day to 5 days post-intervention
timeFrame: T0: baseline, T1: 5 days post-intervention
measure: Change from baseline km traveled/day to 5 days post-intervention
timeFrame: T0: baseline, T1: 5 days post-intervention
measure: Change from baseline number of active hours/day to 5 days post-intervention
timeFrame: T0: baseline, T1: 5 days post-intervention
measure: Change from baseline number of inactive hours/day to 5 days post-intervention
timeFrame: T0: baseline, T1: 5 days post-intervention
measure: Change from Baseline number of hours of sleep/day to 5 days post-intervention
timeFrame: T0: baseline, T1: 5 days post-intervention
measure: Change from baseline heart rate to 5 days post-intervention
timeFrame: T0: baseline, T1: 5 days post-intervention
measure: Change from baseline heart rate variability to 5 days post-intervention
timeFrame: T0: baseline, T1: 5 days post-intervention
measure: Change from estimated kilocalories consumed/day at baseline to 5 days post-intervention
timeFrame: T0: baseline, T1: 5 days post-intervention
measure: Number of Drop Outs
timeFrame: T1: up to 1 week post-intervention
measure: Exact Time of Dropping Out
timeFrame: T1: up to 1 week post-intervention
measure: Underlying Reasons for Dropping Out assessed by an ad hoc questionnaire with open questions
timeFrame: T1: up to 1 week post-intervention
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona, Policlinico G.B. Rossi
state: Veneto
Study officials:
affiliation: Azienda Ospedaliera Universitaria Integrata Verona
name: Michela Rimondini
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Ospedaliera Universitaria Integrata Verona
name: Alberto Gajofatto Study Principal Investigator
role: PRINCIPAL_INVESTIGATOR
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