Intervention for Young Adults With Multiple Sclerosis
ESPRIMO: A Bio-psycho-social Co-created Intervention for Young Adults With Multiple Sclerosis: Study Protocol for a Feasibility Study
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- ESPRIMO
What it measured
Main measures
Change from Baseline Health-related Quality of Life up to 1 week post-intervention
T0: baseline, T1: up to 1 week post-intervention
Physical functionQuality of life (reported by participants)Acceptance and Satisfaction with the Intervention assessed by an ad hoc questionnaire
T1: up to 1 week post-intervention
Quality of life (reported by participants)Feasibility
Other measures (25)
Change from Baseline Resilience Features up to 1 week post-intervention
T0: baseline, T1: up to 1 week post-intervention
Change from Baseline Well-being up to 1 week post-intervention
T0: baseline, T1: up to 1 week post-intervention
Change from Baseline Mindfulness Traits up to 1 week post-intervention
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)
T0: baseline, T1: up to 1 week post-intervention
Change from Baseline Perceived Social Support up to 1 week post-intervention
T0: baseline, T1: up to 1 week post-intervention
Change from Baseline Levels of Anxiety and Depression up to 1 week post-intervention
T0: baseline, T1: up to 1 week post-intervention
Mood and sleepChange from Baseline Illness Representations up to 1 week post-intervention
T0: baseline, T1: up to 1 week post-intervention
PainChange from Baseline Committed Action up to 1 week post-intervention
T0: baseline, T1: up to 1 week post-intervention
Change from Baseline Levels of (Motor and Cognitive) Fatigue up to 1 week post-intervention
T0: baseline, T1: up to 1 week post-intervention
Thinking and memoryFatigueChange from Baseline Perceived Autonomy Support up to 1 week post-intervention
T0: baseline, T1: up to 1 week post-intervention
Physical function
Who could take part
MS (type not specified) · 18 to 45
Show the full criteria
Inclusion 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].
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Poli S, Donisi V, Mazzi MA, Gobbin F, Giusto G, Orlandi R, Schena F, Del Piccolo L, das Nair R, Gajofatto A, Rimondini M. Fostering quality of life in young adults living with multiple sclerosis: a pilot study of a co-created integrated intervention. Front Psychol. 2024 Mar 26;15:1342166. doi: 10.3389/fpsyg.2024.1342166. eCollection 2024.Background
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 revisionsBackground
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.Background
Van Weel C. Functional status in primary care: COOP/WONCA charts. Disabil Rehabil. 1993 Apr-Jun;15(2):96-101. doi: 10.3109/09638289309165878.Background
Connor 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.Background
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.Background
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.Background
Zigmond 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
Broadbent 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.Background
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.
Loading reviews and guidelines…
History
Started
May 2020
Main results due
Jul 2022
Finished
Oct 2022