Multiple Sclerosis
Conditions
Keywords
theory of mind, rehabilitation, multiple sclerosis, neurodegenerative disease
Brief summary
Theory of Mind (ToM) is the ability to understand and attribute mental states to ourselves and others. People with Multiple Sclerosis (pwMS) could present an impairment of this ability, with negative consequences on their social relationships and Quality of Life (QoL). We aimed to design and implement a novel ToM rehabilitation training, testing its efficacy on the promotion of emotional and mental states understanding, on QoL and on the alexithymia traits.
Interventions
BEHAVIORALRehabilitation training
Rehabilitation with behavioural stimuli
Sponsors
Fondazione Don Carlo Gnocchi Onlus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* diagnosis of Relapsing-Remitting (RR), Secondary Progressive (SP) and Primary Progressive (PP) MS; * age ≥ 18 and ≤ 75 years; * years of education ≥ 5; * no change of pharmacological treatment in the 6 months before the enrollment; * no clinical relapses or use of steroid treatment during 3 months before the enrollment; * provided informed consent for study participation.
Exclusion criteria
* history of nervous system disorders different from MS; * unstable psychiatric illness, such as psychosis or major depression; * severe disability with Expanded Disability Status Scale (EDSS) score \> 7.5; * severe cognitive impairment that would not enable PwMS to answer to questionnaires correctly (i.e. dementia), according to the patient's medical records.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| False Belief Task | 4 weeks | A measure of cognitiveToM |
| Reading the Mind from the Eyes (RMET) | 4 weeks | A measure of affective ToM |
| Strange Stories | 4 weeks | A measure of advanced ToM |
| Faux pas | 4 weeks | A measure of both cognitive and affective advanced ToM |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Brief Repeatable Battery of Neuropsychological Test (BRB-NT) | 4 weeks | A measure of cognitive functions in Multiple Sclerosis |
| Toronto Alexithymia Scale (TAS-20) | 4 weeks | A measure of Alexithymia traits |
| Multiple Sclerosis Quality of Life 54 questionnaire (MSQOL54) | 4 weeks | A measure of Quality of Life in Multiple Sclerosis |
| Montreal Cognitive Assessment (MoCA) | 4 weeks | A measure of global cognitive level |
Countries
Italy
Contacts
Primary ContactAlessia d'Arma, MSc
Outcome results
None listed