A ToM Training for People With Multiple Sclerosis: an Efficacy Study.

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of a Novel Theory of Mind Training for People With Multiple Sclerosis: a Randomised Controlled Trial.

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: Rehabilitation training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ToM training<br>ToM training was composed of six lessons two times a week. Through several types of stimuli, the trainer worked together with the participant to comprehend and hypothesize interpretations of the emotions and social interactions, providing discussion occasions to enhance the attribution of mental states and emotions. Every lesson had a duration of 45/60 minutes in order to avoid excessive fatigue in the participant. | Behavioral: Rehabilitation training<br>* Rehabilitation with behavioural stimuli<br>|
| Active Comparator: Non mentalistic training<br>ToM training was composed of six lessons two times a week. Through several types of stimuli, the trainer worked together with the participant to provide a historical and descriptive overview of cinema movies, TV news, documentaries, newspapers, and advertising. Every lesson had a duration of 45/60 minutes in order to avoid excessive fatigue in the participant. | Behavioral: Rehabilitation training<br>* Rehabilitation with behavioural stimuli<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reading the Mind from the Eyes (RMET) | A measure of affective ToM | 4 weeks | 
| Strange Stories | A measure of advanced ToM | 4 weeks | 
| Faux pas | A measure of both cognitive and affective advanced ToM | 4 weeks | 
| False Belief Task | A measure of cognitiveToM | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toronto Alexithymia Scale (TAS-20) | A measure of Alexithymia traits | 4 weeks | 
| Multiple Sclerosis Quality of Life 54 questionnaire (MSQOL54) | A measure of Quality of Life in Multiple Sclerosis | 4 weeks | 
| Montreal Cognitive Assessment (MoCA) | A measure of global cognitive level | 4 weeks | 
| The Brief Repeatable Battery of Neuropsychological Test (BRB-NT) | A measure of cognitive functions in Multiple Sclerosis | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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theory of mind, rehabilitation, multiple sclerosis, neurodegenerative disease