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

Not Applicable

• Conditions: Multiple Sclerosis
• Interventions: Behavioral: Rehabilitation training

• Registration Number: NCT04711941
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-27
• Study First Submitted QC: 2021-01-13
• Study First Posted: 2021-01-15
• Study Start: 2021-02-01
• Status Verified: 2021-05
• Primary Completion: 2021-05
• Last Update Submitted: 2021-05-03
• Last Update Posted: 2021-05-06
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ToM training	Rehabilitation training	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.
Non mentalistic training	Rehabilitation training	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.

Primary Outcome Measures

Name	Time	Method
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
False Belief Task	4 weeks	A measure of cognitiveToM

Secondary Outcome Measures

Name	Time	Method
Montreal Cognitive Assessment (MoCA)	4 weeks	A measure of global cognitive level
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

Trial Locations

Locations (1)

IRCCS Fondazione Don Carlo Gnocchi; 🇮🇹 Milan, Italy