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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Rehabilitation training

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alessia d'Arma, MSc; Phone Number: +39 02 40308436; Email: adarma@dongnocchi.it

Study Locations

• Italy
  • Milan, Italy
    • Recruiting
    • IRCCS Fondazione Don Carlo Gnocchi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ToM 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.	Behavioral: Rehabilitation training; Rehabilitation with behavioural stimuli
ACTIVE_COMPARATOR: Non mentalistic 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.	Behavioral: Rehabilitation training; Rehabilitation with behavioural stimuli

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fondazione Don Carlo Gnocchi Onlus

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2021
• Primary Completion (ANTICIPATED): May 1, 2021
• Study Completion (ANTICIPATED): September 1, 2021

Study Registration Dates

• First Submitted: December 27, 2020
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (ACTUAL): January 15, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 6, 2021
• Last Update Submitted That Met QC Criteria: May 3, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: rehabilitation; multiple sclerosis; theory of mind; neurodegenerative disease
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 5_25/07/2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No