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

Multiple Sclerosis Clinical Trial

— ToM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04711941
• Other study ID #: 5_25/07/2019
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: September 2021

Study information

• Verified date: May 2021
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: Alessia d'Arma, MSc
• Phone: +39 02 40308436
• Email: adarma[@]dongnocchi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Rehabilitation training
Rehabilitation with behavioural stimuli

Locations

Country	Name	City	State
Italy	IRCCS Fondazione Don Carlo Gnocchi	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reading the Mind from the Eyes (RMET)	A measure of affective ToM	4 weeks
Primary	Strange Stories	A measure of advanced ToM	4 weeks
Primary	Faux pas	A measure of both cognitive and affective advanced ToM	4 weeks
Primary	False Belief Task	A measure of cognitiveToM	4 weeks
Secondary	Toronto Alexithymia Scale (TAS-20)	A measure of Alexithymia traits	4 weeks
Secondary	Multiple Sclerosis Quality of Life 54 questionnaire (MSQOL54)	A measure of Quality of Life in Multiple Sclerosis	4 weeks
Secondary	Montreal Cognitive Assessment (MoCA)	A measure of global cognitive level	4 weeks
Secondary	The Brief Repeatable Battery of Neuropsychological Test (BRB-NT)	A measure of cognitive functions in Multiple Sclerosis	4 weeks