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

NCT ID: NCT04711941

Last Updated: 2021-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2021-09-30

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Rehabilitation training

Intervention Type: BEHAVIORAL

Rehabilitation with behavioural stimuli

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.

Group Type: ACTIVE_COMPARATOR

Rehabilitation training

Intervention Type: BEHAVIORAL

Rehabilitation with behavioural stimuli

Interventions

Rehabilitation training

Rehabilitation with behavioural stimuli

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS Fondazione Don Carlo Gnocchi

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Alessia d'Arma, MSc

Role: CONTACT

adarma@dongnocchi.it

+39 02 40308436

Facility Contacts

Laura Mendozzi, MD

Role: primary

lmendozzi@dongnocchi.it

Other Identifiers

5_25/07/2019

Identifier Type: -

Identifier Source: org_study_id