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

Don Carlo Gnocchi Onlus Foundation

Status: Unknown

Conditions: Multiple Sclerosis

Treatments: Behavioral: Rehabilitation training

Study type: Interventional

Funder types: Other

Identifiers

NCT04711941

5_25/07/2019

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

ToM training

Experimental group

Description:

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.

Treatment:

Behavioral: Rehabilitation training

Non mentalistic training

Active Comparator group

Description:

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.

Treatment:

Behavioral: Rehabilitation training