Back to resultsA ToM Training for People With Multiple Sclerosis: an Efficacy Study. (ToM)
Primary Purpose
Multiple Sclerosis
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Rehabilitation training
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring theory of mind, rehabilitation, multiple sclerosis, neurodegenerative disease
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.
Sites / Locations
- IRCCS Fondazione Don Carlo GnocchiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ToM training
Non mentalistic training
Arm 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.
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.
Outcomes
Primary Outcome Measures
Reading the Mind from the Eyes (RMET)
A measure of affective ToM
Strange Stories
A measure of advanced ToM
Faux pas
A measure of both cognitive and affective advanced ToM
False Belief Task
A measure of cognitiveToM
Secondary Outcome Measures
Toronto Alexithymia Scale (TAS-20)
A measure of Alexithymia traits
Multiple Sclerosis Quality of Life 54 questionnaire (MSQOL54)
A measure of Quality of Life in Multiple Sclerosis
Montreal Cognitive Assessment (MoCA)
A measure of global cognitive level
The Brief Repeatable Battery of Neuropsychological Test (BRB-NT)
A measure of cognitive functions in Multiple Sclerosis
Full Information
NCT ID
NCT04711941
First Posted
December 27, 2020
Last Updated
May 3, 2021
Sponsor
Fondazione Don Carlo Gnocchi Onlus
1. Study Identification
Unique Protocol Identification Number
NCT04711941
Brief Title
A ToM Training for People With Multiple Sclerosis: an Efficacy Study.
Acronym
ToM
Official Title
Effectiveness of a Novel Theory of Mind Training for People With Multiple Sclerosis: a Randomised Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Don Carlo Gnocchi Onlus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
theory of mind, rehabilitation, multiple sclerosis, neurodegenerative disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ToM training
Arm Type
Experimental
Arm 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.
Arm Title
Non mentalistic training
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Rehabilitation training
Intervention Description
Rehabilitation with behavioural stimuli
Primary Outcome Measure Information:
Title
Reading the Mind from the Eyes (RMET)
Description
A measure of affective ToM
Time Frame
4 weeks
Title
Strange Stories
Description
A measure of advanced ToM
Time Frame
4 weeks
Title
Faux pas
Description
A measure of both cognitive and affective advanced ToM
Time Frame
4 weeks
Title
False Belief Task
Description
A measure of cognitiveToM
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Toronto Alexithymia Scale (TAS-20)
Description
A measure of Alexithymia traits
Time Frame
4 weeks
Title
Multiple Sclerosis Quality of Life 54 questionnaire (MSQOL54)
Description
A measure of Quality of Life in Multiple Sclerosis
Time Frame
4 weeks
Title
Montreal Cognitive Assessment (MoCA)
Description
A measure of global cognitive level
Time Frame
4 weeks
Title
The Brief Repeatable Battery of Neuropsychological Test (BRB-NT)
Description
A measure of cognitive functions in Multiple Sclerosis
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alessia d'Arma, MSc
Phone
+39 02 40308436
Email
adarma@dongnocchi.it
Facility Information:
Facility Name
IRCCS Fondazione Don Carlo Gnocchi
City
Milan
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Mendozzi, MD
Email
lmendozzi@dongnocchi.it
12. IPD Sharing Statement
Learn more about this trial
A ToM Training for People With Multiple Sclerosis: an Efficacy Study.
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