NCT04711941

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 27, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 15, 2021

Completed
17 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

May 6, 2021

Status Verified

May 1, 2021

Enrollment Period

3 months

First QC Date

December 27, 2020

Last Update Submit

May 3, 2021

Conditions

Multiple Sclerosis

Keywords

theory of mindrehabilitationmultiple sclerosisneurodegenerative disease

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • Toronto Alexithymia Scale (TAS-20)

    4 weeks

  • Multiple Sclerosis Quality of Life 54 questionnaire (MSQOL54)

    4 weeks

  • Montreal Cognitive Assessment (MoCA)

    4 weeks

  • The Brief Repeatable Battery of Neuropsychological Test (BRB-NT)

    4 weeks

Study Arms (2)

ToM training

EXPERIMENTAL

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

Non mentalistic training

ACTIVE COMPARATOR

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

Interventions

Rehabilitation trainingBEHAVIORAL

Rehabilitation with behavioural stimuli

Non mentalistic trainingToM training

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Fondazione Don Carlo Gnocchi

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Multiple SclerosisNeurodegenerative Diseases

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Alessia d'Arma, MSc

CONTACT

+39 02 40308436adarma@dongnocchi.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2020

First Posted

January 15, 2021

Study Start

February 1, 2021

Primary Completion

May 1, 2021

Study Completion

September 1, 2021

Last Updated

May 6, 2021

Record last verified: 2021-05

Locations

IT(1)