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

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

Status unknownNot a drug-phase studyRelapsing and progressiveNCT04711941

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Rehabilitation training

What it measured

Main measures

  • Reading the Mind from the Eyes (RMET)

    4 weeks

  • Strange Stories

    4 weeks

  • Faux pas

    4 weeks

    Thinking and memory

  • False Belief Task

    4 weeks

    Thinking and memory

Other measures (4)

  • Toronto Alexithymia Scale (TAS-20)

    4 weeks

  • Multiple Sclerosis Quality of Life 54 questionnaire (MSQOL54)

    4 weeks

    Quality of life (reported by participants)

  • Montreal Cognitive Assessment (MoCA)

    4 weeks

    Thinking and memory

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

    4 weeks

    Thinking and memory

Who could take part

Relapsing and progressive · 18 to 75

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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    History

      1. Started

        Feb 2021

      2. Main results due

        May 2021

      3. Finished

        Sept 2021

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