Supporting Mental Health in Daily Life After the Diagnosis of Multiple Sclerosis
NCT ID: NCT06403631
Last Updated: 2024-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
123 participants
OBSERVATIONAL
2023-11-06
2026-02-28
Brief Summary
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Detailed Description
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Secondary aims will be to analyze the daily activities preferentially associated with flow, and to evaluate possible changes in daily flow retrieval. Data will be gathered longitudinally from participants recruited in MS centers across Italy. Participants will fill in online questionnaires measuring flow, mindfulness, positive mental health, anxiety and depression. The questionnaires, including both scaled and open-ended questions, will be proposed at the project start (T1) and 6 months later (T2). Hierarchical regressions and qualitative analyses will be conducted to assess study aims. Both flow and mindfulness are expected to independently contribute to participants' mental health. However, considering its usual occurrence in daily contexts, flow is expected to provide a more relevant contribution than mindfulness, and to play a moderating role in the relation between mindfulness and mental health. The investigators also expect that participants will primarily retrieve flow in productive and leisure activities, and that fewer participants would find flow occasions in their daily life after the diagnosis.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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observational
Data will be gathered longitudinally from participants newly diagnosed with multiple sclerosis. Participants will fill in online questionnaires measuring flow, mindfulness, positive mental health, anxiety and depression. The questionnaires, including both scaled and open-ended questions, will be proposed at the project start (T1) and 6 months later (T2).
Eligibility Criteria
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Inclusion Criteria
* clinically-definite MS diagnosed (with McDonald's revised criteria) within the previous 12 months
* steroid treatment for at least 1 month
* written informed consent
Exclusion Criteria
* psychiatric disorders
* severe physical impairment (EDSS=\>8)
* pregnancy
* current or previous attendance in Mindfulness Based Interventions or Acceptance and Commitment Therapy
* severe cognitive impairment in comprehension, attention and execution of inferential-logical operations which could interfere with the ability to fill in questionnaires (equivalent scores 0-1 at Progressive Raven Matrices; score \<11.3 at the visual comprehension of sentences subtest of the Aphasia Neuropsychological Test; score \<37.9 at Symbol Digit Modalities Test; and score \<93.1 at the Brief Test of Intelligence)
18 Years
50 Years
ALL
No
Sponsors
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Italian Multiple Sclerosis Foundation
OTHER
Università Vita-Salute San Raffaele
OTHER
Azienda Ospedaliera Sant'Anna
OTHER
San Luigi Gonzaga Hospital
OTHER
University of Florence
OTHER
University of Bari
OTHER
University of Cagliari
OTHER
Azienda Ospedaliera San Camillo Forlanini
OTHER
University of Catania
OTHER
Marta Bassi
OTHER
Responsible Party
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Marta Bassi
Associate Professor
Locations
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University of Bari
Bari, , Italy
University of Cagliari
Cagliari, , Italy
University of Catania
Catania, , Italy
Azienda Ospedaliera Sant'Anna
Como, , Italy
University of Florence
Florence, , Italy
Università Vita-Salute San Raffaele
Milan, , Italy
San Luigi Gonzaga Hospital
Orbassano, , Italy
Azienda Ospedaliera San Camillo Forlanini
Roma, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022/R-Multi/020
Identifier Type: -
Identifier Source: org_study_id
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