Supporting Mental Health in Daily Life After the Diagnosis of Multiple Sclerosis

NCT06403631 | Completed

• 1 other identifier: 2022/R-Multi/020
• Study Type: observational
• Target: 361
• Locations: 1 country
• Sites: 8

Brief Summary

The overall goal of this observational study is to learn about the psychological resources of mindfulness and flow experience available to persons newly diagnosed with multiple sclerosis (MS). The primary study aim will be to analyze the relation of flow and mindfulness with mental health among individuals who received an MS diagnosis within the last year. Secondary aims will be to analyze the daily activities preferentially associated with flow, and to evaluate possible changes in daily flow retrieval. Participants will answer questionnaires measuring flow, mindfulness, positive mental health, anxiety and depression at project start and 6 months later.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (3)

• Positive mental health (Mental Health Continuum Short Form)

  Mental Health Continuum Short Form, min-max sum values: 0-70, higher scores indicating higher mental health

  The questionnaires will be administered at T1 (within 12 months from diagnosis disclosure) and at T2 (after 6 months)

• Anxiety (subscale of the Hospital Anxiety and Depression Scale)

  Subscale of the Hospital Anxiety and Depression Scale, min-max sum values: 0-21, higher scores indicating higher anxiety levels

  The questionnaires will be administered at T1 (within 12 months from diagnosis disclosure) and at T2 (after 6 months)

• Depression (subscale of the Hospital Anxiety and Depression Scale)

  Subscale of the Hospital Anxiety and Depression Scale, min-max sum values: 0-21, higher scores indicating higher depression levels

  The questionnaires will be administered at T1 (within 12 months from diagnosis disclosure) and at T2 (after 6 months)

Secondary Outcomes (2)

• Flow-related activities (Flow Questionnaire)

  The questions will be administered at T1 (within 12 months from diagnosis disclosure) and at T2 (after 6 months)

• Flow occurrence (Flow Questionnaire)

  The questionnaire will be administered at T1 (within 12 months from diagnosis disclosure) and at T2 (after 6 months)

Interventions

observational OTHER

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

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Outpatients of Neurological Units

You may qualify if:

• age 18-50
• clinically-definite MS diagnosed (with McDonald's revised criteria) within the previous 12 months
• steroid treatment for at least 1 month
• written informed consent

You may not qualify if:

• neurological disorders other than MS
• 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)

Sponsors & Collaborators

• Marta Bassi: lead
• Italian Multiple Sclerosis Foundation: collaborator
• Università Vita-Salute San Raffaele: collaborator
• Azienda Ospedaliera Sant'Anna: collaborator
• San Luigi Gonzaga Hospital: collaborator
• University of Florence: collaborator
• University of Bari: collaborator
• University of Cagliari: collaborator
• Azienda Ospedaliera San Camillo Forlanini: collaborator
• University of Catania: collaborator

Study Sites (8)

University of Bari

Bari, Italy

Location

University of Cagliari

Cagliari, Italy

Location

University of Catania

Catania, Italy

Location

Azienda Ospedaliera Sant'Anna

Como, Italy

Location

University of Florence

Florence, Italy

Location

Università Vita-Salute San Raffaele

Milan, Italy

Location

San Luigi Gonzaga Hospital

Orbassano, Italy

Location

Azienda Ospedaliera San Camillo Forlanini

Roma, Italy

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: May 8, 2024
• Study Start: November 6, 2023
• Primary Completion: December 25, 2025
• Study Completion: February 28, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (8)