CClinicalTrials.gg
CompletedNCT06403631MindFlowMSUpdated Apr 23, 2026

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

An observational study in Multiple Sclerosis, sponsored by Marta Bassi. Completed at 8 sites in Italy. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-04-23.

Sponsored by Marta Bassi · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
361
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the detailed description

The period following Multiple Sclerosis (MS) diagnosis is extremely important to identify and mobilize psychological resources that can support mental health, help cope with challenges, and lead to disease acceptance. Capitalizing on previous studies attesting to the crucial role of attentional skills in disease adjustment, the overall goal of this project is to jointly investigate flow experience and mindfulness as potential resources supporting mental health among newly diagnosed persons. While mindfulness has been widely investigated in relation to MS, flow has been rarely explored. Both constructs are rewarding mental states involving focused attention on the present moment and perceived control over the situation. Yet, they also present relevant differences. Mindfulness is characterized by reflective awareness, while flow by loss of selfconsciousness. Mindfulness can generate initial heightened unpleasant feelings, and its cultivation requires constant practice; instead, flow does not require intensive training and it is reported in association with ordinary daily situations and activities. In light of these differences, it may be suitable to promote flow, or a combination of flow and mindfulness, at the initial stages of MS, as newly diagnosed persons require immediate psychological support and need to find a sense of continuity in life. 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. 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.

02

Conditions studied

  • Multiple Sclerosis

Browse trials for

03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 361 is above the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

This is the only study on the registry with Marta Bassi as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Outpatients of Neurological Units

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
361 participants (actual)
Patient registry
No

Interventions

  • Otherobservational

    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).

06

What researchers measure

Primary outcomes

  1. 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

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

  2. 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

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

  3. 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

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

Secondary outcomes

  1. Flow-related activities (Flow Questionnaire)

    Flow Questionnaire: open-ended questions on activities associated with flow experience

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

  2. Flow occurrence (Flow Questionnaire)

    Flow Questionnaire: dummy variable for flow presence (1) vs. absence (0)

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

07

Study locations

8 sites
  • 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
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06403631
Lead sponsor
Marta Bassi
Collaborators
Italian Multiple Sclerosis Foundation, Università Vita-Salute San Raffaele, Azienda Ospedaliera Sant'Anna, San Luigi Gonzaga Hospital, University of Florence, University of Bari, University of Cagliari, Azienda Ospedaliera San Camillo Forlanini, University of Catania
Responsible party
Marta Bassi (Associate Professor, University of Milan) — Sponsor-investigator
First posted
May 8, 2024
Start date
Nov 6, 2023
Primary completion
Dec 25, 2025
Completion
Feb 28, 2026
Last update
Apr 23, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion