Multiple SclerosisMindFlowMSNCT06403631
Supporting Mental Health in Daily Life After the Diagnosis of Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Marta Bassi at 8 sites in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- observational
- How many people
- 361 participants
- Where
- 8 sitesItaly
- Study dates
- 6 Nov 2023to 28 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Outpatients of Neurological Units
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Italy8 sites
University of Bari
Bari
University of Cagliari
Cagliari
University of Catania
Catania
Azienda Ospedaliera Sant'Anna
Como
University of Florence
Florence
Università Vita-Salute San Raffaele
Milan
San Luigi Gonzaga Hospital
Orbassano
Azienda Ospedaliera San Camillo Forlanini
Roma
About this study
Official title: Supporting Mental Health in Daily Life After the Diagnosis of Multiple Sclerosis: the Role of Flow Experience and Mindfulness
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.
- Conditions
- Multiple Sclerosis
- Being tested
- observational
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationalOther
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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)
Flow Questionnaire: open-ended questions on activities associated with flow experience
Measured: The questions will be administered at T1 (within 12 months from diagnosis disclosure) and at T2 (after 6 months)
Flow occurrence (Flow Questionnaire)
Flow Questionnaire: dummy variable for flow presence (1) vs. absence (0)
Measured: The questionnaire will be administered at T1 (within 12 months from diagnosis disclosure) and at T2 (after 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start6 Nov 2023
- Primary completion25 Dec 2025
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marta Bassi
- Sponsor type
- University, hospital or other
- 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
- Sponsor-investigator, Marta Bassi, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403631
- Sponsor's protocol ID
- 2022/R-Multi/020
- Acronym
- MindFlowMS
- Status last verified
- Apr 2026
- First submitted
- 25 Apr 2024
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Mental Health in Daily Life After the Diagnosis of Multiple Sclerosis: the Role of Flow Experience and Mindfulness
- ClinicalTrials.gov ID
- NCT06403631
- Acronym / sponsor ID
- MindFlowMS / 2022/R-Multi/020
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- Marta BassiUniversity, hospital or other
- 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
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 25 Dec 2025 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 8 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Outpatients of Neurological Units
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observationalData 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). | Other | – |
Primary outcome
Positive mental health (Mental Health Continuum Short Form)
Time frame: The questionnaires will be administered at T1 (within 12 months from diagnosis disclosure) and at T2 (after 6 months)
Mental Health Continuum Short Form, min-max sum values: 0-70, higher scores indicating higher mental health
Anxiety (subscale of the Hospital Anxiety and Depression Scale)
Time frame: The questionnaires will be administered at T1 (within 12 months from diagnosis disclosure) and at T2 (after 6 months)
Subscale of the Hospital Anxiety and Depression Scale, min-max sum values: 0-21, higher scores indicating higher anxiety levels
Depression (subscale of the Hospital Anxiety and Depression Scale)
Time frame: The questionnaires will be administered at T1 (within 12 months from diagnosis disclosure) and at T2 (after 6 months)
Subscale of the Hospital Anxiety and Depression Scale, min-max sum values: 0-21, higher scores indicating higher depression levels
2 secondary outcomes
Flow-related activities (Flow Questionnaire)
Time frame: The questions will be administered at T1 (within 12 months from diagnosis disclosure) and at T2 (after 6 months)
Flow occurrence (Flow Questionnaire)
Time frame: The questionnaire will be administered at T1 (within 12 months from diagnosis disclosure) and at T2 (after 6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Marta Bassi at 8 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive mental health (Mental Health Continuum Short Form) (time frame: The questionnaires will be administered at T1 (within 12 months from diagnosis disclosure) and at T2 (after 6 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.