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

Multiple Sclerosis Clinical Trial

— MindFlowMS  

Official title:

Supporting Mental Health in Daily Life After the Diagnosis of Multiple Sclerosis: the Role of Flow Experience and Mindfulness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06403631
• Other study ID #: 2022/R-Multi/020
• Status: Recruiting
• Start date: November 6, 2023
• Est. completion date: February 28, 2026

Study information

• Verified date: May 2024
• Source: University of Milan
• Contact: Marta Bassi, PhD
• Phone: +390250319709
• Email: marta.bassi[@]unimi.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 123
• Est. completion date: February 28, 2026
• Est. primary completion date: November 25, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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:

• 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)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• 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).

Locations

Country	Name	City	State
Italy	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	Milano
Italy	San Luigi Gonzaga Hospital	Orbassano
Italy	Azienda Ospedaliera San Camillo Forlanini	Roma

Sponsors (10)

Lead Sponsor	Collaborator
Marta Bassi	Azienda Ospedaliera San Camillo Forlanini, Azienda Ospedaliera Sant'Anna, Italian Multiple Sclerosis Foundation, San Luigi Gonzaga Hospital, Università Vita-Salute San Raffaele, University of Bari, University of Cagliari, University of Catania, University of Florence

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Flow-related activities (Flow Questionnaire)	Flow Questionnaire: open-ended questions on activities associated with flow experience	The questions will be administered at T1 (within 12 months from diagnosis disclosure) and at T2 (after 6 months)
Secondary	Flow occurrence (Flow Questionnaire)	Flow Questionnaire: dummy variable for flow presence (1) vs. absence (0)	The questionnaire will be administered at T1 (within 12 months from diagnosis disclosure) and at T2 (after 6 months)