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Completed

NCT Number: NCT06403631

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Bari, Bari, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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).

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

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

  2. 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)

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

Sponsors and collaborators

Lead sponsor

Marta Bassi

Other

Collaborators

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

Registry information

Official study title

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

Acronym: MindFlowMS

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
May 8, 2024
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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