Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06403631
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-04-25
Brief Title:
Supporting Mental Health in Daily Life After the Diagnosis of Multiple Sclerosis
Sponsor:
Marta Bassi
Organization:
University of Milan
Study Overview
Official Title:
Supporting Mental Health in Daily Life After the Diagnosis of Multiple Sclerosis the Role of Flow Experience and Mindfulness
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MindFlowMS
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None