NCT06403631Completed
Supporting Mental Health in Daily Life After the Diagnosis of Multiple Sclerosis
Supporting Mental Health in Daily Life After the Diagnosis of Multiple Sclerosis: the Role of Flow Experience and Mindfulness
Source: ClinicalTrials.gov · Last updated 23 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 361 (actual)
- First submitted
- 25 Apr 2024
- Start date
- 6 Nov 2023
- Primary completion date
- 25 Dec 2025
- Lead sponsor
- Marta Bassi
- Diseases
- Multiple sclerosis
- NCT number
- NCT06403631
What you commit to
- Study type: Observational
- Participants enrolled: 361
- From 6 Nov 2023 to the primary completion date, 25 Dec 2025
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- current or previous attendance in Mindfulness Based Interventions or Acceptance and Commitment Therapy
Other illness
- neurological disorders other than MS
- psychiatric disorders
- severe physical impairment (EDSS=\>8)
- 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)
Other
- pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to 50 years · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Bari Coordinator of this site? Confirm its status | Bari | Italy | Unknown status |
| University of Cagliari Coordinator of this site? Confirm its status | Cagliari | Italy | Unknown status |
| University of Catania Coordinator of this site? Confirm its status | Catania | Italy | Unknown status |
| Azienda Ospedaliera Sant'Anna Coordinator of this site? Confirm its status | Como | Italy | Unknown status |
| University of Florence Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| Università Vita-Salute San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| San Luigi Gonzaga Hospital Coordinator of this site? Confirm its status | Orbassano | Italy | Unknown status |
| Azienda Ospedaliera San Camillo Forlanini Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.