Exploring mindfulness and flow in newly diagnosed multiple sclerosis patients
Supporting Mental Health in Daily Life After the Diagnosis of Multiple Sclerosis: the Role of Flow Experience and Mindfulness
This study is trying to see if practicing mindfulness and finding flow in daily activities can help improve mental health for people who have just been diagnosed with multiple sclerosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 123 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | University of Milan Academic / other |
| Locations | 8 sites (Bari and 7 other locations) |
| Trial ID | NCT06403631 on ClinicalTrials.gov |
What this trial studies
This observational study aims to understand how mindfulness and flow experiences can support mental health in individuals who have been newly diagnosed with multiple sclerosis (MS). Participants, aged 18-50, will complete questionnaires measuring their levels of flow, mindfulness, anxiety, and depression at the start of the study and again after six months. The study seeks to identify daily activities that promote flow and assess changes in participants' mental health over time. By focusing on these psychological resources, the research hopes to provide insights into effective coping strategies for those facing the challenges of an MS diagnosis.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-50 who have received a clinically-definite MS diagnosis within the last year.
Not a fit: Patients with other neurological or psychiatric disorders, severe physical impairments, or those who have previously attended mindfulness-based interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance mental health support for newly diagnosed MS patients by identifying effective psychological resources.
How similar studies have performed: While mindfulness has been widely studied in relation to MS, the exploration of flow as a psychological resource is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Bari and 7 other locations
- University of Bari — Bari, Italy (Recruiting)
- University of Cagliari — Cagliari, Italy (Recruiting)
- University of Catania — Catania, Italy (Recruiting)
- Azienda Ospedaliera Sant'Anna — Como, Italy (Recruiting)
- University of Florence — Florence, Italy (Recruiting)
- Università Vita-Salute San Raffaele — Milano, Italy (Recruiting)
- San Luigi Gonzaga Hospital — Orbassano, Italy (Recruiting)
- Azienda Ospedaliera San Camillo Forlanini — Roma, Italy (Recruiting)
Study contacts
- Study coordinator: Marta Bassi, PhD
- Email: marta.bassi@unimi.it
- Phone: +390250319709
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.