CompletedNot Applicable

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

Italy361 participantsStarted 2023-11-06

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Positive mental health (Mental Health Continuum Short Form)

Timeframe: The questionnaires will be administered at T1 (within 12 months from diagnosis disclosure) and at T2 (after 6 months)

Anxiety (subscale of the Hospital Anxiety and Depression Scale)

Timeframe: The questionnaires will be administered at T1 (within 12 months from diagnosis disclosure) and at T2 (after 6 months)

Depression (subscale of the Hospital Anxiety and Depression Scale)

Timeframe: The questionnaires will be administered at T1 (within 12 months from diagnosis disclosure) and at T2 (after 6 months)

Trial details

NCT IDNCT06403631

SponsorMarta Bassi

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12-25

View on ClinicalTrials.gov More Multiple Sclerosis trials

Plain-language summary

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Positive mental health (Mental Health Continuum Short Form)

Timeframe: The questionnaires will be administered at T1 (within 12 months from diagnosis disclosure) and at T2 (after 6 months)

Anxiety (subscale of the Hospital Anxiety and Depression Scale)

Timeframe: The questionnaires will be administered at T1 (within 12 months from diagnosis disclosure) and at T2 (after 6 months)

Depression (subscale of the Hospital Anxiety and Depression Scale)

Timeframe: The questionnaires will be administered at T1 (within 12 months from diagnosis disclosure) and at T2 (after 6 months)