Caregiver burden for people who care for someone with multiple sclerosis
The Relationship Between Mood, Insomnia Severity, and Caregiver Burden in Caregivers of Patients With Multiple Sclerosis
This study will see how caring for an adult with multiple sclerosis affects family caregivers by collecting information on patient disease status and caregiver sleep, mood, and burden.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Istanbul Physical Medicine Rehabilitation Training and Research Hospital Government |
| Locations | 1 site (Istanbul, Bahcelievler) |
| Trial ID | NCT07549048 on ClinicalTrials.gov |
What this trial studies
This is an observational study enrolling adults aged 18–80 with clinician-diagnosed multiple sclerosis and their primary family caregivers at a single rehabilitation hospital in Istanbul. Investigators will record patient demographics, comorbidities, disease duration, ambulation and continence status, pain, and functional scores including EDSS and MSIS, and will screen patients for anxiety and depression with the HADS. Caregivers will complete the Insomnia Severity Index, HADS, and the Zarit Caregiver Burden instrument to measure sleep problems, mood symptoms, and caregiving burden. No treatments or interventions are given; the study collects cross-sectional clinical and questionnaire data to characterize caregiver needs.
Who should consider this trial
Good fit: Adults aged 18–80 with a neurologist-confirmed diagnosis of multiple sclerosis who are followed in the hospital's physical therapy/rehabilitation clinics and have a regular unpaid family caregiver who can read Turkish and consent to participate.
Not a fit: People without a regular family caregiver, those whose caregivers are paid professionals, or patients or caregivers unable to complete Turkish questionnaires (for example due to severe cognitive impairment or language barriers) are unlikely to benefit from participation.
Why it matters
Potential benefit: Findings could identify unmet needs and inform support or resource planning to reduce caregiver strain and improve caregiver and patient well-being.
How similar studies have performed: Previous observational studies have documented substantial caregiver burden in multiple sclerosis populations, so this approach builds on an established research area rather than being wholly novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-80 years * Clinically diagnosed with multiple sclerosis by a neurologist * Being followed in the physical therapy and rehabilitation clinics during the study period * Having a primary or regular caregiver (family member) * Both patient and caregiver able to read and understand Turkish and complete questionnaires * Willing to participate and provide written informed consent Exclusion Criteria: * Severe cognitive impairment or communication problems preventing questionnaire completion * Acute relapse or hospitalization due to exacerbation within the last month * Severe comorbid neurological, psychiatric, or systemic disease affecting assessments * Caregiver \<18 years old or not providing regular care * Paid professional caregiver * Caregiver with severe psychiatric, neurological, or primary sleep disorder * Refusal to participate
Where this trial is running
Istanbul, Bahcelievler
- Istanbul Physical Medicine and Rehabilitation Trainig and Research Hospital — Istanbul, Bahcelievler, Turkey (Türkiye) (Recruiting)
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.