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Caregiver Burden in Caregivers of Patients With Multiple Sclerosis

The Relationship Between Mood, Insomnia Severity, and Caregiver Burden in Caregivers of Patients With Multiple Sclerosis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07549048
Enrollment
50
Registered
2026-04-23
Start date
2026-04-20
Completion date
2026-05-20
Last updated
2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Brief summary

Individuals aged 18-80 years who have been clinically diagnosed with multiple sclerosis and their caregivers will be included in the study. Demographic data of the patients, including age, height, weight, and comorbidities, will be recorded. Disease-specific characteristics such as disease duration, presence of incontinence, ambulation status, and presence and severity of pain will be assessed. Functional status of the patients will be evaluated using the Expanded Disability Status Scale (EDSS) and the Multiple Sclerosis Impact Scale (MSIS). Symptoms related to depression and anxiety in patients will be assessed using the Hospital Anxiety and Depression Scale (HADS). Subsequently, caregivers of the patients will be evaluated. The severity of insomnia will be assessed using the Insomnia Severity Index (ISI). Symptoms related to anxiety and depression will be evaluated using the Hospital Anxiety and Depression Scale (HADS). Caregiver burden will be assessed using the Zarit Caregiver Burden Scale.

Interventions

OTHERNo intervention

No intervention

Sponsors

Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Zarit Caregiver Burden Scale (Zarit Burden Interview, ZBI)BaselineCaregiver burden will be assessed using the Zarit Caregiver Burden Scale. Higher scores indicate greater caregiver burden.

Secondary

MeasureTime frameDescription
Insomnia Severity Index (ISI)BaselineThe ISI evaluates the severity of insomnia symptoms. Total scores range from 0 to 28, with higher scores indicating more severe insomnia.
Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)BaselineScores range from 0 to 21, with higher scores indicating greater anxiety.
Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D)BaselineScores range from 0 to 21, with higher scores indicating greater depressive symptoms.
Expanded Disability Status Scale (EDSS)BaselineThe EDSS evaluates disability in multiple sclerosis patients, ranging from 0 (normal neurological exam) to 10 (death due to MS).
Multiple Sclerosis Impact Scale (MSIS)BaselineThe MSIS assesses the physical and psychological impact of multiple sclerosis on daily life. Higher scores indicate greater impact.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 24, 2026