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NCT Number: NCT07549048

Caregiver Burden in Caregivers of Patients With Multiple Sclerosis

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.

Recruiting

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Physical Medicine and Rehabilitation Trainig and Research Hospital

Istanbul, Bahcelievler, 34100, Turkey (Türkiye)

Location status: Recruiting

Location contact

Büşra Ş Ahısha

CONTACT

[email protected]

+902124965000

CONTACT

(0212) 856 27 40

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Zarit Caregiver Burden Scale (Zarit Burden Interview, ZBI)

    Time frame: Baseline

    Caregiver burden will be assessed using the Zarit Caregiver Burden Scale. Higher scores indicate greater caregiver burden.

Secondary outcomes

  1. Insomnia Severity Index (ISI)

    Time frame: Baseline

    The ISI evaluates the severity of insomnia symptoms. Total scores range from 0 to 28, with higher scores indicating more severe insomnia.

  2. Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)

    Time frame: Baseline

    Scores range from 0 to 21, with higher scores indicating greater anxiety.

  3. Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D)

    Time frame: Baseline

    Scores range from 0 to 21, with higher scores indicating greater depressive symptoms.

  4. Expanded Disability Status Scale (EDSS)

    Time frame: Baseline

    The EDSS evaluates disability in multiple sclerosis patients, ranging from 0 (normal neurological exam) to 10 (death due to MS).

  5. Multiple Sclerosis Impact Scale (MSIS)

    Time frame: Baseline

    The MSIS assesses the physical and psychological impact of multiple sclerosis on daily life. Higher scores indicate greater impact.

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 23, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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