Caregiver Burden in Caregivers of Patients With Multiple Sclerosis

April 18, 2026 updated by: Fatma Nur Kesiktaş, Istanbul Physical Medicine Rehabilitation Training and Research Hospital

The Relationship Between Mood, Insomnia Severity, and 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Bahcelievler
      • Istanbul, Bahcelievler, Turkey (Türkiye), 34100
        • Recruiting
        • Istanbul Physical Medicine and Rehabilitation Trainig and Research Hospital
        • Contact:
        • Contact:
          • Phone Number: (0212) 856 27 40

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Multiple sclerosis and caregivers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)
Time Frame: Baseline
Scores range from 0 to 21, with higher scores indicating greater anxiety.
Baseline
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.
Baseline
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.
Baseline
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).
Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 20, 2026

Primary Completion (Estimated)

May 20, 2026

Study Completion (Estimated)

May 20, 2026

Study Registration Dates

First Submitted

April 18, 2026

First Submitted That Met QC Criteria

April 18, 2026

First Posted (Actual)

April 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 18, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • istftreah13

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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