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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 20, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 20, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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