Multiple SclerosisNCT07549048
Caregiver Burden in Caregivers of Patients With Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2026to 20 May 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Multiple sclerosis and caregivers
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Physical Medicine and Rehabilitation Trainig and Research Hospital
Istanbul, Bahcelievler, 34100
Büşra Ş Ahısha, +902124965000, bsrn080@gmail.com
(0212) 856 27 40
About this study
Official title: 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.
- Conditions
- Multiple Sclerosis
- Being tested
- No intervention
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Zarit Caregiver Burden Scale (Zarit Burden Interview, ZBI)
Caregiver burden will be assessed using the Zarit Caregiver Burden Scale. Higher scores indicate greater caregiver burden.
Measured: Baseline
Secondary outcomes (5)
Insomnia Severity Index (ISI)
The ISI evaluates the severity of insomnia symptoms. Total scores range from 0 to 28, with higher scores indicating more severe insomnia.
Measured: Baseline
Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)
Scores range from 0 to 21, with higher scores indicating greater anxiety.
Measured: Baseline
Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D)
Scores range from 0 to 21, with higher scores indicating greater depressive symptoms.
Measured: Baseline
Expanded Disability Status Scale (EDSS)
The EDSS evaluates disability in multiple sclerosis patients, ranging from 0 (normal neurological exam) to 10 (death due to MS).
Measured: Baseline
Multiple Sclerosis Impact Scale (MSIS)
The MSIS assesses the physical and psychological impact of multiple sclerosis on daily life. Higher scores indicate greater impact.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start20 Apr 2026 (estimated)
- Primary completion20 May 2026 (estimated)
- Study completion20 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fatma Nur Kesiktaş, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549048
- Sponsor's protocol ID
- istftreah13
- Status last verified
- Apr 2026
- First submitted
- 18 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Mood, Insomnia Severity, and Caregiver Burden in Caregivers of Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07549048
- Acronym / sponsor ID
- istftreah13
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 20 May 2026 (estimated)
- Study completion
- 20 May 2026 (estimated)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Multiple sclerosis and caregivers
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
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.
5 secondary outcomes
Insomnia Severity Index (ISI)
Time frame: Baseline
Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)
Time frame: Baseline
Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D)
Time frame: Baseline
Expanded Disability Status Scale (EDSS)
Time frame: Baseline
Multiple Sclerosis Impact Scale (MSIS)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Istanbul Physical Medicine and Rehabilitation Trainig and Research Hospital
Istanbul, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Zarit Caregiver Burden Scale (Zarit Burden Interview, ZBI) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.