Psychological Resilience and Quality of Life Among Caregivers of Patients With Schizophrenia

September 18, 2026 updated by: Mostafa Yamany Mohamed Kamel, Assiut University

Psychological Resilience and Quality of Life Among Caregivers of Patients With Schizophrenia: A Case Control Study

Schizophrenia is a severe and chronic psychiatric disorder that requires long-term care management, placing family members who serve as informal caregivers under substantial psychological, physical, and financial strain. While caregiver burden, anxiety, and depression are well-documented challenges in this population, psychological resilience can serve as an essential protective buffer against chronic stress. This study aims to evaluate the levels of psychological resilience and Quality of Life (QoL) among family caregivers of patients with schizophrenia compared to a matched control group of caregivers of healthy individuals.

This observational case-control study will be conducted at the Neuropsychiatry Department (inpatient wards and outpatient clinics) of Assiut University Hospital in Assiut, Egypt. Primary informal caregivers aged 18 to 65 years who reside with and care for a patient clinically diagnosed with schizophrenia (DSM-5 / ICD-11 criteria) for at least 6 months will be compared to matched caregivers of healthy individuals recruited from the community.

Participants will undergo structured face-to-face clinical interviews to assess:

  • Quality of Life: Evaluated across physical, psychological, social, and environmental domains using the World Health Organization Quality of Life Brief Version (WHOQOL-BREF).
  • Psychological Resilience: Measurement of individual coping ability, personal competence, and adaptability under stress.
  • Caregiver Burden: Quantified using the Zarit Burden Interview (ZBI).
  • Psychiatric Distress: Clinician-administered assessment of anxiety severity via the Hamilton Anxiety Rating Scale (HAM-A) and depressive symptoms via the Hamilton Depression Rating Scale (HAM-D).

The findings aim to identify sociodemographic and clinical predictors influencing caregiver well-being and provide evidence to guide targeted psychosocial support and intervention programs.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet 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.

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.
130

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population comprises primary informal family caregivers (parents, spouses, siblings, or adult offspring) of patients diagnosed with schizophrenia receiving inpatient or outpatient psychiatric care at Assiut University Hospital in Assiut, Egypt. A matched comparison group includes family caregivers of healthy individuals residing in the same geographic community who have no current or previous personal or family history of schizophrenia or other major psychiatric disorders. Control subjects are matched by age, sex, marital status, educational level, and socioeconomic status.

Description

Inclusion Criteria:

Case Group (Caregivers of Patients with Schizophrenia):

  • Primary informal caregiver defined as an immediate family member (parent, spouse, sibling, or adult child) providing unpaid physical, emotional, or financial assistance.
  • Continuous co-residence with the patient for a minimum duration of 6 months prior to enrollment.
  • Caring for an individual with an established clinical diagnosis of schizophrenia confirmed by a psychiatrist according to DSM-5 or ICD-11 criteria.
  • Caregiver age between 18 and 65 years.
  • Both male and female caregivers.
  • Cognitive and functional ability to comprehend study instruments and complete clinical rating scales during face-to-face interviews.
  • Willingness to provide voluntary written informed consent.

Control Group:

  • Family caregivers of healthy individuals with no current or past history of schizophrenia or other major psychiatric disorders.
  • Matched to the case group by age, sex, marital status, educational level, and socioeconomic status.
  • Willingness to provide voluntary written informed consent.

Exclusion Criteria:

  • Refusal or inability of the caregiver to provide written informed consent.
  • Documented history of major primary psychiatric disorders (e.g., bipolar disorder, schizophrenia, organic psychosis) or severe neurological illness diagnosed prior to assuming the caregiving role.
  • Concurrently providing care for another family member suffering from a severe chronic physical disability, terminal illness, or neurodegenerative disease.
  • Presence of active substance use disorders, severe cognitive impairment, or intellectual disability that impedes reliable questionnaire completion.

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

  • Observational Models: CASE_CONTROL
  • Time Perspectives: CROSS_SECTIONAL

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Caregivers of Patients with Schizophrenia

Primary informal family caregivers (parent, spouse, sibling, or adult child) providing unpaid care and residing continuously for at least 6 months with an individual clinically diagnosed with schizophrenia (DSM-5 or ICD-11 criteria) receiving care at Assiut University Hospital. Caregivers undergo structured face-to-face evaluations to assess psychological resilience, quality of life (WHOQOL-BREF), caregiver burden (Zarit Burden Interview), and anxiety/depression symptoms (HAM-A, HAM-D).
Caregivers of Healthy Individuals

Family caregivers of healthy individuals who have no current or past personal or family history of schizophrenia or other major psychiatric disorders. Control participants are recruited from the same community and matched to the case group by age, sex, marital status, educational level, and socioeconomic status to provide comparative assessments of psychological resilience and quality of life.

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
Quality of Life Score Measured by the WHOQOL-BREF Questionnaire
Time Frame: Baseline

Assessed using the 26-item World Health Organization Quality of Life Brief Version (WHOQOL-BREF) across four domains: Physical Health, Psychological Well-being, Social Relationships, and Environment. Domain scores are transformed linearly to a scale from 0 to 100, where higher scores indicate superior quality of life.
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.
Assiut University

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.
October 1, 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.
October 1, 2027

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.
November 1, 2027

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).
September 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.
September 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.
September 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.
September 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.
September 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.
September 1, 2026

More Information

Terms related to this study

Keywords

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.
  • Caregivers of Schizophrenia

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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