An observational study in Schizophrenia, Caregiver Burden and Quality of Life, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Assiut University · Observational
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:
The findings aim to identify sociodemographic and clinical predictors influencing caregiver well-being and provide evidence to guide targeted psychosocial support and intervention programs.
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's planned enrollment of 130 is below the median of 178 across 506 observational studies indexed under Schizophrenia.
Browse Schizophrenia studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Case Group (Caregivers of Patients with Schizophrenia):
Control Group:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
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.
Quality of Life Score Measured by the WHOQOL-BREF Questionnaire
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.
Time frame: Baseline
No study locations are listed for this record.
Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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