- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07837479
Psychological Resilience and Quality of Life Among Caregivers of Patients With Schizophrenia
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.
Descripción general del estudio
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Población de estudio
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.
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: CASE_CONTROL
- Perspectivas temporales: CROSS_SECTIONAL
Cohortes e Intervenciones
Grupo / Cohorte |
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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). |
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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. |
¿Qué mide el estudio?
Medidas de resultado primarias
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Quality of Life Score Measured by the WHOQOL-BREF Questionnaire
Periodo de tiempo: Baseline
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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
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Colaboradores e Investigadores
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Última actualización enviada que cumplió con los criterios de control de calidad
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Más información
Términos relacionados con este estudio
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Otros números de identificación del estudio
- Caregivers of Schizophrenia
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .