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

18 de septiembre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Tipo de estudio

De observación

Inscripción (Estimado)

130

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

N/A

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Modelos observacionales: CASE_CONTROL
  • Perspectivas temporales: CROSS_SECTIONAL

Cohortes e Intervenciones

Grupo / Cohorte
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Quality of Life Score Measured by the WHOQOL-BREF Questionnaire
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de octubre de 2026

Finalización primaria (Estimado)

1 de octubre de 2027

Finalización del estudio (Estimado)

1 de noviembre de 2027

Fechas de registro del estudio

Enviado por primera vez

18 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

18 de septiembre de 2026

Publicado por primera vez (Actual)

23 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

23 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

18 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

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. .

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