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临床试验/NCT07837479
NCT07837479尚未招募不适用

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

Assiut University0 个研究点目标入组 130 人开始时间: 2026年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
130
主要终点
Quality of Life Score Measured by the WHOQOL-BREF Questionnaire

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

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.

结局指标

主要结局

Quality of Life Score Measured by the WHOQOL-BREF Questionnaire

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mostafa Yamany Mohamed Kamel

Resident of Neuropsychiatry

Assiut University

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