- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание 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.
Обзор исследования
Статус
Тип исследования
Регистрация (Оцененный)
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
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.
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: CASE_CONTROL
- Временные перспективы: CROSS_SECTIONAL
Когорты и вмешательства
Группа / когорта |
|---|
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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. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Quality of Life Score Measured by the WHOQOL-BREF Questionnaire
Временное ограничение: 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
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Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- Caregivers of Schizophrenia
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .