- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07719998
A Psychoeducational Intervention for Reducing Psychological Distress and Caregiver Burnout Among Family Caregivers of Individuals With Bipolar Disorder
A Feasibility Evaluation of a Psychoeducational Intervention for Reducing Psychological Distress and Caregiver Burnout Among Family Caregivers of Individuals With Bipolar Disorder
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Bipolar Disorder is a chronic psychiatric condition characterized by recurrent episodes of mania, hypomania, and depression. Family caregivers play a central role in supporting individuals with Bipolar Disorder; however, prolonged caregiving responsibilities often result in increased psychological distress, emotional exhaustion, and caregiver burden. In Pakistan, limited structured psychoeducational programs are available to support family caregivers despite their significant role in patient care.
This study is a feasibility trial designed to examine the implementation and preliminary effectiveness of a structured psychoeducational intervention for family caregivers of individuals with Bipolar Disorder. The intervention consists of therapist-led sessions focusing on increasing caregivers' understanding of Bipolar Disorder, symptom recognition, treatment adherence, relapse prevention, communication skills, stress management, coping strategies, problem-solving, and self-care practices.
Primary outcomes include psychological distress and caregiver burden, measured using the Kessler Psychological Distress Scale (K10) and the Zarit Burden Interview (ZBI-22), respectively. Participants will complete these measures before the intervention and after completing the psychoeducational program. The study will evaluate the feasibility of recruitment, participant retention, intervention delivery, and participant acceptability, while also examining preliminary changes in caregiver psychological distress and burden following the intervention.
The findings are expected to contribute to the development of culturally appropriate caregiver support programs and provide evidence for integrating psychoeducational interventions into mental health services for families of individuals with Bipolar Disorder in Pakistan.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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-
Punjab Province
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Guiranwala, Punjab Province, Пакистан, 50250
- DHQ Gujranwala
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-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
Primary family caregiver of an individual diagnosed with Bipolar Disorder by a qualified psychiatrist.
Aged between 25 and 40 years. Providing direct care to the patient for at least one year. Able to read, understand, and communicate in Urdu. Willing and able to provide written informed consent. Willing to participate in all psychoeducational intervention sessions and study assessments.
Exclusion Criteria:
Professional, paid, or temporary caregivers. Caregivers currently receiving structured psychotherapy or psychological intervention for psychological distress or caregiver burden.
Individuals with severe psychiatric disorders, cognitive impairment, or neurological conditions that may interfere with participation or completion of assessments.
Caregivers who are unable or unwilling to complete the intervention sessions or study questionnaires.
Caregivers who withdraw consent at any stage of the study.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Psychoeducational Intervention Group
Participants in this arm will receive a structured psychoeducational intervention designed for family caregivers of individuals with Bipolar Disorder.
The intervention includes education about Bipolar Disorder, symptom recognition, treatment adherence, relapse prevention, stress management, coping strategies, communication skills, problem-solving, and caregiver self-care.
Participants will complete outcome assessments at baseline and after completion of the intervention using the Kessler Psychological Distress Scale (K10) and the Zarit Burden Interview (ZBI-22).
|
A structured psychoeducational intervention developed for family caregivers of individuals with Bipolar Disorder.
The intervention consists of therapist-led sessions focusing on understanding Bipolar Disorder, recognizing symptoms and relapse warning signs, treatment adherence, stress management, coping strategies, communication skills, problem-solving, caregiver self-care, and available support resources.
The intervention is designed to reduce psychological distress and caregiver burden while improving caregivers' knowledge, coping abilities, and confidence in managing caregiving responsibilities.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Caregiver Burden
Временное ограничение: Baseline (pre-intervention) and immediately after completion of the psychoeducational intervention (post-intervention; approximately 6 weeks).
|
Caregiver burden will be assessed using the 22-item Zarit Burden Interview (ZBI-22).
Changes in caregiver burden scores will be evaluated between baseline (pre-intervention) and post-intervention.
|
Baseline (pre-intervention) and immediately after completion of the psychoeducational intervention (post-intervention; approximately 6 weeks).
|
|
Psychological Distress
Временное ограничение: Baseline (pre-intervention) and immediately after completion of the psychoeducational intervention (post-intervention; approximately 6 weeks).
|
Psychological distress will be assessed using the Kessler Psychological Distress Scale (K10).
Changes in participants' psychological distress scores will be compared between baseline (pre-intervention) and post-intervention.
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Baseline (pre-intervention) and immediately after completion of the psychoeducational intervention (post-intervention; approximately 6 weeks).
|
Соавторы и исследователи
Спонсор
Следователи
- Учебный стул: Dr Umi Lalia, Phd, GIFT University
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
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
Другие идентификационные номера исследования
- GIFT/PSY/MS/2025/012
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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. .