A Feasibility Evaluation of a Psychoeducational Intervention for Reducing Psychological Distress and Caregiver Burnout Among Family Caregivers of Individuals With Bipolar Disorder
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Caregiver Burden
研究概览
简要总结
This study aims to evaluate the feasibility and preliminary effectiveness of a structured psychoeducational intervention designed for family caregivers of individuals diagnosed with Bipolar Disorder. Family caregivers often experience high levels of psychological distress and caregiver burden due to the long-term demands of caregiving. The intervention is intended to improve caregivers' knowledge about Bipolar Disorder, enhance coping skills, promote self-care, and strengthen strategies for managing caregiving challenges. Psychological distress and caregiver burden will be assessed before and after the intervention using the Kessler Psychological Distress Scale (K10) and the Zarit Burden Interview (ZBI-22). The findings will help determine whether this intervention is feasible and beneficial for caregivers in the Pakistani context.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 24 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Caregiver Burden
时间窗: 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.
Psychological Distress
时间窗: 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.
次要结局
未报告次要终点
研究者
Maryam Asif
Principal Investigator
GIFT University