A Psychoeducation Intervention for Caregivers of Patients With Bipolar Disorder: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in Caregiver Burden as measured by the Burden Assessment Scale at 8 weeks
研究概览
简要总结
Bipolar disorder is a debilitating chronic illness characterized by periods of elation and depression. Since deinstitutionalization of the mentally ill over 40 years ago, families have become major caregivers for patients with bipolar disorder . This illness imposes a substantial and chronic burden on family caregivers Despite their persistent stress and burden, these caregivers have been largely ignored. Interventions to help them have been very limited. One comprehensive intervention was developed and implemented by Miklowitz (2008) and has shown to be effective in reducing caregiver depression and improving health outcomes. However, this intervention and is highly complex, long, and was given on an individual basis, significantly raising the cost of the program. One core component of the Miklowitz (2008) intervention is psychoeducation, which provides the fundamental support and information needed to caregivers on an individual basis.
In this pilot study, the intervention group will receive 7 weekly psychoeducation sessions. After completion of these sessions in the intervention group, the wait list control group will receive the same weekly sessions. In this study, the investigators plan to test the feasibility and potential efficacy of this specific psychoeducation intervention implemented in a group setting. The investigators will also examine the effects of this psychosocial intervention on biological mechanisms (cortisol and inflammatory biomarkers) and health outcomes.
The specific aims are to:
- Test the feasibility of implementing a 7-week group psychoeducation program for family caregivers of patients with bipolar disorder by assessing recruitment and retention rates, attendance, satisfaction with the program, and data and sample collection rate.
- Explore the effect of the intervention on caregiver outcomes (depression, burden, health status, mental wellbeing, cortisol, interleukin (IL)-1 and IL-6 levels.
The intervention will be delivered by at the University of Texas Health Science Center at Houston Center of Excellence for Mood Disorders (CEMD) and at the University of Texas Health Science Center at Houston School of Nursing. Forty family caregivers of patients with bipolar disorder will be recruited into the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •primary family caregiver of a patient with Bipolar Disorder who is age 16 or older;
- •live within a 70 mile radius of the Center for Excellence in Mood Disorders (in the Texas Medical Center)
排除标准
- •unstable major medical illness;
- •health condition that may impact biomarker levels, e.g. is taking corticosteroids or anti-inflammatory drugs;
- •unable to read, write, or speak English
结局指标
主要结局
Change in Caregiver Burden as measured by the Burden Assessment Scale at 8 weeks
时间窗: Baseline, 8 weeks
Change in Caregiver Burden as measured by the Burden Assessment Scale at 16 weeks
时间窗: Baseline, 16 weeks
次要结局
- Change in Caregiver Mental Well Being as measured by the Warwick-Edinburgh Mental Well-Being Scale at 8 weeks(Baseline, 8 weeks)
- Change in Caregiver Mental Well Being as measured by the Warwick-Edinburgh Mental Well-Being Scale at 16 weeks(Baseline, 16 weeks)
- Change in Caregiver Depression as measured by the Quick Inventory of Depressive Symptomatology Clinician-Rated at 8 weeks(Baseline, 8 weeks)
- Change in Caregiver Depression as measured by the Quick Inventory of Depressive Symptomatology Clinician-Rated at 16 weeks(Baseline, 16 weeks)
研究者
Rebecca Lynn Casarez
Associate Professor - Clinical
The University of Texas Health Science Center, Houston