Alzheimer's Caregiver Coping: Mental and Physical Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 2
- 主要终点
- Interleukin-6
研究概览
简要总结
This study evaluates the effectiveness of Behavioral Activation (BA) therapy vs Support and Information for reducing risk for emotional and cardiovascular diseases in Alzheimer's caregivers. Half of participants will receive BA and the other half will receive support and information.
详细描述
The burden of caring for a loved-one with Alzheimer's disease is associated with adverse psychological and general health consequences for the caregiver. These consequences including risk for depression, cardiovascular disease, and earlier mortality. Because preliminary work has demonstrated that an educational programs for caregivers reduce the negative affect associated with caregiving, the investigators wish to determine whether improving mood can also modify pathophysiological changes that have been linked to risk for developing cardiovascular disease.
The investigators aims are to determine whether a 6-week Behavioral Activation (BA) intervention, followed by 3 booster sessions over a period of 6 months, compared to an Information-Support (IS) intervention will be associated with significant improvement in indicators of vascular pathology, modification of psychobiological markers that have been associated with cardiovascular parameters, and to determine whether improvements in indicators of vascular parameters will be mediated by treatment related change in measures of distress and markers of cardiovascular disease risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 55 years or older.
- •Providing in-home care to a spouse with dementia.
排除标准
- •Taking Coumarin anticoagulants.
- •Taking nitrates or niacin.
- •Taking non-selective β-blockers.
- •Glucocorticoid use in the 2 weeks prior to enrollment.
- •Taking Aldomet or labetalol.
- •Neither the caregiver nor Alzheimer's patient can be diagnosed with a terminal illness with a life expectancy of less than 1 year
- •Cognitive impairment
- •Caregivers enrolled in another intervention study or receiving psychotherapy to improve well-being or reduce distress
- •Blood pressure >200/120 mm Hg
研究组 & 干预措施
Behavioral Activation
Behavioral Activation (BA) emphasize self-monitoring as an aid for increasing one's engagement in self-reinforcing activities while simultaneously reducing negative avoidant coping responses. The intervention consists of 6 total face-to-face sessions lasting 60 minutes each.
干预措施: Behavioral Activation (Behavioral)
Information and Support
Information and Support (IS) consists of providing education on Alzheimer's disease, coping with specific stresses prevalent in caregiving, and community-based services available for caregivers. Caregivers choose information most relevant to their current circumstances, and can discuss this with their counselor during the sessions. In addition, the IS condition encompasses elements of supportive therapy including empathy and active listening. The intervention consists of 6 total face-to-face sessions lasting 60 minutes each.
干预措施: Information and Support (Behavioral)
结局指标
主要结局
Interleukin-6
时间窗: Change from baseline to 2-year follow-up
Inflammation (IL-6)
Center for Epidemiologic Studies - Depression (CES-D) scale
时间窗: Change from baseline to 2-year follow-up
Depressive Symptoms
Endothelium-dependent Flow Mediated Dilation (FMD)
时间窗: Change from baseline to 2-year follow-up
Flow-Mediated Dilation
次要结局
- Baroreflex Sensitivity (BRS)(Change from baseline to 2-year follow-up)
- Arterial Compliance (AC)(Change from baseline to 2-year follow-up)
- Carotid Intima Media Thickness (IMT)(Change from baseline to 2-year follow-up)
- D-dimer(Change from baseline to 2-year follow-up)
- C-reactive Protein (CRP)(Change from baseline to 2-year follow-up)
- Tumor Necrosis Factor (TNF)- alpha(Change from baseline to 2-year follow-up)
- von Willebrand Factor (vWF)(Change from baseline to 2-year follow-up)
- Plasminogen Activator Inhibitor (PAI)-1(Change from baseline to 2-year follow-up)
研究者
Brent Mausbach
Associate Professor
University of California, San Diego