Cognitive Training to Protect Immune Systems of Older Caregivers

University of Rochester1 个研究点分布在 1 个国家目标入组 205 人开始时间: 2016年9月8日最近更新: 2022年11月7日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: University of Rochester
入组人数: 205
试验地点: 1
主要终点: Immune aging

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to test whether certain brain training activities can promote cognitive, emotional, and physical health in caregivers of a loved one with dementia. Numerous studies show that family dementia caregiving can be stressful, and can increase mental and physical health risks. This study aims to understand how to reduce those risks.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: Single (Outcomes Assessor)

入排标准

年龄范围: 55 Years 至 85 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•English-speaking (consent process and assessments will be conducted in English only)
•Currently living with or in proximity to, and the primary caregiver for a loved one with dementia who lives in the community-for the purposes of this study, "loved one" refers to a family member such as a spouse, ex-spouse, significant other, sibling, in-law, parent, or other type of close established relationship (e.g., close friend) regarded as family; "primary caregivers" provide daily informal (non-paid) in-person care.
•Currently experiencing moderate to high levels of perceived stress and caregiver burden. Caregivers will be screened for stress levels and caregiving burden using the 10-item Perceived Stress Scale (PSS 10) and the Modified Caregiver Strain Index (MCSI), respectively. Caregivers scoring above the population mean (approx.) on the PSS 10 (> 11), reporting at least moderate caregiver strain (score ≥ 5) on the MCSI will be eligible for participation.

排除标准

•cognitive impairment or dementia (identified by the Montreal Cognitive Assessment (MoCA)). Cutoff scores on the MoCA will be 23 or lower except for subjects who identify as black or African American, in which case cutoffs will be based on scores from the sample population reported in Rossetti et al (2017); subjects scoring greater than one standard deviation below the published score, by respective age and education, will be excluded.
•current major depression (current Major Depression diagnosis and/or Geriatric Depression Scale (GDS 15) score ≥ 10)
•no recent (within 2 months) major surgery
•History of events that cause neurological injury (e.g., stroke, transient ischemic attack, traumatic brain injury or head injury with loss of consciousness)
•Serious psychiatric or alcohol/substance use disorders, including current alcohol dependence, current non-alcohol psychoactive substance use dependence, psychotic disorders or features (current and lifetime), bipolar disorder (determined from Mini International Neuropsychiatric Exam (MINI) modules)
•Autoimmune disorder (e.g., Crohn's disease, lupus, rheumatoid arthritis)
•Active neoplastic disease or receiving immunosuppressive therapy for cancer (or < 6 months post-chemo or radiation) or other diseases (< 3 months prior to enrollment)
•No significant immunodeficiency disorder (e.g., alymphocytosis, hepatitis B or C, HIV)
•Serious cardiovascular disease (e.g., congestive heart failure, pacemaker) or myocardial infarction within past 6 months
•Physical condition precluding required activities as part of the computerized cognitive training (e.g., inability to use a computer mouse; inadequate visual acuity)

研究组 & 干预措施

Online video education

Active Comparator

Participants will have computer access to a library of videos, including various lectures and demonstrations of interest, from which to select and view.

干预措施: Online video education (Behavioral)

Computerized mental exercises

Active Comparator

Participants will use a computer to do a variety of activities which are customizable to their own abilities and progress.

干预措施: Computerized mental exercises (Behavioral)