Mindfulness-Based Stress Reduction for Family Caregivers of Dementia Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Antibody response to influenza vaccination
研究概览
简要总结
This study will examine the effects of the Mindfulness-Based Stress Reduction (MBSR) program and the Living Well program, compared to a control group, to see if the programs might be associated with better immune function (response to current influenza vaccine), physical and emotional health, and well-being.
详细描述
A considerable literature documents that a wide variety of psychosocial interventions can lessen the psychological burden of family or spousal dementia caregiving. Some caregiver intervention studies have included measures of self-reported physical health and sleep, and others have focused on improving inflammation in caregivers. The current study will add to this literature by examining the effects of two behavioral interventions on adaptive immune responses, particularly, antibody response to influenza vaccination, in older adult family caregivers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 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
- 是
入选标准
- •55 years of age and older
- •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 (PSS-10 ≥ 12) and/or caregiver burden (MCSI ≥ 5)
- •Participants will be asked to stabilize medications prior to beginning the trial, and for the duration of the trial (If medication dose changes do occur, analytic models will include those changes as time-varying covariates)
排除标准
- •Loved one with dementia currently resides in a long-term care facility (e.g., nursing home) without the caregiver.
- •Given the didactic and self-directed nature of the MBSR program, individuals with major, uncorrected sensory impairments and cognitive deficits, as determined by a Montreal Cognitive Assessment (MoCA) score of 23 or lower 29, will be excluded, as will participants with other neuropsychological deficits deemed significant enough to interfere with study participation. Low literacy is not an exclusion criterion; questionnaires will be orally administered when necessary.
- •Modules from the Mini International Neuropsychiatric Exam (MINI 30) will be used to exclude subjects who have these psychiatric conditions: current alcohol dependence, current non-alcohol psychoactive substance use dependence, psychotic disorders (current and lifetime), bipolar disorder, and current mood disorder with psychotic features.
- •Subjects will also be excluded for the following reasons: having completed an MBSR program in the past; allergy to eggs (the influenza vaccine is most commonly manufactured using an egg-based process); history of Guillain-Barré syndrome; immunodeficiency or receipt of immunosuppressive therapy; recent major surgery; and active neoplastic disease.
结局指标
主要结局
Antibody response to influenza vaccination
时间窗: pre-vaccination to 6 weeks and 6 months post-vaccination
Change in amount of antibody titers following influenza vaccination
次要结局
- Inflammatory cytokines, interleukin (IL)-6 and tumor necrosis factor (TNF)-alpha(baseline to 6 weeks to 6 months post-intervention)
- Granzyme B (GrzB) activity after influenza vaccination(pre-vaccination to 6 weeks and 6 months post-vaccination)
- Ratio of T-cell cytokines, interferon (IFN)-gamma and IL-10(pre-vaccination to 6 weeks and 6 months post-vaccination)
研究者
Kathi Heffner
Associate Professor
University of Rochester