Mindfulness Meditation and Insomnia in Alzheimer Disease Caregivers (CARES)
Mindfulness Meditation and Insomnia in Alzheimer Disease Caregivers: Inflammatory and Biological Aging Mechanisms
研究概览
详细说明
This randomized controlled trial aims to evaluate the non-inferiority of Mindful Awareness Practices for Insomnia (MAP-I ) vs. Cognitive Behavioral Therapy for Insomnia (CBT-I) on outcomes of insomnia, cellular and genomic markers of inflammation, and cellular aging in older adult AD spousal caregivers with insomnia (N=150) over one-year follow-up. The specific aims of this project are:
Primary Aim 1: Determine the effects of MAP-I vs. CBT-I on subjective and objective dimensions of insomnia.
Secondary Aim 1: Evaluate the effects of MAP-I vs. CBT-I on cellular and genomic markers of inflammation.
Secondary Aim 2: Evaluate the effects of MAP-I vs. CBT-I on markers of cellular aging.
Exploratory Aim 1: Explore moderating effects of caregiver stress (Stress and Adversity Inventory, STRAIN, number & experienced intensity of stress exposure) on insomnia outcomes, and effects of MAP-I vs. CBT-I on caregiver stress, health functioning, chronic medical morbidity and related medication use at follow-up.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
California
-
Los Angeles、California、美国、90095
- Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Alzheimer or other dementia caregivers
- Older than 45 years of age
- Self-identified as the principal person taking care of the patient with Alzheimer or other dementia
- Diagnostic and Statistical Manual Criteria - 5 for Insomnia
Exclusion Criteria:
- Psychiatric disorders including current major depressive disorder or other current DSM-5 psychiatric disorder (e.g. substance dependence) with the exception of anxiety disorder;
- Psychotic symptoms;
- Acute suicidal or violent behavior or history of suicide attempt within the last year
- Other sleep disorders including current or lifetime history of sleep apnea, nocturnal myoclonus, phase-shift disorder as identified by SCID-5 and Duke Structured Interview for Sleep Disorders (DSISD)
- Medical conditions such as acute or uncontrolled medical illness (e.g., major surgery, metastatic cancer, Class III heart failure, inflammatory disorder)
- Chronic infections
- Obesity with body mass index (BMI) >35
- Use of hormone containing medications including steroids or immune modifying drugs
- Daily use of analgesics such as opioids;
- Daily us of sedative hypnotic medications
- Cognitive impairment as evidenced by DSM-5 interview and/or Mini-Mental Status Exam (MMSE < 26)
- Actively practicing a mind body intervention.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：CBT-I
Cognitive behavioral therapy for insomnia (CBT-I), considered the treatment of choice by the American Academy of Sleep Medicine, combines cognitive therapy, stimulus control, sleep restriction, sleep hygiene, and relaxation to improve sleep outcomes, with demonstrated efficacy in adult and older adult populations
|
CBT-I is a behavioral treatment for insomnia
|
|
实验性的：MAP-I
The Mindful Awareness Practices (MAPs) is a validated and curriculum-based meditation similar to Mindfulness Based Stress Reduction, with the exception that MAPs does not include a day-long retreat or yoga and hence takes a more practical and accessible approach that focuses specifically on the practice of mindfulness and its application in everyday life.
(http://marc.ucla.edu)
MAP for Insomnia (MAP-I) is a modified version of MAPs that incorporates practice prior to bed, use of practice in the bed during night-time awakenings, and daily body scan.
|
MAP-I is a mindfulness meditation treatment for insomnia
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Insomnia clinical response
大体时间：One-year
|
Change in severity of insomnia as measured by the Insomnia Severity Index
|
One-year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Insomnia clinical response
大体时间：One year
|
Change in severity of insomnia as measured by clinical diagnosis
|
One year
|
|
Daytime dysfunction
大体时间：One year
|
Change in depressed mood as measured by the Inventory of Depressive Symptoms
|
One year
|
|
Inflammation
大体时间：One year
|
Change in markers of systemic inflammation as measured by C-reactive protein
|
One year
|
|
Cellular aging
大体时间：One year
|
Change in markers of cellular aging as measured by transcriptional profiles of the senescent secretory associated phenotype (SASP)
|
One year
|
合作者和调查者
调查人员
- 首席研究员：Michael R Irwin, M.D.、University of California, Los Angeles
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
CBT-I的临床试验
-
VA Office of Research and DevelopmentVA Finger Lakes Healthcare System招聘中
-
Indiana UniversityIndiana Clinical and Translational Sciences Institute终止
-
University of RochesterNational Institute of Nursing Research (NINR); National Institute of Neurological Disorders... 和其他合作者完全的