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临床试验/NCT03857308
NCT03857308终止不适用

Eudaimonia and Sleep: Effects of a Mindfulness Intervention in Caregivers of People With Dementia

Virginia Commonwealth University2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2019年11月13日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
9
试验地点
2
主要终点
Change in Sleep Quality: Actigraph

研究概览

简要总结

This research study seeks to understand how stress reduction training influences caregiver well-being, sleep, and physiological responses to stress. All participants are caregivers of persons with dementia. Participants will complete a 14-day, online stress-reduction intervention which involves approximately 25-30 minutes of daily practice.

详细描述

The research project will be conducted over approximately 9 months and will consist of three data collection sessions for each participant. The three data sessions will occur before, after, and at 3-month follow-up of an 14-day, online stress-reduction training, in which participants will be asked to complete about 25 to 30 minutes of practice each day in one of two stress-reduction techniques. Participants will be randomly assigned to either a mindfulness training program or a reappraisal training program. The mindfulness training emphasizes mindfulness-based techniques to reduce stress and promote well-being, whereas the reappraisal training emphasizes cognitive strategies to change one's perception of the stressor as a way to reduce stress and promote well-being.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • English speaking
  • Self-reporting informal caregivers of persons with dementia

排除标准

  • Self-reported major depressive disorder with psychotic features
  • History of schizophrenia
  • Bipolar disorder
  • Uncorrected severe sensory impairments or chronic debilitating health problems that could hinder participating in the interventions
  • Previous MBSR training or regular meditative practice within previous 6 months

结局指标

主要结局

Change in Sleep Quality: Actigraph

时间窗: Baseline to 2-weeks (post-intervention), and 3-month follow-up

Actigraphic measure of limb movements used to calculate sleep efficiency, which is an assessment of the quality of sleep participants have.

Change in Sleep Quality

时间窗: Baseline to 2-weeks (post-intervention), and 3-month follow-up

We will use a sleep diary that involves self-reported sleep habits, which we will use to calculate sleep onset, wake after sleep onset, and sleep efficiency. This will allow us to understand any changes in overall sleep quality across the intervention.

Change in Eudaimonic well-being

时间窗: Baseline to 2-weeks (post-intervention), and 3-month follow-up

54 item self-reported scale assessing change in eudaimonic well-being from pre to post-intervention. Will be assessed using the Scales of Psychologica Well-being (SPWB; Ryff \& Keyes, 1995) 1 = strongly disagree, 6 = strongly agree. This scale range applies for the 6 subscales, which can stand-alone, or be summed to obtain a total Eudaimonic Well-Being score. For this study, we are primarily interested in investigated changes over time of the summed score for eudaimonic well-being. Higher scores indicate higher eudaimonic well-being.

次要结局

  • Change in Relationship Quality(Baseline to 2-weeks (post-intervention), and 3-month follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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