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临床试验/NCT05383027
NCT05383027Unknown不适用

Examining the Feasibility of Implementation, Patterns of Association, and Outcomes in HRV Biofeedback (HRVB) Intervention and Music Listening Control (MLC) on Alzheimer's Disease (AD) Family Caregivers (FCGs) Public Title: Caring Relationship Expression Study(CARES)

Arizona State University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Perceived Stress Scale-10

研究概览

简要总结

In a remotely delivered nationwide pilot study, we will be examining a novel 8-week heart rate variability biofeedback (HRVB) intervention vs music listening control (MLC) for 30 family caregivers 18 years and older (FCGs) of Alzheimer's disease (AD) (and related dementias: ADRD) patients to examine feasibility (acceptability/adherence, satisfaction) and direction of change in caregiver burden, stress, resilience, anxiety, self-compassion, and relationship quality.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

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

入选标准

  • •18 years and above
  • •primary, unpaid family caregiver for ADRD patient for 6 months or more
  • •owns and operates a smartphone with a data plan
  • •greater than of equal to 4 on caregiver burden scale

排除标准

  • •regular mind-body practice
  • •under 18 years old
  • •pacemaker
  • •conditions or medications that interfere with heart rate variability

研究组 & 干预措施

Music Listening Control(MLC)

Active Comparator

干预措施: Music Listening Control (MLC) (Behavioral)

Heart Focused Breathing

Experimental

干预措施: Heart Focused Breathing (Behavioral)

结局指标

主要结局

Perceived Stress Scale-10

时间窗: 13 weeks

Measure of stress

Brief Resilience Scale

时间窗: 13 weeks

Measures participant resillience

Zarit Burden Interview

时间窗: 13 weeks

Measures participant burden

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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