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临床试验/NCT05026827
NCT05026827进行中(未招募)不适用

Iyengar Yoga as a Probe of Prolonged Grief Disorder Neurobiology

Medical College of Wisconsin1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2021年8月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
68
试验地点
1
主要终点
Change in circulating endocannabinoid concentrations

研究概览

简要总结

Experiencing the death of a loved one is inevitable for older adults. Before the coronavirus disease 2019 (COVID-19) pandemic, over 2.5 million people died annually in the United States, including 52,000 in Wisconsin alone, and COVID-19 has added to this toll. Each person who dies leaves an average of five grieving people behind. Most grieving older adults are resilient and recover their pre-loss functioning within one year. However, in about 10%, acute grief becomes protracted and debilitating, leading to the development of prolonged grief disorder (PGD), a clinically diagnosable mental health condition. PGD in older adults increases the risk for poorer medical, mental health, and cognitive outcomes; lower quality of life; disability; premature mortality; and suicide. Despite the magnitude of this problem, the neurobiology of PGD in older adults is poorly understood. By using Iyengar Yoga (IY) as a probe for PGD neurobiology, this pilot project aims to address this critical gap.

详细描述

Our goal is to conduct a pilot study to examine in PGD the modulating effects of 10-week IY on circulating endocannabinoid and emotion processing brain circuit, and the associations between biological changes and clinical response.

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
None

入排标准

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

入选标准

  • Male or female greater than or equal to 40 years of age
  • Bereavement >6 months
  • Score greater than or equal to 25 on the Inventory of Complicated Grief (ICG)
  • Presence of PGD (subsyndromal and syndromal)
  • Adequate visual and auditory acuity

排除标准

  • Delirium/unstable medical conditions
  • Lifetime history of neurological illnesses: seizures, stroke, dementia of any etiology, severe head injury, brain tumor or surgery
  • Serious back, joint or neck injuries within the past 3 months
  • Currently practicing yoga
  • Gross structural abnormalities on T1-weighted images
  • Lifetime history of the following psychiatric disorders: bipolar or psychotic disorders, including psychotic depression
  • Current alcohol/drug abuse or dependence
  • Magnetic resonance imaging (MRI) contraindications
  • Acute suicidality

研究组 & 干预措施

Iyengar Yoga

Experimental

Participants will engage in 10 weekly IY classes

干预措施: Iyengar Yoga (Other)

Socialization Control

Active Comparator

Participants will engage in 10 weekly socialization control group sessions

干预措施: Socialization Control (Other)

Healthy Comparison Group

No Intervention

A group of participants will also be followed for 10 weeks

结局指标

主要结局

Change in circulating endocannabinoid concentrations

时间窗: 10 weeks

Change in circulating endocannabinoids from baseline to post-intervention

次要结局

  • Change in neural activity measured using Functional magnetic resonance imaging (fMRI)(10 weeks)
  • Inventory of Complicated Grief (ICG) scale score change(10 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joseph Goveas

Professor

Medical College of Wisconsin

研究点 (1)

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