Probing Brain Network Mechanisms Underlying Late-Life Prolonged Grief Disorder
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Score on the Prolonged Grief 13-Revised (PG-13-R) scale
研究概览
简要总结
After losing a loved one, most successfully navigate acute grief and adapt to the loss within about 1 year, but in about 10%, prolonged grief disorder (PGD) ensues. This study is anticipated to provide novel evidence regarding the neurobiological mechanisms of PGD in older adults. The biological alterations identified here could provide targets to elucidate how currently available therapies work and inform novel mechanism-based interventions for treating late-life PGD.
详细描述
The objectives of this study are to (1) identify functional brain network features that differentiate PGD from integrated grief, and (2) conduct a mechanistic study in older adults with PGD to test whether exposure to 10-weeks of IY and HE modulate brain network targets and clarify how network changes relate to 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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
结局指标
主要结局
Score on the Prolonged Grief 13-Revised (PG-13-R) scale
时间窗: Baseline through study completion, up to 10 weeks
We will measure change in the PG-13-R score from baseline to end of study. The PG-13-R scores range from 10 - 50 (higher scores indicate more severe grief symptoms).
次要结局
未报告次要终点
研究者
Joseph Goveas
Professor, Department of Psychiatry and Behavioral Medicine
Medical College of Wisconsin