Understanding the Role of Sleep in Complicated Grief: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Clinical Global Impression Scales
研究概览
简要总结
The purpose of this study is to learn more about the causes of Complicated Grief (CG) in those who experience the loss of a loved one. This study aims at learning more about the sleep patterns and emotions in participants with CG as compared to those who have lost a loved one but do not have CG.
This study will consist of two aims:
Aim 1: Approximately 10 complicated grief (CG) patients and 10 controls (without a current psychiatric diagnosis) will complete a 3-day home polysomnography (PSG) sleep assessment in addition to several self-report sleep and psychiatric measures.
Aim 2: Approximately 10 CG patients (subsample from Aim 1) will complete 16 weekly sessions of complicated grief therapy (CGT) in addition to completion of repeated PSG assessments and self-report sleep and psychiatric measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Bereaved due to death of a loved one >= 6 months prior (for both CG and control groups)
- •For CG participants: grief is primary psychiatric problem with ICG >= 30 (threshold symptoms; for CG group only). Controls will be free of current psychiatric disorders with the exception of specific phobia.
- •Normal or corrected vision
排除标准
- •Psychiatric or sleep medications in the past 4 weeks (past 6 weeks for fluoxetine)
- •Concurrent grief or exposure based therapy
- •Lifetime bipolar, psychosis, significant neurological disorders
- •Past 6 months of alcohol/substance use disorder
- •Unstable medical illness
- •Serious safety concerns of suicide or homicide
- •Pregnant or nursing
- •Overnight shift work
- •> 4 caffeinated or > 11 alcoholic beverages per week
- •Screening reveals OSA defined as an apnea hypopnea index with 4% desaturation (AHI4%) ≥15 or an AHI4% ≥ with an Epworth >10
研究组 & 干预措施
Complicated Grief Treatment (CGT)
10 adults with CG who successfully completed Aim 1 and will also participate in open complicated grief treatment (CGT), during which they will complete additional subjective and objective sleep assessments.
干预措施: Complicated Grief Therapy (CGT) (Behavioral)
结局指标
主要结局
Clinical Global Impression Scales
时间窗: 16 Weeks
Measure of Clinical Improvement and Severity of illness on a scale of 1-7; 1 being "Very Much Improved"; 7 being Very Much Worse
次要结局
未报告次要终点