跳至主要内容
临床试验/NCT00133263
NCT00133263已完成3 期

Effectiveness of "Primary Bereavement Care" (PBC) in Widows: A Cluster Randomized Controlled Trial

Carlos III Health Institute1 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2001年1月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
87
试验地点
1
主要终点
Texas Revised Inventory of Grief (TRIG)

研究概览

简要总结

The purpose of this study is to evaluate the efficacy of "Primary Bereavement Care" (PBC) -a standardized bereavement intervention- delivered by family physicians (FP), in widows.

详细描述

Nowadays there is little evidence about what is the best bereavement intervention in primary care and each family physician (FP) assists bereaved people in a different way. The death of a loved one is the most stressful life event that can face a person; in fact, bereavement is associated with an increased risk of depression, generalized anxiety and panic disorder, alcohol abuse and use of medications, sudden cardiac events, suicide, and an increased demand for health resources. The FP is the only specialist who -through his position in the health system and in the community- can give emotional support to the bereaved and simultaneously deal with the health problems associated with the process. In response to this, our work group has designed a guide specifically for FP: Primary Bereavement Care (PBC), and is currently testing its efficacy in a randomized controlled study.

Comparison (s): Recently widows attended by FP trained in PBC through seven PBC sessions, compared to recently widows attended by FP not trained in PBC through seven "ordinary" sessions.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
— 至 70 Years(Child, Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Partner death during the last 3 months.

排除标准

  • •Partner death through suicide or AIDS.
  • •Son or daughter death during the last 3 years.
  • •Parent or sibling death the year before.
  • •Alcohol or drug abuse.
  • •Psychotic disorder or dementia.
  • •To be confined to bed
  • •Illiteracy.

研究组 & 干预措施

1

Experimental

干预措施: Primary Bereavement Care (Behavioral)

2

Active Comparator

干预措施: the current bereavement care in primary care (Behavioral)

结局指标

主要结局

Texas Revised Inventory of Grief (TRIG)

时间窗: at 3, 9, 15 and 21 months since death

次要结局

  • General Health Questionnaire - 28 items (GHQ-28)(at 3, 9, 15 and 21 months since death)
  • Grief Experience Inventory (GEI)(at 3, 9, 15 and 21 months since death)
  • SF-36 Health Profile (SF-36)(at 3, 9, 15 and 21 months since death)

研究者

申办方类型
Other Gov

研究点 (1)

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