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临床试验/NCT00598884
NCT00598884已完成1 期

Internet-Based Self-Management Intervention for Prolonged Grief

Boston University2 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2009年8月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
135
试验地点
2
主要终点
Prolonged grief symptoms and other comorbid mental health difficulties

研究概览

简要总结

This study will evaluate the effectiveness of an Internet-based self-help program in treating people who are at risk for developing prolonged grief disorder following a recent loss.

详细描述

Prolonged grief disorder (PGD) is a severe psychiatric condition that occurs in about 10% of people who experience a recent loss. PGD does not just go away with time and is associated with considerable functional impairment, physical and mental health problems, lost productivity, lack of interest in previously enjoyed activities, suicide, and depression. Because the majority of people with PGD are elderly and less capable of pursuing outside care, making readily available treatments for PGD is very important. Current treatments for PGD include psychotherapy and antidepressant medications, but there is very little solid research on the effectiveness of these treatments. Previous studies have shown that Internet-based mental health treatments are an effective and cost-efficient way to provide self-help to people who otherwise would not seek care. Using strategies from the psychotherapy known as cognitive behavioral therapy (CBT), this study will evaluate the effectiveness of an Internet-based self-help program in treating people who are at risk for developing prolonged grief disorder following a recent loss.

This is a randomized, wait-list control design. Participants will be randomized to immediately begin the intervention or to wait for 6-weeks before beginning. The intervention will ask participants to log-on to the study's self-help website three times per week for the 6 weeks of treatment. During these sessions, participants will be offered optional information about grief and coping with grief and will be required to complete computer exercises that involve identifying self-care needs, support systems, and short- and long-term goals. Participants will also be asked to perform off-line activities that are designed to increase self-care and social activities and that may take anywhere from a few minutes to 30 minutes per day. For all participants, there will be four assessments, after randomization, before beginning treatment (these 2 are the same for the immediate group), upon completion of the intervention, at 6 weeks post-intervention, at 3 months post-intervention (for immediate group). Assessments will include questions about mental and physical health adjustment, beliefs about the loss, and coping status.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • 未提供

排除标准

  • Lifetime history of bipolar disorder, schizophrenia, psychosis, or delusional disorders
  • History of substance or alcohol dependence other than nicotine in the year prior to study entry
  • Significant suicidal ideation
  • Concurrent psychotherapy initiated within 3 months prior to study entry, or ongoing psychotherapy specifically targeting loss; general supportive therapy initiated more than 3 months prior to study entry is acceptable

结局指标

主要结局

Prolonged grief symptoms and other comorbid mental health difficulties

时间窗: Measured at Weeks pre-, post-, 6-week, 3-month

次要结局

  • Social functioning and coping styles(Measured at pre-, post-, 6-week, 3-month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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