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临床试验/NCT00438724
NCT00438724Unknown不适用

A Randomized Control Trial of an Intervention for Couples Coping With Alzheimer's Disease

Alzheimer's Association1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2004年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Changes in dyadic (couple) adjustment

研究概览

简要总结

The purpose of this study is to test the efficacy of a new couples counseling intervention for people recently diagnosed with early Alzheimer's disease and their spouses. The study hypothesis is that counseling the couple shortly after the diagnosis, and while the functional impact of the illness is still relatively mild, will have a significant impact on their ability to provide support for each other.

详细描述

The majority of people with Alzheimer's disease (AD) live at home with their spouses. AD erodes the ability of each member of the couple to support each other. Moreover, couples may be unaccustomed to seeking or accepting emotional and practical support from family members or formal resources. Even though AD can have a major negative impact on each member of the couple and on their relationship, their needs have generally been addressed separately, often without sufficient appreciation for the importance of their ongoing relationship. Previous studies suggest that by improving support for both members of the couple, the intervention will have a positive effect on mental health outcomes such as depression and help keep the person with AD at home rather than in a long-term care facility.

One hundred couples will be randomly assigned either to an immediate treatment group or a wait-list control group which will receive treatment four months after enrollment. Participants will receive a formal baseline assessment, consisting of a structured set of questionnaires to assess dyadic (couple) adjustment, social support, depression and anxiety as well as goals for counseling. There will be two follow-up assessments, 2 and 4 months after baseline using the same instruments. All participants will be able to call a counselor for the duration of the study to obtain resource and referral information or in the event of a crisis. The treatment will consist of 6 sessions of couples counseling within a 2-month period. The focus will be on helping each member of the couple to express feelings, needs and issues that have emerged between them as a result of the diagnosis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
21 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Couples, in which one partner has been diagnosed with AD and is in the mild stage of the disease
  • Ages 21 to 90

排除标准

  • Severe psychological or physical illness
  • Unwillingness to participate in all aspects of the study

结局指标

主要结局

Changes in dyadic (couple) adjustment

depression

次要结局

  • Level of anxiety
  • satisfaction with social support

研究者

申办方类型
Other

研究点 (1)

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