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Evaluating a Behavioral Activities Treatment Program for Depressed Nursing Home Residents (BE-ACTIV)

2017年4月11日 更新者:Suzanne Meeks、University of Louisville

BE-ACTIV: Treating Depression in Nursing Homes

This study will evaluate whether a behavioral activities treatment program improves symptoms of depression in nursing home residents.

研究概览

详细说明

Depression is a common mental disorder that affects nearly half of all older people living in nursing homes. Depression can severely impact people's lives, causing them to often feel sad and hopeless, as well as affect people's sleep patterns, concentration, and energy levels. In addition, nursing homes are often understaffed and very busy, making it difficult for older people with depression to receive a proper diagnosis and adequate treatment. Recent studies have shown that an increase in pleasurable activities among residents in nursing homes can improve symptoms of depression. The purpose of this study is to determine whether symptoms of depression can be reduced by increasing opportunities for nursing home residents to engage in pleasant events and build better relationships with nursing home staff members.

Participating nursing homes will be randomly assigned to have their residents receive behavioral activity treatment (BE-ACTIV) or treatment as usual for 12 weeks. Potential participating nursing home residents will complete two brief tests regarding memory, attention, and symptoms of depression. An hour-long interview will then be conducted during which eligible participating residents will discuss their symptoms of depression, rate their health and level of functioning, and assess the quality of their relationship with a staff member. Residents receiving BE-ACTIV will meet with a therapist for weekly 30-minute sessions for 10 weeks. During these sessions, residents will discuss their activity participation and any pleasant events that they recently experienced. Therapists and nursing home activities staff will work together to incorporate more activities of interest into each resident's schedule. Residents of nursing homes assigned to receive treatment as usual will be asked to rate their mood once a week for 10 weeks. Researchers will observe each resident, regardless of treatment group, for 5-minute intervals at various times during the study to assess mood and activity levels. All participating residents will undergo a second interview after 10 weeks to discuss any changes or improvements in mood, symptoms of depression, activity level, or their relationship with staff members. All participating residents will be assessed after 3 months and again after 6 months post-treatment to determine whether the BE-ACTIV program was successful in improving symptoms of depression.

研究类型

介入性

注册 (实际的)

20

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Kentucky
      • Louisville、Kentucky、美国、40292
        • University of Louisville

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Nursing home residents in long-term care beds with an expected stay of 3 months or more
  • Geriatric Depression Scale score of at least 11
  • Meets DSM-IV criteria for major depressive disorder or research diagnostic criteria for minor depressive disorder

Exclusion Criteria:

  • Mini Mental State Exam score below 14
  • Referred to hospice care for a terminal condition
  • Current unstable or terminal medical condition
  • Suicidal
  • Meets DSM-IV criteria for bipolar disorder

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:A
Participants will receive the BE-ACTIV treatment
BE-ACTIV is 10-week behavioral treatment involving increasing pleasant events.
有源比较器:B
Participants will receive treatment as usual
TAU includes usual treatment in nursing care facility.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Depression diagnosis and depressive symptoms as assessed by the Geriatric Depression Scale
大体时间:Measured at Weeks 12, 24, and 48
Measured at Weeks 12, 24, and 48
Functioning as assessed by the Dartmouth COOP Scales for Social Functioning
大体时间:Measured at Weeks 12, 24, and 48
Measured at Weeks 12, 24, and 48

次要结果测量

结果测量
大体时间
Staff attention
大体时间:Measured at Weeks 12, 24, and 48
Measured at Weeks 12, 24, and 48
Positive affect
大体时间:Measured at Weeks 12, 24, and 48
Measured at Weeks 12, 24, and 48
Activity participation
大体时间:Measured at Weeks 12, 24, and 48
Measured at Weeks 12, 24, and 48
Behavior problems
大体时间:Measured at Weeks 12, 24, and 48
Measured at Weeks 12, 24, and 48
Resident satisfaction
大体时间:Measured at Weeks 12, 24, and 48
Measured at Weeks 12, 24, and 48

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Suzanne Meeks, PhD、University of Louisville

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2007年8月1日

初级完成 (实际的)

2013年7月1日

研究完成 (实际的)

2013年11月1日

研究注册日期

首次提交

2007年9月25日

首先提交符合 QC 标准的

2007年9月25日

首次发布 (估计)

2007年9月27日

研究记录更新

最后更新发布 (实际的)

2017年4月13日

上次提交的符合 QC 标准的更新

2017年4月11日

最后验证

2017年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • R01MH074865 (美国 NIH 拨款/合同)
  • DATR A4-GPS

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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