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临床试验/NCT00511680
NCT00511680已完成3 期

Treating Depression in African American Elders: A Community-Academic Partnership

Thomas Jefferson University2 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2008年9月最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
192
试验地点
2
主要终点
Depression

研究概览

简要总结

The specific primary aims of the study are to:

  1. Test the immediate effect of the intervention at 4-months on depression in urban African American older adults (primary trial outcome; between group comparison). Hypothesis: Participants in the intervention group will report fewer depressive symptoms in comparison to control group participants receiving usual care.
  2. Test the maintenance effect of the intervention at 8-months on depression (within group comparison). Hypothesis: Participants in the intervention group will maintain reduced symptom presentation from 4 to 8 months.
  3. Evaluate acceptability (social validity) of the intervention and extent of engagement in activities by study participants (both intervention and wait-list control subjects).

A secondary aim of this study is to assess the feasibility of conducting a clinical trial embedded in a community service setting and its dissemination using a community-academic partnership. We also propose three exploratory aims. First, we seek to evaluate the mechanisms of action, or pathways, by which treatment gains are obtained (Gitlin et al., 2000). Given that behavioral activation represents conceptually the key active ingredient of the proposed intervention, we plan to evaluate its mediational effect. Second, we seek to evaluate whether the intervention has a differential treatment effect based on a study participant's gender, age, and living arrangement (alone or with others). Given that previous research suggests that participant characteristics may moderate depressive symptoms and treatment outcomes, these exploratory analyses will provide insight as to whether this particular treatment benefits some groups more than others. Third, we seek to evaluate whether the intervention has short and long-term effects on quality of life, functional difficulty, and self-efficacy to manage day-to-day tasks. Previous research has shown that depressive symptoms exacerbate functional decline such that minimizing distress may have the added value of enhancing function and perceived efficacy for this group over time.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
盲法
Single (Investigator)

入排标准

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

入选标准

  • African American
  • ≥55 years of age
  • English speaking
  • Cognitively intact (MMSE >24)
  • Depressed as measured by a score ≥5 on the PHQ-9
  • Must have a telephone
  • Planning to live in the area for 8 months

排除标准

  • Not African American
  • <55 years of age
  • Does not speak English
  • Not depressed as measures by a score of <5 on the PHQ-9
  • Does not have a telephone
  • Does not plan to live in the area for 8 months

研究组 & 干预措施

Behavioral based In-home Intervention

Experimental

This group will recieve up to 10 1-hour sessions over a 4 month period.

干预措施: Behavioral Based In-Home Intervention (Behavioral)

结局指标

主要结局

Depression

时间窗: Baseline, t2, t3

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Laura N. Gitlin

Director, Center for Innovative Care in Aging

Johns Hopkins University

研究点 (2)

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