Treating Depression in African American Elders: A Community-Academic Partnership
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:
- 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.
- 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.
- 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
- 否
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
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
Laura N. Gitlin
Director, Center for Innovative Care in Aging
Johns Hopkins University
