跳至主要内容
临床试验/NCT02860741
NCT02860741已完成不适用

Reducing Depressive Symptoms Among Rural African Americans

University of Arkansas8 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
184
试验地点
8
主要终点
Depressive Symptoms - Beck Depression Inventory (BDI-II)

研究概览

简要总结

Rural African Americans are disproportionately impacted by social stressors that place them at risk for experiencing elevated depressive symptoms. This project will test the effectiveness of a culturally adapted behavioral activation intervention (REJOICE) for use within rural African American churches. Further, this project will gather data on strategies necessary to promote the successful implementation of this intervention within rural African American churches.

详细描述

Rural African Americans are disproportionately exposed to numerous stressors such as poverty, racism, and discrimination that place them at risk for experiencing elevated levels of depressive symptoms. Elevated levels of depressive symptoms can lead to a host of negative outcomes including both the development of and poor management of chronic illnesses (i.e. hypertension, diabetes, etc.), poor social functioning, poor occupational functioning, and development of clinical depression. Though effective treatments for decreasing depressive symptoms exist, rural African Americans often fail to receive adequate and timely care.

African American churches have been identified as potential venues for providing depression education and treatment for rural African Americans. Within the African American rural community, churches represent a key portal through which a large proportion (as much as 85%) of the African American community can be reached. Churches have been used to address physical health outcomes in those communities but few have focused primarily on addressing mental health outcomes.

Through the NIMHD funded project entitled, "Faith Academic Initiatives to Transform Health (FAITH) in the Delta", our partnership, consisting of faith community leaders and UAMS researchers, culturally adapted an evidence-based behavioral activation intervention for use with rural African American churches. This 8-session behavioral activation therapy was adapted to include faith-based themes, Scripture, and other aspects of the rural African American faith culture (e.g. bible studies, use of lay leaders to deliver the intervention). In addition to assessing the effectiveness of our intervention, ascertaining ways to implement this intervention with proper fidelity to maintain clinical outcomes is also critically important to increase the efficiency of translating research into practice. Work towards disseminating evidence-based depression interventions to "real world" settings is particularly salient in addressing depression disparities, whereby rural African Americans bear a disproportionate burden. Thus, this application proposes a Hybrid-2 pragmatic-effectiveness implementation trial that seeks to test the effectiveness of the culturally adapted evidence-based intervention and gather preliminary data on the strategies necessary to support successful implementation of this intervention in rural African American churches.

Specifically, this study aims to: 1) Refine a culturally appropriate, evidence-based depression intervention (REJOICE) based on results from our NIMHD-funded pilot study, 2) Determine whether REJOICE is superior to a usual-care control group at post treatment and a 3-month follow-up, 3) Collect pilot data regarding "real world" implementation strategies (i.e. face to face training and coaching calls) on the uptake and maintenance of REJOICE in rural African American churches.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • African American
  • Aged 18 and older
  • Associated with a participating church through membership or participation in a church activity
  • Free of medical problems that might contraindicate participation in a BA intervention (i.e. active intoxication (scores of 3 or more on the AUDIT-C), cognitive decline (score of 4 or more on the Brief Cognitive Screener51).

排除标准

  • Individuals who are experiencing severe levels of depressive symptoms (scores of 21 or higher on BDI-II)

结局指标

主要结局

Depressive Symptoms - Beck Depression Inventory (BDI-II)

时间窗: Immediately upon completion of 8 week intervention

The primary outcome of interest is evaluating differences in BDI-II scores among those individuals in the REJOICE cohort compared to those randomized into the control group during the T1 phase.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

Loading locations...

相似试验