Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02860741 |
| Other study ID # |
205181 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 2016 |
| Est. completion date |
December 2023 |
Study information
| Verified date |
January 2024 |
| Source |
University of Arkansas |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
