Clinical trial NCT02860741: Reducing Depressive Symptoms Among Rural African Americans
Official title: Reducing Depressive Symptoms Among Rural African Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Keywords: Sub-Clinical Depression
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2016-08-09
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

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

Primary outcomes:
measure: Depressive Symptoms - Beck Depression Inventory (BDI-II)
timeFrame: Immediately upon completion of 8 week intervention
Secondary outcomes:
Other outcomes:
Locations:
city: England
country: United States
facility: Second Baptist Church of England
state: Arkansas
city: Helena
country: United States
facility: King Solomon
state: Arkansas
city: Little Rock
country: United States
facility: Greater Christ Temple
state: Arkansas
city: Little Rock
country: United States
facility: Evangelist Temple COGIC
state: Arkansas
Study officials:
affiliation: Assistant Professor
name: Tiffany F Haynes, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor
name: Karen Yeary, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: cnhart@uams.edu
name: Camille Hart, MPH
role: STUDY_DIRECTOR
References:
citation: Haynes T, Turner J, Smith J, Curran G, Bryant-Moore K, Ounpraseuth ST, Kramer T, Harris K, Hutchins E, Yeary KHK. Reducing depressive symptoms through behavioral activation in churches: A Hybrid-2 randomized effectiveness-implementation design. Contemp Clin Trials. 2018 Jan;64:22-29. doi: 10.1016/j.cct.2017.11.010. Epub 2017 Nov 21.