Overview

This trial is active, not recruiting.

Condition depressive symptoms
Treatments rejoice, control
Sponsor University of Arkansas
Start date May 2016
End date April 2020
Trial size 360 participants
Trial identifier NCT02860741, 205181

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking single blind (outcomes assessor)
Primary purpose health services research
Arm
(Experimental)
Churches in the REJOICE intervention arm will provide the REJOICE intervention over an 8 week period
rejoice
Small groups led by lay leaders undergo an 8-session faith-based behavioral activation protocol that provides individuals with education about: identifying depressive symptoms, identifying pleasurable activities, scheduling pleasurable activities, and identifying and addressing avoidant behaviors that act as barriers to completing pleasurable activities
(Other)
Churches in the control arm will receive an educational materials about both identifying depressive symptoms and managing depressive symptoms. This is consistent with self-management interventions commonly utilized for individuals experiencing subclinical levels of depressive symptoms.
control Usual Care
Churches in the control arm will receive an educational materials about identifying depressive symptoms and self-management options for addressing depressive symptoms.

Primary Outcomes

Measure
Depressive Symptoms - Beck Depression Inventory (BDI-II)
time frame: Immediately upon completion of 8 week intervention

Eligibility Criteria

Male or female participants at least 21 years old.

Inclusion Criteria: - African American - Aged 21 and older - Mild to moderate levels of depressive symptoms (scores of 11-20 on the Beck Depression Inventory-II (BDI-II) - 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)

Additional Information

Official title Reducing Depressive Symptoms Among Rural African Americans
Principal investigator Tiffany F Haynes, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Arkansas.