Reducing Depressive Symptoms Among Rural African Americans (REJOICE)
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|ClinicalTrials.gov Identifier: NCT02860741|
Recruitment Status : Recruiting
First Posted : August 9, 2016
Last Update Posted : July 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|Depressive Symptoms||Behavioral: REJOICE Other: Control||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||360 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Reducing Depressive Symptoms Among Rural African Americans|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2021|
Churches in the REJOICE intervention arm will provide the REJOICE intervention over an 8 week period
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
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.
Churches in the control arm will receive an educational materials about identifying depressive symptoms and self-management options for addressing depressive symptoms.
Other Name: Usual Care
- Depressive Symptoms - Beck Depression Inventory (BDI-II) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860741
|Contact: Ellen M Hutchins, MPHfirstname.lastname@example.org|
|Contact: Tiffany F Haynes, PhD||501-526-6613||TFHaynes@uams.edu|
|United States, Arkansas|
|Helena, Arkansas, United States, 72342|
|Greater Christ Temple||Active, not recruiting|
|Little Rock, Arkansas, United States, 72204|
|Evangelist Temple COGIC||Active, not recruiting|
|Little Rock, Arkansas, United States, 72209|
|McGehee, Arkansas, United States|
|Principal Investigator:||Tiffany F Haynes, PhD||Assistant Professor|
|Principal Investigator:||Karen Yeary, PhD||Associate Professor|